title: REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

acronym: REPRISE III

summary: The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

ReferenceCitation: Goel K, O'Leary JM, Barker CM, Levack M, Rajagopal V, Makkar RR, Bajwa T, Kleiman N, Linke A, Kereiakes DJ, Waksman R, Allocco DJ, Rizik DG, Reardon MJ, Lindman BR. Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep;9(17):e017075. doi: 10.1161/JAHA.120.017075. Epub 2020 Aug 28.

name: Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN

name: Cardiovascular Medicine Division Vanderbilt University Medical Center Nashville TN

family: Goel

full_name: Kashish Goel

given: Kashish

family: O’Leary

full_name: Jared M. O’Leary

given: Jared M.

family: Barker

full_name: Colin M. Barker

given: Colin M.

name: Cardiac Surgery Department Vanderbilt University Medical Center Nashville TN

family: Levack

full_name: Melissa Levack

given: Melissa

name: Marcus Heart Valve Center Piedmont Heart Institute Atlanta GA

family: Rajagopal

full_name: Vivek Rajagopal

given: Vivek

name: Smidt Heart Institute, Cedars ‐ Sinai Heart Institute Los Angeles CA

family: Makkar

full_name: Raj R. Makkar

given: Raj R.

name: Aurora Cardiovascular Services Aurora Sinai/Aurora St. Luke’s Medical Centers Milwaukee WI

family: Bajwa

full_name: Tanvir Bajwa

given: Tanvir

name: Department of Cardiovascular Surgery Houston Methodist DeBakey Heart and Vascular Center Houston TX

family: Kleiman

full_name: Neal Kleiman

given: Neal

name: Department of Internal Medicine and Cardiology Heart Center Dresden Technical University of Dresden Germany

family: Linke

full_name: Axel Linke

given: Axel

name: The Christ Hospital Heart and Vascular Center Lindner Research Center Cincinnati OH

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

name: Section of Interventional Cardiology MedStar Washington Hospital Center Washington DC

family: Waksman

full_name: Ron Waksman

given: Ron

name: Clinical Sciences Boston Scientific Corp Marlborough MA

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

name: HonorHealth and the Scottsdale‐Lincoln Health Network Scottsdale AZ

family: Rizik

full_name: David G. Rizik

given: David G.

family: Reardon

full_name: Michael J. Reardon

given: Michael J.

family: Lindman

full_name: Brian R. Lindman

given: Brian R.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Schindler J, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. J Am Heart Assoc. 2019 Nov 5;8(21):e012594. doi: 10.1161/JAHA.119.012594. Epub 2019 Oct 23.

family: Meduri

full_name: Christopher U. Meduri

given: Christopher U.

name: The Christ Hospital Heart and Vascular Center The Lindner Research Center Cincinnati OH

name: Cedars—Sinai Heart Institute Los Angeles CA

name: Aurora St. Luke's Medical Center Milwaukee WI

name: Dresden University Hospital, Heart Center Dresden Germany

name: Washington Hospital Center Washington DC

name: Emory University Hospital Emory University Atlanta GA

name: Baylor Heart & Vascular Hospital Dallas TX

name: University at Buffalo/Gates Vascular Institute Buffalo NY

name: University of Pittsburgh Medical Center Pittsburgh PA

name: Northshore University Health System Evanston Hospital Evanston Illinois

ReferenceCitation: Reardon MJ, Feldman TE, Meduri CU, Makkar RR, O'Hair D, Linke A, Kereiakes DJ, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchétché D, Rovin JD, Lhermusier T, Carrié D, Hodson RW, Allocco DJ, Meredith IT; Reprise III Investigators. Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.

name: Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas

name: Evanston Hospital Cardiology Division, Northshore University Health System, Evanston, Illinois

name: Piedmont Heart Institute, Atlanta, Georgia

name: Cedars-Sinai Heart Institute, Los Angeles, California

name: Aurora St Luke's Medical Center, Milwaukee, Wisconsin

name: Heart Center Dresde, Dresden University Hospital, Dresden, Germany

name: The Lindner Research Center, The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio

name: Washington Hospital Center, Washington, DC

name: Emory University, Emory University Hospital, Atlanta, Georgia

name: Baylor Heart & Vascular Hospital, Dallas, Texas

name: St John's Hospital, Springfield, Illinois

name: HonorHealth, Scottsdale-Lincoln Health Network, Scottsdale, Arizona

name: Gates Vascular Institute, University at Buffalo, Buffalo, New York

name: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: Department of Internal Medicine/Cardiology, Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany

name: Morton Plant Mease Healthcare System, Clearwater, Florida

name: Providence St Vincent Medical Center, Portland, Oregon

name: Boston Scientific Corp, Marlborough, Massachusetts

ReferenceCitation: Asch FM, Vannan MA, Singh S, Khandheria B, Little SH, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ, Weissman NJ. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. 2018 Jun 12;137(24):2557-2567. doi: 10.1161/CIRCULATIONAHA.118.034129. Epub 2018 Mar 12.

name: MedStar Health Research Institute, Washington, DC (F.M.A., N.J.W.).

name: Piedmont Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, GA (M.A.V.)

name: Cedars-Sinai Medical Center, Los Angeles, CA (S.S.).

name: Aurora St. Luke’s Medical Center, Milwaukee, WI (B.K.).

name: Houston Methodist DeBakey Heart and Vascular Center, TX (S.H.L., M.J.R.).

name: Boston Scientific Corporation, Marlborough, MA (D.J.A., I.T.M.).

name: Evanston Hospital Cardiology Division, Northshore University Health System, IL (T.E.F.).

ReferenceCitation: Feldman TE, Reardon MJ, Rajagopal V, Makkar RR, Bajwa TK, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchétché D, Rovin JD, Buchbinder M, Meredith IT, Götberg M, Bjursten H, Meduri C, Salinger MH, Allocco DJ, Dawkins KD. Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial. JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.

name: Aurora St Luke’s Medical Center, Milwaukee, Wisconsin

name: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas

name: University of Leipzig, Heart Center and Leipzig Heart Institute, Leipzig, Germany

name: Christ Hospital Heart and Vascular Center/Lindner Research Center, Cincinnati, Ohio

name: Baylor Heart and Vascular Hospital, Dallas, Texas

name: St John’s Hospital, Springfield, Illinois

name: HonorHealth and the Scottsdale-Lincoln Health Network, Scottsdale, Arizona

name: University at Buffalo/Gates Vascular Institute, Buffalo, New York

name: Foundation for Cardiovascular Medicine, Stanford University, Stanford, California

name: Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden

name: Department of Cardiothoracic Surgery, Clinical Sciences, Lund University, Skåne University University Hospital, Lund, Sweden

location_country:
United States
Netherlands
Germany
France
Australia
Canada

location_facility: Hospital of the University of Pennsylvania

location_facility: Abbott Northwestern Hospital - Minneapolis Heart Institute

location_facility: Ohio Health Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Wake Forest University School of Medicine

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: McGill University Health Centre, Royal Victoria Hospital

location_facility: NC Heart and Vascular Research - Rex Hospital

location_facility: Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital

location_facility: St. John's Hospital - Prairie Cardiovascular Consultants

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Washington University School of Medicine - Barnes Jewish Medical Center

location_facility: Veteran's Administration Palo Alto Medical Center

location_facility: Erasmus MC - University Medical Center Rotterdam

location_facility: University of California at Davis Medical Center


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Alios Biopharma Inc.

enrollment_type: Actual

primary_purpose: Treatment

location_country:
United States
Chile
South Africa
France
Japan
Panama
Thailand
Romania
Australia
New Zealand
Canada
United Kingdom
Taiwan
Colombia

location_facility: Institute for Mother and Child Care "Alfred Rusescu"

location_facility: Canadian Centre for Vaccinology IWK Health Centre

location_facility: Fundacion Cardio Infantil Instituto de Cardiologia

location_facility: Siriraj Hospital, Mahidol University Department of Pediatrics

location_facility: National Center for Child Health and Development

location_facility: Chulalongkorn University Department of Pediatrics

location_facility: Khon Kaen University Department of Pediatrics

location_facility: The Children's Hospital Research Institute of Manitoba

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital

location_facility: Children's Hospital/University of Tennessee

location_facility: Phramongkutklao Hospital Department of Pediatrics

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Texas Children's Hospital/Baylor College of Medicine

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Hospital Materno Infantil Jose Dominog de Obaldila

location_facility: Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach

location_facility: Arkansas Children's Hospital Research Institute

location_facility: The University of California at San Diego

location_facility: NHO Shikoku Medical Center for Children and Adults

location_facility: The University of North Carolina at Chapel Hill

location_facility: The Research Institute at Nationwide Children's Hospital

location_facility: Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

summary: This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

summary: This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.

ReferenceType: derived

ReferenceCitation: Narita I, Ohashi T, Sakai N, Hamazaki T, Skuban N, Castelli JP, Lagast H, Barth JA. Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study. Clin Exp Nephrol. 2020 Feb;24(2):157-166. doi: 10.1007/s10157-019-01810-w. Epub 2019 Dec 30.

family: Narita

full_name: Ichiei Narita

given: Ichiei

sequence: first

family: Ohashi

full_name: Toya Ohashi

given: Toya

sequence: additional

family: Sakai

full_name: Norio Sakai

given: Norio

family: Hamazaki

full_name: Takashi Hamazaki

given: Takashi

family: Skuban

full_name: Nina Skuban

given: Nina

family: Castelli

full_name: Jeffrey P. Castelli

given: Jeffrey P.

family: Lagast

full_name: Hjalmar Lagast

given: Hjalmar

family: Barth

full_name: Jay A. Barth

given: Jay A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical and Experimental Nephrology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Amicus Therapeutics

location_country:
Italy
Austria
Brazil
Spain
France
Japan
Argentina
Australia
Belgium
Egypt
Turkey
Denmark
United States
United Kingdom
Canada


title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-Polio Syndrome

acronym: FORCE

summary:
This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in subjects with post-polio syndrome (PPS).

The main purpose of this study is to select a dose of Flebogamma 5% DIF and confirm the efficacy of the selected Flebogamma® 5% DIF dose by assessing physical performance, as measured by Two-Minute Walk Distance (2MWD) test.

The study will consist of 2 stages, with each stage consisting of a screening period (up to 4 weeks), a treatment period (52 weeks), and a follow-up period (24 weeks).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Instituto Grifols, S.A.

location_country:
Italy
Sweden
Netherlands
Germany
France
Czechia
Poland
Romania
Hungary
Spain
Denmark
United States
Canada

location_facility: Országos Orvosi Rehabilitációs Intézet/ Vegyes Profilú Mozgásszervi Rehabilitációs Osztály

location_facility: Klinik für konservative Orthopädie und des Poliozentrums

location_facility: University of Miami School of Medicine-Deparment of Neurology

location_facility: Montreal Neurological Institute Clinical Research Unit, McGill University

location_facility: Magyar Honvédség Egészségügyi központ,Neurológiai Osztály

location_facility: Aarhus Universitets Hospital-Neurologisk Forskning

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Academisch Medisch Centrum Amsterdam UMC, Locatie AMC

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Thomayerova nemocnice, Klinicko-farmakologická jednotka

location_facility: Danderyds Sjukhus AB Karolinska Universitetssjukhuset i Solna

status_simplified: Ongoing


title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)

summary: This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.

ReferenceCitation: Yarlas A, Lovley A, McCausland K, Brown D, Vera-Llonch M, Conceição I, Karam C, Khella S, Obici L, Waddington-Cruz M. Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR. Neurol Ther. 2021 Dec;10(2):865-886. doi: 10.1007/s40120-021-00268-x. Epub 2021 Aug 5.

family: Yarlas

full_name: Aaron Yarlas

given: Aaron

family: Lovley

full_name: Andrew Lovley

given: Andrew

family: McCausland

full_name: Kristen McCausland

given: Kristen

family: Brown

full_name: Duncan Brown

given: Duncan

family: Vera-Llonch

full_name: Montserrat Vera-Llonch

given: Montserrat

family: Conceição

full_name: Isabel Conceição

given: Isabel

family: Karam

full_name: Chafic Karam

given: Chafic

family: Khella

full_name: Sami Khella

given: Sami

family: Obici

full_name: Laura Obici

given: Laura

family: Waddington-Cruz

full_name: Márcia Waddington-Cruz

given: Márcia

journal_name: Neurology and Therapy

oa_host_type: publisher

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Brannagan TH, Wang AK, Coelho T, Waddington Cruz M, Polydefkis MJ, Dyck PJ, Plante-Bordeneuve V, Berk JL, Barroso F, Merlini G, Conceição I, Hughes SG, Kwoh J, Jung SW, Guthrie S, Pollock M, Benson MD, Gertz M; NEURO-TTR open-label extension investigators. Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial. Eur J Neurol. 2020 Aug;27(8):1374-1381. doi: 10.1111/ene.14285. Epub 2020 May 29.

name: Columbia University Medical Center New York NYUSA

family: Brannagan

full_name: T. H. Brannagan

given: T. H.

name: University of California, Irvine Orange CA USA

family: Wang

full_name: A. K. Wang

given: A. K.

name: Centro Hospitalar do Porto Porto Portugal

family: Coelho

full_name: T. Coelho

given: T.

name: CEPARM Amyloidosis Referral Center Federal University of Rio de Janeiro Rio de Janeiro Brazil

family: Waddington Cruz

full_name: M. Waddington Cruz

given: M.

name: Johns Hopkins University Baltimore MDUSA

family: Polydefkis

full_name: M. J. Polydefkis

given: M. J.

family: Dyck

full_name: P. J. Dyck

given: P. J.

family: Plante‐Bordeneuve

full_name: V. Plante‐Bordeneuve

given: V.

family: Berk

full_name: J. L. Berk

given: J. L.

family: Barroso

full_name: F. Barroso

given: F.

name: Amyloidosis Center IRCCS Policlinico San Matteo University of Pavia Pavia Italy

family: Merlini

name: CHULN, Hospital Santa Maria and Faculdade de MedicinaUniversidade de Lisboa Lisboa Portugal

name: Ionis Pharmaceuticals, Inc. Carlsbad CAUSA

name: Indiana University School of Medicine Indianapolis IN USA

name: for the NEURO‐TTR open‐label extension investigators

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

title: Early data on long‐term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2‐year update from the open‐label extension of the NEURO‐TTR trial

location_country:
Italy
Brazil
Spain
Germany
France
Argentina
Portugal
United States
United Kingdom

location_facility: Universita Degli Studi Di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino"

location_facility: Federal University of Rio de Janeiro - University Hospital

location_facility: CHU Henri Mondor - Department of Neurology

location_facility: UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin

location_facility: University College London - National Amyloidosis Centre

location_facility: CHP-HGSA, Unidade Clinica de Paramiloidose

location_facility: Columbia University Medical Center - The Neurological Institute

location_facility: Boston University School of Medicine - Amyloid Treatment & Research Program

location_facility: Johns Hopkins University Bayview Medical Center

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico San Matteo

location_facility: CHU Bicetre Aphp French Referral Center for FAP/Cornamyl Network


title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

study_type: Observational

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Italy
Austria
South Africa
Switzerland
Germany
France
Korea, Republic of
Greece
Poland
Hungary
Russian Federation
Spain
United States
United Kingdom
Canada

location_facility: Greenville Health System Institute for Translational Oncology Research

location_facility: Wake Forest Baptist Health Medical Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Providence Oncology and Hematology Care Eastside

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: University of Arkansas for Medical Sciences

location_facility: University of North Carolina Chapel Hill

location_facility: Yonsei University Health System Severance Hospital

location_facility: University of Utah Huntsman Cancer Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Allina Health System dba Virginia Piper Cancer Institute

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: The West Clinic PC dba West Cancer Center

location_facility: Investigative Clinical Research of Indiana, LLC

intervention_type: Other


ReferenceCitation: Rubin DT, Dotan I, DuVall A, Bouhnik Y, Radford-Smith G, Higgins PDR, Mishkin DS, Arrisi P, Scalori A, Oh YS, Tole S, Chai A, Chamberlain-James K, Lacey S, McBride J, Panés J; HIBISCUS Study Group. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials. Lancet Gastroenterol Hepatol. 2021 Nov 16. pii: S2468-1253(21)00338-1. doi: 10.1016/S2468-1253(21)00338-1. [Epub ahead of print]

family: Rubin

full_name: David T Rubin

given: David T

family: Dotan

full_name: Iris Dotan

given: Iris

family: DuVall

full_name: Aaron DuVall

given: Aaron

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Radford-Smith

full_name: Graham Radford-Smith

given: Graham

family: Higgins

full_name: Peter D R Higgins

given: Peter D R

family: Mishkin

full_name: Daniel S Mishkin

given: Daniel S

family: Arrisi

full_name: Pablo Arrisi

given: Pablo

family: Scalori

full_name: Astrid Scalori

given: Astrid

family: Oh

full_name: Young S Oh

given: Young S

family: Tole

full_name: Swati Tole

given: Swati

family: Chai

full_name: Akiko Chai

given: Akiko

family: Chamberlain-James

full_name: Kirsten Chamberlain-James

given: Kirsten

family: Lacey

full_name: Stuart Lacey

given: Stuart

family: McBride

full_name: Jacqueline McBride

given: Jacqueline

family: Panés

full_name: Julian Panés

given: Julian

family: Abdulkhakov

full_name: Rustem Abdulkhakov

given: Rustem

family: Abu Bakar

full_name: Norasiah Abu Bakar

given: Norasiah

family: Aguilar

full_name: Humberto Aguilar

given: Humberto

family: Aizenberg

full_name: Diego Aizenberg

given: Diego

family: Akpinar

full_name: Hale Akpinar

given: Hale

family: Akriviadis

full_name: Evangelos Akriviadis

given: Evangelos

family: Alexeeva

full_name: Olga Alexeeva

given: Olga

family: Alikhanov

full_name: Bagdadi Alikhanov

given: Bagdadi

family: Alvarisqueta

full_name: Andres Alvarisqueta

given: Andres

full_name: Carlos Fernando de Magalhães Francesconi

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

name: The Etrolizumab Global Steering Committee

title: Etrolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease: An Overview of the Phase 3 Clinical Program

location_country:
Brazil
Serbia
Hong Kong
Mexico
France
Bulgaria
Poland
Slovakia
Argentina
Australia
Russian Federation
Estonia
United States
Ukraine

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist

location_facility: General Hospital "Djordje Joanovic"; Gastroenterology

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Gastroenterology Associates of Central Georgia

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: Medical and Sanitary Division of Severstal

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

title: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

summary: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.


title: Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

summary: The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

status: Active, not recruiting

lead_sponsor: Coloplast A/S

location_country:
United States
Netherlands
France
Belgium
Australia
Canada

location_facility: Women's Pelvic Health and Continence Center

location_facility: Premier Medical Group of Hudson Valley, PC

location_facility: Center for Urogynecology and Pelvic Surgery, Christiana Care Health System

location_facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery

location_facility: Central Texas Urogynecology and Continence Center

location_facility: Centre for Advanced Reproductive Endosurgery

location_facility: MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery

location_facility: Female Pelvic Medicine & Urogynecology Institute of MI

location_facility: Wellspan Urogynecology and Pelvic Reconstructive Surgery

intervention_type: Device


title: A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

summary: The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
Chile
Switzerland
Mexico
Spain
Germany
France
Czechia
Japan
Hungary
Argentina
Australia
Belgium
Russian Federation
Turkey
United States
United Kingdom
Taiwan
Colombia


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

summary: The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.

status: Unknown status

ReferenceCitation: Ljubenkov PA, Edwards L, Iaccarino L, La Joie R, Rojas JC, Koestler M, Harris B, Boeve BF, Borroni B, van Swieten JC, Grossman M, Pasquier F, Frisoni GB, Mummery CJ, Vandenberghe R, Le Ber I, Hannequin D, McGinnis SM, Auriacombe S, Onofrj M, Goodman IJ, Riordan HJ, Wisniewski G, Hesterman J, Marek K, Haynes BA, Patzke H, Koenig G, Hilt D, Moebius H, Boxer AL. Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients With Progranulin Gene Haploinsufficiency: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2125584. doi: 10.1001/jamanetworkopen.2021.25584.

name: Memory and Aging Center, Department of Neurology, University of California at San Francisco, Weill Institute for Neurosciences, San Francisco

family: Ljubenkov

full_name: Peter A. Ljubenkov

given: Peter A.

family: Edwards

full_name: Lauren Edwards

given: Lauren

family: Iaccarino

full_name: Leonardo Iaccarino

given: Leonardo

family: La Joie

full_name: Renaud La Joie

given: Renaud

family: Rojas

full_name: Julio C. Rojas

given: Julio C.

family: Koestler

full_name: Mary Koestler

given: Mary

name: ROME Therapeutics, Cambridge, Massachusetts

name: Metera Pharmaceuticals, Cambridge, Massachusetts

family: Harris

full_name: Baruch Harris

given: Baruch

family: Boeve

full_name: Bradley F. Boeve

given: Bradley F.

name: Neurology Unit, Centre for Neurodegenerative Disorders, ASST Spedali Civili Brescia, Italy

name: Department of Clinical and Experimental Sciences, University of Brescia, Italy

family: Borroni

full_name: Barbara Borroni

given: Barbara

name: Department of Neurology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: van Swieten

full_name: John C. van Swieten

given: John C.

name: Perelman School of Medicine, University of Pennsylvania, Philadelphia

family: Grossman

full_name: Murray Grossman

given: Murray

name: Lille University, Inserm 1172, CHU Lille, CNR-MAJ, DISTALZ, LiCEND, Lille, France

family: Pasquier

full_name: Florence Pasquier

given: Florence

name: Lab of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

family: Frisoni

full_name: Giovanni B. Frisoni

given: Giovanni B.

name: Dementia Research Centre, Institute of Neurology, University College London, London, United Kingdom

family: Mummery

full_name: Catherine J. Mummery

given: Catherine J.

name: Neurology Service University Hospitals Leuven, Leuven, Belgium

name: Laboratory for Cognitive Neurology, Department of Neurosciences, Leuven Brain Institute, Leuven, Belgium

family: Vandenberghe

full_name: Rik Vandenberghe

given: Rik

name: Paris Brain Institute, Sorbonne University, Paris, France

name: Neurology Department, Reference Centre for Rare or Early Dementias, Paris, France

family: Le Ber

full_name: Isabelle Le Ber

given: Isabelle

name: CHU Rouen Normandie, Service de Neurologie, Rouen University Hospital, Rouen, France

family: Hannequin

full_name: Didier Hannequin

given: Didier

name: Department of Neurology, Massachusetts General Hospital, Charlestown

family: McGinnis

full_name: Scott M. McGinnis

given: Scott M.

name: Neurology Department, CHU Bordeaux, Bordeaux Hospital, Bordeaux, France

family: Auriacombe

full_name: Sophie Auriacombe

given: Sophie

name: Department of Neuroscience Imaging, University G d'Annunzio of Chieti-Pescara, Chieti, Italy

family: Onofrj

full_name: Marco Onofrj

given: Marco

name: Compass Research, Bioclinica, Orlando, Florida

family: Goodman

full_name: Ira J. Goodman

given: Ira J.

name: Worldwide Clinical Trials, King of Prussia, Pennsylvania

family: Riordan

full_name: Henry J. Riordan

given: Henry J.

name: Invicro, A Konica Minolta Company, Boston, Massachusetts

family: Wisniewski

full_name: Gary Wisniewski

given: Gary

name: Institute for Neurodegenerative Disorders, New Haven, Connecticut

family: Hesterman

name: FORUM Pharmaceuticals Incorporated, Waltham, Massachusetts

name: Alector, South San Francisco, California

name: Voyager Therapeutics, Watertown, Massachusetts

name: Arkuda Therapeutics, Watertown, Massachusetts

name: Lysosomal Therapeutics, Cambridge, Massachusetts

name: Frequency Therapeutics, Farmington, Connecticut

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

location_country:
Italy
Netherlands
France
Belgium
United States
United Kingdom

location_facility: Neurological Clinic, University of Brescia, AO Civil Hospital of Brescia

location_facility: Fondazione Universita Gabriele D'Annunzio di Chieti

location_facility: IRCCS - Centro S. Giovanni di Dio FateBeneFratelli

location_facility: The National Hospital for Neurology and Neuroscience


title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)

acronym: DAWN

summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.

ReferenceCitation: Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12:CD010995. doi: 10.1002/14651858.CD010995.pub3. Review.

ReferenceCitation: Liebeskind DS, Saber H, Xiang B, Jadhav AP, Jovin TG, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG; DAWN Investigators. Collateral Circulation in Thrombectomy for Stroke After 6 to 24 Hours in the DAWN Trial. Stroke. 2021 Nov 3:STROKEAHA121034471. doi: 10.1161/STROKEAHA.121.034471. [Epub ahead of print]

name: Neurovascular Imaging Research Core, UCLA (D.S.L., H.S.).

family: Liebeskind

full_name: David S. Liebeskind

given: David S.

family: Saber

full_name: Hamidreza Saber

given: Hamidreza

name: Prospect Analytical, Inc, San Jose, CA (B.X.).

family: Xiang

full_name: Bin Xiang

given: Bin

name: Barrow Neurological Institute, Phoenix, AZ (A.P.J., T.G.J.).

family: Jadhav

full_name: Ashutosh P. Jadhav

given: Ashutosh P.

family: Jovin

full_name: Tudor G. Jovin

given: Tudor G.

name: Emory University School of Medicine/ Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.).

family: Haussen

full_name: Diogo C. Haussen

given: Diogo C.

name: OhioHealth Riverside Methodist Hospital, Columbus, OH (R.F.B.).

family: Budzik

full_name: Ronald F. Budzik

given: Ronald F.

name: Hôpital Gui-de-Chauliac, Montpellier, France (A.B.).

family: Bonafe

full_name: Alain Bonafe

given: Alain

name: Texas Stroke Institute, Dallas-Fort Worth (P.B.).

family: Bhuva

full_name: Parita Bhuva

given: Parita

name: University of Miami Miller School of Medicine–Jackson Memorial Hospital, Miami, FL (D.R.Y.).

family: Yavagal

full_name: Dileep R. Yavagal

given: Dileep R.

name: Baptist Jacksonville, Jacksonville, FL (R.A.H.).

family: Hanel

full_name: Ricardo A. Hanel

given: Ricardo A.

name: Hospital Vall d’Hebrón, Barcelona, Spain (M.R.).

family: Ribo

full_name: Marc Ribo

given: Marc

name: University Hospital of Toulouse, France (C.C.).

family: Cognard

full_name: Christophe Cognard

given: Christophe

name: University Hospital of Cleveland, OH (C.S.).

family: Sila

full_name: Cathy Sila

given: Cathy

name: University of Texas Rio Grande Valley–Valley Baptist Medical Center, Harlingen (A.E.H.).

family: Hassan

full_name: Ameer E. Hassan

given: Ameer E.

name: University of California, San Francisco, San Francisco (W.S.S.).

family: Smith

full_name: Wade S. Smith

given: Wade S.

family: Saver

full_name: Jeffrey L. Saver

given: Jeffrey L.

family: Nogueira

full_name: Raul G. Nogueira

given: Raul G.

journal_name: Stroke

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Liebeskind DS, Saber H, Bhuva P, Xiang B, Yoo AJ, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG, Jovin TG. Serial ASPECTS in the DAWN Trial: Infarct Evolution and Clinical Impact. Stroke. 2021 Oct;52(10):3318-3324. doi: 10.1161/STROKEAHA.120.033477. Epub 2021 Jul 20.

name: Neurovascular Imaging Research Core, UCLA, Los Angeles, CA (D.S.L., H.S.).

name: Texas Stroke Institute, Dallas-Fort Worth (P.B., A.J.Y.).

name: University of Pittsburgh Medical Center, PA (A.P.J., T.G.J.).

name: Emory University School of Medicine/Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.).

name: University of Miami Miller School of Medicine–Jackson Memorial Hospital, FL (D.R.Y.).

name: Hosp Vall d’Hebrón, Barcelona, Spain (M.R.).

name: University of Texas Rio Grande Valley - Valley Baptist Medical Center, Harlingen (A.E.H.).

name: University of California, San Francisco (W.S.S.).

ReferenceCitation: Tekle WG, Hassan AE, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila CA, Smith WS, Saver JL, Liebeskind DS, Shields R, Nogueira RG, Jovin TG; DAWN Trial Investigators. Impact of Periprocedural and Technical Factors and Patient Characteristics on Revascularization and Outcome in the DAWN Trial. Stroke. 2020 Jan;51(1):247-253. doi: 10.1161/STROKEAHA.119.026437. Epub 2019 Nov 20.

name: From the Valley Baptist Medical Center, Harlingen, TX (W.G.T., A.E.H.)

name: The Stroke Institute, Department of Neurology, University of Pittsburgh Medical Center, PA (A.P.J.)

name: Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France (A.B.)

name: Division of Neurointervention, Texas Stroke Institute, Dallas-Fort Worth (P.B.)

name: University of Miami Miller School of Medicine-Jackson Memorial Hospital, FL (D.R.Y.)

name: Lyerly Neurosurgery, Jacksonville, FL (R.A.H.)

name: Stroke Unit, Hospital Vall d’Hebron, Barcelona, Spain (M.R.)

name: Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, France (C.C.)

name: University Hospitals-Cleveland Medical Center, OH (C.A.S.)

name: Department of Neurology, University of California, San Francisco, (W.S.S.)

name: Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles (UCLA) (J.L.S., D.S.L.)

name: Stryker Neurovascular, Fremont, CA (R.S.)

name: Cooper University Hospital, Neurological Institute, Camden, NJ (T.G.J.).

name: on behalf of the DAWN Trial Investigators

ReferenceCitation: Aghaebrahim A, Jadhav AP, Hanel R, Sauvageau E, Granja MF, Zhang Y, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Ribo M, Cognard C, Sila C, Yavagal D, Hassan AE, Smith WS, Saver J, Liebeskind DS, Nogueira RG, Jovin TG; DAWN Investigators. Outcome in Direct Versus Transfer Patients in the DAWN Controlled Trial. Stroke. 2019 Aug;50(8):2163-2167. doi: 10.1161/STROKEAHA.119.025710. Epub 2019 Jul 15.

name: From the Baptist Neurological Institute, Lyerly Neurosurgery, Baptist Health, Jacksonville, FL (A.A., R.H., E.S., M.F.G.)

name: Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, Hermitage, PA (A.P.J.)

name: Stryker Neurovascular, San Francisco, CA (Y.Z.)

name: Department of Neurology, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, GA (R.G.N., D.C.H.)

name: Ohio Health Riverside Methodist Hospital, Columbus (R.F.B.)

name: Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier, France (A.B.)

name: Texas Stroke Institute, Dallas-Fort Worth, Plano (P.B.)

name: Department of Neurology, Hospital Vall d’Hebrón, Barcelona, Spain (M.R.)

name: Department of Diagnostic and Therapeutic Neuroradiology, Centre Hospitalier Universitaire de Toulouse, France (C.C.)

name: University Hospitals of Cleveland, OH (C.S.)

name: Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine–Jackson Memorial Hospital, FL (D.Y.)

name: Department of Neuroscience, Valley Baptist Medical Center, Harlingen, TX (A.E.H.)

name: Department of Neurology, University of California, San Francisco (W.S.S.)

name: David Geffen School of Medicine (J.S., D.S.L.), University of California, Los Angeles.

name: Neurovascular Imaging Research Core, Department of Neurology and Comprehensive Stroke Center (D.S.L.)

name: Cooper Neurological Institute, Cooper University Hospital, Camden, NJ (T.G.J)

ReferenceCitation: Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

name: From the Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, and the Department of Neurology, Emory University School of Medicine, Atlanta (R.G.N., D.C.H., M.R.F.); the Stroke Institute, Departments of Neurology (A.P.J., T.G.J.) and Neurosurgery (B.T.J.), University of Pittsburgh Medical Center, Pittsburgh, and Abington Health, Abington (Q.A.S.) — both in Pennsylvania; the Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier (A.B., V.C.), and the Department of Diagnostic and...

location_country:
United States
France
Australia
Spain
Canada

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute

location_facility: University Hospitals Case Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: JFK Neuroscience Institute at JFK Medical Center

location_facility: Emory University at Grady Memorial Hospital

location_facility: Toronto Western Hospital - University Health Network

location_facility: Florida Hospital; Neuroscience Research Center


title: A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

acronym: McCAVE

summary: This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Austria
France
Australia
Belgium
Spain
United States
United Kingdom

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: University of California San Diego Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

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

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Va Greater Los Angeles Healthcare System

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Hospital Clinico Universitario de Valencia

status_simplified: Unknown


title: A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

acronym: CAPE

summary: This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

lead_sponsor: AbbVie

location_country:
Greece
Romania
Denmark
Croatia
France
Lithuania
Canada
Sweden
Netherlands
Bulgaria
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Czechia
Israel
Spain
Estonia

location_facility: ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679

location_facility: Hospital Universitario Central de Asturias /ID# 163053

location_facility: Massachusetts General Hospital /ID# 141552

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 128256

location_facility: Universitaetsklinikum Aachen /ID# 126591

location_facility: Hospital Universitario Vall d'Hebron /ID# 141778

location_facility: Univ of Mississippi Med Ctr,US /ID# 137239

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 147538

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696

location_facility: SUNY Upstate Medical University /ID# 148437

location_facility: Duplicate_Duplicate_GENERAL HOSPITAL OF THESSALONIKI GENNIMATAS /ID# 163658

location_facility: Medical University of South Carolina /ID# 144473

location_facility: Rady Children's Hospital San Diego /ID# 140883

location_facility: Columbia Univ Medical Center /ID# 144440

location_facility: Univ Alabama, Birmingham CCC /ID# 146060

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809

location_facility: Azienda Sanitaria Locale di Pescara /ID# 141307

location_facility: Compl Hospital Univer de Vigo /ID# 136999

location_facility: Karolinska University Hospital Solna /ID# 129045

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 141667

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829

location_facility: Private practice: Dr. Shervin Rabizadeh /ID# 137269

location_facility: Ctr. Gastroenterologia Ped Oes /ID# 140875

location_facility: Nemours Children's Specilaity Clinic-Jacksonville /ID# 148498

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157872

location_facility: Hospital Universitario Vall d'Hebron /ID# 146015

location_facility: University of Massachusetts Medical Center /ID# 148325

location_facility: Children's Hospital Oklahoma /ID# 144047

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279

location_facility: Hospital Universitario Severo Ochoa /ID# 141545

location_facility: CT Childrens Medical Ctr, US /ID# 137265

location_facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684

location_facility: Duplicate_Ha'Emek Medical Center /ID# 156316

location_facility: Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146

location_facility: Universitatsklinikum Munster /ID# 148441

location_facility: Columbia Univ Medical Center /ID# 144475

location_facility: Christliches Kinderhospital Osnabrueck /ID# 136629

location_facility: Birmingham Childrens Hospital /ID# 136631

location_facility: Edmond And Lily Safra Children /ID# 148730

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962

location_facility: Hospital General de Granollers /ID# 140882

location_facility: Hospital Universitario y Politecnico La Fe /ID# 141847

location_facility: Universitaetsklinikum Regensburg /ID# 137140

location_facility: Children's Clinic Of Tartu Uni /ID# 146017

location_facility: A.O.U. Policlinico G. Martino /ID# 141683

location_facility: Froehlich Gemeinschaftspraxis /ID# 127975

location_facility: Hospital Universitario La Paz /ID# 161152

location_facility: Alder Hey Children's Hospital /ID# 138013

location_facility: Winship Cancer Institute of Emory University /ID# 144274

location_facility: Glasgow West Ambulatory Care Hospital /ID# 127436

location_facility: Sheffield Children's Hospital /ID# 130370

location_facility: Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410

location_facility: University of Dundee - NHS Tayside /ID# 131592

location_facility: Hospital Universitario Dr. Peset /ID# 159484

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 150097

location_facility: CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266

location_facility: Fakult Nem Kralovske Vinohrady /ID# 127697

location_facility: Manchester University NHS Foundation Trust, Royal Manchester Children's Hospital /ID# 128476

location_facility: Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358

location_facility: Multicare Institute for Research and Innovation /ID# 152120

location_facility: Duplicate_Universita di Napoli Federico II /ID# 144280

location_facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu /ID# 130251

location_facility: CCA Braga - Hospital de Braga /ID# 138269

location_facility: Duplicate_Universitaetsklinikum Freiburg /ID# 130010

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 147441

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014

location_facility: Hospital Universitario 12 de Octubre /ID# 136998

location_facility: Children's Ctr Digestive, US /ID# 144625

location_facility: University Of Vermont Medical /ID# 137263

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 139400

location_facility: Universitaetsklinikum Erlangen /ID# 137274

location_facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259

location_facility: Assaf Harofeh Medical Center /ID# 157182

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 165738

location_facility: Univ California, San Francisco /ID# 141312

location_facility: Hospital Universitari Son Espases /ID# 147446

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 137235

location_facility: University Clinical Center Tuzla /ID# 130638

location_facility: Penn State Child Hosp.Hersh,PA /ID# 144476

location_facility: Royal Aberdeen Childrens Hosp /ID# 131296

location_facility: Schneider Children's Medical Center /ID# 152683

location_facility: Children's Hospital Colorado /ID# 137261

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460

location_facility: Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297


ReferenceCitation: Taher AT, Origa R, Perrotta S, Kouraklis A, Ruffo GB, Kattamis A, Goh AS, Huang V, Zia A, Herranz RM, Porter JB. Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias. Health Qual Life Outcomes. 2018 Nov 19;16(1):216. doi: 10.1186/s12955-018-1041-5.

family: Taher

full_name: Ali T. Taher

given: Ali T.

family: Origa

full_name: Raffaella Origa

given: Raffaella

family: Perrotta

full_name: Silverio Perrotta

given: Silverio

family: Kouraklis

full_name: Alexandra Kouraklis

given: Alexandra

family: Ruffo

full_name: Giovan Battista Ruffo

given: Giovan Battista

family: Kattamis

full_name: Antonis Kattamis

given: Antonis

family: Goh

full_name: Ai-Sim Goh

given: Ai-Sim

family: Huang

full_name: Vicky Huang

given: Vicky

family: Zia

full_name: Aiesha Zia

given: Aiesha

family: Herranz

full_name: Raquel Merino Herranz

given: Raquel Merino

family: Porter

full_name: John B. Porter

given: John B.

currency_apc_doaj: GBP

journal_name: Health and Quality of Life Outcomes

oa_colors: green gold

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
iris.unica.it

location_country:
Italy
Austria
United Arab Emirates
Saudi Arabia
Lebanon
Mexico
Germany
France
Malaysia
Greece
Thailand
Argentina
Russian Federation
Spain
United States
United Kingdom

location_facility: Children's Hospital Boston Department of Hematology

location_facility: Children's Hospital of Orange County Onc Dept

location_facility: Weill Cornell Medical College-Cornell University Onc Dept

location_facility: Lurie Children's Hospital of Chicago Onc Dept

location_facility: Children's Hospital of Philadelphia Onc. Dept

title: A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

summary: Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance


design_allocation: Non-Randomized

location_country:
United States
France
Australia
Canada
United Kingdom

type: Other Identifier

title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

summary:
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.

Part A was a repeat dose, dose escalation and expansion phase that identified the recommended phase II dose (RP2D) of trametinib monotherapy. Part B evaluated the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects. Part C was aimed to determine the safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a limited dose escalation of dabrafenib. Part D evaluated the preliminary activity of trametinib in combination with dabrafenib in 2 disease-specific cohorts of subjects.

The overall goal of this trial was to efficiently establish safe, pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with dabrafenib in infants, children and adolescents and determine preliminary activity of trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent, refractory or unresectable childhood tumors.


title: Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

summary: This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.

lead_sponsor: Sierra Oncology, Inc.

location_country:
United States
Germany
France
Australia
Canada


title: VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment

acronym: VIRTUS

summary: This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

ReferenceCitation: Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. Circ Cardiovasc Interv. 2019 Dec;12(12):e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268. Epub 2019 Dec 13.

name: Heart and Vascular Center, St Joseph Hospital, Orange, CA (M.K.R.).

family: Razavi

full_name: Mahmood K. Razavi

given: Mahmood K.

name: Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom (S.B.).

family: Black

full_name: Stephen Black

given: Stephen

name: Vascular Breakthroughs, Darien, CT (P.G.).

family: Gagne

full_name: Paul Gagne

given: Paul

name: R. P. Chiacchierini Consulting, Gaithersburg, MD (R.C.).

family: Chiacchierini

full_name: Richard Chiacchierini

given: Richard

name: Infirmerie Protestante de Lyon, France (P.N.).

family: Nicolini

full_name: Phillipe Nicolini

given: Phillipe

name: Division of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill (W.M.).

family: Marston

full_name: William Marston

given: William

evidence: open (via free pdf)

ReferenceCitation: Razavi M, Marston W, Black S, Bentley D, Neglén P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.

full_name: Mahmood Razavi

given: Mahmood

family: Bentley

full_name: Dana Bentley

given: Dana

family: Neglén

full_name: Peter Neglén

given: Peter

journal_name: Journal of Vascular Surgery: Venous and Lymphatic Disorders

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Netherlands
France
Ireland
Spain
Germany
United Kingdom

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: The University of North Carolina at Chapel Hill

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


lead_sponsor: PTC Therapeutics

location_country:
Italy
Sweden
France
Israel
Belgium
Spain
United States

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

title: An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)

summary: The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnormalities. The secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (FEV1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram [ECG] measurements, vital signs).


title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

summary: The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

primary_purpose: Supportive Care

lead_sponsor: Cook Group Incorporated

location_country:
United States
Canada
France
Netherlands

location_facility:
Hôpital Edouard Herriot
Borland-Groover Clinic
University of Colorado Hospital
Indiana University Hospital
St. Michael's Hospital
University of Pittsburgh Medical Center
Erasmus Medish Centrum
Hôpital L'Archet 2
Wake Forest Baptist Medical Center
University of Virginia Health System
Centre Hospitalier de 1'Université
Moffitt Cancer Center


title: A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

acronym: MONARCH 1

summary: The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

ReferenceType: result

ReferenceCitation: Dickler MN, Tolaney SM, Rugo HS, Cortés J, Diéras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR(+)/HER2(-) Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22. Erratum in: Clin Cancer Res. 2018 Nov 1;24(21):5485.

family: Dickler

full_name: Maura N. Dickler

given: Maura N.

family: Tolaney

full_name: Sara M. Tolaney

given: Sara M.

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

family: Cortés

full_name: Javier Cortés

given: Javier

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Patt

full_name: Debra Patt

given: Debra

family: Wildiers

full_name: Hans Wildiers

given: Hans

family: Hudis

full_name: Clifford A. Hudis

given: Clifford A.

family: O'Shaughnessy

full_name: Joyce O'Shaughnessy

given: Joyce

family: Zamora

full_name: Esther Zamora

given: Esther

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

family: Frenzel

full_name: Martin Frenzel

given: Martin

family: Koustenis

full_name: Andrew Koustenis

given: Andrew

family: Baselga

full_name: José Baselga

given: José

journal_name: Clinical Cancer Research

version: acceptedVersion

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

repository_normalized: dnet

version: submittedVersion

repositories:
PubMed Central
dnet

publisher: American Association for Cancer Research (AACR)

title: MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2− Metastatic Breast Cancer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
United States
Belgium
France
Spain

location_facility: The Center for Cancer and Blood Disorders

location_facility: HOPE Hematology Oncology Physicians and Extenders

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

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

summary: This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

ReferenceCitation: Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4.

name: Genentech, Inc. South San Francisco CA USA

family: Austin

full_name: Cary D. Austin

given: Cary D.

family: Gonzalez Edick

full_name: Melissa Gonzalez Edick

given: Melissa

family: Ferrando

full_name: Ronald E. Ferrando

given: Ronald E.

family: Solon

full_name: Margaret Solon

given: Margaret

family: Baca

full_name: Miriam Baca

given: Miriam

family: Mesh

full_name: Kathryn Mesh

given: Kathryn

name: University of Leicester and Glenfield Hospital Leicester UK

family: Bradding

full_name: Peter Bradding

family: Gauvreau

full_name: Gail M. Gauvreau

given: Gail M.

name: Washington University School of Medicine in St. Louis St Louis MO USA

family: Sumino

full_name: Kaharu Sumino

given: Kaharu

name: University of British Columbia Vancouver BC Canada

family: FitzGerald

full_name: J. Mark FitzGerald

given: J. Mark

name: Brigham and Women’s Hospital Boston MA USA

family: Israel

full_name: Elliot Israel

given: Elliot

family: Bjermer

full_name: Lief Bjermer

given: Lief

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Arron

full_name: Joseph R. Arron

given: Joseph R.

family: Choy

full_name: David F. Choy

given: David F.

family: Olsson

full_name: Julie K. Olsson

given: Julie K.

family: Abreu

full_name: Francis Abreu

given: Francis

family: Howard

full_name: Monet Howard

given: Monet

family: Wong

full_name: Kit Wong

given: Kit

family: Cai

full_name: Fang Cai

given: Fang

family: Peng

full_name: Kun Peng

given: Kun

family: Putnam

full_name: Wendy S. Putnam

given: Wendy S.

family: Holweg

full_name: Cécile T.J. Holweg

given: Cécile T.J.

name: University of Arizona College of Medicine Tucson AZ USA

name: San Francisco Medical Center University of California San Francisco CA USA

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

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

title: A randomized, placebo‐controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER)

location_country:
Sweden
France
Ireland
United States
United Kingdom
Canada

location_facility: McMaster University Health Sciences Center

location_facility: University of California Davis Health System; Division of Pulmonary and Critical Care Medicine

location_facility: Queen's University Belfast; NICRN Respiratory Research Office

location_facility: Temple University Hospital ; Lung Center

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: Wake Forest University Baptist Medical Center; Gastroenterology & Digestive Health

location_facility: University of Iowa Hospitals & Clinics; Internal Medicine

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Brigham and Women's Hospital; Pulmonary Division


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

ReferenceCitation: Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306. doi: 10.1200/JCO.2018.78.7697. Epub 2018 Oct 4. Erratum in: J Clin Oncol. 2019 Jan 20;37(3):261.

name: John H. Strickler, Duke University Medical Center, Durham, NC; Colin D. Weekes, University of Colorado, Aurora, CO; John Nemunaitis, Mary Crowley Cancer Research Center, Dallas, TX; Ramesh K. Ramanathan, Virginia Piper Cancer Center at Honor Health/Translational Genomics Research Institute, Scottsdale, AZ; Rebecca S. Heist, Massachusetts General Hospital Cancer Center, Boston, MA; Daniel Morgensztern, Washington University School of Medicine, St. Louis, MO; Eric Angevin, Gustave Roussy, Villejuif,...

family: Strickler

full_name: John H. Strickler

given: John H.

family: Weekes

full_name: Colin D. Weekes

given: Colin D.

family: Nemunaitis

full_name: John Nemunaitis

given: John

family: Ramanathan

full_name: Ramesh K. Ramanathan

given: Ramesh K.

family: Heist

full_name: Rebecca S. Heist

given: Rebecca S.

family: Morgensztern

full_name: Daniel Morgensztern

given: Daniel

family: Angevin

full_name: Eric Angevin

given: Eric

family: Bauer

full_name: Todd M. Bauer

given: Todd M.

family: Yue

full_name: Huibin Yue

given: Huibin

family: Motwani

full_name: Monica Motwani

given: Monica

family: Parikh

full_name: Apurvasena Parikh

given: Apurvasena

family: Reilly

full_name: Edward B. Reilly

given: Edward B.

family: Afar

full_name: Daniel Afar

family: Naumovski

full_name: Louie Naumovski

given: Louie

family: Kelly

full_name: Karen Kelly

given: Karen

journal_name: Journal of Clinical Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

publisher: American Society of Clinical Oncology (ASCO)

title: First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody–Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors

location_country:
Italy
Finland
France
Japan
Belgium
United States
Korea, Republic of
Taiwan

location_facility: AP-HM - Hopital de la Timone /ID# 151570

location_facility: The University of Chicago Medical Center /ID# 136995

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 129805

location_facility: National Cancer Center Hospital East /ID# 217570

location_facility: Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077

location_facility: Mary Crowley Cancer Research /ID# 123760

location_facility: Dana-Farber Cancer Institute /ID# 168782

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378

location_facility: Northwell Health - Monter Cancer Center /ID# 218170

location_facility: Taipei Veterans General Hosp /ID# 217392

location_facility: Yonsei University Health System Severance Hospital /ID# 217333

location_facility: Massachusetts General Hospital /ID# 129804

location_facility: National Taiwan University Hospital /ID# 167173

location_facility: University of California, Los Angeles /ID# 148295

location_facility: Washington University-School of Medicine /ID# 143798

location_facility: University of Texas MD Anderson Cancer Center /ID# 154648

location_facility: Univ of Colorado Cancer Center /ID# 123759

location_facility: Herbert Herman Cancer Center /ID# 149858

location_facility: Universitair Ziekenhuis Antwerpen /ID# 170118

location_facility: New York Presbyterian Hospital Weill Cornell Medical Center /ID# 218445

location_facility: National Cheng Kung University Hospital /ID# 167175

location_facility: National Cancer Center Hospital /ID# 217571

location_facility: Summit Medical Group-Florham Park /ID# 217651

location_facility: China Medical University Hospital /ID# 217494

location_facility: Virginia Cancer Specialists - Fairfax /ID# 165708


title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

acronym: PERIGON

summary: To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

ReferenceCitation: Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.

name: Department of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, Netherlands

family: Klautz

full_name: Robert J.M. Klautz

given: Robert J.M.

name: Department of Cardio-Thoracic Surgery, Erasmus Medical Centre, Rotterdam, Netherlands

family: Kappetein

full_name: A. Pieter Kappetein

given: A. Pieter

name: German Heart Centre, Technical University of Munich, Munich, Germany

family: Lange

full_name: Rüdiger Lange

given: Rüdiger

name: Deparment of Cardiac Surgery, Québec Heart and Lung Institute, Québec City, Canada

family: Dagenais

full_name: Francois Dagenais

given: Francois

name: Department of Cardiac and Vascular Surgery, University Hospital of Bordeaux, Bordeaux, France

family: Labrousse

full_name: Louis Labrousse

given: Louis

name: Department of Cardiothoracic Surgery, St Thomas’ Hospital, London, UK

family: Bapat

full_name: Vinayak Bapat

given: Vinayak

name: Department of Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, OH, USA

family: Moront

full_name: Michael Moront

given: Michael

name: Department of Cardiac Surgery, Leipzig Heart Centre, University Hospital, Leipzig, Germany

family: Misfeld

full_name: Martin Misfeld

given: Martin

name: Statistical Services Department, Medtronic, Minneapolis, MN, USA

family: Zeng

full_name: Cathy Zeng

given: Cathy

name: Department of Surgery, University Hospitals, Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA

family: Sabik III

full_name: Joseph F. Sabik III

given: Joseph F.

journal_name: European Journal of Cardio-Thoracic Surgery

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis†

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
United States
Switzerland
Netherlands
France
Germany
United Kingdom
Canada

location_facility: University of Michigan Cardiovascular Center

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: London Health Sciences Centre - University Campus

location_facility: University of Southern California (USC) University Hospital

location_facility: Cardiothoracic and Vascular Surgeons (CTVS)

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

location_facility: Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: Riverside Methodist Hospital (OhioHealth)

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Universitätsklinikum Köln - Anstalt des öffentlichen Rechts

location_facility: Leids Universitair Medisch Centrum (LUMC)


title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

acronym: BEACON

summary: This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.

ReferenceCitation: Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.

family: Miere

full_name: Alexandra Miere

given: Alexandra

family: Capuano

full_name: Vittorio Capuano

given: Vittorio

family: Kessler

full_name: Arthur Kessler

given: Arthur

family: Zambrowski

full_name: Olivia Zambrowski

given: Olivia

family: Jung

full_name: Camille Jung

given: Camille

family: Colantuono

full_name: Donato Colantuono

given: Donato

family: Pallone

full_name: Carlotta Pallone

given: Carlotta

family: Semoun

full_name: Oudy Semoun

given: Oudy

family: Petit

full_name: Eric Petit

given: Eric

family: Souied

full_name: Eric Souied

journal_name: Computers in Biology and Medicine

ReferenceCitation: Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, López FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.

family: Kuppermann

full_name: Baruch D. Kuppermann

given: Baruch D.

family: Patel

full_name: Sunil S. Patel

given: Sunil S.

family: Boyer

full_name: David S. Boyer

given: David S.

family: Augustin

full_name: Albert J. Augustin

given: Albert J.

family: Freeman

full_name: William R. Freeman

given: William R.

family: Kerr

full_name: Kevin J. Kerr

given: Kevin J.

family: Guo

full_name: Qiang Guo

given: Qiang

family: Schneider

full_name: Susan Schneider

given: Susan

family: López

full_name: Francisco J. López

given: Francisco J.

location_country:
Italy
United States
France
Australia
Germany
United Kingdom

location_facility: Retinal Consultants of Arizona, Ltd., Retinal Research Institute

location_facility: Lions Eye Institute, University of Western Australia

location_facility: "Universitat Bonn, Abteilung fur Augenheilkunde "

location_facility: "Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "

location_facility: Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology

location_facility: Charlotte Eye Ear Nose & Throat Associates, PA

location_facility: Università di Cagliari (presidio San Giovanni di Dio)

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

location_facility: Mid Atlantic Retina, Wills Eye Retina Surgeons

location_facility: Universita degli Studi di Padova, Dipartimento di Neuroscienze

location_facility: "National Ophthalmic Research Institute Retina Consultants of Southwest Florida"

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: University of California, San Diego, Jacobs Retina Center, Shiley Eye Center

location_facility: Casey Eye Institute, Oregon Health and Science University

location_facility: Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street

location_facility: Royal Hallamshire Hospital, Eye Department

location_facility: Northern California Retina Vitreous Associates

location_facility: "Centre Hospitalier Intercommunal de Creteil "


ReferenceCitation: Hughes TP, Mauro MJ, Cortes JE, Minami H, Rea D, DeAngelo DJ, Breccia M, Goh YT, Talpaz M, Hochhaus A, le Coutre P, Ottmann O, Heinrich MC, Steegmann JL, Deininger MWN, Janssen JJWM, Mahon FX, Minami Y, Yeung D, Ross DM, Tallman MS, Park JH, Druker BJ, Hynds D, Duan Y, Meille C, Hourcade-Potelleret F, Vanasse KG, Lang F, Kim DW. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019 Dec 12;381(24):2315-2326. doi: 10.1056/NEJMoa1902328.

name: From the South Australian Health and Medical Research Institute and the University of Adelaide, Adelaide, SA, Australia (T.P.H., D.Y., D.M.R.); Memorial Sloan Kettering Cancer Center, New York (M.J.M., M.S.T., J.H.P.); University of Texas M.D. Anderson Cancer Center, Houston (J.E.C.); Kobe University Graduate School of Medicine, Kobe (H.M.), and the National Cancer Center Hospital East, Chiba (Y.M.) — both in Japan; Hôpital Saint-Louis, Paris (D.R.), and the University of Bordeaux, Bordeaux (F.-X.M.) —...

family: Hughes

full_name: Timothy P. Hughes

given: Timothy P.

family: Mauro

full_name: Michael J. Mauro

given: Michael J.

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

family: Minami

full_name: Hironobu Minami

given: Hironobu

family: Rea

full_name: Delphine Rea

given: Delphine

family: DeAngelo

full_name: Daniel J. DeAngelo

given: Daniel J.

family: Breccia

full_name: Massimo Breccia

given: Massimo

family: Goh

full_name: Yeow-Tee Goh

given: Yeow-Tee

family: Talpaz

full_name: Moshe Talpaz

given: Moshe

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: le Coutre

full_name: Philipp le Coutre

given: Philipp

family: Ottmann

full_name: Oliver Ottmann

given: Oliver

family: Heinrich

full_name: Michael C. Heinrich

given: Michael C.

family: Steegmann

full_name: Juan L. Steegmann

given: Juan L.

family: Deininger

full_name: Michael W.N. Deininger

given: Michael W.N.

family: Janssen

full_name: Jeroen J.W.M. Janssen

given: Jeroen J.W.M.

family: Mahon

full_name: Francois-Xavier Mahon

given: Francois-Xavier

full_name: Yosuke Minami

given: Yosuke

family: Yeung

full_name: David Yeung

given: David

family: Ross

full_name: David M. Ross

given: David M.

family: Tallman

full_name: Martin S. Tallman

given: Martin S.

family: Park

full_name: Jae H. Park

given: Jae H.

family: Druker

full_name: Brian J. Druker

given: Brian J.

family: Hynds

full_name: David Hynds

family: Duan

full_name: Yuyan Duan

given: Yuyan

location_country:
Italy
United States
Netherlands
France
Japan
Singapore
Australia
Spain
Germany
Korea, Republic of

location_facility: Oregon Health and Science University SC-6

location_facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering

location_facility: University of Texas/MD Anderson Cancer Center UT MD Anderson

location_facility: University of Michigan Comprehensive Cancer Center SC

location_facility: Dana Farber Cancer Institute Hematology / Oncology

title: A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)

summary: The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.


title: An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201

summary: This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

location_country:
Italy
United States
South Africa
Mexico
Germany
Finland
France
Czechia
Poland
Israel
Slovakia
Romania
Hungary
Argentina
Russian Federation
Portugal
Turkey
Canada
United Kingdom
Korea, Republic of


title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066

acronym: CROSSOVER

summary: Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).

location_country:
Netherlands
France
United States
United Kingdom
Canada

location_facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: Illinois Lung and Critical Care Institute

location_facility: El Camino Hospital/Palo Alto Medical Foundation

location_facility: Yale University School of Medicine - Yale New Haven Hospital

location_facility: Royal Brompton Hospital & Chelsea Westminster

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Emphysema COPD Research Center, University of Pittsburgh

location_facility: University of Wisconsin School of Medicine & Public Health

location_facility: University of Alabama Lung Health Center


ReferenceCitation: DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1015-1025. doi: 10.1016/j.jaac.2017.10.006. Epub 2017 Oct 13.

family: DelBello

full_name: Melissa P. DelBello

given: Melissa P.

family: Goldman

full_name: Robert Goldman

given: Robert

family: Phillips

full_name: Debra Phillips

given: Debra

family: Deng

full_name: Ling Deng

given: Ling

family: Cucchiaro

full_name: Josephine Cucchiaro

given: Josephine

family: Loebel

full_name: Antony Loebel

given: Antony

journal_name: Journal of the American Academy of Child & Adolescent Psychiatry

lead_sponsor: Sunovion

location_country:
Mexico
Philippines
France
Bulgaria
Poland
Hungary
Puerto Rico
United States
Korea, Republic of
Colombia
Ukraine

acronym: Illuminate

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Family Psychiatry of The Woodlands, P.A.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

location_facility: University Hospitals Case Medical Center

location_facility: West Visayas State University Medical Center

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: Consultorio Especializado Psiquiatría Infantil y Adolescentes

location_facility: Seoul National University Bundang Hospital

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

location_facility: Chair of Psychiatry and Narcology, Vinnytsia National Medical University, O.I. Yushchenko Regional Psychoneurological Hospital

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

title: A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

summary: A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression


title: An Open-Label, Multicenter, Multinational Extension Study Of The Long-Term Safety And Pharmacokinetics Of Repeated Biweekly Infusions Of Avalglucosidase Alfa In Patients With Pompe Disease

acronym: NEO-EXT

summary:
Primary Objective:

Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa

Secondary Objective:

Long-term effect of avalglucosidase alfa on pharmacodynamic and exploratory efficacy variables

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Netherlands
Germany
France
Belgium
Denmark
United States
United Kingdom

location_facility:
Investigational Site Number 250003
Investigational Site Number 276001
Investigational Site Number 840008
Investigational Site Number 840001
Investigational Site Number 840003
Investigational Site Number 840006
Investigational Site Number 276002
Investigational Site Number 208001
Investigational Site Number 250002
Investigational Site Number 528001
Investigational Site Number 826003
Investigational Site Number 056001
Investigational Site Number 840002
Investigational Site Number 276003
Investigational Site Number 840010
Investigational Site Number 840009
Investigational Site Number 840011