title: APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia

acronym: APRICOT

summary:
The aims of the APRICOT study are:

To establish the incidence of severe critical events in children undergoing anesthesia in Europe.
To describe the differences in paediatric anaesthesia practice throughout Europe.
To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

ReferenceCitation: Dahmani S, Laffargue A, Dadure C, Veyckemans F; French APRICOT trial group. Description of practices and complications in the French centres that participated to APRICOT: A secondary analysis. Anaesth Crit Care Pain Med. 2019 Dec;38(6):637-645. doi: 10.1016/j.accpm.2019.06.001. Epub 2019 Jun 11.

family: Dahmani

full_name: Souhayl Dahmani

given: Souhayl

family: Laffargue

full_name: Anne Laffargue

given: Anne

family: Dadure

full_name: Christophe Dadure

given: Christophe

family: Veyckemans

full_name: Francis Veyckemans

given: Francis

journal_name: Anaesthesia Critical Care & Pain Medicine

ReferenceCitation: Virag K, Sabourdin N, Thomas M, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Epidemiology and incidence of severe respiratory critical events in ear, nose and throat surgery in children in Europe: A prospective multicentre observational study. Eur J Anaesthesiol. 2019 Mar;36(3):185-193. doi: 10.1097/EJA.0000000000000951.

family: Virag

full_name: Katalin Virag

given: Katalin

family: Sabourdin

full_name: Nada Sabourdin

given: Nada

family: Thomas

full_name: Mark Thomas

given: Mark

family: Habre

full_name: Walid Habre

given: Walid

journal_name: European Journal of Anaesthesiology

evidence: open (via free article)

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Engelhardt T, Virag K, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Airway management in paediatric anaesthesia in Europe-insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe. Br J Anaesth. 2018 Jul;121(1):66-75. doi: 10.1016/j.bja.2018.04.013. Epub 2018 May 18.

family: Engelhardt

full_name: T. Engelhardt

given: T.

full_name: K. Virag

given: K.

full_name: F. Veyckemans

given: F.

full_name: W. Habre

given: W.

journal_name: British Journal of Anaesthesia

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: University of Geneva - Archive ouverte UNIGE

title: Airway management in paediatric anaesthesia in Europe—insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe

ReferenceCitation: Habre W, Disma N, Virag K, Becke K, Hansen TG, Jöhr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28. Erratum in: Lancet Respir Med. 2017 May;5(5):e19. Lancet Respir Med. 2017 Jun;5(6):e22.

location_country:
Finland
Greece
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
Croatia
France
Lithuania
Poland
Slovakia
Norway
Slovenia
Turkey
Sweden
Switzerland
Netherlands
Kosovo
Malta
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Israel
Gibraltar
Spain
Estonia
Latvia

location_facility: Schneider Children's Medical center of Israel

location_facility: Maastricht University Medical Center MUMC

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1

location_facility: Pirogov Russian National Research Medical University

location_facility: Clinical University Hospital Department of Anaesthesiology and Intensive Care

location_facility: Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia

location_facility: Gibraltar Health Authority, St. Bernard´s Hospital

location_facility: Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse

location_facility: Queen Silvis Childrens Hospital Sahlgrens University Hospital


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

summary:
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.

family: Rosenfeld

full_name: William E Rosenfeld

given: William E

sequence: first

family: Nisman

full_name: Arkady Nisman

given: Arkady

sequence: additional

family: Ferrari

full_name: Louis Ferrari

given: Louis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Epilepsy Research

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14. Erratum in: Lancet Neurol. 2020 Mar;19(3):e3.

family: Krauss

full_name: Gregory L Krauss

given: Gregory L

family: Klein

full_name: Pavel Klein

given: Pavel

family: Brandt

full_name: Christian Brandt

given: Christian

family: Lee

full_name: Sang Kun Lee

given: Sang Kun

family: Milanov

full_name: Ivan Milanov

given: Ivan

family: Milovanovic

full_name: Maja Milovanovic

given: Maja

family: Steinhoff

full_name: Bernhard J Steinhoff

given: Bernhard J

family: Kamin

full_name: Marc Kamin

given: Marc

journal_name: The Lancet Neurology

ReferenceCitation: Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19. Review.

family: Bialer

full_name: Meir Bialer

given: Meir

family: Johannessen

full_name: Svein I. Johannessen

given: Svein I.

family: Levy

full_name: René H. Levy

given: René H.

family: Perucca

full_name: Emilio Perucca

given: Emilio

family: Tomson

full_name: Torbjörn Tomson

given: Torbjörn

family: White

full_name: H. Steve White

given: H. Steve

location_country:
Serbia
Germany
France
Czechia
Bulgaria
Israel
Poland
Romania
Hungary
Australia
Thailand
Spain
United States
Korea, Republic of
Ukraine

location_facility: The Chaim Sheba Medical Center, Department of Neurology

location_facility: Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics

location_facility: Fakultni nemocnice v Motole, Neurologická klinika

location_facility: University of Virginia Comprehensive Epilepsy Program

location_facility: The Comprehensive Epilepsy Care Center for Children and Adults

location_facility: Lviv Regional Antiepileptic Center based on Department of Neurology of Lviv Regional Clinical Hospital and Chair of Neurology of Lviv National Medical University n.a. Danylo Galytskyy

location_facility: Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah

location_facility: NOVO-MED Zielinski I Wspolnicy Spolka Jawna

location_facility: Hôpital Central - CHU de Nancy - Service de Neurologie

location_facility: Hospital Universitario San Cecilio - Servicio de Neurologia

location_facility: Hospital Clinico Universitario San Carlos, Serv. Neurologia

location_facility: Hospital Universitario y Politecnico La Fe - Servicio Neurologia

location_facility: University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases

location_facility: Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel

location_facility: Clinical of Neurology, Clinical Center of Serbia

location_facility: Neurology of Kharkiv Medical Academy of Postgraduate Education based on Department of Neurology #3 of State Treatment and Prevention Institution "Central Clinical Hospital of Ukrzaliznytsya"

location_facility: University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases

location_facility: Fakultní nemocnice Ostrava, Neurologická klinika

location_facility: Epilepsy Research Centre, Melbourne Brain Centre

location_facility: Thomas Jefferson Comprehensive Epilepsy Center

location_facility: Institute of Neurological Sciences, Prince of Wales Hospital

location_facility: MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department

location_facility: Department #2 of Regional Clinical Center of Neurosurgery and Neurology

location_facility: Western Galilee Hospital, Department of Neurology

location_facility: TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"

location_facility: Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna

location_facility: Fundación Jiminez Diaz-Servicio de Neurologia

location_facility: "First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic

location_facility: Hospital Ruber Internacional - Programa Epilepsia

location_facility: West Los Angeles VA Medical Center, Clinical Research Center

location_facility: M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: Fundacja Epileptologii profesora Jerzego Majkowskiego

location_facility: Roceanu Adina Maria Neurology Individual Medical Center

location_facility: Kaiser Permanente, Department of Neurology

location_facility: Consultants in Epilepsy & Neurology, PLLC


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

summary: The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

status: Terminated

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: McDonald CM, Henricson EK, Han JJ, Abresch RT, Nicorici A, Elfring GL, Atkinson L, Reha A, Hirawat S, Miller LL. The 6-minute walk test as a new outcome measure in Duchenne muscular dystrophy. Muscle Nerve. 2010 Apr;41(4):500-10. doi: 10.1002/mus.21544.

ReferenceCitation: Victor RG, Sweeney HL, Finkel R, McDonald CM, Byrne B, Eagle M, Goemans N, Vandenborne K, Dubrovsky AL, Topaloglu H, Miceli MC, Furlong P, Landry J, Elashoff R, Cox D; Tadalafil DMD Study Group. A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy. Neurology. 2017 Oct 24;89(17):1811-1820. doi: 10.1212/WNL.0000000000004570. Epub 2017 Sep 29.

family: Victor

full_name: Ronald G. Victor

given: Ronald G.

family: Sweeney

full_name: H. Lee Sweeney

given: H. Lee

family: Finkel

full_name: Richard Finkel

given: Richard

family: McDonald

full_name: Craig M. McDonald

given: Craig M.

family: Byrne

full_name: Barry Byrne

given: Barry

family: Eagle

full_name: Michelle Eagle

given: Michelle

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: Vandenborne

full_name: Krista Vandenborne

given: Krista

family: Dubrovsky

full_name: Alberto L. Dubrovsky

given: Alberto L.

family: Topaloglu

full_name: Haluk Topaloglu

given: Haluk

family: Miceli

full_name: M. Carrie Miceli

given: M. Carrie

family: Furlong

full_name: Pat Furlong

given: Pat

family: Landry

full_name: John Landry

given: John

family: Elashoff

full_name: Robert Elashoff

given: Robert

family: Cox

full_name: David Cox

given: David

journal_name: Neurology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

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

host_type: repository

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: California Digital Library - eScholarship

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

publisher: Ovid Technologies (Wolters Kluwer Health)

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.

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Belgium
Argentina
Puerto Rico
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: University of California, Davis - Health Systems

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: Seattle Children's Hospital Research Foundation

location_facility: Univ of Texas Health Science Center at San Antonio

location_facility: Pennsylvania State University College of Medicine

location_facility: Ann and Robert Lurie Children's Hospital of Chicago

location_facility: University of Puerto Rico, Medical Sciences Campus

location_facility: University of Florida Health Science Center


intervention_type: Other

status: Completed

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Greece
Australia
Russian Federation
Denmark
Czech Republic
France
Poland
Lithuania
Slovakia
Canada
Korea, Republic of
Switzerland
Singapore
Hungary
Portugal
Germany
Italy
Spain
Turkey
Latvia

type: EudraCT Number

source: euctr

title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.

summary: This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

lead_sponsor_type: industriel

status_simplified: Completed


title: A Cross-sectional Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

summary:
No investigational drug will be administered in this study for the treatment of Fabry disease.

This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact.

The objectives of the study are:

To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease.
To provide a reference group for comparison with interventional clinical trials of Fabry disease.

The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.

primary_purpose: Basic Science

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Austria
Brazil
Finland
France
Poland
Norway
Hungary
Argentina
Belgium
Spain
United States
United Kingdom
Canada
Taiwan

location_facility:
Investigational Site Number 250002
Investigational Site Number 840009
Investigational Site Number 124004
Investigational Site Number 250001
Investigational Site Number 032001
Investigational Site Number 158001
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 578001
Investigational Site Number 348001
Investigational Site Number 124001
Investigational Site Number 840006
Investigational Site Number 616001
Investigational Site Number 076001
Investigational Site Number 840002
Investigational Site Number 040001
Investigational Site Number 840010
Investigational Site Number 826002
Investigational Site Number 826004
Investigational Site Number 246002
Investigational Site Number 056001
Investigational Site Number 724002

intervention_type: Drug

status_simplified: Unknown


title: A Phase 2, Randomized, Double Blind Placebo Controlled Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of Pf-04360365 (Ponezumab) In Adult Subjects With Probable Cerebral Amyloid Angiopathy

summary: Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.

lead_sponsor: Pfizer

location_country:
Netherlands
France
United States
United Kingdom
Canada

location_facility: Anthinoula A. Martinos Center for Biomedical Imaging

location_facility: University of Calgary/Foothills Medical Centre


title: A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

summary: The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Arribas

full_name: Jose R. Arribas

given: Jose R.

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Gupta

full_name: Samir K. Gupta

given: Samir K.

family: Post

full_name: Frank A. Post

given: Frank A.

family: Bloch

full_name: Mark Bloch

given: Mark

family: Avihingsanon

full_name: Anchalee Avihingsanon

given: Anchalee

family: Crofoot

full_name: Gordon Crofoot

given: Gordon

family: Benson

full_name: Paul Benson

given: Paul

family: Lichtenstein

full_name: Kenneth Lichtenstein

given: Kenneth

family: Ramgopal

full_name: Moti Ramgopal

given: Moti

family: Chetchotisakd

full_name: Ploenchan Chetchotisakd

given: Ploenchan

family: Custodio

full_name: Joseph M. Custodio

given: Joseph M.

family: Abram

full_name: Michael E. Abram

given: Michael E.

family: Wei

full_name: Xuelian Wei

given: Xuelian

family: Cheng

full_name: Andrew Cheng

given: Andrew

family: McCallister

full_name: Scott McCallister

given: Scott

family: SenGupta

full_name: Devi SenGupta

given: Devi

family: Fordyce

full_name: Marshall W. Fordyce

given: Marshall W.

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

ReferenceCitation: Post FA, Tebas P, Clarke A, Cotte L, Short WR, Abram ME, Jiang S, Cheng A, Das M, Fordyce MW. Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.

title: Brief Report

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Mexico
Netherlands
Dominican Republic
France
Thailand
Australia
Spain
United States
United Kingdom

location_facility: Central Manchester University Hospitals NHS foundation Trust

location_facility: Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group

location_facility: Maricopa Integrated Health System - McDowell Clinic

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: The Kansas City Care Clinic (KC Free Health Clinic)

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: University of PA HIV Clinical Trials Unit

location_facility: GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Clinical Research Infectious Diseases Department- Alfred Hospital

location_facility: Community Research Initiative of New England

location_facility: Long Beach Education and Research Consultants

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Germans Trias i Pujol University Hospital

location_facility: Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

location_facility: LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic

location_facility: HIV-NAT, Thai Red Cross AIDS Research Centre

location_facility: Chelsea and Westminster NHS Foundation Trust Hospital


title: Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker

summary: This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Biotronik SE & Co. KG

location_country:
Austria
Switzerland
Germany
France
Hungary
Australia
Canada
Czech Republic

location_facility: CHUS - Centre hospitalier universitaire de Sherbrooke

location_facility: Schwarzwald Baar Klinikum Villingen Schwenningen


title: Intensive Enteral Nutrition in Association With Corticosteroids in Severe Acute Alcoholic Hepatitis: a Multicenter, Randomized, Controlled Trial

summary: To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in association with corticosteroïds in patients with severe acute alcoholic hepatitis.

ReferenceCitation: Moreno C, Deltenre P, Senterre C, Louvet A, Gustot T, Bastens B, Hittelet A, Piquet MA, Laleman W, Orlent H, Lasser L, Sersté T, Starkel P, De Koninck X, Negrin Dastis S, Delwaide J, Colle I, de Galocsy C, Francque S, Langlet P, Putzeys V, Reynaert H, Degré D, Trépo E. Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids. Gastroenterology. 2016 Apr;150(4):903-10.e8. doi: 10.1053/j.gastro.2015.12.038. Epub 2016 Jan 5.

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Deltenre

full_name: Pierre Deltenre

given: Pierre

family: Senterre

full_name: Christelle Senterre

given: Christelle

family: Louvet

full_name: Alexandre Louvet

given: Alexandre

family: Gustot

full_name: Thierry Gustot

given: Thierry

family: Bastens

full_name: Boris Bastens

given: Boris

family: Hittelet

full_name: Axel Hittelet

given: Axel

family: Piquet

full_name: Marie-Astrid Piquet

given: Marie-Astrid

family: Laleman

full_name: Wim Laleman

given: Wim

family: Orlent

full_name: Hans Orlent

given: Hans

family: Lasser

full_name: Luc Lasser

given: Luc

family: Sersté

full_name: Thomas Sersté

given: Thomas

family: Starkel

full_name: Peter Starkel

given: Peter

family: De Koninck

full_name: Xavier De Koninck

given: Xavier

family: Negrin Dastis

full_name: Sergio Negrin Dastis

given: Sergio

family: Delwaide

full_name: Jean Delwaide

given: Jean

family: Colle

full_name: Isabelle Colle

given: Isabelle

family: de Galocsy

full_name: Chantal de Galocsy

given: Chantal

family: Francque

full_name: Sven Francque

given: Sven

family: Langlet

full_name: Philippe Langlet

given: Philippe

family: Putzeys

full_name: Virginie Putzeys

given: Virginie

family: Reynaert

full_name: Hendrik Reynaert

given: Hendrik

family: Degré

full_name: Delphine Degré

given: Delphine

family: Trépo

full_name: Eric Trépo

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_facility:
CHR Saint Joseph-Warquignies
CHU Saint-Pierre
AZ VUB
ULG Sart Tilman
KU Leuven
Hôpital Saint-Joseph
CHU Caen
Hôpital de Jolimont
Erasme University Hospital
Cliniques universitaires Saint-Luc
UZ Gent
CHR La Citadelle
CHU Brugmann
Hôpital Ottignies
Hôpital Ambroise Paré
CHU Lille
Hôpitaux Iris-Sud
UZ Antwerpen
AZ Brugge


title: A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, López JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

lead_sponsor: Amgen

location_country:
United States
South Africa
France
Belgium
Australia
Turkey
Denmark
Canada
Korea, Republic of
Taiwan


ReferenceCitation: Wilson DP, Friedman M, Marulkar S, Hamby T, Bruckert E. Sebelipase alfa improves atherogenic biomarkers in adults and children with lysosomal acid lipase deficiency. J Clin Lipidol. 2018 May - Jun;12(3):604-614. doi: 10.1016/j.jacl.2018.02.020. Epub 2018 Mar 9.

ReferenceCitation: Burton BK, Balwani M, Feillet F, Barić I, Burrow TA, Camarena Grande C, Coker M, Consuelo-Sánchez A, Deegan P, Di Rocco M, Enns GM, Erbe R, Ezgu F, Ficicioglu C, Furuya KN, Kane J, Laukaitis C, Mengel E, Neilan EG, Nightingale S, Peters H, Scarpa M, Schwab KO, Smolka V, Valayannopoulos V, Wood M, Goodman Z, Yang Y, Eckert S, Rojas-Caro S, Quinn AG. A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency. N Engl J Med. 2015 Sep 10;373(11):1010-20. doi: 10.1056/NEJMoa1501365.

ReferenceCitation: Burton BK, Feillet F, Furuya KN, Marulkar S, Balwani M. SEBELIPASE ALFA IN CHILDREN AND ADULTS WITH LYSOSOMAL ACID LIPASE DEFICIENCY: FINAL RESULTS OF THE ARISE STUDY. J Hepatol. 2021 Nov 10. pii: S0168-8278(21)02171-1. doi: 10.1016/j.jhep.2021.10.026. [Epub ahead of print]

family: Burton

full_name: Barbara K. Burton

given: Barbara K.

family: Feillet

full_name: François Feillet

given: François

family: Furuya

full_name: Katryn N. Furuya

given: Katryn N.

family: Marulkar

full_name: Sachin Marulkar

given: Sachin

family: Balwani

full_name: Manisha Balwani

given: Manisha

journal_name: Journal of Hepatology

ReferenceCitation: Valayannopoulos V, Malinova V, Honzík T, Balwani M, Breen C, Deegan PB, Enns GM, Jones SA, Kane JP, Stock EO, Tripuraneni R, Eckert S, Schneider E, Hamilton G, Middleton MS, Sirlin C, Kessler B, Bourdon C, Boyadjiev SA, Sharma R, Twelves C, Whitley CB, Quinn AG. Sebelipase alfa over 52 weeks reduces serum transaminases, liver volume and improves serum lipids in patients with lysosomal acid lipase deficiency. J Hepatol. 2014 Nov;61(5):1135-42. doi: 10.1016/j.jhep.2014.06.022. Epub 2014 Jun 30.

family: Valayannopoulos

full_name: Vassili Valayannopoulos

given: Vassili

family: Malinova

full_name: Vera Malinova

given: Vera

family: Honzík

full_name: Tomas Honzík

given: Tomas

family: Breen

full_name: Catherine Breen

given: Catherine

family: Deegan

full_name: Patrick B. Deegan

given: Patrick B.

family: Enns

full_name: Gregory M. Enns

given: Gregory M.

family: Jones

full_name: Simon A. Jones

given: Simon A.

family: Kane

full_name: John P. Kane

given: John P.

family: Stock

full_name: Eveline O. Stock

given: Eveline O.

family: Tripuraneni

full_name: Radhika Tripuraneni

given: Radhika

family: Eckert

full_name: Stephen Eckert

given: Stephen

family: Schneider

full_name: Eugene Schneider

given: Eugene

family: Hamilton

full_name: Gavin Hamilton

given: Gavin

family: Middleton

full_name: Michael S. Middleton

given: Michael S.

family: Sirlin

repository_institution: University of California - eScholarship University of California

title: Sebelipase alfa over 52weeks reduces serum transaminases, liver volume and improves serum lipids in patients with lysosomal acid lipase deficiency

location_country:
Italy
Mexico
Germany
Croatia
Czechia
France
Japan
Poland
Argentina
Australia
Russian Federation
Spain
Turkey
United States
United Kingdom

title: A Multicenter, Randomized, Placebo-controlled Study of SBC-102 in Patients With Lysosomal Acid Lipase Deficiency

summary:
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid lipase deficiency (LAL-D) (cholesteryl ester storage disease [CESD]).

Late-onset LAL-D is an underappreciated cause of cirrhosis, liver failure and dyslipidemia. There is currently no standard treatment for LAL-D other than supportive care. Enzyme replacement therapy may be a potential new treatment option for LAL-D participants.


title: An Open-Label, Four-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and the Anti-EGFR Antibody Panitumumab in Combination in Subjects With BRAF-mutation V600E Positive Colorectal Cancer and in Subjects With CRC With Secondary Resistance to Prior Anti-EGFR Therapy

summary: This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC. The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD for double (T+P) combination in Part 4A, and assess clinical activity of this combination in two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to anti-EGFR therapy).

ipd_sharing: Yes

ipd_sharing_description:
This product has been acquired by Novartis Pharmaceuticals. 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

location_country:
Italy
Netherlands
France
Japan
Belgium
Spain
United States
United Kingdom

intervention_type: Device


title: A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

summary: This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, 15 and 22.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Serbia
France
Turkey
Germany
United Kingdom
Canada

location_facility: Children's and Women's Health Center / BC Children's Hospital

location_facility: COLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research Building

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: University of Utah; Immunology/Rheumatology/Allergy

location_facility: The Hospital for Sick Children Research Institute

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: Hacettepe University, School of Medicine; Pediatrics Department

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: The Cleveland Clinic Foundation; Rheumatic and Immunologic Diseases

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: Great Ormond Street Children's Hospital; Centre of Paediatric & Adolescent Rheumatology


ReferenceCitation: Fischer M, Moreno L, Ziegler DS, Marshall LV, Zwaan CM, Irwin MS, Casanova M, Sabado C, Wulff B, Stegert M, Wang L, Hurtado FK, Branle F, Geoerger B, Schulte JH. Ceritinib in paediatric patients with anaplastic lymphoma kinase-positive malignancies: an open-label, multicentre, phase 1, dose-escalation and dose-expansion study. Lancet Oncol. 2021 Nov 12. pii: S1470-2045(21)00536-2. doi: 10.1016/S1470-2045(21)00536-2. [Epub ahead of print]

family: Fischer

full_name: Matthias Fischer

given: Matthias

family: Moreno

full_name: Lucas Moreno

given: Lucas

family: Ziegler

full_name: David S Ziegler

given: David S

family: Marshall

full_name: Lynley V Marshall

given: Lynley V

family: Zwaan

full_name: C Michel Zwaan

given: C Michel

family: Irwin

full_name: Meredith S Irwin

given: Meredith S

family: Casanova

full_name: Michela Casanova

given: Michela

family: Sabado

full_name: Constantino Sabado

given: Constantino

family: Wulff

full_name: Beate Wulff

given: Beate

family: Stegert

full_name: Mario Stegert

given: Mario

family: Wang

full_name: Luojun Wang

given: Luojun

family: Hurtado

full_name: Felipe K Hurtado

given: Felipe K

family: Branle

full_name: Fabrice Branle

given: Fabrice

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Schulte

full_name: Johannes H Schulte

given: Johannes H

journal_name: The Lancet Oncology

ReferenceCitation: Brivio E, Zwaan CM. ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects. Pediatr Blood Cancer. 2019 May;66(5):e27645. doi: 10.1002/pbc.27645. Epub 2019 Jan 29.

name: Prinses Maxima CentrumCenter for Pediatric Oncology Utrecht the Netherlands

family: Brivio

full_name: Erica Brivio

given: Erica

name: Department of Pediatric Oncology/HematologyErasmus MC‐Sophia Children's Hospital Rotterdam the Netherlands

full_name: C. Michel Zwaan

given: C. Michel

journal_name: Pediatric Blood & Cancer

license: cc-by-nc

license_normalized: cc-by-nc

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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

acronym: Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALK

location_facility: St Jude s Childrens Research Hospital Dept of Oncology

location_facility: Texas Children's Hospital Dept of Oncology

location_facility: Dana Farber Cancer Institute Dept of Onc

location_facility: Cincinnati Children s Hospital Medical Center Dept of Oncology

title: A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

summary: The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.


location_country:
Greece
Romania
Belgium
Russian Federation
Spain
Croatia
France
Canada
Korea, Republic of
South Africa
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Serbia
Cyprus
Israel
Egypt
Belarus
New Zealand

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Mary Crowley Medical Research Center; Oncology

location_facility: SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2

location_facility: Kyungpook National University Chilgok Hospital

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: Hospital General Universitario de Valencia

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: University of Chicago Medical Center; Medicine, Section of Pulmonary

location_facility: Massachusetts General Hospital Cancer Center

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Hospital Regional Universitario de Malaga; Oncologia

location_facility: Hospital General Universitario Santa Lucia

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: University of Pennsylvania Health System

location_facility: University General Hospital of Heraklion

location_facility: Cancercare Langenhoven Drive Oncology Centre

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

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

location_facility: New York University Medical Center PRIME

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

ipd_sharing: No

title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.


title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)

summary: The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).

ReferenceCitation: Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Planté-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceição I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.

name: From the Indiana University School of Medicine, Indianapolis (M.D.B.); Centro de Estudos em Paramiloidose Antônio Rodrigues de Mello, National Amyloidosis Referral Center, University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro (M.W.-C.); Amyloidosis Center, Boston University School of Medicine (J.L.B.) and Brigham and Women’s Hospital, Harvard Medical School (A.M.S., S.D.S.), Boston; Johns Hopkins University, Baltimore (M.P.); Mayo Clinic, Rochester, MN (P.J.D., W.J.L., M.A.G.);...

family: Benson

full_name: Merrill D. Benson

given: Merrill D.

family: Waddington-Cruz

full_name: Márcia Waddington-Cruz

given: Márcia

family: Berk

full_name: John L. Berk

given: John L.

family: Polydefkis

full_name: Michael Polydefkis

given: Michael

family: Dyck

full_name: Peter J. Dyck

given: Peter J.

full_name: Annabel K. Wang

given: Annabel K.

family: Planté-Bordeneuve

full_name: Violaine Planté-Bordeneuve

given: Violaine

family: Barroso

full_name: Fabio A. Barroso

given: Fabio A.

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

family: Obici

full_name: Laura Obici

given: Laura

family: Scheinberg

full_name: Morton Scheinberg

given: Morton

family: Brannagan

full_name: Thomas H. Brannagan

given: Thomas H.

suffix: III

family: Litchy

full_name: William J. Litchy

given: William J.

family: Whelan

full_name: Carol Whelan

given: Carol

family: Drachman

full_name: Brian M. Drachman

given: Brian M.

family: Adams

full_name: David Adams

given: David

family: Heitner

full_name: Stephen B. Heitner

given: Stephen B.

family: Conceição

full_name: Isabel Conceição

given: Isabel

family: Schmidt

full_name: Hartmut H. Schmidt

given: Hartmut H.

family: Vita

full_name: Giuseppe Vita

given: Giuseppe

family: Campistol

full_name: Josep M. Campistol

given: Josep M.

family: Gamez

full_name: Josep Gamez

given: Josep

family: Gorevic

full_name: Peter D. Gorevic

given: Peter D.

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

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.

ReferenceCitation: Yarlas A, Lovley A, Brown D, Kosinski M, Vera-Llonch M. Responder analysis for neuropathic impairment and quality-of-life assessment in patients with hereditary transthyretin amyloidosis with polyneuropathy in the NEURO-TTR study. J Neurol. 2021 Jun 14. doi: 10.1007/s00415-021-10635-1. [Epub ahead of print]

ReferenceCitation: Yu RZ, Wang Y, Norris DA, Kim TW, Narayanan P, Geary RS, Monia BP, Henry SP. Immunogenicity Assessment of Inotersen, a 2'-O-(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety. Nucleic Acid Ther. 2020 Oct;30(5):265-275. doi: 10.1089/nat.2020.0867. Epub 2020 Aug 19.

name: Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.

name: Janssen Pharmaceuticals, R&D, San Diego, California, USA.

title: Immunogenicity Assessment of Inotersen, a 2′-O-(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety

ReferenceCitation: Dyck PJB, Kincaid JC, Wiesman JF, Polydefkis M, Litchy WJ, Mauermann ML, Ackermann EJ, Guthrie S, Pollock M, Jung SW, Baker BF, Dyck PJ. mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis. Muscle Nerve. 2020 Oct;62(4):502-508. doi: 10.1002/mus.27022. Epub 2020 Aug 13.

name: Department of Neurology Mayo Clinic  Rochester Minnesota USA

name: Department of Neurology Indiana University  Indianapolis Indiana USA

name: Department of Neurology New York University  New York New York USA

name: Department of Neurology Johns Hopkins University  Baltimore Maryland USA

name: Aurora Bio  San Francisco California USA

name: Akcea Therapeutics, Inc.  Cambridge Massachusetts USA

name: Ionis Pharmaceuticals, Inc.  Carlsbad California USA

title: mNIS +7 and lower limb function in inotersen treatment of hereditary transthyretin‐mediated amyloidosis

ReferenceCitation: Dyck PJB, Coelho T, Waddington Cruz M, Brannagan TH 3rd, Khella S, Karam C, Berk JL, Polydefkis MJ, Kincaid JC, Wiesman JF, Litchy WJ, Mauermann ML, Ackermann EJ, Baker BF, Jung SW, Guthrie S, Pollock M, Dyck PJ. Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis. Muscle Nerve. 2020 Oct;62(4):509-515. doi: 10.1002/mus.27023. Epub 2020 Aug 7.

name: Department of Neurosciences Centro Hospitalar do Porto  Porto Portugal

name: Department of Neurology Federal University of Rio de Janeiro, University Hospital  Rio de Janeiro Brazil

name: Department of Peripheral Neuropathy Columbia University Medical Center  New York New York USA

name: Department of Neurology University of Pennsylvania  Philadelphia Pennsylvania USA

name: Department of Neurology Oregon Health & Science University  Portland Oregon USA

name: Department of Medicine Boston University  Boston Massachusetts USA

name: Akcea Therapeutics, Inc.  Boston Massachusetts USA

ReferenceCitation: Coelho T, Yarlas A, Waddington-Cruz M, White MK, Sikora Kessler A, Lovley A, Pollock M, Guthrie S, Ackermann EJ, Hughes SG, Karam C, Khella S, Gertz M, Merlini G, Obici L, Schmidt HH, Polydefkis M, Dyck PJB, Brannagan Iii TH, Conceição I, Benson MD, Berk JL. Inotersen preserves or improves quality of life in hereditary transthyretin amyloidosis. J Neurol. 2020 Apr;267(4):1070-1079. doi: 10.1007/s00415-019-09671-9. Epub 2019 Dec 18.

ReferenceCitation: Pinto MV, Dyck PJB, Gove LE, McCauley BM, Ackermann EJ, Hughes SG, Waddington-Cruz M, Dyck PJ. Kind and distribution of cutaneous sensation loss in hereditary transthyretin amyloidosis with polyneuropathy. J Neurol Sci. 2018 Nov 15;394:78-83. doi: 10.1016/j.jns.2018.08.031. Epub 2018 Aug 30.

ReferenceCitation: Waddington-Cruz M, Ackermann EJ, Polydefkis M, Heitner SB, Dyck PJ, Barroso FA, Wang AK, Berk JL, Dyck PJB, Monia BP, Hughes SG, Tai L, Jesse Kwoh T, Jung SW, Coelho T, Benson MD, Gertz MA. Hereditary transthyretin amyloidosis: baseline characteristics of patients in the NEURO-TTR trial. Amyloid. 2018 Sep;25(3):180-188. doi: 10.1080/13506129.2018.1503593. Epub 2018 Aug 31.

name: Department of Neurology, Hospital Universitario Clementino Fraga, Federeal University of Rio, Rio de Janeiro, Brazil;

name: Clinical Development, Ionis Pharmaceuticals, Carlsbad, California, USA;

name: Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA;

name: Division of Cardiovascular Medicine, Knight Cardiovascular Institute, Portland, Oregon, USA;

name: Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA;

name: Department of Neurology, Institute for Neurological Research Raúl Carrea, FLENI, Buenos Aires, Argentina;

name: Department of Neurology, University of California, Irvine, Orange, California, USA;

name: Amyloidosis Center, Boston University School of Medicine, Boston, Massachusetts, USA;

name: Drug Discovery, Ionis Pharmaceuticals, Carlsbad, California, USA;

name: Biometrics, Ionis Pharmaceuticals, Carlsbad, California, USA;

name: Hospital de Santo Antonio, Centro Hospitalar Porto, Porto, Portugal;

name: Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA;

name: Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA

location_country:
Italy
Brazil
Spain
Germany
France
Argentina
New Zealand
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


status: Active, not recruiting

location_country:
Italy
Austria
Sweden
Hong Kong
Netherlands
France
Korea, Republic of
Israel
Slovakia
Singapore
Hungary
Russian Federation
Spain
United States
United Kingdom
Canada

location_facility: University of Texas/MD Anderson Cancer Center SC - 5

title: An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

summary: The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator

status_simplified: Ongoing


title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

summary: To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

name: Li Ka Shing Knowledge Institute; St Michael's Hospital; University of Toronto; Toronto ON Canada

family: Leiter

full_name: L. A. Leiter

given: L. A.

name: Department of Clinical Endocrinology and Nutrition (IBIMA); Hospital Virgen de la Victoria; University of Málaga; CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); Instituto de Salud Carlos III; Málaga Spain

family: Tinahones

full_name: F. J. Tinahones

given: F. J.

name: Sidney Kimmel Medical College; Thomas Jefferson University; Philadelphia PA USA

family: Karalis

full_name: D. G. Karalis

given: D. G.

family: Bujas-Bobanovic

full_name: M. Bujas-Bobanovic

given: M.

name: Biostatistics and Programming Department; Sanofi, Chilly-Mazarin France

family: Letierce

full_name: A. Letierce

given: A.

family: Mandel

full_name: J. Mandel

given: J.

name: Regeneron Pharmaceuticals, Inc.; Tarrytown NY USA

family: Samuel

full_name: R. Samuel

given: R.

name: Baylor College of Medicine; Houston TX USA

family: Jones

full_name: P. H. Jones

given: P. H.

journal_name: Diabetic Medicine

evidence: oa repository (via pmcid lookup)

license_normalized: no license

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

ReferenceCitation: Farnier M, Jones P, Severance R, Averna M, Steinhagen-Thiessen E, Colhoun HM, Du Y, Hanotin C, Donahue S. Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial. Atherosclerosis. 2016 Jan;244:138-46. doi: 10.1016/j.atherosclerosis.2015.11.010. Epub 2015 Nov 14.

family: Farnier

full_name: Michel Farnier

given: Michel

full_name: Peter Jones

given: Peter

family: Severance

full_name: Randall Severance

given: Randall

family: Averna

full_name: Maurizio Averna

given: Maurizio

family: Steinhagen-Thiessen

full_name: Elisabeth Steinhagen-Thiessen

given: Elisabeth

family: Colhoun

full_name: Helen M. Colhoun

given: Helen M.

family: Du

full_name: Yunling Du

given: Yunling

family: Hanotin

full_name: Corinne Hanotin

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.

name: Departments of Epidemiology and Medicine, College of Public Health University of Iowa  Iowa City Iowa

name: Division of Population Health Sciences, School of Medicine University of Dundee  Dundee Scotland

name: Louisville Metabolic and Atherosclerosis Research Center  Louisville Kentucky

name: Clinical Studies Unit Baylor College of Medicine  Houston Texas

name: Department of Biostatistics Regeneron Pharmaceuticals, Inc.  Tarrytown New York

name: Department of Clinical Research Sanofi  Paris France

name: Department of Clinical Sciences Regeneron Pharmaceuticals, Inc.  Tarrytown New York

repository_institution: University of Dundee - Discovery Research Portal

title: Efficacy and Safety of Alirocumab as Add‐on Therapy in High–Cardiovascular‐Risk Patients With Hypercholesterolemia Not Adequately Controlled With Atorvastatin (20 or 40 mg) or Rosuvastatin (10 or 20 mg): Design and Rationale of the ODYSSEY OPTIONS Studies

location_country:
Italy
United States
Mexico
Germany
France
Australia
Spain
Canada
United Kingdom


title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma

summary: First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
United States
France
Netherlands

location_facility:
Research Site
Greenville Hospital System


title: A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer

summary: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

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

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Norway
Belgium
Australia
Spain
Canada
Korea, Republic of

location_facility: University of Utah - Huntsman Cancer Institute - PPDS

location_facility: Smilow Cancer Hospital Care Center at North Haven

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Ospedaliero Universitaria di Modena Policlinico

location_facility: UCLA University of California Los Angeles

location_facility: Redwood Health Center - ARUP Lab Draw Location

location_facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Pharmacy of National Cancer Center Hospital East

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque


title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation

acronym: KONTINUE

summary: The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

ReferenceCitation: Pilewski JM, De Boeck K, Nick JA, Tian S, DeSouza C, Higgins M, Moss RB. Long-Term Ivacaftor in People Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations. Pulm Ther. 2020 Dec;6(2):303-313. doi: 10.1007/s41030-020-00129-2. Epub 2020 Sep 23.

family: Pilewski

full_name: Joseph M. Pilewski

given: Joseph M.

family: De Boeck

full_name: Kris De Boeck

given: Kris

family: Nick

full_name: Jerry A. Nick

given: Jerry A.

family: Tian

full_name: Simon Tian

given: Simon

family: DeSouza

full_name: Cynthia DeSouza

given: Cynthia

family: Higgins

full_name: Mark Higgins

given: Mark

family: Moss

full_name: Richard B. Moss

given: Richard B.

journal_name: Pulmonary Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Moss RB, Flume PA, Elborn JS, Cooke J, Rowe SM, McColley SA, Rubenstein RC, Higgins M; VX11-770-110 (KONDUCT) Study Group. Efficacy and safety of ivacaftor in patients with cystic fibrosis who have an Arg117His-CFTR mutation: a double-blind, randomised controlled trial. Lancet Respir Med. 2015 Jul;3(7):524-33. doi: 10.1016/S2213-2600(15)00201-5. Epub 2015 Jun 9.

full_name: Richard B Moss

given: Richard B

family: Flume

full_name: Patrick A Flume

given: Patrick A

family: Elborn

full_name: J Stuart Elborn

given: J Stuart

family: Cooke

full_name: Jon Cooke

given: Jon

family: Rowe

full_name: Steven M Rowe

given: Steven M

family: McColley

full_name: Susanna A McColley

given: Susanna A

family: Rubenstein

full_name: Ronald C Rubenstein

given: Ronald C

journal_name: The Lancet Respiratory Medicine

location_country:
United States
United Kingdom
Belgium
France


title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

summary: The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

ReferenceCitation: Azaro A, Baldini C, Rodon J, Soria JC, Yuen E, Lithio A, Oakley G, Benhadji KA, Massard C. Phase 1 study of 2 high dose intensity schedules of the pan-Notch inhibitor crenigacestat (LY3039478) in combination with prednisone in patients with advanced or metastatic cancer. Invest New Drugs. 2021 Feb;39(1):193-201. doi: 10.1007/s10637-020-00944-z. Epub 2020 Sep 11.

family: Azaro

full_name: Analía Azaro

given: Analía

family: Baldini

full_name: Capucine Baldini

given: Capucine

family: Rodon

full_name: Jordi Rodon

given: Jordi

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Yuen

full_name: Eunice Yuen

given: Eunice

family: Lithio

full_name: Andrew Lithio

given: Andrew

family: Oakley

full_name: Gerard Oakley

given: Gerard

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

family: Massard

full_name: Christophe Massard

given: Christophe

journal_name: Investigational New Drugs

ReferenceCitation: Mir O, Azaro A, Merchan J, Chugh R, Trent J, Rodon J, Ohnmacht U, Diener JT, Smith C, Yuen E, Oakley GJ 3rd, Le Cesne A, Soria JC, Benhadji KA, Massard C. Notch pathway inhibition with LY3039478 in soft tissue sarcoma and gastrointestinal stromal tumours. Eur J Cancer. 2018 Nov;103:88-97. doi: 10.1016/j.ejca.2018.08.012. Epub 2018 Sep 12.

family: Mir

full_name: Olivier Mir

given: Olivier

full_name: Analia Azaro

given: Analia

family: Merchan

full_name: Jaime Merchan

given: Jaime

family: Chugh

full_name: Rashmi Chugh

given: Rashmi

family: Trent

full_name: Jonathan Trent

given: Jonathan

family: Ohnmacht

full_name: Ute Ohnmacht

given: Ute

family: Diener

full_name: J.T. Diener

family: Smith

full_name: Claire Smith

given: Claire

full_name: Gerard Joseph Oakley

given: Gerard Joseph

family: Le Cesne

full_name: Axel Le Cesne

ReferenceCitation: Massard C, Azaro A, Soria JC, Lassen U, Le Tourneau C, Sarker D, Smith C, Ohnmacht U, Oakley G, Patel BKR, Yuen ESM, Benhadji KA, Rodon J. First-in-human study of LY3039478, an oral Notch signaling inhibitor in advanced or metastatic cancer. Ann Oncol. 2018 Sep 1;29(9):1911-1917. doi: 10.1093/annonc/mdy244.

location_country:
Germany
France
Spain
Denmark
United States
United Kingdom

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


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

ReferenceCitation: Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

name: Faculty CMC of Lomonosov MSU Moscow Russia

family: Gavrilov

full_name: Sergey Gavrilov

given: Sergey

family: Zhudenkov

full_name: Kirill Zhudenkov

given: Kirill

name: Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology & Safety Sciences BioPharmaceuticals R&D AstraZeneca Boston Massachusetts USA

family: Helmlinger

full_name: Gabriel Helmlinger

given: Gabriel

family: Dunyak

full_name: James Dunyak

given: James

name: Computational Oncology Group I.M. Sechenov First Moscow State Medical University Moscow Russia

family: Peskov

full_name: Kirill Peskov

family: Aksenov

full_name: Sergey Aksenov

currency_apc_doaj: USD

journal_name: CPT: Pharmacometrics & Systems Pharmacology

title: Longitudinal Tumor Size and Neutrophil‐to‐Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non‐Small Cell Lung Cancer Treated With Durvalumab

ReferenceCitation: Sheth S, Gao C, Mueller N, Angra N, Gupta A, Germa C, Martinez P, Soria JC. Durvalumab activity in previously treated patients who stopped durvalumab without disease progression. J Immunother Cancer. 2020 Aug;8(2). pii: e000650. doi: 10.1136/jitc-2020-000650.

family: Sheth

full_name: Siddharth Sheth

given: Siddharth

family: Gao

full_name: Chen Gao

given: Chen

family: Mueller

full_name: Nancy Mueller

given: Nancy

family: Angra

full_name: Natasha Angra

given: Natasha

family: Gupta

full_name: Ashok Gupta

given: Ashok

family: Germa

full_name: Caroline Germa

given: Caroline

family: Martinez

full_name: Pablo Martinez

given: Pablo

journal_name: Journal for ImmunoTherapy of Cancer

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Zajac M, Ye J, Mukhopadhyay P, Jin X, Ben Y, Antal J, Gupta AK, Rebelatto MC, Williams JA, Walker J. Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy. PLoS One. 2020 Apr 27;15(4):e0231936. doi: 10.1371/journal.pone.0231936. eCollection 2020.

title: Optimal PD-L1–high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy

ReferenceCitation: Nordstrom BL, Oguz M, Chu BC, Ouwens M, Arkenau HT, Klein AB. Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison. J Comp Eff Res. 2020 Feb;9(3):191-199. doi: 10.2217/cer-2019-0163. Epub 2020 Jan 9.

name: Evidera, Real-World Evidence, Waltham, MA 02451, USA

name: Evidera, Real-World Evidence, London, UK

name: Payer Models & Real-World Data, AstraZeneca, Mölndal, Sweden

name: Sarah Cannon Research Institute, London, UK

name: AstraZeneca, Oncology Business Unit, Global Medical Affairs, Gaithersburg, MD 20878, USA

journal_name: Journal of Comparative Effectiveness Research

repository_institution: University College London - UCL Discovery

ReferenceCitation: Antonia SJ, Balmanoukian A, Brahmer J, Ou SI, Hellmann MD, Kim SW, Ahn MJ, Kim DW, Gutierrez M, Liu SV, Schöffski P, Jäger D, Jamal R, Jerusalem G, Lutzky J, Nemunaitis J, Calabrò L, Weiss J, Gadgeel S, Bhosle J, Ascierto PA, Rebelatto MC, Narwal R, Liang M, Xiao F, Antal J, Abdullah S, Angra N, Gupta AK, Khleif SN, Segal NH. Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC. J Thorac Oncol. 2019 Oct;14(10):1794-1806. doi: 10.1016/j.jtho.2019.06.010. Epub 2019 Jun 20.

ReferenceCitation: Althammer S, Tan TH, Spitzmüller A, Rognoni L, Wiestler T, Herz T, Widmaier M, Rebelatto MC, Kaplon H, Damotte D, Alifano M, Hammond SA, Dieu-Nosjean MC, Ranade K, Schmidt G, Higgs BW, Steele KE. Automated image analysis of NSCLC biopsies to predict response to anti-PD-L1 therapy. J Immunother Cancer. 2019 May 6;7(1):121. doi: 10.1186/s40425-019-0589-x.

ReferenceCitation: Segal NH, Ou SI, Balmanoukian A, Fury MG, Massarelli E, Brahmer JR, Weiss J, Schöffski P, Antonia SJ, Massard C, Zandberg DP, Khleif SN, Xiao F, Rebelatto MC, Steele KE, Robbins PB, Angra N, Song X, Abdullah S, Butler M. Safety and efficacy of durvalumab in patients with head and neck squamous cell carcinoma: results from a phase I/II expansion cohort. Eur J Cancer. 2019 Mar;109:154-161. doi: 10.1016/j.ejca.2018.12.029. Epub 2019 Feb 4.

ReferenceCitation: Zajac M, Boothman AM, Ben Y, Gupta A, Jin X, Mistry A, Sabalos C, Nielsen A, Manriquez G, Barker C, Antal J, Wang P, Patil P, Schechter N, Rebelatto MC, Walker J. Analytical Validation and Clinical Utility of an Immunohistochemical Programmed Death Ligand-1 Diagnostic Assay and Combined Tumor and Immune Cell Scoring Algorithm for Durvalumab in Urothelial Carcinoma. Arch Pathol Lab Med. 2019 Jun;143(6):722-731. doi: 10.5858/arpa.2017-0555-OA. Epub 2018 Nov 20.

name: From Precision Medicine and Genomics, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom (Drs Zajac, Boothman, and Walker and Mr Barker); Global Medicines Development, AstraZeneca, Gaithersburg, Maryland (Dr Ben); Clinical Development (Dr Gupta and Ms Antal), Biostatistics (Dr Jin), and Translational Sciences and Pathology (Dr Rebelatto), MedImmune, Gaithersburg, Maryland; and Roche Tissue

journal_name: Archives of Pathology & Laboratory Medicine

publisher: Archives of Pathology and Laboratory Medicine

ReferenceCitation: Steele KE, Tan TH, Korn R, Dacosta K, Brown C, Kuziora M, Zimmermann J, Laffin B, Widmaier M, Rognoni L, Cardenes R, Schneider K, Boutrin A, Martin P, Zha J, Wiestler T. Measuring multiple parameters of CD8+ tumor-infiltrating lymphocytes in human cancers by image analysis. J Immunother Cancer. 2018 Mar 6;6(1):20. doi: 10.1186/s40425-018-0326-x.

ReferenceCitation: Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, Lee JL, Ong M, Sridhar SS, Vogelzang NJ, Fishman MN, Zhang J, Srinivas S, Parikh J, Antal J, Jin X, Gupta AK, Ben Y, Hahn NM. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. doi: 10.1001/jamaoncol.2017.2411. Epub 2017 Sep 14.

name: Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, England

name: Department of Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois

name: Department of Cancer Medicine, Institut Gustave Roussy Cancer Centre, Villejuif, France

name: Drug Development Unit, Sarah Cannon Research Institute, University College London Cancer Centre, London, England

name: Division of Genitourinary Medical Oncology, University of California, San Francisco Medical Center

name: School of Medicine, Case Western Reserve University Seidman Cancer Center, Cleveland, Ohio

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

name: Department of Medicine, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

name: Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

name: Department of Medical Oncology, Comprehensive Cancer Centers of Nevada, Las Vegas

name: Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, Florida

name: Division of Medical Oncology, Stanford University, Stanford, California

name: Department of Medicine, Augusta University, Augusta, Georgia

name: Immuno-Oncology Clinical Development, MedImmune, Gaithersburg, Maryland

name: Immuno-Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland

name: Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland

ReferenceCitation: Levy A, Massard C, Soria JC, Deutsch E. Concurrent irradiation with the anti-programmed cell death ligand-1 immune checkpoint blocker durvalumab: Single centre subset analysis from a phase 1/2 trial. Eur J Cancer. 2016 Nov;68:156-162. doi: 10.1016/j.ejca.2016.09.013. Epub 2016 Oct 17.

location_country:
Italy
United States
Germany
France
Belgium
Canada
United Kingdom
Korea, Republic of
Taiwan


ReferenceCitation: Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.

family: Hida

full_name: Toyoaki Hida

given: Toyoaki

family: Satouchi

full_name: Miyako Satouchi

given: Miyako

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Seto

full_name: Takashi Seto

given: Takashi

family: Matsumoto

full_name: Shingo Matsumoto

given: Shingo

family: Kiura

full_name: Katsuyuki Kiura

given: Katsuyuki

family: Nokihara

full_name: Hiroshi Nokihara

given: Hiroshi

family: Murakami

full_name: Haruyasu Murakami

given: Haruyasu

family: Tokushige

full_name: Kota Tokushige

given: Kota

family: Hatano

full_name: Ben Hatano

given: Ben

family: Nishio

full_name: Makoto Nishio

given: Makoto

journal_name: Japanese Journal of Clinical Oncology

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Crinò L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.

name: Lucio Crinò, University Medical School of Perugia, Azienda Ospedale Perugia, Perugia; Filippo De Marinis, European Institute of Oncology, Milan; Giorgio Scagliotti, University of Torino, Torino, Italy; Myung-Ju Ahn, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea; Harry J.M. Groen, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; Heather Wakelee, Stanford University Medical Center, Stanford, CA; Toyoaki Hida, Aichi Cancer...

family: Crinò

full_name: Lucio Crinò

given: Lucio

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: De Marinis

full_name: Filippo De Marinis

given: Filippo

family: Groen

full_name: Harry J.M. Groen

given: Harry J.M.

family: Wakelee

full_name: Heather Wakelee

given: Heather

family: Mok

full_name: Tony Mok

given: Tony

family: Spigel

full_name: David Spigel

given: David

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher: American Society of Clinical Oncology (ASCO)

title: Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2

location_country:
Italy
United States
Hong Kong
Netherlands
France
Japan
Korea, Republic of
Singapore
Spain
Germany
United Kingdom
Canada

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: University of California at Los Angeles Reg-5

location_facility: Stanford University Medical Center Stanford Cancer Center(2)

location_facility: City of Hope National Medical Center Dept of Oncology 2

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: University of Kansas Cancer Center DeptofUofKansas CancerCenter-2

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept of Oncology

location_facility: Massachusetts General Hospital Mass General

title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

summary: A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator


title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

acronym: EYEGUARD™-A

summary: The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

lead_sponsor: XOMA (US) LLC

location_country:
Armenia
Greece
Australia
Russian Federation
Taiwan
France
Poland
Argentina
Korea, Republic of
South Africa
China
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Mexico
Israel
Tunisia
Spain
Turkey


title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

acronym: eMESH 1

summary: Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

enrollment_type: Anticipated

lead_sponsor: Kips Bay Medical, Inc.

location_country:
Italy
Switzerland
Netherlands
United Kingdom
France
United States
Czech Republic

location_facility: Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research


title: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

acronym: CAPTURE

summary:
To monitor post-market performance through evaluation of short and long-term performance via:

Efficacy
Safety
Patient reported outcomes

lead_sponsor: ASTORA Women's Health

location_country:
United States
South Africa
United Kingdom
France
Spain
Germany
Slovenia
Canada

location_facility: Hospital Clínico y Provincial de Barcelona

location_facility: German Pelvic Floor Center, St. Hedwig Hospital

location_facility: Female Pelvic Medicine Institute of Virginia

location_facility: The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre


title: A Large, International, Randomized, Placebo-controlled Trial to Assess the Impact of Dabigatran (a Direct Thrombin Inhibitor) and Omeprazole (a Proton-pump Inhibitor) in Patients Suffering Myocardial Injury After Noncardiac Surgery

acronym: MANAGE

summary: Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.

ReferenceCitation: Duceppe E, Yusuf S, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Franzosi MG, Vincent J, Srinathan SK, Parlow J, Magloire P, Neary J, Rao M, Chaudhry NK, Mayosi B, de Nadal M, Popova E, Villar JC, Botto F, Berwanger O, Guyatt G, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Connolly SJ, Sharma M, Bangdiwala SI, Devereaux PJ. Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE). Can J Cardiol. 2018 Mar;34(3):295-302. doi: 10.1016/j.cjca.2018.01.020. Epub 2018 Feb 2.

ReferenceCitation: Lamy A, Tong W, Mian R, Vincent J, Szczeklik W, Biccard BM, Duceppe E, Franzosi MG, Srinathan SK, Meyhoff CS, Parlow J, Xavier D, Devereaux PJ. The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery. Am J Cardiovasc Drugs. 2021 Jul 26. doi: 10.1007/s40256-021-00489-3. [Epub ahead of print]

family: Lamy

full_name: Andre Lamy

given: Andre

family: Tong

full_name: Wesley Tong

given: Wesley

family: Mian

full_name: Rajibul Mian

given: Rajibul

family: Vincent

full_name: Jessica Vincent

given: Jessica

family: Szczeklik

full_name: Wojciech Szczeklik

given: Wojciech

family: Biccard

full_name: Bruce M. Biccard

given: Bruce M.

family: Duceppe

full_name: Emmanuelle Duceppe

given: Emmanuelle

family: Franzosi

full_name: Maria Graza Franzosi

given: Maria Graza

family: Srinathan

full_name: Sadeesh K. Srinathan

given: Sadeesh K.

family: Meyhoff

full_name: Christian S. Meyhoff

given: Christian S.

family: Parlow

full_name: Joel Parlow

given: Joel

family: Xavier

full_name: Denis Xavier

given: Denis

family: Devereaux

full_name: P. J. Devereaux

given: P. J.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8. Erratum in: Lancet. 2018 Jul 7;392(10141):30.

full_name: P J Devereaux

given: P J

family: Guyatt

full_name: Gordon Guyatt

given: Gordon

family: Tandon

full_name: Vikas Tandon

given: Vikas

family: Rodseth

full_name: Reitze Rodseth

given: Reitze

full_name: Bruce M Biccard

given: Bruce M

location_country:
Italy
Brazil
United States
Peru
India
South Africa
Philippines
Germany
France
Czechia
Poland
Kenya
Argentina
Australia
Spain
Denmark
Canada
United Kingdom
Colombia

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Fundacion Cardioinfantil - Instituto de Cardiologia

location_facility: Queens University - Kingston General Hospital

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: Russell Halls Hospital, Dudley Group NHS

location_facility: University Hospital, London Health Sciences Centre

location_facility: Centre Hospitalier Universitaire de Montreal - St. Luc Hospital

location_facility: IRCCS Istituto Ortopedico Galeazzi Milan

location_facility: Specjalistyczny Szpital im. E. Szczeklika

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Victoria Hospital, London Health Sciences Centre

location_facility: Zakład Opieki Zdrowotnej im. Jana Pawła II

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Amrita Institute of Medical Sciences and Research Institute

location_facility: M.S. Ramaiah Medical College & Hospitals

location_facility: Clinica Parra - Centro de Investigaciones

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Belfast Health and Social Care Trust, Royal Victoria Hospital

location_facility: VA North Texas Health Care System Dallas VA Medical Center


title: The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

acronym: PSR-REVERSE

summary: The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

lead_sponsor: Medtronic

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


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)

acronym: FUSCIA

summary:
Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

lead_sponsor: Sanofi

location_country:
Italy
Austria
Germany
France
Poland
United States
Canada

location_facility:
Investigational Site Number 276007
Investigational Site Number 276001
Investigational Site Number 840061
Investigational Site Number 840046
Investigational Site Number 840053
Investigational Site Number 840045
Investigational Site Number 840088
Investigational Site Number 840005
Investigational Site Number 616002
Investigational Site Number 840089
Investigational Site Number 840064
Investigational Site Number 840078
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616008
Investigational Site Number 250006
Investigational Site Number 840038
Investigational Site Number 840070
Investigational Site Number 840059
Investigational Site Number 840051
Investigational Site Number 040003
Investigational Site Number 616006
Investigational Site Number 250003
Investigational Site Number 840008
Investigational Site Number 840001
Investigational Site Number 616001
Investigational Site Number 124002
Investigational Site Number 840074
Investigational Site Number 380003
Investigational Site Number 840068
Investigational Site Number 840071
Investigational Site Number 276005
Investigational Site Number 840060
Investigational Site Number 840065
Investigational Site Number 840034
Investigational Site Number 380006
Investigational Site Number 840024
Investigational Site Number 840019
Investigational Site Number 840048
Investigational Site Number 616007
Investigational Site Number 616004


title: A Multicenter, Two Stage, Phase II Study, Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

summary:
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.

Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study.

However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.

ReferenceCitation: Fazio N, Buzzoni R, Baudin E, Antonuzzo L, Hubner RA, Lahner H, DE Herder WW, Raderer M, Teulé A, Capdevila J, Libutti SK, Kulke MH, Shah M, Dey D, Turri S, Aimone P, Massacesi C, Verslype C. A Phase II Study of BEZ235 in Patients with Everolimus-resistant, Advanced Pancreatic Neuroendocrine Tumours. Anticancer Res. 2016 Feb;36(2):713-9.

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

location_facility: Dana Farber Cancer Institute GastrointestionalCancer Clinic

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC


title: An Open-label, Multicenter, Single-arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects With Epilepsy Switching From Levetiracetam to Brivaracetam Due to Nonpsychotic Behavioral Side Effects Phase 3b

summary: Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

ReferenceCitation: Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D'Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015 Nov;52(Pt A):165-8. doi: 10.1016/j.yebeh.2015.09.005. Epub 2015 Sep 29.

family: Yates

full_name: Stephen L. Yates

given: Stephen L.

family: Fakhoury

full_name: Toufic Fakhoury

given: Toufic

family: Liang

full_name: Wei Liang

given: Wei

family: Eckhardt

full_name: Klaus Eckhardt

given: Klaus

family: Borghs

full_name: Simon Borghs

given: Simon

family: D'Souza

full_name: Joseph D'Souza

given: Joseph

journal_name: Epilepsy & Behavior

lead_sponsor: UCB Pharma SA

location_country:
United States
France
Spain
Germany
United Kingdom