location_country:
Italy
Austria
Brazil
Mexico
Spain
Germany
France
Czechia
Japan
Israel
Poland
Puerto Rico
Russian Federation
China
Denmark
United States
United Kingdom
Ukraine

acronym: PRONTO-Peds

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: San Jorge Children and Women's Hospital- Shipping Location

location_facility: Children's Hospital Capital Institute of Pediatrics

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Diabetes and Glandular Disease Research Associates PA

location_facility: Hôpital Universitaire Necker enfants malades

location_facility: Siberian State Medical University of Roszdrav

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Institute of the Health Care of Children & Adolescents

location_facility: Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit

location_facility: University of South Florida Diabetes & Endocrinology Center

location_facility: Ivano-Frankivsk regional clinical children hospital

location_facility: Samarskiy Regional Children's Clinical Hospital

location_facility: St.Petersburg Children's City Polyclinic #44

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes

location_facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Research Institute for Pediatric Endocrinology

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital Universitario Central de Asturias

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine

location_facility: Smolensk Regional Children's Clinical Hospital

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Zaporizhzhia regional clinical children hospital

location_facility: Diabetologische Schwerpunktpraxis Dr. Ziegler

location_facility: Niigata University Medical & Dental Hospital

location_facility: Children's Hospital Los Angeles - Dept of Endocrinology

location_facility: Odesa regional children's clinical hospital

location_facility: MultiCare Institute for Research & Innovation

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH

location_facility: Tokyo Women's Medical University Hospital

location_facility: Indiana University- Riley Children's Hospital

title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes

summary: The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).


ReferenceType: derived

ReferenceCitation: Deng X, Salgado-Polo F, Shao T, Xiao Z, Van R, Chen J, Rong J, Haider A, Shao Y, Josephson L, Perrakis A, Liang SH. Imaging Autotaxin In Vivo with (18)F-Labeled Positron Emission Tomography Ligands. J Med Chem. 2021 Oct 28;64(20):15053-15068. doi: 10.1021/acs.jmedchem.1c00913. Epub 2021 Oct 18.

name: Division of Nuclear Medicine and Molecular Imaging, Massachusetts General Hospital & Department of Radiology, Harvard Medical School, Boston, Massachusetts 02114, United States

name: Department of Nuclear Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China

family: Deng

full_name: Xiaoyun Deng

given: Xiaoyun

sequence: first

name: Oncode Institute and Division of Biochemistry, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands

family: Salgado-Polo

full_name: Fernando Salgado-Polo

given: Fernando

sequence: additional

family: Shao

full_name: Tuo Shao

given: Tuo

family: Xiao

full_name: Zhiwei Xiao

given: Zhiwei

name: Department of Chemistry and Biochemistry, University of Oklahoma, Norman, Oklahoma 73019, United States

family: Van

full_name: Richard Van

given: Richard

family: Chen

full_name: Jiahui Chen

given: Jiahui

family: Rong

full_name: Jian Rong

given: Jian

family: Haider

full_name: Ahmed Haider

given: Ahmed

full_name: Yihan Shao

given: Yihan

family: Josephson

full_name: Lee Josephson

given: Lee

family: Perrakis

full_name: Anastassis Perrakis

given: Anastassis

family: Liang

full_name: Steven H. Liang

given: Steven H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Medicinal Chemistry

publisher: American Chemical Society (ACS)

publisher_dissemination: American Chemical Society

publisher_group: American Chemical Society

publisher_normalized: American Chemical Society

title: Imaging Autotaxin In Vivo with 18F-Labeled Positron Emission Tomography Ligands

ReferenceCitation: Maher TM, Kreuter M, Lederer DJ, Brown KK, Wuyts W, Verbruggen N, Stutvoet S, Fieuw A, Ford P, Abi-Saab W, Wijsenbeek M. Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2). BMJ Open Respir Res. 2019 May 21;6(1):e000422. doi: 10.1136/bmjresp-2019-000422. eCollection 2019.

family: Maher

full_name: Toby M Maher

given: Toby M

family: Kreuter

full_name: Michael Kreuter

given: Michael

family: Lederer

full_name: David J Lederer

given: David J

family: Brown

full_name: Kevin K Brown

given: Kevin K

family: Wuyts

full_name: Wim Wuyts

given: Wim

family: Verbruggen

full_name: Nadia Verbruggen

given: Nadia

family: Stutvoet

full_name: Simone Stutvoet

given: Simone

family: Fieuw

full_name: Ann Fieuw

given: Ann

family: Ford

full_name: Paul Ford

given: Paul

family: Abi-Saab

full_name: Walid Abi-Saab

given: Walid

family: Wijsenbeek

repositories:
LIRIAS (KU Leuven)
PubMed Central
repub.eur.nl

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

location_country:
Italy
United States
South Africa
Mexico
Netherlands
Germany
France
Japan
Poland
Israel
Hungary
Argentina
New Zealand
Canada
Korea, Republic of

location_facility: GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

location_facility: Medical University of South Carolina - PPDS

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: National Hospital Organization Ibarakihigashi National Hospital

location_facility: Hospital Privado Centro Médico de Córdoba

location_facility: Instituto Nacional De Enfermedades (INER)

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Hôtel Dieu Du Centre Hospitalier de L'université de Montréal

location_facility: Hospital Universitatorio Dr. Jose Eleuterio González

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

location_facility: University of Michigan Health System (UMHS)

location_facility: McGill University Health Centre Research Institute

location_facility: Tohoku Medical and Pharmaceutical Hospital

location_facility: Instituto de Investigaciones Clínicas Mar Del Plata

location_facility: Mercy Health - St. Vincent Medical Center

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

location_facility: Hospital Zonal Especializado de Agudos y Crónicos Dr. Antonio A. Cetrangolo

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University of California, San Francisco Medical Center

location_facility: University of Arizona College of Medicine

location_facility: University of Cape Town Lung Institute (UCTLI)

location_facility: Presidio Ospedaliero GB Morgagni L Pierantoni

location_facility: Seoul National University Bundang Hospital

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Centre Hospitalier Regional Universitaire Montpellier

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Kobe City Medical Center General Hospital

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B

location_facility: PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.

title: A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

summary: The main purpose of this study is to see how GLPG1690 works together with the current standard treatment on your lung function and IPF disease in general. The study will also investigate how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).


title: Advisor HD Grid Observational Study

summary: The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Vmax voltage mapping (hereafter called "HD Wave") in subjects with PersAF or VT in real-world clinical settings.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Austria
South Africa
Netherlands
Spain
Germany
France
Australia
Portugal
Denmark
Canada

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: A. ö. Krankenhaus der Elisabethinen Linz

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)

summary:
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.

Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

status: Enrolling by invitation

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: MyoKardia, Inc.

location_country:
Italy
Netherlands
Spain
Germany
France
Czechia
Poland
Israel
Belgium
Portugal
Denmark
United States
United Kingdom

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Washington University School of Medicine

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: St. Vincent Hospital and Health Care Center

location_facility: Institut klinicke a experimentalni mediciny

location_facility: University of Texas Southwestern Medical Center

location_facility: University Of Iowa Hospitals And Clinics

intervention_type: Drug

status_simplified: Unknown


title: A Phase 1b/2 Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

summary:
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.

The study is divided into two parts: single agent FT-2102 followed by combination therapy.

Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored.

Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102+nivolumab (hepatobiliary tumors) and FT-2102+gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.

status: Active, not recruiting

design_allocation: Non-Randomized

lead_sponsor: Forma Therapeutics, Inc.

location_country:
France
Australia
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Centre de Lutte Contre Cancre (CLCC) - Institute Bergonie

location_facility: Northwestern University, Lurie Comprehensive Cancer Center

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: Univerity of Iowa, Holden Comprehesive Cancer Institute

location_facility: Medical College of Wisconsin, Froedtert Hospital

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

ReferenceType: result

ReferenceCitation: Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.

family: Winston

full_name: Alan Winston

given: Alan

family: Post

full_name: Frank A Post

given: Frank A

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Di Perri

full_name: Giovanni Di Perri

given: Giovanni

family: Estrada

full_name: Vicente Estrada

given: Vicente

family: Raffi

full_name: François Raffi

given: François

family: Ruane

full_name: Peter Ruane

given: Peter

family: Peyrani

full_name: Paula Peyrani

given: Paula

family: Crofoot

full_name: Gordon Crofoot

given: Gordon

family: Mallon

full_name: Patrick W G Mallon

given: Patrick W G

family: Castelli

full_name: Francesco Castelli

given: Francesco

family: Yan

full_name: Mingjin Yan

given: Mingjin

family: Cox

full_name: Stephanie Cox

given: Stephanie

family: Das

full_name: Moupali Das

given: Moupali

family: Cheng

full_name: Andrew Cheng

given: Andrew

family: Rhee

full_name: Martin S Rhee

given: Martin S

journal_name: The Lancet HIV

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Imperial College London - Spiral

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

family: Gupta

full_name: Samir K. Gupta

given: Samir K.

full_name: Frank A. Post

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

publisher: Ovid Technologies (Wolters Kluwer Health)

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Italy
United States
Sweden
Germany
France
Ireland
Belgium
Puerto Rico
Spain
Denmark
Canada
United Kingdom

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Tarrant County Infectious Disease Associates

location_facility: Centre Hospitalier Universitaire CHU Sart Tilman Liege

location_facility: Highland Hospital - Alameda Health System

location_facility: University of California San Diego (UCSD)

location_facility: La Playa Medical Group and Clinical Research

location_facility: Johann Wolfgang Goethe-University Hospital

location_facility: Hospital Clínico Universitario San Carlos

location_facility: Ospedale Amedeo di Savoia - Specializzato Malattie infettive

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Vancouver ID Research and Care Centre Society

location_facility: ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg


status: Recruiting

lead_sponsor: Celgene

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

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Pittsburgh Medical Center - William M. Cooper Ambulatory Care Pavilion

location_facility: UCLA Medical Centre-Santa Monica Hematology and Oncology

location_facility: Duke Clinical Research Institute Duke University School of Medicine

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of Colorado Anschutz Cancer Pavilion

location_facility: Sarah Cannon Research Institute Center for Blood

location_facility: Centre Hospitalier Univ De Nantes Hotel-Dieu

location_facility: Washington University School of Medicine, Siteman Cancer Center

location_facility: New York Presbyterian Hospital Weil Cornell Medical College

location_facility: University of Utah Huntsman Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematolog

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Baylor University Medical Center at Dallas

type: Registry Identifier

source: euctr

title: A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

summary:
This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.


title: A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

acronym: Diamond-AFII

summary: The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
United States
France
Czechia
Germany
Canada

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

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Klinicke a Experimentalni Mediciny (IKEM)


title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

summary: This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.

name: From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China–Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University...

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

family: Ferguson

full_name: Gary T. Ferguson

given: Gary T.

family: Wang

full_name: Chen Wang

given: Chen

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Trivedi

full_name: Roopa Trivedi

given: Roopa

family: St. Rose

full_name: Earl St. Rose

given: Earl

family: Ballal

full_name: Shaila Ballal

given: Shaila

family: McLaren

full_name: Julie McLaren

given: Julie

family: Darken

full_name: Patrick Darken

given: Patrick

family: Aurivillius

full_name: Magnus Aurivillius

given: Magnus

family: Reisner

full_name: Colin Reisner

given: Colin

family: Dorinsky

full_name: Paul Dorinsky

given: Paul

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct - Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.

location_country:
Peru
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
South Africa
Chile
Sweden
Netherlands
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
New Zealand
Spain


title: An International, Multicentre, Observational, Prospective, Longitudinal Cohort Study to Assess the Impact of Integrated Upper Limb Spasticity Management Including the Use of BoNT-A- Injections on Patient-centred Goal Attainment in Real Life Practice - ULIS III

acronym: ULIS III

summary: The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.

ReferenceCitation: Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770.

apc_source: doaj

family: Turner-Stokes

full_name: L Turner-Stokes

given: L

family: Jacinto

full_name: J Jacinto

given: J

family: Fheodoroff

full_name: K Fheodoroff

given: K

family: Brashear

full_name: A Brashear

given: A

family: Maisonobe

full_name: P Maisonobe

given: P

family: Lysandropoulos

full_name: A Lysandropoulos

family: group

full_name: S group

given: S

currency_apc_doaj: EUR

journal_name: Journal of Rehabilitation Medicine

oa_host_type: publisher

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Medical Journals Sweden AB

publisher_dissemination: Medical Journals Sweden AB

publisher_group: Medical Journals Sweden AB

publisher_normalized: Medical Journals Sweden AB

ReferenceCitation: Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

full_name: Lynne Turner-Stokes

given: Lynne

family: Ashford

full_name: Stephen Ashford

given: Stephen

full_name: Jorge Jacinto

given: Jorge

full_name: Pascal Maisonobe

given: Pascal

family: Balcaitiene

full_name: Jovita Balcaitiene

given: Jovita

full_name: Klemens Fheodoroff

given: Klemens

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

location_country:
Italy
Austria
Brazil
Hong Kong
Mexico
Philippines
Germany
France
Poland
Australia
Russian Federation
Portugal
United States
Taiwan

location_facility: Centre Régional de Rééducation et Réadaptation Fonctionnelle

location_facility: Federal State Hospital for Treatment and Rehabilitation

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Regional State Budgetary Healthcare Institution "City Hospital N°5"

location_facility: Institut Universitaire de Réadaptation de Clémenceau

location_facility: National Institute of Neurology/Rehabilitation

location_facility: Azienda Ospedaliero Universitaria Policlinico "G Martino"

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Hospital dos Clinicas Universitaria de Sao Paulo

location_facility: Liverpool Brain Injury Rehabilitation Unit

location_facility: Pavlov First Saint-Petersburg State Medical University

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico

location_facility: Interregional Cinical and Diagnostic Centre


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis

summary: This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

lead_sponsor: Celtaxsys, Inc.

location_country:
Italy
United States
Germany
France
Belgium
Canada
United Kingdom

location_facility: Universiy of Tennessee Medical Center UHS

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: University of California Davis Medical Center

location_facility: Banner University of Arizona Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Institut für klinische Forschung Pneumologie

location_facility: Carl-Gustav-Klinikum Dresden, Mukoviszidose Centrum "Christiane Herzog"

location_facility: Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University

location_facility: University of Oklahoma Health Sciences Center


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Brazil
Mexico
Philippines
France
Romania
Russian Federation
China
Ukraine

acronym: IMI/REL (MK-7655A) vs. PIP/TAZ for Treatment of Subjects with HABP/VABP

location_facility: Zhujiang Hospital of Southern Medical University ( Site 0148)

location_facility: Ningbo First Hospital-neurosurgery ( Site 0152)

location_facility: Lung Center of the Philippines ( Site 0903)

location_facility: The First Affiliated Hospital ( Site 0100)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0300)

location_facility: The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0301)

location_facility: People s Hospital of Lishui City ( Site 0137)

location_facility: Tianjin Medical University General Hospital ( Site 0113)

location_facility: First Hospital Affiliated to Suzhou University ( Site 0111)

location_facility: Hopital Roger Salengro du Lille ( Site 0601)

location_facility: City Hospital #2 Severodvinsk ( Site 1017)

location_facility: Kiyv city municipal hospital 17 ( Site 1300)

location_facility: The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)

location_facility: First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)

location_facility: City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)

location_facility: ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)

location_facility: Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)

location_facility: Hunan Provincial People Hospital ( Site 0122)

location_facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)

location_facility: Huizhou Municipal Central Hospital ( Site 0140)

location_facility: Peking University First Hospital ( Site 0131)

location_facility: Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)

location_facility: The First Affiliated Hospital of China Medical University ( Site 0116)

location_facility: Guangzhou First People's Hospital ( Site 0101)

location_facility: West Visayas State University Medical Center ( Site 0900)

location_facility: Southern Medical University Nanfang Hospital ( Site 0120)

location_facility: Jiangxi Provincial People's Hospital ( Site 0129)

location_facility: Huashan Hospital of Fudan University ( Site 0105)

location_facility: Shanghai Pulmonary Hospital ( Site 0108)

location_facility: The first people s hospital of Nanning ( Site 0138)

location_facility: People's Hospital of Liaocheng City-Neurology ( Site 0154)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)

location_facility: The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)

location_facility: Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: Affiliated Hospital of Jiangsu University ( Site 0147)

location_facility: General Hospital of Ningxia Medical University ( Site 0135)

location_facility: Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)

location_facility: Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)

location_facility: The first people s hospital of Nanning ( Site 0141)

location_facility: The First Affiliated Hospital of Zhengzhou University ( Site 0121)

location_facility: The First People's Hospital of Changzhou ( Site 0139)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 0132)

location_facility: Huadong Hospital Affiliated Fudan University ( Site 0103)

location_facility: Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)

location_facility: Shiyan City People's Hospital-Neurosurgery ( Site 0155)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 0102)

location_facility: Ivano-Frankivsk regional clinical hospital ( Site 1301)

location_facility: Peking University Third Hospital ( Site 0115)

location_facility: The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)

location_facility: Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)

ipd_sharing: Yes

type: Other Identifier

title: A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

summary: This study will evaluate the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) (MK-7655A) compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed

summary: The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

ReferenceType: background

ReferenceCitation: Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir plus rilpivirine for the maintenance of virologic suppression in HIV-1-infected adults: the phase III, randomized, open-label, active-controlled, noninferiority SWORD-1 and SWORD-2 studies. Lancet [epublished ahead of print] 6 January 2018.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

family: Aboud

full_name: Michael Aboud

given: Michael

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Bogner

full_name: Johannes R Bogner

given: Johannes R

family: Baker

full_name: David Baker

given: David

family: Khuong-Josses

full_name: Marie-Aude Khuong-Josses

given: Marie-Aude

family: Parks

full_name: David Parks

family: Angelis

full_name: Konstantinos Angelis

given: Konstantinos

family: Kahl

full_name: Lesley P Kahl

given: Lesley P

family: Blair

full_name: Elizabeth A Blair

given: Elizabeth A

family: Adkison

full_name: Kimberly Adkison

given: Kimberly

family: Underwood

full_name: Mark Underwood

given: Mark

family: Matthews

full_name: Jessica E Matthews

given: Jessica E

family: Wynne

full_name: Brian Wynne

given: Brian

family: Vandermeulen

full_name: Kati Vandermeulen

given: Kati

family: Gartland

full_name: Martin Gartland

given: Martin

family: Smith

full_name: Kimberly Smith

title: Efficacy and safety of dolutegravir–rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

family: Llibre

full_name: Josep M Llibre

given: Josep M

family: Hung

full_name: Chien-Ching Hung

given: Chien-Ching

family: Brinson

full_name: Cynthia Brinson

given: Cynthia

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Taiwan


lead_sponsor: Albireo

location_country:
Italy
United States
Sweden
Saudi Arabia
Netherlands
Germany
France
Poland
Israel
Belgium
Australia
Spain
Turkey
Canada
United Kingdom

acronym: PEDFIC 1

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Washington University School of Medicine

location_facility: Schneider Children's Medical Center Of Israel

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

location_facility: Universite Paris SUD - Hopitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: Baylor College of Medicine - Texas Children's Liver Center

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Hacettepe University Faculty of Medicine

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: University and Pediatric Hospital of Lyon

location_facility: Columbia University Medical Center - Presbyterian Hospital Building

location_facility: Kinderklinik Tübingen, Universitätsklinikum Tübingen

location_facility: Universitair Medisch Centrum (UMC) Utrecht

title: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

summary: Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

summary: A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

lead_sponsor: Hoffmann-La Roche

location_country:
Switzerland
France
Australia
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM

location_facility: Centre Georges François Leclerc; Pharmacie des Essais Cliniques

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale


title: A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

acronym: SAVAL

summary: Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

ReferenceCitation: Kolte D, Kennedy KF, Shishehbor MH, Abbott JD, Khera S, Soukas P, Mamdani ST, Hyder ON, Drachman DE, Aronow HD. Thirty-Day Readmissions After Endovascular or Surgical Therapy for Critical Limb Ischemia: Analysis of the 2013 to 2014 Nationwide Readmissions Databases. Circulation. 2017 Jul 11;136(2):167-176. doi: 10.1161/CIRCULATIONAHA.117.027625. Epub 2017 May 2.

ReferenceCitation: Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review.

ReferenceCitation: Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989.

ReferenceCitation: Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, de Vries JP, Vos JA, de Borst GJ, Vonken EJ, Wever JJ, Statius van Eps RG, Mali WP, van Overhagen H. Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376. doi: 10.1161/CIRCINTERVENTIONS.114.002376.

ReferenceCitation: Kinlay S. Management of Critical Limb Ischemia. Circ Cardiovasc Interv. 2016 Feb;9(2):e001946. doi: 10.1161/CIRCINTERVENTIONS.115.001946.

ReferenceCitation: Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008. Review.

ReferenceCitation: Conte MS. Critical appraisal of surgical revascularization for critical limb ischemia. J Vasc Surg. 2013 Feb;57(2 Suppl):8S-13S. doi: 10.1016/j.jvs.2012.05.114. Review.

ReferenceCitation: Gray BH, Diaz-Sandoval LJ, Dieter RS, Jaff MR, White CJ; Peripheral Vascular Disease Committee for the Society for Cardiovascular Angiography and Interventions. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):539-45. doi: 10.1002/ccd.25395. Epub 2014 Jul 18.

ReferenceCitation: Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34.

ReferenceCitation: Popplewell MA, Davies HOB, Narayanswami J, Renton M, Sharp A, Bate G, Patel S, Deeks J, Bradbury AW. A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial. Eur J Vasc Endovasc Surg. 2017 Aug;54(2):195-201. doi: 10.1016/j.ejvs.2017.04.020. Epub 2017 Jun 8.

ReferenceCitation: Sadaghianloo N, Jean-Baptiste E, Declemy S, Mousnier A, Brizzi S, Hassen-Khodja R. Percutaneous angioplasty of long tibial occlusions in critical limb ischemia. Ann Vasc Surg. 2013 Oct;27(7):894-903. doi: 10.1016/j.avsg.2013.02.008.

ReferenceCitation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

family: Bosiers

full_name: Marc Bosiers

given: Marc

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

family: Peeters

full_name: Patrick Peeters

given: Patrick

family: Torsello

full_name: Giovanni Torsello

given: Giovanni

family: Zeller

full_name: Thomas Zeller

given: Thomas

family: Deloose

full_name: Koen Deloose

given: Koen

family: Schmidt

full_name: Andrej Schmidt

given: Andrej

family: Tessarek

full_name: Jörg Tessarek

given: Jörg

family: Vinck

full_name: Erwin Vinck

given: Erwin

family: Schwartz

full_name: Lewis B. Schwartz

given: Lewis B.

journal_name: Journal of Vascular Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, de Borst GJ, Vonken EPA, Bijlstra OD, Wever JJ, Statius van Eps RG, Mali WPTM, van Overhagen H. Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia. J Am Heart Assoc. 2017 Apr 14;6(4). pii: e004877. doi: 10.1161/JAHA.116.004877.

ReferenceCitation: de Weger VA, Beijnen JH, Schellens JH. Cellular and clinical pharmacology of the taxanes docetaxel and paclitaxel--a review. Anticancer Drugs. 2014 May;25(5):488-94. doi: 10.1097/CAD.0000000000000093. Review. Erratum in: Anticancer Drugs. 2015 Feb;26(2):240.

ReferenceCitation: Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. Eur J Clin Invest. 2015 Mar;45(3):333-45. doi: 10.1111/eci.12407. Epub 2015 Feb 14. Review.

ReferenceCitation: Dake MD, Van Alstine WG, Zhou Q, Ragheb AO. Polymer-free paclitaxel-coated Zilver PTX Stents--evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011 May;22(5):603-10. doi: 10.1016/j.jvir.2010.12.027. Epub 2011 Mar 17.

ReferenceCitation: Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig MS, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Armstrong EJ, Jeon-Slaughter H, Brilakis ES, Bhatt DL. Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry. Circ Cardiovasc Interv. 2016 Feb;9(2):e002730. doi: 10.1161/CIRCINTERVENTIONS.115.002730. Erratum in: Circ Cardiovasc Interv. 2016 Oct;9(10 ):.

ReferenceCitation: Federman DG, Ladiiznski B, Dardik A, Kelly M, Shapshak D, Ueno CM, Mostow EN, Richmond NA, Hopf HW. Wound Healing Society 2014 update on guidelines for arterial ulcers. Wound Repair Regen. 2016 Jan-Feb;24(1):127-35. doi: 10.1111/wrr.12395. Review.

lead_sponsor: Boston Scientific Corporation

location_country:
Netherlands
France
Japan
Belgium
United States

location_facility: Cardiovascular Institute of the South Clinical Research Corporation

location_facility: Amputation Prevention Center of North Carolina

location_facility: Washington University School of Medicine

location_facility: HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital

location_facility: Advanced Cardiac & Vascular Centers for Amputation Prevention

location_facility: Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: Willis Knighton Bossier Medical Center - Grace Research, LLC

intervention_type: Combination Product


title: Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

acronym: STAGED-PKD

summary:
Primary Objective:

To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2).

Secondary Objectives:

To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2).
To evaluate the pharmacokinetics (PK) of venglustat in Autosomal Dominant Polycystic Kidney Disease patients (Stages 1 and 2).
To determine the effect of venglustat on pain and fatigue, based on patient reported diary (Stages 1 and 2).
Safety/tolerability objective:
To characterize the safety profile of venglustat (Stages 1 and 2).
To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2).
To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).

status: Terminated

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Romania
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Netherlands
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

location_facility:
Investigational Site Number 2030002
Investigational Site Number 2760003
Investigational Site Number 7240003
Investigational Site Number 6420001
Investigational Site Number 7920001
Investigational Site Number 2500004
Investigational Site Number 2760011
Investigational Site Number 8400010
Investigational Site Number 1560002
Investigational Site Number 8260001
Investigational Site Number 6160003
Investigational Site Number 3760003
Investigational Site Number 8400014
Investigational Site Number 5280003
Investigational Site Number 1560009
Investigational Site Number 6420002
Investigational Site Number 8400007
Investigational Site Number 3800001
Investigational Site Number 2760005
Investigational Site Number 3800003
Investigational Site Number 8400021
Investigational Site Number 1560005
Investigational Site Number 8400004
Investigational Site Number 8400001
Investigational Site Number 2760009
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 2030001
Investigational Site Number 3800002
Investigational Site Number 2760001
Investigational Site Number 6420004
Investigational Site Number 8400019
Investigational Site Number 0360001
Investigational Site Number 2760010
Investigational Site Number 3920002
Investigational Site Number 5280002
Investigational Site Number 1560003
Investigational Site Number 8400002
Investigational Site Number 3920009
Investigational Site Number 8400015
Investigational Site Number 7920003
Investigational Site Number 6160001
Investigational Site Number 7240002
Investigational Site Number 7920002
Investigational Site Number 8400003
Investigational Site Number 2760004
Investigational Site Number 3920006
Investigational Site Number 1560004
Investigational Site Number 3920010
Investigational Site Number 3920003
Investigational Site Number 2760012
Investigational Site Number 3920008
Investigational Site Number 1560006
Investigational Site Number 2760007
Investigational Site Number 4100001
Investigational Site Number 0400004
Investigational Site Number 5280001
Investigational Site Number 0400001
Investigational Site Number 3920007
Investigational Site Number 3920005
Investigational Site Number 8400016
Investigational Site Number 2760002
Investigational Site Number 1560007
Investigational Site Number 1560001
Investigational Site Number 8400006
Investigational Site Number 0320001
Investigational Site Number 1240003
Investigational Site Number 0560002
Investigational Site Number 2080001
Investigational Site Number 7240001
Investigational Site Number 1560008
Investigational Site Number 8400011
Investigational Site Number 8400005
Investigational Site Number 6160002
Investigational Site Number 8400027
Investigational Site Number 4100002
Investigational Site Number 1240001
Investigational Site Number 8400008
Investigational Site Number 2500002
Investigational Site Number 3920001
Investigational Site Number 6200004
Investigational Site Number 0360003
Investigational Site Number 6200001
Investigational Site Number 8400020
Investigational Site Number 3920004
Investigational Site Number 6200005
Investigational Site Number 2500001
Investigational Site Number 0560001
Investigational Site Number 2080002
Investigational Site Number 0320003
Investigational Site Number 8400017
Investigational Site Number 1580002
Investigational Site Number 3760002
Investigational Site Number 1580001
Investigational Site Number 0360002


title: A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy, in Combination With mFOLFOX6 (With or Without Nivolumab) and in Combination With Pembrolizumab in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Whose Tumors Have High or Intermediate Claudin (CLDN) 18.2 Expression

acronym: ILUSTRO

summary: The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

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

location_facility: The Angeles Clinic and Research Institute


ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4.

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Garon

full_name: Edward B Garon

given: Edward B

family: Seto

full_name: Takashi Seto

given: Takashi

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: Ponce Aix

full_name: Santiago Ponce Aix

given: Santiago

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Chiu

full_name: Chao-Hua Chiu

given: Chao-Hua

family: Park

full_name: Keunchil Park

given: Keunchil

family: Novello

full_name: Silvia Novello

given: Silvia

family: Nadal

full_name: Ernest Nadal

given: Ernest

family: Imamura

full_name: Fumio Imamura

given: Fumio

family: Yoh

full_name: Kiyotaka Yoh

given: Kiyotaka

family: Shih

full_name: Jin-Yuan Shih

given: Jin-Yuan

family: Au

full_name: Kwok Hung Au

given: Kwok Hung

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Enatsu

full_name: Sotaro Enatsu

given: Sotaro

family: Zimmermann

full_name: Annamaria Zimmermann

given: Annamaria

family: Frimodt-Moller

full_name: Bente Frimodt-Moller

given: Bente

family: Visseren-Grul

full_name: Carla Visseren-Grul

given: Carla

family: Reck

full_name: Martin Reck

family: Chu

full_name: Quincy Chu

given: Quincy

family: Cortot

full_name: Alexis Cortot

given: Alexis

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: Fabre

full_name: Elizabeth Fabre

ReferenceCitation: Reck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21.

title: Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR -Mutant Metastatic Non–Small-Cell Lung Cancer (RELAY): Phase Ib Results

ReferenceCitation: Garon EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8.

title: Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non–Small-Cell Lung Cancer

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

location_country:
Italy
United States
Hong Kong
France
Japan
Greece
Korea, Republic of
Romania
Spain
Turkey
Germany
United Kingdom
Canada
Taiwan

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Cent

location_facility: Hospital Universitario La Fe de Valencia

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Azienda per l'Assistenza Sanitaria n°5 "Friuli Occidentale"

location_facility: Azienda Ospedaliero - Universitaria S. Luigi Gonzaga

location_facility: Hyogo Prefectual Amagasaki General Medical Center

location_facility: Foundation for Biomedical Research and innovation

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: National Hospital Organization Himeji Medical Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Gyeong-Sang National University Hospital

location_facility: Policlinico S. Orsola Malpighi - Universita di Bologna

location_facility: Kobe City Medical Center General Hospital

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Kliniken der Stadt Köln gGmbH Klinikum Köln-Merheim

title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

summary:
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.

The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

ReferenceCitation: Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.

family: Andrews

full_name: J Scott Andrews

given: J Scott

family: Kudrow

full_name: David Kudrow

given: David

family: Rettiganti

full_name: Mallikarjuna Rettiganti

given: Mallikarjuna

family: Oakes

full_name: Tina Oakes

given: Tina

family: Bardos

full_name: Jennifer N Bardos

given: Jennifer N

family: Wenzel

full_name: Richard Wenzel

given: Richard

family: Kuruppu

full_name: Dulanji K Kuruppu

given: Dulanji K

family: Gaul

full_name: Charly Gaul

given: Charly

family: Martinez

full_name: James M Martinez

given: James M

currency_apc_doaj: USD

journal_name: Journal of Pain Research

evidence: oa repository (via pmcid lookup)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.

name: From the NIHR–Wellcome Trust King’s Clinical Research Facility and SLaM Biomedical Research Centre, King’s College London, and King’s College Hospital, London (P.J.G.); the Department of Neurology, Mayo Clinic, Scottsdale, AZ (D.W.D.); the IRCCS Foundation Carlo Besta Neurologic Institute, Milan (M.L.); Eli Lilly, Indianapolis (J.N.B., T.M.O., B.A.M., C.Z., S.A.D., S.K.A., A.H.A., J.-Y.Y., R.R.C., J.M.M.); and the University of Maryland School of Medicine, Baltimore (R.R.C.).

family: Goadsby

full_name: Peter J. Goadsby

given: Peter J.

family: Dodick

full_name: David W. Dodick

given: David W.

family: Leone

full_name: Massimo Leone

given: Massimo

full_name: Jennifer N. Bardos

given: Jennifer N.

full_name: Tina M. Oakes

given: Tina M.

family: Millen

full_name: Brian A. Millen

given: Brian A.

family: Zhou

full_name: Chunmei Zhou

given: Chunmei

family: Dowsett

full_name: Sherie A. Dowsett

given: Sherie A.

location_country:
Italy
United States
Netherlands
Germany
Finland
France
Greece
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: New England Institute for Clinical Research

location_facility: Michigan Head, Pain, and Neurological Institute

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Klinikum der Universität München Campus Großhadern

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

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 Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

summary: A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

lead_sponsor: SecuraBio

location_country:
Italy
France
Belgium
Spain
United States
United Kingdom


ReferenceCitation: Curtis JR, Emery P, Karis E, Haraoui B, Bykerk V, Yen PK, Kricorian G, Chung JB. Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission. Arthritis Rheumatol. 2021 May;73(5):759-768. doi: 10.1002/art.41589. Epub 2021 Mar 24.

family: Curtis

full_name: Jeffrey R. Curtis

given: Jeffrey R.

name: Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds NIHR Leeds Biomedical Research Centre Leeds Teaching Hospitals NHS Trust  Leeds UK

family: Emery

full_name: Paul Emery

given: Paul

family: Karis

full_name: Elaine Karis

given: Elaine

name: Centre Hospitalier de l’Université de Montréal  Montreal Quebec Canada

family: Haraoui

full_name: Boulos Haraoui

given: Boulos

name: Hospital for Special Surgery  New York New York

family: Bykerk

full_name: Vivian Bykerk

given: Vivian

family: Yen

full_name: Priscilla K. Yen

given: Priscilla K.

family: Kricorian

full_name: Greg Kricorian

given: Greg

family: Chung

full_name: James B. Chung

given: James B.

journal_name: Arthritis & Rheumatology

oa_colors: green hybrid

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Dietary Supplement

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

lead_sponsor: Amgen

location_country:
Italy
United States
South Africa
Mexico
Spain
Germany
France
Czechia
Bulgaria
Greece
Poland
Hungary
Argentina
Portugal
Canada

title: A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

summary:
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.

This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.


ReferenceCitation: Andrade RC, Boroni M, Amazonas MK, Vargas FR. New drug candidates for osteosarcoma: Drug repurposing based on gene expression signature. Comput Biol Med. 2021 Jul;134:104470. doi: 10.1016/j.compbiomed.2021.104470. Epub 2021 May 7.

family: Andrade

full_name: Raissa Coelho Andrade

given: Raissa Coelho

family: Boroni

full_name: Mariana Boroni

given: Mariana

family: Amazonas

full_name: Marion Kielmanowicz Amazonas

given: Marion Kielmanowicz

family: Vargas

full_name: Fernando Regla Vargas

given: Fernando Regla

bso_classification: Chemistry

journal_name: Computers in Biology and Medicine

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Faroe Islands
Australia
Spain
Denmark
Canada
United Kingdom

acronym: Phase I trial of afatinib in pediatric tumours

location_facility: The University of Texas Health Science Center at Houston

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: St. Anna Children-Hospital, Children's Cancer Research, Wien

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Azienda Ospedaliera Universitaria di Padova

title: Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

summary:
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.

The trial will consist of 2 parts:

Dose finding part to determine the MTD
Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types


title: A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

summary: The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

ReferenceCitation: Malvehy J, Samoylenko I, Schadendorf D, Gutzmer R, Grob JJ, Sacco JJ, Gorski KS, Anderson A, Pickett CA, Liu K, Gogas H. Talimogene laherparepvec upregulates immune-cell populations in non-injected lesions: findings from a phase II, multicenter, open-label study in patients with stage IIIB-IVM1c melanoma. J Immunother Cancer. 2021 Mar;9(3). pii: e001621. doi: 10.1136/jitc-2020-001621.

location_country:
Italy
Austria
Netherlands
Germany
France
Poland
Greece
Hungary
Belgium
Russian Federation
Spain
United States
United Kingdom


location_country:
Italy
United States
Germany
France
Bulgaria
Czechia
Poland
Hungary
Belgium
Australia
Spain
Canada
United Kingdom

acronym: OI

title: To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

summary: This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.


title: A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus

summary: To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).

primary_purpose: Basic Science

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

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

location_country:
Germany
United States
France
Poland

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Medycyna Kliniczna Marzena Waszczak - Jeka

location_facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil


location_country:
United States
France
Israel
Australia
Spain
Germany
United Kingdom
Korea, Republic of

acronym: Morpheus-TNBC

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Vanderbilt University Medical Center; Vanderbilt University

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: University of California San Diego Medical Center; Moores Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: NYU Langone Medical Center; NYU Perlmutter Cancer Center

location_facility: University of Ulsan College of Medicine - Asan Medical Center

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

summary:
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC.

The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.


title: A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease

summary: The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).

location_country:
United States
Belgium
France

location_facility: University of Colorado School of Medicine

intervention_type: Other


title: A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

summary: This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
United States
United Kingdom
Australia
France

location_facility:
Investigative Site
Investigational Site


lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
France
Japan
Poland
Belgium
Germany

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: CTI Clinical Trial and Consulting Services

location_facility: Centre Hospitalier Specialisé de Rouffach

location_facility: California Research Trials DBA Orange Country Research Institute

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: CTC North GmbH & Co. KGim Spectrum am UKE

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder

summary: The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.


ReferenceCitation: Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. doi: 10.1056/NEJMoa1607887. Epub 2016 Aug 30.

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Milling

full_name: Truman J. Milling

given: Truman J.

suffix: Jr.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: Gibson

full_name: C. Michael Gibson

given: C. Michael

family: Curnutte

full_name: John T. Curnutte

given: John T.

family: Gold

full_name: Alex Gold

given: Alex

family: Bronson

full_name: Michele D. Bronson

given: Michele D.

family: Lu

full_name: Genmin Lu

given: Genmin

family: Conley

full_name: Pamela B. Conley

given: Pamela B.

family: Verhamme

full_name: Peter Verhamme

given: Peter

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

family: Middeldorp

full_name: Saskia Middeldorp

given: Saskia

family: Cohen

full_name: Alexander T. Cohen

given: Alexander T.

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

family: Albaladejo

full_name: Pierre Albaladejo

given: Pierre

family: Lopez-Sendon

full_name: Jose Lopez-Sendon

given: Jose

family: Goodman

full_name: Shelly Goodman

given: Shelly

family: Leeds

full_name: Janet Leeds

given: Janet

family: Wiens

full_name: Brian L. Wiens

given: Brian L.

family: Siegal

full_name: Deborah M. Siegal

given: Deborah M.

family: Zotova

full_name: Elena Zotova

given: Elena

family: Meeks

full_name: Brandi Meeks

given: Brandi

family: Nakamya

full_name: Juliet Nakamya

given: Juliet

family: Lim

full_name: W. Ting Lim

given: W. Ting

family: Crowther

full_name: Mark Crowther

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Birocchi S, Fiorelli EM, Podda GM. Andexanet Alfa for Factor Xa Inhibitor Reversal. N Engl J Med. 2016 Dec 22;375(25):2498-9.

ReferenceCitation: Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr; ANNEXA-4 Investigators. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2019 Apr 4;380(14):1326-1335. doi: 10.1056/NEJMoa1814051. Epub 2019 Feb 7.

name: From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) — all in Canada; Boston Clinical Research Institute (C.M.G.) and Brigham and Women’s Hospital (D.J.P.) — both in Boston; Portola Pharmaceuticals, South San Francisco, CA (J.T.C., J.H.L., P.Y., M.D.B., G.L., P.B.C., S.G., J.L., S.S.); University of Leuven, Leuven, Belgium (P.V.);...

ReferenceCitation: Demchuk AM, Yue P, Zotova E, Nakamya J, Xu L, Milling TJ Jr, Ohara T, Goldstein JN, Middeldorp S, Verhamme P, Lopez-Sendon JL, Conley PB, Curnutte JT, Eikelboom JW, Crowther M, Connolly SJ; ANNEXA-4 Investigators. Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy. Stroke. 2021 Jun;52(6):2096-2105. doi: 10.1161/STROKEAHA.120.030565. Epub 2021 May 10. Erratum in: Stroke. 2021 Aug;52(8):e525.

name: Departments of Clinical Neurosciences and Radiology, Cumming School of Medicine, University of Calgary, AB, Canada (A.M.D.).

name: Portola Pharmaceuticals, Inc, now Alexion Pharmaceuticals, Inc, South San Francisco, CA (P.Y., P.B.C., J.T.C.).

name: Department of Medicine, McMaster University, Hamilton, ON, Canada (E.Z., J.N., L.X., J.W.E., M.C., S.J.C.).

name: Department of Neurology, Seton Dell Medical School Stroke Institute, Austin, TX (T.J.M.).

name: Department of Neurology, Kyoto Prefectural University of Medicine, Japan (T.O.).

name: Department of Emergency Medicine, Massachusetts General Hospital, Boston (J.N.G.).

name: Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef, the Netherlands (S.M.).

name: Center for Molecular and Vascular Biology, University of Leuven, Belgium (P.V.).

name: Department of Cardiology, Hospital Universitario La Paz, IdiPaz, Universidad Autonoma de Madrid, Spain (J.L.L.-S.).

location_country:
United States
Netherlands
Germany
France
Japan
Belgium
Spain
Canada
United Kingdom

title: Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

summary: The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.


title: A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

summary: The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

ipd_sharing: Undecided

lead_sponsor: Aimmune Therapeutics, Inc.

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

location_facility: Rady Children's Hospital, Div. of Allergy & Immunology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants

location_facility: Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology

location_facility: University Hospitals Southampton Foundation NHS Trust

location_facility: Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai

location_facility: Children's Clinical Research Facility, Royal Manchester Children's Hospital

location_facility: National Allergy and Asthma Research, LLC

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center

location_facility: Hopital Saint Vincent de Paul- Service d'Allergologie

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Le Bonheur Children's Hospital, Outpatient Bldg.

location_facility: Cork University Hospital, UCC Department of Paediatrics and Child Health

location_facility: St Mary's Hospital - Paediatric Research Unit

location_facility: Allergy & Asthma Medical Group and Research Center

location_facility: Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital

location_facility: Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center

location_facility: UCSF, Benioff Children's Hospital - Allergy and Immunology

location_facility: Sher Allergy Specialists - Center for Cough

location_facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin

location_facility: Medical Research of Arizona, Allergy, Asthma & Immunology Associates

location_facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia

location_facility: Allergy & Asthma Associates of Santa Clara Valley Research Center

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

location_facility: The University of Chicago Medicine, Comer Children's Hospital

location_facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

location_facility: Madrid Hospital Clinico San Carlos, Servicio de Alergia

location_facility: Family Allergy & Asthma Research Institute

location_facility: University of South Florida, Asthma Allergy & Immunology Clinical Research Unit

location_facility: Allergy & Asthma Associates of Southern California

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Guy & St Thomas' NHS Foundation Trust, Children Allergies Department

location_facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit

location_facility: Specially for Children Allergy, Asthma and Immunology Clinic

location_facility: Univ. of Rochester Medical Center, Golisano Children's Hosp.

location_facility: Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research

intervention_type: Biological


lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country:
Italy
United States
Germany
France
Belgium
Spain
Canada
United Kingdom

acronym: NTHI MCAT-002

title: An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients

summary:
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response.

In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care.

The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at pre-defined timepoints (scheduled study visits).

In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.


ReferenceCitation: Chari A, Munder M, Weisel K, Jenner M, Bygrave C, Petrucci MT, Boccadoro M, Cavo M, van de Donk NWCJ, Turgut M, Demirkan F, Karadogan I, Libby E, Kleiman R, Kuppens S, Bandekar R, Neff T, Heuck C, Qi M, Clemens PL, Goldschmidt H. Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy. Adv Ther. 2021 Feb;38(2):1328-1341. doi: 10.1007/s12325-020-01601-w. Epub 2021 Jan 20.

family: Chari

full_name: Ajai Chari

given: Ajai

family: Munder

full_name: Markus Munder

given: Markus

family: Weisel

full_name: Katja Weisel

given: Katja

family: Jenner

full_name: Matthew Jenner

given: Matthew

family: Bygrave

full_name: Ceri Bygrave

given: Ceri

family: Petrucci

full_name: Maria Teresa Petrucci

given: Maria Teresa

family: Boccadoro

full_name: Mario Boccadoro

given: Mario

family: Cavo

full_name: Michele Cavo

given: Michele

family: van de Donk

full_name: Niels W. C. J. van de Donk

given: Niels W. C. J.

family: Turgut

full_name: Mehmet Turgut

given: Mehmet

family: Demirkan

full_name: Fatih Demirkan

given: Fatih

family: Karadogan

full_name: Ihsan Karadogan

given: Ihsan

family: Libby

full_name: Edward Libby

given: Edward

family: Kleiman

full_name: Robert Kleiman

given: Robert

family: Kuppens

full_name: Steven Kuppens

given: Steven

family: Bandekar

full_name: Rajesh Bandekar

given: Rajesh

family: Neff

full_name: Tobias Neff

given: Tobias

family: Heuck

full_name: Christoph Heuck

given: Christoph

family: Qi

full_name: Ming Qi

given: Ming

family: Clemens

full_name: Pamela L. Clemens

given: Pamela L.

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

journal_name: Advances in Therapy

ReferenceCitation: Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Kuppens S, Bandekar R, Clemens PL, Neff T, Heuck C, Qi M, Hofmeister CC. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 Jul;34(7):1840-1852. doi: 10.1038/s41375-020-0718-z. Epub 2020 Feb 5.

repositories_institution:
INFN Catania - INFM-OAR
PubMed Central - Europe PMC

location_country:
United States
Netherlands
Germany
France
Czechia
Israel
Australia
Russian Federation
Turkey
Canada
United Kingdom

title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

summary: The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.


title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

summary: The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

location_country:
Malaysia
Greece
Belgium
Australia
Russian Federation
Taiwan
Iceland
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain