title: A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.

summary:
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts.

The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.

ipd_sharing_description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.

lead_sponsor: Lungpacer Medical Inc.

location_country:
United States
Germany
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of Texas Southwestern, Zale Lipshy Hospital

location_facility: Indiana University Health Methodist Hospital

location_facility: CHI Health Creighton University Medical Center - Bergan Mercy


study_start_date_type: Actual

acronym: CONTRAIL I

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.

status: Completed

title: A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Two Regimens of Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up and a Long-term Extension (CONTRAIL I)

primary_purpose: Treatment

type: EudraCT Number

type: Other Identifier

source: euctr

enrollment_type: Actual

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

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Hungary
Argentina
Netherlands
Belgium
United States
Spain
Czechia
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients With Relapsed or Refractory Lymphoma

summary: This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage1) and a dose expansion stage (Stage 2).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hutchmed

location_country:
Finland
Italy
Poland
Denmark
United States
Spain
France

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Leo Jenkins Cancer Center/ECU School of Medicine

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: The University of Texas MD Anderson Cancer Center

status_simplified: Ongoing


acronym: DISCREET

lead_sponsor: Amgen

summary:
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe).

Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre

location_facility: Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina

title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

type: Registry Identifier

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
Italy
Belgium
United States
Canada
Puerto Rico
France


title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

ReferenceType: derived

ReferenceCitation: Koblish HK, Wu L, Wang LS, Liu PCC, Wynn R, Rios-Doria J, Spitz S, Liu H, Volgina A, Zolotarjova N, Kapilashrami K, Behshad E, Covington M, Yang YO, Li J, Diamond S, Soloviev M, O'Hayer K, Rubin S, Kanellopoulou C, Yang G, Rupar M, DiMatteo D, Lin L, Stevens C, Zhang Y, Thekkat P, Geschwindt R, Marando C, Yeleswaram S, Jackson J, Scherle P, Huber R, Yao W, Hollis G. Characterization of INCB086550: A Potent and Novel Small-Molecule PD-L1 Inhibitor. Cancer Discov. 2022 Jun 2;12(6):1482-1499. doi: 10.1158/2159-8290.CD-21-1156.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

unpaywall_oa_status: hybrid

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Incyte Corporation

location_country:
Italy
United Kingdom
Belgium
United States
France

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital

location_facility: University of Pennsylvania Health System

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital


title: HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

summary: The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.

status: Active, not recruiting

ReferenceCitation: Adams D, Tournev IL, Taylor MS, Coelho T, Plante-Bordeneuve V, Berk JL, Gonzalez-Duarte A, Gillmore JD, Low SC, Sekijima Y, Obici L, Chen C, Badri P, Arum SM, Vest J, Polydefkis M; HELIOS-A Collaborators. Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial. Amyloid. 2023 Mar;30(1):1-9. doi: 10.1080/13506129.2022.2091985. Epub 2022 Jul 23.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
LIRIAS (KU Leuven)
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);UCL Discovery

publisher_dissemination: Informa

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Argentina
Australia
Brazil
Japan
Canada
France
Portugal
United States
Belgium
Malaysia
Italy
Cyprus
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Sweden


title: Efficacy and Safety of Fixed-Dose Combination (FDC) Products Containing Trazodone and Gabapentin in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose Finding Study.

summary: The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period.

lead_sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

location_country:
Czechia
United Kingdom
Poland
France

location_facility: WroMedica I. Bielicka, A. Strzałkowska s.c.

location_facility: GHR MSA - Hôpital Emile Muller Service de Diabétologie-Endocrinologie-Nutrition

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki Klinika Diabetologii

location_facility: Fondation Hôtel Dieu Groupe SOS Service de Diabétologie

location_facility: Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET

location_facility: Manchester Clinical Research Facility Manchester Royal Infirmary

location_facility: Pro Familia Altera Poradnia Wielospecjalistyczna

location_facility: CHU de Nantes - Hôpital Guillaume-et-René-Laënnec Clinique d'Endocrinologie, maladies métaboliques et nutrition CIC Endocrino - Nutrition - UF 7015

location_facility: Diabetologická ambulance Milan Kvapil s.r.o.

location_facility: Nemocnice Pardubického kraje a.s. Pardubická nemocnice Neurologická klinika

location_facility: Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy

location_facility: Centre de Recherche Clinique G.H.M les Portes du Sud Departement d'Endocrinologie

location_facility: Diabetes Centre George Eliot Hospital NHS Trust

location_facility: Medical Innovation Development and Research Unit (MIDRU) Heartlands Hospital

location_facility: Lancashire Clinical Research Facility The Avondale Unit Royal Preston Hospital

location_facility: Clinical Research Facility Royal Hallamshire Hospital


acronym: FOREMOST

summary: This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.

location_facility: Paramount Medical Research and Consulting LLC

location_facility: Accurate Clinical Research Incorporated Baytown

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Carol and Frank Morsani Center for Advanced Health Care

location_facility: Arthritis, Rheumatic, and Back Disease Associates

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Research Institute of Rheumatology named after V.A.Nasonova

location_facility: Arthritis and Rheumatology Center of Michigan

location_facility: New York University Langone Medical Center

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Humanitas Research Hospital Humanitas Mirasole

location_facility: Municipal Budgetary Healthcare Institution City Emergency Hospital

location_facility: Ziekenhuis Netwerk Antwerpen Jan Palfijn

location_facility: Assistance Publique- Hopitaux de Paris AP-HP

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: University of Florida College of Medicine

location_facility: Mechnikov North-Western State Medical University

location_facility: Moscow Regional Research Institute n.a. Vladimirsky

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Klein and Associates MD, PA - Cumberland

location_facility: Center for Rheumatology, Immunology, and Arthritis

location_facility: Arthritis and Osteoporosis Center of Southwest Ohio

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation

title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD

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


title: A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

summary: A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.

lead_sponsor: Aprea Therapeutics

location_country:
United States
France

location_facility: University of Pittsburgh Medical Center, Hillman Cancer Center

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University of Iowa Hospitals and Clinics, Holden Cancer Center

location_facility: Memorial Health Care System South Florida

location_facility: Stanford University Cancer Research Center

location_facility: Robert H Lurie Comprehensive Cancer Center, Northwestern University


title: Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Various Combinations of BGB-A425 and LBL-007 With Tislelizumab in Patients With Advanced Solid Tumors

summary: This is an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of BGB-A425 and/or LBL-007 with tislelizumab.

design_allocation: Non-Randomized

lead_sponsor: BeiGene

location_country:
Italy
Poland
Australia
United States
Korea, Republic of
Spain
France

location_facility: Cabrini Research and Education Institute

location_facility: Weill Cornell Medical College Newyork Presbyterian Hospital

location_facility: Sunshine Coast Hospital and Health Service

location_facility: The Catholic University of Korea, St Vincents Hospital

location_facility: Cha Bundang Medical Center, Cha University

location_facility: Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

location_facility: Centrum Onkologiiim Prof F Lukaszczyka Wbydgoszczy

location_facility: Centre de Lutte Contre Le Cancer Institut Bergonie

location_facility: Ut Health San Antonio Mays Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Kentucky Markey Cancer Center

location_facility: The Catholic University of Korea, Seoul St Marys Hospital

location_facility: Irccs Azienda Ospedaliero Universitaria Bologna

location_facility: Vall D Hebron Institute of Oncology Vhio

location_facility: University of North Carolina At Chapel Hill

location_facility: Centre de Lutte Contre Le Cancer Francois Baclesse

location_facility: The University of Texas Md Anderson Cancer Center

location_facility: Hospital Universitario Hm Madrid Sanchinarro


acronym: PRONTO-Peds

lead_sponsor: Eli Lilly and Company

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).

location_facility: Ivano-Frankivsk regional clinical children hospital

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

location_facility: Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH

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

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

location_facility: Smolensk Regional Children's Clinical Hospital

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Hôpital Universitaire Necker enfants malades

location_facility: Tokyo Women's Medical University Hospital

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Research Institute for Pediatric Endocrinology

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Diabetologische Schwerpunktpraxis Dr. Ziegler

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Diabetes and Glandular Disease Research Associates PA

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente

location_facility: Samarskiy Regional Children's Clinical Hospital

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Zaporizhzhia regional clinical children hospital

location_facility: Texas Institute for Kidney and Endocrine Disorders

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

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

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

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

location_facility: Children's Hospital Capital Institute of Pediatrics

location_facility: Hospital Universitario Central de Asturias

location_facility: Siberian State Medical University of Roszdrav

location_facility: University of South Florida Diabetes & Endocrinology Center

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

location_facility: Odesa regional children's clinical hospital

location_facility: Morozovsky Children's City Clinical Hospital

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

location_facility: Institute of the Health Care of Children & Adolescents

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Indiana University- Riley Children's Hospital

location_facility: MultiCare Institute for Research & Innovation

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

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


lead_sponsor: Galapagos NV

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

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 18F-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.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Chemical Society

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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Imperial College London - Spiral

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pure.eur.nl;repub.eur.nl;spiral.imperial.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility: Centre Hospitalier Regional Universitaire Montpellier

location_facility: Dr Anil Dhar Professional Medicine Corporation

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

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Presidio Ospedaliero GB Morgagni L Pierantoni

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

location_facility: University of Cape Town Lung Institute (UCTLI)

location_facility: Soon Chun Hyang University Hospital Seoul

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

location_facility: Kobe City Medical Center General Hospital

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

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

location_facility: National Hospital Organization Himeji Medical Center

location_facility: University of Arizona College of Medicine

location_facility: Medical University of South Carolina - PPDS

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: National Hospital Organization Kyushu Medical Center

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

location_facility: Krankenhaus Bethanien - Klinik für Pneumologie und Allergologie

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Privado Centro Médico de Córdoba

location_facility: Universitätsmedizin Greifswald Klinik und Poliklinik für Innere Medizin B

location_facility: Hospital Universitatorio Dr. Jose Eleuterio González

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

location_facility: Instituto de Investigaciones Clínicas Mar Del Plata

location_facility: University of Michigan Health System (UMHS)

location_facility: Seoul National University Bundang Hospital

location_facility: McGill University Health Centre Research Institute

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: University of California, San Francisco Medical Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

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

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Mercy Health - St. Vincent Medical Center

location_facility: Tohoku Medical and Pharmaceutical Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: National Hospital Organization Ibarakihigashi National Hospital

location_facility: Instituto Nacional De Enfermedades (INER)

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

status: Terminated

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

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

status_simplified: Unknown


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_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

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

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: A. ö. Krankenhaus der Elisabethinen Linz

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

intervention_type: Device


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.

lead_sponsor: Bristol-Myers Squibb

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

location_facility:
Local Institution - 0017
Local Institution - 0057
Local Institution - 0029
Local Institution - 0030
Local Institution - 0031
Local Institution - 0003
Local Institution - 0018
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0041
Local Institution - 0067
Local Institution - 0035
Local Institution - 0059
Local Institution - 0072
Local Institution - 0054
Local Institution - 0044
Local Institution - 0015
Local Institution - 0027
Local Institution - 0055
Local Institution - 0002
Local Institution - 0070
Local Institution - 0040
Local Institution - 0032
Local Institution - 0039
Local Institution - 0058
Local Institution - 0024
Local Institution - 0038
Local Institution - 0028
Local Institution - 0064
Local Institution - 0014
Local Institution - 0061
Local Institution - 0034
Local Institution - 0063
Local Institution - 0073
Local Institution - 0052
Local Institution - 0043
Local Institution - 0012
Local Institution - 0016
Local Institution - 0037
Local Institution - 0068
Local Institution - 0020
Local Institution - 0062
Local Institution - 0023
Local Institution - 0001
Local Institution - 0022
Local Institution - 0033
Local Institution - 0065
Local Institution - 0047
Local Institution - 0013
Local Institution - 0049
Local Institution - 0056
Local Institution - 0045
Local Institution - 0050
Local Institution - 0053
Local Institution - 0025
Local Institution - 0048
Local Institution - 0026
Local Institution - 0074
Local Institution - 0066
Local Institution - 0010
Local Institution - 0060
Local Institution - 0051
Local Institution - 0019
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042


title: A Phase 1b/2 Study of FT-2102 in Patients 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.

lead_sponsor: Forma Therapeutics, Inc.

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

location_facility: University of Colorado Anschutz Medical Campus

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

location_facility: Medical College of Wisconsin, Froedtert Hospital

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: Northwestern University, Lurie Comprehensive Cancer Center

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: Washington University School of Medicine

location_facility: University of Iowa, Holden Comprehensive Cancer Institute


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma

summary: A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

ReferenceCitation: Moss MH, Lugogo NL, Castro M, Hanania NA, Ludwig-Sengpiel A, Saralaya D, Dobek R, Ojanguren I, Vyshnyvetskyy I, Bruey JM, Osterhout R, Tompkins CA, Dittrich K, Raghupathi K, Ortega H; LEDA Investigators. Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma. Chest. 2022 Aug;162(2):297-308. doi: 10.1016/j.chest.2022.02.038. Epub 2022 Mar 3.

oa_host_type: publisher

publisher_dissemination: Elsevier

ReferenceCitation: Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.

repositories_concat: PubMed Central

publisher_dissemination: Wiley

lead_sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
Germany
Poland
United Kingdom
Austria
Belgium
United States
Spain
Czechia
Canada
Ukraine
France

location_facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel

location_facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V

location_facility: Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog

location_facility: Allergy and Asthma Diagnostic Treatment Center

location_facility: The Lung Centre, Vancouver General Hospital

location_facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

location_facility: Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal

location_facility: California Allergy and Asthma Medical Group

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Public Enterprise "Hospital #1" under Zhytomyr City Council

location_facility: Allergiste & Immunologue - Clinic/Outpatient Facility

location_facility: SALK University Hospital Salzburg, State Hospital Salzburg

location_facility: St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology

location_facility: Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council

location_facility: Glasgow Clinical Research Facility, Glasgow Royal Infirmary

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

location_facility: Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council

location_facility: Berks Schuylkill Respiratory Specialists, Ltd.

location_facility: University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Allergy and Clinical Immunology Associates

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Institut fuer Allergie - und Asthmaforschung

location_facility: UZ Gent - Department of Respiratory Medicine

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

location_facility: Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council

location_facility: Outpatient Allergology and Neurology Clinic Kasmed Ltd.

location_facility: Public Institution: City Clinical Hospital #6

location_facility: Banner University of Arizona Medical Center

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1

location_facility: Allergy, Asthma & Sinus Consultants, Inc

location_facility: University Hospital Olomouc, Department of Allergology and Clinical Immunology

location_facility: State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)

location_facility: Allergy & Asthma Medical Group and Research Center, A P.C.

location_facility: University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy

location_facility: Public Institution "City Clinical Hospital #4" under Dnipro City Council

location_facility: Pulmonary Outpatient Clinic - Dr. Otakar Hokynar

location_facility: NOUVEL HOPITAL CIVIL - New Civil Hospital

location_facility: Pulmonary Outpatient Clinic Rokycany s.r.o.

location_facility: MultiCare Institute for Research & Innovation


title: Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers

acronym: AURA

summary:
Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC).

Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.

ReferenceCitation: Martinez Chanza N, Soukane L, Barthelemy P, Carnot A, Gil T, Casert V, Vanhaudenarde V, Sautois B, Staudacher L, Van den Brande J, Culine S, Seront E, Gizzi M, Albisinni S, Tricard T, Fantoni JC, Paesmans M, Caparica R, Roumeguere T, Awada A. Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial). BMC Cancer. 2021 Dec 2;21(1):1292. doi: 10.1186/s12885-021-08990-3.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

publisher_dissemination: Springer-Nature

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
Merck KGaA, Darmstadt, Germany

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage


title: Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

acronym: INDURE

summary: Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

ReferenceType: background

ReferenceCitation: Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.

ReferenceCitation: Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.

ReferenceCitation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.

ReferenceCitation: Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729.

ReferenceCitation: Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.

ReferenceCitation: Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwoger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.

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

repository_institution: University of Florence - Florence Research

repositories_concat: LIRIAS (KU Leuven);PubMed Central;air.unimi.it;flore.unifi.it;pure.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

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

location_facility: Institut de Cardiologie de Montréal, Université de Montréal

location_facility: UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie

location_facility: University Hospital Virgen de la Arrixaca

location_facility: L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Rennes

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona


title: An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

summary: Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

lead_sponsor: Albireo

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

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

location_facility: Riley Hospital for Children - Riley Children's Specialists

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: Kinderklinik Tubingen, Universitatsklinikum Tubingen

location_facility: Washington University School of Medicine

location_facility: Universitair Medisch Centrum (UMC) Utrecht

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

location_facility: Instytut Pomnik - Centrum Zarowia Dziecka

location_facility: Schneider Children's Medical Center Of Israel

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

location_facility: Columbia University Medical Center - Presbyterian Hospital Building

location_facility: University and Pediatric Hospital of Lyon

location_facility: Univesitatsklinikum Tubingen Klinik fur Kinder und Jugendmedizin

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

location_facility: Hacettepe University Faculty of Medicine


lead_sponsor: Celgene

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.

location_facility: University Of Michigan Comprehensive Cancer Center

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

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)

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


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:
Germany
Italy
United States
Czechia
Canada
France

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Klinicke a Experimentalni Mediciny (IKEM)

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


acronym:
Systemic Corticosteroids Avoidance Study in Severe Asthma Patients.

 Étude de réduction des corticoïdes systémiques chez des patients souffrant d'asthme sévère.

lead_sponsor: Novartis Pharmaceuticals

summary: The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.

title: A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma

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

location_country:
Germany
Argentina
Thailand
Vietnam
Turkey
Chile
Czechia
France
Colombia
Slovakia
Hungary
United States
Belgium
Peru
Philippines
United Kingdom
Spain
Greece
South Africa
Bulgaria
Russian Federation


title: A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

acronym: ASPEN-OLS

summary: Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.

lead_sponsor: Revance Therapeutics, Inc.

sponsor_collaborators:
Revance Therapeutics, Inc.
Syneos Health

location_country:
Germany
Poland
United Kingdom
Austria
United States
Spain
Czechia
Canada
France

location_facility: Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze

location_facility: The University of Vermont Medical Center

location_facility: The Walton Centre NHS Foundation Trust, Neuroscience Research Centre

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Intrafusion Research Network - Wesley Neurology Clinic

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Houston Methodist Neurological Institute

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Ki Health Partners LLC DBA New England Institute for Clinical Research

location_facility: University Health Network, Toronto Western Hospital

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Nemocnice Pardubickeho kraje, a.s.; Pardubicka nemocnice

intervention_type: Biological


summary: The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: University of California San Diego Health Systems

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Southern Illinois University School of Medicine

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: Synexus Clinical Research - Saint Petersburg

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Progressive Clinical Research - San Antonio

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Artemis Institute for Clinical Research - San Marcos

location_facility: Artemis Institute for Clinical Research - San Diego

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: St. George Dermatology & Skin Care Centre

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: Marietta Dermatology & The Skin Cancer Center

location_facility: Center for Dermatology Clinical Research

location_facility: DelRicht Research - New Orleans - Prytania Street

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula

location_facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

location_facility: Dermatology and Skin Surgery Center - Exton

location_facility: Precision Clinical Research - Corporate Office

location_facility: York Dermatology Clinic and Research Centre

location_facility: University Hospitals Case Medical Center

location_facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi

location_facility: ActivMed Practices and Research - Portsmouth

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

location_country:
Finland
Germany
Italy
Poland
New Zealand
Hungary
Israel
United Kingdom
Australia
Sweden
United States
Spain
Czechia
Canada
Puerto Rico
France


summary: This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

location_facility: Fakultní nemocnice Ostrava, Neurologicka klinika

location_facility: University of Pennsylvania, Department of Neurology

location_facility: New England Institute for Clinical Research

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Houston Methodist Neurological Institute

location_facility: Praxis fuer Neurologie im Bismark Karrée

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: University Health Network, Toronto Western Hospital

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: University of Florida Health Science Center Jacksonville

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Mazowiecki Szpital Brodnowski Sp. z o.o.

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)


title: An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat

summary: The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.

lead_sponsor: RECORDATI GROUP

location_country:
Germany
Poland
Argentina
Japan
Brazil
Costa Rica
Thailand
Turkey
Canada
France
United States
India
Belgium
China
Italy
Austria
Korea, Republic of
Spain
Bulgaria
Russian Federation

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Pennsylvania Medical Center Univ Penn

location_facility: Northwestern University SC - LCI699C2301

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: Columbia University Medical Center New York Presbyterian Neuroendocrine Unit


lead_sponsor: Pfizer

summary:
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.

To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study.

The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Akdeniz University Medical Faculty Hospital

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Ege Universitesi Tip Fakultesi Cocuk Sagligi Ve Hastaliklari Anabilim Dali Pediatric Hematoloji

location_facility: Clinical and Translational Research Unit (CTRU)

location_facility: Kyung Hee University Hospital At Gangdong

location_facility: Mississippi Center for Advanced Medicine

location_facility: Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos - Hemoes

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Gaziantep University Sahinbey Training and Research Hospital

location_facility: Hospital Das Clínicas Da Faculdade de Medicina de Ribeirao Preto Da Universidade de Sao Paulo

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: IRCCS - AOU di Bologna, Policlinico di Sant'Orsola

location_facility: Cliniques universitaires Saint-Luc/Unité d'Hématology et Hémostase

location_facility: The Chaim Sheba Medical Center, The National Hemophilia Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Acibadem Adana Hospital, Department of Pediatric Hematology

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Center for Child Health and Development

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: General Hospital of Athens "Hippokration"

location_facility: Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Centro de Hemoterapia e Hematologia do Para - Fundação HEMOPA

location_facility: Universitatsklinikum Bonn. Anstalt des oeffentlichen Rechts

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: SODc. Malattie Emorragiche e della Coagulazione Centro di Riferimento Regionale per le

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

location_facility: Universität und Universitätsklinikum des Saarlandes

location_facility: lnstituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Università degli studi di Roma "La Sapienza"- Policlinico Umberto I

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Indiana Hemophilia & Thrombosis Center, Inc.

location_facility: Ege Universitesi Tip Fakultesi Hematoloji BD

location_facility: Penn Comprehensive Hemophilia & Thrombosis Program, Hospital of the University of Pennsylvania

title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C≤2%) WHO ARE NEGATIVE FOR NEUTRALIZING nAb TO AAV VECTOR SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C≤1%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (See Detailed Description Section for Official Protocol Title)

primary_purpose: Other

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

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Brazil
Japan
Sweden
Belgium
United States
Korea, Republic of
Saudi Arabia
Spain
Greece
Turkey
Taiwan
Canada
France


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

lead_sponsor: Merck Sharp & Dohme LLC

summary: This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [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.

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

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

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

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

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

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

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

location_facility: Huizhou Municipal Central Hospital ( Site 0140)

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

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

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

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

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

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

location_facility: The First Affiliated Hospital ( Site 0100)

location_facility: Hunan Provincial People Hospital ( Site 0122)

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

location_facility: City Hospital #2 Severodvinsk ( Site 1017)

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

location_facility: Peking University First Hospital ( Site 0131)

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

location_facility: Southern Medical University Nanfang Hospital ( Site 0120)

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

location_facility: Shanghai Pulmonary Hospital ( Site 0108)

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

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

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: Huashan Hospital of Fudan University ( Site 0105)

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

location_facility: Ningbo First Hospital-neurosurgery ( Site 0152)

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

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

location_facility: Lung Center of the Philippines ( Site 0903)

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

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: Kiyv city municipal hospital 17 ( Site 1300)

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

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

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

location_facility: Peking University Third Hospital ( Site 0115)

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

location_facility: Tianjin Medical University General Hospital ( Site 0113)

location_facility: Huadong Hospital Affiliated Fudan University ( Site 0103)

location_facility: Affiliated Hospital of Jiangsu University ( Site 0147)

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

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

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

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

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

location_facility: Hopital Roger Salengro du Lille ( Site 0601)

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

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

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

location_country:
Russian Federation
Romania
Brazil
Mexico
China
Ukraine
Philippines
France


title: Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

acronym: FORMULA-OLS

summary: A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

ipd_sharing: Undecided

lead_sponsor: F2G Biotech GmbH

sponsor_collaborators:
F2G Biotech GmbH
Iqvia Pty Ltd

location_country:
Germany
Poland
Russian Federation
Israel
United Kingdom
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Thailand
Turkey
Vietnam
Egypt
France

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Valley Fever Institute at Kern Medical Center

location_facility: SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: University of California San Diego Medical Center

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

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

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital da Universidade Federal de Santa Maria CEP/UFSM

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

location_facility: Washington University School of Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: The University of Texas Health Science Center at San Antonio


title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).

acronym: TRANSFORM

summary:
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).

All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).

Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.

Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

ReferenceCitation: Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; TRANSFORM Investigators. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022 Jun 18;399(10343):2294-2308. doi: 10.1016/S0140-6736(22)00662-6. Erratum In: Lancet. 2022 Jul 16;400(10347):160.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

oa_host_type: repository

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

repositories_concat: PubMed Central;ora.ox.ac.uk

unpaywall_oa_status: green

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

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

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center


acronym: 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.

ReferenceCitation: Thompson RJ, Arnell H, Artan R, Baumann U, Calvo PL, Czubkowski P, Dalgic B, D'Antiga L, Durmaz O, Fischler B, Gonzales E, Grammatikopoulos T, Gupte G, Hardikar W, Houwen RHJ, Kamath BM, Karpen SJ, Kjems L, Lacaille F, Lachaux A, Lainka E, Mack CL, Mattsson JP, McKiernan P, Ozen H, Rajwal SR, Roquelaure B, Shagrani M, Shteyer E, Soufi N, Sturm E, Tessier ME, Verkade HJ, Horn P. Odevixibat treatment in progressive familial intrahepatic cholestasis: a randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):830-842. doi: 10.1016/S2468-1253(22)00093-0. Epub 2022 Jul 1.

repository_institution: King's College London - Research Portal

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

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

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

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

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: Kinderklinik Tübingen, Universitätsklinikum Tübingen

location_facility: Universitair Medisch Centrum (UMC) Utrecht

location_facility: Schneider Children's Medical Center Of Israel

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

location_facility: Columbia University Medical Center - Presbyterian Hospital Building

location_facility: University and Pediatric Hospital of Lyon

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

location_facility: Hacettepe University Faculty of Medicine

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)


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:
Australia
Switzerland
United States
Korea, Republic of
France

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Washington University School of Medicine

location_facility: Centre Georges François Leclerc; Pharmacie des Essais Cliniques

location_facility: City of Hope Comprehensive Cancer Center


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: Single 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.

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.

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.

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. doi: 10.1016/S0140-6736(05)67704-5.

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.

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):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. 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.

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. No abstract available.

lead_sponsor: Boston Scientific Corporation

location_country:
Japan
Netherlands
Belgium
United States
France

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

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

location_facility: Amputation Prevention Center of North Carolina

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)

location_facility: Cardiovascular Institute of the South Clinical Research Corporation

location_facility: Advanced Cardiac & Vascular Centers for Amputation Prevention


acronym: PRECISION

lead_sponsor: Idorsia Pharmaceuticals Ltd.

summary: The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

ReferenceCitation: Daskalopoulou SS, Khan NA, Quinn RR, Ruzicka M, McKay DW, Hackam DG, Rabkin SW, Rabi DM, Gilbert RE, Padwal RS, Dawes M, Touyz RM, Campbell TS, Cloutier L, Grover S, Honos G, Herman RJ, Schiffrin EL, Bolli P, Wilson T, Feldman RD, Lindsay MP, Hemmelgarn BR, Hill MD, Gelfer M, Burns KD, Vallee M, Prasad GV, Lebel M, McLean D, Arnold JM, Moe GW, Howlett JG, Boulanger JM, Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Bacon SL, Petrella RJ, Milot A, Stone JA, Drouin D, Lamarre-Cliche M, Godwin M, Tremblay G, Hamet P, Fodor G, Carruthers SG, Pylypchuk G, Burgess E, Lewanczuk R, Dresser GK, Penner B, Hegele RA, McFarlane PA, Sharma M, Campbell NR, Reid D, Poirier L, Tobe SW; Canadian Hypertension Education Program. The 2012 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of risk, and therapy. Can J Cardiol. 2012 May;28(3):270-87. doi: 10.1016/j.cjca.2012.02.018.

ReferenceCitation: Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.

ReferenceType: result

ReferenceCitation: Danaietash P, Verweij P, Wang JG, Dresser G, Kantola I, Lawrence MK, Narkiewicz K, Schlaich M, Bellet M; PRECISION investigators. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertens (Greenwich). 2022 Jul;24(7):804-813. doi: 10.1111/jch.14517. Epub 2022 Jun 9.

repository_institution: University of Turku - UTUPub

repositories_concat: PubMed Central;www.utupub.fi

ReferenceCitation: Schlaich MP, Bellet M, Weber MA, Danaietash P, Bakris GL, Flack JM, Dreier RF, Sassi-Sayadi M, Haskell LP, Narkiewicz K, Wang JG; PRECISION investigators. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022 Dec 3;400(10367):1927-1937. doi: 10.1016/S0140-6736(22)02034-7. Epub 2022 Nov 7. Erratum In: Lancet. 2023 Jan 28;401(10373):268.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories_concat: HAL

sponsor_collaborators:
Idorsia Pharmaceuticals Ltd.
Janssen Biotech, Inc.

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Federal State Budget Educational Institution of Higher Education "Saratov State Medical University n.a. V.I. Razumovskiy" of the Ministry of Healthcare of the Russian Federation

location_facility: The First Affiliated Hospital of Baotou Medical College of Inner Mongolia

location_facility: State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"

location_facility: Universitätsklinikum Düsseldorf Klinik für Nephrologie

location_facility: SIU School of Medicine Center for Clinical Research

location_facility: Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique

location_facility: State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"

location_facility: Herzzentrum Leipzig Universitätsklinik für Kardiologie

location_facility: Hospital Virgen del Rocio Departamento de Medicina Interna

location_facility: Metrolina Internal Medicine/Internal Medicine Research

location_facility: National Medical Research Center for Preventive Medicine

location_facility: Universitair Ziekenhuis Gent Cardiologie

location_facility: Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

location_facility: SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

location_facility: Hospital Virgen de las Nieves - Internal Medicine Department

location_facility: Curtin University, Faculty of Health Sciences, School of Public Health

location_facility: Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya

location_facility: Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)

location_facility: Federal State Budget Institution "National Medical Research Center n.a. V.A. Almazov" of the Ministry of healthcare of the Russian Federation

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Klinika Wad Wrodzonych Serca Instytut Kardiologii im. Kardynala Wyszynskiego

location_facility: Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"

location_facility: Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"

location_facility: St. George Kidney Care LLC dba Southern Utah Kidney and Hypertension Center

location_facility: Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Westmead Hospital Department of Renal Medicine

location_facility: State budget healthcare institution of Novosibirsk region "City clinical hospital #34"

location_facility: Hypertension & Kidney Disease / Huma Neurotransmitter Laboratory

location_facility: KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II

location_facility: The Third Xiangya Hospital of Central South University

location_facility: O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Cardiology department

location_facility: State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"

location_facility: Hainan NO.3 Provincial people's Hospital

location_facility: Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council

location_facility: Federal State Budget Institution National Medical Research Center n.a. V.A. Almazov of the Ministry of Healthcare of the Russia

location_facility: Centre Hospitalier Universitaire du Sart-Tilman

location_facility: Cardiovascular Research of Northwest Indiana, L.L.C.

location_facility: Barzilai Medical Center, Cardiovascular Institute

location_facility: State Healthcare Institution "Regional Clinical Cardiology Dispensary"

location_facility: Uniwersyteckie Centrum Kliniczne Centrum Kardiologii

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"

location_facility: Aberdeen Royal Infirmary, Clinical Pharmacology Unit

location_facility: Volyn Regional Center for Cardiovascular Pathology, Rehabilitation Department

location_facility: Scientific Research Institute - Regional Clinical Hospital №1

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)

location_facility: University Hospitals Cleveland Medical Center - Neurological Institute

location_facility: Danylo Halytsky Lviv National Medical University

location_facility: Federal State Military Educational Institution of Higher Professional Education, Military Medical Academy named for S. M. Kirov of the Ministry of Defense of the Russian Federation

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Kyiv Municipal Clinical Emergency Hospital

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Azienda Ospedaliero Universitaria Pisana - Department Clinical and Experimental Medicine

location_facility: Hospital Clínic Universitari de València

location_facility: Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science

location_facility: University Brescia Department Clinical and Experimental Science

location_facility: Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu

location_facility: Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)

location_facility: State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"

location_facility: Royal Perth Hospital Unit - The University of Western Australia

location_facility: Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"

location_facility: FN U Sv.Anny Brno, kardiologická klinika

location_facility: Stephen S. Chow Medicine Professional Corporation

location_facility: Amarillo Heart Clinical Research Institute, Inc.

location_facility: Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia

location_facility: Maastricht University Medical Center, Dept. of Medicine

location_facility: KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach

location_facility: Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -

location_facility: University of Oulu, Medical Research Center

location_facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

location_facility: State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy

location_facility: Hypertension and Nephrology Association PA

title: Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Lithuania
Hungary
United States
Ukraine
Belgium
China
Italy
United Kingdom
Netherlands
Spain
Greece
Russian Federation
Israel