lead_sponsor: Instituto Grifols, S.A.

summary: The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).

location_facility: University of Debrecen Clinical Center, Pediatric Clinic No. I.

location_facility: Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

location_facility: Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic"

location_facility: Petz Aladár County Teaching Hospital, Department of Pediatric Surgery

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

location_facility: Insititute for Health Protection of Children and Youth

location_facility: University of Pécs Clinical Centre, Pediatric Clinic

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"

location_facility: Semmelweis University, 2nd Dpt of Paediatrics

location_facility: Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie"

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: The Urological Institute of Northeastern New York

location_facility: Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu"

location_facility: Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics

title: A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

location_country:
Germany
Hungary
United Kingdom
Romania
Sweden
United States
Bulgaria
Canada
Serbia
France


study_start_date_type: Actual

acronym: MO-Ped

intervention_type: Drug

lead_sponsor: Clementia Pharmaceuticals Inc.

summary: This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).

ReferenceType: background

ReferenceCitation: Inubushi T, Lemire I, Irie F, Yamaguchi Y. Palovarotene Inhibits Osteochondroma Formation in a Mouse Model of Multiple Hereditary Exostoses. J Bone Miner Res. 2018 Apr;33(4):658-666. doi: 10.1002/jbmr.3341. Epub 2017 Nov 30.

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: The Children's Hospital of Philadelphia (CHOP)

location_facility: Shriners Hospital for Children - Chicago

location_facility: Shriners Hospitals for Children - Portland

location_facility: Shriners Hospital for Children - Philadelphia

location_facility: Bezmialem Vakif University Medical Faculty Hospital

location_facility: Shriners Hospital for Children - Sacramento

location_facility: Hôpital universitaire Necker - Enfants Malades

status: Terminated

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects With Multiple Osteochondromas

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Italy
Portugal
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Spain
Turkey
Canada
France

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Unknown


title: An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

summary: this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.

status: Completed

lead_sponsor: ImmuPharma

location_country:
Germany
Hungary
United States
Mauritius
Czechia
Puerto Rico
France

location_facility: Clinic for Rheumatology and Internal Medicine

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Arthritis and Rheumatic Disease Specialties

status_simplified: Completed


title: Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

acronym: KNOCOUT PE

summary: This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

study_type: Observational

time_perspective: Other

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
BTG International Inc.

location_country:
Germany
United Kingdom
Netherlands
Austria
Switzerland
United States
Turkey
France

location_facility: St. Vincent Hospital, Allegheny Health Network

location_facility: West Virginia University Heart & Vascular Institute

location_facility: Metro Health - University of Michigan Health

location_facility: Temple University Hospital, Department of Thoracic Medicine & Surgery

location_facility: Cardiology Associates of Northern Mississippi

location_facility: St. Vincent Hospital/Reliant Medical Group

location_facility: AdventHealth Tampa Pepin Heart Institute

location_facility: Healthfinity, PLLC Advanced Cardiac & Vascular Clinic

intervention_type: Device


title: A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Efavaleukin Alfa in Adult Subjects With Steroid Refractory Chronic Graft Versus Host Disease

summary:
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD).

Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

Due to early termination, the Phase 2 portion of this study was not conducted.

design_allocation: Non-Randomized

ipd_sharing: Yes

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

lead_sponsor: Amgen

location_country:
United States
Japan
Belgium
France

location_facility: The Ohio State University Wexner Medical Center Arthur G James Cancer Hospital and Solove Research

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg


acronym: ATLAS-INH

lead_sponsor: Genzyme, a Sanofi Company

summary: The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).

ReferenceType: derived

ReferenceCitation: The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available.

location_facility:
Investigational Site Number 2701
Investigational Site Number 2703
Investigational Site Number 9108
Investigational Site Number 9106
Investigational Site Number 8601
Investigational Site Number 9005
Investigational Site Number 8204
Investigational Site Number 0128
Investigational Site Number 0135
Investigational Site Number 0104
Investigational Site Number 8202
Investigational Site Number 3904
Investigational Site Number 6101
Investigational Site Number 8801
Investigational Site Number 4407
Investigational Site Number 9001
Investigational Site Number 8605
Investigational Site Number 4905
Investigational Site Number 9006
Investigational Site Number 9103
Investigational Site Number 8602
Investigational Site Number 8803
Investigational Site Number 8805
Investigational Site Number 8001
Investigational Site Number 8002
Investigational Site Number 9102
Investigational Site Number 9004
Investigational Site Number 9111
Investigational Site Number 3402
Investigational Site Number 8804
Investigational Site Number 3301
Investigational Site Number 6003
Investigational Site Number 8103
Investigational Site Number 0105
Investigational Site Number 9104
Investigational Site Number 4906
Investigational Site Number 8110
Investigational Site Number 9003
Investigational Site Number 8203
Investigational Site Number 1102
Investigational Site Number 0119
Investigational Site Number 6004
Investigational Site Number 0111
Investigational Site Number 0103
Investigational Site Number 0136
Investigational Site Number 9002
Investigational Site Number 9105
Investigational Site Number 0115
Investigational Site Number 0137
Investigational Site Number 8003
Investigational Site Number 8604
Investigational Site Number 3901
Investigational Site Number 0139
Investigational Site Number 8603
Investigational Site Number 2702
Investigational Site Number 0117
Investigational Site Number 3303
Investigational Site Number 6104

title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX

type: Other Identifier

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

location_country:
Germany
Italy
India
United Kingdom
Australia
Japan
United States
China
Korea, Republic of
Spain
Malaysia
South Africa
Turkey
Taiwan
Canada
Ukraine
France


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

title: A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Czechia
Canada
Serbia
France
Hungary
Hong Kong
Denmark
United States
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


lead_sponsor: Regeneron Pharmaceuticals

summary: The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.

ReferenceCitation: Raal FJ, Rosenson RS, Reeskamp LF, Hovingh GK, Kastelein JJP, Rubba P, Ali S, Banerjee P, Chan KC, Gipe DA, Khilla N, Pordy R, Weinreich DM, Yancopoulos GD, Zhang Y, Gaudet D; ELIPSE HoFH Investigators. Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Aug 20;383(8):711-720. doi: 10.1056/NEJMoa2004215.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility:
Regeneron Research Site
Regeneron Research Site #2
Regeneron Research Site # 2
Regeneron Research Site #3

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

location_country:
Italy
Australia
Japan
Netherlands
Austria
United States
Greece
South Africa
Canada
Ukraine
France


title: FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

acronym: FAST Registry

summary: The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: The Hospital for Sick Children

sponsor_collaborators:
The Hospital for Sick Children
Labatt Family Heart Centre

location_country:
Finland
United Kingdom
Hong Kong
Australia
Brazil
Netherlands
Sweden
Switzerland
United States
Spain
Czechia
Canada
Russian Federation
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cincinnati Children's Hospital Medical Centre

location_facility: St George's University Hospital Foundation Trust

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Queen Elizabeth University Hospital, Glasgow

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Cohen Children's Medical Centre/Northwell Health - Lake Success

location_facility: National medical research center for obstetrics, gynecology and perinatology

location_facility: Inc Pediatric Cardiology of Austin Practice

location_facility: Associação Beneficente Síria - Hospital do Coração

location_facility: Karolinska University Hospital, Astrid Lindgen Childrens Hospital

location_facility: West Virginia University Research Corporation

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

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


lead_sponsor: Italfarmaco

summary: This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.

sponsor_collaborators: Italfarmaco Cromsource

location_facility: The University of British Columbia, Children's and Womens Health Centre of BC Branch

location_facility: The John Walton Muscular Dystrophy Research Centre

location_facility: U.O.S.D. Centro Traslazionale di Miologia e Patologie Neurodegenerative, Building 16 - ground floor IRCCS Istituto Giannina Gaslini,

location_facility: CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest

location_facility: Fondazione Policlinico Universitario "A.Gemelli", UOC Neuropsichiatria Infantile

location_facility: Neuromuscular Pathology Unit - Hospital Sant Joan de Déu

location_facility: Klinik- und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum HamburgEppendorf, Martinistr. 52

location_facility: Holland Bloorview Kids Rehabilitation Hospital

location_facility: Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN)

location_facility: A.O.U. Policlinico G. Martino, U.O.C. Neurologia e Malattie Neuromuscolari

location_facility: Hospital Universitari i Politècnic La Fe - Servicio Neurologia

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: Rady Children's Hospital center - UCSD Department of Neuroscience

location_facility: Centro Clinico NeMO Fondazione Serena ONLUS Area SUD

location_facility: Klinikum der Universitat Munchen, Campus Innenstadt, Lindwurmstr. 4

location_facility: The Children's Hospital of Philadelphia Colket Translational Research Building

location_facility: Connecticut Children's Medical Center, Neurology Division

location_facility: University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology

location_facility: Universitätsklinikum Essen - Kinder-und Jugendmedizin Neuropadiatrie

location_facility: University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation

location_facility: Ospedale Pediatrico Bambino Gesù, Malattie Neuromuscolari e Neurodegenerative

location_facility: Leiden University Medical Center LUMC, Albinusdreef 2

location_facility: Hôpital Armand Trousseau I-Motion - Plateforme d'essais cliniques pédiatriques Bâtiment Lemariey - Porte 20 * 2ème étage 26 Avenue du Dr Arnold Nette

location_facility: Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111

location_facility: Institute of Neurology - Schneider Children's Medical Center of Israel Kaplan, 14

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica

location_facility: Clinic of Neurology and Psychiatry for Children and Youth - Neurology Department Dr. Subotic 6a,

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD

location_facility: Virginia Commonwealth University Childrens Hospital of Richmond at

location_facility: Kinsmen Research Centre - Alberta Children's Hospital

status: Enrolling by invitation

title: Open Label, Long-term Safety, Tolerability, and Efficacy Study of GIVINOSTAT in All DMD Patients Who Have Been Previously Treated in One of the GIVINOSTAT Studies

location_country:
Germany
Italy
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
Serbia
France

ipd_sharing: Undecided


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

summary: Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

lead_sponsor: Bayer

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
Czechia
France

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Casa di Cura Privata Malzoni - Villa dei Platani

location_facility: IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie

location_facility: Hospital General Universitario de Valencia


intervention_type: Biological

lead_sponsor: BioMarin Pharmaceutical

summary: This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII prophylaxis plus the washout period (3 days for products of standard half-life or plasma-derived and 5 days for products of extended half-life), whichever is later, to last visit by the data cut-off for the 2-year analysis, hereafter referred to as "Post FVIII Prophylaxis to Last Visit"). The study will also assess the impact of BMN 270 (compared to FVIII prophylaxis) on: the number of bleeding episodes requiring exogenous FVIII treatment in "Post FVIII Prophylaxis to Last Visit", FVIII activity as measured by chromogenic sustrate assay at Week 104 following intravenous infusion of BMN 270, usage of exogenous FVIII replacement therapy in "Post FVIII Prophylaxis to Last Visit", health-related quality of life patient-reported outcomes at week 104 following intravenous infusion of BMN 270. The study will also evaluate the safety of the BMN 270.

ReferenceCitation: Quinn J, Delaney KA, Wong WY, Miesbach W, Bullinger M. Psychometric Validation of the Haemo-QOL-A in Participants with Hemophilia A Treated with Gene Therapy. Patient Relat Outcome Meas. 2022 Jul 18;13:169-180. doi: 10.2147/PROM.S357555. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Ozelo MC, Mahlangu J, Pasi KJ, Giermasz A, Leavitt AD, Laffan M, Symington E, Quon DV, Wang JD, Peerlinck K, Pipe SW, Madan B, Key NS, Pierce GF, O'Mahony B, Kaczmarek R, Henshaw J, Lawal A, Jayaram K, Huang M, Yang X, Wong WY, Kim B; GENEr8-1 Trial Group. Valoctocogene Roxaparvovec Gene Therapy for Hemophilia A. N Engl J Med. 2022 Mar 17;386(11):1013-1025. doi: 10.1056/NEJMoa2113708.

oa_colors: green other

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

repository_institution: Imperial College London - Spiral

ReferenceCitation: Rosen S, Tiefenbacher S, Robinson M, Huang M, Srimani J, Mackenzie D, Christianson T, Pasi KJ, Rangarajan S, Symington E, Giermasz A, Pierce GF, Kim B, Zoog SJ, Vettermann C. Activity of transgene-produced B-domain-deleted factor VIII in human plasma following AAV5 gene therapy. Blood. 2020 Nov 26;136(22):2524-2534. doi: 10.1182/blood.2020005683.

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

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

publisher_dissemination: American Society of Hematology

location_facility: Arthur De Siqueira Cavalcanti Hematology State Institute

location_facility: St. Joseph's Children's Hospital, Center for Bleeding and Clotting Disorders

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Barts and The London School of Medicine and Dentistry, Haemophilia Centre

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda, Center for Hemophilia and Thrombosis Angelo Bianchi Bonomi

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Parana's Hematology And Hemotherapy Center (HEMEPAR)

location_facility: Washington University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology

location_facility: Glasgow Royal Infirmary, Department of Hematology

location_facility: Campinas Estadual University (UNICAMP) / Campinas Hemocentro / Hematologia E Hemoterapia Center

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

location_facility: University of Michigan, Pediatric Hematology and Oncology

location_facility: Department of Pediatrics, Kyung Hee University Hospital at Gangdong

location_facility: Wayne State University, Detroit Medical Center

location_facility: University of California San Diego, Hematology and Oncology, Hemophilia &Thrombosis Treatment Center

location_facility: Holy Spirit Hematology and Hemotherapy Center

location_facility: Churchill Hospital, Oxford Hemophilia and Thrombosis Center

location_facility: Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center

location_facility: Los Angeles Orthopedic Hospital, Orthopedic Hemophilia Treatment Center

location_facility: Hopital de la Timone Marseille - Assistance Publique des Hopitaux de Marseille

location_facility: Vivantes Clinic im Friedrichshain- Landsberger Allee

location_facility: Regional University Hospital of Lille (CHRU de Lille)

status: Active, not recruiting

title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Brazil
Belgium
United States
Korea, Republic of
Spain
South Africa
Taiwan
France


title: A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: KarMMa

summary: This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

ReferenceCitation: Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

ReferenceCitation: Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.

ReferenceCitation: Shah N, Mojebi A, Ayers D, Cope S, Dhanasiri S, Davies FE, Hari P, Patel P, Hege K, Dhanda D. Indirect treatment comparison of idecabtagene vicleucel versus conventional care in triple-class exposed multiple myeloma. J Comp Eff Res. 2022 Jul;11(10):737-749. doi: 10.2217/cer-2022-0045. Epub 2022 Apr 29.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Sharma P, Kanapuru B, George B, Lin X, Xu Z, Bryan WW, Pazdur R, Theoret MR. FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma. Clin Cancer Res. 2022 May 2;28(9):1759-1764. doi: 10.1158/1078-0432.CCR-21-3803.

evidence: open (via free pdf)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Delforge M, Shah N, Miguel JSF, Braverman J, Dhanda DS, Shi L, Guo S, Yu P, Liao W, Campbell TB, Munshi NC. Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma. Blood Adv. 2022 Feb 22;6(4):1309-1318. doi: 10.1182/bloodadvances.2021005913.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University of California - eScholarship University of California

repositories:
LIRIAS (KU Leuven)
PubMed Central
escholarship.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org

ReferenceCitation: Da Via MC, Dietrich O, Truger M, Arampatzi P, Duell J, Heidemeier A, Zhou X, Danhof S, Kraus S, Chatterjee M, Meggendorfer M, Twardziok S, Goebeler ME, Topp MS, Hudecek M, Prommersberger S, Hege K, Kaiser S, Fuhr V, Weinhold N, Rosenwald A, Erhard F, Haferlach C, Einsele H, Kortum KM, Saliba AE, Rasche L. Homozygous BCMA gene deletion in response to anti-BCMA CAR T cells in a patient with multiple myeloma. Nat Med. 2021 Apr;27(4):616-619. doi: 10.1038/s41591-021-01245-5. Epub 2021 Feb 22.

publisher_dissemination: Springer-Nature

lead_sponsor: Celgene

location_country:
Germany
Italy
Japan
Belgium
United States
Spain
Canada
France

location_facility:
Local Institution - 803
Local Institution - 503
Local Institution - 106
Local Institution - 105
Local Institution - 101
Local Institution - 108
Local Institution - 802
Local Institution - 602
Local Institution - 102
Local Institution - 501
Local Institution - 109
Local Institution - 301
Local Institution - 103
Local Institution - 601
Local Institution - 701
Local Institution - 401
Local Institution - 702
Local Institution - 104
Local Institution - 801
Local Institution - 804
Local Institution - 201
Local Institution - 502
Local Institution - 402
Local Institution - 107


title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

acronym: Onyx ONE

summary: The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

ReferenceCitation: Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Kahar Bin Abdul Ghapar A, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Ali ZA, Parke M, Lung TH, Stone GW; Onyx ONE Investigators. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12.

license: public-domain

license_normalized: public-domain

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

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.

oa_colors: green hybrid

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Newcastle Univesity - Newcastle University ePrints

lead_sponsor: Medtronic Vascular

location_country:
Ireland
Poland
New Zealand
Australia
Thailand
France
Lithuania
Slovakia
Hong Kong
Switzerland
Latvia
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Bulgaria
Sweden

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Paula Stradina Kliniska universitates slimnica

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Keimyung University Dongsan Medical Center

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Bundaberg Cardiology - Friendly Society Private Hospital

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Hospital General Universitario de Alicante

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Golden Jubilee National Hospital - NHS Trust

location_facility: Stavanger Universitetssjukehus - Helse Stavanger HF

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales (UHW)


lead_sponsor: ACADIA Pharmaceuticals Inc.

summary: The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.

ReferenceCitation: Cummings JL, Ismail Z, Dickerson BC, Ballard C, Grossberg G, McEvoy B, Foff E, Atri A. Development and assessment of a brief screening tool for psychosis in dementia. Alzheimers Dement (Amst). 2021 Dec 7;13(1):e12254. doi: 10.1002/dad2.12254. eCollection 2021. Erratum In: Alzheimers Dement (Amst). 2022 Feb 09;14(1):e12290.

publisher_dissemination: Wiley

ReferenceCitation: Tariot PN, Cummings JL, Soto-Martin ME, Ballard C, Erten-Lyons D, Sultzer DL, Devanand DP, Weintraub D, McEvoy B, Youakim JM, Stankovic S, Foff EP. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021 Jul 22;385(4):309-319. doi: 10.1056/NEJMoa2034634.

repository_institution: University of Exeter - Open Research Exeter

location_facility: IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria

location_facility: MUDr. Beata Dupejova, neurologicka ambulancia s.r.o

location_facility: Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre

location_facility: Neuro-Behavioral Clinical Research, Inc.

location_facility: Clinical Hospital Center Dr Dragisa Misovic-Dedinje

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

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Visionary Investigators Network (Aventura Neurologic Associates)

location_facility: Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research

location_facility: Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac

location_facility: Premier Clinical Research Institute, Inc.

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev

location_facility: Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA

location_facility: Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18

location_facility: Lviv Regional State Clinical Psychiatric Hospital

location_facility: Klinik für Psychiatrie und Psychotherapie der Universität Tübingen

location_facility: Clinic for Psychiatry, Clinical Center Kragujevac

location_facility: State Institution "Institute of Neurology, Psychiatry, and Narcology of the National Academy of Medical Sciences of Ukraine", Department of Clinical, Social, and Paediatric Psychiatry

location_facility: Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay

location_facility: Psychiatric Clinic, Military Medical Academy

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"

location_facility: Azienda Ospedaliera di Padova Clinica Neurologica

location_facility: Visionary Investigators Network (First Choice Neurology Group)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

location_facility: Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"

location_facility: Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1

location_facility: Clinical center of Serbia, Clinic for Neurology

location_facility: Centre de Recherche du Gerontopole - CHU de Toulouse

location_facility: Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"

location_facility: Military Medical Academy, Clinic for Neurology

title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
United States
Spain
Chile
Czechia
Bulgaria
Ukraine
Serbia
France


title: A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)

summary: This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

ReferenceCitation: Le X, Cornelissen R, Garassino M, Clarke JM, Tchekmedyian N, Goldman JW, Leu SY, Bhat G, Lebel F, Heymach JV, Socinski MA. Poziotinib in Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Insertion Mutations After Prior Therapies: ZENITH20-2 Trial. J Clin Oncol. 2022 Mar 1;40(7):710-718. doi: 10.1200/JCO.21.01323. Epub 2021 Nov 29.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
France
Italy
Netherlands
Belgium
United States
Spain
Canada
Israel

location_facility: North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists

location_facility: The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.

location_facility: CTCA - Southeastern Regional Medical Center

location_facility: CTCA - Midwestern Regional Medical Center

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale

location_facility: National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires

location_facility: Oncology Physician's Network Inc./OPN Healthcare

location_facility: North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists

location_facility: UCSF Helen Diller Comprehensive Cancer Center at Mt Zion

location_facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: University Hospital Germans Trias i Pujol, Department of Medical Oncology

location_facility: National Cancer Institute, IRCCS, Department of Medical Oncology

location_facility: Gustave Roussy Oncology Institute, Department of Medical Oncology

location_facility: Ambroise Pare University Hospital Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Montefiore Einstein Medical Center for Cancer Care


title: An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies

summary: Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Quintiles, Inc.

location_country:
United States
United Kingdom
Netherlands
France


title: A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) Versus IV Decitabine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML)

summary: Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
United States
Spain
Czechia
Canada
France

location_facility: Philipps-Universität Marburg, Klinik für Innere medizin, Hämatologie, Onkologie und Immunologie

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Pecs, 1st Department of Internal Medicine

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: Fakultni Nemocnice Kralovske Vinohrady FNKV

location_facility: Charleston Hematology Oncology Associates

location_facility: Oberärztin für Innere Medizin, Hämato-/Onkologie und Palliativmedizin

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi

location_facility: Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve Rosemont

location_facility: ULSS 8 Vicenza - Ospedale San Bortolo di Vicenza

location_facility: Centre de lutte contre le Cancer Leon Berard

location_facility: Baylor Scott & White University Medical Center

location_facility: Princess Margaret Cancer Center - University Health Network

location_facility: Queen Elizabeth II (QEII) Health Sciences Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Compassionate Cancer Care Research Group

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Pittsburgh Hillman Cancer Center

location_facility: Fondazione IRCCS C Granda OM Policlinico

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità Novara

location_facility: Indiana Blood and Marrow Transplantation


summary: Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

location_facility: Abramson Cancer Center at Pennsylvania Hospital

location_facility: Washington Cancer Institute at MedStar Washington Hospital

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

location_facility: University of Minnesota Medical Center Fairview

title: Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

primary_purpose: Supportive Care

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:
Italy
Poland
United Kingdom
Australia
Sweden
United States
Spain
France


title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

lead_sponsor: CymaBay Therapeutics, Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Turkey
Chile
Czechia
Canada
France
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov

location_facility: Richmond Community Hospital LLC., d/b/a Bon Secours Liver Institute of Richmond

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Ege University Medical Faculty, Kazimdirik Mah

location_facility: Portsmouth Hospitals University NHS Trust

location_facility: Interni a Kardiologicka Klinika-Oddeleni Gastroenterologie a Hepatologie

location_facility: U.T. Southwestern Medical Center Investigation Drug Service

location_facility: Southern Therapy and Advanced Research (STAR), LLC

location_facility: California Pacific Medical Center- Sutter Pacific Medical Foundation

location_facility: CINME (Centro de Investigaciones Metabolicas

location_facility: The University of Chicago Institutional Review Board

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

location_facility: Universitatsklinikum Erlangen, Medizinische Klink I, Gastroenterologie

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

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

location_facility: University Hospital Birmingham - Queen Elizabeth Hospital

location_facility: Universitatsklinik Tubingen, Medizinische Klinik, Innere Medizin I

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia", Centre of Liver Studies

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Northwell Health Center for Liver Diseases

location_facility: Ankara Sehir Hastanesi, Universiteler Mahallesi

location_facility: General University Hospital of Larissa Department of Medicine and Research Laboratory of Internal Medicine

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of California, Davis Medical Center

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Liver Disease Center, Sheba Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Gastroenterologii i Hepatologii

location_facility: Seoul National University Bundang Hospital

location_facility: Federal state budget educational institution of high education "Stavropol state medical university"

location_facility: Ankara Gazi University Faculty of Medicine Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Charite Universitatsmedizin Berlin, Medizinische Poliklinik

location_facility: Gastroenterologisch - Hepatologisches Zentrum Kiel

location_facility: Vanderbilt Hepatology and Liver Transplant

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: The Newcastle Upon Tyne Hospital NHS Foundation Trust

location_facility: University of Rochester Medical Center - PPDS


title: A Randomized, Subject- and Investigator-blinded, Placebo Controlled, Multi-center, Multiple Dose Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Moderate to Severe Asthma

summary: An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Slovakia
Israel
Argentina
Denmark
Belgium
United States
France


acronym:
Diabetic Gastroparesis Study 1

 Étude de la gastroparésie diabétique 1

lead_sponsor: Allergan

summary: This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Regional Public Organization Chernivtsi Regional Endocrinology Center

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Ivano-Frankivsk National Medical University

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

location_facility: Synexus Polska sp.z.o.o oddzial Czestochowa

location_facility: Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

location_facility: Municipal Institution City Hospital No. 7

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

location_facility: L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

location_facility: Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

location_facility: Synexus Clinical Research, US, Santa Rosa

location_facility: Kyiv municipal clinical endocrinological center

location_facility: Diacon Hospital and research Center - Diabetology

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: S R Kalla (SRK) Memorial Gastro & General Hospital

location_facility: Indiana University Health University Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi

location_facility: Connecticut Clinical Research Foundation

location_facility: Kyiv Railway hospital on the railway transport #2 of the branch "health

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: West Visayas State University Medical Center

location_facility: Private Small-Scale Enterprise Medical Centre Pulse

location_facility: Digestive Health Specialist of the South East

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Municipal nonprofit entity of Kharkiv municipal council

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology

location_facility: Centrum Medyczne Pratia S.A. Warsaw, Poland

location_facility: Premier Clinical Research d.b.a. STAT Research

location_facility: Family Practice Center of Wadsworth, Inc.

location_facility: Cotton-O'Neil Clinical Research Center - Digestive Health

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Limited Liability Company "Medical Center "Salutem"

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Synexus Polska Sp. z o.o.Oddzial w Poznaniu

location_facility: University of Iowa Hospitals and Clinics

location_facility: NZOZ Vita Diabetica - Malgorzata Buraczyk

location_facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

location_facility: Frederick Gastroenterology Associates, PA an Elligo Health Research Site

location_facility: Hospital Universitario Principe de Asturias

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Family Medical Associates, Research Department

title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

location_country:
Poland
India
Israel
Singapore
Australia
United States
Korea, Republic of
Spain
Thailand
Malaysia
Bulgaria
Ukraine
Philippines
France


lead_sponsor: OHB Neonatology Ltd.

summary: The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

ReferenceCitation: Hellstrom W, Hortensius LM, Lofqvist C, Hellgren G, Tataranno ML, Ley D, Benders MJNL, Hellstrom A, Bjorkman-Burtscher IM, Heckemann RA, Savman K. Postnatal serum IGF-1 levels associate with brain volumes at term in extremely preterm infants. Pediatr Res. 2023 Feb;93(3):666-674. doi: 10.1038/s41390-022-02134-4. Epub 2022 Jun 9.

license: cc-by

license_normalized: cc-by

location_facility: Presidio Ospedaliero Di Treviso Ca' Foncello

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: University of South Alabama Children's and Women's Hospital

location_facility: Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

location_facility: Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

location_facility: Medical University of South Carolina Children Hospital

location_facility: Wilhelmina Children Hospital-University Medical Center Utrecht

location_facility: University of Mississippi Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Virginia Commonwealth University - Children's Hospital of Richmond at VCU

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants Compared to Standard Neonatal Care

primary_purpose: Prevention

type: Registry Identifier

ipd_sharing_description: De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.

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


title: International BPA Registry

summary: The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).

lead_sponsor: International CTEPH Association

location_country:
Germany
Poland
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Czechia
France

location_facility: Centre Hospitalier Universitaire Grenoble-Alpes

location_facility: National Cerebral and Cardiovascular Center

location_facility: National Hospital Organization Okayama Medical Center

intervention_type: Procedure


title: Multiple Cardiac Sensors for the Management of Heart Failure

acronym: MANAGE-HF

summary: The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

primary_purpose: Diagnostic

ReferenceCitation: Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.

ReferenceCitation: Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Germany
France

location_facility: University of Southern California Hospital

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Southeast Texas Clinical Research Center

location_facility: Strong Memorial Hospital of the University of Rochester

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Lindner Center for Research and Education at Christ Hosp


title: A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications

summary: This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.

ReferenceCitation: Mazzaferro V, El-Rayes BF, Droz Dit Busset M, Cotsoglou C, Harris WP, Damjanov N, Masi G, Rimassa L, Personeni N, Braiteh F, Zagonel V, Papadopoulos KP, Hall T, Wang Y, Schwartz B, Kazakin J, Bhoori S, de Braud F, Shaib WL. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. Br J Cancer. 2019 Jan;120(2):165-171. doi: 10.1038/s41416-018-0334-0. Epub 2018 Nov 13.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Basilea Pharmaceutica

location_country:
Germany
Ireland
Italy
United Kingdom
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Humanitas Cancer Center, Istituto Clinico Humanitas IRCCS

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Sant'Orsola-Malpighi Hospital, University of Bologna

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The University of Texas Southwestern Medical Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Winship Cancer Institute of Emory University

location_facility: Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers


lead_sponsor: Wave Life Sciences Ltd.

summary: PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).

ReferenceCitation: Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories_concat: UCL Discovery

publisher_dissemination: IOS Press

ReferenceCitation: Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001.

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

evidence: oa repository (semantic scholar lookup)

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: University of California Davis Medical Center

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Odense University Hospital and University of Southern Denmark

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Royal Devon and Exeter Hospital NHS Trust

title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington's Disease

location_country:
Germany
Poland
United Kingdom
Denmark
Australia
United States
Canada
France


summary: PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Lisbon - Repositório da Universidade de Lisboa

location_facility: Center Hospitalier de l'Universite de Montreal

title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease

location_country:
Germany
Poland
United Kingdom
Denmark
Australia
Canada
France


summary: This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.

ReferenceCitation: O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Univ.of California-San Diego Moores Cancer Center

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: UCLA Jonsson Comprehensive Cancer Center

title: A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Germany
Ireland
Italy
Singapore
Denmark
Australia
Belgium
United States
Spain
France


title: Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)

acronym: Y-ESUS

summary: This study seeks to determine the clinical characteristics of young ESUS patients using diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to determine the rates of stroke recurrence, death, and hospital readmission in a contemporary cohort of young ESUS patients during follow-up of up to 18 months.

lead_sponsor: Population Health Research Institute

location_country:
Germany
Poland
United Kingdom
Argentina
Australia
Switzerland
Mexico
United States
Spain
South Africa
Chile
Canada
France

location_facility: Institute Psychiatry and Neurology, 2 Department of Neurology

location_facility: National Institute of Neurology and Neurosurgery

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust

location_facility: Cambridge University Foundation Trust Hospitals, Addenbrookes site

location_facility: University of Texas Health Center - San Antonio

location_facility: East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital

location_facility: Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia

location_facility: Complejo Médico de la PFA Churruca Visca

location_facility: Yoevil District Hospital Foundation Trust

location_facility: Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym

location_facility: Stroke Center Inselspital University Hospital Bern

location_facility: Asklepios Klinik Nord, Department of Neurology

location_facility: University of South Carolina - School of Medicine - Neurology

location_facility: University of Calgary/Foothills Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Vancouver Stroke Program - Research Offices at Vancouver General Hospital

location_facility: Texas Tech University Health Sciences Center El Paso


title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

summary: The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

ReferenceCitation: Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Denmark
United States
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
South Africa
Jordan
Russian Federation
Israel

location_facility: Ausl Della Romagna-Ospedale Degli Infermi

location_facility: Universitair Medisch Centrum Utrech - Locatie AZU

location_facility: The University Of Texas Health Science Center Houston

location_facility: Royal Free Hospital-Royal Free London NHS Foundation Trust

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2

location_facility: Limmited Liability Company International Medical Centre SOGAZ

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov

location_facility: The Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Ikem Institut Klinicke A Experimentalni Mediciny

location_facility: University Hospital Innsbruck - Tyrolean Hospital

location_facility: Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di

location_facility: Federal State Budget Institution Out-patient Clinic 3

location_facility: Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease

location_facility: Washington University School of Medicine

location_facility: Sourasky Medical Center, Cardiovascular Research Center

location_facility: Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic

location_facility: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica

location_facility: Clinique des maladies lipidiques de Quebec

location_facility: University of Maryland School of Medicine

location_facility: Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn

location_facility: Samara Regional Clinical Cardiologic Dispensary

location_facility: Univerzita Karlova v Praze 1 Lekarska Fakulta

location_facility: Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED

location_facility: National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid


title: A Multi-centre, Double-blind, Parallel-group, Randomised, Placebo Controlled Phase II a Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Different Doses of Orally Administered BI 1467335 During a 12-week Treatment Period Compared to Placebo in Patients With Clinical Evidence of NASH.

summary:
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.

To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.

lead_sponsor: Boehringer Ingelheim

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

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Hospital General Universitario de Valencia

location_facility: The University of North Carolina at Chapel Hill


acronym: ODYSSEY HoFH

summary:
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.

The secondary objectives of the study are:

To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein [Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol [TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides [TG]) in participants with HoFH
To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH
To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH
To assess the potential development of anti-drug (alirocumab) antibodies

ReferenceCitation: Blom DJ, Harada-Shiba M, Rubba P, Gaudet D, Kastelein JJP, Charng MJ, Pordy R, Donahue S, Ali S, Dong Y, Khilla N, Banerjee P, Baccara-Dinet M, Rosenson RS. Efficacy and Safety of Alirocumab in Adults With Homozygous Familial Hypercholesterolemia: The ODYSSEY HoFH Trial. J Am Coll Cardiol. 2020 Jul 14;76(2):131-142. doi: 10.1016/j.jacc.2020.05.027.

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_facility:
Regeneron Study Site
Regeneron Research Site

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial Hypercholesterolemia

location_country:
Germany
Italy
Japan
Austria
United States
Greece
South Africa
Turkey
Taiwan
Czechia
Canada
Ukraine
France


title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)

summary: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201.

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Austria
United States
Spain
Greece
France

location_facility: Hospital of the University of Pennsylvania

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda


title: Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty

summary: Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

lead_sponsor: DePuy Orthopaedics

location_country:
Germany
Ireland
Italy
New Zealand
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Canada
France

location_facility: The Gold Coast Centre for Bone and Joint Surgery

location_facility: CLINICHE GAVAZZENI SPA aka Humanitas Castelli

location_facility: Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology

location_facility: Asklepios Orthopädische Klinik Lindenlohe

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: The Ohio State University Wexner Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: University of Mississippi Medical Center

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche

location_facility: London Health Sciences Centre University Hospital


lead_sponsor: Rainier Therapeutics

summary: This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

location_facility: Washington University School of Medicine

title: A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy

location_country:
Germany
Italy
Poland
Hungary
Denmark
Sweden
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Moldova, Republic of
Ukraine
Serbia
Russian Federation
France


title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

summary: To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.

lead_sponsor: MedImmune LLC

location_country:
United States
Korea, Republic of
France


lead_sponsor: Kite, A Gilead Company

summary: This study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

ReferenceCitation: Ghione P, Palomba ML, Patel AR, Bobillo S, Deighton K, Jacobson CA, Nahas M, Hatswell AJ, Jung AS, Kanters S, Snider JT, Neelapu SS, Ribeiro MT, Brookhart MA, Ghesquieres H, Radford J, Gribben JG. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022 Aug 25;140(8):851-860. doi: 10.1182/blood.2021014375.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Yakoub-Agha I, Oluwole OO, Fung HCH, Rosenblatt J, Rossi JM, Goyal L, Plaks V, Yang Y, Vezan R, Avanzi MP, Neelapu SS. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):91-103. doi: 10.1016/S1470-2045(21)00591-X. Epub 2021 Dec 8.

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: University of Miami Hospital and Clinics

location_facility: University of Rochester Medical Center (URMC)

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

location_country:
United States
France


title: A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

summary: To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

ReferenceCitation: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.

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

repositories_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Immunocore Ltd

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Netherlands
Switzerland
Belgium
United States
Spain
Canada
Ukraine
Russian Federation
France

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

location_facility: The Angeles Clinic and Research Institute

location_facility: Institut Catala d'Oncologia (ICO) - L'Hospitalet

location_facility: Byers Eye Institute, Stanford University

location_facility: Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology

location_facility: Central Adelaide Local Health Network, Royal Adelaide Hospital Cancer Center

location_facility: Institut Roi Albert II Cliniques Universitaires St-Luc

location_facility: Federal State Budget Institution National Medical Research Center of Oncology

location_facility: Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Nationales Centrum für Tumorerkrankungen

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Hospital Universitario General de Valencia

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Istituto Nazionale Tumori - IRCCS Fondazione "G. Pascale" - UOC Melanoma, Immunoterapia Oncologica e Terapie Innovative

location_facility: Universitaetsklinikum Koeln Dermatologie und Venerologie


title: A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

summary: This is a multicenter, open-label Phase 1/2 study of DCC-3014 in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Italy
Poland
United Kingdom
Australia
Netherlands
United States
Spain
Canada
France

location_facility: Gustave Roussy Cancer Campus Grand Paris

location_facility: M. Sklodowska-Curie Memorial Cancer Center

location_facility: Hospital Universitario Virgen del Rocío, Sevilla

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori


title: Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

summary: The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: UCLA Santa Monica Hematology / Oncology SC-2

location_facility: Washington University School of Medicine SC


title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

acronym: ONYX PAS

summary: To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

lead_sponsor: Medtronic Vascular

location_country:
United States
Slovakia
Belgium
France

location_facility: Ziekenhuis Oost Limburg - Campus Sint-Jan

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Michigan Health System - University Hospital

location_facility: Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

location_facility: Columbia University Medical Center/NewYork Presbyterian Hospital


title: Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)

acronym: VISTAX

summary: The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.

ReferenceCitation: Gupta D, Vijgen J, Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen Y, Taghji P, Wright M, Duytschaever M. Quality of life and healthcare utilisation improvements after atrial fibrillation ablation. Heart. 2021 Aug;107(16):1296-1302. doi: 10.1136/heartjnl-2020-318676. Epub 2021 May 5.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;sdu.dk

publisher_dissemination: British Medical Journal

ReferenceCitation: Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen YJ, Taghji P, Wright M, Macours N, Gupta D. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. Europace. 2020 Nov 1;22(11):1645-1652. doi: 10.1093/europace/euaa157.

publisher_dissemination: Oxford University Press

lead_sponsor: Biosense Webster, Inc.

location_country:
Ireland
Italy
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
France

location_facility:
Liverpool Heart and Chest Hospital
LKH Univ. Klinikum Graz
ZOL Genk
AZ Sint-Jan
Mater Private Heart & Vascular Centre
Ospedaliera Universitaria Pisana
Policlinico Caisilino Roma
Medisch Spectrum Twente
Clinique Clairval Marseille
Aarhus Universitetshospital Skejby
Jessa Ziekenhuis
OLV Aalst
Gentofte Hospital
Odense University Hospital
St. Thomas' Hospital
Clinique Pasteur
Herzzentrum, Luzerner Kantonsspital


lead_sponsor: G1 Therapeutics, Inc.

summary:
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.

ReferenceCitation: Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2021 May 15;148(10):2557-2570. doi: 10.1002/ijc.33453. Epub 2021 Jan 12.

ReferenceCitation: Weiss J, Goldschmidt J, Andric Z, Dragnev KH, Gwaltney C, Skaltsa K, Pritchett Y, Antal JM, Morris SR, Daniel D. Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies. Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.

ReferenceCitation: Abraham I, Onyekwere U, Deniz B, Moran D, Chioda M, MacDonald K, Huang H. Trilaciclib and the economic value of multilineage myeloprotection from chemotherapy-induced myelosuppression among patients with extensive-stage small cell lung cancer treated with first-line chemotherapy. J Med Econ. 2021 Nov;24(sup1):71-83. doi: 10.1080/13696998.2021.2014163.

evidence: oa journal (via observed oa rate)

ReferenceCitation: Zeng R, Liu F, Fang C, Yang J, Luo L, Yue P, Gao B, Dong Y, Xiang Y. PIV and PILE Score at Baseline Predict Clinical Outcome of Anti-PD-1/PD-L1 Inhibitor Combined With Chemotherapy in Extensive-Stage Small Cell Lung Cancer Patients. Front Immunol. 2021 Oct 29;12:724443. doi: 10.3389/fimmu.2021.724443. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.

ReferenceCitation: Ferrarotto R, Anderson I, Medgyasszay B, Garcia-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csoszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

sponsor_collaborators:
G1 Therapeutics, Inc.
Roche-Genentech

location_facility: UCLA Medical Center - Santa Monica Hematology And Oncology

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4

location_facility: The Alvin J. Siteman Cancer Center - Center for Advanced Med

location_facility: Chernivtsi Regional Clinical Oncology Center

location_facility: H.U. Quirón Dexeus, Hospital Universitario

location_facility: Redwood Regional Medical Group (RRMG) - Fountain Grove

location_facility: H. Donostia, Hospital Donostia- Servicio de Oncología

location_facility: Daugavpils Regional Hospital, Department of Oncology

location_facility: Lviv State Regional Treatment and Diagnostics Oncology Center

location_facility: Pauls Stradiņš Clinical University Hospital, Oncology Clinic

location_facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia

location_facility: Northside Hospital - Georgia Cancer Specialists

location_facility: Trinity Health - Trinity CancerCare Center

location_facility: Oklahoma University - Peggy and Charles Stephenson Cancer Center

location_facility: East Tallinn Central Hospital Ltd., Clinic of Internal Medicine, Center for Oncology

location_facility: St. Louis Cancer Care, LLP, North County

location_facility: Hospital Clinic de Barcelona- Servicio de Oncología Médica

location_facility: Hospital Universitario Ntra. Sra. de Valme

title: Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)

location_country:
United States
Latvia
Spain
Ukraine
Bulgaria
Estonia
France