title: The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

acronym: CLASSIC

summary: The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

ReferenceCitation: Hjortrup PB, Haase N, Bundgaard H, Thomsen SL, Winding R, Pettilä V, Aaen A, Lodahl D, Berthelsen RE, Christensen H, Madsen MB, Winkel P, Wetterslev J, Perner A; CLASSIC Trial Group; Scandinavian Critical Care Trials Group. Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial. Intensive Care Med. 2016 Nov;42(11):1695-1705. Epub 2016 Sep 30.

ReferenceCitation: Meyhoff TS, Møller MH, Hjortrup PB, Cronhjort M, Perner A, Wetterslev J. Lower vs Higher Fluid Volumes During Initial Management of Sepsis: A Systematic Review With Meta-Analysis and Trial Sequential Analysis. Chest. 2020 Jun;157(6):1478-1496. doi: 10.1016/j.chest.2019.11.050. Epub 2020 Jan 23.

family: Meyhoff

full_name: Tine Sylvest Meyhoff

given: Tine Sylvest

family: Møller

full_name: Morten Hylander Møller

given: Morten Hylander

family: Hjortrup

full_name: Peter Buhl Hjortrup

given: Peter Buhl

family: Cronhjort

full_name: Maria Cronhjort

given: Maria

family: Perner

full_name: Anders Perner

given: Anders

family: Wetterslev

full_name: Jørn Wetterslev

given: Jørn

journal_name: Chest

ReferenceCitation: Kjaer MN, Meyhoff TS, Madsen MB, Hjortrup PB, Møller MH, Egerod I, Wetterslev J, Lange T, Cronhjort M, Laake JH, Jakob SM, Nalos M, Pettilä V, van der Horst ICC, Ostermann M, Mouncey P, Cecconi M, Ferrer R, Malbrain MLNG, Ahlstedt C, Hoffmann S, Bestle MH, Gyldensted L, Nebrich L, Russell L, Vang M, Sølling C, Brøchner AC, Rasmussen BS, Perner A. Long-term patient-important outcomes after septic shock: A protocol for 1-year follow-up of the CLASSIC trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):410-416. doi: 10.1111/aas.13519. Epub 2019 Dec 26.

name: Department of Intensive Care Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark

name: Centre for Research in Intensive Care (CRIC) Copenhagen Denmark

family: Kjær

full_name: Maj‐Brit N. Kjær

given: Maj‐Brit N.

full_name: Tine S. Meyhoff

given: Tine S.

family: Madsen

full_name: Martin B. Madsen

given: Martin B.

full_name: Peter B. Hjortrup

given: Peter B.

family: Egerod

full_name: Ingrid Egerod

given: Ingrid

name: Copenhagen Trial Unit Centre for Clinical Intervention Research Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark

name: Section of Biostatistics Department of Public Health University of Copenhagen Copenhagen Denmark

family: Lange

full_name: Theis Lange

given: Theis

name: Section of Anaesthesia and Intensive Care Department of Clinical Science and Education Södersjukhuset Karolinska Institutet Stockholm Sweden

name: Division of Emergencies and Critical Care Department of Anaesthesiology Oslo University Hospital, Rikshospitalet Oslo Norway

family: Laake

full_name: Jon H. Laake

given: Jon H.

name: Department of Intensive Care Medicine University Hospital Bern (Inselspital) University of Bern Bern Switzerland

family: Jakob

full_name: Stephan M. Jakob

given: Stephan M.

name: Medical Intensive Care Unit 1. Interni klinika Fakultni Nemocnice Plzen Czech Republic

family: Nalos

full_name: Marek Nalos

given: Marek

name: Division of Intensive Care Medicine Department of Anaesthesiology, Intensive Care and Pain Medicine Helsinki University Hospital University of Helsinki Helsinki Finland

family: Pettilä

full_name: Ville Pettilä

given: Ville

name: Department of Intensive Care Maastricht University Medical Center+ University Maastricht Maastrict The Netherlands

family: Horst

full_name: Iwan C. C. Horst

given: Iwan C. C.

name: Department of Intensive Care Guy's and St Thomas' Hospital London UK

name: Clinical Trial Unit Intensive Care National Audit & Research Centre (ICNARC) London UK

name: Department of Intensive Care Medicine Humanitas Research Hospital Milan Italy

name: Department of Intensive Care Hospital Vall d'Hebron Barcelona Spain

name: Department of Intensive Care Medicine University Hospital Brussels (UZB) Jette Belgium

name: Faculty of Medicine and Pharmacy Vrije Universiteit Brussel (VUB) Brussels Belgium

name: Department of Perioperative Medicine and Intensive Care Karolinska University Hospital Huddinge Stockholm Sweden

name: Department of Anaesthesia and Intensive Care Copenhagen University Hospital, Bispebjerg Copenhagen Denmark

name: Department of Anaesthesia and Intensive Care Nordsjællands Hospital University Hospital of Copenhagen Hillerød Denmark

name: Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

name: Department of Intensive Care Gentofte Hospital Gentofte Denmark

name: Department of Anaesthesia and Intensive Care Zealand University Hospital Køge Denmark

name: Department of Anaesthesia and Intensive Care Zealand University Hospital Roskilde Denmark

name: Copenhagen Academy for Medical Education and Simulation, Rigshospitalet Copenhagen Denmark

name: Department of Anaesthesia and Intensive Care Randers Hospital Randers Denmark

name: Department of Anaesthesia and Intensive Care Viborg Hospital Viborg Denmark

name: Department of Anaesthesia and Intensive Care Lillebælt Hospital Kolding Denmark

name: Department of Anaesthesia and Intensive Care Aalborg University Hospital Aalborg Denmark

repository_institution: University of Bern - Bern Open Repository and Information System

repository_normalized: HELDA - Digital Repository of the University of Helsinki

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

title: Long‐term patient‐important outcomes after septic shock: A protocol for 1‐year follow‐up of the CLASSIC trial

location_country: Italy Sweden Switzerland Netherlands Finland France Czechia Norway Belgium Spain Denmark

location_facility: Dept. of Anaesthesia and Intensive Care, Zealand University Hospital Køge

location_facility: Dept. of Intensive Care, Gentofte Hospital

location_facility: Dept. of Anaesthesia and Intensive Care, Viborg Hospital

location_facility: Medical Intensive Care Unit, Fakultni Nemocnice

location_facility: Dept. of Intensive Care, University Medical Center Groningen

location_facility: Dept. of Intensive Care Medicine, Stavanger

location_facility: Dept. of Intensive Care, Copenhagen University Hospital Herlev

location_facility: Dept. of Intensive Care Medicine, Kuopio Hospital

location_facility: Dept. of Anaesthesia and Intensive Care, Slagelse Hospital

location_facility: Dept. of intensive care, Østfold, Kalnes

location_facility: Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital

location_facility: Department of Intensive Care Medicine, Hôpital St. Louis

location_facility: Dept. of Anaesthesia and Intensive Care, Herning Hospital

location_facility: Dept. of Anaesthesia and Intensive Care, Randers Hospital

location_facility: Dept. of Anaesthesia and Intensive Care, Zealand University Hospital Roskilde

location_facility: Dept. of intensive Care, Innlandet Hamar

location_facility: Dept of Intensive Care,Copenhagen University Hospital Rigshospitalet

location_facility: Dept. of Intensive Care, Hillerød Hospital

location_facility: Dept. of Intensive Care, University Hospital Bern

location_facility: Dept. of Anaesthesia and Intensive Care, Lillebaelt Hospital

location_facility: Dept. of Intensive Care, Ancona Hospital

location_facility: Dept. of Intensive Care Medicine, Tampere Hospital

location_facility: Dept. of Intensive Care, Humanitas Research Hospital Castelanza

location_facility: Dept. of Intensive Care Medicine Sundsvall Hospital

location_facility: Dept. of Intensive Care Medicine, Helsinki University Hospital, Helsinki, Finland.

location_facility: Dept. of Intensive Care, Oslo University Hospital

location_facility: Dept. of Intensive Care Medicine, St Göran

location_facility: Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.

location_facility: Dept. of Intensive Care, Hospital Vall d'Hebron


title: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplantation

summary: This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following single lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Zambon SpA

location_country:
United States
France
Israel
Spain
Germany
United Kingdom

location_facility: Indiana University Health Methodist Hospital

location_facility: University of Kentucky Albert B. Chandler Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Non-Randomized

lead_sponsor: Iovance Biotherapeutics, Inc.

location_country:
United States
Switzerland
France
Greece
Spain
Germany
United Kingdom
Canada

acronym: Study of LN-144 and LN-145 in the Treatment of Patients with Solid Tumours

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Regional Universitario de Malaga - Hospital General

type: EudraCT Number

source: euctr

title: A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

summary: A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.


title: An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

acronym: OPTICS

summary: This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

status: Active, not recruiting

lead_sponsor: Cortendo AB

location_country:
Italy
Netherlands
France
Bulgaria
Greece
Israel
Poland
Romania
Hungary
Spain
United States

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Washington University School of Medicine

location_facility: University of New Mexico HSC - HSC Sponsored Projects Office

location_facility: Tel Aviv-Sourasky Medical Center Institute Endocrinology Metabolism & Hypertension

location_facility: Clinica Endocrinologia malattie del Metabolismo

location_facility: Hippokration General Hospital Endocrinology and Diabetes Department

location_facility: Sveti Georgy University Hospital Clinic of Endocrinology and Metabolic Diseases

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: General Hospital of Athens Evangelismos Department of Endocrinology and Diabete

location_facility: AOU Policlinico G. Martino Sezione di Endocrinologia

location_facility: Via Sergio Pansini 5 Uni Naples FedericoII Dept of Molecular&Clinical Endocrinology&Oncology

location_facility: University Specialized Hospital for Active Treatment in Endocrinology

location_facility: Institutul National de Endocrinologie C.I. Parhon

location_facility: Bnai Zion Medical Center Endocrinology Institute

location_facility: Semmelweis Egyetem II. Belgyógyászati Klinika


title: Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

summary: This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

ipd_sharing: No

lead_sponsor: Mardil Medical

location_country: Netherlands France Panama Poland Hungary Germany Canada

location_facility: London Health Sciences Centre, University Hospital

location_facility: Semmelweis University Heart and Vascular Center

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

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawia

location_facility: Libin Cardiovascular Institute, University of Calgary

location_facility: University of British Columbia, St. Paul's Hospital

intervention_type: Device


type: Other Identifier

title: Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP)

summary: The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
Brazil
Netherlands
Spain
France
Argentina
Portugal
United States

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: New York University Langone Medical Center

location_facility: Hospital Universitario Virgen del Rocío Pabellón Infantil

location_facility: Laboratorio de Neuroquimica Dr. N.A. Chamoles S.R.L.

location_facility: Erasmus University Medical Center Rotterdam

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

intervention_type: Other


intervention_type: Biological

lead_sponsor: Celgene

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

location_facility: King's College HospitalGKT School of Medicine

location_facility: University Hospital Tuebingen, Department of Internal Medicine

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Columbia University Medical Center / New York Presbyterian Hospital

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: University of Texas Southwestern Medical Center

title: A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)

summary: This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within one 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), and without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c) Approximately 181 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently.


title: Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

acronym: FORERUNNER

summary: This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

lead_sponsor: Xynomic Pharmaceuticals, Inc.

location_country:
United States
France
Spain

location_facility: Bone Marrow Transplant Hematology Oncology Associates

location_facility: Central Texas Veterans Health Care System - NAVREF

location_facility: Advocate Medical Group - Park Ridge, Luther Lane - Oncology

location_facility: Norton Cancer Institute - St. Matthews Campus


title: International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group

summary: The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.

ipd_sharing: Undecided

lead_sponsor: Charite University, Berlin, Germany

location_country:
Italy
Austria
Sweden
Netherlands
Finland
France
Czechia
Poland
Israel
Norway
Australia
Belgium
Portugal
Denmark
United Kingdom

location_facility: Dpt. SCT and Hematology/Oncology University Wroclaw

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Hòpital Universitaire des Enfants Reine Fabiola

location_facility: Australian & New Zealand Childhood Hematology & Oncology Group

location_facility: Instituto Português de Oncologia de Lisboa

lead_sponsor_type: academique


title: A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

summary: To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

enrollment_type: Actual

ipd_sharing: Yes

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Spain
Germany
France
Czechia
Korea, Republic of
Poland
Russian Federation
Portugal
Denmark
United States
United Kingdom
Canada
Taiwan

location_facility: Sidney Kimmel Comprehensive Cancer Center


title: An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants With Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials

summary: Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials

lead_sponsor: Global Blood Therapeutics

location_country:
Italy
Lebanon
Netherlands
France
Egypt
Turkey
Oman
United States
United Kingdom
Canada
Kenya

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: KEMRI - Centre for Respiratory Disease Research (CRDR)

location_facility: University of Illinois College of Medicine

location_facility: University of North Carolina at Chapel Hill

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: American University of Beirut Medical Center

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: KEMRI (Kenya Medical Research Institute) Kisumu

location_facility: University of Pittsburgh Medical Center Health System


lead_sponsor: Marinus Pharmaceuticals

location_country:
Italy
France
Poland
Israel
Australia
Russian Federation
United States
United Kingdom

acronym: Marigold

location_facility:
Marinus Research Facility
Marinus Research Site

title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment

summary: A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.


lead_sponsor: Gilead Sciences

location_country:
Hong Kong
Spain
France
Dominican Republic
Greece
Japan
Malaysia
Thailand
Puerto Rico
China
Turkey
United States
Korea, Republic of
Taiwan

acronym: Alliance

location_facility: Beijing YouAn Hospital, Capital Medical University

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: Korgialenio-Benakio Greek Red Cross General Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: National Hospital Organization Osaka National Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: Hospital General Universitario de Valencia

location_facility: Thai Red Cross AIDS Research Centre (HIV-NAT)

location_facility: Faculty of Medicine, Chiang Mai University

location_facility: Bamrasnaradura Infectious Diseases Institute

location_facility: AHEPA University Hospital of Thessaloniki

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

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Hospital General Universitario Santa Lucia

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

location_facility: CHUVI - Hospital Universitario Alvaro Cunqueiro

location_facility: 1st Affiliated Hospital of Zhejiang University

location_facility: Ministry of Health and Welfare Taoyuan General Hospital

location_facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

summary: The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.


title: A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

acronym: BE RADIANT

summary: This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

ReferenceType: derived

ReferenceCitation: Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.

family: Gottlieb

full_name: Alice B. Gottlieb

given: Alice B.

sequence: first

family: Warren

full_name: Richard B. Warren

given: Richard B.

sequence: additional

family: Augustin

full_name: Matthias Augustin

given: Matthias

family: Garcia

full_name: Llenalia Garcia

given: Llenalia

family: Cioffi

full_name: Christopher Cioffi

given: Christopher

family: Peterson

full_name: Luke Peterson

given: Luke

family: Pelligra

full_name: Christopher Pelligra

family: Ciaravino

full_name: Valerie Ciaravino

given: Valerie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805. Review.

family: Yeremenko

full_name: Nataliya Yeremenko

given: Nataliya

journal_name: Current Opinion in Rheumatology

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.

name: From the Center for Translational Research in Inflammatory Skin Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (K.R.); the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); the Icahn School of Medicine at Mount Sinai, New York (M.L.); the SKiN Centre for Dermatology, Probity Medical Research, Peterborough, and Queen’s University, Kingston, ON (M.G.), and Dalhousie...

family: Reich

full_name: Kristian Reich

given: Kristian

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available

location_country:
United States
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Turkey
Canada
United Kingdom


title: A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres

acronym: PROstate

summary: Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

lead_sponsor: Merit Medical Systems, Inc.

location_country:
Italy
United States
United Kingdom
France

location_facility: Azienda Ospedaliera S. Croce e Carle Cuneo

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: University of Miami- Miller School of Medicine


title: PeriOperative ISchemic Evaluation-3 Trial

summary: This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

lead_sponsor: Population Health Research Institute

location_country:
Malaysia
Australia
Belgium
Russian Federation
Denmark
India
Pakistan
France
Poland
Canada
South Africa
Chile
Hong Kong
Netherlands
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain

location_facility: Specialistyczny Szpital im. E. Szczeklika w Tarnowie

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

location_facility: Moscow Regional Research & Clinical Institute (MONIKI)

location_facility: Second Hospital of Anhui Medical University

location_facility: University of North Carolina at Chapel Hill

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: University Health Network (Toronto General Hospital)

location_facility: Sumandeep Vidyapeeth & Dhiraj General Hospital

location_facility: V. Negovskiy Reanimatology Research Institute

location_facility: E. Meshalkin National Medical Research Center

location_facility: Sefako Makgatho Health Sciences University (SMU)

location_facility: Hospital Clínico Universitario in Valladolid

location_facility: NH Rabindranath Tagore International Inst. of Cardiac Sciences

location_facility: Steve Biko Academic Hospital - University of Pretoria

location_facility: Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze

location_facility: University of Calgary, O'Brien Institute for Public Health

location_facility: West China Hospital of Sichuan University

location_facility: Hospital of Saint-Petersburg State University


ReferenceCitation: Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Apr 27. pii: annrheumdis-2020-219601. doi: 10.1136/annrheumdis-2020-219601. [Epub ahead of print]

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: Sliwinska-Stanczyk

full_name: Paula Sliwinska-Stanczyk

given: Paula

family: Xu

full_name: Huji Xu

given: Huji

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Gensler

full_name: Lianne S Gensler

given: Lianne S

family: Fleishaker

full_name: Dona Fleishaker

given: Dona

family: Wang

full_name: Lisy Wang

given: Lisy

family: Wu

full_name: Joseph Wu

given: Joseph

family: Menon

full_name: Sujatha Menon

given: Sujatha

full_name: Cunshan Wang

given: Cunshan

family: Dina

full_name: Oluwaseyi Dina

given: Oluwaseyi

family: Fallon

full_name: Lara Fallon

given: Lara

family: Kanik

full_name: Keith S Kanik

given: Keith S

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

status: Completed

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

lead_sponsor: Pfizer

location_country:
United States
France
Bulgaria
Czechia
Israel
Poland
Hungary
Australia
Russian Federation
China
Turkey
Canada
Korea, Republic of
Ukraine

location_facility: RSBHI "Smolensk Regional Clinical Hospital"

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Rheumatology Research Unit Sunshine Coast

location_facility: Limited Liability Company Medical Center "Rheuma-Med"

location_facility: Pest megyei Flór Ferenc Kórház, Reumatológia-és Fizioterápiás Osztály

location_facility: Szpital Sw. Elzbiety, Mokotowskie Centrum Medyczne, Zaklad Diagnostyki

location_facility: Multiprofile Hospital for active treatment "Kaspela" EOOD

location_facility: Military-Medical Clinical Center (Clinical Hospital with 200 beds) of State Border Guard Service of

location_facility: NZOZ JAMED Pracownia Rentgenowska Jerema Antoszewski

location_facility: Trinity Universal Research Associates, Inc.

location_facility: Marmara Univ. Istanbul Pendik Egitim ve Arastirma Hastanesi

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi, Ic Hastaliklari

location_facility: Diagnostic-Consulting Center XVII - Sofia

location_facility: Izmir Katip Celebi Univ Ataturk Egitim ve Arastirma Hastanesi

location_facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology

location_facility: The Third Affiliated Hospital, Sun Yat-Sen University

location_facility: Center for Rheumatology and Bone Research

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)

location_facility: University of California, San Francisco Medical Center

location_facility: Malopolskie Badania Kliniczne Sp. z o.o. s.k.

location_facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

location_facility: Lviv Communal Clinical Hospital #4, Rheumatology department

location_facility: Kyiv City Clinical Hospital # 3, Rheumatology Department

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Ternopil University Hospital, Department of Rheumatology,

location_facility: Rheumatology and Immunology Department, Shanghai Changzheng Hospital

location_facility: Geo Medical Sp. z.o.o Szpital Geo Medical

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, rheumatology department,

location_facility: Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim

location_facility: Izmir Katip Celebi Univ. Ataturk Egitim ve Arastirma Hastanesi

location_facility: Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi

location_facility: Szpital Uniwersytecki w Krakowie, Zaklad Radiologii

location_facility: The First Affiliated Hosptial of Wenzhou Medical University

location_facility: Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA

location_facility: Paramount Medical Research and Consulting, LLC

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Zespol Poradni Specjalistycznych REUMED, Wallenroda Filia nr 1

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

study_completion_date_type: Actual

title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

summary: The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

status_simplified: Completed


title: A Phase II Open-label, Randomized, Three-arm, Multicenter Study of LAG525 Given in Combination With Spartalizumab (PDR001), or With Spartalizumab and Carboplatin, or With Carboplatin, as First or Second Line Therapy in Patients With Advanced Triple-negative Breast Cancer

summary:
The purpose of this study is to assess the efficacy, safety, and PK characteristics of the following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to address key aspects of tumor immunogenicity will be implemented in the study.

LAG525 and spartalizumab are two immuno-agents targeting different immune checkpoints, and have been tested as single agents and in combination. To further enhance the efficacy of checkpoint inhibition, carboplatin will be given with LAG525 or with LAG525 and spartalizumab, based on the observation that the addition of chemotherapy can change the tumor microenvironment to be more favorable to immune response.

location_country:
Italy
United States
Lebanon
Germany
France
Japan
Thailand
Israel
Singapore
Hungary
Belgium
Argentina
Australia
Spain
Canada
Korea, Republic of
Taiwan

location_facility:
Ironwood Cancer and Research Centers
Novartis Investigative Site
Highlands Oncology Group


title: A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)

acronym: STAR

summary: The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).

ReferenceCitation: Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5. Review.

family: Davis

full_name: Janet L. Davis

given: Janet L.

journal_name: American Journal of Ophthalmology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: NightstaRx Ltd, a Biogen Company

location_country:
Netherlands
Germany
Finland
France
Denmark
United States
United Kingdom
Canada

intervention_type: Genetic


status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Hong Kong
Mexico
Germany
Finland
France
Poland
Lithuania
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

acronym: CREAD OLE

location_facility: Alzheimer's Research and Treatment Center

location_facility: Neurodegenerative Disorders Research; Neurology

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Institute for Neurodegenerative Disorders

location_facility: SHI City Psychoneurological Dispensary #7 (with Hospital)

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: National Clinical Research Inc.-Richmond

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: Southern Illinois University, School of Medicine

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Advanced Memory Research Institute of NJ

title: A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease

summary: In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.

status_simplified: Unknown


title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study

acronym: LESS-VT

summary: This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
France
Czechia
Spain
Germany
United Kingdom

location_facility: Hospital of the University of Pennsylvania

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Affinity Cardiovascular Specialists, LLC

location_facility: Hospital General Universitario Gregorio Marañón


title: Pyruvate Kinase Deficiency Global Longitudinal Registry

acronym: PEAK Registry

summary:
This study is an observational (ie, noninterventional), longitudinal, multicenter, global registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic hemolytic anemia.

This Registry will be open for enrollment for 7 years and all enrolled participants will be followed prospectively for a minimum of 2 years, and up to 9 years.

Data will be collected from participating Registry Physicians, participants, and, where appropriate, parents/guardians who have provided informed consent or assent (where relevant) and authorization pursuant to applicable laws and regulations.

Data should include demographic, clinical, and treatment data; and other data of relevance to the management of patients with PK deficiency. Annual chart review and data entry are expected in order to enhance longitudinal understanding of PK deficiency; however, no specific protocol schedule of assessment is required by this Registry protocol.

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Italy
Switzerland
Netherlands
Spain
Germany
France
Czechia
Korea, Republic of
Thailand
Ireland
Portugal
Turkey
Denmark
United States
United Kingdom
Canada

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: University of Arkansas for Medical Sciences

location_facility: Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

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

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Evangelisches Krankenhaus Bielefeld gGmbH

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centro Hospitalar Lisboa Central- Hospital Dona Estefania

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Centro Hospitalar E Universitario de Coimbra EPE


location_country:
Italy
Brazil
United States
India
Switzerland
Lebanon
Germany
France
Belgium
Spain
Turkey
Oman
Canada
United Kingdom
Colombia

location_facility: Institute for Pediatric Cancer and Blood Disorders

location_facility: University of Florida College of Medicine

location_facility: Medical University of South Carolina Medical Uni of South Carolina

location_facility: Children s Hospital of Philadelphia Patient Treatment

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago CTBM100C2407

title: A Phase 2,Multicenter,Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab,With or Without Hydroxyurea/Hydroxycarbamide,in Sequential,Descending Age Groups of Pediatric Sickle Cell Disease Patients With Vaso-Occlusive Crisis

summary: The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.


title: Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

summary: The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

ReferenceType: background

ReferenceCitation: Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.

lead_sponsor: Allena Pharmaceuticals

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Urological Associates of Southern Arizona

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Research center of CHU de Québec - Université Laval (CHUL)

location_facility: Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)

location_facility: University of North Carolina Chapel Hill

location_facility: Washington University School of Medicine

location_facility: University of Alabama, Department of Urology

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Albert Einstein College of Medicine Montefiore Medical Center

location_facility: Universitat Bonn - Zentrum für Kinderheilkunde

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: University of Alberta, Division of Urology

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie

location_facility: Universitatsklinikum Freiburg, Klinik for Urologie

location_facility: PSHI GmbH; PFÜTZNER Science & Health Institute GmbH


title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of BTRC4017A Administered Intravenously in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

summary: This study will evaluate the safety, tolerability, and pharmacokinetics of BTRC4017A in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
France
Japan
Belgium
Australia
Spain
Denmark
Canada
Korea, Republic of
Taiwan

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: National Cancer Center Hospital East; Department of Pharmacy

location_facility: Hospital Universitario Fundacion Jimenez Diaz; Servicio de Farmacia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Universitario HM Sanchinarro - CIOCC; Farmacia - Ensayos Clínicos


title: Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction

summary: The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with DCM and stable heart failure.

lead_sponsor: MyoKardia, Inc.

location_country:
United States
Sweden
Netherlands
Poland
France
Germany
United Kingdom

location_facility: Wojewodzki Szpital Specjalistyczny Im M Kopernika

location_facility: Jacksonville Center for Clinical Research

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny z Pododdzialem Intensywnego Nadzoru Kardiologicznego i Pododdzialem Leczenia Zaburzen Rytmu Serca

location_facility: University of Pennsylvania Heart and Vascular Center


ReferenceCitation: Jonasch E, Donskov F, Iliopoulos O, Rathmell WK, Narayan VK, Maughan BL, Oudard S, Else T, Maranchie JK, Welsh SJ, Thamake S, Park EK, Perini RF, Linehan WM, Srinivasan R; MK-6482-004 Investigators. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 25;385(22):2036-2046. doi: 10.1056/NEJMoa2103425.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (E.J.); Aarhus University Hospital, Aarhus, Denmark (F.D.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (O.I.); Vanderbilt University Medical Center, Nashville (W.K.R.); University of Pennsylvania, Philadelphia (V.K.N.); the University of Utah, Salt Lake City (B.L.M.); Hôpital Européen Georges-Pompidou, University of Paris, Paris (S.O.); the University of Michigan, Ann Arbor (T.E.); the University of...

family: Jonasch

full_name: Eric Jonasch

given: Eric

family: Donskov

full_name: Frede Donskov

given: Frede

family: Iliopoulos

full_name: Othon Iliopoulos

given: Othon

family: Rathmell

full_name: W. Kimryn Rathmell

given: W. Kimryn

family: Narayan

full_name: Vivek K. Narayan

given: Vivek K.

family: Maughan

full_name: Benjamin L. Maughan

given: Benjamin L.

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Else

full_name: Tobias Else

given: Tobias

family: Maranchie

full_name: Jodi K. Maranchie

given: Jodi K.

family: Welsh

full_name: Sarah J. Welsh

given: Sarah J.

family: Thamake

full_name: Sanjay  Thamake

given: Sanjay

family: Park

full_name: Eric K. Park

given: Eric K.

family: Perini

full_name: Rodolfo F. Perini

given: Rodolfo F.

family: Linehan

full_name: W. Marston Linehan

given: W. Marston

family: Srinivasan

full_name: Ramaprasad Srinivasan

given: Ramaprasad

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Belzutifan for Renal Cell Carcinoma in von Hippel–Lindau Disease

lead_sponsor: Peloton Therapeutics, Inc.

location_country:
Denmark
United States
United Kingdom
France

acronym:
Phase 2 Study of PT2977 for Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

 Etude de Phase 2 du PT2977 pour le traitement  du cancer du rein associé à la maladie de VHL

location_facility: University of Pennsylvania Medical Center

location_facility: National Institutes of Health Clinical Center

title: An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

summary: This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.


type: Other Grant/Funding Number

title: Biology of Juvenile Myoclonic Epilepsy

acronym: BIOJUME

summary: The investigators are collecting genetic information through blood samples as well as clinical and EEG data from over 1000 people with Juvenile Myoclonic Epilepsy (JME) across the UK, Europe and North America. This study will draw on both existing and new samples from JME patients. These will be compared to anonymised data from samples for 2000 controls. The goal of this study is to find the genetic cause of JME. Finding the cause will help create better treatments for JME, as well as improve patient outcomes by allowing us to detect it earlier.

time_perspective: Other

lead_sponsor: King's College London

location_country:
Italy
France
Czechia
Norway
Estonia
Denmark
United States
United Kingdom
Canada

location_facility: Commissione Genetica Lega Italiana contro l'Epilepssia

location_facility: Walton Centre for Neurology and Neurosurgery


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

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

location_country:
Finland
Malaysia
Belgium
Australia
Denmark
Taiwan
India
France
Japan
Thailand
Norway
Argentina
Korea, Republic of
Colombia
Sweden
Hong Kong
Netherlands
Singapore
China
Germany
United Kingdom
Brazil
Czechia
Israel
Turkey

title: An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

summary: Efficacy and safety of LNP023 in IgAN patients


title: Natural History of the Progression of Choroideremia Study

acronym: NIGHT

summary: The objective of this natural history study is to gain a better understanding of the progression of choroideremia (CHM) and add to the knowledge base for this rare disease.

ReferenceCitation: Hariri AH, Velaga SB, Girach A, Ip MS, Le PV, Lam BL, Fischer MD, Sankila EM, Pennesi ME, Holz FG, MacLaren RE, Birch DG, Hoyng CB, MacDonald IM, Black GC, Tsang SH, Bressler NM, Larsen M, Gorin MB, Webster AR, Sadda SR; Natural History of the Progression of Choroideremia (NIGHT) Study Group. Measurement and Reproducibility of Preserved Ellipsoid Zone Area and Preserved Retinal Pigment Epithelium Area in Eyes With Choroideremia. Am J Ophthalmol. 2017 Jul;179:110-117. doi: 10.1016/j.ajo.2017.05.002. Epub 2017 May 10.

location_country:
Brazil
Netherlands
Germany
Finland
France
Denmark
United States
United Kingdom
Canada


title: A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors

summary: The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).

lead_sponsor: Eli Lilly and Company

location_country:
Italy
France
Belgium
Spain
Denmark
United States

location_facility: Hospital Clinico Universitario Virgen de la Victoria


title: ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias

summary: The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).

ReferenceCitation: Balwani M, Sardh E, Ventura P, Peiró PA, Rees DC, Stölzel U, Bissell DM, Bonkovsky HL, Windyga J, Anderson KE, Parker C, Silver SM, Keel SB, Wang JD, Stein PE, Harper P, Vassiliou D, Wang B, Phillips J, Ivanova A, Langendonk JG, Kauppinen R, Minder E, Horie Y, Penz C, Chen J, Liu S, Ko JJ, Sweetser MT, Garg P, Vaishnaw A, Kim JB, Simon AR, Gouya L; ENVISION Investigators. Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria. N Engl J Med. 2020 Jun 11;382(24):2289-2301. doi: 10.1056/NEJMoa1913147.

name: From the Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York (M.B.); Porphyria Center Sweden, Center for Inherited Metabolic Diseases, Karolinska Institutet, Karolinska University Hospital, Stockholm (E.S., P.H., D.V.); the Department of Surgical and Medical Sciences for Children and Adults, Internal Medicine Unit, University of Modena and Reggio Emilia, Modena, Italy (P.V.); Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona (P.A.P.); King’s...

family: Balwani

full_name: Manisha Balwani

given: Manisha

family: Sardh

full_name: Eliane Sardh

given: Eliane

family: Ventura

full_name: Paolo Ventura

given: Paolo

family: Peiró

full_name: Paula Aguilera Peiró

given: Paula Aguilera

family: Rees

full_name: David C. Rees

given: David C.

family: Stölzel

full_name: Ulrich Stölzel

given: Ulrich

family: Bissell

full_name: D. Montgomery Bissell

given: D. Montgomery

family: Bonkovsky

full_name: Herbert L. Bonkovsky

given: Herbert L.

family: Windyga

full_name: Jerzy Windyga

given: Jerzy

family: Anderson

full_name: Karl E. Anderson

given: Karl E.

family: Parker

full_name: Charles Parker

given: Charles

family: Silver

full_name: Samuel M. Silver

given: Samuel M.

family: Keel

full_name: Siobán B. Keel

given: Siobán B.

family: Wang

full_name: Jiaan-Der Wang

given: Jiaan-Der

family: Stein

full_name: Penelope E. Stein

given: Penelope E.

family: Harper

full_name: Pauline Harper

given: Pauline

family: Vassiliou

full_name: Daphne Vassiliou

given: Daphne

full_name: Bruce Wang

given: Bruce

family: Phillips

full_name: John Phillips

given: John

family: Ivanova

full_name: Aneta Ivanova

given: Aneta

family: Langendonk

full_name: Janneke G. Langendonk

given: Janneke G.

family: Kauppinen

full_name: Raili Kauppinen

given: Raili

family: Minder

full_name: Elisabeth Minder

given: Elisabeth

location_country:
Italy
United States
Sweden
Mexico
Netherlands
Germany
Finland
France
Bulgaria
Japan
Poland
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan


title: InterStim® Amplitude Study

summary: This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

primary_purpose: Basic Science

lead_sponsor: MedtronicNeuro

location_country:
Italy
United States
Netherlands
France
Belgium
Canada
United Kingdom

location_facility: Academic Urology & Urogynecology of Arizona

location_facility: UZ Leuven - Campus Gasthuisberg - Department Urology

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Aurora Research Institute - Aurora West Allis Women's Pavilion

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Adult Pediatric Urology and Urogynecology

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System

location_facility: University Urology Associates, Toronto Western Hospital


title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer

summary: A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer

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:
Austria
Switzerland
Netherlands
Germany
France
Japan
Australia
Spain
United States
United Kingdom

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Nederlands Kanker Instituut, Antoni van Leeuwenhoek Ziekenhuis

location_facility: University Hospitals Cleveland Medical Center

location_facility: The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: John Hopkins Sidney Kimmel Comprehensive Cancer Center


title: Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC

summary: This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

primary_purpose: Diagnostic

lead_sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

location_country:
Italy
Switzerland
France
United States
United Kingdom
Canada

location_facility: University of Texas Southwestern Medical Center

intervention_type: Procedure


title: A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

summary: This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

lead_sponsor: Neurotech Pharmaceuticals

location_country:
United States
United Kingdom
Australia
France

location_facility: Jules Stein Eye Institute / David Geffen School of Medicine

location_facility: University of Utah John A. Moran Eye Center

location_facility: Retina Consultants of Southern Colorado, P.C.

location_facility: Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust

location_facility: Scripps Clinic Carmel Valley Ambulatory Surgery Center

intervention_type: Combination Product


ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

lead_sponsor: Clementia Pharmaceuticals Inc.

location_country:
Italy
Brazil
United States
Sweden
France
Japan
Argentina
Australia
Spain
Canada
United Kingdom

acronym: MOVE

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hospital Universitari i Politècnic La Fe, Unidad de Reumatología Pediatrica

location_facility: Hospital for Sick Children, 555 University Avenue

location_facility: Istituto Giannina Gaslini, Department of Pediatrics, Unit of Rare Diseases

location_facility: Hospital Italiano de Buenos Aires, Tte General Juan Domingo Peron 4190

location_facility: Royal National Orthopaedic Hospital, Brockely Hill

location_facility: University of California San Francisco, Division of Endocrinology and Metabolism

title: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

summary: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.


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:
Italy
United States
Chile
Netherlands
Spain
Germany
France
Poland
Greece
Israel
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of

location_facility: Universitatsklinik Tubingen, Medizinische Klinik, Innere Medizin I

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of California, Davis Medical Center

location_facility: Northwell Health Center for Liver Diseases

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

location_facility: Hospital Universitario Germans Trias i Pujol

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

location_facility: American Research Corporation at the Texas Liver Institute

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

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: The Liver Institute at Methodist Dallas Medical Center

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

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

location_facility: California Pacific Medical Center- Sutter Pacific Medical Foundation

location_facility: University of Rochester Medical Center - PPDS

location_facility: Gastroenterologisch - Hepatologisches Zentrum Kiel

location_facility: Universitatsklinikum Erlangen, Medizinische Klink I, Gastroenterologie

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

location_facility: Institute for Digestive Tract & Liver Disease

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Portsmouth Hospitals University NHS Trust


title: A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Painful Diabetic Neuropathy (EMPADINE)

acronym: EMPADINE

summary: The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

ReferenceCitation: Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

family: Rice

full_name: Andrew S.C. Rice

given: Andrew S.C.

family: Dworkin

full_name: Robert H. Dworkin

given: Robert H.

family: Finnerup

full_name: Nanna B. Finnerup

given: Nanna B.

family: Attal

full_name: Nadine Attal

given: Nadine

family: Anand

full_name: Praveen Anand

given: Praveen

family: Freeman

full_name: Roy Freeman

given: Roy

family: Piaia

full_name: Alessandro Piaia

given: Alessandro

family: Callegari

full_name: Francesca Callegari

given: Francesca

family: Doerr

full_name: Christie Doerr

given: Christie

family: Mondal

full_name: Subhayan Mondal

given: Subhayan

family: Narayanan

full_name: Nisha Narayanan

given: Nisha

family: Ecochard

full_name: Laurent Ecochard

given: Laurent

family: Flossbach

full_name: Yanina Flossbach

given: Yanina

family: Pandhi

full_name: Shaloo Pandhi

given: Shaloo

journal_name: Pain

oa_host_type: publisher

evidence: open (via free article)

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
Spain
Germany
Finland
France
Bulgaria
Poland
Slovakia
Norway
Hungary
Australia
Belgium
Portugal
Denmark
Canada
United Kingdom


title: A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment

acronym: TARGET

summary: This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.

time_perspective: Retrospective

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United States
Saudi Arabia
Switzerland
Netherlands
France
Turkey
Germany

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Florida College of Medicine

location_facility: Washington University in St. Louis, School of Medicine

location_facility: Foundation IRCCS Istituto Nazionale Tumori

location_facility: Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

location_facility: Istanbul university Istanbul medical school


lead_sponsor: GenSight Biologics

location_country:
Italy
France
Belgium
Spain
United States
United Kingdom
Taiwan

acronym: REFLECT

location_facility: University of Colorado Health Eye Center

location_facility: Wills Eye Institute - Ocular Oncology Service

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna UOC Clinica Neurologica

title: Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year

summary: The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional & structural outcomes in subjects with LHON due to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one year.


type: Registry Identifier

title: REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma

summary: Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

lead_sponsor: Bayer

location_country:
Greece
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Saudi Arabia
Netherlands
China
United States
Italy
Austria
Egypt
Spain
Turkey

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: C.R.Wood Cancer Center, Glen Falls Hospital

location_facility: University of Louisville - Clinical Trials Unit

location_facility: St. Joseph´s Hospital and Medical Center


title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

summary: A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.

lead_sponsor: Hoffmann-La Roche

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

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

location_facility: Dana-Farber Cancer Institute - Gastrointestinal Cancer Treatment Center

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital (NTUH) - Cancer Research Center

location_facility: Mayo Clinic - Rochester; Breast Cancer Center

location_facility: The Catholic University of Korea St. Vincent's Hospital

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

location_facility: Uni of Southern California; Norris Comprehensive Cancer Ctr

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center; Cancer Metastasis Research Center

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Universitari Vall dHebron; Oncology


title: A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

summary: This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous CS previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

lead_sponsor: Cortendo AB

location_country:
Italy
Netherlands
France
Bulgaria
Greece
Israel
Poland
Romania
Hungary
Spain
Denmark
United States

location_facility: Allegheny Neuroendocrinology Center, West Penn Allegheny Health System

location_facility: The Center for Diabetes and Endocrine Care

location_facility: University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika

location_facility: Rabin Medical Center- Beilinson Hospital, "Institute of Endocrinology & Metabolism, Beilinson Campus"

location_facility: University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND

location_facility: Maria Sklodowska-Curie Memorial Institute - Cancer Center Gliwice Branch, Nuclear Medicine and Endocrine Oncology Department

location_facility: Hospital Universidad De La Ribera, Endocrinologia

location_facility: Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Endocrinology

location_facility: Semmelweis Egyetem II. Belgyógyászati Klinika A.épület I.emelet ODM-labor

location_facility: University of Genova, Department of Internal Medicine & Medical Specialties (DiMI)

location_facility: Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases

location_facility: Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center

location_facility: Institutul National de Endocrinologie C.I. Parhon, Sectia Clinica de Endocrinologie II, Patologia tiroidei de corelatie

location_facility: General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre

location_facility: Wojskowy Instytut Medyczny, Klinika Gastroenterologii, Endokrynologii I Chorob Wewnetrznych

location_facility: Rigshospitalet, Copenhagen University Hospital, Endocrinology Department

location_facility: General Hospital of Athens 'Laiko', "National and Kapodistrian University of Athens Medical School Pathophysiology - Endocrinology"

location_facility: UCLA School of Medicine, Medicine/Endocrinology Department

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Sectia Clinica Endocrinologie

location_facility: University General Hospital of Ioannina, Department of Endocrinology

location_facility: Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital

location_facility: Policlinico Universitario Sant'Andrea, Scienze Mediche

location_facility: APHM Hôpital de la Conception, Service d'Endocrinologie, Diabète et Maladies Métaboliques

location_facility: AOU Federico II, Sezione di Endocrinologia (Edificio 1, Secondo Piano)

location_facility: AOU Citta della Salure e della Scienza SC Endocrinologia, Diabetologia e Metabolismo

location_facility: Johns Hopkins University, Endocrinology Department

location_facility: Instytut Centrum Zdrowia Matki Polki, Oddział Endokrynologii i Chorób Metabolicznych

location_facility: Columbia University, College of P&S Medicine/Neuro-endocrine Unit

location_facility: AOU Policlinico G. Martino Sezione di Endocrinologia

location_facility: Leiden University, Leiden University Medical Center, Department of Endocrinology

location_facility: Oregon Health & Science University, Neurological Surgery

location_facility: Tel-Aviv Sourasky Medical Center Institute of Endocrinology, Metabolism and Hypertension

location_facility: Northwestern University, Medicine - Endocrinology

location_facility: Hospital Universitario Ramón y Cajal, Endocrinology and Nutrition

location_facility: Washington University School of Medicine, Endocrinology

location_facility: Evangelismos Athens General Hospital, Department of Endocrinology

location_facility: Hippokration General Hospital, "Endocrinology and Diabetes Department

location_facility: Spitalul Clinic Judetean Mures, Compartimentul de Endocrinologie

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu", Departamentul de Endocrinologie

location_facility: Erasmus Medical Center, Department of Internal Medicine

location_facility: Bnai Zion Medical Center, Institute of Endocrinology

location_facility: Memorial Sloan Kettering Cancer Center, Endocrinology

location_facility: Clinica di Endocrinologia e malattie del Metabolismo, Dipartimento Specialità Mediche

location_facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD Clinic of Endocrinology and Metabolic Diseases


title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

acronym: CITRINO

summary: This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) (mFOLFOX6) or FOL/leucovorin, 5-fluorouracil and irinotecan (IRI) (FOLFIRI), and bevacizumab in participants with advanced solid tumors in a broad range of solid tumors. Participants with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with dostarlimab (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), as well as pharmacodynamics (PDy) data. Part 2A of the study will investigate the anti-tumor activity of TSR-033 and dostarlimab in combination in participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC). Part 2B of the study will investigate the safety and anti-tumor activity of TSR-033 and dostarlimab in combination with chemotherapy (Cohort B1: mFOLFOX6 and Cohort B2: FOLFIRI) and bevacizumab in participants with advanced or metastatic MSS-CRC.

lead_sponsor: Tesaro, Inc.

location_country:
United States
France


title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)

acronym: OPuS One

summary: This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

ReferenceType: result

ReferenceCitation: Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Höh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.

family: Levy

full_name: Jason Levy

given: Jason

family: Hopkins

full_name: Thomas Hopkins

given: Thomas

family: Morris

full_name: Jonathan Morris

given: Jonathan

family: Tran

full_name: Nam D. Tran

given: Nam D.

family: David

full_name: Elizabeth David

given: Elizabeth

family: Massari

full_name: Francesco Massari

given: Francesco

family: Farid

full_name: Hamed Farid

given: Hamed

family: Vogel

full_name: Alexander Vogel

given: Alexander

family: O’Connell

full_name: William G. O’Connell

given: William G.

family: Sunenshine

full_name: Peter Sunenshine

given: Peter

family: Dixon

full_name: Robert Dixon

given: Robert

family: Gangi

full_name: Afshin Gangi

given: Afshin

family: von der Höh

full_name: Nicolas von der Höh

given: Nicolas

family: Bagla

full_name: Sandeep Bagla

given: Sandeep

journal_name: Journal of Vascular and Interventional Radiology

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

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

location_country:
Luxembourg
United States
France
Germany
Canada

location_facility: Banner - University Medical Center Phoenix

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: University of Texas (UT) Southwestern Medical Center


location_country:
Italy
Austria
Switzerland
Netherlands
Germany
France
Czechia
Japan
Singapore
Argentina
Australia
Belgium
Spain
United States
Taiwan

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: H Lee Moffitt Cancer Center and Research Institute Inc

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

title: A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

summary: The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.


title: Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

summary: The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Italy
Austria
Netherlands
Germany
France
United States
United Kingdom

location_facility: The University of Texas Health Science Center at Houston

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo


title: Phase I/II, Open-Label, Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Childhood Cerebral Adrenoleukodystrophy (CCALD)

summary: This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: NeuroVia, Inc.

location_country:
Chile
France
Argentina
Australia
Russian Federation
United Kingdom
Colombia
Ukraine

location_facility: Hospital General de ninos Pedro de Elizalde

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Great Ormond Street Hospital for Children

location_facility: National Children's Specialized Hospital 'OKHMATDET'

location_facility: Moscow Morozov's Children Clinical Hospital


title: CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

summary: The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.

ReferenceCitation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156.

name: Department of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham, Alabama, USA

family: Calhoun

full_name: David A Calhoun

given: David A

name: Lady Davis Institute of Medical Research, and Department of Medicine, Sir Mortimer B. Davis-Jewish General Hospital, McGill University, Montreal, Quebec, Canada

family: Schiffrin

full_name: Ernesto L Schiffrin

given: Ernesto L

name: Division of General Medicine, Hypertension Section, Department of Medicine, Springfield, Illinois, USA

family: Flack

full_name: John M Flack

given: John M

journal_name: American Journal of Hypertension

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Resistant Hypertension: An Update

lead_sponsor: Vascular Dynamics, Inc.

location_country:
United States
Netherlands
France
Germany
United Kingdom

location_facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital


title: Clinical and Basic Investigations Into Phosphomannomutase Deficiency (PMM2-CDG)

summary:
Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG)

This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia).

ReferenceCitation: Čechová A, Honzík T, Edmondson AC, Ficicioglu C, Serrano M, Barone R, De Lonlay P, Schiff M, Witters P, Lam C, Patterson M, Janssen MCH, Correia J, Quelhas D, Sykut-Cegielska J, Plotkin H, Morava E, Sarafoglou K. Should patients with Phosphomannomutase 2-CDG (PMM2-CDG) be screened for adrenal insufficiency? Mol Genet Metab. 2021 Aug;133(4):397-399. doi: 10.1016/j.ymgme.2021.06.003. Epub 2021 Jun 11.

family: Čechová

full_name: Anna Čechová

given: Anna

family: Honzík

full_name: Tomáš Honzík

given: Tomáš

family: Edmondson

full_name: Andrew C. Edmondson

given: Andrew C.

family: Ficicioglu

full_name: Can Ficicioglu

given: Can

family: Serrano

full_name: Mercedes Serrano

given: Mercedes

family: Barone

full_name: Rita Barone

given: Rita

family: De Lonlay

full_name: Pascale De Lonlay

given: Pascale

family: Schiff

full_name: Manuel Schiff

given: Manuel

family: Witters

full_name: Peter Witters

family: Lam

full_name: Christina Lam

given: Christina

family: Patterson

full_name: Marc Patterson

given: Marc

family: Janssen

full_name: Mirian C.H. Janssen

given: Mirian C.H.

family: Correia

full_name: Joana Correia

given: Joana

family: Quelhas

full_name: Dulce Quelhas

given: Dulce

family: Sykut-Cegielska

full_name: Jolanta Sykut-Cegielska

given: Jolanta

family: Plotkin

full_name: Horacio Plotkin

given: Horacio

family: Morava

full_name: Eva Morava

given: Eva

family: Sarafoglou

full_name: Kyriakie Sarafoglou

given: Kyriakie

journal_name: Molecular Genetics and Metabolism

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

location_country:
Italy
Netherlands
Spain
France
Czechia
Poland
Belgium
Portugal
United States

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: Radboud University Nejmegen Medical Center

location_facility: Mother and Child Institute (Instytut Matki i Dziecka)


title: Micra Atrial Tracking Using a Ventricular Accelerometer Study

acronym: MARVEL

summary:
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.

A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

primary_purpose: Device Feasibility

ReferenceCitation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.

family: Chinitz

full_name: Larry Chinitz

given: Larry

family: Ritter

full_name: Philippe Ritter

given: Philippe

family: Khelae

full_name: Surinder Kaur Khelae

given: Surinder Kaur

family: Iacopino

full_name: Saverio Iacopino

given: Saverio

family: Garweg

full_name: Christophe Garweg

given: Christophe

family: Grazia-Bongiorni

full_name: Maria Grazia-Bongiorni

given: Maria

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Johansen

full_name: Jens Brock Johansen

given: Jens Brock

family: Mont

full_name: Lluis Mont

given: Lluis

family: Gonzalez

full_name: Efrain Gonzalez

given: Efrain

family: Sagi

full_name: Venkata Sagi

given: Venkata

family: Duray

full_name: Gabor Z. Duray

given: Gabor Z.

family: Clementy

full_name: Nicolas Clementy

given: Nicolas

family: Sheldon

full_name: Todd Sheldon

given: Todd

family: Splett

full_name: Vincent Splett

given: Vincent

family: Stromberg

full_name: Kurt Stromberg

given: Kurt

family: Wood

full_name: Nicole Wood

given: Nicole

family: Steinwender

full_name: Clemens Steinwender

given: Clemens

journal_name: Heart Rhythm

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
France
Czechia
Malaysia
Belgium
Spain
Denmark
United States

location_facility: Kepler Universitätsklinikum Med Campus III

location_facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

location_facility: Hospital Universitari Clínic de Barcelona


title: Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary 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 complex primary total knee arthroplasty.

lead_sponsor: DePuy Orthopaedics

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

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

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

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: University of Mississippi Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

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

location_facility: The Ohio State University Wexner Medical Center

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

location_facility: London Health Sciences Centre University Hospital

location_facility: Asklepios Orthopädische Klinik Lindenlohe


title: A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma

summary: The primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma.

ReferenceCitation: Xiong Y, Guo Y, Liu Y, Wang H, Gong W, Liu Y, Wang X, Gao Y, Yu F, Su D, Wang F, Zhu Y, Zhao Y, Wu Y, Qin Z, Sun X, Ren B, Jiang B, Jin W, Shen Z, Tang Z, Song X, Wang L, Liu X, Zhou C, Jiang B. Pamiparib is a potent and selective PARP inhibitor with unique potential for the treatment of brain tumor. Neoplasia. 2020 Sep;22(9):431-440. doi: 10.1016/j.neo.2020.06.009. Epub 2020 Jul 8.

family: Xiong

full_name: Yao Xiong

given: Yao

family: Guo

full_name: Yin Guo

given: Yin

family: Liu

full_name: Ye Liu

given: Ye

family: Wang

full_name: Hexiang Wang

given: Hexiang

family: Gong

full_name: Wenfeng Gong

given: Wenfeng

full_name: Yong Liu

given: Yong

full_name: Xing Wang

given: Xing

family: Gao

full_name: Yajuan Gao

given: Yajuan

family: Yu

full_name: Fenglong Yu

given: Fenglong

family: Su

full_name: Dan Su

given: Dan

full_name: Fan Wang

given: Fan

family: Zhu

full_name: Yutong Zhu

given: Yutong

family: Zhao

full_name: Yuan Zhao

given: Yuan

family: Wu

full_name: Yiyuan Wu

given: Yiyuan

family: Qin

full_name: Zhen Qin

given: Zhen

family: Sun

full_name: Xuebing Sun

given: Xuebing

family: Ren

full_name: Bo Ren

given: Bo

family: Jiang

full_name: Bin Jiang

given: Bin

family: Jin

full_name: Wei Jin

given: Wei

family: Shen

full_name: Zhirong Shen

given: Zhirong

family: Tang

full_name: Zhiyu Tang

given: Zhiyu

family: Song

full_name: Xiaomin Song

given: Xiaomin

full_name: Lai Wang

given: Lai

location_country:
United States
France
Switzerland
Netherlands

location_facility: Massachusetts General Hospital Pappas Center for Neuro-Oncology

location_facility: Universitätsspital Zuerich - Klinik fur Neurologie

location_facility: Sarah Cannon Research Institute at Health One

location_facility: University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

location_facility: University of California at San Francisco

location_facility: Penn State Milton S Hershey Medical Center