title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

summary: The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Ireland
Poland
Argentina
Australia
Brazil
Chile
Czechia
France
Colombia
Hungary
United States
Romania
China
Italy
United Kingdom
Mexico
Spain
Taiwan
Bulgaria
Russian Federation

location_facility: Greater Chicago Specialty Physicians - Orland Park

location_facility: Centro Internacional de Estudios Clinicos (CIEC)

location_facility: Arthritis Center of Lexington-Bluegrass Community Research, Inc.

location_facility: St. Luke's Intermountain Research Center-St. Luke's Clinic - Rheumatology

location_facility: Arthritis, Rheumatic & Bone Disease Associates, Affiliate of Trabecular Medical Group, LLC

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière-RHEUMATOLOGIE

location_facility: Arizona Arthritis & Rheumatology Associates

location_facility: Great Lakes Clinical Trials - Ravenswood

location_facility: Amarillo Center for Clinical Research-Research

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: CHU Montpellier Lapeyronie Hospital-Rhumatologie

location_facility: Arthritis and Rheumatism Associates (ARA) - Jonesboro

location_facility: University Hospitals Cleveland Medical Center-Dermatology

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Arthritis & Rheumatology Research Institute


title: APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

acronym: APPROACH-IS II

summary: This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Moons P, Goossens E, Luyckx K, Kovacs AH, Andresen B, Moon JR, Van De Bruaene A, Rassart J, Van Bulck L; APPROACH-IS II consortium and ISACHD. The COVID-19 pandemic as experienced by adults with congenital heart disease from Belgium, Norway, and South Korea: impact on life domains, patient-reported outcomes, and experiences with care. Eur J Cardiovasc Nurs. 2022 Aug 29;21(6):620-629. doi: 10.1093/eurjcn/zvab120.

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 OAI-PMH doi match)

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
irua

repositories_concat: LIRIAS (KU Leuven);PubMed Central;irua

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ipd_sharing: No

ipd_sharing_description: Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.

lead_sponsor: KU Leuven

location_country:
Argentina
Australia
Brazil
Japan
Malta
Senegal
Turkey
Pakistan
Chile
Canada
France
Colombia
Portugal
Denmark
Switzerland
United States
Ethiopia
India
Belgium
Malaysia
Cameroon
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Botswana
Greece
Taiwan
Bulgaria
Sweden

location_facility: Chiba Cerebral and Cardiovascular Center

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Montreal Heart Institute, Université de Montréal

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto

location_facility: University of Southwestern Medical Center

location_facility: Lucile Packard Children's Hospital and Stanford Health Care

location_facility: Ege University Health Application and Research Center, Cardiology Department

location_facility: Centre Hospitalier universitaire vaudois

location_facility: College of Health sciences, Addis Ababa University

location_facility: Reference Center of Congenital Heart Disease , University Hospital Center of São João

location_facility: Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Royal Brompton Hospital, Royal Brompton & Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust

location_facility: Taussig Heart Center of Johns Hopkins Hospital

location_facility: Paediatric & Congenital Heart Centre, IJN (National Heart Institute)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo

summary: The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Yes

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
United States
Canada
France

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: George Washington Medical Faculty Associates

location_facility: Centre Hospitalier Universitaire Henri Mondor

intervention_type: Drug


lead_sponsor: Biogen

summary:
The primary objective of this study is to demonstrate efficacy of BIIB059 (litifilimab) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.

Secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE; and to evaluate immunogenicity of BIIB059 in participants with active SLE.

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC

location_facility: Rheumatology Associates of Central Florida

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Consultorio Privado Dr. Miguel Cortes Hernandez

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

location_facility: Precision Comprehensive Clinical Research Solution

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

location_facility: CETI - Centro de Estudos em Terapias Inovadoras Ltda.

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Washington University School of Medicine

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

location_facility: University of California San Diego School of Medicine

location_facility: Northwell Health Center for Advanced Medicine

location_facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center

location_facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation

location_facility: Niepubliczny Zakład Opieki Zdrowotnej 'Biogenes' Sp. z o.o.

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Diseno y Planeacion en Investigacion Medica S.C.

location_facility: Oncovida - Centro de Onco-Hematologia de Mato Grosso

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Clinical Research of West Florida - Corporate

location_facility: Arthritis & Rheumatic Disease Specialties

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: AA MRC LLC Ahmed Arif Medical Research Center

location_facility: SBIH 'Orenburg Regional Clinical Hospital'

location_facility: Centro Peninsular de Investigacion Clinica, SCP

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

status: Recruiting

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

study_completion_date_type: Anticipated

location_country:
Poland
Russian Federation
Australia
Brazil
Sweden
Mexico
United States
Korea, Republic of
Spain
Greece
Chile
Taiwan
Bulgaria
Philippines
France

status_simplified: Ongoing


acronym: MORNINGSKY

lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.

sponsor_collaborators:
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

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

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Sanatorio Medico de Diagnostico Y Tratamiento

location_facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: PanAmerican Clinical Research, Querétaro

location_facility: Hospital E Maternidade Celso Pierro PUCCAMP

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: National Hospital Organization Kasumigaura Medical Center

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Fujita Health University Banbuntane Hotokukai Hospital

location_facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

location_facility: Institute of Infectious Diseases Emilio Ribas

location_facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

location_facility: Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

location_facility: Panamerican Clinical Research S.A de C.V.

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC

location_facility: Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases

location_facility: Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center

location_facility: Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20

status: Terminated

title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

location_country:
Germany
Italy
Colombia
Portugal
Argentina
Denmark
Japan
Brazil
Romania
Mexico
Belgium
Switzerland
South Africa
Turkey
Ukraine
France

status_simplified: Unknown


title: ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

acronym: ELEVATE

summary: This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

time_perspective: Prospective

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Italy
France
United Kingdom
United States
Sweden


lead_sponsor: Boehringer Ingelheim

summary:
This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Dawes Fretzin Clinical Research Group, LLC

status: Active, not recruiting

title: An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Germany
Italy
Poland
Norway
Australia
Netherlands
United States
Spain
Czechia
Canada
France


title: A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

acronym: Mylight

summary:
Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.

The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

lead_sponsor: Sandoz

location_country:
Germany
Lithuania
Poland
Portugal
Slovakia
Hungary
Israel
Australia
Japan
Austria
United States
Latvia
Spain
Czechia
Bulgaria
France

intervention_type: Biological


title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

summary:
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).

The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Spain
Canada
France

location_facility:
Hopital Lyon Sud
Local Institution - 102
Hopital Claude Huriez
Local Institution - 403
Local Institution - 402
Local Institution - 401
Local Institution - 101
Local Institution - 104
Local Institution - 103
Local Institution - 202
CHU Montpellier - Hôpital Saint Eloi
Local Institution - 201


type: Registry Identifier

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

summary: The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

location_country:
Germany
Poland
Argentina
Australia
Mexico
United States
Taiwan
Russian Federation
France

location_facility: Oklahoma Medical Research Foundation-ORRC

location_facility: Clinical Research Center of the Carolinas

location_facility: University of Central Florida College of Medicine

location_facility: CHU de Bordeaux Hop St ANDRE-Service de Dermatologie

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Rheumatology

location_facility: Hôpital Tenon-Dermatology and allergology

location_facility: Ohio State University Wexner Medical Centre-Dermatology West


title: A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (hATTR-PN)

summary: This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.

lead_sponsor: Akcea Therapeutics

sponsor_collaborators:
Akcea Therapeutics
United BioSource, LLC

location_country:
Germany
Italy
United States
Spain
Greece
Canada
France

location_facility:
Study Center
Study Centre


type: Other Identifier

title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

ReferenceCitation: Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer. Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

publisher_dissemination: Future Science Ltd

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

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hong Kong
United States
India
Belgium
China
Puerto Rico
Norway
Singapore
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

location_facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul

location_facility: Institut Català d'Oncologia (ICO) - Badalona

location_facility: Xiangya Hospital, Central South University

location_facility: Parkway Cancer Centre - Gleneagles Hospital

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Southern Medical University Nanfang Hospital

location_facility: Hospices Civils de Lyon - Hopital Louis Pradel

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: National Taiwan University Cancer Center (NTUCC)

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Tongji Medical College of Huazhong University of Science and Technology

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: Seoul National University Bundang Hospital

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Harbin Medical University Cancer Hospital

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

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: West China Hospital of Sichuan University

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)


summary: The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

location_facility: Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

location_facility: SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

title: A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

location_country:
Finland
Ireland
Italy
Poland
Portugal
New Zealand
Argentina
Romania
Brazil
Mexico
United States
Spain
Turkey
Chile
Czechia
Russian Federation
France


title: A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

acronym: HI-PEITHO

summary:
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.

Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

ReferenceType: background

ReferenceCitation: Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1):1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan. No abstract available.

ReferenceCitation: Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10.

ReferenceCitation: Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum In: Chest. 2016 Oct;150(4):988.

ReferenceCitation: Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21. Erratum In: Circulation. 2012 Aug 14;126(7):e104. Circulation. 2012 Mar 20;125(11):e495.

ReferenceCitation: Becattini C, Agnelli G, Lankeit M, Masotti L, Pruszczyk P, Casazza F, Vanni S, Nitti C, Kamphuisen P, Vedovati MC, De Natale MG, Konstantinides S. Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model. Eur Respir J. 2016 Sep;48(3):780-6. doi: 10.1183/13993003.00024-2016. Epub 2016 May 12.

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

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evidence: open (via free article)

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Bajaj NS, Kalra R, Arora P, Ather S, Guichard JL, Lancaster WJ, Patel N, Raman F, Arora G, Al Solaiman F, Clark DT 3rd, Dell'Italia LJ, Leesar MA, Davies JE, McGiffin DC, Ahmed MI. Catheter-directed treatment for acute pulmonary embolism: Systematic review and single-arm meta-analyses. Int J Cardiol. 2016 Dec 15;225:128-139. doi: 10.1016/j.ijcard.2016.09.036. Epub 2016 Sep 20.

ReferenceCitation: Kucher N, Boekstegers P, Muller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Muller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Hartel D, Grunwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

ReferenceCitation: Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

ReferenceCitation: Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

ReferenceCitation: Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

ReferenceCitation: Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

ReferenceCitation: GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.

ReferenceCitation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

ReferenceCitation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

ReferenceCitation: Liu VX, Lu Y, Carey KA, Gilbert ER, Afshar M, Akel M, Shah NS, Dolan J, Winslow C, Kipnis P, Edelson DP, Escobar GJ, Churpek MM. Comparison of Early Warning Scoring Systems for Hospitalized Patients With and Without Infection at Risk for In-Hospital Mortality and Transfer to the Intensive Care Unit. JAMA Netw Open. 2020 May 1;3(5):e205191. doi: 10.1001/jamanetworkopen.2020.5191.

ReferenceCitation: Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.

ReferenceCitation: Quiroz R, Kucher N, Schoepf UJ, Kipfmueller F, Solomon SD, Costello P, Goldhaber SZ. Right ventricular enlargement on chest computed tomography: prognostic role in acute pulmonary embolism. Circulation. 2004 May 25;109(20):2401-4. doi: 10.1161/01.CIR.0000129302.90476.BC. Epub 2004 May 17.

ReferenceCitation: Stein PD, Matta F, Yaekoub AY, Goodman LR, Sostman HD, Weg JG, Hales CA, Hull RD, Leeper KV Jr, Beemath A, Saeed IM, Woodard PK. Reconstructed 4-chamber views compared with axial imaging for assessment of right ventricular enlargement on CT pulmonary angiograms. J Thromb Thrombolysis. 2009 Oct;28(3):342-7. doi: 10.1007/s11239-009-0331-5. Epub 2009 Mar 27.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Klok FA, Cohn DM, Middeldorp S, Scharloo M, Buller HR, van Kralingen KW, Kaptein AA, Huisman MV. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. J Thromb Haemost. 2010 Mar;8(3):523-32. doi: 10.1111/j.1538-7836.2009.03726.x. Epub 2009 Dec 15.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Burnett AE, Mahan CE, Vazquez SR, Oertel LB, Garcia DA, Ansell J. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016 Jan;41(1):206-32. doi: 10.1007/s11239-015-1310-7.

ReferenceCitation: Cech DJ, Martin ST. Evaluation of function, activity, and participation. Functional Movement Development Across the Life Span (Third Edition), 2012.

ReferenceCitation: Saris-Baglama RN, Dewey CJ, Chisholm GB, et al. QualityMetric health outcomes™ scoring software 4.0. Lincoln, RI: QualityMetric Incorporated, 2010, p. 138.

ReferenceCitation: Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: University of Geneva - Archive ouverte UNIGE

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

license: cc-by

license_normalized: cc-by

repository_institution: Russian Cardiology Society - Russian Cardiology Journal

ReferenceCitation: Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: Leiden University - Leiden Repository

publisher_dissemination: Elsevier

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
National PERT Consortium, Inc.
University Medical Center Mainz

location_country:
Ireland
Germany
Poland
United Kingdom
Netherlands
Austria
Switzerland
United States
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Guys and St. Thomas NHS Foundation Trust

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: University of Maryland School of Medicine

location_facility: University of Oklahoma Health Science Center


title: VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation

acronym: VANTAGE

summary: Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Netherlands
Spain
France

location_facility: Universitätsmedizin Berlin - Charité Campus Mitte (CCM)

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Universität Mainz (Johannes Gutenberg-Universität Mainz)

location_facility: Hospital General Universitario Dr. Balmis

intervention_type: Device


summary: This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Universitätsklinikum Heidelberg; KiTZ Hopp-Kindertumorzentrum

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: University of Michigan, C.S. Mott Children's Hospital

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Lucile Packard Children's Hospital; Division of Child Neurology

location_facility: Rigshospitalet; Ny Medicin til Børn med Kræft

title: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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


summary: The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology

title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

location_country:
Germany
Poland
United Kingdom
Argentina
Romania
Australia
Brazil
Japan
Mexico
Korea, Republic of
Spain
Canada
France


lead_sponsor: Merck Sharp & Dohme LLC

summary: The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

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evidence: oa journal (via doaj)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

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location_facility: Fourth Hospital of Hebei Medical University ( Site 3366)

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)

location_facility: Seoul National University Hospital ( Site 3203)

location_facility: Private Practice - Dr. Etokhana ( Site 0089)

location_facility: Clinica del Nino y la Madre ( Site 1005)

location_facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 2155)

location_facility: Optumcare Colorado Springs, LLC ( Site 0022)

location_facility: Ningbo Women and Children's Hospital ( Site 3314)

location_facility: Fukui-ken Saiseikai Hospital ( Site 3064)

location_facility: BC Women s Hospital and Health Centre ( Site 0506)

location_facility: Children's National Hospital ( Site 0076)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3208)

location_facility: Cliniques Universitaires Saint-Luc ( Site 2005)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)

location_facility: Dalian Women and Children Medical Treatment Center(Hope Square Children's Branch Hospital) ( Site 33

location_facility: University of Utah School of Medicine ( Site 0006)

location_facility: CHU de Quebec Universite de Laval ( Site 0501)

location_facility: Guangdong Provincial People's Hospital ( Site 3341)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2555)

location_facility: FVR, Järvenpään rokotetutkimusklinikka ( Site 2154)

location_facility: Children's Hospital Colorado ( Site 0066)

location_facility: DCOL Center for Clinical Research ( Site 0042)

location_facility: McGill University Health Centre - Vaccine Study Centre ( Site 0500)

location_facility: Yuncheng Central Hospital - Eastern Hospital ( Site 3318)

location_facility: Multicare Institute For Research And Innovation ( Site 0045)

location_facility: University Of The Orange Free State ( Site 2507)

location_facility: Tribe Clinical Research, LLC ( Site 0015)

location_facility: Cabinet Médical Demeulemeester ( Site 2002)

location_facility: Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)

location_facility: Sociedad Medica de Rionegro SOMER S.A. ( Site 1157)

location_facility: The Children's Hospital of Chongqing Medical University ( Site 3333)

location_facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1252)

location_facility: Multicare Health System Institute for Research and Innovation ( Site 0025)

location_facility: Jiangxi Pingxiang People's Hospital ( Site 3312)

location_facility: Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)

location_facility: Hospital Raja Perempuan Zainab II ( Site 3106)

location_facility: CAIMED Investigación en Salud S.A de C.V ( Site 1209)

location_facility: Xiamen Maternity and Child Health Care Hospital ( Site 3351)

location_facility: Long Beach Memorial Medical Center ( Site 0014)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 2437)

location_facility: FVR, Oulun rokotetutkimusklinikka ( Site 2158)

location_facility: University Health System- San Antonio ( Site 0048)

location_facility: Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)

location_facility: Hamilton Medical Research Group ( Site 0509)

location_facility: St.Luke's International Hospital ( Site 3062)

location_facility: Erciyes University Medical Faculty-pediatric infection ( Site 2554)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 2601)

location_facility: University of Calgary - Alberta Children Hospital ( Site 0504)

location_facility: Prince of Songkla University Faculty of Medicine ( Site 3255)

location_facility: Centenario Hospital Miguel Hidalgo ( Site 1204)

location_facility: Renmin Hospital of Wuhan University ( Site 3316)

location_facility: Children's Clinic of Jonesboro, PA ( Site 0058)

location_facility: Ege University Medical Faculty ( Site 2553)

location_facility: UH Bristol Education Centre ( Site 2607)

location_facility: Facultad Medicina Universidad de Chile ( Site 1105)

location_facility: FVR, Porin rokotetutkimusklinikka ( Site 2156)

location_facility: Xiangya Hospital Central South University ( Site 3347)

location_facility: Chulalongkorn University-Pediatrics ( Site 3252)

location_facility: Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)

location_facility: A.O. Policlinico Consorziale di Bari ( Site 2309)

location_facility: Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)

location_facility: University of Texas Medical Branch at Galveston ( Site 0059)

location_facility: Ageo Central General Hospital ( Site 3051)

location_facility: Canadian Center for Vaccinology ( Site 0503)

location_facility: Regionshospitalet Nordjylland ( Site 2102)

location_facility: University of the Philippines-Philippine General Hospital ( Site 3152)

location_facility: Midwest Children's Health Research Institute, LLC ( Site 0044)

location_facility: The Third Affiliated Hospital of Guangzhou Medical University ( Site 3348)

location_facility: Oxford University Hospital NHS Foundation Trust ( Site 2604)

location_facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 1155)

location_facility: Changde First People's Hospital ( Site 3311)

location_facility: Pusan National University Hospital ( Site 3206)

location_facility: Aalborg Universitetshospital, Nord-Børne- og Ungeafdelingen ( Site 2100)

location_facility: Soroka University Medical Center Rahat Family health center ( Site 2355)

location_facility: Alliance for Multispecialty Research, LLC ( Site 0092)

location_facility: Acevedo Clinical Research Associates ( Site 0002)

location_facility: Madera Family Medical Group ( Site 0046)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 2310)

location_facility: Jiangxi Provincial Children's Hospital ( Site 3313)

location_facility: Zhongda Hospital Southeast University ( Site 3353)

location_facility: Jeonbuk National University Hospital ( Site 3210)

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 2456)

location_facility: Soroka University Medical Center Ramot Family health center ( Site 2354)

location_facility: St. Marianna University School of Medicine Hospital ( Site 3060)

location_facility: Severance Hospital Yonsei University Health System ( Site 3201)

location_facility: SANATORIO DEL SALVADOR-Pediatria ( Site 1008)

location_facility: Sabah Womens & Childrens Hospital ( Site 3102)

location_facility: Orange County Research Institute ( Site 0057)

location_facility: Marshall University School of Medicine and Medical Center ( Site 0064)

location_facility: Maebashi Red Cross Hospital ( Site 3057)

location_facility: Instituto Nacional de Pediatria ( Site 1202)

location_facility: Peking University Third Hospital ( Site 3339)

location_facility: National Hospital Organization Beppu Medical Center ( Site 3063)

location_facility: Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2458)

location_facility: Hunan Provincial People's Hospital ( Site 3355)

location_facility: Chengdu Women and Children Center Hospital ( Site 3332)

location_facility: WIP Warsaw IBD Point Profesor Kierkus ( Site 2441)

location_facility: Guangdong Maternity and Child Health Care Hospital ( Site 3340)

location_facility: Spitalul Cinic de Obstretica si Ginecologie Cuza Voda ( Site 2452)

location_facility: Javara - Privia Medical Group North Texas - Frisco ( Site 0086)

location_facility: Universitair Ziekenhuis Antwerpen ( Site 2001)

location_facility: Clinica Privada del Sol S.A ( Site 1013)

location_facility: Northwest Arkansas Pediatric Clinic ( Site 0050)

location_facility: Rutgers University-Pediatric Clinical Research Center ( Site 0055)

location_facility: Asociacion Civil Selva Amazonica ( Site 1255)

location_facility: Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)

location_facility: Groupe Hospitalier Pellegrin ( Site 2218)

location_facility: FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 2159)

location_facility: Hebei Petro China Central Hospital ( Site 3365)

location_facility: Universita degli studi di Padova Patologia e TIN ( Site 2305)

location_facility: Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)

location_facility: Meridian Clinical Research, LLC ( Site 0082)

location_facility: Next Phase Research Alliance, LLC ( Site 0071)

location_facility: Children's Hospital of Fudan University ( Site 3361)

location_facility: Instytut Mikroekologii Sp. Z o.o. & Co. Sp. Komandytowa ( Site 2412)

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)

location_facility: Seoul National University Bundang Hospital-Pediatrics ( Site 3204)

location_facility: The Maternal and Child Health Hospital of Hunan Province ( Site 3334)

location_facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 2157)

location_facility: Chungang University Hospital ( Site 3211)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 2438)

location_facility: Korea University Ansan Hospital ( Site 3212)

location_facility: Enhancing Care Foundation-DICRS ( Site 2506)

location_facility: MedStar Georgetown Pediatrics ( Site 0047)

location_facility: Hallym University Sacred Heart Hospital ( Site 3207)

location_facility: FVR, Turun rokotetutkimusklinikka ( Site 2151)

location_facility: Gazi Universitesi Saglık Arastırma ve Uygulama Merkezi ( Site 2552)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)

location_facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)

location_facility: Empilweni Services and Research Unit ( Site 2504)

location_facility: Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)

location_facility: Jiangjin District Central Hospital ( Site 3319)

location_facility: JOHAS Yokohama Rosai Hospital ( Site 3058)

location_facility: The Third Hospital of Nanchang ( Site 3325)

location_facility: Tottori University Hospital ( Site 3053)

location_facility: Dartmouth-Hitchcock Medical Center ( Site 0031)

location_facility: Spitalul Clinic "Filantropia" Clinica Obstetrica-Ginecologie ( Site 2451)

location_facility: Hunan Shaoyang No.1 People's Hospital ( Site 3345)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 3254)

location_facility: Shizuoka City Shimizu Hospital ( Site 3061)

location_facility: Philippine Children s Medical Center ( Site 3154)

location_facility: Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093)

location_facility: Steve Biko Academic Hospital ( Site 2505)

location_facility: Meridian Clinical Research, LLC ( Site 0083)

location_facility: Clinica Peruano Americana S.A. ( Site 1253)

location_facility: The First People's Hospital of Hangzhou ( Site 3342)

location_facility: Pediatric Research of Charlottesville, LLC ( Site 0073)

location_facility: Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)

location_facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3209)

location_facility: FVR, Espoon rokotetutkimusklinikka ( Site 2152)

location_facility: MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)

location_facility: UPMC Children's Hospital of Pittsburgh - Primary Care Center - Oakland ( Site 0043)

location_facility: Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)

location_facility: Policlinico Universitario Gemelli ( Site 2301)

location_facility: Centre Hospitalier de Versailles ( Site 2206)

location_facility: MultiCare Rockwood Cheney Clinic ( Site 0068)

location_facility: FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 2153)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 3253)

location_facility: Southeastern Pediatric Associates, P.A. ( Site 0008)

location_facility: Ohio Pediatric Research Association ( Site 0063)

location_facility: Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 1154)

title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

primary_purpose: Prevention

type: Other Grant/Funding Number

location_country:
Finland
Poland
Argentina
Japan
Thailand
Turkey
Chile
Canada
France
Colombia
Denmark
United States
Romania
Belgium
China
Malaysia
Peru
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
South Africa
Israel


title: Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa

summary:
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa.

Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine.

Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked.

At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Germany
Italy
Poland
Norway
Australia
Netherlands
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Dawes Fretzin Clinical Research Group, LLC


acronym: XTEND-Kids

lead_sponsor: Bioverativ, a Sanofi company

summary:
Primary Objective:

- To evaluate the safety of BIVV001 in previously treated pediatric subjects with hemophilia A

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes
To evaluate the efficacy of BIVV001 for perioperative management
To evaluate the safety and tolerability of BIVV001 treatment
To assess the pharmacokinetics (PK) of BIVV001

location_facility: Childrens Hospital Of Columbus-Site Number:8400012

location_facility: Rush University Medical Center-Site Number:8400001

location_facility: Children's Healthcare of Atlanta-Site Number:8400019

location_facility: East Carolina University/Brody Medical Sciences Building-Site Number:8400015

location_facility: Cincinnati Children's Hospital Medical Center-Site Number:8400008

location_facility: Children's Hospital Los Angeles-Site Number:8400006

location_facility: University of Florida-Site Number:8400009

location_facility: NY Presbyterian - Weill Cornell Medical Center-Site Number:8400020

location_facility: Children's Hospital Of Wisconsin-Site Number:8400005

location_facility: University of Iowa Hospitals and Clinics-Site Number:8400002

title: A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

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

location_country:
Germany
Ireland
Italy
Hungary
United Kingdom
Australia
Sweden
Netherlands
Switzerland
United States
Spain
Turkey
Taiwan
Canada
France


title: Valved Graft Post-Market Clinical Follow-up Study

summary: Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Austria
United States
Spain
Greece
France

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology

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

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Hospital of the University of Pennsylvania

location_facility: Groupe Hospitalier Bichat - Claude Bernard


title: An Open Label, Multicenter Roll-over Extension Program (REP) to Characterize the Long-term Safety and Tolerability of Iptacopan (LNP023) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Completed PNH Phase 2 and Phase3 Studies With Iptacopan

summary: This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Lithuania
United Kingdom
Singapore
Japan
Brazil
Netherlands
United States
China
Korea, Republic of
Spain
Malaysia
Taiwan
Czechia
France


title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata

summary: The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).

study_start_date_type: Anticipated

status: Withdrawn

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Australia
Japan
France

location_facility: St George Dermatology & Skin Cancer Centre

location_facility: University of Pittsburgh Department of Dermatology

location_facility: The Juntendo Tokyo Koto Geriatric Medical Center


summary: This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

ReferenceCitation: Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.

oa_host_type: closed

publisher_dissemination: American Chemical Society

location_facility: Emory University School of Medicine/Winship Cancer Institute G2304 - C2301

location_facility: Uni of TX MD Anderson Cancer Cntr Dept of MD Anderson CancerCent

location_facility: Massachusetts General Hospital Cancer Center

title: A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

design_allocation: Non-Randomized

location_country:
Germany
Italy
Hong Kong
Denmark
Australia
Japan
Netherlands
Singapore
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France


title: Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers

acronym: IGuideU

summary: This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).

primary_purpose: Diagnostic

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Germany
United Kingdom
Australia
United States
France

location_facility:
C.H.U. Dijon
Wollongong Hospital
Royal Perth Hospital
CH Vichy
Northwestern
Vascular Care Connecticut
Englewood Hospital and Medical Center
NYU Langone Health
Atrium Health
Northwick Park Hospital
Guys and St. Thomas' Hospital
Royal Free London NHS Foundation Trust
Klinikum Hochsauerland GmbH
Cardiovascular Institute of the South
CHU Strasbourg
Florida Cardiology, P.A.
Vein Center of Southwest Louisiana

intervention_type: Diagnostic Test


title: A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for the Treatment of Unresectable and/or Metastatic Solid Tumors Harboring HER2 Activating Mutations Regardless of Tumor Histology

summary: This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo Co., Ltd.

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


lead_sponsor: FibroGen

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every 2 weeks in ambulatory participants with Duchenne muscular dystrophy (DMD) (age 6 to <12 years).

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: University of California San Diego Health

location_facility: Washington University School of Medicine in St. Louis

location_facility: University of Kansas Medical Center Research Institute

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital of The King's Daughters

location_facility: University of Florida Health Shands Hospital

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: West China Second University Hospital, Sichuan University

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Virginia Children's Hospital

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

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Xiangya Hospital Central South University

location_facility: Centre Hospitalier Universitaire Nantes - Hôtel Dieu

location_facility: University of Massachusetts Memorial Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: The 1st Affiliated Hospital, Sun Yat-sen University

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: University of California Davis Children's Hospital

location_facility: Children's Hospital of Chongqing Medical University

title: A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)

location_country:
Italy
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
China
Spain
Canada
France

ipd_sharing: Undecided


title: RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

summary: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

lead_sponsor: CymaBay Therapeutics, Inc.

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

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: Fakultni nemocnice Ostrava- Interni a Kardiologicka Klinika, Oddeleni gastroenterologie, hepatologie a pankreatologie

location_facility: The Institute for Liver Health DBA Arizona Liver Health

location_facility: Hospital Universitario German Trias i Pujol

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

location_facility: Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: Marmara University Pendik Training and Research Hospital

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

location_facility: Tulane University Health Sciences Center

location_facility: Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine

location_facility: Clinic of High Medical Technologies n.a. N.I. Pirogov

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Toronto Digestive Disease Associates Inc

location_facility: University of Texas Southwestern Medical Center

location_facility: Institute for Digestive Tract & Liver Disease

location_facility: Universitatsklinikum Frankfurt. Medizinische Klinik I

location_facility: University Hospitals Cleveland Medical Center

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: University of Zurich, Gastroenterology and Hepatology

location_facility: Medical Center OK!Clinic+LLC International Institute of Clinical Research

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

location_facility: Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Hospital Universitario Margues de Valdecilla

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

location_facility: Bon Secours Richmond Community Hospital LLC

location_facility: Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of California, Davis Medical Center

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Liver Disease Center, Sheba Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Ankara Gazi University Faculty of Medicine Hospital

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases

location_facility: CINME (Centro de Investigaciones Metabolicas)

location_facility: Gastroenterology Research Unit Dunedin Hospital

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)

location_facility: Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc

location_facility: Hospital Universitario Dr. Jose Eleuterio González

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: State budget institution of healthcare of Moscow city "Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov" of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology


title: Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

summary: This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

lead_sponsor: Steba Biotech S.A.

collaborators:
Medpace, Inc.
PrimeVigilance
ICON plc

sponsor_collaborators:
Steba Biotech S.A.
Medpace, Inc.
PrimeVigilance
ICON plc

location_country:
Germany
France
Italy
Austria
United States
Spain
Israel

location_facility: Urologie und Andrologie Ordensklinikum Linz GmbH Elisabethinen

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center

location_facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center


lead_sponsor: Pharvaris Netherlands B.V.

summary: This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

title: A Phase II, Double-blind, Placebo-controlled, Randomized, Cross-over, Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-inhibitor Deficiency Type I and II

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Netherlands
United States
Spain
Czechia
Bulgaria
Canada
France


title: A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

summary: This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

lead_sponsor: Hoffmann-La Roche

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

location_facility: Abington Neurological Associates Willow Grove

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: Center for Advanced Research & Education

location_facility: Alzheimer?s Research and Treatment Center

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia

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

location_facility: Charing Cross Hospital; Imperial Memory Unit, Level 10 West

location_facility: Ospedale Cardinale Panico; Dip.Ricerca Clinica in Neurologia ? UO Malattie Neurodegenerative

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia


title: A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma

acronym: LIMBER

summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

ipd_sharing_description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
France

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

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


title: A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

location_country:
Italy
United Kingdom
Belgium
United States
Spain
France

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: University of Maryland-Greenebaum Cancer Center

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

acronym: APPLAUSE-IgAN

summary: The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

ReferenceCitation: Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.

publisher_dissemination: Wolters Kluwer Health

location_country:
Germany
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Slovenia
Colombia
Slovakia
Hungary
Denmark
United States
India
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

summary: A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.

lead_sponsor: JCR Pharmaceuticals Co., Ltd.

location_country:
Germany
Poland
United Kingdom
Argentina
Brazil
United States
Spain
Turkey
France

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

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Gazi University Medicine Faculty Hospital

location_facility: Great Ormond Street Hospital for Children NHS Trust - Metabolic Medicine

location_facility: Instituto de Genética e Erros Inatos do Metabolismo

location_facility: University of North Carolina at Chapel Hill Medical School Wing E

location_facility: Instituto de Medicina Integral Prof. Fernando Figueira - Imip

location_facility: Chu De Montpellier Hopital Gui De Chauliac


title: An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN

acronym: NOBLE

summary: This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Italy
United Kingdom
Argentina
Australia
Brazil
Netherlands
Austria
Switzerland
United States
Spain
France

location_facility: Keck School of Medicine, University of Southern California

location_facility: Center Hospitalier Universitaire de Montpellier

location_facility: Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner

location_facility: Hopital Edouard Herriot, Hospices Civils de Lyon

location_facility: Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

location_facility: Hospital Universitario 12 de Octubre, Nephrology Department

location_facility: Santa Casa de Misericordia de Belo Horizonte


title: A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer

acronym: PRIME

summary:
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.

This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

ipd_sharing_description: Anonymised data will be available at request for bona fide researchers with important research questions subject to approval by the study steering committee.

lead_sponsor: University College, London

location_country:
Finland
Germany
Italy
United Kingdom
Argentina
Denmark
Australia
Brazil
Netherlands
Singapore
Belgium
United States
Spain
Canada
France

location_facility: University College London and University College London Hospital

lead_sponsor_type: academique


acronym: BALANCE

lead_sponsor: Ionis Pharmaceuticals, Inc.

summary: The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

sponsor_collaborators:
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics

location_facility: Academic Medical Center - Department of Vascular Medicine

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Hospital da Senhora da Oliveira - Guimaraes

location_facility: Advocate Health and Hospitals Corporation - Lutheran General Hospital

location_facility: Institute de Recherches Cliniques de Montreal

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Assistance Publique - Hopitaux de Marseille

location_facility: Ascension St. Vincent Cardiovascular Research Institute

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz

location_facility: Metabolicke centrum MUDr Katariny Raslovej s. r. o.

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: University of Michigan- Endocrinology & Metabolism

location_facility: The Lipid Clinic (Oslo University Hospital)

location_facility: West Virginia University Heart and Vascular Institute

location_facility: Diabetes/Lipid Management & Research Center

location_facility: University of California, San Francisco (UCSF) - Medical Center

location_facility: New York University (NYU) Langone Medical Center

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Manchester University NHS Foundation Trust (MFT)

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

location_country:
France
Italy
Portugal
Slovakia
Hungary
Norway
United Kingdom
Sweden
Netherlands
United States
Spain
Canada
Israel


title: Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease & Hyperkalaemia (APPETIZE).

acronym: APPETIZE

summary: This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.

ReferenceCitation: Thomsen RW, Nicolaisen SK, Hasvold P, Sanchez RG, Pedersen L, Adelborg K, Egstrup K, Egfjord M, Sorensen HT. Elevated potassium levels in patients with chronic kidney disease: occurrence, risk factors and clinical outcomes-a Danish population-based cohort study. Nephrol Dial Transplant. 2018 Sep 1;33(9):1610-1620. doi: 10.1093/ndt/gfx312.

ReferenceCitation: Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjolander A, Evans M, Carrero JJ. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant. 2020 Sep 1;35(9):1518-1526. doi: 10.1093/ndt/gfz150.

ReferenceCitation: Noel JA, Bota SE, Petrcich W, Garg AX, Carrero JJ, Harel Z, Tangri N, Clark EG, Komenda P, Sood MM. Risk of Hospitalization for Serious Adverse Gastrointestinal Events Associated With Sodium Polystyrene Sulfonate Use in Patients of Advanced Age. JAMA Intern Med. 2019 Aug 1;179(8):1025-1033. doi: 10.1001/jamainternmed.2019.0631. Erratum In: JAMA Intern Med. 2020 Feb 24;:

ReferenceCitation: Zann V, McDermott J, Jacobs JW, Davidson JP, Lin F, Korner P, Blanks RC, Rosenbaum DP. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017 Sep 6;11:2663-2673. doi: 10.2147/DDDT.S143461. eCollection 2017.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

collaborators: Labcorp Corporation of America Holdings, Inc

collaborators: ERT: Clinical Trial Technology Solutions

location_country:
Italy
Sweden
United States
Spain
Canada
France


title: HORIZON: A Phase II, Open-label, Outcomes-assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

summary: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

lead_sponsor: Gyroscope Therapeutics Limited

sponsor_collaborators:
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals

location_country:
Germany
Poland
United Kingdom
Australia
United States
Spain
France

location_facility: Retinal Research Institute (retina consultants of AZ)

location_facility: Moorfields Eye Hospital - NHS Foundation Trust

location_facility: Oftalmika Spolka z ograniczona odpowiedzialnoscia

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Retina Vitreous Associates Medical Group

location_facility: University of California (UC) Davis Medical Group Eye Center

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Northern California Retina Vitreous Associates

location_facility: Mid Atlantic Retina - Wills Eye Hospital