ReferenceCitation: Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Pérol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021 Mar;17(7):763-773. doi: 10.2217/fon-2020-0935. Epub 2020 Nov 5.

name: Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

family: Solomon

full_name: Benjamin J Solomon

given: Benjamin J

name: Shanghai Pulmonary Hospital, Shanghai, China

family: Zhou

full_name: Cai Cun Zhou

given: Cai Cun

name: Memorial Sloan Kettering Cancer Center, Manhattan, NY 10065, USA

family: Drilon

full_name: Alexander Drilon

given: Alexander

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

family: Park

full_name: Keunchil Park

given: Keunchil

name: Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany

family: Wolf

full_name: Jürgen Wolf

given: Jürgen

name: The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Elamin

full_name: Yasir Elamin

given: Yasir

name: Eli Lilly and Company, Indianapolis, IN 46225, USA

family: Davis

full_name: Hannah M Davis

given: Hannah M

family: Soldatenkova

full_name: Victoria Soldatenkova

given: Victoria

family: Sashegyi

full_name: Andreas Sashegyi

given: Andreas

family: Lin

full_name: Aimee Bence Lin

given: Aimee Bence

full_name: Boris K Lin

given: Boris K

name: The Chinese University of Hong Kong, Hong Kong, China

family: F Loong

full_name: Herbert H F Loong

given: Herbert H

name: Department of Oncology, AOU San Luigi-Orbassano, University of Turin, Italy

family: Novello

full_name: Silvia Novello

given: Silvia

family: Arriola

full_name: Edurne Arriola

given: Edurne

name: Léon Bérard Cancer Center of Lyon, Lyon, France

family: Pérol

full_name: Maurice Pérol

given: Maurice

name: National Cancer Center Hospital East, Chiba, Japan

family: Goto

full_name: Koichi Goto

given: Koichi

name: Oncology Center, Hospital Sírio Libanês, Sao Paulo, Brazil

family: Santini

full_name: Fernando C Santini

given: Fernando C

oa_colors: green other

version: submittedVersion

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories: University of Melbourne - Minerva Access

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

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
China
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: The First Affiated Hospital Of Guangzhou Medical Collage

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Spitalul Universitar de Urgență București

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

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

location_facility: Fundacion CENIT para la Investigacion en Neurociencias

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

location_facility: Hospital Universitario La Fe de Valencia

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Samara Regional Clinical Oncology Center

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Vrije Universiteit Medisch Centrum Amsterdam

location_facility: Grupo COI - Clínicas Oncológicas Integradas

location_facility: Chernivtsi Regional Oncological Dispensary

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

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

location_facility: Izmir Ataturk Training and Research Hospital

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

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

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Centro de Oncología e Investigación de Buenos Aires

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Seoul National University Bundang Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: Sumy regional clinical oncological dispensary

location_facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

location_facility: Hospital General Universitario de Alicante

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"

location_facility: GBUZ Republican Clinical Oncological Dispensary

location_facility: Harbin Medical University Cancer Hospital

location_facility: St-Petersburg scientifical practical cente spec medical care

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: CHU Grenoble Alpes- Hopital Albert Michallon

location_facility: Krasnodar regional clinical hospital#1 n.a.S.V. Ochapovskogo

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: University General Hospital of Heraklion

location_facility: Hacettepe University Faculty of Medicine

location_facility: Health Pharma Professional Research S.A. de C.V:

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

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

title: LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

summary: The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


type: Other Identifier

title: A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)

acronym: CIPHER

summary: The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom
Ukraine

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II

location_facility: National Waiting Times Centre Board Golden Jubilee National Hospital

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik für Innere Medizin B

location_facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o

location_facility: Washington University School of Medicine

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'

location_facility: Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie

location_facility: SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: University Of Colorado Cardiac And Vascular Center

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: University of New Mexico School of Medicine

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: The Houston Methodist Research Institute

location_facility: Medizinische Klinik und Poliklinik V - LMU

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Randomized

intervention_type: Drug

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

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

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Treatment

location_country:
Guatemala
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Vietnam
Philippines
China
Portugal
United States
Germany
United Kingdom
Mauritius
Italy
Brazil
Mexico
Czechia
Spain
Turkey
Latvia

acronym: SELUNE

ipd_sharing: Undecided

type: EudraCT Number

source: euctr

title: A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

summary: The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).


ReferenceType: derived

ReferenceCitation: Beaumont H, Evans TL, Klifa C, Guermazi A, Hong SR, Chadjaa M, Monostori Z. Discrepancies of assessments in a RECIST 1.1 phase II clinical trial - association between adjudication rate and variability in images and tumors selection. Cancer Imaging. 2018 Dec 11;18(1):50. doi: 10.1186/s40644-018-0186-0.

family: Beaumont

full_name: Hubert Beaumont

given: Hubert

sequence: first

family: Evans

full_name: Tracey L. Evans

given: Tracey L.

sequence: additional

family: Klifa

full_name: Catherine Klifa

given: Catherine

family: Guermazi

full_name: Ali Guermazi

given: Ali

family: Hong

full_name: Sae Rom Hong

given: Sae Rom

family: Chadjaa

full_name: Mustapha Chadjaa

given: Mustapha

family: Monostori

full_name: Zsuzsanna Monostori

given: Zsuzsanna

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cancer Imaging

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Discrepancies of assessments in a RECIST 1.1 phase II clinical trial – association between adjudication rate and variability in images and tumors selection

ReferenceCitation: Evans TL, Cho BC, Udud K, Fischer JR, Shepherd FA, Martinez P, Ramlau R, Syrigos KN, Shen L, Chadjaa M, Wolf M. Cabazitaxel Versus Topotecan in Patients with Small-Cell Lung Cancer with Progressive Disease During or After First-Line Platinum-Based Chemotherapy. J Thorac Oncol. 2015 Aug;10(8):1221-8. doi: 10.1097/JTO.0000000000000588.

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Udud

full_name: Katalin Udud

given: Katalin

family: Fischer

full_name: Juergen R. Fischer

given: Juergen R.

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Martinez

full_name: Pablo Martinez

given: Pablo

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Syrigos

full_name: Konstantinos N. Syrigos

given: Konstantinos N.

family: Shen

full_name: Liji Shen

given: Liji

location_country:
Italy
Brazil
Chile
Germany
France
Korea, Republic of
Greece
Poland
Norway
Hungary
Romania
Russian Federation
Spain
United States
Canada
Ukraine

location_facility:
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 380001
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 642003
Investigational Site Number 300005
Investigational Site Number 124004
Investigational Site Number 380004
Investigational Site Number 616002
Investigational Site Number 643001
Investigational Site Number 300002
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 724001
Investigational Site Number 300001
Investigational Site Number 250006
Investigational Site Number 804002
Investigational Site Number 804001
Investigational Site Number 276006
Investigational Site Number 642005
Investigational Site Number 578001
Investigational Site Number 152005
Investigational Site Number 152001
Investigational Site Number 250003
Investigational Site Number 578002
Investigational Site Number 348001
Investigational Site Number 840001
Investigational Site Number 380005
Investigational Site Number 124001
Investigational Site Number 840006
Investigational Site Number 410002
Investigational Site Number 616001
Investigational Site Number 124002
Investigational Site Number 410003
Investigational Site Number 076001
Investigational Site Number 724004
Investigational Site Number 410001
Investigational Site Number 804004
Investigational Site Number 300004
Investigational Site Number 300003
Investigational Site Number 643006
Investigational Site Number 643005
Investigational Site Number 643003
Investigational Site Number 642001
Investigational Site Number 724005
Investigational Site Number 642002
Investigational Site Number 124003
Investigational Site Number 348003
Investigational Site Number 380002
Investigational Site Number 348002
Investigational Site Number 348004
Investigational Site Number 578003
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 250007
Investigational Site Number 724002
Investigational Site Number 616004

title: Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

To assess disease progression free rate at 12 weeks
To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
To assess Overall Survival (OS)
To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
To assess the Health-Related Quality of Life (HRQoL)


ReferenceType: result

ReferenceCitation: Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, van Vollenhoven R, Cioffi C, Ecoffet C, Gervitz L, Ionescu L, Peterson L, Fleischmann R. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/S0140-6736(16)31651-8. Epub 2016 Nov 15. Erratum in: Lancet. 2017 Feb 4;389(10068):e2.

family: Smolen

full_name: Josef S Smolen

given: Josef S

family: Burmester

full_name: Gerd-Rüdiger Burmester

given: Gerd-Rüdiger

family: Combe

full_name: Bernard Combe

given: Bernard

family: Curtis

full_name: Jeffrey R Curtis

given: Jeffrey R

family: Hall

full_name: Stephen Hall

given: Stephen

family: Haraoui

full_name: Boulos Haraoui

given: Boulos

family: van Vollenhoven

full_name: Ronald van Vollenhoven

given: Ronald

family: Cioffi

full_name: Christopher Cioffi

given: Christopher

family: Ecoffet

full_name: Cécile Ecoffet

given: Cécile

family: Gervitz

full_name: Leon Gervitz

given: Leon

family: Ionescu

full_name: Lucian Ionescu

given: Lucian

family: Peterson

full_name: Luke Peterson

given: Luke

family: Fleischmann

full_name: Roy Fleischmann

given: Roy

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

name: Department of Immunology CIC1408 GIMAP EA3064 Université Jean Monnet Saint Étienne France

family: Paul

full_name: Stéphane Paul

given: Stéphane

name: Department of Rheumatology SAINBOISE AINBIOSE INSERM 1059 University of Lyon Saint‐Étienne France

family: Marotte

full_name: Hubert Marotte

name: Division of Rheumatology, Allergy & Immunology University of California San Diego School of Medicine La Jolla California USA

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

name: Department of Rheumatology University Hospital of ToursEA 7501 Tours France

family: Goupille

full_name: Philippe Goupille

given: Philippe

name: Department of Rheumatology Diakonhjemmet Hospital Oslo Norway

family: Kvien

full_name: Tore K. Kvien

given: Tore K.

family: Longueville

full_name: Marc Longueville

given: Marc

family: Mulleman

full_name: Denis Mulleman

given: Denis

name: Department of Medicine University of California San Diego La Jolla California USA

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Vande Casteele

full_name: Niels Vande Casteele

given: Niels

title: Exposure–Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis

location_country:
Italy
Austria
United States
Switzerland
Mexico
Spain
Germany
United Kingdom
France
Bulgaria
Czechia
Greece
Poland
Romania
Hungary
Australia
Ireland
Portugal
Canada
Monaco

title: A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

summary: This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.


ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

status: Active, not recruiting

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

enrollment_type: Actual

location_country:
Switzerland
Netherlands
Germany
France
Israel
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Charite Paediatric Pulmonology Department

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: Schneider Children's Medical Center of Israel

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Great Ormond Street Hospital for Sick Children

title: A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

summary: This study will evaluate the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in subjects with CF who are 6 years of age and older with F/MF genotypes.


title: A Multicenter, Two Part, Randomized, Parallel Group, Placebo and Sitagliptin Controlled Study to Evaluate the Safety and Efficacy of GSK256073 Administered Once or Twice Daily for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

summary: The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

status: Completed

study_completion_date_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United States
United Kingdom
France
Spain

status_simplified: Completed


title: Study of GSK2241658A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary: The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma.

ReferenceType: background

ReferenceCitation: American Joint Committee on Cancer. 2002. Cancer staging manual. Sixth edition. Springer editions.

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

location_country:
Italy
Austria
Switzerland
Netherlands
France
Australia
Germany
United Kingdom

intervention_type: Biological


title: An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY 1000394 Given Twice Daily in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies

summary: Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies

lead_sponsor: Bayer

location_country:
Germany
United States
France


title: A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

summary: This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Poland
Belgium
Spain
Germany
United Kingdom


title: A Phase I/II, Open-label, Non-controlled, Escalating Dose, Multicentre Clinical Trial Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of MP0112 Injected Intravitreally in Patients With Wet Age Related Macular Degeneration (AMD)

summary: The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with wet Age Related Macular Degeneration.

status: Terminated

ReferenceCitation: Souied EH, Devin F, Mauget-Faÿsse M, Kolář P, Wolf-Schnurrbusch U, Framme C, Gaucher D, Querques G, Stumpp MT, Wolf S; MP0112 Study Group. Treatment of exudative age-related macular degeneration with a designed ankyrin repeat protein that binds vascular endothelial growth factor: a phase I/II study. Am J Ophthalmol. 2014 Oct;158(4):724-732.e2. doi: 10.1016/j.ajo.2014.05.037. Epub 2014 Jun 5.

family: Souied

full_name: Eric H. Souied

given: Eric H.

family: Devin

full_name: François Devin

given: François

family: Mauget-Faÿsse

full_name: Martine Mauget-Faÿsse

given: Martine

family: Kolář

full_name: Petr Kolář

given: Petr

family: Wolf-Schnurrbusch

full_name: Ute Wolf-Schnurrbusch

given: Ute

family: Framme

full_name: Carsten Framme

given: Carsten

family: Gaucher

full_name: David Gaucher

given: David

family: Querques

full_name: Giuseppe Querques

given: Giuseppe

family: Stumpp

full_name: Michael T. Stumpp

given: Michael T.

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

journal_name: American Journal of Ophthalmology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

repository_institution: Masarykiana Brunensis Universitas - Veřejné služby Informačního systému

title: Treatment of Exudative Age-Related Macular Degeneration with a Designed Ankyrin Repeat Protein that Binds Vascular Endothelial Growth Factor: a Phase I/II Study

lead_sponsor: Allergan

location_country:
Czech Republic
France
Switzerland

location_facility:
Ustrendi Vojenska Nemocnice
Fakultni Nemocnice Olomouc
Hopitaux Universitaires
Fakultni Nemocnice Brno
Inselspital
Centre Paradis-Monticelli
Centre Rabelais
Hopital Intercommunual de Creteil

status_simplified: Unknown


title: A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS

summary: To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.

lead_sponsor: BTG International Inc.

location_country:
France
Poland
Russian Federation
Belgium
Spain
Germany

location_facility: Klinikum Osnabrück Klinik für Neurologie

location_facility: Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf

location_facility: Medical University of Gdansk Ul. Nowe Ogrody 1-6

location_facility: hospital # 33 pr. Lenina 54, Nizniy Novgorod

location_facility: Upper Silezian Medical Center SAM Ul Ziolowa 45/47

location_facility: Universitätsklinikum Charité, Campus Mitte

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: City hospital # 9 Str. B. Gornaya 43, Saratov

location_facility: CHU Clermont Ferrand-Hôpital Gabriel Montpied-

location_facility: State Medical University named after I.P. Pavlov

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Moscow regional institute of clinical research named after M.F. Vladimirsky

location_facility: Institute of Human Brain, str. Acad. Pavlov, St-Petersburg

location_facility: CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital

location_facility: Hospital Universitario Ntra Sra de la Candelaria


title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease

summary: This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-related disease (IgG4-RD).

primary_purpose: Prevention

lead_sponsor: Viela Bio

location_country:
Australia
Ukraine
India
France
Japan
Poland
Argentina
Canada
Sweden
Hong Kong
Netherlands
Hungary
Ireland
China
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey

location_facility:
Viela Bio Investigative Site 2
Viela Bio Investigative Site
Viela Bio Investigative Site 4
Viela Bio Investigative Site 1
Viela Bio Investigative Siite
Viela Bio Investigative Site 3


title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

summary: The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

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
Netherlands
France
Bulgaria
Poland
Spain
Germany
Canada

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Diagnostic Consultative Center Ii Sofia Eood

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

location_facility: The Dermatology and Laser Center of San Antonio

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni

location_facility: International Clinical Research Tennessee Llc

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: Diagnostic Consultative Center Xxviii - Sofia - Eood

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu


lead_sponsor: Eli Lilly and Company

location_country:
Italy
Switzerland
Mexico
Netherlands
France
Czechia
Belgium
Argentina
Spain
Denmark
Germany
United Kingdom

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Universitäts-Kinderspital beider Basel UKBB

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: H.R.U Málaga - Hospital Materno-infantil

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: UMC Utrecht - Wilhelmina Kinderziekenhuis

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Oxford University Hospitals - Nuffield Orthopaedic Centre

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

title: Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

summary: The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis [JoAS]) and juvenile psoriatic arthritis (JPsA).


lead_sponsor: Concert Pharmaceuticals

location_country:
France
Poland
Spain
United States
Canada

location_facility: Dermatology Associates Of Plymouth Meeting

location_facility: Hospital Clínico Y Provincial de Barcelona

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

location_facility: Wake Forest University Health Sciences, Department of Dermatology

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: UC Irvine Dermatology Clinical Research Center

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: University of Minnesota Department of Dermatology

location_facility: SimcoDerm Medical and Surgical Dermatology Center

location_facility: Hôpital Saint Louis, Centre de Santé Sabouraud

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Clinical Research Center of the Carolinas

location_facility: Dermatology Treatment and Research Center

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Colorado Center for Dermatology and Skin Surgery

location_facility: Skin Laser and Surgery Specialists of NJ

location_facility: California Dermatology & Clinical Research Institute

location_facility: Yale University, Church Street Research Unit

location_facility: Northwestern Memorial Hospital, Department of Dermatology

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Clinical Investigation Specialists, Inc.

title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

acronym: CAHtalyst

summary: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult subjects with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6 month randomized, double blind, placebo-controlled period, followed by 1 year of treatment with crinecerfont. Duration of participation is approximately 20 months.

lead_sponsor: Neurocrine Biosciences

location_country:
Italy
Austria
United States
Sweden
Spain
Germany
France
Bulgaria
Czechia
Greece
Poland
Belgium
Portugal
Canada
United Kingdom


title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

acronym: DREAMM 8

summary: This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

location_country:
Italy
United States
France
Czechia
Greece
Israel
Poland
Australia
Russian Federation
New Zealand
Spain
Turkey
Germany
United Kingdom
Korea, Republic of


title: A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

acronym: IONA-MM

summary:
Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

study_type: Observational

time_perspective: Prospective

lead_sponsor: Sanofi

location_country:
Austria
Switzerland
Germany
France
Japan
Puerto Rico
United States

location_facility:
Investigational Site Number 8400012
Investigational Site Number 2760025
Investigational Site Number 8400008
Investigational Site Number 5760001
Investigational Site Number 2760012
Investigational Site Number 3920008
Investigational Site Number 8400009
Investigational Site Number 8400021
Investigational Site Number 2760016
Investigational Site Number 2760007
Investigational Site Number 2760026
Investigational Site Number 2760003
Investigational Site Number 3920001
Investigational Site Number 8400024
Investigational site number 2760001
Investigational Site Number 8400001
Investigational Site Number 2760020
Investigational Site Number 2760009
Investigational Site Number 3920007
Investigational site number 2500007
Investigational Site Number 8400023
Investigational site number 400002
Investigational Site Number 2760014
Investigational Site Number 2760017
Investigational Site Number 3920005
Investigational Site Number 5760002
Investigational Site Number 8400020
Investigational Site Number 2760013
Investigational Site Number 3920004
Investigational site number 2500004
Investigational Site Number 8400013
Investigational Site Number 8400019
Investigational Site Number 8400016
Investigational Site Number 8400026
Investigational Site Number 2760002
Investigational Site Number 2760011
Investigational site number 2500005
Investigational Site Number 2760019
Investigational Site Number 2760006
Investigational Site Number 8400006
Investigational site number 2500001
Investigational Site Number 8400010
Investigational Site Number 8400025
Investigational Site Number 2760010
Investigational Site Number 2760008
Investigational Site Number 3920002
Investigational Site Number 8400017
Investigational Site Number 2760015
Investigational Site Number 3920009
Investigational Site Number 2760021
Investigational Site Number 8400015
Investigational site number 2500006
Investigational Site Number 8400011
Investigational site number 0400003
Investigational Site Number 8400018
Investigational Site Number 8400007


title: A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

summary: This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

design_allocation: Non-Randomized

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/members/ourmembers/). 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).

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
Switzerland
Netherlands
Spain
Germany
France
Poland
Israel
Belgium
Australia
New Zealand
Russian Federation
Canada
United Kingdom
Korea, Republic of

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Univ of Calif, San Francisco; Breast Cancer Center

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Chao Family Comprehensive Cancer Center UCI

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: CIC-CPCET; CIC - CPCET - Batiment F - 1er étage

location_facility: Jewish General Hospital; Sir Mortimer B. Davis

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

summary: This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

location_country: Netherlands Germany France Norway Spain Denmark Canada

location_facility:
MD Anderson Cancer Center - Orlando
Novartis Investigative Site


title: A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.

summary: For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.

lead_sponsor: Kuros Biosurgery AG

location_country:
Italy
Switzerland
France
Poland
Hungary
Australia
Spain
Germany
United Kingdom

location_facility: Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)

location_facility: Fovárosi Önkormányzat Szent János Kórháza és Észak (54)

location_facility: Università degli Studi di Roma "Tor Vergata" (10)

location_facility: Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)

location_facility: Norfolk and Norwich University Hospital (44)

location_facility: Hospital Universitario Virgen de la Victoria (51)

location_facility: Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)

location_facility: Szegedi Egyetem AOK Kari Gyogyszertar (27)

location_facility: Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)

location_facility: SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)

location_facility: Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)

location_facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)

location_facility: N. Bristol NHS Trust + Univ. of Bristol (52)

location_facility: Katedra i Klinika Ortopedii - Traumatologii PAM (34)

location_facility: Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)

location_facility: Petz Alandar County Teaching Hospital (55)

location_facility: Hospital Universitario de la Princesa (18)


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

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

location_country:
Brazil
Peru
Mexico
Germany
France
Argentina
Russian Federation
Spain
Turkey
United States
United Kingdom
Colombia

acronym: RUXCOVID

title: Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

summary: This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.


title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

summary: This protocol provides access to eculizumab treatment for participants with severe COVID-19.

status: No longer available

study_type: Expanded Access

lead_sponsor: Alexion Pharmaceuticals

location_country:
United States
France

location_facility: The Ohio State University Wexner Medical Center


title: A Phase 1b Dose Escalation and Expansion Study of CAN04, a Monoclonal Antibody Targeting IL1RAP, in Combination With Modified FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

acronym: CAPAFOUR

summary: This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.

lead_sponsor: Cantargia AB

location_country: France Spain

location_facility: START MADRID_Hospital Universitario Fundacion Jimenez Diaz

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals


title: A Randomized, Controlled, Pilot Study to Evaluate Safety and Feasibility of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy in Patients With Extensive ST Elevation Inferior Wall Myocardial Infarction Presenting With TIMI 0 or 1 and Symptom Duration ≤ 12 Hours Treated Adjunct to Percutaneous Coronary Intervention (PCI) Compared to Standard PCI.

acronym: PiCSO-AMI-V

summary: The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Miracor Medical SA

location_country:
United Kingdom
France
Switzerland

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: EOC Ospedale Regionale di Lugano - Civico

location_facility: CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Device


lead_sponsor: Celgene

location_country:
Italy
France
Poland
Spain
United States
United Kingdom

location_facility: Insular-Maternal and Child University Hospital Complex

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Augusta University - Georgia Cancer Center

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Novant Health Presbyterian Medical Center

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

title: A Phase 2, Multicenter, Open-label, Multi-cohort Study to Assess Safety and Efficacy of CC-90011 in Combination With Checkpoint Inhibitor(s) in Subjects With Advanced Cancers

summary:
This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.

The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts:

Cohort A: SCLC in ICI naïve subjects
Cohort B: SCLC in ICI progressor subjects
Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1.

In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.

In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.


title: Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

acronym: GuideView

summary:
The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.

Approximately 195 participants will be enrolled to ensure that at least 156 participants complete the [18F]CTT1057 PET/CT scan procedure (i.e. investigational imaging agent administration and successful completion of the PET/CT scan), which will be required for the calculation of the co-primary endpoints.

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy France Spain


lead_sponsor: Galapagos NV

location_country: Poland France Greece Hungary Spain Germany Ukraine

acronym: GLIDER

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

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome

summary: This is a first exploration of GLPG3970 in subjects with active primary Sjogren's Syndrome to evaluate the efficacy, safety and tolerability and determine its pharmacokinetics (PK) profile compared to placebo.


title: First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PPSGG (PN-1007) in Anti-MAG Neuropathy Patients

summary:
In this study, the new drug called PPSGG (PN-1007) will be tested. Preliminary studies conducted in animals suggest PPSGG (PN-1007) might be a good treatment for reducing levels of anti-MAG antibodies in patients with anti-MAG neuropathy.

This is the first research of PPSGG (PN-1007) in people and its main purpose is to test its safety and acceptability in patients. In this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-MAG neuropathy. PPSGG (PN-1007) will be tested at several different doses.

lead_sponsor: Polyneuron Pharmaceuticals AG

location_country:
Switzerland
Netherlands
France
Spain
United Kingdom

location_facility: Referral centre for neuromuscular diseases and ALS, hôpital La Timone

location_facility: Service de Neurologie Centre de Référence Neuropathies Périphériques Rares, CHU Limoges

location_facility: Département de Neurologie Pôle Neurosciences Centre de Référence des Neuropathies Amyloïdes Familiales et autres Neuropathies Périphériques Rares Centre Hospitalier Universitaire de Bicêtre

location_facility: National hospital for neurology and neurosurgery, Queen London


title: An International Multicentric Open-label Descriptive Study to Assess the Effects and Evaluate the Tolerance of the Cosmetic Care Product RV3278A in the Follow-up Phase of Facial Acne in Teenagers and Young Adults for 1 Year

summary:
Acne is a chronic inflammatory disease of the pilo-sebaceous unit in the skin. Indeed, your skin is covered with tiny holes called hair follicles, or pores. These pores contain sebaceous glands (also called oil glands) that make sebum, an oil that moistens your hair and skin. Most of the time, the glands make the right amount of sebum and the pores are fine. But sometimes a pore gets clogged up with too much sebum, dead skin cells, and germs called bacteria. This can cause acne.

Pierre Fabre Laboratories have developed a cosmetic care product, a cream which is commercialized since September 2019. This leave-on skin care product is adapted for acne-prone skin.

In this study, we are interested in the effects of this care product in facial acne evolution for 12 months (quality of life, acne severity, number of acne flares). Also, we are interested in the subject's satisfaction regarding the use of this care product. This study will also enable to know if the product is well tolerated in such application circumstances.

This clinical study will be carried out in 54 subjects (female or male), aged between 12 and 35 years, in about 10 centers in different European countries.

The maximal duration of the study for a subject will be 1 year. If you give your consent to take part in this study, you will receive a cosmetic care product, also called study product, that you will apply on your face twice a day (morning and evening) for the whole duration of the study.

What makes this study original is the use of a smartphone application to help you to comply with the study procedures and to help the investigator to follow you.

time_perspective: Other

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_country: Italy France Poland

location_facility: Centre de Santé Sabouraud - Hôpital Saint Louis


title: A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of 2-hydroxyoleic Acid (2-OHOA) in Combination With Radiotherapy and Temozolomide Standard of Care Treatment.

acronym: CLINGLIO

summary: The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of 2-OHOA versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then 2-OHOA or placebo in monotherapy.

lead_sponsor: Laminar Pharmaceuticals

location_country:
Italy
France
Israel
Spain
United Kingdom

location_facility: Freeman Hospital's Northern Centre of Cancer Care

location_facility: Istituto Nazionale Neurologico Carlo Besta

location_facility: Hospital Universitari i Politécnic La Fe.

location_facility: Reaserch Fund of the Hadassah Medical Organization

location_facility: Istituto Nazionale Tumori "Regina Elena"

intervention_type: Radiation


title: A Chart Review Study of Patients With Haemophilia A With Inhibitors Treated With rFVIIIFc (Elocta®) for Immune Tolerance Induction

summary: A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
Saudi Arabia
Switzerland
France
Kuwait
Norway
Ireland
Germany

location_facility: Swedish Orphan Biovitrum Research Site (p)

location_facility: Swedish Orphan Biovitrum Research Site (a)


ReferenceCitation: Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Muñoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.

ReferenceCitation: Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

name: Department of Medicine, Stanford University, Stanford, California, USA

family: Jacobson

full_name: Karen B Jacobson

given: Karen B

name: Stanford Center for Clinical Research, Stanford University, Stanford, California, USA

family: Rao

full_name: Mallika Rao

given: Mallika

family: Bonilla

full_name: Hector Bonilla

given: Hector

family: Subramanian

full_name: Aruna Subramanian

given: Aruna

family: Hack

full_name: Isabelle Hack

given: Isabelle

family: Madrigal

full_name: Martina Madrigal

given: Martina

name: Department of Microbiology and Immunology, Stanford University, Stanford, California, USA

family: Singh

full_name: Upinder Singh

given: Upinder

family: Jagannathan

full_name: Prasanna Jagannathan

given: Prasanna

family: Grant

full_name: Philip Grant

given: Philip

journal_name: Clinical Infectious Diseases

evidence: open (via free article)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Sweden
Hong Kong
Netherlands
Spain
Switzerland
France
Japan
Singapore
China
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

location_facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: James J. Peters Veterans Administration Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

location_facility: Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: Hospital of the University of Pennsylvania

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: The University of Michigan Hospitals and Health Systems

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: Manchester University NHS Foundation Trust

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Prisma Health Richland Hospital, 701 Grove Road

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue

location_facility: UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

location_facility: Mission Hospital Regional Medical Center

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: SCL Health St. Joseph Hospital, 200 Exempla Circle.

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: Baylor University Medical Center, 1400 8th Ave

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Hospital Regional Universitario de Málaga

location_facility: Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: Baylor University Medical Center, 2401 S. 31st St.

location_facility: North Shore University Hospital, 270-05 76th Ave

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

location_facility: University Hospitals Cleveland Medical Center

location_facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

location_facility: Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Providence Regional Medical Center Everett

title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19

summary: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.


title: Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

acronym: OPTICO-LM

summary:
Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT.

This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

ReferenceCitation: Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum in: Lancet. 2016 Dec 3;388(10061):2742.

ReferenceCitation: Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. Erratum in: Eur Heart J. 2019 Oct 1;40(37):3096.

ReferenceCitation: Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. Epub 2004 Oct 18.

ReferenceCitation: de la Torre Hernandez JM, Hernández Hernandez F, Alfonso F, Rumoroso JR, Lopez-Palop R, Sadaba M, Carrillo P, Rondan J, Lozano I, Ruiz Nodar JM, Baz JA, Fernandez Nofrerias E, Pajin F, Garcia Camarero T, Gutierrez H; LITRO Study Group (Spanish Working Group on Interventional Cardiology). Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study. J Am Coll Cardiol. 2011 Jul 19;58(4):351-8. doi: 10.1016/j.jacc.2011.02.064.

ReferenceCitation: Nørgaard BL, Leipsic J, Gaur S, Seneviratne S, Ko BS, Ito H, Jensen JM, Mauri L, De Bruyne B, Bezerra H, Osawa K, Marwan M, Naber C, Erglis A, Park SJ, Christiansen EH, Kaltoft A, Lassen JF, Bøtker HE, Achenbach S; NXT Trial Study Group. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014 Apr 1;63(12):1145-1155. doi: 10.1016/j.jacc.2013.11.043. Epub 2014 Jan 30.

lead_sponsor: University Hospital Inselspital, Berne

location_country: Switzerland Germany France Japan

location_facility: Universitätsklinikum Giessen Justus-Liebig Universität

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Department of Cardiovascular Medicine Shinshu University School of Medicine

location_facility: Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie

location_facility: Medical Corporation Ouyuukai Tokorozawa Heart Center

intervention_type: Diagnostic Test

lead_sponsor_type: academique


ReferenceCitation: Spinner CD, Gottlieb RL, Criner GJ, Arribas López JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349.

name: Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany

family: Spinner

full_name: Christoph D. Spinner

given: Christoph D.

name: Baylor University Medical Center, Dallas, Texas

family: Gottlieb

full_name: Robert L. Gottlieb

given: Robert L.

name: Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania

family: Criner

full_name: Gerard J. Criner

given: Gerard J.

name: Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain

family: Arribas López

full_name: José Ramón Arribas López

given: José Ramón

name: Azienda Ospedaliera di Padova, Padova, Italy

family: Cattelan

full_name: Anna Maria Cattelan

given: Anna Maria

name: Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain

family: Soriano Viladomiu

full_name: Alex Soriano Viladomiu

given: Alex

name: Yale School of Medicine, New Haven, Connecticut

family: Ogbuagu

full_name: Onyema Ogbuagu

given: Onyema

name: North Shore University Hospital, Manhasset, New York

family: Malhotra

full_name: Prashant Malhotra

given: Prashant

name: University of Chicago, Chicago, Illinois

family: Mullane

full_name: Kathleen M. Mullane

given: Kathleen M.

name: IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy

family: Castagna

full_name: Antonella Castagna

given: Antonella

name: National University Health System, Singapore

family: Chai

full_name: Louis Yi Ann Chai

given: Louis Yi Ann

name: Leiden University Medical Center, Leiden, the Netherlands

family: Roestenberg

full_name: Meta Roestenberg

given: Meta

name: Princess Margaret Hospital, Hong Kong, China

family: Tsang

full_name: Owen Tak Yin Tsang

given: Owen Tak Yin

name: Ente Ospedaliero Cantonale, Bellinzona, Switzerland

family: Bernasconi

full_name: Enos Bernasconi

given: Enos

family: Le Turnier

full_name: Paul Le Turnier

given: Paul

name: National Taiwan University Hospital, Taipei, Taiwan

family: Chang

full_name: Shan-Chwen Chang

given: Shan-Chwen

name: Gilead Sciences, Foster City, California

family: SenGupta

full_name: Devi SenGupta

given: Devi

family: Hyland

full_name: Robert H. Hyland

given: Robert H.

family: Osinusi

full_name: Anu O. Osinusi

given: Anu O.

family: Cao

full_name: Huyen Cao

given: Huyen

family: Blair

full_name: Christiana Blair

given: Christiana

family: Wang

full_name: Hongyuan Wang

given: Hongyuan

family: Gaggar

full_name: Anuj Gaggar

given: Anuj

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: McPhail

full_name: Mark J. McPhail

given: Mark J.

name: Seoul Medical Center, Seoul, South Korea

name: Virginia Commonwealth University, Richmond

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

ReferenceCitation: Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8:CD014962. doi: 10.1002/14651858.CD014962.

name: Department of Intensive Care Medicine; Medical Faculty, RWTH Aachen University; Aachen Germany

name: Department of Anaesthesiology and Intensive Care; University of Leipzig Medical Center; Leipzig Germany

name: Department of Infectious Diseases and Respiratory Medicine; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin; Berlin Germany

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

name: Cochrane Metabolic and Endocrine Disorders Group; Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf; Düsseldorf Germany

title: Remdesivir for the treatment of COVID-19

location_facility: Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

location_facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: James J. Peters Veterans Administration Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

location_facility: Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: NHS Lothian, Royal lnfirmary of Edinburgh

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: Hospital of the University of Pennsylvania

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: The University of Michigan Hospitals and Health Systems

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: Manchester University NHS Foundation Trust

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Prisma Health Richland Hospital, 701 Grove Road

location_facility: Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue

location_facility: Weill Cornell Medical College/NYU Presbyterian Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Kaiser Permanente Los Angeles Medical Center,13651 Willard Street

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

location_facility: Mission Hospital Regional Medical Center

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: SCL Health St. Joseph Hospital, 200 Exempla Circle.

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: Columbia University Irving Medical Center

location_facility: Baylor University Medical Center, 1400 8th Ave

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Hospital Regional Universitario de Málaga

location_facility: Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova

title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment

summary: The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.


title: A Phase 3, Multicenter, Open-Label, Single-Arm Study of Bentracimab (PB2452) in Ticagrelor-Treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial)

acronym: REVERSE-IT

summary:
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.

Approximately 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.

lead_sponsor: PhaseBio Pharmaceuticals Inc.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
France
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital Universitario 12 de Octubre, Residencia general

location_facility: St. Michael's Hospital, Unity Health Toronto

location_facility: East and North Hertfordshire, NHS Trust, Lister Cardiac Research Office, Cardiology Green Zone, Lister Hospital

location_facility: Ziekenhuis Oost-Limburg Study Center Intensive Care

location_facility: Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology

location_facility: University of Florida Health, Jacksonville

location_facility: CHU de Poitiers, Centre Cardio-Vasculaire

location_facility: CHRU de Tours - Hopital Trousseau Service de Cardiologie-USCI 2 eme etage

location_facility: Hospital Universitario Vírgen de la Victoria

location_facility: AZ Sint-Jan Brugge-Oostende AV Poli Cardiologie

location_facility: Azienda Ospedaliero-Universitaria di Parma Cardiologia

location_facility: Duke Heart Center at Southeastern Health

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Clinico San Carlos - Instituto Cardiovascular (ICV)

location_facility: Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care Medicine

location_facility: Sheffield Teaching Hospitals, NHS Foundation Trust, Northern General Hospital

location_facility: Jessa Hospital Hartcentrum Hasselt Research Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: University Hospital Leuven, Universitair Ziekenhuis Leuven Dienst Bloedings- en Vaatziekten

location_facility: CHU de Lille Service USIC, Institut Coeur Poumon

location_facility: Universitatsspital Basel Department of Cardiology

location_facility: Region Uppsala, Akademiska Hospital Cardio and Pulmonary Medicine and Clinical Physiology

location_facility: Skane University Hospital, Department of Cardiology

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) Pitie-Salpetriere Hospital

location_facility: Ascension St. John Clinical Research Institute

location_facility: Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval

location_facility: University Hospital Antwerp Cardiology Department - Clinical Trials


lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Russian Federation
France
Netherlands

acronym: PH2a,12-week, 3 RD of 10 mg/kg IV every 4 weeks, efficacy and safety study in asthma pts with AFAD

title: A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)

summary: This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.


title: Staphylococcus Aureus Surgical Site Infection Multinational Epidemiology in Europe

acronym: SALT

summary:
This is a retrospective multinational, multicenter cohort study with a nested case-control. The study includes all surgical procedures performed at a participating site to prevent bias.

Data will be assessed in two populations.

Cohort population: Export of electronic file data on demographics, surgical procedure ICPM code, duration of procedure, American Society of Anesthesiologists (ASA) score, body mass index, comorbidity ICD codes, and wound class of all patients undergoing surgery.

Nested case-control population: For patients establishing S. aureus SSI and 1:1 matched controls from the same center further data will be captured: Length of hospitalization, length of ICU stay and reason as well as attribution to SSI, survival at 30 and at 90 days, antibiotic treatments including duration, functional status at admission and at final discharge; necessity for surgical revision, and death attributed to SSI.

If readmission is necessary, reason and attribution to SSI, length of hospitalization and length of ICU stay as well as all antibiotic treatments and their duration will be recorded.

The cases causative pathogens including resistance patterns and type of SSI according to CDC criteria will be captured.

Matching criteria comprise the following:

Type of procedure
Age
ASA score
BMI
Duration of procedure (as percentile for this procedure)
Diabetes
Sex

time_perspective: Retrospective

ReferenceCitation: Mellinghoff SC, Vehreschild JJ, Liss BJ, Cornely OA. Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study. JMIR Res Protoc. 2018 Mar 12;7(3):e63. doi: 10.2196/resprot.8177. Erratum in: JMIR Res Protoc. 2019 Jan 07;8(1):e10712.

family: Mellinghoff

full_name: Sibylle C Mellinghoff

given: Sibylle C

family: Vehreschild

full_name: Jörg Janne Vehreschild

given: Jörg Janne

family: Liss

full_name: Blasius J Liss

given: Blasius J

family: Cornely

full_name: Oliver A Cornely

given: Oliver A

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

evidence: oa repository (semantic scholar lookup)

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: University of Cologne

location_country:
Italy
France
Spain
Germany
United Kingdom

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Centre Hospitalier Régional et Universitaire de Tours

location_facility: Hospital General Universitario Gregorio Marañón e Instituto de Investigación Sanitaria Gregorio Marañón

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: University of Udine and Azienda Sanitaria Universitaria Integrata

location_facility: Manchester University NHS Foundation Trust (MFT)