title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients

acronym: FRI

summary:
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.

However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.

A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.

The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.

The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.

lead_sponsor: Bicetre Hospital

location_country: Israel Germany France Spain

location_facility: Department of Anesthesiology and Intensive Care Sheba Medical Centre

location_facility: Unidad de cuidados intensivos, Fundacion Jimenez Diaz


title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

summary: The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Photocure

location_country: Norway Germany France

location_facility: Department of Obstetrics and Gyneacology, Lille University Hospital

location_facility: Department of Obstetrics and Gynaecology, Ullevål University Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.

summary: The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

study_start_date_type: Actual

status: Completed

ReferenceType: derived

ReferenceCitation: Levi M, Vincent JL, Tanaka K, Radford AH, Kayanoki T, Fineberg DA, Hoppensteadt D, Fareed J. Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy. Crit Care Med. 2020 Aug;48(8):1140-1147. doi: 10.1097/CCM.0000000000004426.

family: Levi

full_name: Marcel Levi

given: Marcel

sequence: first

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

sequence: additional

family: Tanaka

full_name: Kosuke Tanaka

given: Kosuke

family: Radford

full_name: Amanda H. Radford

given: Amanda H.

family: Kayanoki

full_name: Toshihiko Kayanoki

given: Toshihiko

family: Fineberg

full_name: David A. Fineberg

given: David A.

family: Hoppensteadt

full_name: Debra Hoppensteadt

given: Debra

family: Fareed

full_name: Jawed Fareed

given: Jawed

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care Medicine

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Vincent JL, Francois B, Zabolotskikh I, Daga MK, Lascarrou JB, Kirov MY, Pettilä V, Wittebole X, Meziani F, Mercier E, Lobo SM, Barie PS, Crowther M, Esmon CT, Fareed J, Gando S, Gorelick KJ, Levi M, Mira JP, Opal SM, Parrillo J, Russell JA, Saito H, Tsuruta K, Sakai T, Fineberg D; SCARLET Trial Group. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1993-2002. doi: 10.1001/jama.2019.5358.

name: Department of Intensive Care, Erasme Hospital, Université libre de Bruxelles, Brussels, Belgium

name: ICU Department, Inserm CIC-1435 & UMR-1092, CHU Dupuytren, Limoges, France

family: Francois

full_name: Bruno Francois

given: Bruno

name: Department of Anesthesiology, Intensive Care and Transfusiology, Kuban State Medical University, Krasnodar, Russia

family: Zabolotskikh

full_name: Igor Zabolotskikh

given: Igor

name: Department of Medicine, Maulana Azad Medical College and associated hospitals, New Delhi, India

family: Daga

full_name: Mradul Kumar Daga

given: Mradul Kumar

name: Centre Hospitalier Universitaire de Nantes, Nantes, France

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

name: Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russia

family: Kirov

full_name: Mikhail Y. Kirov

given: Mikhail Y.

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

family: Pettilä

full_name: Ville Pettilä

given: Ville

name: Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

name: Faculté de Médecine, Université de Strasbourg (UNISTRA), Hôpitaux Universitaires de Strasbourg, Service de Réanimation, Nouvel Hôpital Civil, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: Médecine Intensive Réanimation, CHRU de Tours, Tours, France

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

name: Intensive Care Division, Hospital de Base, São José do Rio Preto, SP, Brazil

name: Departments of Surgery and Medicine, Weill Cornell Medicine, New York, New York

name: Department of Medicine, McMaster University and St Joseph’s Hospital, Hamilton, Canada

name: Coagulation Biology Laboratory, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma

name: Pathology and Pharmacology, Loyola University Medical Center, Maywood, Illinois

name: Acute and Critical Care Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan

name: Zymo Consulting Group LLC, Newtown Square, Massachusetts

name: Department of Medicine, University College London Hospitals and Cardiometabolic Programme-NIHR UCLH/UCL BRC, London, United Kingdom

name: Universite´Paris Descartes, Sorbonne Paris Cite´, Faculte´ de Me´-decine Cochin University Hospital, AP-HP, Paris, France

name: Division of Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island

name: Department of Medicine, New Jersey Medical School of Rutgers University, Hackenseck

name: Heart and Vascular Hospital, Hackensack University Medical Center, Hackensack, New Jersey

name: Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, Vancouver, Canada

name: National Hospital Organization, Nagoya Medical Center, Nagoya, Japan

name: Asahi-Kasei Pharma Corporation, Tokyo, Japan

name: Asahi-Kasei Pharma America Corporation, Waltham, Massachusetts

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
Taiwan
India
Croatia
France
Argentina
Canada
Korea, Republic of
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Brazil
Serbia
Czechia
Israel
New Zealand
Spain

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2)

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto

location_facility: University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation

location_facility: Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron

location_facility: Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases

location_facility: Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road

location_facility: University Hospital Brno, Department of Infectious Diseases

location_facility: Clinical Hospital Center Zagreb, Medical ICU

location_facility: University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Hospital Nacional Almenara Yrigoyen - EsSALUD

location_facility: Szent Imre Hospital, Anesthesiology and Intensive Care Unit

location_facility: Taichung Veterans General Hospital [Pulmonology]

location_facility: Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH))

location_facility: Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia

location_facility: Hospital Universitario Mutua Terrassa Intensive Care

location_facility: Mazumdar Shaw Medical Centre (Unit of Narayana Health)

location_facility: Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation

location_facility: Keski-Suomen Keskussairaala (Central Finland Central Hospital)

location_facility: City Clinical Hospital #3 n.a. M.A. Pogorbunskiy

location_facility: General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine

location_facility: Mechnikov North-Western State Medical University n.a. I.I. Mechnikov

location_facility: Harper Hospital - Wayne State University School of Medicine

location_facility: University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine

location_facility: King Edward Memorial Hospital & Research Centre

location_facility: Service de reanimation médicale. CHU Hotel Dieu

location_facility: Clinic for Infectious Diseases, Clinical Center Nis

location_facility: Centre Hospitalier Départemental de Vendée-Les Oudairies

location_facility: Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre

location_facility: KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

location_facility: Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv

location_facility: Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital)

location_facility: Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital)

location_facility: Maulana Azad Medical College and Associated L N Hospital


type: EudraCT Number

title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI

acronym: EURO-SKI

summary:
The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.

Secondary goals include:

Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
Evaluation of quality of life (QoL) in patients stopping TKI
Evaluation of medico-economic impact of stopping TKI
Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500

ReferenceType: background

ReferenceCitation: Richter J, Lübking A, Söderlund S, Lotfi K, Markevärn B, Själander A, Stenke L, Deneberg S, Ahlstrand E, Myhr-Eriksson K, Panayiotidis P, Gedde-Dahl T, Žáčková D, Mayer J, Olsson-Strömberg U, Mahon FX, Saussele S, Hjorth-Hansen H, Koskenvesa P. Molecular status 36 months after TKI discontinuation in CML is highly predictive for subsequent loss of MMR-final report from AFTER-SKI. Leukemia. 2021 Aug;35(8):2416-2418. doi: 10.1038/s41375-021-01173-w. Epub 2021 Feb 15.

ReferenceCitation: Söderlund S, Persson I, Ilander M, Guilhot J, Hjorth-Hansen H, Koskenvesa P, Richter J, Saussele S, Mustjoki S, Olsson-Strömberg U. Plasma proteomics of biomarkers for inflammation or cancer cannot predict relapse in chronic myeloid leukaemia patients stopping tyrosine kinase inhibitor therapy. Leuk Res. 2020 Mar;90:106310. doi: 10.1016/j.leukres.2020.106310. Epub 2020 Jan 23.

ReferenceCitation: Bouillon AS, Ventura Ferreira MS, Awad SA, Richter J, Hochhaus A, Kunzmann V, Dengler J, Janssen J, Ossenkoppele G, Westerweel PE, Te Boekhorst PAW, Mahon FX, Hjorth-Hansen H, Isfort S, Fioretos T, Hummel S, Schemionek M, Wilop S, Koschmieder S, Saußele S, Mustjoki S, Beier F, Brümmendorf TH. Telomere shortening correlates with leukemic stem cell burden at diagnosis of chronic myeloid leukemia. Blood Adv. 2018 Jul 10;2(13):1572-1579. doi: 10.1182/bloodadvances.2018017772.

ReferenceCitation: Schütz C, Inselmann S, Saussele S, Dietz CT, Mu Ller MC, Eigendorff E, Brendel CA, Metzelder SK, Bru Mmendorf TH, Waller C, Dengler J, Goebeler ME, Herbst R, Freunek G, Hanzel S, Illmer T, Wang Y, Lange T, Finkernagel F, Hehlmann R, Huber M, Neubauer A, Hochhaus A, Guilhot J, Xavier Mahon F, Pfirrmann M, Burchert A. Expression of the CTLA-4 ligand CD86 on plasmacytoid dendritic cells (pDC) predicts risk of disease recurrence after treatment discontinuation in CML. Leukemia. 2017 Apr;31(4):829-836. doi: 10.1038/leu.2017.9. Epub 2017 Jan 11. Erratum in: Leukemia. 2018 Jan 30;:.

ReferenceType: result

ReferenceCitation: Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, Janssen JJWM, Mayer J, Koskenvesa P, Panayiotidis P, Olsson-Strömberg U, Martinez-Lopez J, Rousselot P, Vestergaard H, Ehrencrona H, Kairisto V, Machová Poláková K, Müller MC, Mustjoki S, Berger MG, Fabarius A, Hofmann WK, Hochhaus A, Pfirrmann M, Mahon FX; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018 Jun;19(6):747-757. doi: 10.1016/S1470-2045(18)30192-X. Epub 2018 May 4.

family: Saussele

full_name: Susanne Saussele

given: Susanne

family: Richter

full_name: Johan Richter

given: Johan

family: Guilhot

full_name: Joelle Guilhot

given: Joelle

family: Gruber

full_name: Franz X Gruber

given: Franz X

family: Hjorth-Hansen

full_name: Henrik Hjorth-Hansen

given: Henrik

family: Almeida

full_name: Antonio Almeida

given: Antonio

family: Janssen

full_name: Jeroen J W M Janssen

given: Jeroen J W M

family: Mayer

full_name: Jiri Mayer

given: Jiri

family: Koskenvesa

full_name: Perttu Koskenvesa

given: Perttu

family: Panayiotidis

full_name: Panayiotis Panayiotidis

given: Panayiotis

family: Olsson-Strömberg

full_name: Ulla Olsson-Strömberg

given: Ulla

family: Martinez-Lopez

full_name: Joaquin Martinez-Lopez

given: Joaquin

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Vestergaard

full_name: Hanne Vestergaard

given: Hanne

family: Ehrencrona

full_name: Hans Ehrencrona

given: Hans

family: Kairisto

full_name: Veli Kairisto

given: Veli

family: Machová Poláková

full_name: Katerina Machová Poláková

given: Katerina

family: Müller

full_name: Martin C Müller

given: Martin C

family: Mustjoki

full_name: Satu Mustjoki

given: Satu

family: Berger

full_name: Marc G Berger

given: Marc G

family: Fabarius

full_name: Alice Fabarius

given: Alice

family: Hofmann

full_name: Wolf-Karsten Hofmann

given: Wolf-Karsten

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Ilander M, Olsson-Strömberg U, Schlums H, Guilhot J, Brück O, Lähteenmäki H, Kasanen T, Koskenvesa P, Söderlund S, Höglund M, Markevärn B, Själander A, Lotfi K, Dreimane A, Lübking A, Holm E, Björeman M, Lehmann S, Stenke L, Ohm L, Gedde-Dahl T, Majeed W, Ehrencrona H, Koskela S, Saussele S, Mahon FX, Porkka K, Hjorth-Hansen H, Bryceson YT, Richter J, Mustjoki S. Increased proportion of mature NK cells is associated with successful imatinib discontinuation in chronic myeloid leukemia. Leukemia. 2017 May;31(5):1108-1116. doi: 10.1038/leu.2016.360. Epub 2016 Nov 28.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Rinaldetti S, Pfirrmann M, Manz K, Guilhot J, Dietz C, Panagiotidis P, Spiess B, Seifarth W, Fabarius A, Müller M, Pagoni M, Dimou M, Dengler J, Waller CF, Brümmendorf TH, Herbst R, Burchert A, Janβen C, Goebeler ME, Jost PJ, Hanzel S, Schafhausen P, Prange-Krex G, Illmer T, Janzen V, Klausmann M, Eckert R, Büschel G, Kiani A, Hofmann WK, Mahon FX, Saussele S. Effect of ABCG2, OCT1, and ABCB1 (MDR1) Gene Expression on Treatment-Free Remission in a EURO-SKI Subtrial. Clin Lymphoma Myeloma Leuk. 2018 Apr;18(4):266-271. doi: 10.1016/j.clml.2018.02.004. Epub 2018 Feb 8.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

title: Effect of ABCG2 , OCT1 , and ABCB1 ( MDR1 ) Gene Expression on Treatment-Free Remission in a EURO-SKI Subtrial

location_country: Sweden Netherlands Finland France Czechia Greece Norway Portugal Denmark Germany

location_facility: Universitätsmedizin Mannheim, Universität Heidelberg

location_facility: Norwegian University of Science and Technology

location_facility: Instituto Português de Oncologia Francisco Gentil

location_facility: University of Athens, Society of Hematology

location_facility: Centre Hospitalier Universitaire (CHU) de Nantes

location_facility: Hopital de la Milétrie, Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Oslo universitetssykehus HF Rikshospitalet

location_facility: Universitätsklinikum Giessen und Marburg GmbH


ReferenceCitation: Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, André T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.

name: Digestive Oncology, University Hospitals Leuven and KU LeuvenLeuvenBelgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Department of Experimental Medicine, Università degli studi della Campania Luigi VanvitelliNaplesItaly

family: Martinelli

full_name: Erika Martinelli

given: Erika

name: Clinica di Oncologia Medica, Azienda Ospedaliero Universitaria Ospedali RiunitiAnconaItaly

family: Cascinu

full_name: Stefano Cascinu

given: Stefano

name: Medical Oncology, IRCCS Ospedale San Martino ISTGenovaItaly

family: Sobrero

full_name: Alberto Sobrero

given: Alberto

name: Department of Oncology and Advanced Technologies, Oncology Unit, Azienda Ospedaliera S. Maria Nuova/IRCCSReggio EmiliaItaly

family: Banzi

full_name: Maria Banzi

given: Maria

name: Department of Digestive Oncology, Aix‐Marseille University, Assistance Publique Hôpitaux de MarseilleMarseilleFrance

family: Seitz

full_name: Jean‐François Seitz

given: Jean‐François

name: Medical Oncology, University Hospital A. GemelliRomeItaly

family: Barone

full_name: Carlo Barone

given: Carlo

name: Department of Medical Oncology, Institut Régional du Cancer de Montpellier (ICM), MontpellierFrance

family: Ychou

full_name: Marc Ychou

given: Marc

name: Center for Oncological Research, Antwerp University HospitalEdegemBelgium

family: Peeters

full_name: Marc Peeters

name: Institute of Oncology, Davidoff Cancer Center, Rabin Medical CenterPetah TikvaIsrael

name: Sackler Faculty of Medicine, Tel‐Aviv UniversityTel AvivIsrael

family: Brenner

full_name: Baruch Brenner

given: Baruch

name: Interdisciplinary Tumor Center, University Hospital Mannheim, University of HeidelbergMannheimGermany

family: Hofheinz

full_name: Ralf Dieter Hofheinz

given: Ralf Dieter

name: Department of Oncology, IRCCS Casa Sollievo della Sofferenza, San Giovanni RotondoItaly

family: Maiello

full_name: Evaristo Maiello

given: Evaristo

name: Service d'Oncologie Médicale, Hôpital Saint‐Antoine Paris and Sorbonne Universités, UPMC Paris 06ParisFrance

family: André

full_name: Thierry André

given: Thierry

name: Department of Oncology and Haematology, Division of Oncology, University Hospital of ModenaModenaItaly

family: Spallanzani

full_name: Andrea Spallanzani

given: Andrea

name: Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS)SevillaSpain

family: Garcia‐Carbonero

full_name: Rocio Garcia‐Carbonero

given: Rocio

name: Division of Hematology and Oncology, University of Texas Southwestern Medical CenterDallasTexasUSA

family: Arriaga

full_name: Yull E. Arriaga

given: Yull E.

family: Verma

full_name: Udit Verma

given: Udit

name: Department of Oncology, Mayo ClinicRochesterMinnesotaUSA

family: Grothey

full_name: Axel Grothey

given: Axel

name: Clinical Statistics, Global Clinical Oncology, Bayer AGBerlinGermany

family: Kappeler

full_name: Christian Kappeler

given: Christian

name: Benefit Risk Management, Bayer HealthCare Pharmaceuticals, WhippanyNew JerseyUSA

family: Miriyala

full_name: Ashok Miriyala

given: Ashok

name: Development, Oncology, Bayer AGBerlinGermany

family: Kalmus

full_name: Joachim Kalmus

given: Joachim

name: Department of Medical Oncology, University of PisaPisaItaly

family: Falcone

full_name: Alfredo Falcone

given: Alfredo

name: Department of Oncology, Fondazione PoliambulanzaBresciaItaly

family: Zaniboni

full_name: Alberto Zaniboni

journal_name: The Oncologist

title: Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single‐Arm, Open‐Label Phase IIIb CONSIGN Study

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
France
Poland
Norway
Canada
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain

title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

summary:
This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.


title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

acronym: LTFU

summary: There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

study_type: Observational

time_perspective: Other

ReferenceCitation: Menne J, Delmas Y, Fakhouri F, Licht C, Lommelé Å, Minetti EE, Provôt F, Rondeau E, Sheerin NS, Wang J, Weekers LE, Greenbaum LA. Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study. BMC Nephrol. 2019 Apr 10;20(1):125. doi: 10.1186/s12882-019-1314-1.

family: Menne

full_name: Jan Menne

given: Jan

family: Delmas

full_name: Yahsou Delmas

given: Yahsou

family: Fakhouri

full_name: Fadi Fakhouri

given: Fadi

family: Licht

full_name: Christoph Licht

given: Christoph

family: Lommelé

full_name: Åsa Lommelé

given: Åsa

family: Minetti

full_name: Enrico E. Minetti

given: Enrico E.

family: Provôt

full_name: François Provôt

given: François

family: Rondeau

full_name: Eric Rondeau

given: Eric

family: Sheerin

full_name: Neil S. Sheerin

given: Neil S.

family: Wang

full_name: Jimmy Wang

given: Jimmy

family: Weekers

full_name: Laurent E. Weekers

given: Laurent E.

family: Greenbaum

full_name: Larry A. Greenbaum

given: Larry A.

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: University of Liège - Open Repository and Bibliography

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Alexion Pharmaceuticals

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

location_facility: Le Kremlin Bicetre Hospital, Nephrology Unit

location_facility: CHU-CH Charles Nicolle Pavillon de Pédiatrie

location_facility: Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten

location_facility: Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse

location_facility: City Hospital, Nottingham University Hospitals, NHS Trust

location_facility: Hopital Robert-Debré, Service de Néphrologie Pédiatrique

location_facility: Nephrology Clinic, Karolinska University Hospital

location_facility: Le Centre Hospitalier Universitaire de Nice

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico

location_facility: The Methodist Hospital Research Institute

location_facility: Providence Sacred Heart Medical Center & Children's Hospital

location_facility: Hopital de la Timone Enfants, Unité de Néphrologie

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Centre Hospitalier Inter-Communal de Cornouaille

location_facility: Centre Hospitalier Universitaire (CHU) Sainte-Justine

location_facility: Universitatsklinik fur Innere Medizin Medizinische Universitat Graz

location_facility: Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse

location_facility: INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie

location_facility: Dunwoody Pediatrics & Children's Healthcare of Atlanta

location_facility: Radboud University Nijmegen Medical Centre Nijmegen


title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

summary: The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Sweden
Mexico
Germany
France
Poland
Greece
Ireland
Argentina
Australia
New Zealand
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: North Shore Long Island Jewish Health System

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: University Of Colorado Denver And Hospital

location_facility: Washington University School Of Medicine

status_simplified: Completed


type: Other Identifier

title: A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

summary: This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

ReferenceCitation: Chen SC, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, Li C. Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens. Br J Clin Pharmacol. 2017 Dec;83(12):2767-2777. doi: 10.1111/bcp.13381. Epub 2017 Sep 3.

name: Genentech, Inc. South San Francisco CA USA

family: Chen

full_name: Shang‐Chiung Chen

given: Shang‐Chiung

family: Quartino

full_name: Angelica Quartino

given: Angelica

name: Metrum Research Group Tariffville CT USA

family: Polhamus

full_name: Daniel Polhamus

given: Daniel

family: Riggs

full_name: Matthew Riggs

given: Matthew

family: French

full_name: Jonathan French

given: Jonathan

full_name: Xin Wang

given: Xin

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

family: Smitt

full_name: Melanie Smitt

given: Melanie

family: Hoersch

full_name: Silke Hoersch

given: Silke

family: Strasak

full_name: Alexander Strasak

given: Alexander

family: Jin

full_name: Jin Yan Jin

given: Jin Yan

family: Girish

full_name: Sandhya Girish

given: Sandhya

family: Li

full_name: Chunze Li

given: Chunze

journal_name: British Journal of Clinical Pharmacology

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Population pharmacokinetics and exposure–response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2‐targeted regimens

ReferenceCitation: Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743-754. doi: 10.1016/S1470-2045(17)30313-3. Epub 2017 May 16.

family: Krop

full_name: Ian E Krop

given: Ian E

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Martin

full_name: Antonio Gonzalez Martin

given: Antonio Gonzalez

family: LoRusso

ReferenceCitation: Krop IE, Kim SB, González-Martín A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H; TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):689-99. doi: 10.1016/S1470-2045(14)70178-0. Epub 2014 May 2.

location_country:
Belgium
Australia
Russian Federation
Czech Republic
India
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain


title: A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

acronym: TIME

summary:
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC).

TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen.

TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.

ReferenceCitation: Tosch C, Bastien B, Barraud L, Grellier B, Nourtier V, Gantzer M, Limacher JM, Quemeneur E, Bendjama K, Préville X. Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC. J Immunother Cancer. 2017 Sep 19;5(1):70. doi: 10.1186/s40425-017-0274-x.

family: Tosch

full_name: Caroline Tosch

given: Caroline

family: Bastien

full_name: Bérangère Bastien

given: Bérangère

family: Barraud

full_name: Luc Barraud

given: Luc

family: Grellier

full_name: Benoit Grellier

given: Benoit

family: Nourtier

full_name: Virginie Nourtier

given: Virginie

family: Gantzer

full_name: Murielle Gantzer

given: Murielle

family: Limacher

full_name: Jean Marc Limacher

given: Jean Marc

family: Quemeneur

full_name: Eric Quemeneur

given: Eric

family: Bendjama

full_name: Kaïdre Bendjama

given: Kaïdre

family: Préville

full_name: Xavier Préville

given: Xavier

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Quoix E, Lena H, Losonczy G, Forget F, Chouaid C, Papai Z, Gervais R, Ottensmeier C, Szczesna A, Kazarnowicz A, Beck JT, Westeel V, Felip E, Debieuvre D, Madroszyk A, Adam J, Lacoste G, Tavernaro A, Bastien B, Halluard C, Palanché T, Limacher JM. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23.

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Lena

full_name: Hervé Lena

given: Hervé

family: Losonczy

full_name: Gyorgy Losonczy

given: Gyorgy

family: Forget

full_name: Frédéric Forget

given: Frédéric

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Papai

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: Abington Hematology Oncology Associates Inc

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri

location_facility: START Madrid. Centro Integral Oncologico Clara Campal

location_facility: CHU de Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

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

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Centre Hospitalier Intercommunal de la Haute Saone

location_facility: Southampton University Hospitals NHS Trust

location_facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaza

location_facility: Hôpital Pasteur - Service de médecine F- Pavillon 43

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: CH Mulhouse Hopital Emile Muller Moenchsberg

location_facility: Institut Paoli-Calmettes, Service d'oncologie médicale


title: A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

summary: This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

ReferenceCitation: Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, Musselman D, Brockwell L, Shittu E, Klearman M, Fleming TR. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095.

name: Columbia University College of Physicians & Surgeons New York New York

family: Giles

full_name: Jon T. Giles

given: Jon T.

family: Sattar

full_name: Naveed Sattar

given: Naveed

name: Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey

family: Gabriel

full_name: Sherine Gabriel

given: Sherine

name: Brigham and Women’s HospitalHarvard Medical School Boston Massachusetts

family: Ridker

full_name: Paul M. Ridker

given: Paul M.

name: University Hospital Zurich Zurich Switzerland

family: Gay

full_name: Steffen Gay

given: Steffen

name: Roche Products Ltd. Welwyn Garden City UK

family: Warne

full_name: Charles Warne

given: Charles

name: Genentech, Inc. South San Francisco California

family: Musselman

full_name: David Musselman

given: David

family: Brockwell

full_name: Laura Brockwell

given: Laura

family: Shittu

full_name: Emma Shittu

given: Emma

family: Klearman

full_name: Micki Klearman

given: Micki

family: Fleming

full_name: Thomas R. Fleming

given: Thomas R.

journal_name: Arthritis & Rheumatology

oa_host_type: repository

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: The University of Glasgow - Enlighten: Publications

lead_sponsor: Hoffmann-La Roche

location_country:
Malaysia
Greece
Romania
Belgium
Russian Federation
Ecuador
India
Croatia
France
Lithuania
Poland
Argentina
Canada
South Africa
Chile
Netherlands
Philippines
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Israel
Spain
Turkey
Latvia

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

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft

location_facility: Whipps Cross Hospital; Rheumatology Dept

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: University of Pittsburgh Medical Center Health System; Infectious Disease

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: Allergy & Rheumatology Medical Clinic, Inc

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Scientific and research medical complex Your Health

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Siauliai Republican Hospital Public Institution

location_facility: CEIM Consultorios Especializados en Investigaciones Médicas

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

location_facility: Leningradskaya Regional Clinical Hospital; Rheumatology Dept

location_facility: Hospital Christus Muguerza del Parque; Reumatologia

location_facility: Groote Schuur Hospital; Rheumatology Unit

location_facility: Arthritis Rheumatic & Back Disease Associates

location_facility: Arizona Arthritis & Rheumatology Research, Pllc

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: University Hospitals Case Medical Center

location_facility: MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant

location_facility: Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii

location_facility: Centro de Estudios Clinicos V Region Limitada

location_facility: CHU d'Amiens Hôpital Nord; Pharmacie Clinique

location_facility: Cebu Doctors' University Hospital- North General Hospital

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: OrthoArkansas; Orthopedics & Sports Medicine

location_facility: Jacksonville Center For Clinical Research

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Centrul de Boli Reumatismale Dr. Ioan Stoia

location_facility: Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology

location_facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

location_facility: Royal London Hospital Outpatients Department

location_facility: Centre for Arthritis and Rheumatic Diseases

location_facility: Comite Mexicano Para la Prevencion de Osteoporosis AC

location_facility: Rheumatology Associates of North Alabama

location_facility: Alytus Regional S. Kudirkos Hospital, Public Institution

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

location_facility: Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A

location_facility: Landesklinikum Weinviertel Stockerau; Rheumatologie

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: State institution of healthcare "Regional hospital for war veterans"

location_facility: Hospital Municipal Nuestra Sra. de Lujan

location_facility: Ospedale San Giovanni Bosco; Divisione di Reumatologia

location_facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Chris Hani Baragwanath Hospital; Rheumatology Department

location_facility: Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: Inland Rheumatology; Clinical Trials, Inc.

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: Hospital de Cruces; Servicio de Reumatologia

location_facility: University Clinical Center of the Republic of Srpska

location_facility: P. Stradins Clinical University Hospital

location_facility: Head Clinical Hospital of Internal Affair Ministry of Russia

location_facility: Hospital Clinico Pontificia Universidad Catolica de Chile

location_facility: Columbia Arthritis Center (Partnership Practice)

location_facility: Atencion Integral En Reumatologia Buenos Aires

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie

location_facility: Rheumatology, P.C.; Medical Arts Building

location_facility: CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Specialty Medical Clinic and Research Center

location_facility: University of Pretoria; Clinical Trial Unit

location_facility: Southampton General Hospital; Rheumatology

location_facility: Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Hôpital Saint-Antoine; Service de Psychiatrie

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Memorial Medical Group Clinical Research

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: St. Luke's Intermountain Research Center

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Nashua Rheumatology - Foundation Medical Partners

location_facility: Arthritis Health Associates; Clinical Research

location_facility: Hospital General de Castellon; Servicio de Reumatologia

location_facility: FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Vilnius District Central Outpatient Clinic, Public Institution

location_facility: Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.

location_facility: Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus

location_facility: Hospital Central Dr. Ignacio Morones Prieto

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Instituto Centralizado de Asistencia e Investigaci

location_facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses

location_facility: University General Hospital of Heraklion

location_facility: Clinical Interventions Research Institute

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

location_facility: SEI of HPE "Altay State Medical University of Roszdrav"

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: Hospital General de Agudos Dr. J. M. Ramos Mejia

location_facility: Hospital Privado San Jose de Ciudad Obregon SA de CV

location_facility: Southend Hospital; Rheumatology Department

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Arthritis and Rheumatic Disease Associates

location_facility: St. Joseph'S/Candler Health System, Inc.; Office of Research

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Leading Edge Research, PA; Office of Dr. Burbano

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny

location_facility: Arthritis & Osteoporosis Medical Associates, Pllc

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: Hôpital Edouard Herriot; Service de Rhumatologie

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Moscow State Medical Stomatological University

location_facility: Uni Of Alabama,Birmingham; Medicine - Rheumatology

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: General Hospital of Thessaloniki Hippokration

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

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Special Hospital for Medical Rehabilitation

location_facility: Euroclinic of Athens; Internal Medicine & Immunology Dept.

location_facility: Unidad de Atencion Medica e Investigacion en Salud S.C.

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas


title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

acronym: LUMINOUS

summary: This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

time_perspective: Prospective

ReferenceCitation: Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS™ study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.

family: Holz

full_name: Frank G. Holz

given: Frank G.

family: Minnella

full_name: Angelo M. Minnella

given: Angelo M.

family: Tuli

full_name: Raman Tuli

given: Raman

family: Yoganathan

full_name: Pradeepa Yoganathan

given: Pradeepa

family: Parikh

full_name: Soumil Parikh

given: Soumil

family: Hamilton

full_name: Robin Hamilton

given: Robin

journal_name: PLOS ONE

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Leys AM, Ramboer E, Favreau M, Denhaerynck K, MacDonald K, Abraham I, Brié H. Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUS(TM) Study. Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.

family: Leys

full_name: Anita M Leys

given: Anita M

family: Ramboer

full_name: Eva Ramboer

given: Eva

family: Favreau

full_name: Mérédis Favreau

given: Mérédis

family: Denhaerynck

full_name: Kris Denhaerynck

given: Kris

family: MacDonald

full_name: Karen MacDonald

given: Karen

family: Abraham

full_name: Ivo Abraham

given: Ivo

family: Brié

full_name: Heidi Brié

given: Heidi

journal_name: Clinical Ophthalmology

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Taylor and Francis Group - Dove Medical Press

title: Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study

ReferenceCitation: Pearce I, Clemens A, Brent MH, Lu L, Gallego-Pinazo R, Minnella AM, Creuzot-Garcher C, Spital G, Sakamoto T, Dunger-Baldauf C, McAllister IL; all the LUMINOUS™ study investigators. Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study. PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.

name: on behalf of all the LUMINOUS™ study investigators

ReferenceCitation: Mitchell P, Sheidow TG, Farah ME, Mahmood S, Minnella AM, Eter N, Eldem B, Al-Dhibi H, Macfadden W, Parikh S, Dunger-Baldauf C, Mahgoub MM, Schmidt-Erfurth U; LUMINOUS study investigators. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.

name: on behalf of the LUMINOUS study investigators

ReferenceCitation: Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Monés J, Richard G, Bandello F; European Society of Retina Specialists. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014 Sep;98(9):1144-67. doi: 10.1136/bjophthalmol-2014-305702. Review.

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Peru
Guatemala
Malaysia
Greece
Australia
Belgium
Russian Federation
Czech Republic
Ukraine
Ecuador
India
Costa Rica
France
Japan
Panama
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Chile
Saudi Arabia
Hong Kong
Netherlands
Singapore
Hungary
Ireland
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Dominican Republic
Venezuela
Israel
Egypt
Spain
Turkey


title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Isaacs

full_name: John D. Isaacs

given: John D.

family: Chen

full_name: Lea Ann Chen

given: Lea Ann

family: Wang

full_name: Wenjin Wang

given: Wenjin

family: Marren

full_name: Amy Marren

given: Amy

family: Kwok

full_name: Kenneth Kwok

given: Kenneth

full_name: Lisy Wang

given: Lisy

family: Chan

full_name: Gary Chan

given: Gary

family: Su

full_name: Chinyu Su

given: Chinyu

journal_name: Digestive Diseases and Sciences

evidence: open (via crossref license)

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, Mamolo C. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1753-1759. doi: 10.1111/jdv.13702. Epub 2016 Jun 7.

name: Department of Dermatology Faculty of Medicine University of Chile and Probity Medical Research Santiago Chile

family: Valenzuela

full_name: F. Valenzuela

given: F.

name: Toulouse University and Larrey Hospital Toulouse France

family: Paul

full_name: C. Paul

given: C.

family: Mallbris

full_name: L. Mallbris

given: L.

family: Tan

full_name: H. Tan

given: H.

family: Papacharalambous

full_name: J. Papacharalambous

given: J.

family: Valdez

full_name: H. Valdez

family: Mamolo

full_name: C. Mamolo

journal_name: Journal of the European Academy of Dermatology and Venereology

title: Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient‐reported outcomes from a Phase 3 study

ReferenceCitation: Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, Yakusevich V, Chimenti S, Papacharalambous J, Proulx J, Gupta P, Tan H, Tawadrous M, Valdez H, Wolk R; OPT Compare Investigators. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015 Aug 8;386(9993):552-61. doi: 10.1016/S0140-6736(14)62113-9. Epub 2015 Jun 4.

location_country:
Belgium
Russian Federation
Denmark
Croatia
France
Poland
Slovakia
Argentina
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Hungary
Germany
United Kingdom
Austria
Bosnia and Herzegovina
Czechia
Israel
Spain
Turkey

location_facility: LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

location_facility: Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Dres.Kirsten Prepeneit und Volker Streit

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

location_facility: Department of Dermatovenerology, University Hospital Center Osijek

location_facility: Department for skin and venerial diseases, Clinical Center University of Sarajevo

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

location_facility: Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

location_facility: Department of Dermatology, Aarhus University Hospital

location_facility: MBAL na Voennomeditsinska akademia- Sofia

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

location_facility: Skanes Universitetssjukhus i Malmo, Hudkliniken

location_facility: State Research Center of Dermatovenerology, Department of clinical dermatology

location_facility: Severance Hospital, Yonsei University College of Medicine/Department of Dermatology

location_facility: Hopital Ambroise Pare, Service de Dermatologie

location_facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

location_facility: Hôpital de Brabois / Bâtiment Philippe Canton

location_facility: Kralska zdravotni a.s., Masarykovy nemocnice o.z.

location_facility: Istanbul university Istanbul Medical Faculty

location_facility: Centro de Investigacion Clinica de la Universidad del Rosario

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Centro de Investigaciones Dermatologicas

location_facility: IMAI (Instituto Medico de Asistencia e Investigaciones)

location_facility: Hospital Clinico Universidad de Chile, Departamento Dermatologia

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: State Research Center of Dermatovenerology, Department of dermatology

location_facility: Centro Integral de Reumatología del Caribe Circaribe S.A

location_facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

location_facility: Department of dermatovenerology, University Hospital Center Zagreb

location_facility: Samsung Medical Center / Department of Dermatology

location_facility: Amphia Hospital Location Molengracht / Department Dermatology

location_facility: Hospital General Universitario de Alicante

location_facility: Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

location_facility: Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Clinical hospital of emergency care N.V. Soloviev

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: Tsentar za kozhno-venericheski zaboliavania" EOOD

location_facility: Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

location_facility: LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

location_facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

location_facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

location_facility: North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

location_facility: Dermatovenerologic dispensary #10 of Vyborg region

location_facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)


title: Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

summary: This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

ReferenceCitation: Schymik G, Lefèvre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.

family: Schymik

full_name: Gerhard Schymik

given: Gerhard

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Bartorelli

full_name: Antonio L. Bartorelli

given: Antonio L.

family: Rubino

full_name: Paolo Rubino

given: Paolo

family: Treede

full_name: Hendrik Treede

given: Hendrik

family: Walther

full_name: Thomas Walther

given: Thomas

family: Baumgartner

full_name: Helmut Baumgartner

given: Helmut

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Wendler

full_name: Olaf Wendler

given: Olaf

family: Urban

full_name: Philip Urban

given: Philip

family: Mandinov

full_name: Lazar Mandinov

given: Lazar

family: Thomas

full_name: Martyn Thomas

given: Martyn

family: Vahanian

full_name: Alec Vahanian

given: Alec

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: European Experience With the Second-Generation Edwards SAPIEN XT Transcatheter Heart Valve in Patients With Severe Aortic Stenosis

lead_sponsor: Edwards Lifesciences

location_country:
Italy
Austria
South Africa
Switzerland
Netherlands
Germany
Finland
France
Czechia
Greece
Israel
Poland
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve

location_facility: The Cardinal Stefan Wyszyński Institute of Cardiology

location_facility: Klinikum der Universität München - Großhadern

location_facility: Centre Hospitalier De Universite of Montreal

location_facility: KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG

location_facility: St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera Policlinico Universitario

intervention_type: Device


title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY

acronym: PREVAIL

summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2021 Sep 13. doi: 10.1038/s41391-021-00447-9. [Epub ahead of print]

family: Tombal

full_name: Bertrand F. Tombal

given: Bertrand F.

family: Freedland

full_name: Stephen J. Freedland

given: Stephen J.

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

family: Beer

full_name: Tomasz M. Beer

given: Tomasz M.

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Sternberg

full_name: Cora N. Sternberg

given: Cora N.

family: Hussain

full_name: Maha Hussain

given: Maha

family: Ganguli

full_name: Arijit Ganguli

given: Arijit

family: Ramaswamy

full_name: Krishnan Ramaswamy

given: Krishnan

family: Bhadauria

full_name: Hemant Bhadauria

given: Hemant

family: Ivanescu

full_name: Cristina Ivanescu

given: Cristina

family: Turnbull

full_name: James Turnbull

given: James

family: Holmstrom

full_name: Stefan Holmstrom

given: Stefan

family: Saad

full_name: Fred Saad

given: Fred

journal_name: Prostate Cancer and Prostatic Diseases

ReferenceCitation: Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.

family: Lin

full_name: Ping Lin

given: Ping

full_name: Bertrand Tombal

given: Bertrand

family: Higano

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

name: Division of Medical Oncology and Urology, Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, North Carolina

name: Biostatistics, Pfizer Inc, Cambridge, Massachusetts

name: Biostatistics, Pfizer Inc, San Francisco, California

name: Clinical Development, Pfizer Inc, San Francisco, California

name: Biostatistics, Astellas Pharma Inc, Northbrook, Illinois

name: Clinical Development, Astellas Pharma Inc, Northbrook, Illinois

name: Division of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium

name: Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, New York

name: Division of Clinical Studies, The Institute of Cancer Research, The Royal Marsden National Health Service Foundation Trust, London, United Kingdom

name: Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York

name: Division of Hematology/Medical Oncology, OHSU Knight Cancer Institute, Oregon Health & Science University, Portland

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.

ReferenceCitation: Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.

name: Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, New York

name: Department of Hematology/Medical Oncology, OHSU Knight Cancer Institute, Oregon Health and Science University, Portland

name: Gustave Roussy, Cancer Campus, Department of Cancer Medicine, University of Paris Saclay, Villejuif, France

name: Department of Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington

name: Divisions of Medical Oncology and Urology, Duke University Medical Center, Duke Cancer Institute, Duke University, Durham, North Carolina

name: Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy

name: Division of Clinical Studies, Royal Marsden Hospital and Institute of Cancer Research, London, England

name: Department of Clinical Development, Medivation, LLC, a Pfizer company, San Francisco, California

name: formerly with Department of Biostatistics, Medivation, LLC, a Pfizer company, San Francisco, California

name: Department of Biostatistics, Astellas Pharma Europe BV, Leiden, The Netherlands

name: Department of Medical Oncology, Astellas Pharma, Inc, Northbrook, Illinois

ReferenceCitation: Kim CS, Choi YD, Lee SE, Lee HM, Ueda T, Yonese J, Fukagai T, Chiong E, Lau W, Abhyankar S, Theeuwes A, Tombal B, Beer TM, Kimura G. Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer. Medicine (Baltimore). 2017 Jul;96(27):e7223. doi: 10.1097/MD.0000000000007223.

ReferenceCitation: Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. doi: 10.1186/s12955-017-0704-y.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.

ReferenceCitation: Kim CS, Theeuwes A, Kwon DD, Choi YD, Chung BH, Lee HM, Lee KH, Lee SE. The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investig Clin Urol. 2016 May;57(3):174-83. doi: 10.4111/icu.2016.57.3.174. Epub 2016 May 10.

name: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

name: Biostatistics, Astellas Pharma Europe B.V., Leiden, The Netherlands.

name: Department of Urology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Korea.

name: Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.

name: Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

name: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

name: Department of Urology, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.

name: Department of Urology, Seoul National University Bundang Hospital, Seongnam, Korea.

ReferenceCitation: Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW, Forer D, Parli T, Phung D, Tombal B, Beer TM, Sternberg CN. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Ann Oncol. 2016 Feb;27(2):286-94. doi: 10.1093/annonc/mdv542. Epub 2015 Nov 16.

ReferenceCitation: Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.

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

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

repository_institution: Tampere University - Tampere University Institutional Repository

repositories_institution: Tampere University - Tampere University Institutional Repository

title: Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

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

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
France
Japan
Lithuania
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Netherlands
Singapore
United States
Germany
United Kingdom
Italy
Austria
Israel
Spain

location_facility: Centre Hospitalier Universitaire de Liege-Urologie

location_facility: Medical University of South Carolina - Urology Services

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Tom Baker Cancer Centre - Holy Cross Site

location_facility: The Ottawa Hospital Cancer Centre, General Campus

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: Centre de recherche clinique el evaluative en oncologie (CRCEO)

location_facility: University of Queensland Centre for Clinical Research (UQCCR)

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Azienda USL8-Presidio Ospedaliero S.Donato

location_facility: MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: University of Wisconsin Hospital and Clinics

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: Hospital Universitario German Trias i Pujol

location_facility: Oncology Eastern Clinical Research Unit (ECRU)

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Universitaetsklinikum Mannheim, Klinik fuer Urologie

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden an der

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: University College London Hospital NHS Trust

location_facility: North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera San. Camillo Forlanini

location_facility: Jewish Hospital & St. Mary's Healthcare, Inc.

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Division of Oncourology, National Cancer Institute

location_facility: British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior

location_facility: Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie

location_facility: Chonnam National University Hwasun Hospital

location_facility: North County Oncology Medical Clinic, Inc

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

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

location_facility: University Medical Center Groningen, Department of Urology

location_facility: State Educational Institution of Higher Professional Education

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

location_facility: Washington University School of Medicine

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Vrije Universiteit Medical Center, Department of Medical Oncology

location_facility: Seoul National University Bundang Hospital

location_facility: Royal North Shore Hospital, Department of Medical Oncology

location_facility: HIA Begin, Service de Medecine Interne et Oncologie

location_facility: Clinical Investigations and Research Unit, Royal Sussex County Hospital

location_facility: The University of Arizona Cancer Certer-North Campus

location_facility: Centre Eugene Marquis-Service d'Oncologie Medicale

location_facility: Hematology / Oncology MUSC Hollings Cancer Center

location_facility: Lismore Base Hospital, Lismore Cancer Care and Haematology Unit

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: QEII Health Sciences Centre, Nova Scotia Cancer Centre.

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: London RegCancer Program, London Health Sciences Centre

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica

location_facility: University of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: Department of Urology, National University Hospital

location_facility: Niigata University Medical and Dental Hospital

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: Universitaetsklinikum Heidelberg, Klinik Fuer Urologie

location_facility: UROEXAM, spol. s r.o. urologicka ambulancia

location_facility: Azienda Socio Sanitaria Territoriale di Cremona


ReferenceCitation: Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.

name: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, 9500 Euclid Avenue/U10, Cleveland, OH 44195, USA

family: Cohen

full_name: Jeffrey A. Cohen

given: Jeffrey A.

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

family: Tenenbaum

full_name: Nadia Tenenbaum

given: Nadia

name: Novartis Healthcare Pvt. Ltd., Hyderabad, India

family: Bhatt

full_name: Alit Bhatt

given: Alit

family: Zhang

full_name: Ying Zhang

given: Ying

name: Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: Therapeutic Advances in Neurological Disorders

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Guatemala
Jordan
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Panama
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Egypt
Spain
Estonia

ipd_sharing: Yes

source: euctr

title: A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

summary: The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.