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NCT03593590Completed

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.

Status (registry)
Completed
Study type
Observational
Enrollment
1710 (actual)
First submitted
11 Jul 2018
Start date
12 Nov 2018
Primary completion date
19 Jan 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT03593590

What you commit to

  • Study type: Observational
  • Participants enrolled: 1710
  • From 12 Nov 2018 to the primary completion date, 19 Jan 2026
  • 158 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design)
  • Not receiving ocrelizumab in line with the SmPC

Who the study is looking for

  • Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice
  • Must be prescribed ocrelizumab in line with the SmPC
  • Must have provided signed informed consent
  • Must be able and willing to complete the PROs as per clinical practice

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (158)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mediclinic Parkview Hospital
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Dubai-UAEUnited Arab EmiratesUnknown status
Landesklinikum Amstetten
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AmstettenAustriaUnknown status
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
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InnsbruckAustriaUnknown status
Kepler Universitätsklinikum GmbH - Neuromed Campus
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LinzAustriaUnknown status
Kepler Universitätskliniken GmbH - Med Campus III
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LinzAustriaUnknown status
Multiple Sklerose Zentrum
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MelkAustriaUnknown status
Klinik Floridsdorf
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ViennaAustriaUnknown status
Imeldaziekenhuis
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BonheidenBelgiumUnknown status
AZ KLINA
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BrasschaatBelgiumUnknown status
Cliniques Universitaires St-Luc
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BrusselsBelgiumUnknown status
UZ Brussel
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BrusselsBelgiumUnknown status
Hospital Erasme
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BrusselsBelgiumUnknown status
CHU de Charleroi
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CharleroiBelgiumUnknown status
UZ Antwerpen
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EdegemBelgiumUnknown status
CNRF - Centre Neurologique et Réadaptation Fonctionnelle
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FraitureBelgiumUnknown status
Jessa Zkh (Campus Virga Jesse)
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HasseltBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
CHU Tivoli
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La LouvièreBelgiumUnknown status
CHC MontLégia
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LiègeBelgiumUnknown status
Nationaal MS Centrum
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MelsbroekBelgiumUnknown status
CHU UCL Mont-Godinne
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Mont-godinneBelgiumUnknown status
AZ Oostende
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OstendBelgiumUnknown status
Revalidatie en MS Centrum
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OverpeltBelgiumUnknown status
AZ Delta (Campus Rumbeke)
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RoeselareBelgiumUnknown status
Umhat 'Dr. Georgi Stranski', Ead
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PlevenBulgariaUnknown status
UMHAT Sveti Georgi Clinic of neurology
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PlovdivBulgariaUnknown status
Shat Np Sveti Naum
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SofiaBulgariaUnknown status
Multiprofile Hosp. for Active Treatment
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SofiaBulgariaUnknown status
UMHAT Tsaritsa Yoanna ISUL EAD
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SofiaBulgariaUnknown status
UMHAT Alexandrovska EAD
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SofiaBulgariaUnknown status
First MHAT
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SofiaBulgariaUnknown status
"City Clinic UMHAC" EOOD
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SofiaBulgariaUnknown status
Acibadem City Clinic Tokuda Hospital Ead
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SofiaBulgariaUnknown status
UMHAT "Sv. Ivan Rilski", EAD
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SofiaBulgariaUnknown status
MBAL St. Marina
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VarnaBulgariaUnknown status
Hospital de Base do Distrito Federal
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BrasíliaBrazilUnknown status
Instituto de Neurologia de Curitiba
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CuritibaBrazilUnknown status
Hospital Universitario Gaffree e Guinle
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Rio de JaneiroBrazilUnknown status
Clinica Amo Assistencia Medica Em Oncologia
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SalvadorBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
Clinica Las Condes
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SantiagoChileUnknown status
Centro Javeriano de Oncología
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BogotáColombiaUnknown status
Organizacion Sanitas Internacional
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BogotáColombiaUnknown status
Fundacion ABOOD Shaio
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Bogota, DCColombiaUnknown status
Fundacion Clinica Valle del Lili
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CaliColombiaUnknown status
Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
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Santo DomingoDominican RepublicUnknown status
Faculty of Medicine-Ain Shams University
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CairoEgyptUnknown status
Clinical Research Center-Alex university
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CairoEgyptUnknown status
Al Qahira Al Fatmiya Hospital
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CairoEgyptUnknown status
Complejo Hospitalario Universitario A Coruña (CHUAC)
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A CoruñaSpainUnknown status
Hospital Nuestra Senora de Sonsoles
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ÁvilaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Germans Trias i Pujol
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BarcelonaSpainUnknown status
Hospital Puerta del Mar
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CadizSpainUnknown status
Hospital General Universitario Santa Lucia
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Cartagena (Murcia)SpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital de Donostia
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Donostia / San SebastianSpainUnknown status
Hospital General Universitario de Elche
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ElcheSpainUnknown status
Hospital de Figueres
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FigueresSpainUnknown status
Hospital Regional Universitario de Malaga - Hospital General
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MálagaSpainUnknown status
Hospital Universitario Virgen de Arrixaca
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MurciaSpainUnknown status
Corporacio Sanitaria Parc Tauli
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SabadellSpainUnknown status
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainUnknown status
Hospital Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Hospital Virgen Del Rocio
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SevilleSpainUnknown status
Hospital Univ. Nuestra Señora de Valme
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SevilleSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
Hospital Universitario de Araba
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Vitoria-GasteizSpainUnknown status
Royal Victoria Hospital
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BelfastUnited KingdomUnknown status
University Hospital Coventry
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CoventryUnited KingdomUnknown status
Raigmore Hospital
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InvernessUnited KingdomUnknown status
Leeds General Infirmary
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LeedsUnited KingdomUnknown status
Lincoln County Hospital
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LincolnUnited KingdomUnknown status
St. George's Hospital
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LondonUnited KingdomUnknown status
Luton General Hospital
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LutonUnited KingdomUnknown status
James Cook Hospital
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MiddlesbroughUnited KingdomUnknown status
John Radcliffe Hospital
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OxfordUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Sunderland Royal Hospital
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SunderlandUnited KingdomUnknown status
Morriston Hospital
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SwanseaUnited KingdomUnknown status
Southmead Hospital
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Westbury-on-Trym, BristolUnited KingdomUnknown status
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
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BariItalyUnknown status
Ospedale Binaghi
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CagliariItalyUnknown status
Ospedale F. Ferrari
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CasaranoItalyUnknown status
AOU Policlinico V. Emanuele - P.O G. Rodolico
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CataniaItalyUnknown status
Arcispedale Sant'Anna
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ConaItalyUnknown status
Ospedale S.Antonio Abate
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GallarateItalyUnknown status
Irccs A.O.U.San Martino Ist
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GenoaItalyUnknown status
Ospedale San Salvatore
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L’AquilaItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
IRCCS Ospedale San Raffaele
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MilanItalyUnknown status
Fond. Istituto Neurologico C.Besta
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MilanItalyUnknown status
Ospedale Regina Montis Regalis
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Mondovì (CN)ItalyUnknown status
Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyUnknown status
AOU Seconda Università degli Studi
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NaplesItalyUnknown status
AOU Policlinico Giaccone
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PalermoItalyUnknown status
A.O.U di Parma
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ParmaItalyUnknown status
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
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PaviaItalyUnknown status
IRCCS Istituto Neurologico Neuromed
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PozzilliItalyUnknown status
Azienda Ospedaliera Sant'Andrea
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RomeItalyUnknown status
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
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RomeItalyUnknown status
Policlinico San Donato
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San Donato MilaneseItalyUnknown status
Presidio Ospedaliero S.O.P.A. Micone
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Sestri Ponente (GE)ItalyUnknown status
AOU Senese - Presidio Ospedaliero Le Scotte
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SienaItalyUnknown status
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
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Torrette - AnconaItalyUnknown status
Ibn Sina Hospital
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Kuwait CityKuwaitUnknown status
Clinical Center of Montenegro
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PodgoricaMontenegroUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
St. Antonius Ziekenhuis Nieuwegein
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NieuwegeinNetherlandsUnknown status
Maasstadziekenhuis
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NL -rotterdamNetherlandsUnknown status
Ziekenhuis VieCuri Medisch Centrum
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VenloNetherlandsUnknown status
Isala
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ZwolleNetherlandsUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandUnknown status
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
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GdanskPolandUnknown status
Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
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Głogów MałopolskiPolandUnknown status
Gornoslaskie Centrum Medyczne
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KatowicePolandUnknown status
UCK im. prof. K. Gibinskiego SUM
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KatowicePolandUnknown status
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
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LodzPolandUnknown status
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
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RybnikPolandUnknown status
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
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WarsawPolandUnknown status
Instytut Psychiatrii I Neurologii
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WarsawPolandUnknown status
SPSK nr 1
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ZabrzePolandUnknown status
Hospital Santo Antonio dos Capuchos
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LisbonPortugalUnknown status
Centro Hospitalar do Porto
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PortoPortugalUnknown status
Hospital Central del Instituto de Previsión Social
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AsunciónParaguayUnknown status
Hamad General Hospital
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DohaQatarUnknown status
Fundeni Clinical Institute
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BucharestRomaniaUnknown status
Spitalul Universitar de Urgență București
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BucharestRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
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Cluj-NapocaRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Sibiu
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SibiuRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Mures
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Târgu MureşRomaniaUnknown status
Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Regional clinical hospital named after prof. S.V. Ochapovsky
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KrasnodarRussiaUnknown status
Jusupovskaya Hospital
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MoscowRussiaUnknown status
State Novosibirsk Regional Clinical Hospital
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NovosibirskRussiaUnknown status
National Center of Social Significant Disease
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Saint PetersburgRussiaUnknown status
King Abdul Aziz Medical City, King Fahd National Guard
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RiyadhSaudi ArabiaUnknown status
Nemocnica akademika Ladislava Derera
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BratislavaSlovakiaUnknown status
Univerzitná nemocnica Bratislava - Nemocnica Ružinov
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BratislavaSlovakiaUnknown status
Univerzitna Nemocnica - Nemocnica svateho Michala
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BratislavaSlovakiaUnknown status
Univerzitna nemocnica Martin
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MartinSlovakiaUnknown status
Ustredna vojenska nemocnica SNP Ruzomberok
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RužomberokSlovakiaUnknown status
Fakultna nemocnica Trnava
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TrnavaSlovakiaUnknown status
Hacettepe University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Istanbul School of Medicine
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IstanbulTurkey (Türkiye)Unknown status
Ege University Medical Faculty
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IzmirTurkey (Türkiye)Unknown status
Kocaeli University Hospital
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KocaeliTurkey (Türkiye)Unknown status
Mersin University Medical Faculty
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MersinTurkey (Türkiye)Unknown status
Ondokuz Mayis Univ. Med. Fac.
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SamsunTurkey (Türkiye)Unknown status
Karadeniz Tecnical Uni Med Fac
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TrabzonTurkey (Türkiye)Unknown status

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