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NCT05841537Active, not recruiting

An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)

Source: ClinicalTrials.gov · Last updated 9 May 2025

Brief summary (registry, in English)

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1019 (actual)
First submitted
24 Apr 2023
Start date
9 Jun 2023
Primary completion date
Jul 2028
Lead sponsor
AbbVie
NCT number
NCT05841537

What you commit to

  • Study type: Observational
  • Participants enrolled: 1019
  • From 9 Jun 2023 to the primary completion date, Jul 2028
  • 154 sites in 11 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

  • Participants previously exposed to risankizumab.

Other

  • Females who are pregnant or breast feeding at baseline.
  • Participants with any contraindication to risankizumab.
  • Participants currently participating in an interventional clinical trial.

Who the study is looking for

  • Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices.
  • Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care.
  • Participants prescribed risankizumab in accordance with the approved local label.
  • Participants able to understand and communicate with the investigator and comply with the requirements of the study.
  • Participants willing and able to provide authorization to use and disclose personal health information.
  • Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (154)

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

SiteCityCountrySite status
Cleveland Clinic Abu Dhabi /ID# 261681
Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesUnknown status
Burjeel Day Surgery Center /ID# 259188
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Abu DhabiUnited Arab EmiratesUnknown status
Sheikh Shakhbout Medical City /ID# 276665
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Abu DhabiUnited Arab EmiratesUnknown status
Rashid Hospital /ID# 259264
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DubaiUnited Arab EmiratesUnknown status
Medizinische Universitaet Graz /ID# 253559
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GrazAustriaUnknown status
Medizinische Universitaet Innsbruck /ID# 253563
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InnsbruckAustriaUnknown status
Universitaetsklinikum St. Poelten /ID# 258828
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Sankt PöltenAustriaUnknown status
Medizinische Universitaet Wien /ID# 261472
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ViennaAustriaUnknown status
Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824
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ViennaAustriaUnknown status
Klinikum Wels-Grieskirchen GmbH /ID# 253558
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WelsAustriaUnknown status
University of Calgary /ID# 254511
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CalgaryCanadaUnknown status
Gastroenterology and Internal Medicine Research Institution /ID# 253319
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EdmontonCanadaUnknown status
South Edmonton Gastroenterology Research Clinic /ID# 253160
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EdmontonCanadaUnknown status
Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661
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HamiltonCanadaUnknown status
Dr. Sundeep Singh, Inc /ID# 254250
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KelownaCanadaUnknown status
Six08 Gastroenterology /ID# 254513
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LethbridgeCanadaUnknown status
The Moncton Hospital /ID# 252960
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MonctonCanadaUnknown status
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522
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MontrealCanadaUnknown status
Royal Victoria Hospital / McGill University Health Centre /ID# 254626
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MontrealCanadaUnknown status
Fraser Clinical Trials Inc /ID# 254512
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New WestminsterCanadaUnknown status
Scott Shulman Medicine Professional Corporation /ID# 252961
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North BayCanadaUnknown status
Physician's Clinical Research Inc. /ID# 256494
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North YorkCanadaUnknown status
Toronto Immune and Digestive Health Institute Inc /ID# 253946
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North YorkCanadaUnknown status
Taunton surgical centre /ID# 253812
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OshawaCanadaUnknown status
Diex Recherche Québec /ID# 254016
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QuébecCanadaUnknown status
CIUSSS de l'Estrie - CHUS /ID# 254591
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SherbrookeCanadaUnknown status
Toronto Digestive Disease Associates /ID# 253813
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VaughanCanadaUnknown status
Percuro Clinical Research, Ltd /ID# 256339
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VictoriaCanadaUnknown status
Berner IBD Study Group /ID# 259351
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BernSwitzerlandUnknown status
Inselspital, Universitaetsspital Bern /ID# 259485
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BernSwitzerlandUnknown status
Gastroentérologie Beaulieu SA /ID# 259490
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LausanneSwitzerlandUnknown status
Hôpital de La Tour /ID# 259489
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MeyrinSwitzerlandUnknown status
Kantonsspital St. Gallen /ID# 261931
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Sankt GallenSwitzerlandUnknown status
Hirslanden Klinik /ID# 262093
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ZurichSwitzerlandUnknown status
University Hospital Zurich /ID# 259491
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ZurichSwitzerlandUnknown status
Praxis Jessen/Grimm /ID# 257610
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AltenholzGermanyUnknown status
Praxis Heil & Mueller /ID# 265211
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AndernachGermanyUnknown status
Praxis Dr. Schiffelholz /ID# 265218
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AugsburgGermanyUnknown status
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 260995
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BerlinGermanyUnknown status
Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262711
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BerlinGermanyUnknown status
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 262462
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BerlinGermanyUnknown status
Krankenhaus Waldfriede /ID# 262341
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Berlin-ZehlendorfGermanyUnknown status
Praxis S. Tetzlaff /ID# 257608
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BuedelsdorfGermanyUnknown status
Medizinisches Versorgunszentrum Dachau /ID# 262592
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DachauGermanyUnknown status
Dr. Janschek /ID# 260993
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DresdenGermanyUnknown status
Dres. Ende / Weisflog /ID# 262038
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ErfurtGermanyUnknown status
Universitaetsklinikum Erlangen /ID# 269946
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ErlangenGermanyUnknown status
Dres. Bauer/Doerflinger /ID# 262531
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Freiburg im BreisgauGermanyUnknown status
Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 261361
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FriedrichsthalGermanyUnknown status
Dres. Behrens/Fechner/Streudel /ID# 257601
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HalleGermanyUnknown status
Gastroenterologische Schwerpunktpraxis /ID# 275444
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HanoverGermanyUnknown status
Mueller/Mueller-Ziehm, Hanover /ID# 261599
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HanoverGermanyUnknown status
Universitaetsklinikum Heidelberg /ID# 272329
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HeidelbergGermanyUnknown status
Praxis fuer Gastroenterologie /ID# 260994
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HeidelbergGermanyUnknown status
Städtisches Kh. Heinsberg GmbH /ID# 258671
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HeinsbergGermanyUnknown status
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 261122
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HerneGermanyUnknown status
MVZ Dres. Al-Kadi & Partner /ID# 260996
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IserlohnGermanyUnknown status
Praxisgemeinschaft Jerichow Schulze /ID# 262036
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JerichowGermanyUnknown status
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895
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KasselGermanyUnknown status
Dres. Breitschwerdt/Glas/Gurtler /ID# 257612
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LeipzigGermanyUnknown status
Praxis fuer Gastroenterologie /ID# 257607
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LübeckGermanyUnknown status
Gastropraxis Magdeburg /ID# 261340
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MagdeburgGermanyUnknown status
Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148
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MindenGermanyUnknown status
Gastro.Praxis am Meerbachbogen /ID# 265900
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NienburgGermanyUnknown status
Dres. Hundorfean/Tex /ID# 261530
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NurembergGermanyUnknown status
Praxisklinik Nürnberg /ID# 261682
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NurembergGermanyUnknown status
Magen-Darm-Zentrum-Remscheid /ID# 260681
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RemscheidGermanyUnknown status
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 257602
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SaarbrückenGermanyUnknown status
Praxis fuer Gastroenterologie /ID# 266305
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SchwerinGermanyUnknown status
Praxis Dr. Kempelmann /ID# 261583
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TostedtGermanyUnknown status
Klinikum Worms gGmbH /ID# 269803
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WormsGermanyUnknown status
Dr. Schirin-Sokhan /ID# 266003
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WürselenGermanyUnknown status
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 261228
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El PalmarSpainUnknown status
Hospital Juan Ramon Jimenez /ID# 261227
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HuelvaSpainUnknown status
Hospital Universitari de Bellvitge /ID# 261198
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario 12 de Octubre /ID# 261200
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MadridSpainUnknown status
Hospital Universitario La Paz /ID# 261199
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 261201
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MajadahondaSpainUnknown status
Hospital Universitario de Salamanca /ID# 261197
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SalamancaSpainUnknown status
Hospital Universitario Marques de Valdecilla /ID# 261196
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SantanderSpainUnknown status
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261195
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio /ID# 261202
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SevilleSpainUnknown status
Hospital Universitario Virgen Macarena /ID# 261225
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SevilleSpainUnknown status
Hospital Alvaro Cunqueiro CHUVI /ID# 261224
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VigoSpainUnknown status
CHU Amiens-Picardie Site Sud /ID# 253089
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AmiensFranceUnknown status
CHU de Besancon - Jean Minjoz /ID# 253098
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BesançonFranceUnknown status
Hopital de la Cavale Blanche /ID# 253100
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BrestFranceUnknown status
CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368
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CaenFranceUnknown status
CHRU Tours - Hopital Trousseau /ID# 253369
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Chambray-lès-ToursFranceUnknown status
Clinique de Bercy /Id# 253139
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Charenton-le-PontFranceUnknown status
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088
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ColmarFranceUnknown status
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091
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CréteilFranceUnknown status
Centre Hospitalier de Dunkerque /ID# 253837
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DunkirkFranceUnknown status
CH Annecy Genevois - Site Annecy /ID# 253103
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Epagny Metz TessyFranceUnknown status
CH Haguenau /ID# 253109
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HaguenauFranceUnknown status
AP-HP - Hopital Bicetre /ID# 253093
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Le Kremlin-BicêtreFranceUnknown status
CHRU Lille - Hopital Claude Huriez /ID# 253099
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LilleFranceUnknown status
HCL - Hopital de la Croix-Rousse /ID# 256413
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LyonFranceUnknown status
APHM - Hopital Nord /ID# 253364
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MarseilleFranceUnknown status
CHU Montpellier - Hopital Saint Eloi /ID# 253096
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MontpellierFranceUnknown status
Clinique Jules Verne /ID# 253939
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NantesFranceUnknown status
CHU de Nantes, Hotel Dieu -HME /ID# 254047
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NantesFranceUnknown status
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 253358
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Neuilly-sur-SeineFranceUnknown status
Hôpital l'Archet /ID# 253097
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NiceFranceUnknown status
CHU NIMES - Hopital Caremeau /ID# 254060
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NîmesFranceUnknown status
AP-HP - Hopital Saint-Antoine /ID# 254044
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ParisFranceUnknown status
Centre Hospitalier Universitaire de Bordeaux /ID# 253095
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PessacFranceUnknown status
HCL - Hopital Lyon Sud /ID# 253104
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Pierre-BéniteFranceUnknown status
Centre Hospitalier de Quimper /ID# 254052
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QuimperFranceUnknown status
CHU Reims - Hôpital Robert Debre /ID# 253366
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ReimsFranceUnknown status
CHU de Rouen /ID# 253107
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RouenFranceUnknown status
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 253102
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St-Priest-en-JarezFranceUnknown status
Centre Hospitalier Tarbes-Lourdes /ID# 253943
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TarbesFranceUnknown status
CHU Toulouse - Hopital Rangueil /ID# 253094
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ToulouseFranceUnknown status
Hôpital Schuman /ID# 254781
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VantouxFranceUnknown status
Shaare Zedek Medical Center /ID# 258738
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JerusalemIsraelUnknown status
Rabin Medical Center /ID# 257058
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 258737
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 257057
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Tel AvivIsraelUnknown status
A.O.U. Consorziale Policlinico di Bari /ID# 264739
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BariItalyUnknown status
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 265289
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BolognaItalyUnknown status
Azienda Ospedaliero Universitaria Careggi /ID# 265159
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FlorenceItalyUnknown status
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 263592
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MessinaItalyUnknown status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263587
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MilanItalyUnknown status
IRCCS Ospedale San Raffaele /ID# 265127
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MilanItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 263918
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RomeItalyUnknown status
IRCCS Istituto Clinico Humanitas /ID# 262991
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RozzanoItalyUnknown status
Asahikawa Medical University Hospital /ID# 256842
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Asahikawa-shiJapanUnknown status
Institute of Science Tokyo Hospital /ID# 256669
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Bunkyo-kuJapanUnknown status
Chiba University Hospital /ID# 256721
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ChibaJapanUnknown status
Fukuoka University Chikushi Hospital /ID# 256113
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Chikushino-shiJapanUnknown status
Fukuoka University Hospital /ID# 256718
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FukuokaJapanUnknown status
Hamamatsu University Hospital /ID# 256723
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HamamatsuJapanUnknown status
Kansai Medical University Hospital /ID# 256548
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Hirakata-shiJapanUnknown status
Hirosaki University Hospital /ID# 256887
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Hirosaki-shiJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine /ID# 266206
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KyotoJapanUnknown status
Kitasato University Kitasato Institute Hospital /ID# 256724
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Minato-kuJapanUnknown status
The Jikei University Hospital /ID# 255741
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Minato-kuJapanUnknown status
Kyorin University Hospital /ID# 254076
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Mitaka-shiJapanUnknown status
Nagoya University Hospital /ID# 257302
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NagoyaJapanUnknown status
Hyogo Medical University Hospital /ID# 256720
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Nishinomiya-shiJapanUnknown status
Shiga University of Medical Science Hospital /ID# 256549
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ŌtsuJapanUnknown status
Saga University Hospital /ID# 256726
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SagaJapanUnknown status
Toho University Sakura Medical Center /ID# 256668
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Sakura-shiJapanUnknown status
Sapporo Medical University Hospital /ID# 256544
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SapporoJapanUnknown status
Tohoku University Hospital /ID# 255867
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SendaiJapanUnknown status
Jichi Medical University Hospital /ID# 256665
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Shimotsuke-shiJapanUnknown status
Keio University Hospital /ID# 257239
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Shinjuku-kuJapanUnknown status
Tokyo Women's Medical University Hospital /ID# 255868
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Shinjuku-kuJapanUnknown status
Iwate Medical University Hospital /ID# 256722
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Shiwa-gunJapanUnknown status
Yokohama City University Medical Center /ID# 256719
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YokohamaJapanUnknown status
Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 268085
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HeerlenNetherlandsUnknown status
Radboudumc /ID# 266526
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NijmegenNetherlandsUnknown status
Elisabeth TweeSteden Ziekenhuis /ID# 267140
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TilburgNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.