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NCT02130362Active, not recruiting

A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

Source: ClinicalTrials.gov · Last updated 16 Jul 2025

Brief summary (registry, in English)

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1446 (actual)
First submitted
1 May 2014
Start date
28 Aug 2014
Primary completion date
30 Nov 2030
Lead sponsor
AbbVie
NCT number
NCT02130362

What you commit to

  • Study type: Observational
  • Participants enrolled: 1446
  • From 28 Aug 2014 to the primary completion date, 30 Nov 2030
  • 148 sites in 22 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

  • Patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures.
  • Patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA.

Who the study is looking for

  • For a patient enrolling into the HUMIRA treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed Humira therapy according to the routine clinical practice.
  • For a patient enrolling into the immunosuppressant therapy treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed azathioprine, 6-mercaptopurine or methotrexate.
  • Parent or guardian; or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric CD investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) after the nature of the registry has been explained and the patient, patient's parent or legal guardian has had the opportunity to ask questions.

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (148)

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

SiteCityCountrySite status
SHAT Hematologic Diseases /ID# 143572
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SofiaBulgariaUnknown status
Alberta Health Services /ID# 128717
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EdmontonCanadaUnknown status
IWK Health Center /ID# 127912
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HalifaxCanadaUnknown status
The Univ of Western Ontario /ID# 137962
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LondonCanadaUnknown status
Hospital for Sick Children /ID# 127910
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TorontoCanadaUnknown status
Duplicate_University of Manitoba / Health Scuience Centre / John Buhler Research /ID# 141310
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WinnipegCanadaUnknown status
Fakultní nemocnice Hradec Králové - Sokolská /ID# 128521
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Hradec KrálovéCzechiaUnknown status
Fakultni nemocnice Olomouc /ID# 127437
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OlomoucCzechiaUnknown status
Fakultni Nemocnice Ostrava /ID# 127913
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OstravaCzechiaUnknown status
Fakultni nemocnice Kralovske Vinohrady /ID# 127697
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PragueCzechiaUnknown status
Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829
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Ústí nad LabemCzechiaUnknown status
Universitaetsklinikum Aachen /ID# 126591
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AachenGermanyUnknown status
Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696
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DresdenGermanyUnknown status
Duplicate_Universitaetsklinikum Erlangen /ID# 137274
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ErlangenGermanyUnknown status
Froehlich Gemeinschaftspraxis /ID# 127975
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ForchheimGermanyUnknown status
Duplicate_Universitaetsklinikum Freiburg /ID# 130010
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Freiburg im BreisgauGermanyUnknown status
Kinderarztpraxis Neuhausen /ID# 144402
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MunichGermanyUnknown status
Duplicate_Universitaetsklinikum Muenster /ID# 148441
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MunsterGermanyUnknown status
Christliches Kinderhospital Osnabrueck /ID# 136629
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OsnabrückGermanyUnknown status
Universitaetsklinikum Regensburg /ID# 137140
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RegensburgGermanyUnknown status
Universitaetsklinikum Ulm /ID# 148444
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UlmGermanyUnknown status
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013
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HvidovreDenmarkUnknown status
Tallinn Children's Hospital /ID# 126974
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TallinnEstoniaUnknown status
Children's Clinic Of Tartu Uni /ID# 146017
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TartuEstoniaUnknown status
Complejo Hospitalario Universitario A Coruña /ID# 137235
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A CoruñaSpainUnknown status
Hospital Universitario Germans Trias i Pujol /ID# 139400
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BadalonaSpainUnknown status
OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781
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BarakaldoSpainUnknown status
Hospital Universitario Vall d'Hebron /ID# 141778
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BarcelonaSpainUnknown status
Hospital Universitario Vall d'Hebron /ID# 146015
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BarcelonaSpainUnknown status
Hospital General de Granollers /ID# 140882
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BarcelonaSpainUnknown status
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460
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El PalmarSpainUnknown status
Hospital Sant Joan de Deu /ID# 152059
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Esplugues de LlobregatSpainUnknown status
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462
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FerrolSpainUnknown status
Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572
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GironaSpainUnknown status
Hospital Universitario Severo Ochoa /ID# 141545
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LeganésSpainUnknown status
Hospital Universitario La Paz /ID# 161152
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MadridSpainUnknown status
Hospital Infantil Universitario Nino Jesus /ID# 165738
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre /ID# 136998
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157872
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MajadahondaSpainUnknown status
Hospital Regional Universitario de Malaga /ID# 144289
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MálagaSpainUnknown status
Hospital Universitario Central de Asturias /ID# 163053
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OviedoSpainUnknown status
Hospital Universitari Son Espases /ID# 147446
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Palma de MallorcaSpainUnknown status
Compl Hospital Univer de Vigo /ID# 136999
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PontevedraSpainUnknown status
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029
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SabadellSpainUnknown status
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 141667
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Dr. Peset /ID# 159484
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ValenciaSpainUnknown status
Hospital Universitario y Politecnico La Fe /ID# 141847
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ValenciaSpainUnknown status
Duplicate_Hôpital Pierre Wertheimer /ID# 128193
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BronFranceUnknown status
AP-HP - Hopital Necker /ID# 147702
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ParisFranceUnknown status
NHS Grampian /ID# 131296
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AberdeenUnited KingdomUnknown status
Birmingham Women's and Children's NHS Foundation Trust /ID# 136631
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BirminghamUnited KingdomUnknown status
Duplicate_Cambridge University Hospitals NHS Foundation Trust /ID# 143779
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CambridgeUnited KingdomUnknown status
St Helier Hospital /ID# 150097
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CarshaltonUnited KingdomUnknown status
University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592
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DerbyUnited KingdomUnknown status
Duplicate_NHS Greater Glasgow and Clyde /ID# 127436
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GlasgowUnited KingdomUnknown status
Alder Hey Children's Hospital /ID# 138013
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LiverpoolUnited KingdomUnknown status
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 128471
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LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust /ID# 128476
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ManchesterUnited KingdomUnknown status
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438
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Newcastle upon TyneUnited KingdomUnknown status
Sheffield Children's Hospital NHS Foundation Trust /ID# 130370
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SheffieldUnited KingdomUnknown status
University Hospital Southampton NHS Foundation Trust /ID# 147538
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SouthamptonUnited KingdomUnknown status
St George's University Hospitals NHS Foundation Trust /ID# 131590
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TootingUnited KingdomUnknown status
Agia Sofia Hospital /ID# 134349
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AthensGreeceUnknown status
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690
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AthensGreeceUnknown status
Venizeleio General Hospital /ID# 147335
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HeraklionGreeceUnknown status
Iatriko Kentro Athinon /ID# 130639
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MarousiGreeceUnknown status
General Hospital of Thessaloniki Gennimatas /Id# 163658
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ThessalonikiGreeceUnknown status
Zadar General Hospital /ID# 129830
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ZadarCroatiaUnknown status
Klinicki bolnicki centar Sestre milosrdnice /ID# 128256
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ZagrebCroatiaUnknown status
Our Lady's Hospital /ID# 127438
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ManorhamiltonIrelandUnknown status
Duplicate_Ha'Emek Medical Center /ID# 156316
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AfulaIsraelUnknown status
Rambam Health Care Campus /ID# 162061
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HaifaIsraelUnknown status
The Lady Davis Carmel Medical Center /ID# 151519
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HaifaIsraelUnknown status
Shaare Zedek Medical Center /ID# 144277
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JerusalemIsraelUnknown status
Schneider Children's Medical Center /ID# 152683
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Petah TikvaIsraelUnknown status
Edmond And Lily Safra Children /ID# 148730
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Ramat GanIsraelUnknown status
Duplicate_Kaplan Medical Center /ID# 152945
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RehovotIsraelUnknown status
Yitzhak Shamir Medical Center /ID# 157182
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TsrifinIsraelUnknown status
Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347
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BolognaItalyUnknown status
Duplicate_A.O.U. Policlinico G. Martino /ID# 141683
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MessinaItalyUnknown status
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279
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MilanItalyUnknown status
ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679
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MilanItalyUnknown status
Duplicate_Universita di Napoli Federico II /ID# 144280
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NaplesItalyUnknown status
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 152684
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PalermoItalyUnknown status
Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410
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PalermoItalyUnknown status
Azienda Ospedaliero-Universitaria di Parma /ID# 147441
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ParmaItalyUnknown status
Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 141307
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PescaraItalyUnknown status
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962
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RomeItalyUnknown status
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809
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KaunasLithuaniaUnknown status
Vilnius University Hospital Santaros Klinikos /ID# 127810
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VilniusLithuaniaUnknown status
Duplicate_Academisch Medisch Centrum /ID# 141843
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AmsterdamNetherlandsUnknown status
Duplicate_Erasmus Medisch Centrum /ID# 141841
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RotterdamNetherlandsUnknown status
Ctr. Gastroenterologia Ped Oes /ID# 140875
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MayagüezPuerto RicoUnknown status
San Jorge Children Hospital /ID# 138067
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San JuanPuerto RicoUnknown status
2CA-Braga, Hospital de Braga /ID# 138269
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BragaPortugalUnknown status
Unidade Local de Saude Sao Joao, EPE /ID# 138146
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PortoPortugalUnknown status
Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358
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BucharestRomaniaUnknown status
Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297
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Cluj-NapocaRomaniaUnknown status
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014
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Târgu MureşRomaniaUnknown status
Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251
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TimișoaraRomaniaUnknown status
Karolinska University Hospital Solna /ID# 129045
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SolnaSwedenUnknown status
Sodersjukhuset /ID# 152685
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StockholmSwedenUnknown status
Children's Ctr Digestive, US /ID# 144625
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AtlantaUnited StatesUnknown status
Winship Cancer Institute of Emory University /ID# 144274
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AtlantaUnited StatesUnknown status
Children's Hospital Colorado - Aurora /ID# 137261
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AuroraUnited StatesUnknown status
Univ Alabama, Birmingham CCC /ID# 146060
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BirminghamUnited StatesUnknown status
Tufts Medical Center /ID# 143581
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BostonUnited StatesUnknown status
Boston Children's Hospital /ID# 164102
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BostonUnited StatesUnknown status
Massachusetts General Hospital /ID# 141552
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BostonUnited StatesUnknown status
Women and Childrens Hosp /ID# 143778
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BuffaloUnited StatesUnknown status
University Of Vermont Medical /ID# 137263
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BurlingtonUnited StatesUnknown status
Univ NC Chapel Hill /ID# 137236
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Chapel HillUnited StatesUnknown status
Duplicate_Medical University of South Carolina /ID# 144473
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CharlestonUnited StatesUnknown status
Children's Medical Center /ID# 149256
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DallasUnited StatesUnknown status
Geisinger Medical Center /ID# 149910
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DanvilleUnited StatesUnknown status
Duke Cancer Center /ID# 137268
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DurhamUnited StatesUnknown status
Pediatric Specialty of VA /ID# 142831
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FairfaxUnited StatesUnknown status
Cook Children's Med. Center /ID# 144474
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Fort WorthUnited StatesUnknown status
Connecticut Children's Medical Center - Hartford /ID# 137265
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HartfordUnited StatesUnknown status
Penn State Child Hosp.Hersh,PA /ID# 144476
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HersheyUnited StatesUnknown status
Texas Children's Hospital /ID# 148211
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HoustonUnited StatesUnknown status
Univ of Mississippi Med Ctr,US /ID# 137239
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JacksonUnited StatesUnknown status
Nemours Children's Health System /ID# 148498
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JacksonvilleUnited StatesUnknown status
Private practice: Dr. Shervin Rabizadeh /ID# 137269
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Los AngelesUnited StatesUnknown status
Children's Hospital Los Angeles /ID# 141551
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Los AngelesUnited StatesUnknown status
University of Miami /ID# 140893
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MiamiUnited StatesUnknown status
Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259
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MilwaukeeUnited StatesUnknown status
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238
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MinneapolisUnited StatesUnknown status
University of South Alabama /ID# 137255
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MobileUnited StatesUnknown status
Goryeb Children's Hospital /ID# 144275
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MorristownUnited StatesUnknown status
Yale University School of Medicine /ID# 137257
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New HavenUnited StatesUnknown status
CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266
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New Hyde ParkUnited StatesUnknown status
Children's Hospital New Orleans /ID# 144477
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New OrleansUnited StatesUnknown status
Columbia Univ Medical Center /ID# 144440
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New YorkUnited StatesUnknown status
Columbia Univ Medical Center /ID# 144475
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New YorkUnited StatesUnknown status
Children's Hospital Oklahoma /ID# 144047
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Oklahoma CityUnited StatesUnknown status
Phoenix Children's Hospital /ID# 141336
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PhoenixUnited StatesUnknown status
Maine Medical Partners /ID# 147685
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PortlandUnited StatesUnknown status
Mayo Clinic - Rochester /ID# 149245
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RochesterUnited StatesUnknown status
Rady Children's Hospital San Diego /ID# 140883
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San DiegoUnited StatesUnknown status
Univ California, San Francisco /ID# 141312
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San FranciscoUnited StatesUnknown status
Seattle Children's Hospital /ID# 140879
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SeattleUnited StatesUnknown status
Duplicate_Swedish Medical Center /ID# 137258
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SeattleUnited StatesUnknown status
Univ Med Ctr at Stony Brook /ID# 140913
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Stony BrookUnited StatesUnknown status
SUNY Upstate Medical University /ID# 148437
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SyracuseUnited StatesUnknown status
MultiCare Institute for Research & Innovation /ID# 152120
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TacomaUnited StatesUnknown status
Duplicate_UMass Chan Medical School /ID# 148325
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WorcesterUnited StatesUnknown status
University Clinical Center Tuzla /ID# 130638
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TuzlaBosnia and HerzegovinaUnknown status

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