ID

11994

Descrição

A Study of NeuroVax, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02200718 Principal Investigator: Dennis Bourdette, MD F.A.A.N.

Link

https://clinicaltrials.gov/show/NCT02200718

Palavras-chave

  1. 30/08/2015 30/08/2015 -
Transferido a

30 de agosto de 2015

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT02200718

Eligibility Multiple Sclerosis NCT02200718

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Ages Eligible for Study: 5 Years to 17 Years
Descrição

Ages Eligible for Study: 5 Years to 17 Years

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Genders Eligible for Study: Both
Descrição

Genders Eligible for Study: Both

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
Accepts Healthy Volunteers: No Criteria
Descrição

Accepts Healthy Volunteers: No Criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1708335
Subject is between 5 and 17 years of age, inclusive
Descrição

Subject is between 5 and 17 years of age, inclusive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Clinically diagnosed Pediatric MS
Descrição

Clinically diagnosed Pediatric MS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C1521725
Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
Descrição

Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C1521725
Expanded Disability Status Scale (EDSS) <= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
Descrição

Expanded Disability Status Scale (EDSS) <= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
Laboratory values within the following limits:
Descrição

Laboratory values within the following limits:

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022885
Creatinine 1 . 5 x high normal
Descrição

Creatinine 1 . 5 x high normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010294
Hemoglobin
Descrição

Hemoglobin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019046
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Subjects currently prescribed Campath or Lemtrada
Descrição

Subjects currently prescribed Campath or Lemtrada

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0939276

Similar models

Eligibility Multiple Sclerosis NCT02200718

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
Ages Eligible for Study: 5 Years to 17 Years
boolean
C0001779 (UMLS CUI [1])
gender
Item
Genders Eligible for Study: Both
boolean
C0079399 (UMLS CUI [1])
Healthy Volunteers
Item
Accepts Healthy Volunteers: No Criteria
boolean
C1708335 (UMLS CUI [1])
age
Item
Subject is between 5 and 17 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis;Pediatric
Item
Clinically diagnosed Pediatric MS
boolean
C0026769 (UMLS CUI [1])
C1521725 (UMLS CUI [2])
pediatric MS
Item
Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course
boolean
C0026769 (UMLS CUI [1])
C1521725 (UMLS CUI [2])
Kurtzke multiple sclerosis rating scale
Item
Expanded Disability Status Scale (EDSS) <= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening
boolean
C0451246 (UMLS CUI [1])
laboratory values
Item
Laboratory values within the following limits:
boolean
C0022885 (UMLS CUI [1])
creatinine
Item
Creatinine 1 . 5 x high normal
boolean
C0010294 (UMLS CUI [1])
hemoglobin
Item
Hemoglobin
boolean
C0019046 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
campath
Item
Subjects currently prescribed Campath or Lemtrada
boolean
C0939276 (UMLS CUI [1])

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