ID

25935

Description

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00437060

Link

https://clinicaltrials.gov/show/NCT00437060

Keywords

Versions (1)
  1. 9/27/17 9/27/17 -
Uploaded on

September 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility B-cell Childhood Acute Lymphoblastic Leukemia NCT00437060

English

Eligibility B-cell Childhood Acute Lymphoblastic Leukemia NCT00437060

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of acute lymphoblastic leukemia
Description

Acute lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023449
enrolled on cog-aall0434 (cohort #1 only) or cog-aall0232 (cohorts #1 and #2)
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance.
Description

Methotrexate High dose | Methotrexate Dose Increasing

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0444956
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0442808
no cns-3 disease
Description

CNS3 Disease Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3899748
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2828389
patients must enroll within 8-24 months after completion of therapy on cog-aall0232 and no evidence of relapsed or secondary malignancy
Description

Study Subject Participation Status | Recurrent Malignant Neoplasm Absent | Secondary Malignant Neoplasm Absent

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1458156
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3266877
UMLS CUI [3,2]
C0332197
no known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:
Description

Neurodevelopmental Disorders Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1535926
UMLS CUI [1,2]
C2828389
down syndrome
Description

Down Syndrome Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0013080
UMLS CUI [1,2]
C2828389
fragile x mental retardation
Description

Fragile X Syndrome Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0016667
UMLS CUI [1,2]
C2828389
autism
Description

Autistic Disorder Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0004352
UMLS CUI [1,2]
C2828389
pervasive developmental disability
Description

Pervasive Development Disorder Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0524528
UMLS CUI [1,2]
C2828389
seizure disorder
Description

Epilepsy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C2828389
attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed
Description

Attention deficit hyperactivity disorder | Learning Disability Specific | Dyslexia

Data type

boolean

Alias
UMLS CUI [1]
C1263846
UMLS CUI [2,1]
C0751265
UMLS CUI [2,2]
C0205369
UMLS CUI [3]
C0476254
no sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness)
Description

Hypesthesia Excluded | Visual Impairment uncorrected Pre-existing Exclusion | Deafness Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0020580
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C3665347
UMLS CUI [2,2]
C4072785
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C2828389
UMLS CUI [3,1]
C0011053
UMLS CUI [3,2]
C2828389
no cranial radiation therapy
Description

Therapeutic radiology procedure cranial Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0037303
UMLS CUI [1,3]
C2828389
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Similar models

Eligibility B-cell Childhood Acute Lymphoblastic Leukemia NCT00437060

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia
Item
diagnosis of acute lymphoblastic leukemia
boolean
C0023449 (UMLS CUI [1])
Study Subject Participation Status
Item
enrolled on cog-aall0434 (cohort #1 only) or cog-aall0232 (cohorts #1 and #2)
boolean
C2348568 (UMLS CUI [1])
Methotrexate High dose | Methotrexate Dose Increasing
Item
patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance.
boolean
C0025677 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442808 (UMLS CUI [2,3])
CNS3 Disease Excluded
Item
no cns-3 disease
boolean
C3899748 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Study Subject Participation Status | Recurrent Malignant Neoplasm Absent | Secondary Malignant Neoplasm Absent
Item
patients must enroll within 8-24 months after completion of therapy on cog-aall0232 and no evidence of relapsed or secondary malignancy
boolean
C2348568 (UMLS CUI [1])
C1458156 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3266877 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Neurodevelopmental Disorders Excluded
Item
no known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:
boolean
C1535926 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Down Syndrome Excluded
Item
down syndrome
boolean
C0013080 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Fragile X Syndrome Excluded
Item
fragile x mental retardation
boolean
C0016667 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Autistic Disorder Excluded
Item
autism
boolean
C0004352 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Pervasive Development Disorder Excluded
Item
pervasive developmental disability
boolean
C0524528 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Epilepsy Excluded
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Attention deficit hyperactivity disorder | Learning Disability Specific | Dyslexia
Item
attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed
boolean
C1263846 (UMLS CUI [1])
C0751265 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0476254 (UMLS CUI [3])
Hypesthesia Excluded | Visual Impairment uncorrected Pre-existing Exclusion | Deafness Excluded
Item
no sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness)
boolean
C0020580 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C2828389 (UMLS CUI [2,4])
C0011053 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Therapeutic radiology procedure cranial Exclusion
Item
no cranial radiation therapy
boolean
C1522449 (UMLS CUI [1,1])
C0037303 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
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