ID

30812

Description

Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI); ODM derived from: https://clinicaltrials.gov/show/NCT00714571

Link

https://clinicaltrials.gov/show/NCT00714571

Keywords

Versions (1)
  1. 6/21/18 6/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT00714571

English

Eligibility Multiple Sclerosis (Primary or Secondary Progressive Phase). NCT01144117

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
general inclusion criteria (all patients):
Description

Inclusion criteria General

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205246
a minimum of 12 years of education or attainment of a graduation equivalency diploma;
Description

Education Year Quantity | Graduation Diploma Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013622
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1711333
UMLS CUI [2,2]
C1549966
UMLS CUI [2,3]
C0205163
all medications stable for approximately 3 months;
Description

Pharmaceutical Preparations Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
no history of severe mental illness;
Description

Severe Mental Disorders Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C0332197
no current untreated alcohol or substance abuse/dependence;
Description

Substance Use Disorders Untreated Absent | Substance Dependence Untreated Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0332155
UMLS CUI [2,3]
C0332197
english as native and preferred language;
Description

Native language English | Preferred language english

Data type

boolean

Alias
UMLS CUI [1]
C2135511
UMLS CUI [2]
C3249910
mri-compatible if taking part in fmri studies 7) able to give informed consent.
Description

MRI Compatible | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332290
UMLS CUI [2]
C0021430
treatment with steroids in the last 30 days
Description

Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
diagnosis of amnestic mci based on criteria set forth by petersen (2004). additionally, other potential causes of cognitive deficit ruled out by the referring physician;
Description

Mild cognitive disorder Amnestic | Exclusion Causes Other Impaired cognition

Data type

boolean

Alias
UMLS CUI [1,1]
C1270972
UMLS CUI [1,2]
C0002625
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C0338656
55 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
tbi inclusion criteria:
Description

Inclusion criteria Traumatic Brain Injury

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0876926
history of a mild to moderate tbi;
Description

Mild Traumatic Brain Injury | Moderate traumatic brain injury

Data type

boolean

Alias
UMLS CUI [1]
C3508472
UMLS CUI [2]
C3508473
no history of other neurological disease or injury;
Description

Nervous system disorder Other Absent | Nervous System Trauma Other Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0751792
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
a minimum of 6 months and maximum of 5 years post-onset of tbi;
Description

Timespan Post Onset of Traumatic Brain Injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0332162
UMLS CUI [1,4]
C0876926
18 - 45 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of neurological disease or injury (other than tbi)
Description

Nervous system disorder | Trauma, Nervous System | Exception Traumatic Brain Injury

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0751792
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0876926
history of severe mental illness
Description

Mental Disorders, Severe

Data type

boolean

Alias
UMLS CUI [1]
C4046029
current untreated alcohol or substance abuse
Description

Substance Use Disorders untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332155
other conditions may exclude; please discuss with contact
Description

Condition Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis (Primary or Secondary Progressive Phase). NCT01144117

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria General
Item
general inclusion criteria (all patients):
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Education Year Quantity | Graduation Diploma Equivalent
Item
a minimum of 12 years of education or attainment of a graduation equivalency diploma;
boolean
C0013622 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1711333 (UMLS CUI [2,1])
C1549966 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Pharmaceutical Preparations Stable
Item
all medications stable for approximately 3 months;
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Severe Mental Disorders Absent
Item
no history of severe mental illness;
boolean
C4046029 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Substance Use Disorders Untreated Absent | Substance Dependence Untreated Absent
Item
no current untreated alcohol or substance abuse/dependence;
boolean
C0038586 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0038580 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Native language English | Preferred language english
Item
english as native and preferred language;
boolean
C2135511 (UMLS CUI [1])
C3249910 (UMLS CUI [2])
MRI Compatible | Informed Consent
Item
mri-compatible if taking part in fmri studies 7) able to give informed consent.
boolean
C0024485 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Steroid therapy
Item
treatment with steroids in the last 30 days
boolean
C0149783 (UMLS CUI [1])
Mild cognitive disorder Amnestic | Exclusion Causes Other Impaired cognition
Item
diagnosis of amnestic mci based on criteria set forth by petersen (2004). additionally, other potential causes of cognitive deficit ruled out by the referring physician;
boolean
C1270972 (UMLS CUI [1,1])
C0002625 (UMLS CUI [1,2])
C2828389 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0338656 (UMLS CUI [2,4])
Age
Item
55 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Inclusion criteria Traumatic Brain Injury
Item
tbi inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0876926 (UMLS CUI [1,2])
Mild Traumatic Brain Injury | Moderate traumatic brain injury
Item
history of a mild to moderate tbi;
boolean
C3508472 (UMLS CUI [1])
C3508473 (UMLS CUI [2])
Nervous system disorder Other Absent | Nervous System Trauma Other Absent
Item
no history of other neurological disease or injury;
boolean
C0027765 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0751792 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Timespan Post Onset of Traumatic Brain Injury
Item
a minimum of 6 months and maximum of 5 years post-onset of tbi;
boolean
C0872291 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0876926 (UMLS CUI [1,4])
Age
Item
18 - 45 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Nervous system disorder | Trauma, Nervous System | Exception Traumatic Brain Injury
Item
history of neurological disease or injury (other than tbi)
boolean
C0027765 (UMLS CUI [1])
C0751792 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0876926 (UMLS CUI [3,2])
Mental Disorders, Severe
Item
history of severe mental illness
boolean
C4046029 (UMLS CUI [1])
Substance Use Disorders untreated
Item
current untreated alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Condition Additional
Item
other conditions may exclude; please discuss with contact
boolean
C0348080 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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