ID

30812

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00714571

Nyckelord

Versioner (1)
  1. 2018-06-21 2018-06-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT00714571

Engelsk

Eligibility Mild Cognitive Impairment NCT00714571

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Inclusion criteria General

Datatyp

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;
Beskrivning

Education Year Quantity | Graduation Diploma Equivalent

Datatyp

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;
Beskrivning

Pharmaceutical Preparations Stable

Datatyp

boolean

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

Severe Mental Disorders Absent

Datatyp

boolean

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

Substance Use Disorders Untreated Absent | Substance Dependence Untreated Absent

Datatyp

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;
Beskrivning

Native language English | Preferred language english

Datatyp

boolean

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

MRI Compatible | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332290
UMLS CUI [2]
C0021430
mci inclusion criteria:
Beskrivning

Inclusion criteria Mild cognitive disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1270972
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;
Beskrivning

Mild cognitive disorder Amnestic | Exclusion Causes Other Impaired cognition

Datatyp

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.
Beskrivning

Age

Datatyp

boolean

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

Inclusion criteria Traumatic Brain Injury

Datatyp

boolean

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

Mild Traumatic Brain Injury | Moderate traumatic brain injury

Datatyp

boolean

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

Nervous system disorder Other Absent | Nervous System Trauma Other Absent

Datatyp

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;
Beskrivning

Timespan Post Onset of Traumatic Brain Injury

Datatyp

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.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Mental Disorders, Severe

Datatyp

boolean

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

Substance Use Disorders untreated

Datatyp

boolean

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

Condition Additional

Datatyp

boolean

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

Eligibility Mild Cognitive Impairment NCT00714571

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Inclusion criteria Mild cognitive disorder
Item
mci inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1270972 (UMLS CUI [1,2])
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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