ID

13281

Description

Multicenter Vitamin E Trial in Aging Persons With Down Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01594346

Link

https://clinicaltrials.gov/show/NCT01594346

Keywords

Versions (1)
  1. 1/29/16 1/29/16 -
Uploaded on

January 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer's Disease NCT01594346

English

Eligibility Alzheimer's Disease NCT01594346

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
presence of clinically determined down syndrome (karyotypes optional)
Description

down syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
appropriately signed and witnessed consent form
Description

consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age of 50 years or older at the start of the protocol
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
medically stable
Description

Medical status

Data type

boolean

Alias
UMLS CUI [1]
C3899485
medications stable more than 1 month
Description

Medication status

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1547775
involvement/cooperation of informant/caregiver
Description

caregiver

Data type

boolean

Alias
UMLS CUI [1]
C0085537
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical/neurological condition (other than alzheimer disease) associated with dementia
Description

medical/neurological condition associated with dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0497327
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0002395
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0497327
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0002395
inability to adequately perform the brief praxis test, as demonstrated by a score <20
Description

brief praxis test

Data type

boolean

Alias
UMLS CUI [1,1]
C0009240
UMLS CUI [1,2]
C0746940
UMLS CUI [1,3]
C0039593
in the presence of dementia, modified hachinski score > 4 at screening visit
Description

hachinski score

Data type

boolean

Alias
UMLS CUI [1]
C0475492
major depression within 3 months
Description

major depression

Data type

boolean

Alias
UMLS CUI [1]
C1269683
history of coagulopathy (inherited or acquired)
Description

coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
current use of anticoagulants
Description

anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
use of experimental medications within 2 months
Description

experimental medications

Data type

boolean

Alias
UMLS CUI [1]
C0304229
regular use of vitamin e greater than 50 units per day during the previous 6 months
Description

vitamin e

Data type

boolean

Alias
UMLS CUI [1,1]
C1142098
UMLS CUI [1,2]
C0178602
allergy to vitamin e
Description

allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C002051
UMLS CUI [1,2]
C0042874
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Similar models

Eligibility Alzheimer's Disease NCT01594346

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
down syndrome
Item
presence of clinically determined down syndrome (karyotypes optional)
boolean
C0013080 (UMLS CUI [1])
consent
Item
appropriately signed and witnessed consent form
boolean
C0021430 (UMLS CUI [1])
age
Item
age of 50 years or older at the start of the protocol
boolean
C0001779 (UMLS CUI [1])
Medical status
Item
medically stable
boolean
C3899485 (UMLS CUI [1])
Medication status
Item
medications stable more than 1 month
boolean
C0013227 (UMLS CUI [1,1])
C1547775 (UMLS CUI [1,2])
caregiver
Item
involvement/cooperation of informant/caregiver
boolean
C0085537 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
medical/neurological condition associated with dementia
Item
medical/neurological condition (other than alzheimer disease) associated with dementia
boolean
C0027765 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0002395 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0002395 (UMLS CUI [2,4])
brief praxis test
Item
inability to adequately perform the brief praxis test, as demonstrated by a score <20
boolean
C0009240 (UMLS CUI [1,1])
C0746940 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
hachinski score
Item
in the presence of dementia, modified hachinski score > 4 at screening visit
boolean
C0475492 (UMLS CUI [1])
major depression
Item
major depression within 3 months
boolean
C1269683 (UMLS CUI [1])
coagulopathy
Item
history of coagulopathy (inherited or acquired)
boolean
C0005779 (UMLS CUI [1])
anticoagulants
Item
current use of anticoagulants
boolean
C0003280 (UMLS CUI [1])
experimental medications
Item
use of experimental medications within 2 months
boolean
C0304229 (UMLS CUI [1])
vitamin e
Item
regular use of vitamin e greater than 50 units per day during the previous 6 months
boolean
C1142098 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
allergy
Item
allergy to vitamin e
boolean
C002051 (UMLS CUI [1,1])
C0042874 (UMLS CUI [1,2])
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