ID

17394

Descripción

n-3 PUFA for Vascular Cognitive Aging; ODM derived from: https://clinicaltrials.gov/show/NCT01953705

Link

https://clinicaltrials.gov/show/NCT01953705

Palabras clave

Versiones (1)
  1. 11/9/16 11/9/16 -
Subido en

11 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Age Related Cognitive Decline NCT01953705

Inglés

Eligibility Age Related Cognitive Decline NCT01953705

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-demented or mild cognitive impairment, defined as clinical dementia rating =0 or 0.5.
Descripción

cognitive impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338656
age 80 and older, male and female
Descripción

age, sex

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
total wmh volume ≥ 6 cc (>80% of our oregon brain aging study population meets this criterion)
Descripción

wmh volume

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0682708
UMLS CUI [1,2]
C0449468
plasma pufa (epa + dha) < 110 ug/ml or < 5 weight percent (>85% of our obas population meets this)
Descripción

plasma pufa

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032615
UMLS CUI [1,2]
C0032105
sufficient english language skills to complete all tests
Descripción

english language skills

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0376245
geriatric depression scale - 15 < 6 documenting absence of a significant depressive syndrome
Descripción

geriatric depression scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451184
sufficient vision and hearing to complete all tests
Descripción

vision and hearing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2706921
informant available with frequent (at least 1 hour/day or 1 day/week) contact with subject to verify functional status and cdr rating
Descripción

functional status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0598463
general health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)
Descripción

health status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any dementing illness (ad, vascular dementia, normal pressure hydrocephalus, or parkinson's disease); dementia defined by cdr ≥ 1
Descripción

dementing illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
significant disease of the cns such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis
Descripción

cns disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
alcohol or substance abuse according to dsm-iv criteria within the last 2 years
Descripción

substance abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
major depression, schizophrenia, or other major psychiatric disorder defined by dsm-iv criteria
Descripción

psychiatric disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
abnormal labs indicating vitamin b12 deficiency, thyroid disease, or uti (documented bacterial colonization is acceptable)
Descripción

b12 deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042847
unstable or significantly symptomatic cvd (e.g. cad with frequent angina, chf with dyspnea at rest)
Descripción

cvd

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
hypertension: either 1) blood pressure > 150/90 or 2) > 2 medications to control
Descripción

hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
clinical symptomatic orthostatic hypotension
Descripción

orthostatic hypotension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020651
diabetes mellitus that requires insulin injections
Descripción

diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
history of cortical stroke
Descripción

cortical stroke

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
cancer within the last 5 years, with the exception of localized prostate cancer (gleason grade < 3) and non-metastatic skin cancers (melanoma).
Descripción

cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
illness that requires >1 visit /month to a clinician
Descripción

illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221423
progressive vision loss (age-related macular degeneration already beginning to degrade vision)
Descripción

vision loss

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3665347
contraindications to mri (i.e., heart pacemaker, metal plates or objects in head, metal worker)
Descripción

contraindications to mri

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079164
UMLS CUI [1,2]
C0024485
analgesics: frequent use of high doses
Descripción

analgesics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002771
sedatives: except for those used occasionally for sleep (use limited to ≤ twice per week)
Descripción

sedatives

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036557
cns active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and ssris)
Descripción

cns active meds

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1874882
active hypertension on > 2 meds or using cns active agents (propranolol or clonidine)
Descripción

active hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit
Descripción

neuroleptics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040615
over the counter supplements are not by themselves exclusionary, however, subjects are asked not to change the dosing regimen over the course of the trial unless medically indicated; the presence and dose of these agents are recorded
Descripción

supplements

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242295
taking omega 3 pufa supplements and a screen plasma pufa > 5 weight percent of total fatty acids for epa+dha will confirm supplementation of o3pufa history
Descripción

omega 3

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015689
cholinesterase inhibitors (i.e., aricept)
Descripción

cholinesterase inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008425
investigational drugs within five half-lives prior to baseline
Descripción

investigational drug

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
anticoagulation therapy: vitamin k agonist, warfarin, factor xa inhibitors, low molecular weight heparins.
Descripción

anticoagulation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003281
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Similar models

Eligibility Age Related Cognitive Decline NCT01953705

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
cognitive impairment
Item
non-demented or mild cognitive impairment, defined as clinical dementia rating =0 or 0.5.
boolean
C0338656 (UMLS CUI [1])
age, sex
Item
age 80 and older, male and female
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
wmh volume
Item
total wmh volume ≥ 6 cc (>80% of our oregon brain aging study population meets this criterion)
boolean
C0682708 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
plasma pufa
Item
plasma pufa (epa + dha) < 110 ug/ml or < 5 weight percent (>85% of our obas population meets this)
boolean
C0032615 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
english language skills
Item
sufficient english language skills to complete all tests
boolean
C0376245 (UMLS CUI [1])
geriatric depression scale
Item
geriatric depression scale - 15 < 6 documenting absence of a significant depressive syndrome
boolean
C0451184 (UMLS CUI [1])
vision and hearing
Item
sufficient vision and hearing to complete all tests
boolean
C2706921 (UMLS CUI [1])
functional status
Item
informant available with frequent (at least 1 hour/day or 1 day/week) contact with subject to verify functional status and cdr rating
boolean
C0598463 (UMLS CUI [1])
health status
Item
general health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dementing illness
Item
any dementing illness (ad, vascular dementia, normal pressure hydrocephalus, or parkinson's disease); dementia defined by cdr ≥ 1
boolean
C0497327 (UMLS CUI [1])
cns disease
Item
significant disease of the cns such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis
boolean
C0007682 (UMLS CUI [1])
substance abuse
Item
alcohol or substance abuse according to dsm-iv criteria within the last 2 years
boolean
C0038586 (UMLS CUI [1])
psychiatric disorder
Item
major depression, schizophrenia, or other major psychiatric disorder defined by dsm-iv criteria
boolean
C0004936 (UMLS CUI [1])
b12 deficiency
Item
abnormal labs indicating vitamin b12 deficiency, thyroid disease, or uti (documented bacterial colonization is acceptable)
boolean
C0042847 (UMLS CUI [1])
cvd
Item
unstable or significantly symptomatic cvd (e.g. cad with frequent angina, chf with dyspnea at rest)
boolean
C0007222 (UMLS CUI [1])
hypertension
Item
hypertension: either 1) blood pressure > 150/90 or 2) > 2 medications to control
boolean
C0020538 (UMLS CUI [1])
orthostatic hypotension
Item
clinical symptomatic orthostatic hypotension
boolean
C0020651 (UMLS CUI [1])
diabetes mellitus
Item
diabetes mellitus that requires insulin injections
boolean
C0011849 (UMLS CUI [1])
cortical stroke
Item
history of cortical stroke
boolean
C0038454 (UMLS CUI [1])
cancer
Item
cancer within the last 5 years, with the exception of localized prostate cancer (gleason grade < 3) and non-metastatic skin cancers (melanoma).
boolean
C0006826 (UMLS CUI [1])
illness
Item
illness that requires >1 visit /month to a clinician
boolean
C0221423 (UMLS CUI [1])
vision loss
Item
progressive vision loss (age-related macular degeneration already beginning to degrade vision)
boolean
C3665347 (UMLS CUI [1])
contraindications to mri
Item
contraindications to mri (i.e., heart pacemaker, metal plates or objects in head, metal worker)
boolean
C0079164 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
analgesics
Item
analgesics: frequent use of high doses
boolean
C0002771 (UMLS CUI [1])
sedatives
Item
sedatives: except for those used occasionally for sleep (use limited to ≤ twice per week)
boolean
C0036557 (UMLS CUI [1])
cns active meds
Item
cns active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and ssris)
boolean
C1874882 (UMLS CUI [1])
active hypertension
Item
active hypertension on > 2 meds or using cns active agents (propranolol or clonidine)
boolean
C0020538 (UMLS CUI [1])
neuroleptics
Item
neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit
boolean
C0040615 (UMLS CUI [1])
supplements
Item
over the counter supplements are not by themselves exclusionary, however, subjects are asked not to change the dosing regimen over the course of the trial unless medically indicated; the presence and dose of these agents are recorded
boolean
C0242295 (UMLS CUI [1])
omega 3
Item
taking omega 3 pufa supplements and a screen plasma pufa > 5 weight percent of total fatty acids for epa+dha will confirm supplementation of o3pufa history
boolean
C0015689 (UMLS CUI [1])
cholinesterase inhibitor
Item
cholinesterase inhibitors (i.e., aricept)
boolean
C0008425 (UMLS CUI [1])
investigational drug
Item
investigational drugs within five half-lives prior to baseline
boolean
C0013230 (UMLS CUI [1])
anticoagulation therapy
Item
anticoagulation therapy: vitamin k agonist, warfarin, factor xa inhibitors, low molecular weight heparins.
boolean
C0003281 (UMLS CUI [1])
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