ID

14196

Description

Alzheimer's in Long-Term Care--Treatment for Agitation; ODM derived from: https://clinicaltrials.gov/show/NCT00161473

Link

https://clinicaltrials.gov/show/NCT00161473

Keywords

Versions (1)
  1. 4/4/16 4/4/16 -
Uploaded on

April 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00161473

English

Eligibility Alzheimer Disease NCT00161473

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
no age limit
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
probable/possible alzheimer's disease diagnosis
Description

alzheimers disease

Data type

boolean

Alias
UMLS CUI [1]
C0002395
disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
Description

Agitation; aggression; pacing

Data type

boolean

Alias
UMLS CUI [1]
C0085631
UMLS CUI [2]
C0001807
UMLS CUI [3]
C0562458
no hypotension
Description

hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
no concurrent use of alpha-1-blockers
Description

alpha-1-blockers

Data type

boolean

Alias
UMLS CUI [1]
C0304512
no delirium, schizophrenia, mania, psychotic symptoms.
Description

delirium; schizophrenia; mania; psychotic symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0678190
UMLS CUI [4]
C0871189
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (av) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
Description

cardiovascular disease unstable angina myocardial infarction atrioventricular block

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0002965
UMLS CUI [1,3]
C0027051
UMLS CUI [1,4]
C0004245
other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
Description

renal failure; hepatic failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0085605
exclusionary medications: current treatment with prazosin, other alpha-1-blockers
Description

prazosin; alpha 1 blockers

Data type

boolean

Alias
UMLS CUI [1]
C0032912
UMLS CUI [2]
C0304512
current enrollment in a separate investigational drug trial
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. although not formally rated, this improvement is equivalent to a clinical global impression of change (cgic) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
Description

psychoactive medications; antipsychotics; anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003286
psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
Description

schizophrenia; delirium; panic disorder; psychotic symptoms; substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0011206
UMLS CUI [3]
C0030319
UMLS CUI [4]
C0871189
UMLS CUI [5]
C0740858
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Similar models

Eligibility Alzheimer Disease NCT00161473

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
no age limit
boolean
C0001779 (UMLS CUI [1])
alzheimers disease
Item
probable/possible alzheimer's disease diagnosis
boolean
C0002395 (UMLS CUI [1])
Agitation; aggression; pacing
Item
disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
boolean
C0085631 (UMLS CUI [1])
C0001807 (UMLS CUI [2])
C0562458 (UMLS CUI [3])
hypotension
Item
no hypotension
boolean
C0020649 (UMLS CUI [1])
alpha-1-blockers
Item
no concurrent use of alpha-1-blockers
boolean
C0304512 (UMLS CUI [1])
delirium; schizophrenia; mania; psychotic symptoms
Item
no delirium, schizophrenia, mania, psychotic symptoms.
boolean
C0011206 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0678190 (UMLS CUI [3])
C0871189 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
cardiovascular disease unstable angina myocardial infarction atrioventricular block
Item
cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (av) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
boolean
C0007222 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0004245 (UMLS CUI [1,4])
renal failure; hepatic failure
Item
other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
boolean
C0035078 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
prazosin; alpha 1 blockers
Item
exclusionary medications: current treatment with prazosin, other alpha-1-blockers
boolean
C0032912 (UMLS CUI [1])
C0304512 (UMLS CUI [2])
investigational drug
Item
current enrollment in a separate investigational drug trial
boolean
C0013230 (UMLS CUI [1])
psychoactive medications; antipsychotics; anticonvulsants
Item
psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. although not formally rated, this improvement is equivalent to a clinical global impression of change (cgic) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
boolean
C0033978 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
schizophrenia; delirium; panic disorder; psychotic symptoms; substance abuse
Item
psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
boolean
C0036341 (UMLS CUI [1])
C0011206 (UMLS CUI [2])
C0030319 (UMLS CUI [3])
C0871189 (UMLS CUI [4])
C0740858 (UMLS CUI [5])
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