ID

13355

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. 2/9/16 2/9/16 -
Uploaded on

February 9, 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

possible alzheimers disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0002395
UMLS CUI [1,2]
C0332149
Disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
Description

disruptive agitated behaviors

Data type

boolean

Alias
UMLS CUI [1]
C0474416
UMLS CUI [2]
C0700075
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

psychotic disorders

Data type

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0024713
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 disorders

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0004245
UMLS CUI [4]
C0020649
UMLS CUI [5]
C0020651
Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
Description

unstable medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C2936476
UMLS CUI [3]
C0009488
Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
Description

prazosin

Data type

boolean

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

participation in other trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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

Data type

boolean

Alias
UMLS CUI [1]
C2065419
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0003286
UMLS CUI [4]
C2917435
UMLS CUI [5]
C0003289
UMLS CUI [6]
C0005064
UMLS CUI [7]
C0006462
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

psychiatric

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0011206
UMLS CUI [3]
C0024713
UMLS CUI [4]
C0011581
UMLS CUI [5]
C0018524
UMLS CUI [6]
C0011253
UMLS CUI [7]
C0038586
UMLS CUI [8,1]
C1321605
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0009488
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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])
possible alzheimers disease
Item
Probable/possible alzheimer's disease diagnosis
boolean
C0002395 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
disruptive agitated behaviors
Item
Disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
boolean
C0474416 (UMLS CUI [1])
C0700075 (UMLS CUI [2])
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])
psychotic disorders
Item
No delirium, schizophrenia, mania, psychotic symptoms
boolean
C0011206 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0024713 (UMLS CUI [3])
C0871189 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
cardiovascular disorders
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
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0004245 (UMLS CUI [3])
C0020649 (UMLS CUI [4])
C0020651 (UMLS CUI [5])
unstable medical condition
Item
Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
boolean
C0022661 (UMLS CUI [1])
C2936476 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
prazosin
Item
Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
boolean
C0032912 (UMLS CUI [1])
C0304512 (UMLS CUI [2])
participation in other trial
Item
Current enrollment in a separate investigational drug trial
boolean
C2348568 (UMLS CUI [1])
psychoactive medications
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
C2065419 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C2917435 (UMLS CUI [4])
C0003289 (UMLS CUI [5])
C0005064 (UMLS CUI [6])
C0006462 (UMLS CUI [7])
psychiatric
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])
C0024713 (UMLS CUI [3])
C0011581 (UMLS CUI [4])
C0018524 (UMLS CUI [5])
C0011253 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
C1321605 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0009488 (UMLS CUI [8,3])
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