ID

14235

Descrição

Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT); ODM derived from: https://clinicaltrials.gov/show/NCT00385684

Link

https://clinicaltrials.gov/show/NCT00385684

Palavras-chave

Versões (1)
  1. 05/04/2016 05/04/2016 -
Transferido a

5 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00385684

Inglês

Eligibility Alzheimer Disease NCT00385684

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
55 years of age or older;
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
must have a diagnosis of dementia;
Descrição

dementia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0497327
advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
Descrição

dementia stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743034
unable to report pain in a reliable and consistent manner;
Descrição

pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030193
have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
Descrição

painad score

Tipo de dados

boolean

the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
Descrição

medical condition pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1405025
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the existence of an effective analgesia treatment regimen;
Descrição

treatment regimen analgesia

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C3202977
pain treatment related to angina or pain judged to be related to angina;
Descrição

Pain management; pain angina

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002766
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0002962
current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
Descrição

Compliance behavior pain therapy opiates

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0002766
UMLS CUI [1,4]
C0376196
current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
Descrição

Pain management tramadol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0002766
UMLS CUI [1,2]
C0040610
presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
Descrição

concomitant medication hydrocodone acetaminophen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0020264
UMLS CUI [1,3]
C0000970
a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
Descrição

hypersensitivity hydrocodone acetaminophen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020264
UMLS CUI [1,3]
C0000970
constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
Descrição

constipation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009806
the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
Descrição

liver disease; encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0085584
the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
Descrição

renal failure; serum creatinine levels

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1533077
UMLS CUI [2]
C0600061
evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
Descrição

comorbidity infection fever; geriatrician

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0015967
UMLS CUI [2]
C0586872
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Similar models

Eligibility Alzheimer Disease NCT00385684

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
55 years of age or older;
boolean
C0001779 (UMLS CUI [1])
dementia
Item
must have a diagnosis of dementia;
boolean
C0497327 (UMLS CUI [1])
dementia stage
Item
advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
boolean
C0743034 (UMLS CUI [1])
pain
Item
unable to report pain in a reliable and consistent manner;
boolean
C0030193 (UMLS CUI [1])
painad score
Item
have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
boolean
medical condition pain
Item
the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
boolean
C1405025 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
treatment regimen analgesia
Item
the existence of an effective analgesia treatment regimen;
boolean
C0040808 (UMLS CUI [1,1])
C3202977 (UMLS CUI [1,2])
Pain management; pain angina
Item
pain treatment related to angina or pain judged to be related to angina;
boolean
C0002766 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0002962 (UMLS CUI [2,2])
Compliance behavior pain therapy opiates
Item
current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0002766 (UMLS CUI [1,3])
C0376196 (UMLS CUI [1,4])
Pain management tramadol
Item
current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
boolean
C0002766 (UMLS CUI [1,1])
C0040610 (UMLS CUI [1,2])
concomitant medication hydrocodone acetaminophen
Item
presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
boolean
C2347852 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C0000970 (UMLS CUI [1,3])
hypersensitivity hydrocodone acetaminophen
Item
a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
boolean
C0020517 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C0000970 (UMLS CUI [1,3])
constipation
Item
constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
boolean
C0009806 (UMLS CUI [1])
liver disease; encephalopathy
Item
the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
boolean
C0023895 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
renal failure; serum creatinine levels
Item
the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
boolean
C1533077 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
comorbidity infection fever; geriatrician
Item
evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
boolean
C0009488 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0586872 (UMLS CUI [2])
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