ID

37422

Beschrijving

Fesoterodine on Urgency Episodes in Parkinson's Disease Population; ODM derived from: https://clinicaltrials.gov/show/NCT02385500

Link

https://clinicaltrials.gov/show/NCT02385500

Trefwoorden

Versies (1)
  1. 24-07-19 24-07-19 -
Houder van rechten

See clinicaltrials.gov

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24 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Urinary Bladder, Overactive NCT02385500

Engels

Eligibility Urinary Bladder, Overactive NCT02385500

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 50-85 years-old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
self-reported oab symptoms for ≥3 months
Beschrijving

Symptoms Overactive Bladder Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0878773
UMLS CUI [1,3]
C0449238
a mean of ≥8 micturitions/ 24 hr
Beschrijving

Micturition Quantity per 24 hours | Micturition Quantity mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042034
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0456696
UMLS CUI [2,1]
C0042034
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0444504
≥3 urgency episodes/24 hr on a 3-day bladder diary
Beschrijving

Urgency Episode Quantity per 24 hours | Urgency Episode Quantity Bladder diary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085606
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0456696
UMLS CUI [2,1]
C0085606
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0430970
at least "some moderate problems" on the patient perception of bladder condition (ppbc)
Beschrijving

Problem Moderate Bladder | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033213
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0005682
UMLS CUI [2]
C3846158
montreal cognitive assessment (moca) score ≥24
Beschrijving

Montreal cognitive assessment

Datatype

boolean

Alias
UMLS CUI [1]
C3496286
stable dose of dopaminergic medications and levodopa (between 300 and 1200 mg daily)
Beschrijving

Dopamine Agonists Dose Stable U/day | Levodopa Dose Stable U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178601
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
urinary retention: pvr >150 ml (as assessed by bladder scan)
Beschrijving

Urinary Retention | URINARY POSTVOID RESIDUAL Bladder scan

Datatype

boolean

Alias
UMLS CUI [1]
C0080274
UMLS CUI [2,1]
C0749943
UMLS CUI [2,2]
C1096192
contra-indications to fesoterodine
Beschrijving

Medical contraindication Fesoterodine

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2343853
unwilling to stop current antimuscarinics
Beschrijving

Muscarinic Antagonists Discontinue Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003385
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
patients on anticholinergics for motor disturbances
Beschrijving

Anticholinergic Agents Motor disturbances

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242896
UMLS CUI [1,2]
C2220255
dementia based on clinical evaluation
Beschrijving

Dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
atypical parkinsonian syndrome
Beschrijving

Parkinsonian Disorders Atypical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0205182
deep brain stimulation
Beschrijving

Deep Brain Stimulation

Datatype

boolean

Alias
UMLS CUI [1]
C0394162
presence of hallucination
Beschrijving

Hallucinations

Datatype

boolean

Alias
UMLS CUI [1]
C0018524
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Similar models

Eligibility Urinary Bladder, Overactive NCT02385500

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 50-85 years-old
boolean
C0001779 (UMLS CUI [1])
Symptoms Overactive Bladder Duration
Item
self-reported oab symptoms for ≥3 months
boolean
C1457887 (UMLS CUI [1,1])
C0878773 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Micturition Quantity per 24 hours | Micturition Quantity mean
Item
a mean of ≥8 micturitions/ 24 hr
boolean
C0042034 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0456696 (UMLS CUI [1,3])
C0042034 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0444504 (UMLS CUI [2,3])
Urgency Episode Quantity per 24 hours | Urgency Episode Quantity Bladder diary
Item
≥3 urgency episodes/24 hr on a 3-day bladder diary
boolean
C0085606 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0456696 (UMLS CUI [1,4])
C0085606 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0430970 (UMLS CUI [2,4])
Problem Moderate Bladder | Other Coding
Item
at least "some moderate problems" on the patient perception of bladder condition (ppbc)
boolean
C0033213 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0005682 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Montreal cognitive assessment
Item
montreal cognitive assessment (moca) score ≥24
boolean
C3496286 (UMLS CUI [1])
Dopamine Agonists Dose Stable U/day | Levodopa Dose Stable U/day
Item
stable dose of dopaminergic medications and levodopa (between 300 and 1200 mg daily)
boolean
C0178601 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0023570 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Urinary Retention | URINARY POSTVOID RESIDUAL Bladder scan
Item
urinary retention: pvr >150 ml (as assessed by bladder scan)
boolean
C0080274 (UMLS CUI [1])
C0749943 (UMLS CUI [2,1])
C1096192 (UMLS CUI [2,2])
Medical contraindication Fesoterodine
Item
contra-indications to fesoterodine
boolean
C1301624 (UMLS CUI [1,1])
C2343853 (UMLS CUI [1,2])
Muscarinic Antagonists Discontinue Unwilling
Item
unwilling to stop current antimuscarinics
boolean
C0003385 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Anticholinergic Agents Motor disturbances
Item
patients on anticholinergics for motor disturbances
boolean
C0242896 (UMLS CUI [1,1])
C2220255 (UMLS CUI [1,2])
Dementia
Item
dementia based on clinical evaluation
boolean
C0497327 (UMLS CUI [1])
Parkinsonian Disorders Atypical
Item
atypical parkinsonian syndrome
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
Deep Brain Stimulation
Item
deep brain stimulation
boolean
C0394162 (UMLS CUI [1])
Hallucinations
Item
presence of hallucination
boolean
C0018524 (UMLS CUI [1])
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