ID

44721

Beschrijving

Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea; ODM derived from: https://clinicaltrials.gov/show/NCT01268891

Link

https://clinicaltrials.gov/show/NCT01268891

Trefwoorden

Versies (1)
  1. 28/09/2021 28/09/2021 -
Houder van rechten

H. Lundbeck A/S

Geüploaded op

28 de setembro de 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Parkinson's Disease NCT01268891

Engels

Eligibility Parkinson's Disease NCT01268891

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with idiopathic pd
Beschrijving

Idiopathic Parkinson Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0030567
patients with motor fluctuations averaging at least 1 hour daily in the off state during the waking hours (not including morning akinesia)
Beschrijving

Motor fluctuations averaging at least 1 hour daily, not including morning akinesia

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868976
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0332173
UMLS CUI [1,4]
C0332170
UMLS CUI [1,5]
C0085623
UMLS CUI [1,6]
C1705847
patients with a modified hoehn and yahr stage <5 in the off state
Beschrijving

MDS-UPDRS - Hoehn and Yahr Stage

Datatype

boolean

Alias
UMLS CUI [1]
C3639483
patients taking optimised levodopa/dopa decarboxylase inhibitor (ddi) therapy for at least 14 days prior to baseline
Beschrijving

Optimised levodopa therapy duration | Optimised dopa decarboxylase inhibitor (ddi) therapy duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C2698650
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0598272
UMLS CUI [2,2]
C2698650
UMLS CUI [2,3]
C0449238
patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
Beschrijving

Quantity of daily doses of levodopa, except a bedtime dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0521112
UMLS CUI [1,5]
C3174092
UMLS CUI [1,6]
C1705847
patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation
Beschrijving

Ability to keep accurate 24-hour diaries

Datatype

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0443131
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
Beschrijving

Clinically significant or unstable comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0443343
patients taking any disallowed medication according to the azilect® approved label
Beschrijving

Concomitant Therapy contraindicated according to the azilect®

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0525678
UMLS CUI [1,4]
C0013191
patients taking mao inhibitors within 3 months prior to baseline visit
Beschrijving

Recent use of mao inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026457
UMLS CUI [1,2]
C0332185
patients with a known serious adverse reaction to selegiline
Beschrijving

Hypersensitivity to selegiline

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036579
UMLS CUI [1,2]
C0020517
patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
Beschrijving

Significant mental disorder compromising the ability to provide an informed consent or to participate fully in the study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C0085732
UMLS CUI [1,5]
C2945640
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0085732
UMLS CUI [2,5]
C2945640
patients with a mini mental state examination (mmse) score <=24
Beschrijving

Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1]
C0451306
patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
Beschrijving

Melanoma diagnosis | History of melanoma | Suspicious lesion

Datatype

boolean

Alias
UMLS CUI [1]
C0025202
UMLS CUI [2,1]
C0025202
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0037284
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C0025202
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Similar models

Eligibility Parkinson's Disease NCT01268891

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Idiopathic Parkinson Disease
Item
patients with idiopathic pd
boolean
C0030567 (UMLS CUI [1])
Motor fluctuations averaging at least 1 hour daily, not including morning akinesia
Item
patients with motor fluctuations averaging at least 1 hour daily in the off state during the waking hours (not including morning akinesia)
boolean
C1868976 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
C0085623 (UMLS CUI [1,5])
C1705847 (UMLS CUI [1,6])
MDS-UPDRS - Hoehn and Yahr Stage
Item
patients with a modified hoehn and yahr stage <5 in the off state
boolean
C3639483 (UMLS CUI [1])
Optimised levodopa therapy duration | Optimised dopa decarboxylase inhibitor (ddi) therapy duration
Item
patients taking optimised levodopa/dopa decarboxylase inhibitor (ddi) therapy for at least 14 days prior to baseline
boolean
C0023570 (UMLS CUI [1,1])
C2698650 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0598272 (UMLS CUI [2,1])
C2698650 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Quantity of daily doses of levodopa, except a bedtime dose
Item
patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0521112 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,5])
C1705847 (UMLS CUI [1,6])
Ability to keep accurate 24-hour diaries
Item
patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0443131 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clinically significant or unstable comorbidity
Item
patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
boolean
C0009488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Concomitant Therapy contraindicated according to the azilect®
Item
patients taking any disallowed medication according to the azilect® approved label
boolean
C1707479 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0525678 (UMLS CUI [1,3])
C0013191 (UMLS CUI [1,4])
Recent use of mao inhibitors
Item
patients taking mao inhibitors within 3 months prior to baseline visit
boolean
C0026457 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Hypersensitivity to selegiline
Item
patients with a known serious adverse reaction to selegiline
boolean
C0036579 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Significant mental disorder compromising the ability to provide an informed consent or to participate fully in the study
Item
patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
boolean
C0004936 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C2945640 (UMLS CUI [1,5])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0085732 (UMLS CUI [2,4])
C2945640 (UMLS CUI [2,5])
Mini-mental state examination
Item
patients with a mini mental state examination (mmse) score <=24
boolean
C0451306 (UMLS CUI [1])
Melanoma diagnosis | History of melanoma | Suspicious lesion
Item
patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
boolean
C0025202 (UMLS CUI [1])
C0025202 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0037284 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C0025202 (UMLS CUI [3,3])
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