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ID

44721

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01268891

Keywords

versioni (1)
  1. 28/09/21 28/09/21 -
Titolare del copyright

H. Lundbeck A/S

Caricato su

28 settembre 2021

DOI

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Licenza

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

    Inglese

    Eligibility Parkinson's Disease NCT01268891

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with idiopathic pd
    Descrizione

    Idiopathic Parkinson Disease

    Tipo di dati

    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)
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    MDS-UPDRS - Hoehn and Yahr Stage

    Tipo di dati

    boolean

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

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

    Tipo di dati

    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
    Descrizione

    Quantity of daily doses of levodopa, except a bedtime dose

    Tipo di dati

    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
    Descrizione

    Ability to keep accurate 24-hour diaries

    Tipo di dati

    boolean

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

    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
    Descrizione

    Clinically significant or unstable comorbidity

    Tipo di dati

    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
    Descrizione

    Concomitant Therapy contraindicated according to the azilect®

    Tipo di dati

    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
    Descrizione

    Recent use of mao inhibitors

    Tipo di dati

    boolean

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

    Hypersensitivity to selegiline

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    Mini-mental state examination

    Tipo di dati

    boolean

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

    Melanoma diagnosis | History of melanoma | Suspicious lesion

    Tipo di dati

    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
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Parkinson's Disease NCT01268891

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    Ritorna all'inizio della pagina 

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