0 Evaluaciones
ID

44721

Descripción

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

Palabras clave

Versiones (1)
  1. 28/9/21 28/9/21 -
Titular de derechos de autor

H. Lundbeck A/S

Subido en

28 de septiembre de 2021

DOI

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Licencia

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

    Inglés

    Eligibility Parkinson's Disease NCT01268891

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with idiopathic pd
    Descripción

    Idiopathic Parkinson Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0030567 (Parkinson Disease)
    SNOMED
    49049000
    patients with motor fluctuations averaging at least 1 hour daily in the off state during the waking hours (not including morning akinesia)
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1868976 (Motor fluctuations)
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,3]
    C0332173 (Daily)
    SNOMED
    69620002
    LOINC
    LA14799-3
    UMLS CUI [1,4]
    C0332170 (Morning)
    SNOMED
    73775008
    LOINC
    LA14971-8
    UMLS CUI [1,5]
    C0085623 (Akinesia)
    SNOMED
    33994004
    UMLS CUI [1,6]
    C1705847 (Exception - Property or Attribute)
    patients with a modified hoehn and yahr stage <5 in the off state
    Descripción

    MDS-UPDRS - Hoehn and Yahr Stage

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3639483 (MDS-UPDRS - Hoehn and Yahr Stage)
    patients taking optimised levodopa/dopa decarboxylase inhibitor (ddi) therapy for at least 14 days prior to baseline
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570 (levodopa)
    SNOMED
    15383004
    UMLS CUI [1,2]
    C2698650 (Optimization)
    UMLS CUI [1,3]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [2,1]
    C0598272 (DOPA Decarboxylase Inhibitors)
    SNOMED
    418795002
    UMLS CUI [2,2]
    C2698650 (Optimization)
    UMLS CUI [2,3]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
    Descripción

    Quantity of daily doses of levodopa, except a bedtime dose

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570 (levodopa)
    SNOMED
    15383004
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [1,4]
    C0521112 (Bedtime (qualifier value))
    SNOMED
    21029003
    UMLS CUI [1,5]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI [1,6]
    C1705847 (Exception - Property or Attribute)
    patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation
    Descripción

    Ability to keep accurate 24-hour diaries

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3890583 (Subject Diary)
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [1,3]
    C0443131 (Accurate (qualifier))
    SNOMED
    263656005
    LOINC
    LA9926-2
    Exclusion Criteria
    Descripción

    Exclusion Criteria

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

    Clinically significant or unstable comorbidity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488 (Comorbidity)
    UMLS CUI [1,2]
    C2826293 (Clinical Significance)
    UMLS CUI [2,1]
    C0009488 (Comorbidity)
    UMLS CUI [2,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    patients taking any disallowed medication according to the azilect® approved label
    Descripción

    Concomitant Therapy contraindicated according to the azilect®

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1707479 (Concomitant Therapy)
    UMLS CUI [1,2]
    C1444657 (Contraindicated)
    SNOMED
    410536001
    LOINC
    LA4216-3
    UMLS CUI [1,3]
    C0525678 (rasagiline)
    SNOMED
    419010007
    UMLS CUI [1,4]
    C0013191 (Drug Labeling)
    patients taking mao inhibitors within 3 months prior to baseline visit
    Descripción

    Recent use of mao inhibitors

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0026457 (Monoamine Oxidase Inhibitors)
    SNOMED
    373281001
    UMLS CUI [1,2]
    C0332185 (Recent)
    SNOMED
    6493001
    patients with a known serious adverse reaction to selegiline
    Descripción

    Hypersensitivity to selegiline

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0036579 (selegiline)
    SNOMED
    108466000
    UMLS CUI [1,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [1,3]
    C0021430 (Informed Consent)
    UMLS CUI [1,4]
    C0085732 (Ability)
    UMLS CUI [1,5]
    C2945640 (compromise)
    UMLS CUI [2,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [2,3]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,4]
    C0085732 (Ability)
    UMLS CUI [2,5]
    C2945640 (compromise)
    patients with a mini mental state examination (mmse) score <=24
    Descripción

    Mini-mental state examination

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0451306 (Mini-mental state examination)
    SNOMED
    273617000
    LOINC
    LP156457-6
    patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
    Descripción

    Melanoma diagnosis | History of melanoma | Suspicious lesion

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0025202 (melanoma)
    SNOMED
    2092003
    UMLS CUI [2,1]
    C0025202 (melanoma)
    SNOMED
    2092003
    UMLS CUI [2,2]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [3,1]
    C0037284 (Skin lesion)
    SNOMED
    95324001
    UMLS CUI [3,2]
    C0750493 (Suspicious)
    LOINC
    LA13813-3
    UMLS CUI [3,3]
    C0025202 (melanoma)
    SNOMED
    2092003
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    Similar models

    Eligibility Parkinson's Disease NCT01268891

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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