0 Evaluaciones
ID

43019

Descripción

Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00642928

Link

https://clinicaltrials.gov/show/NCT00642928

Palabras clave

Versiones (2)
  1. 21/3/18 21/3/18 -
  2. 17/9/21 17/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

17 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Excessive Daytime Sleepiness NCT00642928

    Inglés

    Eligibility Excessive Daytime Sleepiness NCT00642928

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    idiopathic parkinson disease
    Descripción

    Parkinson Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0030567
    hoehn and yahr < 5
    Descripción

    Hoehn and Yahr Scale score

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C4274823
    stable treatment of parkinson disease for at least 4 weeks
    Descripción

    Therapeutic procedure Stable Parkinson Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [1,3]
    C0030567
    excessive daytime sleepiness : epworth scale superior or equal to 13
    Descripción

    Excessive daytime somnolence Epworth Sleepiness Scale Questionnaire

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C4551761
    UMLS CUI [1,2]
    C3541276
    none psychostimulant treatment intake for 2 weeks
    Descripción

    Psychostimulant Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0304403
    UMLS CUI [1,2]
    C0332197
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    other degenerative parkinsonian syndrome
    Descripción

    Parkinsonian syndrome degenerative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0242422
    UMLS CUI [1,2]
    C0011164
    other condition than pd that is the primary cause of excessive daytime sleepiness
    Descripción

    Condition Etiology Excessive daytime somnolence | Exception Parkinson Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0015127
    UMLS CUI [1,3]
    C4551761
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0030567
    severe depression or suicidal risk
    Descripción

    Severe depression | At risk for suicide

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0588008
    UMLS CUI [2]
    C0563664
    pregnant or breast-feeding women
    Descripción

    Pregnancy | Breast Feeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    patients having an occupation that requires night shift
    Descripción

    Night shift worker

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0555008
    history of drugs, alcohol, narcotic or other substance abuse or dependence
    Descripción

    Substance Use Disorders | Substance Dependence | Narcotic Abuse | Narcotic Dependence

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    UMLS CUI [3]
    C0524661
    UMLS CUI [4]
    C1527402
    refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
    Descripción

    Excessive daytime somnolence | Therapeutic procedure Discontinue Refused | Therapeutic procedure Discontinue At risk Patient

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C4551761
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [2,3]
    C1705116
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1444662
    UMLS CUI [3,3]
    C1444641
    UMLS CUI [3,4]
    C0030705
    any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency
    Descripción

    Physical Examination Abnormal Finding | Laboratory test result abnormal | Liver Dysfunction | Renal Insufficiency

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826636
    UMLS CUI [2]
    C0438215
    UMLS CUI [3]
    C0086565
    UMLS CUI [4]
    C1565489
    any significant serious abnormality of the ecg e.g. myocardial infarction,
    Descripción

    Electrocardiogram abnormal | Electrocardiogram: myocardial infarction

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0522055
    UMLS CUI [2]
    C0428953
    electrocardiogram corrected qt interval higher than 450 ms
    Descripción

    Electrocardiogram QT corrected interval

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0855331
    other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
    Descripción

    Illness Interferes with Study Execution | Illness Medical contraindication Investigational Therapy | Illness At risk Patient

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0681872
    UMLS CUI [2,1]
    C0221423
    UMLS CUI [2,2]
    C1301624
    UMLS CUI [2,3]
    C0949266
    UMLS CUI [3,1]
    C0221423
    UMLS CUI [3,2]
    C1444641
    UMLS CUI [3,3]
    C0030705
    dementia with mms inferior or equal to 24
    Descripción

    Dementia | Mini-mental state examination

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0497327
    UMLS CUI [2]
    C0451306
    patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
    Descripción

    Therapeutic procedure Associated Illicit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0332281
    UMLS CUI [1,3]
    C0332266
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    Similar models

    Eligibility Excessive Daytime Sleepiness NCT00642928

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Parkinson Disease
    Item
    idiopathic parkinson disease
    boolean
    C0030567 (UMLS CUI [1])
    Hoehn and Yahr Scale score
    Item
    hoehn and yahr < 5
    boolean
    C4274823 (UMLS CUI [1])
    Therapeutic procedure Stable Parkinson Disease
    Item
    stable treatment of parkinson disease for at least 4 weeks
    boolean
    C0087111 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0030567 (UMLS CUI [1,3])
    Excessive daytime somnolence Epworth Sleepiness Scale Questionnaire
    Item
    excessive daytime sleepiness : epworth scale superior or equal to 13
    boolean
    C4551761 (UMLS CUI [1,1])
    C3541276 (UMLS CUI [1,2])
    Psychostimulant Absent
    Item
    none psychostimulant treatment intake for 2 weeks
    boolean
    C0304403 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Parkinsonian syndrome degenerative
    Item
    other degenerative parkinsonian syndrome
    boolean
    C0242422 (UMLS CUI [1,1])
    C0011164 (UMLS CUI [1,2])
    Condition Etiology Excessive daytime somnolence | Exception Parkinson Disease
    Item
    other condition than pd that is the primary cause of excessive daytime sleepiness
    boolean
    C0348080 (UMLS CUI [1,1])
    C0015127 (UMLS CUI [1,2])
    C4551761 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [2,1])
    C0030567 (UMLS CUI [2,2])
    Severe depression | At risk for suicide
    Item
    severe depression or suicidal risk
    boolean
    C0588008 (UMLS CUI [1])
    C0563664 (UMLS CUI [2])
    Pregnancy | Breast Feeding
    Item
    pregnant or breast-feeding women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Night shift worker
    Item
    patients having an occupation that requires night shift
    boolean
    C0555008 (UMLS CUI [1])
    Substance Use Disorders | Substance Dependence | Narcotic Abuse | Narcotic Dependence
    Item
    history of drugs, alcohol, narcotic or other substance abuse or dependence
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    C0524661 (UMLS CUI [3])
    C1527402 (UMLS CUI [4])
    Excessive daytime somnolence | Therapeutic procedure Discontinue Refused | Therapeutic procedure Discontinue At risk Patient
    Item
    refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy
    boolean
    C4551761 (UMLS CUI [1])
    C0087111 (UMLS CUI [2,1])
    C1444662 (UMLS CUI [2,2])
    C1705116 (UMLS CUI [2,3])
    C0087111 (UMLS CUI [3,1])
    C1444662 (UMLS CUI [3,2])
    C1444641 (UMLS CUI [3,3])
    C0030705 (UMLS CUI [3,4])
    Physical Examination Abnormal Finding | Laboratory test result abnormal | Liver Dysfunction | Renal Insufficiency
    Item
    any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency
    boolean
    C2826636 (UMLS CUI [1])
    C0438215 (UMLS CUI [2])
    C0086565 (UMLS CUI [3])
    C1565489 (UMLS CUI [4])
    Electrocardiogram abnormal | Electrocardiogram: myocardial infarction
    Item
    any significant serious abnormality of the ecg e.g. myocardial infarction,
    boolean
    C0522055 (UMLS CUI [1])
    C0428953 (UMLS CUI [2])
    Electrocardiogram QT corrected interval
    Item
    electrocardiogram corrected qt interval higher than 450 ms
    boolean
    C0855331 (UMLS CUI [1])
    Illness Interferes with Study Execution | Illness Medical contraindication Investigational Therapy | Illness At risk Patient
    Item
    other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
    boolean
    C0221423 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0681872 (UMLS CUI [1,3])
    C0221423 (UMLS CUI [2,1])
    C1301624 (UMLS CUI [2,2])
    C0949266 (UMLS CUI [2,3])
    C0221423 (UMLS CUI [3,1])
    C1444641 (UMLS CUI [3,2])
    C0030705 (UMLS CUI [3,3])
    Dementia | Mini-mental state examination
    Item
    dementia with mms inferior or equal to 24
    boolean
    C0497327 (UMLS CUI [1])
    C0451306 (UMLS CUI [2])
    Therapeutic procedure Associated Illicit
    Item
    patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
    boolean
    C0087111 (UMLS CUI [1,1])
    C0332281 (UMLS CUI [1,2])
    C0332266 (UMLS CUI [1,3])
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