0 Bedömningar
ID

12099

Beskrivning

Randomized Safety Study of CVT-301 Compared to an Observational Control Group; ODM derived from: https://clinicaltrials.gov/show/NCT02352363

Länk

https://clinicaltrials.gov/show/NCT02352363

Nyckelord

Versioner (2)
  1. 2015-09-22 2015-09-22 - Julian Varghese
  2. 2015-09-22 2015-09-22 - Julian Varghese
Uppladdad den

22 september 2015

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Idiopathic Parkinson's Disease NCT02352363

    Engelsk

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
    Beskrivning

    Contraceptive methods | Female of child bearing age | serum human chorionic gonadotropin (hCG) measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C1960468
    UMLS CUI [3]
    C2208823
    patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
    Beskrivning

    PARKINSON IDIOPATHIC

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0747270
    patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
    Beskrivning

    severity; staging; stage; state

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3639483
    patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
    Beskrivning

    Motor fluctuations

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1868976
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
    Beskrivning

    Dyskinetic syndrome; Severities

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013384
    UMLS CUI [1,2]
    C0439793
    pregnant or lactating females or females wishing to become pregnant.
    Beskrivning

    pregnant or lactating females

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2828358
    UMLS CUI [2]
    C0549206
    patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
    Beskrivning

    Levodopa; Contraindication | melanoma | Angle Closure Glaucoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023570
    UMLS CUI [1,2]
    C0522473
    UMLS CUI [2]
    C0025202
    UMLS CUI [3]
    C0017605
    patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
    Beskrivning

    Surgery specialty; Parkinson Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0038894
    UMLS CUI [1,2]
    C0030567
    patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
    Beskrivning

    Psychotic symptom | Suicide ideation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0871189
    UMLS CUI [2]
    C1821181
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    Similar models

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed.
    boolean
    C0021430 (UMLS CUI [1])
    Contraceptive methods | Female of child bearing age | serum human chorionic gonadotropin (hCG) measurement
    Item
    women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study.
    boolean
    C0700589 (UMLS CUI [1])
    C1960468 (UMLS CUI [2])
    C2208823 (UMLS CUI [3])
    PARKINSON IDIOPATHIC
    Item
    patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years.
    boolean
    C0747270 (UMLS CUI [1])
    severity; staging; stage; state
    Item
    patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity.
    boolean
    C3639483 (UMLS CUI [1])
    Motor fluctuations
    Item
    patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period.
    boolean
    C1868976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Dyskinetic syndrome; Severities
    Item
    patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
    boolean
    C0013384 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    pregnant or lactating females
    Item
    pregnant or lactating females or females wishing to become pregnant.
    boolean
    C2828358 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    Levodopa; Contraindication | melanoma | Angle Closure Glaucoma
    Item
    patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma.
    boolean
    C0023570 (UMLS CUI [1,1])
    C0522473 (UMLS CUI [1,2])
    C0025202 (UMLS CUI [2])
    C0017605 (UMLS CUI [3])
    Surgery specialty; Parkinson Disease
    Item
    patients who have had previous surgery for pd (including but not limited to deep brain stimulation [dbs] or cell transplantation).
    boolean
    C0038894 (UMLS CUI [1,1])
    C0030567 (UMLS CUI [1,2])
    Psychotic symptom | Suicide ideation
    Item
    patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months (stable regimens [for at least 4 weeks prior to screening visit 1 (sv1)] of anti-depressant and certain low-dose atypical antipsychotic medications are permitted).
    boolean
    C0871189 (UMLS CUI [1])
    C1821181 (UMLS CUI [2])
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