0 Avaliações
ID

12098

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02352363

Palavras-chave

Versões (2)
  1. 22/09/2015 22/09/2015 - Julian Varghese
  2. 22/09/2015 22/09/2015 - Julian Varghese
Transferido a

22 de setembro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Eligibility Idiopathic Parkinson's Disease NCT02352363

    Inglês

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 Formulários  
    Inclusion Criteria
    Descrição

    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.
    Descrição

    Informed Consent

    Tipo de dados

    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.
    Descrição

    contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg

    Tipo de dados

    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.
    Descrição

    united kingdom; diseases; other; brain; drugs; age

    Tipo de dados

    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.
    Descrição

    severity; staging; stage; state

    Tipo de dados

    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.
    Descrição

    screening; confirmed; daily; motor; time; self; day; per

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1868976
    Exclusion Criteria
    Descrição

    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.
    Descrição

    procedure(s); procedures; severity; study

    Tipo de dados

    boolean

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

    pregnant or lactating females

    Tipo de dados

    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.
    Descrição

    malignant melanoma; glaucoma; levodopa

    Tipo de dados

    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).
    Descrição

    transplantation; not limited; surgery; brain

    Tipo de dados

    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).
    Descrição

    anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low

    Tipo de dados

    boolean

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

    Eligibility Idiopathic Parkinson's Disease NCT02352363

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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])
    contraception; contraceptive; negative; screening; duration; protocol; current; serum; form; child; study; test; hcg
    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])
    united kingdom; diseases; other; brain; drugs; age
    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])
    screening; confirmed; daily; motor; time; self; day; per
    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)
    procedure(s); procedures; severity; study
    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])
    malignant melanoma; glaucoma; levodopa
    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])
    transplantation; not limited; surgery; brain
    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])
    anti-depressant; medications; treatment; screening; symptoms; suicide; stable; visit; dose; low
    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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