0 Avaliações
ID

44031

Descrição

Non-randomized natural history study involving 12 subjects with Down Syndrome, who are aged 30-60 years old. This study will observe 3 different groups: four non-demented subjects between ages 30-40 years old, four non-demented subjects between ages 40-50 years old, and four demented subjects 50-60 years old. ODM derived from: https://clinicaltrials.gov/show/NCT02141971

Link

https://clinicaltrials.gov/show/NCT02141971

Palavras-chave

Versões (2)
  1. 26/03/2019 26/03/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

Michael Rafii

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0
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    Study of Alzheimer's Disease in Down Syndrome NCT02141971

    Inglês

    Eligibility

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of down syndrome due to trisomy 21.
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C3537167
    Patient must have a study partner (parent or other reliable caregiver) who has at least 10 hours of contact and who agrees to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms.
    Descrição

    Caregiver

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0085537
    UMLS CUI [1,2]
    C1521721
    UMLS CUI [1,3]
    C2348568
    Patient is able to speak/communicate.
    Descrição

    Communication with the patient

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0564215
    Patient is willing and has no contraindications to MRI scanning.
    Descrição

    Patient is able to have an MRI scanning

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    Patient or parent/legal guardian provides consent
    Descrição

    Informed consent of patient or parent/legal guardian

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0600634
    UMLS CUI [3,1]
    C0021430
    UMLS CUI [3,2]
    C0023226
    Patient must agree to allow for indefinite storage of his/her data and samples.
    Descrição

    Patient must agree to allow for indefinite storage of his/her data and samples

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0242578
    UMLS CUI [1,2]
    C0332187
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Patients is anarthric or mute.
    Descrição

    Patient is not able to communicate verbally

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0234517
    UMLS CUI [2]
    C0564216
    Patient does not fulfill the criteria for the diagnosis of Down Syndrome
    Descrição

    Patient needs to fulfill all criteria for the diagnosis of Down Syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0013080
    Patient is unwilling or unable to participate in all tests and procedures.
    Descrição

    Patient is unwilling or unable to participate in all tests and procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C0558080
    Patient has unstable medical or behavioral issues.
    Descrição

    The patient's general condition is unstable

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004927
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [2,1]
    C3843040
    UMLS CUI [2,2]
    C0443343
    Patient is unable or unwilling to perform MRI and/or PET imaging.
    Descrição

    Patient is not able or unwilling to perform MRI or PET imaging

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [2,1]
    C0024485
    UMLS CUI [2,2]
    C0558080
    UMLS CUI [3,1]
    C0032743
    UMLS CUI [3,2]
    C1299582
    UMLS CUI [4,1]
    C0032743
    UMLS CUI [4,2]
    C0558080
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    Similar models

    Eligibility

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of down syndrome due to trisomy 21.
    boolean
    C0001779 (UMLS CUI [1])
    C3537167 (UMLS CUI [2])
    Caregiver
    Item
    Patient must have a study partner (parent or other reliable caregiver) who has at least 10 hours of contact and who agrees to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms.
    boolean
    C0085537 (UMLS CUI [1,1])
    C1521721 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Verbal communication
    Item
    Patient is able to speak/communicate.
    boolean
    C0564215 (UMLS CUI [1])
    MRI
    Item
    Patient is willing and has no contraindications to MRI scanning.
    boolean
    C0024485 (UMLS CUI [1])
    Informed consent
    Item
    Patient or parent/legal guardian provides consent
    boolean
    C0021430 (UMLS CUI [1])
    C0600634 (UMLS CUI [2])
    C0021430 (UMLS CUI [3,1])
    C0023226 (UMLS CUI [3,2])
    Data privacy
    Item
    Patient must agree to allow for indefinite storage of his/her data and samples.
    boolean
    C0242578 (UMLS CUI [1,1])
    C0332187 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Inability to communicate verbally
    Item
    Patients is anarthric or mute.
    boolean
    C0234517 (UMLS CUI [1])
    C0564216 (UMLS CUI [2])
    Diagnosis
    Item
    Patient does not fulfill the criteria for the diagnosis of Down Syndrome
    boolean
    C0011900 (UMLS CUI [1,1])
    C0013080 (UMLS CUI [1,2])
    Procedure compliance
    Item
    Patient is unwilling or unable to participate in all tests and procedures.
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    Unstable general condition
    Item
    Patient has unstable medical or behavioral issues.
    boolean
    C0004927 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C3843040 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    Body-imaging
    Item
    Patient is unable or unwilling to perform MRI and/or PET imaging.
    boolean
    C0024485 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0024485 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    C0032743 (UMLS CUI [3,1])
    C1299582 (UMLS CUI [3,2])
    C0032743 (UMLS CUI [4,1])
    C0558080 (UMLS CUI [4,2])
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