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ID

44002

Descrizione

Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's; ODM derived from: https://clinicaltrials.gov/show/NCT00322036

collegamento

https://clinicaltrials.gov/show/NCT00322036

Keywords

  1. 05/04/16 05/04/16 -
  2. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00322036

    Eligibility Alzheimer Disease NCT00322036

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. have had a diagnosis of probable alzheimer's disease
    Descrizione

    alzheimers disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0002395 (Alzheimer's Disease)
    SNOMED
    26929004
    2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
    Descrizione

    gender; age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
    Descrizione

    language comprehension

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0233733 (Language comprehension)
    SNOMED
    46977006
    5. at least 6 years of education, or sufficient work history to exclude mental retardation.
    Descrizione

    mental retardation; education

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0025362 (Mental Retardation)
    UMLS CUI [2]
    C0013658 (Educational Status)
    SNOMED
    266981003
    6. female subjects must be surgically sterile or postmenopausal for > 1 year.
    Descrizione

    contraception status female; postmenopausal

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0420837 (Contraception status)
    SNOMED
    243816001
    UMLS CUI [1,2]
    C0086287 (Females)
    SNOMED
    1086007
    UMLS CUI [2]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    7. adequate vision and hearing to participate in study assessments.
    Descrizione

    vision; hearing

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0042789 (Vision)
    SNOMED
    281004000
    LOINC
    LP30560-4
    UMLS CUI [2]
    C0018767 (Hearing)
    SNOMED
    47078008
    LOINC
    LP30518-2
    8. subjects must have a reliable caregiver who can read, understand and speak same language.
    Descrizione

    caregiver

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0085537 (Caregiver)
    SNOMED
    133932002
    LOINC
    LP76010-5
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. current evidence of other causes of dementia.. .
    Descrizione

    dementia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    2. history of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
    Descrizione

    malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    UMLS CUI [3]
    C0007137 (Squamous cell carcinoma)
    SNOMED
    28899001
    LOINC
    LP17968-6
    UMLS CUI [4]
    C0600139 (Prostate carcinoma)
    SNOMED
    254900004
    3. use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
    Descrizione

    investigational therapy; immunotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0949266 (Therapies, Investigational)
    UMLS CUI [1,2]
    C0205420 (Concurrent)
    SNOMED
    68405009
    UMLS CUI [2]
    C0021083 (Immunotherapy)
    SNOMED
    76334006
    4. major surgery and related complications not resolved within 12 weeks prior to day 1.
    Descrizione

    major surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0679637 (major surgery)
    5. previous participation in an mpc-7869 clinical study.
    Descrizione

    Study Subject Participation Status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)

    Similar models

    Eligibility Alzheimer Disease NCT00322036

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    alzheimers disease
    Item
    1. have had a diagnosis of probable alzheimer's disease
    boolean
    C0002395 (UMLS CUI [1])
    gender; age
    Item
    2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    informed consent
    Item
    3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
    boolean
    C0021430 (UMLS CUI [1])
    language comprehension
    Item
    4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
    boolean
    C0233733 (UMLS CUI [1])
    mental retardation; education
    Item
    5. at least 6 years of education, or sufficient work history to exclude mental retardation.
    boolean
    C0025362 (UMLS CUI [1])
    C0013658 (UMLS CUI [2])
    contraception status female; postmenopausal
    Item
    6. female subjects must be surgically sterile or postmenopausal for > 1 year.
    boolean
    C0420837 (UMLS CUI [1,1])
    C0086287 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    vision; hearing
    Item
    7. adequate vision and hearing to participate in study assessments.
    boolean
    C0042789 (UMLS CUI [1])
    C0018767 (UMLS CUI [2])
    caregiver
    Item
    8. subjects must have a reliable caregiver who can read, understand and speak same language.
    boolean
    C0085537 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    dementia
    Item
    1. current evidence of other causes of dementia.. .
    boolean
    C0497327 (UMLS CUI [1])
    malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer
    Item
    2. history of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    C0007137 (UMLS CUI [3])
    C0600139 (UMLS CUI [4])
    investigational therapy; immunotherapy
    Item
    3. use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
    boolean
    C0949266 (UMLS CUI [1,1])
    C0205420 (UMLS CUI [1,2])
    C0021083 (UMLS CUI [2])
    major surgery
    Item
    4. major surgery and related complications not resolved within 12 weeks prior to day 1.
    boolean
    C0679637 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    5. previous participation in an mpc-7869 clinical study.
    boolean
    C2348568 (UMLS CUI [1])

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