0 Avaliações

ID

14478

Descrição

A Study of Healthy Subjects to Assess the Effect of LY450139 on Amyloid Beta Peptide Production Rate and or Dose Response.; ODM derived from: https://clinicaltrials.gov/show/NCT00765115

Link

https://clinicaltrials.gov/show/NCT00765115

Palavras-chave

  1. 17/04/2016 17/04/2016 -
Transferido a

17 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00765115

    Eligibility Alzheimer Disease NCT00765115

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    healthy volunteers: men within the ages of 21 and 50
    Descrição

    healthy volunteers; men; age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1708335 (Healthy Volunteers)
    UMLS CUI [2]
    C0025266 (Male population group)
    SNOMED
    339947000
    UMLS CUI [3]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    have serious or unstable medical conditions
    Descrição

    Compliance behavior Limited Comorbidity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
    Descrição

    head trauma; unconsciousness

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018674 (Craniocerebral Trauma)
    SNOMED
    82271004
    UMLS CUI [2]
    C0041657 (Unconscious State)
    SNOMED
    418107008
    LOINC
    LA17711-5
    have a history of primary or recurrent malignant disease
    Descrição

    malignant disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
    Descrição

    laboratory test abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,2]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    have a history of chronic alcohol or drug abuse within the past 5 years
    Descrição

    Substance Use Disorder

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    have a known history of human immunodeficiency virus (hiv), afebrile seizures, or clinically significant multiple drug allergies
    Descrição

    human immunodeficiency virus; afebrile seizures; Drug Allergy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [2]
    C0863106 (Afebrile seizure)
    SNOMED
    444229001
    UMLS CUI [3]
    C0013182 (Drug Allergy)
    SNOMED
    416098002
    LOINC
    MTHU002637
    are judged clinically by the investigator to be at serious risk for suicide
    Descrição

    suicidal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0438696 (Suicidal)
    SNOMED
    267073005
    LOINC
    LA29198-1
    have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
    Descrição

    electrocardiogram

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
    Descrição

    concomitant medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    have criteria that would preclude a lp such as allergy to all local anesthetics; have a local infection at the site of the lp or have any medical condition requiring treatment with warfarin or heparin.
    Descrição

    hypersensitivity local anesthetics; local infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0002921 (Local anesthesia)
    SNOMED
    386761002
    UMLS CUI [2]
    C1400591 (local; infection)
    have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    Descrição

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    are investigator site personnel directly affiliated with this study and or immediate families.
    Descrição

    investigator

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    are lilly employees
    Descrição

    employees

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0599987 (Employee)
    SNOMED
    224528001

    Similar models

    Eligibility Alzheimer Disease NCT00765115

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    healthy volunteers; men; age
    Item
    healthy volunteers: men within the ages of 21 and 50
    boolean
    C1708335 (UMLS CUI [1])
    C0025266 (UMLS CUI [2])
    C0001779 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Compliance behavior Limited Comorbidity
    Item
    have serious or unstable medical conditions
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    head trauma; unconsciousness
    Item
    have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
    boolean
    C0018674 (UMLS CUI [1])
    C0041657 (UMLS CUI [2])
    malignant disease
    Item
    have a history of primary or recurrent malignant disease
    boolean
    C0006826 (UMLS CUI [1])
    laboratory test abnormal
    Item
    have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
    boolean
    C0022885 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    Substance Use Disorder
    Item
    have a history of chronic alcohol or drug abuse within the past 5 years
    boolean
    C0038586 (UMLS CUI [1])
    human immunodeficiency virus; afebrile seizures; Drug Allergy
    Item
    have a known history of human immunodeficiency virus (hiv), afebrile seizures, or clinically significant multiple drug allergies
    boolean
    C0019682 (UMLS CUI [1])
    C0863106 (UMLS CUI [2])
    C0013182 (UMLS CUI [3])
    suicidal
    Item
    are judged clinically by the investigator to be at serious risk for suicide
    boolean
    C0438696 (UMLS CUI [1])
    electrocardiogram
    Item
    have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
    boolean
    C0013798 (UMLS CUI [1])
    concomitant medication
    Item
    use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
    boolean
    C2347852 (UMLS CUI [1])
    hypersensitivity local anesthetics; local infection
    Item
    have criteria that would preclude a lp such as allergy to all local anesthetics; have a local infection at the site of the lp or have any medical condition requiring treatment with warfarin or heparin.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0002921 (UMLS CUI [1,2])
    C1400591 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    boolean
    C2348568 (UMLS CUI [1])
    investigator
    Item
    are investigator site personnel directly affiliated with this study and or immediate families.
    boolean
    C2826892 (UMLS CUI [1])
    employees
    Item
    are lilly employees
    boolean
    C0599987 (UMLS CUI [1])

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