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ID

14478

Description

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

Lien

https://clinicaltrials.gov/show/NCT00765115

Mots-clés

  1. 17/04/2016 17/04/2016 -
Téléchargé le

17 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00765115

    Eligibility Alzheimer Disease NCT00765115

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    healthy volunteers: men within the ages of 21 and 50
    Description

    healthy volunteers; men; age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1708335
    UMLS CUI [2]
    C0025266
    UMLS CUI [3]
    C0001779
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    have serious or unstable medical conditions
    Description

    Compliance behavior Limited Comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    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
    Description

    head trauma; unconsciousness

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018674
    UMLS CUI [2]
    C0041657
    have a history of primary or recurrent malignant disease
    Description

    malignant disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
    Description

    laboratory test abnormal

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0205161
    have a history of chronic alcohol or drug abuse within the past 5 years
    Description

    Substance Use Disorder

    Type de données

    boolean

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

    human immunodeficiency virus; afebrile seizures; Drug Allergy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0863106
    UMLS CUI [3]
    C0013182
    are judged clinically by the investigator to be at serious risk for suicide
    Description

    suicidal

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0438696
    have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
    Description

    electrocardiogram

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013798
    use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
    Description

    concomitant medication

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    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.
    Description

    hypersensitivity local anesthetics; local infection

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0002921
    UMLS CUI [2]
    C1400591
    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.
    Description

    Study Subject Participation Status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    are investigator site personnel directly affiliated with this study and or immediate families.
    Description

    investigator

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826892
    are lilly employees
    Description

    employees

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0599987

    Similar models

    Eligibility Alzheimer Disease NCT00765115

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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