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ID

39032

Beschrijving

Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01153607

Link

https://clinicaltrials.gov/show/NCT01153607

Trefwoorden

Versies (1)
  1. 22/11/19 22/11/19 -
Houder van rechten

See clinicaltrials.gov

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22 de noviembre de 2019

DOI

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Creative Commons BY 4.0
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    Eligibility Diagnostic Imaging NCT01153607

    Engels

    Eligibility Diagnostic Imaging NCT01153607

    1 Formulieren  
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    all:
    Beschrijving

    All

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0444868 (All)
    LOINC
    LA18187-7
    males or females aged >/- 50 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
    Beschrijving

    Comprehension Study Protocol | Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    UMLS CUI [2]
    C0021430 (Informed Consent)
    healthy volunteers for brain imaging:
    Beschrijving

    Healthy Volunteers Imaging of brain

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335 (Healthy Volunteers)
    UMLS CUI [1,2]
    C0203860 (Imaging of brain)
    SNOMED
    441986001
    mini-mental state examination (mmse) score of >/= 28
    Beschrijving

    Mini-mental status exam score (___/30)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2225229 (mini-mental status exam score (___/30))
    cdr score of zero (0)
    Beschrijving

    Clinical dementia rating scale

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0451074 (Clinical dementia rating scale)
    SNOMED
    273367002
    LOINC
    LP156476-6
    patients for brain imaging:
    Beschrijving

    Patients Imaging of brain

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C0203860 (Imaging of brain)
    SNOMED
    441986001
    patient fulfills diagnostic and statistical manual of mental disorders (dsm-iv) and national institute of neurological and communicative disorders and stroke, alzheimer's disease and related disorders association (nincds-adrda) criteria for probable alzheimer's disease (ad), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
    Beschrijving

    Alzheimer's Disease Probable | Impaired cognition | Memory impairment | Aphasia | Apraxia | Agnosia | Executive dysfunction

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0002395 (Alzheimer's Disease)
    SNOMED
    26929004
    UMLS CUI [1,2]
    C0033204 (Probability)
    LOINC
    LA12746-6
    UMLS CUI [2]
    C0338656 (Impaired cognition)
    SNOMED
    386806002
    UMLS CUI [3]
    C0233794 (Memory impairment)
    SNOMED
    386807006
    LOINC
    LP36329-8
    UMLS CUI [4]
    C0003537 (Aphasia)
    SNOMED
    87486003
    LOINC
    MTHU020799
    UMLS CUI [5]
    C0003635 (Apraxias)
    SNOMED
    6950007
    UMLS CUI [6]
    C0001816 (Agnosia)
    SNOMED
    42341009
    UMLS CUI [7]
    C2748208 (Executive dysfunction)
    patient has mild to moderate dementia with a dementia score of >/= 20 on the mini mental state examination (mmse) / with a clinical dementia rating score of 1 or 2 (cdr)
    Beschrijving

    Mild dementia Mini-mental status exam score (___/30) | Moderate dementia Mini-mental status exam score (___/30) | Mild dementia Clinical dementia rating scale | Moderate dementia Clinical dementia rating scale

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3494623 (Mild dementia)
    SNOMED
    428051000124108
    UMLS CUI [1,2]
    C2225229 (mini-mental status exam score (___/30))
    UMLS CUI [2,1]
    C3494871 (Moderate dementia)
    SNOMED
    430771000124100
    UMLS CUI [2,2]
    C2225229 (mini-mental status exam score (___/30))
    UMLS CUI [3,1]
    C3494623 (Mild dementia)
    SNOMED
    428051000124108
    UMLS CUI [3,2]
    C0451074 (Clinical dementia rating scale)
    SNOMED
    273367002
    LOINC
    LP156476-6
    UMLS CUI [4,1]
    C3494871 (Moderate dementia)
    SNOMED
    430771000124100
    UMLS CUI [4,2]
    C0451074 (Clinical dementia rating scale)
    SNOMED
    273367002
    LOINC
    LP156476-6
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    all:
    Beschrijving

    All

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0444868 (All)
    LOINC
    LA18187-7
    no significant disease or drug use
    Beschrijving

    Disease Significant Absent | Drug use Absent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [1,3]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,1]
    C0242510 (Drug usage)
    LOINC
    MTHU047471
    UMLS CUI [2,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    patients for brain imaging:
    Beschrijving

    Patients Imaging of brain

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C0203860 (Imaging of brain)
    SNOMED
    441986001
    evidence for any other neurological or psychiatric disease
    Beschrijving

    Nervous system disorder Other | Mental disorder Other

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    healthy volunteers for brain imaging:
    Beschrijving

    Healthy Volunteers Imaging of brain

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335 (Healthy Volunteers)
    UMLS CUI [1,2]
    C0203860 (Imaging of brain)
    SNOMED
    441986001
    family history of alzheimer's disease in a 1st or 2nd degree relative under 75 years of age
    Beschrijving

    Family history of Alzheimer's disease | First Degree Relative | Second Degree Relative | Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1271045 (FH: Alzheimer's disease)
    SNOMED
    394877006
    UMLS CUI [2]
    C1517194 (First Degree Relative)
    UMLS CUI [3]
    C1519210 (Second Degree Relative)
    UMLS CUI [4]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
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    Similar models

    Eligibility Diagnostic Imaging NCT01153607

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    All
    Item
    all:
    boolean
    C0444868 (UMLS CUI [1])
    Age
    Item
    males or females aged >/- 50 years
    boolean
    C0001779 (UMLS CUI [1])
    Comprehension Study Protocol | Informed Consent
    Item
    participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2])
    Healthy Volunteers Imaging of brain
    Item
    healthy volunteers for brain imaging:
    boolean
    C1708335 (UMLS CUI [1,1])
    C0203860 (UMLS CUI [1,2])
    Mini-mental status exam score (___/30)
    Item
    mini-mental state examination (mmse) score of >/= 28
    boolean
    C2225229 (UMLS CUI [1])
    Clinical dementia rating scale
    Item
    cdr score of zero (0)
    boolean
    C0451074 (UMLS CUI [1])
    Patients Imaging of brain
    Item
    patients for brain imaging:
    boolean
    C0030705 (UMLS CUI [1,1])
    C0203860 (UMLS CUI [1,2])
    Alzheimer's Disease Probable | Impaired cognition | Memory impairment | Aphasia | Apraxia | Agnosia | Executive dysfunction
    Item
    patient fulfills diagnostic and statistical manual of mental disorders (dsm-iv) and national institute of neurological and communicative disorders and stroke, alzheimer's disease and related disorders association (nincds-adrda) criteria for probable alzheimer's disease (ad), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
    boolean
    C0002395 (UMLS CUI [1,1])
    C0033204 (UMLS CUI [1,2])
    C0338656 (UMLS CUI [2])
    C0233794 (UMLS CUI [3])
    C0003537 (UMLS CUI [4])
    C0003635 (UMLS CUI [5])
    C0001816 (UMLS CUI [6])
    C2748208 (UMLS CUI [7])
    Mild dementia Mini-mental status exam score (___/30) | Moderate dementia Mini-mental status exam score (___/30) | Mild dementia Clinical dementia rating scale | Moderate dementia Clinical dementia rating scale
    Item
    patient has mild to moderate dementia with a dementia score of >/= 20 on the mini mental state examination (mmse) / with a clinical dementia rating score of 1 or 2 (cdr)
    boolean
    C3494623 (UMLS CUI [1,1])
    C2225229 (UMLS CUI [1,2])
    C3494871 (UMLS CUI [2,1])
    C2225229 (UMLS CUI [2,2])
    C3494623 (UMLS CUI [3,1])
    C0451074 (UMLS CUI [3,2])
    C3494871 (UMLS CUI [4,1])
    C0451074 (UMLS CUI [4,2])
    Item Group
    C0680251 (UMLS CUI)
    All
    Item
    all:
    boolean
    C0444868 (UMLS CUI [1])
    Disease Significant Absent | Drug use Absent
    Item
    no significant disease or drug use
    boolean
    C0012634 (UMLS CUI [1,1])
    C0750502 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C0242510 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Patients Imaging of brain
    Item
    patients for brain imaging:
    boolean
    C0030705 (UMLS CUI [1,1])
    C0203860 (UMLS CUI [1,2])
    Nervous system disorder Other | Mental disorder Other
    Item
    evidence for any other neurological or psychiatric disease
    boolean
    C0027765 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Healthy Volunteers Imaging of brain
    Item
    healthy volunteers for brain imaging:
    boolean
    C1708335 (UMLS CUI [1,1])
    C0203860 (UMLS CUI [1,2])
    Family history of Alzheimer's disease | First Degree Relative | Second Degree Relative | Age
    Item
    family history of alzheimer's disease in a 1st or 2nd degree relative under 75 years of age
    boolean
    C1271045 (UMLS CUI [1])
    C1517194 (UMLS CUI [2])
    C1519210 (UMLS CUI [3])
    C0001779 (UMLS CUI [4])
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