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ID

39032

Beschreibung

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

Stichworte

Versionen (1)
  1. 22.11.19 22.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

22. November 2019

DOI

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Creative Commons BY 4.0
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    Eligibility Diagnostic Imaging NCT01153607

    Englisch

    Eligibility Diagnostic Imaging NCT01153607

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    all:
    Beschreibung

    All

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0444868
    males or females aged >/- 50 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    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
    Beschreibung

    Comprehension Study Protocol | Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0021430
    healthy volunteers for brain imaging:
    Beschreibung

    Healthy Volunteers Imaging of brain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335
    UMLS CUI [1,2]
    C0203860
    mini-mental state examination (mmse) score of >/= 28
    Beschreibung

    Mini-mental status exam score (___/30)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2225229
    cdr score of zero (0)
    Beschreibung

    Clinical dementia rating scale

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0451074
    patients for brain imaging:
    Beschreibung

    Patients Imaging of brain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0203860
    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)
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0002395
    UMLS CUI [1,2]
    C0033204
    UMLS CUI [2]
    C0338656
    UMLS CUI [3]
    C0233794
    UMLS CUI [4]
    C0003537
    UMLS CUI [5]
    C0003635
    UMLS CUI [6]
    C0001816
    UMLS CUI [7]
    C2748208
    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)
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3494623
    UMLS CUI [1,2]
    C2225229
    UMLS CUI [2,1]
    C3494871
    UMLS CUI [2,2]
    C2225229
    UMLS CUI [3,1]
    C3494623
    UMLS CUI [3,2]
    C0451074
    UMLS CUI [4,1]
    C3494871
    UMLS CUI [4,2]
    C0451074
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    all:
    Beschreibung

    All

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0444868
    no significant disease or drug use
    Beschreibung

    Disease Significant Absent | Drug use Absent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0750502
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2,1]
    C0242510
    UMLS CUI [2,2]
    C0332197
    patients for brain imaging:
    Beschreibung

    Patients Imaging of brain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0203860
    evidence for any other neurological or psychiatric disease
    Beschreibung

    Nervous system disorder Other | Mental disorder Other

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0027765
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C0004936
    UMLS CUI [2,2]
    C0205394
    healthy volunteers for brain imaging:
    Beschreibung

    Healthy Volunteers Imaging of brain

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335
    UMLS CUI [1,2]
    C0203860
    family history of alzheimer's disease in a 1st or 2nd degree relative under 75 years of age
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1271045
    UMLS CUI [2]
    C1517194
    UMLS CUI [3]
    C1519210
    UMLS CUI [4]
    C0001779
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Diagnostic Imaging NCT01153607

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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