0 Evaluaciones
ID

14227

Descripción

The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00255086

Link

https://clinicaltrials.gov/show/NCT00255086

Palabras clave

Versiones (1)
  1. 5/4/16 5/4/16 -
Subido en

5 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Alzheimer Disease NCT00255086

    Inglés

    Eligibility Alzheimer Disease NCT00255086

    1 formularios  
    Criteria
    Descripción

    Criteria

    2. 50-95 years of age inclusive.
    Descripción

    age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. mmse at screen and baseline 7-28 inclusive.
    Descripción

    Mini-mental state examination

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0451306
    4. conversant in english.
    Descripción

    english speaking

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0376245
    5. caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
    Descripción

    compliance behaviour caregiver

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0085537
    6. able to ingest oral medication.
    Descripción

    oral medication intake

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2222393
    exclusion criteria:1. history of clinically significant stroke without substantial recovery.
    Descripción

    exclusion criteria; stroke

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C0038454
    2. neurological or medical conditions causing significant disability independent of dementia.
    Descripción

    neurological conditions; dementia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2359473
    UMLS CUI [2]
    C0497327
    3. parkinson's disease.
    Descripción

    parkinsons disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0030567
    4. history in past two years of focal brain lesion, head injury with loss of consciousness or dsm-iv criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
    Descripción

    brain lesion; head injury; dsm-iv classification; Unconscious State; psychiatric disorder; psychosis; bipolar disorder; substance abuse

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0221505
    UMLS CUI [2]
    C0455587
    UMLS CUI [3]
    C0236962
    UMLS CUI [4]
    C0041657
    UMLS CUI [5]
    C0004936
    UMLS CUI [6]
    C0033975
    UMLS CUI [7]
    C0005586
    UMLS CUI [8]
    C0687130
    5. dementia due to korsakoff's syndrome or infectious diseases such as creutzfeldt-jakob disease, herpes, encephalitis, or human immunodeficiency virus.
    Descripción

    dementia; Wernicke-Korsakoff Syndrome; creutzfeldt-jakob disease; encephalitis; human immunodeficiency virus

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0497327
    UMLS CUI [2]
    C0349464
    UMLS CUI [3]
    C0022336
    UMLS CUI [4]
    C0014038
    UMLS CUI [5]
    C0019682
    6. sensory impairment that would prevent subject from participating in or cooperating with the protocol.
    Descripción

    Compliance behavior Limited sensory impairment

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0020580
    7. significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
    Descripción

    Compliance behavior Limited Comorbidity; systemic disease; laboratory abnormality

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    UMLS CUI [2]
    C0442893
    UMLS CUI [3]
    C0438215
    8. clinical contraindication to the use of memantine (e.g., hypersensitivity).
    Descripción

    medical contraindication memantine; hypersensitivity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0025242
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0025242
    9. history of seizure within past 5 years prior to screening.
    Descripción

    medical history seizure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0036572
    10. platelet count < 100,000/mm3.
    Descripción

    platelet count

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    11. history of claustrophobia
    Descripción

    medical history claustrophobia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0008909
    12. presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
    Descripción

    implants metallic pacemakers aneurysm clips

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0021102
    UMLS CUI [1,2]
    C2986473
    UMLS CUI [1,3]
    C0810633
    UMLS CUI [1,4]
    C0179977
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    Similar models

    Eligibility Alzheimer Disease NCT00255086

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    age
    Item
    2. 50-95 years of age inclusive.
    boolean
    C0001779 (UMLS CUI [1])
    Mini-mental state examination
    Item
    3. mmse at screen and baseline 7-28 inclusive.
    boolean
    C0451306 (UMLS CUI [1])
    english speaking
    Item
    4. conversant in english.
    boolean
    C0376245 (UMLS CUI [1])
    compliance behaviour caregiver
    Item
    5. caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0085537 (UMLS CUI [1,2])
    oral medication intake
    Item
    6. able to ingest oral medication.
    boolean
    C2222393 (UMLS CUI [1])
    exclusion criteria; stroke
    Item
    exclusion criteria:1. history of clinically significant stroke without substantial recovery.
    boolean
    C0680251 (UMLS CUI [1])
    C0038454 (UMLS CUI [2])
    neurological conditions; dementia
    Item
    2. neurological or medical conditions causing significant disability independent of dementia.
    boolean
    C2359473 (UMLS CUI [1])
    C0497327 (UMLS CUI [2])
    parkinsons disease
    Item
    3. parkinson's disease.
    boolean
    C0030567 (UMLS CUI [1])
    brain lesion; head injury; dsm-iv classification; Unconscious State; psychiatric disorder; psychosis; bipolar disorder; substance abuse
    Item
    4. history in past two years of focal brain lesion, head injury with loss of consciousness or dsm-iv criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
    boolean
    C0221505 (UMLS CUI [1])
    C0455587 (UMLS CUI [2])
    C0236962 (UMLS CUI [3])
    C0041657 (UMLS CUI [4])
    C0004936 (UMLS CUI [5])
    C0033975 (UMLS CUI [6])
    C0005586 (UMLS CUI [7])
    C0687130 (UMLS CUI [8])
    dementia; Wernicke-Korsakoff Syndrome; creutzfeldt-jakob disease; encephalitis; human immunodeficiency virus
    Item
    5. dementia due to korsakoff's syndrome or infectious diseases such as creutzfeldt-jakob disease, herpes, encephalitis, or human immunodeficiency virus.
    boolean
    C0497327 (UMLS CUI [1])
    C0349464 (UMLS CUI [2])
    C0022336 (UMLS CUI [3])
    C0014038 (UMLS CUI [4])
    C0019682 (UMLS CUI [5])
    Compliance behavior Limited sensory impairment
    Item
    6. sensory impairment that would prevent subject from participating in or cooperating with the protocol.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0020580 (UMLS CUI [1,3])
    Compliance behavior Limited Comorbidity; systemic disease; laboratory abnormality
    Item
    7. significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    C0442893 (UMLS CUI [2])
    C0438215 (UMLS CUI [3])
    medical contraindication memantine; hypersensitivity
    Item
    8. clinical contraindication to the use of memantine (e.g., hypersensitivity).
    boolean
    C1301624 (UMLS CUI [1,1])
    C0025242 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0025242 (UMLS CUI [2,2])
    medical history seizure
    Item
    9. history of seizure within past 5 years prior to screening.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0036572 (UMLS CUI [1,2])
    platelet count
    Item
    10. platelet count < 100,000/mm3.
    boolean
    C0032181 (UMLS CUI [1])
    medical history claustrophobia
    Item
    11. history of claustrophobia
    boolean
    C0262926 (UMLS CUI [1,1])
    C0008909 (UMLS CUI [1,2])
    implants metallic pacemakers aneurysm clips
    Item
    12. presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
    boolean
    C0021102 (UMLS CUI [1,1])
    C2986473 (UMLS CUI [1,2])
    C0810633 (UMLS CUI [1,3])
    C0179977 (UMLS CUI [1,4])
    Volver a la parte superior de la página 

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