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ID

14799

Description

Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01584440

Lien

https://clinicaltrials.gov/show/NCT01584440

Mots-clés

  1. 28/04/2016 28/04/2016 -
Téléchargé le

28 avril 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Agitation NCT01584440

    Eligibility Agitation NCT01584440

    1. StudyEvent: Eligibility
      1. Eligibility Agitation NCT01584440
    Inclusion Criteria
    Description

    Inclusion Criteria

    diagnosis of probable alzheimer's disease (ad).
    Description

    Alzheimer's Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0002395 (Alzheimer's Disease)
    SNOMED
    26929004
    the patient has clinically significant symptoms of agitation secondary to ad, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
    Description

    Agitation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0085631 (Agitation)
    SNOMED
    24199005
    LOINC
    LA6150-2
    either out-patients or residents of an assisted-living facility or a skilled nursing home.
    Description

    living in assisted living facility

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2136015 (living in assisted living facility)
    cgi-s score is ≥ 4 (moderately ill) at screening and baseline.
    Description

    cgi-s score

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3639708 (Clinical global impression scale)
    mini mental state examination (mmse) score at screening between 8 and 28 (inclusive).
    Description

    mini mental state examination

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0451306 (Mini-mental state examination)
    SNOMED
    273617000
    LOINC
    LP156457-6
    caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. in order to qualify as a caregiver for this study, the individual should spend time with the patient for a minimum of 4 hours on 4 separate days per week.
    Description

    Protocol Compliance Comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2]
    C0009488 (Comorbidity)
    Exclusion criteria
    Description

    Exclusion criteria

    patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia).
    Description

    dementia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including qtc prolongation, or unstable valvular heart disease).
    Description

    confound the interpretation of the safety results of the study

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2]
    C0009488 (Comorbidity)
    patients with myasthenia gravis.
    Description

    myasthenia gravis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0026896 (Myasthenia Gravis)
    SNOMED
    91637004
    LOINC
    LA15158-1

    Similar models

    Eligibility Agitation NCT01584440

    1. StudyEvent: Eligibility
      1. Eligibility Agitation NCT01584440
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Inclusion Criteria
    Alzheimer's Disease
    Item
    diagnosis of probable alzheimer's disease (ad).
    boolean
    C0002395 (UMLS CUI [1])
    Agitation
    Item
    the patient has clinically significant symptoms of agitation secondary to ad, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
    boolean
    C0085631 (UMLS CUI [1])
    living in assisted living facility
    Item
    either out-patients or residents of an assisted-living facility or a skilled nursing home.
    boolean
    C2136015 (UMLS CUI [1])
    cgi-s score
    Item
    cgi-s score is ≥ 4 (moderately ill) at screening and baseline.
    boolean
    C3639708 (UMLS CUI [1])
    mini mental state examination
    Item
    mini mental state examination (mmse) score at screening between 8 and 28 (inclusive).
    boolean
    C0451306 (UMLS CUI [1])
    Protocol Compliance Comorbidity
    Item
    caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. in order to qualify as a caregiver for this study, the individual should spend time with the patient for a minimum of 4 hours on 4 separate days per week.
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Item Group
    Exclusion criteria
    dementia
    Item
    patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia).
    boolean
    C0497327 (UMLS CUI [1])
    confound the interpretation of the safety results of the study
    Item
    patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including qtc prolongation, or unstable valvular heart disease).
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    myasthenia gravis
    Item
    patients with myasthenia gravis.
    boolean
    C0026896 (UMLS CUI [1])

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