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ID

16669

Beschrijving

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT00324376

Link

https://clinicaltrials.gov/show/NCT00324376

Trefwoorden

  1. 31-07-16 31-07-16 -
Geüploaded op

31 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Chronic Kidney Disease NCT00324376

    Eligibility Chronic Kidney Disease NCT00324376

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    life expectancy of at least 12 months,
    Beschrijving

    Life Expectancy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patients have received hemodialysis three times per week for 3 months or longer,
    Beschrijving

    Hemodialysis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019004
    patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
    Beschrijving

    sevelamer | Phosphate Binder | serum phosphorus measurement

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0718050
    UMLS CUI [2]
    C2267031
    UMLS CUI [3]
    C2229833
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    active bowel obstruction,
    Beschrijving

    Intestinal Obstruction

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021843
    dysphagia,
    Beschrijving

    Deglutition Disorders

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0011168
    wallowing dsisorders,
    Beschrijving

    swallowing disorder

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0011168
    severe gastrointestinal motility disorders,
    Beschrijving

    Gastrointestinal motility disorder Severe

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0854121
    UMLS CUI [1,2]
    C0205082
    active ethanol or drug abuse (excluding tobacco),
    Beschrijving

    Substance Use Disorders | Tobacco Use Disorder

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0040336
    need for antidysrhythmic or antiseizure medications used to control these conditions,
    Beschrijving

    Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0521124
    UMLS CUI [1,3]
    C0003811
    UMLS CUI [1,4]
    C0027552
    UMLS CUI [2,1]
    C0521306
    UMLS CUI [2,2]
    C0027552
    poorly controlled diabetes mellitus or hypertension,
    Beschrijving

    poorly controlled diabetes mellitus | Poor hypertension control

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0554876
    UMLS CUI [2]
    C0421190
    active vasculitis,
    Beschrijving

    Vasculitis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0042384
    active malignancy other than basal-cell carcinoma,
    Beschrijving

    Malignant Neoplasms | Basal cell carcinoma

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0007117
    hiv infection,
    Beschrijving

    HIV Infections

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    any clinically significant unstable medical condition as judged by the investigator.
    Beschrijving

    medical condition Unstable Clinical Significance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [1,3]
    C2826293

    Similar models

    Eligibility Chronic Kidney Disease NCT00324376

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Life Expectancy
    Item
    life expectancy of at least 12 months,
    boolean
    C0023671 (UMLS CUI [1])
    Hemodialysis
    Item
    patients have received hemodialysis three times per week for 3 months or longer,
    boolean
    C0019004 (UMLS CUI [1])
    sevelamer | Phosphate Binder | serum phosphorus measurement
    Item
    patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
    boolean
    C0718050 (UMLS CUI [1])
    C2267031 (UMLS CUI [2])
    C2229833 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Intestinal Obstruction
    Item
    active bowel obstruction,
    boolean
    C0021843 (UMLS CUI [1])
    Deglutition Disorders
    Item
    dysphagia,
    boolean
    C0011168 (UMLS CUI [1])
    swallowing disorder
    Item
    wallowing dsisorders,
    boolean
    C0011168 (UMLS CUI [1])
    Gastrointestinal motility disorder Severe
    Item
    severe gastrointestinal motility disorders,
    boolean
    C0854121 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Substance Use Disorders | Tobacco Use Disorder
    Item
    active ethanol or drug abuse (excluding tobacco),
    boolean
    C0038586 (UMLS CUI [1])
    C0040336 (UMLS CUI [2])
    Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed
    Item
    need for antidysrhythmic or antiseizure medications used to control these conditions,
    boolean
    C0013227 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0003811 (UMLS CUI [1,3])
    C0027552 (UMLS CUI [1,4])
    C0521306 (UMLS CUI [2,1])
    C0027552 (UMLS CUI [2,2])
    poorly controlled diabetes mellitus | Poor hypertension control
    Item
    poorly controlled diabetes mellitus or hypertension,
    boolean
    C0554876 (UMLS CUI [1])
    C0421190 (UMLS CUI [2])
    Vasculitis
    Item
    active vasculitis,
    boolean
    C0042384 (UMLS CUI [1])
    Malignant Neoplasms | Basal cell carcinoma
    Item
    active malignancy other than basal-cell carcinoma,
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    HIV Infections
    Item
    hiv infection,
    boolean
    C0019693 (UMLS CUI [1])
    medical condition Unstable Clinical Significance
    Item
    any clinically significant unstable medical condition as judged by the investigator.
    boolean
    C3843040 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])

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