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ID

16669

Beschreibung

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

Stichworte

Versionen (1)
  1. 31.07.16 31.07.16 -
Hochgeladen am

31. Juli 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Chronic Kidney Disease NCT00324376

    Englisch

    Eligibility Chronic Kidney Disease NCT00324376

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    life expectancy of at least 12 months,
    Beschreibung

    Life Expectancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    patients have received hemodialysis three times per week for 3 months or longer,
    Beschreibung

    Hemodialysis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019004 (Hemodialysis)
    SNOMED
    302497006
    LOINC
    LA9975-9
    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).
    Beschreibung

    sevelamer | Phosphate Binder | serum phosphorus measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0718050 (sevelamer)
    SNOMED
    329195003
    UMLS CUI [2]
    C2267031 (Phosphate Binder [EPC])
    UMLS CUI [3]
    C2229833 (serum phosphorus measurement)
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    active bowel obstruction,
    Beschreibung

    Intestinal Obstruction

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021843 (Intestinal Obstruction)
    SNOMED
    81060008
    dysphagia,
    Beschreibung

    Deglutition Disorders

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011168 (Deglutition Disorders)
    SNOMED
    288939007
    wallowing dsisorders,
    Beschreibung

    swallowing disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011168 (Deglutition Disorders)
    SNOMED
    288939007
    severe gastrointestinal motility disorders,
    Beschreibung

    Gastrointestinal motility disorder Severe

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0854121 (Gastrointestinal motility disorder)
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    active ethanol or drug abuse (excluding tobacco),
    Beschreibung

    Substance Use Disorders | Tobacco Use Disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    UMLS CUI [2]
    C0040336 (Tobacco Use Disorder)
    SNOMED
    89765005
    LOINC
    LP36308-2
    need for antidysrhythmic or antiseizure medications used to control these conditions,
    Beschreibung

    Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0521124 (Against)
    SNOMED
    65897001
    UMLS CUI [1,3]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [1,4]
    C0027552 (Needs)
    SNOMED
    410525008
    UMLS CUI [2,1]
    C0521306 (Anticonvulsant therapy)
    SNOMED
    46589004
    UMLS CUI [2,2]
    C0027552 (Needs)
    SNOMED
    410525008
    poorly controlled diabetes mellitus or hypertension,
    Beschreibung

    poorly controlled diabetes mellitus | Poor hypertension control

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0554876 (poorly controlled diabetes mellitus)
    UMLS CUI [2]
    C0421190 (Poor hypertension control)
    SNOMED
    170578008
    active vasculitis,
    Beschreibung

    Vasculitis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042384 (Vasculitis)
    SNOMED
    31996006
    LOINC
    LA17783-4
    active malignancy other than basal-cell carcinoma,
    Beschreibung

    Malignant Neoplasms | Basal cell carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    hiv infection,
    Beschreibung

    HIV Infections

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    any clinically significant unstable medical condition as judged by the investigator.
    Beschreibung

    medical condition Unstable Clinical Significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    UMLS CUI [1,3]
    C2826293 (Clinical Significance)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Chronic Kidney Disease NCT00324376

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

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