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ID

32385

Description

Sleep Disordered Breathing in Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00863421

Link

https://clinicaltrials.gov/show/NCT00863421

Keywords

Versions (1)
  1. 10/29/18 10/29/18 -
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October 29, 2018

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Creative Commons BY 4.0
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    Eligibility Sleep-disordered Breathing NCT00863421

    English

    Eligibility Sleep-disordered Breathing NCT00863421

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    stable chronic heart failure(nyha ii-iv), defined as
    Description

    Chronic heart failure Stable New York Heart Association Classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0264716
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [1,3]
    C1275491
    a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
    Description

    Condition Duration | Therapy Maximal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0205289
    without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
    Description

    Symptoms unchanged | Pharmaceutical Preparations unchanged

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0442739
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0442739
    by the absence of any hospitalizations during the previous 3 month
    Description

    Hospitalization Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0332197
    ejection fraction equal or below 35%
    Description

    Cardiac ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232174
    age between 18 and 80 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    instable angina pectoris
    Description

    Angina, Unstable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002965
    acute coronary syndrome within the last 6 months
    Description

    Acute Coronary Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948089
    cerebrovascular events (tia, prind, stroke) within the last 12 months
    Description

    Event Cerebrovascular | Transient Ischemic Attack | Prolonged reversible ischemic neurologic deficit | Cerebrovascular accident

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C1880018
    UMLS CUI [2]
    C0007787
    UMLS CUI [3]
    C2114798
    UMLS CUI [4]
    C0038454
    primary pulmonary hypertension(systolic pap > 45 mmhg)
    Description

    Primary pulmonary hypertension | Pulmonary artery systolic pressure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0152171
    UMLS CUI [2]
    C0428643
    congenital heart failure
    Description

    Congenital cardiac failure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0410933
    primary heart valve disease
    Description

    Heart valve disease Primary

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018824
    UMLS CUI [1,2]
    C0205225
    regular use of benzodiazepines, other sedatives, or opiate derivatives
    Description

    Benzodiazepines Regular | Sedatives Regular | Opiate Derivative Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005064
    UMLS CUI [1,2]
    C0205272
    UMLS CUI [2,1]
    C0036557
    UMLS CUI [2,2]
    C0205272
    UMLS CUI [3,1]
    C0376196
    UMLS CUI [3,2]
    C1527240
    UMLS CUI [3,3]
    C0205272
    severe renal(s-creatinine > 3 mg/dl) and/or liver disease(gpt > 3xuln)
    Description

    Kidney Disease Severe | Creatinine measurement, serum | Liver disease Severe | Alanine aminotransferase increased

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022658
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2]
    C0201976
    UMLS CUI [3,1]
    C0023895
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [4]
    C0151905
    clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
    Description

    CNS disorder | Epilepsy | Multiple Sclerosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007682
    UMLS CUI [2]
    C0014544
    UMLS CUI [3]
    C0026769
    known moderate to severe chronic obstructive pulmonary disease(fev1/(f)vc < 70% und fev1 < 50% soll) or restrictive lung disease with total lung capacity < 70%
    Description

    Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | FEV1/FVC percent | FEV1 | Restrictive lung disease | Total Lung Capacity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0730605
    UMLS CUI [2]
    C0730607
    UMLS CUI [3]
    C0730560
    UMLS CUI [4]
    C0849974
    UMLS CUI [5]
    C0085581
    UMLS CUI [6]
    C0040509
    untreated hormonal disease(e.g.hypothyreosis,....)
    Description

    Hormonal disorder untreated | Hypothyroidism

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3263685
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2]
    C0020676
    daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
    Description

    Alcohol consumption units/day | Gender

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560578
    UMLS CUI [2]
    C0079399
    implantation of a pacemaker or icd within the previous 6 months
    Description

    Implantation of cardiac pacemaker | Implantation ICD

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0189842
    UMLS CUI [2,1]
    C0021107
    UMLS CUI [2,2]
    C0162589
    st.p. aortocoronary bypass surgery or lung resection within the previous 12 month
    Description

    Status post Coronary Artery Bypass Surgery | Status post Lung excision

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0231290
    UMLS CUI [1,2]
    C0010055
    UMLS CUI [2,1]
    C0231290
    UMLS CUI [2,2]
    C0396565
    women of child-bearing age
    Description

    Childbearing Potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118
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    Similar models

    Eligibility Sleep-disordered Breathing NCT00863421

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic heart failure Stable New York Heart Association Classification
    Item
    stable chronic heart failure(nyha ii-iv), defined as
    boolean
    C0264716 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [1,3])
    Condition Duration | Therapy Maximal
    Item
    a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
    boolean
    C0348080 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0205289 (UMLS CUI [2,2])
    Symptoms unchanged | Pharmaceutical Preparations unchanged
    Item
    without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
    boolean
    C1457887 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [2,1])
    C0442739 (UMLS CUI [2,2])
    Hospitalization Absent
    Item
    by the absence of any hospitalizations during the previous 3 month
    boolean
    C0019993 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Cardiac ejection fraction
    Item
    ejection fraction equal or below 35%
    boolean
    C0232174 (UMLS CUI [1])
    Age
    Item
    age between 18 and 80 years
    boolean
    C0001779 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Angina, Unstable
    Item
    instable angina pectoris
    boolean
    C0002965 (UMLS CUI [1])
    Acute Coronary Syndrome
    Item
    acute coronary syndrome within the last 6 months
    boolean
    C0948089 (UMLS CUI [1])
    Event Cerebrovascular | Transient Ischemic Attack | Prolonged reversible ischemic neurologic deficit | Cerebrovascular accident
    Item
    cerebrovascular events (tia, prind, stroke) within the last 12 months
    boolean
    C0441471 (UMLS CUI [1,1])
    C1880018 (UMLS CUI [1,2])
    C0007787 (UMLS CUI [2])
    C2114798 (UMLS CUI [3])
    C0038454 (UMLS CUI [4])
    Primary pulmonary hypertension | Pulmonary artery systolic pressure
    Item
    primary pulmonary hypertension(systolic pap > 45 mmhg)
    boolean
    C0152171 (UMLS CUI [1])
    C0428643 (UMLS CUI [2])
    Congenital cardiac failure
    Item
    congenital heart failure
    boolean
    C0410933 (UMLS CUI [1])
    Heart valve disease Primary
    Item
    primary heart valve disease
    boolean
    C0018824 (UMLS CUI [1,1])
    C0205225 (UMLS CUI [1,2])
    Benzodiazepines Regular | Sedatives Regular | Opiate Derivative Regular
    Item
    regular use of benzodiazepines, other sedatives, or opiate derivatives
    boolean
    C0005064 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    C0036557 (UMLS CUI [2,1])
    C0205272 (UMLS CUI [2,2])
    C0376196 (UMLS CUI [3,1])
    C1527240 (UMLS CUI [3,2])
    C0205272 (UMLS CUI [3,3])
    Kidney Disease Severe | Creatinine measurement, serum | Liver disease Severe | Alanine aminotransferase increased
    Item
    severe renal(s-creatinine > 3 mg/dl) and/or liver disease(gpt > 3xuln)
    boolean
    C0022658 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0201976 (UMLS CUI [2])
    C0023895 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0151905 (UMLS CUI [4])
    CNS disorder | Epilepsy | Multiple Sclerosis
    Item
    clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
    boolean
    C0007682 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    C0026769 (UMLS CUI [3])
    Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | FEV1/FVC percent | FEV1 | Restrictive lung disease | Total Lung Capacity
    Item
    known moderate to severe chronic obstructive pulmonary disease(fev1/(f)vc < 70% und fev1 < 50% soll) or restrictive lung disease with total lung capacity < 70%
    boolean
    C0730605 (UMLS CUI [1])
    C0730607 (UMLS CUI [2])
    C0730560 (UMLS CUI [3])
    C0849974 (UMLS CUI [4])
    C0085581 (UMLS CUI [5])
    C0040509 (UMLS CUI [6])
    Hormonal disorder untreated | Hypothyroidism
    Item
    untreated hormonal disease(e.g.hypothyreosis,....)
    boolean
    C3263685 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0020676 (UMLS CUI [2])
    Alcohol consumption units/day | Gender
    Item
    daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
    boolean
    C0001948 (UMLS CUI [1,1])
    C0560578 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2])
    Implantation of cardiac pacemaker | Implantation ICD
    Item
    implantation of a pacemaker or icd within the previous 6 months
    boolean
    C0189842 (UMLS CUI [1])
    C0021107 (UMLS CUI [2,1])
    C0162589 (UMLS CUI [2,2])
    Status post Coronary Artery Bypass Surgery | Status post Lung excision
    Item
    st.p. aortocoronary bypass surgery or lung resection within the previous 12 month
    boolean
    C0231290 (UMLS CUI [1,1])
    C0010055 (UMLS CUI [1,2])
    C0231290 (UMLS CUI [2,1])
    C0396565 (UMLS CUI [2,2])
    Childbearing Potential
    Item
    women of child-bearing age
    boolean
    C3831118 (UMLS CUI [1])
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