0 Ratings

ID

12607

Description

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF; ODM derived from: https://clinicaltrials.gov/show/NCT02007720

Link

https://clinicaltrials.gov/show/NCT02007720

Keywords

  1. 12/4/15 12/4/15 -
Uploaded on

December 4, 2015

DOI

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License

Creative Commons BY 4.0

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    Eligibility Acute Heart Failure NCT02007720

    Eligibility Acute Heart Failure NCT02007720

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male or female ≥ 18 years of age,
    Description

    Patient age and sex

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150831
    UMLS CUI [2]
    C0001779
    hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
    Description

    hospitalized for ahf

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0264714
    UMLS CUI [1,2]
    C0870668
    dyspnea at rest or with minimal exertion
    Description

    dyspnea at rest or with minimal exertion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013404
    UMLS CUI [1,2]
    C0231807
    pulmonary congestion on chest x-ray,
    Description

    pulmonary congestion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0242073
    brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
    Description

    brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1095989
    UMLS CUI [2]
    C3272900
    systolic bp ≥125 mmhg at the start and at the end of screening
    Description

    systolic blood pressure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
    Description

    able to be randomized within 16 hours from presentation to the hospital,

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1320532
    received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute hf episode
    Description

    received intravenous furosemide

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0354100
    UMLS CUI [1,2]
    C1391960
    renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75ml/min/1.73m2, calculated using the modification of diet in renal disease formula (or modified smdrd formula according to specific ethnic groups and local practice guidelines).
    Description

    renal impairment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    with body weight ≤ 160 kg
    Description

    body weight

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005910
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    dyspnea primarily due to non-cardiac causes
    Description

    dyspnea primarily due to non-cardiac causes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013404
    temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection requiring iv anti-microbial treatment or known presence or evidence of human immunodeficiency virus (hiv) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
    Description

    temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015967
    UMLS CUI [2]
    C0009450
    clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
    Description

    acute coronary syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948089
    ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
    Description

    significant arrhythmias

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003811
    hepatic disease unrelated to heart failure etiology and as determined by any one of the following: ast and/or alt values exceeding 3 x uln and/or bilirubin > 1.5 x uln at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic hepatitis b (presence of hepatitis b surface antigen production: positive hbsag), or chronic hepatitis c infection (presence of hepatitis c genetic replication: positive hepatitis c viral rna, based on history and/or clinical findings, including laboratory results obtained during screening period).
    Description

    hepatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmhg on prior or current echocardiogram), and severe mitral stenosis
    Description

    significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007194
    UMLS CUI [2]
    C1960707
    history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
    Description

    malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    other protocol defined inclusion/exclusion criteria may apply.
    Description

    other protocol defined inclusion/exclusion criteria may apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205394
    UMLS CUI [2]
    C1516637

    Similar models

    Eligibility Acute Heart Failure NCT02007720

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Patient age and sex
    Item
    male or female ≥ 18 years of age,
    boolean
    C0150831 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    hospitalized for ahf
    Item
    hospitalized for ahf; ahf is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
    boolean
    C0264714 (UMLS CUI [1,1])
    C0870668 (UMLS CUI [1,2])
    dyspnea at rest or with minimal exertion
    Item
    dyspnea at rest or with minimal exertion
    boolean
    C0013404 (UMLS CUI [1,1])
    C0231807 (UMLS CUI [1,2])
    pulmonary congestion
    Item
    pulmonary congestion on chest x-ray,
    boolean
    C0242073 (UMLS CUI [1])
    brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
    Item
    brain natriuretic peptide (bnp) ≥350 pg/ml or nt-probnp ≥1,400 pg/ml
    boolean
    C1095989 (UMLS CUI [1])
    C3272900 (UMLS CUI [2])
    systolic blood pressure
    Item
    systolic bp ≥125 mmhg at the start and at the end of screening
    boolean
    C0871470 (UMLS CUI [1])
    able to be randomized within 16 hours from presentation to the hospital,
    Item
    able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
    boolean
    C1320532 (UMLS CUI [1])
    received intravenous furosemide
    Item
    received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute hf episode
    boolean
    C0354100 (UMLS CUI [1,1])
    C1391960 (UMLS CUI [1,2])
    renal impairment
    Item
    renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75ml/min/1.73m2, calculated using the modification of diet in renal disease formula (or modified smdrd formula according to specific ethnic groups and local practice guidelines).
    boolean
    C1565489 (UMLS CUI [1])
    body weight
    Item
    with body weight ≤ 160 kg
    boolean
    C0005910 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    dyspnea primarily due to non-cardiac causes
    Item
    dyspnea primarily due to non-cardiac causes
    boolean
    C0013404 (UMLS CUI [1])
    temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection
    Item
    temperature >38.5°c (oral or equivalent), sepsis, active and clinically significant infection requiring iv anti-microbial treatment or known presence or evidence of human immunodeficiency virus (hiv) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
    boolean
    C0015967 (UMLS CUI [1])
    C0009450 (UMLS CUI [2])
    acute coronary syndrome
    Item
    clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
    boolean
    C0948089 (UMLS CUI [1])
    significant arrhythmias
    Item
    ahf due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute
    boolean
    C0003811 (UMLS CUI [1])
    hepatic disease
    Item
    hepatic disease unrelated to heart failure etiology and as determined by any one of the following: ast and/or alt values exceeding 3 x uln and/or bilirubin > 1.5 x uln at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic hepatitis b (presence of hepatitis b surface antigen production: positive hbsag), or chronic hepatitis c infection (presence of hepatitis c genetic replication: positive hepatitis c viral rna, based on history and/or clinical findings, including laboratory results obtained during screening period).
    boolean
    C0023895 (UMLS CUI [1])
    significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy
    Item
    significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmhg on prior or current echocardiogram), and severe mitral stenosis
    boolean
    C0007194 (UMLS CUI [1])
    C1960707 (UMLS CUI [2])
    malignancy
    Item
    history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
    boolean
    C0006826 (UMLS CUI [1])
    other protocol defined inclusion/exclusion criteria may apply
    Item
    other protocol defined inclusion/exclusion criteria may apply.
    boolean
    C0205394 (UMLS CUI [1])
    C1516637 (UMLS CUI [2])

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