0 Avaliações
ID

13647

Descrição

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01347970

Link

https://clinicaltrials.gov/show/NCT01347970

Palavras-chave

Versões (1)
  1. 22/02/2016 22/02/2016 -
Transferido a

22 de fevereiro de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Cancer Survivor NCT01347970

    Inglês

    Eligibility Cancer Survivor NCT01347970

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    cancer diagnosis prior to 22 years of age, irrespective of current age
    Descrição

    diagnosis cancer; age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2]
    C0001779
    lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (zinecard) therapy
    Descrição

    dose anthracycline; dexrazoxane

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0282564
    UMLS CUI [2]
    C0086444
    time from completion of cancer treatment to study entry: >= 2 years
    Descrição

    cancer treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    receiving treatment for cardiomyopathy or congestive heart failure
    Descrição

    treatment cardiomyopathy; treatment congestive heart failure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0878544
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0018802
    resting ejection fraction < 50% or fractional shortening < 25%
    Descrição

    ejection fraction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0489482
    uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
    Descrição

    valvular disease; Ventricular Outflow Obstruction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018824
    UMLS CUI [2]
    C0042512
    low resting systolic blood pressure: < 90 mm hemoglobin (hg)
    Descrição

    systolic blood pressure; hemoglobin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    UMLS CUI [2]
    C0019046
    bradycardia: heart rate < 50 beats per minute (bpm)
    Descrição

    bradycardia; heart rate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0428977
    UMLS CUI [2]
    C0018810
    sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrio-ventricular block or sick sinus syndrome)
    Descrição

    ventricular dysrhythmias; sick sinus syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085612
    UMLS CUI [2]
    C0037052
    history or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
    Descrição

    obstructive pulmonary disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0600260
    significant hepatic (serum aspartate aminotransferase [ast] and/or alanine aminotransferase [alt] > 3 time upper limit of normal institutional normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
    Descrição

    Aspartate aminotransferase/Alanine aminotransferase; Gastrointestinal dysfunction

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0364051
    UMLS CUI [2]
    C0679407
    endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
    Descrição

    endocrine disorders; primary aldosteronism

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0014130
    UMLS CUI [2]
    C1384514
    females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e.: intrauterine device [iud] or oral contraceptives for 3 months prior to entry into the study)
    Descrição

    Contraception status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0420837
    history of drug sensitivity or allergic reaction to alpha- or beta-blockers
    Descrição

    hypersensitivity beta-blockers

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0001645
    anemia (hematocrit < 28%)
    Descrição

    anemia; hematocrit

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    UMLS CUI [2]
    C0018935
    use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
    Descrição

    investigational drug beta adrenergic blockers

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0001645
    use of select cytochrome p450 2d6 (cyp2d6) inhibitor medications
    Descrição

    Cytochrome P-450 CYP2D6

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0057223
    inability to swallow pills
    Descrição

    pills

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0994475
    unwillingness or inability to cooperate, or, for the parents or guardians of minors, to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation with the study
    Descrição

    compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
    Descrição

    medication blood pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0005823
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    Similar models

    Eligibility Cancer Survivor NCT01347970

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    diagnosis cancer; age
    Item
    cancer diagnosis prior to 22 years of age, irrespective of current age
    boolean
    C0011900 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0001779 (UMLS CUI [2])
    dose anthracycline; dexrazoxane
    Item
    lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (zinecard) therapy
    boolean
    C3174092 (UMLS CUI [1,1])
    C0282564 (UMLS CUI [1,2])
    C0086444 (UMLS CUI [2])
    cancer treatment
    Item
    time from completion of cancer treatment to study entry: >= 2 years
    boolean
    C0920425 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    treatment cardiomyopathy; treatment congestive heart failure
    Item
    receiving treatment for cardiomyopathy or congestive heart failure
    boolean
    C0087111 (UMLS CUI [1,1])
    C0878544 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0018802 (UMLS CUI [2,2])
    ejection fraction
    Item
    resting ejection fraction < 50% or fractional shortening < 25%
    boolean
    C0489482 (UMLS CUI [1])
    valvular disease; Ventricular Outflow Obstruction
    Item
    uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
    boolean
    C0018824 (UMLS CUI [1])
    C0042512 (UMLS CUI [2])
    systolic blood pressure; hemoglobin
    Item
    low resting systolic blood pressure: < 90 mm hemoglobin (hg)
    boolean
    C0871470 (UMLS CUI [1])
    C0019046 (UMLS CUI [2])
    bradycardia; heart rate
    Item
    bradycardia: heart rate < 50 beats per minute (bpm)
    boolean
    C0428977 (UMLS CUI [1])
    C0018810 (UMLS CUI [2])
    ventricular dysrhythmias; sick sinus syndrome
    Item
    sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrio-ventricular block or sick sinus syndrome)
    boolean
    C0085612 (UMLS CUI [1])
    C0037052 (UMLS CUI [2])
    obstructive pulmonary disease
    Item
    history or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
    boolean
    C0600260 (UMLS CUI [1])
    Aspartate aminotransferase/Alanine aminotransferase; Gastrointestinal dysfunction
    Item
    significant hepatic (serum aspartate aminotransferase [ast] and/or alanine aminotransferase [alt] > 3 time upper limit of normal institutional normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
    boolean
    C0364051 (UMLS CUI [1])
    C0679407 (UMLS CUI [2])
    endocrine disorders; primary aldosteronism
    Item
    endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
    boolean
    C0014130 (UMLS CUI [1])
    C1384514 (UMLS CUI [2])
    Contraception status
    Item
    females of child bearing potential who are pregnant, lactating, or sexually active and not taking adequate contraceptive precautions (i.e.: intrauterine device [iud] or oral contraceptives for 3 months prior to entry into the study)
    boolean
    C0420837 (UMLS CUI [1])
    hypersensitivity beta-blockers
    Item
    history of drug sensitivity or allergic reaction to alpha- or beta-blockers
    boolean
    C0020517 (UMLS CUI [1,1])
    C0001645 (UMLS CUI [1,2])
    anemia; hematocrit
    Item
    anemia (hematocrit < 28%)
    boolean
    C0002871 (UMLS CUI [1])
    C0018935 (UMLS CUI [2])
    investigational drug beta adrenergic blockers
    Item
    use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
    boolean
    C0013230 (UMLS CUI [1,1])
    C0001645 (UMLS CUI [1,2])
    Cytochrome P-450 CYP2D6
    Item
    use of select cytochrome p450 2d6 (cyp2d6) inhibitor medications
    boolean
    C0057223 (UMLS CUI [1])
    pills
    Item
    inability to swallow pills
    boolean
    C0994475 (UMLS CUI [1])
    compliance
    Item
    unwillingness or inability to cooperate, or, for the parents or guardians of minors, to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation with the study
    boolean
    C1321605 (UMLS CUI [1])
    medication blood pressure
    Item
    use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
    boolean
    C0013227 (UMLS CUI [1,1])
    C0005823 (UMLS CUI [1,2])
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