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ID

13647

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01347970

Keywords

versioni (1)
  1. 22/02/16 22/02/16 -
Caricato su

22 febbraio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Cancer Survivor NCT01347970

    Inglese

    Eligibility Cancer Survivor NCT01347970

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    cancer diagnosis prior to 22 years of age, irrespective of current age
    Descrizione

    diagnosis cancer; age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    lifetime cumulative anthracycline dose: >= 300 mg/m^2 without the protection of dexrazoxane (zinecard) therapy
    Descrizione

    dose anthracycline; dexrazoxane

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI [1,2]
    C0282564 (Anthracyclines)
    UMLS CUI [2]
    C0086444 (dexrazoxane)
    SNOMED
    417741009
    time from completion of cancer treatment to study entry: >= 2 years
    Descrizione

    cancer treatment

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0920425 (cancer treatment)
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    receiving treatment for cardiomyopathy or congestive heart failure
    Descrizione

    treatment cardiomyopathy; treatment congestive heart failure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0878544 (Cardiomyopathies)
    SNOMED
    57809008
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    resting ejection fraction < 50% or fractional shortening < 25%
    Descrizione

    ejection fraction

    Tipo di dati

    boolean

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

    valvular disease; Ventricular Outflow Obstruction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018824 (Heart valve disease)
    SNOMED
    368009
    UMLS CUI [2]
    C0042512 (Ventricular Outflow Obstruction)
    low resting systolic blood pressure: < 90 mm hemoglobin (hg)
    Descrizione

    systolic blood pressure; hemoglobin

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [2]
    C0019046 (Hemoglobin)
    SNOMED
    38082009
    LOINC
    LP32067-8
    bradycardia: heart rate < 50 beats per minute (bpm)
    Descrizione

    bradycardia; heart rate

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0428977 (Bradycardia)
    SNOMED
    48867003
    LOINC
    LA17394-0
    UMLS CUI [2]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    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)
    Descrizione

    ventricular dysrhythmias; sick sinus syndrome

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0085612 (Ventricular arrhythmia)
    SNOMED
    44103008
    UMLS CUI [2]
    C0037052 (Sick Sinus Syndrome)
    SNOMED
    36083008
    history or current clinical evidence of moderate -to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
    Descrizione

    obstructive pulmonary disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0600260 (Lung Diseases, Obstructive)
    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
    Descrizione

    Aspartate aminotransferase/Alanine aminotransferase; Gastrointestinal dysfunction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0364051 (Aspartate aminotransferase/Alanine aminotransferase:CRto:Pt:Ser/Plas:Qn)
    LOINC
    1916-6
    UMLS CUI [2]
    C0679407 (Gastrointestinal dysfunction)
    endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
    Descrizione

    endocrine disorders; primary aldosteronism

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0014130 (Endocrine System Diseases)
    SNOMED
    362969004
    UMLS CUI [2]
    C1384514 (Conn Syndrome)
    SNOMED
    258117004
    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)
    Descrizione

    Contraception status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0420837 (Contraception status)
    SNOMED
    243816001
    history of drug sensitivity or allergic reaction to alpha- or beta-blockers
    Descrizione

    hypersensitivity beta-blockers

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    anemia (hematocrit < 28%)
    Descrizione

    anemia; hematocrit

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0002871 (Anemia)
    SNOMED
    271737000
    LOINC
    MTHU020823
    UMLS CUI [2]
    C0018935 (Hematocrit procedure)
    SNOMED
    28317006
    LOINC
    LP15101-6
    use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of randomization
    Descrizione

    investigational drug beta adrenergic blockers

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,2]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    use of select cytochrome p450 2d6 (cyp2d6) inhibitor medications
    Descrizione

    Cytochrome P-450 CYP2D6

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0057223 (Cytochrome P-450 CYP2D6)
    SNOMED
    425292000
    inability to swallow pills
    Descrizione

    pills

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0994475 (Pills)
    SNOMED
    46992007
    LOINC
    LA15806-5
    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
    Descrizione

    compliance

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
    Descrizione

    medication blood pressure

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
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    Similar models

    Eligibility Cancer Survivor NCT01347970

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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