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ID

18189

Beskrivning

A Multiple Myeloma Trial in Patients With Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00104104

Länk

https://clinicaltrials.gov/show/NCT00104104

Nyckelord

  1. 2016-10-24 2016-10-24 -
Uppladdad den

24 oktober 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Multiple Myeloma NCT00104104

    Eligibility Multiple Myeloma NCT00104104

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients 18 years of age or older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    confirmed diagnosis of multiple myeloma
    Beskrivning

    Multiple Myeloma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0026764 (Multiple Myeloma)
    SNOMED
    55921005
    stable renal function defined as two serum creatinine determinations of < 3 mg/dl
    Beskrivning

    Renal function Stable | Serum creatinine measurement Quantity

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [1,2]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    UMLS CUI [2,1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    calculated creatinine clearance of greater than or equal to 30 ml/min
    Beskrivning

    Estimation of creatinine clearance by Cockcroft-Gault formula

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2711451 (Estimation of creatinine clearance by Cockcroft-Gault formula)
    SNOMED
    442407001
    ecog performance status of 0 or 1
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    life expectancy of greater than or equal to 9 months
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
    Beskrivning

    Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    UMLS CUI [2]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    UMLS CUI [3,1]
    C0002453 (Amenorrhea)
    SNOMED
    14302001
    UMLS CUI [3,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    ability to comply with trial requirements and give informed consent.
    Beskrivning

    Protocol Compliance | Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0525058 (Protocol Compliance)
    UMLS CUI [2]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    iv bisphosphonate therapy for more than 3 years.
    Beskrivning

    Diphosphonates Intravenous

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012544 (Diphosphonates)
    SNOMED
    372907000
    UMLS CUI [1,2]
    C1522726 (Intravenous Route of Drug Administration)
    SNOMED
    47625008
    LOINC
    LP200078-6
    patients with a diagnosis of amyloidosis.
    Beskrivning

    amyloidosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002726 (Amyloidosis)
    SNOMED
    17602002
    LOINC
    LP209029-0
    known hypersensitivity to zoledronic acid or other bisphosphonates
    Beskrivning

    Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0257685 (zoledronic acid)
    SNOMED
    134600006
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0012544 (Diphosphonates)
    SNOMED
    372907000
    pregnant patients or lactating patients.
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    women of childbearing potential not on a medically recognized form of contraception
    Beskrivning

    Childbearing Potential Contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
    Beskrivning

    Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2]
    C1868885 (Uncontrolled hypertension)
    UMLS CUI [3]
    C0743118 (DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED)

    Similar models

    Eligibility Multiple Myeloma NCT00104104

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    patients 18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Multiple Myeloma
    Item
    confirmed diagnosis of multiple myeloma
    boolean
    C0026764 (UMLS CUI [1])
    Renal function Stable | Serum creatinine measurement Quantity
    Item
    stable renal function defined as two serum creatinine determinations of < 3 mg/dl
    boolean
    C0232804 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0201976 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    calculated creatinine clearance of greater than or equal to 30 ml/min
    boolean
    C2711451 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of greater than or equal to 9 months
    boolean
    C0023671 (UMLS CUI [1])
    Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration
    Item
    if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    C0002453 (UMLS CUI [3,1])
    C0449238 (UMLS CUI [3,2])
    Protocol Compliance | Informed Consent
    Item
    ability to comply with trial requirements and give informed consent.
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Diphosphonates Intravenous
    Item
    iv bisphosphonate therapy for more than 3 years.
    boolean
    C0012544 (UMLS CUI [1,1])
    C1522726 (UMLS CUI [1,2])
    amyloidosis
    Item
    patients with a diagnosis of amyloidosis.
    boolean
    C0002726 (UMLS CUI [1])
    Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
    Item
    known hypersensitivity to zoledronic acid or other bisphosphonates
    boolean
    C0020517 (UMLS CUI [1,1])
    C0257685 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0012544 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    pregnant patients or lactating patients.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods
    Item
    women of childbearing potential not on a medically recognized form of contraception
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
    Item
    patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1868885 (UMLS CUI [2])
    C0743118 (UMLS CUI [3])

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