0 Ratings
ID

44239

Description

Marinobufagenin as a Target for DIGIBIND in Hypertensive Patients With End-stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00852787

Link

https://clinicaltrials.gov/show/NCT00852787

Keywords

Versions (2)
  1. 5/2/18 5/2/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

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September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Hypertension NCT00852787

    English

    Eligibility Hypertension NCT00852787

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    aged 18-75 years of age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    on hemodialysis with predialysis bp > 150/90 but ≤ 180/110
    Description

    Hemodialysis | Blood pressure Pre Dialysis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019004 (Hemodialysis)
    SNOMED
    302497006
    LOINC
    LA9975-9
    UMLS CUI [2,1]
    C0005824 (Blood pressure determination)
    SNOMED
    46973005
    UMLS CUI [2,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2,3]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    on at least one anti-hypertensive medication for 6 consecutive readings
    Description

    Antihypertensive Agents Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003364 (Antihypertensive Agents)
    SNOMED
    1182007
    LOINC
    LP31453-1
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    able to have blood pressure measured in an arm
    Description

    Blood pressure measurement Arm

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005824 (Blood pressure determination)
    SNOMED
    46973005
    UMLS CUI [1,2]
    C1269078 (Entire upper limb)
    SNOMED
    182245002
    women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
    Description

    Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,3]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [2,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [2,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    receiving adequate dialysis (kt/v > 1.2)
    Description

    Dialysis kt/V

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [1,2]
    C0429662 (hemodialysis - kt/V)
    SNOMED
    251868007
    compliant with the dialysis schedule and duration
    Description

    Compliance Dialysis Schedule | Compliance Dialysis Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [1,3]
    C0086960 (Schedule (document type))
    UMLS CUI [2,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,2]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [2,3]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    pregnant or nursing women
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    arm blood pressure is not possible to obtain
    Description

    Blood pressure measurement Arm Unsuccessful

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005824 (Blood pressure determination)
    SNOMED
    46973005
    UMLS CUI [1,2]
    C1269078 (Entire upper limb)
    SNOMED
    182245002
    UMLS CUI [1,3]
    C1272705 (Unsuccessful)
    SNOMED
    385671000
    currently on digitalis
    Description

    Digitalis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0304520 (Digitalis preparation)
    SNOMED
    387521006
    on any digibind-type product in the past
    Description

    Digibind Type Product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0687706 (Digibind)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    UMLS CUI [1,3]
    C1514468 (product)
    history of allergies to antibiotics
    Description

    Allergy to antibiotic agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0455591 (allergy to antibiotic agents)
    history of asthma
    Description

    Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
    Description

    Disease Unstable | Mental disorders Unstable | Disease Interferes with Research results | Mental disorders Interfere with Research results | Disease Interferes with Study Subject Participation Status | Mental disorders Interfere with Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    UMLS CUI [2,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2,2]
    C0443343 (Unstable status)
    SNOMED
    263922001
    LOINC
    LP28572-3
    UMLS CUI [3,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [3,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [3,3]
    C0683954 (research results)
    UMLS CUI [4,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [4,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [4,3]
    C0683954 (research results)
    UMLS CUI [5,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [5,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [5,3]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [6,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [6,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [6,3]
    C2348568 (Study Subject Participation Status)
    history of use of, or evidence of need for, digitalis-like products
    Description

    Digitalis Similar Product | Patient need for Digitalis Similar Product

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304520 (Digitalis preparation)
    SNOMED
    387521006
    UMLS CUI [1,2]
    C2348205 (Similarity)
    UMLS CUI [1,3]
    C1514468 (product)
    UMLS CUI [2,1]
    C0686904 (Patient need for (contextual qualifier))
    SNOMED
    103325001
    UMLS CUI [2,2]
    C0304520 (Digitalis preparation)
    SNOMED
    387521006
    UMLS CUI [2,3]
    C2348205 (Similarity)
    UMLS CUI [2,4]
    C1514468 (product)
    inability to understand or provide informed consent
    Description

    Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
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    Similar models

    Eligibility Hypertension NCT00852787

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged 18-75 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Hemodialysis | Blood pressure Pre Dialysis
    Item
    on hemodialysis with predialysis bp > 150/90 but ≤ 180/110
    boolean
    C0019004 (UMLS CUI [1])
    C0005824 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    C0011946 (UMLS CUI [2,3])
    Antihypertensive Agents Quantity
    Item
    on at least one anti-hypertensive medication for 6 consecutive readings
    boolean
    C0003364 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Blood pressure measurement Arm
    Item
    able to have blood pressure measured in an arm
    boolean
    C0005824 (UMLS CUI [1,1])
    C1269078 (UMLS CUI [1,2])
    Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
    Item
    women of child bearing potential must not be pregnant; must use contraception during the study and for one month after the study
    boolean
    C3831118 (UMLS CUI [1,1])
    C0032961 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C3831118 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    Dialysis kt/V
    Item
    receiving adequate dialysis (kt/v > 1.2)
    boolean
    C0011946 (UMLS CUI [1,1])
    C0429662 (UMLS CUI [1,2])
    Compliance Dialysis Schedule | Compliance Dialysis Duration
    Item
    compliant with the dialysis schedule and duration
    boolean
    C1321605 (UMLS CUI [1,1])
    C0011946 (UMLS CUI [1,2])
    C0086960 (UMLS CUI [1,3])
    C1321605 (UMLS CUI [2,1])
    C0011946 (UMLS CUI [2,2])
    C0449238 (UMLS CUI [2,3])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding
    Item
    pregnant or nursing women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Blood pressure measurement Arm Unsuccessful
    Item
    arm blood pressure is not possible to obtain
    boolean
    C0005824 (UMLS CUI [1,1])
    C1269078 (UMLS CUI [1,2])
    C1272705 (UMLS CUI [1,3])
    Digitalis
    Item
    currently on digitalis
    boolean
    C0304520 (UMLS CUI [1])
    Digibind Type Product
    Item
    on any digibind-type product in the past
    boolean
    C0687706 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1514468 (UMLS CUI [1,3])
    Allergy to antibiotic agents
    Item
    history of allergies to antibiotics
    boolean
    C0455591 (UMLS CUI [1])
    Asthma
    Item
    history of asthma
    boolean
    C0004096 (UMLS CUI [1])
    Disease Unstable | Mental disorders Unstable | Disease Interferes with Research results | Mental disorders Interfere with Research results | Disease Interferes with Study Subject Participation Status | Mental disorders Interfere with Study Subject Participation Status
    Item
    medical or psychiatric disorders which are unstable or which might interfere with study assessments or safe participation in the study
    boolean
    C0012634 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    C0012634 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C0683954 (UMLS CUI [3,3])
    C0004936 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0683954 (UMLS CUI [4,3])
    C0012634 (UMLS CUI [5,1])
    C0521102 (UMLS CUI [5,2])
    C2348568 (UMLS CUI [5,3])
    C0004936 (UMLS CUI [6,1])
    C0521102 (UMLS CUI [6,2])
    C2348568 (UMLS CUI [6,3])
    Digitalis Similar Product | Patient need for Digitalis Similar Product
    Item
    history of use of, or evidence of need for, digitalis-like products
    boolean
    C0304520 (UMLS CUI [1,1])
    C2348205 (UMLS CUI [1,2])
    C1514468 (UMLS CUI [1,3])
    C0686904 (UMLS CUI [2,1])
    C0304520 (UMLS CUI [2,2])
    C2348205 (UMLS CUI [2,3])
    C1514468 (UMLS CUI [2,4])
    Informed Consent Unable
    Item
    inability to understand or provide informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
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