0 Bedömningar

ID

12876

Beskrivning

RIvaroxaban for Valvular Heart disease and atRial Fibrillation Trial -RIVER Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02303795

Länk

https://clinicaltrials.gov/show/NCT02303795

Nyckelord

  1. 2016-01-04 2016-01-04 -
Uppladdad den

4 januari 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Valvular Heart Disease NCT02303795

    Eligibility Valvular Heart Disease NCT02303795

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. male and female patients aged >18 and < 80 years at time of inclusion
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
    Beskrivning

    Paroxysmal atrial fibrillation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0235480 (Paroxysmal atrial fibrillation)
    SNOMED
    282825002
    the patient must be able to give informed consent
    Beskrivning

    informed consent

    Datatyp

    boolean

    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
    Beskrivning

    cardiovascular disease; tumor

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [2]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    active endocarditis
    Beskrivning

    endocarditis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0014118 (Endocarditis)
    SNOMED
    56819008
    LOINC
    LA7432-3
    uncontrolled hypertension
    Beskrivning

    uncontrolled hypertension

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1868885 (Uncontrolled hypertension)
    2. hemorrhage risk-related criteria
    Beskrivning

    hemorrhage

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    active internal bleeding
    Beskrivning

    internal bleeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1390214 (Internal hemorrhage)
    LOINC
    MTHU020848
    history of, or condition associated with, increased bleeding risk
    Beskrivning

    Medical History hemorrhage

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    3. concomitant conditions and therapies
    Beskrivning

    concomitant conditions

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0243086 (undefined)
    history of previous thromboembolism with high risk of bleeding:
    Beskrivning

    thromboembolism

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0040038 (Thromboembolism)
    SNOMED
    13713005
    LOINC
    LP269975-1
    severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
    Beskrivning

    stroke

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
    Beskrivning

    thrombosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0040053 (Thrombosis)
    SNOMED
    118927008
    LOINC
    LP31622-1
    acute mi within the last 14 days prior to randomization
    Beskrivning

    Acute myocardial infarction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0155626 (Acute myocardial infarction)
    SNOMED
    57054005
    treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
    Beskrivning

    aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004057 (aspirin)
    SNOMED
    7947003
    UMLS CUI [2]
    C1096021 (Antiplatelet therapy)
    UMLS CUI [3]
    C0003211 (Anti-Inflammatory Agents, Non-Steroidal)
    SNOMED
    16403005
    anemia
    Beskrivning

    anemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002871 (Anemia)
    SNOMED
    271737000
    LOINC
    MTHU020823
    pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
    Beskrivning

    pregnancy; lactating

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    calculated creatinine clearance b30 ml/min
    Beskrivning

    creatinine clearance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    known significant liver disease or alanine aminotransferase n3× the upper limit of normal
    Beskrivning

    liver disease; alanine aminotransferase

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [2]
    C0001899 (Alanine Transaminase)
    SNOMED
    56935002
    previous participation in this study.
    Beskrivning

    Study Subject Participation Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)

    Similar models

    Eligibility Valvular Heart Disease NCT02303795

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    1. male and female patients aged >18 and < 80 years at time of inclusion
    boolean
    C0001779 (UMLS CUI [1])
    Paroxysmal atrial fibrillation
    Item
    2. patients with persistent or paroxysmal atrial fibrillation with bioprosthetic mitral valves.
    boolean
    C0235480 (UMLS CUI [1])
    informed consent
    Item
    the patient must be able to give informed consent
    boolean
    Item Group
    C0680251 (UMLS CUI)
    cardiovascular disease; tumor
    Item
    1. cardiovascular-related conditions as known presence of cardiac thrombus or tumor
    boolean
    C0007222 (UMLS CUI [1])
    C0027651 (UMLS CUI [2])
    endocarditis
    Item
    active endocarditis
    boolean
    C0014118 (UMLS CUI [1])
    uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    hemorrhage
    Item
    2. hemorrhage risk-related criteria
    boolean
    C0019080 (UMLS CUI [1])
    internal bleeding
    Item
    active internal bleeding
    boolean
    C1390214 (UMLS CUI [1])
    Medical History hemorrhage
    Item
    history of, or condition associated with, increased bleeding risk
    boolean
    C0262926 (UMLS CUI [1,1])
    C0019080 (UMLS CUI [1,2])
    concomitant conditions
    Item
    3. concomitant conditions and therapies
    boolean
    C0243086 (UMLS CUI [1])
    thromboembolism
    Item
    history of previous thromboembolism with high risk of bleeding:
    boolean
    C0040038 (UMLS CUI [1])
    stroke
    Item
    severe, disabling stroke (modified rankin score of 4-5, inclusive) within 3 months
    boolean
    C0038454 (UMLS CUI [1])
    thrombosis
    Item
    acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
    boolean
    C0040053 (UMLS CUI [1])
    Acute myocardial infarction
    Item
    acute mi within the last 14 days prior to randomization
    boolean
    C0155626 (UMLS CUI [1])
    aspirin; Antiplatelet therapy; nonsteroidal antiinflammatory drug
    Item
    treatment with: chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; intravenous antiplatelets; fibrinolytics; anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; systemic treatment with a strong inhibitor of cytochrome p450 3a4, such as ketoconazole or protease inhibitors; treatment with a strong inducer of cytochrome p450 3a4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
    boolean
    C0004057 (UMLS CUI [1])
    C1096021 (UMLS CUI [2])
    C0003211 (UMLS CUI [3])
    anemia
    Item
    anemia
    boolean
    C0002871 (UMLS CUI [1])
    pregnancy; lactating
    Item
    pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    creatinine clearance
    Item
    calculated creatinine clearance b30 ml/min
    boolean
    C0373595 (UMLS CUI [1])
    liver disease; alanine aminotransferase
    Item
    known significant liver disease or alanine aminotransferase n3× the upper limit of normal
    boolean
    C0023895 (UMLS CUI [1])
    C0001899 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    previous participation in this study.
    boolean
    C2348568 (UMLS CUI [1])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial