0 Avaliações
ID

31261

Descrição

To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00662896

Link

https://clinicaltrials.gov/show/NCT00662896

Palavras-chave

Versões (1)
  1. 05/08/2018 05/08/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de agosto de 2018

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Osteoarthritis NCT00662896

    Inglês

    Eligibility Osteoarthritis NCT00662896

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    men/women, 40 or older, diagnosed with hip or knee osteoarthritis.
    Descrição

    Age | Osteoarthritis of hip | Osteoarthritis, Knee

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0029410 (Osteoarthritis of hip)
    SNOMED
    239872002
    UMLS CUI [3]
    C0409959 (Osteoarthritis, Knee)
    SNOMED
    239873007
    hypertensive patient with treated and controlled essential hypertension.
    Descrição

    Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020538 (Hypertensive disease)
    SNOMED
    38341003
    LOINC
    MTHU020789
    UMLS CUI [2,1]
    C0085580 (Essential Hypertension)
    SNOMED
    59621000
    UMLS CUI [2,2]
    C1522326 (Treating)
    UMLS CUI [3,1]
    C0085580 (Essential Hypertension)
    SNOMED
    59621000
    UMLS CUI [3,2]
    C2911690 (Disease Controlled)
    must receive at least one antihypertensive treatment from the following drug classes: diuretic, angiotensin-converting enzyme (ace) inhibitor, angiotensin receptor blockers (arb) or beta-blocker (bb).
    Descrição

    Antihypertensive therapy Quantity | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0585941 (Antihypertensive therapy)
    SNOMED
    308116003
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [2]
    C0012798 (Diuretics)
    SNOMED
    30492008
    LOINC
    LP18047-8
    UMLS CUI [3]
    C0003015 (Angiotensin-Converting Enzyme Inhibitors)
    SNOMED
    372733002
    UMLS CUI [4]
    C0521942 (Angiotensin II receptor antagonist)
    SNOMED
    372913009
    UMLS CUI [5]
    C0001645 (Adrenergic beta-Antagonists)
    SNOMED
    373254001
    must be current chronic user of nsaids or acetaminophen.
    Descrição

    NSAIDs chronic | Acetaminophen chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0003211 (Anti-Inflammatory Agents, Non-Steroidal)
    SNOMED
    16403005
    UMLS CUI [1,2]
    C0205191 (chronic)
    SNOMED
    90734009
    UMLS CUI [2,1]
    C0000970 (acetaminophen)
    SNOMED
    90332006
    UMLS CUI [2,2]
    C0205191 (chronic)
    SNOMED
    90734009
    must discontinue all analgesic therapy at screening.
    Descrição

    Analgesic therapy To be stopped

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0412784 (Analgesic technique)
    SNOMED
    241715001
    UMLS CUI [1,2]
    C1272691 (To be stopped)
    SNOMED
    385654001
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    more than two different classes of antihypertensive drugs.
    Descrição

    Antihypertensive Agents Class Quantity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0003364 (Antihypertensive Agents)
    SNOMED
    1182007
    LOINC
    LP31453-1
    UMLS CUI [1,2]
    C0456387 (Class)
    SNOMED
    277046005
    UMLS CUI [1,3]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    uncontrolled diabetes.
    Descrição

    Diabetic - poor control

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0421258 (Diabetic - poor control)
    SNOMED
    268519009
    hepatic or renal impairment.
    Descrição

    Hepatic impairment | Renal Insufficiency

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0948807 (Hepatic impairment)
    UMLS CUI [2]
    C1565489 (Renal Insufficiency)
    SNOMED
    236423003
    a history of alcohol/drug abuse.
    Descrição

    Substance Use Disorders

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
    Descrição

    Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0038358 (Gastric ulcer)
    SNOMED
    397825006
    UMLS CUI [2]
    C0013295 (Duodenal Ulcer)
    SNOMED
    51868009
    UMLS CUI [3]
    C1096494 (Gastroduodenal haemorrhage)
    history of congestive heart failure.
    Descrição

    Congestive heart failure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    clinically relevant abnormal ecg.
    Descrição

    ECG abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk.
    Descrição

    Disease Interferes with Study Protocol | Disease At risk Patient safety

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [1,3]
    C2348563 (Study Protocol)
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C1444641 (At risk)
    SNOMED
    410519009
    LOINC
    LA19952-3
    UMLS CUI [2,3]
    C1113679 (patient safety)
    current or expected use of anticoagulants.
    Descrição

    Anticoagulants | Anticoagulants Expected

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003280 (Anticoagulants)
    SNOMED
    81839001
    UMLS CUI [2,1]
    C0003280 (Anticoagulants)
    SNOMED
    81839001
    UMLS CUI [2,2]
    C1517001 (Expected (qualifier))
    participation within 30 days prior to pre-screening in another investigational study.
    Descrição

    Study Subject Participation Status | Clinical Trial

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
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    Similar models

    Eligibility Osteoarthritis NCT00662896

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Osteoarthritis of hip | Osteoarthritis, Knee
    Item
    men/women, 40 or older, diagnosed with hip or knee osteoarthritis.
    boolean
    C0001779 (UMLS CUI [1])
    C0029410 (UMLS CUI [2])
    C0409959 (UMLS CUI [3])
    Hypertensive disease | Essential Hypertension Treated | Essential Hypertension Controlled
    Item
    hypertensive patient with treated and controlled essential hypertension.
    boolean
    C0020538 (UMLS CUI [1])
    C0085580 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0085580 (UMLS CUI [3,1])
    C2911690 (UMLS CUI [3,2])
    Antihypertensive therapy Quantity | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-Antagonists
    Item
    must receive at least one antihypertensive treatment from the following drug classes: diuretic, angiotensin-converting enzyme (ace) inhibitor, angiotensin receptor blockers (arb) or beta-blocker (bb).
    boolean
    C0585941 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0012798 (UMLS CUI [2])
    C0003015 (UMLS CUI [3])
    C0521942 (UMLS CUI [4])
    C0001645 (UMLS CUI [5])
    NSAIDs chronic | Acetaminophen chronic
    Item
    must be current chronic user of nsaids or acetaminophen.
    boolean
    C0003211 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C0000970 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    Analgesic therapy To be stopped
    Item
    must discontinue all analgesic therapy at screening.
    boolean
    C0412784 (UMLS CUI [1,1])
    C1272691 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Antihypertensive Agents Class Quantity
    Item
    more than two different classes of antihypertensive drugs.
    boolean
    C0003364 (UMLS CUI [1,1])
    C0456387 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Diabetic - poor control
    Item
    uncontrolled diabetes.
    boolean
    C0421258 (UMLS CUI [1])
    Hepatic impairment | Renal Insufficiency
    Item
    hepatic or renal impairment.
    boolean
    C0948807 (UMLS CUI [1])
    C1565489 (UMLS CUI [2])
    Substance Use Disorders
    Item
    a history of alcohol/drug abuse.
    boolean
    C0038586 (UMLS CUI [1])
    Gastric ulcer | Duodenal Ulcer | Gastroduodenal haemorrhage
    Item
    diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
    boolean
    C0038358 (UMLS CUI [1])
    C0013295 (UMLS CUI [2])
    C1096494 (UMLS CUI [3])
    Congestive heart failure
    Item
    history of congestive heart failure.
    boolean
    C0018802 (UMLS CUI [1])
    ECG abnormal
    Item
    clinically relevant abnormal ecg.
    boolean
    C0522055 (UMLS CUI [1])
    Disease Interferes with Study Protocol | Disease At risk Patient safety
    Item
    current or history of a medical disease that could interfere with the study objectives or put the patient's safety at risk.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C2348563 (UMLS CUI [1,3])
    C0012634 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C1113679 (UMLS CUI [2,3])
    Anticoagulants | Anticoagulants Expected
    Item
    current or expected use of anticoagulants.
    boolean
    C0003280 (UMLS CUI [1])
    C0003280 (UMLS CUI [2,1])
    C1517001 (UMLS CUI [2,2])
    Study Subject Participation Status | Clinical Trial
    Item
    participation within 30 days prior to pre-screening in another investigational study.
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2])
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