0 Avaliações
ID

36379

Descrição

Oral Nitrite Placebo Controlled Trial for Hypertension and Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT02517697

Link

https://clinicaltrials.gov/show/NCT02517697

Palavras-chave

Versões (1)
  1. 08/05/2019 08/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Metabolic Syndrome NCT02517697

    Inglês

    Eligibility Metabolic Syndrome NCT02517697

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age 18-60 years
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    bmi ≥ 30 kg/m2
    Descrição

    Body mass index

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure
    Descrição

    Hypertensive disease | Systolic Pressure | Diastolic blood pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2]
    C0871470
    UMLS CUI [3]
    C0428883
    ≥85 mm hg
    Descrição

    ID.4

    Tipo de dados

    boolean

    waist circumference: >102 cm in men, >88 cm in women
    Descrição

    Waist Circumference | Gender

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0455829
    UMLS CUI [2]
    C0079399
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    positive urine pregnancy test or breastfeeding
    Descrição

    Urine pregnancy test positive | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0430059
    UMLS CUI [2]
    C0006147
    concurrent use of medications affecting glucose or lipid metabolism (oral hypoglycemics, insulin, statins, atypical antipsychotics)
    Descrição

    Pharmaceutical Preparations Affecting Glucose metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Oral hypoglycemic | Insulin | Statins | Atypical antipsychotic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0596620
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0598783
    UMLS CUI [3]
    C0359086
    UMLS CUI [4]
    C0021641
    UMLS CUI [5]
    C0360714
    UMLS CUI [6]
    C1276996
    recent addition or change in dosing of hormonal contraceptive medications (ocp, iud, depoprovera)
    Descrição

    Oral Hormonal Contraceptives Dosage Addition | Oral Hormonal Contraceptives Change in drug dosage | Contraceptives, Oral | Intrauterine Devices | Depo-Provera

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009907
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0332287
    UMLS CUI [2,1]
    C0009907
    UMLS CUI [2,2]
    C0420247
    UMLS CUI [3]
    C0009905
    UMLS CUI [4]
    C0021900
    UMLS CUI [5]
    C0699700
    current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
    Descrição

    Antihypertensive Agents Quantity | Independent of Control of blood pressure | Antihypertensive Agent Single Normal blood pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0003364
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2,1]
    C0332291
    UMLS CUI [2,2]
    C1753303
    UMLS CUI [3,1]
    C0003364
    UMLS CUI [3,2]
    C0205171
    UMLS CUI [3,3]
    C2712122
    current use of pd5 inhibitors or organic nitrates
    Descrição

    Phosphodiesterase 5 inhibitor | Nitrates organic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1318700
    UMLS CUI [2,1]
    C0028125
    UMLS CUI [2,2]
    C0747055
    not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
    Descrição

    Therapeutic procedure Unstable | Medication dose Changing Blood Pressure | Medication dose Changing Contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0443343
    UMLS CUI [2,1]
    C3174092
    UMLS CUI [2,2]
    C0392747
    UMLS CUI [2,3]
    C0005823
    UMLS CUI [3,1]
    C3174092
    UMLS CUI [3,2]
    C0392747
    UMLS CUI [3,3]
    C0700589
    known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
    Descrição

    Chronic mental disorder | Chronic disease | Diabetes Mellitus chronic | Chronic liver disease | Chronic Kidney Diseases | Obesity chronic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0870281
    UMLS CUI [2]
    C0008679
    UMLS CUI [3,1]
    C0011849
    UMLS CUI [3,2]
    C0205191
    UMLS CUI [4]
    C0341439
    UMLS CUI [5]
    C1561643
    UMLS CUI [6,1]
    C0028754
    UMLS CUI [6,2]
    C0205191
    tsh >8 miu/ml
    Descrição

    Thyroid stimulating hormone measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0202230
    smoker
    Descrição

    Tobacco use

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    anemia (central lab hemoglobin < 11g/dl)
    Descrição

    Anemia | Hemoglobin measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    UMLS CUI [2]
    C0518015
    active periodontal disease
    Descrição

    Periodontal Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0031090
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    Similar models

    Eligibility Metabolic Syndrome NCT02517697

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age 18-60 years
    boolean
    C0001779 (UMLS CUI [1])
    Body mass index
    Item
    bmi ≥ 30 kg/m2
    boolean
    C1305855 (UMLS CUI [1])
    Hypertensive disease | Systolic Pressure | Diastolic blood pressure
    Item
    hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure
    boolean
    C0020538 (UMLS CUI [1])
    C0871470 (UMLS CUI [2])
    C0428883 (UMLS CUI [3])
    ID.4
    Item
    ≥85 mm hg
    boolean
    Waist Circumference | Gender
    Item
    waist circumference: >102 cm in men, >88 cm in women
    boolean
    C0455829 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Urine pregnancy test positive | Breast Feeding
    Item
    positive urine pregnancy test or breastfeeding
    boolean
    C0430059 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Pharmaceutical Preparations Affecting Glucose metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Oral hypoglycemic | Insulin | Statins | Atypical antipsychotic
    Item
    concurrent use of medications affecting glucose or lipid metabolism (oral hypoglycemics, insulin, statins, atypical antipsychotics)
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0596620 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0598783 (UMLS CUI [2,3])
    C0359086 (UMLS CUI [3])
    C0021641 (UMLS CUI [4])
    C0360714 (UMLS CUI [5])
    C1276996 (UMLS CUI [6])
    Oral Hormonal Contraceptives Dosage Addition | Oral Hormonal Contraceptives Change in drug dosage | Contraceptives, Oral | Intrauterine Devices | Depo-Provera
    Item
    recent addition or change in dosing of hormonal contraceptive medications (ocp, iud, depoprovera)
    boolean
    C0009907 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0332287 (UMLS CUI [1,3])
    C0009907 (UMLS CUI [2,1])
    C0420247 (UMLS CUI [2,2])
    C0009905 (UMLS CUI [3])
    C0021900 (UMLS CUI [4])
    C0699700 (UMLS CUI [5])
    Antihypertensive Agents Quantity | Independent of Control of blood pressure | Antihypertensive Agent Single Normal blood pressure
    Item
    current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
    boolean
    C0003364 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0332291 (UMLS CUI [2,1])
    C1753303 (UMLS CUI [2,2])
    C0003364 (UMLS CUI [3,1])
    C0205171 (UMLS CUI [3,2])
    C2712122 (UMLS CUI [3,3])
    Phosphodiesterase 5 inhibitor | Nitrates organic
    Item
    current use of pd5 inhibitors or organic nitrates
    boolean
    C1318700 (UMLS CUI [1])
    C0028125 (UMLS CUI [2,1])
    C0747055 (UMLS CUI [2,2])
    Therapeutic procedure Unstable | Medication dose Changing Blood Pressure | Medication dose Changing Contraception
    Item
    not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0443343 (UMLS CUI [1,2])
    C3174092 (UMLS CUI [2,1])
    C0392747 (UMLS CUI [2,2])
    C0005823 (UMLS CUI [2,3])
    C3174092 (UMLS CUI [3,1])
    C0392747 (UMLS CUI [3,2])
    C0700589 (UMLS CUI [3,3])
    Chronic mental disorder | Chronic disease | Diabetes Mellitus chronic | Chronic liver disease | Chronic Kidney Diseases | Obesity chronic
    Item
    known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
    boolean
    C0870281 (UMLS CUI [1])
    C0008679 (UMLS CUI [2])
    C0011849 (UMLS CUI [3,1])
    C0205191 (UMLS CUI [3,2])
    C0341439 (UMLS CUI [4])
    C1561643 (UMLS CUI [5])
    C0028754 (UMLS CUI [6,1])
    C0205191 (UMLS CUI [6,2])
    Thyroid stimulating hormone measurement
    Item
    tsh >8 miu/ml
    boolean
    C0202230 (UMLS CUI [1])
    Tobacco use
    Item
    smoker
    boolean
    C0543414 (UMLS CUI [1])
    Anemia | Hemoglobin measurement
    Item
    anemia (central lab hemoglobin < 11g/dl)
    boolean
    C0002871 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    Periodontal Disease
    Item
    active periodontal disease
    boolean
    C0031090 (UMLS CUI [1])
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