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ID

44289

Description

Smoking Study With Behavioral Therapy for Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00879177

Lien

https://clinicaltrials.gov/show/NCT00879177

Mots-clés

  1. 18/12/2017 18/12/2017 -
  2. 20/09/2021 20/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2021

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Cigarette Smoking NCT00879177

    Eligibility Cigarette Smoking NCT00879177

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    regular smokers, with no period of abstinence exceeding 3 months in past year
    Description

    Tobacco use Regular | Abstinence Period Lacking

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0205272
    UMLS CUI [2,1]
    C0814442
    UMLS CUI [2,2]
    C1948053
    UMLS CUI [2,3]
    C0332268
    expired co of at least 8 ppm
    Description

    Expired carbon monoxide concentration

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0429695
    self-reported desire to stop smoking
    Description

    wishes to stop smoking

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2203279
    at least 18 years of age
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    resting systolic bp of 120-160 mmhg and/or diastolic bp of 80-100 mmhg but otherwise in good health (see exclusion criteria)
    Description

    Systolic blood pressure at rest | Diastolic blood pressure at rest | General health good

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2039694
    UMLS CUI [2]
    C2183311
    UMLS CUI [3]
    C1277245
    if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
    Description

    Antihypertensive Agents unchanged

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0003364
    UMLS CUI [1,2]
    C0442739
    english speaking
    Description

    Able to speak English Language

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0564215
    UMLS CUI [1,2]
    C0376245
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
    Description

    Smoking cessation therapy | Smoking cessation drug therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1095963
    UMLS CUI [2]
    C4075828
    serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
    Description

    Disease; Serious | Disease Unstable | Myocardial Infarction | Malignant Neoplasms | Congestive heart failure | Kidney Failure | Cerebrovascular accident | Seizures

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0443343
    UMLS CUI [3]
    C0027051
    UMLS CUI [4]
    C0006826
    UMLS CUI [5]
    C0018802
    UMLS CUI [6]
    C0035078
    UMLS CUI [7]
    C0038454
    UMLS CUI [8]
    C0036572
    evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ecg) abnormalities
    Description

    Allergic Reaction Varenicline | Medical contraindication Varenicline | Laboratory test result abnormal | ECG abnormality

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C1569608
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C1569608
    UMLS CUI [3]
    C0438215
    UMLS CUI [4]
    C0522055
    breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
    Description

    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Lacking

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0032961
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0332268
    arm circumference of >42 cm, which precludes accurate bp monitoring
    Description

    Circumference of arm Excludes Blood pressure monitoring

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2075184
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0026426
    serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
    Description

    Mental disorders Serious | Schizophrenia | Psychotic Disorders | At risk for suicide | Substance Dependence | Exception Nicotine Dependence

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2]
    C0036341
    UMLS CUI [3]
    C0033975
    UMLS CUI [4]
    C0563664
    UMLS CUI [5]
    C0038580
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0028043
    use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
    Description

    Tobacco use | Exception Cigarette | Smoking abstinence Unwilling

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0677453
    UMLS CUI [3,1]
    C0814442
    UMLS CUI [3,2]
    C0558080
    ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
    Description

    Nicotine replacement therapy | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Mood Stabilizers | Naltrexone

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278444
    UMLS CUI [2]
    C0026457
    UMLS CUI [3]
    C0040615
    UMLS CUI [4]
    C4020582
    UMLS CUI [5]
    C0027360
    in recovery for pathological gambling
    Description

    Recovery Pathological Gambling

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0237820
    UMLS CUI [1,2]
    C0030662

    Similar models

    Eligibility Cigarette Smoking NCT00879177

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Tobacco use Regular | Abstinence Period Lacking
    Item
    regular smokers, with no period of abstinence exceeding 3 months in past year
    boolean
    C0543414 (UMLS CUI [1,1])
    C0205272 (UMLS CUI [1,2])
    C0814442 (UMLS CUI [2,1])
    C1948053 (UMLS CUI [2,2])
    C0332268 (UMLS CUI [2,3])
    Expired carbon monoxide concentration
    Item
    expired co of at least 8 ppm
    boolean
    C0429695 (UMLS CUI [1])
    wishes to stop smoking
    Item
    self-reported desire to stop smoking
    boolean
    C2203279 (UMLS CUI [1])
    Age
    Item
    at least 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Systolic blood pressure at rest | Diastolic blood pressure at rest | General health good
    Item
    resting systolic bp of 120-160 mmhg and/or diastolic bp of 80-100 mmhg but otherwise in good health (see exclusion criteria)
    boolean
    C2039694 (UMLS CUI [1])
    C2183311 (UMLS CUI [2])
    C1277245 (UMLS CUI [3])
    Antihypertensive Agents unchanged
    Item
    if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months
    boolean
    C0003364 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    Able to speak English Language
    Item
    english speaking
    boolean
    C0564215 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Smoking cessation therapy | Smoking cessation drug therapy
    Item
    receipt of smoking cessation treatment (behavioral or pharmacological) in the past month
    boolean
    C1095963 (UMLS CUI [1])
    C4075828 (UMLS CUI [2])
    Disease; Serious | Disease Unstable | Myocardial Infarction | Malignant Neoplasms | Congestive heart failure | Kidney Failure | Cerebrovascular accident | Seizures
    Item
    serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0012634 (UMLS CUI [2,1])
    C0443343 (UMLS CUI [2,2])
    C0027051 (UMLS CUI [3])
    C0006826 (UMLS CUI [4])
    C0018802 (UMLS CUI [5])
    C0035078 (UMLS CUI [6])
    C0038454 (UMLS CUI [7])
    C0036572 (UMLS CUI [8])
    Allergic Reaction Varenicline | Medical contraindication Varenicline | Laboratory test result abnormal | ECG abnormality
    Item
    evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ecg) abnormalities
    boolean
    C1527304 (UMLS CUI [1,1])
    C1569608 (UMLS CUI [1,2])
    C1301624 (UMLS CUI [2,1])
    C1569608 (UMLS CUI [2,2])
    C0438215 (UMLS CUI [3])
    C0522055 (UMLS CUI [4])
    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Lacking
    Item
    breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential
    boolean
    C0006147 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0332268 (UMLS CUI [3,3])
    Circumference of arm Excludes Blood pressure monitoring
    Item
    arm circumference of >42 cm, which precludes accurate bp monitoring
    boolean
    C2075184 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0026426 (UMLS CUI [1,3])
    Mental disorders Serious | Schizophrenia | Psychotic Disorders | At risk for suicide | Substance Dependence | Exception Nicotine Dependence
    Item
    serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine)
    boolean
    C0004936 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0036341 (UMLS CUI [2])
    C0033975 (UMLS CUI [3])
    C0563664 (UMLS CUI [4])
    C0038580 (UMLS CUI [5])
    C1705847 (UMLS CUI [6,1])
    C0028043 (UMLS CUI [6,2])
    Tobacco use | Exception Cigarette | Smoking abstinence Unwilling
    Item
    use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation
    boolean
    C0543414 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0677453 (UMLS CUI [2,2])
    C0814442 (UMLS CUI [3,1])
    C0558080 (UMLS CUI [3,2])
    Nicotine replacement therapy | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Mood Stabilizers | Naltrexone
    Item
    ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone
    boolean
    C1278444 (UMLS CUI [1])
    C0026457 (UMLS CUI [2])
    C0040615 (UMLS CUI [3])
    C4020582 (UMLS CUI [4])
    C0027360 (UMLS CUI [5])
    Recovery Pathological Gambling
    Item
    in recovery for pathological gambling
    boolean
    C0237820 (UMLS CUI [1,1])
    C0030662 (UMLS CUI [1,2])

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