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ID

38997

Description

A Complex Contraception Registry; ODM derived from: https://clinicaltrials.gov/show/NCT02219269

Link

https://clinicaltrials.gov/show/NCT02219269

Keywords

Versions (2)
  1. 11/18/19 11/18/19 -
  2. 11/19/19 11/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Diabetes NCT02219269

    English

    Eligibility Diabetes NCT02219269

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02219269
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. ethnic background: no limitation, will include minorities
    Description

    Ethnic group Limitation Absent | Minority Groups Included

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015031
    UMLS CUI [1,2]
    C0449295
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2,1]
    C0026192
    UMLS CUI [2,2]
    C0332257
    2. sexually active with men
    Description

    Sexually active Partner in relationship Gender

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0241028
    UMLS CUI [1,2]
    C0682323
    UMLS CUI [1,3]
    C0079399
    3. diagnosis with at least one of the following conditions
    Description

    Diagnosis Condition Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C1265611
    diabetes and other endocrine disorders
    Description

    Diabetes Mellitus | Endocrine System Diseases

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    UMLS CUI [2]
    C0014130
    cardiovascular disease, such as ischemic heart disease, valvular disease, hypertension or pulmonary hypertension
    Description

    Cardiovascular Diseases | Myocardial Ischemia | Valvular disease | Hypertensive disease | Pulmonary Hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0151744
    UMLS CUI [3]
    C3258293
    UMLS CUI [4]
    C0020538
    UMLS CUI [5]
    C0020542
    epilepsy, migraine, and other neurologic disorders
    Description

    Epilepsy | Migraine Disorders | Nervous system disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0014544
    UMLS CUI [2]
    C0149931
    UMLS CUI [3]
    C0027765
    history of or current cancer
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    history of or planning bariatric surgery
    Description

    Bariatric Surgery | Bariatric Surgery Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1456587
    UMLS CUI [2,1]
    C1456587
    UMLS CUI [2,2]
    C1301732
    history of or planning solid organ transplant
    Description

    Solid organ transplant | Solid organ transplant Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0730400
    UMLS CUI [2,1]
    C0730400
    UMLS CUI [2,2]
    C1301732
    systematic lupus erythematous and other rheumatologic conditions
    Description

    Lupus Erythematosus, Systemic | Rheumatic disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024141
    UMLS CUI [2]
    C3495832
    history of or current venous thrombosis embolism
    Description

    Venous thrombosis/embolism

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3150390
    other medical conditions (such as sickle cell disease or cystic fibrosis)
    Description

    Other medical condition | Anemia, Sickle Cell | Cystic Fibrosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3843040
    UMLS CUI [2]
    C0002895
    UMLS CUI [3]
    C0010674
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. pregnant at time of recruitment
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    2. history of hysterectomy, bilateral oophorectomy, or sterilization procedure
    Description

    Hysterectomy | Bilateral oophorectomy | Sexual sterilization

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020699
    UMLS CUI [2]
    C0278321
    UMLS CUI [3]
    C0038288
    3. unable to provide informed consent
    Description

    Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1299582
    4. attempting to become pregnant at time of recruitment
    Description

    Pregnancy Attempt

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C1516084
    5. not sexually active with men
    Description

    Absence Sexually active Partner in relationship Gender

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0241028
    UMLS CUI [1,3]
    C0682323
    UMLS CUI [1,4]
    C0079399
    6. no active telephone number or email for follow up
    Description

    Telephone Number Lacking Follow-up | E-mail Address Lacking Follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C0332268
    UMLS CUI [1,3]
    C3274571
    UMLS CUI [2,1]
    C1705961
    UMLS CUI [2,2]
    C0332268
    UMLS CUI [2,3]
    C3274571
    women who are pregnant will be excluded from this study. however, no pregnancy testing will be conducted; pregnancy status will be based on self-reporting by subjects.
    Description

    Pregnancy Self-Report | Pregnancy Tests Absent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C2700446
    UMLS CUI [2,1]
    C0032976
    UMLS CUI [2,2]
    C0332197
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    Similar models

    Eligibility Diabetes NCT02219269

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Diabetes NCT02219269
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Ethnic group Limitation Absent | Minority Groups Included
    Item
    1. ethnic background: no limitation, will include minorities
    boolean
    C0015031 (UMLS CUI [1,1])
    C0449295 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C0026192 (UMLS CUI [2,1])
    C0332257 (UMLS CUI [2,2])
    Sexually active Partner in relationship Gender
    Item
    2. sexually active with men
    boolean
    C0241028 (UMLS CUI [1,1])
    C0682323 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [1,3])
    Diagnosis Condition Quantity
    Item
    3. diagnosis with at least one of the following conditions
    boolean
    C0011900 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    Diabetes Mellitus | Endocrine System Diseases
    Item
    diabetes and other endocrine disorders
    boolean
    C0011849 (UMLS CUI [1])
    C0014130 (UMLS CUI [2])
    Cardiovascular Diseases | Myocardial Ischemia | Valvular disease | Hypertensive disease | Pulmonary Hypertension
    Item
    cardiovascular disease, such as ischemic heart disease, valvular disease, hypertension or pulmonary hypertension
    boolean
    C0007222 (UMLS CUI [1])
    C0151744 (UMLS CUI [2])
    C3258293 (UMLS CUI [3])
    C0020538 (UMLS CUI [4])
    C0020542 (UMLS CUI [5])
    Epilepsy | Migraine Disorders | Nervous system disorder
    Item
    epilepsy, migraine, and other neurologic disorders
    boolean
    C0014544 (UMLS CUI [1])
    C0149931 (UMLS CUI [2])
    C0027765 (UMLS CUI [3])
    Malignant Neoplasms
    Item
    history of or current cancer
    boolean
    C0006826 (UMLS CUI [1])
    Bariatric Surgery | Bariatric Surgery Planned
    Item
    history of or planning bariatric surgery
    boolean
    C1456587 (UMLS CUI [1])
    C1456587 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Solid organ transplant | Solid organ transplant Planned
    Item
    history of or planning solid organ transplant
    boolean
    C0730400 (UMLS CUI [1])
    C0730400 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Lupus Erythematosus, Systemic | Rheumatic disorder
    Item
    systematic lupus erythematous and other rheumatologic conditions
    boolean
    C0024141 (UMLS CUI [1])
    C3495832 (UMLS CUI [2])
    Venous thrombosis/embolism
    Item
    history of or current venous thrombosis embolism
    boolean
    C3150390 (UMLS CUI [1])
    Other medical condition | Anemia, Sickle Cell | Cystic Fibrosis
    Item
    other medical conditions (such as sickle cell disease or cystic fibrosis)
    boolean
    C3843040 (UMLS CUI [1])
    C0002895 (UMLS CUI [2])
    C0010674 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy
    Item
    1. pregnant at time of recruitment
    boolean
    C0032961 (UMLS CUI [1])
    Hysterectomy | Bilateral oophorectomy | Sexual sterilization
    Item
    2. history of hysterectomy, bilateral oophorectomy, or sterilization procedure
    boolean
    C0020699 (UMLS CUI [1])
    C0278321 (UMLS CUI [2])
    C0038288 (UMLS CUI [3])
    Informed Consent Unable
    Item
    3. unable to provide informed consent
    boolean
    C0021430 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Pregnancy Attempt
    Item
    4. attempting to become pregnant at time of recruitment
    boolean
    C0032961 (UMLS CUI [1,1])
    C1516084 (UMLS CUI [1,2])
    Absence Sexually active Partner in relationship Gender
    Item
    5. not sexually active with men
    boolean
    C0332197 (UMLS CUI [1,1])
    C0241028 (UMLS CUI [1,2])
    C0682323 (UMLS CUI [1,3])
    C0079399 (UMLS CUI [1,4])
    Telephone Number Lacking Follow-up | E-mail Address Lacking Follow-up
    Item
    6. no active telephone number or email for follow up
    boolean
    C1515258 (UMLS CUI [1,1])
    C0332268 (UMLS CUI [1,2])
    C3274571 (UMLS CUI [1,3])
    C1705961 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    C3274571 (UMLS CUI [2,3])
    Pregnancy Self-Report | Pregnancy Tests Absent
    Item
    women who are pregnant will be excluded from this study. however, no pregnancy testing will be conducted; pregnancy status will be based on self-reporting by subjects.
    boolean
    C0032961 (UMLS CUI [1,1])
    C2700446 (UMLS CUI [1,2])
    C0032976 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
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