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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