ID

16475

Descrição

Exercise in Women at Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00092950

Link

https://clinicaltrials.gov/show/NCT00092950

Palavras-chave

  1. 17/07/2016 17/07/2016 -
  2. 18/07/2016 18/07/2016 -
Transferido a

18 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00092950

Eligibility Breast Neoplasms NCT00092950

Criteria
Descrição

Criteria

this study will enroll 40 breast cancer survivors and 40 women at high risk for breast cancer. all participants must fulfill the following criteria:
Descrição

Breast Carcinoma Survivors | Gender At high risk for breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C4047809
age 18 to 75.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
sedentary at baseline, as defined by a weekly leisure-time activity score of 15 or less on the godin leisure-time exercise questionnaire. this cutoff is equivalent to engaging in moderate activity less than 3 times a week.
Descrição

Sedentary | Leisure Activities Weekly Score | Exercise Leisure Questionnaires | Moderate activity Weekly Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1532253
UMLS CUI [2,1]
C0023292
UMLS CUI [2,2]
C0332174
UMLS CUI [2,3]
C0449820
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0086542
UMLS CUI [3,3]
C0034394
UMLS CUI [4,1]
C3833417
UMLS CUI [4,2]
C0332174
UMLS CUI [4,3]
C1265611
ability to complete all study questionnaires, or a willing friend or family member who will assist in questionnaire completion.
Descrição

Clinical Trial Subject Questionnaire Completion Ability | Clinical Trial Subject Questionnaire Completion Assisted

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3890411
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C3890411
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1269765
ecog performance status 0-1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
ability to successfully perform the level of physical activity prescribed by the protocol, as assessed by the physical activity readiness questionnaire (par-q).
Descrição

Physical activity Level Perform Ability

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026606
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C0884358
UMLS CUI [1,4]
C0085732
any participant who answers yes to any of the questions in this screening tool will undergo medical evaluation at the clinical center, as appropriate, prior to enrolling on the study.
Descrição

answered questions Screening | Clinical Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0508431
UMLS CUI [1,2]
C0220908
UMLS CUI [2]
C1261322
cardiac risk will be assessed after a complete history and physical exam, and will be determined by the examining physician. only patients who are felt to be increased cardiac risk will have an ekg performed. this will include patients who answer yes to any of the questions on the par-q that assess cardiac risk (#1,2,3,4,6). patients with worrisome ekg findings or findings in the history or physical exam that warrant further work-up in the opinion of the health care provider will be referred to the cardiology consult service, or if non-urgent, will be referred back to their source of regular medical care for clearance prior to enrolling on the study.
Descrição

Cardiac heart disease risk | Physical Examination | Electrocardiography Due to Cardiac heart disease risk Increased | Medical care Regular

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2734561
UMLS CUI [2]
C0031809
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C2734561
UMLS CUI [3,4]
C0205217
UMLS CUI [4,1]
C0496675
UMLS CUI [4,2]
C0205272
if history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment and no history of cancer directed treatment in the 2 years preceding enrollment.
Descrição

Malignant Neoplasms | Invasive carcinoma of breast | Squamous cell carcinoma of skin | Basal cell carcinoma | Disease Evidence of | cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0853879
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0007117
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332120
UMLS CUI [6]
C0920425
breast cancer survivors:
Descrição

Breast Carcinoma Survivors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
eligible breast cancer survivors will be women with a documented history of stage i, ii or iii invasive breast cancer who are at least two months from the completion of their primary therapy, including surgery, radiation and chemotherapy. current use of hormonal therapy such as tamoxifen or aromatase inhibitors, will be permitted, however subjects must have completed 2 months of hormonal therapy prior to beginning the study in order to achieve steady state.
Descrição

Breast Carcinoma Survivors | Gender | Invasive carcinoma of breast | TNM clinical staging | First line treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Tamoxifen | Aromatase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0206194
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0853879
UMLS CUI [4]
C3258246
UMLS CUI [5]
C1708063
UMLS CUI [6]
C0543467
UMLS CUI [7]
C1522449
UMLS CUI [8]
C0392920
UMLS CUI [9]
C0279025
UMLS CUI [10]
C0039286
UMLS CUI [11]
C0593802
women at high risk for breast cancer:
Descrição

Gender At high risk for breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C4047809
women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
Descrição

Gender At high risk for breast cancer | criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C4047809
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
a gail model risk of greater than or equal to1.7 percent over 5 years from study entry or a claus model lifetime risk of greater than 20 percent.
Descrição

Gail Risk Model | Claus Model Lifetime Risk

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1511297
UMLS CUI [2,1]
C1707405
UMLS CUI [2,2]
C1517878
lobular neoplasia.
Descrição

Lobular Neoplasia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0861352
atypical ductal hyperplasia.
Descrição

Atypical ductal hyperplasia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0442834
ductal carcinoma in situ (dcis) that has been previously treated. patients must be at least 2 months from completion of primary therapy, and if treated with hormonal therapy, they must have completed at least two months of hormonal therapy.
Descrição

Prior Therapy Noninfiltrating Intraductal Carcinoma | First line treatment Complete | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007124
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0279025
deleterious mutations in brca-1 or 2 or a priori risk assessment of 20 percent chance or greater of carrying a brca1/2 gene mutation. the brcapro model (109) will be used to assess this risk.
Descrição

BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation | Risk Assessment BRCAPRO | BRCA1 gene mutation | BRCA2 gene mutation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376571
UMLS CUI [1,2]
C2985436
UMLS CUI [2,1]
C0598034
UMLS CUI [2,2]
C2985436
UMLS CUI [3,1]
C0086930
UMLS CUI [3,2]
C1879774
UMLS CUI [4]
C1511022
UMLS CUI [5]
C1511024
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant or planning to become pregnant during the study period. pregnancy will be assessed in women of childbearing potential prior to enrolling in stage ii of the study. postmenopausal women and women who have had a previous hysterectomy, oophorectomy or tubal ligation will not be required to undergo a pregnancy test.
Descrição

Pregnancy | Pregnancy, Planned | Childbearing Potential | Postmenopausal state | Hysterectomy | Ovariectomy | Tubal Ligation | Pregnancy Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0029936
UMLS CUI [7]
C0520483
UMLS CUI [8]
C0032976
uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Recent myocardial infarction | Cerebrovascular accident Recent | Mental disorder Compliance behavior Limited | social situation Compliance behavior Limited

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C1998297
UMLS CUI [7,1]
C0038454
UMLS CUI [7,2]
C0332185
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C1321605
UMLS CUI [8,3]
C0439801
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C1321605
UMLS CUI [9,3]
C0439801
physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
Descrição

Physical Condition Exclusion Walking Daily Quantity | Requirement Study Protocol | Arthritis Severe | Walker user | Cane user | Wheelchair bound

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0080331
UMLS CUI [1,4]
C0332173
UMLS CUI [1,5]
C1265611
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C2348563
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0920121
UMLS CUI [5]
C0920240
UMLS CUI [6]
C0558195
medical or psychiatric disorder which would, in the opinion of the principal investigator, render the subject unable to provide informed consent.
Descrição

Disease Informed Consent Unable | Mental disorder Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0021430
UMLS CUI [2,3]
C1299582
patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.
Descrição

Metastatic Neoplasm | Recurrent disease | research results Interpretation Difficult | Gender | Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0683954
UMLS CUI [3,2]
C0459471
UMLS CUI [3,3]
C0332218
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0392920

Similar models

Eligibility Breast Neoplasms NCT00092950

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Breast Carcinoma Survivors | Gender At high risk for breast cancer
Item
this study will enroll 40 breast cancer survivors and 40 women at high risk for breast cancer. all participants must fulfill the following criteria:
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C4047809 (UMLS CUI [2,2])
Age
Item
age 18 to 75.
boolean
C0001779 (UMLS CUI [1])
Sedentary | Leisure Activities Weekly Score | Exercise Leisure Questionnaires | Moderate activity Weekly Quantity
Item
sedentary at baseline, as defined by a weekly leisure-time activity score of 15 or less on the godin leisure-time exercise questionnaire. this cutoff is equivalent to engaging in moderate activity less than 3 times a week.
boolean
C1532253 (UMLS CUI [1])
C0023292 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
C0015259 (UMLS CUI [3,1])
C0086542 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C3833417 (UMLS CUI [4,1])
C0332174 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Clinical Trial Subject Questionnaire Completion Ability | Clinical Trial Subject Questionnaire Completion Assisted
Item
ability to complete all study questionnaires, or a willing friend or family member who will assist in questionnaire completion.
boolean
C3890411 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C3890411 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Physical activity Level Perform Ability
Item
ability to successfully perform the level of physical activity prescribed by the protocol, as assessed by the physical activity readiness questionnaire (par-q).
boolean
C0026606 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
answered questions Screening | Clinical Evaluation
Item
any participant who answers yes to any of the questions in this screening tool will undergo medical evaluation at the clinical center, as appropriate, prior to enrolling on the study.
boolean
C0508431 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2])
Cardiac heart disease risk | Physical Examination | Electrocardiography Due to Cardiac heart disease risk Increased | Medical care Regular
Item
cardiac risk will be assessed after a complete history and physical exam, and will be determined by the examining physician. only patients who are felt to be increased cardiac risk will have an ekg performed. this will include patients who answer yes to any of the questions on the par-q that assess cardiac risk (#1,2,3,4,6). patients with worrisome ekg findings or findings in the history or physical exam that warrant further work-up in the opinion of the health care provider will be referred to the cardiology consult service, or if non-urgent, will be referred back to their source of regular medical care for clearance prior to enrolling on the study.
boolean
C2734561 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C1623258 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C2734561 (UMLS CUI [3,3])
C0205217 (UMLS CUI [3,4])
C0496675 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
Malignant Neoplasms | Invasive carcinoma of breast | Squamous cell carcinoma of skin | Basal cell carcinoma | Disease Evidence of | cancer treatment
Item
if history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment and no history of cancer directed treatment in the 2 years preceding enrollment.
boolean
C0006826 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0007117 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0332120 (UMLS CUI [5,2])
C0920425 (UMLS CUI [6])
Breast Carcinoma Survivors
Item
breast cancer survivors:
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
Breast Carcinoma Survivors | Gender | Invasive carcinoma of breast | TNM clinical staging | First line treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Tamoxifen | Aromatase Inhibitors
Item
eligible breast cancer survivors will be women with a documented history of stage i, ii or iii invasive breast cancer who are at least two months from the completion of their primary therapy, including surgery, radiation and chemotherapy. current use of hormonal therapy such as tamoxifen or aromatase inhibitors, will be permitted, however subjects must have completed 2 months of hormonal therapy prior to beginning the study in order to achieve steady state.
boolean
C0678222 (UMLS CUI [1,1])
C0206194 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0853879 (UMLS CUI [3])
C3258246 (UMLS CUI [4])
C1708063 (UMLS CUI [5])
C0543467 (UMLS CUI [6])
C1522449 (UMLS CUI [7])
C0392920 (UMLS CUI [8])
C0279025 (UMLS CUI [9])
C0039286 (UMLS CUI [10])
C0593802 (UMLS CUI [11])
Gender At high risk for breast cancer
Item
women at high risk for breast cancer:
boolean
C0079399 (UMLS CUI [1,1])
C4047809 (UMLS CUI [1,2])
Gender At high risk for breast cancer | criteria Fulfill
Item
women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
boolean
C0079399 (UMLS CUI [1,1])
C4047809 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Gail Risk Model | Claus Model Lifetime Risk
Item
a gail model risk of greater than or equal to1.7 percent over 5 years from study entry or a claus model lifetime risk of greater than 20 percent.
boolean
C1511297 (UMLS CUI [1])
C1707405 (UMLS CUI [2,1])
C1517878 (UMLS CUI [2,2])
Lobular Neoplasia
Item
lobular neoplasia.
boolean
C0861352 (UMLS CUI [1])
Atypical ductal hyperplasia
Item
atypical ductal hyperplasia.
boolean
C0442834 (UMLS CUI [1])
Prior Therapy Noninfiltrating Intraductal Carcinoma | First line treatment Complete | Hormone Therapy
Item
ductal carcinoma in situ (dcis) that has been previously treated. patients must be at least 2 months from completion of primary therapy, and if treated with hormonal therapy, they must have completed at least two months of hormonal therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0007124 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation | Risk Assessment BRCAPRO | BRCA1 gene mutation | BRCA2 gene mutation
Item
deleterious mutations in brca-1 or 2 or a priori risk assessment of 20 percent chance or greater of carrying a brca1/2 gene mutation. the brcapro model (109) will be used to assess this risk.
boolean
C0376571 (UMLS CUI [1,1])
C2985436 (UMLS CUI [1,2])
C0598034 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
C0086930 (UMLS CUI [3,1])
C1879774 (UMLS CUI [3,2])
C1511022 (UMLS CUI [4])
C1511024 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Childbearing Potential | Postmenopausal state | Hysterectomy | Ovariectomy | Tubal Ligation | Pregnancy Test
Item
currently pregnant or planning to become pregnant during the study period. pregnancy will be assessed in women of childbearing potential prior to enrolling in stage ii of the study. postmenopausal women and women who have had a previous hysterectomy, oophorectomy or tubal ligation will not be required to undergo a pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0029936 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0032976 (UMLS CUI [8])
Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Recent myocardial infarction | Cerebrovascular accident Recent | Mental disorder Compliance behavior Limited | social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1998297 (UMLS CUI [6])
C0038454 (UMLS CUI [7,1])
C0332185 (UMLS CUI [7,2])
C0004936 (UMLS CUI [8,1])
C1321605 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C1321605 (UMLS CUI [9,2])
C0439801 (UMLS CUI [9,3])
Physical Condition Exclusion Walking Daily Quantity | Requirement Study Protocol | Arthritis Severe | Walker user | Cane user | Wheelchair bound
Item
physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
boolean
C3714565 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C1265611 (UMLS CUI [1,5])
C1514873 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0003864 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0920121 (UMLS CUI [4])
C0920240 (UMLS CUI [5])
C0558195 (UMLS CUI [6])
Disease Informed Consent Unable | Mental disorder Informed Consent Unable
Item
medical or psychiatric disorder which would, in the opinion of the principal investigator, render the subject unable to provide informed consent.
boolean
C0012634 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Metastatic Neoplasm | Recurrent disease | research results Interpretation Difficult | Gender | Chemotherapy
Item
patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.
boolean
C2939420 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0683954 (UMLS CUI [3,1])
C0459471 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4])
C0392920 (UMLS CUI [5])

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