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ID

16475

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00092950

Stichworte

  1. 17.07.16 17.07.16 -
  2. 18.07.16 18.07.16 -
Hochgeladen am

18. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Breast Neoplasms NCT00092950

    Eligibility Breast Neoplasms NCT00092950

    Criteria
    Beschreibung

    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:
    Beschreibung

    Breast Carcinoma Survivors | Gender At high risk for breast cancer

    Datentyp

    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.
    Beschreibung

    Age

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    ECOG performance status

    Datentyp

    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).
    Beschreibung

    Physical activity Level Perform Ability

    Datentyp

    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.
    Beschreibung

    answered questions Screening | Clinical Evaluation

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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:
    Beschreibung

    Breast Carcinoma Survivors

    Datentyp

    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.
    Beschreibung

    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

    Datentyp

    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:
    Beschreibung

    Gender At high risk for breast cancer

    Datentyp

    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:
    Beschreibung

    Gender At high risk for breast cancer | criteria Fulfill

    Datentyp

    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.
    Beschreibung

    Gail Risk Model | Claus Model Lifetime Risk

    Datentyp

    boolean

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

    Lobular Neoplasia

    Datentyp

    boolean

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

    Atypical ductal hyperplasia

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    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.
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    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

    Datentyp

    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.).
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    Disease Informed Consent Unable | Mental disorder Informed Consent Unable

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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

    Ähnliche Modelle

    Eligibility Breast Neoplasms NCT00092950

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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