Gender | Age | Women's Health Initiative (WHI) Study | Study Subject Participation Status
Item
1. women ≥ 65 years of age participating in the whi extension study. if fewer than 12,000 women from whi agree to participate, additional women aged ≥ 65 years who were contacted for but not randomized into the vital trial will also be included.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2737276 (UMLS CUI [3,1])
C2603343 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
Gender | Age | Clinical Trials
Item
2. men ≥ 60 years of age who were contacted for but not randomized into the vital trial.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
Informed Consent | Consent Forms Complete
Item
3. willing to participate, as evidenced by providing informed consent and completing all required baseline forms.
boolean
C0021430 (UMLS CUI [1])
C0009797 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Myocardial Infarction | Cerebrovascular accident
Item
1. history of myocardial infarction or stroke.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
invasive cancer | non-melanoma skin cancer
Item
2. diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to randomization.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Illness | Study Subject Participation Status Limited | Compliance behavior Limited
Item
3. any serious illness that would preclude participation or completion of the trial.
boolean
C0221423 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Cocoa extract | Multivitamin preparation Oral supplement
Item
4. taking cocoa extract or multivitamin supplements and not willing to forego use during the trial.
boolean
C1138626 (UMLS CUI [1])
C0301532 (UMLS CUI [2,1])
C0351437 (UMLS CUI [2,2])
Vitamin D Oral supplement Total
Item
5. taking total supplemental vitamin d > 1,000 iu/day and not willing to forego use during the trial
boolean
C0042866 (UMLS CUI [1,1])
C0351437 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Calcium supplement Total
Item
6. taking total supplemental calcium > 1,200 mg/day and not willing to forego use during the trial
boolean
C3661604 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Hypersensitivity Caffeine
Item
7. extreme sensitivity to caffeine.
boolean
C0020517 (UMLS CUI [1,1])
C0006644 (UMLS CUI [1,2])
Consumption Volume Oral Supplement | Run-in Period
Item
8. consume < 75% of the expected number of both types of supplements during the run-in phase.
boolean
C1551353 (UMLS CUI [1,1])
C0351437 (UMLS CUI [1,2])
C3274438 (UMLS CUI [2])
Unable to communicate English Language | Language Barriers | Mental handicap
Item
9. unable to communicate in english due to language barrier or mental incapacity.
boolean
C0566000 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0237167 (UMLS CUI [2])
C1306341 (UMLS CUI [3])