ID

43835

Description

COcoa Supplement and Multivitamin Outcomes Study; ODM derived from: https://clinicaltrials.gov/show/NCT02422745

Link

https://clinicaltrials.gov/show/NCT02422745

Keywords

Versions (2)
  1. 5/6/16 5/6/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02422745

English

Eligibility Cardiovascular Disease NCT02422745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

Gender | Age | Women's Health Initiative (WHI) Study | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C2737276
UMLS CUI [3,2]
C2603343
UMLS CUI [4]
C2348568
2. men ≥ 60 years of age who were contacted for but not randomized into the vital trial.
Description

Gender | Age | Clinical Trials

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0008976
3. willing to participate, as evidenced by providing informed consent and completing all required baseline forms.
Description

Informed Consent | Consent Forms Complete

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0009797
UMLS CUI [2,2]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of myocardial infarction or stroke.
Description

Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
2. diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to randomization.
Description

invasive cancer | non-melanoma skin cancer

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
3. any serious illness that would preclude participation or completion of the trial.
Description

Illness | Study Subject Participation Status Limited | Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
4. taking cocoa extract or multivitamin supplements and not willing to forego use during the trial.
Description

Cocoa extract | Multivitamin preparation Oral supplement

Data type

boolean

Alias
UMLS CUI [1]
C1138626
UMLS CUI [2,1]
C0301532
UMLS CUI [2,2]
C0351437
5. taking total supplemental vitamin d > 1,000 iu/day and not willing to forego use during the trial
Description

Vitamin D Oral supplement Total

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C0351437
UMLS CUI [1,3]
C0439810
6. taking total supplemental calcium > 1,200 mg/day and not willing to forego use during the trial
Description

Calcium supplement Total

Data type

boolean

Alias
UMLS CUI [1,1]
C3540037
UMLS CUI [1,2]
C0439810
7. extreme sensitivity to caffeine.
Description

Hypersensitivity Caffeine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006644
8. consume < 75% of the expected number of both types of supplements during the run-in phase.
Description

Consumption Volume Oral Supplement | Run-in Period

Data type

boolean

Alias
UMLS CUI [1,1]
C1551353
UMLS CUI [1,2]
C0351437
UMLS CUI [2]
C3274438
9. unable to communicate in english due to language barrier or mental incapacity.
Description

Unable to communicate English Language | Language Barriers | Mental handicap

Data type

boolean

Alias
UMLS CUI [1,1]
C0566000
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0237167
UMLS CUI [3]
C1306341
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Similar models

Eligibility Cardiovascular Disease NCT02422745

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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
C3540037 (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])
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