ID

40032

Description

Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT01463085

Link

https://clinicaltrials.gov/show/NCT01463085

Keywords

Versions (1)
  1. 3/10/20 3/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01463085

English

Eligibility Hypertension NCT01463085

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is a female or male, 20-69 years of age, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has a bmi of 18.5 to 39.9 kg/m2, inclusive.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subject has resting blood pressure measurements meeting the criteria for pre-hypertension (sbp = 120 to 139 mm hg and/or dbp = 80 to 89 mm hg) or stage 1 hypertension (sbp = 140 to 159 mm hg or dbp = 90 to 99 mm hg)
Description

Blood pressure determination Resting | Criteria Fulfill Prehypertension | Systolic Pressure | Diastolic blood pressure | Hypertensive disease Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0035253
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C1696708
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
UMLS CUI [5,1]
C0020538
UMLS CUI [5,2]
C0699749
subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
Description

Dairy food intake Serving U/day | Part Diet

Data type

boolean

Alias
UMLS CUI [1,1]
C0559267
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0449719
UMLS CUI [2,2]
C0012155
subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
Description

Dairy food intake Serving U/day | Treatment Phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0559267
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1710475
subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
Description

Maintains stable weight | Diet Habitual Maintenance | Physical activity Maintenance | Exception Investigational New Drugs Study Protocol | Exception Alcohol consumption Study Protocol | Exception Physical activity Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0517922
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C0205353
UMLS CUI [2,3]
C0024501
UMLS CUI [3,1]
C0026606
UMLS CUI [3,2]
C0024501
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C2348563
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0001948
UMLS CUI [5,3]
C2348563
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0026606
UMLS CUI [6,3]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known coronary heart disease (chd) or a chd risk equivalent
Description

Coronary heart disease | Coronary heart disease Risk Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205163
subject has a history of any major trauma or major surgical event
Description

Major injury | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0679637
subject has digital deformities that would prevent endopat measurements.
Description

Deformity Digital | Prevents Endo-Pat Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0302142
UMLS CUI [1,2]
C0582802
UMLS CUI [2,1]
C1292733
UMLS CUI [2,2]
C2985468
UMLS CUI [2,3]
C0242485
subject has used medications known to alter body weight
Description

Pharmaceutical Preparations Changing Body Weight

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0005910
subject has used medications or dietary supplements that, in the opinion of the investigator, have strong potential to influence blood pressure or endothelial function
Description

Pharmaceutical Preparations Influence Blood Pressure | Pharmaceutical Preparations Influence Function Endothelial | Dietary Supplements Influence Blood Pressure | Dietary Supplements Influence Function Endothelial

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0031843
UMLS CUI [2,4]
C0014257
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0005823
UMLS CUI [4,1]
C0242295
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0031843
UMLS CUI [4,4]
C0014257
subject has extreme dietary habits (e.g., atkins diet, very high protein/low carbohydrate).
Description

Dietary Habits Extreme | Atkins Diet | Diet, High-Protein | Diet, Carbohydrate-Restricted

Data type

boolean

Alias
UMLS CUI [1,1]
C0086152
UMLS CUI [1,2]
C0205403
UMLS CUI [2]
C1319849
UMLS CUI [3]
C0425403
UMLS CUI [4]
C0259836
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Similar models

Eligibility Hypertension NCT01463085

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is a female or male, 20-69 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
subject has a bmi of 18.5 to 39.9 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Blood pressure determination Resting | Criteria Fulfill Prehypertension | Systolic Pressure | Diastolic blood pressure | Hypertensive disease Stage
Item
subject has resting blood pressure measurements meeting the criteria for pre-hypertension (sbp = 120 to 139 mm hg and/or dbp = 80 to 89 mm hg) or stage 1 hypertension (sbp = 140 to 159 mm hg or dbp = 90 to 99 mm hg)
boolean
C0005824 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C1696708 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
C0020538 (UMLS CUI [5,1])
C0699749 (UMLS CUI [5,2])
Dairy food intake Serving U/day | Part Diet
Item
subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
boolean
C0559267 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0449719 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
Dairy food intake Serving U/day | Treatment Phase
Item
subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
boolean
C0559267 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1710475 (UMLS CUI [2,2])
Maintains stable weight | Diet Habitual Maintenance | Physical activity Maintenance | Exception Investigational New Drugs Study Protocol | Exception Alcohol consumption Study Protocol | Exception Physical activity Study Protocol
Item
subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
boolean
C0517922 (UMLS CUI [1])
C0012155 (UMLS CUI [2,1])
C0205353 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
C0026606 (UMLS CUI [3,1])
C0024501 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0001948 (UMLS CUI [5,2])
C2348563 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0026606 (UMLS CUI [6,2])
C2348563 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Coronary heart disease | Coronary heart disease Risk Equivalent
Item
subject has known coronary heart disease (chd) or a chd risk equivalent
boolean
C0010068 (UMLS CUI [1])
C0010068 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Major injury | Major surgery
Item
subject has a history of any major trauma or major surgical event
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Deformity Digital | Prevents Endo-Pat Measurement
Item
subject has digital deformities that would prevent endopat measurements.
boolean
C0302142 (UMLS CUI [1,1])
C0582802 (UMLS CUI [1,2])
C1292733 (UMLS CUI [2,1])
C2985468 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Pharmaceutical Preparations Changing Body Weight
Item
subject has used medications known to alter body weight
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
Pharmaceutical Preparations Influence Blood Pressure | Pharmaceutical Preparations Influence Function Endothelial | Dietary Supplements Influence Blood Pressure | Dietary Supplements Influence Function Endothelial
Item
subject has used medications or dietary supplements that, in the opinion of the investigator, have strong potential to influence blood pressure or endothelial function
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0031843 (UMLS CUI [2,3])
C0014257 (UMLS CUI [2,4])
C0242295 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0005823 (UMLS CUI [3,3])
C0242295 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0031843 (UMLS CUI [4,3])
C0014257 (UMLS CUI [4,4])
Dietary Habits Extreme | Atkins Diet | Diet, High-Protein | Diet, Carbohydrate-Restricted
Item
subject has extreme dietary habits (e.g., atkins diet, very high protein/low carbohydrate).
boolean
C0086152 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C1319849 (UMLS CUI [2])
C0425403 (UMLS CUI [3])
C0259836 (UMLS CUI [4])
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