ID

35702

Description

The primary purpose of the study is to evaluate the impact of strawberry intake on select measures of cardiovascular function in overweight and obese adolescent males.; ODM derived from: https://clinicaltrials.gov/show/NCT01705093

Link

https://clinicaltrials.gov/show/NCT01705093

Keywords

Versions (2)
  1. 3/12/19 3/12/19 -
  2. 3/16/19 3/16/19 -
Copyright Holder

University of California, Davis

Uploaded on

March 16, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effects of Strawberries on Parameters of Cardiovascular Health NCT01705093

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Male subject
Description

Gender of patient

Data type

boolean

Alias
UMLS CUI [1]
C0079399
Age between 14 -18 years
Description

age of patient

Data type

boolean

Alias
UMLS CUI [1]
C0001779
BMI for age and gender >75th percentile (based on cdc growth charts)
Description

BMI of patient

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Subject is willing and able to comply with the study protocols.
Description

ability and willingness to comply with the study protocols

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Inability to wear PAT probes
Description

Patient is not able to wear PAT probes

Data type

boolean

Alias
UMLS CUI [1]
C0182400
Patient is not able to remain still and quiet during test procedures
Description

Inability to remain still and quiet during test procedures

Data type

boolean

Alias
UMLS CUI [1]
C1321605
BMI for age and gender below 75th percentile (based on cdc growth charts)
Description

BMI of patient

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Medication that affects the vascular function
Description

Medication of patient with an impact on vascular function

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0232337
Regular use of dietary supplements during the last 6 months
Description

regular use of dietary supplements during the last 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0205272
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0332185
Blood pressure for age, gender and height ≥ 95th percentile
Description

Blood pressure of patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C1521725
Chronic/routine high intensity exercise or current participation in a sports program
Description

Training program of patient

Data type

boolean

Alias
UMLS CUI [1]
C1820660
UMLS CUI [2,1]
C0815170
UMLS CUI [2,2]
C4081854
Self/parent reported use of anticoagulation agents including NSAIDs
Description

Anticoagulation agents use of patient

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C0003211
Self/Parent reported use of oral cortisone or other immunosuppressive agents
Description

Use of oral cortisone or other immunosuppressive agents

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C3209977
Self/Parent reported diabetes
Description

self/parent reported diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Food faddists or those taking a non-traditional diet
Description

food faddists or patients taking a non-traditional diet

Data type

boolean

Alias
UMLS CUI [1]
C0086310
UMLS CUI [2,1]
C0184625
UMLS CUI [2,2]
C0332197
Allergies to fruit
Description

patient's allergies to fruit

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016767
Abnormal liver, CBC or chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician
Description

Liver laboratory, CBC or chemistry panels which are clinically significant pathological

Data type

boolean

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438216
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C0022885
Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
Description

Malabsorption of nutrition by patient

Data type

boolean

Alias
UMLS CUI [1]
C0024523
Patient with asthma which can be worsened by mild to moderate food allergies.
Description

Patient diagnosed with asthma (can be worsened by mild to moderate food allergies)

Data type

boolean

Alias
UMLS CUI [1]
C0004096
Self/Parent reported underlying neoplasia or immunological disease
Description

Self/Parent reported underlying neoplasia or immunological disease

Data type

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2]
C0021053
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
Male subject
boolean
C0079399 (UMLS CUI [1])
Age
Item
Age between 14 -18 years
boolean
C0001779 (UMLS CUI [1])
BMI
Item
BMI for age and gender >75th percentile (based on cdc growth charts)
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance
Item
Subject is willing and able to comply with the study protocols.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
PAT probes
Item
Inability to wear PAT probes
boolean
C0182400 (UMLS CUI [1])
Compliance during test procedures
Item
Patient is not able to remain still and quiet during test procedures
boolean
C1321605 (UMLS CUI [1])
BMI
Item
BMI for age and gender below 75th percentile (based on cdc growth charts)
boolean
C1305855 (UMLS CUI [1])
Medication
Item
Medication that affects the vascular function
boolean
C0013227 (UMLS CUI [1,1])
C0232337 (UMLS CUI [1,2])
Dietary supplements
Item
Regular use of dietary supplements during the last 6 months
boolean
C0205272 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Blood pressure
Item
Blood pressure for age, gender and height ≥ 95th percentile
boolean
C0005823 (UMLS CUI [1,1])
C1521725 (UMLS CUI [1,2])
Physical training
Item
Chronic/routine high intensity exercise or current participation in a sports program
boolean
C1820660 (UMLS CUI [1])
C0815170 (UMLS CUI [2,1])
C4081854 (UMLS CUI [2,2])
Anticoagulation agents
Item
Self/parent reported use of anticoagulation agents including NSAIDs
boolean
C0003281 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
Immunosuppression
Item
Self/Parent reported use of oral cortisone or other immunosuppressive agents
boolean
C0021079 (UMLS CUI [1])
C3209977 (UMLS CUI [2])
Diabetes
Item
Self/Parent reported diabetes
boolean
C0011849 (UMLS CUI [1])
Food habits
Item
Food faddists or those taking a non-traditional diet
boolean
C0086310 (UMLS CUI [1])
C0184625 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Allergies to fruit
Item
Allergies to fruit
boolean
C0020517 (UMLS CUI [1,1])
C0016767 (UMLS CUI [1,2])
Laboratory values
Item
Abnormal liver, CBC or chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician
boolean
C0005774 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438216 (UMLS CUI [2])
C0023884 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Malabsorption of nutrition
Item
Self/Parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas).
boolean
C0024523 (UMLS CUI [1])
Pulmonary disease
Item
Patient with asthma which can be worsened by mild to moderate food allergies.
boolean
C0004096 (UMLS CUI [1])
Neoplasia or immunological disease
Item
Self/Parent reported underlying neoplasia or immunological disease
boolean
C1882062 (UMLS CUI [1])
C0021053 (UMLS CUI [2])
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