ID

31690

Description

Resveratrol for the Treatment of Non Alcoholic Fatty Liver Disease and Insulin Resistance in Overweight Adolescents; ODM derived from: https://clinicaltrials.gov/show/NCT02216552

Link

https://clinicaltrials.gov/show/NCT02216552

Keywords

Versions (2)
  1. 9/16/18 9/16/18 -
  2. 9/21/18 9/21/18 -
Copyright Holder

University of Manitoba

Uploaded on

September 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility NAFLD NCT02216552

English

Eligibility NAFLD NCT02216552

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility NAFLD NCT02216552
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
13 to <18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi considered overweight (bmi > 25 kg/m2 ) or obese (bmi > 30 kg/m2 )
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
confirmed 1h-mrs defined hepatic steatosis (>5.5% fat/water)
Description

Hepatic steatosis

Data type

boolean

Alias
UMLS CUI [1,1]
C2711227
UMLS CUI [1,2]
C3850002
parent/guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
Description

Informed consent by guardian and patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1274041
UMLS CUI [2,1]
C0514052
UMLS CUI [2,2]
C0026193
sexually active subjects must be willing to use an acceptable method of contraception
Description

Willing to use contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
females of child bearing potential must have a negative pregnancy test at screening.
Description

Pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
Description

Concomitant medication except natural health products or contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0240320
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205296
UMLS CUI [3,3]
C0013227
UMLS CUI [3,4]
C1705847
UMLS CUI [3,5]
C3653317
adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:
Description

Insulin snesitivity and altered tissue lipid content

Data type

boolean

Alias
UMLS CUI [1]
C0920563
UMLS CUI [2,1]
C0424619
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0028754
type 2 diabetes; present or previous malignancy, renal disease, hypertension (anyone who has bps over the 99th percentile for age and gender) or liver disease;
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0022658
significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
Description

Recent weight loss or participation in weight loss program

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3179079
UMLS CUI [2,2]
C0332185
self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
report using non-prescription recreational drugs;
Description

Drug use

Data type

boolean

Alias
UMLS CUI [1]
C0242508
allergies or sensitivities to any of the ingredients in the investigational product or placebo;
Description

Hypersensitivities to drug ingredients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0032042
females breastfeeding at screening or planning on becoming pregnant at any time during the study;
Description

Pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032992
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Similar models

Eligibility NAFLD NCT02216552

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility NAFLD NCT02216552
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
13 to <18 years of age
boolean
C0001779 (UMLS CUI [1])
BMI
Item
bmi considered overweight (bmi > 25 kg/m2 ) or obese (bmi > 30 kg/m2 )
boolean
C1305855 (UMLS CUI [1])
Hepatic steatosis
Item
confirmed 1h-mrs defined hepatic steatosis (>5.5% fat/water)
boolean
C2711227 (UMLS CUI [1,1])
C3850002 (UMLS CUI [1,2])
Informed consent by guardian and patient
Item
parent/guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
boolean
C0021430 (UMLS CUI [1,1])
C1274041 (UMLS CUI [1,2])
C0514052 (UMLS CUI [2,1])
C0026193 (UMLS CUI [2,2])
Willing to use contraception
Item
sexually active subjects must be willing to use an acceptable method of contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Pregnancy test
Item
females of child bearing potential must have a negative pregnancy test at screening.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Concomitant medication except natural health products or contraception
Item
the use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
boolean
C0240320 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0205296 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C1705847 (UMLS CUI [3,4])
C3653317 (UMLS CUI [3,5])
Insulin snesitivity and altered tissue lipid content
Item
adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:
boolean
C0920563 (UMLS CUI [1])
C0424619 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0028754 (UMLS CUI [2,3])
Comorbidity
Item
type 2 diabetes; present or previous malignancy, renal disease, hypertension (anyone who has bps over the 99th percentile for age and gender) or liver disease;
boolean
C0011860 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
Recent weight loss or participation in weight loss program
Item
significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
boolean
C1262477 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3179079 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Alcohol consumption
Item
self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
boolean
C0001948 (UMLS CUI [1])
Drug use
Item
report using non-prescription recreational drugs;
boolean
C0242508 (UMLS CUI [1])
Hypersensitivities to drug ingredients
Item
allergies or sensitivities to any of the ingredients in the investigational product or placebo;
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0032042 (UMLS CUI [2,3])
Pregnancy or breastfeeding
Item
females breastfeeding at screening or planning on becoming pregnant at any time during the study;
boolean
C0006147 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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