ID

35174

Description

Effects of Niacin Therapy on Lipoprotein Composition and Function; ODM derived from: https://clinicaltrials.gov/show/NCT02322203

Link

https://clinicaltrials.gov/show/NCT02322203

Keywords

Versions (1)
  1. 2/21/19 2/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 21, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Cardiovascular Disease NCT02322203

English

Eligibility Cardiovascular Disease NCT02322203

1 forms  
Criteria
Description

Criteria

males and females who are at least 18 years of age at time of enrollment
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject understands the investigational nature of the study and provides written, informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects taking any lipid modification therapy, including but not limited to statins, fibrates and bile acid sequestrants.
Description

Lipid Modification Therapy | Statins | Fibrates | Bile acid sequestrants

Data type

boolean

Alias
UMLS CUI [1,1]
C0023779
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0360714
UMLS CUI [3]
C1449704
UMLS CUI [4]
C2917337
subjects taking fish oil or any other supplements, which in the investigator s opinion may interfere with the study.
Description

Fish Oil Interferes with Clinical Trial | Supplements Interfere with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0016157
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
subjects with acute liver disease or active peptic ulcer disease.
Description

Liver disease | Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0030920
subjects with elevated uric acid levels or gout
Description

Increased uric acid level | Gout

Data type

boolean

Alias
UMLS CUI [1]
C0041981
UMLS CUI [2]
C0018099
pregnancy or women currently breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female subjects taking hormonal contraceptives or hormone replacement therapy may be included in this study only if they have been on a stable dose for at least 3 months.
Description

Gender Hormonal Contraceptives | Gender Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009907
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0282402
bmi less than 18.5
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subjects with weight that varies greater than 20% over the past 3 months.
Description

Body Weight Variation Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0205419
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0872291
subjects taking the following medications for at least six weeks, which may interfere with the study, will be excluded: bas, antibiotics, anticoagulants, anticonvulsants, antiarrhythmic, cyclosporine, mycophenolate and synthroid. subjects with chronic diarrhea, gastric bypass or lap band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
Description

Pharmaceutical Preparations Interfere with Clinical Trial | Bile acid sequestrants | Antibiotics | Anticoagulants | Anticonvulsants | Anti-Arrhythmia Agents | Cyclosporine | MYCOPHENOLATE | Synthroid | Chronic diarrhea | Gastric Bypass | Gastric band | Ostomy | Motility disorder of intestine | Condition Affecting Intestinal fat absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C2917337
UMLS CUI [3]
C0003232
UMLS CUI [4]
C0003280
UMLS CUI [5]
C0003286
UMLS CUI [6]
C0003195
UMLS CUI [7]
C0010592
UMLS CUI [8]
C0883242
UMLS CUI [9]
C0728762
UMLS CUI [10]
C0401151
UMLS CUI [11]
C0017125
UMLS CUI [12]
C1960832
UMLS CUI [13]
C0029473
UMLS CUI [14]
C0400865
UMLS CUI [15,1]
C0348080
UMLS CUI [15,2]
C0392760
UMLS CUI [15,3]
C0232653
subjects initiating new medications or patients on multiple medications may also be excluded.
Description

Pharmaceutical Preparations New | Pharmaceutical Preparations Multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0439064
inability to swallow capsules
Description

Lacking Able to swallow Capsule

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0006935
patients with a history of type i or type ii diabetes or hba1c greater than 6.5%.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0474680
volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
Description

Condition Interferes with Research results | Disease Interferes with Research results | Condition At risk Patient safety | Disease At risk Patient safety

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C1113679
Back to the top of the page

Similar models

Eligibility Cardiovascular Disease NCT02322203

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
males and females who are at least 18 years of age at time of enrollment
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject understands the investigational nature of the study and provides written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lipid Modification Therapy | Statins | Fibrates | Bile acid sequestrants
Item
subjects taking any lipid modification therapy, including but not limited to statins, fibrates and bile acid sequestrants.
boolean
C0023779 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0360714 (UMLS CUI [2])
C1449704 (UMLS CUI [3])
C2917337 (UMLS CUI [4])
Fish Oil Interferes with Clinical Trial | Supplements Interfere with Clinical Trial
Item
subjects taking fish oil or any other supplements, which in the investigator s opinion may interfere with the study.
boolean
C0016157 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Liver disease | Peptic Ulcer
Item
subjects with acute liver disease or active peptic ulcer disease.
boolean
C0023895 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
Increased uric acid level | Gout
Item
subjects with elevated uric acid levels or gout
boolean
C0041981 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or women currently breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Hormonal Contraceptives | Gender Hormone replacement therapy
Item
female subjects taking hormonal contraceptives or hormone replacement therapy may be included in this study only if they have been on a stable dose for at least 3 months.
boolean
C0079399 (UMLS CUI [1,1])
C0009907 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0282402 (UMLS CUI [2,2])
Body mass index
Item
bmi less than 18.5
boolean
C1305855 (UMLS CUI [1])
Body Weight Variation Percentage Timespan
Item
subjects with weight that varies greater than 20% over the past 3 months.
boolean
C0005910 (UMLS CUI [1,1])
C0205419 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0872291 (UMLS CUI [1,4])
Pharmaceutical Preparations Interfere with Clinical Trial | Bile acid sequestrants | Antibiotics | Anticoagulants | Anticonvulsants | Anti-Arrhythmia Agents | Cyclosporine | MYCOPHENOLATE | Synthroid | Chronic diarrhea | Gastric Bypass | Gastric band | Ostomy | Motility disorder of intestine | Condition Affecting Intestinal fat absorption
Item
subjects taking the following medications for at least six weeks, which may interfere with the study, will be excluded: bas, antibiotics, anticoagulants, anticonvulsants, antiarrhythmic, cyclosporine, mycophenolate and synthroid. subjects with chronic diarrhea, gastric bypass or lap band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2917337 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
C0003280 (UMLS CUI [4])
C0003286 (UMLS CUI [5])
C0003195 (UMLS CUI [6])
C0010592 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
C0728762 (UMLS CUI [9])
C0401151 (UMLS CUI [10])
C0017125 (UMLS CUI [11])
C1960832 (UMLS CUI [12])
C0029473 (UMLS CUI [13])
C0400865 (UMLS CUI [14])
C0348080 (UMLS CUI [15,1])
C0392760 (UMLS CUI [15,2])
C0232653 (UMLS CUI [15,3])
Pharmaceutical Preparations New | Pharmaceutical Preparations Multiple
Item
subjects initiating new medications or patients on multiple medications may also be excluded.
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
Lacking Able to swallow Capsule
Item
inability to swallow capsules
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
patients with a history of type i or type ii diabetes or hba1c greater than 6.5%.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Condition Interferes with Research results | Disease Interferes with Research results | Condition At risk Patient safety | Disease At risk Patient safety
Item
volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial