ID

35174

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02322203

Palavras-chave

Versões (1)
  1. 21/02/2019 21/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02322203

Inglês

Eligibility Cardiovascular Disease NCT02322203

1 Formulários  
Criteria
Descrição

Criteria

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

Age

Tipo de dados

boolean

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

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

Lipid Modification Therapy | Statins | Fibrates | Bile acid sequestrants

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Liver disease | Peptic Ulcer

Tipo de dados

boolean

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

Increased uric acid level | Gout

Tipo de dados

boolean

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

Pregnancy | Breast Feeding

Tipo de dados

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.
Descrição

Gender Hormonal Contraceptives | Gender Hormone replacement therapy

Tipo de dados

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
Descrição

Body mass index

Tipo de dados

boolean

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

Body Weight Variation Percentage Timespan

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Pharmaceutical Preparations New | Pharmaceutical Preparations Multiple

Tipo de dados

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
Descrição

Lacking Able to swallow Capsule

Tipo de dados

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%.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
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Similar models

Eligibility Cardiovascular Disease NCT02322203

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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