ID

28764

Beschrijving

Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00552747

Link

https://clinicaltrials.gov/show/NCT00552747

Trefwoorden

Versies (1)
  1. 02-02-18 02-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00552747

Engels

Eligibility Coronary Heart Disease NCT00552747

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male patients 18-60 years of age
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
stable coronary heart disease (no cardiovascular event 3 months prior to enrollment)
Beschrijving

Coronary heart disease Stable | Cardiovascular event Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1320716
UMLS CUI [2,2]
C0332197
stable lipid-modifying drug therapy (previous 2 months)
Beschrijving

LIPID MODIFYING AGENTS Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3653535
UMLS CUI [1,2]
C0205360
low-dose statin therapy with ldl-c at goal (< 100 mg/dl)
Beschrijving

Statins Low dose | Serum LDL cholesterol measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0445550
UMLS CUI [2]
C0428474
triglyceride levels 151-500 mg/dl
Beschrijving

Triglycerides measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202236
hdl-c levels <40 mg/dl
Beschrijving

Serum HDL cholesterol measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428472
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes mellitus
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
uncontrolled hypertension systolic blood pressure >160 mmhg and/or diastolic blood pressure >100 mmhg
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
subjects with renal (serum creatinine >1.5 times the upper limit of normal (uln)), hepatobiliary (cholelithiasis, biliary cirrhosis, ast and/or alt >2x uln) or active thyroid disease (tsh >1.5x uln or <0.05 uui/ml)
Beschrijving

Kidney Disease | Serum creatinine raised | Hepatobiliary disease | Cholelithiasis | Biliary cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased | Thyroid Disease | Increased serum TSH | Measurement of serum thyroid stimulating hormone

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0267792
UMLS CUI [4]
C0008350
UMLS CUI [5]
C0023892
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
UMLS CUI [8]
C0040128
UMLS CUI [9]
C1848788
UMLS CUI [10]
C1277938
hypersensitivity to fenofibrate or to any other component of its formula
Beschrijving

Fenofibrate allergy | Hypersensitivity Component Fenofibrate Formula

Datatype

boolean

Alias
UMLS CUI [1]
C0571869
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0033228
UMLS CUI [2,4]
C1705501
history of photoallergic reaction or phototoxicity to fenofibrate or ketoprofen
Beschrijving

Photoallergic drug reaction Fenofibrate | Phototoxicity Fenofibrate | Photoallergic drug reaction Ketoprofen | Phototoxicity Ketoprofen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0406696
UMLS CUI [1,2]
C0033228
UMLS CUI [2,1]
C1527358
UMLS CUI [2,2]
C0033228
UMLS CUI [3,1]
C0406696
UMLS CUI [3,2]
C0022635
UMLS CUI [4,1]
C1527358
UMLS CUI [4,2]
C0022635
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Similar models

Eligibility Coronary Heart Disease NCT00552747

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male patients 18-60 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Coronary heart disease Stable | Cardiovascular event Absent
Item
stable coronary heart disease (no cardiovascular event 3 months prior to enrollment)
boolean
C0010068 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1320716 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
LIPID MODIFYING AGENTS Stable
Item
stable lipid-modifying drug therapy (previous 2 months)
boolean
C3653535 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Statins Low dose | Serum LDL cholesterol measurement
Item
low-dose statin therapy with ldl-c at goal (< 100 mg/dl)
boolean
C0360714 (UMLS CUI [1,1])
C0445550 (UMLS CUI [1,2])
C0428474 (UMLS CUI [2])
Triglycerides measurement
Item
triglyceride levels 151-500 mg/dl
boolean
C0202236 (UMLS CUI [1])
Serum HDL cholesterol measurement
Item
hdl-c levels <40 mg/dl
boolean
C0428472 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension systolic blood pressure >160 mmhg and/or diastolic blood pressure >100 mmhg
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Kidney Disease | Serum creatinine raised | Hepatobiliary disease | Cholelithiasis | Biliary cirrhosis | Aspartate aminotransferase increased | Alanine aminotransferase increased | Thyroid Disease | Increased serum TSH | Measurement of serum thyroid stimulating hormone
Item
subjects with renal (serum creatinine >1.5 times the upper limit of normal (uln)), hepatobiliary (cholelithiasis, biliary cirrhosis, ast and/or alt >2x uln) or active thyroid disease (tsh >1.5x uln or <0.05 uui/ml)
boolean
C0022658 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0267792 (UMLS CUI [3])
C0008350 (UMLS CUI [4])
C0023892 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C0040128 (UMLS CUI [8])
C1848788 (UMLS CUI [9])
C1277938 (UMLS CUI [10])
Fenofibrate allergy | Hypersensitivity Component Fenofibrate Formula
Item
hypersensitivity to fenofibrate or to any other component of its formula
boolean
C0571869 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0033228 (UMLS CUI [2,3])
C1705501 (UMLS CUI [2,4])
Photoallergic drug reaction Fenofibrate | Phototoxicity Fenofibrate | Photoallergic drug reaction Ketoprofen | Phototoxicity Ketoprofen
Item
history of photoallergic reaction or phototoxicity to fenofibrate or ketoprofen
boolean
C0406696 (UMLS CUI [1,1])
C0033228 (UMLS CUI [1,2])
C1527358 (UMLS CUI [2,1])
C0033228 (UMLS CUI [2,2])
C0406696 (UMLS CUI [3,1])
C0022635 (UMLS CUI [3,2])
C1527358 (UMLS CUI [4,1])
C0022635 (UMLS CUI [4,2])
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