ID

29874

Beskrivning

Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia; ODM derived from: https://clinicaltrials.gov/show/NCT00438425

Länk

https://clinicaltrials.gov/show/NCT00438425

Nyckelord

Versioner (2)
  1. 2018-04-24 2018-04-24 -
  2. 2018-04-24 2018-04-24 -
Rättsinnehavare

See clinicaltrials.gov

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24 april 2018

DOI

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Creative Commons BY 4.0
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Eligibility Hyperlipidemia NCT00438425

Engelsk

Eligibility Hyperlipidemia NCT00438425

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men over the age of 21 years and postmenopausal women with mild-to-moderate hypercholesterolaemia, for whom cholesterol lowering medications are being considered
Beskrivning

Gender | Age | Postmenopausal state | Hypercholesterolemia Mild | Hypercholesterolemia Moderate | Anticholesteremic Agents considered

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0020443
UMLS CUI [4,2]
C2945599
UMLS CUI [5,1]
C0020443
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C0003277
UMLS CUI [6,2]
C0750591
body mass index <35 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
treated by diet
Beskrivning

Diet therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0012159
alcohol intake < 14 drinks per week.
Beskrivning

Alcohol consumption Drinks per week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0332174
fasting plasma triglyceride (tg) concentration <4.5 mmol/l.
Beskrivning

Plasma fasting triglyceride measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583331
fasting plasma ldl cholesterol concentration > 4.1 mmol/l at diagnosis or within 30% of their target levels based on risk
Beskrivning

Plasma fasting LDL cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583328
patients with previous adverse effects on statins (e.g. muscle pains) will also be accepted if the physician responsible for their care considers it appropriate.
Beskrivning

Adverse effects Statins | Myalgia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0360714
UMLS CUI [2]
C0231528
individuals who prior to cholesterol lowering therapy or after discontinuing cholesterol lowering therapy are within 30% of their treatment ldl-c goals may be permitted to enter the study with the approval of their responsible physician.
Beskrivning

LDL cholesterol Treatment goal Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0202117
UMLS CUI [1,2]
C0679840
UMLS CUI [1,3]
C0439165
fit individuals who have had a myocardial infarction or cardiac bypass surgery in the past will not be excluded. their responsible physician will be asked to provide a letter confirming their suitability for the study.
Beskrivning

Patients Fit | Previous myocardial infarction | Coronary Artery Bypass Surgery Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0424576
UMLS CUI [2]
C0155668
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C0205156
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle.
Beskrivning

Premenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
patients will be excluded if they are taking cholesterol medications at the start of the study. however, with their physician's approval, those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for one month before starting the study and throughout the study.
Beskrivning

Anticholesteremic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003277
patients will be excluded if they are taking cholesterol lowering natural health products such as psyllium, red yeast rice, cholest, polycosanol etc. however, they will be allowed to join the study if they are willing to discontinue these products at least 2 weeks before the start of the study and throughout the study.
Beskrivning

Anticholesteremic Agents Natural Products | Psyllium | Red yeast rice | Other Coding | 1-octacosanol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003277
UMLS CUI [1,2]
C1566558
UMLS CUI [2]
C0033979
UMLS CUI [3]
C0763533
UMLS CUI [4]
C3846158
UMLS CUI [5]
C0044548
patients with uncontrolled high blood pressure will be excluded. the cut off for raised blood pressure has been taken as > 140/90mmhg. patients with systolic blood pressure between 140-150mmhg and diastolic blood pressure between 90-95mmhg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. for patients in the above normal range (as above), a letter will be required from the physician responsible for their care. patients will be excluded if they change the type or dose of their blood pressure treatment during the study.
Beskrivning

Uncontrolled hypertension | Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Type Change | Antihypertensive therapy Change in drug dosage

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0497247
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
UMLS CUI [5,1]
C0585941
UMLS CUI [5,2]
C0332307
UMLS CUI [5,3]
C0392747
UMLS CUI [6,1]
C0585941
UMLS CUI [6,2]
C0420247
patients will be excluded if they are judged as having a likelihood of being non-compliant with instructions for whatever reason. those with low compliance to lipid-lowering therapy will not be selected.
Beskrivning

Compliance behavior Unlikely | Compliance behavior Poor Lipid-lowering therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0542537
UMLS CUI [2,3]
C0585943
patients will be excluded if they have evidence or history of diabetes, renal disease, liver disease or gastrointestinal disease. patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyper-absorbers of plant sterols.
Beskrivning

Diabetes Mellitus | Kidney Disease | Liver disease | Gastrointestinal Disease | Xanthoma Gross | Cardiovascular Disease Premature Advanced

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0017178
UMLS CUI [5,1]
C0302314
UMLS CUI [5,2]
C0439806
UMLS CUI [6,1]
C0007222
UMLS CUI [6,2]
C0205252
UMLS CUI [6,3]
C0205179
individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will be excluded.
Beskrivning

Predisposition Brain hemorrhage | Increase in blood pressure untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220898
UMLS CUI [1,2]
C0553692
UMLS CUI [2,1]
C0497247
UMLS CUI [2,2]
C0332155
patients will be excluded from the study if they have a history of any form of cancer apart from non melanoma skin cancer or are considered at high risk for cancer. however, if such patients wish to join the study, we would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study. if the study oncologist does not believe it is safe to enroll the participant, the patient will be excluded from the study.
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma | High risk of Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0006826
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Similar models

Eligibility Hyperlipidemia NCT00438425

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Postmenopausal state | Hypercholesterolemia Mild | Hypercholesterolemia Moderate | Anticholesteremic Agents considered
Item
men over the age of 21 years and postmenopausal women with mild-to-moderate hypercholesterolaemia, for whom cholesterol lowering medications are being considered
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0020443 (UMLS CUI [4,1])
C2945599 (UMLS CUI [4,2])
C0020443 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0003277 (UMLS CUI [6,1])
C0750591 (UMLS CUI [6,2])
Body mass index
Item
body mass index <35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Diet therapy
Item
treated by diet
boolean
C0012159 (UMLS CUI [1])
Alcohol consumption Drinks per week
Item
alcohol intake < 14 drinks per week.
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
Plasma fasting triglyceride measurement
Item
fasting plasma triglyceride (tg) concentration <4.5 mmol/l.
boolean
C0583331 (UMLS CUI [1])
Plasma fasting LDL cholesterol measurement
Item
fasting plasma ldl cholesterol concentration > 4.1 mmol/l at diagnosis or within 30% of their target levels based on risk
boolean
C0583328 (UMLS CUI [1])
Adverse effects Statins | Myalgia
Item
patients with previous adverse effects on statins (e.g. muscle pains) will also be accepted if the physician responsible for their care considers it appropriate.
boolean
C0879626 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0231528 (UMLS CUI [2])
LDL cholesterol Treatment goal Percentage
Item
individuals who prior to cholesterol lowering therapy or after discontinuing cholesterol lowering therapy are within 30% of their treatment ldl-c goals may be permitted to enter the study with the approval of their responsible physician.
boolean
C0202117 (UMLS CUI [1,1])
C0679840 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Patients Fit | Previous myocardial infarction | Coronary Artery Bypass Surgery Previous
Item
fit individuals who have had a myocardial infarction or cardiac bypass surgery in the past will not be excluded. their responsible physician will be asked to provide a letter confirming their suitability for the study.
boolean
C0030705 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C0155668 (UMLS CUI [2])
C0010055 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Premenopausal state
Item
premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle.
boolean
C0232969 (UMLS CUI [1])
Anticholesteremic Agents
Item
patients will be excluded if they are taking cholesterol medications at the start of the study. however, with their physician's approval, those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for one month before starting the study and throughout the study.
boolean
C0003277 (UMLS CUI [1])
Anticholesteremic Agents Natural Products | Psyllium | Red yeast rice | Other Coding | 1-octacosanol
Item
patients will be excluded if they are taking cholesterol lowering natural health products such as psyllium, red yeast rice, cholest, polycosanol etc. however, they will be allowed to join the study if they are willing to discontinue these products at least 2 weeks before the start of the study and throughout the study.
boolean
C0003277 (UMLS CUI [1,1])
C1566558 (UMLS CUI [1,2])
C0033979 (UMLS CUI [2])
C0763533 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C0044548 (UMLS CUI [5])
Uncontrolled hypertension | Increase in blood pressure | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Type Change | Antihypertensive therapy Change in drug dosage
Item
patients with uncontrolled high blood pressure will be excluded. the cut off for raised blood pressure has been taken as > 140/90mmhg. patients with systolic blood pressure between 140-150mmhg and diastolic blood pressure between 90-95mmhg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. for patients in the above normal range (as above), a letter will be required from the physician responsible for their care. patients will be excluded if they change the type or dose of their blood pressure treatment during the study.
boolean
C1868885 (UMLS CUI [1])
C0497247 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
C0585941 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0392747 (UMLS CUI [5,3])
C0585941 (UMLS CUI [6,1])
C0420247 (UMLS CUI [6,2])
Compliance behavior Unlikely | Compliance behavior Poor Lipid-lowering therapy
Item
patients will be excluded if they are judged as having a likelihood of being non-compliant with instructions for whatever reason. those with low compliance to lipid-lowering therapy will not be selected.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0585943 (UMLS CUI [2,3])
Diabetes Mellitus | Kidney Disease | Liver disease | Gastrointestinal Disease | Xanthoma Gross | Cardiovascular Disease Premature Advanced
Item
patients will be excluded if they have evidence or history of diabetes, renal disease, liver disease or gastrointestinal disease. patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyper-absorbers of plant sterols.
boolean
C0011849 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0302314 (UMLS CUI [5,1])
C0439806 (UMLS CUI [5,2])
C0007222 (UMLS CUI [6,1])
C0205252 (UMLS CUI [6,2])
C0205179 (UMLS CUI [6,3])
Predisposition Brain hemorrhage | Increase in blood pressure untreated
Item
individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will be excluded.
boolean
C0220898 (UMLS CUI [1,1])
C0553692 (UMLS CUI [1,2])
C0497247 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Skin carcinoma | High risk of Malignant Neoplasms
Item
patients will be excluded from the study if they have a history of any form of cancer apart from non melanoma skin cancer or are considered at high risk for cancer. however, if such patients wish to join the study, we would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study. if the study oncologist does not believe it is safe to enroll the participant, the patient will be excluded from the study.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
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