ID

40825

Description

Randomized Controlled Trial of Lipid Apheresis in Patients With Elevated Lipoprotein(a); ODM derived from: https://clinicaltrials.gov/show/NCT01064934

Link

https://clinicaltrials.gov/show/NCT01064934

Keywords

Versions (1)
  1. 5/19/20 5/19/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 19, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hyperlipoproteinemia(a) NCT01064934

English

Eligibility Hyperlipoproteinemia(a) NCT01064934

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
above 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
male or female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
lipoprotein(a) >=60 mg/dl
Description

Lipoprotein (a) measurement

Data type

boolean

Alias
UMLS CUI [1]
C1096202
low-density lipoprotein cholesterol <130 mg/dl
Description

Low density lipoprotein cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202117
progressive cardiovascular disease
Description

Cardiovascular Disease Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205329
positive recommendation by the inclusion committee
Description

Recommendation Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0034866
UMLS CUI [1,2]
C1514241
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current participation in a lipid apheresis program
Description

Participation Lipid Apheresis Program

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0023779
UMLS CUI [1,3]
C0005791
UMLS CUI [1,4]
C3484370
previous participation in a lipid apheresis program
Description

Lipid Apheresis Program | Participation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0023779
UMLS CUI [1,2]
C0005791
UMLS CUI [1,3]
C3484370
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0205156
low-density lipoprotein cholesterol >=130 mg/dl under maximally tolerated (or necessary) drug treatment
Description

Low density lipoprotein cholesterol measurement | Pharmacotherapy Maximum Tolerated Dose

Data type

boolean

Alias
UMLS CUI [1]
C0202117
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0752079
triglyceride concentrations >=450 mg/dl
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
known homozygous familial hypercholesterolemia
Description

Familial hypercholesterolemia - homozygous

Data type

boolean

Alias
UMLS CUI [1]
C0342881
known type iii hyperlipoproteinemia
Description

Hyperlipoproteinemia Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0020476
UMLS CUI [1,2]
C0332307
pregnancy, breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of malignant disease (with the exception of non-melanoma carcinomas of the skin and carcinoma in situ of the cervix)
Description

Malignant disease | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
planned major surgical procedures in the next 3 months
Description

Major surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1301732
current participation in another interventional trial
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
previous randomization in the current trial (applies only for the rct)
Description

Study Subject Participation Status | Randomization Previous

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0205156
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Similar models

Eligibility Hyperlipoproteinemia(a) NCT01064934

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
above 18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Lipoprotein (a) measurement
Item
lipoprotein(a) >=60 mg/dl
boolean
C1096202 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
low-density lipoprotein cholesterol <130 mg/dl
boolean
C0202117 (UMLS CUI [1])
Cardiovascular Disease Progressive
Item
progressive cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Recommendation Positive
Item
positive recommendation by the inclusion committee
boolean
C0034866 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Participation Lipid Apheresis Program
Item
current participation in a lipid apheresis program
boolean
C0679823 (UMLS CUI [1,1])
C0023779 (UMLS CUI [1,2])
C0005791 (UMLS CUI [1,3])
C3484370 (UMLS CUI [1,4])
Lipid Apheresis Program | Participation Previous
Item
previous participation in a lipid apheresis program
boolean
C0023779 (UMLS CUI [1,1])
C0005791 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Low density lipoprotein cholesterol measurement | Pharmacotherapy Maximum Tolerated Dose
Item
low-density lipoprotein cholesterol >=130 mg/dl under maximally tolerated (or necessary) drug treatment
boolean
C0202117 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
Triglycerides measurement
Item
triglyceride concentrations >=450 mg/dl
boolean
C0202236 (UMLS CUI [1])
Familial hypercholesterolemia - homozygous
Item
known homozygous familial hypercholesterolemia
boolean
C0342881 (UMLS CUI [1])
Hyperlipoproteinemia Type
Item
known type iii hyperlipoproteinemia
boolean
C0020476 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy, breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant disease | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of malignant disease (with the exception of non-melanoma carcinomas of the skin and carcinoma in situ of the cervix)
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Major surgery Planned
Item
planned major surgical procedures in the next 3 months
boolean
C0679637 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Study Subject Participation Status | Interventional Study
Item
current participation in another interventional trial
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Study Subject Participation Status | Randomization Previous
Item
previous randomization in the current trial (applies only for the rct)
boolean
C2348568 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
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