ID

38456

Description

Doxycycline Outcomes in Lupus Erythematosus; ODM derived from: https://clinicaltrials.gov/show/NCT01014260

Link

https://clinicaltrials.gov/show/NCT01014260

Keywords

Versions (1)
  1. 10/18/19 10/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01014260

English

Eligibility Cardiovascular Disease NCT01014260

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a clinical diagnosis of sle, with a hs-crp above > 3mg/l, (high risk level) for the last 3 months, are eligible.
Description

Lupus Erythematosus, Systemic | hs-CRP increased

Data type

boolean

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C1963867
2. patients must be 18 years of age or older and able to give informed consent.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
3. contraception other than ocps is necessary if a woman is at risk for pregnancy.
Description

At risk Pregnancy | Contraceptive methods | Exception Oral Contraceptives

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0032961
UMLS CUI [2]
C0700589
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009905
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. sle patients who are allergic to doxycycline or other tetracyclines.
Description

Systemic Lupus Erythematosus Associated with Doxycycline allergy | Systemic Lupus Erythematosus Associated with Tetracycline allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0024141
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0571496
UMLS CUI [2,1]
C0024141
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0039645
2. patients who are pregnant or are planning to become pregnant.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
3. patients who are on oral contraceptives (any method of contraception other than ocps can be used.
Description

Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009905
4. tetracycline use within the previous 2 weeks of enrollment.
Description

Tetracycline

Data type

boolean

Alias
UMLS CUI [1]
C0039644
5. patients who are currently on statins will be excluded, because statins might reduce hs- crp.
Description

Statins

Data type

boolean

Alias
UMLS CUI [1]
C0360714
6. patients who are on warfarin.
Description

Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
7. patients whose most recent ekg shows significant cardiac dysrhythmias or heart block.
Description

Cardiac Arrhythmia ECG | Heart Block by ECG Finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0013798
UMLS CUI [2]
C0344413
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Similar models

Eligibility Cardiovascular Disease NCT01014260

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lupus Erythematosus, Systemic | hs-CRP increased
Item
1. patients with a clinical diagnosis of sle, with a hs-crp above > 3mg/l, (high risk level) for the last 3 months, are eligible.
boolean
C0024141 (UMLS CUI [1])
C1963867 (UMLS CUI [2])
Age | Informed Consent
Item
2. patients must be 18 years of age or older and able to give informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
At risk Pregnancy | Contraceptive methods | Exception Oral Contraceptives
Item
3. contraception other than ocps is necessary if a woman is at risk for pregnancy.
boolean
C1444641 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0009905 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Systemic Lupus Erythematosus Associated with Doxycycline allergy | Systemic Lupus Erythematosus Associated with Tetracycline allergy
Item
1. sle patients who are allergic to doxycycline or other tetracyclines.
boolean
C0024141 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0571496 (UMLS CUI [1,3])
C0024141 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0039645 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
2. patients who are pregnant or are planning to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Contraceptives, Oral
Item
3. patients who are on oral contraceptives (any method of contraception other than ocps can be used.
boolean
C0009905 (UMLS CUI [1])
Tetracycline
Item
4. tetracycline use within the previous 2 weeks of enrollment.
boolean
C0039644 (UMLS CUI [1])
Statins
Item
5. patients who are currently on statins will be excluded, because statins might reduce hs- crp.
boolean
C0360714 (UMLS CUI [1])
Warfarin
Item
6. patients who are on warfarin.
boolean
C0043031 (UMLS CUI [1])
Cardiac Arrhythmia ECG | Heart Block by ECG Finding
Item
7. patients whose most recent ekg shows significant cardiac dysrhythmias or heart block.
boolean
C0003811 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0344413 (UMLS CUI [2])
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