ID

31839

Descripción

Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00555230

Link

https://clinicaltrials.gov/show/NCT00555230

Palabras clave

Versiones (1)
  1. 1/10/18 1/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00555230

Inglés

Eligibility Rheumatoid Arthritis NCT00555230

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women, 18 years of age or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
clinical diagnosis of ra with a duration of at least 6 month
Descripción

Rheumatoid Arthritis Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
prednisolone < =10 mg/day
Descripción

Prednisolone U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032950
UMLS CUI [1,2]
C0456683
nsaid or dmard
Descripción

NSAID | DMARD

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0242708
informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
little or no ability for self-care
Descripción

Impaired self-care | Self-care Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518084
UMLS CUI [2,1]
C3872897
UMLS CUI [2,2]
C1299582
type 1 diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
uncontrolled hypertension(> 160/95 mmhg)
Descripción

Uncontrolled hypertension | Blood pressure determination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
Descripción

Serum total cholesterol measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1445957
history of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
Descripción

History of coronary artery bypass grafting | Myocardial Infarction | Ventricular Dysfunction, Left | Left ventricular ejection fraction | Heart valve disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275842
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0242698
UMLS CUI [4]
C0428772
UMLS CUI [5]
C0018824
current treatment with ace inhibitor, angiotensin ii receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins
Descripción

ACE Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Hypolipidemic Agents | Medical contraindication Statins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0086440
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0360714
current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study
Descripción

Oral Contraceptives Discontinue Unwilling | Estrogens Discontinue Unwilling | Progestins Discontinue Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0014939
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0033306
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
current treatment with antioxidant therapy (vitamin c or multivitamin)
Descripción

Antioxidant therapy | Vitamin C | Multivitamins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1879713
UMLS CUI [2]
C0003968
UMLS CUI [3]
C0301532
received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening
Descripción

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
clinically significant renal disease(serum creatinine level ≥ 270 µmol/l) or aspartate aminotransferase(ast), alanine aminotransferase alt), or creatine kinase (ck)≥ 2 x uln
Descripción

Kidney Disease | Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated creatine kinase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151576
female of childbearing potential, unwilling to use adequate contraception during the study
Descripción

Childbearing Potential Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
current or recent (within the past 3 months) pregnancy and cancer
Descripción

Pregnancy | Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006826
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Similar models

Eligibility Rheumatoid Arthritis NCT00555230

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women, 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Duration
Item
clinical diagnosis of ra with a duration of at least 6 month
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Prednisolone U/day
Item
prednisolone < =10 mg/day
boolean
C0032950 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
NSAID | DMARD
Item
nsaid or dmard
boolean
C0003211 (UMLS CUI [1])
C0242708 (UMLS CUI [2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Impaired self-care | Self-care Unable
Item
little or no ability for self-care
boolean
C0518084 (UMLS CUI [1])
C3872897 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension(> 160/95 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Serum total cholesterol measurement
Item
total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
boolean
C1445957 (UMLS CUI [1])
History of coronary artery bypass grafting | Myocardial Infarction | Ventricular Dysfunction, Left | Left ventricular ejection fraction | Heart valve disease
Item
history of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
boolean
C1275842 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0242698 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
C0018824 (UMLS CUI [5])
ACE Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Hypolipidemic Agents | Medical contraindication Statins
Item
current treatment with ace inhibitor, angiotensin ii receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0086440 (UMLS CUI [4])
C1301624 (UMLS CUI [5,1])
C0360714 (UMLS CUI [5,2])
Oral Contraceptives Discontinue Unwilling | Estrogens Discontinue Unwilling | Progestins Discontinue Unwilling
Item
current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study
boolean
C0009905 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0014939 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0033306 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Antioxidant therapy | Vitamin C | Multivitamins
Item
current treatment with antioxidant therapy (vitamin c or multivitamin)
boolean
C1879713 (UMLS CUI [1])
C0003968 (UMLS CUI [2])
C0301532 (UMLS CUI [3])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Kidney Disease | Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated creatine kinase
Item
clinically significant renal disease(serum creatinine level ≥ 270 µmol/l) or aspartate aminotransferase(ast), alanine aminotransferase alt), or creatine kinase (ck)≥ 2 x uln
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151576 (UMLS CUI [5])
Childbearing Potential Contraceptive methods Unwilling
Item
female of childbearing potential, unwilling to use adequate contraception during the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Pregnancy | Malignant Neoplasms
Item
current or recent (within the past 3 months) pregnancy and cancer
boolean
C0032961 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
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