ID

29298

Beschrijving

Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00844714

Link

https://clinicaltrials.gov/show/NCT00844714

Trefwoorden

Versies (1)
  1. 16-03-18 16-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 maart 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Endothelial Function NCT00844714

Engels

Eligibility Endothelial Function NCT00844714

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
able and willing to give written informed consent and comply with the requirements of the study protocol
Beschrijving

Informed Consent | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
negative serum pregnancy test (for women of child bearing age)
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
Beschrijving

Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
igg & igm levels within normal limits
Beschrijving

Normal IgG levels | Normal IgM levels

Datatype

boolean

Alias
UMLS CUI [1]
C1833177
UMLS CUI [2]
C1855783
adequate renal function as indicated by serum creatinine measurements.
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
no previous biological use (investigational or approved) except for the three approved anti-tnf alpha therapies
Beschrijving

Biological Factors Absent | Exception Anti-tumor necrosis factor therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0281481
UMLS CUI [2,3]
C1265611
patients who have been treated with anti-tnf alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
Beschrijving

Anti-tumor necrosis factor therapy | Infliximab Discontinued | Adalimumab Discontinued | Etanercept Discontinued

Datatype

boolean

Alias
UMLS CUI [1]
C0281481
UMLS CUI [2,1]
C0666743
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1122087
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0717758
UMLS CUI [4,2]
C1444662
no use of phosphodiesterase type 5 inhibitors (pde5) (i.e. sildenafil, tadalafil, and vardenafil) 1 week prior to the study and during the course of the study.
Beschrijving

Phosphodiesterase 5 inhibitor Absent | Sildenafil Absent | Tadalafil Absent | Vardenafil Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1318700
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0529793
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1176316
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0971579
UMLS CUI [4,2]
C0332197
sbp ≤ 140/90 for two months prior to study enrollment
Beschrijving

Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of mi, cva, cabg, ptca, or peripheral vascular disease
Beschrijving

Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Peripheral Vascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0010055
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0085096
any serious concomitant medical condition that could interfere with the study.
Beschrijving

Comorbidity Interferes with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
patients with insulin dependent diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
failure to provide written consent.
Beschrijving

Informed Consent failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
individuals with hiv infections
Beschrijving

HIV Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
sbp > 140/90 at two months prior to study enrollment
Beschrijving

Systolic Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
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Similar models

Eligibility Endothelial Function NCT00844714

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Protocol Compliance
Item
able and willing to give written informed consent and comply with the requirements of the study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative
Item
negative serum pregnancy test (for women of child bearing age)
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods
Item
men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Normal IgG levels | Normal IgM levels
Item
igg & igm levels within normal limits
boolean
C1833177 (UMLS CUI [1])
C1855783 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
adequate renal function as indicated by serum creatinine measurements.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Biological Factors Absent | Exception Anti-tumor necrosis factor therapy Quantity
Item
no previous biological use (investigational or approved) except for the three approved anti-tnf alpha therapies
boolean
C0005515 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0281481 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Anti-tumor necrosis factor therapy | Infliximab Discontinued | Adalimumab Discontinued | Etanercept Discontinued
Item
patients who have been treated with anti-tnf alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
boolean
C0281481 (UMLS CUI [1])
C0666743 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1122087 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0717758 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Phosphodiesterase 5 inhibitor Absent | Sildenafil Absent | Tadalafil Absent | Vardenafil Absent
Item
no use of phosphodiesterase type 5 inhibitors (pde5) (i.e. sildenafil, tadalafil, and vardenafil) 1 week prior to the study and during the course of the study.
boolean
C1318700 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0529793 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1176316 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0971579 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Systolic Pressure
Item
sbp ≤ 140/90 for two months prior to study enrollment
boolean
C0871470 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Cerebrovascular accident | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Peripheral Vascular Diseases
Item
prior history of mi, cva, cabg, ptca, or peripheral vascular disease
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
Comorbidity Interferes with Clinical Trial
Item
any serious concomitant medical condition that could interfere with the study.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
patients with insulin dependent diabetes
boolean
C0011854 (UMLS CUI [1])
Informed Consent failed
Item
failure to provide written consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
HIV Infections
Item
individuals with hiv infections
boolean
C0019693 (UMLS CUI [1])
Systolic Pressure
Item
sbp > 140/90 at two months prior to study enrollment
boolean
C0871470 (UMLS CUI [1])
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