ID

16154

Beschrijving

To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00189319

Link

https://clinicaltrials.gov/show/NCT00189319

Trefwoorden

  1. 02-07-16 02-07-16 -
  2. 02-07-16 02-07-16 -
Geüploaded op

2 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00189319

Eligibility Atrial Fibrillation NCT00189319

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in sinus rhythm at treatment initiation
Beschrijving

Sinus rhythm During Therapeutic procedure Initiation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232201
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1704686
experienced symptomatic af episodes
Beschrijving

Atrial Fibrillation Episode Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0231220
left ventricular ejection fraction of at least 40%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
females of child bearing potential must be using reliable method of contraception
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
intolerance and/or failure of previous therapy with flecainide immediate release
Beschrijving

intolerance to Flecainide Immediate Release | Flecainide Immediate Release Prior Therapy failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0016229
UMLS CUI [1,3]
C1708470
UMLS CUI [2,1]
C0016229
UMLS CUI [2,2]
C1708470
UMLS CUI [2,3]
C1514463
UMLS CUI [2,4]
C0231175
currently receiving >200mg/day flecainide immediate release
Beschrijving

Flecainide Immediate Release Daily Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016229
UMLS CUI [1,2]
C1708470
UMLS CUI [1,3]
C2348070
severe symptoms during episodes of arrhythmia
Beschrijving

Symptom severe During Cardiac Arrhythmia Episode

Datatype

boolean

Alias
UMLS CUI [1,1]
C0436345
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0003811
UMLS CUI [1,4]
C0332189
history of other cardiac conditions/abnormalities
Beschrijving

Heart Diseases | Congenital Heart Defects

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018798
heart surgery within the last 2 months
Beschrijving

Cardiac Surgery procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
renal failure
Beschrijving

Kidney Failure

Datatype

boolean

Alias
UMLS CUI [1]
C0035078
pregnant or lactating females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant extra cardiac or systemic disease
Beschrijving

Heart Diseases Significant Additional | Systemic disease Significant Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C1524062
abnormal electrolyte levels
Beschrijving

Electrolytes abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0151613
receiving defined cardiac and/or other treatments
Beschrijving

Heart Therapeutic procedure Defined | Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1704788
UMLS CUI [2]
C0087111

Similar models

Eligibility Atrial Fibrillation NCT00189319

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Sinus rhythm During Therapeutic procedure Initiation
Item
in sinus rhythm at treatment initiation
boolean
C0232201 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1704686 (UMLS CUI [1,4])
Atrial Fibrillation Episode Symptomatic
Item
experienced symptomatic af episodes
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction of at least 40%
boolean
C0428772 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
females of child bearing potential must be using reliable method of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
intolerance to Flecainide Immediate Release | Flecainide Immediate Release Prior Therapy failed
Item
intolerance and/or failure of previous therapy with flecainide immediate release
boolean
C1744706 (UMLS CUI [1,1])
C0016229 (UMLS CUI [1,2])
C1708470 (UMLS CUI [1,3])
C0016229 (UMLS CUI [2,1])
C1708470 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Flecainide Immediate Release Daily Dose
Item
currently receiving >200mg/day flecainide immediate release
boolean
C0016229 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Symptom severe During Cardiac Arrhythmia Episode
Item
severe symptoms during episodes of arrhythmia
boolean
C0436345 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
Heart Diseases | Congenital Heart Defects
Item
history of other cardiac conditions/abnormalities
boolean
C0018799 (UMLS CUI [1])
C0018798 (UMLS CUI [2])
Cardiac Surgery procedures
Item
heart surgery within the last 2 months
boolean
C0018821 (UMLS CUI [1])
Kidney Failure
Item
renal failure
boolean
C0035078 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Diseases Significant Additional | Systemic disease Significant Additional
Item
significant extra cardiac or systemic disease
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
Electrolytes abnormal
Item
abnormal electrolyte levels
boolean
C0151613 (UMLS CUI [1])
Heart Therapeutic procedure Defined | Therapeutic procedure
Item
receiving defined cardiac and/or other treatments
boolean
C0018787 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2])

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