ID

16148

Descripción

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

Palabras clave

Versiones (2)
  1. 2/7/16 2/7/16 -
  2. 2/7/16 2/7/16 -
Subido en

2 de julio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Atrial Fibrillation NCT00189319

Inglés

Eligibility Atrial Fibrillation NCT00189319

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
in sinus rhythm at treatment initiation
Descripción

Sinus rhythm During Therapeutic procedure Initiation

Tipo de datos

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
Descripción

Atrial Fibrillation Episode Symptomatic

Tipo de datos

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%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

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

Childbearing Potential Contraceptive methods

Tipo de datos

boolean

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

Exclusion Criteria

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

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

Tipo de datos

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
Descripción

Flecainide Immediate Release Daily Dose

Tipo de datos

boolean

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

Symptom severe During Cardiac Arrhythmia Episode

Tipo de datos

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
Descripción

Heart Diseases | Congenital Heart Defects

Tipo de datos

boolean

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

Cardiac Surgery procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018821
renal failure
Descripción

Kidney Failure

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Heart Diseases Significant | Systemic disease Significant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0750502
abnormal electrolyte levels
Descripción

Electrolytes abnormal

Tipo de datos

boolean

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

Heart Therapeutic procedure Defined | Therapeutic procedure

Tipo de datos

boolean

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

Eligibility Atrial Fibrillation NCT00189319

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 | Systemic disease Significant
Item
significant extra cardiac or systemic disease
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
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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