ID

25848

Beschreibung

Safety Study of Tecadenoson to Treat Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00713401

Link

https://clinicaltrials.gov/show/NCT00713401

Stichworte

Versionen (1)
  1. 21.09.17 21.09.17 -
Hochgeladen am

21. September 2017

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00713401

Englisch

Eligibility Atrial Fibrillation NCT00713401

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of atrial fibrillation in need of treatment for rate control
Beschreibung

Atrial Fibrillation | Treatment required for rate control

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0489879
be able and willing to abstain from any antiarrhythmics, including atrioventricular (av) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment
Beschreibung

Abstinence Anti-Arrhythmia Agents | Abstinence Pharmaceutical Preparations AV node Blocking | Exception Esmolol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C0003195
UMLS CUI [2,1]
C3843422
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0004247
UMLS CUI [2,4]
C0332206
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0116569
be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications
Beschreibung

Abstinence Food Containing Xanthine | Abstinence Food Containing Chocolate | Abstinence Beverages Containing Xanthine | Abstinence Beverages Containing Chocolate | Abstinence Pharmaceutical Preparations Containing Xanthine | Abstinence Pharmaceutical Preparations Containing Chocolate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C0016452
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0043314
UMLS CUI [2,1]
C3843422
UMLS CUI [2,2]
C0016452
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0008299
UMLS CUI [3,1]
C3843422
UMLS CUI [3,2]
C0005329
UMLS CUI [3,3]
C0332256
UMLS CUI [3,4]
C0043314
UMLS CUI [4,1]
C3843422
UMLS CUI [4,2]
C0005329
UMLS CUI [4,3]
C0332256
UMLS CUI [4,4]
C0008299
UMLS CUI [5,1]
C3843422
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0043314
UMLS CUI [6,1]
C3843422
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C0332256
UMLS CUI [6,4]
C0008299
females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. males and females must be using adequate contraception during the study.
Beschreibung

Postmenopausal state | Female Sterilization | Childbearing Potential Breast Feeding Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Planned Pregnancy Absent | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0006147
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0032992
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a known accessory pathway
Beschreibung

Accessory cardiac pathway

Datentyp

boolean

Alias
UMLS CUI [1]
C1963785
have active myocardial ischemia or recent acute coronary syndrome
Beschreibung

Myocardial Ischemia | Acute Coronary Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0948089
have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock
Beschreibung

Heart failure | Bradycardia | Second degree atrioventricular block | Complete atrioventricular block | Shock, Cardiogenic

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0428977
UMLS CUI [3]
C0264906
UMLS CUI [4]
C0151517
UMLS CUI [5]
C0036980
have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents
Beschreibung

Esmolol allergy | Aminophylline allergy | Hypersensitivity Esmolol Constituents | Hypersensitivity Aminophylline Constituents | Medical contraindication Esmolol | Medical contraindication Aminophylline | Medical contraindication Esmolol Constituents | Medical contraindication Aminophylline Constituents

Datentyp

boolean

Alias
UMLS CUI [1]
C0570888
UMLS CUI [2]
C0571074
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0116569
UMLS CUI [3,3]
C0729650
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0002575
UMLS CUI [4,3]
C0729650
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0116569
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0002575
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0116569
UMLS CUI [7,3]
C0729650
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0002575
UMLS CUI [8,3]
C0729650
have a supine cuff systolic blood pressure < 90 mm hg
Beschreibung

Lying systolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1319895
be undergoing treatment with theophylline/aminophylline preparations, trental®
Beschreibung

Theophylline | Aminophylline | Trental

Datentyp

boolean

Alias
UMLS CUI [1]
C0039771
UMLS CUI [2]
C0002575
UMLS CUI [3]
C0699487
(pentoxifylline), or carbamazepine
Beschreibung

Pentoxifylline | Carbamazepine

Datentyp

boolean

Alias
UMLS CUI [1]
C0030899
UMLS CUI [2]
C0006949
have asthma or other reactive airways disease currently on-treatment
Beschreibung

Therapeutic procedure Asthma | Therapeutic procedure Reactive airway disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3714497
have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
Beschreibung

Pancreatic Disease | Pancreatic Disease chronic | Serum amylase raised | Serum lipase raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2,1]
C0030286
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0476327
UMLS CUI [4]
C3670924
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00713401

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | Treatment required for rate control
Item
have a diagnosis of atrial fibrillation in need of treatment for rate control
boolean
C0004238 (UMLS CUI [1])
C0332121 (UMLS CUI [2,1])
C0489879 (UMLS CUI [2,2])
Abstinence Anti-Arrhythmia Agents | Abstinence Pharmaceutical Preparations AV node Blocking | Exception Esmolol
Item
be able and willing to abstain from any antiarrhythmics, including atrioventricular (av) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment
boolean
C3843422 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])
C3843422 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0004247 (UMLS CUI [2,3])
C0332206 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0116569 (UMLS CUI [3,2])
Abstinence Food Containing Xanthine | Abstinence Food Containing Chocolate | Abstinence Beverages Containing Xanthine | Abstinence Beverages Containing Chocolate | Abstinence Pharmaceutical Preparations Containing Xanthine | Abstinence Pharmaceutical Preparations Containing Chocolate
Item
be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications
boolean
C3843422 (UMLS CUI [1,1])
C0016452 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0043314 (UMLS CUI [1,4])
C3843422 (UMLS CUI [2,1])
C0016452 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0008299 (UMLS CUI [2,4])
C3843422 (UMLS CUI [3,1])
C0005329 (UMLS CUI [3,2])
C0332256 (UMLS CUI [3,3])
C0043314 (UMLS CUI [3,4])
C3843422 (UMLS CUI [4,1])
C0005329 (UMLS CUI [4,2])
C0332256 (UMLS CUI [4,3])
C0008299 (UMLS CUI [4,4])
C3843422 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0043314 (UMLS CUI [5,4])
C3843422 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0332256 (UMLS CUI [6,3])
C0008299 (UMLS CUI [6,4])
Postmenopausal state | Female Sterilization | Childbearing Potential Breast Feeding Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Planned Pregnancy Absent | Contraceptive methods
Item
females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. males and females must be using adequate contraception during the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0006147 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0032992 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0700589 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Accessory cardiac pathway
Item
have a known accessory pathway
boolean
C1963785 (UMLS CUI [1])
Myocardial Ischemia | Acute Coronary Syndrome
Item
have active myocardial ischemia or recent acute coronary syndrome
boolean
C0151744 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
Heart failure | Bradycardia | Second degree atrioventricular block | Complete atrioventricular block | Shock, Cardiogenic
Item
have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock
boolean
C0018801 (UMLS CUI [1])
C0428977 (UMLS CUI [2])
C0264906 (UMLS CUI [3])
C0151517 (UMLS CUI [4])
C0036980 (UMLS CUI [5])
Esmolol allergy | Aminophylline allergy | Hypersensitivity Esmolol Constituents | Hypersensitivity Aminophylline Constituents | Medical contraindication Esmolol | Medical contraindication Aminophylline | Medical contraindication Esmolol Constituents | Medical contraindication Aminophylline Constituents
Item
have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents
boolean
C0570888 (UMLS CUI [1])
C0571074 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0116569 (UMLS CUI [3,2])
C0729650 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0002575 (UMLS CUI [4,2])
C0729650 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0116569 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0002575 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0116569 (UMLS CUI [7,2])
C0729650 (UMLS CUI [7,3])
C1301624 (UMLS CUI [8,1])
C0002575 (UMLS CUI [8,2])
C0729650 (UMLS CUI [8,3])
Lying systolic blood pressure
Item
have a supine cuff systolic blood pressure < 90 mm hg
boolean
C1319895 (UMLS CUI [1])
Theophylline | Aminophylline | Trental
Item
be undergoing treatment with theophylline/aminophylline preparations, trental®
boolean
C0039771 (UMLS CUI [1])
C0002575 (UMLS CUI [2])
C0699487 (UMLS CUI [3])
Pentoxifylline | Carbamazepine
Item
(pentoxifylline), or carbamazepine
boolean
C0030899 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
Therapeutic procedure Asthma | Therapeutic procedure Reactive airway disease
Item
have asthma or other reactive airways disease currently on-treatment
boolean
C0087111 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C3714497 (UMLS CUI [2,2])
Pancreatic Disease | Pancreatic Disease chronic | Serum amylase raised | Serum lipase raised
Item
have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
boolean
C0030286 (UMLS CUI [1])
C0030286 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0476327 (UMLS CUI [3])
C3670924 (UMLS CUI [4])
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