ID

37453

Description

Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00951301

Link

https://clinicaltrials.gov/show/NCT00951301

Keywords

Versions (1)
  1. 7/29/19 7/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00951301

English

Eligibility Atrial Fibrillation NCT00951301

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
candidates for this study must meet all of the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
age >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
documented atrial fibrillation with a clinically indicated cardioversion.
Description

Atrial Fibrillation | Indication Electric Countershock

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013778
anticoagulation with therapeutic inr or ptt as per mayo clinic cardioversion guidelines.
Description

Anticoagulation Therapy | INR therapeutic range | PTT therapeutic range

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0460097
UMLS CUI [3,1]
C0030605
UMLS CUI [3,2]
C0460097
provision of written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be excluded if any of the following conditions apply:
Description

Study Subject Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0332196
presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
Description

Atrial Fibrillation Secondary to Cause Reversible | Thyrotoxicosis | Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
UMLS CUI [2]
C0040156
UMLS CUI [3]
C0001948
myocardial infarction within 1 month, cabg or cardiac surgery including surgical maze or af radiofrequency ablation within the past 3 months
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiac Surgery procedures | Maze procedure for atrial fibrillation | Atrial Fibrillation Radiofrequency ablation

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0018821
UMLS CUI [4]
C0397414
UMLS CUI [5,1]
C0004238
UMLS CUI [5,2]
C0850292
presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
Description

Artificial cardiac pacemaker | Defibrillator Atrial | Defibrillator Ventricular

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C0180307
UMLS CUI [2,2]
C0018792
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C0018827
history of bleeding diathesis or coagulopathy
Description

Bleeding tendency | Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
known atrial thrombus or contra-indication to cardioversion
Description

Atrial thrombus | Medical contraindication Electric Countershock

Data type

boolean

Alias
UMLS CUI [1]
C0340517
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013778
active infection or collagen vascular disease with active inflammation
Description

Communicable Disease | Collagen-vascular disease | Inflammation

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0262428
UMLS CUI [3]
C0021368
current use of corticosteroids
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
gastrointestinal (gi) or genitourinary bleed within the past six months requiring transfusion
Description

Gastrointestinal Hemorrhage Requirement Transfusion | Genitourinary tract hemorrhage Requirement Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1879316
UMLS CUI [2,1]
C0919591
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1879316
concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
Description

Comorbidity Excludes Protocol Compliance | Comorbidity Interferes with Interpretation Research data | Comorbidity Limiting Life Expectancy | Malignant Neoplasms | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0023671
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0018802
known allergy to juice components
Description

Hypersensitivity Juice Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1268568
UMLS CUI [1,3]
C1705248
inability or refusal to cooperate with study procedures
Description

Protocol Compliance Unable | Protocol Compliance Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1705116
unsuccessful cardioversion
Description

Electric Countershock Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C1272705
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Similar models

Eligibility Atrial Fibrillation NCT00951301

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
candidates for this study must meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation | Indication Electric Countershock
Item
documented atrial fibrillation with a clinically indicated cardioversion.
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
Anticoagulation Therapy | INR therapeutic range | PTT therapeutic range
Item
anticoagulation with therapeutic inr or ptt as per mayo clinic cardioversion guidelines.
boolean
C0003281 (UMLS CUI [1])
C0525032 (UMLS CUI [2,1])
C0460097 (UMLS CUI [2,2])
C0030605 (UMLS CUI [3,1])
C0460097 (UMLS CUI [3,2])
Informed Consent
Item
provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Excluded
Item
subjects will be excluded if any of the following conditions apply:
boolean
C0681850 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Atrial Fibrillation Secondary to Cause Reversible | Thyrotoxicosis | Alcohol consumption
Item
presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
C0040156 (UMLS CUI [2])
C0001948 (UMLS CUI [3])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiac Surgery procedures | Maze procedure for atrial fibrillation | Atrial Fibrillation Radiofrequency ablation
Item
myocardial infarction within 1 month, cabg or cardiac surgery including surgical maze or af radiofrequency ablation within the past 3 months
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
C0397414 (UMLS CUI [4])
C0004238 (UMLS CUI [5,1])
C0850292 (UMLS CUI [5,2])
Artificial cardiac pacemaker | Defibrillator Atrial | Defibrillator Ventricular
Item
presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C0180307 (UMLS CUI [3,1])
C0018827 (UMLS CUI [3,2])
Bleeding tendency | Blood Coagulation Disorder
Item
history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Atrial thrombus | Medical contraindication Electric Countershock
Item
known atrial thrombus or contra-indication to cardioversion
boolean
C0340517 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
Communicable Disease | Collagen-vascular disease | Inflammation
Item
active infection or collagen vascular disease with active inflammation
boolean
C0009450 (UMLS CUI [1])
C0262428 (UMLS CUI [2])
C0021368 (UMLS CUI [3])
Adrenal Cortex Hormones
Item
current use of corticosteroids
boolean
C0001617 (UMLS CUI [1])
Gastrointestinal Hemorrhage Requirement Transfusion | Genitourinary tract hemorrhage Requirement Transfusion
Item
gastrointestinal (gi) or genitourinary bleed within the past six months requiring transfusion
boolean
C0017181 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,3])
C0919591 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1879316 (UMLS CUI [2,3])
Comorbidity Excludes Protocol Compliance | Comorbidity Interferes with Interpretation Research data | Comorbidity Limiting Life Expectancy | Malignant Neoplasms | Congestive heart failure
Item
concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0009488 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
Hypersensitivity Juice Component
Item
known allergy to juice components
boolean
C0020517 (UMLS CUI [1,1])
C1268568 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Protocol Compliance Unable | Protocol Compliance Refused
Item
inability or refusal to cooperate with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Electric Countershock Unsuccessful
Item
unsuccessful cardioversion
boolean
C0013778 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
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