ID

37605

Descripción

Cardiac Surgery and the Risk of Atrial Fibrillation: an Intervention Trial Evaluating Melatonin; ODM derived from: https://clinicaltrials.gov/show/NCT02099331

Link

https://clinicaltrials.gov/show/NCT02099331

Palabras clave

  1. 11/8/19 11/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02099331

Eligibility Atrial Fibrillation NCT02099331

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age over the age of 18.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures)
Descripción

Cardiac Surgery elective Scheduled | Coronary Artery Bypass Surgery | Valve Surgery | Procedure Combined

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1186983
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205195
3. enroll at least 48 hours before surgery is scheduled
Descripción

Enrollment | Status pre- Patient scheduled for surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C3242215
4. presence of normal sinus rhythm on screening electrocardiogram.
Descripción

Electrocardiogram: normal sinus rhythm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960147
5. be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so).
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of prior atrial fibrillation
Descripción

Atrial Fibrillation Previous

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205156
2. inability to give informed consent.
Descripción

Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
3. use of anti-arrhythmic drugs other than beta-blockers
Descripción

Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003195
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304516
4. chronic nsaid or antioxidant use
Descripción

NSAIDs chronic | Antioxidants chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0003402
UMLS CUI [2,2]
C0205191
5. history of severe autoimmune disorders with the need for autoimmune medications.
Descripción

Autoimmune Diseases Severe | Patient need for Pharmaceutical Preparations Autoimmune Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0004364
6. history of epilepsy.
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
7. compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal)
Descripción

Liver Dysfunction | Transaminases increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0438717
8. current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team)
Descripción

Pregnancy Serum pregnancy test positive | Pregnancy Urine pregnancy test positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430063
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0430059
9. non-english speakers
Descripción

Lacking Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
10. current use of warfarin, nifedipine, fluvoxamine.
Descripción

Warfarin | Nifedipine | Fluvoxamine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0028066
UMLS CUI [3]
C0085228

Similar models

Eligibility Atrial Fibrillation NCT02099331

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age over the age of 18.
boolean
C0001779 (UMLS CUI [1])
Cardiac Surgery elective Scheduled | Coronary Artery Bypass Surgery | Valve Surgery | Procedure Combined
Item
2. scheduled for elective cardiac surgery (coronary artery bypass grafting, valvular surgery or combined procedures)
boolean
C0018821 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0010055 (UMLS CUI [2])
C1186983 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0184661 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
Enrollment | Status pre- Patient scheduled for surgery
Item
3. enroll at least 48 hours before surgery is scheduled
boolean
C1516879 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C3242215 (UMLS CUI [2,2])
Electrocardiogram: normal sinus rhythm
Item
4. presence of normal sinus rhythm on screening electrocardiogram.
boolean
C1960147 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
5. be willing to provide informed consent (which may be provided by a legally authorized representative if the patient is not able to do so).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Previous
Item
1. history of prior atrial fibrillation
boolean
C0004238 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Informed Consent Unable
Item
2. inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists
Item
3. use of anti-arrhythmic drugs other than beta-blockers
boolean
C0003195 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
NSAIDs chronic | Antioxidants chronic
Item
4. chronic nsaid or antioxidant use
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003402 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Autoimmune Diseases Severe | Patient need for Pharmaceutical Preparations Autoimmune Diseases
Item
5. history of severe autoimmune disorders with the need for autoimmune medications.
boolean
C0004364 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0004364 (UMLS CUI [2,3])
Epilepsy
Item
6. history of epilepsy.
boolean
C0014544 (UMLS CUI [1])
Liver Dysfunction | Transaminases increased
Item
7. compromised hepatic function (aminotransferase levels > 1.5 times the upper limit of normal)
boolean
C0086565 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
Pregnancy Serum pregnancy test positive | Pregnancy Urine pregnancy test positive
Item
8. current pregnancy (determined by either serum or urine pregnancy test, as ordered by the primary team)
boolean
C0032961 (UMLS CUI [1,1])
C0430063 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430059 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
9. non-english speakers
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Warfarin | Nifedipine | Fluvoxamine
Item
10. current use of warfarin, nifedipine, fluvoxamine.
boolean
C0043031 (UMLS CUI [1])
C0028066 (UMLS CUI [2])
C0085228 (UMLS CUI [3])

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