ID

34840

Descrizione

SMART China, A Multi-center Clinical Registry Study; ODM derived from: https://clinicaltrials.gov/show/NCT02485925

collegamento

https://clinicaltrials.gov/show/NCT02485925

Keywords

versioni (1)
  1. 31/01/19 31/01/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

31 gennaio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02485925

Inglese

Eligibility Atrial Fibrillation NCT02485925

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years or older
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. failure of at least one antiarrhythmic drug (aad) for af (class i or iii, or av nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic af, or intolerance to the aad
Descrizione

Anti-Arrhythmia Agents Atrial Fibrillation | Anti-Arrhythmia Agents Quantity failed | Anti-Arrhythmia Agents Class | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers | Recurrent symptomatic atrial fibrillation | Intolerance to Anti-Arrhythmia Agents

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0003195
UMLS CUI [3,2]
C0456387
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0006684
UMLS CUI [6]
C1739416
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0003195
3. patients with paroxysmal af eligible for catheter ablation
Descrizione

Paroxysmal atrial fibrillation Eligible Catheter ablation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0162563
4. patients with symptomatic paf who have had at least one documented af episode in the six (6) months prior to enrollment. documentation may include but is not limited to electrocardiogram (ecg), holter monitor (hm) or transtelephonic monitor (ttm)
Descrizione

Paroxysmal atrial fibrillation Symptomatic | Paroxysmal atrial fibrillation Episode Quantity | Electrocardiography | Holter Electrocardiography | Other Coding

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C1623258
UMLS CUI [4]
C0013801
UMLS CUI [5]
C3846158
5. able and willing to comply with all pre-, post- and follow-up testing and requirements
Descrizione

Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
6. be able to sign irb/ec-approved informed consent form
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Descrizione

Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Disease | Atrial Fibrillation Reversible | Atrial Fibrillation Absence Cause cardiac

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0342579
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0040128
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0205343
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0015127
UMLS CUI [4,4]
C0018787
2. previous surgical or catheter ablation for af
Descrizione

Destructive procedure (surgical) Atrial Fibrillation | Catheter ablation for atrial fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1261381
UMLS CUI [1,2]
C0004238
UMLS CUI [2]
C2702800
3. any pci, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
Descrizione

Percutaneous Coronary Intervention | Cardiac Surgery procedures | Heart Valve Operative Surgical Procedures | Heart Valve Procedure Percutaneous | Ventriculotomy | Incision of atrium of heart | Repair of heart valve | Heart valve replacement | Heart Valve Prosthesis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0018821
UMLS CUI [3,1]
C0018826
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C0184661
UMLS CUI [4,3]
C0522523
UMLS CUI [5]
C0750201
UMLS CUI [6]
C0189760
UMLS CUI [7]
C0190112
UMLS CUI [8]
C0190173
UMLS CUI [9]
C0018825
4. any carotid stenting or endarterectomy.
Descrizione

Carotid Artery Stenting | Carotid Endarterectomy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007272
UMLS CUI [1,2]
C2348535
UMLS CUI [2]
C0014099
5. coronary artery bypass graft (cabg) procedure within the last 180 days (6 months)
Descrizione

Coronary Artery Bypass Surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010055
6. af episodes lasting longer than 7 days or terminated via cardioversion
Descrizione

Episode of Atrial Fibrillation Duration | Cardioversion Episode of Atrial Fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0004238
7. documented left atrial thrombus on imaging
Descrizione

Thrombus of left atrium Imaging

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0011923
8. uncontrolled heart failure or new york heart association (nyha) class iii or iv
Descrizione

Heart failure Uncontrolled | Heart failure New York Heart Association Classification

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
9. myocardial infarction within the previous 60 days (2 months)
Descrizione

Myocardial Infarction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
10. documented thromboembolic event (including tia) within the past 12 months
Descrizione

Thromboembolism | Transient Ischemic Attack

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0007787
11. rheumatic heart disease
Descrizione

Rheumatic Heart Disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0035439
12. awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
Descrizione

Heart Transplantation Anticipated | Cardiac Surgery procedure Anticipated

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C3840775
13. significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
Descrizione

Lung diseases | Restrictive pulmonary disease | Airway constriction | Chronic Obstructive Airway Disease | Lung malfunction | Respiration Disorders | Respiratory Failure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0877013
UMLS CUI [3]
C0231818
UMLS CUI [4]
C0024117
UMLS CUI [5,1]
C0024109
UMLS CUI [5,2]
C0231174
UMLS CUI [6]
C0035204
UMLS CUI [7]
C1145670
14. significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Descrizione

Congenital Abnormality Study Subject Participation Status Excluded | Medical Problem Study Subject Participation Status Excluded

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
15. active illness or active systemic infection or sepsis
Descrizione

Illness | Sepsis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0243026
16. diagnosed atrial myxoma
Descrizione

Atrial myxoma

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151241
17. unstable angina within the past 60 days (2 months)
Descrizione

Angina, Unstable

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002965
18. history of blood clotting or bleeding abnormalities
Descrizione

Blood coagulation | Bleeding tendency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005778
UMLS CUI [2]
C1458140
19. life expectancy less than 365 days (12 months)
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
20. hypertrophic obstructive cardiomyopathy
Descrizione

Hypertrophic Cardiomyopathy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007194
21. presence of implanted icd
Descrizione

Implantable defibrillator

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0162589
22. contraindication to anticoagulation
Descrizione

Medical contraindication Anticoagulation Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
23. contraindication to isoproterenol
Descrizione

Medical contraindication Isoproterenol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0022245
24. presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
Descrizione

Thrombus intramural Excludes Catheterization | Malignant Neoplasm Excludes Catheterization | Abnormality Excludes Catheterization | Thrombus intramural Excludes Manipulation of catheter | Malignant Neoplasm Excludes Manipulation of catheter | Abnormality Excludes Manipulation of catheter

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0205102
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0007430
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0007430
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0007430
UMLS CUI [4,1]
C0087086
UMLS CUI [4,2]
C0205102
UMLS CUI [4,3]
C0332196
UMLS CUI [4,4]
C0522773
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0522773
UMLS CUI [6,1]
C1704258
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0522773
25. women who are pregnant and/or breast feeding
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
26. presence of a condition that precludes vascular access.
Descrizione

Condition Excludes Vascular access

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0750138
27. patients presenting contraindications for study catheter(s), as indicated in the respective instructions for use
Descrizione

Medical contraindication Clinical Trial Catheter

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0085590
28. enrollment in an investigational study evaluating another device, biologic, or drug.
Descrizione

Study Subject Participation Status | Clinical Trial Investigational | Evaluation Investigational Medical Device | Evaluation Biological agents | Evaluation Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C2346570
UMLS CUI [4,1]
C1261322
UMLS CUI [4,2]
C0005515
UMLS CUI [5,1]
C1261322
UMLS CUI [5,2]
C0013230
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Similar models

Eligibility Atrial Fibrillation NCT02485925

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Anti-Arrhythmia Agents Atrial Fibrillation | Anti-Arrhythmia Agents Quantity failed | Anti-Arrhythmia Agents Class | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers | Recurrent symptomatic atrial fibrillation | Intolerance to Anti-Arrhythmia Agents
Item
2. failure of at least one antiarrhythmic drug (aad) for af (class i or iii, or av nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic af, or intolerance to the aad
boolean
C0003195 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0003195 (UMLS CUI [3,1])
C0456387 (UMLS CUI [3,2])
C0304516 (UMLS CUI [4])
C0006684 (UMLS CUI [5])
C1739416 (UMLS CUI [6])
C1744706 (UMLS CUI [7,1])
C0003195 (UMLS CUI [7,2])
Paroxysmal atrial fibrillation Eligible Catheter ablation
Item
3. patients with paroxysmal af eligible for catheter ablation
boolean
C0235480 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0162563 (UMLS CUI [1,3])
Paroxysmal atrial fibrillation Symptomatic | Paroxysmal atrial fibrillation Episode Quantity | Electrocardiography | Holter Electrocardiography | Other Coding
Item
4. patients with symptomatic paf who have had at least one documented af episode in the six (6) months prior to enrollment. documentation may include but is not limited to electrocardiogram (ecg), holter monitor (hm) or transtelephonic monitor (ttm)
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1623258 (UMLS CUI [3])
C0013801 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
Protocol Compliance
Item
5. able and willing to comply with all pre-, post- and follow-up testing and requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
6. be able to sign irb/ec-approved informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Secondary to Electrolyte imbalance | Atrial Fibrillation Secondary to Thyroid Disease | Atrial Fibrillation Reversible | Atrial Fibrillation Absence Cause cardiac
Item
1. af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0342579 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0040128 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
C0004238 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0018787 (UMLS CUI [4,4])
Destructive procedure (surgical) Atrial Fibrillation | Catheter ablation for atrial fibrillation
Item
2. previous surgical or catheter ablation for af
boolean
C1261381 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C2702800 (UMLS CUI [2])
Percutaneous Coronary Intervention | Cardiac Surgery procedures | Heart Valve Operative Surgical Procedures | Heart Valve Procedure Percutaneous | Ventriculotomy | Incision of atrium of heart | Repair of heart valve | Heart valve replacement | Heart Valve Prosthesis
Item
3. any pci, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
boolean
C1532338 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
C0018826 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0018826 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0522523 (UMLS CUI [4,3])
C0750201 (UMLS CUI [5])
C0189760 (UMLS CUI [6])
C0190112 (UMLS CUI [7])
C0190173 (UMLS CUI [8])
C0018825 (UMLS CUI [9])
Carotid Artery Stenting | Carotid Endarterectomy
Item
4. any carotid stenting or endarterectomy.
boolean
C0007272 (UMLS CUI [1,1])
C2348535 (UMLS CUI [1,2])
C0014099 (UMLS CUI [2])
Coronary Artery Bypass Surgery
Item
5. coronary artery bypass graft (cabg) procedure within the last 180 days (6 months)
boolean
C0010055 (UMLS CUI [1])
Episode of Atrial Fibrillation Duration | Cardioversion Episode of Atrial Fibrillation
Item
6. af episodes lasting longer than 7 days or terminated via cardioversion
boolean
C0332189 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0013778 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Thrombus of left atrium Imaging
Item
7. documented left atrial thrombus on imaging
boolean
C3532827 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Heart failure Uncontrolled | Heart failure New York Heart Association Classification
Item
8. uncontrolled heart failure or new york heart association (nyha) class iii or iv
boolean
C0018801 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
Myocardial Infarction
Item
9. myocardial infarction within the previous 60 days (2 months)
boolean
C0027051 (UMLS CUI [1])
Thromboembolism | Transient Ischemic Attack
Item
10. documented thromboembolic event (including tia) within the past 12 months
boolean
C0040038 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Rheumatic Heart Disease
Item
11. rheumatic heart disease
boolean
C0035439 (UMLS CUI [1])
Heart Transplantation Anticipated | Cardiac Surgery procedure Anticipated
Item
12. awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
boolean
C0018823 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Lung diseases | Restrictive pulmonary disease | Airway constriction | Chronic Obstructive Airway Disease | Lung malfunction | Respiration Disorders | Respiratory Failure
Item
13. significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
boolean
C0024115 (UMLS CUI [1])
C0877013 (UMLS CUI [2])
C0231818 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0024109 (UMLS CUI [5,1])
C0231174 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C1145670 (UMLS CUI [7])
Congenital Abnormality Study Subject Participation Status Excluded | Medical Problem Study Subject Participation Status Excluded
Item
14. significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
boolean
C0000768 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1254481 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Illness | Sepsis
Item
15. active illness or active systemic infection or sepsis
boolean
C0221423 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Atrial myxoma
Item
16. diagnosed atrial myxoma
boolean
C0151241 (UMLS CUI [1])
Angina, Unstable
Item
17. unstable angina within the past 60 days (2 months)
boolean
C0002965 (UMLS CUI [1])
Blood coagulation | Bleeding tendency
Item
18. history of blood clotting or bleeding abnormalities
boolean
C0005778 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
Life Expectancy
Item
19. life expectancy less than 365 days (12 months)
boolean
C0023671 (UMLS CUI [1])
Hypertrophic Cardiomyopathy
Item
20. hypertrophic obstructive cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
Implantable defibrillator
Item
21. presence of implanted icd
boolean
C0162589 (UMLS CUI [1])
Medical contraindication Anticoagulation Therapy
Item
22. contraindication to anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
Medical contraindication Isoproterenol
Item
23. contraindication to isoproterenol
boolean
C1301624 (UMLS CUI [1,1])
C0022245 (UMLS CUI [1,2])
Thrombus intramural Excludes Catheterization | Malignant Neoplasm Excludes Catheterization | Abnormality Excludes Catheterization | Thrombus intramural Excludes Manipulation of catheter | Malignant Neoplasm Excludes Manipulation of catheter | Abnormality Excludes Manipulation of catheter
Item
24. presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
boolean
C0087086 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0007430 (UMLS CUI [1,4])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0007430 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
C0087086 (UMLS CUI [4,1])
C0205102 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0522773 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0522773 (UMLS CUI [5,3])
C1704258 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0522773 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
25. women who are pregnant and/or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Excludes Vascular access
Item
26. presence of a condition that precludes vascular access.
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
Medical contraindication Clinical Trial Catheter
Item
27. patients presenting contraindications for study catheter(s), as indicated in the respective instructions for use
boolean
C1301624 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0085590 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial Investigational | Evaluation Investigational Medical Device | Evaluation Biological agents | Evaluation Investigational New Drugs
Item
28. enrollment in an investigational study evaluating another device, biologic, or drug.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C1261322 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C1261322 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
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