ID

28452

Beskrivning

Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.; ODM derived from: https://clinicaltrials.gov/show/NCT00421252

Länk

https://clinicaltrials.gov/show/NCT00421252

Nyckelord

Versioner (2)
  1. 2018-01-13 2018-01-13 -
  2. 2018-01-14 2018-01-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00421252

Engelsk

Eligibility Coronary Artery Disease NCT00421252

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient less than 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient referred as an outpatient for elective cardiac catheterization with coronary angiography and ad hoc percutaneous coronary intervention (if coronary anatomy suitable)
Beskrivning

Outpatient | Referral for Cardiac Catheterization Procedures elective | Coronary angiography | Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C2585524
UMLS CUI [2,2]
C0018795
UMLS CUI [2,3]
C0439608
UMLS CUI [3]
C0085532
UMLS CUI [4]
C1532338
3. patient has stable angina or a stress test suggestive of ischemia and/or prior myocardial infarction
Beskrivning

Stable angina | Stress Test Suggestive of Ischemia | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0340288
UMLS CUI [2,1]
C3494508
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0022116
UMLS CUI [3]
C0027051
4. anticipated femoral arterial approach for the cardiac catheterization procedure
Beskrivning

Femoral artery Approach Anticipated | Cardiac Catheterization Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015801
UMLS CUI [1,2]
C0449445
UMLS CUI [1,3]
C3840775
UMLS CUI [2]
C0018795
5. patient provides written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded if any of the following are present:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure
Beskrivning

Clopidogrel | Ticlopidine

Datatyp

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2]
C0040207
2. known hypersensitivity to clopidogrel (regardless of desensitization) or to any other components of plavix
Beskrivning

Hypersensitivity Clopidogrel | Desensitization Independent of | Hypersensitivity Plavix Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0070166
UMLS CUI [2,1]
C0178702
UMLS CUI [2,2]
C0332291
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0633084
UMLS CUI [3,3]
C1705248
3. contraindication to clopidogrel, including
Beskrivning

Medical contraindication Clopidogrel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0070166
1. pre-existing bleeding disorder or hematological dyscrasia
Beskrivning

Blood Coagulation Disorder Pre-existing | Blood dyscrasia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0018939
2. inr >1.4 immediately prior to the scheduled procedure
Beskrivning

INR

Datatyp

boolean

Alias
UMLS CUI [1]
C0525032
3. platelet count <50 k/ul
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
4. significant bleeding during the 14 days prior to the scheduled procedure
Beskrivning

Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
5. surgery or invasive procedure at a non-compressible location during the 30 days prior to the scheduled procedure
Beskrivning

Operative Surgical Procedure Location Compressing Lacking | Invasive procedure Location Compressing Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0332260
UMLS CUI [1,4]
C0332268
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C0450429
UMLS CUI [2,3]
C0332260
UMLS CUI [2,4]
C0332268
6. anticipated need for surgery or other invasive procedure within 30 days following the scheduled procedure
Beskrivning

Operative Surgical Procedure Need Anticipated | Invasive procedure Need Anticipated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0027552
UMLS CUI [1,3]
C3840775
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C0027552
UMLS CUI [2,3]
C3840775
7. patient states unwillingness to undergo transfusion of red blood cells even in the event of life threatening bleeding
Beskrivning

Red Blood Cell Transfusion Unwilling | Relationship Hemorrhage Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C2826244
4. unstable cardiac status
Beskrivning

Cardiac Status Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C0443343
1. patient was admitted for a cardiac condition and referred as an inpatient for cardiac catheterization
Beskrivning

Patient Admission Cardiac problem | Inpatient Referral for Cardiac Catheterization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0262402
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C2585524
UMLS CUI [2,3]
C0018795
2. myocardial infarction diagnosed as occurring during the 30 days prior to the scheduled procedure
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
3. pre-procedure troponin-t >0.01 ng/ml
Beskrivning

Troponin T Assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1141947
4. unstable angina
Beskrivning

Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
i. ischemic symptoms at rest ii. ischemic symptoms with mild exertion (e.g., walking one to two level blocks or climbing one flight of stairs) e. pre-procedure electrocardiogram with st segment changes indicative of ongoing myocardial injury or ischemia
Beskrivning

Symptoms Ischemic At rest | Symptoms Ischemic Exertion Mild | Walking One Block | Climbing One Flight of Stairs | EKG ST segment changes | Myocardial injury | Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C0443144
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0475224
UMLS CUI [2,3]
C0015264
UMLS CUI [2,4]
C2945599
UMLS CUI [3]
C3827522
UMLS CUI [4]
C3831081
UMLS CUI [5]
C0232326
UMLS CUI [6]
C0746730
UMLS CUI [7]
C0151744
5. chronic renal failure (which may raise troponin-t levels)
Beskrivning

Kidney Failure, Chronic | Troponin T increased Possible

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2,1]
C1142294
UMLS CUI [2,2]
C0332149
1. patient currently undergoing dialysis
Beskrivning

Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
2. serum creatinine >2 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
3. estimated glomerular filtratation rate (egfr using the mdrd formula) <45 ml/min/1.73 m2
Beskrivning

eGFR MDRD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C3839656
6. procedural factors
Beskrivning

Procedure Factor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1521761
1. patient does not require coronary angiography as part of the scheduled cardiac catheterization
Beskrivning

Coronary angiography Redundant | Cardiac Catheterization Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085532
UMLS CUI [1,2]
C1313915
UMLS CUI [2,1]
C0018795
UMLS CUI [2,2]
C0205539
2. patient is not a candidate for percutaneous coronary intervention during the same procedure as the diagnostic coronary angiography
Beskrivning

Patient Inappropriate Percutaneous Coronary Intervention | Coronary angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1532338
UMLS CUI [2]
C0085532
3. anticipated need for arterial access using brachial, radial or other non-femoral approach
Beskrivning

Arterial Access Approach Brachial | Arterial Access Approach Radius | Arterial Access Approach Other | Exception Approach Femoral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3272298
UMLS CUI [1,2]
C0449445
UMLS CUI [1,3]
C0445456
UMLS CUI [2,1]
C3272298
UMLS CUI [2,2]
C0449445
UMLS CUI [2,3]
C0034627
UMLS CUI [3,1]
C3272298
UMLS CUI [3,2]
C0449445
UMLS CUI [3,3]
C0205394
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0449445
UMLS CUI [4,3]
C0015811
4. anticipated need to access the femoral artery via a femoral bypass graft
Beskrivning

Access Femoral artery Femoral bypass graft

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0015801
UMLS CUI [1,3]
C0850111
5. anticipated need for an arterial sheath 6 french in size or larger (e.g., planned evaluation of aortic stenosis or hypertrophic cardiomyopathy)
Beskrivning

Other Coding | Aortic Stenosis Evaluation Planned | Hypertrophic Cardiomyopathy Evaluation Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0003507
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0007194
UMLS CUI [3,2]
C1261322
UMLS CUI [3,3]
C1301732
6. anticipated need for heparin anticoagulation during the diagnostic cardiac catheterization procedure (e.g., crossing a stenosed aortic valve with a 0.035" wire, planned intra-vascular ultrasound or pressure wire study)
Beskrivning

Heparin | Cardiac Catheterization Procedures | Aortic Valve Stenosis Guide wire | Intravascular ultrasound | Intracoronary pressure guide wire

Datatyp

boolean

Alias
UMLS CUI [1]
C0019134
UMLS CUI [2]
C0018795
UMLS CUI [3,1]
C0003507
UMLS CUI [3,2]
C0181089
UMLS CUI [4]
C1456025
UMLS CUI [5]
C1299422
7. woman of child-bearing potential who does not have a negative pregnancy test immediately prior to the scheduled procedure
Beskrivning

Childbearing Potential Pregnancy test negative Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C0332268
8. participation in another non-observational clinical study that has not yet completed all mandatory follow-up (i.e., patients who are participating in a "natural history" observational registry where no active therapy is being investigated may participate)
Beskrivning

Study Subject Participation Status | Clinical Study Follow-up Incomplete

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205257
9. prior participation in this study
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
10. inability to provide written informed consent or demonstrate understanding of the risks and benefits associated with participation in this study
Beskrivning

Informed Consent Unable | Study Protocol Comprehension Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
Tillbaka till toppen

Similar models

Eligibility Coronary Artery Disease NCT00421252

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Outpatient | Referral for Cardiac Catheterization Procedures elective | Coronary angiography | Percutaneous Coronary Intervention
Item
2. patient referred as an outpatient for elective cardiac catheterization with coronary angiography and ad hoc percutaneous coronary intervention (if coronary anatomy suitable)
boolean
C0029921 (UMLS CUI [1])
C2585524 (UMLS CUI [2,1])
C0018795 (UMLS CUI [2,2])
C0439608 (UMLS CUI [2,3])
C0085532 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
Stable angina | Stress Test Suggestive of Ischemia | Myocardial Infarction
Item
3. patient has stable angina or a stress test suggestive of ischemia and/or prior myocardial infarction
boolean
C0340288 (UMLS CUI [1])
C3494508 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0022116 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
Femoral artery Approach Anticipated | Cardiac Catheterization Procedure
Item
4. anticipated femoral arterial approach for the cardiac catheterization procedure
boolean
C0015801 (UMLS CUI [1,1])
C0449445 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0018795 (UMLS CUI [2])
Informed Consent
Item
5. patient provides written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded if any of the following are present:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Clopidogrel | Ticlopidine
Item
1. use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure
boolean
C0070166 (UMLS CUI [1])
C0040207 (UMLS CUI [2])
Hypersensitivity Clopidogrel | Desensitization Independent of | Hypersensitivity Plavix Component
Item
2. known hypersensitivity to clopidogrel (regardless of desensitization) or to any other components of plavix
boolean
C0020517 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0178702 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0633084 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Medical contraindication Clopidogrel
Item
3. contraindication to clopidogrel, including
boolean
C1301624 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
Blood Coagulation Disorder Pre-existing | Blood dyscrasia
Item
1. pre-existing bleeding disorder or hematological dyscrasia
boolean
C0005779 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0018939 (UMLS CUI [2])
INR
Item
2. inr >1.4 immediately prior to the scheduled procedure
boolean
C0525032 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count <50 k/ul
boolean
C0032181 (UMLS CUI [1])
Hemorrhage
Item
4. significant bleeding during the 14 days prior to the scheduled procedure
boolean
C0019080 (UMLS CUI [1])
Operative Surgical Procedure Location Compressing Lacking | Invasive procedure Location Compressing Lacking
Item
5. surgery or invasive procedure at a non-compressible location during the 30 days prior to the scheduled procedure
boolean
C0543467 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C4048276 (UMLS CUI [2,1])
C0450429 (UMLS CUI [2,2])
C0332260 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Operative Surgical Procedure Need Anticipated | Invasive procedure Need Anticipated
Item
6. anticipated need for surgery or other invasive procedure within 30 days following the scheduled procedure
boolean
C0543467 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C4048276 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Red Blood Cell Transfusion Unwilling | Relationship Hemorrhage Life Threatening
Item
7. patient states unwillingness to undergo transfusion of red blood cells even in the event of life threatening bleeding
boolean
C0086252 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
Cardiac Status Unstable
Item
4. unstable cardiac status
boolean
C1999091 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Patient Admission Cardiac problem | Inpatient Referral for Cardiac Catheterization
Item
1. patient was admitted for a cardiac condition and referred as an inpatient for cardiac catheterization
boolean
C0030673 (UMLS CUI [1,1])
C0262402 (UMLS CUI [1,2])
C0021562 (UMLS CUI [2,1])
C2585524 (UMLS CUI [2,2])
C0018795 (UMLS CUI [2,3])
Myocardial Infarction
Item
2. myocardial infarction diagnosed as occurring during the 30 days prior to the scheduled procedure
boolean
C0027051 (UMLS CUI [1])
Troponin T Assay
Item
3. pre-procedure troponin-t >0.01 ng/ml
boolean
C1141947 (UMLS CUI [1])
Angina, Unstable
Item
4. unstable angina
boolean
C0002965 (UMLS CUI [1])
Symptoms Ischemic At rest | Symptoms Ischemic Exertion Mild | Walking One Block | Climbing One Flight of Stairs | EKG ST segment changes | Myocardial injury | Myocardial Ischemia
Item
i. ischemic symptoms at rest ii. ischemic symptoms with mild exertion (e.g., walking one to two level blocks or climbing one flight of stairs) e. pre-procedure electrocardiogram with st segment changes indicative of ongoing myocardial injury or ischemia
boolean
C1457887 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0475224 (UMLS CUI [2,2])
C0015264 (UMLS CUI [2,3])
C2945599 (UMLS CUI [2,4])
C3827522 (UMLS CUI [3])
C3831081 (UMLS CUI [4])
C0232326 (UMLS CUI [5])
C0746730 (UMLS CUI [6])
C0151744 (UMLS CUI [7])
Kidney Failure, Chronic | Troponin T increased Possible
Item
5. chronic renal failure (which may raise troponin-t levels)
boolean
C0022661 (UMLS CUI [1])
C1142294 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
Dialysis
Item
1. patient currently undergoing dialysis
boolean
C0011946 (UMLS CUI [1])
Creatinine measurement, serum
Item
2. serum creatinine >2 mg/dl
boolean
C0201976 (UMLS CUI [1])
eGFR MDRD
Item
3. estimated glomerular filtratation rate (egfr using the mdrd formula) <45 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1,1])
C3839656 (UMLS CUI [1,2])
Procedure Factor
Item
6. procedural factors
boolean
C0184661 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
Coronary angiography Redundant | Cardiac Catheterization Scheduled
Item
1. patient does not require coronary angiography as part of the scheduled cardiac catheterization
boolean
C0085532 (UMLS CUI [1,1])
C1313915 (UMLS CUI [1,2])
C0018795 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Patient Inappropriate Percutaneous Coronary Intervention | Coronary angiography
Item
2. patient is not a candidate for percutaneous coronary intervention during the same procedure as the diagnostic coronary angiography
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0085532 (UMLS CUI [2])
Arterial Access Approach Brachial | Arterial Access Approach Radius | Arterial Access Approach Other | Exception Approach Femoral
Item
3. anticipated need for arterial access using brachial, radial or other non-femoral approach
boolean
C3272298 (UMLS CUI [1,1])
C0449445 (UMLS CUI [1,2])
C0445456 (UMLS CUI [1,3])
C3272298 (UMLS CUI [2,1])
C0449445 (UMLS CUI [2,2])
C0034627 (UMLS CUI [2,3])
C3272298 (UMLS CUI [3,1])
C0449445 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0449445 (UMLS CUI [4,2])
C0015811 (UMLS CUI [4,3])
Access Femoral artery Femoral bypass graft
Item
4. anticipated need to access the femoral artery via a femoral bypass graft
boolean
C0444454 (UMLS CUI [1,1])
C0015801 (UMLS CUI [1,2])
C0850111 (UMLS CUI [1,3])
Other Coding | Aortic Stenosis Evaluation Planned | Hypertrophic Cardiomyopathy Evaluation Planned
Item
5. anticipated need for an arterial sheath 6 french in size or larger (e.g., planned evaluation of aortic stenosis or hypertrophic cardiomyopathy)
boolean
C3846158 (UMLS CUI [1])
C0003507 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0007194 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
Heparin | Cardiac Catheterization Procedures | Aortic Valve Stenosis Guide wire | Intravascular ultrasound | Intracoronary pressure guide wire
Item
6. anticipated need for heparin anticoagulation during the diagnostic cardiac catheterization procedure (e.g., crossing a stenosed aortic valve with a 0.035" wire, planned intra-vascular ultrasound or pressure wire study)
boolean
C0019134 (UMLS CUI [1])
C0018795 (UMLS CUI [2])
C0003507 (UMLS CUI [3,1])
C0181089 (UMLS CUI [3,2])
C1456025 (UMLS CUI [4])
C1299422 (UMLS CUI [5])
Childbearing Potential Pregnancy test negative Lacking
Item
7. woman of child-bearing potential who does not have a negative pregnancy test immediately prior to the scheduled procedure
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Study Follow-up Incomplete
Item
8. participation in another non-observational clinical study that has not yet completed all mandatory follow-up (i.e., patients who are participating in a "natural history" observational registry where no active therapy is being investigated may participate)
boolean
C2348568 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
Study Subject Participation Status
Item
9. prior participation in this study
boolean
C2348568 (UMLS CUI [1])
Informed Consent Unable | Study Protocol Comprehension Unable
Item
10. inability to provide written informed consent or demonstrate understanding of the risks and benefits associated with participation in this study
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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