ID

28434

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00421252

Palavras-chave

Versões (2)
  1. 13/01/2018 13/01/2018 -
  2. 14/01/2018 14/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de janeiro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
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Eligibility Coronary Artery Disease NCT00421252

Inglês

Eligibility Coronary Artery Disease NCT00421252

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Age

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Stable angina | Stress Test Suggestive of Ischemia | Myocardial Infarction

Tipo de dados

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
Descrição

Femoral artery Approach Anticipated | Cardiac Catheterization Procedure

Tipo de dados

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
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

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

Criteria Fulfill

Tipo de dados

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
Descrição

Clopidogrel | Ticlopidine

Tipo de dados

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
Descrição

Hypersensitivity Clopidogrel | Desensitization Independent of | Hypersensitivity Plavix Component

Tipo de dados

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
Descrição

Medical contraindication Clopidogrel

Tipo de dados

boolean

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

Blood Coagulation Disorder Pre-existing | Blood dyscrasia

Tipo de dados

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
Descrição

INR

Tipo de dados

boolean

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

Platelet Count measurement

Tipo de dados

boolean

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

Hemorrhage

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Operative Surgical Procedure Need Anticipated | Invasive procedure Need Anticipated

Tipo de dados

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
Descrição

Red Blood Cell Transfusion Unwilling | Relationship Hemorrhage Life Threatening

Tipo de dados

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
Descrição

Cardiac Status Unstable

Tipo de dados

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
Descrição

Patient Admission Cardiac problem | Inpatient Referral for Cardiac Catheterization

Tipo de dados

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
Descrição

Myocardial Infarction

Tipo de dados

boolean

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

Troponin T Assay

Tipo de dados

boolean

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

Angina, Unstable

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

Kidney Failure, Chronic | Troponin T increased Possible

Tipo de dados

boolean

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

Dialysis

Tipo de dados

boolean

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

Creatinine measurement, serum

Tipo de dados

boolean

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

eGFR MDRD

Tipo de dados

boolean

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

Procedure Factor

Tipo de dados

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
Descrição

Coronary angiography Redundant | Cardiac Catheterization Scheduled

Tipo de dados

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
Descrição

Absence Percutaneous Coronary Intervention Scheduled | Coronary angiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0085532
3. anticipated need for arterial access using brachial, radial or other non-femoral approach
Descrição

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

Tipo de dados

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
Descrição

Access Femoral artery Femoral bypass graft

Tipo de dados

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)
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Childbearing Potential Pregnancy test negative Lacking

Tipo de dados

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)
Descrição

Study Subject Participation Status | Clinical Study Follow-up Incomplete

Tipo de dados

boolean

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

Study Subject Participation Status

Tipo de dados

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
Descrição

Informed Consent Unable | Study Protocol Comprehension Unable

Tipo de dados

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
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Eligibility Coronary Artery Disease NCT00421252

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Absence Percutaneous Coronary Intervention Scheduled | Coronary angiography
Item
2. patient is not a candidate for percutaneous coronary intervention during the same procedure as the diagnostic coronary angiography
boolean
C0332197 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0205539 (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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