ID

32824

Beskrivning

Targeting Inflammation Using Salsalate for Type 2 Diabetes-stage II; ODM derived from: https://clinicaltrials.gov/show/NCT00799643

Länk

https://clinicaltrials.gov/show/NCT00799643

Nyckelord

Versioner (1)
  1. 2018-11-16 2018-11-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00799643

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00799643

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue (including sfu, non-sfu, and dipeptidyl peptidase iv (dpp-4) inhibitors), alpha-glucosidase inhibitors, or bile acid sequestrants (dosed once per day such that study drug can be administered ≥ 4 hours prior to sequestrant); or a combination of up to two of these at maximal dose. dosing must be stable for 8 weeks prior to screening. participant must have been diagnosed with t2d at least 8 weeks before screening.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin | Pills Insulin Release | Sulfonylureas | Other Coding | Dipeptidyl-Peptidase IV Inhibitors | alpha-Glucosidase Inhibitors | Bile acid sequestrants Dose times/day | Combined Modality Therapy Maximum Tolerated Dose | Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4]
C0025598
UMLS CUI [5,1]
C0994475
UMLS CUI [5,2]
C0021641
UMLS CUI [5,3]
C1283071
UMLS CUI [6]
C0038766
UMLS CUI [7]
C3846158
UMLS CUI [8]
C1827106
UMLS CUI [9]
C1299007
UMLS CUI [10,1]
C2917337
UMLS CUI [10,2]
C0178602
UMLS CUI [10,3]
C0439511
UMLS CUI [11,1]
C0009429
UMLS CUI [11,2]
C0752079
UMLS CUI [12,1]
C0178602
UMLS CUI [12,2]
C0205360
2. fpg ≤ 225 mg/dl and hba1c≥7% and ≤ 9.5% at screening.
Beskrivning

Plasma fasting glucose measurement | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0474680
3. age ≥18 and <75
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm)
Beskrivning

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0042241
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no prior participation in stage i of tinsal-t2d ; exception: a participant who failed screening for hba1c in stage i will be allowed to re-screen for stage ii.
Beskrivning

Study Subject Participation Status | Clinical Trial Specified Non-Insulin-Dependent Diabetes Mellitus | Exception Screening HbA1c failed

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C0011860
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0220908
UMLS CUI [3,3]
C0019018
UMLS CUI [3,4]
C0231175
2. type 1 diabetes and/or history of ketoacidosis determined by medical history
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
3. history of severe diabetic neuropathy including autonomic neuropathy, gastroporesis or lower limb ulceration or amputation
Beskrivning

Diabetic Neuropathy Severe | Autonomic neuropathy | Gastroparesis | Leg Ulcer | Amputation of lower limb

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011882
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0259749
UMLS CUI [3]
C0152020
UMLS CUI [4]
C0023223
UMLS CUI [5]
C0337308
4. history of long-term therapy with insulin (>30 days) within the last year
Beskrivning

Insulin regime Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0443252
5. therapy with rosiglitazone (avandia) or pioglitazone (actos), alone or in combination in the previous 6 months; or extendin-4 (byetta), alone or in combination in the previous 3 months
Beskrivning

rosiglitazone | Avandia | pioglitazone | Actos | exenatide | Byetta | Combined Modality Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0875967
UMLS CUI [3]
C0071097
UMLS CUI [4]
C0875954
UMLS CUI [5]
C0167117
UMLS CUI [6]
C1636686
UMLS CUI [7]
C0009429
6. pregnancy or lactation
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients requiring oral corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
Beskrivning

Patient need for Adrenal Cortex Hormones Oral | Steroid therapy Oral Recurrent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C2945760
8. use of weight loss drugs [e.g., xenical (orlistat), meridia (sibutramine), acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
Beskrivning

Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Phenylpropanolamine | Non-Prescription Drugs Similar | Intentional weight loss Amount Timespan

Datatyp

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0732649
UMLS CUI [3]
C0076275
UMLS CUI [4]
C0635898
UMLS CUI [5]
C0074493
UMLS CUI [6]
C0031495
UMLS CUI [7,1]
C0013231
UMLS CUI [7,2]
C2348205
UMLS CUI [8,1]
C1563041
UMLS CUI [8,2]
C1265611
UMLS CUI [8,3]
C0872291
9. surgery within 30 days prior to screening
Beskrivning

Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
10. serum creatinine >1.4 for women and >1.5 for men or egfr <60 [possible chronic kidney disease stage 3 or greater calculated using the modification of diet in renal disease (mdrd) equation
Beskrivning

Creatinine measurement, serum | Gender | Renal function GFR estimation by MDRD | Chronic kidney disease stage Possible

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3]
C2170215
UMLS CUI [4,1]
C2074731
UMLS CUI [4,2]
C0332149
11. history of chronic liver disease including hepatitis b or c
Beskrivning

Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
12. history of peptic ulcer or endoscopy demonstrated gastritis
Beskrivning

Peptic Ulcer | Gastritis Endoscopy

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017152
UMLS CUI [2,2]
C0014245
13. history of acquired immune deficiency syndrome or human immunodeficiency virus (hiv)
Beskrivning

AIDS | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0001175
UMLS CUI [2]
C0019693
14. history of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
Beskrivning

Malignant Neoplasms | Exception Disease Free of | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
15. new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure
Beskrivning

Cardiac Status New York Heart Association Classification | Hospitalization Due to Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0018802
16. history of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
Beskrivning

Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Revascularization

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0581603
17. uncontrolled hypertension (defined as systolic blood pressure >150 mmhg or diastolic blood pressure >95 mmhg on three or more assessments on more than one day). if on blood pressure medications, dosing should be stable for 2 weeks prior to randomization.
Beskrivning

Uncontrolled hypertension | Systolic Pressure Assessment Quantity | Diastolic blood pressure Assessment Quantity | Antihypertensive Agents Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
18. history of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed dccktail containing 1 ounce of alcohol)
Beskrivning

Substance Use Disorders | Alcohol consumption units/week

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0560579
19. hemoglobin <12 g/dl (males), <10 g/dl (females) at screening*
Beskrivning

Hemoglobin measurement | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
20. platelets <100,000 cu mm at screening
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
21. ast (sgot) >2.50 x uln or alt (sgpt) >2.50 x uln at screening
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
22. total bilirubin >1.50 x uln at screening
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
23. triglycerides (tg) >500 mg/dl at screening
Beskrivning

Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
24. poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
Beskrivning

Poor cognition | Protocol Compliance Difficult

Datatyp

boolean

Alias
UMLS CUI [1]
C1836387
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332218
25. previous allergy to aspirin
Beskrivning

Aspirin allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0004058
26. chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
Beskrivning

Non-Steroidal Anti-Inflammatory Agents chronic | Non-Steroidal Anti-Inflammatory Agents Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0332173
27. use of warfarin (coumadin), clopidogrel (plavix), dipyridamole (persantine), heparin or other anticoagulants
Beskrivning

Warfarin | Coumadin | clopidogrel | Plavix | Dipyridamole | Persantine | heparin | Anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0070166
UMLS CUI [4]
C0633084
UMLS CUI [5]
C0012582
UMLS CUI [6]
C0700020
UMLS CUI [7]
C0019134
UMLS CUI [8]
C0003280
28. use of probenecid (benemid, probalan), sulfinpyrazone (anturane) or other uricosuric agents
Beskrivning

Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0033209
UMLS CUI [2]
C0591159
UMLS CUI [3]
C0038742
UMLS CUI [4]
C0591099
UMLS CUI [5]
C0041983
29. macroalbuminuria, defined as spot urine protein >300 mcg/mg cr at screening
Beskrivning

High urine albumin levels | Spot urine procedure | Urine creatinine measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1654921
UMLS CUI [2]
C1272574
UMLS CUI [3]
C1318439
30. pre-existing chronic tinnitus
Beskrivning

TINNITUS CHRONIC Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0749513
UMLS CUI [1,2]
C2347662
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00799643

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin | Pills Insulin Release | Sulfonylureas | Other Coding | Dipeptidyl-Peptidase IV Inhibitors | alpha-Glucosidase Inhibitors | Bile acid sequestrants Dose times/day | Combined Modality Therapy Maximum Tolerated Dose | Dose Stable
Item
1. type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue (including sfu, non-sfu, and dipeptidyl peptidase iv (dpp-4) inhibitors), alpha-glucosidase inhibitors, or bile acid sequestrants (dosed once per day such that study drug can be administered ≥ 4 hours prior to sequestrant); or a combination of up to two of these at maximal dose. dosing must be stable for 8 weeks prior to screening. participant must have been diagnosed with t2d at least 8 weeks before screening.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0994475 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C1283071 (UMLS CUI [5,3])
C0038766 (UMLS CUI [6])
C3846158 (UMLS CUI [7])
C1827106 (UMLS CUI [8])
C1299007 (UMLS CUI [9])
C2917337 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0439511 (UMLS CUI [10,3])
C0009429 (UMLS CUI [11,1])
C0752079 (UMLS CUI [11,2])
C0178602 (UMLS CUI [12,1])
C0205360 (UMLS CUI [12,2])
Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
2. fpg ≤ 225 mg/dl and hba1c≥7% and ≤ 9.5% at screening.
boolean
C0583513 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Age
Item
3. age ≥18 and <75
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm
Item
4. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Specified Non-Insulin-Dependent Diabetes Mellitus | Exception Screening HbA1c failed
Item
1. no prior participation in stage i of tinsal-t2d ; exception: a participant who failed screening for hba1c in stage i will be allowed to re-screen for stage ii.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0019018 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
2. type 1 diabetes and/or history of ketoacidosis determined by medical history
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Diabetic Neuropathy Severe | Autonomic neuropathy | Gastroparesis | Leg Ulcer | Amputation of lower limb
Item
3. history of severe diabetic neuropathy including autonomic neuropathy, gastroporesis or lower limb ulceration or amputation
boolean
C0011882 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2])
C0152020 (UMLS CUI [3])
C0023223 (UMLS CUI [4])
C0337308 (UMLS CUI [5])
Insulin regime Long-term
Item
4. history of long-term therapy with insulin (>30 days) within the last year
boolean
C0557978 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
rosiglitazone | Avandia | pioglitazone | Actos | exenatide | Byetta | Combined Modality Therapy
Item
5. therapy with rosiglitazone (avandia) or pioglitazone (actos), alone or in combination in the previous 6 months; or extendin-4 (byetta), alone or in combination in the previous 3 months
boolean
C0289313 (UMLS CUI [1])
C0875967 (UMLS CUI [2])
C0071097 (UMLS CUI [3])
C0875954 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1636686 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
6. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patient need for Adrenal Cortex Hormones Oral | Steroid therapy Oral Recurrent
Item
7. patients requiring oral corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
boolean
C0686904 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0149783 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2945760 (UMLS CUI [2,3])
Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Phenylpropanolamine | Non-Prescription Drugs Similar | Intentional weight loss Amount Timespan
Item
8. use of weight loss drugs [e.g., xenical (orlistat), meridia (sibutramine), acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
boolean
C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0635898 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C0031495 (UMLS CUI [6])
C0013231 (UMLS CUI [7,1])
C2348205 (UMLS CUI [7,2])
C1563041 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0872291 (UMLS CUI [8,3])
Operative Surgical Procedures
Item
9. surgery within 30 days prior to screening
boolean
C0543467 (UMLS CUI [1])
Creatinine measurement, serum | Gender | Renal function GFR estimation by MDRD | Chronic kidney disease stage Possible
Item
10. serum creatinine >1.4 for women and >1.5 for men or egfr <60 [possible chronic kidney disease stage 3 or greater calculated using the modification of diet in renal disease (mdrd) equation
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C2170215 (UMLS CUI [3])
C2074731 (UMLS CUI [4,1])
C0332149 (UMLS CUI [4,2])
Chronic liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
11. history of chronic liver disease including hepatitis b or c
boolean
C0341439 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Peptic Ulcer | Gastritis Endoscopy
Item
12. history of peptic ulcer or endoscopy demonstrated gastritis
boolean
C0030920 (UMLS CUI [1])
C0017152 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
AIDS | HIV Infection
Item
13. history of acquired immune deficiency syndrome or human immunodeficiency virus (hiv)
boolean
C0001175 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Malignant Neoplasms | Exception Disease Free of | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
14. history of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Cardiac Status New York Heart Association Classification | Hospitalization Due to Congestive heart failure
Item
15. new york heart association class iii or iv cardiac status or hospitalization for congestive heart failure
boolean
C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0018802 (UMLS CUI [2,3])
Angina, Unstable | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack | Revascularization
Item
16. history of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0581603 (UMLS CUI [5])
Uncontrolled hypertension | Systolic Pressure Assessment Quantity | Diastolic blood pressure Assessment Quantity | Antihypertensive Agents Dose Stable
Item
17. uncontrolled hypertension (defined as systolic blood pressure >150 mmhg or diastolic blood pressure >95 mmhg on three or more assessments on more than one day). if on blood pressure medications, dosing should be stable for 2 weeks prior to randomization.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0428883 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0003364 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Substance Use Disorders | Alcohol consumption units/week
Item
18. history of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed dccktail containing 1 ounce of alcohol)
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0560579 (UMLS CUI [2,2])
Hemoglobin measurement | Gender
Item
19. hemoglobin <12 g/dl (males), <10 g/dl (females) at screening*
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
20. platelets <100,000 cu mm at screening
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
21. ast (sgot) >2.50 x uln or alt (sgpt) >2.50 x uln at screening
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Elevated total bilirubin
Item
22. total bilirubin >1.50 x uln at screening
boolean
C0741494 (UMLS CUI [1])
Triglycerides measurement
Item
23. triglycerides (tg) >500 mg/dl at screening
boolean
C0202236 (UMLS CUI [1])
Poor cognition | Protocol Compliance Difficult
Item
24. poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
boolean
C1836387 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
Aspirin allergy
Item
25. previous allergy to aspirin
boolean
C0004058 (UMLS CUI [1])
Non-Steroidal Anti-Inflammatory Agents chronic | Non-Steroidal Anti-Inflammatory Agents Daily
Item
26. chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
Warfarin | Coumadin | clopidogrel | Plavix | Dipyridamole | Persantine | heparin | Anticoagulants
Item
27. use of warfarin (coumadin), clopidogrel (plavix), dipyridamole (persantine), heparin or other anticoagulants
boolean
C0043031 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0070166 (UMLS CUI [3])
C0633084 (UMLS CUI [4])
C0012582 (UMLS CUI [5])
C0700020 (UMLS CUI [6])
C0019134 (UMLS CUI [7])
C0003280 (UMLS CUI [8])
Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents
Item
28. use of probenecid (benemid, probalan), sulfinpyrazone (anturane) or other uricosuric agents
boolean
C0033209 (UMLS CUI [1])
C0591159 (UMLS CUI [2])
C0038742 (UMLS CUI [3])
C0591099 (UMLS CUI [4])
C0041983 (UMLS CUI [5])
High urine albumin levels | Spot urine procedure | Urine creatinine measurement
Item
29. macroalbuminuria, defined as spot urine protein >300 mcg/mg cr at screening
boolean
C1654921 (UMLS CUI [1])
C1272574 (UMLS CUI [2])
C1318439 (UMLS CUI [3])
TINNITUS CHRONIC Pre-existing
Item
30. pre-existing chronic tinnitus
boolean
C0749513 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
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