ID

32824

Description

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

Lien

https://clinicaltrials.gov/show/NCT00799643

Mots-clés

Versions (1)
  1. 16/11/2018 16/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Type 2 Diabetes Mellitus NCT00799643

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00799643

1 Formulaires  
Inclusion Criteria
Description

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.
Description

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

Type de données

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.
Description

Plasma fasting glucose measurement | Hemoglobin A1c measurement

Type de données

boolean

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

Age

Type de données

boolean

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

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

Type de données

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
Description

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.
Description

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

Type de données

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
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Type de données

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
Description

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

Type de données

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
Description

Insulin regime Long-term

Type de données

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
Description

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

Type de données

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
Description

Pregnancy | Breast Feeding

Type de données

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)
Description

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

Type de données

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
Description

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

Type de données

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
Description

Operative Surgical Procedures

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

boolean

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

Peptic Ulcer | Gastritis Endoscopy

Type de données

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)
Description

AIDS | HIV Infection

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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.
Description

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

Type de données

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)
Description

Substance Use Disorders | Alcohol consumption units/week

Type de données

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*
Description

Hemoglobin measurement | Gender

Type de données

boolean

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

Platelet Count measurement

Type de données

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Type de données

boolean

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

Elevated total bilirubin

Type de données

boolean

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

Triglycerides measurement

Type de données

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
Description

Poor cognition | Protocol Compliance Difficult

Type de données

boolean

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

Aspirin allergy

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

Probenecid | Benemid | Sulfinpyrazone | Anturane | Uricosuric Agents

Type de données

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
Description

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

Type de données

boolean

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

TINNITUS CHRONIC Pre-existing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0749513
UMLS CUI [1,2]
C2347662
Retour au début de la page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00799643

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial