ID

19155

Beskrivning

Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine; ODM derived from: https://clinicaltrials.gov/show/NCT00062465

Länk

https://clinicaltrials.gov/show/NCT00062465

Nyckelord

Versioner (1)
  1. 2016-12-08 2016-12-08 -
Uppladdad den

8 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00062465

Engelsk

Eligibility Rheumatoid Arthritis NCT00062465

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients between 18 and 75 years of age
Beskrivning

Outpatients | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
females must be of non-childbearing potential (post-menopausal, surgically sterilized or post hysterectomy) or using a double-barrier method of birth control for the duration of the study. a protocol acceptable method of double barrier method of birth control includes any combination of two or three of the following: condom, spermicidal and diaphragm.
Beskrivning

Childbearing Potential | Postmenopausal state | Female Sterilization | Status post total hysterectomy | Barrier Contraception double | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C2349921
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C0221829
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0042241
documented diagnosis of rheumatoid arthritis of at least six (6) months duration, as defined by the american rheumatism association 1987 revised criteria
Beskrivning

Rheumatoid Arthritis disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
american rheumatism association functional class i, ii, or iii
Beskrivning

Rheumatoid Arthritis Class Functional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0205245
meet the criteria for (active disease) at both screening and baseline visits by achieving all of the criteria below:
Beskrivning

Disease criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
6 or more painful/tender joints
Beskrivning

Painful Joints Quantity | Tender joint count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3896992
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0451530
6 or more swollen joints
Beskrivning

Swollen joint count

Datatyp

boolean

Alias
UMLS CUI [1]
C0451521
visual analog scale (vas) for pain of at least 3 (on scale of 1-10, where 1 is mild)
Beskrivning

Visual Analog Pain Scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0042815
c-reactive protein (crp) greater than or equal to 0.6 mg/dl or esr greater than 25 mm/hr.
Beskrivning

C-reactive protein measurement | Erythrocyte sedimentation rate measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C1176468
prior/current therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
a. subjects must be either dmard or biological anti-ra agent naive or have failed a dmard/biological ra agent, other than sulfasalazine, and have stopped this dmard/biological one (1) month prior to randomization unless they have a flare in disease activity upon discontinuing dmard/biological therapy as part of this protocol. dmards include but are not limited to methotrexate, leflunomide, minocycline, hydroxychloroquine, gold, cyclosporine, and biologics include anti-tnf and anti-il-1 agents.
Beskrivning

Disease-Modifying Antirheumatic Drugs naive | Patient receiving first-time biologic disease modifying anti-rheumatic drug therapy for rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs failed | Biological Factors Against Rheumatoid Arthritis failed | Sulfasalazine | Methotrexate | leflunomide | Minocycline | Hydroxychloroquine | Gold | Cyclosporine | Anti-tumor necrosis factor alpha drug | Interleukin-1 Receptor Antagonist

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C2368600
UMLS CUI [3,1]
C0242708
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0005515
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0003873
UMLS CUI [4,4]
C0231175
UMLS CUI [5]
C0036078
UMLS CUI [6]
C0025677
UMLS CUI [7]
C0063041
UMLS CUI [8]
C0026187
UMLS CUI [9]
C0020336
UMLS CUI [10]
C0018026
UMLS CUI [11]
C0010592
UMLS CUI [12]
C1562242
UMLS CUI [13]
C3536785
b. subjects may be taking nsaids, provided the dose and frequency have been stable for 30 days prior to randomization. however if the patient meets the flare criteria they can be enrolled even if they have not fulfilled the criteria of being on a stable dose of nsaids and steroids for 30 days prior to randomization. at the time of flare neither steroids nor nsaids can be increased.
Beskrivning

Non-Steroidal Anti-Inflammatory Agents Dose Stable | Non-Steroidal Anti-Inflammatory Agents Frequency Stable | Flare | Steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0376249
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C1517205
UMLS CUI [4]
C0038317
c. subjects may be taking corticosteroid therapy equivalent to prednisone less than or equal to 7.5 mg/day. this dose must be stable for at least 1 month prior to randomization. subjects may not change the dose of their corticosteroid or receive intra-articular or intra-muscular injections of corticosteroids, within 1 month of randomization or during the study. note section 9.3 of the protocol, concomitant medication, has been amended to read: if it is medically necessary a one joint steroid injection is acceptable. this must be noted on the crf and the joint excluded from the joint count.
Beskrivning

Steroid therapy Dose Stable | Prednisone Equivalent | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular injection | Injection of steroid into joint

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
UMLS CUI [3]
C2064783
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0021492
UMLS CUI [5]
C0394848
d. subjects may not be taking other complementary and/or alternative medications for ra for the last 1-month prior to randomization.
Beskrivning

Pharmaceutical Preparations Additional Rheumatoid Arthritis | Pharmaceutical Preparations Alternative Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0003873
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1523987
UMLS CUI [2,3]
C0003873
subjects must provide written informed consent prior to any study-related screening tests.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with ra for less than six months duration, or onset before age 16 (jra)
Beskrivning

Rheumatoid Arthritis disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
clinically significant, uncontrolled concurrent neurological, hematological, renal, hepatic, endocrine, pulmonary, or cardiovascular disease
Beskrivning

nervous system disorder Clinical Significance Uncontrolled | Hematological Disease | Kidney Diseases | Liver diseases | Endocrine System Diseases | Lung diseases | Cardiovascular Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0007222
subjects with evidence of an active clinically important cardiovascular disease as evidenced by an ecg at screening
Beskrivning

Cardiovascular Disease Evidence Electrocardiogram

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0332120
UMLS CUI [1,3]
C0013798
concomitant therapy or therapy within the last 30 days with another investigational drug
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
subjects with screening laboratory values that deviate from the upper or lower limits of normal by greater that the percentages listed below:
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
liver function tests: total bilirubin above the upper limit of normal (uln). ast, alt, 1.5 x greater than uln
Beskrivning

Liver Function Tests | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023901
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
hematology: total white blood count (wbc) less than 3500mm3. hemoglobin and hematocrit less than 10 g/dl or 30%, unless stable for at least 3 months), and platelet count less than 100k or greater than 750 k.
Beskrivning

Hematology procedure | White Blood Cell Count procedure | Hemoglobin measurement | Hematocrit procedure | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200627
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0018935
UMLS CUI [5]
C0032181
renal function tests: bun or creatinine greater than 1.2 x above the uln
Beskrivning

Kidney Function Tests | Blood urea nitrogen measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0022662
UMLS CUI [2]
C0005845
UMLS CUI [3]
C0201976
urinalysis: on dipstick - proteinuria / hematuria / leukocytes greater than trace.
Beskrivning

Urinalysis | Urine dipstick test | Proteinuria | Hematuria | White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0042014
UMLS CUI [2]
C0430370
UMLS CUI [3]
C0033687
UMLS CUI [4]
C0018965
UMLS CUI [5]
C0023508
subjects with serological evidence of chronic hepatitis b (positive hbsag) or hepatitis c (positive c ab), hiv
Beskrivning

Chronic Hepatitis B Evidence Serological | Hepatitis B surface antigen positive | Chronic Hepatitis C Evidence Serological | Hepatitis C antibody positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
UMLS CUI [2]
C0149709
UMLS CUI [3,1]
C0524910
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0205473
UMLS CUI [4]
C0281863
UMLS CUI [5]
C0019699
subjects with evidence of active peptic ulcer disease or who have a reliable positive history of gastrointestinal bleeding within the past five (5) years. any recurrent or history of an intestinal disorder that may interfere with the proper absorption of the drug
Beskrivning

Peptic Ulcer | Gastrointestinal Hemorrhage | Intestinal Disease Interferes with drug absorption

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
UMLS CUI [3,1]
C0021831
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0678745
pregnant women or nursing mothers
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who plan to donate blood or blood products during the study or within 30 days following the last study visit.
Beskrivning

Blood Donation Planned | Blood product Donation Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0080231
UMLS CUI [2,3]
C1301732
one re-screening to meet criterion 6.1.5 will be allowed. multiple screenings, beyond one for failure to meet criterion 6.1.5 are not allowed (at either screening or baseline).
Beskrivning

Screening Repeat criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C1550543
abuse of alcohol or drugs. the subject should not consume more than 2 units of alcohol per day. (a unit of alcohol is considered: 12 oz of beer, 6 oz of wine or 1 oz of spirits). this is on a per day basis and not the average for the week.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
subjects with a sulfonamide allergy
Beskrivning

Allergy to sulfonamides

Datatyp

boolean

Alias
UMLS CUI [1]
C0038757
subjects who have known g6pd deficiency
Beskrivning

Deficiency of glucose-6-phosphate dehydrogenase

Datatyp

boolean

Alias
UMLS CUI [1]
C2939465
subjects who are unable or unwilling to follow the protocol
Beskrivning

Protocol Compliance Unwilling | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
recent major trauma or major surgery or serious infection
Beskrivning

Major injury | major surgery | Communicable Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205404
subjects who started but left, or were dropped out of this study, for any reason (subjects who left or are dropped will not be replaced).
Beskrivning

Study Subject Participation Status Subject dropped out

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1710677
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Similar models

Eligibility Rheumatoid Arthritis NCT00062465

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients between 18 and 75 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential | Postmenopausal state | Female Sterilization | Status post total hysterectomy | Barrier Contraception double | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm
Item
females must be of non-childbearing potential (post-menopausal, surgically sterilized or post hysterectomy) or using a double-barrier method of birth control for the duration of the study. a protocol acceptable method of double barrier method of birth control includes any combination of two or three of the following: condom, spermicidal and diaphragm.
boolean
C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C2349921 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0042241 (UMLS CUI [8])
Rheumatoid Arthritis disease length
Item
documented diagnosis of rheumatoid arthritis of at least six (6) months duration, as defined by the american rheumatism association 1987 revised criteria
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Class Functional
Item
american rheumatism association functional class i, ii, or iii
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Disease criteria Fulfill
Item
meet the criteria for (active disease) at both screening and baseline visits by achieving all of the criteria below:
boolean
C0012634 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Painful Joints Quantity | Tender joint count
Item
6 or more painful/tender joints
boolean
C3896992 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0451530 (UMLS CUI [2])
Swollen joint count
Item
6 or more swollen joints
boolean
C0451521 (UMLS CUI [1])
Visual Analog Pain Scale
Item
visual analog scale (vas) for pain of at least 3 (on scale of 1-10, where 1 is mild)
boolean
C0042815 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
c-reactive protein (crp) greater than or equal to 0.6 mg/dl or esr greater than 25 mm/hr.
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Therapeutic procedure
Item
prior/current therapy:
boolean
C0087111 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs naive | Patient receiving first-time biologic disease modifying anti-rheumatic drug therapy for rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs failed | Biological Factors Against Rheumatoid Arthritis failed | Sulfasalazine | Methotrexate | leflunomide | Minocycline | Hydroxychloroquine | Gold | Cyclosporine | Anti-tumor necrosis factor alpha drug | Interleukin-1 Receptor Antagonist
Item
a. subjects must be either dmard or biological anti-ra agent naive or have failed a dmard/biological ra agent, other than sulfasalazine, and have stopped this dmard/biological one (1) month prior to randomization unless they have a flare in disease activity upon discontinuing dmard/biological therapy as part of this protocol. dmards include but are not limited to methotrexate, leflunomide, minocycline, hydroxychloroquine, gold, cyclosporine, and biologics include anti-tnf and anti-il-1 agents.
boolean
C0242708 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C2368600 (UMLS CUI [2])
C0242708 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0005515 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0003873 (UMLS CUI [4,3])
C0231175 (UMLS CUI [4,4])
C0036078 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0063041 (UMLS CUI [7])
C0026187 (UMLS CUI [8])
C0020336 (UMLS CUI [9])
C0018026 (UMLS CUI [10])
C0010592 (UMLS CUI [11])
C1562242 (UMLS CUI [12])
C3536785 (UMLS CUI [13])
Non-Steroidal Anti-Inflammatory Agents Dose Stable | Non-Steroidal Anti-Inflammatory Agents Frequency Stable | Flare | Steroids
Item
b. subjects may be taking nsaids, provided the dose and frequency have been stable for 30 days prior to randomization. however if the patient meets the flare criteria they can be enrolled even if they have not fulfilled the criteria of being on a stable dose of nsaids and steroids for 30 days prior to randomization. at the time of flare neither steroids nor nsaids can be increased.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1517205 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
Steroid therapy Dose Stable | Prednisone Equivalent | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular injection | Injection of steroid into joint
Item
c. subjects may be taking corticosteroid therapy equivalent to prednisone less than or equal to 7.5 mg/day. this dose must be stable for at least 1 month prior to randomization. subjects may not change the dose of their corticosteroid or receive intra-articular or intra-muscular injections of corticosteroids, within 1 month of randomization or during the study. note section 9.3 of the protocol, concomitant medication, has been amended to read: if it is medically necessary a one joint steroid injection is acceptable. this must be noted on the crf and the joint excluded from the joint count.
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C2064783 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0021492 (UMLS CUI [4,2])
C0394848 (UMLS CUI [5])
Pharmaceutical Preparations Additional Rheumatoid Arthritis | Pharmaceutical Preparations Alternative Rheumatoid Arthritis
Item
d. subjects may not be taking other complementary and/or alternative medications for ra for the last 1-month prior to randomization.
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
Informed Consent
Item
subjects must provide written informed consent prior to any study-related screening tests.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rheumatoid Arthritis disease length
Item
subjects with ra for less than six months duration, or onset before age 16 (jra)
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
nervous system disorder Clinical Significance Uncontrolled | Hematological Disease | Kidney Diseases | Liver diseases | Endocrine System Diseases | Lung diseases | Cardiovascular Diseases
Item
clinically significant, uncontrolled concurrent neurological, hematological, renal, hepatic, endocrine, pulmonary, or cardiovascular disease
boolean
C0027765 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
Cardiovascular Disease Evidence Electrocardiogram
Item
subjects with evidence of an active clinically important cardiovascular disease as evidenced by an ecg at screening
boolean
C0007222 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,3])
Investigational New Drugs
Item
concomitant therapy or therapy within the last 30 days with another investigational drug
boolean
C0013230 (UMLS CUI [1])
Laboratory test result abnormal
Item
subjects with screening laboratory values that deviate from the upper or lower limits of normal by greater that the percentages listed below:
boolean
C0438215 (UMLS CUI [1])
Liver Function Tests | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function tests: total bilirubin above the upper limit of normal (uln). ast, alt, 1.5 x greater than uln
boolean
C0023901 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Hematology procedure | White Blood Cell Count procedure | Hemoglobin measurement | Hematocrit procedure | Platelet Count measurement
Item
hematology: total white blood count (wbc) less than 3500mm3. hemoglobin and hematocrit less than 10 g/dl or 30%, unless stable for at least 3 months), and platelet count less than 100k or greater than 750 k.
boolean
C0200627 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0018935 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Kidney Function Tests | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
renal function tests: bun or creatinine greater than 1.2 x above the uln
boolean
C0022662 (UMLS CUI [1])
C0005845 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Urinalysis | Urine dipstick test | Proteinuria | Hematuria | White Blood Cell Count procedure
Item
urinalysis: on dipstick - proteinuria / hematuria / leukocytes greater than trace.
boolean
C0042014 (UMLS CUI [1])
C0430370 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
C0018965 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
Chronic Hepatitis B Evidence Serological | Hepatitis B surface antigen positive | Chronic Hepatitis C Evidence Serological | Hepatitis C antibody positive | HIV Seropositivity
Item
subjects with serological evidence of chronic hepatitis b (positive hbsag) or hepatitis c (positive c ab), hiv
boolean
C0524909 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0149709 (UMLS CUI [2])
C0524910 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0205473 (UMLS CUI [3,3])
C0281863 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Peptic Ulcer | Gastrointestinal Hemorrhage | Intestinal Disease Interferes with drug absorption
Item
subjects with evidence of active peptic ulcer disease or who have a reliable positive history of gastrointestinal bleeding within the past five (5) years. any recurrent or history of an intestinal disorder that may interfere with the proper absorption of the drug
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0021831 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Blood Donation Planned | Blood product Donation Planned
Item
subjects who plan to donate blood or blood products during the study or within 30 days following the last study visit.
boolean
C0005794 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0080231 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Screening Repeat criteria Fulfill
Item
one re-screening to meet criterion 6.1.5 will be allowed. multiple screenings, beyond one for failure to meet criterion 6.1.5 are not allowed (at either screening or baseline).
boolean
C1710477 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1550543 (UMLS CUI [1,4])
Substance Use Disorders
Item
abuse of alcohol or drugs. the subject should not consume more than 2 units of alcohol per day. (a unit of alcohol is considered: 12 oz of beer, 6 oz of wine or 1 oz of spirits). this is on a per day basis and not the average for the week.
boolean
C0038586 (UMLS CUI [1])
Allergy to sulfonamides
Item
subjects with a sulfonamide allergy
boolean
C0038757 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
subjects who have known g6pd deficiency
boolean
C2939465 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
subjects who are unable or unwilling to follow the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Major injury | major surgery | Communicable Disease Serious
Item
recent major trauma or major surgery or serious infection
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Study Subject Participation Status Subject dropped out
Item
subjects who started but left, or were dropped out of this study, for any reason (subjects who left or are dropped will not be replaced).
boolean
C2348568 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
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