ID

37143

Descripción

Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT02202395

Link

https://clinicaltrials.gov/show/NCT02202395

Palabras clave

Versiones (1)
  1. 4/7/19 4/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de julio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02202395

Inglés

Eligibility Rheumatoid Arthritis NCT02202395

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements
Descripción

Age | Gender | Postmenopausal | Parous | Nulliparous

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0232970
UMLS CUI [4]
C2045006
UMLS CUI [5]
C0425979
1987 acr diagnostic criteria or 2009 acr/eular diagnostic criteria. x ray of evaluable joint in phase i/ii/iii, joint function in phase i/ii/iii
Descripción

Diagnostic criteria Specified | Joint Evaluable Phase X-ray | Joint function Phase

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C1516986
UMLS CUI [2,3]
C0205390
UMLS CUI [2,4]
C0034571
UMLS CUI [3,1]
C1535551
UMLS CUI [3,2]
C0205390
active ra
Descripción

Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
continuously taking mtx for at least three months, ≥7.5mg/week. before first study dose, keep in stable mtx dose for at least 4 weeks
Descripción

Methotrexate Dose Stable U/week

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
keep in stable nsaids dose or low-dose glucocorticoids for at least 4 weeks before first study dose
Descripción

NSAIDs Dose Stable | Glucocorticoids Low dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0445550
using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose
Descripción

Combined Modality Therapy Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
using dmard should have appropriate withdrawal period:
Descripción

DMARD | Withdrawal Period Appropriate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C2349954
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C1548787
withdrawal for 4 weeks: sulfasalazine, azathioprine, chloroquine,
Descripción

Withdrawal Week Quantity | Sulfasalazine | Azathioprine | Chloroquine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0036078
UMLS CUI [3]
C0004482
UMLS CUI [4]
C0008269
*hydroxychloroquine, auranofin, penicillamine, traditional chinese medicine preparation(tgp, sinomenine)
Descripción

Hydroxychloroquine | Auranofin | Penicillamine | Traditional Chinese Medicine Pharmaceutical Preparations | Chinese peony root extract | sinomenine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020336
UMLS CUI [2]
C0004320
UMLS CUI [3]
C0030817
UMLS CUI [4,1]
C0025124
UMLS CUI [4,2]
C0013227
UMLS CUI [5]
C1337153
UMLS CUI [6]
C0074568
withdrawal for 8 weeks: leflunomide
Descripción

Withdrawal Week Quantity | leflunomide

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0063041
withdrawal for 8 weeks: intramuscular, intravenous, intra-articular injection glucocorticoids
Descripción

Withdrawal Week Quantity | Glucocorticoids Intramuscular injection | Glucocorticoids Intravenous Injection | Glucocorticoids Intra-Articular Injection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0021492
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0021494
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C0021488
women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical
Descripción

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
voluntary informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
willing to follow the required regimen and schedule, follow-up examination
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. currently suffering or have suffered from other inflammatory joint diseases, such as mixed connective tissue disease, scleroderma, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, reiter's syndrome, bone arthritis, rheumatoid arthritis, gouty arthritis, diagnosis of arthritis before 16yrs
Descripción

Inflammatory joint disease | Mixed Connective Tissue Disease | Scleroderma | Lupus Erythematosus, Systemic | Ankylosing spondylitis | Arthritis, Psoriatic | Reiter Syndrome | Bone Arthritis | Rheumatoid Arthritis | Arthritis, Gouty | Arthritis Previous

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2]
C0026272
UMLS CUI [3]
C0011644
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0038013
UMLS CUI [6]
C0003872
UMLS CUI [7]
C0035012
UMLS CUI [8,1]
C0262950
UMLS CUI [8,2]
C0003864
UMLS CUI [9]
C0003873
UMLS CUI [10]
C0003868
UMLS CUI [11,1]
C0003864
UMLS CUI [11,2]
C0205156
2. with severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
Descripción

High fever | Pneumonia, Interstitial | Pleurisy | Pericarditis | Vasculitis Severe | Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743973
UMLS CUI [2]
C0206061
UMLS CUI [3]
C0032231
UMLS CUI [4]
C0031046
UMLS CUI [5,1]
C0042384
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0442874
3. the evaluable joint underwent the surgical treatment within 2 months
Descripción

Operative Surgical Procedure Joint Evaluable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1516986
4. currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases
Descripción

Disease Serious | Disease Progression | Disease Uncontrolled | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Respiration Disorders | Cardiovascular Diseases | Nervous system disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0018939
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0025517
UMLS CUI [10]
C0035204
UMLS CUI [11]
C0007222
UMLS CUI [12]
C0027765
5. currently or have malignancy, lymphoproliferative disease history
Descripción

Malignant Neoplasms | Lymphoproliferative Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0024314
6. continuously use tripterygium preparations for more than three months and have no effect
Descripción

Tripterygium Preparations failed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0969732
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0231175
7. history of using tnf-a inhibitors of biological agents.(adalimumab, infliximab, etanercept)
Descripción

Tumor necrosis factor alpha inhibitors | Biological agents | adalimumab | infliximab | Etanercept

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3653350
UMLS CUI [2]
C0005515
UMLS CUI [3]
C1122087
UMLS CUI [4]
C0666743
UMLS CUI [5]
C0717758
8. severe or persistent infection within 3 months
Descripción

Communicable Disease Severe | Communicable Disease Persistent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205322
9. x-ray shows active pulmonary infection
Descripción

Infectious disease of lung X-ray

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0876973
UMLS CUI [1,2]
C0034571
10. hbv, hcv, hiv, aids
Descripción

Hepatitis B | Hepatitis C | HIV Infection | AIDS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0001175
11. wbc<4.0×10^9/l, plt<100×10^9/l, hb<85g/l
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
12. ast>2×uln, alt>2×uln
Descripción

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
13. cr>135umol/l
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
14. used oral contraceptive druds within 3 months
Descripción

Contraceptives, Oral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009905
15. pregnancy test was positive or lactating patients or patients with birth preparation
Descripción

Pregnancy test positive | Breast Feeding | Birth Preparation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0005615
UMLS CUI [3,2]
C1521827
16. have to use the prohibited drugs
Descripción

Patient need for Illicit Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0086190
17. with clinical symptoms of a serious history of drug abuse or alcohol abuse
Descripción

Symptoms Substance Use Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0038586
18. history of any durg clinical trials within 3 months
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
19. allergy to tripterygium
Descripción

Hypersensitivity Tripterygium

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0969732
20. other reasons depends by the investigator
Descripción

Exclusion Criteria Additional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT02202395

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender | Postmenopausal | Parous | Nulliparous
Item
35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C2045006 (UMLS CUI [4])
C0425979 (UMLS CUI [5])
Diagnostic criteria Specified | Joint Evaluable Phase X-ray | Joint function Phase
Item
1987 acr diagnostic criteria or 2009 acr/eular diagnostic criteria. x ray of evaluable joint in phase i/ii/iii, joint function in phase i/ii/iii
boolean
C0679228 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0022417 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C0205390 (UMLS CUI [2,3])
C0034571 (UMLS CUI [2,4])
C1535551 (UMLS CUI [3,1])
C0205390 (UMLS CUI [3,2])
Rheumatoid Arthritis
Item
active ra
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dose Stable U/week
Item
continuously taking mtx for at least three months, ≥7.5mg/week. before first study dose, keep in stable mtx dose for at least 4 weeks
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
NSAIDs Dose Stable | Glucocorticoids Low dose
Item
keep in stable nsaids dose or low-dose glucocorticoids for at least 4 weeks before first study dose
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Combined Modality Therapy Dose Stable
Item
using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose
boolean
C0009429 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
DMARD | Withdrawal Period Appropriate
Item
using dmard should have appropriate withdrawal period:
boolean
C0242708 (UMLS CUI [1])
C2349954 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
Withdrawal Week Quantity | Sulfasalazine | Azathioprine | Chloroquine
Item
withdrawal for 4 weeks: sulfasalazine, azathioprine, chloroquine,
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0036078 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
Hydroxychloroquine | Auranofin | Penicillamine | Traditional Chinese Medicine Pharmaceutical Preparations | Chinese peony root extract | sinomenine
Item
*hydroxychloroquine, auranofin, penicillamine, traditional chinese medicine preparation(tgp, sinomenine)
boolean
C0020336 (UMLS CUI [1])
C0004320 (UMLS CUI [2])
C0030817 (UMLS CUI [3])
C0025124 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1337153 (UMLS CUI [5])
C0074568 (UMLS CUI [6])
Withdrawal Week Quantity | leflunomide
Item
withdrawal for 8 weeks: leflunomide
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0063041 (UMLS CUI [2])
Withdrawal Week Quantity | Glucocorticoids Intramuscular injection | Glucocorticoids Intravenous Injection | Glucocorticoids Intra-Articular Injection
Item
withdrawal for 8 weeks: intramuscular, intravenous, intra-articular injection glucocorticoids
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C0021492 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0021494 (UMLS CUI [3,2])
C0017710 (UMLS CUI [4,1])
C0021488 (UMLS CUI [4,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
voluntary informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing to follow the required regimen and schedule, follow-up examination
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inflammatory joint disease | Mixed Connective Tissue Disease | Scleroderma | Lupus Erythematosus, Systemic | Ankylosing spondylitis | Arthritis, Psoriatic | Reiter Syndrome | Bone Arthritis | Rheumatoid Arthritis | Arthritis, Gouty | Arthritis Previous
Item
1. currently suffering or have suffered from other inflammatory joint diseases, such as mixed connective tissue disease, scleroderma, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, reiter's syndrome, bone arthritis, rheumatoid arthritis, gouty arthritis, diagnosis of arthritis before 16yrs
boolean
C0683381 (UMLS CUI [1])
C0026272 (UMLS CUI [2])
C0011644 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0038013 (UMLS CUI [5])
C0003872 (UMLS CUI [6])
C0035012 (UMLS CUI [7])
C0262950 (UMLS CUI [8,1])
C0003864 (UMLS CUI [8,2])
C0003873 (UMLS CUI [9])
C0003868 (UMLS CUI [10])
C0003864 (UMLS CUI [11,1])
C0205156 (UMLS CUI [11,2])
High fever | Pneumonia, Interstitial | Pleurisy | Pericarditis | Vasculitis Severe | Neuropathy
Item
2. with severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
boolean
C0743973 (UMLS CUI [1])
C0206061 (UMLS CUI [2])
C0032231 (UMLS CUI [3])
C0031046 (UMLS CUI [4])
C0042384 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0442874 (UMLS CUI [6])
Operative Surgical Procedure Joint Evaluable
Item
3. the evaluable joint underwent the surgical treatment within 2 months
boolean
C0543467 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1516986 (UMLS CUI [1,3])
Disease Serious | Disease Progression | Disease Uncontrolled | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Respiration Disorders | Cardiovascular Diseases | Nervous system disorder
Item
4. currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0035204 (UMLS CUI [10])
C0007222 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
Malignant Neoplasms | Lymphoproliferative Disorder
Item
5. currently or have malignancy, lymphoproliferative disease history
boolean
C0006826 (UMLS CUI [1])
C0024314 (UMLS CUI [2])
Tripterygium Preparations failed
Item
6. continuously use tripterygium preparations for more than three months and have no effect
boolean
C0969732 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Tumor necrosis factor alpha inhibitors | Biological agents | adalimumab | infliximab | Etanercept
Item
7. history of using tnf-a inhibitors of biological agents.(adalimumab, infliximab, etanercept)
boolean
C3653350 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
C0666743 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
Communicable Disease Severe | Communicable Disease Persistent
Item
8. severe or persistent infection within 3 months
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Infectious disease of lung X-ray
Item
9. x-ray shows active pulmonary infection
boolean
C0876973 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C | HIV Infection | AIDS
Item
10. hbv, hcv, hiv, aids
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
11. wbc<4.0×10^9/l, plt<100×10^9/l, hb<85g/l
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
12. ast>2×uln, alt>2×uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum
Item
13. cr>135umol/l
boolean
C0201976 (UMLS CUI [1])
Contraceptives, Oral
Item
14. used oral contraceptive druds within 3 months
boolean
C0009905 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding | Birth Preparation
Item
15. pregnancy test was positive or lactating patients or patients with birth preparation
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0005615 (UMLS CUI [3,1])
C1521827 (UMLS CUI [3,2])
Patient need for Illicit Drugs
Item
16. have to use the prohibited drugs
boolean
C0686904 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Symptoms Substance Use Disorder
Item
17. with clinical symptoms of a serious history of drug abuse or alcohol abuse
boolean
C1457887 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
18. history of any durg clinical trials within 3 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hypersensitivity Tripterygium
Item
19. allergy to tripterygium
boolean
C0020517 (UMLS CUI [1,1])
C0969732 (UMLS CUI [1,2])
Exclusion Criteria Additional
Item
20. other reasons depends by the investigator
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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