ID

20931

Description

Interferon-Induced Gene Expression in Liver Cells and Peripheral Blood Lymphocytes; ODM derived from: https://clinicaltrials.gov/show/NCT00324389

Link

https://clinicaltrials.gov/show/NCT00324389

Keywords

Versions (1)
  1. 3/28/17 3/28/17 -
Uploaded on

March 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00324389

English

Eligibility Hepatitis C NCT00324389

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male non-hispanic african-american or non-hispanic caucasian patients between 18 and 65 years of age
Description

African American | Caucasians | Age

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0043157
UMLS CUI [3]
C0001779
2. abstinence from any ingestion of alcohol and smoking for at least 7 days prior to study for those who drink or smoke socially
Description

Alcohol Abstinence | smoking abstinence | social drinking | Tobacco use social

Data type

boolean

Alias
UMLS CUI [1]
C0678274
UMLS CUI [2]
C0814442
UMLS CUI [3]
C0740872
UMLS CUI [4,1]
C0543414
UMLS CUI [4,2]
C0728831
3. hcv genotype 1 (1a, 1b or mixture of 1a and 1b). hcv genotyping will be performed at the molecular diagnostic laboratory at utmb using the lipa assay (innogenetics)
Description

Hepatitis C virus genotype determination Line Probe Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C1533728
UMLS CUI [1,2]
C3539666
4. presence of hcv rna in serum (>10 [to the fifth power] copies/ml)
Description

Serum HCV RNA Present

Data type

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C1868902
UMLS CUI [1,3]
C0150312
5. not previously treated with any interferon and/ or ribavirin
Description

Interferon Absent | Ribavirin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C0332197
6. compensated liver disease with the following laboratory criteria:
Description

Compensated liver disease | Laboratory criteria

Data type

boolean

Alias
UMLS CUI [1]
C3839044
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0243161
hemoglobin greater than or equal to 13 gm/dl for males
Description

Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
granulocyte count greater than or equal to 1,000/cubic mm
Description

Granulocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0857490
platelets greater than or equal to 100,000/cubic mm
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
prothrombin time <2 sec. elevation
Description

Elevated prothrombin time Seconds

Data type

boolean

Alias
UMLS CUI [1,1]
C2674387
UMLS CUI [1,2]
C0457385
total bilirubin (0.1-1.1 mg/dl). if elevated, the conjugated bilirubin must be within normal limits (0-0.3 mg/dl)
Description

Serum total bilirubin measurement | Elevated total bilirubin | Bilirubin conjugated normal

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0855626
serum albumin within normal limits (3.5-5.0 g/dl)
Description

Serum albumin normal

Data type

boolean

Alias
UMLS CUI [1]
C0580492
serum creatinine within normal limits (0.7-1.7 mg/ml)
Description

Serum creatinine normal

Data type

boolean

Alias
UMLS CUI [1]
C0438244
7. absence of other known causes of liver disease (e.g. autoimmune hepatitis, hemochromatosis, wilson's diseases, alpha-1 anti-trypsin deficiency, drug-induced liver injury, alcoholic liver disease)
Description

Liver disease Causes Absent | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Drug-Induced Liver Injury | Alcoholic Liver Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0241910
UMLS CUI [3]
C0018995
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0221757
UMLS CUI [6]
C3658290
UMLS CUI [7]
C0023896
8. no other systemic antiviral or immunosuppressive therapy within the last 6 months
Description

Systemic antiviral treatment Absent | Therapeutic immunosuppression Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0854610
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0332197
9. absence of concurrent medical and psychiatric illnesses (e.g. other viral co-infection such as hbv or hiv, renal failure, poorly controlled diabetes, cardiac-pulmonary diseases, cns disease, active alcoholism, depression, psychosis)
Description

Comorbidity Absent | Comorbidity Psychiatric Absent | Coinfection Viral | HBV coinfection | HIV coinfection | Kidney Failure | poorly controlled diabetes mellitus | Disease Cardiopulmonary | CNS disorder | Alcoholic Intoxication, Chronic | Depressive disorder | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205487
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0275524
UMLS CUI [3,2]
C0521026
UMLS CUI [4]
C2242656
UMLS CUI [5]
C4062778
UMLS CUI [6]
C0035078
UMLS CUI [7]
C0554876
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0553534
UMLS CUI [9]
C0007682
UMLS CUI [10]
C0001973
UMLS CUI [11]
C0011581
UMLS CUI [12]
C0033975
10. no history of type 1 or type 2 diabetes mellitis
Description

Insulin-Dependent Diabetes Mellitus Absent | Non-Insulin-Dependent Diabetes Mellitus Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0332197
11. tsh within normal limits (0.49-4.7 micro iu/ml)
Description

Thyroid stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202230
12. ana <1:160
Description

Anti-nuclear antibody measurement

Data type

boolean

Alias
UMLS CUI [1]
C0587178
13. no history of hepatocellular carcinoma
Description

Liver carcinoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332197
14. alpha fetoprotein within normal limits (0-20 ng/ml) obtained within 6 months of enrollment.
Description

Alpha-fetoprotein normal

Data type

boolean

Alias
UMLS CUI [1]
C0428522
15. if participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used with his partner simultaneously while receiving medication, and for 6 months after stopping the medications. the following are considered reliable and effective methods of birth control.
Description

Sexual activity Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
1) condoms with or without a spermicidal agent 2) diaphragm or cervical cap with spermicide 3) iud 4) hormonal-based contraception 16. exceptions may include if study participant/partner is surgically sterile 17. willingness to comply with procedures and treatment as outlined in the protocols and provide written informed consent
Description

Female Condoms | Spermatocidal Agents | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal Spermicides | Intrauterine Devices | Hormonal contraception | Sterilization Partner | Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0221829
UMLS CUI [2]
C0037862
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0493327
UMLS CUI [5]
C0087145
UMLS CUI [6]
C0021900
UMLS CUI [7]
C2985296
UMLS CUI [8,1]
C0038288
UMLS CUI [8,2]
C0682323
UMLS CUI [9]
C0525058
UMLS CUI [10]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. interferon or ribavirin therapy at any previous time
Description

Interferon therapy | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2]
C0035525
2. any investigational drug <= 24 weeks prior to the first dose of study drug
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
3. any alternative or folk medicine within 24 weeks of screening
Description

Alternative medicine agent | Medicine, Folk

Data type

boolean

Alias
UMLS CUI [1]
C1626216
UMLS CUI [2]
C0016419
4. any systemic antiviral therapy <= 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. exception: patients who have taken or are expected to require acyclovir for herpetic lesions
Description

Systemic antiviral treatment | Acyclovir | Herpetic lesions

Data type

boolean

Alias
UMLS CUI [1]
C0854610
UMLS CUI [2]
C0001367
UMLS CUI [3]
C3809769
5. patient with a baseline increased risk for anemia (e.g. hemoglobinopathies such as thalassemia, spherocytosis, sickle cell anemia or a history of symptomatic recurring gi bleeding, etc.) or for whom anemia would be medically problematic
Description

At risk for anemia Increased | Hemoglobinopathies | Thalassemia | Spherocytosis | Anemia, Sickle Cell | Recurrent gastrointestinal bleeding Symptomatic | Medical Problem Due to Anemia

Data type

boolean

Alias
UMLS CUI [1,1]
C3536601
UMLS CUI [1,2]
C0205217
UMLS CUI [2]
C0019045
UMLS CUI [3]
C0039730
UMLS CUI [4]
C0553720
UMLS CUI [5]
C0002895
UMLS CUI [6,1]
C0585174
UMLS CUI [6,2]
C0231220
UMLS CUI [7,1]
C1254481
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0002871
6. evidence of alcohol and/or drug abuse within 6 months
Description

Substance Use Disorders Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332120
7. history of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
Description

Immune System Disease | Inflammatory Bowel Disease | idiopathic thrombocytopenic purpura | Lupus Erythematosus | Autoimmune hemolytic anemia | Scleroderma | Psoriasis Severe | Rheumatoid Arthritis Evidence Clinical

Data type

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0272292
UMLS CUI [4]
C0409974
UMLS CUI [5]
C0002880
UMLS CUI [6]
C0011644
UMLS CUI [7,1]
C0033860
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0003873
UMLS CUI [8,2]
C3887511
UMLS CUI [8,3]
C0205210
8. evidence of an active or suspected cancer or a history of malignancy
Description

Malignant Neoplasm | Malignant Neoplasm Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
9. history of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <= 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Description

Antineoplastic Agents Systemic | Immunomodulators | Steroids High dose | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1527392
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0444956
UMLS CUI [4]
C1522449
10. history of major organ transplantation with an existing functional graft
Description

Organ Transplantation Major | Graft Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0332835
UMLS CUI [2,2]
C0205245
11. history of bone marrow transplantation
Description

Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0005961
12. anything that in the opinion of the investigator puts the patient at increased risk, or increases the likelihood that the patient may not be able to complete the protocol
Description

Patient At risk Increased | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0205217
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Hepatitis C NCT00324389

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
African American | Caucasians | Age
Item
1. male non-hispanic african-american or non-hispanic caucasian patients between 18 and 65 years of age
boolean
C0085756 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Alcohol Abstinence | smoking abstinence | social drinking | Tobacco use social
Item
2. abstinence from any ingestion of alcohol and smoking for at least 7 days prior to study for those who drink or smoke socially
boolean
C0678274 (UMLS CUI [1])
C0814442 (UMLS CUI [2])
C0740872 (UMLS CUI [3])
C0543414 (UMLS CUI [4,1])
C0728831 (UMLS CUI [4,2])
Hepatitis C virus genotype determination Line Probe Assay
Item
3. hcv genotype 1 (1a, 1b or mixture of 1a and 1b). hcv genotyping will be performed at the molecular diagnostic laboratory at utmb using the lipa assay (innogenetics)
boolean
C1533728 (UMLS CUI [1,1])
C3539666 (UMLS CUI [1,2])
Serum HCV RNA Present
Item
4. presence of hcv rna in serum (>10 [to the fifth power] copies/ml)
boolean
C0229671 (UMLS CUI [1,1])
C1868902 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
Interferon Absent | Ribavirin Absent
Item
5. not previously treated with any interferon and/ or ribavirin
boolean
C3652465 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Compensated liver disease | Laboratory criteria
Item
6. compensated liver disease with the following laboratory criteria:
boolean
C3839044 (UMLS CUI [1])
C0022877 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
Hemoglobin measurement | Gender
Item
hemoglobin greater than or equal to 13 gm/dl for males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Granulocyte count
Item
granulocyte count greater than or equal to 1,000/cubic mm
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
platelets greater than or equal to 100,000/cubic mm
boolean
C0032181 (UMLS CUI [1])
Elevated prothrombin time Seconds
Item
prothrombin time <2 sec. elevation
boolean
C2674387 (UMLS CUI [1,1])
C0457385 (UMLS CUI [1,2])
Serum total bilirubin measurement | Elevated total bilirubin | Bilirubin conjugated normal
Item
total bilirubin (0.1-1.1 mg/dl). if elevated, the conjugated bilirubin must be within normal limits (0-0.3 mg/dl)
boolean
C1278039 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0855626 (UMLS CUI [3])
Serum albumin normal
Item
serum albumin within normal limits (3.5-5.0 g/dl)
boolean
C0580492 (UMLS CUI [1])
Serum creatinine normal
Item
serum creatinine within normal limits (0.7-1.7 mg/ml)
boolean
C0438244 (UMLS CUI [1])
Liver disease Causes Absent | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Drug-Induced Liver Injury | Alcoholic Liver Disease
Item
7. absence of other known causes of liver disease (e.g. autoimmune hepatitis, hemochromatosis, wilson's diseases, alpha-1 anti-trypsin deficiency, drug-induced liver injury, alcoholic liver disease)
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0241910 (UMLS CUI [2])
C0018995 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0221757 (UMLS CUI [5])
C3658290 (UMLS CUI [6])
C0023896 (UMLS CUI [7])
Systemic antiviral treatment Absent | Therapeutic immunosuppression Absent
Item
8. no other systemic antiviral or immunosuppressive therapy within the last 6 months
boolean
C0854610 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Comorbidity Absent | Comorbidity Psychiatric Absent | Coinfection Viral | HBV coinfection | HIV coinfection | Kidney Failure | poorly controlled diabetes mellitus | Disease Cardiopulmonary | CNS disorder | Alcoholic Intoxication, Chronic | Depressive disorder | Psychotic Disorders
Item
9. absence of concurrent medical and psychiatric illnesses (e.g. other viral co-infection such as hbv or hiv, renal failure, poorly controlled diabetes, cardiac-pulmonary diseases, cns disease, active alcoholism, depression, psychosis)
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0275524 (UMLS CUI [3,1])
C0521026 (UMLS CUI [3,2])
C2242656 (UMLS CUI [4])
C4062778 (UMLS CUI [5])
C0035078 (UMLS CUI [6])
C0554876 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C0553534 (UMLS CUI [8,2])
C0007682 (UMLS CUI [9])
C0001973 (UMLS CUI [10])
C0011581 (UMLS CUI [11])
C0033975 (UMLS CUI [12])
Insulin-Dependent Diabetes Mellitus Absent | Non-Insulin-Dependent Diabetes Mellitus Absent
Item
10. no history of type 1 or type 2 diabetes mellitis
boolean
C0011854 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Thyroid stimulating hormone measurement
Item
11. tsh within normal limits (0.49-4.7 micro iu/ml)
boolean
C0202230 (UMLS CUI [1])
Anti-nuclear antibody measurement
Item
12. ana <1:160
boolean
C0587178 (UMLS CUI [1])
Liver carcinoma Absent
Item
13. no history of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Alpha-fetoprotein normal
Item
14. alpha fetoprotein within normal limits (0-20 ng/ml) obtained within 6 months of enrollment.
boolean
C0428522 (UMLS CUI [1])
Sexual activity Contraceptive methods Quantity
Item
15. if participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used with his partner simultaneously while receiving medication, and for 6 months after stopping the medications. the following are considered reliable and effective methods of birth control.
boolean
C0036864 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Female Condoms | Spermatocidal Agents | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Vaginal Spermicides | Intrauterine Devices | Hormonal contraception | Sterilization Partner | Protocol Compliance | Informed Consent
Item
1) condoms with or without a spermicidal agent 2) diaphragm or cervical cap with spermicide 3) iud 4) hormonal-based contraception 16. exceptions may include if study participant/partner is surgically sterile 17. willingness to comply with procedures and treatment as outlined in the protocols and provide written informed consent
boolean
C0221829 (UMLS CUI [1])
C0037862 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0493327 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0038288 (UMLS CUI [8,1])
C0682323 (UMLS CUI [8,2])
C0525058 (UMLS CUI [9])
C0021430 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Interferon therapy | Ribavirin
Item
1. interferon or ribavirin therapy at any previous time
boolean
C0279030 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Investigational New Drugs
Item
2. any investigational drug <= 24 weeks prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
Alternative medicine agent | Medicine, Folk
Item
3. any alternative or folk medicine within 24 weeks of screening
boolean
C1626216 (UMLS CUI [1])
C0016419 (UMLS CUI [2])
Systemic antiviral treatment | Acyclovir | Herpetic lesions
Item
4. any systemic antiviral therapy <= 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. exception: patients who have taken or are expected to require acyclovir for herpetic lesions
boolean
C0854610 (UMLS CUI [1])
C0001367 (UMLS CUI [2])
C3809769 (UMLS CUI [3])
At risk for anemia Increased | Hemoglobinopathies | Thalassemia | Spherocytosis | Anemia, Sickle Cell | Recurrent gastrointestinal bleeding Symptomatic | Medical Problem Due to Anemia
Item
5. patient with a baseline increased risk for anemia (e.g. hemoglobinopathies such as thalassemia, spherocytosis, sickle cell anemia or a history of symptomatic recurring gi bleeding, etc.) or for whom anemia would be medically problematic
boolean
C3536601 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0019045 (UMLS CUI [2])
C0039730 (UMLS CUI [3])
C0553720 (UMLS CUI [4])
C0002895 (UMLS CUI [5])
C0585174 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C1254481 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0002871 (UMLS CUI [7,3])
Substance Use Disorders Evidence of
Item
6. evidence of alcohol and/or drug abuse within 6 months
boolean
C0038586 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Immune System Disease | Inflammatory Bowel Disease | idiopathic thrombocytopenic purpura | Lupus Erythematosus | Autoimmune hemolytic anemia | Scleroderma | Psoriasis Severe | Rheumatoid Arthritis Evidence Clinical
Item
7. history of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical evidence of rheumatoid arthritis)
boolean
C0021053 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0272292 (UMLS CUI [3])
C0409974 (UMLS CUI [4])
C0002880 (UMLS CUI [5])
C0011644 (UMLS CUI [6])
C0033860 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0003873 (UMLS CUI [8,1])
C3887511 (UMLS CUI [8,2])
C0205210 (UMLS CUI [8,3])
Malignant Neoplasm | Malignant Neoplasm Suspected
Item
8. evidence of an active or suspected cancer or a history of malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Antineoplastic Agents Systemic | Immunomodulators | Steroids High dose | Therapeutic radiology procedure
Item
9. history of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <= 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
boolean
C0003392 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1527392 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
Organ Transplantation Major | Graft Functional
Item
10. history of major organ transplantation with an existing functional graft
boolean
C0029216 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332835 (UMLS CUI [2,1])
C0205245 (UMLS CUI [2,2])
Bone Marrow Transplantation
Item
11. history of bone marrow transplantation
boolean
C0005961 (UMLS CUI [1])
Patient At risk Increased | Protocol Compliance Unable
Item
12. anything that in the opinion of the investigator puts the patient at increased risk, or increases the likelihood that the patient may not be able to complete the protocol
boolean
C0030705 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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