Rheumatoid Arthritis
Item
1. diagnosis of ra according to the revised 1987 american rheumatism association criteria
boolean
C0003873 (UMLS CUI [1])
Absence Feature Suggestive of Communicable Disease | Absence Feature Suggestive of Neoplasms | Absence Feature Suggestive of Sarcoidosis | Absence Feature Suggestive of Interstitial Lung Disease | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia | Collagen-vascular disease | Exposure to Fibrogenesis Pharmaceutical Preparations | Exposure to Exogenous Factors
Item
2. absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than uip or nsip, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors
boolean
C0332197 (UMLS CUI [1,1])
C2348519 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0009450 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C2348519 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C0027651 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C2348519 (UMLS CUI [3,2])
C0332299 (UMLS CUI [3,3])
C0036202 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C2348519 (UMLS CUI [4,2])
C0332299 (UMLS CUI [4,3])
C0206062 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C1800706 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1290344 (UMLS CUI [6,2])
C0262428 (UMLS CUI [7])
C0332157 (UMLS CUI [8,1])
C0596570 (UMLS CUI [8,2])
C0013227 (UMLS CUI [8,3])
C0332157 (UMLS CUI [9,1])
C1516998 (UMLS CUI [9,2])
Progressive Interstitial Pneumonia | Idiopathic Pulmonary Fibrosis Subtype | Nonspecific interstitial pneumonia Subtype
Item
3. diagnosis of progressive interstitial pneumonia of uip or nsip subtype, based on the following criteria
boolean
C0206061 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
C1290344 (UMLS CUI [3,1])
C0449560 (UMLS CUI [3,2])
Symptoms Consistent with Interstitial Lung Disease
Item
1. clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.
boolean
C1457887 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0206062 (UMLS CUI [1,3])
Worsening
Item
2. worsening as demonstrated by any one of the following within the past year:
boolean
C0332271 (UMLS CUI [1])
Forced vital capacity decreased
Item
> 10% decrease in forced vital capacity (fvc)
boolean
C1846678 (UMLS CUI [1])
Infiltration Increasing Chest X-ray | Infiltration Increasing High Resolution Computed Tomography | Resting Dyspnea Worsening | Dyspnea on exertion Worsening
Item
increasing infiltrates on chest x-ray or high resolution computed tomography (hrct), or worsening dyspnea at rest or on exertion
boolean
C0332448 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,3])
C0332448 (UMLS CUI [2,1])
C0442808 (UMLS CUI [2,2])
C1512457 (UMLS CUI [2,3])
C0743330 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0231807 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Idiopathic Pulmonary Fibrosis | Nonspecific interstitial pneumonia
Item
3. diagnosis of uip or nsip by either of the following:
boolean
C1800706 (UMLS CUI [1])
C1290344 (UMLS CUI [2])
Idiopathic Pulmonary Fibrosis Open biopsy of lung | Idiopathic Pulmonary Fibrosis Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Open biopsy of lung | Nonspecific interstitial pneumonia Video-assisted thoracoscopic lung biopsy | Idiopathic Pulmonary Fibrosis Probable Open biopsy of lung | Idiopathic Pulmonary Fibrosis Probable Video-assisted thoracoscopic lung biopsy | Nonspecific interstitial pneumonia Probable Open biopsy of lung | Nonspecific interstitial pneumonia Probable Video-assisted thoracoscopic lung biopsy
Item
open or video-assisted thoracic surgery (vats) lung biopsy showing definite or probable uip or nsip
boolean
C1800706 (UMLS CUI [1,1])
C0176514 (UMLS CUI [1,2])
C1800706 (UMLS CUI [2,1])
C0860958 (UMLS CUI [2,2])
C1290344 (UMLS CUI [3,1])
C0176514 (UMLS CUI [3,2])
C1290344 (UMLS CUI [4,1])
C0860958 (UMLS CUI [4,2])
C1800706 (UMLS CUI [5,1])
C0332148 (UMLS CUI [5,2])
C0176514 (UMLS CUI [5,3])
C1800706 (UMLS CUI [6,1])
C0332148 (UMLS CUI [6,2])
C0860958 (UMLS CUI [6,3])
C1290344 (UMLS CUI [7,1])
C0332148 (UMLS CUI [7,2])
C0176514 (UMLS CUI [7,3])
C1290344 (UMLS CUI [8,1])
C0332148 (UMLS CUI [8,2])
C0860958 (UMLS CUI [8,3])
Idiopathic Pulmonary Fibrosis High Resolution Computed Tomography | Nonspecific interstitial pneumonia High Resolution Computed Tomography | Idiopathic Pulmonary Fibrosis Probable High Resolution Computed Tomography | Nonspecific interstitial pneumonia Probable High Resolution Computed Tomography | Lung function testing abnormal | Forced vital capacity decreased | Decreased DLCO | Impaired gas exchange At rest | Impaired gas exchange Exercise | Dyspnea Explanation Lacking | Exertion Inspiratory crackles Auscultation
Item
hrct scan showing definite or probable uip or nsip and abnormal pulmonary function tests (reduced fvc or decreased diffusing capacity of carbon monoxide (dlco) or impaired gas exchange at rest or with exercise) and insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation
boolean
C1800706 (UMLS CUI [1,1])
C1512457 (UMLS CUI [1,2])
C1290344 (UMLS CUI [2,1])
C1512457 (UMLS CUI [2,2])
C1800706 (UMLS CUI [3,1])
C0332148 (UMLS CUI [3,2])
C1512457 (UMLS CUI [3,3])
C1290344 (UMLS CUI [4,1])
C0332148 (UMLS CUI [4,2])
C1512457 (UMLS CUI [4,3])
C0476405 (UMLS CUI [5])
C1846678 (UMLS CUI [6])
C4073175 (UMLS CUI [7])
C0150034 (UMLS CUI [8,1])
C0443144 (UMLS CUI [8,2])
C0150034 (UMLS CUI [9,1])
C0015259 (UMLS CUI [9,2])
C0013404 (UMLS CUI [10,1])
C0681841 (UMLS CUI [10,2])
C0332268 (UMLS CUI [10,3])
C0015264 (UMLS CUI [11,1])
C0577961 (UMLS CUI [11,2])
C0004339 (UMLS CUI [11,3])
Forced vital capacity
Item
4. fvc > 50% of predicted value at screening
boolean
C1287681 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
5. dlco >30% of predicted value at screening
boolean
C1516251 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs unchanged
Item
5. no change of disease-modifying anti-rheumatic drug (dmard) treatment within the last 3 months
boolean
C0242708 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Environmental Exposure Causing Pulmonary Fibrosis | Drug exposure Causing Pulmonary Fibrosis
Item
1. history of clinically significant environmental or drug exposure known to cause pulmonary fibrosis.
boolean
C0014412 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0034069 (UMLS CUI [1,3])
C0743284 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0034069 (UMLS CUI [2,3])
FEV1/FVC ratio pre bronchodilator
Item
2. forced expiratory volume in one second (fev1) fev1/fvc ratio < 0.6 at screening (pre-
boolean
C0429745 (UMLS CUI [1,1])
C2599602 (UMLS CUI [1,2])
FEV1/FVC ratio post bronchodilator
Item
or post-bronchodilator).
boolean
C0429745 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
Lung residual volume measurement
Item
3. residual volume > 120% predicted at screening
boolean
C0429713 (UMLS CUI [1])
Communicable Disease
Item
4. evidence of active infection
boolean
C0009450 (UMLS CUI [1])
Condition Pulmonary Life Expectancy Shortened | Exception Idiopathic Pulmonary Fibrosis | Exception Nonspecific interstitial pneumonia
Item
5. any pulmonary condition other than uip/nsip, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year
boolean
C0348080 (UMLS CUI [1,1])
C2709248 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1282927 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1800706 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1290344 (UMLS CUI [3,2])
Heart Disease Unstable | Heart Disease Worsening | Nervous system disorder Unstable | Nervous system disorder Worsening
Item
6. history of unstable or deteriorating cardiac or neurologic disease
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
7. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cyclophosphamide | Cyclosporine | Interferon gamma | Interferon-beta | anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Endothelin Receptor Antagonists | Investigational Therapy Rheumatoid Arthritis
Item
8. treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (il1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis
boolean
C0010583 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C2757040 (UMLS CUI [3])
C0015980 (UMLS CUI [4])
C0281481 (UMLS CUI [5])
C3536785 (UMLS CUI [6])
C2266875 (UMLS CUI [7])
C0949266 (UMLS CUI [8,1])
C0003873 (UMLS CUI [8,2])
Serum creatinine raised
Item
9. creatinine > 1.5 x upper limit of normal range (uln) at screening
boolean
C0700225 (UMLS CUI [1])
Hematology finding abnormal | White Blood Cell Count procedure | Absolute neutrophil count
Item
10. hematology outside of specified limits: white blood cell (wbc) < 2,500/mm^3 or absolute neutrophil count (anc) < 1500
boolean
C0475182 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Hematocrit level | Platelet Count measurement
Item
11. hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening
boolean
C0518014 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HEPATITIS B SEROLOGY POSITIVE | Hepatitis C Serology positive
Item
12. positive hepatitis b or c serology
boolean
C0744838 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0242089 (UMLS CUI [2,2])
Medical condition Adverse effects Due to Study Subject Participation Status
Item
13. any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study
boolean
C3843040 (UMLS CUI [1,1])
C0001688 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Recurrent infections | Recurrent bacterial infection
Item
14. history of recurrent significant infection or history of recurrent bacterial infections
boolean
C0239998 (UMLS CUI [1])
C1844383 (UMLS CUI [2])
Bacterial Infections | Virus Diseases | Mycoses | Mycobacterium Infections | Communicable Diseases | Tuberculosis | Mycobacterium Infections, Nontuberculous | Exception Nail bed infection fungal | Communicable Disease Episode Major Hospitalization Required | Communicable Disease Episode Requirement Intravenous antibiotic therapy
Item
15. known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0026918 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
C0026919 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C2242531 (UMLS CUI [8,2])
C0009450 (UMLS CUI [9,1])
C0332189 (UMLS CUI [9,2])
C0205164 (UMLS CUI [9,3])
C1708385 (UMLS CUI [9,4])
C0009450 (UMLS CUI [10,1])
C0332189 (UMLS CUI [10,2])
C1514873 (UMLS CUI [10,3])
C0559680 (UMLS CUI [10,4])
Neurological examination abnormal | CNS disorder | Paresis | Impaired cognition | Abnormal coordination
Item
16. abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination
boolean
C1112537 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0030552 (UMLS CUI [3])
C0338656 (UMLS CUI [4])
C0520966 (UMLS CUI [5])
Study Subject Participation Status
Item
17. current enrollment in another clinical trial
boolean
C2348568 (UMLS CUI [1])
Fever
Item
18. fever (>99.5º f)
boolean
C0015967 (UMLS CUI [1])
rituximab
Item
19. history of previous rituximab administration
boolean
C0393022 (UMLS CUI [1])
Vaccines | Attenuated Live Virus Vaccine
Item
20. receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose
boolean
C0042210 (UMLS CUI [1])
C1516086 (UMLS CUI [2])
Decreased immunoglobulin G (IgG) | IgM deficiency
Item
21. decreased immunoglobulin g (igg) and immunoglobulin m (igm) levels (below lower limit of normal range)
boolean
C1859344 (UMLS CUI [1])
C0239989 (UMLS CUI [2])
Malignant Neoplasms
Item
22. present or past malignancy
boolean
C0006826 (UMLS CUI [1])
Severe allergy Humanized Monoclonal Antibodies | Severe allergy Monoclonal Antibodies Murine | Anaphylaxis severe Humanized Monoclonal Antibodies | Anaphylaxis severe Monoclonal Antibodies Murine
Item
23. history of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies
boolean
C2945656 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
C0026809 (UMLS CUI [2,3])
C0002792 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2985546 (UMLS CUI [3,3])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0003250 (UMLS CUI [4,3])
C0026809 (UMLS CUI [4,4])
HIV Seropositivity
Item
24. positive human immunodeficiency virus (hiv) serology
boolean
C0019699 (UMLS CUI [1])