ID

15992

Beschreibung

Tocilizumab (TCZ) in New-onset Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02293837

Link

https://clinicaltrials.gov/show/NCT02293837

Stichworte

  1. 25.06.16 25.06.16 -
Hochgeladen am

25. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0

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    Eligibility Type 1 Diabetes Mellitus NCT02293837

    Eligibility Type 1 Diabetes Mellitus NCT02293837

    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. participants who meet the american diabetes association type 1 diabetes mellitus (t1dm) criteria
    Beschreibung

    Diabetes Mellitus, Insulin-Dependent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    2. diagnosis of t1dm within 100 days of enrollment
    Beschreibung

    Diabetes Mellitus, Insulin-Dependent | Enrollment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011854
    UMLS CUI [2]
    C1516879
    3. positive for at least one diabetes-related autoantibody, including but not limited to:
    Beschreibung

    Diabetes Related Autoantibody positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011847
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0853878
    1. glutamate decarboxylase (gad-65)
    Beschreibung

    Glutamate Decarboxylase

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0017785
    2. insulin, if obtained within 10 days of the onset of exogenous insulin therapy
    Beschreibung

    Insulin Insulin regime Exogenous

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021641
    UMLS CUI [1,2]
    C0557978
    UMLS CUI [1,3]
    C0205228
    3. insulinoma antigen-2 (ia-2)
    Beschreibung

    Insulinoma antigen 2, human

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1568433
    4. zinc transporter- (znt)
    Beschreibung

    zinc transporter

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1608304
    5. islet-cell antibodies (ica).
    Beschreibung

    islet cell antibody

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0063900
    4. peak stimulated c-peptide level >= 0.2 pmol/ml following a mixed-meal tolerance test (mmtt) conducted at least 21 days from diagnosis and within 37 days of randomization
    Beschreibung

    Insulin C-peptide measurement Peak Stimulated | Meal Mixed Tolerance test

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0202100
    UMLS CUI [1,2]
    C0444505
    UMLS CUI [1,3]
    C1948023
    UMLS CUI [2,1]
    C1998602
    UMLS CUI [2,2]
    C0205430
    UMLS CUI [2,3]
    C0201777
    5. signed informed consent (and informed assent of minor, if applicable).
    Beschreibung

    Informed Consent | Assent Minor

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C1879749
    UMLS CUI [2,2]
    C0026193
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
    Beschreibung

    severe reaction Monoclonal Antibodies human | severe reaction Antibodies, Monoclonal, Humanized | severe reaction Monoclonal Antibodies mouse | anaphylaxis Monoclonal Antibodies human | anaphylaxis Antibodies, Monoclonal, Humanized | anaphylaxis Monoclonal Antibodies mouse

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3242604
    UMLS CUI [1,2]
    C0003250
    UMLS CUI [1,3]
    C0086418
    UMLS CUI [2,1]
    C3242604
    UMLS CUI [2,2]
    C2985546
    UMLS CUI [3,1]
    C3242604
    UMLS CUI [3,2]
    C0003250
    UMLS CUI [3,3]
    C0026809
    UMLS CUI [4,1]
    C0002792
    UMLS CUI [4,2]
    C0003250
    UMLS CUI [4,3]
    C0086418
    UMLS CUI [5,1]
    C0002792
    UMLS CUI [5,2]
    C2985546
    UMLS CUI [6,1]
    C0002792
    UMLS CUI [6,2]
    C0003250
    UMLS CUI [6,3]
    C0026809
    2. history of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
    Beschreibung

    Malignant Neoplasms | Cardiovascular Diseases Serious Uncontrolled | nervous system disorder | Lung diseases | Kidney Diseases | Gastrointestinal Diseases | Dyslipidemias Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0007222
    UMLS CUI [2,2]
    C0205404
    UMLS CUI [2,3]
    C0205318
    UMLS CUI [3]
    C0027765
    UMLS CUI [4]
    C0024115
    UMLS CUI [5]
    C0022658
    UMLS CUI [6]
    C0017178
    UMLS CUI [7,1]
    C0242339
    UMLS CUI [7,2]
    C0750502
    3. any history of recent serious bacterial, viral, fungal, or other opportunistic infections
    Beschreibung

    Bacterial Infections Serious | Virus Diseases | Mycoses | Opportunistic Infections

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2]
    C0042769
    UMLS CUI [3]
    C0026946
    UMLS CUI [4]
    C0029118
    4. have serologic evidence of current or past hiv (human immunodeficiency virus), hepatitis b, or hepatitis c
    Beschreibung

    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0856706
    UMLS CUI [3]
    C1112419
    5. positive quantiferon tuberculosis (tb) test, history of tb, or active tb infection
    Beschreibung

    QUANTIFERON-TB GOLD Test Positive | H/O: tuberculosis | Tuberculosis infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1875713
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C1446409
    UMLS CUI [2]
    C0455460
    UMLS CUI [3]
    C0041296
    6. active infection with epstein-barr virus (ebv) as defined by ebv viral load >=10,000 copies per ml of whole blood
    Beschreibung

    Epstein-Barr Virus Infections | Epstein-Barr Virus Viral Load Measurement whole blood

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149678
    UMLS CUI [2,1]
    C3274388
    UMLS CUI [2,2]
    C0370231
    7. active infection with cytomegalovirus (cmv) as defined by cmv viral load >= 10,000 copies per ml of whole blood
    Beschreibung

    Cytomegalovirus Infections | Cytomegalovirus Viral Load Measurement whole blood

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0010823
    UMLS CUI [2,1]
    C3274383
    UMLS CUI [2,2]
    C0370231
    8. diagnosis of liver disease or elevated hepatic enzymes, as defined by alanine aminotransferase (alt), aspartate aminotransferase (ast), or both > 1.5 x the upper limit of age-determined normal (uln) or total bilirubin > uln
    Beschreibung

    Liver diseases | Elevated liver enzymes | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0235996
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201899
    UMLS CUI [5]
    C0201913
    9. current or prior treatment that is known to cause a significant, ongoing change in the course of t1d or immunologic status
    Beschreibung

    Therapeutic procedure Causing Diabetes Mellitus, Insulin-Dependent Changed status Significant | Therapeutic procedure Causing Immunity Changed status Significant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0678227
    UMLS CUI [1,3]
    C0011854
    UMLS CUI [1,4]
    C0443172
    UMLS CUI [1,5]
    C0750502
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0678227
    UMLS CUI [2,3]
    C0020964
    UMLS CUI [2,4]
    C0443172
    UMLS CUI [2,5]
    C0750502
    10. current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors, or amylin)
    Beschreibung

    Pharmaceutical Preparations Therapeutic procedure Hyperglycemia | Insulin | Metformin | Sulfonylurea | Glinide | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0020456
    UMLS CUI [2]
    C0021641
    UMLS CUI [3]
    C0025598
    UMLS CUI [4]
    C3536898
    UMLS CUI [5]
    C2266929
    UMLS CUI [6]
    C1257987
    UMLS CUI [7]
    C0167117
    UMLS CUI [8]
    C1456408
    UMLS CUI [9]
    C1827106
    UMLS CUI [10]
    C0063684
    11. current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin)
    Beschreibung

    Pharmaceutical Preparations Affecting glucose tolerance | Atypical antipsychotic | Phenytoin | Niacin

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C0178665
    UMLS CUI [2]
    C1276996
    UMLS CUI [3]
    C0031507
    UMLS CUI [4]
    C0027996
    12. any of the following hematologic abnormalities, confirmed by repeat tests:
    Beschreibung

    Hematological abnormality

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0850715
    1. white blood count <3,000/microl or >14,000/microl
    Beschreibung

    White Blood Cell Count procedure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    2. lymphocyte count <500/microl
    Beschreibung

    Lymphocyte Count measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200635
    3. platelet count <150,000 /microl hemoglobin <.5 g/dl
    Beschreibung

    Platelet Count measurement | Hemoglobin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2]
    C0518015
    4. neutrophil count <2,000 cells/microl.
    Beschreibung

    Neutrophil count

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200633
    13. females who are pregnant, lactating, or planning on pregnancy during the 2- year study period
    Beschreibung

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    14. history or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease
    Beschreibung

    Autoimmune Diseases | Thyroid Diseases Stable | Celiac Disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2,1]
    C0040128
    UMLS CUI [2,2]
    C0205360
    UMLS CUI [3]
    C0007570
    15. history of alcohol, drug or chemical abuse within 1 year prior to screening
    Beschreibung

    Substance abuse problem

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0740858
    16. any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial
    Beschreibung

    Compliance behavior Limited

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    17. prior participation in a clinical trial that could increase risks associated with this clinical trial
    Beschreibung

    Study Subject Participation Status | Clinical Trial Risk Increased

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2,1]
    C0008976
    UMLS CUI [2,2]
    C0035647
    UMLS CUI [2,3]
    C0442805
    18. receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus calmette-guérin, and small pox) in the 6 weeks before randomization
    Beschreibung

    Vaccines, Attenuated | Chickenpox Vaccine | Measles Vaccine | Mumps Vaccine | Rubella virus vaccine | Live Attenuated Influenza Vaccine | Bacillus Calmette-Guerin | Smallpox

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0042211
    UMLS CUI [2]
    C0078048
    UMLS CUI [3]
    C0025010
    UMLS CUI [4]
    C0026782
    UMLS CUI [5]
    C0035923
    UMLS CUI [6]
    C3272757
    UMLS CUI [7]
    C0085957
    UMLS CUI [8]
    C0037354
    19. high lipid levels (fasting low-density lipoprotein (ldl) cholesterol >=160 mg/dl).
    Beschreibung

    Serum fasting LDL cholesterol measurement Lipid level High

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0582830
    UMLS CUI [1,2]
    C0428460
    UMLS CUI [1,3]
    C0205250

    Ähnliche Modelle

    Eligibility Type 1 Diabetes Mellitus NCT02293837

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diabetes Mellitus, Insulin-Dependent
    Item
    1. participants who meet the american diabetes association type 1 diabetes mellitus (t1dm) criteria
    boolean
    C0011854 (UMLS CUI [1])
    Diabetes Mellitus, Insulin-Dependent | Enrollment
    Item
    2. diagnosis of t1dm within 100 days of enrollment
    boolean
    C0011854 (UMLS CUI [1])
    C1516879 (UMLS CUI [2])
    Diabetes Related Autoantibody positive
    Item
    3. positive for at least one diabetes-related autoantibody, including but not limited to:
    boolean
    C0011847 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0853878 (UMLS CUI [1,3])
    Glutamate Decarboxylase
    Item
    1. glutamate decarboxylase (gad-65)
    boolean
    C0017785 (UMLS CUI [1])
    Insulin Insulin regime Exogenous
    Item
    2. insulin, if obtained within 10 days of the onset of exogenous insulin therapy
    boolean
    C0021641 (UMLS CUI [1,1])
    C0557978 (UMLS CUI [1,2])
    C0205228 (UMLS CUI [1,3])
    Insulinoma antigen 2, human
    Item
    3. insulinoma antigen-2 (ia-2)
    boolean
    C1568433 (UMLS CUI [1])
    zinc transporter
    Item
    4. zinc transporter- (znt)
    boolean
    C1608304 (UMLS CUI [1])
    islet cell antibody
    Item
    5. islet-cell antibodies (ica).
    boolean
    C0063900 (UMLS CUI [1])
    Insulin C-peptide measurement Peak Stimulated | Meal Mixed Tolerance test
    Item
    4. peak stimulated c-peptide level >= 0.2 pmol/ml following a mixed-meal tolerance test (mmtt) conducted at least 21 days from diagnosis and within 37 days of randomization
    boolean
    C0202100 (UMLS CUI [1,1])
    C0444505 (UMLS CUI [1,2])
    C1948023 (UMLS CUI [1,3])
    C1998602 (UMLS CUI [2,1])
    C0205430 (UMLS CUI [2,2])
    C0201777 (UMLS CUI [2,3])
    Informed Consent | Assent Minor
    Item
    5. signed informed consent (and informed assent of minor, if applicable).
    boolean
    C0021430 (UMLS CUI [1])
    C1879749 (UMLS CUI [2,1])
    C0026193 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    severe reaction Monoclonal Antibodies human | severe reaction Antibodies, Monoclonal, Humanized | severe reaction Monoclonal Antibodies mouse | anaphylaxis Monoclonal Antibodies human | anaphylaxis Antibodies, Monoclonal, Humanized | anaphylaxis Monoclonal Antibodies mouse
    Item
    1. severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
    boolean
    C3242604 (UMLS CUI [1,1])
    C0003250 (UMLS CUI [1,2])
    C0086418 (UMLS CUI [1,3])
    C3242604 (UMLS CUI [2,1])
    C2985546 (UMLS CUI [2,2])
    C3242604 (UMLS CUI [3,1])
    C0003250 (UMLS CUI [3,2])
    C0026809 (UMLS CUI [3,3])
    C0002792 (UMLS CUI [4,1])
    C0003250 (UMLS CUI [4,2])
    C0086418 (UMLS CUI [4,3])
    C0002792 (UMLS CUI [5,1])
    C2985546 (UMLS CUI [5,2])
    C0002792 (UMLS CUI [6,1])
    C0003250 (UMLS CUI [6,2])
    C0026809 (UMLS CUI [6,3])
    Malignant Neoplasms | Cardiovascular Diseases Serious Uncontrolled | nervous system disorder | Lung diseases | Kidney Diseases | Gastrointestinal Diseases | Dyslipidemias Significant
    Item
    2. history of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
    boolean
    C0006826 (UMLS CUI [1])
    C0007222 (UMLS CUI [2,1])
    C0205404 (UMLS CUI [2,2])
    C0205318 (UMLS CUI [2,3])
    C0027765 (UMLS CUI [3])
    C0024115 (UMLS CUI [4])
    C0022658 (UMLS CUI [5])
    C0017178 (UMLS CUI [6])
    C0242339 (UMLS CUI [7,1])
    C0750502 (UMLS CUI [7,2])
    Bacterial Infections Serious | Virus Diseases | Mycoses | Opportunistic Infections
    Item
    3. any history of recent serious bacterial, viral, fungal, or other opportunistic infections
    boolean
    C0004623 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0042769 (UMLS CUI [2])
    C0026946 (UMLS CUI [3])
    C0029118 (UMLS CUI [4])
    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
    Item
    4. have serologic evidence of current or past hiv (human immunodeficiency virus), hepatitis b, or hepatitis c
    boolean
    C0019699 (UMLS CUI [1])
    C0856706 (UMLS CUI [2])
    C1112419 (UMLS CUI [3])
    QUANTIFERON-TB GOLD Test Positive | H/O: tuberculosis | Tuberculosis infection
    Item
    5. positive quantiferon tuberculosis (tb) test, history of tb, or active tb infection
    boolean
    C1875713 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C1446409 (UMLS CUI [1,3])
    C0455460 (UMLS CUI [2])
    C0041296 (UMLS CUI [3])
    Epstein-Barr Virus Infections | Epstein-Barr Virus Viral Load Measurement whole blood
    Item
    6. active infection with epstein-barr virus (ebv) as defined by ebv viral load >=10,000 copies per ml of whole blood
    boolean
    C0149678 (UMLS CUI [1])
    C3274388 (UMLS CUI [2,1])
    C0370231 (UMLS CUI [2,2])
    Cytomegalovirus Infections | Cytomegalovirus Viral Load Measurement whole blood
    Item
    7. active infection with cytomegalovirus (cmv) as defined by cmv viral load >= 10,000 copies per ml of whole blood
    boolean
    C0010823 (UMLS CUI [1])
    C3274383 (UMLS CUI [2,1])
    C0370231 (UMLS CUI [2,2])
    Liver diseases | Elevated liver enzymes | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement
    Item
    8. diagnosis of liver disease or elevated hepatic enzymes, as defined by alanine aminotransferase (alt), aspartate aminotransferase (ast), or both > 1.5 x the upper limit of age-determined normal (uln) or total bilirubin > uln
    boolean
    C0023895 (UMLS CUI [1])
    C0235996 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    C0201913 (UMLS CUI [5])
    Therapeutic procedure Causing Diabetes Mellitus, Insulin-Dependent Changed status Significant | Therapeutic procedure Causing Immunity Changed status Significant
    Item
    9. current or prior treatment that is known to cause a significant, ongoing change in the course of t1d or immunologic status
    boolean
    C0087111 (UMLS CUI [1,1])
    C0678227 (UMLS CUI [1,2])
    C0011854 (UMLS CUI [1,3])
    C0443172 (UMLS CUI [1,4])
    C0750502 (UMLS CUI [1,5])
    C0087111 (UMLS CUI [2,1])
    C0678227 (UMLS CUI [2,2])
    C0020964 (UMLS CUI [2,3])
    C0443172 (UMLS CUI [2,4])
    C0750502 (UMLS CUI [2,5])
    Pharmaceutical Preparations Therapeutic procedure Hyperglycemia | Insulin | Metformin | Sulfonylurea | Glinide | Thiazolidinediones | exenatide | liraglutide | Dipeptidyl-Peptidase IV Inhibitors | Amylin
    Item
    10. current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, dpp-iv inhibitors, or amylin)
    boolean
    C0013227 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0020456 (UMLS CUI [1,3])
    C0021641 (UMLS CUI [2])
    C0025598 (UMLS CUI [3])
    C3536898 (UMLS CUI [4])
    C2266929 (UMLS CUI [5])
    C1257987 (UMLS CUI [6])
    C0167117 (UMLS CUI [7])
    C1456408 (UMLS CUI [8])
    C1827106 (UMLS CUI [9])
    C0063684 (UMLS CUI [10])
    Pharmaceutical Preparations Affecting glucose tolerance | Atypical antipsychotic | Phenytoin | Niacin
    Item
    11. current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin)
    boolean
    C0013227 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C0178665 (UMLS CUI [1,3])
    C1276996 (UMLS CUI [2])
    C0031507 (UMLS CUI [3])
    C0027996 (UMLS CUI [4])
    Hematological abnormality
    Item
    12. any of the following hematologic abnormalities, confirmed by repeat tests:
    boolean
    C0850715 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    1. white blood count <3,000/microl or >14,000/microl
    boolean
    C0023508 (UMLS CUI [1])
    Lymphocyte Count measurement
    Item
    2. lymphocyte count <500/microl
    boolean
    C0200635 (UMLS CUI [1])
    Platelet Count measurement | Hemoglobin measurement
    Item
    3. platelet count <150,000 /microl hemoglobin <.5 g/dl
    boolean
    C0032181 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    Neutrophil count
    Item
    4. neutrophil count <2,000 cells/microl.
    boolean
    C0200633 (UMLS CUI [1])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    13. females who are pregnant, lactating, or planning on pregnancy during the 2- year study period
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Autoimmune Diseases | Thyroid Diseases Stable | Celiac Disease
    Item
    14. history or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease
    boolean
    C0004364 (UMLS CUI [1])
    C0040128 (UMLS CUI [2,1])
    C0205360 (UMLS CUI [2,2])
    C0007570 (UMLS CUI [3])
    Substance abuse problem
    Item
    15. history of alcohol, drug or chemical abuse within 1 year prior to screening
    boolean
    C0740858 (UMLS CUI [1])
    Compliance behavior Limited
    Item
    16. any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Study Subject Participation Status | Clinical Trial Risk Increased
    Item
    17. prior participation in a clinical trial that could increase risks associated with this clinical trial
    boolean
    C2348568 (UMLS CUI [1])
    C0008976 (UMLS CUI [2,1])
    C0035647 (UMLS CUI [2,2])
    C0442805 (UMLS CUI [2,3])
    Vaccines, Attenuated | Chickenpox Vaccine | Measles Vaccine | Mumps Vaccine | Rubella virus vaccine | Live Attenuated Influenza Vaccine | Bacillus Calmette-Guerin | Smallpox
    Item
    18. receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus calmette-guérin, and small pox) in the 6 weeks before randomization
    boolean
    C0042211 (UMLS CUI [1])
    C0078048 (UMLS CUI [2])
    C0025010 (UMLS CUI [3])
    C0026782 (UMLS CUI [4])
    C0035923 (UMLS CUI [5])
    C3272757 (UMLS CUI [6])
    C0085957 (UMLS CUI [7])
    C0037354 (UMLS CUI [8])
    Serum fasting LDL cholesterol measurement Lipid level High
    Item
    19. high lipid levels (fasting low-density lipoprotein (ldl) cholesterol >=160 mg/dl).
    boolean
    C0582830 (UMLS CUI [1,1])
    C0428460 (UMLS CUI [1,2])
    C0205250 (UMLS CUI [1,3])

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