ID

15992

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02293837

Palabras clave

Versiones (1)
  1. 25/6/16 25/6/16 -
Subido en

25 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02293837

Inglés

Eligibility Type 1 Diabetes Mellitus NCT02293837

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

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

Diabetes Mellitus, Insulin-Dependent | Enrollment

Tipo de datos

boolean

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

Diabetes Related Autoantibody positive

Tipo de datos

boolean

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

Glutamate Decarboxylase

Tipo de datos

boolean

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

Insulin Insulin regime Exogenous

Tipo de datos

boolean

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

Insulinoma antigen 2, human

Tipo de datos

boolean

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

zinc transporter

Tipo de datos

boolean

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

islet cell antibody

Tipo de datos

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
Descripción

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

Tipo de datos

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).
Descripción

Informed Consent | Assent Minor

Tipo de datos

boolean

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

Exclusion Criteria

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Bacterial Infections Serious | Virus Diseases | Mycoses | Opportunistic Infections

Tipo de datos

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
Descripción

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Cytomegalovirus Infections | Cytomegalovirus Viral Load Measurement whole blood

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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)
Descripción

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

Tipo de datos

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)
Descripción

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

Tipo de datos

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:
Descripción

Hematological abnormality

Tipo de datos

boolean

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

White Blood Cell Count procedure

Tipo de datos

boolean

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

Lymphocyte Count measurement

Tipo de datos

boolean

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

Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

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

Neutrophil count

Tipo de datos

boolean

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

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

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
Descripción

Autoimmune Diseases | Thyroid Diseases Stable | Celiac Disease

Tipo de datos

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
Descripción

Substance abuse problem

Tipo de datos

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
Descripción

Compliance behavior Limited

Tipo de datos

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
Descripción

Study Subject Participation Status | Clinical Trial Risk Increased

Tipo de datos

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
Descripción

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

Tipo de datos

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).
Descripción

Serum fasting LDL cholesterol measurement Lipid level High

Tipo de datos

boolean

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

Eligibility Type 1 Diabetes Mellitus NCT02293837

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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