Information:
Fel:
ID
13892
Beskrivning
Anti-IL-1 Treatment in Children DKA at Diagnosis of Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01477476
Länk
https://clinicaltrials.gov/show/NCT01477476
Nyckelord
Versioner (1)
- 2016-03-13 2016-03-13 -
Uppladdad den
13 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type I Diabetes NCT01477476
Eligibility Type I Diabetes NCT01477476
- StudyEvent: Eligibility
Similar models
Eligibility Type I Diabetes NCT01477476
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age; Diabetes type 1
Item
age 8-18 years at diagnosis of type 1 diabetes
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
diabetic ketoacidosis; plasma glucose concentration; venous ph; serum bicarbonate concentration; Ketone Measurement
Item
diabetic ketoacidosis: plasma glucose concentration >300 mg/dl, venous ph< 7.30 or serum bicarbonate concentration <15 mmol/l, and ketones in urine or serum
boolean
C0011880 (UMLS CUI [1])
C2584434 (UMLS CUI [2])
C2097160 (UMLS CUI [3])
C0364096 (UMLS CUI [4])
C1881306 (UMLS CUI [5])
C2584434 (UMLS CUI [2])
C2097160 (UMLS CUI [3])
C0364096 (UMLS CUI [4])
C1881306 (UMLS CUI [5])
hematology; white blood cells; platelets; hemoglobin
Item
hematology: wbc> 3000 x 109/l; platelets > 100,000 x 109/l; hemoglobin > 10.0 g/dl
boolean
C0474523 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0023508 (UMLS CUI [2])
negative pregnancy test
Item
negative blood pregnancy test in females.
boolean
C0427780 (UMLS CUI [1])
immune deficiency disorder; type 1 diabetes; malignancy; Organ Transplantation; corticosteroid use
Item
children with underlying disorders, including: active autoimmune or immune deficiency disorder other than type 1 diabetes, malignancy, organ transplant, any condition requiring chronic corticosteroid use
boolean
C0021051 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C0029216 (UMLS CUI [4])
C0239126 (UMLS CUI [5])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C0029216 (UMLS CUI [4])
C0239126 (UMLS CUI [5])
immunotherapy; Diabetes type 1
Item
previous immunotherapy to prevent type 1 diabetes
boolean
C0021083 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,1])
C0441729 (UMLS CUI [2,2])
hiv; Hepatitis B and hepatitis C
Item
current or prior infection with hiv, hepatitis b or hepatitis c assessed by history
boolean
C0019682 (UMLS CUI [1])
C2711110 (UMLS CUI [2])
C2711110 (UMLS CUI [2])
Compliance behavior Limited Comorbidity;
Item
patients who present with dka concomitant with alcohol or drug use, head trauma, meningitis or other conditions which might affect neurological function
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0025289 (UMLS CUI [2])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0025289 (UMLS CUI [2])
renal failure
Item
renal failure
boolean
C1533077 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject's participation
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
hypersensitivity anakinra
Item
patients with a history of known hypersensitivity to e coli-derived proteins, anakinra, or any components of the investigational drug product
boolean
C0020517 (UMLS CUI [1,1])
C0245109 (UMLS CUI [1,2])
C0245109 (UMLS CUI [1,2])