ID

13892

Descripción

Anti-IL-1 Treatment in Children DKA at Diagnosis of Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01477476

Link

https://clinicaltrials.gov/show/NCT01477476

Palabras clave

Versiones (1)
  1. 13/3/16 13/3/16 -
Subido en

13 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type I Diabetes NCT01477476

Inglés

Eligibility Type I Diabetes NCT01477476

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 8-18 years at diagnosis of type 1 diabetes
Descripción

age; Diabetes type 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441729
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
Descripción

diabetic ketoacidosis; plasma glucose concentration; venous ph; serum bicarbonate concentration; Ketone Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C2584434
UMLS CUI [3]
C2097160
UMLS CUI [4]
C0364096
UMLS CUI [5]
C1881306
hematology: wbc> 3000 x 109/l; platelets > 100,000 x 109/l; hemoglobin > 10.0 g/dl
Descripción

hematology; white blood cells; platelets; hemoglobin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474523
UMLS CUI [2]
C0023508
negative blood pregnancy test in females.
Descripción

negative pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Descripción

immune deficiency disorder; type 1 diabetes; malignancy; Organ Transplantation; corticosteroid use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441729
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0029216
UMLS CUI [5]
C0239126
previous immunotherapy to prevent type 1 diabetes
Descripción

immunotherapy; Diabetes type 1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0441729
current or prior infection with hiv, hepatitis b or hepatitis c assessed by history
Descripción

hiv; Hepatitis B and hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C2711110
patients who present with dka concomitant with alcohol or drug use, head trauma, meningitis or other conditions which might affect neurological function
Descripción

Compliance behavior Limited Comorbidity;

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0025289
renal failure
Descripción

renal failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1533077
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
Descripción

Compliance behavior Limited Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients with a history of known hypersensitivity to e coli-derived proteins, anakinra, or any components of the investigational drug product
Descripción

hypersensitivity anakinra

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0245109
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Similar models

Eligibility Type I Diabetes NCT01477476

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
negative pregnancy test
Item
negative blood pregnancy test in females.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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])
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