ID

39599

Descrição

The Effect of Anakinra on Insulin Secretion; ODM derived from: https://clinicaltrials.gov/show/NCT01285232

Link

https://clinicaltrials.gov/show/NCT01285232

Palavras-chave

Versões (1)
  1. 02/02/2020 02/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de fevereiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Glucose Intolerance NCT01285232

Inglês

Eligibility Glucose Intolerance NCT01285232

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/l) and/or hba1c levels of 5.7-6.4%
Descrição

Decreased glucose tolerance Oral Glucose Tolerance Test | Impaired fasting glycaemia | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0151671
UMLS CUI [1,2]
C0029161
UMLS CUI [2]
C1272092
UMLS CUI [3]
C0474680
bmi >25 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
age 40-70 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known diabetes mellitus
Descrição

Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
fasting plasma glucose ≥ 7.0 mmol/l or hba1c ≥ 6.5%
Descrição

Plasma fasting glucose measurement | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0474680
immunodeficiency or immunosuppressive treatment (including tnfα blocking agents and corticosteroids)
Descrição

Immunodeficiency | Immunosuppressive Agents | Tumor necrosis factor alpha blockers | Adrenal Cortex Hormones

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C0021081
UMLS CUI [3]
C2170827
UMLS CUI [4]
C0001617
use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
Descrição

Anti-Inflammatory Agents | Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Aspirin Dose allowed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003209
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0003211
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0683607
signs of current infection (fever, c-reactive protein >30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis)
Descrição

Signs Communicable Disease | Fever | C-reactive protein measurement | Antibiotic therapy | Tuberculosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0009450
UMLS CUI [2]
C0015967
UMLS CUI [3]
C0201657
UMLS CUI [4]
C0338237
UMLS CUI [5]
C0041296
a history of recurrent infections
Descrição

Recurrent infections

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0239998
pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
Descrição

Pregnancy | Breast Feeding | Contraceptive methods Required

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1514873
liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
Descrição

Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
renal disease defined as mdrd < 60 ml/min/1.73m2
Descrição

Kidney Disease MDRD

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C3839656
neutropenia < 2x 109/l
Descrição

Neutropenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027947
inability to understand the nature and extent of the trial and the procedures required.
Descrição

Study Protocol Comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
any medical condition that might interfere with the current study protocol
Descrição

Medical condition Interferes with Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
participation in a drug trial within 60 days prior to the first dose
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Glucose Intolerance NCT01285232

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Decreased glucose tolerance Oral Glucose Tolerance Test | Impaired fasting glycaemia | Hemoglobin A1c measurement
Item
impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/l) and/or hba1c levels of 5.7-6.4%
boolean
C0151671 (UMLS CUI [1,1])
C0029161 (UMLS CUI [1,2])
C1272092 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Body mass index
Item
bmi >25 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age 40-70 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
known diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
fasting plasma glucose ≥ 7.0 mmol/l or hba1c ≥ 6.5%
boolean
C0583513 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Immunodeficiency | Immunosuppressive Agents | Tumor necrosis factor alpha blockers | Adrenal Cortex Hormones
Item
immunodeficiency or immunosuppressive treatment (including tnfα blocking agents and corticosteroids)
boolean
C0021051 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C2170827 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
Anti-Inflammatory Agents | Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Aspirin Dose allowed
Item
use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
boolean
C0003209 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0004057 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Signs Communicable Disease | Fever | C-reactive protein measurement | Antibiotic therapy | Tuberculosis
Item
signs of current infection (fever, c-reactive protein >30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis)
boolean
C0311392 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0338237 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
Recurrent infections
Item
a history of recurrent infections
boolean
C0239998 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods Required
Item
pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Kidney Disease MDRD
Item
renal disease defined as mdrd < 60 ml/min/1.73m2
boolean
C0022658 (UMLS CUI [1,1])
C3839656 (UMLS CUI [1,2])
Neutropenia
Item
neutropenia < 2x 109/l
boolean
C0027947 (UMLS CUI [1])
Study Protocol Comprehension Unable
Item
inability to understand the nature and extent of the trial and the procedures required.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Medical condition Interferes with Study Protocol
Item
any medical condition that might interfere with the current study protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a drug trial within 60 days prior to the first dose
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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