ID

19435

Beschreibung

Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist; ODM derived from: https://clinicaltrials.gov/show/NCT00303394

Link

https://clinicaltrials.gov/show/NCT00303394

Stichworte

Versionen (1)
  1. 02.01.17 02.01.17 -
Hochgeladen am

2. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00303394

Englisch

Eligibility Type 2 Diabetes NCT00303394

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >20
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diabetes mellitus type 2 (american diabetes association criteria) of at least 3 months duration
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c >7.5%
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
body-mass index (bmi) > 27
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive gad 65 or ia-2 antibodies at inclusion.
Beschreibung

Glutamate decarboxylase 65 antibody Positive | Anti-IA2 antibody positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0806227
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C3495754
hba1c >12%, polyuria and thirst (exclusion of severely decompensated patients)
Beschreibung

Glucohemoglobin measurement | Polyuria | Thirst | Patients Decompensated Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2]
C0032617
UMLS CUI [3]
C0039971
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0205434
UMLS CUI [4,3]
C0205082
c-peptide < 400pmol/l (basal )
Beschreibung

C-peptide measurement Basal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202100
UMLS CUI [1,2]
C0650607
established anti-inflammatory therapy (includiung cortisone, nsaid, cox-2-inhibitor). low dose aspirin (£ 100mg) will be tolerated.
Beschreibung

Antiinflammatory therapy Established | Cortisone | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Aspirin Low Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096024
UMLS CUI [1,2]
C0443211
UMLS CUI [2]
C0010137
UMLS CUI [3]
C0003211
UMLS CUI [4]
C1257954
UMLS CUI [5]
C2608320
crp >30 mg/dl, fever, current treatment with antibiotics, or chronic granulomatous infections (e.g. tuberculosis) in the history or on a screening chest x-ray.
Beschreibung

C-reactive protein measurement | Fever | Antibiotic therapy | Granulomatous infection chronic | Tuberculosis | Plain chest X-ray

Datentyp

boolean

Alias
UMLS CUI [1]
C0201657
UMLS CUI [2]
C0015967
UMLS CUI [3]
C0338237
UMLS CUI [4,1]
C1610637
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0041296
UMLS CUI [6]
C0039985
neutropenia or anemia (leucocyte count < 2.0x109 /l, hemoglobin <11g/dl for ma les or <10g/dl for females)
Beschreibung

Neutropenia | Anemia | White Blood Cell Count procedure | Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0079399
pregnancy or breast-feeding. when appropriate (fertile women),anticonception for at last 3 month prior inclusion will be required.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
severe liver or renal disease ( ast or alt>3 times the upper limit of normal laboratory range, serum creatinine >130mm)
Beschreibung

Liver disease Severe | Kidney Disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0201976
ongoing malignant neoplasm
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
use of any investigational drug within 30 days of enrollment into the study or within 5 half-lives of the investigational drug (whichever is longer)
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
immunosuppressive treatment or immunodeficient diseases.
Beschreibung

Therapeutic immunosuppression | Immunologic Deficiency Syndromes

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0021051
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00303394

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >20
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diabetes mellitus type 2 (american diabetes association criteria) of at least 3 months duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c >7.5%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body-mass index (bmi) > 27
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Glutamate decarboxylase 65 antibody Positive | Anti-IA2 antibody positive
Item
positive gad 65 or ia-2 antibodies at inclusion.
boolean
C0806227 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3495754 (UMLS CUI [2])
Glucohemoglobin measurement | Polyuria | Thirst | Patients Decompensated Severe
Item
hba1c >12%, polyuria and thirst (exclusion of severely decompensated patients)
boolean
C0202054 (UMLS CUI [1])
C0032617 (UMLS CUI [2])
C0039971 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C0205434 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C-peptide measurement Basal
Item
c-peptide < 400pmol/l (basal )
boolean
C0202100 (UMLS CUI [1,1])
C0650607 (UMLS CUI [1,2])
Antiinflammatory therapy Established | Cortisone | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Aspirin Low Dose
Item
established anti-inflammatory therapy (includiung cortisone, nsaid, cox-2-inhibitor). low dose aspirin (£ 100mg) will be tolerated.
boolean
C1096024 (UMLS CUI [1,1])
C0443211 (UMLS CUI [1,2])
C0010137 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C1257954 (UMLS CUI [4])
C2608320 (UMLS CUI [5])
C-reactive protein measurement | Fever | Antibiotic therapy | Granulomatous infection chronic | Tuberculosis | Plain chest X-ray
Item
crp >30 mg/dl, fever, current treatment with antibiotics, or chronic granulomatous infections (e.g. tuberculosis) in the history or on a screening chest x-ray.
boolean
C0201657 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
C0338237 (UMLS CUI [3])
C1610637 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0041296 (UMLS CUI [5])
C0039985 (UMLS CUI [6])
Neutropenia | Anemia | White Blood Cell Count procedure | Hemoglobin measurement | Gender
Item
neutropenia or anemia (leucocyte count < 2.0x109 /l, hemoglobin <11g/dl for ma les or <10g/dl for females)
boolean
C0027947 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or breast-feeding. when appropriate (fertile women),anticonception for at last 3 month prior inclusion will be required.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Liver disease Severe | Kidney Disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased | Creatinine measurement, serum
Item
severe liver or renal disease ( ast or alt>3 times the upper limit of normal laboratory range, serum creatinine >130mm)
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Malignant Neoplasms
Item
ongoing malignant neoplasm
boolean
C0006826 (UMLS CUI [1])
Investigational New Drugs
Item
use of any investigational drug within 30 days of enrollment into the study or within 5 half-lives of the investigational drug (whichever is longer)
boolean
C0013230 (UMLS CUI [1])
Therapeutic immunosuppression | Immunologic Deficiency Syndromes
Item
immunosuppressive treatment or immunodeficient diseases.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
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