ID

29096

Descripción

Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01039532

Link

https://clinicaltrials.gov/show/NCT01039532

Palabras clave

Versiones (1)
  1. 23/2/18 23/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 [C19.246.300] NCT01039532

Inglés

Eligibility Diabetes Mellitus, Type 2 [C19.246.300] NCT01039532

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetics >/= 18 yrs of age diabetic for >/= 6months
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0001779
inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d
Descripción

Therapeutic procedure Control Inadequate | Premixed insulin Frequency Duration | Metformin Dose | Pioglitazone Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0243148
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C2069057
UMLS CUI [2,2]
C0439603
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0071097
UMLS CUI [4,2]
C0178602
single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
Descripción

Insulin Dose Single | Unit Quantity | Insulin Total Daily Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205171
UMLS CUI [2,1]
C1519795
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C2348070
if post lunch blood glucose is not controlled
Descripción

Post-prandial blood glucose Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428569
UMLS CUI [1,2]
C0205318
if hba1c ≥7%
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
no major cardiac events in the preceding 6 months.
Descripción

Cardiac event Major Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0741923
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332197
nyha <= class ii.
Descripción

New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1275491
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
deranged lft's- ast,alt or alp values >= 2 times.
Descripción

Liver function tests abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151849
deranged rft sr. creatinine >=1.5
Descripción

Renal function tests abnormal | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0236151
UMLS CUI [2]
C0700225
allergy to insulin or its products.
Descripción

Insulin allergy | Hypersensitivity Insulin product

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C1514468
recent intake of any new medications for sugar control.
Descripción

Pharmaceutical Preparations New Blood Glucose control

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0005802
UMLS CUI [1,4]
C0243148
illiterate to the level that she/he cannot understand the study.
Descripción

Illiteracy | Comprehension Study Protocol Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020899
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1299582
any other acute co morbid illness.
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
pregnancy.
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
decompensated heart failure/usa/mi all within last 12month
Descripción

Decompensated cardiac failure | Angina, Unstable | Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0581377
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
untreated proliferative retinopathy/ maculopathy
Descripción

Proliferative retinopathy untreated | Disorder of macula of retina untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332155
drug or alcohol dependence
Descripción

Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Diabetes Mellitus, Type 2 [C19.246.300] NCT01039532

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length | Age
Item
type 2 diabetics >/= 18 yrs of age diabetic for >/= 6months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Therapeutic procedure Control Inadequate | Premixed insulin Frequency Duration | Metformin Dose | Pioglitazone Dose
Item
inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d
boolean
C0087111 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C2069057 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
Insulin Dose Single | Unit Quantity | Insulin Total Daily Dose
Item
single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C1519795 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C2348070 (UMLS CUI [3,2])
Post-prandial blood glucose Uncontrolled
Item
if post lunch blood glucose is not controlled
boolean
C0428569 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
if hba1c ≥7%
boolean
C0202054 (UMLS CUI [1])
Cardiac event Major Absent
Item
no major cardiac events in the preceding 6 months.
boolean
C0741923 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
New York Heart Association Classification
Item
nyha <= class ii.
boolean
C1275491 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver function tests abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
deranged lft's- ast,alt or alp values >= 2 times.
boolean
C0151766 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal function tests abnormal | Serum creatinine raised
Item
deranged rft sr. creatinine >=1.5
boolean
C0236151 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Insulin allergy | Hypersensitivity Insulin product
Item
allergy to insulin or its products.
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1514468 (UMLS CUI [2,3])
Pharmaceutical Preparations New Blood Glucose control
Item
recent intake of any new medications for sugar control.
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0243148 (UMLS CUI [1,4])
Illiteracy | Comprehension Study Protocol Unable
Item
illiterate to the level that she/he cannot understand the study.
boolean
C0020899 (UMLS CUI [1])
C0233733 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Comorbidity
Item
any other acute co morbid illness.
boolean
C0009488 (UMLS CUI [1])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Decompensated cardiac failure | Angina, Unstable | Myocardial Infarction
Item
decompensated heart failure/usa/mi all within last 12month
boolean
C0581377 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Proliferative retinopathy untreated | Disorder of macula of retina untreated
Item
untreated proliferative retinopathy/ maculopathy
boolean
C0339467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Substance Dependence
Item
drug or alcohol dependence
boolean
C0038580 (UMLS CUI [1])
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