ID

29096

Beschrijving

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

Trefwoorden

Versies (1)
  1. 23-02-18 23-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length | Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Insulin Dose Single | Unit Quantity | Insulin Total Daily Dose

Datatype

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
Beschrijving

Post-prandial blood glucose Uncontrolled

Datatype

boolean

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

Glucohemoglobin measurement

Datatype

boolean

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

Cardiac event Major Absent

Datatype

boolean

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

New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

boolean

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

Renal function tests abnormal | Serum creatinine raised

Datatype

boolean

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

Insulin allergy | Hypersensitivity Insulin product

Datatype

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.
Beschrijving

Pharmaceutical Preparations New Blood Glucose control

Datatype

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.
Beschrijving

Illiteracy | Comprehension Study Protocol Unable

Datatype

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.
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
pregnancy.
Beschrijving

Pregnancy

Datatype

boolean

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

Decompensated cardiac failure | Angina, Unstable | Myocardial Infarction

Datatype

boolean

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

Proliferative retinopathy untreated | Disorder of macula of retina untreated

Datatype

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
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial