ID

37379

Beschrijving

Study on the Efficacy aNd Safety of Jinlida Granules in Patients With Inadequately cOntrolled tYpe-2 Diabetes and dysLIpidemia Under liFe Style Intervention (ENJOY LIFE Study); ODM derived from: https://clinicaltrials.gov/show/NCT02035644

Link

https://clinicaltrials.gov/show/NCT02035644

Trefwoorden

Versies (1)
  1. 20-07-19 20-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 juli 2019

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 Type 2 Diabetes NCT02035644

Engels

Eligibility Type 2 Diabetes NCT02035644

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age of 20-70 years;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Control Inadequate | Lifestyle Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0243148
UMLS CUI [2,2]
C0205412
UMLS CUI [3]
C1517876
3. hba1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/l at baseline;
Beschrijving

Hemoglobin A1c measurement | Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0583513
4. diagnosed with dislipidemia with triglycerides>150mg/dl (1.70mmol/l), and/or total cholesterol >200mg/dl (5.16mmol/l), and/or ldl-c>100mg/dl (2.58mmol/l)
Beschrijving

Dyslipidemia | Triglycerides measurement | Serum total cholesterol measurement | Serum LDL cholesterol measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0242339
UMLS CUI [2]
C0202236
UMLS CUI [3]
C1445957
UMLS CUI [4]
C0428474
5. body mass index (bmi): 20<bmi<40 kg/m2;
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. moderate or severe liver dysfunction, abnormal renal function;
Beschrijving

Liver Dysfunction Moderate | Liver Dysfunction Severe | Abnormal renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0151746
2. severe dysfunction of the heart;
Beschrijving

Heart dysfunction Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0340515
UMLS CUI [1,2]
C0205082
3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
Beschrijving

Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperglycemic Hyperosmolar Nonketotic Coma

Datatype

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0020457
4. psychiatric disease or severe infection;
Beschrijving

Mental disorders | Communicable Disease Severe

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
5. pregnancy or planned pregnancy;
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
Beschrijving

Pharmacotherapy Diabetes Mellitus | Pharmacotherapy Dyslipidemia | Insulin regime

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0242339
UMLS CUI [3]
C0557978
7. use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
Beschrijving

Glucocorticoids, Systemic | Growth hormone treatment

Datatype

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2]
C0744483
8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Diabetes Type Specific

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0085207
UMLS CUI [3,1]
C0011847
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C0205369
9. history of malignant tumor within 5 years.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Terug naar het begin van de pagina

Similar models

Eligibility Type 2 Diabetes NCT02035644

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age of 20-70 years;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Control Inadequate | Lifestyle Therapy
Item
2. diagnosed with type 2 diabetes inadequately controlled under life style intervention with 3 months before screening;
boolean
C0011860 (UMLS CUI [1])
C0243148 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C1517876 (UMLS CUI [3])
Hemoglobin A1c measurement | Plasma fasting glucose measurement
Item
3. hba1c ≥6.5% and ≤10.0%, and fasting plasma glucose ≥7 and ≤13.3mmol/l at baseline;
boolean
C0474680 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Dyslipidemia | Triglycerides measurement | Serum total cholesterol measurement | Serum LDL cholesterol measurement
Item
4. diagnosed with dislipidemia with triglycerides>150mg/dl (1.70mmol/l), and/or total cholesterol >200mg/dl (5.16mmol/l), and/or ldl-c>100mg/dl (2.58mmol/l)
boolean
C0242339 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
C1445957 (UMLS CUI [3])
C0428474 (UMLS CUI [4])
Body mass index
Item
5. body mass index (bmi): 20<bmi<40 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver Dysfunction Moderate | Liver Dysfunction Severe | Abnormal renal function
Item
1. moderate or severe liver dysfunction, abnormal renal function;
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151746 (UMLS CUI [3])
Heart dysfunction Severe
Item
2. severe dysfunction of the heart;
boolean
C0340515 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperglycemic Hyperosmolar Nonketotic Coma
Item
3. histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
boolean
C0342257 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Mental disorders | Communicable Disease Severe
Item
4. psychiatric disease or severe infection;
boolean
C0004936 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
5. pregnancy or planned pregnancy;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Pharmacotherapy Diabetes Mellitus | Pharmacotherapy Dyslipidemia | Insulin regime
Item
6. use of any drug (including insulin) for treatment of diabetes or dyslipidemia within 3 months;
boolean
C0013216 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3])
Glucocorticoids, Systemic | Growth hormone treatment
Item
7. use of chronic (>7 days) systemic glucocorticoid therapy within 8 weeks or receive growth hormone therapy within 6 months;
boolean
C3540777 (UMLS CUI [1])
C0744483 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Gestational Diabetes | Diabetes Type Specific
Item
8. diagnosed with type 1 diabetes, or gestational diabetes, or other specific types of diabetes;
boolean
C0011854 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
C0011847 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Malignant Neoplasms
Item
9. history of malignant tumor within 5 years.
boolean
C0006826 (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