ID

44000

Descrição

Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00499148

Link

https://clinicaltrials.gov/show/NCT00499148

Palavras-chave

Versões (2)
  1. 04/07/2017 04/07/2017 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Type 2 Diabetes NCT00499148

Inglês

Eligibility Type 2 Diabetes NCT00499148

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
between 18 and 75 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
Descrição

Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum Period

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0086839
if of childbearing potential, is practicing birth control
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
bmi is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
if on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
Descrição

Hypoglycemic Agents Dosage Constant | Antihypertensive Agents Dosage Constant | Antilipemic agent Dosage Constant | Thyroid preparations Dosage Constant | Hormone Therapy Dosage Constant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1948059
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1948059
UMLS CUI [3,1]
C0086440
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1948059
UMLS CUI [4,1]
C0279175
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1948059
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C1948059
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
uses insulin for glucose control or has type 1 diabetes
Descrição

Insulin | Glucose control | Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0726398
UMLS CUI [3]
C0011854
history of diabetic ketoacidosis.
Descrição

Diabetic Ketoacidosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011880
current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
Descrição

Communicable Diseases | Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0003232
active malignancy
Descrição

Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
Descrição

Cardiovascular event | Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0018802
end state organ failure or status post organ transplant
Descrição

Organ failure End-stage | Organ Transplantation Status post

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0349410
UMLS CUI [1,2]
C0205088
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C0231290
history of renal disease
Descrição

Kidney Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
current hepatic disease
Descrição

Liver diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
history of severe gastroparesis
Descrição

Gastroparesis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0205082
has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
Descrição

Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019693
currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
Descrição

Herbal Drugs | Dietary Supplements | Pharmaceutical Preparations Affecting Blood Glucose | Hypoglycemic Agents Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C0242295
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005802
UMLS CUI [4,1]
C0020616
UMLS CUI [4,2]
C2828389
clotting or bleeding disorders
Descrição

Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
allergic or intolerant to any ingredient found in the study products
Descrição

Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
Voltar ao início da página

Similar models

Eligibility Type 2 Diabetes NCT00499148

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
between 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Postpartum Period
Item
male or non-pregnant, non-lactating female, at least 6 weeks postpartum
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0086839 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
if of childbearing potential, is practicing birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Body mass index
Item
bmi is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Dosage Constant | Antihypertensive Agents Dosage Constant | Antilipemic agent Dosage Constant | Thyroid preparations Dosage Constant | Hormone Therapy Dosage Constant
Item
if on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1948059 (UMLS CUI [2,3])
C0086440 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1948059 (UMLS CUI [3,3])
C0279175 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1948059 (UMLS CUI [4,3])
C0279025 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C1948059 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Insulin | Glucose control | Diabetes Mellitus, Insulin-Dependent
Item
uses insulin for glucose control or has type 1 diabetes
boolean
C0021641 (UMLS CUI [1])
C0726398 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis.
boolean
C0011880 (UMLS CUI [1])
Communicable Diseases | Operative Surgical Procedures | Adrenal Cortex Hormones | Antibiotics
Item
current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
boolean
C0009450 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
Malignant Neoplasms
Item
active malignancy
boolean
C0006826 (UMLS CUI [1])
Cardiovascular event | Congestive heart failure
Item
significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Organ failure End-stage | Organ Transplantation Status post
Item
end state organ failure or status post organ transplant
boolean
C0349410 (UMLS CUI [1,1])
C0205088 (UMLS CUI [1,2])
C0029216 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Kidney Diseases
Item
history of renal disease
boolean
C0022658 (UMLS CUI [1])
Liver diseases
Item
current hepatic disease
boolean
C0023895 (UMLS CUI [1])
Gastroparesis Severe
Item
history of severe gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chronic infectious disease | Tuberculosis | Hepatitis B | Hepatitis C | HIV Infection
Item
has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv
boolean
C0151317 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Herbal Drugs | Dietary Supplements | Pharmaceutical Preparations Affecting Blood Glucose | Hypoglycemic Agents Excluded
Item
currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
boolean
C1360419 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C0020616 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Blood Coagulation Disorders
Item
clotting or bleeding disorders
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs Ingredient | Intolerance to Investigational New Drugs Ingredient
Item
allergic or intolerant to any ingredient found in the study products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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