ID

38822

Descripción

The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones; ODM derived from: https://clinicaltrials.gov/show/NCT02180334

Link

https://clinicaltrials.gov/show/NCT02180334

Palabras clave

Versiones (1)
  1. 6/11/19 6/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02180334

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT02180334

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
bmi < 35 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c 6.5~8.0% for whom is on lifestyle modification only, 6.0~8.0% for whom is taking oral antidiabetic drug(s).
Descripción

Hemoglobin A1c measurement | Life Style Modification | Antidiabetics Oral

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C3840684
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
on lifestyle modification or oral antidiabetic therapy (sulfonylurea, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and dpp-4 inhibitors)
Descripción

Life Style Modification | Antidiabetics Oral | Sulfonylurea | Biguanides | Thiazolidinediones | alpha-Glucosidase Inhibitors | DPP-4 Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023676
UMLS CUI [1,2]
C3840684
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0038766
UMLS CUI [4]
C0005382
UMLS CUI [5]
C1257987
UMLS CUI [6]
C1299007
UMLS CUI [7]
C2917254
who read and signed the informed consent agreement
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic disease(s) requiring medication other than diabetes mellitus
Descripción

Chronic disease Requirement Pharmaceutical Preparations | Exception Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
type 1 diabetes mellitus or history of diabetic ketoacidosis
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
on insulin therapy or requiring insulin therapy
Descripción

Insulin regime | Requirement Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0557978
history of gastrointestinal surgery excluding appendectomy, hernia repair and hemorrhoid surgery
Descripción

Gastrointestinal Surgical Procedure | Exception Appendectomy | Exception Herniorrhaphy | Exception Hemorrhoid operation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019328
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0176866
serum aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) to be more than 2.5 times above the upper limit of normal
Descripción

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
estimated glomerular filtration rate to be less than 50 ml/min/1.73m2
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
genetic disorders associated with digestion and absorption such as galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption
Descripción

Hereditary Diseases Associated with Digestion | Hereditary Diseases Associated with Absorption | Galactosemias | Lapp Lactase deficiency | Glucose-galactose malabsorption

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019247
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0012238
UMLS CUI [2,1]
C0019247
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0237442
UMLS CUI [3]
C0016952
UMLS CUI [4,1]
C0337904
UMLS CUI [4,2]
C0302813
UMLS CUI [5]
C0268186
history of hypersensitivity including anaphylaxis and angioedema to mosapride citrate, linagliptin, or paracetamol (acetaminophen)
Descripción

Hypersensitivity Mosapride citrate | Hypersensitivity Linagliptin | Allergy to acetaminophen | Anaphylaxis Mosapride citrate | Anaphylaxis Linagliptin | Anaphylaxis Acetaminophen | Angioedema Paracetamol Induced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0245956
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2746078
UMLS CUI [3]
C0570513
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0245956
UMLS CUI [5,1]
C0002792
UMLS CUI [5,2]
C2746078
UMLS CUI [6,1]
C0002792
UMLS CUI [6,2]
C0000970
UMLS CUI [7,1]
C0002994
UMLS CUI [7,2]
C0000970
UMLS CUI [7,3]
C0205263
history of asthma associated with aspirin or nonsteroidal anti-inflammatory drugs (nsaids)
Descripción

Asthma Associated with Aspirin | Asthma Associated with NSAIDs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0004057
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0003211
currently taking drugs that can prolong qt interval, including procainamide, quinidine, flecainide, sotalol, tricyclic antidepressants
Descripción

Pharmaceutical Preparations Causing Prolonged QT interval | Procainamide | Quinidine | Flecainide | Sotalol | Tricyclic Antidepressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2]
C0033216
UMLS CUI [3]
C0034414
UMLS CUI [4]
C0016229
UMLS CUI [5]
C0037707
UMLS CUI [6]
C0003290
currently taking anticholinergics such as atropine sulfate, scopolamine butylbromide
Descripción

Anticholinergic Agents | Atropine Sulfate | scopolamine butylbromide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242896
UMLS CUI [2]
C0596005
UMLS CUI [3]
C0006519
child-bearing or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women in reproductive age who disagree with contraception with proper method or urine pregnancy test during the study period
Descripción

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Urine pregnancy test Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02180334

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
bmi < 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement | Life Style Modification | Antidiabetics Oral
Item
hba1c 6.5~8.0% for whom is on lifestyle modification only, 6.0~8.0% for whom is taking oral antidiabetic drug(s).
boolean
C0474680 (UMLS CUI [1])
C0023676 (UMLS CUI [2,1])
C3840684 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Life Style Modification | Antidiabetics Oral | Sulfonylurea | Biguanides | Thiazolidinediones | alpha-Glucosidase Inhibitors | DPP-4 Inhibitors
Item
on lifestyle modification or oral antidiabetic therapy (sulfonylurea, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and dpp-4 inhibitors)
boolean
C0023676 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3])
C0005382 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
Informed Consent
Item
who read and signed the informed consent agreement
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic disease Requirement Pharmaceutical Preparations | Exception Diabetes Mellitus
Item
chronic disease(s) requiring medication other than diabetes mellitus
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
type 1 diabetes mellitus or history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Insulin regime | Requirement Insulin regime
Item
on insulin therapy or requiring insulin therapy
boolean
C0557978 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0557978 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure | Exception Appendectomy | Exception Herniorrhaphy | Exception Hemorrhoid operation
Item
history of gastrointestinal surgery excluding appendectomy, hernia repair and hemorrhoid surgery
boolean
C0524722 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003611 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0019328 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0176866 (UMLS CUI [4,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) to be more than 2.5 times above the upper limit of normal
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate to be less than 50 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Hereditary Diseases Associated with Digestion | Hereditary Diseases Associated with Absorption | Galactosemias | Lapp Lactase deficiency | Glucose-galactose malabsorption
Item
genetic disorders associated with digestion and absorption such as galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption
boolean
C0019247 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012238 (UMLS CUI [1,3])
C0019247 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0016952 (UMLS CUI [3])
C0337904 (UMLS CUI [4,1])
C0302813 (UMLS CUI [4,2])
C0268186 (UMLS CUI [5])
Hypersensitivity Mosapride citrate | Hypersensitivity Linagliptin | Allergy to acetaminophen | Anaphylaxis Mosapride citrate | Anaphylaxis Linagliptin | Anaphylaxis Acetaminophen | Angioedema Paracetamol Induced
Item
history of hypersensitivity including anaphylaxis and angioedema to mosapride citrate, linagliptin, or paracetamol (acetaminophen)
boolean
C0020517 (UMLS CUI [1,1])
C0245956 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2746078 (UMLS CUI [2,2])
C0570513 (UMLS CUI [3])
C0002792 (UMLS CUI [4,1])
C0245956 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C2746078 (UMLS CUI [5,2])
C0002792 (UMLS CUI [6,1])
C0000970 (UMLS CUI [6,2])
C0002994 (UMLS CUI [7,1])
C0000970 (UMLS CUI [7,2])
C0205263 (UMLS CUI [7,3])
Asthma Associated with Aspirin | Asthma Associated with NSAIDs
Item
history of asthma associated with aspirin or nonsteroidal anti-inflammatory drugs (nsaids)
boolean
C0004096 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0003211 (UMLS CUI [2,3])
Pharmaceutical Preparations Causing Prolonged QT interval | Procainamide | Quinidine | Flecainide | Sotalol | Tricyclic Antidepressive Agents
Item
currently taking drugs that can prolong qt interval, including procainamide, quinidine, flecainide, sotalol, tricyclic antidepressants
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0033216 (UMLS CUI [2])
C0034414 (UMLS CUI [3])
C0016229 (UMLS CUI [4])
C0037707 (UMLS CUI [5])
C0003290 (UMLS CUI [6])
Anticholinergic Agents | Atropine Sulfate | scopolamine butylbromide
Item
currently taking anticholinergics such as atropine sulfate, scopolamine butylbromide
boolean
C0242896 (UMLS CUI [1])
C0596005 (UMLS CUI [2])
C0006519 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
child-bearing or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Urine pregnancy test Unwilling
Item
women in reproductive age who disagree with contraception with proper method or urine pregnancy test during the study period
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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