ID

37387

Descrição

Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02291666

Link

https://clinicaltrials.gov/show/NCT02291666

Palavras-chave

Versões (1)
  1. 22/07/2019 22/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02291666

Inglês

Eligibility Type 2 Diabetes NCT02291666

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants will be ≥18 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
body weight index ≤35,
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
non-smokers (>3 months)
Descrição

Non-smoker

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0337672
patients with type 2 diabetes and good glycemic control (a1c<7) or poor glycemic control (a1c>7.5) and healthy non-diabetic subjects will be elligible.
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Glycaemia control Good | Hemoglobin A1c measurement | Poor glycemic control | Healthy Volunteers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C3267174
UMLS CUI [2,2]
C0205170
UMLS CUI [3]
C0474680
UMLS CUI [4]
C0342299
UMLS CUI [5]
C1708335
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with estimated glomerular filtration (mdrd) <50ml/min/1.73m2
Descrição

GFR estimation by MDRD

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2170215
alt and ast 3 times above the upper limit of normal
Descrição

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases)
Descrição

Transplanted organ Recipient | Inflammatory disorder | Polyarthritis | Liver Cirrhosis Severe | Communicable Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524930
UMLS CUI [1,2]
C1709854
UMLS CUI [2]
C1290884
UMLS CUI [3]
C0162323
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0009450
previous history of or an active cancer (except non-melanoma skin cancer)
Descrição

Malignant Neoplasms | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
uncontrolled thyroid functions
Descrição

Thyroid function Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2242456
UMLS CUI [1,2]
C0205318
pregnant
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
history of drug or alcohol abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
subjects with a history of or current inflammatory bowel diseases including ulcerous colitis and crohn's disease, and bariatric surgery
Descrição

Inflammatory Bowel Diseases | Ulcerative Colitis | Crohn Disease | Bariatric Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0010346
UMLS CUI [4]
C1456587
drugs known to modulate cyp450 activities, subject taking one of the following therapies will be excluded: antibiotics, antivirals, anticancers, cyp450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, st-john's wort), cyp450 inhibitors (amiodarone, fluvoxamine, fluoxetine, verapamil), immunosuppressors, warfarin, infs, antibodies or grapefruit juice (<4 weeks) or an investigational drug
Descrição

Pharmaceutical Preparations Modulating CYP450 Activity | Antibiotics | Antiviral Agents | Antineoplastic Agents | CYP450 Inducers | Carbamazepine | Phenobarbital | Phenytoin | Rifampin | ST. JOHN'S WORT EXTRACT | CYP450 Inhibitors | Amiodarone | Fluvoxamine | Fluoxetine | Verapamil | Immunosuppressive Agents | Warfarin | Interferons | Antibodies | Grapefruit juice | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0443264
UMLS CUI [1,3]
C0010762
UMLS CUI [1,4]
C0205177
UMLS CUI [2]
C0003232
UMLS CUI [3]
C0003451
UMLS CUI [4]
C0003392
UMLS CUI [5]
C3500477
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0031412
UMLS CUI [8]
C0031507
UMLS CUI [9]
C0035608
UMLS CUI [10]
C0813171
UMLS CUI [11]
C2962191
UMLS CUI [12]
C0002598
UMLS CUI [13]
C0085228
UMLS CUI [14]
C0016365
UMLS CUI [15]
C0042523
UMLS CUI [16]
C0021081
UMLS CUI [17]
C0043031
UMLS CUI [18]
C0021747
UMLS CUI [19]
C0003241
UMLS CUI [20]
C0452456
UMLS CUI [21]
C0013230
intolerance or hypersensitivity to probe drugs in the crchum-mt cocktail or chlorzoxazone/acetaminophen
Descrição

Intolerance to Investigational New Drugs | Hypersensitivity Investigational New Drugs | Intolerance to Chlorzoxazone | CHLORZOXAZONE ALLERGY | Intolerance to Acetaminophen | Allergy to acetaminophen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0008296
UMLS CUI [4]
C0742387
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0000970
UMLS CUI [6]
C0570513
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Similar models

Eligibility Type 2 Diabetes NCT02291666

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participants will be ≥18 years old
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body weight index ≤35,
boolean
C1305855 (UMLS CUI [1])
Non-smoker
Item
non-smokers (>3 months)
boolean
C0337672 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glycaemia control Good | Hemoglobin A1c measurement | Poor glycemic control | Healthy Volunteers
Item
patients with type 2 diabetes and good glycemic control (a1c<7) or poor glycemic control (a1c>7.5) and healthy non-diabetic subjects will be elligible.
boolean
C0011860 (UMLS CUI [1])
C3267174 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
C0342299 (UMLS CUI [4])
C1708335 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
GFR estimation by MDRD
Item
subjects with estimated glomerular filtration (mdrd) <50ml/min/1.73m2
boolean
C2170215 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt and ast 3 times above the upper limit of normal
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Transplanted organ Recipient | Inflammatory disorder | Polyarthritis | Liver Cirrhosis Severe | Communicable Diseases
Item
organ transplant recipient, inflammatory illnesses (i.e., polyarthritis, severe cirrhosis, infectious diseases)
boolean
C0524930 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
C0162323 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5])
Malignant Neoplasms | Exception Skin carcinoma
Item
previous history of or an active cancer (except non-melanoma skin cancer)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Thyroid function Uncontrolled
Item
uncontrolled thyroid functions
boolean
C2242456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Inflammatory Bowel Diseases | Ulcerative Colitis | Crohn Disease | Bariatric Surgery
Item
subjects with a history of or current inflammatory bowel diseases including ulcerous colitis and crohn's disease, and bariatric surgery
boolean
C0021390 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C1456587 (UMLS CUI [4])
Pharmaceutical Preparations Modulating CYP450 Activity | Antibiotics | Antiviral Agents | Antineoplastic Agents | CYP450 Inducers | Carbamazepine | Phenobarbital | Phenytoin | Rifampin | ST. JOHN'S WORT EXTRACT | CYP450 Inhibitors | Amiodarone | Fluvoxamine | Fluoxetine | Verapamil | Immunosuppressive Agents | Warfarin | Interferons | Antibodies | Grapefruit juice | Investigational New Drugs
Item
drugs known to modulate cyp450 activities, subject taking one of the following therapies will be excluded: antibiotics, antivirals, anticancers, cyp450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, st-john's wort), cyp450 inhibitors (amiodarone, fluvoxamine, fluoxetine, verapamil), immunosuppressors, warfarin, infs, antibodies or grapefruit juice (<4 weeks) or an investigational drug
boolean
C0013227 (UMLS CUI [1,1])
C0443264 (UMLS CUI [1,2])
C0010762 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0003232 (UMLS CUI [2])
C0003451 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C3500477 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0031412 (UMLS CUI [7])
C0031507 (UMLS CUI [8])
C0035608 (UMLS CUI [9])
C0813171 (UMLS CUI [10])
C2962191 (UMLS CUI [11])
C0002598 (UMLS CUI [12])
C0085228 (UMLS CUI [13])
C0016365 (UMLS CUI [14])
C0042523 (UMLS CUI [15])
C0021081 (UMLS CUI [16])
C0043031 (UMLS CUI [17])
C0021747 (UMLS CUI [18])
C0003241 (UMLS CUI [19])
C0452456 (UMLS CUI [20])
C0013230 (UMLS CUI [21])
Intolerance to Investigational New Drugs | Hypersensitivity Investigational New Drugs | Intolerance to Chlorzoxazone | CHLORZOXAZONE ALLERGY | Intolerance to Acetaminophen | Allergy to acetaminophen
Item
intolerance or hypersensitivity to probe drugs in the crchum-mt cocktail or chlorzoxazone/acetaminophen
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0008296 (UMLS CUI [3,2])
C0742387 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C0570513 (UMLS CUI [6])
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