ID

37387

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02291666

Nyckelord

Versioner (1)
  1. 2019-07-22 2019-07-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 juli 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Type 2 Diabetes NCT02291666

Engelsk

Eligibility Type 2 Diabetes NCT02291666

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Body mass index

Datatyp

boolean

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

Non-smoker

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

GFR estimation by MDRD

Datatyp

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma

Datatyp

boolean

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

Thyroid function Uncontrolled

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

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

Substance Use Disorders

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Type 2 Diabetes NCT02291666

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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