ID

20307

Beskrivning

Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00343395

Länk

https://clinicaltrials.gov/show/NCT00343395

Nyckelord

Versioner (1)
  1. 2017-02-20 2017-02-20 -
Uppladdad den

20 februari 2017

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 Coronary Artery Disease NCT00343395

Engelsk

Eligibility Coronary Artery Disease NCT00343395

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient (male or non-pregnant female) must be > 18 years of age.
Beskrivning

Age | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery.
Beskrivning

Coronary Artery Disease angiography | Coronary artery Major Percent Diameter Stenosis Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0002978
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C3897965
stabilized post any prior acs event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months
Beskrivning

Stabilization Post Acute Coronary Syndrome | Ischemic pain At rest | Congestive heart failure | Cardiac Arrhythmia Malignant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1293130
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0948089
UMLS CUI [2,1]
C0745417
UMLS CUI [2,2]
C0443144
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205282
fasting blood glucose 87-125 mg/dl
Beskrivning

Fasting blood glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428568
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
known hypersensitivity to metformin or rosiglitazone
Beskrivning

Metformin allergy | Hypersensitivity rosiglitazone

Datatyp

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0289313
renal insufficiency defined as calculated creatinine clearance (crcl) <40 ml/min using the following formula:
Beskrivning

Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2711451
men: crcl (ml/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dl) women: 0.85 x the value calculated for men
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0079399
pregnant and/or lactating women, and women of child bearing potential are excluded from this trial
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
co-morbidity such that the patient is not expected to survive >2 years
Beskrivning

Comorbidity | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
current therapy with rosiglitazone or metformin
Beskrivning

rosiglitazone | Metformin

Datatyp

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0025598
pci within the previous six months (other than for the qualifying event)
Beskrivning

Percutaneous Coronary Intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
prior cabg within the previous two months, scheduled cabg, or a decision to perform cabg made prior to enrollment
Beskrivning

Coronary Artery Bypass Surgery | Coronary Artery Bypass Surgery Scheduled | Coronary Artery Bypass Surgery Perform Decision

Datatyp

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C0884358
UMLS CUI [3,3]
C0679006
overt diabetes mellitus (fbg>126 or antidiabetic therapy)
Beskrivning

Diabetes Mellitus | Fasting blood glucose measurement | Antidiabetics

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0935929
any diagnosis of congestive heart failure
Beskrivning

Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: ast, alt, ggt, total bilirubin, or alkaline phosphatase >3x upper limit normal, not related to mi
Beskrivning

Hepatobiliary disease Obstructive | Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Elevated total bilirubin | Alkaline phosphatase raised | Myocardial Infarction Relationship Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0267792
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151662
UMLS CUI [6]
C0741494
UMLS CUI [7]
C0151849
UMLS CUI [8,1]
C0027051
UMLS CUI [8,2]
C0439849
UMLS CUI [8,3]
C0332197
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | product marketing

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0683746
Tillbaka till toppen

Similar models

Eligibility Coronary Artery Disease NCT00343395

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy
Item
the patient (male or non-pregnant female) must be > 18 years of age.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representatives
Item
the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Coronary Artery Disease angiography | Coronary artery Major Percent Diameter Stenosis Measurement
Item
angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery.
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C0205042 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C3897965 (UMLS CUI [2,3])
Stabilization Post Acute Coronary Syndrome | Ischemic pain At rest | Congestive heart failure | Cardiac Arrhythmia Malignant
Item
stabilized post any prior acs event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months
boolean
C1293130 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0948089 (UMLS CUI [1,3])
C0745417 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
Fasting blood glucose measurement
Item
fasting blood glucose 87-125 mg/dl
boolean
C0428568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Metformin allergy | Hypersensitivity rosiglitazone
Item
known hypersensitivity to metformin or rosiglitazone
boolean
C0571648 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0289313 (UMLS CUI [2,2])
Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal insufficiency defined as calculated creatinine clearance (crcl) <40 ml/min using the following formula:
boolean
C1565489 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
men: crcl (ml/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dl) women: 0.85 x the value calculated for men
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant and/or lactating women, and women of child bearing potential are excluded from this trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Comorbidity | Life Expectancy
Item
co-morbidity such that the patient is not expected to survive >2 years
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
rosiglitazone | Metformin
Item
current therapy with rosiglitazone or metformin
boolean
C0289313 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Percutaneous Coronary Intervention
Item
pci within the previous six months (other than for the qualifying event)
boolean
C1532338 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Coronary Artery Bypass Surgery Scheduled | Coronary Artery Bypass Surgery Perform Decision
Item
prior cabg within the previous two months, scheduled cabg, or a decision to perform cabg made prior to enrollment
boolean
C0010055 (UMLS CUI [1])
C0010055 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C0884358 (UMLS CUI [3,2])
C0679006 (UMLS CUI [3,3])
Diabetes Mellitus | Fasting blood glucose measurement | Antidiabetics
Item
overt diabetes mellitus (fbg>126 or antidiabetic therapy)
boolean
C0011849 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
Congestive heart failure
Item
any diagnosis of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Hepatobiliary disease Obstructive | Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Elevated total bilirubin | Alkaline phosphatase raised | Myocardial Infarction Relationship Absent
Item
obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: ast, alt, ggt, total bilirubin, or alkaline phosphatase >3x upper limit normal, not related to mi
boolean
C0267792 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151662 (UMLS CUI [5])
C0741494 (UMLS CUI [6])
C0151849 (UMLS CUI [7])
C0027051 (UMLS CUI [8,1])
C0439849 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Study Subject Participation Status | Investigational New Drugs | product marketing
Item
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0683746 (UMLS CUI [3])
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