ID

16721

Beschreibung

Statins in Proteinuric Nephropathies; ODM derived from: https://clinicaltrials.gov/show/NCT00199927

Link

https://clinicaltrials.gov/show/NCT00199927

Stichworte

Versionen (1)
  1. 02.08.16 02.08.16 -
Hochgeladen am

2. August 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Chronic Nephropathy NCT00199927

Englisch

Eligibility Chronic Nephropathy NCT00199927

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >16 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hypertension, defined as a systolic or diastolic blood pressure > 140 or 90 mmhg respectively (or less in patients with concomitant antihypertensive therapy)
Beschreibung

Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0585941
creatinine clearance >20 ml/min/1.73m2 (with variation of less than 30% in the 3 months prior to study entry)
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
urinary protein excretion rate persistently > 1 g/24 hours (average of at least two measurements in two urine collections two weeks apart) without evidence of urinary tract infection or overt heart failure (new york heart association class iii or more)
Beschreibung

Protein measurement, urine, quantitative 24 hour | Urinary tract infection Evidence | Heart failure | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0202204
UMLS CUI [2,1]
C0042029
UMLS CUI [2,2]
C3887511
UMLS CUI [3]
C0018801
UMLS CUI [4]
C1275491
written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
specific contraindication to statin therapy because of a previous coronary event or serum ldl-cholesterol levels > 190 mg/dl despite a low cholesterol (<200 mg/day) diet and a saturated fatty acid in take less than 7% of total calories will not be included
Beschreibung

Medical contraindication Statins | Coronary heart disease | Serum LDL cholesterol measurement | Cholesterol-lowering diet | Saturated fat Percent Calories

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0360714
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0428474
UMLS CUI [4]
C0311170
UMLS CUI [5,1]
C0597423
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C1556156
chronic treatment with corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs
Beschreibung

Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0021081
acute myocardial infarction or cerebrovascular accident in the six months preceding the study - severe uncontrolled hypertension (diastolic blood pressure >115 and/or systolic blood pressure >220 mmhg)
Beschreibung

Myocardial Infarction | Cerebrovascular accident | Uncontrolled hypertension Severe | Diastolic blood pressure | Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0428883
UMLS CUI [5]
C0871470
evidence or suspicion of renovascular disease, obstructive uropathy, type 1 diabetes mellitus, vasculitides, cancer
Beschreibung

Renovascular disorders | Urinary tract obstruction | Diabetes Mellitus, Insulin-Dependent | Vasculitis | Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C2748383
UMLS CUI [2]
C0178879
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0042384
UMLS CUI [5]
C0006826
elevated serum aminotransferase concentrations - chronic cough
Beschreibung

Transaminases Serum Concentration Elevated | Chronic cough

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002594
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C1446561
UMLS CUI [1,4]
C3163633
UMLS CUI [2]
C0010201
history of poor tolerance or allergy to acei, ata or statins
Beschreibung

Tolerance Poor Angiotensin-Converting Enzyme Inhibitors | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors | Tolerance Poor Angiotensin II receptor antagonist | Hypersensitivity Angiotensin II receptor antagonist | Tolerance Poor Statins | Hypersensitivity Statins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013220
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0003015
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003015
UMLS CUI [3,1]
C0013220
UMLS CUI [3,2]
C0542537
UMLS CUI [3,3]
C0521942
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0521942
UMLS CUI [5,1]
C0013220
UMLS CUI [5,2]
C0542537
UMLS CUI [5,3]
C0360714
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0360714
drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy, breast feeding and ineffective contraception
Beschreibung

Pregnancy | Breast Feeding | Contraceptive methods ineffective

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C3242229
legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
Beschreibung

Study Protocol Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
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Ähnliche Modelle

Eligibility Chronic Nephropathy NCT00199927

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >16 years
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy
Item
hypertension, defined as a systolic or diastolic blood pressure > 140 or 90 mmhg respectively (or less in patients with concomitant antihypertensive therapy)
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4])
Creatinine clearance measurement
Item
creatinine clearance >20 ml/min/1.73m2 (with variation of less than 30% in the 3 months prior to study entry)
boolean
C0373595 (UMLS CUI [1])
Protein measurement, urine, quantitative 24 hour | Urinary tract infection Evidence | Heart failure | New York Heart Association Classification
Item
urinary protein excretion rate persistently > 1 g/24 hours (average of at least two measurements in two urine collections two weeks apart) without evidence of urinary tract infection or overt heart failure (new york heart association class iii or more)
boolean
C0202204 (UMLS CUI [1])
C0042029 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Statins | Coronary heart disease | Serum LDL cholesterol measurement | Cholesterol-lowering diet | Saturated fat Percent Calories
Item
specific contraindication to statin therapy because of a previous coronary event or serum ldl-cholesterol levels > 190 mg/dl despite a low cholesterol (<200 mg/day) diet and a saturated fatty acid in take less than 7% of total calories will not be included
boolean
C1301624 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0010068 (UMLS CUI [2])
C0428474 (UMLS CUI [3])
C0311170 (UMLS CUI [4])
C0597423 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C1556156 (UMLS CUI [5,3])
Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents
Item
chronic treatment with corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs
boolean
C0001617 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Myocardial Infarction | Cerebrovascular accident | Uncontrolled hypertension Severe | Diastolic blood pressure | Systolic Pressure
Item
acute myocardial infarction or cerebrovascular accident in the six months preceding the study - severe uncontrolled hypertension (diastolic blood pressure >115 and/or systolic blood pressure >220 mmhg)
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C1868885 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0428883 (UMLS CUI [4])
C0871470 (UMLS CUI [5])
Renovascular disorders | Urinary tract obstruction | Diabetes Mellitus, Insulin-Dependent | Vasculitis | Malignant Neoplasms
Item
evidence or suspicion of renovascular disease, obstructive uropathy, type 1 diabetes mellitus, vasculitides, cancer
boolean
C2748383 (UMLS CUI [1])
C0178879 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0042384 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
Transaminases Serum Concentration Elevated | Chronic cough
Item
elevated serum aminotransferase concentrations - chronic cough
boolean
C0002594 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1446561 (UMLS CUI [1,3])
C3163633 (UMLS CUI [1,4])
C0010201 (UMLS CUI [2])
Tolerance Poor Angiotensin-Converting Enzyme Inhibitors | Hypersensitivity Angiotensin-Converting Enzyme Inhibitors | Tolerance Poor Angiotensin II receptor antagonist | Hypersensitivity Angiotensin II receptor antagonist | Tolerance Poor Statins | Hypersensitivity Statins
Item
history of poor tolerance or allergy to acei, ata or statins
boolean
C0013220 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0003015 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
C0013220 (UMLS CUI [3,1])
C0542537 (UMLS CUI [3,2])
C0521942 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0521942 (UMLS CUI [4,2])
C0013220 (UMLS CUI [5,1])
C0542537 (UMLS CUI [5,2])
C0360714 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0360714 (UMLS CUI [6,2])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Contraceptive methods ineffective
Item
pregnancy, breast feeding and ineffective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C3242229 (UMLS CUI [3,2])
Study Protocol Comprehension Unable
Item
legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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