Eligibility Kidney Disease NCT00974636

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StudyEvent: Eligibility
1. Eligibility Kidney Disease NCT00974636

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Criteria Fulfill

Item

individuals eligible to participate in this study must meet all of the following criteria:

boolean

C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])

Informed Consent

Item

willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.

boolean

C0021430 (UMLS CUI [1])

Age

Item

age ≥ 18 years and ≤ 85 years.

boolean

C0001779 (UMLS CUI [1])

Protocol Compliance

Item

willing and able to comply with all study procedures.

boolean

C0525058 (UMLS CUI [1])

Other Coding | Renal function GFR estimation by MDRD | Clinical course Stable

Item

patients with egfr of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) mdrd equation and a relatively stable clinical course.

boolean

C3846158 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
C0449259 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])

Sitting systolic blood pressure | Risk Hypotension | Etiology Dietary salt Reduction

Item

sitting systolic blood pressure ≥ 100 mmhg prior to study entry (to exclude people at risk from hypotension from dietary salt reduction).

boolean

C1319893 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0020649 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0206136 (UMLS CUI [3,2])
C0392756 (UMLS CUI [3,3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Criteria Fulfill

Item

individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:

boolean

C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])

Acute illness | Illness Minor | Common Cold Recovered | Allergic rhinitis

Item

recent acute illness (≤1 month). minor ailments such as a recovered common cold or allergic rhinitis would not be considered as exclusion criteria but would be left to the site pi's discretion.

boolean

C4061114 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205165 (UMLS CUI [2,2])
C0009443 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C2607914 (UMLS CUI [4])

Hospitalization | Exception Elective procedure Minor | Interference Bioelectric Impedance Analysis Unlikely

Item

recent hospitalization (≤1 month) unless clearly for a minor elective procedure unlikely to interfere with bia measurements. the final decision will be left to the site pi's discretion.

boolean

C0019993 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0747973 (UMLS CUI [2,2])
C0205165 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C1704746 (UMLS CUI [3,2])
C0750558 (UMLS CUI [3,3])

Mental condition Interferes with Protocol Compliance | Alcoholic Intoxication, Chronic

Item

any psychological condition (including alcoholism) that could interfere with the patient's ability to comply with the study protocol.

boolean

C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0001973 (UMLS CUI [2])

24 hour urine sodium output measurement

Item

subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.

boolean

C1278233 (UMLS CUI [1])

Amputation of limb | Exception Fingers | Exception Toes

Item

amputation of a limb other than fingers or toes.

boolean

C0002689 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0016129 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0040357 (UMLS CUI [3,2])

Item

pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).

boolean

C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
C0021438 (UMLS CUI [3])
C0481488 (UMLS CUI [4])
C0175718 (UMLS CUI [5])
C1139930 (UMLS CUI [6])
C0336536 (UMLS CUI [7,1])
C1268086 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0178866 (UMLS CUI [8,2])

Coronary artery stent | Suture Metallic Heart

Item

coronary stents or metal suture material in the heart.

boolean

C0687568 (UMLS CUI [1])
C0038969 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C0018787 (UMLS CUI [2,3])

Investigational New Drugs | Investigational Medical Device

Item

use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.

boolean

C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])

Body Weight

Item

weight over 300 pounds (limitation for examination table).

boolean

C0005910 (UMLS CUI [1])

Pregnancy | Breast Feeding

Item

pregnancy or lactation.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Kidney Diseases Associated with Salt wasting

Item

patients with kidney diseases known to be associated with salt wasting (see above).

boolean

C0022658 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1846347 (UMLS CUI [1,3])

Atrial Fibrillation | At risk Blood pressure ambulatory Measurement

Item

patients with atrial fibrillation as ambulatory blood pressure measurements may not be accurate in this setting.

boolean

C0004238 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0855316 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])

Condition At risk Compliance behavior Limited | Condition At risk Clinical Trial Incomplete

Item

any condition that, in the view of the pi, places the subject at high risk of poor treatment compliance or of not completing the study.

boolean

C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205257 (UMLS CUI [2,4])

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Eligibility Kidney Disease NCT00974636