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The objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Healthy adults |
| |
| Cohort B | Adults with stable chronic morbidities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine collection for NEPHROCLEAR CCL14 Test | Diagnostic Test | Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reference interval as defined by Clinical and Laboratory Standards Institute guideline EP28 for urinary C-C motif chemokine 14 concentration measured with the NEPHROCLEAR CCL14 Test within each cohort | Determined for urine sample collected at baseline |
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Cohort A
Inclusion Criteria:
Exclusion Criteria:
Cohort B
Inclusion Criteria:
i. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. Chronic coagulation abnormality iv. Chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma) v. Chronic pancreatitis vi. Chronic renal insufficiency vii. Congestive heart failure viii. Coronary artery disease ix. Diabetes mellitus (Type 1 or Type 2) x. Gout xi. Hyper- or hypothyroidism xii. Hyperlipidemia (includes hypercholesterolemia) xiii. Hypertension xiv. Immunocompromised xv. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) xvi. Liver cirrhosis xvii. Neuromuscular disease xviii. Peripheral vascular disease (a.k.a. peripheral artery disease) xix. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus c. Provide written informed consent for study participation.
Exclusion Criteria:
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Apparently Healthy Adults and Adults With Chronic, Stable Morbidities
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Contact | 314-728-1603 | IA-clinical-affairs@biomerieux.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cyn3rgy Research | Recruiting | Gresham | Oregon | 97030 | United States |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Urine
| D008919 | Investigative Techniques |