Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT00199459
Eligibility Criteria:
Inclusion Criteria:
* Controls:
* Ages 18 to 65 years of age
* No history of stone disease and no radiographical evidence of stone (as demonstrated by negative ultrasound)
* No family history of stones
* Healthy and no autoimmune or systemic disease that may affect renal function (see exclusion criteria)
Stone patients
* Ages 18 to 65 years of age
* Solitary stone of any size, in any location along the urinary tract (except lower renal calyceal stones and bladder stones)
* Radiology of any modality proving the existence of the stone (ultrasound, computed tomography, intravenous pyelogram, kidney-ureter-bladder x-ray)
Exclusion Criteria:
* ALL:
* Pregnant females
* Male patients treated for with benign prostate hyperplasia (BPH) (ongoing medical treatment or surgical intervention within 6 months)
* Positive urine culture
* Any cancer (excluding superficial skin, brain)
* Chronic Recurrent urinary infections (prostate, cystitis, vaginosis/vaginitis)
* Gross hematuria
* Autoimmune disease that may affect renal function (eg Systemic lupus erythematosus)
* Renal dysfunction or its common causes:
* Diabetes
* Uncontrolled hypertension (with concurrent microalbuminuria) (diastolic BP \> 90 mmHg)
* glomerulonephritis
* Renal transplant
* Genetic stone disease (e.g. Cystine stones, xanthinuria)
* Medullary sponge kidney, or other renal anomalies such as horseshoe kidney
* GI disorders: Inflammatory bowel disease, short bowel
* Hypercalcemic disorders (hyperparathyroidism, sarcoidosis, Paget's disease)
* Renal tubular acidosis
* Immunodeficient patients e.g. HIV (indinavir stones)
* Unable to provide informed consent
* Anyone in the opinion of the investigator who would be inappropriate
Controls :
* In addition to criteria above.....
* persistent thiazide use
* Family history of stones (this will exclude any genetic factors since a positive family history increases the risk of urolithiasis)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00199459
Study Brief:
Protocol Section:
NCT00199459