Park City

Researchers are evaluating the effects of Microbial Transplant Therapy (MTT) on 24-hour urine measurements in people with recurrent kidney stones that contain high levels of calcium or oxalate. The study focuses on patients with urinary stone disease who produce at least 50% calcium-oxalate stones. It is an early phase 1 clinical trial conducted at the Park City Urology Clinic, aiming to better understand how this therapy might change urine chemistry related to kidney stones. Participants will be divided into four groups based on their urine calcium and oxalate levels: two treatment groups with hyperoxaluria or hypercalciuria and two control groups. All participants will receive a 3-day course of oral antibiotics (vancomycin and neomycin) to prepare for the transplant. After 48 to 72 hours, they will take either the MTT microbial capsules or placebo capsules twice daily for seven days. Stool samples will be collected before treatment to analyze gut bacteria. During the study, participants will undergo screening, physical exams, and multiple 24-hour urine collections to measure calcium, oxalate, and other urinary substances. Researchers will monitor safety by tracking adverse events up to 30 days after the transplant. The study includes follow-up visits and telephone check-ins to assess safety and treatment effects on urine chemistry over several weeks.

Researchers are conducting a prospective, observational online study called the Healing ALS Registry Observational Study (HAROS) to evaluate people diagnosed with Amyotrophic Lateral Sclerosis (ALS), Motor Neuron Disease (MND), or Primary Lateral Sclerosis (PLS). The study aims to confirm previous findings that these conditions may not be uniformly fatal and to assess the effectiveness of various treatments and educational programs on patient outcomes. The study intends to enroll at least 1000 participants from the USA and other countries, including those confirmed by neurologists to have ALS, MND, or PLS. Participants will enter data monthly into an online registry for at least one year, with the option to continue up to 10 years. They will report information on symptoms, physical function scores, dietary intake, supplements, medications, and other therapies such as integrative medicine approaches, diets, exercise, and emotional support. Optional online education about treatment options and integrative therapies is free and encouraged. Participants choose their own treatments and may join other research studies, provided they record all relevant information. Throughout the study, participants will be assessed annually using the ALS Functional Rating Scale - Revised, the ALS Supplementary Questionnaire, and the Mindset Score, for up to 10 years or until withdrawal. Researchers will monitor physical outcomes, the effectiveness of treatments and education, and correlations between therapies and clinical results. Monthly data entry takes about one hour, and the study emphasizes tracking real-world patient experiences and treatment effects over time.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Long COVID is a condition where symptoms like difficulty concentrating, memory problems ("brain fog"), and fatigue last for months after a COVID-19 infection. This research aims to study the effects of NE3107 on these neurological symptoms in adults with Long COVID. The trial is a Phase 2 study comparing NE3107 to a placebo to see if it can improve neurocognitive and fatigue symptoms. Participants will take either NE3107 20 mg capsules or placebo capsules twice a day for 84 days. The study includes five clinic visits for checkups and tests, along with a follow-up phone call. The treatment period is carefully monitored to assess the impact of NE3107 compared to placebo. During the study, participants will undergo various assessments including the Cogstate Cognition battery to measure changes in cognitive performance after 12 weeks. Researchers will collect blood samples, monitor symptoms, and track adherence. The total involvement includes regular visits and a final follow-up to ensure safety and evaluate outcomes over the treatment period.

Researchers are evaluating the use of the PIVO device, a needle-free blood draw tool, for collecting blood cultures in emergency departments to potentially reduce needlesticks while ensuring accurate detection of bloodstream pathogens. This prospective study is conducted at three primary Intermountain Health emergency departments with plans to expand to three secondary sites based on initial results. The study aims to monitor blood culture contamination rates and PIVO device utilization over a one-year period starting November 2025. The study involves training clinical staff at each emergency department on PIVO use, including indications, technical instructions, workflow, and documentation. The protocol includes three scenarios for using the PIVO device within 24 hours of IV placement to obtain blood cultures. Blood cultures will also be collected using standard venipuncture methods for comparison. After initial data collection and feedback, the protocol may be expanded to additional sites with ongoing data collection throughout the study. Participants include emergency department patients having blood cultures drawn. Data collection includes blood culture results, contamination rates, device usage logs, and clinician surveys assessing ease of use and satisfaction. Interim analyses at 3, 6, and 9 months will guide ongoing training and protocol adjustments. The study will compare contamination rates between PIVO and standard methods to assess non-inferiority. Final analysis and reporting are planned for October 2026.