Park City

Researchers are evaluating the effect of Microbial Transplant Therapy MTT on 24-hour urine parameters in patients who frequently develop kidney stones composed mainly of calcium oxalate. This early phase 1 study focuses on individuals with recurrent hypercalciuric and hyperoxaluric kidney stones, aiming to understand how MTT impacts urinary components related to stone formation. Participants will be divided into four groups based on their urine calcium and oxalate levels, with some receiving MTT capsules and others receiving placebo capsules. Before treatment, all participants will take antibiotics for three days to prepare for the transplant. Then, participants will take two capsules daily for seven days, either containing the microbial transplant or placebo. Stool samples will be collected before and after the treatment to analyze changes in gut bacteria. Throughout the study, participants will undergo screenings, physical exams, and provide 24-hour urine samples to measure various substances like calcium, oxalate, and uric acid. Researchers will monitor for any adverse events up to 30 days after treatment and assess changes in urine parameters over several weeks. Follow-up includes telephone calls to check safety and ongoing sample collections to understand the treatments effects on microbiota and stone-related urine measures.

Researchers are conducting a prospective, observational online study called the Healing ALS Registry Observational Study HAROS involving people diagnosed with Amyotrophic Lateral Sclerosis ALS, Motor Neuron Disease MND, or Primary Lateral Sclerosis PLS. The study aims to verify earlier findings suggesting that these conditions may not always be fatal and could be reversible. It will also evaluate the effects of various therapies and education programs, enrolling at least 1000 participants from the USA and other countries. Participants will enter monthly data into an online registry about their functional status using the ALSFRS-R scale, symptoms, dietary intake, supplements, medications, and therapies, including integrative medicine approaches like acupuncture and meditation. Education about treatment options is available online but optional. Participants choose their own treatment plans and may participate in other studies while recording all relevant information in the registry. Throughout the study, participants will update their information monthly for at least one year and up to ten years. Researchers will assess outcomes annually using various tools such as the ALS Functional Rating Scale - Revised, supplementary questionnaires, and mindset scores. They will also track changes in weight, blood markers, and urine toxins to analyze treatment effectiveness and disease progression over time.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the use of the PIVO device, a needle-free blood draw tool, for collecting blood cultures in emergency department patients. The study focuses on reducing the number of needle sticks while ensuring accurate detection of potential bloodstream infections. The research is observational and will assess the devices usage and blood culture contamination rates in several emergency departments within a large healthcare system. The study will start at three main emergency departments with over 100,000 annual visits combined and may expand to three more sites depending on initial findings. Staff will receive structured training on how to use the PIVO device, including workflow and documentation procedures. Blood cultures will be collected using PIVO in different scenarios aligned with FDA approval, and standard blood draw methods will also be used for comparison. Data collection will last 13 months with periodic interim analyses and a survey of clinical staff comfort and recommendations about the device. Participants will be patients having blood cultures drawn in the emergency department. Researchers will gather data from electronic health records, device logs, and manual culture reviews. They will measure PIVO use rates, contamination rates of blood cultures, and staff satisfaction with the device. Interim analyses will guide ongoing use at study sites, and final results will be prepared after full data review. The study covers a full year of data collection following staff training and includes surveys to assess usability and workflow impact.