Framingham

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

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.

Researchers are evaluating the safety and effectiveness of three different 1% tolnaftate antifungal stick formulations for treating tinea pedis, also known as athlete's foot. This Phase 2 study focuses on individuals aged 16 and older who have a confirmed diagnosis of tinea pedis using potassium hydroxide (KOH) microscopy, although one cohort allows positive symptomology without KOH confirmation. The study aims to assess how well these novel stick-based vehicles deliver the medication and their ability to completely cure the infection. Participants will use one of three topical 1% tolnaftate stick formulations, labeled Formula A, Formula B, and Formula C. Each formulation is applied twice daily for approximately four weeks, with Formula C specifically used for 30 days. These treatments are designed as easy-to-use sticks for direct application to the affected foot areas. The study compares the effectiveness and safety of these different formulations delivered through the novel stick vehicles. During the study, researchers will monitor participants' response to treatment, focusing on the percentage of subjects achieving a complete cure by week 4. Participants will be evaluated clinically and may undergo tests to confirm infection clearance. Safety will be closely observed throughout the treatment period. The total duration of participation includes treatment and follow-up to assess treatment outcomes and any side effects.