Framingham

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

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.

Researchers are studying the experiences of adults living with autoimmune neurological disorders, starting with myasthenia gravis MG, to understand how symptoms, daily functioning, and quality of life change over time. The study is an observational registry aiming to learn about treatments used by participants, treatment challenges, and how these relate to symptoms and health. This registry may expand in the future to include other autoimmune neurological disorders beyond MG. Participants with MG join the registry remotely through a secure website or mobile app. They complete an enrollment survey and monthly follow-up surveys about their MG symptoms, treatments, and quality of life. They may provide information to confirm their diagnosis, share medical records voluntarily, and report on antibody testing, treatments, and healthcare use. The study does not assign treatments or request changes to usual medical care. During participation, individuals complete standardized questionnaires measuring MG symptoms and quality of life over up to 10 years. Researchers also collect information on MG exacerbations and healthcare visits. Data quality is monitored through electronic checks and participant follow-up. The registry collects and stores data securely, with privacy protections and optional medical record verification. The study aims to support research on MGs natural history and improve future care by analyzing long-term participant-reported data.

Researchers are studying the safety and effectiveness of several 1% tolnaftate formulations delivered through new stick-based applicators for treating tinea pedis, also known as athletes foot. This phase 2 clinical trial focuses on individuals diagnosed with potassium hydroxide KOH-positive tinea pedis to evaluate how well these topical treatments work and how safe they are to use. Participants will receive one of three different formulations of 1% tolnaftate in a stick applicator Formula A, Formula B, or Formula C. All three formulations are applied topically to the affected foot area twice daily for four weeks. The study does not use random assignment or blinding, and each group will use their assigned formulation throughout the treatment period. During the study, participants will be monitored for a complete cure at week 4, which is the primary outcome measure. They will need to comply with the study protocol and be available for the entire study duration. Safety and response to treatment will be assessed by clinical evaluations and microscopy confirmation. The total participation time includes the 4-week treatment and necessary follow-up visits to check for effectiveness and any side effects.