Maryville

Researchers are evaluating an investigational vaccine aimed at protecting healthy adults from Escherichia coli (E coli). The main goal is to assess the safety and how well adults tolerate these E coli vaccines when given as shots into the muscle. This is a Phase 1 study focusing on healthy volunteers aged 18 to 64 years. Participants will receive one of several candidate E coli vaccines or a placebo, each given in two doses spaced six months apart (at 0 and 6 months). The study includes different versions and doses of the vaccine, all administered intramuscularly following the same schedule. The placebo group follows the same 0 and 6-month dosing interval for comparison. Throughout the study, participants will be monitored for local and systemic reactions within seven days after each vaccination, as well as any adverse events from the first vaccination until one month after the last dose. Additionally, medically attended and serious adverse events will be tracked for up to 12 months after the final vaccination, with the entire observation period lasting up to 18 months. Safety and tolerability will be carefully evaluated through these measures.

Researchers are evaluating how well proton beam radiation therapy compares with intensity modulated photon radiotherapy in treating patients with stage I to IVA esophageal cancer. This phase III trial aims to determine if proton beam therapy can improve overall survival and reduce serious heart and lung side effects compared to photon therapy. The study also looks at symptom impact, quality of life, treatment costs, response rates, and hospitalization length between the two treatments. Participants are randomly assigned to receive either proton beam therapy or intensity modulated photon therapy, both given in 28 sessions over 5.5 weeks alongside chemotherapy. Chemotherapy options include carboplatin/paclitaxel, FOLFOX/CAPOX, or docetaxel/fluorouracil regimens, selected by the patient and physician. After completing chemoradiation, patients may have surgery to remove the tumor if it is safe and feasible. During the study, blood samples and imaging scans such as PET/CT or CT are collected to monitor progress. Patients are followed every 3 to 6 months for three years and then yearly to track survival, side effects, and disease status. Researchers also assess patient-reported symptoms and quality of life. The main outcomes measured are overall survival and the occurrence of serious heart and lung side effects related to treatment over up to eight years. Additional assessments include immune cell levels, disease recurrence, and treatment toxicity.

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.