Plymouth

Researchers are evaluating the safety and effects of a study medicine called PF-07799933 in people aged 16 years and older who have advanced solid tumors with specific BRAF gene alterations. The study focuses on participants whose cancers have progressed after prior treatments and for whom no satisfactory alternative options remain. The trial is a phase 1, open-label study aiming to assess PF-07799933 alone and in combination with other study medicines. Participants will receive PF-07799933 tablets twice daily. Depending on the study part and tumor type, participants may also receive binimetinib tablets twice daily, or cetuximab injections weekly or every two weeks. Some participants with colorectal cancer may additionally receive a chemotherapy regimen called mFOLFOX6. Treatment duration may last about two years, with close monitoring during regular clinic visits. Throughout the study, participants will have their safety evaluated by tracking dose-limiting toxicities, adverse events, laboratory and vital sign changes, and physical exams. Researchers will also monitor treatment responses and pharmacokinetics of PF-07799933. Dose adjustments or interruptions may occur due to side effects. The study includes ongoing assessments during and up to 28 days after treatment, with overall participation lasting up to two years or more.

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 evaluating the effectiveness and tolerability of two dosing schedules of budesonide orodispersible tablets for adults with active eosinophilic esophagitis EoE. The study aims to prove that taking 1 mg twice daily is not less effective than taking 2 mg once daily for inducing clinico-pathological remission. This Phase III, randomized, double-blind trial is sponsored by Dr. Falk Pharma GmbH and focuses on treatment for this condition. Participants are randomly assigned to one of two groups one group receives a 2 mg budesonide orodispersible tablet once daily, while the other takes a 1 mg tablet twice daily, both for six weeks. After this, there is an open-label extension where participants receive either 0.5 mg or 1 mg budesonide tablets twice daily. The tablets are taken 30 minutes after a meal, and the study uses a sequential design to compare these regimens. Throughout the study, participants will be monitored for histological remission after six weeks, which is the primary outcome. Clinical remission is also assessed as a secondary outcome. Safety and tolerability are evaluated during the treatment phases. The total study duration extends until March 2028, with primary completion expected by December 2026. Participants undergo regular assessments to evaluate their response to treatment and overall health during the trial.

The Vanguard Study is exploring the use of blood tests called multi-cancer detection MCD tests to screen for multiple cancers at once in adults aged 45 to 75 without cancer. The study aims to understand how these tests perform as cancer screening tools and how patients and doctors respond to test results. It also seeks to assess the feasibility of recruiting participants and collecting necessary data for a future larger trial. Participants are randomly assigned to one of three groups two groups receive different MCD tests Shield or Avantect with blood samples collected at enrollment and after one year, while a control group undergoes blood collection without MCD testing. Some sites provide test results to participants, and those with abnormal results are advised to follow up with their clinicians. After the one-year intervention period, all participants are monitored passively for up to 10 years. Throughout the study, participants complete questionnaires and provide blood samples as scheduled. Researchers collect medical record information and track follow-up adherence, test result return times, and diagnostic outcomes for abnormal results. The study measures feasibility outcomes, cancer detection accuracy, participant anxiety, and other effects related to the screening process. Participant follow-up and data collection may continue for up to 10 years after the intervention period ends.