Petersburg

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride KarXT in adults diagnosed with schizophrenia in the United States. The study aims to understand how these medications are used and their impact on patients, including treatment switches and titration over time. Participants diagnosed with schizophrenia who have started treatment with KarXT will be observed according to the product label for up to 20 weeks. The study includes those newly starting KarXT or switching from other antipsychotic treatments, with data collected on dosing changes, adverse events, symptom improvement, and treatment continuation. During the study, participants will undergo regular clinical assessments, including monitoring of weight, psychiatric symptoms using the Clinical Global Impressions - Improvement score, and recording any schizophrenia-related relapses or hospital visits. Researchers will track medication adherence, reasons for stopping treatment, and use of antiemetic medications for gastrointestinal symptoms, with baseline and follow-up data collected up to 20 weeks.

Researchers are evaluating the efficacy and safety of SPN-812 viloxazine extended release in children aged 4 to 5 years with Attention-DeficitHyperactivity Disorder ADHD. This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-DeficitHyperactivity Disorder Rating Scale, 4th Edition, Preschool Version ADHD-RS-IV-P and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.

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 lumateperone for treating irritability in pediatric patients aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD based on DSM-5-TR criteria and confirmed by K-SADS-PL. This multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to understand the effects and safety of lumateperone in this population. The study includes three phases a screening period lasting up to 14 days to assess eligibility a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone 42 mg for ages 13-17, a low dose of lumateperone 21 mg for ages 13-17, or placebo once daily and a safety follow-up visit about one week after the last dose to monitor safety. Participants will attend clinic visits for screening, treatment, and safety follow-up. Researchers will assess irritability using the Aberrant Behavior Checklist - Irritability subscale ABC-I at week 6 as the primary outcome, alongside secondary measures like Clinical Global Impression-Severity CGI-S. Safety and well-being will be monitored throughout, with the entire study lasting approximately 7 weeks from screening to follow-up.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.