Butler County

Researchers are conducting a Phase 2, multicenter platform study to evaluate the safety and effectiveness of several investigational treatments for adults with moderately to severely active Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The study focuses on assessing multiple experimental oral or injectable therapies to better understand their effects on these conditions. Participants will receive one of the study drugs, MT-501 or MT-201, as part of this evaluation. The study aims to gather data on how these treatments perform in terms of safety, how the body processes them (pharmacokinetics), and their biological effects (pharmacodynamics). Treatment effects will be measured over a period of up to 13 weeks. During the study, participants will be monitored for any side effects, serious adverse events, and laboratory test changes. Researchers will also assess the participants' clinical remission status and improvements seen through endoscopic evaluations at 12 to 13 weeks. The total involvement duration includes screening and treatment periods, with careful tracking of outcomes and safety throughout.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

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 the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are evaluating the best approach to post-hospitalization follow-up care for children hospitalized due to common infections like pneumonia, skin and soft tissue infections, acute gastroenteritis, or urinary tract infections. The study compares automatic follow-up visits, which are routinely scheduled after discharge, against as-needed (PRN) follow-ups where parents monitor symptoms and decide if a visit is necessary. This trial aims to see if the PRN approach is as effective as automatic visits in preventing hospital readmissions and ensuring continuity of care, while also considering the burden of missed work, school, and extra costs for families. Children enrolled in the study are randomly assigned to either receive a recommendation for automatic follow-up visits or a recommendation for PRN follow-up at hospital discharge. The automatic group is instructed to schedule and attend a follow-up visit regardless of symptom improvement, whereas the PRN group is advised that follow-up visits are not required unless symptoms warrant it. The study involves a total of 2,674 children, with half in each group, to compare the outcomes of these two follow-up strategies. Participants and their families will be monitored for hospital readmission within 14 days after discharge, which is the primary outcome. Researchers will also assess additional medical interventions, child quality of life, symptom duration, healthcare use, parent anxiety and confidence, satisfaction with care, and communications with medical providers. Safety outcomes such as medical errors and infection-related readmissions will be tracked. The study includes assessments of time and cost burdens on parents and children, and will gather extensive information through questionnaires and medical records during the follow-up period.

Researchers are gathering information on children treated with radiation therapy for cancer through the Proton and Photon Consortium Registry (PPCR). This registry aims to better understand which patients receive different types of radiation therapy and to compare their short- and long-term outcomes. Proton Beam Radiation Therapy (PBRT) has shown promising results in previous studies, with more precise radiation targeting and fewer severe long-term side effects, but more data is needed to confirm these benefits. Participants will receive their cancer treatment, including surgeries, chemotherapy, and radiation therapy, as determined by their doctors following standard care. The study records all treatments given before, during, and after radiation therapy. Data collected includes treatment details, side effects, and cancer progression. No additional interventions are provided as part of this study. During the study, a research nurse or coordinator will review medical records annually to update the participant's health status in the registry. Information collected includes demographics, diagnosis, lab tests, imaging, side effects, hospitalizations, new medical conditions, medications, and use of special services in school. Participants may be contacted yearly to monitor their long-term health outcomes. The study intends to track participants' health for their lifetime to support research on radiation therapy effects.

Researchers are evaluating treatment strategies for people with active rheumatoid arthritis (RA) who have not improved despite using tumor necrosis factor inhibitor (TNFi) biologic drugs. The study compares switching to a non-TNFi biologic drug (such as rituximab, abatacept, tocilizumab, or sarilumab) versus switching to a targeted synthetic disease-modifying antirheumatic drug (tsDMARD) like tofacitinib, baricitinib, or upadacitinib. This comparative effectiveness research addresses a critical gap in evidence, as current treatment choices are often based on physician experience or insurance preferences rather than strong data. The study uses patient-reported outcomes (PROs) to provide meaningful information for patient-centered care. Participants will be assigned to receive either a non-TNFi biologic or a tsDMARD as their new treatment for active RA after TNFi biologic therapy. The study allows participants to continue certain conventional synthetic DMARDs (such as methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) if they have been stable on these for a specified period. Treatment choice is supported by insurance or patient assistance programs to ensure access. This pragmatic trial is designed to reflect real-world practice and includes patients with comorbidities to assess effectiveness and safety in a broad population. During the study, participants will be monitored for changes in functional ability over 12 months using the Health Assessment Questionnaire (HAQ), a sensitive measure for RA impact. Researchers will also evaluate quality of life, productivity, and side effects. The study aims to generate evidence that helps patients and payers make informed decisions about RA treatments based on outcomes that matter most to patients. Total participation includes baseline assessments and follow-up evaluations throughout the 12-month treatment period.