Butler County

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohns Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease IBD. This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

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 evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.

This research aims to compare two different approaches to post-hospitalization follow-up care for children hospitalized with common infections such as pneumonia, skin and soft tissue infections, acute gastroenteritis, or urinary tract infections. The study evaluates whether automatic follow-up visits scheduled at discharge or a more flexible as-needed PRN follow-up approach, where parents monitor symptoms and decide on visits, impact hospital readmission rates and other health outcomes. Participants are randomly assigned to one of two groups. One group receives a recommendation for automatic follow-up, instructing them to schedule and attend a follow-up visit regardless of symptom improvement. The other group receives a recommendation for PRN follow-up, where scheduling a visit at discharge is not required, and parents decide if a visit is necessary based on their childs symptoms. Both groups are monitored to compare outcomes over time. During the study, researchers will track hospital readmissions within 14 days of discharge as the primary outcome. Secondary outcomes include medical interventions and the childs health-related quality of life measured seven days after discharge. Additional factors like healthcare use, parent anxiety, satisfaction, and costs will also be assessed. The study includes follow-up through communications with healthcare providers and monitoring of immunizations and well-child visits. Participation lasts at least through the 14-day post-discharge period to capture these outcomes.

This research aims to gather detailed information about children treated with radiation therapy for cancer to better understand and compare different radiation types, including Proton Beam Radiation Therapy PBRT. PBRT has shown promise in previous studies for targeting radiation more precisely and possibly causing fewer long-term side effects, but more data is needed to confirm these findings. The study collects data from multiple centers to describe the population receiving radiation and support collaborative research efforts. Participants will receive cancer treatment and follow-up care as determined by their doctors according to standard practices at their clinics. The study records all treatments, including surgeries and chemotherapy before or after radiation therapy. Data collection includes patient demographics, diagnosis, imaging, lab tests, treatment details, side effects, and additional therapies received alongside radiation. Participants will be followed over time with annual chart reviews by study staff to update health status, treatment outcomes, side effects, and development of new medical conditions or cancers. The study aims to track long-term outcomes and quality of life for children treated with radiation. Data access is shared among participating centers and authorized entities to support the research. The study plans to establish and maintain this registry for many years, collecting data throughout participants lives.

Researchers are comparing treatments for people with active rheumatoid arthritis RA who have not responded well to tumor necrosis factor inhibitor TNFi biologics. This study evaluates switching to either a non-TNFi biologic drug including rituximab, abatacept, tocilizumab, or sarilumab or a targeted synthetic DMARD tsDMARD such as tofacitinib, baricitinib, or upadacitinib. The study aims to provide important real-world data on patient-reported outcomes PROs to help guide treatment decisions, as current guidelines are based on limited evidence and often influenced by insurance or physician preference. Participants will be randomized to one of two groups switching to a targeted synthetic DMARD or switching to a non-TNFi biologic drug. Both treatment options are widely used in clinical practice, but have not been directly compared in a pragmatic trial focusing on PROs. The study will allow patients to continue stable doses of conventional synthetic DMARDs like methotrexate if used for at least three months. The trial will assess changes over 12 months, focusing on functional limitation and quality of life. During the trial, participants will be monitored regularly to assess their function and symptoms using patient-reported tools such as the Health Assessment Questionnaire HAQ. Researchers will collect information on treatment effectiveness, side effects, and safety in a real-world population, including those with other health conditions. The study is designed to reflect routine clinical care and will last for at least 12 months, with follow-up to evaluate changes from baseline in physical function and other outcomes important to patients.