Hillsboro

Researchers are evaluating the safety of atezolizumab alone or combined with bevacizumab as first-line treatment in adults with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis. This Phase II, open-label study involves participants who have not received prior systemic therapy for their condition and aims to understand treatment safety in this specific population. Participants will be assigned to one of two groups: one receiving atezolizumab plus bevacizumab, and the other receiving atezolizumab alone. Atezolizumab is given as an intravenous infusion at a dose of 1200 mg on the first day of each 21-day cycle. Bevacizumab is administered by intravenous infusion at 15 mg/kg on the same schedule. The study is conducted across multiple centers and includes multiple cohorts to evaluate these treatments separately. During the study, researchers will monitor participants for adverse events from the start until up to approximately 36 months. Assessments include measuring disease status with imaging and clinical evaluations, checking blood tests for liver and kidney function, and monitoring overall health and safety. Participants will be followed closely throughout the treatment and observation periods to gather safety data and evaluate treatment tolerability.

Inpatient falls cause serious physical harm and increase healthcare costs, affecting both patients and hospitals. The Centers for Medicare & Medicaid Services (CMS) classify falls with injury as "never events," meaning they are preventable errors that negatively impact hospital safety ratings and reimbursement. Despite evidence showing that fall prevention alarms are not effective, these alarms are still widely used in hospitals. This study aims to reduce the use of these alarms by applying tailored strategies based on education, audit and feedback, and opinion leaders, guided by the Choosing Wisely De-implementation Framework. It will compare different coaching intensities to find effective ways to reduce alarm use in hospital units. The study involves 30 medical or medical-surgical hospital units across the US. These units will be randomly assigned to receive either high-intensity or low-intensity coaching to implement the tailored strategies for reducing fall prevention alarm use. Coaches will train hospital staff in quality improvement and fall prevention practices, customizing their support to each site's needs. This approach may help future efforts to reduce low-value alarm use in other healthcare settings with high fall risks. Participants include stakeholders involved in fall prevention at the participating hospitals. The study will monitor the prevalence of fall prevention alarms and record patient falls monthly over 30 months. Researchers will assess how well the coaching strategies reduce alarm use and improve patient safety. The findings will inform best practices for de-implementing ineffective alarms and may guide broader quality improvement initiatives in healthcare.

Researchers are evaluating the Galleri4 multi-cancer early detection (MCED) test in a multi-center prospective cohort study involving the Medicare population aged 50 years and older. This study aims to understand the real-world clinical impact of the test, including its safety and how well it detects cancers early. The study seeks to enroll participants who represent the Medicare population, including those with Traditional Medicare or Medicare Advantage coverage. Participants in the study are divided into two groups: one group receives the Galleri test through blood collection and multi-cancer early detection testing with return of results, while the other group receives usual care without the Galleri test. The study excludes individuals who have previously had an MCED test, are undergoing clinical evaluation for suspected cancer, have certain recent or untreated cancer histories, are pregnant, or are currently inpatient at a participating site. The study is designed to monitor participants over time without specifying a maximum age limit. During the study, researchers will track the incidence rates of stage IV cancers over a period of up to 3 years. Participants will be monitored for safety and test performance outcomes. The study involves informed consent from participants who are capable of providing it directly, and it excludes those who cannot comply with study procedures or who are not registered patients at participating centers. This research aims to provide data on the effectiveness and safety of the Galleri test in a real-world Medicare population setting.

Researchers are evaluating the effectiveness of a special conversation tool designed to help patients with lung cancer who are making treatment decisions. This study focuses on how patients choose their lung cancer treatments and the information they need to make those choices, especially targeting patients with lower health literacy. The goal is to improve shared decision-making between patients and their doctors. Participants are randomly assigned to one of two groups. One group reviews a decision aid tool designed to help understand treatment options, while the other group receives standard care without the tool. Some participants and their healthcare providers will have their clinic conversations recorded for further analysis. Follow-up assessments occur at 2 weeks, 3 months, and 6 months after the intervention. During the study, participants will complete questionnaires and interviews to evaluate their knowledge about lung cancer, their confidence in making decisions, satisfaction with communication, and their self-efficacy. Researchers will use these measures to understand how well the conversation tool supports patient-centered health and decision-making outcomes over a period of up to 6 months.

Researchers are evaluating a new medicine called PF-08634404 to see how well it works in adults with colorectal cancer that has spread or returned after previous treatments. This study focuses on whether PF-08634404 combined with approved chemotherapy can help patients compared to another approved medicine called Bevacizumab combined with chemotherapy. The study is a Phase 3, double-blind, randomized trial involving participants who have metastatic colorectal cancer and have not received prior systemic therapy for metastatic disease. Participants will be randomly assigned to one of two groups: one receiving PF-08634404 plus chemotherapy, and the other receiving Bevacizumab plus chemotherapy. Both treatments are given by intravenous infusion in cycles. Participants may continue treatment if it is beneficial and side effects are manageable. Treatments are administered at clinical sites with medical staff monitoring participants during and after each infusion. During the approximately 33-month study, participants will visit the study site regularly for treatment, health checks, and tests. After stopping treatment, there will be a follow-up visit about 30 to 37 days later to assess health and side effects. Participants will also have follow-up every 12 weeks by phone, in person, or through health record reviews to monitor their health status and any new treatments. The main outcomes measured include progression-free survival and overall survival over about 4 years.