Champaign

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second FEV1, record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.

This research aims to understand how alcohol affects social and individual behaviors by studying young adults aged 21 to 30 who regularly drink alcohol. It focuses on how alcohol influences social bonding, mood, and brain activity during interactions between pairs of people. The study uses brain scanning techniques to observe brain patterns and measures mood and social feelings to explore alcohols role in social rewards and risks for alcohol use disorder. Participants will attend two laboratory sessions about one week apart, each involving interactions with a stranger while consuming either an alcoholic beverage targeting a blood alcohol concentration of 0.08% or a similar non-alcoholic drink. The order of these sessions is randomized. During each session, participants perform various tasks, including music perception, attention tests, and natural social interactions, while brain activity is recorded simultaneously from both people using EEG hyperscanning. Throughout the study, participants complete questionnaires on mood and social closeness, and nonverbal behaviors are observed during interactions. Researchers analyze brain synchrony within and between participants and track drinking behavior over time. The main outcomes include brain activity patterns during and after beverage intake and long-term alcohol use reports. The total participation involves two laboratory visits and follow-up assessments lasting up to 24 months.

This trial evaluates the effectiveness of a new personalized health e-library app called SavvyHealth for people living with multiple sclerosis MS. The study aims to understand how using this app may support self-management among individuals diagnosed with MS. It is sponsored by the University of Illinois at Urbana-Champaign and involves a randomized design without masking. Participants are randomly assigned to either use the SavvyHealth app for 21 days or be placed on a waiting list without intervention. Those using the app will engage with it daily during this period. The study compares outcomes between these two groups to assess the apps impact. During the study, participants complete a survey before using the app and another survey after the 21-day period. Researchers measure self-management skills related to MS through the MS Self-management Scale, averaged weekly through study completion. The total participation time involves the initial survey, use of the app or waiting period, and a post-use survey to evaluate changes.

Researchers are evaluating a smartphone technology called bpMedManage to improve medication adherence for high blood pressure in older adults with mild cognitive impairment MCI. This 16-week randomized controlled trial will include 100 participants aged 60 and older. The study compares two groups to see how well the smartphone tools support taking blood pressure medications as prescribed. Participants will first complete baseline assessments and 4 weeks of medication adherence monitoring. After this, they will be randomly assigned to one of two groups the bpMedManage-S group, which uses a smartphone app with medication reminders plus educational materials about hypertension and medications or the bpMedManage-P group, which uses the smartphone only to access educational materials. Both groups will be assessed for immediate outcomes 4 weeks after starting the intervention and again at 12 weeks for follow-up. During the study, participants will use their smartphones and complete various assessments including medication adherence measured by electronic monitoring and self-report. Blood pressure readings and knowledge about hypertension will also be evaluated. Participants will be monitored for usability of the system and followed for a total of 16 weeks. The research aims to measure changes in medication adherence and related health outcomes over this period.

Researchers are evaluating digital assistant technology tools designed to support older adults, including those with Mild Cognitive Impairment MCI and lower socioeconomic status, in managing healthcare activities. The study aims to enhance cognitive support for tasks such as accessing support services, managing healthcare finances, and using Medicare.gov tools. This pilot randomized clinical trial focuses on the feasibility, acceptability, and usability of a digital support tool called SideKick, adapted for Medicare tasks. Participants will be randomly assigned to one of two groups the SideKick condition or the usual-tool control condition using medicare.gov. Those in the SideKick group will receive an introduction to Large Language Models, learn how to use SideKick for queries, and practice constructing prompts. The control group will be guided through the medicare.gov website, learning about its structure and navigation. Participants will complete a series of Medicare enrollment and plan selection queries of varying complexity using their assigned tool. Throughout the study, participants will undergo baseline assessments and complete task performance sessions during which their accuracy and perceptions of system usefulness and usability will be evaluated. The primary outcomes include measuring perceived system usefulness and performance accuracy immediately after task completion. The study involves adults aged 60 and older with varying cognitive abilities and includes monitoring participant engagement and feedback to inform digital tool development.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.