Layton

This research aims to evaluate how well two new drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. The study includes participants aged 8 to under 18 years who have overweight or obesity. It is a Phase 3 trial that compares these new drugs with semaglutide, a drug already prescribed for weight management, and a placebo to understand their effects on weight loss. Participants in the main study are randomly assigned to receive one of four treatments CagriSema, cagrilintide, semaglutide, or placebo. All treatments are given once weekly as subcutaneous injections, starting with a dose escalation phase lasting up to 16 weeks, followed by a maintenance phase for 52 weeks. Those who receive semaglutide do not join the extension study. Participants in the extension study continue treatment with either CagriSema or cagrilintide for up to 156 weeks, while placebo participants follow a specific dosing regimen before continuing in the extension. During the study, participants will be monitored for changes in body mass index BMI and weight over time, with assessments at baseline, week 68, and for some measures, week 224. Researchers will also track body composition, metabolic markers, quality of life, and safety events. The entire duration for participants can be up to nearly five years if they take part in both the main and extension studies, involving regular visits and evaluations to understand the treatments effects and safety.

This research aims to evaluate how tirzepatide affects body weight and cardiovascular risk factors in adolescents aged 12 to 17 who have obesity along with multiple weight-related health conditions. The study is a Phase 3 clinical trial focusing on the safety and effectiveness of tirzepatide combined with healthy nutrition and physical activity. Participants will be randomly assigned to receive either tirzepatide or a placebo through weekly injections under the skin. The main study period lasts about 72 weeks with up to 23 visits, and participants who completed a prior related study and meet certain criteria may continue receiving tirzepatide for an additional 156 weeks while maintaining lifestyle interventions. During the study, participants will undergo various assessments including measurements of body mass index BMI, blood pressure, blood sugar HbA1c, triglycerides, body fat by DXA scan, and sleep apnea index. Researchers will monitor changes from baseline to week 72 in these areas to evaluate the treatments impact. Safety and adherence to the study schedule will also be closely observed throughout the trial.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

Researchers are evaluating the effectiveness of adding the drug tirzepatide to the existing treatment with ixekizumab in adults with moderate-to-severe plaque psoriasis who are also overweight or obese and have at least one related health condition. This Phase 4 study aims to understand how well this combination works in routine clinical practice over a period of up to 12 months. During the study, participants will continue their treatment with ixekizumab and will start taking tirzepatide by subcutaneous injection according to the medication label. The study is open-label and involves a single group of participants receiving this combined treatment regimen. The main focus is to assess improvements in quality of life and weight reduction over the 12-month period. Participants will be monitored regularly to measure their skin condition using tools like the Dermatology Life Quality Index and body surface area affected by psoriasis. Weight changes and other health assessments will be tracked at 6 and 12 months. Safety and treatment adherence will also be observed throughout the study duration to gather comprehensive data on the effects of adding tirzepatide to ixekizumab therapy.

Researchers are evaluating the adaptation and implementation of an innovative clinical decision support CDS tool called ePNa, originally validated in emergency departments, for use in urgent care clinics to improve pneumonia diagnosis and treatment. This study aims to combine ePNa with Stanfords CheXED artificial intelligence model to classify chest images quickly and accurately. The goal is to enhance pneumonia care in ambulatory settings where high patient volumes may benefit from updated and efficient diagnostic tools, especially as COVID-19 evolves. The study involves adapting ePNa for use in urgent care clinics by modifying it to work with the more limited patient data available in these settings and incorporating a chest imaging prompt. The combined ePNa-CheXED tool will be piloted among super user clinicians during clinic shifts. One of two clusters of urgent care clinics will receive the adapted tool, while the other will serve as usual care control. Additionally, a physician survey will assess clinicians experiences with ePNa-CheXED six months after implementation. Participants will be patients aged 12 and older diagnosed with pneumonia, confirmed by radiographic imaging. Physicians and advanced practice clinicians in selected urgent care clinics will also participate by completing surveys. The study will monitor outcomes including the accuracy of pneumonia diagnosis, changes in transfer rates to emergency departments, unplanned subsequent ED visits or hospitalizations, and overall healthcare resource use. The study will continue for up to three years, with ongoing evaluation of ePNa use and impact in the urgent care clinical environment.

Researchers are studying Brivekimig, a medication given as a subcutaneous injection, in people with moderate to severe hidradenitis suppurativa HS. This Phase 2b, global, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of different doses of Brivekimig for treating HS. Participants have had HS for at least six months and have moderate to severe symptoms affecting multiple areas of the body. Participants will be randomly assigned to receive one of three dosing regimens of Brivekimig or a matching placebo. The study drug is given through injections and the treatment period lasts up to approximately 48 weeks. Some participants may continue into a longer-term extension study, making total participation last up to about 52 to 60 weeks. The trial includes a maintenance period following the initial treatment. During the study, participants will have regular visits to assess their skin condition, pain levels, quality of life, and any side effects. Researchers will measure improvements using tools like the Hidradenitis Suppurativa Clinical Response HiSCR at various points up to Week 16. Safety will be monitored throughout the study, including tracking adverse events and laboratory tests. Participants drug levels and immune responses will also be checked. Overall, the trial will last up to about 60 weeks depending on extension participation.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

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.