Springfield

Researchers are evaluating the safety and effectiveness of pulsed field ablation (PFA) therapy for treating persistent atrial fibrillation (PersAF) that does not respond to medication. The study compares PFA targeting pulmonary veins plus extra-PV sources identified by electrographic flow (EGF) mapping against PFA targeting pulmonary veins plus the left atrial posterior wall (PVI + PWA). The goal is to establish safety and to show that the new method is not less effective than the current approach in patients with symptomatic, drug-refractory PersAF. Participants will receive treatment using several devices, including the FARAPOINT Pulsed Field Ablation System, the OptiMap System for electrogram analysis, and the FARAWAVE NAV Catheter combined with the Opal HDx Mapping System for detailed heart mapping. All subjects will undergo electroanatomical mapping of the entire left atrium, followed by pulsed field ablation of the pulmonary veins, with additional ablation of either EGF-identified sources or the posterior wall, depending on the assigned treatment group. During the study, participants will be monitored for safety outcomes at 60 days and effectiveness outcomes at 365 days. They will receive a LUX-Dx insertable cardiac monitor to track heart rhythm continuously. Researchers will collect clinical data, imaging, and follow-up assessments to evaluate treatment impact and safety. The study includes ongoing follow-up visits to ensure thorough monitoring of heart function and study outcomes over one year.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are conducting a Phase 3 study to evaluate the safety and effectiveness of an intravitreal injection called KSI-101 in adults with macular edema caused by inflammation, known as MESI. This condition involves swelling in the central part of the retina and can affect vision. The study aims to compare KSI-101 to sham injections to understand its impact on improving vision. Participants will receive either KSI-101 or sham injections directly into the eye. The treatment is given through intravitreal injections, which deliver medication inside the eye. The study is randomized, double-masked, and sham-controlled, meaning neither participants nor doctors know who receives the active drug or sham injections. This design helps provide clear and unbiased results. Throughout the study, participants will have their vision assessed, including measuring changes in best-corrected visual acuity (BCVA) at 24 weeks. Researchers will monitor the thickness of the central retina area and check for safety and side effects. Participants will be followed regularly to track vision changes and eye health during the study period.

Researchers are conducting a Phase 3 clinical trial to evaluate the effectiveness and safety of an investigational drug called KSI-101 for people with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study focuses on participants who have specific retinal thickness and vision measurements and includes those with active or inactive non-infectious inflammation in one eye. The trial aims to understand how well KSI-101 works compared to a sham injection in improving vision. Participants will receive either KSI-101 through an injection into the eye (intravitreal injection) or a sham injection as a comparison. The study is double-masked and randomized, meaning neither the participants nor the researchers know which treatment is given. The treatment schedule and detailed dosing are not specified here, but the trial includes careful monitoring of participants over time. During the study, participants' vision will be assessed, specifically measuring the change in best-corrected visual acuity (BCVA) after 24 weeks. Other assessments include measuring retinal thickness with imaging technology. Researchers will monitor safety and any side effects throughout the trial. Participation involves regular visits for these evaluations, and the study is designed to gather detailed information on how the treatment affects vision and eye health over the study period.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating the effectiveness of two types of tai ji quan exercises compared to stretching exercises in reducing falls among older adults with mild cognitive impairment. This study focuses on community-dwelling individuals aged 65 to 95 who have memory complaints and a history of falls or slowed mobility, aiming to find better ways to prevent accidental falls in this population. Participants will be assigned to one of three groups: dual-task tai ji quan training, standard tai ji quan training, or stretching exercise. Each intervention involves specific exercise routines designed to improve balance and cognitive function. The study compares these approaches to determine which is more effective in lowering fall risk. During the study, participants will report the number of falls they experience monthly, from the start of the study through six months after the intervention ends. Researchers will also monitor physical abilities and cognitive status to assess changes over time. This monitoring helps in understanding the safety and impact of the exercises on fall prevention in older adults with mild cognitive issues.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating overall survival in men with metastatic castration-resistant prostate cancer (mCRPC), a form of prostate cancer that has spread beyond the prostate and no longer responds to hormone therapies. This Phase 3 randomized trial compares pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC), against placebo with BSC to understand the length of time participants survive from the start of treatment. Participants receive pasritamig or placebo through intravenous infusion along with best supportive care, which is provided at the treating physician's discretion. The study focuses on men who have previously undergone multiple prostate cancer treatments including androgen-receptor pathway inhibitors, taxane chemotherapy, radioligand therapy, and possibly PARP inhibitors. Patients must continue ongoing hormone therapy during the treatment phase. During the study, participants are monitored for overall survival up to 2 years and 8 months. Assessments include clinical evaluations and laboratory tests to measure kidney and liver function, blood counts, and general health status. Safety and treatment effects are closely observed, with eligibility based on performance status and organ function. The trial aims to provide detailed long-term outcome data for this advanced prostate cancer treatment approach.