Orange County

Researchers are evaluating the safety and effectiveness of combining the drugs glofitamab, gemcitabine, and oxaliplatin in adults in the United States who have relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study especially includes under-represented racial and ethnic groups. This phase 1 study aims to better understand how these treatments work together and their impact on this type of lymphoma. Participants will receive intravenous glofitamab for up to 12 cycles, with each cycle lasting 21 days. They will also receive intravenous gemcitabine and oxaliplatin for up to 8 cycles, each cycle also lasting 21 days. Before starting these treatments, participants will get intravenous obinutuzumab. If needed, intravenous tocilizumab will be given to manage cytokine release syndrome, a potential side effect. During the study, participants will be closely monitored for any adverse events and their response to treatment will be assessed for up to 3 years. Researchers will collect data on side effects and measure the complete response rate to treatment. Patients will undergo regular evaluations, including scans and laboratory tests, to track the progress of their lymphoma and any treatment effects over time.

Researchers are evaluating how well sonrotoclax combined with obinutuzumab or rituximab compares to venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 3, open-label study will also assess the safety of these treatment combinations. The study is sponsored by BeOne Medicines, previously known as BeiGene, and involves multiple centers. Participants will receive one of the following treatments: sonrotoclax taken orally with intravenous obinutuzumab, sonrotoclax taken orally with intravenous rituximab, or venetoclax taken orally with intravenous rituximab. The treatments are given according to the study protocol, and participants are randomly assigned to one of these groups. The study monitors how these combinations work over time. During the study, participants will be regularly assessed through evaluations such as imaging, laboratory tests, and physical exams to monitor disease progression and treatment effects. Researchers will measure progression-free survival, which is how long participants live without disease worsening, with follow-up lasting up to about 51 months. Safety is also closely monitored to understand any side effects. The total duration of participation depends on the individual treatment and follow-up schedules.

This research aims to understand how avacincaptad pegol, a treatment approved in the US, is used for people with geographic atrophy caused by age-related macular degeneration (AMD). Geographic atrophy is an advanced stage of AMD where cells in the retina waste away, leading to worsening central vision and possible permanent vision loss. The study focuses on observing treatment patterns and safety in routine clinical practice rather than testing new effects. Participants in this study will receive avacincaptad pegol through intravitreal injections, which are injections into the eye. The study collects information from patients who have already been prescribed this treatment by their doctors. There is no experimental intervention from the study team, and treatment decisions are made by the patients' doctors. The study follows patients for up to 3 to 5 years, depending on when they join. While in the study, participants will have regular eye exams as part of their usual care. They will also complete surveys about their eye health at the start of treatment, every 6 months for the first 2 years, then annually afterward. Researchers will track treatment details like the number and dose of injections, treatment duration, reasons for stopping treatment, and patient characteristics. Safety and treatment patterns are monitored through medical records during and after treatment.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

Neurotrophic keratopathy (NK) is a degenerative eye disease caused by nerve damage that reduces corneal sensitivity and harms the health of corneal cells. This trial aims to compare the safety and effectiveness of a new eye drop called RGN-259 against a placebo in treating NK. This Phase 3 study focuses on patients with persistent corneal defects and reduced corneal sensation. Participants will receive either RGN-259, a preservative-free eye drop containing Tß4, or a placebo eye drop without Tß4. Both treatments are applied directly to the affected eye(s) five times daily for 28 days. The study monitors healing progress during this treatment period. Throughout the study, participants will undergo evaluations including eye exams to assess corneal healing, sensitivity testing, and vision measurement. The main result measured is the percentage of patients whose persistent corneal defects fully heal by Day 29. Safety and tolerance of the eye drops will also be closely observed during the treatment and follow-up visits.

This research aims to assess the safety and effectiveness of a non-hormonal gel called 7-940 as an additional treatment for women diagnosed with vaginal atrophy following vaginal laser therapy. The study focuses on improving symptoms related to vaginal atrophy, including dryness, itching, tenderness, and painful intercourse, by supporting healing of the vaginal mucosa. It is a Phase 4 study involving patients who have already undergone a laser therapy session schedule. Participants will use the 7-940 gel daily after their laser therapy session. This gel helps maintain vaginal health by promoting a moist environment that supports faster healing without the side effects of hormonal or steroid treatments. The gel relieves various symptoms such as burning, pain, and tissue irritation and is intended for long-term use to improve the vaginal mucosal condition. During the study, participants will be monitored for safety and symptom changes over a 30 to 45-day period. Researchers will evaluate outcomes using scores that measure vaginal health and quality of life related to vulvar disease, as well as investigator assessments of symptom improvement and patient-reported recovery. Participants will need access to digital devices and email to support study communications and data collection throughout the observation period.

Researchers are studying patients with depressed mood to develop models that predict how individuals respond to different treatments. The study focuses on using real-world clinical data to understand treatment outcomes and support personalized depression care. It includes patients treated with esketamine, conventional transcranial magnetic stimulation (TMS), or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT). Retrospective data from existing databases may also be used to help build and test these predictive models. Participants will receive treatments as part of their usual clinical care with either esketamine, conventional TMS, or SAINT. The study collects data from these treatments and may incorporate previously collected clinical and research information, when authorized, to improve the accuracy of prediction tools. The goal is to evaluate the usefulness of integrating various clinical datasets for guiding personalized treatment choices in depression. During the study, patients will complete the Patient Health Questionnaire 9-item (PHQ-9) before treatment, after treatment, two weeks post-treatment, and monthly for up to 12 months. These assessments help measure changes in mood and treatment response over time. Participants must provide informed consent and comply with study requirements. Safety is monitored by investigators, who can exclude individuals if participation is not safe. The study duration and follow-up span at least one year for ongoing evaluation.

Researchers are investigating the best way to use Selective Laser Trabeculoplasty (SLT) therapy for people with glaucoma or ocular hypertension. The study aims to find out if performing SLT at a low energy level is as effective as using the standard energy level. It also evaluates whether repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting until the effects of the initial SLT wear off before repeating the treatment. Participants will receive SLT treatments at either low energy or standard energy levels. The study compares these two approaches to see which is more effective over time. Some participants will have their low energy SLT repeated annually to assess if this schedule helps in managing their eye condition better than waiting for the treatment effects to diminish before repeating SLT. During the study, participants will be monitored for up to 48 months to track their survival without requiring daily eye drops, with primary outcome measures at 12 and 48 months. Researchers will check eye pressure and overall eye health regularly, ensuring safety and effectiveness of the treatments. Participants need to attend scheduled visits and follow study procedures throughout the study duration, which may include periodic eye exams and assessments.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

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.