Clinton

Researchers are evaluating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat people with triple-negative breast cancer TNBC that is locally recurrent, unresectable, or metastatic. The study aims to determine if these treatments help participants live longer overall or without their cancer growing or spreading compared to chemotherapy chosen by their physician. This is a phase 3, randomized, open-label trial focusing on patients whose tumors express PD-L1 at less than 10 combined positive score CPS. Participants are assigned to one of three groups. One group receives sacituzumab tirumotecan intravenously every two weeks until disease progression, toxicity, or stopping treatment. Another group gets the same sacituzumab tirumotecan schedule plus pembrolizumab intravenously every six weeks for up to about two years. The third group receives the physicians choice of chemotherapy, which may include paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin, given intravenously on various schedules until disease progression, toxicity, or discontinuation. Pre-medications are given before sacituzumab tirumotecan to help manage side effects. Participants will be monitored for how long they live without their cancer worsening and overall survival, with follow-up lasting up to around 61 months. Researchers will assess treatment response, quality of life using questionnaires, and physical and emotional functioning. Safety will be closely tracked by recording adverse events and treatment discontinuations. The total participation time depends on treatment duration and follow-up assessments.

Researchers are studying the use of XEN1101 as an additional treatment for people aged 12 years and older who have primary generalized tonic-clonic seizures PGTCS associated with generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the clinical effectiveness, safety, and tolerability of XEN1101 when added to existing anti-seizure medications. Participants are currently taking 1 to 3 anti-seizure medications and have had probable or possible PGTCS for at least one year. Participants will be randomly assigned to receive either XEN1101 or a placebo. Those aged 18 years and older will receive a 25 mg daily dose of XEN1101 or placebo. Participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo daily. The study includes a baseline period lasting up to 9.5 weeks to track seizure frequency, followed by a 12-week double-blind treatment period where participants will take the assigned capsules once daily with an evening meal. After completing this period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week post-treatment follow-up if they do not enroll. During the study, participants will keep accurate seizure diaries and attend scheduled visits to monitor their health and response to treatment. Researchers will evaluate changes in monthly seizure frequency as the main outcome. Additional assessments will track safety, tolerability, and other measures throughout the treatment and follow-up periods. Overall participation may last several months, including baseline assessment, treatment, possible extension, and follow-up phases.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are investigating the effects of IGC-AD1, an oral medication containing THC and melatonin, on agitation in patients aged 60 and older with mild to severe Alzheimers dementia. The study is a multi-center, double-blind, randomized, placebo-controlled clinical trial aiming to assess how IGC-AD1 impacts agitation symptoms compared to a placebo. Participants must have clinically significant agitation lasting at least two weeks and meet specific criteria to ensure the agitation is related to Alzheimers dementia. Participants will receive either the active oral solution of IGC-AD1 or a placebo, both administered twice daily for 42 days followed by a two-day dose taper. The study includes safety monitoring with frequent phone calls to review medication use, adverse events, and study partner logbook entries. Blood samples will be taken during the trial to analyze drug levels, brain-related biomarkers, and genetic factors. During the study, participants and their caregivers will complete various assessments, including the Cohen-Mansfield Agitation Inventory CMAI to measure changes in agitation over six weeks and at two weeks. Safety and medication adherence will be closely monitored. The total participation time includes the treatment period and follow-up safety calls. Researchers will also evaluate secondary and exploratory outcomes related to agitation and collect pharmacokinetic data.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This research aims to support the creation and use of a database for patients with coronary microvascular disease CMD. The study focuses on collecting, storing, and sharing data about CMD patients to help research in this area. It is an observational study led by Medstar Health Research Institute to better understand CMD through detailed patient information. The study involves identifying patients with CMD and gathering their medical data both retrospectively and prospectively. Researchers will follow these patients for up to five years to observe short-term and long-term outcomes related to the disease. This process helps build a registry to support ongoing and future research. Participants will be part of a data registry where their medical information is collected and stored securely. Researchers will analyze this information over time to study patient outcomes. The main goal is to establish and maintain a CMD patient registry over ten years, supporting a better understanding of the disease and its effects.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

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.

Researchers are studying how different pacing rates affect exercise tolerance in patients with persistent atrial fibrillation AF and heart failure with preserved ejection fraction HFpEF who have undergone cardiac resynchronization therapy CRT after atrioventricular node AVN ablation. This study aims to find out if setting a pacing rate at 80 beats per minute bpm improves exercise capacity compared to 60 bpm. The study is a prospective, randomized crossover trial comparing these two pacing rates over time. Participants will be randomly divided into two groups one group will start with a pacing rate of 60 bpm for 3 months, then switch to 80 bpm for the next 3 months the other group will start with 80 bpm for 3 months, then switch to 60 bpm. The study will monitor patient mortality, heart failure hospitalizations, and various health measures at each phase. Treatments involve device-based pacing adjustments, and no placebo is used. During the study, participants will undergo assessments including electrocardiograms, echocardiograms, pacemaker checks, blood tests for BNP and creatinine, and questionnaires on quality of life and physical activity. The main outcome measure is exercise tolerance evaluated by the six-minute walk test at 3 months. Secondary measures include heart failure symptoms, atrial fibrillation burden, hospitalizations, and mortality related to heart and vascular events. The total study duration per participant is 6 months, with evaluations at baseline, 3 months, and 6 months.