Brick Township

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.

Researchers are evaluating the combination of BP1001 plus venetoclax plus decitabine in adults with acute myeloid leukemia AML who cannot or choose not to receive intensive chemotherapy. The study aims to determine if this combination offers better results, such as complete remission, compared to venetoclax plus decitabine alone or to intensive chemotherapy in patients with untreated or relapsedrefractory AML. This Phase IIa trial focuses on patients who are fragile or ineligible for aggressive treatment, addressing a need for targeted therapies that may improve outcomes while being tolerable. Participants will receive one of three treatment combinations depending on their AML status untreated patients receive BP1001 with venetoclax and decitabine relapsed or refractory patients receive BP1001 with venetoclax and decitabine and a third group of relapsed or refractory patients who are resistant or intolerant to venetoclax receive BP1001 plus decitabine. The study uses an open-label design and will enroll about 19 participants per cohort initially, with potential expansion based on interim data review. The treatment involves multiple drug administrations to assess safety, pharmacokinetics, pharmacodynamics, and efficacy. During the study, participants will undergo regular assessments including bone marrow biopsies or aspirates to measure treatment response over 180 days. Safety will be monitored through evaluations up to 30 days post-treatment, along with pharmacokinetic studies of BP1001. Researchers will also assess minimal residual disease status and overall survival. Participants must meet specific health criteria and will provide informed consent before enrollment. The study is sponsored by Bio-Path Holdings, Inc. and is expected to continue until December 2028.

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 evaluating lung cancer screening uptake among patients aged 50 to 80 who are at risk due to smoking history. The study aims to improve lung screening knowledge, awareness, and uptake by using a Social Determinants of Health SDoH screening tool embedded in the Emergency Departments Electronic Health Record EHR. This pilot Type 1 Hybrid Effectiveness-Implementation Trial will first assess the reach of this approach and then test its preliminary effectiveness compared to enhanced usual care. Participants will be randomly assigned to one of two groups. One group will use LungTalk, an interactive iPad-based educational tool tailored to smoking status and barriers, featuring audio, video, and animations to improve lung screening knowledge and beliefs. The other group will receive a non-tailored lung screening pamphlet via email and follow-up navigation support within 48 hours. Both interventions aim to encourage lung cancer screening through education and patient navigation. During the study, participants will be assessed at 1 week, 1 month, and 6 months after the intervention. Researchers will measure lung cancer screening uptake and participants stage of adoption of lung screening. Additional assessments include health literacy, medical mistrust, perceived stigma and risk, benefits and barriers to screening, self-efficacy, knowledge about lung cancer, and fatalism. The study involves data collection from randomized trial methods and EHR records to evaluate outcomes over time.

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.

This research aims to evaluate whether the use of Tamsulosin can reduce the high rate of postoperative urinary retention POUR in older men undergoing thoracic cancer surgery. POUR is a common issue, especially in older men with enlarged prostates, leading to urinary tract infections, discomfort, and longer hospital stays. This pilot study focuses on men aged 55 and older scheduled for oncological thoracic surgery to see if Tamsulosin can help lower POUR incidence and identify when normal urinary function returns after surgery. Participants will receive a prescription for Tamsulosin at a dose of 0.4 mg daily, starting seven days before their planned surgery and continuing up to the day of surgery. They will take the medication with a meal and record their daily usage in a diary. After surgery, bladder function will be monitored using ultrasound to measure urine volume and residual urine. If spontaneous urination does not occur or excess urine remains, standard bladder management including intermittent catheterization may be applied based on specific guidelines. During the study, researchers will observe and record whether participants can urinate spontaneously within 6 to 8 hours after surgery, the timing and volume of urination within 24 hours, and the amount of residual urine. Those unable to urinate spontaneously may receive catheter interventions. The study will include regular assessments using a BladderScanner and follow participants until urinary function resumes. The total study duration varies depending on surgery and recovery timelines.

Researchers are collecting observational data to evaluate the safety and performance of the Serranator4 balloon catheter in treating peripheral artery disease PAD and dysfunctional native or synthetic arteriovenous dialysis fistulae. This registry study observes patients treated under routine medical care to gather real-world evidence for clinical evaluation. Participants will undergo serration balloon angioplasty targeting arteries such as the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and pedal arteries, or dysfunctional dialysis fistulae. The study includes subjects with claudication or ischemic rest pain who have new or recurrent lesions in these areas. During the study, data on peri-procedural performance and safety endpoints will be collected while participants receive standard care. The researchers will monitor outcomes related to the devices use in real-world settings. Participation involves observation and data gathering without altering usual treatment, continuing until the study ends in August 2026.

Researchers are studying targeted genomic analysis of blood and tissue samples from patients with cancer, focusing on rare cancers with poor prognosis or limited treatment options. This observational research aims to identify genetic changes using genomic sequencing to help understand cancer development and to provide clinicians with mutation data that may guide treatment or referral to relevant studies. The study also collects clinical outcomes and tumor genome data for future analysis and cancer model development. The study involves analyzing previously collected tumor tissue samples using next-generation sequencing to detect mutations. Patients may also provide blood samples for analysis of circulating cell-free DNA and circulating tumor cells. These procedures support the identification of actionable mutations that may have available targeted therapies. The research includes correlative laboratory biomarker analysis. Participants are followed after study completion every 3 months for 2 years, then every 6 months for up to 15 years to monitor clinical outcomes and mutation frequencies. Researchers measure the frequency of specific mutations and the rate of actionable mutations in rare or poor prognosis cancers over this period. This long-term follow-up helps correlate genomic findings with patient outcomes and supports future research developments.

Researchers are evaluating an expanded Transitions of Care Clinic TOCC program aimed at improving care for patients with heart failure with preserved ejection fraction HFpEF during the vulnerable period after hospital discharge. This study focuses on reducing hospital readmissions and enhancing quality of life for patients treated for acute exacerbations of HFpEF, a group with limited treatment options and high readmission rates. The TOCC team includes a pharmacist and nurse practitioner who provide education, tools, and resources to support patients chronic disease management. Participants receiving the TOCC intervention will watch educational videos on an iPad and receive a heart failure HF kit containing essential tools and log sheets for self-monitoring daily weight, blood pressure, and heart rate before discharge. The program also includes scheduling follow-up appointments with outpatient providers and structured follow-up phone calls from the TOCC team at 1 to 3 days and again at 21 to 24 days post discharge to review instructions, medication education, and assess clinical status. A comparison group will receive standard education and follow-up care. During the study, participants will be monitored for hospital readmission within 30 days post discharge as the primary outcome. Secondary measures include follow-up with providers within 7 days after discharge and patient satisfaction with the transition of care within 31 to 45 days. The study spans from hospital discharge through roughly six weeks of follow-up, tracking adherence and patient needs to improve self-management and continuity of care.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.