Brick Township

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children aged 6 to under 18 years who have severe eosinophilic asthma. This study focuses on patients with a history of asthma attacks and uncontrolled symptoms despite using high-dose inhaled corticosteroids and at least one additional asthma controller medication. The study is a Phase III, randomized, double-blind, placebo-controlled trial designed to measure the time to first asthma exacerbation. The study includes a screening period lasting between 4 to 12 weeks to determine eligibility. Participants are randomly assigned to receive either benralizumab or a placebo injection during the double-blind treatment period, which lasts at least 16 weeks or until an asthma exacerbation occurs. Those who experience an exacerbation during this period may continue treatment in an open-label extension phase lasting at least 48 weeks, followed by an end-of-treatment visit 8 weeks after the last dose. During the study, participants will have regular visits for assessments including asthma control questionnaires, symptom scoring, lung function tests, and blood tests for benralizumab levels and antibodies. Researchers will monitor asthma exacerbations, medication use, night-time awakenings, and quality of life measures. Safety and treatment adherence will be closely observed throughout the study and the extension period, with total participation lasting over a year depending on individual progress.

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 drug's 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 relapsed/refractory 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 the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are evaluating the effectiveness of two digital mindfulness-based interventions for younger breast cancer survivors who experience elevated depressive symptoms. This phase III clinical trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their primary cancer treatments at least six months prior. The study aims to identify which digital mindfulness approach best improves mental health and well-being, while exploring factors that influence intervention benefits and cost-effectiveness. The study includes three groups: one attends live, instructor-led mindfulness sessions via Zoom once a week for six weeks; another uses a self-paced mindfulness app with structured lessons and exercises over six weeks; and a control group accesses guided audio mindfulness meditations. Participants without digital devices or internet access will be provided with tablets and hotspots. Both English and Spanish speakers are included in live and audio meditation groups, while the app group includes English speakers only. All groups have access to the mindfulness app for up to six months. Participants will attend sessions or use digital tools over six weeks, with daily home practice encouraged. Researchers will assess depressive symptoms shortly after the intervention and up to six months later, along with fatigue symptoms. Use of mindfulness materials and session attendance will be tracked to measure engagement. The study also collects information on emotion regulation, demographic factors, and social determinants of health to understand how these influence outcomes. Participation lasts approximately six months, with ongoing access to mindfulness resources during follow-up.

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 Department's 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 evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

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 device's 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.