Binghamton

Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography LDCT screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood tests sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

Researchers are studying ways to reduce falls in older adults by comparing two methods of delivering the Otago Exercise Program OEP, a proven fall prevention exercise routine that focuses on muscle strengthening and balance. The study aims to bridge the gap between research and community use by testing a smartphone-based home program against a traditional in-person community program. This research also looks at how practical, acceptable, and easy to use each delivery method is for older adults at risk of falling. Participants who are at intermediate or high risk of falling will be randomly assigned to one of two groups a smartphone-based program delivered through an app with weekly phone support, or an in-person group exercise program at a community center. Both groups will undergo individualized 60-minute training sessions twice a week for eight weeks, following the structure of the OEP. The smartphone group will use an app to track and review exercises, while the community group will exercise together under professional guidance. Throughout the study, participants will complete various tests and surveys before and after the program, including balance and mobility assessments, depression scales, and fall risk evaluations. Gait speed will be measured weekly via smartphone. Researchers will monitor outcomes such as gait velocity and physical performance to assess the effectiveness of each delivery mode. The total participation includes the 8-week training and follow-up assessments, with testers and trainers blinded to group assignments and baseline results.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

This research aims to understand how babies of mothers with postpartum major depression develop attentional biases toward emotional facial expressions. The study focuses on how infant attention and arousal may contribute to this risk and explores these processes in infants from both high-risk and low-risk groups, based on their mothers depression history. The goal is to learn more about early emotional development in these infants and how maternal depression may influence it. Infants will participate in two main tasks. The first is a computer-based task where infants view faces showing different emotions angry, happy, sad, neutral while an eye tracker monitors their gaze. The second is a standardized mother-infant interaction task consisting of three three-minute stages normal play without toys, a sad or depressed interaction with minimal movement or contact, and a return to normal play. These tasks will help assess infant gaze and physiological responses. Participants will be assessed at the start and then at 3, 6, 9, and 12 months follow-up. During these visits, researchers will measure infant eye gaze during both tasks, heart rate, and respiratory sinus arrhythmia to monitor infant arousal. They will also evaluate infant social-emotional problems over time. The study involves healthy infants born full-term and normal weight, with ongoing monitoring through the first year of life.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Underage drinking is a significant issue in the United States, with many high school students using alcohol and facing negative consequences such as academic problems, impaired functioning, and risky behaviors. This research aims to test the effectiveness of two web-based interventions, the e-CHECKUP TO GO eCTG alone and combined with an electronic Parent-Based Intervention ePBI, in reducing alcohol use among high school juniors and seniors. The study uses a nationally representative sample to address the limited interventions available for older high school students. Participants are randomly assigned to one of four groups the eCTG program, the combined eCTGePBI program, the e-Parent Intervention alone, or a control group receiving no intervention. The eCTG provides personalized feedback about alcohol use and risks, while the e-Parent Intervention offers an electronic handbook to guide parents in discussing drinking with their teens. Data are collected over five waves including baseline, and 3-, 6-, 9-, and 12-month follow-ups, with one wave involving parents at 3 months. During the study, participants and their parents complete assessments on alcohol use and consequences at multiple time points. Researchers measure changes in alcohol consumption and related negative outcomes throughout the year. The studys goal is to evaluate how these digital interventions affect drinking behavior and reduce harm. Participation involves completing surveys and using the web programs as assigned, with ongoing monitoring of outcomes up to 12 months.

Researchers are evaluating the long-term effects of maridebart cafraglutide in adults with obesity or overweight. This extension study follows participants from a previous trial to assess the medications ongoing efficacy, safety, and tolerability over an extended period. The trial is designed as a phase 3 randomized and double-blind study to provide comprehensive information on treatment outcomes. Participants will receive different doses of maridebart cafraglutide administered by subcutaneous injection at varying intervals, including once every 4, 8, or 12 weeks. Some participants who received placebo or lower doses in the previous trial will undergo dose escalation or re-randomization to different dose groups or placebo. The study includes a dose-escalation phase for certain participants before initiating the assigned high dose. During the study, participants will be regularly monitored for changes in body weight compared to the original trial baseline, treatment-emergent adverse events, and serious adverse events. Additional assessments will track waist circumference, quality of life related to weight, and maintenance of weight loss. Participants are expected to complete visits and evaluations over approximately 48 weeks, with safety data collected up to 60 weeks from the start of the extension trial.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.