Binghamton

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of TP-05 in healthy adults who are at high risk of tick exposure and Lyme disease. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how TP-05 performs compared to a placebo in preventing Lyme borreliosis. The study enrolls adults aged 18 to 70 years who are overtly healthy and able to comply with study procedures. Participants will be randomly assigned to receive either a low dose or high dose of TP-05 or a matching placebo, all administered orally according to a predefined dosing schedule. The study includes a screening period, a treatment period lasting up to 24 weeks, and a safety follow-up period. During treatment, participants will be monitored closely for any adverse effects and signs of Lyme borreliosis. Throughout the study, participants will undergo safety assessments including monitoring of adverse events, clinical laboratory tests, vital signs, physical exams, and electrocardiograms. Researchers will follow participants for approximately 15 months to track safety outcomes and any tick bites or symptoms of Lyme disease. Key measures include changes from baseline in laboratory results, vital signs, and ECG parameters, ensuring thorough safety evaluation over the study course.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating the Freenome Multiomics Blood Test as a tool to help detect lung cancer earlier in people at high risk. This prospective, multi-center observational study involves participants eligible for standard lung cancer screening using a low-dose computed tomography (LDCT) scan. The study collects blood samples and compares the test's results with routine screening to see how well the blood test detects lung cancer over time. Participants who qualify and consent will have 50 ml of blood drawn for analysis by Freenome or its designee. Blood collection is done within 30 days of consent, and ideally on the same day as the LDCT screening, but up to 45 days after blood collection is allowed for the scan. The study collects detailed clinical and demographic information, including medical history, lifestyle, family history, and exposure risks, along with diagnostic and follow-up imaging and pathology reports related to lung cancer diagnosis. Participants will be followed for at least 24 months from their initial screening CT scan or until early study exit due to withdrawal or death. The researchers will monitor the sensitivity and specificity of the blood test in detecting lung cancer during this period. All clinical data, imaging, lab tests, and outcomes related to lung cancer diagnosis will be carefully recorded and analyzed to evaluate the blood test's performance.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are evaluating two ways to deliver the Otago Exercise Program (OEP), a fall prevention exercise routine for older adults. The study focuses on community-dwelling adults aged 55 and older who are at intermediate or high risk of falling. The goal is to compare a smartphone-based home exercise program with an in-person group exercise program to see which is more effective and user-friendly. The study also aims to support better implementation and adherence to fall prevention exercises in the community. Participants will be randomly assigned to either a remotely delivered, smartphone-based OEP or an in-person, community-based OEP at a senior center. Both groups will receive individualized 60-minute training sessions twice a week for eight weeks, totaling sixteen sessions. The smartphone group will use an app to track and review exercises, with weekly phone check-ins for support. The community group will exercise together with supervision from physical therapy students and licensed therapists. Before and after the exercise program, participants complete surveys and physical tests measuring balance, mobility, depression, and confidence related to falls. Gait speed will be monitored weekly using smartphone measurements. All assessments are done by staff blinded to group assignments. The study measures include changes in walking speed and other functional outcomes to evaluate program effectiveness and participant experience.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

This research aims to understand how infants of mothers with postpartum major depression develop attentional biases toward emotional facial expressions. The study explores whether infant arousal plays a role in these attentional patterns, which may be a risk mechanism linked to maternal depression. It focuses on comparing infants from mothers with a history of major depressive disorder to those without any depressive or psychiatric diagnoses. Infants participate in two main tasks. In the Passive Viewing Task, infants view different emotional faces (angry, happy, sad, neutral) while an eye tracker records their gaze. In the Interaction Task, mothers and infants engage in a three-stage interaction lasting three minutes each: a normal play session, a period where mothers simulate sadness and limit interaction, and another normal play session. These tasks help assess infant gaze and physiological responses. Participants are evaluated at the start and followed up at 3, 6, 9, and 12 months. Researchers measure eye gaze during both tasks and monitor infant heart rate and respiratory sinus arrhythmia as indicators of physiological response. The study includes assessments of infant attention and arousal, with careful monitoring to understand the development of attentional biases over time.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.