Salisbury

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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.

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.

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 evaluating the WearME systems effectiveness in monitoring the severity and respiratory function of people with Chronic Obstructive Pulmonary Disease COPD. This observational study compares the systems measurements with standard clinical assessments such as spirometry and capnography. The study aims to provide innovative technology access to underserved patients in low-income, rural, and diverse ethnic communities in the Mid-Atlantic region to help detect early signs of worsening lung function and reduce hospital readmissions. Participants will wear the WearME device during a data collection session lasting 145 minutes. The study will assess parameters including forced expiratory volume FEV1, forced vital capacity FVC, respiratory rate, heart rate, inspiratory to expiratory IE ratio, spinal range of motion ROM, and activity levels. The WearME-Pro systems measurements will be compared to gold standard FDA-cleared devices used in clinical practice. Up to 128 COPD patients will be grouped by severity using the GOLD standard and monitored simultaneously with the WearME-Basic and WearME-Pro systems. During the study, participants will wear the device while undergoing reference testing with standard medical devices. Researchers will evaluate the agreement between WearME-Pro and standard devices for lung function measures and validate the WearME-Basic system for vital signs and activity accuracy. The primary outcome focuses on the agreement of FEV1FVC measurements, with secondary outcomes assessing respiration rate, heart rate, IE ratio, and ROM accuracy. The total participation involves a single data collection period and associated clinical assessments, with monitoring conducted within six months of study start.

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.

Amyotrophic Lateral Sclerosis ALS is a serious neurodegenerative disease where motor neuron cells in the brain and spinal cord gradually deteriorate and die, leading to severe physical decline. Since there is currently no cure, this study focuses on understanding factors that affect the quality of life QoL for people diagnosed with ALS. Researchers aim to explore how physical functioning and disease stage relate to patients reported quality of life over time, addressing gaps in knowledge about these impacts. This is a prospective, longitudinal observational study conducted at TidalHealth Peninsula Regional. Participants will complete the Amyotrophic Lateral Sclerosis Assessment Questionnaire ALSAQ-40 for quality of life every other routine clinic visit, while their physical function will be measured at every visit using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised ALSFRS-R. Disease severity will also be assessed regularly using the Kings Clinical Severity Staging System. The study will continue for up to two years. During the study, participants will attend their usual care clinic visits where standard evaluations of function and disease stage will be recorded. They will complete quality-of-life questionnaires at alternating visits over the two-year period. Researchers will analyze the relationship between functional scores and quality of life scores and how disease progression affects this link. This study helps identify factors influencing life quality in ALS patients while monitoring changes over time under typical clinical care.

Chronic low back pain LBP is a leading cause of disability worldwide and a major contributor to healthcare costs and opioid use in the United States. This trial evaluates how to improve physical therapy access and effectiveness for patients with chronic LBP living in rural communities, where barriers such as provider availability, transportation, and missed work limit care. The study aims to compare risk-informed telerehabilitation approaches to standard educational methods to better match treatment to patient risk of poor outcomes. Participants will be randomized to either a standardized education group receiving web-based evidence-based information and exercises for self-management or a risk-informed telerehabilitation group receiving tailored video physical therapy visits based on a psychosocial risk screening tool. The telerehabilitation group includes either standard physical therapy telehealth visits or psychologically informed physical therapy telehealth visits depending on risk level. Treatments last 8 weeks, with education delivered via a secure website and telerehabilitation via video visits. Participants will attend primary care clinics serving rural areas and provide informed consent before randomization. Outcomes include changes in disability related to LBP measured by the Oswestry Disability Index and opioid use after 12 weeks. Additional assessments include physical function, quality of life, and healthcare use up to one year. The study also gathers feedback from patients and providers through surveys and interviews to understand implementation and barriers. The total study period extends through 2028.

This trial evaluates inclisiran, a subcutaneous injection given twice yearly, for preventing major cardiovascular and limb events in patients who have undergone percutaneous coronary intervention PCI or peripheral endovascular intervention PVI. The study focuses on patients with atherosclerotic cardiovascular disease, including coronary artery disease and peripheral artery disease, aiming to assess inclisirans role alongside standard care in real-world settings. It is a randomized, double-blind, placebo-controlled, phase 4 study involving about 6,000 participants. Participants will receive either 300 mg of inclisiran or a matching placebo by subcutaneous injection on Day 1 within 14 days of their intervention, at Month 3, and then every 6 months thereafter. The study compares inclisiran to placebo while all participants continue their usual care prescribed by their physicians. The treatment duration varies with event accrual and follow-up but is expected to last approximately 4 years, with individual participants receiving treatment for up to about 45 months. Throughout the study, participants will be regularly monitored for major adverse cardiovascular events MACE and major adverse limb events MALE up to about 4 years from randomization. Additional assessments include tracking cardiovascular death, all-cause death, and venous thromboembolic events. The study includes safety monitoring and follow-up visits to evaluate the outcomes and adherence to the intervention and usual care during the entire study period.

Researchers are evaluating the IntraOsseous BioPlasty4 IOBP4 surgical technique to treat subchondral bone pathology SBP in the knee. This prospective, multicenter clinical study includes both male and female patients aged 18 to 60 years who have symptomatic SBP that has not improved with conservative treatments. The main goal is to assess whether IOBP4 can prevent the need for additional knee surgeries such as knee replacement, high tibial osteotomy, or calcium phosphate stabilization over a five-year period. The study involves subjects receiving the IOBP4 procedure, which includes injecting a biologic mixture of bone marrow concentrate and allograft into the subchondral bone lesion of the knee. Participants are identified from the investigators patient population and must be scheduled for this surgical intervention. This observational study monitors patients over time to evaluate outcomes related to the treatment of SBP. Participants will undergo regular assessments including pain measurement using the Visual Analog Pain Scale at multiple time points from before surgery up to five years after. Knee function and symptoms will be evaluated using the International Knee Documentation Committee Subjective Knee Evaluation Form and the Knee Injury and Osteoarthritis Outcome Score KOOS. Imaging studies such as X-rays and MRI will be performed at six months and one year to monitor the knee condition. Safety monitoring focuses on adverse events and the need for further surgery during the five-year follow-up period.