All Clinical Trials

This study evaluates whether adding a polygenic risk score evaluation to standard breast cancer risk assessment tools helps African American and Hispanic women make more informed decisions about accepting additional breast cancer screening and prevention strategies. Traditional breast cancer risk assessments rely mostly on the presence of standard clinical risk factors including family history, reproductive history, and mammographic breast density. This information can be combined with validated risk estimation models to provide a measure of a patient's 10 year and lifetime risk for breast cancer. A polygenic risk score helps to estimate breast cancer risk in a more individualized way by evaluating a patient's genetics. Adding a polygenic risk score evaluation to traditional screening techniques may help minority women make more informed decisions about screening and prevention strategies for breast cancer. Read Less

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management. It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere. The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. Read Less

This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to: 1. compare the efficacy, and 2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC). Participants in the intervention group will receive aPDT prior to surgery on the day of surgery. Participants in the control group will receive standard of care surgical site prevention measures prior to surgery. Read Less

Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas. Read Less

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine. Read Less

Type 1 Diabetes carries high burden for affected youth and their families. Advances in insulin therapy and technology have been associated with increased obesity with 1/3 adolescents being overweight/obese. Since obesity runs in families and carries risk for poor outcomes psychologically and medically, the investigators are adapting our successful evidence-based Family Based Treatment for hybrid delivery to improve obesity and metabolic control in the affected youth and improve obesity and related co-morbidities in their parents. Read Less

The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings. Read Less

The combination of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) has been suggested as a promising brain imaging tool for identifying biomarkers of brain health. In this pilot study, study investigators will explore the neurophysiological metrics of brain health with a non-invasive brain imaging technique, alongside behavioral and fMRI metrics collected through another study (NCT04869111). Read Less

Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States. These rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. Due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients. In the last few years, several genes for CGL (AGPAT2, BSCL2, CAV1 and PTRF); FPL (LMNA, PPARG, AKT2, CIDEC, LIPE, PLIN1, PCYT1A and ADRA2A); MAD (LMNA and ZMPSTE24); APS (LMNA); autoinflammatory (PSMB8); NPS (FBN1, CAV1); SHORT syndrome (PIK3R1); and MDP syndrome (POLD1) have been identified. However, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality. To overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic or acquired lipodystrophy syndromes. Patients will be assessed on a yearly basis for approximately 5 to 7 years to collect robust clinical, metabolic, morbidity and mortality data. Medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. Clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available. Read Less

Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures. Read Less

Sickle cell disease (SCD) is associated with significant morbidity and mortality. Pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. Recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. Gut dysbiosis has been linked to inflammation in certain diseases. Omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. The aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease Read Less

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. Read Less