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Researchers are evaluating a fruit and vegetable prescription F&V Rx program designed to improve diabetes management among low-income Hispanic adults with type 2 diabetes. The study aims to test how F&V prescriptions affect participation in diabetes self-management education and support DSMES, fruit and vegetable intake, diet quality, blood sugar control measured by hemoglobin A1c, and the programs acceptability and sustainability. This pilot randomized controlled trial addresses gaps in understanding the role of F&V prescriptions combined with DSMES attendance in diabetes care. The study includes three groups one receiving usual care, one receiving usual care plus four monthly F&V Rx vouchers regardless of DSMES attendance, and one receiving usual care plus F&V Rx vouchers contingent on monthly DSMES group attendance over 16 weeks. Participants in the intervention groups receive vouchers to purchase fruits and vegetables at local stores. The trial tests the impact of these approaches on education uptake and retention as well as health and dietary outcomes. Participants will attend study visits at the beginning and end of the 16-week period for assessments including blood samples for A1c and plasma carotenoids, dietary intake surveys, and diabetes self-management questionnaires. Researchers will monitor voucher use, DSMES attendance, and collect feedback from both participants and care providers to evaluate program implementation. The study is conducted with cultural adaptations and community involvement to support relevance for Hispanic adults with type 2 diabetes.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure who have a left ventricular ejection fraction LVEF between 40% and 70%. This clinical trial is designed as a multi-center, randomized, quadruple-blind, sham-controlled study to compare CCM therapy delivered through the OPTIMIZER Smart Mini System against a sham control. The trial includes two parts the first focuses on functional capacity and health status, while the second examines clinical outcomes. Participants will have the OPTIMIZER Smart Mini System implanted and be randomly assigned in a 21 ratio to either receive active CCM therapy CCM ON or sham therapy CCM OFF for the first 18 months. CCM therapy involves delivering seven one-hour treatment phases spread evenly over each 24-hour period. After 18 months, those initially in the sham group will have CCM therapy activated. Part I of the trial enrolls 450 participants, who will be followed through Part II, which includes up to an additional 1,050 participants. During the study, participants will undergo screening and baseline evaluations before device implantation. Researchers will assess changes in walking distance using a 6-minute walk test and health status via the Kansas City Cardiomyopathy Questionnaire at 6 months. Safety will be monitored by tracking device- or procedure-related complications over 12 months. The study will also evaluate a composite of mortality, morbidity, and health status outcomes up to 18 months. The total duration of participant involvement spans up to 18 months with ongoing follow-up and monitoring.

Researchers are evaluating the effectiveness of the iCHART integrated Care to Help At-Risk Teens intervention for adolescents aged 12 to 18 who are experiencing depression or suicidal behavior. This study aims to reduce suicide-related events by comparing iCHART to usual treatment in a randomized controlled trial including 900 participants. The study also examines factors that affect treatment response and uses implementation science to assess barriers, facilitators, and outcomes like acceptability and feasibility to support health equity. iCHART combines three main parts a Safety Planning App that helps providers deliver care through an app instead of paper, a Mental Health Screener questionnaire to personalize treatment plans, and a series of text messages over 2 to 3 weeks to encourage engagement with safety plans and treatment. Participants are randomly assigned to either receive iCHART or treatment as usual, which may include a paper safety plan and standard care from their providers. Participants will be actively involved through mental health assessments at baseline and follow-up points up to 12 months, including evaluations of depression severity and suicidal thoughts and behaviors. The study also tracks service use, app usage, and participants views on the interventions acceptability, usability, feasibility, and appropriateness. This comprehensive monitoring helps understand how well iCHART works and informs future use in pediatric care settings.

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 the impact of an electronic medical record clinical decision support CDS tool on controlling abnormal blood sugar levels, known as dysglycemia, in hospitalized patients with diabetes or stress-related hyperglycemia. The study aims to examine how this tool affects clinical outcomes, hospital costs, and healthcare providers knowledge and practice performance in both academic and community hospital settings. This research involves non-intensive care patients and explores the tools influence on improving hospital care delivery and reducing complications related to high glucose. The study uses an innovative alert-CDS tool integrated into the electronic medical record system. This tool automatically identifies dysglycemia and inadequate insulin use, then sends alerts with treatment recommendations to healthcare providers during active phases of the study. The trial alternates between six active 3-month periods when alerts are sent and six inactive 3-month periods without alerts, covering a total of 36 months. During inactive periods, data on care gaps are collected but alerts are not shown. This setup allows comparison between standard care and care supported by the alert-CDS tool. Participants include adult patients hospitalized or receiving ambulatory care at several hospitals within the health system. The study tracks multiple outcomes such as hospital length of stay, glycemic control measures, rates of complications, mortality, hospital resource use, and economic impacts. Provider perspectives and decision-making related to dysglycemia management are also assessed through surveys. The total observation period spans up to three months per hospital admission, with some measures extending up to a year after discharge.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

This research aims to evaluate the impact of offering self-sampled human papillomavirus HPV tests to increase participation in cervical cancer screening among female patients aged 30 to 65 at a residency clinic. The study compares the acceptability and completion rates of self-sampled HPV tests versus clinician-sampled tests and measures any increase in overall cervical cancer screening rates within the clinic population. The purpose is to understand if self-sampling can improve screening participation. Participants who are due for cervical cancer screening will be offered a choice to take a self-sampled HPV test after their appointment, schedule an in-person screening for a later date, or decline screening at this time. Those who choose self-sampling receive a test kit with instructions, a lab requisition form, and a pre-paid envelope to return the sample to the lab. Scheduled in-person screenings are arranged at checkout if chosen. Results from the self-sampled tests are sent securely to the clinic and recorded in medical records, with follow-up care arranged based on HPV risk levels. During the study, participants test requests and completions are tracked, and medical records are updated with test results and follow-up actions. Patients are contacted for additional procedures if their test shows high-risk or low-risk HPV. The study measures the number of patients requesting and completing tests over 12 months and assesses changes in cervical cancer screening rates three months after enrollment ends. Participation involves minimal additional visits, focusing on choice and follow-through with screening options.