Reading

Researchers are investigating how a fruit and vegetable prescription (F&V Rx) program affects adults with type 2 diabetes, especially those from low-income, Hispanic communities. The study focuses on whether providing vouchers for fruits and vegetables can improve attendance and retention in diabetes self-management education and support (DSME/S), as well as improve diet quality and blood sugar control. This pilot randomized controlled trial will help design future studies by exploring different ways of linking F&V prescriptions to DSME/S attendance. The study includes three groups: one receiving usual care, one receiving usual care plus F&V prescriptions independent of DSME/S attendance, and one receiving usual care plus F&V prescriptions tied to DSME/S attendance. The intervention lasts 16 weeks, during which participants receive up to four fruit and vegetable prescriptions. The research team will also assess how well the program fits the community, how acceptable it is to participants and providers, and how sustainable it may be. Participants will be adults aged 18 or older with type 2 diabetes and elevated blood sugar levels, recruited from a medical center. They will provide blood samples and respond to contacts over the study period. Researchers will monitor diabetes education attendance, dietary intake, blood sugar changes, and program experiences. The study will last 16 weeks, with ongoing assessments to evaluate the impact of the F&V Rx program on diabetes management and participant outcomes.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

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 prospective, multi-center, randomized, quadruple-blind, and sham-controlled, aiming to assess CCM therapy delivered through the OPTIMIZER Smart Mini System. The study is divided into two parts: Part I focuses on safety and effectiveness based on functional capacity and health status, while Part II focuses on clinical outcome data. Participants will have the OPTIMIZER Smart Mini System implanted and then be randomized in a 2:1 ratio to either have CCM therapy turned ON or OFF for the first 18 months, during which the trial is blinded. CCM therapy is programmed to deliver seven one-hour treatment phases evenly spaced over 24 hours. After 18 months, participants initially assigned to the CCM OFF (sham) group will have the therapy turned ON. Subjects enrolled in Part I will continue to be followed through Part II to contribute data for safety and effectiveness evaluation. Throughout the study, participants will undergo various assessments including the 6-minute walk test and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to measure changes in functional capacity and health status at 6 months. Safety will be monitored by tracking device- or procedure-related complications up to 12 months. The study also measures a composite of mortality, morbidity, and health status outcomes over an 18-month period. Follow-up and monitoring continue throughout the study duration to capture these outcomes and ensure participant safety.

Researchers are evaluating an intervention called iCHART (integrated Care to Help At-Risk Teens) aimed at reducing suicidal behavior and depression in adolescents aged 12 to 18. This study is part of a larger effort within the ETUDES Center grant focusing on treatment development for risk factors such as sleep problems, anhedonia, and cybervictimization-related stress. The trial will enroll 900 adolescents and compare the iCHART intervention to treatment as usual (TAU), with the goal of decreasing suicide-related events by 50%. The study also aims to assess barriers and facilitators to implementing iCHART and a predictive algorithm to promote health equity across diverse populations. iCHART consists of three components: a Safety Planning App called BRITE to help primary care providers deliver emotion regulation and safety plans to suicidal youth via phone; a Mental Health Screener questionnaire to tailor referrals and treatment plans based on symptoms, preferences, and readiness; and personalized text messages sent for 2-3 weeks to encourage engagement with safety plans and recommended treatments. Participants randomized to the TAU group will receive usual care, which may include a paper safety plan. The study will assess the effectiveness of iCHART in reducing suicide-related events at 6 months, as well as examine mediators like referrals, treatment engagement, and safety planning. Participants will be involved in assessments at baseline and follow-ups at 1, 3, 6, and 12 months to measure depression severity and suicidal ideation and behavior. Researchers will also review electronic health records to assess safety planning and treatment engagement. The study includes evaluation of implementation outcomes such as acceptability, feasibility, appropriateness, and cost of iCHART and the predictive algorithm. Caregivers or parents must be involved as legal guardians, and participants need access to a phone or tablet to use intervention components. Overall participation covers multiple months with ongoing monitoring and support.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating the impact of an electronic medical record clinical decision support (CDS) tool on managing blood sugar abnormalities, including high and low glucose levels, in hospitalized adults with or without diabetes. The study aims to assess how this tool affects clinical outcomes, hospital length of stay, economic factors, and healthcare providers' knowledge and practice in both academic and community hospitals. This tool is designed to support clinicians in recognizing and treating glucose abnormalities without overriding their judgement. The study lasts 36 months and alternates between six 3-month periods when the CDS tool is active (ON periods) and six 3-month periods when it is inactive (OFF periods). During ON periods, the tool automatically detects gaps in diabetes care from patients' electronic medical records and sends alert messages with care recommendations to inpatient providers in real time. During OFF periods, the tool records these care gaps but does not send alerts to providers. Participants are hospitalized or ambulatory adults over 18 years old at several hospitals within the Penn State Health system. Researchers will measure outcomes including the average hospital length of stay up to 3 months. Providers' perspectives, knowledge, and practice performance related to glucose management will also be evaluated. Data collection occurs throughout the 36 months, allowing comparison of clinical, economic, and provider-related outcomes between periods with and without the CDS tool.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.