State College

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 studying how people without prior experience communicating with individuals who have amyotrophic lateral sclerosis (ALS) perceive the speech of people with ALS compared to age-matched speakers. The study focuses on speech produced in both interactive and non-interactive settings to understand if these contexts affect how speech is understood. This research aims to explore differences in speech perception related to ALS using a behavioral approach. Participants in the study will listen remotely to recorded speech samples from people with ALS and age-matched speakers. These recordings include vowels and consonants produced during different tasks reflecting interactive and non-interactive situations. Listeners will use their own computers and headphones to hear the recordings and select which word they heard from four options shown on the screen. Attention checks and performance thresholds will be used to ensure participants are engaged and providing reliable responses. The study involves a single group of about 1300 listeners recruited online through the Prolific platform. Participants will complete one 20-minute session where their ability to understand recorded speech will be measured. The main outcome is how clearly the recorded speech is understood by the listeners. Researchers will analyze the perceptual judgments to compare effects across speech contexts and participant groups, aiming for strong statistical power to detect meaningful differences.

Researchers are evaluating a brief smartphone-based mindfulness therapy to understand its effects on people with Generalized Anxiety Disorder (GAD). This study addresses the lack of evidence for short mindfulness treatments delivered through smartphones, despite their growing use and the existing mental health treatment gap. The trial also explores whether mindfulness can improve attention control, executive functioning, perspective-taking, and social skills in this group. Participants will be randomly assigned to one of two groups. The treatment group uses a mindfulness ecological momentary intervention (MEMI) via the Personal Analytics Companion (PACO) app, which prompts them five times daily for 14 days to practice core mindfulness strategies like open monitoring, acceptance, paying attention to small moments, and slow diaphragmatic breathing. They also receive a bedtime reminder that mindfulness is a lifelong practice. The comparison group uses a self-monitoring placebo (SMP) on the same app with prompts to notice thoughts and rate distress without mindfulness training. Both groups practice five times a day for 14 days. Participants will complete self-reports and neuropsychological assessments before the treatment, immediately after the 14-day period, and again at one-month follow-up. Researchers will measure changes in anxiety symptoms, worry, negative thinking, attention control, executive functions, mindfulness, empathy, and perspective-taking. The study aims to find if MEMI leads to greater improvements compared to SMP in these areas, helping to understand the benefits of brief, technology-assisted mindfulness therapy for anxiety.

This research aims to explore how different healthy diets containing eggs affect heart health markers in adults aged 30 to 60 years. It focuses on comparing a diet with 2 eggs per day to one with 3 eggs per week, following the 2020-2025 Dietary Guidelines for Americans, and targets individuals with certain cholesterol, blood pressure, and metabolic profiles. The study is classified as Phase 3 and involves people with cardiovascular concerns who meet specific health criteria. Participants will follow two different dietary patterns in a randomized crossover design. One diet includes 2 whole large Grade A eggs per day per 2000 kcal, while the other includes 3 eggs per week per 2000 kcal. Each diet period lasts 4 weeks, during which participants consume controlled meals adhering to these egg intake levels. After completing one diet phase, participants switch to the other diet, allowing direct comparison within the same individual. During the study, researchers will monitor changes in LDL cholesterol after each 4-week diet period. Participants' blood pressure, fasting blood glucose, triglycerides, and body weight changes are also considered. The study excludes people with certain medical conditions or medication use that could affect results. Total participation includes screening and two 4-week diet periods with detailed dietary control and health monitoring.

Researchers are investigating two digital stress reduction programs tailored for first-year college students: a personalized mindfulness program called Equa and a problem-solving based stress management program called Coping Control. The study aims to compare these two approaches, focusing on their effects on student stress levels, mental health, sleep duration, and academic performance over the course of the spring 2026 semester. This randomized controlled trial includes 200 participants from Carnegie Mellon University, the University of Notre Dame, Columbia University, and Pennsylvania State University. Participants will be randomly assigned to complete 14 days of smartphone audio-guided lessons in either the Equa mindfulness program or the Coping Control stress management program. Both are evidence-based behavioral interventions, with Equa focusing on attention monitoring, acceptance, concentration, and clarity, and Coping Control emphasizing problem-solving for cognitive coping. Throughout the semester, participants will wear a Fitbit device to track sleep and physical activity. Before starting the intervention, students will complete baseline assessments of stress, psychological well-being, and health behaviors, as well as daily diaries for 7 days. They will continue daily diaries for 7 days after finishing the 14-day program. Additional online surveys will be completed within 10 days after the intervention and at the semester's end. Researchers will measure adherence to the programs, app engagement, user satisfaction, changes in perceived stress and depressive symptoms, sleep duration, and grade point averages to evaluate the impact of each intervention.

Researchers are evaluating the effectiveness of the Building a Strong Identity and Coping Skills (BaSICS) program in low-income and minoritized youth aged 11 to 14 who are seeking mental health treatment and are on a waitlist for services. The study aims to confirm previous findings on BaSICS, observe changes in coping mechanisms and symptoms throughout the intervention, and explore biological stress responses related to anxiety, depression, and suicide risk. Participants will be randomly assigned into two groups: one group will take part in the BaSICS program, which is a psychoeducational behavioral intervention designed to teach coping skills, promote healthy identity development, and encourage collective social action; the other group will not receive the intervention. Each group will consist of 10 participants per cohort, with multiple cohorts enrolled over the study period. During the study, researchers will assess anxiety, depression, and suicide risk markers at the start, after 3 months, and during follow-ups at 6 and 12 months. They will also measure changes in coping skills and physiological stress responses to understand the biological impact of the program. The total participation timeline includes initial evaluation, intervention or control period, and follow-up assessments to monitor long-term effects.

Researchers are evaluating the precision and reliability of three imaging technologies: the GE Lunar iDXA, Hologic Horizon W DXA scanners, and the Stratec peripheral quantitative computed tomography (pQCT) scanner. These devices measure bone mineral density, bone geometry, and body composition, important for understanding conditions like osteoporosis and obesity. The study aims to assess variability due to factors such as different technicians, scanning equipment, positioning, and post-scan processing, as well as to determine the least significant change for bone and soft tissue measurements. It also seeks to identify strengths and limitations of these devices and to build a quality control database for future research use. Participants will undergo precision testing involving multiple scans using the DXA and pQCT devices. No active treatments are administered; the study observes the reproducibility of measurement results from these imaging methods. Testing will assess within-day and between-day variability, technician differences, and equipment comparisons. The study includes healthy adults from two age groups: 18 to 40 years and older than 40 years. Throughout the study, participants will receive multiple scans to evaluate the consistency of bone and body composition measurements. Researchers will monitor data such as bone mineral density, bone geometry, fat mass, and lean mass. The study involves careful positioning and scanning by trained technicians to ensure data quality. Outcome measures focus on precision within one month. Safety considerations include monitoring radiation exposure, which is low and justified by the benefits of validating the scanning devices for clinical and research use.

Researchers are studying cardiovascular health in mothers and their children through a trial called ENRICH, funded by the National Heart Lung & Blood Institute. The trial aims to test whether a home visiting program can improve heart health and reduce health differences in mothers and young children. The study involves 3309 mother-child pairs from various communities where heart disease risk is high. The study compares two groups: one receives the ENRICH intervention, where home visitors provide heart health education and activities during visits starting in pregnancy and continuing until the child turns 2 years old. This includes guidance on healthy eating, physical activity, weight management, tobacco use, sleep, and stress reduction. Participants also receive tools like scales, Fitbits, and blood pressure monitors for self-checking. The comparison group receives usual home visits without heart health content. Participants will be involved from pregnancy through their child's early years, with home visits to deliver the intervention. Researchers will measure parents' physical activity, diet quality using the Mediterranean Eating Pattern for Americans scale, body mass index, and blood pressure 12 months after birth. This helps assess how well the program supports heart health in mothers and children over time.

Researchers are investigating the connection between endometriosis and increased risk of cardiovascular disease in women aged 18 to 45. Endometriosis is an inflammatory condition where tissue similar to the uterine lining grows outside the uterus, causing pain and infertility. The study focuses on understanding how inflammation and a receptor called LOX-1 contribute to cardiovascular problems in women with this condition. Participants will receive either a drug called salsalate, which reduces inflammation by blocking a specific pathway (NFkB), or a placebo. The study compares the effects of these treatments on cardiovascular health markers related to blood vessel function and inflammation. The treatments are evaluated over a five-day period after administration. During the study, women's blood flow, artery size, and levels of specific proteins related to inflammation and cardiovascular health will be measured. Researchers will collect blood samples and tissue biopsies to assess changes in the LOX-1 receptor and other indicators. The primary outcomes focus on vascular conductance, artery diameter, blood flow velocity, and LOX-1 protein expression five days after treatment.

Researchers are studying how communicative interaction affects verbal communication in people with amyotrophic lateral sclerosis (ALS) compared to age-matched adults without ALS. The goal is to understand differences in speech when participants speak alone versus during interactive communication. This research includes people with ALS and similar-aged adults to explore how speech challenges impact communication. Participants will complete four speech tasks: one solo clear speech task and three interactive tasks involving structured and unstructured communicative interactions with an unfamiliar person. During these tasks, participants use tablets and audio devices to record their speech at home. The study involves pairs where one person speaks and the other listens, responding to prompts like clicking on a word or identifying differences in pictures, with feedback provided after each trial. Participants will be recorded and assessed through video conferencing, with speech analyzed for clarity, speech sound duration, and language features across multiple one-hour sessions. The study will measure formant frequencies, intelligibility, syntax, pragmatics, and duration of speech sounds. The trial aims to enroll 100 people with ALS and 50 age-matched adults to compare speech patterns and better understand communication difficulties in ALS.