State College

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.

This research aims to understand how solo, inexperienced listeners perceive speech from people with amyotrophic lateral sclerosis ALS compared to age-matched speakers. It focuses on speech produced in both interactive and non-interactive situations with an unfamiliar conversation partner. The study is designed to explore whether the context of speech affects perception similarly across these two groups. Listeners will hear recorded vowels and consonants from people with ALS and age-matched speakers, produced in different task settings. Participants will use their own computers and headphones to listen remotely and respond by selecting one of four words displayed on their screen that best matches what they heard. The study uses a single group design where all listeners complete the same tasks. Participants will be recruited online and take part in one 20-minute session. They will be assessed on how well they understand the recorded speech, with performance monitored through attention checks to ensure engagement. The primary outcome is the intelligibility of the speech recordings. The study will analyze results using standard statistical methods to compare perceptions across contexts and groups.

Researchers are studying whether a brief, smartphone-based mindfulness program can help adults with generalized anxiety disorder GAD. This randomized controlled trial compares a 14-day mindfulness ecological momentary intervention MEMI with a self-monitoring placebo SMP to see if mindfulness training improves anxiety symptoms, attentional control, executive functioning, empathy, and perspective-taking. The study aims to fill gaps in knowledge about the benefits of short mindfulness therapies delivered via smartphone apps in people with GAD. Participants will be randomly assigned to either the MEMI group or the SMP group. Those in the MEMI group will receive prompts five times a day through a smartphone app to practice mindfulness skills such as open monitoring, acceptance, noticing small moments, and diaphragmatic breathing, plus bedtime reminders about mindfulness as a lifelong practice. The SMP group will also receive five daily prompts but will only practice self-monitoring of thoughts and feelings without mindfulness instructions. The intervention lasts for 14 consecutive days. Participants will complete self-report questionnaires and neuropsychological tests before treatment, after the 14-day intervention, and at a one-month follow-up. Researchers will measure changes in anxiety symptoms, perseverative thoughts, attentional control, working memory, set-shifting, inhibitory control, verbal fluency, empathy, interpersonal reactivity, and trait mindfulness. The study will use these assessments to evaluate the impact of the mindfulness intervention compared to self-monitoring over time.

Researchers are evaluating the impact of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health, and diet quality in adults with prediabetes. This 16-week randomized controlled trial compares two groups to understand how pecan snacking affects these health factors in individuals aged 25 to 65 years who have prediabetes and meet specific health criteria. Participants will be randomly assigned to one of two groups. One group will replace their usual snacks with 1.5 ounces of pecans daily, while the other group will continue their habitual diet. Both groups will be followed for 16 weeks, with the pecan group receiving pecans and the usual diet group receiving a grocery voucher of similar value. Testing will occur at the start and end of the study period to measure changes. Throughout the study, participants will undergo assessments including blood sugar tests such as HbA1c, heart health evaluations, and dietary intake reviews at baseline and after 16 weeks. Researchers will monitor various health markers such as glucose levels, cholesterol, blood pressure, insulin resistance, and diet quality. The study aims to gather detailed information on how pecan snacking influences these outcomes, with safety and adherence closely observed during the 16-week participation.

Researchers are studying the effects of a healthy diet containing different amounts of eggs on heart health in adults aged 30 to 60. This controlled feeding study compares a diet following the 2020-2025 Dietary Guidelines for Americans with either 2 eggs per day or 3 eggs per week. The study aims to see how these diets affect markers related to cardiovascular diseases over a 4-week period. Participants will follow two different dietary patterns in a randomized, crossover design. One diet includes 2 eggs per day per 2000 kcal intake HDE, and the other includes 3 eggs per week per 2000 kcal intake HD. Each diet phase lasts 4 weeks, and participants will switch diets during the study. The study is double-blinded and controlled to carefully evaluate the impact of egg consumption on heart health biomarkers. During the study, participants will undergo monitoring of several heart health indicators including LDL cholesterol, triglycerides, total cholesterol, HDL cholesterol, blood pressure, insulin levels, glucose, and other related measures. These will be collected after each 4-week dietary phase. Researchers will also track changes in body weight, dietary adherence, and safety parameters. The total participation period includes both diet phases with detailed assessments at regular intervals to measure cardiovascular function and metabolic responses.

Researchers are evaluating the effectiveness of the Building a Strong Identity and Coping Skills BaSICS program for low-income and minoritized youth aged 11 to 14 who are seeking mental health treatment and currently waitlisted for services. The study aims to confirm BaSICSs benefits by replicating earlier results, track changes in coping skills and symptom improvement during the program, and study biological stress responses related to anxiety, depression, and suicide risk. Participants are randomly assigned to one of two groups the BaSICS intervention group or a control group without intervention. The intervention involves 16 sessions held twice weekly, focusing on teaching coping strategies, healthy identity development, and collective social action to help manage chronic stress. Both groups complete assessments before and after the intervention, as well as follow-ups at 6 and 12 months. Participants will undergo evaluations of anxiety, depression, and suicide risk markers at multiple points, including before and after the intervention and during follow-ups at 6 and 12 months. Researchers will also measure coping skills acquisition, physiological stress responses via HPA reactivity profiles, collaborative coping, and sociocultural identity development. The total participation spans over a year with ongoing assessments to monitor changes and outcomes.

This research aims to evaluate the precision and reliability of three scanning devices the GE Lunar iDXA, Hologic Horizon W DXA, and the Stratec peripheral quantitative computed tomography pQCT scanner. The study focuses on measuring bone mineral content, bone geometry, and soft tissues in both inanimate objects and adults. It assesses variability in testing due to factors like day-to-day changes, technician differences, positioning, and different equipment, while also establishing the least significant change for these measurements and examining device strengths and limitations. Participants undergo precision testing using the DXA devices and pQCT scanner, which measure bone mineral density and body composition including fat mass and lean mass. The study uses standard protocols to scan regions prone to fractures or responsive to interventions. The pQCT provides 3D imaging to assess bone strength components separately. This testing helps ensure quality control and cross-calibration of scanners across sites. During the study, participants will have multiple scans performed to evaluate measurement reproducibility. Researchers will monitor scan precision and variability related to technicians and equipment. The primary outcomes include precision measurements and least significant change of bone mineral density and body composition within one month. The study spans multiple visits with no treatment administered, focusing on observation and data collection to build a database of test results and quality control procedures.

Researchers are evaluating a home visiting intervention aimed at improving cardiovascular health for mothers and their children. This cluster randomized clinical trial, called Early Intervention to Promote Cardiovascular Health of Mothers and Children ENRICH, is funded by the National Heart Lung & Blood Institute. It seeks to reduce disparities in maternal and early childhood cardiovascular health by working with community programs where cardiovascular disease risk factors are common. The study compares two groups one receiving home visits enriched with cardiovascular health promotion content and one receiving usual home visits without this added content. The enhanced intervention starts during pregnancy and continues until children turn 2 years old. It includes information on healthy eating, physical activity, weight management, tobacco use, sleep, and stress reduction. Participants also receive tools such as scales, Fitbits, and blood pressure monitors to help with self-monitoring, along with guidance on infant nutrition, feeding, growth, and emotional care. Participants include mother-child pairs recruited from evidence-based home visiting programs. Researchers will assess outcomes like parent physical activity, diet quality using the Mediterranean Eating Pattern for Americans scale, body mass index, and blood pressure at 12 months after birth. Child body mass index will also be measured at 24 months. The study uses double masking and randomization to assign groups. Participation involves regular home visits and monitoring over the first two years after birth, with study-related assessments during this time.

Researchers are studying the connection between endometriosis and a higher risk of cardiovascular disease in women. This study aims to understand the underlying mechanisms, focusing on inflammation and the role of the lectin-like oxidized LDL receptor LOX-1 in causing blood vessel dysfunction. The research explores how systemic inflammation from endometriosis may contribute to heart and blood vessel problems in affected women. Participants will receive either 3000 mg per day of salsalate, taken as 1500 mg twice daily for 5 days, or a placebo capsule with microcrystalline cellulose twice daily for 5 days. This study uses a randomized, crossover design, meaning participants will receive both treatments at different times. Salsalate is studied for its potential to reduce inflammation by blocking a key inflammatory pathway. During the study, participants will be monitored through various assessments including measurements of blood flow and blood vessel diameter, protein expression related to LOX-1 in blood and tissue samples, and analysis of reproductive hormones and inflammatory markers. These evaluations occur 5 days after treatment. The trial includes healthy women and women with endometriosis between 18 and 45 years old. Safety and response to treatment will be closely followed throughout the study period, which is expected to complete by the end of 2026.

This research aims to understand how communicative interaction affects verbal communication in people with amyotrophic lateral sclerosis ALS compared to age-matched adults. The study explores differences in speech production across various tasks to clarify the impact of ALS-related speech difficulties. It is designed as a single-group study involving both people with ALS and age-matched speakers. Participants will complete one solo speech production task and three interactive tasks involving structured and unstructured communicative interactions, using tablets and audio recording devices at home. They will work with unfamiliar interlocutors during these tasks, which include reading words and sentences with instructions to overenunciate in some cases. Speech will be recorded both locally and remotely via videoconferencing. During the study, participants will perform speech tasks in sessions lasting about 60 minutes each. Researchers will analyze speech features such as formant frequencies, intelligibility, syntactic and pragmatic properties, and speech sound duration. The study uses statistical models to assess effects and variability, with participation expected to involve remote guidance and feedback over the course of the sessions.