Winfield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease PD under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participants needs. During the study, participants will complete Parkinsons Disease diaries to track On and Off motor states, and researchers will measure changes in Good On time and Off time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

This observational study focuses on people with Parkinsons disease who continue to have movement symptoms despite taking standard Parkinsons medications. Researchers aim to better understand how the disease progresses over time, the challenges faced by patients and their care partners, and how current treatments work in real life. The study is designed to fill gaps in knowledge by following patients longer and collecting comprehensive information. Participants will continue their usual treatments as determined by their doctors, without any investigational drugs or changes to their care plans. Data will be collected from patients and care partners through questionnaires, medical records, digital movement tracking devices, blood samples, and skin biopsies. The study includes a single group of patients with motor complications and their care partners. Participants will be followed for up to five years, with data collected on demographics, medical history, medications, movement and non-movement symptoms, genetics, and the burden of care. Researchers will use rating scales, diaries, and logs to assess symptoms and quality of life. The main outcomes include summaries of motor and non-motor symptoms, treatments received, and psychological and economic impacts on care partners.

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.

Researchers are studying very low-risk and low-risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer, to maintain excellent treatment outcomes while reducing therapy burdens. This phase III trial also evaluates how well patients with certain DNA mutations respond to different chemotherapy regimens and examines the use of centralized molecular risk stratification in treatment planning. The study aims to improve outcomes by adjusting therapy intensity based on molecular features. Patients are assigned to one of three treatment regimens based on their risk level and mutation status. Very low-risk patients receive vincristine and dactinomycin over 24 weeks in 8 cycles. Low-risk patients receive 12 weeks of vincristine, dactinomycin, and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin, totaling 8 cycles. Patients with MYOD1 or TP53 mutations switch to an intensified 12-13 cycle regimen including vincristine, dactinomycin, and cyclophosphamide. Radiation therapy may be given at cycle 5 for some patients. Treatments are administered intravenously every 21 days. Throughout the study, participants undergo CT scans, MRI, bone scans, PET scans, and tumor biopsies to monitor disease status. Blood and tissue samples are collected at various times for research purposes. Researchers measure failure-free survival and overall survival over several years to assess treatment success. The trial lasts up to five years with ongoing assessments to track patient outcomes and safety.

This research aims to analyze data from the Fitbit wearable device to predict infections after surgery in children with complicated appendicitis. The study focuses on how this prediction affects clinical decision-making, time to first contact with healthcare, and postoperative healthcare use. The study involves children aged 3 to 18 who have undergone laparoscopic appendectomy for complicated appendicitis, with the goal of improving early infection detection and patient care. Participants will wear Fitbit devices that collect heart rate, physical activity, and sleep data in near-real time. Machine learning methods will be applied to this data to develop and validate an algorithm that detects postoperative infection. The study has two main parts first, developing and validating the infection prediction algorithm using Fitbit data second, assessing how access to real-time infection alerts influences clinicians decisions and healthcare use. This includes daily reports and alerts sent to surgeons for patients in the implementation phase. Throughout the study, Fitbit data and daily symptom diaries will be collected for 30 days from enrollment to monitor recovery. Researchers will analyze changes in physical activity, heart rate, sleep patterns, symptom reports, healthcare visits, and clinician decision-making. The study includes surveys and qualitative assessments to understand the impact of Fitbit data on care. Participants are monitored for postoperative infection and healthcare utilization during this period, supporting early detection and improved management.

Researchers are investigating how walking in different outdoor environments affects psychological and physiological stress in adults with prediabetes. This randomized crossover trial compares the effects of walking in urbansuburban nature areas versus built commercial environments. The study aims to understand if one environment leads to greater improvements in anxiety, stress, mood, and physiological stress markers such as heart rate variability. Participants will walk for 150 minutes per week over six weeks in one of the two designated outdoor settings, then have a five-week break before switching to the other environment for another six weeks. Each walking session lasts 30 to 50 minutes at moderate intensity. The study includes two groups differing in the order they experience the environments, allowing participants to serve as their own controls. During the trial, participants will visit the clinic four times for assessments before and after each walking period. Psychological measures including anxiety, perceived stress, mood, and restorativeness will be collected alongside physiological markers such as heart rate variability and salivary cortisol. Participants will also monitor ambient air quality during walks. The total study duration includes two six-week walking phases separated by the washout period, with careful monitoring of health and activity throughout.