Warwick

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This trial investigates the efficacy and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma. These participants are already treated with a medium-dose inhaled corticosteroid and long-acting beta2-agonist ICS-LABA. The study compares adding benralizumab to increasing the inhaled therapy to a higher dose ICS-LABA. The research is a randomized, double-blind, active-controlled phase 3b trial designed to evaluate these treatments in people with a history of eosinophilic asthma who remain uncontrolled on medium-dose ICS-LABA with or without other controllers except oral corticosteroids. Participants are randomly assigned to one of two groups one receives benralizumab 30 mg by subcutaneous injection along with medium-dose ICS-LABA, and the other receives a placebo injection plus high-dose ICS-LABA. Doses of benralizumab or placebo are given every 4 weeks for the first three doses, then every 8 weeks, with up to seven injections during the study. The study treatment schedules continue for 48 weeks. During the study, participants will undergo assessments including lung function tests, asthma control questionnaires, and quality of life surveys. Researchers will track the annual rate of asthma exacerbations, time to first exacerbation, and safety events throughout the 48-week period. Compliance with asthma controller medication is monitored via daily diaries. This comprehensive evaluation helps understand the impact of adding benralizumab compared to increasing inhaled therapy dose in uncontrolled eosinophilic asthma.

This research aims to evaluate a technology-based collaborative care model called RI-SPHERES among postpartum patients with hypertensive disorders of pregnancy HDP. The trial will test whether RI-SPHERES is not worse than a standard self-measured blood pressure SMBP program in controlling persistent hypertension six weeks after delivery and improving preventive care attendance within one year. The study addresses challenges like low adherence to blood pressure checks due to barriers such as childcare and transportation, especially in racial or ethnic minority groups. Participants will be randomly assigned to one of two groups the RI-SPHERES group or the standard SMBP program group. The RI-SPHERES group will use a LTE-enabled blood pressure cuff syncing to a smartphone app that sends automated reminders and adaptive messages based on blood pressure readings and symptoms, with a nurse practitioner-led collaborative care team supporting patients. The first six weeks focus on blood pressure control, then shift to preventive care support for up to one year. The standard SMBP group will manually enter blood pressure readings into an electronic record to be reviewed by clinical staff, with recommendations for monthly blood pressure checks and preventive care after six weeks postpartum. Participants will be involved for one year postpartum, during which blood pressure measurements, preventive care visits, and maternal health outcomes will be monitored. Assessments include short- and long-term blood pressure control, severe maternal morbidity, emergency visits, hospital readmissions, medication adjustments, and patient satisfaction. The study will also evaluate equity in care related to race, ethnicity, language, and geography. Data will be collected through the app, electronic medical records, and regular communications with the study team to track adherence and health outcomes.

Researchers are studying perinatal health outcomes in Rhode Island, focusing on improving maternal and infant health by addressing social determinants of health SDOH such as food, housing, and transportation. The project aims to reduce adverse outcomes and racial disparities by integrating hospital services with community health workers, doulas, and community organizations. This effort is structured as a stepped wedge cluster randomized trial across six prenatal clinics over four years. The study involves implementing the Community-based Maternal Support Services COMSS program, which includes universal screening for risk factors at multiple prenatal and postpartum visits. Patients who screen positive receive coordinated care from care managers and community health workers, including doula care and referrals to address social needs. The intervention is introduced sequentially to all clinics, and data will be collected before and after the program to evaluate its impact. Participants will undergo screenings at their first prenatal visit, second and third trimesters, delivery, and 2-6 weeks postpartum. Those identified with risks will receive ongoing support and follow-up, with care continuing until at least three months postpartum before transitioning to primary care. Researchers will assess outcomes such as rates of severe maternal morbidity and mortality, cesarean births, prenatal care adequacy, postpartum depression screening, substance abstinence during pregnancy, infant death, and preterm birth.

Researchers are conducting a multicenter screening study to identify the prevalence of the KIT D816V mutation in adults suspected of having clonal mast cell disease. The study focuses on people with various symptoms and conditions linked to mast cell activation or involvement, including those with chronic myelomonocytic leukemia and cutaneous mast cell disease. The purpose is to better understand mutation occurrence in these select populations. Participants are grouped into four cohorts based on their symptoms or confirmed diagnoses. The study involves collecting blood or bone marrow samples after participants provide consent and share relevant medical history. The main assessments include measuring the KIT D816V mutation in peripheral blood using digital droplet polymerase chain reaction and an ultra-sensitive super rolling circle amplification assay. No treatments or drugs are given as this is an observational screening study. During the study, participants will provide samples and information about their health. Researchers will analyze these samples to determine mutation presence and frequency. The study aims to collect data on mutation prevalence for each cohort on the first day of participation. The overall study period extends until October 2028, with outcomes primarily measured early after enrollment. Participants usual healthcare is not altered by this study.

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.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.