Marquette

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.

This research focuses on adults with opioid use disorder who are unemployed and living in poverty, aiming to evaluate a low-cost Therapeutic Workplace intervention. The study seeks to address the chronic challenges of opioid addiction and poverty by developing a community-based program that promotes drug abstinence and employment through wage incentives. The trial is a Stage III randomized controlled study conducted in partnership with a community clinic to test the real-world impact of this approach. Participants will be randomly assigned to one of three groups after a 4-week induction period Usual Care Control, Initiation Only, or Initiation and Maintenance. All receive methadone or buprenorphine treatment and support from an employment specialist for 48 weeks. The Initiation Only and Initiation and Maintenance groups can earn high-magnitude abstinence-contingent wage supplements during the first 24 weeks. The Initiation and Maintenance group will continue to receive lower-magnitude incentives during weeks 25 to 48 to sustain abstinence and employment. Participants will be assessed every four weeks during the Maintenance period to measure drug abstinence and employment rates. The study includes a 4-week induction, followed by 48 weeks of support, focusing on long-term drug abstinence, employment maintenance, and poverty reduction. Researchers will monitor urine samples for drug use, employment status via pay stubs, and provide counseling and employment services as part of care. The goal is to determine if this community-adapted Therapeutic Workplace can be a sustainable intervention for opioid use disorder.

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.

Researchers are evaluating the feasibility and effectiveness of NeuroTrainer cognitive training to improve attention and executive control functions in students aged 11 to 17, including those with and without attention-related difficulties such as ADHD. The study aims to determine if NeuroTrainer can improve these cognitive functions, engage targets related to ADHD inattention symptoms, and transfer skills to improve academic behaviors. Participants with various ADHD types and severity levels are included. The study compares two groups one using the NeuroTrainer VR-based cognitive training program and a control group receiving standard educational interventions. The NeuroTrainer group participates in 30-minute virtual reality sessions combining physical activity and cognitive tasks about three times a week for 12 weeks. The control group continues with regular classroom instruction and academic tasks without additional cognitive training. Participants will undergo assessments at Week 1, Month 2, Month 3, and Month 9 using several NIH Toolbox cognitive tests measuring attention, inhibitory control, working memory, and processing speed. Additional evaluations include ADHD symptom scales and academic performance ratings. The study uses random assignment to groups and single masking, with a total follow-up of at least 9 months to monitor changes and maintenance of cognitive and academic improvements.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

Researchers are evaluating a text-based program designed to help rural cancer survivors who smoke to quit smoking. This phase III trial compares an eight-week scheduled gradual reduction SGR intervention delivered via personalized text messages combined with the National Cancer Institutes Smokefree.TXT service to a control group receiving a smoking cessation booklet. The study aims to assess how effective these approaches are in achieving biochemically validated smoking cessation six months after quitting, as well as their impact on quality of life. Participants are randomly assigned to one of two groups. The first group follows a personalized eight-week gradual reduction schedule, supported by cessation messages sent by text for 12 weeks. The second group receives the NCI Clearing the Air booklet to assist in planning gradual smoking cessation. After completing the interventions, participants are followed for a total of six months post-quit date to evaluate outcomes. During the study, participants will provide urine samples and complete questionnaires to measure smoking status and quality of life at baseline, 30 days, and six months after quitting. The research team uses biochemical validation to confirm smoking cessation. Participants must have texting capability on a cell phone or smartphone and be able to read and speak English. The total participation includes the intervention period plus follow-up to monitor smoking cessation and quality of life changes.