Marquette

Researchers are studying the effects of a 12-week indoor rock climbing program on heart health, mental well-being, and behavioral health in generally healthy adults aged 18 to 35 who are not physically active. This pilot study aims to provide information for a larger trial and focuses on how climbing physical activity may impact cardiovascular and general health-related fitness measures. The study will observe changes in physical fitness, quality of life, and behavior related to exercise. Participants will engage in a supervised indoor rock climbing program using ropes on a climbing wall and bouldering. The training starts with two 60-minute sessions per week for the first 4 weeks and progresses to three 60-minute sessions per week for the remaining 8 weeks. The program targets moderate effort levels, monitored through ratings of perceived exertion and climbing duration, to guide exercise intensity and progression. Throughout the study, participants will visit the research lab for assessments at four time points: before starting, at 6 weeks, at 12 weeks, and again at 24 weeks after beginning the program. These assessments include measuring blood pressure, fasting glucose, lipids, hemoglobin A1c, physical fitness components, quality of life, and behavior changes related to physical activity. Participants will complete a total of 12 data collection visits during these periods to track their progress and health outcomes.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

This research aims to develop and evaluate a low-cost Therapeutic Workplace program designed to help adults with opioid use disorder who are unemployed and living in poverty. The Therapeutic Workplace pays participants to work and encourages drug abstinence by requiring drug-free urine samples to receive maximum wages. This study focuses on creating a version of this program that community treatment centers can implement, addressing both addiction and poverty through employment-based abstinence reinforcement. Participants will be involved in a randomized controlled study at a community clinic, REACH Health Services, where they will receive methadone or buprenorphine treatment alongside support from an employment specialist for 48 weeks. The study includes a 4-week induction period followed by random assignment to one of three groups: Usual Care Control, Initiation Only, or Initiation and Maintenance. Those in the Initiation Only and Initiation and Maintenance groups will earn high-value wage supplements linked to drug-free urine tests during the first 24 weeks, while the Initiation and Maintenance group will also receive lower-value supplements from weeks 25 to 48. Throughout the study, participants will be regularly assessed every four weeks during the maintenance period to measure drug abstinence and employment status. Researchers will collect urine samples to monitor abstinence and track employment outcomes to evaluate the program’s effectiveness in reducing poverty. The total participation includes an induction phase and nearly a year of ongoing support and monitoring, aiming to provide evidence for a sustainable community-based treatment model for opioid addiction.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating NeuroTrainer, a virtual reality-based cognitive training program, to see if it can improve attention and executive control in students aged 11 to 17 years, both with and without attention-related difficulties such as ADHD. The study aims to determine whether NeuroTrainer can engage targets related to ADHD inattention symptoms and whether improvements transfer to better academic behaviors. Participants in the intervention group will take part in virtual reality sessions that combine physical activity with cognitive training designed to maximize performance and adapt to varying task demands. These sessions will be compared to a control condition to assess the effectiveness of NeuroTrainer. During the study, participants will undergo several assessments at Week 1, Month 2, Month 3, and Month 9, including tests measuring inhibitory control, attention, working memory, processing speed, and cognitive flexibility. Researchers will monitor these outcomes to evaluate changes in attentional and executive functions over time.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

Researchers are evaluating a phase III trial to compare a text-based smoking cessation intervention with a printed manual to help rural cancer survivors who smoke quit smoking. The study focuses on patients diagnosed with cancer in the past 10 years who currently smoke at least five cigarettes daily and live in rural areas. The trial aims to assess the effectiveness of a scheduled gradual reduction program paired with support messages versus an informational booklet for quitting smoking. Participants are randomly assigned to one of two groups. One group follows an eight-week personalized schedule to gradually reduce cigarette use and receives cessation support messages via text for 12 weeks. The other group receives the National Cancer Institute's Clearing the Air booklet to guide gradual quitting. After completing the intervention, patients are followed up at six months to evaluate outcomes. During the study, participants complete questionnaires and provide urine samples to biochemically validate smoking cessation. Researchers measure smoking cessation success up to six months after the quit date and assess quality of life at 30 days and six months post-quit. The study includes ongoing monitoring through text messages and patient-completed measures, ensuring comprehensive data collection over the follow-up period.