Holyoke

Researchers are evaluating the Integrated Cancer Repository for Cancer Research (iCaRe2), a comprehensive multi-institutional resource developed by the Fred & Pamela Buffett Cancer Center. This resource collects and manages standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, those at high risk, and normal controls. iCaRe2 includes data from a wide geographic area covering many small and rural hospitals and cancer centers, supporting studies on cancer risk factors, development, progression, and strategies for prevention, screening, early detection, and personalized treatment. iCaRe2 is a web-based, secure, HIPAA-compliant registry that integrates multiple specialized cancer collaborative registries covering a broad range of cancers such as pancreatic, breast, thyroid, thoracic, genitourinary, gastrointestinal, central nervous system, leukemia, gynecological, sarcoma, melanoma, and more. The system allows participating centers to contribute data and biospecimens like tumor samples, germ line DNA, serum, urine, and plasma. This flexible "confederation model" enables centers with different expertise and resources to collaborate on diverse research projects through a common platform. Participants include adult individuals aged 19 and older who have a cancer diagnosis or history, are at risk for cancer, have suspicious clinical findings, or have no history of cancer (normal controls). Data collection includes demographic, clinical, and biospecimen information. The registry supports multi-dimensional data mining and sharing to advance cancer research. The primary outcome is the ongoing development and implementation of this web-based cancer collaborative registry, with long-term data collection and collaboration planned over many years.

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.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the effectiveness of MISSION, a multi-component team approach combined with medication for opioid use disorder (MOUD), compared to MOUD alone in people with co-occurring opioid use and mental health disorders (COD). This 4-year, 5-arm randomized control trial in Massachusetts will enroll 1,000 adults with COD to examine the benefits of MISSION or its parts plus MOUD on treatment engagement, substance use, and mental health outcomes. The study also aims to understand the mechanisms behind MISSION's effects and its cost-effectiveness. Participants will be randomly assigned to one of five groups: MOUD alone; full MISSION plus MOUD; or one of three combinations of two MISSION components plus MOUD. MISSION includes Critical Time Intervention (CTI), Dual Recovery Therapy (DRT), and Peer Support (PS). This team-based, time-limited treatment lasts 6 months and integrates psychosocial therapy with assertive outreach to help clients engage in care and recovery services. After treatment, participants will be followed for an additional year. During the study, researchers will assess engagement in treatment, medication adherence, substance use through self-report and drug screening, and mental health symptoms including PTSD, psychiatric severity, and suicide risk at multiple time points up to 12 months. They will also measure recovery capital, therapeutic alliance, health functioning, chronic pain, and motivation for treatment. Data collection includes baseline and follow-up interviews, questionnaires, and drug tests to monitor progress and safety throughout participation.