Holyoke

Researchers are establishing the Integrated Cancer Repository for Cancer Research iCaRe2 as a multi-institutional resource to collect and manage standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, individuals at high risk, and normal controls. This resource covers a wide geographical area including small and rural hospitals and cancer centers. The goal is to advance comprehensive studies on cancer risk factors and enable development of new strategies for cancer prevention, screening, early detection, and personalized treatment. The iCaRe2 resource collects data and biospecimens such as tumor samples, germline DNA, serum, urine, and plasma from participants across multiple cancer registries covering various cancer types. It operates as a web-based, HIPAA-compliant platform allowing centers with different expertise to contribute and collaborate. This repository supports cohort and population studies by providing a secure, standardized, and interoperable system for cancer-related data collection and sharing. Participants include adult patients with cancer, individuals at risk, and normal controls who can provide informed consent. Data collected includes clinical information, biospecimens, and longitudinal follow-up. The study measures include the development and implementation of the web-based registry and banking of biological materials for future research. Participation involves consent and data contribution, with monitoring and data validation ensuring quality. The repository enables ongoing research collaborations to study cancer biology, genetics, epidemiology, and patient care.

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 registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are evaluating treatments for people with both opioid use disorder and mental health disorders co-occurring disorders, COD in this 4-year study. The study aims to find out if adding MISSION, a team-based approach, or parts of it to medication for opioid use disorder MOUD leads to better outcomes than MOUD alone. The study will include 1,000 participants and looks at improvements in treatment engagement, substance use, and mental health. Participants will be randomly assigned to one of five groups MOUD alone full MISSION plus MOUD or one of three combinations of MISSION components plus MOUD. MISSION includes three evidence-based parts Critical Time Intervention CTI, Dual Recovery Therapy DRT, and Peer Support PS. Each participant will receive 6 months of treatment and then be followed for 1 year to assess outcomes. During the study, participants will be evaluated at multiple time points for engagement in treatment, substance use through self-reports and drug screens, mental health symptoms, and other health measures. Researchers will also assess motivation, recovery support, and medication adherence. Safety and health outcomes will be monitored throughout the 6-month treatment and 1-year follow-up period to understand the benefits and costs of adding MISSION or its parts to MOUD.