Cook County

Researchers are evaluating whether adding Osteopathic Manipulative Therapy (OMT) to the usual medical care at the VA improves treatment outcomes for people with chronic low back pain (CLBP). OMT involves hands-on techniques like stretching, gentle pressure, resistance, and applying forces to specific body areas. This feasibility trial aims to understand the treatment effects of combining OMT with usual care for individuals experiencing low back pain. Participants will receive either the usual VA care provided by Physical Medicine and Rehabilitation clinicians or the usual care combined with up to four OMT visits over a 12-week period following their first visit (baseline). The OMT sessions include manual techniques designed to address muscle and joint issues related to low back pain. During the study, researchers will assess participants' low-back pain intensity at the start, at 12 weeks, and again at 24 weeks. Participants will be monitored for their pain levels and response to treatments throughout the study duration. The goal is to gather information on how OMT might affect pain management when added to standard care.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating three different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are considered frail or intermediate-fit and are not eligible for stem cell transplant. This phase III trial focuses on comparing these three-drug induction treatments followed by either double- or single-drug maintenance therapy. The study aims to determine which treatment combination better controls the disease and improves progression-free survival and overall survival. Patients are randomly assigned to one of three treatment groups. Arm 1 (VRd-Lite) receives bortezomib by injection under the skin, lenalidomide by mouth, and dexamethasone by mouth during induction cycles, followed by lenalidomide alone for maintenance. Arm 2 (DRd-R) receives daratumumab and hyaluronidase-fihj injections, lenalidomide, and dexamethasone during induction, followed by lenalidomide alone during maintenance. Arm 3 (DRd-DR) receives the same induction as Arm 2, but maintenance includes both daratumumab and lenalidomide. Induction cycles last up to 9 cycles of 28 days each, and maintenance cycles continue every 28 days if the disease does not progress or toxicity occurs. Participants undergo assessments including tumor evaluations, whole-body imaging, blood tests, and quality-of-life questionnaires. After completing treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years. Researchers will measure progression-free survival, overall survival, response rates, safety, minimal residual disease, and patient-reported health outcomes to understand the treatments' effects and support future care decisions.

Researchers are evaluating a phase II Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

Researchers are comparing two approaches of standard therapy for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. This phase III trial evaluates whether giving chemotherapy and immunotherapy before and after surgery (perioperative) is more effective than giving the same treatments only after surgery (adjuvant). The study aims to find out which method leads to better event-free survival and overall survival over several years. Participants are randomly assigned to one of two groups. In the adjuvant group, patients have surgery first, followed by up to four cycles of platinum-based chemotherapy and up to one year of immune checkpoint inhibitor treatment if there is no disease progression or unacceptable side effects. In the perioperative group, patients receive chemotherapy combined with immune checkpoint inhibitors before surgery, then have surgery, and continue immune checkpoint inhibitor therapy for up to one year afterward. Chemotherapy drugs used may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine, and immunotherapy drugs may include nivolumab, pembrolizumab, or atezolizumab. During the study, patients undergo imaging tests such as CT scans, MRI, or PET/CT scans to monitor their condition. After completing treatment, they are followed for up to 10 years with check-ups every six months. Researchers measure event-free survival at three years, overall survival up to 10 years, surgical outcomes, side effects, and other treatment-related factors to understand which approach offers better results for patients with resectable NSCLC.

Researchers are evaluating copper Cu 64 PSMA I&T injection for PET/CT imaging in men newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer. This prospective, open-label Phase 3 study focuses on patients planning to undergo radical prostatectomy with pelvic lymph node dissection to assess the diagnostic accuracy of this imaging method. Each participant will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA I&T. PET/CT scans will be performed between 1 and 4 hours after injection. Three independent readers, blinded to patient information, will interpret the images to identify prostate cancer lesions in pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and other tissues. The results will be compared to histopathology and conventional imaging to determine sensitivity and specificity. Participants will undergo baseline conventional imaging and have their PET/CT scans evaluated for cancer detection. The study will measure the accuracy of copper Cu 64 PSMA I&T PET/CT in detecting prostate cancer lesions compared to the reference standard of histopathology. Safety monitoring and image interpretation consistency will be maintained throughout the study, which involves approximately 439 patients.

Diabetic foot ulcers are a serious and costly complication of diabetes, affecting many Veterans, especially Black and rural populations. This research investigates the use of remote foot temperature monitoring to reduce the risk of foot ulcer recurrence, a condition where 40% of individuals experience a new ulcer within one year of healing, and 65% within five years. The study aims to evaluate the effectiveness of this monitoring system compared to usual care, assess costs, and understand challenges to its use among patients and providers in the VA healthcare system. Participants will be randomly assigned to either a remote temperature monitoring group or an enhanced usual care group. The remote monitoring uses a smart mat placed at home that measures foot temperatures and sends data wirelessly to a monitoring team who collaborates with VA providers to identify early signs of foot damage. The usual care group will receive standard VA amputation prevention care alongside educational resources on nutrition, physical activity, and wellness. The study plans to enroll at least 406 Veterans with a history of foot ulcers or amputations, following them over 24 months. Throughout the study, participants will be regularly assessed at 6, 12, 18, and 24 months for ulcer development and other health outcomes like amputations, hospital visits, quality of life, and satisfaction with care. Researchers will collect data on healthcare use and costs, and conduct interviews with Veterans and providers to explore how well the remote monitoring system integrates into care. The study's results will help inform broader implementation of this technology to improve care access and outcomes for high-risk Veterans.

Kidney transplantation greatly improves health and quality of life for Veterans with end stage kidney disease (ESKD). Despite excellent early survival of patients and grafts, long-term outcomes remain challenging, with about half of recipients eventually dying with functioning kidney grafts. This is mainly caused by cardiovascular disease in patients who often have multiple existing heart risk factors. Recent studies show that SGLT2 inhibitors can protect kidneys and hearts and improve outcomes in chronic kidney disease patients, including those with type 2 diabetes, but kidney transplant recipients were excluded from these trials due to concerns about infection risk, graft function, and effects on immunosuppressive drugs. This trial studies the safety and effects of the SGLT2 inhibitor empagliflozin in kidney transplant recipients with or without type 2 diabetes. It is an open-label Phase 4 trial conducted at five VA medical centers with expertise in transplantation and diabetes care. Eligible participants will receive empagliflozin and be closely monitored for adverse events, kidney graft function, and diabetes management. A matched control group of kidney transplant recipients not receiving SGLT2 inhibitors will be created from VA data to compare cardiovascular outcomes, kidney disease progression, and healthcare costs. Participants will be followed for about two years while taking empagliflozin. Researchers will assess if and when participants stop the medication as the main outcome. Throughout the study, safety and side effects will be carefully monitored. The trial will provide important information on the safety and benefits of empagliflozin in this specific transplant population, potentially leading to better long-term care and reducing late graft loss.

Researchers are investigating a new treatment for Veterans who have mild traumatic brain injury (mTBI) and experience suicidal thoughts, impulsivity, and difficulties in social and work functioning. These problems often occur together, and the study aims to see if a high-powered magnetic pulse called intermittent theta burst stimulation (iTBS), applied to the front of the head, can improve these symptoms. This early-phase study will gather information on the safety and effectiveness of iTBS for these specific issues, which currently have no evidence-based treatments for this population. Participants will receive either active or placebo iTBS using specialized devices that deliver magnetic pulses to the brain. The treatment targets the frontal pole region to potentially strengthen brain connections involved in controlling impulsive and suicidal behaviors. The study is randomized and double-blinded, meaning neither participants nor researchers know who is receiving active treatment. The iTBS sessions will be given over about two weeks. During the study, participants will be assessed at the beginning, middle, and end, including evaluations of social and occupational functioning and impulsivity. Brain imaging will be used before and after treatment to study changes in neural connections. Researchers will track how many treatment sessions are completed and monitor safety throughout. This information will help guide future larger studies and better understand who might benefit most from this treatment.

Spinal cord injury (SCI) is a lifelong condition that affects many aspects of a person's life, including health, daily activities, and quality of life. People with SCI have a high risk of developing pressure injuries (PrIs), which are areas of skin and tissue damage caused by pressure and shear, often over bony areas. Unlike most pressure injuries that happen in hospitals or nursing homes, those with SCI often develop them in the community. This research is evaluating a decision support tool called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT) to see how well it works in clinics and prevents community-acquired pressure injuries (CAPrIs). The CAPP-FIT includes two main parts: a Veteran survey to identify risks, needed actions, and resources to prevent CAPrIs, and a Provider Report that appears in the electronic health record showing the Veteran's survey responses along with recommended evidence-based actions for providers. The survey can be completed securely at home via email or on an iPad in the clinic. The tool will be introduced in seven VA Spinal Cord Injury clinics in a staggered manner. Providers will receive training and simulation to learn how to use the tool. After implementation, clinics will determine how to maintain the tool in their regular workflow during a maintenance phase. Participants will complete the Veteran survey and receive follow-up support from research staff. The study will measure how many new community-acquired pressure injuries occur within six months after starting CAPP-FIT, hospitalizations related to these injuries, and satisfaction from both Veterans and providers. Researchers will also assess how many providers and Veterans use the tool, how risks identified by Veterans are addressed, and what helps or hinders the tool's use. The study aims to support long-term use of CAPP-FIT in clinical practice to improve prevention of pressure injuries in people with spinal cord injury.