Cook County

Researchers are evaluating the effects of semaglutide, a GLP-1 receptor agonist, on moderate to severe alcohol use disorder AUD in U.S. Veterans. This randomized, double-blind, placebo-controlled phase 3 trial compares semaglutide to placebo to determine its safety and effectiveness in reducing risky drinking. The study addresses a critical need for new AUD treatments, given the limitations of current medications and the large number of Veterans affected by AUD yet not receiving pharmacotherapy. Participants will receive weekly subcutaneous injections of either semaglutide or placebo for 24 weeks. Semaglutide dosing starts at 0.25 mg per week for the first 4 weeks, then gradually increases up to a maximum of 2.4 mg weekly, depending on tolerance. The placebo group receives injections that mimic the treatment procedure. After the treatment phase, a 4-week safety assessment period will follow. During the study, participants will be monitored for alcohol consumption using the Timeline Follow-Back interview and other assessments of drinking risk and symptoms. Researchers will also evaluate safety, tolerability, psychiatric symptoms, quality of life, and healthcare utilization. The primary outcome is a two-level reduction in World Health Organization risk drinking level during the last 28 days of treatment. The total study duration includes recruitment, treatment, follow-up, data cleaning, and analysis phases spanning several years.

Researchers are evaluating whether adding Osteopathic Manipulative Therapy OMT to the usual medical care provided at the VA improves treatment outcomes for individuals with chronic low back pain CLBP. This study focuses on understanding the effects of OMT, a hands-on technique involving muscle and joint movements like stretching, gentle pressure, and resistance, when combined with standard care. The trial aims to explore treatment effects such as effect sizes to inform future care approaches for CLBP. Participants will be randomly assigned to receive either usual VA care alone or usual VA care plus OMT. Usual care includes medical history review, physical exams, and possible additional tests or treatments by VA physiatrists. The OMT treatment involves physicians using hands-on techniques to move muscles and joints during the usual care visits. Participants may be asked to change positions while receiving OMT, which is provided by VA physicians involved in the study. During the study, participants will be assessed at baseline, 12 weeks, and 24 weeks for pain intensity specific to low back pain, along with other measures like general pain, activity enjoyment, anxiety, depression, sleep duration, healthcare costs, and patient impressions of change. Various questionnaires and scales will be used to track these outcomes. The study will monitor participants responses over time to evaluate the added impact of OMT alongside usual care. The trial is expected to run until August 2027.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

Researchers are comparing two treatment approaches for patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery. The study evaluates whether giving standard therapy before and after surgery perioperative is better than giving it only after surgery adjuvant. This phase III trial focuses on chemotherapy and immunotherapy, which are current standard treatments aimed at controlling tumor growth and helping the immune system fight cancer. Patients are divided into two groups. One group undergoes surgery followed by chemotherapy and immunotherapy for up to one year if the disease does not progress or cause severe side effects. The other group receives chemotherapy combined with immunotherapy before surgery, then surgery, followed by immunotherapy alone for up to one year. Chemotherapy drugs may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine. Imaging tests like CT, MRI, or PETCT scans are done throughout the study. Participants will have surgery within a month of joining and receive treatments according to their assigned group. They will be monitored with scans and followed up every six months for up to 10 years to assess survival, disease progression, surgical outcomes, side effects, and immune responses. Researchers will measure event-free survival and overall survival as main results, as well as response rates and safety information over the long term.

Researchers are evaluating copper Cu 64 PSMA I&T injection as a PETCT imaging tracer in men newly diagnosed with unfavorable intermediate high-risk, high-risk, or very high-risk prostate cancer. This Phase 3, open-label study aims to assess the diagnostic accuracy of this imaging method in staging prostate cancer before surgery. The study involves patients who are planning to undergo radical prostatectomy with pelvic lymph node dissection. Participants will receive an intravenous dose of approximately 8 mCi of copper Cu 64 PSMA I&T. PETCT scans will be performed between 1 to 4 hours after the injection. The images will be independently reviewed by three experts who will identify and score lesions positive for prostate cancer in the pelvic lymph nodes, prostate, extra pelvic lymph nodes, bones, and soft tissues. The imaging results will be compared to findings from histopathology and conventional imaging to determine sensitivity and specificity. During the study, patients will undergo PETCT imaging and their scans will be carefully analyzed to evaluate the detection of cancer lesions. Researchers will monitor safety by tracking any adverse events up to 72 hours after the injection. The primary measures include sensitivity and specificity of the imaging at 4 hours post-injection. Additional assessments include agreement among image readers and predictive values. The study is expected to last until September 2026.

Researchers are investigating the use of empagliflozin, a type of SGLT2 inhibitor, in Veterans who have received kidney transplants and have chronic kidney disease CKD, with or without type 2 diabetes mellitus T2DM. Although kidney transplantation improves health and quality of life, long-term outcomes remain challenging due to a high risk of cardiovascular disease and graft loss. Previous studies showed benefits of SGLT2 inhibitors in CKD patients but excluded kidney transplant recipients due to safety concerns. This trial aims to assess the safety and effects of empagliflozin in this specific population. This open-label clinical trial will treat eligible kidney transplant recipients with empagliflozin 12.5 mg once daily. The study is conducted at multiple VA medical centers with expertise in transplant and diabetes care. Researchers will closely monitor participants for adverse events and any effects on graft function or diabetes management. Data from non-treated kidney transplant recipients will be used for comparison to further evaluate cardiovascular outcomes, kidney disease progression, and healthcare costs associated with empagliflozin use. Participants will be followed for about two years, during which researchers will assess discontinuation of empagliflozin and monitor infections, hypoglycemia, major cardiac and kidney events, graft dysfunction, rejection episodes, and other safety concerns. Laboratory tests, kidney biopsies, and assessments of kidney function, blood sugar control, body weight, and blood pressure will also be performed. The study aims to provide important safety and feasibility data to improve care for kidney transplant recipients.

Researchers are studying a treatment for suicidal thoughts, impulsivity, and difficulties in social and work functions following a mild traumatic brain injury mTBI in Veterans. These symptoms are linked, and the study aims to see if intermittent theta burst stimulation iTBS, a high-powered magnetic pulse applied to the front of the head, can improve these conditions. The goal is to gather early data on the safety and effects of this treatment, which is approved by the FDA but not yet for these specific symptoms or location. The trial compares active iTBS treatment to a placebo sham iTBS. The iTBS is delivered using specialized devices that stimulate the brain to promote connections between brain areas involved in impulsivity and suicidal thinking. This randomized, double-blinded study focuses on Veterans aged 22 to 65 with mTBI, impulsivity, and suicidal ideation. Treatment sessions occur over about two weeks. Participants will be assessed before, during, and after treatment using scales measuring social and occupational functioning and suicidal thoughts. Brain imaging will be done to examine changes in brain connectivity related to treatment. The main outcomes include treatment session completion rates and changes in functioning and suicidal ideation. Safety, tolerability, and feasibility of the treatment will also be monitored throughout the study.

Spinal cord injury SCI is a lifelong condition that affects health, daily activities, and quality of life. People with SCI face a high risk of developing pressure injuries, which are areas of skin and tissue damage caused by pressure and shear, typically occurring over bony areas. Unlike most pressure injuries acquired in hospitals or nursing homes, those in people with SCI often develop in the community, leading to serious, costly problems. This research evaluates how well a decision support tool called the Community Acquired Pressure Injury Prevention Field Implementation Tool CAPP-FIT works in preventing community-acquired pressure injuries CAPrIs and how well it is used in clinical practice. The study involves implementing the CAPP-FIT at seven Veterans Affairs VA spinal cord injury clinics across the country in a staggered way. The tool includes a Veteran survey to identify risks and needed actions, and a Provider Report available in the electronic health record that recommends evidence-based actions. Veterans complete the survey via secure email or an iPad in the clinic. The study includes training providers, redesigning clinic workflows, and evaluating how the tool is adopted and maintained. After initial implementation, each site decides how to keep using the CAPP-FIT to support long-term use. Participants will complete the Veteran survey and attend scheduled clinic visits where providers use the Provider Report. Researchers will monitor new pressure injuries, hospitalizations related to these injuries, and satisfaction of both Veterans and providers over six months following implementation. They will also track how many providers and Veterans use the tool, how risks are managed, and barriers or facilitators to its use. The study lasts through implementation and maintenance phases, with ongoing evaluation of how the CAPP-FIT fits into regular care.