East Orange

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Researchers are evaluating the efficacy and safety of duvakitug, a drug given by subcutaneous injection, in people with moderately to severely active Ulcerative Colitis UC. This Phase 3 randomized, double-blind, placebo-controlled study includes participants aged 16 to 80 years and aims to assess clinical remission and other health improvements over a series of treatment periods. The study lasts up to 35 weeks and includes a screening period followed by three possible sub-studies a 12-week open-label induction, a 12-week pivotal induction, and a 12-week extended induction for those who do not respond initially. Participants receive injections of either duvakitug at one of two doses or placebo according to the study protocol, with up to 15 visits scheduled for those in extended induction. During the study, participants will undergo assessments including clinical remission rates at week 12, endoscopic and histological improvements, symptom tracking, quality of life questionnaires, and safety monitoring for adverse events. Follow-up visits occur up to 45 days after the last dose for those not continuing in the maintenance study. Researchers will also measure drug levels and immune responses over the study period to better understand treatment effects.

Researchers are investigating a care approach called Concordant Care to improve how Veterans with Long-COVID are treated. This approach focuses on validating the patients experience, building a shared understanding of Long-COVID, and creating personalized action plans to manage the condition. The study addresses the current lack of training for clinicians on providing this care to Veterans with poorly understood conditions like Long-COVID. The study has two parts. In Part 1, researchers will adapt and refine Concordant Care training through interviews and focus groups with Veterans and primary care providers. In Part 2, a randomized trial will compare clinicians receiving Concordant Care training to those receiving an education packet about Long-COVID. Clinicians in the training group will complete online modules, participate in tele-mentoring sessions, receive reminder tools, and Veterans will get prompts to discuss their Long-COVID with their clinicians. Veterans participating in the study will complete assessments before and about three months after their appointments with participating clinicians. Researchers will evaluate changes in clinicians use of recommended care practices and Veterans perceptions of shared understanding. They will also measure patient satisfaction, adherence to care, and disability related to Long-COVID. The study will monitor outcomes over this timeframe to explore the effectiveness of Concordant Care training.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

This research aims to compare the impact of Exposure and Response Prevention ERP therapy versus a stress management training control on Veterans with Obsessive Compulsive Disorder OCD, including those with both OCD and posttraumatic stress disorder PTSD. The study will evaluate how these treatments affect Veterans functioning, quality of life, and OCD symptoms. Additionally, the study will explore the potential for implementing ERP in Veterans Affairs VA mental health settings through mixed-methods evaluation. Participants will be randomly assigned to receive either 16 weekly sessions of ERP or 16 weekly sessions of stress management training, both delivered via video telehealth VTH. ERP sessions, lasting 90 minutes each, involve psychoeducation, assessment, exposures to feared situations, and homework assignments focused on coping with OCD triggers. Stress management training includes psychoeducation and sessions teaching relaxation and coping skills. Assessments will be conducted after treatment and six months later. ERP participants will also provide feedback on treatment satisfaction and participate in qualitative interviews. Veterans will be involved in completing assessments of their work and social adjustment, quality of life, and OCD symptoms at baseline, post-treatment, and six months post-treatment. Researchers will collect data on treatment effects and implementation potential. Therapy sessions will be audio-recorded. The total participation lasts through treatment and follow-up visits up to six months after treatment completion.

Researchers are investigating whether N-Acetyl Cysteine NAC can reduce chronic oxidative stress and restore antioxidant levels in veterans with Gulf War Illness GWI. This study focuses on understanding how NAC affects mitochondrial function and oxidative stress in the central nervous system CNS, which are believed to contribute to the symptoms of GWI such as fatigue, pain, and neurological issues. The study is an early-phase, randomized, placebo-controlled trial aimed at exploring NACs impact on serum glutathione levels and CNS oxidative stress. Participants will be randomly assigned to receive either NAC 900 mg twice daily or a matching placebo for 8 weeks. The intervention is designed to assess NACs ability to target mitochondrial dysfunction and oxidative stress compared to placebo. The study includes a follow-up period extending to 16 weeks to monitor treatment-related adverse events and changes in glutathione levels. During the study, participants will undergo blood specimen collection and neuroimaging to measure glutathione levels and oxidative stress markers. Researchers will evaluate these markers from baseline through 8 weeks of treatment, with additional safety monitoring up to 16 weeks. Participants will be required to attend follow-up visits and provide written consent, with the total study duration covering the treatment and observation periods.

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.

Researchers are evaluating whether adding PET-directed local therapy to standard systemic therapy SST can improve castration-resistant prostate cancer-free survival for Veterans with oligometastatic prostate cancer. This condition involves having 1-10 metastatic sites, and the study focuses on both newly diagnosed and recurrent prostate cancer cases. The trial aims to assess if combining treatments can better control the disease compared to SST alone, and also explores differences in progression patterns, survival, quality of life, and the impact of tumor DNA mutations. Participants will be randomly assigned to receive SST alone or SST plus PET-directed local therapy. SST includes hormonal treatments such as androgen deprivation therapy and may involve chemotherapy or novel hormonal agents. PET-directed local therapy involves surgery or radiation to metastatic sites, and for some participants, treatment of the primary tumor or local recurrence using radiation, surgery, or other local therapies. Treatment choices are personalized through shared decision-making between the physician and Veteran. The study is designed as a seamless phase II to phase III trial conducted at multiple centers. During the study, Veterans will undergo imaging assessments including PETCT scans and bone scans, along with laboratory tests like PSA and testosterone levels. Researchers will monitor disease progression, survival, side effects, and patient-reported quality of life over several years. The primary outcome is castration-resistant prostate cancer-free survival measured at four years. Additional outcomes include progression-free survival, metastasis-free survival, prostate cancer-specific survival, overall survival, treatment toxicity, and health-related quality of life assessed through validated questionnaires. Participation involves regular follow-up visits for evaluations and monitoring throughout the study period.