Hampton

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the effectiveness of a long-acting injectable form of buprenorphine compared to the daily sublingual under the tongue buprenorphine in treating Veterans with moderate to severe opioid use disorder OUD. This open-label, randomized controlled trial aims to see which treatment better retains Veterans in opioid therapy and helps sustain opioid abstinence. The study also examines secondary outcomes such as substance use, overdose incidents, infectious disease testing, psychiatric symptoms, housing status, dental health, and cost-effectiveness. Participants are Veterans aged 18 and older diagnosed with moderate to severe OUD and beginning a new treatment episode. After an induction period on daily sublingual buprenorphine, participants are randomly assigned to receive either a 28-day supply of daily sublingual buprenorphine or a monthly injectable buprenorphine shot administered in the clinic. Doses for the injectable form target 300mg, with a 100mg option for those who cannot tolerate the higher dose. Study visits occur weekly during the first month, then every two weeks until week 52, including medication management. Throughout the 52-week active phase, participants report opioid use and provide urine samples every two weeks to evaluate abstinence and treatment retention. Additional assessments include HIV, Hepatitis B and C testing, psychiatric questionnaires, risk behavior evaluations, and dental health surveys. After the active phase, participants are followed passively using medical records for up to 10 years to monitor long-term outcomes. The study expects to recruit 952 Veterans over 7 years across multiple VA Medical Centers.

Researchers are studying pirtobrutinib, an oral drug, to understand how well it works and how safe it is for people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study focuses on participants who have previously received 1 to 3 treatments, including a covalent Bruton tyrosine kinase BTK inhibitor, as well as those with treatment-nafve CLLSLL who have a specific genetic change called 17p deletion. This is a Phase 2 open-label trial sponsored by Loxo Oncology, Inc. The study has two parts. Part 1 tests three different dose levels of pirtobrutinib in participants with relapsed or refractory CLLSLL who have prior treatment experience, lasting about 3 years. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have the 17p deletion, with participation lasting up to 2 years. All doses are given orally. Participants will take the study drug orally and attend visits for up to 3 years in Part 1 or up to 2 years in Part 2. Researchers will monitor how well the disease responds to treatment using overall response rate and how long the response lasts. Safety will be tracked throughout. Participants ability to swallow oral medication and their overall health status will be assessed before and during the study to ensure suitability and safety.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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 evaluating two treatment approaches for men with intermediate risk prostate cancer that is localized. This study compares the effects, both positive and negative, of hypofractionated proton radiation therapy alone versus proton therapy combined with androgen suppression therapy. The goal is to better understand the benefits and risks of adding hormone therapy to radiation in this patient group. Participants receive one of two treatments either proton radiation therapy alone given in 28 treatments totaling 70 Gy over 5.5 to 6.5 weeks, high dose radiation with IMRT alone at 81 Gy over 9 to 10 weeks, or intraoperative LDR brachytherapy combined with IMRT totaling 45 Gy. The other group receives androgen suppression therapy for about 6 months starting 8 to 10 weeks before radiation, combined with radiation therapy. The androgen suppression uses FDA-approved LHRH agonists. Treatment schedules and doses are carefully monitored. Throughout the study, participants undergo regular evaluations including toxicity assessments for urinary and gastrointestinal side effects at 6 months and 3 years, quality of life measures, and long-term outcomes such as biochemical failure and survival over 5 years. Researchers also correlate pathology, imaging, and hormone levels with outcomes. Monitoring for treatment-related side effects continues yearly after initial follow-up. Participants are closely followed to assess safety and effectiveness of each treatment approach.

Researchers are evaluating proton radiation therapy as a treatment option for women with early stage breast cancer. This study aims to compare the effects, both positive and negative, of proton therapy against traditional radiation methods. The focus is on whether limiting radiation to the original tumor area, rather than the whole breast, can reduce side effects and improve convenience and cost without compromising treatment effectiveness. The study involves delivering proton radiotherapy at a dose of 4.0 Gy RBE per session across 10 sessions, totaling 40 Gy RBE. This partial breast irradiation approach targets the tumor area specifically, potentially minimizing radiation exposure to surrounding healthy breast tissue. The treatment is non-invasive and uses advanced imaging guidance, with some patients possibly requiring markers placed in the surgical area to assist with accurate targeting. Participants start treatment within 12 weeks of surgery or 8 weeks after chemotherapy completion. Participants will be closely monitored through regular assessments every six months, including evaluations of breast cancer recurrence, treatment-related toxicity, dosimetry related to breast size, quality of life, and overall survival, with key outcomes reviewed at three years. Safety and effectiveness are continuously assessed, and participants health status will be followed long-term. The total duration of involvement varies as lifetime follow-up is planned for toxicity and quality of life measures.

This research study focuses on collecting and analyzing information from patients undergoing various types of radiation therapy for neoplasms. It aims to define treatment outcomes and improve patient care by understanding the results and patient populations at participating institutions. The study is observational and sponsored by the Proton Collaborative Group. Participants receive different forms of radiation therapy including proton therapy, photon therapy, stereotactic radiosurgery SRS, and brachytherapy. The study includes 16 different groups based on disease sites to capture detailed patient data. It tracks outcomes and evaluates strategies to improve patient results and reduce treatment-related toxicities over time. During the study, participants treatment and clinical data are collected through chart reviews at participating institutions. Researchers assess patient outcomes and treatment-related side effects annually or as needed. The study contributes to a better understanding of radiation therapy effects and patient care improvements. Participation duration varies, with ongoing data collection planned through 2039.

Chronic low back pain cLBP is a common and costly condition, especially among US Veterans, with about half experiencing chronic pain. This study aims to find the best non-surgical and non-drug treatments for cLBP using a two-step randomized design. The first step compares continued care and active monitoring CCAM, an internet-based pain self-management program called Pain EASE, and an enhanced physical therapy program combining Pain EASE with personalized exercises. Veterans who do not improve significantly after Step 1 or want more treatment enter Step 2, where they are randomized to yoga, spinal manipulation therapy SMT, or cognitive behavioral therapy CBT, allowing participants to exclude one option based on their preference. In Step 1, participants receive either CCAM, Pain EASE, or enhanced physical therapy with up to 8 sessions guided by a physical therapist. CCAM involves usual care and monitoring without new treatments like CBT, chiropractic, or yoga. Step 2 treatments last about 3 months with up to 10 sessions therapist-led CBT, chiropractor-led SMT, or weekly 60-minute yoga classes plus home practice. These interventions reflect current guidelines and patient preferences and are designed to be accessible and safe for Veterans. Participants will be followed for one year after their final treatment to assess lasting effects. Researchers will measure pain interference using the Brief Pain Inventory at 3 months as the main outcome, along with other assessments like pain severity, physical function, mood, sleep, fatigue, and quality of life. The study will also track treatment adherence, patient and provider acceptance, costs, and healthcare use. A total of 2529 Veterans across 20 centers will participate, helping to guide the best approaches to managing chronic low back pain within the VA healthcare system.

Researchers are evaluating sacituzumab govitecan-hziy alone and in combination with other therapies for people with metastatic urothelial cancer mUC that cannot be removed or has spread. The study aims to assess how well these treatments work and their safety. This is a Phase II open-label trial sponsored by Gilead Sciences, including multiple cohorts with different treatment plans to better understand the effects in various patient groups. Participants receive sacituzumab govitecan-hziy intravenously on Days 1 and 8 of a 21-day cycle, alone or combined with other drugs like pembrolizumab, cisplatin, avelumab, zimberelimab, and others depending on the cohort. Some cohorts receive combinations with chemotherapy drugs such as carboplatin and gemcitabine, with dose adjustments based on tolerability. Maintenance therapies involving avelumab or zimberelimab may follow initial treatment cycles if the disease does not progress. During the study, participants undergo regular imaging scans such as CT or MRI to measure tumor response following RECIST 1.1 criteria. Researchers monitor treatment responses, progression-free survival, overall survival, and adverse events through scheduled visits and assessments for up to two years after treatment. Laboratory tests and safety monitoring occur throughout the treatment and follow-up periods, with continued tumor evaluation even if treatment stops before progression is confirmed.