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  • Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)

    Phase

    3

    Span

    298 weeks

    Sponsor

    Shanghai Junshi Bioscience Co., Ltd.

    Saint Louis, Missouri

    Recruiting

  • TheraSphere With Durvalumab and Tremelimumab for HCC

    A global open-label, prospective, multi-center Phase II trial designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients who are not a candidate for resection, thermal ablation or liver transplant at the time of study entry.

    Phase

    2

    Span

    191 weeks

    Sponsor

    Boston Scientific Corporation

    Saint Louis, Missouri

    Recruiting

  • Music Therapy and Social Work Telehealth for Older Adult Well-Being

    The goal of this quantitative pilot study is to evaluate the effectiveness of a collaborative music therapy and social work telehealth framework for community-dwelling older adults with and without dementia with regards to their emotions, well-being, cognition, and perceived service quality. This pilot study builds on a feasibility study that field tested logistics and provided proof-of-concept of the novel telehealth framework. Specifically, the feasibility study evaluated the acceptability, barriers, and facilitators of this framework for older adults with and without dementia. Both music-based interventions were grounded in the person-centered Clinical Practice Model for Persons with Dementia, which provides guidelines for adjusting the degree of support and challenge offered to an individual. The investigators developed a collaborative social work referral worksheet. The investigators conducted semi-structured qualitative interviews with participants and care partners, who offered input about all aspects of the study. The investigators also refined recruitment, data collection, protocol training, and intervention processes. This pilot study builds on this past feasibility work. Older adults often experience changes in health, finances, and social support which impede community involvement. Social distancing surrounding COVID-19 exacerbated such hurdles and enhanced risk for loneliness, depression, and cognitive decline. Although many services including music therapy and social work transitioned from in-person to telehealth during the pandemic, the rapid shift suggests that innovation occurred reactively, without sufficient time to evaluate the quality or effectiveness of this service delivery model. Telehealth is likely to continue to be a component of the music therapy profession and more broadly in healthcare. With thoughtful and systematic development to bridge the digital divide, telehealth may offer some benefit to community-dwelling older adults. This goal may be accomplished through interprofessional collaboration. Music therapists can address psychosocial needs through a variety of flexible and age-appropriate music experiences, while social workers have expertise to reach isolated individuals and connect them to appropriate supports. This pilot study advances a line of research to test a novel telehealth framework that integrates social work and music therapy to promote older adult well-being. In this quantitative pilot study, the investigators will test methods and procedures that will be used in a future larger clinical trial to enhance the rigor and reproducibility of this research. The objectives of this pilot study are to examine the effects of the collaborative telehealth framework on older adults' well-being (primary aim), cognition, loneliness, perception of service quality, and (in response to music therapy) emotions, and to gather preliminary data for effect size estimation. Participants and interventionists will be invited to engage in a semi-structured qualitative interview at the conclusion of the study to inform further optimization of the collaborative telehealth framework. Participants have the option to use their own or borrow equipment (iPads). To reach those with limited resources, there will be 2 iPads with cellular data available to ship to enable study participation. Participants will be community-dwelling older adults with and without dementia. All participants will receive music therapy via telehealth and social work wellness sessions via telehealth. Collaboration is the key difference in the levels of independent variable: participants will be randomly assigned to either a collaborative condition, or non-collaborative condition. In the collaborative condition, information collected during music therapy will inform social work wellness sessions following a protocol developed during the feasibility study. In the non-collaborative condition, social workers and music therapists will operate telehealth services independently.

    Phase

    N/A

    Span

    67 weeks

    Sponsor

    Alaine E Hernandez, PhD

    Saint Louis, Missouri

    Recruiting

    Healthy Volunteers

  • US National OCS Liver Perfusion (OLP) Registry

    Phase

    N/A

    Span

    525 weeks

    Sponsor

    TransMedics

    Saint Louis, Missouri

    Recruiting

  • GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)

    This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.

    Phase

    N/A

    Span

    198 weeks

    Sponsor

    Merit Medical Systems, Inc.

    St Louis, Missouri

    Recruiting

  • Telehealth as a Modality to Increase the Uptake of PrEP Services in Black and Latino: "e-PrEP"

    The goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for PrEP delivery with the support of navigation leads to increased uptake and persistence of PrEP in young MSM/transgender of color and individuals in rural communities that have disproportionately not used PrEP. The investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. Our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of PrEP amongst communities who historically have had many barriers to care and have not started PrEP.

    Phase

    4

    Span

    107 weeks

    Sponsor

    Vivent Health

    Saint Louis, Missouri

    Recruiting

    Healthy Volunteers

  • Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

    Phase

    N/A

    Span

    276 weeks

    Sponsor

    University of British Columbia

    Saint Louis, Missouri

    Recruiting

  • Assessment of Combined CCM and ICD Device in HFrEF

    Phase

    N/A

    Span

    137 weeks

    Sponsor

    Impulse Dynamics

    Saint Louis, Missouri

    Recruiting

  • High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

    This is an unblinded, three cohort phase II study evaluating the efficacy of high dose testosterone (BAT) for patients with mCRPC and inactivating mutations in ATM, CDK12 or CHEK2. Patients will receive BAT until disease progression or intolerance, whichever occurs first. Throughout the study, safety and tolerability will be assessed by frequent recording of adverse events, vital signs and safety laboratory assessments. Progression will be evaluated with bone scan, CT of the abdomen/pelvis and PSA as per PCWG3 criteria.

    Phase

    2

    Span

    313 weeks

    Sponsor

    VA Office of Research and Development

    Saint Louis, Missouri

    Recruiting

  • Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

    Prostate Cancer is the most commonly diagnosed cancer among Veterans, comprising 30% of new cancer diagnoses in the VA. Eighty-five percent of men present with localized prostate cancer, which is typically treated with active surveillance or curative local therapy using surgery or radiation therapy. Unfortunately, twenty percent of Veterans undergoing curative local therapy will develop metastatic recurrence. These men typically receive palliative systemic hormonal therapy to control their disease. Despite this, over half of men will have cancer progression within 1-2 years and half will die within 5 years. Two diverging paradigms have been studied in recent years to improve the survival of men with recurrent metastatic prostate cancer. First, a subset of patients has oligometastatic disease. These patients are hypothesized to have an intermediate clinical state in which ablative local therapy with surgery or radiation to all metastatic sites of disease (metastasis-directed therapy; MDT) can lead to durable disease control and potentially cure in select patients. Recent Phase II randomized trials have demonstrated improved long-term progression-free survival with MDT in the absence of systemic therapy. Yet, 75% of patients receiving MDT for oligometastatic cancer develop progression in new areas, arguing that systemic therapy is needed to treat occult metastases. This is supported by data demonstrating that earlier palliative hormonal therapy is associated with improved survival. In fact, the second approach that has been studied in recent years, is whether escalating hormonal therapy by adding novel androgen receptor axis targeted agents or chemotherapy improves outcomes in men with metastatic prostate cancer. Multiple phase III randomized trials demonstrate that escalating hormonal therapy with these novel therapeutic agents improves progression-free survival and overall survival dramatically. Therefore, these agents have been integrated as an option into today's standard systemic therapy (SST) for metastatic prostate cancer. Given the promise of MDT to induce long-term cancer control and the effectiveness of SST to prevent further cancer progression, there is an urgent need to determine whether adding MDT to SST improves disease outcomes further. Additionally, prior studies have excluded patients with local recurrence. However, these comprise a large proportion of Veterans with recurrent oligometastatic prostate cancer. The primary goal of our study is to determine if adding PET-directed local therapy (MDT and treatment of primary tumor [de novo] or primary tumor local recurrence on PET/CT if applicable) improves disease control compared to SST alone in Veterans with oligometastatic prostate cancer. This is a multi-institutional phase II/III randomized trial comparing SST with or without PET-directed local therapy. Other goals of the study are to determine any differences in patterns of cancer progression, survival, and quality of life. We also will determine if certain mutations present in tumor DNA can predict if Veterans will benefit from PET-directed local therapy.

    Phase

    2/3

    Span

    231 weeks

    Sponsor

    VA Office of Research and Development

    Saint Louis, Missouri

    Recruiting

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