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  • Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

    Phase

    4

    Span

    138 weeks

    Sponsor

    Jessica Merlin

    Baltimore, Maryland

    Recruiting

  • Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

    There is a significant burden of opioid and polysubstance use, disproportionately affecting underserved, rural areas of the US. Yet many rural communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use.The availability of telemedicine aboard a mobile treatment unit (TM-MTU), led by University of Maryland Baltimore in partnership with Maryland Department of Health, has helped fill the void of rural practitioners by providing buprenorphine for OUD treatment in rural areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use via the TM-MTU using a reinforcement-based approach. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in rural areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers. This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=180) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on polysubstance use, as well as OUD treatment retention and buprenorphine adherence. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.

    Phase

    N/A

    Span

    220 weeks

    Sponsor

    University of Maryland, College Park

    Baltimore, Maryland

    Recruiting

  • GLP-1R Agonist Treatment for Opioid Use Disorder

    The purpose of this study is to determine whether 12 weeks of once-weekly treatment with the glucagon-like peptide-1 receptor (GLP-1R) agonist, semaglutide, will reduce illicit opioid use over a 19 week period (133 days) among individuals in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment (i.e., medication for opioid use disorder; MOUD). Following successful consent and screening, participants will complete a baseline evaluation and be randomly assigned to semaglutide or placebo control arms, in a 1:1 ratio using a permuted-block randomization algorithm stratified by site and MOUD, and begin a 1-week baseline period. Semaglutide (injector pen) or placebo will be administered as a subcutaneously (SC) once per week for 12 weeks, starting at a dose of 0.25 mg SC and advanced on a fixed-flexible dose schedule, based on tolerability, to a dose of 1.0 mg SC per week, or the maximum tolerated dose if less than 1.0 mg. Participants will receive study intervention in an outpatient setting for a total of 12 weeks. After the 12-week intervention, participants will discontinue semaglutide or placebo and be observed for an additional week (wash-out period). A final follow-up visit will then take place 5 weeks after the last treatment visit. During each study visit, participants will undergo urine drug screening and pregnancy testing, vital signs collection, and complete mental health and drug use questionnaires. Participants will also complete smartphone surveys sent at set times during the study. Blood samples will be collected at 2 of the visits (screening and the study week 14) and a physical examination and medical history collection will be done at the baseline visit.

    Phase

    2

    Span

    98 weeks

    Sponsor

    Milton S. Hershey Medical Center

    Baltimore, Maryland

    Recruiting

  • Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

    The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).

    Phase

    1

    Span

    169 weeks

    Sponsor

    Acerand Therapeutics (Hong Kong) Limited

    Baltimore, Maryland

    Recruiting

  • Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA

    Part A will consist of 1 sentinel dosing group of 2 subjects randomized 1:1 to receive VENBETA6890 or placebo and will evaluate VENBETA6890 at dose levels of 15 mg/kg. On Day 1, subjects will receive 15 mg/kg in the morning and a second dose of 15 mg/kg 8 - 12 h later in the outpatient clinic. On Day 2, they will receive a third dose of 15 mg/kg at approximately 8 - 12 h after the last dose on Day 1. The occurrence of local and systemic reactogenicity (solicited AEs) over the subsequent 7-days post-dosing will be collected; non-solicited non-serious AEs will be collected through 28-days post-dosing and serious adverse events (SAEs) will be collected through 2 months. An independent Safety Monitoring Committee (SMC) will review the cumulative 7-day safety data for the sentinel group and must approve for the study to proceed to Part B. Part B will consist of a single inpatient cohort of up to 34 subjects who will be randomized 1:1 to receive VENBETA6890 15 mg/kg, or placebo on Day -1 at approximately 12 h pre-challenge, Day 1 at approximately 1 h pre-challenge, and Day 1 at approximately 12 h post-challenge. All subjects will be challenged with wild-type ETEC strain H10407 and will be closely monitored on the inpatient unit for ETEC diarrheal illness. Subjects will receive the 3-day course of antibiotic therapy starting on Day 6 or earlier dependent on symptoms. Discharge from the inpatient unit is contingent upon the absence of ETEC diarrheal illness, including no diarrhea and no fever, plus two sequential negative stool cultures for ETEC separated by at least 12 hours. An SMC will review the cumulative safety data after data collected during the Day 29 visit of the inpatient challenge cohort has been compiled.

    Phase

    1

    Span

    15 weeks

    Sponsor

    Mark Klempner

    Baltimore, Maryland

    Recruiting

    Healthy Volunteers

  • Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

    Linshom Medical (Linshom) has developed the FDA-cleared Continuous Predictive Respiratory Monitor (CPRM) a small and inexpensive sensor and monitor that provides continuous real-time tracking of these critical indicators of RDE. Linshom technology is based on our novel Linshom thermal sensor which is regulated by a thermoelectric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patient's inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, relative Tidal Volume (rTV), relative Minute Ventilation (rMV), seconds since last breath (SSLB), and inspiratoryexpiratory (I/E) ratio. The CPRM solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, rTV, rMV (calculation of RR x rTV), seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. In Phase I, investigators will conduct a clinical study in 145 post-operative patients comparing Linshom's CPRM to current SOC (clinical attention + pulse oximetry) and capnography. We will collect SOC, CPRM and capnography data simultaneously from each patient to demonstrate the ability of Linshom CPRM to identify Respiratory Depression Episodes in advance of SOC and/or capnography. In Phase II, investigators will conduct a continuation of the phase I clinical study until the enrollment for this phase (175 patients) is reached, which would give an adequate statistical power for development of the Linshom CPRM alarm function. Specific aims: Aim 1: Demonstrate that Linshom CPRM is able to identify RDE earlier than pulse oximetry and capnography. o Outcome: Investigators expect to successfully demonstrate that Linshom CPRM is capable of identifying RDE in advance of pulse oximetry and capnography by performing statistical analyses (non-inferiority and superiority hypothesis tests). Aim 2: Identify parameters and threshold values for the alarm function of Linshom CPRM for RR, rTV percent change, rMV percent change, I:E ratio and SSLB. Outcome: Investigators will identify Linshom CPRM parameters and threshold values with high predictive abilities for RDE. These parameters and threshold values will be incorporated into future product to alert for clinicians and allow them to provide timely interventions to patients.

    Phase

    N/A

    Span

    104 weeks

    Sponsor

    Linshom Medical, Inc.

    Baltimore, Maryland

    Recruiting

  • Black and African Americans Connections to Parkinson's Disease (BLAAC PD)

    Research studies have found connections between genes and Parkinson's disease (PD). But those results have mostly come from studies with non-Black or African American volunteers. BLAAC PD aims to learn more about gene changes that may cause Parkinson's in Black and African American people. Study volunteers at sites across the United States will attend one visit and will give either a blood or saliva sample, complete a smell test, and may be asked to complete a physical exam. This new data could lead to future Parkinson's tests and treatments for Black and African American people and it may help better understand disease in other groups, too. This pioneering initiative will fill a gap of knowledge about PD in Black and African American people.

    Phase

    N/A

    Span

    320 weeks

    Sponsor

    Michael J. Fox Foundation for Parkinson's Research

    Baltimore, Maryland

    Recruiting

    Healthy Volunteers

  • Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV

    This will be a phase 2, open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). At baseline, BM-EABE with HIV, HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) will provide blood samples and anal swabs for evaluation of HPV immunity, anal HPV and anal dysplasia. All participants will undergo a 3-dose vaccine series of the Gardasil vaccine (at Day 0, Month 2 and Month 6). Participants will then return one month after completion of third vaccine (Month 7) to provide repeat blood samples and anal swabs. Samples will be compared pre and post vaccination and in-between participants based on HIV and exposure to androgen blockers or estrogen (EABE). Any participant with human papillomavirus 16 (HPV16) and/or anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy (HRA) for clinical management. Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis, including confocal microscopy. Those who had anal dysplasia at study entry will undergo repeat HRA, as clinically indicated, and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs.

    Phase

    2

    Span

    151 weeks

    Sponsor

    University of Maryland, Baltimore

    Baltimore, Maryland

    Recruiting

    Healthy Volunteers

  • 2321GCCC: CRD3874-SI in Patients with Relapsed/refractory AML

    Phase

    1

    Span

    179 weeks

    Sponsor

    University of Maryland, Baltimore

    Baltimore, Maryland

    Recruiting

  • Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength

    This condition, known as disuse muscle atrophy, poses a substantial challenge to the health and well-being of individuals, particular those hospitalized. To tackle this problem , the project focuses on a specific group of individuals particularly vulnerable to this issues: Veterans with chronic kidney disease (CKD). This disease affects a substantial population of over 500,000 Veterans, leading to a progressive decline in mobility, unfavorable changes in lean body mass, and heightened hospitalization rates. To comprehensively address this concern, the project indents to develop and implement assessment and intervention strategies tailored to the target cohort's needs. By concentrating on Veterans with CKD, the project seeks to generate approaches that can be widely applied to address muscle atrophy among individuals with similar conditions. To achieve this, the project twill commence by establishing a baseline cohort of Veterans with Stage 3 and 4 CKD at two distinct Veterans Affairs sites located in Denver and Baltimore. Upon enrollment, the Veterans muscles health will be assessed, encompassing various dimensions such as strength, lean muscle mass, muscle composition, mobility, and intrinsic capacity. This comprehensive evaluation will provide a snapshot of their pre-hospitalization muscle health. Subsequently, the enrolled Veterans will be closely monitored for at least two years. The project's approach involves conducting regular assessments of their muscle health every six months. Additionally, the participating Veterans will provide information about their strength and functional status every quarter, facilitated through a smartphone application. A particular noteworthy aspect of the project is its inclusion of a pragmatic rehabilitation intervention trail. Veterans who experience hospitalization during the study will have the opportunity to participate in this trial. They will be assigned to either a supervised flywheel strengthening exercise group or receive usual care over 16 weeks. This intervention trial aims to assess the effective ness of targeted exercise in mitigating the effects of disuse muscle atrophy post-hospitalization. The overarching design of the project encompasses three main objectives: Aim 1: Identify effective muscle assessment sites for disuse muscle atrophy. Aim 2: Assess if standardized intrinsic capacity and physical resilience assessments predict hospital outcomes. The investigators anticipate that physical resilience scores will improve hospitalization and strength outcomes predictions. Aim 3: Evaluate a supervised flywheel exercise program against usual care. Both groups are expected to improve, with the supervised group have better results.

    Phase

    N/A

    Span

    234 weeks

    Sponsor

    VA Office of Research and Development

    Baltimore, Maryland

    Recruiting

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