Maryland Paid Clinical Trials

The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Read Less

The United States is experiencing an unprecedented opioid epidemic. Medications for opioid use disorder (MOUD), such as methadone, buprenorphine, and extended-release naltrexone, are the recommended standard of care. There are, however, many barriers to MOUD initiation so that only a minority of individuals who could benefit from MOUD treatment ever receive it. Even among individuals presenting to a residential level of specialty SUD care, only about 20% of individuals with OUD initiate MOUD leaving them at a higher risk of opioid relapse, overdose, and death. Thus, the goal of this expansion of scope pilot study is to address this gap by modifying our currently R34-funded intervention (RFA-DA-22-034; Project # 1R34DA057627-01) that leverages the impact of peer recovery support services (PRSS) to promote MOUD initiation. Although PRSS for MOUD initiation shows promise within emergency department settings, the impact of PRSS for MOUD initiation within residential substance use disorder (SUD) settings is unknown. Residential SUD settings are an ideal opportunity to initiate medications because individuals with OUD typically have access to medically-managed withdrawal and the opportunity to learn about and initiate onto MOUD. This PRSS intervention has already been developed in the R34 parent grant to promote MOUD retention, and in this expanded scope project it will be further adapted and tested with a small pilot sample of individuals (N = 10-20) who are further upstream in the cascade of care (COC). Peers will be embedded within the inpatient program unit where the study will take place. Early into their inpatient stay and before MOUD initiation occurs, peers will introduce themselves to patients and provide motivational enhancements for MOUD initiation and inpatient treatment retention through a variety of strategies. Peer strategies will be based on the existing PRSS intervention in the parent grant and may include exploration of MOUD knowledge and attitudes, discussion of relevant lived experience, MOUD psycho-education, and a collaboratively completed wellness plan. Upon discharge, peers will use other strategies to encourage uptake and retention of MOUD such as assertive outreach and emphasize return to care after treatment dropout and/or relapse. The proposed project will explore the feasibility and acceptability of PRSS on MOUD initiation in residential SUD treatment by pilot testing the PRSS intervention with a sample of 10-20 participants receiving an 8-week course of treatment. During the intervention period, the PRSS approach will be adapted and refined with feedback from peer recovery support coaches who have helped develop and test the parent intervention for MOUD retention. Our primary outcomes are: 1) MOUD initiation (yes/no) upon discharge of the inpatient SUD program, and 2) PRSS feasibility and acceptability as measured by a participant satisfaction survey. If this pilot work is successful, the investigators would further test this MOUD initiation-focused version of the PRSS intervention via a future R01-funded Randomized Controlled Trial. Read Less

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory. Read Less

To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims: * Examine neural markers that predict the sleep transition (Aim 1); * Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2); * Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3) * Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4) Read Less

This study will assess growth over time and the clinical course of HCH in children by collecting growth measurements and other variables of interest. Read Less

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data. Read Less

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors. Read Less

MMR-deficient cancers of any histologic type appear to be very sensitive to PD-1 blockade with pembrolizumab, and similar data are also beginning to emerge for nivolumab and other immune checkpoint inhibitors. Among the MMR-deficient cancers, the best antitumor responses are often associated with high microsatellite instability (MSI-H status), higher tumor mutational burden (TMB), and higher predicted neoantigen load. Prevalence estimates of MMR deficiency across solid tumor types range from 1% to 20% depending on the type of malignancy. In prostate cancer, 1-3% of unselected cases harbor MMR deficiency and/or microsatellite instability. For men who previously received definitive treatment for prostate cancer and subsequently develop detectable prostate specific antigen (PSA) levels, the clinical state is known as biochemically recurrent prostate cancer. The current standard of care treatment for patients with biochemically recurrent prostate cancer is either surveillance or androgen deprivation therapy (ADT). ADT has not been shown to provide a survival benefit in this setting, and the decision to initiate ADT will depend on patient preference and perceived risks of the disease. A non-hormonal therapy such as nivolumab would provide an alternative to ADT in patients with biomarker selected (i.e. dMMR, MSI-H, high TMB, or CDK12-altered) biochemically recurrent prostate cancer. Read Less

Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. The pain may begin as early as one week after stroke, although peak onset and severity occurs around four months, and persists into the chronic stage. Chronic post stroke shoulder pain (PSSP) interferes with motor recovery, decreases quality of life, and contributes to depression. PSSP is thought to be caused mainly by damage to the myofascial tissues around the shoulder joint. Interestingly, an MRI study in patients with PSSP showed that the degree of structural damage to the muscles did not correlate with the degree of pain. Thus, the pathophysiology of myofascial dysfunction and pain in PSSP has not been elucidated leading to missed opportunities for early diagnosis and variable success with pain management. The accumulation of hyaluronic acid (HA) in muscle and its fascia can cause myofascial dysfunction. HA is a glycosaminoglycan (GAG) consisting of long-chain polymers of disaccharide units of glucuronic acid and N-acetylglucosamine and is a chief constituent of the extracellular matrix of muscle. In physiologic quantities, HA functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during contraction and stretch. Reduced joint mobility and spasticity result in focal accumulation and alteration of HA in muscle. This can lead to the development of stiff areas and taut bands, dysfunctional gliding of deep fascia and muscle layers, reduced range of motion (ROM), and pain. However, the association of muscle HA accumulation with PSSP has not been established. The investigators have quantified the concentration of HA in muscle using T1rho (T1ρ) MRI and found that T1ρ relaxation time is increased in post stroke shoulder pain and stiffness. Furthermore, dynamic US imaging using shear strain mapping can quantify dysfunctional gliding of muscle that may generate pain during ROM. Myofascial dysfunction can result in non-painful reduction in ROM (latent PSSP), which may become painful due to episodic overuse injury producing greater shear dysfunction (active PSSP). Hence, shear strain mapping may differentiate between latent versus active PSSP. Thus, quantitative Motor Recovery (MR) and US imaging may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction. Read Less

There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges. Read Less

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection. Read Less

The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses. Read Less