Clinical trials

The primary objective of this study is to determine if increasing age confers greater vulnerability to the acute A) cognitive (e.g., memory, attention, psychomotor function), B) subjective (e.g., anxiogenic and rewarding effects), and C) cardiovascular (heart rate and blood pressure), effects of THC in adults \> 21 years old. The secondary aims of the study are to explore age-related acute effects of THC on electrophysiological indices of information processing (e.g., auditory steady-state response (ASSR), oddball paradigm \[P300\], and resting state cortical noise) and to determine age-related differences in the metabolism of THC.

This study is a mixed-methods pilot designed to evaluate the feasibility, acceptability, and appropriateness of a brief digital micro-intervention aimed at reducing stigma-related barriers to pre-exposure prophylaxis (PrEP) engagement among people who use drugs (PWUD) in Kazakhstan. Participants will complete baseline and post-intervention surveys and receive structured informational content via Telegram or WhatsApp over approximately 2-3 weeks. The intervention focuses on addressing anticipated stigma, confidentiality concerns, and misinformation that may prevent PWUD from seeking PrEP services. No clinical procedures, medication provision, or biological specimen collection are involved.

This exploratory project will assess the acceptability and feasibility of monthly extended-release subcutaneous buprenorphine (BRIXADI; XR-B) to treat opioid use disorder (OUD) among persons in the community receiving care on a mobile pharmacy clinic (MPC). Participants who are interested in initiating monthly or weekly injections of subcutaneous XR-B (BRIXADI) as a treatment for their OUD will be enrolled in a 6-month study assessing the acceptability and feasibility of receiving XR-B on an MPC.

This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.

The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using \[11C\]UCB-J PET imaging.

This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.

The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control. The main question\[s\] it aims to answer are: * To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control. * Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport Participants will have: * A screening visit * placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0 * Additional visits/phone calls for intensification of diabetes management and nutrition visits * Second magnetic resonance spectroscopy (MRS) at week 12

Brain disease and heart disease are the leading causes of death and disability in the US; at least 60% of cases can be attributed to modifiable risk factors such as hypertension, dyslipidemia, and poor-quality diet. Our mission is to deliver high-quality preventive care to whole geopolitically defined communities, reaching every resident. ThumpThump is a novel implementation strategy that 1) uses sociology, marketing, and behavioral science to engage residents and 2) adapts population health methods from high-functioning health systems to geopolitically defined communities. ThumpThump is starting with hypertension in Derby, CT in collaboration with city residents and city leaders. The ThumpThump Pilot Study will estimate the likelihood that a large, definitive trial of ThumpThump can succeed. The pilot study will enroll 150 residents who are at least 40 years of age. Specific aims are: 1) demonstrate ThumpThump can reach residents of Derby, 2) measure and achieve fidelity to standard hypertension care, and 3) measure success in applying our implementation strategy. The pilot is a one-arm trial. Proven population health methods from high-functioning health systems will be used to first classify participants according to hypertension (none, controlled, uncontrolled) and then help those in need get to goal. Home blood pressure cuffs will be given to all participants. Participants with no or controlled hypertension will have blood pressure re-measured at three and six months. Participants with uncontrolled hypertension will be offered two options: 1) to continue care from their personal healthcare professional or 2) to receive hypertension care directly from our team. With either method, the study will continue to monitor their blood pressure regularly. If they continue to receive care from their personal professional, participants will be offered support in following that professional's plan and the study will communicate and coordinate with their professional as appropriate. If they chose our team, a treatment algorithm will be used to help them get to their BP goal. Community health workers will be employed for participant enrollment and follow-up care (e.g., health education, blood pressure monitoring, treatment implementation, and navigation within health systems). Team care will include working with local health care professionals and institutions to advance a mutual mission, not replace their function. If successful, funds for a definitive trial will be sought with the long-term goal of targeting more risk factors and expanding to more communities.

This study investigates the therapeutic benefit of consolidative local therapy with extirpative surgery for participants with locally advanced or oligo-metastatic urothelial carcinoma that have disease control with enfortumab vedotin-based systemic therapy and surgically resectable or previously radiated metastatic sites.

The goals of this sub-study is to assess CB1R availability in early abstinent individuals with OUD (following opioid agonist therapy - OAT stabilization) and in matched healthy controls.

South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high. Using experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.

The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.

The goal of this observational study is to evaluate the role of blood pressure (BPV) variability in patients suffering from acute ischemic stroke. The main questions it aims to answer are: 1. To determine the association of BPV with functional/cognitive outcome after ischemic stroke. 2. To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome. 3. To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke.

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from regions affected by glioma prior to surgery.

The purpose of this study is to examine the acute effects of exercise on cognitive flexibility and symptom reactivity. The main questions it aims to answer are: Does moderate intensity physical activity reduce subjective distress, compulsive urges, and intrusions- and increase cognitive flexibility- in adults with obsessive-compulsive disorder compared to low-intensity physical activity? Researchers will compare low- to moderate-intensity exercise to see if moderate physical activity increases cognitive flexibility and reduces symptom reactivity in adults with obsessive-compulsive disorder (OCD). Participants will: Complete self-report surveys, psychiatric interviews, and cognitive tasks. Be assigned to either a low- or moderate-intensity exercise condition and complete physical activity. Repeat cognitive and symptom measures following the exercise intervention.

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642

This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.

The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural). The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.

The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.

The focus of this pilot will be on falls and neurocognitive symptoms, and the impact of alcohol, cannabis use, and medications on these outcomes. The rationale is that alcohol use at any level may interact with neurocognitively active medications, alcohol, and cannabis use leading to falls and impaired cognition.

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

The proposed randomized, double-blind research study will use functional magnetic resonance neuroimaging using state-of-the-art HCP acquisition protocols and analytic pipelines, to identify predictors and correlates of response to an accepted first-line pharmacological treatment for obsessive-compulsive disorder.

This trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder.