Clinical trials

The purpose of this study is to examine the impact of nasal spray treatment on Meibomian gland function and ocular surface health in symptomatic dry eye patients with mild to moderate Meibomian gland dysfunction (MGD).

This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring electricity or daily user action. Two cluster randomized controlled trials will be conducted in Kano State (North-West Nigeria) and Cross River State (South-South Nigeria). Communities will be randomized to either receive in-line chlorination installed at eligible communal water systems or serve as controls with no chlorination. The unit of randomization is a community or a cluster of communities that share water system for drinking water. The primary objective is to estimate the causal impact of in-line chlorination on household drinking water quality. Outcomes include the prevalence of Escherichia coli contamination in tap water and stored household water as well as the presence of free chlorine residual. Secondary objectives assess water source usage and adoption of chlorinated sources, as well as reduction in diarrheal disease. Implementation fidelity and operational performance of chlorination devices will also be monitored.

The goal of this clinical trial is to evaluate the effects of a high-intensity exercise program on recovery in individuals with post-stroke aphasia. The high-intensity exercise program has been specifically designed for individuals with post-stroke aphasia and includes an interval training full-body workout, which can increase cardiovascular fitness, improve muscle strength and motor performance, and maximize cognitive and language gains. The main question this study aims to answer is: • Does participation in a high-intensity exercise program lead to changes in physical health, language, cognitive, motor recovery, psychological and/or psychosocial domains? Participants will be randomly assigned to either a high-intensity exercise program (target intervention) or a low-intensity exercise program (control intervention) delivered over 12-weeks in a group setting. Outcome measures will be collected once immediately after the intervention period and once during the following 12-week maintenance period to capture short- and long-term effects of the exercise program.

The goal of this clinical trial is to learn if infrastructure and equipment installed to cool homes reduce adverse health outcomes. The main questions it aims to answer are: What is the impact of the intervention on indoor heat stress? What is the impact of the intervention on personal exposure to heat stress? What is the impact of the intervention on health outcomes, including heart rate, and heart rate variability, and sleep quality? Participants will have cooling infrastructure and/or equipment installed in their home; have heat stress sensors installed inside and outside their home and wear personal heat stress monitors; allow some biological functions such as heat rate, heat rate variability, and sleep quality.

Remote-store-and-forward teledermatology has recently grown exponentially in popularity and use as an efficient, accurate, and cost-effective way to improve the health and well-being of countless patients. Despite advances in machine learning and computer vision, the screening and reading of dermatological images still depends on the visual system of human observers (e.g., clinicians), who receive extensive training to best recognize lesions and anomalies. In remote store-and-forward teledermatology settings, clinicians may examine hundreds of images on a daily basis, seeing several images one after the other. A main underlying assumption of their work is that clinician percepts and decisions about a current image are completely independent from prior viewings. However, we and other groups demonstrated that the visual system has visual serial dependencies (VSDs) at many levels, from perception to decision making, including in clinical tasks. These sequential dependencies, replicated hundreds of times in the literature, mean that what was seen in the past influences (and captures) what is seen and reported at this moment. Theoretically, VSDs are helpful in an autocorrelated natural world, but they are suboptimal in visual tasks conducted in artificial situations where images are not always related. Importantly, serial dependencies in perceptual processing could thus produce significant errors during diagnostic judgments of dermatological images. Our central hypothesis is that VSD can have a disruptive effect in asynchronous remote-store-and-forward teledermatology judgments that impairs accurate detection and recognition of lesions. This hypothesis is supported by our robust pilot data, which show that VSD strongly biases lesion classification in both untrained observers and expert clinicians. The rationale for the proposed research projects is that once it is known how serial dependence arises and how it impacts judgments, we can understand how to control for it. Hence, accuracy of lesion detection and diagnosis can significantly improve. The specific objectives of this proposal are to establish (Aim 1), identify (Aim 2) and mitigate (Aim 3) the impact of VSD on remote-store-and-forward dermatological judgments.

The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.

Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity.

The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in the Mission community for Latino patients with depression and/or anxiety. 213 participants will be enrolled in a one-armed trial comparing self-guided vs. supported dCBT (SilverCloud).

The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.

The goal of the experimental study is to understand the impact of heat stress on core temperature and telomere length. Investigators will recruit rickshaw drivers who use manual power to push their rickshaws and randomly assign half of them to receive battery-powered rickshaws to use for four months. Investigators will assess how this change impacts their core body temperature while they work, the length of their telomeres (caps on the end of DNA that are associated with aging), and kidney function.

The goal of this clinical trial is to understand how well a culturally-specific "prebunking" video can improve vaccine information literacy and vaccine confidence among individuals in the Nusantara sociocultural sphere. The investigators hypothesize the individuals who watch the co-created "prebunking" intervention video will have improved vaccine literacy skills and vaccine confidence compared to individuals who watch a video about safe medication disposal.

The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.