Clinical trials

Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time. To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM). Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes. The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services. If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.

The goal of this observational study is to learn about dietary quality and barriers to healthy eating among older adults who participate in the Los Angeles County Food Rx Produce Distribution Program. The study will also evaluate whether a newer dietary assessment tool, the Global Diet Quality Questionnaire (GDQQ), performs similarly to an established dietary assessment tool, the Mediterranean Diet Scale (PREDIMED MDS), in measuring diet quality among adults aged 60 years and older. The main questions it aims to answer are: * Is the GDQQ associated with diet quality scores measured by the PREDIMED Mediterranean Diet Scale? * Does the GDQQ predict self-reported body mass index (BMI) as well as or better than the PREDIMED Mediterranean Diet Scale? * What barriers and facilitators influence healthy eating and participation in produce distribution programs among older adults? Participants will: * Complete questionnaires about their dietary habits, demographic characteristics, and food access experiences. * Complete two dietary quality assessment tools: the PREDIMED Mediterranean Diet Scale and the Global Diet Quality Questionnaire. * If randomly selected, participate in a one-time semi-structured interview to discuss healthy eating, food access, experiences with produce distribution events, and challenges to improving dietary quality.

The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone. Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: \[1\] TR and usual care; \[2\] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.

The goal of this clinical trial is to evaluate the clinical safety and efficacy of Extracorporeal Shockwave Therapy (ESWT) for the management of high-grade Bone Stress Injuries (BSIs) in collegiate and recreational athletes compared to a control group receiving standard of care with sham ESWT. The primary and secondary endpoints of the study are to evaluate the safety and feasibility of extracorporeal shockwave therapy for the treatment of pelvic and lower limb extremity fracture or BSI. Researchers will compare the ESWT group to the sham ESWT group to see if ESWT results in better safety and efficacy outcomes for treating high-grade BSIs. Participants will: * Undergo a screening period to determine eligibility. * Receive up to 4 treatment sessions of ESWT, with the frequency of sessions being approximately every 5 days (within a range of every 3-10 days). * Be monitored for up to 6 months for research follow-up, with further questionnaires and check-ins during the standard of care follow-up period until they are able to return to sport activity level.

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin. The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.

The goal of this clinical trial is to investigate for the first time in people with schizophrenia a neural mechanism that is thought to facilitate the formation of social connections - inter-brain synchrony - in order to improve scientific understanding of the neural mechanisms of social dysfunction in the disorder, and to provide a basis for the development of new and better treatments to improve social functioning and connectedness in the illness. The main questions it aims to answer are: 1. Investigate inter-brain synchrony as a neural mechanism of social connection in schizophrenia 2. Manipulate social closeness and test for effects on inter-brain synchrony across groups The investigators will compare results from people with schizophrenia to a healthy comparison group (controls) who do not have psychotic disorders to see if inter-brain synchrony is greater in controls. Investigators will also compare measures of inter-brain synchrony before and after the social closeness manipulation to see if inter-brain synchrony changes with increasing closeness. Participants will: * Have a clinicial diagnostic interview and be assessed for clinical symptoms * Have an EEG recorded while interacting with another person. Participants will first work with the other person to draw a figure, and then tap fingers together. Participants will then either undergo the experimental manipulation to increase social closeness (called, "fast friends") or undergo the control condition that does not increase social closeness (called "small talk"). Participants will then repeat the drawing and finger tapping assessment. * After completing the experimental or control condition, participants will then repeat the procedure with the other condition that was not yet done. * Be interviewed on the number and quality of social interactions.

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.

This project studies the effectiveness of brain stimulation on borderline personality disorder (BPD) symptoms. This study is blinded, randomized and will enroll up to 30 participants. Participant will be consented for the study remotely via a secure internet platform called Zoom. Participants will undergo up to 2 MRI scans, 2 brain wave recording sessions and up to 30 brain stimulation treatments, and complete symptom assessments and cognitive behavioral tasks on a computer. Participation requires minimum of 17 in person visits over the course of 2.5 months. Participants are randomly assigned active or sham brain stimulation. Participants who received sham brain stimulation have the option to receive additional 15 active brain stimulation session.

This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).

Myofascial Pelvic Pain (MPP) is an often-misdiagnosed condition affecting up to 26% of women during their lives and imposing enormous costs on national health care systems. It frequently involves comorbidities such as bladder, bowel, and sexual dysfunction. There are no quantitative measures that adequately guide the physician and accurate diagnosis typically requires an internal examination by a tertiary specialist. This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations by providing an inexpensive, reliable and easily available method for a variety of providers to address MPP.

The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.

The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects.

The goal of this clinical trial is to learn if a Suzetrigine-based multimodal pain regimen can reduce the volume of opioid consumption while maintaining non-inferior pain control compared to an opioid-based multimodal pain regimen after common ambulatory orthopaedic sports procedures. The main questions it aims to answer are: 1. Does including Suzetrigine in the multimodal pain regimen lower the volume of opioids consumed by participants while maintaining non-inferior pain control? 2. How does the side-effect profile of a Suzetrigine-based multimodal postop pain regimen compare to that of an opioid-based multimodal postoperative pain regimen? Eligible participants will be assigned to receive one of the postop pain regimens and report their opioid use, their pain level, and the side effects they faced every day for 7 days.

The purpose of this study is to determine whether consumption of 355 ml of watermelon juice will: 1. improve cardiovascular and overall metabolic health markers like blood pressure, heart rate, stiffness/flexibility of arteries (blood vessels), blood sugar, cholesterol), and gut hormones 2. contribute to the body's ability to protect itself from the potential cell damage caused by harmful chemical compounds (produced when skin is exposed to ultraviolet (UV) B light, for example). This will be evaluated by measuring how resistant skin is to the damage from UVB light exposure, as well as several markers of bodily stress blood and urine. This will be determined immediately after consuming the juice (to evaluate the effects the juice has on health right away), as well as after 4 weeks of daily juice consumption (to evaluate the effects the juice has on health when consumed consistently over time).

This study will implement an adapted peer navigation intervention to improve linkage to and retention in HIV care for people living with HIV who experience substance use within Los Angeles County.

This study aims to improve how lab results are communicated to older adults by refining a predictive model that uses electronic health record (EHR) data. The model was originally developed to estimate the risk of chronic kidney disease (CKD) progression. Researchers will use existing health data to test and improve the accuracy of the model and explore how it might be adapted for use in other health conditions. The study does not involve direct interaction with patients and is conducted entirely using de-identified data in a secure environment.

The aging process entails a multitude of structural and functional alterations within the brain, culminating in a gradual and progressive decline in cognitive function. Recent research has indicated that various spices may hold the key to enhancing brain health and combating the effects of aging on cognitive abilities. The hypothesis is that a mixture of spices, acknowledged for their reported memory protection potential, may yield a more potent beneficial effect on memory function than a single spice. The spice mixture will be used at culinary dose, and therefore side effects are anticipated. In this study, the effects of spice mixture will be evaluated, as well as their anti-oxidant, and anti-inflammatory properties. The proposed pilot study will include 50 adults (ages 50-80), exhibiting typical age-related mild cognitive decline, excluding dementia or major neurocognitive disorders. They will be randomized 1:1 assigned into a daily intake of either 4.00 g spice mixture capsules or 4.00 g maltodextrin capsules over 3 months, and explore the sustainable effect over 3 additional months. The changes in symptoms of cognition, fatigue, and mood symptoms of the spice group vs. placebo group will be compared. The outcome of the investigation of the effects of mixed spice consumption will provide important novel information on dietary recommendation of spice to preserve cognitive function in aging population.

The incidence of thyroid cancer has exploded in the past 5 decades, with a roughly three-fold increase since 1995. Fortunately, many new cases are small, early-stage thyroid cancers. The American Thyroid Association guidelines state that patients with papillary thyroid cancers less than 4 cm can choose either thyroid lobectomy or total thyroidectomy. However, it is unclear why patients will sometimes choose more aggressive treatments that carry additional operative risk when a less aggressive option is available. When investigators examined thyroid specialists' recommendations for thyroid cancer treatment, investigators found significant variation between physicians' risk estimates and their treatment recommendations. This illustrated that patients may receive inconsistent counseling regarding their diagnosis and treatment options from different providers. Worse yet, other studies have shown that patients often do not perceive a choice in their treatment. When patients undergo treatments that do not align with their own priorities and values, they may experience regret and low satisfaction. Decision aids have been shown to help patients feel more educated about their options but have not had an effect on their treatment choice, decision regret, or satisfaction. The aim of this study is to use an ethnographic approach to map the patient decision-making process and develop a Decision Navigation Tool to improve decision outcomes for thyroid cancer patients. An ethnographic approach seeks to understand the social norms, culture, and context that influence these decisions. Investigators will do so in 3 phases: 1) elicit patient decision criteria in selecting initial treatment for thyroid cancer, 2) construction and validation of decision-tree model for initial treatment of thyroid cancer, and 3) pilot randomized controlled trial of a Decision Navigation Tool. To construct the decision model, investigators will recruit a diverse sample of patients with varying age, gender, race/ethnicity, and operative and cancer outcomes. The Decision Navigation Tool will highlight patients' values and priorities and empower them to select a treatment aligned with their preferences. This study will provide important insights into the patient experience of decision-making in thyroid cancer and test the feasibility of a future multi-center large-scale clinical trial of a Decision Navigation Tool to improve decision outcomes.

This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements. Secondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery. Reduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects.

This study is being done because the investigators want to learn about how stigma and culture in Indonesia affects how much contact people living with HIV have with the healthcare system and also how it might affect their health status.

Social determinants of health (SDOH) exert a powerful influence on the everyday management of type 1 diabetes (T1D) and short and long term outcomes of T1D. Experts agree that identifying and addressing negative social determinants of health (SDOH) may help accomplish numerous T1D care goals and promote health equity in treatment. However, fundamental research gaps in achieving these goals remain, including optimal screening and management processes for identification of negative social determinants of health (SDOH) , and how to develop robust partnerships with community-based organizations (CBOs) that address social determinants of health (SDOH) with high potential for sustainability and scalability. This project will generate new knowledge regarding how to implement a social work-led social determinants of health (SDOH) screening and referral program designed to aid families of youth with T1D who face several vulnerabilities, including food insecurity. The team will implement a single arm, pragmatic clinical trial with contemporaneous, non- randomized controls; whereby all families with a child enrolled in the California Children's Services (CCS) program (which provides specialized medical care for low-income families of youth with a qualifying chronic medical condition) will receive access to a novel social work-led social determinants of health (SDOH) screening and referral program. Outcomes will be compared against youth with T1D who are also seen in our Westwood Pediatric Endocrinology clinic but who are not enrolled in the CCS program and will not receive access to the social determinants of health (SDOH) intervention. The study team has established partnerships with several community-based organizations (CBOs) across Los Angeles County that provide social services, including food-related services, to receive referrals for CCS families who screen positive for having a social need. The study team will assess the feasibility and acceptability of this screening and referral protocol among families, CBOs, and providers (Aim 1) by measuring key implementation outcomes (comprehensive documentation of social determinants of health (SDOH) screening, result, and referral in the patients' medical record) and acceptability outcomes (self-reported satisfaction with the program by families and barriers and facilitators by CBOs and providers). The team will additionally estimate the effect of this intervention (Aim 2) by measuring changes (pre/post intervention) in families reported social needs, diabetes-related quality of life, and in the child's glycemic control (measured by HbA1c). Results from this work can provide a roadmap for sustainable and scalable social determinants of health (SDOH) interventions with potential to improve outcomes for youth with T1D in an equity-informed manner.

Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to demonstrate the safety and efficacy of Fimepinostat in the treatment of patients with de novo, persistent, and/or recurrent CD recruited at the University of California, Los Angeles. The trial will have a 2-arm design and will simultaneously examine two different doses of Fimepinostat. The study will allow the investigators to determine the efficacy and safety of these doses in the treatment of CD and guide dose selection for subsequent, larger studies. Funding Source - FDA OOPD.

This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.

The goal of this project is to test whether regulating emotions with help from a friend is more effective and long-lasting in adolescents than regulating alone, and to characterize age-related differences in the neural mechanisms supporting social versus cognitive emotion regulation. Participants will complete a psychology experiment while undergoing fMRI scanning.

UCLA researchers looking for healthy older adults (aged 65+) to participate in a study investigating how writing about experiences can affect your brain and body. Once a week for 6 weeks, participants will write about their experiences and fill out online questionnaires. Participants will also come to the UCLA campus to complete a neuroimaging session (fMRI), provide a blood spot sample, and fill out questionnaires 2 times: once prior to the 6-week writing period and once immediately after the 6-week writing period.