Clinical trials

The goal of this study is to test a meditative neurofeedback intervention for depressed mood.

SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.

This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.

The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies. PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.

Anxiety disorders remain are among the most prevalent psychiatric conditions and are associated with negative outcomes spanning poor health to increased suicide risk. While exposure therapy is recognized as a gold standard empirically supported treatment, many individuals fail to achieve adequate response. Exposure therapy is grounded in fear extinction learning models, which suggest that anxiety diminishes when individuals repeatedly confront their fears. To improve exposure-based interventions, it is critical to enhance our understanding of underlying mechanisms of fear extinction and how to better target these mechanisms. Fear extinction requires basic neurocognitive abilities that allow individuals to learn from and adapt to experiences confronting feared situations. Emerging cross sectional and experimental data suggest that working memory is a particularly important neurocognitive process that is associated with fear learning outcomes. By enhancing working memory through experimental manipulations like cognitive training, we may improve the fear extinction learning processes essential for successful exposure therapy. Unlike other neurocognitive enhancements (e.g., medications), computer-based working memory training offers high mechanistic precision, ease of administration, and low cost. The long-term goal of this research is to develop a novel mechanistic understanding of the neurocognitive processes involved in exposure-based fear extinction learning, ultimately aiming to improve interventions for anxiety disorders. This study will test the effects of manipulating working memory prior to a massed exposure paradigm, comparing working memory training plus massed exposure (WMT+Ex) to a sham training plus massed exposure (ST+Ex) condition. Using public speaking anxiety as a clinical exemplar, we will employ a rigorous experimental trial design combined with a validated single-visit speech exposure paradigm to assess fear extinction learning outcomes through multiple measures, including behavioral, physiological, neural, and self-report. The central hypothesis is that WMT+Ex will improve markers of fear extinction learning considered to underlie clinical response in exposure therapy. Specific aims are to 1) determine the extent to which working memory training delivered prior to massed exposure improves behavioral and neural markers of fear extinction learning, and 2) evaluate the effects of working memory training delivered prior to massed exposure on fear extinction learning occurring during exposure. This study is expected to achieve two goals: first, to advance our understanding of the neurocognitive mechanisms of fear extinction through a rigorous experimental design, and second, to validate a combined working memory training and exposure paradigm. If successful in enhancing fear extinction, this approach could be further explored in therapeutic formats to assess its clinical effects.

The goal of this clinical trial is to learn if a low dose of dexamethasone can prevent cytokine release syndrome in participants treated with tebentafusp for advanced uveal melanoma. The main questions the study aims to answer are: How many participants get cytokine release syndrome? How severe is the cytokine release syndrome? What other side effects happen due to dexamethasone and/or tebentafusp? Participants will be treated with tebentafusp per standard practices. For this study, participants will receive dexamethasone before infusion of the first 4 doses of tebentafusp. Participants will have visits for checkups and tests at the time they are given the medications and 9 weeks after they started. Other visits will be approximately every 6 months for at least 2 years and can be done in person or remotely (telehealth).

The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are: Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take standard of care drugs? Researchers will compare drugs matched to tumor DNA mutations to standard of care drugs to see if the matched drugs work better, and to see if tumor worsening can be delayed for longer the more DNA mutations the drugs target. Participants will: Take drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule of the drugs. Visit the clinic every approximately 2 months for checkups and tumor imaging.

Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms.

The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.

To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors, CT1-DAP001, into the corpus striatum in patients with Parkinson's disease

Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them. This study will develop and evaluate a recovery-oriented suicide prevention group program for young people at clinical high risk for psychosis. The program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person. The study will first gather feedback from participants, caregivers, clinicians, and community advisors to refine the program. Researchers will then compare the program plus standard care with standard care alone to determine whether it improves personal recovery and increases participants' ability to remember and use suicide prevention strategies. Researchers will also collect feedback from participants and program staff to better understand how the program can be integrated into early psychosis services.

The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth. The main questions this study aims to answer are: * Does using the chatbot improve postpartum pelvic floor health knowledge? * Does using the chatbot help reduce feelings of loneliness during the postpartum period? * Does using the chatbot impact pelvic floor symptoms? Researchers will compare standard postpartum care to standard care plus the chatbot. Participants will: Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot. If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period. Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress. The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.

Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide. Besides causing symptoms that impair movement, PD also causes non-motor symptoms, such as problems thinking and orthostatic hypotension (OH), i.e., low blood pressure (BP) when standing. About one-third of people with PD have OH, which can cause sudden, temporary symptoms while upright, including lightheadedness, dizziness, and fainting. People with PD and OH can also experience problems thinking that happen only while upright and not while sitting - this can occur without other symptoms, such as feeling dizzy or faint. However, the level of low BP that can affect thinking remains unknown, and no guidelines exist for treating OH when it happens without symptoms. This is significant because OH could be a treatable risk factor for thinking problems in PD, but OH is often not treated if people do not report obvious symptoms. This project's goal is to determine how BP affects brain function in PD. The proposed experiments will measure BP and brain blood flow continuously in real-time using innovative wearable technology. Persons with PD with OH and without OH will undergo repeated cognitive tests while supine (lying down) and while upright. I will study the associations between BP, thinking abilities, and brain blood flow, and will compare groups with and without OH. These findings could be important because if a certain level of BP correlates with thinking abilities, then treating OH in PD may prevent thinking problems, which would improve health-related quality of life and reduce disability and healthcare costs.

\*\*Participants must live in San Diego County\*\* The purpose of this study is to learn more about an experimental Sleep \& Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.

The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation therapy (ADT) in patients with prostate cancer. The investigators want to find out if these drugs work the same way if they are given for 6 months or for the usual 18 months in patients who receive also definitive external beam radiotherapy. The investigators will also learn about the safety of the treatments. The main questions the study aims to answer are: Do patients who get radiation therapy plus 6 months of androgen deprivation therapy need other hormone therapy or develop castration resistance at a higher rate within 5 years, compared to patients who get radiation therapy plus 18 months of androgen deprivation therapy? Participants will: Be treated with definitive external beam radiation therapy and receive androgen deprivation therapy for 6 months or 18 months. Have visits once every 3 months for checkups and tests for at least 5 years. The visits at 3 months, 1 year, and 5 years need to be done in person; all the other visits can be done in person or remotely (telehealth). Keep a diary of the missed doses of the androgen deprivation therapy.

This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality.

This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)

The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are: 1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy? 2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy. Participants will: 1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily 2. Visit the clinic every 3 months for checkups, tests and imaging studies

The mechanisms leading to opioid tolerance or dependence are not well understood and there are currently no biomarkers for predicting who is at risk for development of OUD. The purpose of this project is to support the feasibility of detecting a miRNA bio-behavioral signature of opioid misuse risk that will demonstrate improved predictive precision compared to current tools such as polygenic risk scores (PRS). Specifically, the study will address key goals of the Wellcome Leap program to develop scalable measures assessing individual addiction susceptibility and quantifying addiction risk and progression during prescription drug use. The study will utilize behavioral, genomics, and bioinformatics pipelines to characterize opioid-induced miRNA expression dynamics among trauma and surgical patients prescribed opioids at discharge. Based on results from this study, the research will develop a high-throughput screening assay to predict risk for opioid use disorder (OUD). The hypothesis is that miRNAs will serve as powerful bio-signatures for predicting long-term clinical outcomes in patients treated with opioids for pain management following trauma injury and/or surgery.

To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus

This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism. The main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function. Participants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period. Study visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.

The goal of this study is to understand why some people receiving chimeric antigen receptor (CAR) T-cell therapy for cancer experience neurotoxicity. The main question it aims to answer is: Can a novel tool be developed to identify early the patients who will develop immune effector cell-associated neurotoxicity syndrome (ICANS, also called neurotoxicity) after chimeric antigen receptor (CAR) T-cell therapy? Participants already scheduled for chimeric antigen receptor (CAR) T-cell therapy as part of the medical care for their cancer will be evaluated with advanced neuroimaging techniques. In addition, neurocognitive assessments using questionnaires and measurement of biomarkers in blood (liquid biomarkers) will be performed to provide a comprehensive characterization of neurotoxicity following chimeric antigen receptor T-cell therapy. Assessments will be performed in the acute phase (2 to 14 days after chimeric antigen receptor (CAR) T-cell therapy) and after approximately 3 months.

This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.

Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk. There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.

This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.