San Diego, CA Paid Clinical Trials

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Read Less

Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital. Read Less

The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected. Read Less

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA). Read Less

Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project. The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program\* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour). Read Less

This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism. Read Less

This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer. Read Less

Vasospasm is a common complication after rupture of intracranial aneurysms causing devastating neurologic deficits and death. Vasospasm has been directly associated with the amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and lumbar drain (LD) have been compared retrospectively yet remain controversial as to which method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would be a prospective randomized trial in which patients would be assigned to EVD or LD and observed to see if one method of intervention is associated with preventing clinical vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an optimal treatment modality to benefit all future patients with ruptured intracranial aneurysms. Read Less

The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter syndrome. In this open label, single arm study, all participants will receive ELAPRASE treatment and a prophylactic ITR. Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. The prophylactic ITR will consist of a 5-week cycle of: Rituximab (intravenously \[IV\], weekly for 4 weeks); Methotrexate (oral, 3 times per week for 5 weeks) and intravenous immunoglobulin (IVIG) (IV, every 4 weeks of the cycle). Following the completion of 1 cycle, an assessment will be made at Month 6, 12, and 18 regarding the need for administering another 5-week cycle of the ITR. Participants will be in the study for approximately 112 weeks (including 6 weeks for screening, up to 104 weeks for treatment, and 2 weeks for follow-up). Read Less

This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI. Read Less

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Read Less

This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline. Read Less