Davis

Researchers are evaluating the safety and tolerability of a single dose of INS1201 administered via intrathecal injection in ambulatory male children with Duchenne Muscular Dystrophy DMD. This phase 1, open-label study focuses on males aged 2 to less than 5 years who can walk at least 10 meters without assistance and have a confirmed genetic diagnosis of DMD involving specific mutations in the DMD gene. Participants are divided into cohorts based on age and receive a single intrathecal injection of INS1201 at one of two dose levels on Day 1. The study includes children aged 2 to less than 3 years and those aged 3 to less than 5 years, with treatment groups for each age range. The study is sequential and non-randomized, evaluating safety, biodistribution, and dosing over time. Throughout the study, participants will be monitored for treatment-emergent adverse events up to 96 weeks. Assessments include measuring micro-dystrophin DNA and protein expression at baseline, Week 16, and Week 48 to evaluate biological effects. Regular follow-ups and motor assessments are conducted to track safety, tolerability, and motor function changes during the study period lasting over 2 years.

Researchers are evaluating wound management methods for adults with severe open tibia fractures requiring multiple irrigation and debridement surgeries. This Phase III trial compares an antibiotic cement bead pouch to negative pressure wound therapy NPWT to see which better reduces complications. The study addresses uncertainty about the best temporary wound care between surgeries and aims to fill gaps in knowledge about these two approaches. Participants will be randomly assigned to one of two groups. One group receives an antibiotic bead pouch where antibiotic-laden cement beads are placed in the wound and sealed with a dressing. Beads may be replaced during subsequent surgeries. The other group receives NPWT, a sealed dressing connected to a vacuum pump that removes fluid and promotes healing. NPWT settings and changes are managed by the surgeon, typically every 24-72 hours until final fracture treatment. Participants will be followed for six months with assessments at 6 weeks, 3 months, and 6 months after surgery. Researchers will evaluate a composite outcome including mortality, amputation, unplanned reoperations, and fracture healing using the Functional IndeX for Trauma FIX-IT tool. Safety events and outcomes will be reviewed by committees. The total study duration for each participant spans these follow-up periods to monitor healing and complications.

Researchers are evaluating the safety, feasibility, and effectiveness of prolonged automated robotic transcranial Doppler TCD monitoring in critically ill patients with severe traumatic brain injury TBI. The study aims to assess this technology across multiple clinical sites with varying levels of TCD availability and experience to better understand its clinical utility. Participants will undergo daily sessions of automated robotic TCD monitoring for up to 4 hours each day, for a minimum of 3 days and up to 5 days when possible. The monitoring uses a robotic system with bilateral 2-MHz Doppler probes to continuously record cerebral blood flow velocity in both middle cerebral arteries. This system includes automated angle correction to maintain optimal measurement quality. During the study, participants will be monitored for safety concerns such as discomfort, device dislodgement, and skin changes at the probe site. Feedback will be collected from nurses and clinicians to evaluate safety and feasibility. Researchers will also assess the adequacy of temporal windows and insonation quality of the arteries. The total study duration includes up to 5 days of monitoring with ongoing safety and usability assessments.

Researchers are evaluating how products containing Chardonnay marc, combined with cocoa flavanols, affect heart and metabolic health. This research focuses on measuring how these products influence blood vessel function and related health markers, including the gut microbiome, in adult males aged 30 to 50. The study aims to gather data that will help design future dietary trials and understands how different product forms impact the bodys response, especially 6 hours after consumption when certain metabolites peak in the bloodstream. The study uses a randomized, double-blind, crossover design involving up to 5 participants. Each participant will consume different test products on separate occasions low flavanol cocoa powder, high flavanol cocoa powder, and various servings of Vine to Bar Chocolate containing both cocoa flavanols and Chardonnay marc, including a version with almonds. Responses will be measured after single intakes followed over 6 hours to compare effects across these products. Participants will undergo assessments including the Framingham Reactive Hyperemia Index fRHI at 6 hours, along with tests for platelet aggregation, oxidative enzymes, glucose, insulin, and nitrate levels. The study involves close monitoring of vascular and metabolic responses after product intake. Participants will follow all procedures and visit schedules as outlined, with the total involvement lasting for the duration of these acute testing visits.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

Researchers are evaluating whether a natural product supplement can enhance collagen synthesis after ingesting collagen protein in young healthy adults aged 18 to 30 years. The study uses a model of natural products certified as safe to stimulate collagen synthesis and aims to see if the supplement increases the bodys collagen production response. This trial involves dietary supplements and focuses on connective tissue and exercise effects. Participants will consume either a natural product supplement containing hydrolyzed collagen, vitamin C, epicatechin, vitamin E, and stevia extract or a placebo supplement with hydrolyzed collagen, vitamin C, and sweetener. Blood samples are taken before and one hour after consumption. Participants will perform load-bearing exercise and take the assigned supplement daily for seven days, with a final blood collection four hours after the last exercise session. During the study, researchers will measure collagen protein synthesis over seven days and assess the strength and collagen content of engineered ligament constructs 60 minutes after exercise. Blood samples and exercise responses will be monitored to evaluate the supplements effects. The total participation period spans one week, with close monitoring of exercise and supplement intake under controlled conditions.

Researchers are studying how early life experiences influence young childrens ability to delay gratification and how this behavior relates to later life outcomes. The study focuses on whether waiting experiences in early childhood predict delaying behavior in different situations, and how social customs, effort, and choices affect these links. The trial involves typically developing children aged 4 to 7 years and is sponsored by the University of California, Davis. Participants will take part in several activities across sessions. Children will complete delay of gratification tasks with either a sweet treat or a wrapped gift as rewards, assigned randomly. They will also perform games measuring inhibition, cognitive flexibility, and proactive control, including computerized tasks with eye-tracking using a camera. Parents will answer questionnaires about their childs behavior and experiences with waiting at home. One year after the initial sessions, participants and parents will repeat a subset of these assessments. During the study, researchers will measure multiple outcomes such as choice delay, executive function, social conventions, academic readiness, inhibitory control, cognitive flexibility, problem behaviors, and experiences waiting at home. They will also collect secondary data including pupil dilation, behavior during delaying, subjective effort, proactive control, and child temperament. The study involves initial and follow-up sessions over one year, with no blinding and randomized assignment to different delay tasks.

Researchers are evaluating a machine learning ML algorithm that combines pulse oximetry features, including oxygen saturation and perfusion measurements, to screen for critical congenital heart disease CCHD in newborns. This study aims to externally validate the algorithm previously tested internally, assessing if adding perfusion measures and repeated measurements improves detection accuracy and reduces false positives. Participants will have non-invasive oxygen saturation SpO2 and perfusion index PIx measured using pulse oximeters. The ML screening algorithm will analyze these measurements continuously, assigning predictions every minute. The study includes repeated measurements up to four times, including after 48 hours of age, which can be done outpatient. This approach supports creating a dynamic model that incorporates new data over time. During the study, newborns suspected of or undergoing screening for CCHD will have their SpO2 and PIx monitored. Researchers will collect data to evaluate the algorithms performance by measuring sensitivity, specificity, and the area under the receiver operating characteristic curve over approximately four years. Safety monitoring and follow-up are integrated into usual care with assessments through the newborn period up to 22 days of age.

Researchers are investigating whether daily beef intake can help improve how zinc from the diet is absorbed into cells and support better metabolic and cardiovascular health in adults aged 55 to 70. This study focuses on older individuals who may have a higher risk of zinc deficiency and cardiovascular problems. The goal is to see if beef, as part of a heart-healthy diet, affects zinc-dependent processes that benefit blood vessel function. The study uses a randomized crossover design comparing two 4-week diet periods. One diet includes a beef stew providing 8.8 mg zinc and 37.9 mg protein, while the other uses a plant protein stew with the same zinc and protein content. Participants will switch between these diets to evaluate the effects of beef versus non-meat protein sources on zinc absorption and vascular health. Participants will undergo assessments of cellular zinc status using a novel zinc tracer in red blood cells and measurements of microvascular function through digital peripheral tonometry. Additional lab tests will monitor plasma lipids, fatty acids, and oxylipins. The study includes close dietary control and monitoring over the two 4-week periods, with outcomes focused on zinc uptake into cells and blood vessel health, lasting about 8 weeks in total.