Moreno Valley

Researchers are evaluating whether oral vancomycin can prevent Clostridioides difficile infection C. diff in adults who are critically ill and at high risk due to their medical conditions and hospital stay. This trial also aims to understand the safety of vancomycin in this setting. The main questions are whether vancomycin lowers the infection rate and how carrier status of C. diff affects infection and clearance when vancomycin is used as primary prevention. Participants will be randomly assigned to receive either oral vancomycin 125 mg daily or a matching placebo while they are on systemic antibiotics, continuing up to five days after the last antibiotic dose, with the antibiotic treatment not exceeding 21 days. If discharged before completing the study medication, participants will continue taking it at home. Stool samples or rectal swabs will be collected to assess C. diff carrier status and changes in stool microbiome, including vancomycin-resistant Enterococcus VRE. During the study, participants will be monitored every three days until hospital discharge for adherence and side effects. After finishing the treatment, follow-up calls will be made to check for diarrhea or any adverse effects. The primary outcome is the rate of healthcare facility-onset C. diff infection, measured up to four months, along with secondary outcomes like VRE colonization, community-onset infections, time to infection in symptomatic patients, colonization at discharge, hospital stay length, and in-hospital mortality.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

Researchers are developing a new behavioral program to help pregnant women stop smoking, focusing on those in San Bernardino County. This study aims to reduce disparities in quitting smoking during pregnancy by combining prenatal care with support from community health workers CHWs. The trial is a pilot randomized controlled study testing the feasibility, acceptability, and effectiveness of adding home visits by CHWs to usual prenatal care. Participants will be randomly assigned to one of two groups. One group will receive up to eight home visits from CHWs who will provide brief behavioral smoking cessation support before, during, and after a planned quit date, including watching educational videos and reviewing self-help materials. The other group will receive standard care, which includes referrals to community-based smoking cessation resources. During the study, participants will be monitored from enrollment until about one month after giving birth, usually around ten months in total. Researchers will assess tobacco abstinence by self-report and measure carbon monoxide levels. Participants in the CHW visit group will also share their satisfaction with the intervention. The study tracks changes from baseline through the postpartum period to evaluate the programs impact and acceptability.

This research aims to evaluate whether using Steri-Strips, which are adhesive strips placed over surgical incisions, provides additional benefits after cesarean section C-section surgery. The study focuses on women undergoing C-sections and investigates if Steri-Strips reduce wound complications such as infections, fluid buildup under the skin, or reopening of the incision. Researchers also want to assess if Steri-Strips improve recovery, scar appearance, and cost-effectiveness compared to standard wound closure alone. Participants will be randomly assigned to one of two groups. One group will receive the usual cesarean skin closure followed by application of Steri-Strip adhesive strips according to a standardized protocol. The other group will receive the standard skin closure without Steri-Strips. The study will compare wound healing outcomes, complications, patient recovery, and costs between these two approaches. During the study, participants will be monitored for wound complications within 30 days after delivery. Researchers will track hospital stay length, readmissions related to wound issues, and the overall cost of wound care during this period. The study will last from cesarean delivery through 30 days postpartum, with participants involved in follow-up evaluations aimed at understanding the effects of Steri-Strips on healing and recovery.

Researchers are evaluating the safety and effectiveness of the GORE Tissue Reinforcement for Breast Reconstruction TRBR Device in women undergoing breast reconstruction after mastectomy. This study compares data collected from women receiving the investigational TRBR Device during two-stage implant-based breast reconstruction with data from women who previously had similar surgeries without additional tissue reinforcement. The study aims to assess safety and the success of breast reconstruction using this new device, which has not yet been approved by the FDA for this use. Participants in the Treatment Arm will receive the TRBR Device, which is designed to reinforce the soft tissue around the tissue expander before placing the breast implant after mastectomy. The device is used during immediate, two-stage implant-based breast reconstruction, either under the pectoral muscle subpectoral or above it prepectoral. The Control Arm includes data from subjects who had reconstruction without the device. This study includes women having unilateral or bilateral mastectomy for breast cancer treatment or prevention. During the study, participants will be monitored for major adverse events related to the device or procedure for one year after the initial surgery. Researchers will also assess physical well-being using the BREAST-Q questionnaire at one year post-procedure. Participants must comply with follow-up visits and protocol procedures. The study will continue until July 2030, with close observation of device safety and reconstruction outcomes.