Moreno Valley

Researchers are evaluating whether oral vancomycin can prevent Clostridioides difficile infection (C.diff) in critically ill adults who are at high risk of this infection due to their medical conditions and hospitalization. This study also aims to assess the safety of vancomycin in this setting and to understand if being a carrier of C.diff affects infection rates or clearance when vancomycin is used as a preventive measure. The trial compares oral vancomycin to a placebo to see if it effectively lowers the rate of C.diff infection in hospitalized high-risk patients. Participants will be randomly assigned to receive either vancomycin 125 mg orally once daily or a placebo solution. They will take the assigned study medication while receiving systemic antibiotics and continue for up to five days after the last antibiotic dose, with the total antibiotic treatment not exceeding 21 days. Rectal swabs will be taken before randomization and at the end of the study or hospital discharge to check for C.diff colonization and possible vancomycin-resistant Enterococcus colonization. During the study, participants will provide stool or rectal samples to monitor C.diff carrier status and changes in stool microbiome, including resistant bacteria. Researchers will check adherence and monitor for adverse events every three days until discharge. After the intervention, participants will be contacted by phone to assess if they developed diarrhea or any side effects from the study medication. The main outcome measured is the rate of healthcare facility-onset C.diff infection over a period of up to four months.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

Researchers are developing a new behavioral program to help pregnant smokers in San Bernardino County quit smoking. This study focuses on reducing disparities in smoking cessation among pregnant women by integrating community health workers (CHWs) into prenatal care. The goal is to test the feasibility, acceptability, and effectiveness of adding home visits by CHWs to the usual healthcare model to support tobacco cessation around a planned quit date. Participants will be randomly assigned to one of two groups. In the intervention group, CHWs will visit participants' homes up to eight times to provide brief behavioral support, including watching educational videos and reviewing self-help materials before, during, and after the quit date. In the control group, participants 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 postpartum, typically ten months later. Researchers will assess smoking cessation through self-reports comparing baseline enrollment to the postpartum visit. The study will also evaluate the program's feasibility and acceptability. Safety and adherence will be monitored through the ongoing interactions with CHWs and prenatal care providers.

Researchers are evaluating the safety and success of a new medical device called the GORE Tissue Reinforcement for Breast Reconstruction (TRBR) Device in women undergoing breast reconstruction after mastectomy. This study compares two groups: one using the investigational TRBR Device to reinforce soft tissue around the tissue expander and a control group who previously had breast reconstruction surgery without additional tissue reinforcement. The study focuses on women receiving immediate, two-stage, implant-based breast reconstruction for cancer treatment or prevention. Participants will be divided into two arms. The Treatment Arm involves the use of the TRBR Device during breast reconstruction surgery, while the Control Arm collects data from patients who underwent surgery without this device. The TRBR Device is designed to support tissue around the tissue expander before breast implant placement. Both unilateral and bilateral mastectomies are included, with reconstruction performed either under or over the chest muscle. The device is investigational and not yet FDA approved. During the study, participants will be closely monitored for one year after surgery to assess the absence of major adverse events related to the device or procedure. Researchers will collect data on safety and breast reconstruction success. Participants must be able to follow all protocol procedures and attend follow-up visits. The study excludes those with prior radiation to the chest, recent chemotherapy, infections, certain medical conditions, or use of other reinforcement materials. The total duration of participation is at least one year post-procedure to evaluate outcomes.