Lompoc

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Central Line-Associated Bloodstream Infections (CLABSIs) are a serious problem in U.S. hospitals, leading to more deaths, longer hospital stays, and higher costs. This trial evaluates whether giving hospital Infection Preventionists access to a machine learning (ML) model that predicts possible CLABSI risk can reduce infection rates compared to standard care. The study is a prospective, multi-center, cluster-randomized trial conducted at 20 Providence hospitals with the highest CLABSI rates, aiming to assess the clinical impact of deploying the ML model in real-world hospital settings. In the trial, Infection Preventionists at intervention hospitals use a daily dashboard showing patients at risk for CLABSI based on the ML model's predictions. They review flagged cases and provide targeted education and recommendations focused on central line care best practices, including line necessity evaluation, alternative IV access suggestions, and ensuring proper line maintenance such as clean dressings and daily chlorhexidine baths. The intervention group receives this support for four to five months, while the control group continues routine clinical practice. Participants are adult inpatients with central lines in place for more than 48 hours. Researchers measure the rate of CLABSI events per 1,000 central line-days from hospital admission through discharge. Additional outcomes include the proportion of central lines removed within 48 hours of alerts, positive blood culture rates, frequency of Infection Preventionist interventions, and safety monitoring for complications like pneumothorax and hemorrhage. The study plans interim and final analyses to evaluate the effectiveness of the ML-guided intervention over a five-month period.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are collecting whole blood and serum samples from adults with untreated Hepatocellular Carcinoma (HCC) and from those undergoing surveillance for HCC to help develop and validate a new multi-analyte blood test called Helio. The study includes participants diagnosed with HCC as well as those without cancer who are at risk and undergoing routine monitoring. The goal is to improve detection of liver cancer using this blood test by studying DNA methylation and protein markers. Participants are divided into two main groups: those with HCC and those without. The group without HCC is further split based on the imaging method used to confirm the absence of cancer, either CT/MRI or ultrasound. Those in the ultrasound subgroup will have a follow-up ultrasound about 6 months after enrollment to confirm they remain cancer-free. Blood samples collected will be analyzed for specific DNA and protein markers related to liver cancer. During the study, participants will provide blood samples and have imaging results reviewed. Researchers will assess the blood test's accuracy in detecting HCC by measuring sensitivity and specificity within 1 to 9 months. The study excludes participants who have received prior HCC treatment or other recent cancer therapies and monitors safety and compliance throughout. Participants must be adults with liver cirrhosis or meeting guidelines for HCC surveillance, and the study aims to represent major causes of liver disease in the US population.

Researchers are evaluating the Hintermann Series H3 Total Ankle Replacement System, a mobile bearing total ankle replacement device approved by the FDA in 2019. This prosthesis is intended to replace painful arthritic ankle joints caused by primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory diseases such as rheumatoid arthritis and hemochromatosis. The study aims to provide ongoing assurance of the device's safety and effectiveness through required post-approval data submission to the FDA. Participants will receive the FDA-approved Hintermann Series H3 Total Ankle Replacement System, which includes a tibial component, a polyethylene inlay, and a talar component. The device is non-cemented and designed for mobile bearing total ankle replacement. This post-approval study collects data to monitor the device's performance over time. During the study, participants will undergo follow-up visits to assess the device's safety and effectiveness up to five years after implantation. Researchers will monitor primary safety and effectiveness outcomes during this period. Participants will provide health data for evaluation, and the study includes assessments to ensure ongoing suitability and monitor any complications or changes related to the ankle replacement.

Researchers are studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.

Researchers are evaluating the effectiveness of BHV-7000 in treating adults with refractory focal onset epilepsy, a condition where seizures originate in specific areas of the brain and have not responded to previous treatments. This Phase 2/3 trial aims to assess the safety, tolerability, and ability of BHV-7000 to reduce seizure frequency in participants who continue to have seizures despite using anti-seizure medications. The study follows classification criteria set by the International League Against Epilepsy and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either BHV-7000 at doses of 50 mg or 75 mg once daily, or a matching placebo, in a double-blind setup where neither participants nor researchers know which treatment is given. The treatment period focuses on monitoring changes in seizure frequency over 28-day averages from baseline through weeks 8 to 16. The study design includes careful control and comparison to evaluate the investigational drug's impact. During the study, participants will keep accurate seizure diaries to track their seizures. Researchers will measure changes in the average number of seizures over 28-day periods as the primary outcome. Safety and tolerability will also be monitored closely. The study requires participants to be currently treated with one to three anti-seizure medications and to meet specific epilepsy criteria. Overall participation includes screening, treatment, and follow-up to assess the drug's effects and participant safety.

Researchers are evaluating how telehealth self-management coaching sessions affect the quality of life for people who have metastatic pancreatic adenocarcinoma and their family caregivers. Patients with this type of pancreatic cancer often face many symptoms from the disease and its treatment, which can lower their quality of life. Both patients and their families often lack supportive programs that help manage physical symptoms and emotional, social, and spiritual well-being during treatment. Participants will either attend telehealth coaching sessions focused on self-management or receive the usual standard of care. The coaching sessions aim to support patients and caregivers in managing symptoms and improving overall quality of life through regular remote counseling. Additional questionnaires and interviews may be conducted as part of ancillary studies. During the study, participants will complete questionnaires to report their quality of life at the start and three months after randomization. The study will monitor how the telehealth sessions impact patients and caregivers over time. The total duration includes these assessments and ongoing support during the study period.