Lompoc

Researchers are evaluating the pharmacodynamic effect, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis gMG. This phase 2 study focuses on participants aged 18 to 80 years who have generalized muscle weakness and fall within the MGFA clinical classification II-IV. The study aims to better understand how Povetacicept affects immunoglobulin levels and the safety profile in this population. Participants will be randomly assigned to receive one of two doses of Povetacicept or a placebo via subcutaneous injection for the initial 12 weeks. Those who are eligible may continue treatment with Povetacicept for an additional 96 weeks in a long-term extension phase. This study uses a double-blind, placebo-controlled design to evaluate the treatment over a total period of up to 108 weeks. During the study, participants will undergo evaluations of immunoglobulin G levels at baseline and week 12. Safety and tolerability will be monitored throughout the entire treatment period by tracking adverse and serious adverse events. The study includes regular assessments to measure outcomes and monitor participant health, with the goal of completing by March 2029.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are evaluating the efficacy and safety of Imeroprubart in adults with active Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a condition affecting the peripheral nerves. This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study aims to understand how well Imeroprubart works compared to placebo in treating CIDP. The study is sponsored by Immunovant Sciences GmbH and focuses specifically on adults meeting diagnostic criteria for typical or variant forms of CIDP. Participants will receive either Imeroprubart or a matching placebo by subcutaneous injection once weekly. The treatment period includes an initial 24-week phase Period 1 with Imeroprubart or placebo, followed by an extension to 52 weeks Period 2 for continued evaluation. Imeroprubart dosing is given once weekly via subcutaneous injection. Placebo is provided similarly during the first 24 weeks. During the study, participants will be monitored through clinical assessments including relapse status by Week 24, as well as measurements of disability, grip strength, muscle strength, and symptom scores. Electrodiagnostic tests support diagnosis at baseline. Safety and efficacy will be closely observed during treatment, with follow-up visits scheduled to assess outcomes. The total participation duration covers at least 24 weeks for the primary outcome assessment, with ongoing monitoring as defined by the study protocol.

Central Line-Associated Bloodstream Infections CLABSIs are a serious problem in U.S. hospitals, leading to higher death rates, longer hospital stays, and increased costs. This research evaluates whether a machine learning ML model that predicts possible CLABSI risk can help Infection Preventionists IPs reduce infection rates compared to usual practices. The study is a prospective, multi-center, cluster-randomized trial conducted in 20 hospitals with the highest CLABSI rates. In this trial, hospitals are split into early and late groups. Early hospitals get access to the ML model via a daily dashboard that flags high-risk patients. Infection Preventionists use this information to provide targeted education and recommend best practices for central line care, including line removal when appropriate. The model was built using extensive patient data and predicts infection risk with high accuracy. The control hospitals continue with routine clinical practice without access to the model during the study period. Participants are hospitalized adults with central lines, and the model scores patients daily if their line has been in place for over 48 hours. Researchers monitor CLABSI rates per 1,000 central line-days, central line removals within 48 hours of alerts, positive blood culture rates, and IP intervention frequencies. Safety outcomes such as pneumothorax and hemorrhage are also tracked. The study duration is about five months with interim and final analyses planned to assess the impact of providing the ML model to Infection Preventionists.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are collecting whole blood and serum samples from adults diagnosed with untreated Hepatocellular Carcinoma HCC and from individuals undergoing surveillance for HCC without the disease. The purpose is to use these samples to develop and validate the Helio multi-analyte blood test, which aims to detect liver cancer by analyzing DNA methylation and protein markers. Participants include those with cirrhosis or at risk of HCC, representing major liver disease causes such as alcoholic steatohepatitis, hepatitis B or C, non-alcoholic fatty liver disease, and genetic conditions like hemochromatosis. Participants fall into three groups those recently diagnosed with untreated HCC confirmed by CT scan, MRI, or biopsy those confirmed negative for HCC by CT or MRI and those confirmed negative by ultrasound. The ultrasound-negative group will have a follow-up ultrasound 5 to 9 months after enrollment to reconfirm the absence of HCC. Blood samples collected will be used to study the performance of selected DNA methylation and protein markers for liver cancer diagnosis. Participants are screened based on medical history and recent imaging results to confirm eligibility. Assessments include blood collection and imaging studies, with additional follow-up imaging for some. Researchers will measure the sensitivity and specificity of the blood test within 1 to 9 months and investigate the effects of interfering substances, reference ranges, and sample stability. The study is observational, with no treatment administered, and is expected to continue through December 2028.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

Researchers are evaluating telehealth self-management coaching sessions to improve quality of life for people who have survived pancreatic cancer and their family caregivers. Pancreatic cancer and its treatments often cause many symptoms that can negatively affect well-being, and there are few quality of life programs available to support patients and their families during treatment. This trial aims to see if telehealth coaching can help manage physical symptoms and support emotional, social, and spiritual well-being for both patients and caregivers. Participants in the study are divided into two groups. One group attends telehealth coaching sessions lasting 40 to 60 minutes every two weeks for a total of 6 sessions over 3 months. The other group receives the usual standard of care without additional coaching. Both patients and their family caregivers take part in the intervention sessions and assessments. During the study, researchers collect information on patient-reported quality of life at the start and after 3 months. They also track symptom severity, psychological distress, caregiver burden, and overall survival over 6 months. Participants complete questionnaires and interviews at various time points, and the study monitors enrollment, completion rates, and participant experiences. The total participation time may extend up to 6 months to gather follow-up data and evaluate the impact of the coaching sessions.