Sioux City

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, including granulomatosis with polyangiitis or microscopic polyangiitis. This phase 4 randomized, double-blind, placebo-controlled trial focuses on participants newly diagnosed or experiencing a relapse who require induction treatment with cyclophosphamide or rituximab and have specific antibody positivity and disease activity criteria. Participants will receive oral avacopan or placebo alongside standard of care immunosuppressive therapy for induction and maintenance, tailored by the investigator according to guidelines and patient needs. The study monitors treatment effects and safety over an extended period, up to 60 months, assessing adverse events and clinical changes. Throughout the study, participants will undergo regular evaluations including vital signs, blood tests, and urinalysis to detect any significant changes from baseline. The main outcomes measured include the percentage of participants experiencing various types of adverse events, serious adverse events, and events leading to withdrawal or death, all tracked up to 60 months to ensure comprehensive long-term safety data.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

This research aims to evaluate the rate of malposition and related clinical problems of the Hydrus Microstent device within 24 months after surgery in patients with primary open angle glaucoma. Participants will have an operable, age-related cataract and a diagnosis of glaucoma treated with up to four eye pressure-lowering medications. The study is a prospective, non-randomized, single-arm clinical trial sponsored by Alcon following acquisition of Ivantis, Inc. Participants will undergo uncomplicated cataract surgery using standard anesthesia and phacoemulsification, followed by implantation of a commercially available monofocal intraocular lens (IOL) and placement of the Hydrus Microstent device through the trabecular meshwork into Schlemm's canal. The Hydrus Microstent is a crescent-shaped nitinol device designed as a permanent implant to help fluid drainage in the eye. The study involves a screening visit, surgery on Day 0, and eight follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. Researchers will monitor the occurrence of clinically significant device malposition and any related clinical effects during this 24-month postoperative period. Assessments will include visual acuity, intraocular pressure, optic nerve appearance, and other protocol-defined evaluations to ensure safety and device performance.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating a method using Optical Coherence Tomography (OCT) image analysis to measure the tilt and decentration of intraocular lenses (IOLs) in patients who have received TECNIS refractive or diffractive non-toric IOL implants. This prospective, multi-center, non-interventional, open-label, randomized clinical study aims to test the repeatability and reproducibility of this assessment method. The study focuses on patients who have undergone unilateral or bilateral implantation of the specified IOL types at least three months prior. Participants will undergo an OCT imaging test to assess the magnitude and direction of IOL tilt and decentration in the implanted eye(s). This study involves only one study visit during which the OCT imaging and measurements will be performed. There are no additional treatment groups or interventions, as this is a diagnostic evaluation study. During the single study visit, participants will provide informed consent and be evaluated to confirm eligibility. The primary outcome measured is the magnitude and direction of IOL decentration and tilt based on OCT images. Safety and adherence to protocol instructions will be monitored. The study includes adults aged 22 years or older who have specific TECNIS IOL implants and excludes those with certain ocular or medical conditions that could affect study procedures or imaging results.