Corvallis

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the combination of intismeran autogene plus pembrolizumab compared to placebo plus pembrolizumab as adjuvant treatments for participants with margin negative, completely resected Stage II, IIIA, or IIIB (with nodal involvement N2) non-small cell lung cancer (NSCLC). The study aims to determine if intismeran autogene plus pembrolizumab improves disease-free survival (DFS) compared to placebo plus pembrolizumab. This is a phase 3, randomized, double-blind clinical trial sponsored by Merck Sharp & Dohme LLC. Participants are randomly assigned to one of two groups: one receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for 9 doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to 9 doses, and the other receives a placebo injection matching intismeran autogene on the same schedule plus pembrolizumab. Treatment continues until disease recurrence, unacceptable side effects, or approximately 1 year, whichever occurs first. During the study, participants will be closely monitored for disease-free survival over about 78 months and overall survival and lung cancer-specific outcomes for up to 12 years. Researchers will assess quality of life, physical and role functioning, breathlessness, coughing, chest pain, and record any adverse events or treatment discontinuations. The study includes long-term follow-up to evaluate safety and effectiveness outcomes.

Researchers are evaluating the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has a specific genetic mutation called PIK3CA. This phase 3 study aims to assess both the effectiveness and safety of this combination treatment. Participants can remain in the study as long as the treatment is helping control the cancer without causing unbearable side effects. Participants will receive Tersolisib orally in combination with an oral CDK4/6 inhibitor and endocrine therapy (ET), which may be given orally or by intramuscular injection. The study includes different groups: one receiving two different doses of Tersolisib plus CDK4/6 inhibitor and ET, another receiving one dose of Tersolisib plus CDK4/6 inhibitor and ET, and a placebo group receiving placebo with CDK4/6 inhibitor and ET. The CDK4/6 inhibitors used include ribociclib, palbociclib, or abemaciclib, while ET options include anastrozole, letrozole, exemestane, or fulvestrant. During the study, participants will undergo evaluations that include measuring tumor response, progression-free survival, overall survival, and quality of life using questionnaires. Researchers will monitor participants regularly through scans, lab tests, and clinical assessments to track treatment response and side effects. The study may last up to 7 years to observe long-term outcomes, and participants will be closely followed to assess how the cancer responds and how the treatments affect their health and well-being over time.

Researchers are evaluating the efficacy, safety, and tolerability of AZD4144 in adults aged 18 to 80 years who have sepsis-associated acute kidney injury. This Phase IIa, randomized, double-blind, placebo-controlled study aims to compare kidney function between participants receiving AZD4144 and those receiving a placebo. Participants must be admitted to an intensive care unit with sepsis due to suspected or confirmed bacterial infection and have developed acute kidney injury within 72 hours of sepsis onset. Participants will be randomly assigned to receive either intravenous AZD4144 or a placebo once daily during the treatment period. The study includes a screening period, followed by the treatment period where the assigned drug is administered daily according to the protocol. After the treatment period, participants will continue to have daily assessments while hospitalized and attend up to two follow-up visits after discharge. During the study, participants will undergo daily safety monitoring, blood and urine sample collections, and other assessments to track kidney function and overall health. Researchers will measure outcomes such as 24-hour creatinine clearance and other kidney function biomarkers during treatment, and monitor clinical events like days alive and free of kidney replacement therapy through the study completion, averaging 30 days. Safety and tolerability will be closely observed throughout the study and follow-up periods.

Researchers are evaluating how daily walnut consumption over 12 weeks affects cognitive function, inflammation markers, oxidative stress, and the gut microbiome in healthy adults aged 55 and older. The study aims to see if walnuts can help reduce age-related cognitive decline by changing gut bacteria and lowering inflammation and oxidative damage. Participants are randomly assigned to one of two groups: one consumes 1.5 ounces (42.5 g) of plain walnuts daily for 12 weeks, while the other consumes a caloric equivalent of non-whole grain crackers for the same period. The study is single-blinded, meaning participants do not know which group they are in. During the study, participants will complete cognitive tests measuring memory, cognitive flexibility, and processing speed at the start and after 12 weeks. Researchers will also analyze gut microbiome composition, lipid oxidation, inflammatory biomarkers, and blood pressure. Additional measures include urolithin concentrations and weight. Participants must follow dietary restrictions and attend scheduled assessments throughout the 12-week study.

Researchers are evaluating the effect of tozorakimab as an addition to standard care in adults hospitalized with viral lung infections who require supplemental oxygen. The goal is to see if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). This is a Phase III, randomized, double-blind, placebo-controlled study sponsored by AstraZeneca. Participants will be randomly assigned in equal numbers to receive either a single intravenous dose of tozorakimab or a matching placebo on Day 1. About 2870 participants will take part, with approximately 1435 in each group. This treatment is given once, and participants are monitored for outcomes related to lung infection and respiratory failure. During the study, researchers will assess how many participants die or need advanced breathing support by Day 28, along with several other outcomes tracked up to Day 60. Assessments include survival, time spent outside the ICU, time without supplemental oxygen or ventilation, and clinical progression scales. The study includes safety monitoring and measures of immune response. Participation involves hospitalization and follow-up assessments over at least 60 days from treatment.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points: at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in adults aged 18 to 80 with atherosclerotic cardiovascular disease (ASCVD) who have elevated lipoprotein(a) (Lp(a)) levels and are already receiving inclisiran for elevated low-density lipoprotein cholesterol (LDL-C). This Phase 3 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to understand how pelacarsen affects Lp(a) levels and cardiovascular health in this population. Participants are randomly assigned to one of two groups. One group receives pelacarsen via monthly subcutaneous injections for 12 months, while the other group receives placebo injections monthly for the first 6 months. After month 6, all participants receive pelacarsen 80 mg injections for the next 6 months during an open-label treatment period. All participants also receive background inclisiran treatment with two initial loading doses followed by maintenance doses every 6 months. Throughout the study, participants undergo regular assessments including blood tests to measure changes in Lp(a) levels at baseline and month 6, safety monitoring for treatment-emergent events up to 16 months, and evaluations of serious side effects or discontinuations due to adverse events. The study includes a run-in period to ensure stable background therapy and involves ongoing monitoring to assess the impact of the treatments over the full study duration ending in February 2028.

Researchers are evaluating whether adding up to ten sequential 24-hour treatments using the Selective Cytopheretic Device (SCD) to continuous kidney replacement therapy (CKRT) can improve survival and reduce the need for long-term dialysis in patients with Acute Kidney Injury (AKI) who require CKRT. This pivotal, randomized, controlled study involves approximately 339 patients in intensive care units across multiple sites. The study aims to compare outcomes between patients receiving standard CKRT care alone and those receiving CKRT plus SCD treatments. Participants in the experimental group will receive standard CKRT plus up to ten consecutive 24-hour sessions with the SCD integrated into their existing CKRT circuit. The SCD device, which includes a synthetic hollow fiber membrane cartridge connected in series with the CKRT hemofilter, is designed to modulate inflammation by binding activated white blood cells during treatment. Regional citrate anticoagulation will be used throughout the blood circuit. The control group will receive standard CKRT therapy alone as appropriate. Treatments will be monitored over time to assess safety and efficacy. Throughout the study, patients will be closely monitored using clinical assessments and laboratory tests. The primary outcome is a combined measure of mortality or dialysis dependency at 90 days after treatment. Secondary outcomes include dialysis dependence at one year, ICU-free days within the first 28 days, and mortality at 28 days. Patient safety will be observed continuously, and the total study participation may extend over several months to evaluate long-term effects of the therapies.

Researchers are collecting real-world data on the use of the Optilume™ BPH Catheter System to treat men with symptomatic benign prostatic hyperplasia (BPH). This observational study monitors men who have received this treatment to understand its effects and safety in everyday clinical practice. The study is sponsored by Urotronic Inc. and aims to gather information on patient outcomes over time. Participants are men treated with the Optilume drug-coated catheter system according to its instructions for use. There is only one study group involved, and the focus is on collecting data from these patients as they receive standard care. No additional treatments or placebo groups are involved in this registry study. During the study, researchers will track changes in symptom scores using the International Prostate Symptom Score (IPSS) from baseline to 12 months, and monitor safety by recording any treatment-related serious adverse events. Additional measures include symptom severity, urinary flow rates, residual urine volume, and the need for repeat interventions over an average follow-up of 2 years. Data collection will continue throughout this period to provide insights into the treatment's real-world performance and safety.