Castro Valley

Researchers are evaluating the healing progress of chronic wounds, specifically venous leg ulcers and diabetic foot ulcers, using an absorbent dressing called Mepilex Up. The study is designed as a prospective, open, multi-center, interventional, non-comparative trial involving about 68 participants across up to 8 centers in the US. The goal is to monitor wound area changes and wound condition over a 6-week period following local standard care. Participants will use the Mepilex Up dressing, which is designed to absorb exudate, maintain a moist healing environment, and minimize pain and skin trauma during dressing changes. The dressing contains a soft silicone wound contact layer, a flexible absorbent foam pad, and a breathable but waterproof outer film. Participants will wear the dressing for up to six weeks or until their wound heals, with dressings changed weekly during scheduled visits. Participants will attend seven visits: one baseline and six weekly follow-ups to assess wound healing progress, dressing performance, pain, comfort, and quality of life. Safety will be monitored throughout. One target wound per participant will be followed, with measurements taken from baseline to the last follow-up, up to a maximum of 44 days or until healing occurs.

Researchers are evaluating the safety and effectiveness of apixaban compared with aspirin in patients who recently had an intracerebral hemorrhage (ICH) and also have atrial fibrillation (AF). The study aims to find out if apixaban is better than aspirin in preventing any type of stroke or death from any cause. It also looks at whether apixaban leads to better functional recovery measured by the modified Rankin Scale. This is a phase III, randomized, double-blinded trial enrolling 700 patients over 3.5 years. Participants will be randomly assigned to receive either apixaban, an oral blood thinner that inhibits Factor Xa, or aspirin, an oral antiplatelet medication. The study lasts from 12 months up to 36 months of follow-up after enrollment. Treatments are given orally, and patients will be monitored throughout the study period. Recruitment and coordination occur through NIH/NINDS StrokeNet sites. During the study, participants will undergo assessments including brain imaging (CT or MRI) to confirm diagnosis, functional outcome measurements using the modified Rankin Scale, and monitoring for any strokes or death. Safety will be closely observed, and patients will provide informed consent before joining. The primary outcome measured is stroke or death up to 3 years, and secondary outcomes include functional status changes. Participants are followed regularly to track these outcomes and overall health status.

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 evaluating treatments for patients with metastatic kidney cancer to see if adding surgery to standard immunotherapy-based drug combinations improves outcomes. This phase III trial focuses on kidney cancer that has spread to other parts of the body. The study compares standard immunotherapy drugs, which help the immune system fight cancer, with or without the surgical removal of the kidney, known as nephrectomy. Doctors currently do not agree on whether surgery adds benefit when combined with these immunotherapy treatments. Participants first receive one of three immunotherapy-based drug regimens, including combinations of nivolumab, ipilimumab, pembrolizumab, avelumab, and axitinib, given through intravenous infusions and oral tablets over several weeks. After 10-14 weeks of this initial treatment, patients are randomly assigned to either continue immunotherapy drugs alone or to also have kidney surgery followed by the same drugs. Surgery may be done by different methods and must occur within 8 weeks of randomization. Axitinib is stopped at least 24 hours before surgery. During the study, participants undergo regular scans of the chest, abdomen, and pelvis to assess disease status. They are monitored for survival for up to 7 years after randomization, with follow-up visits every 3 months in the first year, then every 6 months for two years, and annually thereafter. Researchers also evaluate tumor response, surgical complications, and drug side effects. Specimens are collected for future research, and participants' health and treatment effects are closely followed throughout the study period.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

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 Matrion14 (LifeNet Health, Inc.), a specialized placental membrane product, as a treatment for diabetic foot ulcers compared to standard wound care. Matrion is made from donated human birth tissue, including amniotic, chorionic, and trophoblast layers. It is carefully processed to be acellular and sterile, making it suitable for surgical use in healing wounds. Participants receive either the Matrion graft applied weekly to the cleaned wound, followed by conventional care such as dressing and off-loading, or they receive standard wound dressing materials with moist therapy and appropriate gauze coverings. Dressings are maintained for about 5 to 9 days before being changed, and off-loading to reduce pressure on the wound is required for both groups. During the study, participants will have their wounds regularly assessed over 12 weeks to measure healing progress. Researchers will monitor the wound condition, infection status, and overall safety. Participants must comply with dressing changes, off-loading, and study visits. The study evaluates wound healing effectiveness and safety of the treatments in adults aged 21 to 80 with diabetic foot ulcers.

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 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 evaluating the safety and effectiveness of MTX-001 in patients with non-infected venous stasis ulcers (VSU) that have not improved after at least 4 weeks of standard wound care. This Phase 2, randomized, double-blind, placebo-controlled study includes patients who have wounds caused by venous reflux disease and meet specific wound size and age criteria. The goal is to assess whether MTX-001 can help this difficult-to-heal type of ulcer. The study is conducted in two parts. In Part 1, 11 patients received MTX-001 either once weekly or once every two weeks alongside standard care. In Part 2, about 70 patients are randomized to receive either MTX-001 or a placebo injection weekly with standard care over 12 weeks. The treatment involves localized subcutaneous injections into and around the wound during weekly clinic visits. Participants will be assessed at screening, baseline, and weeks 4, 8, and 12. Researchers will measure wound surface area reduction, wound healing progress, and total wound closure by week 12. Safety and tolerability are monitored throughout the 12-week treatment period. Patients' pain levels and other health assessments will also be collected to evaluate preliminary treatment effects.