Westwood

Researchers are comparing two treatment approaches for patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery. The study evaluates whether giving standard therapy before and after surgery perioperative is better than giving it only after surgery adjuvant. This phase III trial focuses on chemotherapy and immunotherapy, which are current standard treatments aimed at controlling tumor growth and helping the immune system fight cancer. Patients are divided into two groups. One group undergoes surgery followed by chemotherapy and immunotherapy for up to one year if the disease does not progress or cause severe side effects. The other group receives chemotherapy combined with immunotherapy before surgery, then surgery, followed by immunotherapy alone for up to one year. Chemotherapy drugs may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine. Imaging tests like CT, MRI, or PETCT scans are done throughout the study. Participants will have surgery within a month of joining and receive treatments according to their assigned group. They will be monitored with scans and followed up every six months for up to 10 years to assess survival, disease progression, surgical outcomes, side effects, and immune responses. Researchers will measure event-free survival and overall survival as main results, as well as response rates and safety information over the long term.

Lymphedema is a chronic and progressive condition that causes swelling in the upper or lower limbs and affects millions of people. Currently, there are no effective drug treatments, and management mainly relies on compression therapy. This research aims to evaluate the potential benefits of glucagon-like peptide-1 receptor agonists GLP-1 RAs, which are commonly used for obesity and diabetes, for improving quality of life and clinical outcomes in lymphedema patients. The study addresses an important gap by providing prospective data on this treatment approach. Participants will receive GLP-1 RA treatment prescribed by their primary care provider for six months to assess its effects on lymphedema. The study is designed as a prospective, single-arm trial involving adults with unilateral upper or lower extremity lymphedema. Follow-up visits will occur at baseline, three months, and six months post-treatment to monitor progress. The study will collect data on limb volume, bioimpedance, compression use, and incidence of cellulitis alongside quality of life measures. During the study, participants will complete the Lymphedema Life Impact Scale LLIS to report their quality of life. Researchers will also measure limb volume, bioimpedance, body mass index BMI, compression use, and record any episodes of cellulitis. Safety will be monitored throughout, and serious adverse events will be reported promptly. The total participation period is 24 months, including follow-up and data analysis, to evaluate the treatments impact comprehensively.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

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.

This trial studies adults with advanced non-small cell lung cancer NSCLC that has spread outside the lungs and has specific mutations in the EGFR gene. Researchers are comparing two treatment approaches osimertinib alone versus osimertinib combined with bevacizumab. The study aims to evaluate how these treatments affect the time patients live without disease progression and overall survival, as well as their effects on brain metastases and treatment safety. Participants are randomly assigned to one of two groups. One group receives osimertinib pills daily every 21 days, while the other group receives osimertinib daily plus an intravenous infusion of bevacizumab every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants undergo tests including echocardiography, MUGA scans, CT scans, and possibly MRI, along with blood and urine sample collection. After treatment ends, participants are followed every three months for up to 10 years to monitor disease status and survival. Researchers will assess progression-free survival, overall survival, response rates, time to brain progression, and side effects. The study includes long-term follow-up to understand the lasting effects of these treatments and to explore resistance mechanisms through tumor DNA analysis.

Researchers are evaluating the effectiveness and safety of CARTISTEM, a combination of stem cells derived from human umbilical cord blood and a sodium hyaluronate gel, compared to a surgical procedure called debridement in people with knee cartilage lesions and osteoarthritis. The trial aims to show whether CARTISTEM can better reduce knee pain and improve knee function than debridement two years after treatment. It also explores if CARTISTEM might slow down the progression of osteoarthritis by using MRI scans. Participants are randomly assigned to one of two groups one group receives CARTISTEM along with debridement surgery on the affected knee, while the other group undergoes debridement surgery alone. CARTISTEM includes stem cells suspended in a gel that is applied during the procedure. The study follows participants for 24 months after treatment to assess results and safety. During the study, participants will have their knee pain and function measured using standard scales like the Visual Analog Scale VAS and WOMAC function score. MRI scans will be used to observe cartilage repair and osteoarthritis changes. Participants will be monitored regularly throughout the two-year follow-up period to track outcomes and any side effects. This trial lasts from enrollment through 24 months post-treatment, providing comprehensive evaluations over time.

Researchers are evaluating an experimental drug called REGN7508 in adults undergoing elective, unilateral total knee replacement surgery. The study aims to assess how well REGN7508 prevents venous thromboembolism VTE and related conditions following surgery. It also investigates potential side effects, the levels of the drug in the blood over time, and the bodys antibody response to the drug. Participants in this phase 3 trial receive one of several treatments REGN7508 alone, REGN7508 with placebo, apixaban, or enoxaparin, all administered according to protocol. The study uses a randomized, parallel design with double blinding to compare these treatments. The treatment period focuses on the first 12 days after surgery, with extended monitoring up to approximately 90 days to assess drug concentration and antibody formation. During the study, participants will undergo assessments including monitoring for symptomatic and asymptomatic VTE events, bleeding incidents, and adverse events up to day 90. Blood tests will measure drug levels and antibodies against REGN7508. Safety and effectiveness outcomes are tracked closely with visits approximately 14 days post-surgery for primary measures and follow-up assessments around day 90. Total participation lasts through the treatment and extended safety evaluation period.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are evaluating the safety and effectiveness of the COMS One device in treating people with refractory diabetic foot ulcers DFUs. This prospective randomized, double-blinded, sham-controlled clinical trial aims to show that the COMS One device, used alongside standard care, can better promote wound closure compared to a sham device over 24 weeks. The main goal is to measure the time until complete wound healing, defined by full skin re-epithelialization without drainage. The study involves two groups one receiving the COMS One device and the other a sham device. Both devices include a reusable housing with controls and magnetic stimulation coils, a single-use sterile base called COMStouch, and a single-use strap called COMSfix to hold the device in place. Treatments are applied locally and participants continue standard wound care. The study plans to enroll 224 subjects after screening up to 450, with treatments lasting up to 24 weeks. Participants will attend regular visits to assess wound healing progress, safety, pain levels, and quality of life. Researchers will measure wound closure at multiple timepoints up to 24 weeks and monitor for adverse events, ulcer recurrence, and any need for amputation. The study includes careful monitoring of wound area reduction and participant-reported outcomes to evaluate the devices performance and safety throughout the trial.