Cranberry Township

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease DED who have a specific TNFR1 genotype. This study is a phase 2b3, double-masked, randomized, vehicle-controlled trial aimed at understanding how licaminlimab affects symptoms of dry eye in this particular group. Participants first undergo a run-in period using artificial tear drops three times daily for about 14 days. Following this, they are randomly assigned to receive either licaminlimab eye drops or a placebo vehicle, both administered three times daily for 29 days. The study compares these two treatments to assess their impact on dry eye discomfort. During the study, participants eye discomfort severity is measured at the start and after 29 days of treatment, focusing especially on those with the specific genotype. Additional assessments include overall symptom changes regardless of genotype. The study tracks safety and effectiveness over this period, with the total participation lasting approximately 43 days including the run-in and treatment phases.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating the efficacy and safety of DFL24498, a topical ophthalmic solution, compared with a vehicle solution in adults with dry eye disease. This Phase 2, randomized, double-masked, vehicle-controlled study will enroll about 417 participants aged 18 years or older across multiple centers in the US. The study duration is up to 16 weeks and consists of three distinct periods. Participants are assigned to receive either DFL24498 or the vehicle solution, both administered as one drop in each eye four times daily for 12 weeks. The study includes a vehicle-controlled parallel group design. After the 12-week treatment period, there is a 2-week follow-up phase to monitor safety and outcomes. Throughout the study, participants will undergo assessments including corneal fluorescein staining, ocular dryness symptom evaluation using the SANDE questionnaire, tear production measurement with the Schirmer I test, and conjunctival fluorescein staining. Researchers will also track treatment-emergent adverse events. The primary outcome focuses on the change in corneal staining from baseline to week 12, with safety monitored during and after treatment.

Researchers are evaluating whether adding biennial contrast-enhanced mammography CEM to annual 3D mammography digital breast tomosynthesis or DBT improves breast cancer detection while keeping false positives low in women with a personal history of breast cancer. The study aims to see if CEM can maintain or improve cancer detection rates compared to annual DBT alone, potentially finding cancers missed by DBT. This trial is prospective and involves women aged 30 to 79 who have had breast cancer and are at least one year past surgery or treatment. Participants will receive a baseline CEM exam along with their routine annual 3D mammogram, then have follow-up CEM exams at 24 and 48 months after the baseline. Throughout the study, they will continue their usual annual 3D mammograms as part of standard care. Two radiologists will independently review the mammograms and CEM images in different sequences to evaluate detection rates and false positives. During the study, women will attend screening visits to receive their imaging exams and have their results interpreted by radiologists. Researchers will measure how many additional cancers are detected at 24, 48, and 62 months, the rate of false-positive recalls, and the positive predictive value of the combined imaging. The study will monitor participant safety and outcomes over several years, with the total participation lasting at least four years.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

Diabetic foot ulcers DFU are a common and serious complication for people with type 2 diabetes, often leading to hospitalization and amputation. This research investigates whether DFUs with a history of biofilm infection heal with weakened skin barrier function and if this impaired healing, shown by high trans-epidermal water loss TEWL, increases the chance of wound recurrence. The study also explores the molecular mechanisms behind biofilm-related damage to skin barrier integrity in DFU patients. In this observational study, 405 patients with clinically diagnosed DFUs suspected of infection will be enrolled. Researchers will collect wound swabs for culture, take digital images of wounds, and perform assessments including health surveys and pain scales. Tests such as transcutaneous oxygen measurement, ankle-brachial index, and hemoglobin A1c will be conducted as needed. Tissue samples from the wound area will be collected to study biofilm presence. Participants will be followed for up to 16 weeks or until their wound closes. Participants will undergo regular evaluations including wound site checks and questionnaires on wound impact and pain. Monitoring involves reviewing medical records and contacting patients or care facilities to confirm wound closure. The primary outcomes being measured are biofilm infection levels at 16 weeks and TEWL at 12 weeks. This thorough monitoring aims to understand how biofilm infection affects wound healing and recurrence in diabetic foot ulcers.

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.

This research aims to evaluate the rate of malposition and related clinical outcomes of the Hydrus Microstent within 24 months after implantation. The study focuses on adults aged 45 and older who have primary open angle glaucoma and an operable cataract. Participants will undergo cataract surgery combined with the placement of a monofocal intraocular lens IOL followed by Hydrus Microstent implantation. Participants will have the Hydrus Microstent implanted immediately after cataract surgery and IOL placement. The cataract surgery uses standard anesthesia and phacoemulsification techniques. After surgery, participants will attend follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 to monitor outcomes. Throughout the study, participants will be evaluated for device positioning and any associated clinical consequences. Researchers will assess the occurrence of device malposition, intraoperative ocular adverse events, and sight-threatening or other postoperative ocular events up to 24 months after surgery. This schedule of visits and evaluations aims to gather comprehensive safety and performance data over a two-year period.