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 aims to understand if licaminlimab can reduce the discomfort caused by DED. It is a Phase 2b/3, randomized, double-masked, and vehicle-controlled clinical trial conducted at multiple centers. Participants first use artificial tear eye drops three times daily for about 14 days as a run-in period. After this, they are randomly assigned to receive either licaminlimab ophthalmic solution or a placebo vehicle, both administered three times daily for 29 days. Licaminlimab is given as a 60 mg/mL eye drop solution, and the study compares its effects to the inactive vehicle solution. During the study, participants will have their ocular discomfort severity measured from the start to Day 29 to assess treatment impact, especially focusing on those with the specific genotype. Researchers will monitor safety and efficacy throughout. The study includes genotype testing and requires participants to have a recent physician diagnosis of Dry Eye Disease. The total participation involves initial run-in treatment followed by the randomized treatment period, with evaluations to capture symptom changes and safety.

Dry Eye Disease (DED) is a long-term condition caused by insufficient lubrication in the eyes due to low tear production or poor tear quality. This study aims to compare the safety and effectiveness of a new artificial tear formulation called ABBV-444 with Refresh Optive UD over a 90-day period in adults diagnosed with DED. The research involves around 250 participants across approximately 20 sites in the US to evaluate these treatments for managing dry eye symptoms. Participants first undergo a 7-day run-in period using REFRESH PLUS® eye drops. Those who qualify are then randomly assigned to receive either ABBV-444 or REFRESH OPTIVE® Unit Dose eye drops, both given as needed but at least twice daily for 90 days. This double-masked, randomized trial compares these two treatments during the study period to assess their impact on dry eye disease. Throughout the study, participants will attend multiple visits at the study sites for medical assessments and complete questionnaires to monitor treatment effects and side effects. Researchers will measure changes in the Ocular Surface Disease Index (OSDI) score and track any adverse events from baseline to day 90. Additional evaluations include tear breakup time and ocular surface staining to assess changes in eye surface health during the treatment period.

Researchers are evaluating a fixed-dose combination of lifitegrast and perfluorohexyloctane eye drops to study their effects on signs and symptoms of dry eye disease. This Phase 2, randomized, double-masked, parallel-group, active-controlled, multicenter study aims to assess the safety and efficacy of treatments administered twice daily over four weeks. The study includes adults aged 18 and older who have experienced dry eye disease symptoms for at least six months. Participants will be assigned randomly to one of six groups receiving either the lifitegrast/perfluorohexyloctane combination, lifitegrast alone, perfluorohexyloctane alone, or a placebo vehicle. All treatments consist of topical ocular drops administered twice daily for four weeks. The study compares the combination therapy with individual drugs and placebo to evaluate their effects on dry eye disease. During the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline over 29 days. Researchers will monitor signs and symptoms of dry eye disease at screening, baseline, and throughout the treatment period. Participants are expected to follow all trial instructions and attend visits for evaluations to track treatment impact and safety.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

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 II/III 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 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 the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

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.