Pittsburg

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 lifitegrastperfluorohexyloctane 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 the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

Researchers are evaluating treatment options for patients with nasal and paranasal sinus squamous cell carcinoma that can be surgically removed. This phase II randomized trial compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to see if giving chemotherapy first can shrink tumors and help preserve important nearby structures like the skull base and orbit, while also looking at overall survival and progression-free survival. Participants are randomly assigned to one of two groups. One group has surgery followed by radiation therapy, with additional chemotherapy if certain risk factors are found after surgery. The other group receives chemotherapy first, then surgery, followed by radiation therapy with possible additional chemotherapy. Chemotherapy drugs studied include docetaxel, cisplatin, and carboplatin, all given through intravenous infusions. Radiation therapy is delivered using image-guided intensity-modulated radiation therapy IMRT daily for several weeks. During the study, participants undergo scans like MRI and PETCT to assess tumor response and help predict outcomes. They are monitored regularly for side effects and treatment effects, with follow-up visits every three months for up to two years and then every six months up to five years. Researchers also collect data on tobacco use and its impact on treatment outcomes. The main outcomes measured are the rate of preserving the skull base and orbit and overall survival over five 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 players 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 users 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 collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

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.

Researchers are comparing two treatment approaches for patients with stage II to IIIB non-small cell lung cancer NSCLC that can be surgically removed. The study evaluates whether giving standard therapy both before and after surgery perioperative is more effective than giving it only after surgery adjuvant. The trial is phase III and aims to understand which approach leads to better survival and fewer complications in patients with resectable lung cancer. Participants are randomly assigned to one of two treatment groups. In the first group, patients have surgery within 28 days of joining the study, followed by up to four cycles of platinum-based chemotherapy and up to one year of immunotherapy if the cancer does not progress or cause unacceptable side effects. In the second group, patients receive chemotherapy combined with immunotherapy before surgery, then undergo surgery, and continue immunotherapy after surgery for up to one year under similar conditions. Throughout the study, patients may have CT scans, and possibly MRI or PETCT scans at the start. During the trial, researchers will monitor patients closely over time, including follow-up visits every six months for up to 10 years after treatment ends. They will assess outcomes such as survival without events like cancer recurrence or progression, overall survival, rates of surgery and complete tumor removal, side effects leading to treatment stops or hospitalizations, and the bodys response to treatment. This comprehensive monitoring helps evaluate the benefits and risks of each treatment approach.

Researchers are evaluating the impact of the Cost Communication and Financial Navigation CostCOM program on how well cancer patients stick to their treatment plans and manage financial stress. Many people with cancer face financial difficulties due to high out-of-pocket costs and changes in employment or insurance, which can cause delays or interruptions in care and lower quality of life. This study compares CostCOM with enhanced usual care to see if it helps reduce financial hardship and improve care adherence and patient satisfaction. Participants are randomly assigned to one of two groups. One group receives a brochure about financial navigation services from the Patient Advocate Foundation. The other group receives standard financial care plus CostCOM financial counseling sessions lasting about an hour, given within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants, such as providers or coordinators, may take part in surveys and interviews to share their experiences with the CostCOM program. Patients will be followed for 12 months after completing the intervention. During this time, they will complete surveys about their adherence to cancer care, financial hardship, worry, quality of life, and satisfaction with care at several points. Researchers will also assess the accuracy of cost estimates given to patients and explore neighborhood characteristics. The study includes interviews and surveys with non-patient participants conducted 15 to 39 months after the first patient enrollment.