Englewood

Researchers are evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the devices use in breast reconstruction.

Researchers are evaluating the safety and effectiveness of targeted treatments, with or without the immune therapy drug atezolizumab, in women with recurrent or persistent endometrial cancer. This Phase IBII study uses genetic testing of tumor samples to assign participants to different groups based on specific tumor markers. The study aims to better understand how these targeted agents work in combination with or without immunotherapy and to identify the best treatment options for specific tumor profiles. Participants will first provide tumor tissue for genomic testing using the FoundationOne companion diagnostic. Based on the tumors genetic features, participants will be placed into specific study groups receiving targeted drugs alone or combined with atezolizumab. Treatments include various intravenous and oral drugs administered in cycles of 21 or 28 days. Each group enrolls about 20 to 24 participants and can be closed or expanded depending on results. The study also allows for additional groups to be added over time. During the study, participants will receive regular treatments and be monitored for tumor response, survival, and disease progression over several months. Researchers will assess overall response rates and the duration participants remain free from disease progression. Safety and side effects will also be closely monitored. Participants may have tumor scans, blood tests, and other evaluations to track the study drugs effects. The total follow-up period for outcomes like survival is up to 48 months, ensuring long-term observation of treatment impact.

Researchers are investigating whether Viv, a consumer-grade dietary supplement made from Magnolia officinalis bark extract, affects immune activity markers in adults with psoriasis. This clinical trial compares Viv to a placebo to understand its impact on inflammation-related proteins. Participants have stable psoriasis confirmed by a dermatologist and may have related conditions like psoriatic arthritis if not requiring systemic treatments. Participants will be randomly assigned to take either Viv, containing 200 mg of Magnolia officinalis bark extract, or a placebo daily for three months. The study is triple-blinded, meaning neither the participants nor researchers know who receives which treatment. Participants will use the supplement at home and collect blood samples themselves at the start, after one month, and after three months using provided kits. During the study, participants will complete electronic questionnaires about their psoriasis symptoms and quality of life at the beginning, one month, and three months. Researchers will analyze blood samples to measure changes in inflammatory proteins and immune cells over time. The primary outcome is the change in plasma Beta defensin 2 levels after 12 weeks. The total study period for participants is three months, with ongoing safety and adherence monitored remotely.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

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.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

Researchers are evaluating if active surveillance combined with hormonal therapy can effectively manage ductal cell carcinoma in situ DCIS, an early stage of breast cancer. This study aims to determine whether new endocrine therapies increase the number of patients suitable for long-term active surveillance instead of surgery, which often has significant health effects. The trial is a Phase 2 randomized study focusing on treatment options for hormone receptor-positive DCIS in women. Participants will receive one of several hormonal treatments standard or low-dose tamoxifen for premenopausal women, aromatase inhibitors for postmenopausal women, or investigational therapies including a testosterone plus anastrazole pellet, elacestrant, or z-endoxifen capsules. Treatments are taken orally or via subcutaneous pellet insertion, with dosing schedules ranging from daily oral medication to pellet insertion every three months, continuing for up to three years. Participants undergo MRI evaluations at baseline, 3 months, and 6 months, followed by alternating MRI and mammogram scans every 6 months for up to 5 years. If evaluations suggest surgery is needed, participants stop the study treatment and proceed with surgery as standard care. During the study, participants provide blood samples to assess immune status, saliva samples for genetic testing, and tissue samples from any surgery performed as part of their care. They are followed annually for 10 years to monitor outcomes. The main outcome measured is the number of patients remaining on active surveillance at 7 months. Secondary outcomes assess long-term suitability for surveillance, progression to invasive cancer, quality of life, lesion changes on imaging, adherence to surveillance, and risk predictions based on mammography over several years.