Plant City

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating treatments for adults with psoriatic arthritis (PsA) who have not responded well to tumor necrosis factor inhibitors (TNFi). The study aims to compare switching to guselkumab, a selective interleukin 23 inhibitor, versus switching to another TNFi called golimumab. This Phase 3 trial tests whether changing to a new mechanism of action provides better results than trying a second TNFi, addressing an important question for patients with PsA who have inadequate responses to current therapy. Participants will receive either guselkumab or golimumab, both given as subcutaneous injections. The study is open-label and randomized, meaning both patients and researchers know which treatment is given, and patients are randomly assigned to one of the two options. The trial will observe patients over 12 months to assess treatment effectiveness. During the study, participants will have regular assessments including measuring disease activity with the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) and evaluating psoriasis severity. Researchers will monitor safety and treatment response through these measures and the Investigator Global Assessment of Psoriasis. The total participation duration is 12 months, allowing time to capture treatment effects and side effects.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

Researchers are evaluating whether 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy is as effective as 12 months of the same treatment for patients with early-stage HER2-positive breast cancer who have no remaining invasive cancer after preoperative chemotherapy with trastuzumab. This phase III trial focuses on patients who achieved a pathologic complete response (pCR), aiming to assess recurrence-free survival and quality of life outcomes. The study also explores differences in side effects and survival among subgroups based on treatment delivery and hormone receptor status. Participants are randomly assigned to receive either 6 or 12 months of HER2-targeted therapy, including trastuzumab and possibly pertuzumab, administered intravenously or subcutaneously every 21 days. The treatment cycles continue up to 9 or 17 cycles respectively, unless disease progression or unacceptable side effects occur. Throughout the trial, patients undergo regular heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, patients complete quality of life questionnaires and are monitored for cancer recurrence and side effects. Follow-up visits occur every 6 months for 5 years and then annually up to 10 years after registration. The main outcomes measured include time without cancer recurrence and patient-reported quality of life at 12 months. Safety and long-term effects of the different treatment durations are also assessed.