Auburn

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.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the real-world effectiveness of nemolizumab in treating moderate-to-severe Prurigo Nodularis (PN) in adults. This non-interventional, prospective, multicenter study focuses on physician assessments and patient-reported outcomes over approximately 12 months in routine clinical settings. The study aims to measure improvements using both investigator and patient evaluations at Month 6. Treatment with nemolizumab (Nemluvio) is decided by the participant's physician before enrollment, with no additional visits or tests beyond usual care. Visit schedules follow standard medical practice rather than study requirements. A sub-study in Germany and the UK involves daily remote completion of Peak Pruritus Numerical Rating Scale (PP NRS) and Sleep Disturbance NRS from Day -1 to Day 14 without clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcomes are collected. The main outcomes measured include the Investigator Global Assessment of chronic Prurigo (IGA-CPG stage) and Peak Pruritus Numerical Rating Scale at 6 months. Data collection relies on standard practice, with no extra procedures, and monitoring occurs throughout the study duration of about one year.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

Researchers are evaluating whether starting treatment early with venetoclax and obinutuzumab improves overall survival compared to delayed treatment in patients newly diagnosed with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase III trial focuses on patients who have asymptomatic disease but high-risk factors such as a high CLL-International Prognostic Index score or complex cytogenetics. Venetoclax is a drug that blocks a protein needed for cancer cell survival, while obinutuzumab is an immunotherapy that may help the immune system attack cancer cells and prevent tumor growth. Participants are randomly assigned to one of two groups: early treatment or delayed treatment. Both groups receive obinutuzumab intravenously on specific days in cycles and venetoclax orally daily during treatment cycles, with each cycle lasting 28 days for up to 12 cycles unless the disease progresses or unacceptable side effects occur. The early treatment group starts therapy as soon as they meet eligibility, while the delayed group begins once standard criteria for active treatment are met. Throughout the study, participants undergo procedures including CT scans, blood sample collection, and bone marrow aspiration and biopsy. During the study, participants are monitored closely through various tests and questionnaires to assess overall survival, quality of life using the FACT-Leukemia scale, response to treatment, and disease progression. The trial also studies measurable residual disease and various biomarkers to understand treatment impact. After treatment, participants are followed for up to 10 years to observe long-term outcomes and safety.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating a combination therapy for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to determine if adding bortezomib improves overall survival, especially in patients with minimal residual disease (MRD), while also assessing side effects, progression-free survival, and patient-reported outcomes related to quality of life and neuropathy. Treatment begins with a standard induction phase where all patients receive daratumumab subcutaneously, lenalidomide orally, and dexamethasone orally over nine 28-day cycles. After induction, patients are randomized to receive consolidation therapy either with the four-drug combination including bortezomib or the three-drug combination without bortezomib for nine additional 28-day cycles. Following consolidation, maintenance therapy with daratumumab and lenalidomide is given in repeated 28-day cycles until disease progression or unacceptable side effects occur. The study also incorporates imaging and biomarker assessments to evaluate treatment response and risk. Participants undergo regular evaluations including blood tests, bone marrow biopsies, and imaging scans to monitor disease status and treatment effects. Patient-reported questionnaires assess quality of life and symptoms such as neuropathy. After treatment, follow-up visits occur every three months for up to two years, then every six months for three years, and annually thereafter for up to 15 years. The primary outcome measured is overall survival from the time of randomization to the date of death or last known alive status.