Massachusetts Paid Clinical Trials

One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services. Read Less

The goal of this observational study is to quantify ergonomic risk associated with traditional protective equipment in operators working in the cardiac catheterization laboratory as compared with a mobile protection system. The main questions it aims to answer is: What is the mean time spent by operators in positions of high ergonomic postural risk during cases? Participants will wear IMU, EMG, and radiation sensors, as well as complete baseline and discomfort surveys for several catheterization procedures. Read Less

Myotonic dystrophy is associated with central sleep apnea, excessive daytime sleepiness, diminished working memory, impaired visuospatial skills, and deficits in problem-solving skills. Cerebrospinal fluid (CSF) is a clear, colorless fluid that surrounds and protects the brain. Changes in the composition of CSF can serve as early indicators of changes in brain activity and function. The purpose of this research is to learn about myotonic dystrophy by examining cerebrospinal fluid and brain activity in participants. The tests will be low risk and are well tolerated. The information that we gather from this study may help us evaluate, prevent, diagnose, treat, and improve our understanding of myotonic dystrophy. Funding Source- FDA OOPD Read Less

The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy) Read Less

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham). Read Less

Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target. Read Less

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles. Read Less

This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers. Read Less

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for IBD in a cohort of patients cared for by gastroenterologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices. Read Less

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices. Read Less

The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery. The main questions are: 1. Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia? 2. Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery? 3. Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain? Read Less

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis Read Less