Massachusetts Paid Clinical Trials

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient. Read Less

The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with \[68Ga\]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo \[68Ga\]CBP8 PET/MRI imaging as a healthy control group. The primary hypothesis of this study is that \[68Ga\]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that \[68Ga\]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that \[68Ga\]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration). Read Less

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination. Read Less

The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods. Read Less

Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments. Read Less

This 6 - 12 week longitudinal study will include patients with Dementia. Participants will be randomized into one of two groups: a) an intervention group, in which patients will listen to music using Rubato Life app, and b) a control group, in which patients will receive standard of care. Patients in intervention group will be asked to listen to at least 30 minutes per day, (or a total of 3.5 hours per week) for a period of 6 -12 weeks, coming up to their scheduled follow up appointment. Patients in the Intervention group will wear smartwatches to monitor heart rate variability throughout the study. Read Less

In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally. The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis. Read Less

A prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. Read Less

Approximately 30% of children will experience an anxiety disorder, making anxiety the most common mental health problem among children in the United States. However, few children receive treatment and even our most effective anxiety treatments leave up to half of children in need of additional intervention. Despite the well-established role of parent anxiety in transmitting and maintaining child anxiety, the lack of data on specific parent mechanisms underlying the intergenerational transmission of anxiety is a critical barrier to informing novel targets of personalized treatments. Consistent with NIMH's Strategic Plan, Objective 2.2 to understand risk factors and behavioral indicators of mental illness across the lifespan and to identify novel intervention targets based on knowledge of psychological mechanisms, the current study focuses on interpretation bias, the tendency to perceive threat in ambiguous situations. The overall objective of this project is to empirically test a theoretical model of the intergenerational transmission of anxiety focused on parent interpretation bias as a root cause. Our specific aims are to test theorized effects of parent interpretation bias on (1) parent behavior and (2) child interpretation bias and (3) evaluate potential moderators to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. Our central hypothesis is that parent interpretation bias influences child interpretation bias through its effects on maladaptive, anxiety-promoting parenting behaviors, such as accommodation and modeling of avoidant coping. To test this hypothesis, we will randomize 300 parents of children ages 7-12 to complete four weeks of a smartphone delivered interpretation bias manipulation vs. a self-assessment smartphone app condition. The interpretation bias intervention teaches parents to interpret ambiguous situations in a non-threatening manner via quick, repeated practice and corrective feedback. Before and after completing their randomly assigned condition, parent-child dyads will complete self-report and behavioral tasks designed to elicit anxiety-promoting behaviors from parents depending upon their interpretation of the ambiguous situation (speech and puzzle tasks). Parents will also complete Ecological Momentary Assessment (EMA) of parenting behaviors to capture the time course of effects. Finally, we will examine downstream effects of the interpretation manipulation on child interpretation bias at pre- and post- visits. We will test moderators (e.g., parent anxiety and gender) to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. The long-term goal of this work is to inform personalized, mechanism-focused interventions to improve mental health outcomes for anxious children and their parents. Future studies will translate knowledge gained from this project into a scalable treatment that can be implemented entirely remotely via smartphone thereby increasing access to care Read Less

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation. Read Less

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI. Read Less

This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth. Read Less