Mass General - Division of Clinical Research

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Type: Interventional

Start Date: Aug 2022

open study

The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.

Type: Interventional

Start Date: Mar 2021

open study

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham & Women's Hospital/Brigham & Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.

Type: Interventional

Start Date: May 2019

open study

Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2. Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).

Type: Interventional

Start Date: Apr 2024

open study

This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.

Type: Interventional

Start Date: Jan 2025

open study

First-degree relatives of people with inflammatory bowel disease ("IBD," including Crohn's disease and ulcerative colitis) have an increased risk for developing IBD themselves. This study will follow unaffected first-degree relatives (who do not have IBD) over time to understand if their behaviors, diet, and biomarkers for IBD can help predict who gets IBD and if IBD can be prevented in these high-risk individuals. Participants will be asked once per year to complete a questionnaire and have their blood, stool, and urine collected. The anticipated length of the study (registry) is approximately 10 years or longer. Parts of this study, such as the questionnaires and stool and urine collection, may be done from home, while other parts, such as the blood draw, will need to be done from Massachusetts General Hospital.

Type: Observational [Patient Registry]

Start Date: Dec 2024

open study

Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.

Type: Interventional

Start Date: Oct 2020

open study

This research is being done to see how effective the drug niraparib is against cancer that has metastasized to the central nervous system (CNS). - This research study involves the study drug niraparib.

Type: Interventional

Start Date: Apr 2022

open study

Testing the effect of Virtual Reality - guided imagery acupuncture

Type: Interventional

Start Date: Jul 2024

open study

An exercise regimen (PRIME: Proximal Resistance In-House Movement Exercise) has been designed for patients with myotonic dystrophy type 2 (DM2). The hypothesis is that this patient-friendly physical therapist (PT)-guided exercise program associates with improved functional capacity and muscle composition in DM2 in this two-period two-sequence cross-over study. Thus, participant will be randomized to one of the three possible groups. Participants in GROUP A will perform exercise routine in clinic under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP B will perform exercise routine virtually under the direct supervision of a physical therapist twice a week for the first three months, then they will continue with same exercise routine at home for the last 3 months on their own. Participants in GROUP C will perform exercise routine on their own during the first 3 months, then they will perform exercise routine virtually under the direct supervision of a physical therapist. Each group will include around 8 participants. Duration of the study is 6 months. In addition to exercise sessions, participants will have evaluation of their strength, motor function and muscle composition at three time points: initiation, 3 months and completion of the study at 6 months. Muscle composition will be assessed by electrical impedance myography which is a portable, non-invasive, painless and non-radiation tool that applies a weak high multifrequency electrical current to the examined muscle and allows to obtain information about its composition.

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells.

Type: Interventional

Start Date: Apr 2025

open study

Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.

Type: Interventional

Start Date: Jun 2023

open study

The goal of this study is to see if patients with myeloproliferative disorders are able to successfully complete the Cardiac Lifestyle Program(CLP). The goal of the CLP is to teach patients how to become more active and eat healthier foods. The name of the intervention used in this research study is: Cardiac Lifestyle Program (a 12-week, tailored nutrition and physical activity program)

Type: Interventional

Start Date: Mar 2024

open study

This study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.

Type: Observational

Start Date: Aug 2022

open study

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

Type: Observational

Start Date: Jul 2021

open study

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

Type: Interventional

Start Date: Apr 2021

open study

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.

Type: Interventional

Start Date: Dec 2017

open study

Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis. The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.

Type: Observational [Patient Registry]

Start Date: Jan 2017

open study

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Type: Interventional

Start Date: Jul 2024

open study

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Type: Interventional

Start Date: Sep 2024

open study

The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up. This study will receive support from and inclusion in the HEAL Initiative (https://heal.nih.gov/).

Type: Interventional

Start Date: Oct 2024

open study

This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Type: Interventional

Start Date: Jan 2023

open study

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Type: Interventional

Start Date: Jul 2022

open study

We are doing this research to identify biomarkers in individuals who are at-risk for familial prion disease. We hope to use these biomarkers to predict timing of disease onset in pre-symptomatic individuals and to guide the direction of future clinical trials.

Type: Observational [Patient Registry]

Start Date: Dec 2017

open study

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Type: Interventional

Start Date: Dec 2020

open study