Mass General - Division of Clinical Research

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Type: Interventional

Start Date: Mar 2015

open study

This is a 4-year, longitudinal study of 100 active-duty Navy SEALs. The goal of the study is to determine whether repeated blast exposure affects SEAL brain health and to develop an initial diagnostic testing protocol that detects repeated blast brain injury.

Type: Interventional

Start Date: Oct 2025

open study

This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

Type: Interventional

Start Date: Oct 2025

open study

This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain signals reaching the brain, which should reduce the refractory pain due to small fiber neuropathy (SFN).

Type: Interventional

Start Date: Oct 2025

open study

The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.

Type: Interventional

Start Date: Aug 2025

open study

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL). The names of the study drugs involved in this study are: - bendamustine (a type of alkylating agent) - rituximab (a type of monoclonal antibody) - cytarabine (a type of antineoplastic) - zanubrutinib (a type of kinase inhibitor) - sonrotoclax (a type of BCL2 inhibitor)

Type: Interventional

Start Date: Apr 2025

open study

Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.

Type: Interventional

Start Date: Apr 2025

open study

Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.

Type: Interventional

Start Date: Feb 2025

open study

Mg OSTEOCRETE is a bone substitute used to fill a defect in bone caused by excision of a tumor, orthopaedic hardware that has become loosened, or a trauma-related condition. The aim of this study is to determine the amount of time it takes for bone to heal after treatment with Mg OSTEOCRETE, and to better understand the efficacy of this treatment through clinical and patient-reported outcomes.

Type: Observational

Start Date: Mar 2025

open study

This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Type: Interventional

Start Date: Sep 2024

open study

The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic polytrauma patients. The main questions this study aims to answer are: 1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo? 2. Does scheduled ketorolac during the first five hospital days improve functional responses to pain at discharge, 3 months, and 6 months after injury? 3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both? Participants will be enrolled and randomized to either the ketorolac (treatment) group or placebo group to be given every 6 hours during the first five hospital days. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury. Researchers will compare ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain.

Type: Interventional

Start Date: Feb 2025

open study

This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.

Type: Interventional

Start Date: Feb 2024

open study

This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies - EN10.A/RAINBO BLUE: POLE-mutated EC - EN10.B/TAPER: p53 wildtype / NSMP EC

Type: Interventional

Start Date: Dec 2022

open study

The aim of this study is to identify the optimal dose for Vosilasarm (EP0062) as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer

Type: Interventional

Start Date: Jan 2023

open study

Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.

Type: Interventional

Start Date: Jan 2023

open study

Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.

Type: Observational

Start Date: Nov 2019

open study

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts). The investigators hypothesize that: 1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery. 2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke. 3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.

Type: Observational

Start Date: Mar 2021

open study

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Type: Interventional

Start Date: Oct 2018

open study

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.

Type: Interventional

Start Date: May 2018

open study

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Type: Interventional

Start Date: May 2018

open study

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Type: Observational [Patient Registry]

Start Date: Jul 2015

open study

This study aims to evaluate a preoperative fracture analysis tool that uses 3D visualization and biomechanical modeling to assist surgeons in planning screw and plate fixation for complex tibial plateau fractures. By simulating different fixation strategies based on patient-specific CT data, the tool provides insights into construct stability, potentially improving surgical precision and reducing intraoperative uncertainty. The study also investigates the tool's feasibility within current clinical workflows without altering the standard of care.

Type: Interventional

Start Date: Sep 2025

open study

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings. Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide

Type: Interventional

Start Date: Dec 2024

open study

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Type: Observational [Patient Registry]

Start Date: Aug 2023

open study

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

Type: Interventional

Start Date: Feb 2023

open study