Mass General - Division of Clinical Research

A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).

Type: Interventional

Start Date: Feb 2023

open study

This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/ The name of the study intervention involved in this study is: -- implantable microdevice

Type: Interventional

Start Date: Nov 2023

open study

The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.

Type: Interventional

Start Date: Oct 2025

open study

Language is a signature human cognitive skill, but the precise computations that support language understanding remain unknown. This study aims to combine high-quality human neural data obtained through intracranial recordings with advances in computational modeling of human cognition to shed light on the construction and understanding of speech.

Type: Interventional

Start Date: Apr 2021

open study

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Type: Interventional

Start Date: Jan 2022

open study

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.

Type: Interventional

Start Date: Feb 2022

open study

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Type: Interventional

Start Date: May 2021

open study

Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.

Type: Interventional

Start Date: Jun 2021

open study

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Type: Interventional

Start Date: Dec 2019

open study

In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.

Type: Observational

Start Date: Jul 2012

open study

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Gaucher disease population. - To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

Type: Observational [Patient Registry]

Start Date: Apr 1991

open study

This decentralized, randomized study seeks to assess the feasibility, acceptability, and preliminary effectiveness of two approaches to assisting Neurofibromatosis 1 (NF1) patients with low health literacy improve their understanding of NF1 symptoms and care recommendations. Participants will be provided with personalized NF1 care letters for themselves and their doctors, along with either NF1 educational videos or a call with an NF1 peer navigator. Adults with NF1 from across the U.S. who have upcoming annual wellness visits 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/nfpeer

Type: Interventional

Start Date: Dec 2025

open study

This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.

Type: Interventional

Start Date: Nov 2025

open study

This is a feasibility study of a Work Support (WorkS) intervention designed to ameliorate employment challenges for people preparing to return to work after allogeneic stem cell transplantation. The aim of this study is to evaluate "proof of concept" by: 1. examining the feasibility and acceptability of the WorkS intervention and the study procedures, and 2. exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.

Type: Interventional

Start Date: Jul 2024

open study

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress. The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem. - Cognitive Behavioral Therapy (CBT) - Acceptance Commitment Therapy (ACT) - Mindfulness-Based Cognitive Therapy (MBCT) - Mindfulness-Based Stress Reduction (MBSR) - Meaning-Centered Psychotherapy (MCP) - Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT for other cancer-related physical symptoms like pain, fatigue, and nausea. Participation in this research study is expected to last about 26 weeks. It is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.

Type: Interventional

Start Date: Jan 2023

open study

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on pediatric Type 1 diabetes.

Type: Interventional

Start Date: Mar 2022

open study

This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalation phase, a dose expansion phase, and phase 2A cohorts. Up to 200 patients will be accrued for this study. Up to 15 study sites in the United States will participate in the study.

Type: Interventional

Start Date: Oct 2019

open study

This research study is evaluating the investigational software for magnetic resonance imaging (MRI) systems and techniques to process magnetic resonance (MR) images

Type: Interventional

Start Date: Apr 2019

open study

The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers.

Type: Interventional

Start Date: Sep 2018

open study

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine. Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy. In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.

Type: Interventional

Start Date: Jun 2014

open study

Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC. Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores. Groups: 1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit. 2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). 3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes). 4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes). All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.

Type: Interventional

Start Date: Sep 2025

open study

This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.

Type: Interventional

Start Date: Aug 2025

open study

This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643. Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.

Type: Interventional

Start Date: Jan 2025

open study

The goal of this observational study is to research the impact of molecular signals from the heart, liver and fat tissue on cardiovascular disease risk, and the presentation of Type II Diabetes and diseases that affect the heart, blood vessels and metabolism (Cardiometabolic Disease). Specifically, the focus is on the content and function of Extracellular Vesicles (EVs), small sacs released from a cell's surface that contain important molecular cargo. The main questions it aims to answer are: 1. What molecular cargo do adipose-tissue EVs carry? 2. How do these cargo impact cardiac and hepatic function? 3. Are changes in EV content related to cardiac function and adiposity with weight loss? Tissue samples from fat tissue and blood samples will be collected from patients receiving bariatric weight loss surgery.

Type: Observational

Start Date: Feb 2019

open study

The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer. The main questions it aims to answer are: - If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer - What age a MRI is useful clinically for prostate cancer screening - If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers Participants will: - Get a prostate specific antigen (PSA) blood test - Get an mpMRI - Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing - Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI

Type: Interventional

Start Date: May 2024

open study