Mass General - Division of Clinical Research

The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta. This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

Type: Interventional

Start Date: Sep 2018

open study

The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. One way to provide anxiety management skills to more children, and to potentially prevent worsening outcomes, is to offer online and self-guided educational programs that parents can complete without a clinician. This randomized trial will evaluate the effects of two brief, online, self-guided parent education programs designed to improve parents' understanding of anxiety and teach parents way to help their children cope with anxiety. Parents will be randomly assigned to one of the three programs. The main aim of the study is to examine whether the parent programs, compared to an educational control reduce parental accommodation of anxiety across a 1-, 4-, and 8-month follow-up period. As a secondary aim, the investigators will explore whether the parent programs reduce children's anxiety symptoms over the 8-month follow-up period. Results will inform the development of a scalable, low-cost model for promoting access to evidence-based treatment to young children.

Type: Interventional

Start Date: Sep 2025

open study

The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.

Type: Interventional

Start Date: Oct 2023

open study

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.

Type: Interventional

Start Date: Jul 2025

open study

To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.

Type: Observational

Start Date: Mar 2023

open study

This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

Type: Observational [Patient Registry]

Start Date: Aug 2021

open study

This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4

Type: Interventional

Start Date: Jan 2025

open study

This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

Type: Interventional

Start Date: Jul 2025

open study

The goal of this clinical trial is to promote lung cancer screening (LCS) uptake among Hispanic current and former smokers. The main questions it aims to answer are: - What barriers do current and former Hispanic smokers face in the identification and documentation of their smoking status? - How can digital delivery of an educational video promote LCS uptake among current and former Hispanic smokers? Participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.

Type: Observational

Start Date: Feb 2023

open study

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

Type: Observational

Start Date: Mar 2016

open study

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

Type: Interventional

Start Date: May 2025

open study

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

Type: Interventional

Start Date: Nov 2024

open study

In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan.

Type: Interventional

Start Date: Feb 2025

open study

This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows: 1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use); 2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits; 3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.

Type: Interventional

Start Date: Feb 2023

open study

The goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (aSDoH) on oral health linkage to care for emergency department patients. Researchers will compare three groups: Patients in Arm A will receive paper handouts with general oral health and aSDoH resources. Patients in Arm B will receive paper handouts with geographically-proximate oral health and aSDoH resources. Patients in Arm C will receive geographically-proximate oral health and aSDoH resources plus active navigational assistance.

Type: Interventional

Start Date: Aug 2023

open study

Development of a central repository for PD-related genomic data for future research.

Type: Observational [Patient Registry]

Start Date: Dec 2020

open study

SMaHRT (Stroke Motor reHabiliation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.

Type: Observational

Start Date: Jun 2017

open study

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML

Type: Interventional

Start Date: Apr 2024

open study

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.

Type: Observational [Patient Registry]

Start Date: Nov 2023

open study

This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Type: Interventional

Start Date: Mar 2023

open study

Our overall objective is to obtain an initial assessment of the potential value of using [18F]3F4AP for imaging demyelinating diseases such as multiple sclerosis: - Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events. - Aim 2) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and MS patients. Hypothesis 2: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls and MS subjects. The kinetics in demyelinated lesions will be slower than in healthy control areas. - Aim 3) Assess the reproducibility of [18F]3F4AP in humans. Hypothesis 3: the test/retest variability of [18F]3F4AP within the same subject will be lower than 10%. - Aim 4) Correlate MR brain images with [18F]3F4AP PET brain images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. - Aim 5) Correlate [18F]3F4AP PET signal with neuropsychological testing in people with MS. Hypothesis 5: increased PET signal (VT or SUV) will correlate with impaired Single Digit Modality Test (SDMT) scores. - Aim 6) Correlate [18F]3F4AP PET signal with EDSS score in people with MS. Hypothesis 6: increased PET signal (VT or SUV) will correlate with higher EDSS scores.

Type: Interventional

Start Date: Mar 2021

open study

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.

Type: Interventional

Start Date: May 2018

open study

This proposal aims to study the role that the dorsal prefrontal cortex plays in human social cognition.

Type: Interventional

Start Date: May 2022

open study

Investigators use a genome-wide approach within a case-control design to identify SNPs that show evidence of association with lung cancer risk and survival.

Type: Observational

Start Date: Jun 1993

open study

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.

Type: Interventional

Start Date: Mar 2023

open study