Mass General - Division of Clinical Research

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

Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.

Type: Observational

Start Date: Mar 2014

open study

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Type: Interventional

Start Date: Sep 2023

open study

The goal of this clinical trial is to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed, Inc.) on patient well-being with chronic lower back pain (CLBP). The main questions it aims to answer are: 1. Assess the effect of non-weightbearing stationary ellipticals on clinical outcomes inclduing vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP. 2. Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program Participants will participate in 60 minute training sessions to see if there are effects to their CLBP.

Type: Interventional

Start Date: Sep 2023

open study

This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.

Type: Interventional

Start Date: Sep 2020

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

This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.

Type: Interventional

Start Date: Sep 2021

open study

This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for one hour intervals, in a multi-crossover design.

Type: Interventional

Start Date: May 2023

open study

This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.

Type: Interventional

Start Date: Jan 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 goal of this study is to investigate the efficacy of [68Ga]CBP8 to detect collagen deposition in radiation induced tissue injury.

Type: Interventional

Start Date: Jul 2020

open study

We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.

Type: Observational

Start Date: Sep 2017

open study

The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).

Type: Interventional

Start Date: Jun 2022

open study

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.

Type: Interventional

Start Date: Jun 2022

open study

The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflammation and cardiometabolic profiles in postoperative patients in the cardiac surgical ICU on enteral nutrition.

Type: Interventional

Start Date: Feb 2022

open study

This project aims to rigorously evaluate a potential treatment for inflammation-related Obsessive-Compulsive Disorder (OCD) symptoms in children. To accomplish this goal, the investigators will conduct a double-blind, randomized, placebo-controlled trial of Naproxen Sodium, a nonsteroidal anti-inflammatory drug (NSAID) in participants diagnosed with Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infections (PANDAS). This research fills a gap in the empirical evidence base for the treatment of PANDAS, and will add to a growing literature of empirically-derived practices for PANDAS.

Type: Interventional

Start Date: Oct 2020

open study

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years).

Type: Interventional

Start Date: Nov 2016

open study

The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney disease. The aim of the combined transplant is to treat both your underlying blood disorder and kidney disease. We expect to have about 10 people participate in this study. Additionally, because the same person who is donating the kidney will also be donating the bone marrow, there may be a smaller chance of kidney rejection and less need for long-term use of anti-rejection drugs. Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to prepare a subject's body for bone marrow transplant. This is associated with a high risk for serious complications, even in subjects without kidney disease. This therapy can be toxic to the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that standard therapy may be associated with a higher risk of a complication called graft versus host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently, less intense chemotherapy and radiation regimens have been employed (these are called reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed older and less healthy patients to undergo bone marrow transplant. In this study, a reduced intensity regimen of chemotherapy and radiation will be used with the intent of producing fewer toxicities than standard therapy. Typical therapy following a standard kidney transplant includes multiple lifelong medications that aim to prevent the recipient's body from attacking or rejecting the donated kidney. These are called immunosuppressant drugs and they work by "quieting" the recipient's immune system to allow the donated kidney to function properly. One goal in our study is to decrease the duration you will need to be on immunosuppressant drugs following your kidney transplant as the bone marrow transplant will provide you with the donor's immune system which should not attack the donor kidney.

Type: Interventional

Start Date: Nov 2012

open study

The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.

Type: Interventional

Start Date: Oct 2004

open study

This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on plasma reduction-oxidation reactions of patients undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.

Type: Interventional

Start Date: Jul 2019

open study

The use of the conditioning open-label placebo (COLP) paradigm will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid intake to diminish side effects as well as the risk of addiction associated with opioid treatment.

Type: Interventional

Start Date: Aug 2022

open study

This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer. The interventions involved in this study are: - Trifluridine (TAS-102) - Radiation Therapy

Type: Interventional

Start Date: Oct 2017

open study

RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.

Type: Observational

Start Date: Sep 2020

open study

This research study involves Niraparib as a possible treatment for triple negative breast cancer.

Type: Interventional

Start Date: Jul 2019

open study

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Type: Interventional

Start Date: Aug 2018

open study