Mass General - Division of Clinical Research

The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. The names of the study drugs involved in this study are: - Avatrombopag (a thrombopoietin receptor agonist) - Matching placebo

Type: Interventional

Start Date: Nov 2023

open study

A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.

Type: Interventional

Start Date: Sep 2022

open study

The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.

Type: Interventional

Start Date: Aug 2022

open study

The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.

Type: Interventional

Start Date: Sep 2022

open study

In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: - Acalabrutinib - Rituximab or similar CD20 antibody

Type: Interventional

Start Date: Nov 2021

open study

This research study is examining the effectiveness of pembrolizumab plus cryoablation or aveluma plus cryoablation on people with urothelial carcinoma, including bladder cancer, that has spread.

Type: Interventional

Start Date: Jun 2021

open study

The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.

Type: Observational [Patient Registry]

Start Date: Mar 2021

open study

To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.

Type: Interventional

Start Date: Dec 2016

open study

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Type: Interventional

Start Date: Sep 2014

open study

The goal of this study is to objectively test one's sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations. Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.

Type: Observational

Start Date: May 2023

open study

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: - Investigational Drug Sub-Study A: Siltuximab - Investigation Drug Sub-Study B: Erenumab-Aooe

Type: Interventional

Start Date: Aug 2023

open study

A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.

Type: Interventional

Start Date: Dec 2022

open study

The purpose of this study is to learn more about how to better track smell recovery in people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Many people who have been infected by this virus develop changes in their sense of smell (olfaction). We are interested in measuring smell function objectively via smell cards that test odor intensity, identification, and discrimination. Objective and precise olfactory testing that can be performed in the convenience of one's home will help identify people with smell loss after infection by SARS-CoV-2. We will use results from this test to better understand the relationship between SARS-CoV-2 infection and recovery of olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable olfactory function tracking tool to quantify smell loss in the context of COVID infection. These results may inform the design of therapeutic clinical trials to accelerate the recovery of smell function.

Type: Observational [Patient Registry]

Start Date: Nov 2022

open study

In this research study the investigators want to find out if a non-invasive electrical brain stimulation method called RAVANS (also called tVNS) can have a beneficial effect on cognition in older individuals. The investigators also want to understand whether certain individual factors contribute to the effect of RAVANS on cognition. RAVANS is only used in research studies.

Type: Interventional

Start Date: Nov 2021

open study

This study is researching an investigational drug called REGN5668. Participants will receive additional investigational drugs in combination with REGN5668. These additional drugs include cemiplimab or REGN4018 (with or without sarilumab). The main purposes of this study are to: - Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus - Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: - Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab or REGN4018 - How REGN5668 works in the body either alone and/or in combination with cemiplimab or REGN4018 - How much of the study drugs (REGN5668, cemiplimab, REGN4018) are in the blood - To see if REGN5668 in combination with cemiplimab or REGN4018 works to treat cancer - To find out how safe, tolerable, and effective in mitigating Cytokine Release Syndrome (CRS) sarilumab pretreatment is when given before REGN4018

Type: Interventional

Start Date: Dec 2020

open study

The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g. ACE/CHIP and mosaicism).

Type: Observational [Patient Registry]

Start Date: Sep 2020

open study

This research is being done to see how well the combination of a standard of care drug, investigational drug, and radiation therapy work against unresectable vulvar squamous cell carcinoma. This research study involves the following: - Cisplatin (standard of care drug) - Pembrolizumab (investigational drug) - Radiation Therapy (standard of care intervention)

Type: Interventional

Start Date: Jul 2020

open study

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.

Type: Observational

Start Date: Mar 2020

open study

IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Type: Interventional

Start Date: Feb 2020

open study

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.

Type: Interventional

Start Date: Sep 2014

open study

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Type: Interventional

Start Date: Sep 2019

open study

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Type: Interventional

Start Date: May 2017

open study

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

Type: Observational [Patient Registry]

Start Date: Nov 2017

open study

The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.

Type: Interventional

Start Date: Aug 2016

open study

Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma. This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

Type: Observational

Start Date: Jan 2023

open study