Mass General - Division of Clinical Research

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

Type: Interventional

Start Date: Feb 2024

open study

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

Type: Interventional

Start Date: Jan 2024

open study

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).

Type: Interventional

Start Date: Feb 2023

open study

NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.

Type: Interventional

Start Date: Nov 2023

open study

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

Type: Interventional

Start Date: Jan 2021

open study

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.

Type: Interventional

Start Date: Jun 2021

open study

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Type: Observational [Patient Registry]

Start Date: Mar 2020

open study

This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).

Type: Interventional

Start Date: Nov 2023

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 first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.

Type: Interventional

Start Date: Sep 2019

open study

The objective of this feasibility study is to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment of additional patients to develop the tumor detection algorithm.

Type: Interventional

Start Date: Mar 2019

open study

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Type: Observational [Patient Registry]

Start Date: Oct 2016

open study

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 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

OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

Type: Observational [Patient Registry]

Start Date: Aug 2023

open study

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress due to their illness and/or treatment. 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 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 100 people and 15 therapists will take part in this research study.

Type: Interventional

Start Date: Jan 2023

open study

The goal of this research study is to test the feasibility and preliminary efficacy of using a virtual reality (VR) psychosocial intervention for improving quality of life and psychological distress in patients hospitalized for bone marrow transplantation (BMT). Participants will be randomly assigned into one of the study groups: the virtual reality psychosocial intervention (BMT-VR) + usual care versus usual care alone. The BMT-VR intervention has several components: 1. Psychoeducation to enhance preparedness, manage expectations, and mobilize social supports. 2. Psychosocial skill building to promote effective coping and facilitate acceptance while living with uncertainty of treatment outcomes. 3. Self-care to promote effective coping and enhance patient's sense of control as they transition from inpatient to outpatient care

Type: Interventional

Start Date: Dec 2022

open study

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.

Type: Interventional

Start Date: Jul 2022

open study

The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.

Type: Interventional

Start Date: Jun 2021

open study

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .

Type: Interventional

Start Date: Aug 2019

open study

FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

Type: Interventional

Start Date: May 2018

open study

Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS. The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session, monitor and participant ratings of subjective drug effects during and after each drug session. This study comprises approximately a 28-day screening period (Days 28 to 1). After screening and enrollment, participants will be randomized to an immediate treatment group or a delayed treatment group ("waitlist control" condition). Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37), integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments. As a safety precaution, participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3, 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed. At the end of the delay period, all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group. Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session. The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3-, 6 , and 12- month follow-up visits (Days 120, 240, 365).

Type: Interventional

Start Date: Jan 2024

open study

The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS) for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning will uncover distinct genetic vulnerabilties that underlie treatment response and resistance for patient with TNKL.

Type: Observational [Patient Registry]

Start Date: Jan 2024

open study

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study groups in this research study are: - Proton Radiation Therapy (PBT) - Conventional or "Photon" Radiation Therapy (XRT)

Type: Interventional

Start Date: Aug 2023

open study

This project aims to optimize a critical but understudied ingredient of language intervention provided to children with developmental language disorder (DLD) - feedback. The project will bridge a gap between previous findings in our lab of inefficient feedback processing in DLD and clinical practice by identifying the conditions under which feedback-based learning can be improved in DLD. The investigators hypothesize that the effectiveness of feedback can be significantly enhanced for children with DLD when it is tailored to their unique learning strengths. The rationale for this project is based on evidence that feedback-based learning can be improved by enhancing the dominance of an intact learning system. The project will achieve its aim by manipulating (1) the timing of the feedback (immediate vs. delayed) and (2) the level of the learner's involvement in error correction dictated by feedback (active vs. passive correction). Aim 1 will determine the effect of manipulating feedback timing on learning in 140 school-age children (8-12 years) with DLD. While immediate feedback is processed by the striatum, which is also implicated in implicit learning, delaying the feedback by a few seconds shifts feedback processing to the mediate temporal lobe (MTL)-based declarative learning system. Evidence that delaying feedback improves learning in DLD would support the hypothesis of the implicit deficit theory that intervention should capitalize on declarative learning mechanisms. The project will test a novel alternative feedback-learning parity hypothesis whereby feedback-based learning is optimized when the timing of the feedback is aligned with the dominant learning system at a given time (i.e., immediate feedback during striatal-based probabilistic learning; delayed feedback during MTL-based declarative learning). Within the same group of children, Aim 2 will compare feedback-based learning in children with DLD when feedback (a) prompts active self-correction or (b) passively exposes learners to error corrections (corrective recast). Children will engage in two nonword-object paired-associate learning tasks. In one task, feedback will promote active self-correction, which is in line with declarative learning. In the other task, feedback will passively expose the learner to corrective feedback in a manner consistent with teaching approaches aiming at reducing awareness of errors. The project will determine whether children with DLD learn better when feedback prompts self-correction or when they are exposed to passive corrections. Electrophysiological measures will indicate whether passive corrections (corrective recast) are processed as negative feedback by children with DLD. For both aims, behavioral indicators of response to feedback will be complemented by electrophysiological measures of feedback processing that can determine the involvement of the striatum and MTL brain systems during the learning process. This work is scientifically and clinically significant because elucidating what manipulations optimize feedback-based learning will enhance our understanding of the impaired learning mechanism in DLD and will provide clinical guidance on what type of feedback to use during an intervention.

Type: Interventional

Start Date: Jul 2023

open study