Woburn, Massachusetts Clinical Trials

M Michael Young, MD

An Ethical Approach to Detecting Covert Consciousness

This study aims to develop an ethical approach to developing and deploying novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.

M Margaret G Distler, MD, PhD

Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose …

B Bridget M Hron, MD

Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology

Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room …

J Jonathan D Schoenfeld, MD, MPH

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

This research is being conducted to understand if treatment can be tailored for participants with HPV-related oropharynx cancers using both clinical features (stage of the tumor, smoking status) combined with an investigational HPV blood test. The names of the test and treatments involved in this study are: NavDx® HPV ctDNA …

R Rick Lee

An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease

Fosigotifator is an investigational drug being researched for the treatment of Vanishing White Matter disease in adult, pediatric and infant participants. This is a 201-week, open-label, multiple cohort study enrolling adults, pediatric and infant participants with Vanishing White Matter disease. Participants will attend regular visits during the course of the …

K Kendall Lewis

A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, …

A Aimee Luat, MD

Longitudinal Studies to Identify Biomarkers for Sturge-Weber Syndrome

Individuals with Sturge-Weber Syndrome (SWS) sometimes have brain involvement which can result in seizures, stroke-like episodes and neurologic deficits. The purpose of this study is to integrate longitudinal clinical data, radiological data, and blood biomarkers of Sturge-Weber syndrome patients. The research aims are: To integrate longitudinal clinical data, radiological data, …

M Michael Winter, MD

Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate …

H Hisham Abdel-Azim, MD

Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma

A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and …