Brigham Research Institute (BRI) - Brigham and Women's Hospital

A phase 1/2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T cells [CABA-201]) in subjects with active, pemphigus vulgaris

Type: Interventional

Start Date: Sep 2020

open study

This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: - Pembrolizumab (MK3475) - Ibrutinib - Rituximab (or biosimilar)

Type: Interventional

Start Date: Aug 2020

open study

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).

Type: Interventional

Start Date: May 2017

open study

This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma. The name of the study drug involved in this study is: -Azenosertib (a type of Wee1 inhibitor)

Type: Interventional

Start Date: Apr 2025

open study

This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.

Type: Interventional

Start Date: Apr 2025

open study

The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)

Type: Interventional

Start Date: Jan 2024

open study

The purpose of this study is to determine whether a 16-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among Black men with prostate cancer undergoing active surveillance. The name of the study intervention involved in this study is: Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Type: Interventional

Start Date: Jan 2024

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. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.

Type: Interventional

Start Date: May 2023

open study

This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: - Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program - Attention control (AC) - Home-based stretching program

Type: Interventional

Start Date: Apr 2022

open study

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

Type: Interventional

Start Date: Feb 2022

open study

Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

Type: Observational

Start Date: Jul 2021

open study

This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.

Type: Interventional

Start Date: Dec 2020

open study

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham & Women's Hospital/Brigham & Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.

Type: Interventional

Start Date: May 2019

open study

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Type: Interventional

Start Date: Oct 2024

open study

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) > 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

Type: Interventional

Start Date: Jan 2025

open study

Obesity has become an important public health issue that leads to insulin resistance, diabetes, hypertension, dyslipidemia, and cardiovascular diseases. Although weight loss with calorie restriction and increased physical activity improve these complications, many people fail these lifestyle interventions. Therefore, pharmacologic agents have been used for weight management in addition to lifestyle interventions. In the past few years, one of the widely used pharmacologic agents for weight management is Glucagon-like peptide 1 receptor agonists (GLP1 RAs). Overall, this class of medications improves both metabolic and cardiovascular profiles while causing weight loss, but their effects can vary between individuals. Therefore, it is essential to understand who will respond best to this therapy. Based on previous research on the interaction between a cell membrane molecule, caveolin-1, and glucagon-like peptide 1 receptor, we hypothesize that genetic variations in the caveolin-1 gene explain the variable cardiometabolic responses.

Type: Observational

Start Date: Nov 2023

open study

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.

Type: Observational

Start Date: Feb 2024

open study

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Type: Observational [Patient Registry]

Start Date: Jan 2019

open study

This research study is a Phase 1/2 clinical trial testing the safety, tolerance and efficacy of the drug Acalabrutinib for people with recurrent or refractory central nervous system lymphoma (CNSL).

Type: Interventional

Start Date: Aug 2021

open study

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.

Type: Interventional

Start Date: Jun 2021

open study

The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function. The names of the study interventions involved in this study are/is: - High-Intensity Interval Training (HIIT)

Type: Interventional

Start Date: Jul 2021

open study

The purpose of this research is to determine whether a 16-week exercise program for individuals with breast cancer and have completed treatment (i.e., surgery, chemotherapy, or radiation) for breast cancer will decrease inflammation in fat tissue.

Type: Interventional

Start Date: Aug 2021

open study

To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.

Type: Interventional

Start Date: Dec 2023

open study

The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants. Participants will: - complete 2 inpatient stays - be provided with test meals - have frequent blood draws

Type: Interventional

Start Date: Dec 2024

open study

The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure. Participants will: complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples

Type: Interventional

Start Date: Nov 2024

open study