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

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

Type: Interventional

Start Date: Oct 2020

open study

This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

Type: Interventional

Start Date: May 2020

open study

This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.

Type: Interventional

Start Date: Aug 2023

open study

Obstructive sleep apnea (OSA) is a highly prevalent disorder that has major consequences for cardiovascular health, neurocognitive function, risk of traffic accidents, daytime sleepiness, and quality of life. For years, a "classic" model of OSA has been used to describe the disorder, which fails to capture it's complexity. Recently, a model for OSA called drive-dependent OSA was discovered be more prevalent in the OSA population. This drive-dependent OSA is due to ventilation instability that occurs during respiratory events however these individuals have spontaneous increases in drive during respiratory events that stabilize their airway (i.e., via improving upper airway muscle activity) and reduce the risk of respiratory events in people with OSA. Therefore, by stabilizing the ventilatory drive, OSA should be treatable. Acetazolamide is a pharmacological ventilatory stimulant and has been previously shown to reduce OSA severity. As such in this study, the goal is to demonstrate acetazolamide improves OSA severity in 'drive-dependent' OSA people by improving drive-related pharyngeal obstructions compared to the 'classic' OSA people.

Type: Interventional

Start Date: Jan 2024

open study

This is a prospective pilot clinical study of subjects with cardiac amyloidosis and control subjects without amyloidosis where we plan to evaluate changes in myocardial blood flow, systolic and diastolic function before and after sonotherapy.

Type: Interventional

Start Date: Aug 2023

open study

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: - Sacituzumab govitecan (SG) - Pembrolizumab (combination therapy with SG)

Type: Interventional

Start Date: Jul 2020

open study

Design: U.S.-based, single-center, proof-of-concept study Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation will be compared with a standard clinically-indicated baseline contrast-enhanced chest CT scan using a previously-studied and previously-validated 3-dimensional reconstruction technique to assess changes in the pulmonary vasculature in patients with acute pulmonary embolism (PE). This previously-studied and previously-validated 3-dimensional reconstruction technique has been used to assess the response of the pulmonary vasculature to catheter-based fibrinolysis in acute PE as well as to assess the pulmonary vasculature in a number of chronic lung diseases. However, the pulmonary vascular response to standard anticoagulation for acute PE has not been assessed previously. Purpose: To compare the pulmonary vasculature before and after standard clinically-indicated anticoagulation for acute PE using a previously-studied and previously-validated 3-dimensional reconstruction technique applied with a standard clinically-indicated baseline contrast-enhanced chest CT scan (used to diagnose the acute PE) and a standard clinical contrast-enhanced chest CT scan performed 48 hours later as indicated by the study protocol. Population: Inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Enrollment: 10 subjects with acute PE Clinical Site Location: Single-center, Brigham and Women's Hospital Study Duration: 12 months Primary Imaging Outcome: CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Secondary Imaging Outcome: CT-determined percent change in right ventricular (RV) volume from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.

Type: Observational

Start Date: Dec 2019

open study

this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.

Type: Interventional

Start Date: Jul 2019

open study

Children and adults with XLH recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy. The investigators hypothesize that treatment of adults and children with XLH alone will improve serum phosphate levels and skeletal mineralization without causing an increase in kidney calcifications. The study will also examine if calcitriol therapy will improve growth in children.

Type: Interventional

Start Date: Mar 2019

open study

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Type: Observational

Start Date: Apr 2023

open study

This proposal will measure the effects of mannitol administration versus placebo in hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in patient symptoms and blood pressure stability.

Type: Interventional

Start Date: Apr 2021

open study

The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with [68Ga]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo [68Ga]CBP8 PET/MRI imaging as a healthy control group. The primary hypothesis of this study is that [68Ga]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that [68Ga]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that [68Ga]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration).

Type: Interventional

Start Date: Jan 2023

open study

The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.

Type: Interventional

Start Date: Feb 2019

open study

The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)

Type: Interventional

Start Date: Jan 2023

open study

The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.

Type: Interventional

Start Date: Apr 2023

open study

Atomoxetine-plus-oxybutynin therapy (AtoOxy) has been shown to substantially reduce obstructive sleep apnea severity (OSA) in about half of patients. Here, the investigators will study which patients respond meaningfully to therapy using pathophysiological traits measured at baseline sleep studies.

Type: Interventional

Start Date: May 2022

open study

The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.

Type: Interventional

Start Date: Nov 2021

open study

Vitamin D status has been shown to have an effect on post-operative outcomes in total joint arthroplasty. The goal of this study is to determine if pre-operative supplementation and correction of Vitamin D deficiency can reduce postoperative complications.

Type: Interventional

Start Date: Sep 2019

open study

The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.

Type: Observational

Start Date: May 2013

open study

The purpose of this study is to examine the effect of a moderately low blood sugar stress on the nervous system. The investigators hope that information obtained from completing this study will help to reveal information about how a non-psychological stress impacts the parts of the brain that react to stress and the autonomic nervous system. The autonomic nervous system is the part of the nervous system that provides the body with involuntary or automatic control of heart rate, blood pressure, and breathing.

Type: Interventional

Start Date: Oct 2019

open study

This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

Type: Interventional

Start Date: Oct 2018

open study

This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.

Type: Observational [Patient Registry]

Start Date: Aug 2012

open study

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.

Type: Interventional

Start Date: Mar 2019

open study

This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. The investigators propose that cognitive impairment influences surgical morbidity because of underlying immune disequilibrium / dysfunction (risk marker) and that this shapes the immune response to surgery and defines immunological hallmarks of postoperative morbidity (disease marker). The overarching goal of this application therefore is to define and better understand the clinical immunology underlying the relationship between cognition and geriatric surgical morbidity.

Type: Observational

Start Date: Sep 2019

open study

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: - to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. - patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: - to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; - to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; - to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; - to utilize collected pathological material for research collaborations.

Type: Observational [Patient Registry]

Start Date: Sep 2016

open study