464 matching studies

Sponsor Condition of Interest
Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation
Brigham and Women's Hospital Post-stroke
The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles1 expand

The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home.

Type: Observational

Start Date: Feb 2024

open study

Emergency Care at Home
Brigham and Women's Hospital Emergency Medical Services Emergency Department Visits
This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department. expand

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

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Columbia University Monoclonal Gammopathy
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 means1 expand

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

Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)
Laura M. Spring, MD Triple Negative Breast Cancer Hormone Receptor Positive (HR+), HER2-negative Breast Cancer Biopsy-proven, Positive Lymph Node(s)
This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are:1 expand

This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer. The names of the study interventions involved in this study are: - Radiation Therapy (RT) - Immunotherapy: Pembrolizumab (MK-3475) - Chemotherapies: - Paclitaxel - Doxorubicin (also called Adriamycin) - Cyclophosphamide - Carboplatin (optional, and in TN only) - Capecitabine (optional, and in TN only)

Type: Interventional

Start Date: Dec 2020

open study

Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Con1
Brigham and Women's Hospital Venous Thromboembolism
Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban redu1 expand

Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death compared with short-duration enoxaparin. Obstacles to integration of these data in the hospitalized Medical Service patient population, including failure to identify at-risk patients, educational gaps in strategies for VTE prevention after discharge, and medication nonadherence, can be overcome with alert-based computerized decision support. This study is a single-center, 400-patient, randomized controlled trial of an EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase prescription of extended-duration post-discharge thromboprophylaxis and decrease symptomatic VTE in high-risk patients hospitalized with medical illness. Specific Aim #1: To determine the impact of electronic alert-based CDS (EPIC Best Practice Advisory [BPA]) on prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge. Specific Aim #2: To estimate the impact of electronic alert-based CDS (EPIC BPA) on the frequency of symptomatic VTE in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.

Type: Interventional

Start Date: Feb 2019

open study

Cognitive Training to Enhance Brain Concordance During Acupuncture
Spaulding Rehabilitation Hospital Fibromyalgia
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 su1 expand

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

Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma
Massachusetts General Hospital Multiple Myeloma
This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care. expand

This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care.

Type: Interventional

Start Date: Dec 2023

open study

Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation
Brigham and Women's Hospital Hemodialysis
This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients. expand

This randomized placebo-controlled clinical trial will evaluate the effect of sacubitril/valsartan (compared with placebo) on echocardiographic measures of hypervolemia, preservation of residual renal function, and key safety parameters in incident hemodialysis patients.

Type: Interventional

Start Date: Oct 2022

open study

Ultrahypofractionation and Normal Tissue Toxicity
Massachusetts General Hospital Breast Cancer Breast Cancer Female Breast Cancer Stage II Breast Cancer Stage III Myocardial Fibrosis
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 grou1 expand

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

Chronic Non-Specific Neck Pain Treated With Tai Chi and Chiropractic Care
Harvard University Faculty of Medicine Neck Pain Chronic Pain
This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP). expand

This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).

Type: Interventional

Start Date: Oct 2023

open study

Fecal Microbiota Transplant National Registry
American Gastroenterological Association Fecal Microbiota Transplantation Clostridium Difficile Infection Gut Microbiome
A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness expand

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Type: Observational [Patient Registry]

Start Date: Sep 2017

open study

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Major Extremity Trauma Research Consortium Post Operative Surgical Site Infection
The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot. expand

The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.

Type: Interventional

Start Date: May 2021

open study

Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
Brigham and Women's Hospital Primary Sclerosing Cholangitis
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 21 expand

This is a multicenter, randomized, double-blinded placebo controlled trial to assess the benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with PSC. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.

Type: Interventional

Start Date: Jul 2018

open study

Deucravacitinib for the Treatment of Palmoplantar Pustulosis
Brigham and Women's Hospital Palmoplantar Pustulosis
A prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks. expand

A prospective, single-arm, open-label trial of deucravacitinib 6 mg daily in patients with PPP. All participants will receive deucravacitinib 6 mg daily for 24 weeks, with study visits every 4 weeks.

Type: Interventional

Start Date: Jul 2023

open study

Urologic Lymphadenectomy in AMIGO
Dana-Farber Cancer Institute Urologic Cancer Lymph Node Metastasis
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer. expand

This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.

Type: Interventional

Start Date: Apr 2022

open study

A Novel Pharmacological Therapy for Obstructive Sleep Apnea
Brigham and Women's Hospital Sleep Apnea
A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study wil1 expand

A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study will answer the following questions: Does ongoing, repeated-dose administration of atomoxetine-plus-oxybutynin (referred to as "AtoOxy") improve OSA severity, and do patients exhibit signs of symptomatic relief? Most importantly, which phenotypic subgroup of patients preferentially benefit from this intervention?

Type: Interventional

Start Date: Sep 2019

open study

Health Effects of Substituting Sugary Beverages With Artificially-sweetened Beverages or Water
Brigham and Women's Hospital Body Weight
Sugar-sweetened beverages (SSBs) contribute an alarming ~7% of calories in the US diet among adults, making SSBs the single largest source of added sugar. However, whether artificially sweetened beverages are a healthful alternative for reducing SSB intake among habitual SSB consumers is unknown. T1 expand

Sugar-sweetened beverages (SSBs) contribute an alarming ~7% of calories in the US diet among adults, making SSBs the single largest source of added sugar. However, whether artificially sweetened beverages are a healthful alternative for reducing SSB intake among habitual SSB consumers is unknown. Therefore, the investigators will conduct a 4-arm randomized diet intervention trial to test the effects of substituting SSBs with calorie-free alternatives on body weight and health, among habitual SSB consumers with overweight/obesity.

Type: Interventional

Start Date: Apr 2021

open study

The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk1
Massachusetts General Hospital Breast Cancer Stage II Breast Cancer Stage III
The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation expand

The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation

Type: Observational

Start Date: Oct 2017

open study

The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing
Massachusetts General Hospital Pregnancy Related Burnout, Professional Wellness, Psychological
The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care. The main questions it aims to answer are whether this set of interventions will improve trainee wellbeing1 expand

The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care. The main questions it aims to answer are whether this set of interventions will improve trainee wellbeing and decrease medical error. Participants will be randomized to intervention and control groups. The intervention group will receive: 1. A Snoo smart sleep bassinet 2. A Willow wearable breast pump 3. Access to Maven Clinic for 24/7 on-demand perinatal care 4. A faculty mentor in their own department The control group will receive the standard support currently offered by training programs. All participants will wear a Fitbit to track sleep and will take a series of surveys querying pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction. Researchers will compare intervention and control groups to see if the intervention group has: 1. decreased rates of burnout 2. increased professional fulfillment 3. decreased thoughts of leaving the profession 4. increased perception of organizational and personal value alignment 5. increased sleep 6. decreased risk of medical errors 7. increased personal fulfillment of breastfeeding goals 8. decreased risk of postpartum depression

Type: Interventional

Start Date: May 2023

open study

Feasibility of [11C]Acetate-PET in LAM and TSC
Brigham and Women's Hospital Lymphangioleiomyomatosis Tuberous Sclerosis Complex
This study aims to assess [11C]acetate positron emission tomography (PET)/computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM) and an early biomarker of response to rapamycin in LAM patients. [11C]Acetate is a radioactive form of acetate, a1 expand

This study aims to assess [11C]acetate positron emission tomography (PET)/computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM) and an early biomarker of response to rapamycin in LAM patients. [11C]Acetate is a radioactive form of acetate, a nutrient commonly processed in our body's cells to generate fat and energy. Preclinical studies support the hypothesis that TSC tumors enhance lipid synthesis compared to normal tissues, suggesting that quantification of [11C]acetate in these tumors by PET/CT may provide a metabolic biomarker of disease. Participants in the study will undergo 1 or 2 PET/CT scans over 3 to 6 months at the Massachusetts General Hospital (Boston, MA). [11C]acetate is administered through an intravenous catheter. This small amount of radioactivity is short-lived and eliminated from the body within a few hours.

Type: Interventional

Start Date: Aug 2021

open study

Atomoxetine and DAW2022 on OSA Severity
Brigham and Women's Hospital Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxy1 expand

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine.

Type: Interventional

Start Date: Jun 2022

open study

COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
Brigham and Women's Hospital Heart Failure
This is a randomized, open-label, initiative within the Mass General Brigham healthcare system testing two remote care strategies for optimizing the prescription of guideline-directed medical therapies in patients with heart failure, regardless of left ventricular ejection fraction (LVEF). expand

This is a randomized, open-label, initiative within the Mass General Brigham healthcare system testing two remote care strategies for optimizing the prescription of guideline-directed medical therapies in patients with heart failure, regardless of left ventricular ejection fraction (LVEF).

Type: Interventional

Start Date: May 2023

open study

NAD Augmentation in Diabetes Kidney Disease
Brigham and Women's Hospital Type2diabetes Diabetic Kidney Disease
A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 m1 expand

A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.

Type: Interventional

Start Date: Apr 2023

open study

Patient-Centered Surgical Prehabilitation
Dana-Farber Cancer Institute Bladder Cancer Cystectomy
The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure. expand

The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.

Type: Interventional

Start Date: Mar 2023

open study

Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated1
Massachusetts General Hospital Pediatric Patients Treated With Radiation Therapy
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there1 expand

In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better results in treating patients with cancer, both because there is better control of where in the body the radiation is directed and because it is associated with less severe long term side effects. However, there is limited published data demonstrating these results. The goal of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with radiation in order to describe the population that currently receives radiation and better compare the short-term and long-term benefits of different types of radiotherapy. The data collected from this study will help facilitate research on radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data that many centers that deliver radiation therapy already collect in routine operations.

Type: Observational

Start Date: Jul 2012

open study