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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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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