Clinical Studies for Emergency Medicine

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Title: Detection of Novel Urine Biomarkers During Inflammation and Infection
Brief Title: AccUrine testing for host response to infection
Brief Summary: The purpose of this study is to explore a new laboratory test that measures specific proteins in urine to determine the presence of a bacterial or viral infection. This study involves collecting urine and blood for research testing and comparing the results to the results of any tests patients have done for their regular clinical care. We hope the information that we learn from this study can be used to develop a new way of diagnosing an infection.
For info regarding 2025P000133 please contact ED Research Team at (617)-650-0042 or edresearch@bidmc.harvard.edu
 
Title: Evaluating Comprehension of Emergency Department Discharge Instructions Translated by Large Language Models using Spanish-Speaking Patients
Brief Title: Machine Translated Spanish Discharge Instructions
Brief Summary: This study is being done to evaluate the safety and impact of providing Spanish-speaking patients with machine translations of their discharge instructions after an Emergency Department (ED) visit. When patients are discharged from the ED, they are provided with a summary of their diagnosis, the results of their tests (e.g. blood tests, imaging studies), and instructions on how to care for themselves at home and when to return to the hospital. Because we dont have enough interpreters to translate every single discharge instruction document for patients who dont speak English, we are testing a computer program that can translate these instructions automatically.
For info regarding 2025P000001 please contact ED Research Team at (617)-650-0042 or edresearch@bidmc.harvard.edu
 
Title: Sysmex CN-6000 – D-dimer Studies for VTE Exclusion Claim
Brief Title: CN6000-DD-VTE Exclusion-01
Brief Summary: We are studying an investigational blood test that may be used to rule out clots in the lungs or legs. The main purpose of this study is to determine whether the investigational blood test can be used to rule out blood clots in the lungs or legs. We are inviting people to take part in this study if they have been suspected to have a clot in a blood vessel (venous thromboembolism [VTE]) in the lungs and/or in the deep veins in their legs.
For info regarding 2024P001071 please contact ED Research Team at (617) 650-0042 or cottanel@bidmc.harvard.edu
 
Title: Sleep monitoring using Oura rings for hospitalized older adults
Brief Title: Sleep monitoring using Oura rings
For info regarding 2024P000977 please contact ED Research Team at (617)650-0042 or edresearch@bidmc.harvard.edu
 
Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN7544, an Antagonist Monoclonal Antibody to NPR1, in Patients with Sepsis-Induced Hypotension
Brief Title: R7544-SIH-2435
Brief Summary: This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on adult patients (18 to 85 years) hospitalized due to a serious infection (called "sepsis") and receiving standard-of-care medications for low blood pressure (called "vasopressors") due to sepsis. The aim of the study is to see how safe, tolerable, and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during your stay in the hospital. The study is looking at several other research questions, including: - How the study drug changes the blood pressure and the amount of intravenous (IV) fluids given to participants with low blood pressure due to sepsis - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
For info regarding 2024P000957 please contact Nathan Shapiro at 617-754-2334 or nshapiro@bidmc.harvard.edu
 
Title: Mind Body Intervention for Chronic Migraine Headaches
Brief Title: PSRT for Migraines
Brief Summary: The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.
For info regarding 2024P000778 please contact Michael Donnino, MD at mindbodystudy@bidmc.harvard.edu
 
Title: Measurement of interstitial fluid analytes using noninvasive Cambridge Medical Technologies biosensor
Brief Title: CMT biosensor
Brief Summary: In this study, we will learn how well a new device made by Cambridge Medical Technologies (CMT), called the CMT biosensor, is able to measure the amount of glucose and lactate in your body. The current way of measuring these substances is by drawing blood. The downside of blood draws is that they can cause discomfort, increased risk of infection, damage to blood vessels, and delay in measurement. The CMT biosensor uses a new way to sample fluid from your body without the pain associated with a blood draw using a gentle (painless) electrical pulse. The data we get from this study will be used to see how well the CMT biosensor works compared to standard blood draw testing and improve it, so one day, it can be used without the need to draw blood.
For info regarding 2024P000674 please contact Carlo Ottanelli at 617-650-0042 or cottanel@bidmc.harvard.edu
 
Title: Multicenter SymphonyTM IL-6 Monitoring Sepsis ICU Validation Study
Brief Title: CES-0008
Brief Summary: The primary objective of this discarded/blood draw study is to validate an IL-6 concentration cutoff and optimal time points for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.
For info regarding 2024P000354 please contact ED Research Team at 617-754-2287 or cottanel@bidmc.harvard.edu
 
Title: Family-based epidemiological study of Helicobacter pylori prevalence in the United States
Brief Title: Family-based study of Helicobacter pylori prevalence
Brief Summary: The goal of this study is to evaluate the prevalence of H. pylori infection within the household. H. pylori is a bacterial infection of the stomach that can cause stomach ulcers and increase risk of stomach cancers. H. pylori infection is spread between people in close contact. We want to test family members of patients who have had H. pylori to see if they also have H. pylori infection.
For info regarding 2023P001092 please contact Brian Li at 617-297-8819 or bli3@bidmc.harvard.edu
 
Title: Evaluation of Vaccine induced Immune Activity against SARS-CoV-2 and RSV (IVY-6-sera)
Brief Title: IVY-6 Vaccine Activity
Brief Summary: The purpose of this study is to understand immune responses in people who receive FDA-approved SARS-CoV-2 (COVID) or RSV vaccines. This will help figure out if the SARS-CoV-2 or RSV vaccines will work against the viruses. We also want to figure out if your immune response is protective against new forms of the virus. We will obtain blood from individuals vaccinated against SARS-CoV-2 or RSV who meet eligibility criteria before vaccine dose, at 3 to 6 weeks after a vaccine dose and/or 12 to 16 weeks after a vaccine dose. For SARS-CoV-2, the collection of blood from fully vaccinated individuals will help ensure that the data generated from antigenic studies is consistent and can be compared over time.
For info regarding 2023P001072 please contact ED Research Team at 6170650-0042 or cottanel@bidmc.harvard.edu
 
Title: Mind Body Intervention for Chronic Upper Extremity Pain
Brief Title: PSRT for CUEP
Brief Summary: We are recruiting for a research study to test a mind-body approach to reduce or eliminate chronic upper extremity pain and improve the quality of life for people suffering from chronic upper extremity pain and who do not respond well to pharmacological (medicine) or surgical interventions
For info regarding 2023P000579 please contact Mind Body Study Team at 617-754-2882 or mindbodystudy@bidmc.harvard.edu
 
Title: Mind Body RCT for Long COVID
Brief Title: RCT for LC
Brief Summary: We are testing if a mind-body approach will help to reduce symptoms in patients living with Long Covid and who have had an unrevealing medical workup for their persistent symptoms. The study is offered remotely via a HIPAA-compliant video platform. This is a randomized trial; patients initially randomized to the control group (no intervention) will be offered the intervention after the initial study period.
For info regarding 2023P000529 please contact Michael Donnino, MD at mindbodystudy@bidmc.harvard.edu
 
Title: Video-Assisted Frailty Measurement in the Emergency Department
Brief Title: Frailty
Brief Summary: A prospective, observational cohort study of a convenience sample of adults aged 65 or older who present to the Beth Israel Deaconess Medical Center ED. This study will help us determine whether a video recording taken in the emergency department accurately measures frailty.
For info regarding 2023P000306 please contact ED Research Team at 617-754-2287 or cottanel@bidmc.harvard.edu
 
Title: Mind Body Back Pain Study
Brief Title: treatment of Chronic Pain
Brief Summary: The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
For info regarding 2020P000147 please contact Michael Donnino, MD at 617-754-2884 or mindbodystudy@bidmc.harvard.edu
 
Title: Predicting anemia in conjunctiva using a smartphone app
Brief Title: Conjunctiva app
Brief Summary: The purpose of the study is to help us learn if a color scale mobile application (app) is able to give researchers useful information to use in a medical setting in diagnosing patients with anemia (low red blood cell levels). You may help the study doctors gather data to develop an inexpensive and faster system that could be used in other medical settings to diagnose anemia at the bedside where lab results cannot be easily obtained.
For info regarding 2020P000111 please contact ED Research Team at 617-754-2287 or cottanel@bidmc.harvard.edu