This page includes clinical trials where organization or lead sponsor is BIDMC or Lahey Clinic as reported at clinicaltrials.gov.

Clinical Trials

Clinical Trials

Description

This research study aims to explore whether a set of simple breathing techniques and guided meditations can improve the psychological well-being and recovery of ICU survivors and their caregivers.

ICU survivors and their caregivers often experience high levels of stress, anxiety, and depression after discharge. This study investigates whether practicing Isha Kriya, a guided meditation, and Nadi Shuddhi, a breathing technique, can support their mental health and relationship quality. These practices are delivered through a mobile app or in a group setting.

Participants enroll as a caregiver-patient dyad and will engage in these techniques throughout the study. In addition to the practices, brain activity will be recorded using a safe, non-invasive EEG device. The EEG, a lightweight cap with small sensors, measures brainwaves to assess potential changes in brain function and connection. EEG recordings will take place in the hospital during two sessions, each lasting approximately 40 minutes.

Participants will also complete short surveys at five time points throughout the study, assessing mood, stress, and relationship quality. Baseline demographic information will be collected, and at the conclusion of the study, a brief interview will be conducted to gather feedback on the experience.

The study spans approximately seven weeks, with the overall goal of determining whether these breathing and meditation practices can provide accessible and scalable mental health support for ICU survivors and their caregivers.

Description

A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.

Description

This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.

Description

The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.

Description

This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.

Description

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

Description

The overall goal of this study is to open up the promising treatment of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective against seizures in patients with surface neocortical foci, to a much larger population of patients with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are not currently considered good rTMS candidates.

The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients with deep seizure foci by targeting its usage to accessible cortical partner regions. In this study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic stimulation protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).

Description

The goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.

Description

The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.

Description

The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.

Description

This is a single-center, cross-sectional study that will recruit approximately fifty (50) meditators and fifty controls. Individuals that have learned at least the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and a sleepimage ring. Participants will be asked to wear the two devices while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights (Friday and Saturday nights). While meditating during the day, participants will only wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the NIH toolbox during one virtual visit via video call. Meditators who join the study will be asked to invite a control subject to the study, matched for age and comorbidities.

Description

The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections.

The specific aims of the study include:

Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention.

Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.

Description

The purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general population, and would benefit from imaging in order to detect cancer early.

Description

The goal of this prospective observational cohort study is to validate previously developed Hepatocellular Carcinoma (HCC) risk prediction algorithms, the Liver Risk Computation (LIRIC) models, which are based on electronic health records.

The main questions it aims to answer are:

Will our retrospectively developed general population LIRIC models, developed on routine EHR data, perform similarly when prospectively validated, and reliably and accurately predict HCC in real-time?

What is the average time from model deployment and risk prediction, to the date of HCC development and what is the stage of HCC at diagnosis?

The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

Description

The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, steerability, and focality. In the proposed early phase human experiment, the ability to apply TI stimulation will be assessed along spatial dimensions to selectively modulate neural activity and assess the feasibility of selective targeting deep brain structures without exciting overlaying cortex. The overall goal of the study is to advance TI methodology and its translation to humans.

The specific aims in this study are to

Assess the safety of TI stimulation.

Assess the feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex)

It is hypothesized that TI stimulation can be used to impact different regions of the visual field that are represented within the calcarine fissure of the human brain.

It is hypothesized that TI will be well tolerated by human subjects and side effects will be consistent with other forms of transcranial electric current stimulation (tES).

Description

Mania is a core symptom of bipolar disorder involving periods of euphoria. Decreased inhibitory control, increased risk-taking behaviors, and aberrant reward processing are some of the more recognized symptoms of bipolar disorder and are included in the diagnostic criteria for mania. Current drug therapies for mania are frequently intolerable, ineffective, and carry significant risk for side effects. Presently there are no neurobiologically informed therapies that treat or prevent mania. However, using a newly validated technique termed lesion network mapping, researchers demonstrated that focal brain lesions having a causal role in the development of mania in people without a psychiatric history can occur in different brain locations, such as the right orbitofrontal cortex (OFC), right dorsolateral prefrontal cortex (DLPFC), and right inferior temporal gyrus (ITG). This lesion network evidence converges with existing cross-sectional and longitudinal observations in bipolar mania that have identified specific disruptions in network communication between the amygdala and ventro-lateral prefrontal cortex. The OFC is associated with inhibitory control, risk-taking behavior, and reward learning which are major components of bipolar mania. Thus, the association between OFC with mania symptoms, inhibitory control, risk-taking behavior, and reward processing suggests that this region could be targeted using non-invasive brain stimulation.

Description

The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.

Description

There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth.

The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.

Description

This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.

Description

It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening. THWART-TB is a prospective longitudinal cohort study of health workers (HWs) in Cape Town, South Africa, where our preliminary data reveals HWs have a high annual TB infection risk (34%). This cohort, who will undergo frequent serial evaluation (every 3 months) with a combination of novel assays never previously evaluated together, presents a unique opportunity to evaluate immune responses at the time of initial infection and to characterize the dynamic profile of these immune responses over time in a high-risk population. The knowledge generated will improve our understanding of TB infection and help to identify which people exposed to TB may remain at risk, enabling us to better target preventive strategies.

Description

The aim of this study is to assess the feasibility and acceptability (e.g., enrollment, adherence, retention, acceptability of procedures and interventions) of a pilot factorial study design that will help elucidate components of mind-body exercise interventions. The study involves completing a walking program, a mindful attention program, a walking program that includes mindful attention, or no program at all. A "pilot" study is a smaller study that helps researchers to understand whether the study design can be carried out and what participants think about the study.

Description

To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid levels, inflammation and menopausal symptoms in postmenopausal women.

Description

The purpose of this study is to determine the feasibility of a conversational artificial intelligence (AI) system to have a meaningful clinical conversation with a patient prior to an urgent care visit with their primary care physician. In this study, patients who are seeking an urgent care visit (that is, any type of medical visit with their primary care provider for a new complaint) will first have a conversation with an AI system. This interaction with the AI system will happen less than a week before their visit with their physician, and will be supervised by an independent physician who will interrupt in case there are any concerns about patient safety. After the interaction, a summary of the conversation will be sent to the patient's PCP, who will review prior to the in-person visit.

The researchers will investigate:

Patient views on the AI system

PCP views on the AI system

Overall safety, as measured by the physician safety supervisor

Quality of clinical conversations, measured by standardized rubrics

Quality of diagnostic and management plans generated by the AI; these will not be shared with the patient or physician, but will be generated after the fact and compared with the actual diagnosis and management plan.

Description

The goal of this research study is to asses the safety and efficacy of the combination of AGEN1423 and Botensilimab with or without chemotherapies, gemcitabine and nab-paclitaxel, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has progressed after at least one previous line of cancer therapy.

The names of the study drugs involved in this study are:

AGEN1423

Botensilimab

Participants will receive study treatment for about 2 years and will be followed for 1 year after.

Description

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting.

The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources.

This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care.

Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.

Description

The study is a randomized, proof of concept study. 30 patients aged 18 and over with HS will be included in this single center, randomized, double-blind, parallel-group study. Dosage of deucravacitinib will be given according to the investigational regimen as follows: 6 mg po bid for 16 weeks. The study compromises a 4-week screening period, a 16-week study period, and a 4-week follow-up period. The follow-up period consists of a follow-up phone call 4 weeks after the last study drug dose.

Description

In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.

Description

The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question[s] it aims to answer are:

Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people?

Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding?

Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.

Description

The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).

The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.

Description

This study, "Psychobiological Follow-up Study of Transition from Prodrome to Early Psychosis", will be conducted in collaboration with the Shanghai Mental Health Center (SMHC) and several data processing sites in the United States. The current study builds on findings from the investigator's previous work that identified several biomarkers in participants at clinical high risk (CHR) for psychosis that may be related to clinical outcomes such as the development of psychosis. This study responds to the critical need to understand links between biomarkers (could be clinical, cognitive, biological or other abnormalities) and later clinical outcomes.

Participants will receive either one of two real interventions or one of two sham (a procedure that looks like the real treatment but is not) interventions, involving either: 1. repetitive transcranial magnetic stimulation (rTMS)1; or 2. mindfulness-based real time fMRI neurofeedback (mb-rt-fMRI-NFB). Both procedures will measure brain capacity for change in CHR individuals, thus paving the way forward for future therapeutic interventions.

The main hypotheses to be addressed by this study are:

- Following real interventions, novel biomarkers will be more effective predictors of clinical outcome than standard biomarkers in participants at CHR for psychosis

- Following real interventions, novel biomarkers will be more effective predictors of clinical outcomes in participants who received the real intervention than in participants who received sham treatments

- The novel interventions will reduce biomarker abnormalities in individuals with CHR relative to their own baselines and relative to healthy controls (HC)

- The sham interventions will will not reduce biomarker abnormalities in individuals with CHR relative to their own baselines or relative to HC

Description

This study is to evaluate whether thiamine can increase oxygen consumption and lower lactate in patients who initially survive an in-hospital cardiac arrest. Patients who are successfully resuscitated after an in-hospital cardiac arrest and who are on mechanical ventilation in the intensive care unit will be enrolled, and will get either thiamine or placebo. Their oxygen consumption and lactate will be measured at serial time points and compared between groups. The investigators' hypothesis is that thiamine will help restore the body's ability to metabolize oxygen normally (aerobic metabolism), leading to an increase in oxygen consumption and a decrease in lactate.

Description

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers.

The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.

Description

The purpose of this protocol is to perform a pilot prospective randomized controlled clinical trial to evaluate the potential role of lung fissure completion strategy (experimental intervention) in addition to endobronchial valve (EBV) placement (representing "standard-of-care") in select patients with severe COPD/emphysema and with evidence for <95% fissure completion between adjacent lung lobes. In select patients, lung fissure completion strategy will be performed by either video-assisted thorascopic surgery (VATS)-guided or robotic-guided stapling along the lung fissures in an attempt to reduce collateral ventilation and determine whether or not this experimental strategy will improve outcome following subsequent EBV placement. EBV placement will follow successful VATS-guided or robotic-guided fissure stapling.

The study will enroll approximately 20 patients at BIDMC, and outcomes will focus on procedure-related complications, physiological measurements (ex., FEV1 by pulmonary function testing) and clinical symptoms (i.e., questionnaires). Patient will be followed for 3-month period, receiving usual standard of care during the 3 months of follow-up. The goal of this protocol is to determine if elimination of significant collateral lung ventilation between lung lobes is possible, and whether such strategy to eliminate collateral lung ventilation between lobes improves outcomes following subsequent EBV placement (i.e. promotes atelectasis of diseased lung segments) in the management of severe COPD/emphysema in appropriate candidates. For subjects in the medical management control group, upon completion of the 3-month F/U period, they will be eligible for EBV if they choose.

Description

This research is being done to determine how effective dostarlimab in combination with cobolimab is in metastatic or recurrent cervical cancer.

Description

The purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.

Description

Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.

Description

The goal of this clinicial trial is to test the acceptability and feasibility of linear cognitive aid intervention to support EMS teams in responding to pediatric emergencies. We are testing the hypothesis that cognitive aids with linear logic will be feasible to use and acceptable to EMS teams in urban and rural areas.

Researchers will compare technical performance, teamwork, and self-assessed cognitive load of participants to see the difference between performing resuscitations using their current standard with existing cognitive aids and using our linear cognitive aid.

Participants' teams will:

perform in situ high-fidelity simulation of two critical children's resuscitation scenarios

be randomized to 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our linear cognitive aid.

Description

The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).

To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain

To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.

To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.

Description

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Description

Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized.

The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.

Description

Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation.

This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.

Description

Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.

Description

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.

Description

Pain is among the most frequently reported symptoms in Long COVID, along with sleep disturbances, fatigue, and cognitive impairments. Sleep plays a critical role in maintaining a pain-free state. The goal of this study is to characterize the type and severity of pain in Long COVID, to characterize sleep and sleep disturbances in Long COVID, and to understand the role of sleep in the development and persistence of pain symptoms in Long COVID.

Description

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

Description

The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects.

Description

The purpose of this protocol is to investigate the effect of treatment with the study drug Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food intake.

Description

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.

The name of the study drug involved in this study is:

-Apixiban (a type of anticoagulant)

Description

Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.

The goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:

For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?

What are the facilitators and barriers to using high flow oxygen in these settings?

Does high flow or standard flow oxygen use more oxygen?

Participants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.

The study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.

Description

Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy.

This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.