Clinical Trials

The purpose of this research is to determine whether BOTOX injections will reduce seizure frequency and severity. We chose to test its effects on epilepsy because epilepsy and migraine have common features so, are often treated with common drugs.

The purpose of this small-scale pilot study (10 patients) is to test the study protocol for an RCT comparing IVF outcomes between day 3 and day 5 embryo transfer in patients with five or fewer embryos in a fresh embryo transfer in vitro fertilization (IVF) cycle. Information derived from this RCT would allow us to maximize the chances of success for these patients undergoing IVF.

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.

The purpose of this study is to understand better the mechanisms of action of calcitonin gene related peptide (CGRP) targeted monoclonal antibodies in migraine prevention. Specifically, the protocol will allow the investigators to determine whether the main site of action of this novel and recently-approved class of migraine prophylactic drugs act inside or outside the brain and if so, where.

Acute pancreatitis (AP) represents a critical health concern nationwide, with estimated 274,000 admissions annually and at a cost of 2.6 billion dollars. Current treatment strategies for AP are limited to supportive care with fluid resuscitation, analgesia, nutrition and prevention of end organ damage. Abdominal pain is often the predominant symptom in patients with AP and is treated with analgesics. As there is currently no disease-specific medical treatment to change the natural history of pancreatitis, pain control remains central to the treatment of AP. Among the analgesics, opioids have been shown to be provide safe and effective pain control in patients with AP. Current literature shows that there is no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options. Among hospitalized AP patients, adequate pain control often requires the use of intravenous (IV) opiates in the first 24-48 hours, which can later be transitioned to oral (PO) opioids. While there are various methods of delivering opioid medications such as IV, PO, and transdermal to name a few, IV opioids are commonly administered, either on a scheduled and/or on an as needed (PRN) basis as directed by the attending physician. In contrast to the conventional, method of physician directed IV opioid delivery, patient-controlled analgesia (PCA) is a form of IV opioid medication delivery in which the patient can rapidly titrate the opioid dose to manage variable levels of pain. This modality of opioid administration is often preferred by patients and has been widely used in postsurgical and obstetric patients to effectively treat their pain. PCA allows for faster intervention on pain limiting time to treatment and peak pain levels and has also been shown to decrease total opioid dose. However, there is limited evidence in published literature assessing the feasibility of using PCA to treat the pain of AP or comparing its efficacy and safety profile compared to the more traditional physician directed analgesia. One retrospective study has shown that use of PCA was surprisingly associated with longer hospital stays and higher rates of outpatient opioid use when compared to routine physician-directed analgesia (PDA), however there are no prospective trials to study this comparison. Hence, in this study, the investigators will compare the effects of using PCA among patients with AP to that of conventional PDA.

The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

This is a laboratory study where the investigators hope to look at chromosomal events implicated in bladder cancer.

This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.

The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease

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.

The objective of this study is to develop a rationale for the selective treatment of small fiber neuropathy with immune globulin (IVIG) in the appropriate patients.

The investigators hypothesize that individuals with auto-antibodies targeting neuronal antigens (TS-HDS and FGFR3) and confirmed evidence of small fiber neuropathy (by skin biopsy analysis of intra-epidermal nerve fiber density) will have an improvement in both nerve fiber density and pain after treatment with immune globulin.

The co-primary endpoints will be a change in neuropathic pain (by VAS pain score) and a change in intra-epidermal nerve fiber density (by punch skin biopsy).

The data gained from this pilot study will establish a rationale, with an appropriate screening test, for the use of immune globulin for the treatment of small fiber neuropathy.

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.

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

There is an increased risk of diastolic heart failure in post menopausal women. Estrogen plays a positive role in regulating molecular pathways in heart remodeling. Such pathways may work through purinergic signaling and its downstream effects on the heart's mitochondrial metabolism and angiogenic response to stress. Loss of estrogen functionality in post menopausal women may account for the increased risk of diastolic heart failure. The investigators will explore said pathways using cardiac tissue obtained from patients undergoing cardiac surgery.

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA). .

The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.

Patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. Few studies to date have looked at the relationship between blood glucose (sugar) and migraine. We are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.

The purpose of the study is to determine the cost-effectiveness of different surgical strategies to treat cervical spondylotic myelopathy. The study will use data generated from the CSM-S Trial (NCT02076113).

To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.

To determine the relative cost-effectiveness between anterior cervical discectomy and fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.

This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.

The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

This double-blinded, placebo-control trial clinical trial aims to investigate the effect of IV oxytocin infusion on peri-operative opioid consumption following a minimally invasive hysterectomy under general anesthesia. The patient population will be women scheduled for an elective, minimally invasive hysterectomy at Beth Israel Deaconess Medical Center.

The investigators hypothesize that, compared to a placebo, exposure to intravenous (IV) oxytocin will reduce the amount of opioid consumption for women after a minimally invasive hysterectomy procedure.

The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue.

This study will have several aims.

One aim is to examine the effect of 72 hours of fasting on fibroblast growth factor-21 (FGF-21) levels. Participants will spend 3 days and nights in the Clinical Research Center at the Beth Israel Deaconess Medical Center in Boston, MA. Daily blood samples will be taken. Two fat samples will be taken prior to and at the end of the fast. A subset of participants will also have two MRIs, one prior to and one at the end of the fast. We will study healthy adults and obese adults with liver-biopsy-diagnosed non-alcoholic fatty liver disease (NAFLD). THIS STUDY ARM IS CURRENTLY NOT RECRUITING

Another aim is to examine the effect of low-calorie diet on FGF-21 levels. Subjects will follow a hypocaloric diet that will be designed to achieve 3-5% weight loss. We will enroll participants with liver-biopsy-diagnosed non-alcoholic fatty liver disease. Participants will report weekly to the Clinical Research Center at Beth Israel Deaconess Medical Center for weight measurements. Blood will be drawn before and after the weight loss. Participants will also have an MRI before and after the weight loss.

THIS ARM IS CURRENTLY NOT RECRUITING

Another aim of the study is to examine the effect of acute ingestion of glucose, fructose, and other sugars on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

THIS ARM IS CURRENTLY RECRUITING

This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.

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.

The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.

This is a prospective cohort study of older patients receiving implantable cardioverter-defibrillators. The purpose of the TRACER-ICD study is to conduct a prospective cohort investigation with the goal of 500 patients age >65 receiving new primary prevention implantable cardioverter-defibrillators (ICDs). Patients will be followed quarterly for 18 months with interviews, electronic record review, and remote monitoring to characterize clinical and functional trajectories following device implantation, with permission for extended electronic follow-up for up to 10 years (Aim 1). This cohort will support validation and refinement of an established model for predicting personalized outcome profiles for ICD therapies and death (Aim 2). Lastly, we will combine electronic record review with semi-structured interviews with patients and physicians to evaluate physician and patient experiences with a prototype individualized shared decision-making (SDM) tool (Aim 3).

Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are; to find out what features of individual men's cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.

The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are:

Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time?

What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer 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.

This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.

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.

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.

This research study is evaluating the use of Cardiac Magnetic Resonance Imaging (CMR) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.

This research study is examining whether Neratinib has any activity in participants with prostate cancer that has spread and is no longer responding to hormonal treatment.

The names of the study drug involved in this study is neratinib.

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.

The purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision-making about KPD among potential live kidney donor and kidney transplant patients.

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.

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.

This research study is studying a cancer vaccine called Dendritic Cell/MM Fusion vaccine (DC/MM vaccine) in combination with nivolumab, as a possible treatment for multiple myeloma (MM).

The drugs involved in this study are:

Dendritic Cell/MM Fusion vaccine (DC/MM vaccine)

Nivolumab, an immunotherapy drug

The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.

Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising area of investigation is the development of immunotherapeutic approaches that stimulate the immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone following standard of care chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will prevent or delay the disease from coming back.

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).

The interventions involved in this study are:

-Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)

The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.

This research study is studying a combination of two drug interventions called rosuvastatin and enoxaparin as a possible preventative measure against developing venous blood clots (such deep vein thrombosis or pulmonary embolism). .

The drugs involved in this study are:

Rosuvastatin, also known as Crestor

Enoxaparin

This research study is evaluating the effectiveness of Zafirlukast to prevent tumor activity in participants with tumor marker-only relapsed ovarian cancer.

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

Zafirlukast

The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation (RFA) for the treatment of hepatocellular cancer (HCC). Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. During RFA a needle is inserted into the tumor tissue and heat is used to kill the tumor cells. Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot be treated with surgery. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA.

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

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.

The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease.

This study is funded by the National Institutes of Health.

A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if giving low-dose (25-50%) nitrous oxide at the time of UDS affects the measurements taken during the procedure, such as how much volume your bladder can hold, and pressures during urination. If the measurements are the same with and without self-administered nitrous oxide (SANO), it could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and pain during UDS.