Clinical Trials

This is an observational, prospective study of patients undergoing a surgical procedure. Three parallel studies are taking place with collaborators in other countries. This study aims to bring novel insights regarding the benefits of pre-oxygenation combining standard oxygen facemask with high-flow nasal oxygen (HFNO), as opposed to standard oxygen facemask alone by assessing end-tidal oxygen (ETO2) levels after intubation.

This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the presence of the circulating regulatory as compared to activated T cell populations will be assessed.The recovery of DC populations post-transplant will be examined, along with the effect of the regimen on disease free and overall survival.

In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. The investigators anticipate that this approach will lead to more optimal use of mammography screening and breast cancer prevention interventions in women in their 40s and as a result will improve care of these women.

To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.

The aim of this study is to test whether an educational pamphlet on mammography designed for women aged 75 and older improves older women's decision-making around mammography screening. The investigators aim to show that the educational pamphlet improves older women's knowledge of the pros and cons or screening and leads to fewer women in poor health with short life expectancy being screened.

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.

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.

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.

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

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.

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 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 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.

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.

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.

Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.

The purposes of the study are:

Study Aim 1. To assess the mechanisms underlying the biological effects of short-term walnut consumption on appetite with functional magnetic resonance imaging (fMRI) and assessing neurocognitive function/memory

Study Aim 2. To investigate the effects of walnut consumption (48g per day over 5 days) on appetite and satiety by analyzing molecules which regulate energy homeostasis such as adipokines, as well as resting metabolic rate which measures energy expenditure.

Study Aim 3. To investigate the effects of walnuts (48g per day over 5 days) on insulin resistance, lipids, and inflammatory markers in obesity as well as the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.

In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric antibiotics for all patients with advanced cirrhosis admitted to the hospital without an existing indication for new antibiotic use. Specifically, the investigators will assess the incidence of infection after the time of enrollment and associated outcomes. Subjects will be randomly assigned to receive antibiotics vs placebo.

The main purpose of this study is to learn about the influence of two different behavioral interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the mechanisms involved. There is research evidence that healthy sleep promotes heart-health and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be influenced by sex. This research will compare two interventions that are each designed to improve sleep health, and will investigate sex differences in response. The project includes 3 in-hospital stays with biological measurements to evaluate the underlying mechanisms associated with the effectiveness of two different blood pressure lowering behavioral interventions.

To further understanding of the relationship between sleep and memory the investigators will address and attempt to answer three questions, (1) how memories evolve across wake and sleep, (2) how different aspects of this memory evolution are reflected both behaviorally and in the EEG signal, and (3) what stages and features of sleep affect memory evolution. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in memory consolidation. Such knowledge would be of practical importance for educational practices, whether in schools, on the job, or in the military, and would also provide valuable information to the fields of sleep medicine and psychiatry, where interactions between sleep disorders and cognitive functioning are of great importance.

The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.

The enhanced recovery after surgery (ERAS) pathway is a well-described evidence-based protocol to optimize patient post-operative recovery. Patients undergoing cesarean hysterectomies are a unique surgical population. These procedures are most commonly performed for patients with placenta accreta spectrum or severe postpartum hemorrhage. In recent studies examining the effectiveness of the ERAS pathway, post-operative cesarean patients experienced decreased average inpatient opioid exposure without an increase in pain scores, early mobilization and nutrition targets without increases in adverse outcomes after program implementation. Post-operative hysterectomy patients with gynecologic indications experienced shorter lengths of stay and decreased opioid consumption. Additionally, patients have significantly higher satisfaction scores. The investigators suspect that this population may also benefit similarly.

This research is a pre- and post- study to assess and describe surgical outcomes and parameters surrounding patients' post-operative recovery and experience before and after the ERAS pathway is implemented at a high volume placenta accreta spectrum Center of Excellence.

Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.

This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).

The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients.

The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.

Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.

The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.

The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.

This is a quality improvement health services study in the Division of Gastroenterology at Beth Israel Deaconess Medical Center (BIDMC).

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

Specific aim: To determine whether optokinetic stimulation can improve gait abnormalities.

Hypothesis: Optokinetic stimulation stimulates the vestibular system and can improve vestibular induced gait disorders.

This study aims to assess the impact of Isha Kriya, a freely available guided meditation, on mental health - specifically anxiety and depression.

The present study is a feasibility study in which we will determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome.

The purpose of this study is to optimize magnetic resonance imaging (MRI) sequences for imaging pancreatic ductal adenocarcinoma and correlate MRI biomarkers with the expression of the tumor suppressor gene SMAD4 and clinical outcomes with the goal of identifying which biomarkers are predictive of treatment response or non-response. This study will test magnetic resonance techniques on FDA approved clinical MRI machines in treatment-naïve patients with biopsy-proven PDAC.

The study is a randomized controlled trail with an observational arm and aims at collecting information on the prevalence of COVID 19 infection in seasoned yoga practitioners by comparing it with the prevalence of COVID-19 infection prevalence rates among age and gender matched control participants who do not practice yoga.

The study hypothesizes that yoga practice promotes protection and enhances recovery from the COVID-19 infection. To prove the hypothesis, the study investigators are collecting and comparing responses from seasoned yoga practitioners to age and gender matched controls participants (who do not practice yoga routinely) regarding their recovery from the COVID 19 infection. Based on validated questionnaires on perceived stress, anxiety, depression, well-being, mindfulness, joy disposition, and resilience in participants over the study duration, the investigators also collect information on participant's mental and emotional predispositions.

This protocol outlines a prospective study evaluating safety and clinical outcomes of magnetic resonance imaging (MRI) examinations performed on patients with cardiac implantable electrical devices (CIEDs) including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). This prospective study aims to improve the evidence base regarding this common clinical scenario. Specifically, the investigators aim to address whether results of MRI in PM/ICD patients affect physician decision making related to clinical management strategy and planning treatment interventions. Further, this study will evaluate whether the results of MRI in these patients affects patient outcomes related to survival and adverse events during or after MRI scanning.

The main purpose of this study is to better understand the effects of two types of treadmill exercise programs that include education and/or techniques that may be helpful for exercise among individuals with, or at risk for, metabolic syndrome.

The main purpose of this study is to find the long-term effects of daily administration of 40 IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI; DM group treated with placebo; control group treated with INI and the control group treated with placebo. The INI or placebo will be delivered into the nose. The investigators are interested to see whether INI can improve memory and cognition and blood flow in the brain in the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term period.

The proposed trial is entitled "Pilot study of Motivational Interviewing for Loved Ones (MILO)." The study population is parents and concerned significant others (PCSO) of individuals experiencing recent (past five years) onset of a psychotic disorder (hereafter referred to as individuals with psychosis, "IP") who are not currently engaged with, or at risk for disengagement from, treatment. MILO is a brief and structured intervention that teaches motivational interviewing communication strategies. The initial aim (phase 1) of this pilot study is to evaluate feasibility of the intervention. The secondary aims are to evaluate the effectiveness of MILO for (1) enhancing the engagement of IP with evidence-based treatments and (2) reducing distress among PCSO. I hypothesize that the intervention will be superior to control condition for both enhancing IP engagement with mental health services and reducing PCSO distress.

The goal of this study is to examine the effect of chronic and acute hyperglycemia in type 1 diabetes mellitus (T1DM) on brain glutamate levels using magnetic resonance spectroscopy (MRS), and associations of brain glutamate with symptoms of depression.

The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndromes (CMS).

The mortality burden of trauma in the United States is substantial, and is currently the leading cause of death in warfare and in civilians below age 45. Infection and sepsis are leading causes of morbidity and death in early survivors. Pneumonia (PNA) occurs in 17-36% of ventilated trauma patients; far more than non-trauma patients. The long held dogmatic notion of a mechanical predisposition to development of pneumonia in trauma has lacked robust support. However, there is evidence of the innate immune response to injury plays a major role in increasing susceptibility to infection.

This application is for support of a Focused Program Award addressing the role that "danger signaling" due to "danger associated molecular patterns" (or DAMPs) derived from somatic tissue injuries play in altering innate immune signaling in the lung in ways that predisposes to PNA. This innate immune response plays a pivotal role in the development and progression of lung inflammation. The organization of the Focused Program Award is into six Projects with collaborators from the Departments of Surgery, Medicine and Anesthesiology at Beth Israel Deaconess Medical Center; the Department of Surgery at Brigham and Women's Hospital and the Departments of Biology and Biological Engineering at Massachusetts Institute of Technology.

The human subjects interaction portion of this project is covered in the Human Subjects & Samples Project of the Award, although the information and tissues obtained from this Project will be shared with the other Projects, and the activities planned for those Projects are outlined in this application.