Clinical Trials

This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved lenalidomide for your type of cancer.

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, this study will determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

There are some participants with multiple myeloma or lymphoma who have had very long remissions after a bone marrow/stem cell transplantation from another person. This is believed to be the effect of the donor's immune system reaction against the recipient's multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it might be able to potentiate that reaction. This study is being done to determine if the use of lenalidomide is safe in transplant participants and if it can facilitate an immune reaction resulting in regression of the myeloma or lymphoma.

During this study you will be evaluated for side effects from the treatment with lenalidomide (including graft versus host disease) and for response of the myeloma to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of lenalidomide. If this is found to be safe then the second group will be treated at a higher dose

It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using statins. The investigators propose a pilot study to extend our research to examine PCr recovery kinetics in 20 statin users randomized in a parallel arm study to either ubiquinol or placebo over 4 weeks.

Patients who have stents placed in their coronary arteries require treatment with at least two medications to prevent platelets from sticking to the stainless steel stent and forming a blood clot that can result in a heart attack. The 2 anti-platelet medications used for most patients with stents are aspirin and clopidogrel (Plavix). These are usually prescribed for 1-12 months (the length of time depends on the number and types of stents implanted). Although the typical long-term dose of clopidogrel is 75 mg by mouth once daily, a larger dose (known as a loading dose) is usually given at the start of treatment to help the medication take effect more quickly.

Prior to January 2006, most patients at the Beth Israel Deaconess Medical Center (BIDMC) who were undergoing PCI and who had not already been taking clopidogrel would receive a loading dose of 300-600 mg of clopidogrel in the cardiac catheterization procedure room immediately after the angioplasty and stenting portion of the procedure. However, several recent studies suggest that administering clopidogrel 600 mg at least two hours prior to an angioplasty procedure can reduce the rate of complications afterwards (especially reducing the chances of detectable damage to the heart muscle).

The main purpose of this study is to see whether giving a loading dose of clopidogrel 600 mg to outpatients scheduled to undergo cardiac catheterization with coronary angiography can decrease the risk of procedure-related complications during the 14 days following the cardiac catheterization compared to a strategy of giving clopidogrel 600 mg after the procedure only to those who undergo angioplasty. We will focus our attention particularly on detecting damage to heart muscle following angioplasty (which might be expected to improve with a loading dose of clopidogrel before the procedure) and on bleeding and other groin complications (which might worsen with clopidogrel loading before the procedure).

The drug clopidogrel has been approved by the Food and Drug Administration (FDA) for use in patients with a recent or ongoing heart attack, narrowings in major blood vessels outside the heart, or recent stroke with a loading dose of 300 mg followed by 75 mg once daily. It has been used in several large studies with a loading dose of 600 mg without a significant increase in major adverse effects. However, we do not yet know if it is useful or safe when given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable symptoms and who are not thought to be in the midst of a heart attack.

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor (movement) and mood symptoms due to Parkinson's disease (PD).

Use of a computer-based treatment will reduce level of depression.

This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation.

There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

You are invited to take part in a research study about the role of leptin (a fat cell hormone that normally circulates in the blood) on maintaining a reduced body weight. This study will also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used at rest), autonomic nervous function (the part of your brain that controls your heart rate and breathing), changes in body composition and your sense of appetite. Under normal conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and regulate energy usage and hormone levels. When obese individuals lose weight, their leptin levels go down, which may cause them to later regain the weight. This study will provide leptin as an investigational medication (not yet approved by the Food and Drug Administration) to increase the levels of the leptin hormone that normally circulates in your blood back to a normal range. We will see if this can help you to maintain your reduced body weight and improve your hormonal and metabolic function.

The purpose of the study is to develop an emergency electroencephalogram (EEG) device, StatNet, that can be placed quickly by minimally-trained personnel and interpreted remotely for rapid identification of seizures.

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.

The purpose of this study is to demonstrate that the use of a continuous ambulatory monitoring device will reduce both the time to effective rate control and the health care expenditures associated with standard methods of rate control monitoring in patients presenting with atrial fibrillation with a rapid heart rate.

The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.

This study will evaluate various performance metrics of emergency department operations after the implementation of computerized physician order entry in an academic emergency department.

The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.

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

The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo.

The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.

The purpose of this study is to compare two different types of three-dimensional electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems will be compared in regards to its ability to successfully map and ablate a clinical arrhythmia, as well as the time invested in this activity.

The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.

This study will look how using taken from your tumors and mixed with special immune stimulating cells from another person's blood in given back to you in a series "fusion cell" injections, will effect your body. The primary goal of the study is to see if giving the experimental fusion cell injections is safe. We will also be looking to see what effect the experimental treatment as on your immune system and whether it has an effect on your cancer.

The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).

The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group.

This study aims to determine if the vacccine can be used safely in patients with advanced melanoma (cancer of the pigment cells) and whether the cells in this vaccine are capabale of producing immune responses against your own cancer.

To test the strength and physical performance outcomes of a 12-week progressive resistance training (PRT) exercise program in a small cohort of patients with Class III obesity who are preparing for bariatric weight loss surgery at Beth Israel Deaconess. The study will also test patient compliance to the 12 week PRT program. Whereas PRT exercise is currently recommended as a part of preoperative clinical care for bariatric surgery patients, little research has been done to measure the acceptance and effectiveness of a standardized PRT exercise protocol for improving health and perioperative care. Preliminary data from this study could be used to justify larger studies and further investigation.

This is a study to assess whether healing suggestions and enhancing visual milieu (large fine art photographs) will improve mental and physical measures of well-being and recovery from surgery. The study will compare breast cancer patients undergoing identical skin sparing mastectomy and reconstruction surgery randomized to three groups:

Usual care control group

Usual care and exposure to fine art photograph

Usual care and fine art photograph and guided visualization tapes.

This study will assess the behavioral effects of an amino acid mixture thought to influence serotonin function in individuals who have recovered from anorexia nervosa.

The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by your fat cells). Our hope is that they will improve sugar and fat metabolism and positively affect the body fat changes you have noticed while taking HAART.

The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone fracture.

This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small pieces of tissue) and brushings (to collect the cells that form the lining of the airway) from the airways of patients with these diseases and analyze these samples in a laboratory to try and determine the mechanism of disease. We will compare the results with that of patients with normal airways.

The purpose of this study is to determine whether a painless and noninvasive procedure called Transcranial Direct Current Stimulation (tDCS) can be an effective therapy for the treatment of migraine and migraine-associated pain.

Stimulation of the motor cortex with tDCS has already been shown to relieve pain in patients with other chronic pain syndromes, including traumatic spinal cord injury and fibromyalgia. Patients with migraine are usually extremely sensitive to pain. A treatment that targets the areas of the brain that are related to the experience of pain may also help decrease pain in patients with migraine. Pain control with this localized approach may help avoid the problems due to pain medications that affect all organs in the body.

We hypothesize that 10 sessions of Transcranial Direct Current Stimulation (tDCS) applied over the area of the brain that controls pain and motor function will decrease pain and headache frequency in patients with migraine.

The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.

This is a phase II study that aims to investigate prospectively a new therapy for a cohort of patients with chronic pain attributed to pancreatic cancer. The justification of this study is that the pain is the most important factor for the quality of life of these patients and rTMS has been shown to be significantly associated with pain improvement in patients with abdominal pain due to chronic pancreatitis. This therapeutic trial will be a 10-day, randomized, parallel-group design, double-blind, incomplete cross-over, placebo controlled clinical trial conducted at Beth Israel Deaconess Medical Center. The principal aim of this investigation is the study of pain after a therapeutic intervention. The primary outcome is pain reduction indexed by pain reduction and or analgesic intake reduction. The second aim of the study is to assess the safety this new treatment in patients with pancreatic cancer. The third aim of this study is to investigate whether rTMS treatment is associated with a change in the activity of right secondary somatosensory cortex using magnetic resonance spectroscopy. Because patients with locally advanced or advanced pancreatic cancer often require increasing doses of narcotic pain medications, such as morphine, oxycodone and fentanyl, in order to control their pain, adverse side effects are frequent observed in this population of patients. Therefore rTMS treatment might represent a new therapeutic approach that might be useful not only for pancreatic cancer but also to other types of cancer.

We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.

This study will compare group singing to group speech therapy without singing. You may be eligible for this study if you have been diagnosed with PD for one year or more and you have a quiet voice or difficulty being understood.

The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.

The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads).

Primary hypothesis:

Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP.

Secondary hypotheses:

Hypertonic saline therapy will result with fewer complications than mannitol

ICP reduction duration will be longer using hypertonic saline when compared with mannitol

Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and other ventilatory parameters during maximal exercise in the resting normoxic Chronic Obstructive Pulmonary Disease population is poorly defined. The investigators performed a randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise tests on room air and supplemental oxygen. The investigators compared maximal oxygen consumption and other ventilatory parameters in each individual subject under the two conditions.

Study hypothesis is that we can reproduce results of islet transplantation in type one diabetics in patients with a kidney transplant.

The main purpose of this study is to learn about the effects of sleep disruption (two days in a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain processing (your own experiences/perceptions of pain). In this research project, we are trying to figure out if we can change the effects of sleep disruption on inflammation, mood, and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2 weeks can change how we respond to sleep disruption. For example, does the sensitivity to pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold water) change with sleep disruption, and can low-dose aspirin influence this change. We are also interested in seeing how inflammation changes in relation to your own perceived experience of pain.

The main purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with hepatitis C virus and cirrhosis awaiting liver transplantation.

The primary purpose of this study is to examine how much change in depressive symptoms will be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a control group at pre-, mid-point, and post-test assessments.

Some antiseizure medication levels are affected by hormones. This study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

This study is investigating the most effective way to sterilize duodenoscopes ("scopes") used at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of high level disinfection to sterilize scopes. Because infections have been passed by scopes at other institutions in the U.S., the investigators are exploring whether or not adding two different sterilization processes will reduce this risk of contamination.

Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is contaminated, bacteria may be passed from the scope to the patient. In order to understand how bacteria are passed, the investigators will be taking samples of the patient's intestinal bacteria to compare to the bacteria, if any, found on the scope.

Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

The investigators conducted a controlled trial to assess the effectiveness of electronic medical record (EMR) reminders, with or without a panel manager, on completion of health care proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients age 65 or older. The investigators hypothesized that EMR reminders would improve adherence to practice guidelines and that benefits would be enhanced with the support of a panel manager.

This is a pilot study evaluating the feasibility of a new family-based intervention for schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the devastating effects of neurocognitive deficits on everyday functioning (Family-Directed Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to devastating functional impairments and caregiver burden, as clients rely on caregivers for help with basic living needs, such as personal hygiene, time management, social skills, and progress towards vocational and educational goals.

Specifically, we will 1) Develop a manualized, family treatment program designed to improve adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility study to evaluate the acceptability and feasibility of this intervention, and to collect preliminary outcome data. This will lay the foundation for a controlled trial of the efficacy of the intervention. We expect that:

The FCA intervention will be well-received and well-tolerated by clients and families, as demonstrated by a high level of interest in the program, a low rate of attrition, and a high rate of participant satisfaction.

Client participants in the FCA intervention will show improvements in adaptive, independent-living skills (e.g., personal hygiene and self-care, medication management, time management, social skills, and responsibility for health maintenance) that will be maintained three and six months following completion of the intervention.

Family members participating in the FCA program will show reduced burden of care and time spent caregiving, greater satisfaction in their relationship with the client, improved self-efficacy in the caregiver role, and reduced psychological distress (e.g., depression, anxiety, and hopelessness) at the completion of the program and at three and six-month follow-up interviews.

This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid injectable emulsions are an essential nutrient for neonatal growth and development. Traditionally, lipid injectable emulsions have been commercially available in sterile glass bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions stored in glass bottles versus those in plastic, significant differences were noted in the population of large-diameter fat globules by globule size analysis, reflective of a less stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has proposed to limit this large diameter fat globule population to a volume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid concentration. (At the present time, the USP monograph is not officially recognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate 55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal number of products packaged in plastic. We hypothesize this difference may explain the recent clinical observations. We will compare the incidence of hypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic. The study will attempt to discern whether the differences in packaging influence the stability and subsequent tolerance of lipid injectable emulsions.

This study is being conducted this study to determine whether injections of Xeomin®, a type of botulinum toxin into the glands that produce saliva (one pair just below and in front of the ear and the other just under the jaw line) are safe and effective to treat excessive saliva, or drooling in patients with Parkinson's Disease (PD)/parkinsonism.

The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:

cardiovascular and flexibility exercise

strength training, cardiovascular and flexibility exercise

Arthritis Foundation's Fibromyalgia Self-Help course

a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions

Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.