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Abdominal Aortic Aneurysm


Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Amblyopia


Structural Changes on Ocular Coherence Tomography Angiography (OCTA) in Amblyopic Eyes

Amblyopia is a disorder of the visual developmental system in which visual acuity is decreased in the absence of clinically visible anatomic pathology. It can be caused by visual deprivation (i.e. ptosis, cataract), strabismus, and/or anisometropic refractive error and is one of the most prevalent and treatable eye diseases in children. Children who have a delay in treatment may have lifelong visual impairments. Though previous understanding of amblyopia precluded any structural ocular anomaly and was largely attributed to abnormalities of the visual cortex, recent studies have suggested otherwise. Sub-clinical changes noted in amblyopic eyes by optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) imaging that have been reported in the literature include optic nerve hypoplasia1, increased choroidal thickness2, decreased retinal outer segment layer thickness3, attenuation of the ellipsoid zone4, increased foveal thickness5, and decreased retinal capillary density6. With appropriate treatment of amblyopia, some studies have reported a measurable structural change in retinal anatomy, such as an increase in outer segment length, based on OCT imaging3.

The ability to objectively quantify structural ocular changes correlating with improvement in visual acuity in amblyopia treatment would shed light on underlying etiologies of amblyopia. Furthermore, examining the absence of structural changes or improvements on OCTA despite appropriate amblyopia treatment could potentially answer the question of why certain amblyopic children are refractory to standard-of-care treatment regimens despite good compliance.

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Amyloidosis


A Multicenter Randomized Double-blind Phase 2b Study of NEOD001 in Previously Treated Subjects with Systemic Light-chain (AL) Amyloidosis and Persistent Renal Involvement

The purpose of this study is to evaluate whether NEOD001 is safe and effective specifically in subjects with light chain (AL) amyloidosis affecting the kidneys. This study will also evaluate whether NEOD001 improves the function of subjects’ organs that have been affected by amyloid deposits.

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A Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis

The study is being conducted to determine the safety, tolerability and maximum tolerated dose of Venetoclax and dexamethasone in relapsed or refractory amyloid light chain (AL) amyloidosis patients. AL amyloidosis is a disease involving cells called plasma cells that make antibodies as part of your immune system. These cells are not functioning the way they are supposed to and they start to produce abnormal fragments of antibodies that are toxic to your body and can form amyloid. The antibody fragments are called "light chains." They can cause damage to organs, especially the kidneys, heart, skin, liver, and lungs.

Researchers are looking for ways to stop the light chains from being formed to treat the disease. Under some circumstances, patients will receive chemotherapy drugs in order to manage the disease. However, researchers do not know what the best treatment is for relapsed AL amyloidosis, so the researchers are testing new drugs or new combinations of drugs to see what will work best with the least side effects.

The researchers want to find out if Venetoclax (ABT-199) in addition to dexamethasone will reduce or eliminate AL amyloidosis plasma cells.

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Characterization of T Cell Distribution in Stem Cell Mobilization

The purpose of this study is to collect blood samples from Tufts Medical Center multiple myeloma or AL amyloidosis patients being prepared for autologous stem cell transplant in order to analyze variations in T-cell populations through the stem cell mobilization process

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Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients with AL Amyloidosis

This study will assess AL amyloidosis patients who achieve good responses to treatment for minimal residual disease (MRD). MRD is the small amount of disease that may still be present below the clinically detectable level even after good response to treatment. This study will see if there is a correlation between presence or absence of MRD and disease relapse.We will use three laboratory techniques on donated blood and bone marrow samples to determine if MRD is present for each patient. This protocol will help provide insight into ways that the disease changes and progresses. Minimal Residual Disease testing is likely an important next step in AL management

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Anxiety


An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

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Aortic Aneurysm


A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and Penetrating Atherosclerotic Ulcers (PAUs) within the descending thoracic area.

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Asthma


Effectiveness of the Aeroneb compared to a jet nubulizer for the delivery of bronchodilator therapy of acute severe asthma

Background: The bronchodilator therapy is an essential component of the management of asthma exacertbation. The delivery of the bronchodilator to the lungs in asthma exacerbations is usually achieved through nebulizing the bronchodilator medications. The commonly used nebulizer device is a small volume jet nebulizer which has not been persistently reliable in delivering the bronchodilator therapy. Aeroneb nebulize device is a FDA approved device which produced consistently respirable sized particles which could potentially result in better bronchodilator effect.

Aim: To study whether Aeroneb nebulizer is more effective than small volume jet nebulizer in delivering bronchodilators in severe asthma exacerbation.

Experiment Design: Patients will be randomized (lie a flip of a coin) to receive the bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer.

Subjects: Adults patients between the age of 18 and 66 years who present to the emergency room with severe asthma exacerbation with peak respiratory flow rate <50% of predicted.

Study Procedure: When enrolled int he study and after randomization, we will then collect data that is standard for the hospital like heart rate, blood pressure and breathing indices and also some non-routine things like some scoring scales for shortness of breath and serial measurements of the peak expiratory flow rate.

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Atherosclerotic Ulcers


A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and Penetrating Atherosclerotic Ulcers (PAUs) within the descending thoracic area.

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Babesiosis


Host Genetic Determinants and Pathogenesis of Severe Babesiosis

Babesiosis is an emerging infectious disease in the United States, The disease is caused by a parasite that invades and eventually ruptures red blood cells. The parasite is transmitted by the deer tick but also can be acquired during blood transfusion. Symptoms include fever, fatigue, chills and sweats. In some individuals, the disease is so severe that hospitalization is required. In others, the infection is mild or event silent. The study is designed to identify factors that determine whether a given individual is prone to experience severe or mild babesiosis or no disease at all.

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Blood Stream Infection


Neonatal Salivary Transcriptomics

The ability to monitor the health status of premature neonates for research purposes has long been limited by these infants' fragile medical conditions and small blood volumes. Advancements in salivary technology suggests that transcriptomic and proteomic salivary analysis is an innovative, highly informative, and noninvasive means to monitor this patient population, and correlate medical and neurodevelopmental outcomes with specific gene expression profiles. The purpose of this study is to use normally obtained and routinely discarded neonatal salivary samples to noninvasively generate transcriptomic and proteomic profiles of premature neonates. Saliva will be collected serially from infants born greater to or equal to 24 weeks' gestation who are admitted to the Tufts Medical Center NICU or MIU. Our research is focused on two areas of neonatal physiology and pathology . The first area of interest involves monitoring infants during the learning process of oral feeding. Our second area of interest involves feeding intolerance and gastrointestinal disease (i.e. necrotizing enterocolitis) and infection. Healthy term neonates will serve as comparative controls. Both short and long term medical and neurological (up to 24 months corrected age) outcomes, will be correlated with the distinct gene expression profiles in order to better understand neonatal physiology, pathology and overall health status.

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Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

The purpose of this study is to test the safety of DSTA4637S, an investigational drug, at different dose levels and to find out what effects, good or bad, DSTA4637S, has on you while treating the S. aureus infection in your blood. DSTA4637S will be given in addition to the antibiotics you are already receiving for your S. aureus infection.

DSTA4637S is an investigational antibiotic to treat serious infections caused by the bacteria S. aureus. DSTA4637S is an experimental drug, which means that the Food and Drug Administration (FDA) or other health authorities that regulate new drugs have not approved DSTA4637S for the treatment of S. aureus bacteremia, except for testing in clinical trials.

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Brain Cancer


Evaluating the Expression Levels of MicroRNA-10B in Patients with Primary Gliomas

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and when feasible, cerebrospinal fluid samples will be obtained from patients diagnosed with Grade III and Grade IV gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.

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METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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Brain Malformations


A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.

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Brain Tumors


A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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Evaluating the Expression Levels of MicroRNA-10B in Patients with Primary Gliomas

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and when feasible, cerebrospinal fluid samples will be obtained from patients diagnosed with Grade III and Grade IV gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.

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METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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Breast Cancer


A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer

The purpose of this study is to test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard. Using tumor tissue samples from a prior surgery, treatment reccomendations will be made based on DNA sequencing of the tumor cells by a Cancer Genomics Tumor Board facilitated by the Hoosier Cancer Research Network. Subjects will be randomized to one of several treatment options based on their specific tumor genetic make-up, prior treatment history and tolerance, and medical history.

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Mammography - Accuracy Using Optical Mammography

The purpose of this project is to study how well near-infrared light (that is, light in the red region and beyond the visible limit in the wavelength range 600-1,000 nm) is at detecting and monitoring breast cancer during treatment.

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Palbociclib Collaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.

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Preventing Anthracycline Cardiovascular Toxicity with Statins

The overall purpose of this study is to determine if atorvastin (generic for Lipitor) 40mg by mouth daily decreases the chance of developing heart problems in patients receiving Anthracycline based chemotherapy for breast cancer or lymphoma.

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Cancer


Evaluating Neuropsychological and Psychological Screening in Cancer Survivors

The overall aim of this research project is to assess the feasibility and performance of neuropsychological and psychological screening measures completed by adolescents and young adults (AYA), and adults, who receive care at the Reid R. Sacco AYA Cancer Clinic or the Adult Cancer Survivorship Clinic, both at Tufts MC. The AYA Clinic provides cancer survivorship care to individuals between the ages of 18-39 years, while the Adult Clinic serves survivors ages >40. Two screening measures will be assessed: (1) the Montreal Cognitive Assessment (MOCA), a screener for mild cognitive impairment1 and (2) the Brief Symptom Inventory-18 (BSI), a screener for psychological distress.2 The results from these well-validated screeners will guide future care for these participants at Tufts MC and beyond.

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Cardiac Failure


A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with preserved Ejection Fraction (HFpEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

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A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

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Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. Currently only accepted patients who have HIV and Diastolic Dysfunction. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, and echocardiography to determined characteristics unique to this patient population.

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Dilated Cardiomyopathy Precision Medicine Study

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. The genetic screening done for this study will be returned to the subject. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM. We are collaborating with Dr. Ray Hershberger from The Ohio State University in the Dilated Cardiomyopathy (DCM) Precision Medicine Study, a family-based study aimed at enrolling individuals of European or African ancestry, and identifying the genes responsible for idiopathic DCM. Ours is one of several sites forming part of the DCM Consortium, a multi-institutional group established to conduct DCM research. This study requires one in person visit and a 10-15 minute phone call annually.

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Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is beind done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failurea nd are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pumpt). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

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Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

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Prospective Hemodynamic Assessment of Cardica Resynchronization Therapy Effectiveness Following Left Ventricular Assist Device Support

To understated the effects of different pacemaker settings on heart function in patients with LVADS.

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Subcutaneous Furosemide in Acute Decompensated Heart Failure

The purpose of this study is to test if sending you home early from the hospital with a furosemide pump will improve your outcome after a heart failure admission. An investigational pump and drug combination - the sc2WearPump and Furosemide Injection Solution (SCP-101, made scPharmaceuticals), will be used to provide you with the drug you need and the study will also determine if this combination product is safe. "Investigational" means that the combination pump/drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use. Furosemide is already approved by the FDA for the treatment of heart failure, but tihs study will test a furosemide injection given under the skin using a pump (sc2Wear Pump) applied to the belly.

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The Global cVAD Registry Protocol

The global cVAD registry collects clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple Impella devices during routine clinical care. Patients who qualify for this registry include patients who received the Impella 2.5, Impella CP, or Impella 5.0 for left ventricular support as well as the Impella RP for right ventricular support during their inpatient stay. The registry is an observational, multicenter, retrospective records review. In order to best represent real-world practice, patients receiving Impella devices will be included in the registry without pre-selection. The purpose of the registry is to capture data that reflects "real world"? use of the Implella devices in clinical practice and provide insight into patients characteristics, comorbid conditions, patterns of care, quality of care and performance measurements.

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Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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Cardiomyopathy


A Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.

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A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with preserved Ejection Fraction (HFpEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

More

A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

More

A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

More

Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. Currently only accepted patients who have HIV and Diastolic Dysfunction. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, and echocardiography to determined characteristics unique to this patient population.

More

Dilated Cardiomyopathy Precision Medicine Study

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. The genetic screening done for this study will be returned to the subject. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM. We are collaborating with Dr. Ray Hershberger from The Ohio State University in the Dilated Cardiomyopathy (DCM) Precision Medicine Study, a family-based study aimed at enrolling individuals of European or African ancestry, and identifying the genes responsible for idiopathic DCM. Ours is one of several sites forming part of the DCM Consortium, a multi-institutional group established to conduct DCM research. This study requires one in person visit and a 10-15 minute phone call annually.

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Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is beind done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failurea nd are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pumpt). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

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Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

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Subcutaneous Furosemide in Acute Decompensated Heart Failure

The purpose of this study is to test if sending you home early from the hospital with a furosemide pump will improve your outcome after a heart failure admission. An investigational pump and drug combination - the sc2WearPump and Furosemide Injection Solution (SCP-101, made scPharmaceuticals), will be used to provide you with the drug you need and the study will also determine if this combination product is safe. "Investigational" means that the combination pump/drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use. Furosemide is already approved by the FDA for the treatment of heart failure, but tihs study will test a furosemide injection given under the skin using a pump (sc2Wear Pump) applied to the belly.

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Cardiovascular Disease


HeartMate PHP™ Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

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A Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.

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A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with preserved Ejection Fraction (HFpEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension after Left Ventricular Assist Device

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device implantation. The purpose of this study is to evaluate the effect of the study drug, macitentan, on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the study drug in subjects with PH after LVAD implantation. Macitentan is a study drug that works by blocking the effect of a substance called endothelin, which is produced in increased amounts in patients with pulmonary hypertension. Endothelin causes blood vessels to narrow (constrict), and overgrowth of the muscle in the walls of the blood vessels in the lung occurs. By blocking the action of endothelin, macitentan may reduce the blood pressure in the lung and improve activity level and wellbeing.In this study, half of the subjects will receive study drug/macitentan, while the other half of subjects will receive a placebo (inactive substance or sugar pill). he treatment period will last for about 12 weeks, with a follow-up period of 30 days. In total, including the screening period and a 30-day safety follow-up at the end of the study, the study will last no longer than 5.5 months, with up to 6 planned visits.

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A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

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Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT)

This is a study to evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). Approximately 610 subjects will be randomized with approximately 305 subjects targeted to receive the study device.

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Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. Currently only accepted patients who have HIV and Diastolic Dysfunction. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, and echocardiography to determined characteristics unique to this patient population.

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Dilated Cardiomyopathy Precision Medicine Study

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. The genetic screening done for this study will be returned to the subject. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM. We are collaborating with Dr. Ray Hershberger from The Ohio State University in the Dilated Cardiomyopathy (DCM) Precision Medicine Study, a family-based study aimed at enrolling individuals of European or African ancestry, and identifying the genes responsible for idiopathic DCM. Ours is one of several sites forming part of the DCM Consortium, a multi-institutional group established to conduct DCM research. This study requires one in person visit and a 10-15 minute phone call annually.

More

Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is beind done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failurea nd are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

More

How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pumpt). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

More

Subcutaneous Furosemide in Acute Decompensated Heart Failure

The purpose of this study is to test if sending you home early from the hospital with a furosemide pump will improve your outcome after a heart failure admission. An investigational pump and drug combination - the sc2WearPump and Furosemide Injection Solution (SCP-101, made scPharmaceuticals), will be used to provide you with the drug you need and the study will also determine if this combination product is safe. "Investigational" means that the combination pump/drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use. Furosemide is already approved by the FDA for the treatment of heart failure, but tihs study will test a furosemide injection given under the skin using a pump (sc2Wear Pump) applied to the belly.

More

Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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Childbirth


Hypomethylated Fraction of Cell-Free DNA in Pregnant Women at Term: A Mechanistic Understanding of Spontaneous Labor

This research study involves enhancing our understanding of how normal spontaneous labor happens. Cell-free DNA is small segments of DNA that is released from multiple different types of cells into the circulation, and is normally found in everyone's blood. When a woman is pregnant, some portion of the circulating cell-free DNA is from the placenta, and is therefore considered "fetal". The amount of cell-free fetal DNA is thought to decrease after delivery of the baby and placenta. This research study is attempting to determine whether levels of cell-free fetal DNA vary across a spectrum of patient weight, and whether these levels platy a role in initiating or starting normal labor. Peripheral blood samples are collected in lean and obese pregnant women at term when they present to Tufts Medical Center for delivery. We subsequently process the blood samples to analyze the level of cell-free fetal DNA. In addition, the placenta is usually discarded after delivery, For our study, we will take a small biopsy of the placenta.

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Cholesterol


Role of EPA and DHA in fish oil on inflammation and lipid metabolism

Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.

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Chronic Kidney Disease


A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (Forxiga)

Dapagliflozin (ForxigaTM/FarxigaTM) is currently used for treating type 2 diabetic patients worldwide and is approved by the U.S. Food and Drug Administration (FDA) for type 2 diabetes. Because it is being evaluated in subjects with chronic kidney disease, with or without type 2 diabetes, its use in this study is considered investigational. Previous data from dapagliflozin and similar type of medications indicate that they might have beneficial effects on chronic kidney disease. Dapagliflozin decreases blood sugar in diabetic patients but should not influence blood sugar if you do not have diabetes. This research study is carried out to see if dapagliflozin is effective in chronic kidney disease by preventing the gradual loss of kidney function and in the long run to improve the survival for patients with chronic kidney disease.

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Chronic Lymphocytic Leukemia


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Chronic Pain


Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

We are analyzing how many opioid tabs are required post-operatively for adequate pain control after total laparoscopic hysterectomy for benign indications

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Congestive Heart Failure


A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

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Inorganic Nitrate Delivery to Improve Exercise Capacity in HFpEF

The purpose of this study is to test if an investigational drug, Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of physical activity, including exercise, and thus improve quality of life in people who have chronic diastolic heart failure. "Investigational" means that the study drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use to treat heart failure.

More

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

More

Preventing Anthracycline Cardiovascular Toxicity with Statins

The overall purpose of this study is to determine if atorvastin (generic for Lipitor) 40mg by mouth daily decreases the chance of developing heart problems in patients receiving Anthracycline based chemotherapy for breast cancer or lymphoma.

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The Global cVAD Registry Protocol

The global cVAD registry collects clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple Impella devices during routine clinical care. Patients who qualify for this registry include patients who received the Impella 2.5, Impella CP, or Impella 5.0 for left ventricular support as well as the Impella RP for right ventricular support during their inpatient stay. The registry is an observational, multicenter, retrospective records review. In order to best represent real-world practice, patients receiving Impella devices will be included in the registry without pre-selection. The purpose of the registry is to capture data that reflects "real world"? use of the Implella devices in clinical practice and provide insight into patients characteristics, comorbid conditions, patterns of care, quality of care and performance measurements.

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Constipation


Impact of Naloxegol (Movantik) on Prevention of Lower Gastrointestinal Tract Paralysis in Critically Ill Adults Initiated on Scheduled IV Opioid Therapy: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Single-Center, Proof of Concept Study

Among the more than 5 million adults who are admitted to the ICU each year in the USA, most have pain and thus receive a pain (analgesic) medication called an opioid. Opioid use in critically ill adults continues to increase given the greater awareness of untreated pain in the ICU population and a recent strong recommendation in the Society of Critical Care Medicine’s Pain, Agitation, and Delirium Guidelines for Critically Ill Adults that an opioid-first approach be used to optimize patient safety and comfort and improve tolerance with breathing machines (i.e. mechanical ventilation). Similar to constipation, paralysis of the lower gastrointestinal (GI) tract is defined as the inability to pass stool due to impaired gut movements, and is a common effect of opioid use in the critically ill. Lower GI tract paralysis will often lead to nausea, vomiting, aspiration, compromise the ability to administer tube feeds (enteral nutrition), increases abdominal pain, and has been shown to delay getting off mechanical ventilation. One recent randomized study found that aggressive use of laxatives to prevent lower GI tract paralysis in critically ill adults was associated with lower daily organ dysfunction [as measured by the Sequential Organ Failure Assessment (SOFA) score]. The lower GI tract paralysis that occurs in the critically ill often responds poorly to laxative medication therapy (e.g., senna, bisacodyl, lactulose). While stool softener medications like docusateare routinely administered to patients on opioids, laxative-based protocols are frequently not initiated in the ICU until signs of lower GI tract paralysis start to appear. There is therefore an important and unmet need for a safe and efficacious medication to prevent lower GI tract paralysis in critically ill adults who are initiated on opioid therapy. Naloxegol (Movantik) is a naloxone-like drug that blocks the effect of opioids on the opioid µ receptor in the gut. Naloxegol is currently approved by the Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in non-ICU patients receiving scheduled moderate to high dose opioids for the treatment of chronic non-cancer pain. Naloxegol has a mechanism of action, efficacy, convenience of administration, and safety profile that make it an ideal candidate for use as a preventative medication for lower GI tract paralysis in critically ill adults receiving opioid therapy through the vein [intravenous (IV)]. We therefore propose a pilot study in which we will test the hypothesis that naloxegol (versus placebo) will reduce the time to the first spontaneous bowel movement (SBM) that the ICU patient has, that it will prevent lower GI tract paralysis in critically ill adults initiated on scheduled IV opioid therapy, and its use will not result in side effects that are concerning to doctors or patients. We will randomize 36 critically ill ICU patients (18 in each arm) to receive naloxegol [25mg or 12.5mg (in patients with kidney problems] or placebo. This pilot study will provide valuable information to help guide future, larger studies of naloxegol in ICU patients.

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Contact Lens Discomfort


Assessment of cellular and soluble mediators in contact lens discomfort and neuropathic corneal pain

The study will investigate the nerve changes and tear protein levels in contact lens users with and without symptoms of dry eye, and patients with contact lens intolerance, and compare these individuals with neuropathic corneal pain and normal non-contact lens users without symptoms.

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COPD


Pilot Study of Physiological Effect of High-Flow Nasal Cannula on Respiratory Pattern and Work of Breathing in Severe COPD Patients

Patients affected with severe chronic obstructive pulmonary disease (COPD) and other lung disease experience shortness of breath and increased load on respiratory muscles, making it harder to breath.  These patients may  progressively become dependent on oxygen therapy and sometimes they may need noninvasive ventilation (a mask covering mouth and nose and connected to a blowing machine) to help them in reducing the breathing effort. Optiflow is a nasal high flow oxygen delivery system that, providing warm and humidified air/oxygen blend, could be better tolerated and increase oxygen levels in the blood more than standard oxygen therapy.

Our aim is to generate pilot data that can be used to inform sample size calculations for future studies that will compare outcomes at several different flow rates. We will ask 15 adult patients affected with stable COPD requiring oxygen to participate in our research. Subjects participating in the study will be asked to come in to the sleep lab at Tufts Medical Center. As part of the study 2 small tubes will be inserted through the nostril into the stomach and the esophagus. Baseline data like breathing rate, heart rate, and oxygen level in the blood will be recorded. Then each patient will receive oxygen via High Flow Nasal Cannula, using 3 different settings, and 3 different levels of positive pressure (CPAP) via a nasal mask.

Subjects will be randomized to receive 2 different treatments in a crossover fashion. They will be randomized to different setting within each treatment arm using a computer generated randomization scheme. Each setting will last 1-0 minutes and data will be collected at the end of each setting. Then the tubes will be removed.

We will describe the effects of varying settings of high-flow nasal oxygen on respiratory rate, tidal volume and diaphragmatic work of breathing in patients with severe COPD. We will also describe changes in gas exchange and effects on the subjects' comfort and dyspnea.

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Corneal Pain


Assessment of cellular and soluble mediators in contact lens discomfort and neuropathic corneal pain

The study will investigate the nerve changes and tear protein levels in contact lens users with and without symptoms of dry eye, and patients with contact lens intolerance, and compare these individuals with neuropathic corneal pain and normal non-contact lens users without symptoms.

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Coronary Artery Disease


Door To Unloading with IMPELLA® CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study

A multi-center, prospective randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI. Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasibility. The primary objective of this study is to evaluate whether the use of the Impella CP System for unloading of the left ventricle prior to PPCI has the potential to limit infarct size in patients presenting with STEMI. A secondary objective of the trial is to evaluate the need for 30 minutes of active left ventricular unloading prior to PPCI. Up to 50 subjects will be randomized int he study, 25 in each study arm.

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HeartMate PHP™ Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

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Critical Limb Ischemia


A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for Revascularization (PACE Study)

This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.

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Crohn's Disease


A Long-Term Non-Invasive Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Pediatric Patients with Moderately to Severly Active Crohn’s Disease

To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.

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Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

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Cystic Fibrosis


A Long Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis (CF) Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors

This is a prospective observational study to determine the incidence of fibrosing colonpathy in patients with CF.

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Depression


Omega-3 Fatty Acids for MDD with High Inflammation: A Personalized Approach

The purpose of this research study is to compare the effects of three different doses of an investigational omega-3 fatty acid dietary supplement, eicosapentaenoic acid (EPA), versus placebo on immune system markers in the blood and on treating the symptoms of major depression. Placebo is a pill that looks like the study drug, but contains no active substance. Eicosapentaenoic acid (EPA) is a common omega-3 fatty acid. EPA is available in low dosages in some types of dietary supplements found in health food stores.

In order to qualify for this study you cannot be taking any antidepressants, and you must have a BMI of >25.

If you qualify, you will be randomly assigned (like the flip of a coin) to the EPA or placebo treatment group. You will have a 25% (1 in 4) chance of being assigned to one of the following groups:

  • Group 1 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 1 g/day.
  • Group 2 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 2 g/day.
  • Group 3 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 4 g/day.
  • Group 4 will receive capsules containing placebo (an inactive substance).

Neither you nor the investigator will know to what group you are assigned. This is to make sure that the research study results are not affected by what you or the investigator may expect to happen.

We will ask you to make 9 visits over the course of 12 weeks to our clinic at MGH. At each visit you will meet with a clinician to fill out a number of questionnaires to monitor your progress and you will also receive study medication for the duration of the study. Blood samples will also be collected six times during this study, twice to determine your eligibility to participate in the study, and 4 times to measure changes in immune markers.

You can receive up to $280 total, if you complete all study visits. If you have to drive to come to MGH, you will also be provided with parking vouchers at all visits for the MGH garages. At the conclusion of the study, you will be offered 3 months of free follow up care with one of the study physicians.

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Developmental Disabilities


A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.

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Neonatal Salivary Transcriptomics

The ability to monitor the health status of premature neonates for research purposes has long been limited by these infants' fragile medical conditions and small blood volumes. Advancements in salivary technology suggests that transcriptomic and proteomic salivary analysis is an innovative, highly informative, and noninvasive means to monitor this patient population, and correlate medical and neurodevelopmental outcomes with specific gene expression profiles. The purpose of this study is to use normally obtained and routinely discarded neonatal salivary samples to noninvasively generate transcriptomic and proteomic profiles of premature neonates. Saliva will be collected serially from infants born greater to or equal to 24 weeks' gestation who are admitted to the Tufts Medical Center NICU or MIU. Our research is focused on two areas of neonatal physiology and pathology . The first area of interest involves monitoring infants during the learning process of oral feeding. Our second area of interest involves feeding intolerance and gastrointestinal disease (i.e. necrotizing enterocolitis) and infection. Healthy term neonates will serve as comparative controls. Both short and long term medical and neurological (up to 24 months corrected age) outcomes, will be correlated with the distinct gene expression profiles in order to better understand neonatal physiology, pathology and overall health status.

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Diabetes Type 2


A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (Forxiga)

Dapagliflozin (ForxigaTM/FarxigaTM) is currently used for treating type 2 diabetic patients worldwide and is approved by the U.S. Food and Drug Administration (FDA) for type 2 diabetes. Because it is being evaluated in subjects with chronic kidney disease, with or without type 2 diabetes, its use in this study is considered investigational. Previous data from dapagliflozin and similar type of medications indicate that they might have beneficial effects on chronic kidney disease. Dapagliflozin decreases blood sugar in diabetic patients but should not influence blood sugar if you do not have diabetes. This research study is carried out to see if dapagliflozin is effective in chronic kidney disease by preventing the gradual loss of kidney function and in the long run to improve the survival for patients with chronic kidney disease.

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Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

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Diabetic Foot Ulcers


A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers

Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic foot ulcers (DFUs) will be treated using Aurix in approximately 100 sites in the US. A physician can enroll a patient in the study for Aurix treatment provided inclusion/exclusion criteria are met. Patients will receive Aurix + Usual and Customary Care (UCC) or UCC alone twice a week for the first two weeks and, then, once a week thereafter. The primary endpoint of the trial is to determine the time to heal at 12 weeks DFUs treated with Aurix + UCC versus UCC alone.

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Dislocations


Outcomes of Patellofemoral Dislocation Treated with Medial Patellofemoral Ligament Reconstruction and or Repair

Subjects will be identified through billing searches based on CPT (27420, 27427, 29873, 27427, 27405.) and ICD-9 codes (836.3, 717.89, 717.86). We will include both skeletally mature and skeletally immature patients, but will analyze the data separately. Skeletal maturity will be determined based on an evaluation of the patient's radiographs. Potential participants will be identified from medical records then called to determine interest and inform them that they will be mailed the ICF/Assent and study questionnaires. They will then be mailed the recruitment letter, ICF, Assent form and all study questionnaires, to be returned in a provided stamped envelope. If the study team does not receive the study documents back from the patients that were sent the materials, they will be called using the submitted telephone script. They will then be mailed another packet to complete or asked to complete the one already sent if they still have it. All questionnaires and documentation of consent/assent will be written via mailed documents and a signed copy of the consent/assent will be mailed back to the participants. Participation in the study is entirely optional and if a patient chooses not to participate, it will not impact their treatment at Tufts Medical Center. Patients who provide their verbal consent will have the option to complete research questionnaires, including the VAS pain score, Kujala Score, Lysholm Knee Scale and Tegner Score. Study participation will end upon completion of surveys. Additionally we will retrospectively collect data from follow-up clinic notes including: range of motion, pain score and instability. We will also document cases of radiolocation and revisions as well as when the patient was able to resume participation in sports and to what extent.

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Eosinophilic Esophagitis


Development, Validation, and Evaluation of an Adult and Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study

Eosinophilic Esophagitis (EoE) is a swallowing disorder which is caused by an allergy-like inflammation of the esophagus. It is diagnosed by esophageal biopsies and can be treated with anti-inflammatory medicines. There are cases of EoE in children and adults and the symptoms primarily present with difficulty swallowing or the feeling of food being stuck in the esophagus. Currently there is no exact way to define the activity of Eosinophilic Esophagitis. An activity index for measuring the disease severity has not been developed so there is difficulty in measuring the treatment responses in clinical studies. The creation of an Activity Index (or a score) for EoE will allow the objective measurement of patient symptoms.

The aim of the current multi-center study is to develop, validate and evaluate an EoE activity index for pediatric and adult patients. Our site at Tufts will soley be involved in the adult population of patients with EoE. The study is purely observational and involves undergoing a structured interview from the research coordinator involved in the study in addition to the standard medical care (including medicines, endoscopic evaluations and biopsies, for example) by one of the investigators of the study. There is also a questionnaire that the patients will have to fill out. There are several items in the questionnaire measuring the symptoms (eg frequency of dysphagia, dysphagia in relation to distinct food consistencies). There is also a component where the biologic activity (number of eosinophils in esophageal biopsy or presence of signs of acute inflammation in esophagoscopy) will be incorporated. The biologic activity component will be completed by the principal or co-investigators who are caring for the patients.

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Fallopian Tube Cancer


Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

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Fractures


HIP Fracture Accelerated Surgical TreaTment and Care TracK (HIP ATTACK) Trial

If you consent to participate, you will be randomly assigned to one of two groups. if you are in the first group, you will receive surgery when you would normally have it if you were not in this study (usually within 36 hours). Your surgery will not be delayed because of the study. In the second group, you will receive surgery within 6 hours of your hip fracture diagnosis.

A few simple blood tests will be done before and after your surgery regardless of which group you are in the HIP ATTACK Trial nurses will take medical information from your chart and follow your course in the hospital. They will also follow-up with you by telephone after you go home.

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Gastrointestinal Tumors


A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

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Genitourinary Tumors


A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

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Giant Cell Arteritis


A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis

GlaxoSmithKline is evaluating a study drug called sirukumab for patients with Giant Cell Arteritis. Sirukumab may help block the activity of interleukin-6 (IL-6), which is involved in changes in the immune system related to GCA. The purpose of this study is to test how well sirukumab keeps GCA from returning once prednisone has been stopped. Sirukumab is given with a tapered prednisone regimen. Participants may also enroll in secondary studies evaluating the genetics and biomarkers associated with GCA.

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Glioma


A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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Healthy Volunteers


Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

More

Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Quality CPR Training Intervention for Health Care Providers Assessed by Simulated Mock Code-Blue

In this multicenter simulation based research study, we evaluate hospital code-team members on their CPR quality (individually and in teams) and teamwork performance during simulated medical resuscitations both at baseline and after a standardized educational intervention across 5 medical centers. The educational intervention uses a combination of simulation debriefing, didactics and hands-on deliberate practice training with a real-time audiovisual CPR feedback device (ZOLL R-Series Monitor Defibrillator).

The primary endpoint is to assess quality of CPR and teamwork performance by hospital code teams across 5 sites through NESERC (New England Simulaiton, Education and Research Consortium) in a high fidelity simulation at baseline and following a standardized educational intervention, incorporating teamwork communication skills and hands-on training for high quality CPR

The secondary endpoint is to assess the ability of individual code team members to perform high quality CPR for a 2 minute period while given audio visual CPR feedback.

Each of the 5 sites of study will recruit 10 teams of 4 individuals. The total target sample size is 50 teams or 200 individual participants. Participants will be healthcare providers who are members of hospital code teams or at least expected to provide CPR during a medical code in their immediate patient care area.

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Safe and effective delivery of supplemental iron to healthy volunteers

Iron deficiency-related anemia is the most common nutritional deficiency disorder in the world, mainly affecting children, women and older adults in underdeveloped countries.To combat iron deficiency, inorganic forms of iron (such as ferrous sulfate) are used as iron supplements. However, providing large doses of this iron produces negative health effects, including diarrhea, changes in the bacteria in the gut and increased inflammation. In this study, we are comparing participants consuming the form of iron commonly used in iron supplements (ferrous sulfate) versus participants consuming other forms of iron in order to determine the effects of these iron supplements on intestinal health, immune function and iron status. The findings from this research study are important because they will inform the development of safer treatments for iron deficiency.

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Social Media as a Vehicle for Expression of Self-Harm and Risk-Taking Behavior in Adolescents

The primary objective of this study is to develop and administer a survey tool based on previously validated survey measures to identify adolescents who engage in non-suicidal self-injury (NSSI) and/or sharing of sexually explicit material.

A secondary objective of the study will be to determine if any correlation exists between adolescents self-reporting to engage in NSSI behaviors and/or sharing of sexually explicit messages and socio-demographic variables, substance use, academic performance and bullying.

  1. Determine percentage of the adolescents who engage in NSSI, what percentage use social media to express intent to engage in NSSI and/or connect with other adolescents who engage in NSSI;
  2. Determine percentage of the adolescents who engage in sharing of sexually explicit material, what percentage use social media as the platform to share sexually explicit materials; and
  3. Determine how much time adolescents who engage in self-harm behaviors and/or sharing of sexually explicit messages spend on social media compared to adolescents who do not engage in self-harm behaviors and/or sharing of explicit messages
Our hypothesis is adolescents who engage in NSSI behaviors and/or sharing of sexually explicit material spend greater amounts of time on social media than adolescents who do not engage in NSSI behaviors and/or sharing of sexually explicit materials

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Heart Diseases


HeartMate PHP™ Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,

hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

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A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

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A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

More

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

More

Prospective Hemodynamic Assessment of Cardica Resynchronization Therapy Effectiveness Following Left Ventricular Assist Device Support

To understated the effects of different pacemaker settings on heart function in patients with LVADS.

More

The Global cVAD Registry Protocol

The global cVAD registry collects clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple Impella devices during routine clinical care. Patients who qualify for this registry include patients who received the Impella 2.5, Impella CP, or Impella 5.0 for left ventricular support as well as the Impella RP for right ventricular support during their inpatient stay. The registry is an observational, multicenter, retrospective records review. In order to best represent real-world practice, patients receiving Impella devices will be included in the registry without pre-selection. The purpose of the registry is to capture data that reflects "real world"? use of the Implella devices in clinical practice and provide insight into patients characteristics, comorbid conditions, patterns of care, quality of care and performance measurements.

More

Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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Heart Failure


A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).

This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with preserved Ejection Fraction (HFpEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.

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A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

More

A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

More

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

More

Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. Currently only accepted patients who have HIV and Diastolic Dysfunction. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, and echocardiography to determined characteristics unique to this patient population.

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Dilated Cardiomyopathy Precision Medicine Study

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. The genetic screening done for this study will be returned to the subject. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM. We are collaborating with Dr. Ray Hershberger from The Ohio State University in the Dilated Cardiomyopathy (DCM) Precision Medicine Study, a family-based study aimed at enrolling individuals of European or African ancestry, and identifying the genes responsible for idiopathic DCM. Ours is one of several sites forming part of the DCM Consortium, a multi-institutional group established to conduct DCM research. This study requires one in person visit and a 10-15 minute phone call annually.

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Entrestotm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

The purpose of this study is to test whether EntrestoTM, a newly approved drug for heart failure that combines sacubitril and valsartan, improves symptoms and outcomes in persons with advanced heart failure in comparison to treatment with valsartan alone over 24 weeks. EntrestoTM has been studied in only a very small number of patients with advanced heart failure, like you. This study is beind done to obtain more information on the benefits and risks of EntrestoTM in patients with advanced heart failure. Both EntrestoTM and valsartan have previously been approved by the U.S. Food and Drug Administration (FDA)for people with heart failurea nd are available by prescription from a licensed medical doctor. Currently EntrestoTM is only available under the brand name EntrestoTM, there is no generic form of EntrestoTM. You do not have to take part in this study in order to receive EntrestoTM.

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How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pumpt). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

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Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

More

Prospective Hemodynamic Assessment of Cardica Resynchronization Therapy Effectiveness Following Left Ventricular Assist Device Support

To understated the effects of different pacemaker settings on heart function in patients with LVADS.

More

Subcutaneous Furosemide in Acute Decompensated Heart Failure

The purpose of this study is to test if sending you home early from the hospital with a furosemide pump will improve your outcome after a heart failure admission. An investigational pump and drug combination - the sc2WearPump and Furosemide Injection Solution (SCP-101, made scPharmaceuticals), will be used to provide you with the drug you need and the study will also determine if this combination product is safe. "Investigational" means that the combination pump/drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use. Furosemide is already approved by the FDA for the treatment of heart failure, but tihs study will test a furosemide injection given under the skin using a pump (sc2Wear Pump) applied to the belly.

More

The Global cVAD Registry Protocol

The global cVAD registry collects clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple Impella devices during routine clinical care. Patients who qualify for this registry include patients who received the Impella 2.5, Impella CP, or Impella 5.0 for left ventricular support as well as the Impella RP for right ventricular support during their inpatient stay. The registry is an observational, multicenter, retrospective records review. In order to best represent real-world practice, patients receiving Impella devices will be included in the registry without pre-selection. The purpose of the registry is to capture data that reflects "real world"? use of the Implella devices in clinical practice and provide insight into patients characteristics, comorbid conditions, patterns of care, quality of care and performance measurements.

More

Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial  (TAVR UNLOAD)

The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

More

Heart Transplantation


Evaluation of BK Virus Reactivation and Kidney Disease in Heart Transplant Recipients

BK virus reactivation and disease is emerging as an important cause of allograft dysfunction and loos, and the incidence of BKV reactivation and disease appears to be rising. This has been attributed to the recent us of newer, highly potent immunosuppressive agents. Little is known about the biologic behavior of the virus after reactivation and it progression to disease in heart transplant recipients. We aim to describe the prevalence of BK reactivation in urine and plasma samples of 100 pilot patients to begin to elucidate these gaps in our knowledge that may impact morbidity and mortality following heart transplantation.

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Hematologic Disorders


Epideermal Growth Factor (EGF) Analysis in Patients with Plasma Cell Diseases

The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.

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Hematologic Malignancies


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Herpes Zoster


Supportive Care: Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine after Autologous Transplantation

This study is to test whether or not an investigational vaccine works to protect against a condition called “shingles,” which is caused by the Herpes Zoster virus. The vaccine will be tested in people who have received a transplant with their own blood stem cells. Subjects are either planning to receive this type of transplant or just received the transplant. Shingles is caused by the same virus that causes chickenpox. After that, the virus stays in the body but is asleep. A person can get shingles when the virus wakes up. If a person's immune system (resistance to disease) is weakened, the risk of getting shingles increases. This can happen after an autologous transplant with blood stem cells, so the researchers for this study are trying to find new ways to protect against this condition.

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Hidradenitis Suppurativa


Open-label, Investigator-Initiated, Single Site Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa

The purpose of this study is to find out more about a drug call subcutaneous (injectable) secukinumab in people iwth hidranetis suppurativa. Secukinumab may be successful in treating hidranetis suppurativa because it is an injectable drug known as a "biologic" that blocks a specific molecule of the immune system called interleukin-7A. This molecule is increased in people with hidranetis suppurativa. By blocking interleukin-17A, we believe that secukinumab will help treat the lesions of hidranetis suppurativa.

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High Blood Pressure


A Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension after Left Ventricular Assist Device

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device implantation. The purpose of this study is to evaluate the effect of the study drug, macitentan, on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the study drug in subjects with PH after LVAD implantation. Macitentan is a study drug that works by blocking the effect of a substance called endothelin, which is produced in increased amounts in patients with pulmonary hypertension. Endothelin causes blood vessels to narrow (constrict), and overgrowth of the muscle in the walls of the blood vessels in the lung occurs. By blocking the action of endothelin, macitentan may reduce the blood pressure in the lung and improve activity level and wellbeing.In this study, half of the subjects will receive study drug/macitentan, while the other half of subjects will receive a placebo (inactive substance or sugar pill). he treatment period will last for about 12 weeks, with a follow-up period of 30 days. In total, including the screening period and a 30-day safety follow-up at the end of the study, the study will last no longer than 5.5 months, with up to 6 planned visits.

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Hip Injuries and Disorders


HIP Fracture Accelerated Surgical TreaTment and Care TracK (HIP ATTACK) Trial

If you consent to participate, you will be randomly assigned to one of two groups. if you are in the first group, you will receive surgery when you would normally have it if you were not in this study (usually within 36 hours). Your surgery will not be delayed because of the study. In the second group, you will receive surgery within 6 hours of your hip fracture diagnosis.

A few simple blood tests will be done before and after your surgery regardless of which group you are in the HIP ATTACK Trial nurses will take medical information from your chart and follow your course in the hospital. They will also follow-up with you by telephone after you go home.

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HIV/AIDS


Characterizing HIV-related Diastolic Dysfunction

This is a multicenter clinical trial of a cross section of HIV+ patients with and without diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100 HIV+/DD+ & 100 HIV+/DD-) will be enrolled. Currently only accepted patients who have HIV and Diastolic Dysfunction. This study will evaluate biomarkers, phenomapping, metabolomics, cMRI, and echocardiography to determined characteristics unique to this patient population.

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Hodgkin Lymphoma


A Phase I Study With an Expansion Cohort of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients With Relapsed/Refractory Hodgkin Lymphoma

This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment.

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A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

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Hypertension


A Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension after Left Ventricular Assist Device

This is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension (PH) after left ventricular assist device implantation. The purpose of this study is to evaluate the effect of the study drug, macitentan, on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the study drug in subjects with PH after LVAD implantation. Macitentan is a study drug that works by blocking the effect of a substance called endothelin, which is produced in increased amounts in patients with pulmonary hypertension. Endothelin causes blood vessels to narrow (constrict), and overgrowth of the muscle in the walls of the blood vessels in the lung occurs. By blocking the action of endothelin, macitentan may reduce the blood pressure in the lung and improve activity level and wellbeing.In this study, half of the subjects will receive study drug/macitentan, while the other half of subjects will receive a placebo (inactive substance or sugar pill). he treatment period will last for about 12 weeks, with a follow-up period of 30 days. In total, including the screening period and a 30-day safety follow-up at the end of the study, the study will last no longer than 5.5 months, with up to 6 planned visits.

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Inflammation


Role of EPA and DHA in fish oil on inflammation and lipid metabolism

Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.

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Inflammatory Bowel Disease


Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

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Intracranial Pressure


Prospective evaluation of non-invasive intracranial pressure monitoring

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.

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Juvenile Idiopathic Arthritis


Late Formative/Usability Validation of an Auto-Injector for Juvenile Idiopathic Arthritis

The goal of this study is to see how easy or hard it is for children with Juvenile Idiopathic Arthritis to learn how to use the auto-injector. The auto-injector is being made to deliver medication to people with inflammation or swelling of the joints (JIA).

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Knee Injuries and Disorders


Longitudinal Associations between Femoral Cartilage Ultrasound Outcomes and Patient Reported Outcomes Following Anterior Cruciate Ligament Reconstruction

The purpose of this study is to determine the diagnostic, prognostic, and burden of disease performance for a clinically accessible knee cartilage ultrasound assessment in relation to patient reported outcomes in individuals following anterior cruicate ligament reconstruction. We will assess knee cartilage status using ultrasound and patient reported outcomes at several key clinical tine points throughout the first year following anterior cruciate ligament reconstruction. This study is a needed first step to validate knee cartilage outcomes as biomarkers for early decline in patient health.

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Leptomeningeal Metastases


NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults

This research is being done to collect information about adults with neoplastic meningitis. Tufts Medical Center and several other selected national sites will gather information about adults with neoplastic meningitis so that we can better understand this condition, the treatments that people with neoplastic meningitis receive, and how these treatments help them.

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Liver Diseases


Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

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Lower GI Tract Paralysis


Impact of Naloxegol (Movantik) on Prevention of Lower Gastrointestinal Tract Paralysis in Critically Ill Adults Initiated on Scheduled IV Opioid Therapy: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Single-Center, Proof of Concept Study

Among the more than 5 million adults who are admitted to the ICU each year in the USA, most have pain and thus receive a pain (analgesic) medication called an opioid. Opioid use in critically ill adults continues to increase given the greater awareness of untreated pain in the ICU population and a recent strong recommendation in the Society of Critical Care Medicine’s Pain, Agitation, and Delirium Guidelines for Critically Ill Adults that an opioid-first approach be used to optimize patient safety and comfort and improve tolerance with breathing machines (i.e. mechanical ventilation). Similar to constipation, paralysis of the lower gastrointestinal (GI) tract is defined as the inability to pass stool due to impaired gut movements, and is a common effect of opioid use in the critically ill. Lower GI tract paralysis will often lead to nausea, vomiting, aspiration, compromise the ability to administer tube feeds (enteral nutrition), increases abdominal pain, and has been shown to delay getting off mechanical ventilation. One recent randomized study found that aggressive use of laxatives to prevent lower GI tract paralysis in critically ill adults was associated with lower daily organ dysfunction [as measured by the Sequential Organ Failure Assessment (SOFA) score]. The lower GI tract paralysis that occurs in the critically ill often responds poorly to laxative medication therapy (e.g., senna, bisacodyl, lactulose). While stool softener medications like docusateare routinely administered to patients on opioids, laxative-based protocols are frequently not initiated in the ICU until signs of lower GI tract paralysis start to appear. There is therefore an important and unmet need for a safe and efficacious medication to prevent lower GI tract paralysis in critically ill adults who are initiated on opioid therapy. Naloxegol (Movantik) is a naloxone-like drug that blocks the effect of opioids on the opioid µ receptor in the gut. Naloxegol is currently approved by the Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in non-ICU patients receiving scheduled moderate to high dose opioids for the treatment of chronic non-cancer pain. Naloxegol has a mechanism of action, efficacy, convenience of administration, and safety profile that make it an ideal candidate for use as a preventative medication for lower GI tract paralysis in critically ill adults receiving opioid therapy through the vein [intravenous (IV)]. We therefore propose a pilot study in which we will test the hypothesis that naloxegol (versus placebo) will reduce the time to the first spontaneous bowel movement (SBM) that the ICU patient has, that it will prevent lower GI tract paralysis in critically ill adults initiated on scheduled IV opioid therapy, and its use will not result in side effects that are concerning to doctors or patients. We will randomize 36 critically ill ICU patients (18 in each arm) to receive naloxegol [25mg or 12.5mg (in patients with kidney problems] or placebo. This pilot study will provide valuable information to help guide future, larger studies of naloxegol in ICU patients.

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Lung Cancer


Pilot study of the interaction between the GI microbiota and checkpoint inhibitors in patients with cancer

The bacteria living in the intestines (microbiota) server important roles in preserving gut and overall body health. The effect of cancer treatment on the microbiome is not known. Patients starting new therapy with a checkpoint inhibitor (anti-PDL1) will be asked to provide samples of blood, urine and stool at up to 6 time points over the course of 6 months.

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Lyme Disease


Xenodiagnosis After Antibiotic Treatment for Lyme Disease – Phase 2 study

Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using the natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease.

Our objectives include: (1) assessing the link between the detection of B. Burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans.

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Lymphomas


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Preventing Anthracycline Cardiovascular Toxicity with Statins

The overall purpose of this study is to determine if atorvastin (generic for Lipitor) 40mg by mouth daily decreases the chance of developing heart problems in patients receiving Anthracycline based chemotherapy for breast cancer or lymphoma.

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Mammography


Mammography - Accuracy Using Optical Mammography

The purpose of this project is to study how well near-infrared light (that is, light in the red region and beyond the visible limit in the wavelength range 600-1,000 nm) is at detecting and monitoring breast cancer during treatment.

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Mantle Cell Lymphoma


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Melanoma


Pilot study of the interaction between the GI microbiota and checkpoint inhibitors in patients with cancer

The bacteria living in the intestines (microbiota) server important roles in preserving gut and overall body health. The effect of cancer treatment on the microbiome is not known. Patients starting new therapy with a checkpoint inhibitor (anti-PDL1) will be asked to provide samples of blood, urine and stool at up to 6 time points over the course of 6 months.

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Mild Cognitive Impairment


Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

The purpose of this study is to examine how brain imaging with amyloid PET help guide your doctors in how to treat patients with mild cognitive impairment (MCI) or dementia and whether these changes in treatment lead to better medical outcomes. The hypothesis is that amyloid PET will decrease uncertainty and increase confidence in the underlying cause of cognitive impairment, that this will translate into earlier counseling and interventions in these domains, and that these interventions will lead to improved outcomes.

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Mood Disorders


An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

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MRSA


Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

The purpose of this study is to test the safety of DSTA4637S, an investigational drug, at different dose levels and to find out what effects, good or bad, DSTA4637S, has on you while treating the S. aureus infection in your blood. DSTA4637S will be given in addition to the antibiotics you are already receiving for your S. aureus infection.

DSTA4637S is an investigational antibiotic to treat serious infections caused by the bacteria S. aureus. DSTA4637S is an experimental drug, which means that the Food and Drug Administration (FDA) or other health authorities that regulate new drugs have not approved DSTA4637S for the treatment of S. aureus bacteremia, except for testing in clinical trials.

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Multiple Myeloma


A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

This study will assess whether taking ixazomib as maintenance therapy after standard treatments extends the period of time that a patient’s cancer stays inactive.

Maintenance therapy means that a drug is taken for a relatively long period (in this study, up to 24 months) to prolong the time that the myeloma remains under control after a prior therapy; in this study the prior therapy must not include autologous stem cell transplant.  It is not yet proven whether maintenance therapy given to people with multiple meyloma is better than waiting until the myeloma comes back to receive additional treatment.  The study will assess whether taking ixazomib immediately after responding to a prior therapy allows people with multiple myeloma to live longer by preventing or delaying the return of their disease.

This study is also being performed for these additional research purposes:

  • To evaluate the safety of ixazomib and to learn about the side effects associated with the use of this drug when it is used as a maintenance therapy.
  • To find out whether the presence of certain genes and proteins in the cancer cells of patients with multiple myeloma can predict whether ixazomib will work on cancers similar to yours.
  • To evaluate the health and overall well-being of patients while they are taking ixazomib.

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    Characterization of T Cell Distribution in Stem Cell Mobilization

    The purpose of this study is to collect blood samples from Tufts Medical Center multiple myeloma or AL amyloidosis patients being prepared for autologous stem cell transplant in order to analyze variations in T-cell populations through the stem cell mobilization process

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    Myelodysplastic Syndromes


    A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

    The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician’s choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).

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    A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

    This is a Phase 2, open-label, 3-arm randomized, multicenter study designed to determine the safety, pharmacokinetics, and efficacy of venetoclax when administered with azacitidine, compared to azacitidine alone, in subjects with treatment-naïve higher-risk MDS.

    Approximately 90 subjects, from approximately 50 sites, will be enrolled with approximately 30 subjects to be randomized to each arm.

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    Myocardial Heart Disease


    A Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

    The purpose of this phase 2 open-label pilot study is to evaluate the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of MYK-461 in subjects with symptomatic HCM and LVOT obstruction aged 18-70 years.

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    Nephrotic Syndrome


    Practice patterns and outcomes of ACTHar use in children with nephrotic syndrome

    This is a registry study which will collect safety health information from children 6 months to 21 years of age with nephrotic syndrome of any cause, and treated with ACTHar therapy. All the data collection will take place during the routine hospital visits. There is no additional visits and invasive procedures for this study.

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    Neuroblastoma


    NMTT: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

    The purpose of this research study is to evaluate an investigational drug (DFMO) for Neuroblastoma that is in remission. Remission means that there are no current signs of active cancer. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to keep neuroblastoma in remission and will also look at the safety and tolerability of DFMO.

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    Neuromuscular Disorders


    Ulnar neuropathy at the the elbow: protective role of the Martin Gruber anastomosis

    The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.

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    Non Small Cell Lung Cancer


    METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

    The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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    Obesity


    Omega-3 Fatty Acids for MDD with High Inflammation: A Personalized Approach

    The purpose of this research study is to compare the effects of three different doses of an investigational omega-3 fatty acid dietary supplement, eicosapentaenoic acid (EPA), versus placebo on immune system markers in the blood and on treating the symptoms of major depression. Placebo is a pill that looks like the study drug, but contains no active substance. Eicosapentaenoic acid (EPA) is a common omega-3 fatty acid. EPA is available in low dosages in some types of dietary supplements found in health food stores.

    In order to qualify for this study you cannot be taking any antidepressants, and you must have a BMI of >25.

    If you qualify, you will be randomly assigned (like the flip of a coin) to the EPA or placebo treatment group. You will have a 25% (1 in 4) chance of being assigned to one of the following groups:

    • Group 1 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 1 g/day.
    • Group 2 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 2 g/day.
    • Group 3 will receive capsules containing an EPA enriched omega-3 fatty acid preparation for a total dose of 4 g/day.
    • Group 4 will receive capsules containing placebo (an inactive substance).

    Neither you nor the investigator will know to what group you are assigned. This is to make sure that the research study results are not affected by what you or the investigator may expect to happen.

    We will ask you to make 9 visits over the course of 12 weeks to our clinic at MGH. At each visit you will meet with a clinician to fill out a number of questionnaires to monitor your progress and you will also receive study medication for the duration of the study. Blood samples will also be collected six times during this study, twice to determine your eligibility to participate in the study, and 4 times to measure changes in immune markers.

    You can receive up to $280 total, if you complete all study visits. If you have to drive to come to MGH, you will also be provided with parking vouchers at all visits for the MGH garages. At the conclusion of the study, you will be offered 3 months of free follow up care with one of the study physicians.

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    Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients

    Morbidly obese patients scheduled for abdominal surgery duration at least two hours are randomized in two groups, ventilation with high PEEP and recruitment maneuvers or low PEEP and no recruitment. the incidence of postoperative pulmonary complications as well as intraoperative side effects is recorded.

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    Obstetric Anesthesia


    A Randomized Controlled Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

    This is a randomized controlled trial which compares the effect of chloroprocaine versus bupivacaine for cervical cerclage.

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    Osteoarthritis


    A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

    Samumed is evaluating a new drug called SM04690 to learn more about the safety and effectiveness of a one-time knee injection for patients with moderate to severe knee osteoarthritis. SM04690 is an investigational drug that has not been approved by the FDA. The study drug aims to target the Wnt pathway in order to reduce cartilage loss among patients who have knee osteoarthritis. There are a total of 6 treatment groups in the study; 4 will receive varying doses of the study medication and 2 will receive a placebo.

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    Ovarian Cancer


    Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

    This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

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    Pancreatic Cancer


    Nab-Paclitaxel (Abraxane®) Plus Gemcitabine In Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-Label, Multi-Center, Phase 2 Study (LAPACT)

    This clinical study is in subjects with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment.

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    Parkinson's Disease


    Management of Parkinson’s Disease Psychosis in Actual Practice (The INSYTE Study)

    To examine the current disease progression of Parkinson’s Disease Psychosis (PDP), the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers.

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    Observational Study In Parkinson’s Patient Volunteers To Characterize Digital Signatures Associated With Motor Portion Of The Updrs, Daily Living Activities And Speech

    This study is looking at how sensor, audio, and video recordings can be used to identify unique characteristics that can be compared and monitored in patients with Parkinson’s disease.

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    Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

    The purpose of this study is:

    • To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease.
    • To establish whether these measures can be used to identify patients with PD in the premotor phase.
    • To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

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    Pelvic Pain


    Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

    We are analyzing how many opioid tabs are required post-operatively for adequate pain control after total laparoscopic hysterectomy for benign indications

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    Peritoneal Cancer


    Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

    This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

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    Polycystic Kidney Disease


    A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease

    The purpose of this study is to find out if the experimental study drug, tesevatinib, works as a treatment for ADPKD and if it is safe. Tesevatinib is made by Kadmon, who provides funding to this facility for the conduct of this study.

    About 100 subjects will participate in this study across the U.S. Half the subjects (50 subjects) will receive tesevatinib, and the other half (50 subjects) will receive placebo. The study will last approximately 2 years, and will require frequent visits to Tufts Medical Center

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    A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

    Living with the pain, high blood pressure, and other symptoms of autosomal dominant polycystic kidney disease (ADPKD) can be overwhelming. And because ADPKD may be passed from one generation to the next, you may have seen how it has affected your family and wonder how the disease will affect you.

    If you have ADPKD, and have participated in a previous Tolvaptan research study, you may want to learn more about the Open Label clinical research study.

    What is the Open Label study?

    The purpose of the Open Label study is to evaluate the long-term safety and effectiveness of an investigational medication called tolvaptan in patients with ADPKD.

    Who can participate?

    You may be able to join the study if you:

    • Have participated in a previous Tolvaptan research study
    • Are diagnosed with ADPKD

    What is the investigational medication?

    Tolvaptan is being investigated in this study as a potential treatment to slow the progression of cyst growth in the kidneys of adults with ADPKD.

    What are the potential risks and benefits?

    Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

    The information learned from the study and your participation may help us learn about how to develop future treatment options for people with ADPKD.

    Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.

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    Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease

    This study will involve patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and is supported by the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Program. The study has started at Tufts Medical Center and the University of Maryland (Baltimore). Drs. Ronald Perrone and Dana Miskulin of Tufts Medical Center and Drs. Terry Watnick and Steve Seliger of the University of Maryland will conduct the study at these clinical sites. The study will test the safety and tolerability of the antidiabetic drug metformin, which has been shown in animal models to slow the progression of PKD. Metformin is a widely used generic drug that is FDA approved for the treatment of diabetes.

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    Post-Operative Pain


    A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Dose Finding Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectal Surgery

    We are studying a medication called VVZ-149. We want to know how well it works for pain, after colon surgery that uses a camera-based approach. We will also be looking for any bad reactions that people may have to it. Patients in the study receive VVZ-149 for a total of about 11 hours. They also receive the usual pain medicines.

    Some pain medicines have a lot of side effects, like opioids. These medicines include morphine, hydromorphone, and heroin. When we give less opioid, patients have fewer side effects, like dangerously slow breathing or addiction. However, there are only a few medicines that help as well for pain. The medicine we are studying works on pain in a different way. VVZ-149 is not an opioid.

    So far, there have been a few early studies. In animals, VVZ-149 has been shown to work as well as morphine for pain. It has also been given to people. When healthy people took it, they sometimes complained of feeling sick to one’s stomach, dizzy, or sleepy. It has also been given to patients who have had stomach surgery. These patients needed less opioid. They did not have any more problems than healthy people did.

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    Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

    We are analyzing how many opioid tabs are required post-operatively for adequate pain control after total laparoscopic hysterectomy for benign indications

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    Premature Babies


    Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

    The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.

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    Premature Birth


    Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

    The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.

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    Molecular Assessment of the Consequences of Preterm Birth

    This study is being conducted to find out what genes are turned on or off (called "gene expression") in babies born preterm and how that may be related to complications of prematurity or other health conditions they may experience during or after their initial hospitalizations

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    Pressure Ulcers


    A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers

    Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix in approximately 100 sites in the US. A physician can enroll a patient in the study for Aurix treatment provided inclusion/exclusion criteria are met. Patients will receive Aurix + Usual and Customary Care (UCC) or UCC alone twice a week for the first two weeks and, then, once a week thereafter. The primary endpoint of the trial is to determine the time to heal at 12 weeks pressure ulcers treated with Aurix + UCC versus UCC alone.

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    Preterm Birth


    Molecular Assessment of the Consequences of Preterm Birth

    This study is being conducted to find out what genes are turned on or off (called "gene expression") in babies born preterm and how that may be related to complications of prematurity or other health conditions they may experience during or after their initial hospitalizations

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    Psychotic Disorders


    An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

    Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

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    Pulmonary Hypertension


    A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

    This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).

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    Development of Microfluidic Platforms to Non-Invasively Predict Bronchopulmonary Dysplasia (BPD) and BPD-associated Pulmonary Hypertension (PH) in Premature Neonates

    This study is an observational study conducted over the first 18 months of life for preterm infants born less than 30 weeks’ gestation. We aim to develop transcriptomic (RNA), proteomic (protein), and metabolomic (protein-protein interaction) ‘foot-prints’ in blood, urine, and saliva of preterm infants who a) develop BPD; b) develop BPD with PH; and c) develop neither BPD or BPD with PH (control infants).

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    Pulmonary Vascular Resistance


    Transesophageal Echocardiographic Assessment of Pulmonary Vascular Resistance

    Collection of TRV and RVOT VTI from TEE and right heart pressures and CO from PA catheter.

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    Renal Disease


    Biological Determinants of Peritoneal Dialysis

    In people with kidney failure, water and many different types of toxins build up in the body. In the process of peritoneal dialysis (PD), water and toxins are moved from the blood across the lining of the abdomen into the dialysis fluid so that they can be removed from the body, since the kidneys can no longer perform this job on their own. The lining of the abdomen is called the peritoneal membrane. Previous studies have shown that different people react differently to the process of PD. In some people, toxins move faster across the peritoneal membrane than in others. Similarly, in some people, more water crosses the peritoneal membrane than in others. Also, in some people treated with PD, the amount of water that crosses the peritoneal membrane decreases with time. All of these differences can affect how well people tolerate receiving PD. In this study, we want to find out if these differences we observe in how the peritoneal membrane works depend upon the genes that different people inherit (i.e., the DNA with which people are born).

    This study will be conducted at Dialysis Clinic Inc. (DCI) Somerville. Up to 100 subjects will be enrolled at DCI Somerville. All sample and data analysis will be performed at the University of Washington in Seattle. This study is funded by a grant from the National Institute of Health.

    We would like to collect a sample of your blood to obtain your DNA and plasma. Further, we would like to get information from a sample of your dialysis fluid and your medical records related to how much and how quickly toxins and water transfer across your peritoneal membrane. By comparing any changes in these transfers as you continue with PD treatment, we would like to identify factors that might be contributing to the decrease in the amount of water being transferred during dialysis in some people. To identify these factors, we may look at your unique genetic information in many ways. Some methods look only for specific portions of your DNA, while other methods “read” or sequence much larger portions (the exome) of DNA. We may also use your sample to look at the entire sequence of your DNA, which is called the genome. One technique, the Genome Wide Association Studies (GWAS), compares sequence patterns in genomes from different people.

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    Coherent Hemodynamics Spectroscopy

    When there is a sudden change in blood pressure in your body, the blood vessels in your brain will typically widen or narrow as necessary in order to keep your blood flow stable. This process is called “cerebral autoregulation”, and it is important, because without appropriate blood flow, your brain cannot continue to function properly. Decreases in blood flow can lead to lightheadedness, and in severe cases people can lose consciousness and parts of the brain can be damaged. While this process of “cerebral autoregulation” works fine in most healthy individuals, diseases that affect the health or function of the blood vessels supplying your brain (collectively called "cerebrovascular disease") can make it difficult for your brain to adjust to these blood pressure changes.

    Cerebrovascular disease is especially common among dialysis patients. Because dialysis causes frequent drops in blood pressure and dialysis patients tend to have unhealthy brain blood vessels to begin with, there is a risk that patients may have problems keeping their brain blood supply stable during the dialysis procedure, as described above. It would therefore be useful to monitor brain blood flow in the dialysis clinic. Currently, the options for monitoring brain blood flow in real time during dialysis without using invasive equipment are very limited.

    This study is focused on a new, non-invasive imaging technique called Coherent Hemodynamic Spectroscopy (CHS) designed to monitor blood flow, blood oxygenation, and “cerebral autoregulation” in your brain. Near-infrared light, when passed between optical fibers attached to your scalp, can be used to detect changes in the concentration and oxygenation of blood in your brain. This process is called Near-Infrared Spectroscopy (NIRS). Dr. Sergio Fantini at Tufts University has developed a new computational model that translates the data generated by this NIRS imaging into useful clinical markers that describe how well your brain is being supplied with blood and how efficiently your brain is adjusting to changes in blood pressure. This technique may help to diagnose and monitor brain blood flow issues in dialysis patients, and may also be helpful with patients suffering from stroke, traumatic brain injury, concussion, and other brain disorders. It may also be valuable in operating room contexts.

    To test the usefulness of this technique in a clinical setting, 32 hemodialysis patients from Dialysis Clinic, Inc. (DCI) Boston and DCI Somerville will be monitored with CHS before, during, and after three of their regularly scheduled dialysis sessions, with one week between each session. In order to obtain complete, usable data for 32 patients, it may be necessary to enroll more patients in the study, with maximum enrollment estimated at 50. CHS monitoring will occur using electrodes that will be attached to optical fibers and placed on your scalp. These electrodes will be held in place with an elastic sports headband, which you will wear throughout the dialysis procedure.

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    Epideermal Growth Factor (EGF) Analysis in Patients with Plasma Cell Diseases

    The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.

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    Retinopathy of Prematurity


    RAINBOW study: a randomized controlled study evaluating the fficacy and safety of ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity

    The RAINBOW study is a clinical research study that will help doctors learn whether a drug called ranibizumab works in treating retinopathy of prematurity. Ranibizumab is a drug that blocks a substance in the body called vascular endothelial growth factor, or VEGF. This controls the growth of blood vessels in the back of the eye, and premature babies who develop retinopathy of prematurity have too much of this substance.  The purpose of the study is to determine if ranibizumab can help those blood vessels grow normally again, and the study will look at whether one or both doses of the drug work, compared to the current treatment, laser therapy.

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    Rheumatoid Arthritis


    Pathogenic role of autoreactive anergic B cells in Rheumatoid Arthritis

    The goal of the study is to determine the role of a particular type of white blood cell called immune cells in the development of Rheumatoid arthritis. Our study is focused on a specific type of immune cells (B lymphocytes) that circulate in the blood and normally provide protection against bacteria and viruses that cause diseases. However, sometimes the immune cells may get "confused" and will start attacking the body itself; this process is called autoimmunity. In Rheumatoid arthritis, the immune system (system in the body that protects the body against diseases) attacks joint tissue which resultsin joint stiffness, swelling and eventually leads to irreversible joint damage. This study plans to learn more about the reason why the immune system turns against the body's own joint tissue by separating immune cells from blood samples and carrying out biochemical tests on theses cells.

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    Rheumatologic Conditions


    Observational Study for Pediatric Rheumatic Disease: The CARRA Registry Study

    The goal of this study is to longitudinally gather information on the outcomes in all pediatric rheumatology patients in the USA. The study will be enrolling patients with the following diagnosis: Juvenile Ankylosing Spondylitis, Juvenile Idiopathic Arthritis Probably Systemic Juvenile Idiopathic Arthritis (sJIA), systemic lupus erythematosus, juvenile dermatomyositis, localized scleroderma, mixed connective tissue disease, vasculitis, uveitis, fibromyalgia, systemic sclerosis, sarcoidosis, and sjogren syndrome.

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    Seizures


    A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

    Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.

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    Short Bowel Syndrome


    A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome

    NPS Pharmaceuticals Inc. wants to collect information about the long-term safety profile of people with short bowel syndrome (SBS) who are treated with teduglutide. The purpose of this registry is to evaluate the long-term safety profile and clinical course for people with SBS who are treated with teduglutide in a routine clinical setting, as well as those who are not being treated with teduglutide. The primary objective is to determine the occurrence of colorectal cancer in people with SBS with a remnant colon taking teduglutide. The study will also evaluate the long-term clinical outcomes in people with SBS.

    Participants who decide to take part in this registry study have informaiton collected about their health as part of their routine medical care and give this information to NPS Pharmaceuticals, Inc. or its designee to include in the registry.

    Each person who joins this registry study will have his/her information collected for the registry for at least 10 years.

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    Solid Tumors


    A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

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    Staphylococcus aureus


    Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

    The purpose of this study is to test the safety of DSTA4637S, an investigational drug, at different dose levels and to find out what effects, good or bad, DSTA4637S, has on you while treating the S. aureus infection in your blood. DSTA4637S will be given in addition to the antibiotics you are already receiving for your S. aureus infection.

    DSTA4637S is an investigational antibiotic to treat serious infections caused by the bacteria S. aureus. DSTA4637S is an experimental drug, which means that the Food and Drug Administration (FDA) or other health authorities that regulate new drugs have not approved DSTA4637S for the treatment of S. aureus bacteremia, except for testing in clinical trials.

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    Stent-Grafts


    A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

    The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and Penetrating Atherosclerotic Ulcers (PAUs) within the descending thoracic area.

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    Stroke


    Stroke and Young Adults: A qualitative assessment of the hospitalization for acute stroke, shared decision-making, and perception of risk

    The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.

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    Thyroid Cancer


    Clinical Performance Evaluation of a New Thyroglobulin Assay in Subjects with Differentiated Thyroid Cancer (DTC)

    The goal of the study is to collect information on how well a new diagnostic test works. The test was developed to measure proteins - called biomarkers - in blood, which aid diagnosis and treatment decisions in differentiated thyroid cancer (DTC). The biomarker thyroglobulin (Tg), which is measured through the course of the study, is already in use for treatment decisions and diagnosis in DTC patients in other countries, but has not yet been approved for use in the United States. Current Tg testing available to physicians is not always able to detect lower levels of disease. The new test under investigation is very sensitive and may potentially replace the uncomfortable hormone withdrawal/application in certain circumstances. The planned study is an observational study, meaning that you will receive all the care you normally would receive.

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    Tickborne Diseases


    Host Genetic Determinants and Pathogenesis of Severe Babesiosis

    Babesiosis is an emerging infectious disease in the United States, The disease is caused by a parasite that invades and eventually ruptures red blood cells. The parasite is transmitted by the deer tick but also can be acquired during blood transfusion. Symptoms include fever, fatigue, chills and sweats. In some individuals, the disease is so severe that hospitalization is required. In others, the infection is mild or event silent. The study is designed to identify factors that determine whether a given individual is prone to experience severe or mild babesiosis or no disease at all.

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    Transplant


    Supportive Care: Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine after Autologous Transplantation

    This study is to test whether or not an investigational vaccine works to protect against a condition called “shingles,” which is caused by the Herpes Zoster virus. The vaccine will be tested in people who have received a transplant with their own blood stem cells. Subjects are either planning to receive this type of transplant or just received the transplant. Shingles is caused by the same virus that causes chickenpox. After that, the virus stays in the body but is asleep. A person can get shingles when the virus wakes up. If a person's immune system (resistance to disease) is weakened, the risk of getting shingles increases. This can happen after an autologous transplant with blood stem cells, so the researchers for this study are trying to find new ways to protect against this condition.

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    Twin-Twin Transfusion Syndrome


    Evolution of Cerebral Development in Twin-Twin Transfusion Syndrome (TTTS)

    The study includes 30 pregnant women with twin pregnancy - 15 carrying twin fetuses that have been prenatally diagnosed with twin-twin transfusion syndrome (TTTS), and 15 carrying healthy twin fetuses. These women may be offered a fetal MRI scan at no cost to the women. Dr. Tarui will look for differences and changes in the fetal brains with TTTS compared to unaffected twin fetuses.

    The study also includes children of women who participate in the study. Children will be followed up after the birth and their neurodevelopmental outcome will be precisely recorded by battery of neurodevelopmental testing at 18 month of age.

    The study’s goal is to establish anatomical landmarks for fetal brain development in TTTS that can subsequently predict future neurodevelopmental outcome of affected children.

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    Ulcerative Colitis


    Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

    Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

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    Ulnar Neuropathy


    Ulnar neuropathy at the the elbow: protective role of the Martin Gruber anastomosis

    The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.

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    Valvular Heart Disease


    Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT)

    This is a study to evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). Approximately 610 subjects will be randomized with approximately 305 subjects targeted to receive the study device.

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    Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial  (TAVR UNLOAD)

    The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.

    Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis

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    Venous Ulcers


    A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers

    Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLUs) will be treated using Aurix in approximately 100 sites in the US. A physician can enroll a patient in the study for Aurix treatment provided inclusion/exclusion criteria are met. Patients will receive Aurix + Usual and Customary Care (UCC) or UCC alone twice a week for the first two weeks and, then, once a week thereafter. The primary endpoint of the trial is to determine the time to heal at 12 weeks VLUs treated with Aurix + UCC versus UCC alone.

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    Wound Care


    Evaluation of the Safety Performance of 3M™ Tegaderm™ Finishing Dressing

    The objective of this study is to eavluate the safety performance of Tegarderm™ Finishing Dressing when worn on various chronic wounds for up to four weeks of treatment.

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