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Acute Myeloid Leukemia


A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission

The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.

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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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Ankylosing Spondylitis


A Multicenter, Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study To Evaluate The Efficacy And Safety Of Bimekizumab In Subjects With Active Ankylosing Spondylitis

BE AGILE 1 is evaluating a new drug called bimekizumab for patients with Ankylosing spondylitis. Bimekizumab is investigational, which means it is still being tested and has not yet been approved for treatment by health authorities. Bimekizumab may help lower the level of activity of interleukin-17A (IL-A) and interleukin-17F (IL-17F); two proteins that are involved in an inflammatory response believed to cause the symptoms of anklysing spondylitis. The purpose of this study is to help us understand how safe and effective different doses of bimekizumab are in treating your condition. It will also help us understand how bimekizumab acts in your body, and how your body reacts to bimekizumab.

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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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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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Bone Marrow Transplant


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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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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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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Breast Cancer


A Phase 1, Open Label, Dose Escalation Study of MGA271 (Fcoptimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

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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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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 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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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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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 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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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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Cardiovascular 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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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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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 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 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

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.

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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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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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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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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


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.

More

Epilepsy


A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study To Assess The Efficacy And Safety Of Brivaracetam Administered Intravenously As Treatment For Increased Seizure Activity In An Epilepsy Monitoring Unit Setting

This is an open-label, randomized, parallel-group, active-controlled study to assess the efficacy and safety of brivaracetam (BRV) administered intravenously as treatment for increased seizure activity in an epilepsy monitoring unit (EMU) setting. The primary objective is to assess the efficacy of intravenous (iv) BRV compared to iv lorazepam (LZP) in subjects with epilepsy undergoing EMU evaluation who experience seizures that require prompt treatment.

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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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Fetal Growth Restriction


Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development

This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preterm preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.

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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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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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GVHD


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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Healthy Volunteers


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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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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Hodgkin Lymphoma


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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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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Intracerebral Hemorrhage


Impact of Fever Prevention in Brain Injured Patients (INTREPID)

This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.

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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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Leukemia


A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission

The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.

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AALL0932:  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

This is a protocol for people with newly diagnosed Standard Risk Acute Lymphoblastic Leukemia. The study is broken up into parts. Each part of the study will be exploring different phases of chemotherapy such as Induction, Post-Induction, and Maintenance. In each phase of the study, researchers will be testing different experimental drug regimens versus standard treatments to see which one works better. Additionally, participants will be grouped based on their risk level and may receive different  chemotherapy regimens based on their risk.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Lung Cancer


An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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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.

More

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.

More

AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

More

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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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.

More

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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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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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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    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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    Neonatal Abstinence Syndrome


    Improving outcome in neonatal abstinence syndrome with included sub-study: Establishing Risk in Neonatal Abstinence Syndrome (NAS) Genomics Component

    The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.

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    Neonatal Conditions


    Improving outcome in neonatal abstinence syndrome with included sub-study: Establishing Risk in Neonatal Abstinence Syndrome (NAS) Genomics Component

    The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.

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    Neuroblastoma


    ANBL1232: Utilizing Response and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma: A Groupwide Historically Controlled Phase III Study

    In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.

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    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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    Non Small Cell Lung Cancer


    An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

    The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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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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    Ovarian Cancer


    A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

    The purpose of this study is to compare the effect on ovarian cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for ovarian cancer.

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    A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer

    This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.

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    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


    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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    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


    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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    Preeclampsia


    Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development

    This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preterm preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.

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    Premature 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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    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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    Pulmonary Hypertension


    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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    Renal Disease


    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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    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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus

    The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in patients in super-refractory status epilepticus (SRSE). SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to seizure medications.

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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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    Stroke


    Impact of Fever Prevention in Brain Injured Patients (INTREPID)

    This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.

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    Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) comparing rivaroxaban 15 mg once daily with aspirin 100 mg

    The purpose of this study is to find out whether a new anti-clotting medication called rivaroxaban leads to fewer blood clots in your brain (stroke) or in other blood vessels in your body when compared with aspirin.

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    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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    Subarachnoid Hemorrhage


    Impact of Fever Prevention in Brain Injured Patients (INTREPID)

    This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.

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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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    Twin Pregnancy


    Development of non-invasive prenatal screening test for multiple pregnancies based on fetal DNA isolated from Maternal blood.

    The purpose of the study is to determine whether current testing for fetal chromosomal abnormality using maternal blood to analyze fetal DNA can be used also to determine chorionicity (i.e., the arrangement of placentas and fetal membranes) in patients with twin pregnancies.

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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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    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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