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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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Abdominal Infection


A Phase 2, Randomized, Active Comparator-controlled, Multicenter, Double-blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects with Complicated Intra-Abdominal Infection 

This trial evaluates the safety and efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem plus placebo in pediatric subjects from birth (defined as >32 weeks gestational age and >7 days postnatal) to <18 years of age with complicated intraabdominal infection (cIAI). The total duration of study treatment (IV only or IV + oral) is a minimum of 5 days and maximum of 14 days. After receiving at least 9 doses of double-blind IV study treatment, subjects in either treatment arm may be switched to open-label, standard of-care oral step-down antibiotic therapy at the investigator's discretion. Oral step-down therapy is considered study treatment.

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Long-Term Outcomes Protocol of Premature Infants Enrolled in the NICHD-2013-ABS01 (SCAMP) study

The purpose of this study is to look at the frequency of neurodevelopmental impairment and long-term gastrointestinal outcomes in premature infants enrolled in the SCAMP study for treatment of complicated intrabdominal infections.

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Alports Syndrome


A Phase 2/3 Trial of the Efficacy and Safety of Bardolxolone Methyl in Patients with Alports Syndrome

CARDINAL is a Phase 2/3 clinical study evaluating the safety and effectiveness of bardoxolone methyl (an oral investigational drug) for the treatment of Alport syndrome

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Amyloidosis


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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A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

The experimental drug used in this study is called daratumumab, or JNJ-54767414, a CD38 monoclonal antibody. The purpose of this study is to see if daratumumab when given with three other drugs [cyclophosphamide, bortezomib (VELCADE®) and dexamethasone] is useful for treating participants with Amyloid light chain Amyloidosis (also known as AL Amyloidosis). The study will look at what happens (both good and bad) when daratumumab is given with these three drugs compared to just giving those three drugs alone. The safety of daratumumab when given with cyclophosphamide, bortezomib and dexamethasone (CyBorD) will also be studied.

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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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Anesthesia


A Randomized Controlled Trial of Tegaderm vs. Eyegard for Eye Protection During Anesthesia

Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study we will compare two tapes, Tegaderm and Eyegard to determine if one is less likely to causes eyelid irritation in an effort to improve care for future patients. 

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Ankylosing Spondylitis


 A randomized, double-blind, parallel-group, multicenter study of secukinumab to compare 300 mg and 150 mg at Week 52 in patients with Ankylosing Spondylitis who are randomized to dose escalation after not achieving inactive disease during an initial 16 weeks of open-label treatment with secukinumab 150 mg (ASLeap)   

The purpose of this study is to estimate the difference in clinical response between 300 mg and 150 mg of secukinumab at Week 52 in patients with Ankylosing Spondylitis (AS). Patients will be on an open-label secukinumab 150 mg until Week 16, followed by a randomization phase to receive either secukinumab 150 mg or secukinumab 300 mg. This study will also investigate the link between secukinumab and sleep disturbances, and daytime activity patterns.

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Tufts Spondyloarthritis Registry

This is an observational study of people who have spondyloarthritis. This includes diseases such as ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease associated arthritis. Those in the registry must be patients of providers in the Tufts rheumatology clinic. 

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Atopic Dermatitis


A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

Study I4V-MC-JAHN (JAHN) is a Phase 3, multicenter, double-blind study to evaluate the long-term safety and efficacy of baricitnib (1-mg once daily, 2-mg once daily and 4-mg once daily) in adult patients with AD for approximately 2 years.

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Atrial Fibrillation


AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Sometimes, following open heart surgery, patients can develop irregular heart rhythms like atrial fibrillation. Atrial Fibrillation can occur in 30-50% of patients following open heart surgery. This is called, postoperative atrial fibrillation (POAF). POAF and related stroke/TIAs impact dying, and quality of life (QoL) for patients undergoing structural heart disease procedures. Usually these heart rhythms straighten out within your hospital stay but are typically treated with some drugs to decrease the ability of you blood to clot. Some people that have a high risk of bleeding cannot take blood thinners. This study is collecting information on the treatment of those subjects that develop POAF. This research study is also comparing how LAA closure impacts the physical health and quality of life (QoL) versus not having it closed in a special group of people, The left atrial appendage (LAA) is a small sac located on the upper chamber of your heart. This sac is thought to be the site where blood clots form and is believed to be associated with a significant risk of stroke/TIA in patients with specific risk factors like age, hypertension, atrial fibrillation, and diabetes. 

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Autism


Understanding Disparities in Shared-Decision Making among Patients with Autism Spectrum Disorder

Racial and ethnic minority families receive less family-centered care than their majority counterparts, resulting in disparities in treatment engagement and adverse child outcomes among children diagnosed with Autism Spectrum Disorder (Autism). Shared-decision making (SDM) increases family-centered care by identifying treatments that meet the needs and goals of the family, and increases engagement, adherence and outcomes. In the context of Autism, a valuable opportunity to engage families in SDM occurs at their first diagnostic encounter, where treatment options are initially discussed. The proposed stakeholder engaged T2 pilot project, draws upon qualitative and quantitative mixed methods to produce objective information about SDM in the context of Autism diagnosis and treatment. This innovative project will aim to identify key elements of SDM during initial diagnostic encounters, explore patient perspectives and the role of race/ethnicity, and investigate provider perspectives in their use of SDM with families. Through direct observation, measurement scales, and qualitative interviews, we will identify the frequency of SDM elements used between 30 parent-provider dyads, as well as information about family preferences, values, and treatment goals for children with Autism, and particularly how they vary by race/ethnicity. Knowledge gained from this foundational research will result in several translational funding opportunities for future SDM interventions: decision aids, provider/parent training, and care system redesign. Our ultimate goal is to increase the use of SDM in clinical practice to provide a system of care for Autism that more fully considers the preferences, values, and treatment goals of families, regardless of their racial/ethnic background.

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Brain Cancer


Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) 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


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) 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


Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer

The purpose of this study is to test the effectiveness of the combination of niraparib and pembrolizumab in patients with triple negative breast cancer or ovarian cancer.

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Burkitt Lymphoma


A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen

The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.

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Cardiac Failure


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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Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

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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


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

Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

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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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Cardiovascular Tissue and DNA Banking Study

Collecting and storing heart tissue and blood samples from consented Tufts Medical Center patients for the purpose of cardiovascular research.

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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.

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

Cesarean Section


A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction

This study is to assess patient satisfaction and anxiety level in the setting of music or no music during a cesarean delivery. Some studies demonstrated that specific selections of Mozart piano sonatas, which have a specific rhythm and mode, improve patient anxiety through a biochemical mechanism. Therefore, in this study, when we refer to "music," we will specifically plan on using the same Mozart sonatas. Satisfaction will be measured using 22-question survey on day one after delivery during the hours of 8am - 1pm. Anxiety levels will be assess at several time points using a simple numeric rating score from 0-10, where 0 is no anxiety and 10 is the greatest anxiety.

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Chronic Kidney Disease


A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with Rare Chronic Kidney Diseases

PHOENIX is a phase 2 trial evaluating the safety and effectiveness of bardoxolone methyl in patients with rare chronic kidney diseases: CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). 

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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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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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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


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.

More

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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Cystoid Macular Edema


Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema: The ACME study

This is a proof of concept study to determine the safety of subconjunctival aflibercept injection, an anti-vascular endothelial growth factor (VEGF) medication, in the treatment of recalcitrant pseudophakic cystoid macular edema (CME)

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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.

More

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.

More

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 Disorders


A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis

This study is being conducted to test the efficacy and safety of AK002 in patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis and requires nine study visits over the course of 24 weeks. Participants will receive study drug or placebo via infusion during four of these visits. 

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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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Epilepsy


A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy

This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency. 

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Cognitive Debriefing and Usability Testing of an Epilepsy Seizure Diary

Evaluation of a seizure diary.

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Fallopian Tube Cancer


A Phase III, Multicenter, Randomized, Study of Atezolizumab versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to patients with Newly Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In this study, subjects will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy based treatments are standard for patients with ovarian, fallopian tube, or primary peritoneal cancer. In addition to these standard treatments, subjects will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

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Growth problems


A Phase 3, Open-labeled, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly Mod-4023 Compared to Daily Genotropin© Therapy in Pre-pubertal Children with Growth Hormone Deficiency 

The purpose of this study is to compare the effectiveness, safety and handling of the investigational drug MOD-4023 (weekly injections, dose of 0.66 mg/kg/week) to standard of care treatment with Genotropin (daily injections, dose of 0.034 mg/kg/day over one year. The study will include approximately 220 children worldwide. 

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GVHD


A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study of itacitinib or placebo in combination with corticosteroids as first-line treatment of subjects with Grade II to IV aGVHD. Subjects will be randomized 1:1 to itacitinib 200 mg once daily (QD) plus corticosteroids or matching placebo plus corticosteroids. Randomization will be stratified by GVHD risk status (standard risk vs high risk). Subjects will receive randomized study treatment until treatment failure (progression of disease, no response, or requiring additional systemic therapy), unacceptable toxicity, completion of taper, or death. Transfusion support and continued use of anti-infective medications, GVHD prophylaxis medications (including calcineurin inhibitors), and topical steroid therapy is permitted.

GVHD staging and grading will be assessed for efficacy as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria; safety and tolerability will be assessed as per NCI CTCAE v4.03. An independent data monitoring committee will perform an interim analysis for futility once 112 subjects (56 per cohort) have completed the Day 28 visit. If the futility boundary is crossed, the study will be terminated. Otherwise, the primary analysis will be conducted once the last subject completes the Day 28 visit or withdraws from the study. The study will end once 75% of subjects have achieved 2-year transplant-related mortality, have died, or have been lost to follow-up.

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Head and Neck Cancer


A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

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A Two-arm, Open-label, Randomized Phase II Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)

This is a study of pembrolizumab versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.

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Healthy Volunteers


Development of Blood Pressure Imager

Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.

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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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TLR function on alveolar macrophages is altered in the elderly

Perform a pilot study to establish the average and standard deviations from experimental readouts reflective of TLR function in human alveolar macrophages (AM) collected from healthy young and old people.

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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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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 Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF)

This study will evaluate the safety and efficacy of 3 doses of IW-1973 compared with placebo, a drug that looks like the study drug but has none of the active ingredients. During the study participants will be asked to take the drug daily for about 12 weeks, 2 weeks of taking the drug twice-daily followed by 10 weeks of taking the drug once-daily. At the Day 1 Visit, patients will spend about 2 hours going through study required assessments to help determine if they qualify for the study. Once those assessments are finished patients will be randomized, randomly assigned to one of the groups: 10mg study drug, 20mg study drug, 40mg study drug, or placebo daily. After Visit 1 participants will be asked to return to the clinical at Week 4, Week 8, and End of Treatment for study drug administration; safety efficacy, and a few additional assessments; and to receive additional study drug and other supplies, as applicable. Patients will return to the clinic 28 days (day 113+/-7) after their last study drug dose for the final Follow-up Visit. 

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Accuracy of echocardiographic estimation of atrial pressure: A prospective, observational study

The purpose of this study is to determine how accurate transthoracic echocardiogram (echo) is at estimating the pressures within your heart, as compared to the most accurate test of right heart catheterization (RHC, also called "Swan" catheter). Echo is a test that uses ultrasound to get pictures of your heart through an ultrasound probe that is placed on your chest or upper abdomen. RHC is a procedure where a catheter is inserted into your heart through a large vein (in your neck or groin), and the pressures within your heart are measured directly. This study will show us if echo measurements can be used reliability in patients in the future without having to do invasive catheterization. Patients undergoing both echo and RHC, as determined by their doctor, while in the hospital as part of standard medical care will be enrolled in this study. There is no additional testing that will be done as part of this study. 

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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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Non-Invasive Measurement of Capillary Oxygenation during Exercise in Ambulatory Advanced Heart Failure Patients

At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.

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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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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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High Blood Pressure


Development of Blood Pressure Imager

Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.

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Hypertension


Development of Blood Pressure Imager

Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.

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The Dialysate Sodium Lowering Trial (DeSaLT)

This is a pilot randomized clinical triaql in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (na) of 135 mEq/L or a standard dialysate Na or 138 mEq/L.Patients will be randomized 2:! to the low arm. Dialysate Na will be lowered 1 meE1/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hyotension (IDH) episodes (systolic BP <90 or intervention for symptoms of BP drop during dialysis), achievemenbt of dry weight. The trial will last for 6 to 12 monthws, for an individual, depending on when the entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotention episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialystic weight change, symptoms of thirst and dry mouth, self reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extracellular fluid volume (via bioimpedance).

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Hypertrophic Cardiomyopathy


Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS")

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)

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Induced Labor


Using Angle of Progression and Cervical Consistency Index to Predict Induction of Labor Success

The aim of this study is to compare ultrasound measurements from women who undergo successful induction of labor (defined as a vaginal delivery or operative vaginal delivery) with those with failed induction of labor (defined as a cesarean section). We will obtain ultrasound measurements prior to start of induction. Ultrasound measurements that will be measured will be angle of progression (AOP) and cervical consistency index (CCI). We expect to reproduce the finding of other studies and see a narrow angle of progression (<95 degrees) associated with failed induction of labor and a wide angle of progress (>120 degrees) associated with successful induction. We also expect to find an inverse relationship between CCI (measured in %) and induction success. In addition, we hypothesize that the combination of narrow AOP and low CCI has increased positive predictive value for induction sucess.

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Inflammatory Bowel Disease


Metabolic Signature of Colonic Migcroorganisms in Inflammatory Bowel Disease

Characterization of anaerobic microorganisms in the bowel of patients with inflammatory bowel disease.

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Intensive Care


GLO: Glucose and Lactate OptiScanner Study

The objective of this study is to demonstrate that the OptiScanner® can identify elevated and changing blood lactate levels in surgical ICU subjects.

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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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Keratitis


Analysis of Tear Immune Mediators in Herpes Simplex Keratitis and Correlation of In Vivo Confocal Microscopy Nerve Alterations

This study entitled 'Analysis of Tear Immune Mediators in Herpes Simplex Keratitis and Correlation of In Vivo Confocal Microscopy Nerve Alterations' is a new prospective observational study, investigating the correlation between tear immune inflammatory cytokines and neuropeptides and alterations in corneal nerves visualized by in vivo confocal microscopy (IVCM) and conjunctival blood flow analysed by optical coherence tomography angiography (OCTA).

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Kidney Diseases


Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners

Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, we are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.

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Kidney Failure


The Dialysate Sodium Lowering Trial (DeSaLT)

This is a pilot randomized clinical triaql in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (na) of 135 mEq/L or a standard dialysate Na or 138 mEq/L.Patients will be randomized 2:! to the low arm. Dialysate Na will be lowered 1 meE1/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hyotension (IDH) episodes (systolic BP <90 or intervention for symptoms of BP drop during dialysis), achievemenbt of dry weight. The trial will last for 6 to 12 monthws, for an individual, depending on when the entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotention episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialystic weight change, symptoms of thirst and dry mouth, self reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extracellular fluid volume (via bioimpedance).

More

Labor and Delivery


Using Angle of Progression and Cervical Consistency Index to Predict Induction of Labor Success

The aim of this study is to compare ultrasound measurements from women who undergo successful induction of labor (defined as a vaginal delivery or operative vaginal delivery) with those with failed induction of labor (defined as a cesarean section). We will obtain ultrasound measurements prior to start of induction. Ultrasound measurements that will be measured will be angle of progression (AOP) and cervical consistency index (CCI). We expect to reproduce the finding of other studies and see a narrow angle of progression (<95 degrees) associated with failed induction of labor and a wide angle of progress (>120 degrees) associated with successful induction. We also expect to find an inverse relationship between CCI (measured in %) and induction success. In addition, we hypothesize that the combination of narrow AOP and low CCI has increased positive predictive value for induction sucess.

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Leukemia


International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzyme needed for cell growth. Drugs used in chemotherapy, work in different ways to stop growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinin mesylate and combination chemotherapy may work better in treating patients with Philadelphia positive acute lymphoblastic leukemia. 

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Long QT Syndrome


Exercise in Genetic Cardiovascular Conditions (Lifestyle and Exercise in Hypertrophic Cardiomyopathy "LIVE-HCM"/Lifestyle and Exercise in the Long QT Syndrome "LIVE-LQTS")

The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)

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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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Lupus Erythematosus


Open label phase 2 pilot trial of oral tofacitinib in adult subjects with discoid lupus erythematosus (DLE) and systemic Lupus erythematosus (SLE)

Open label phase 2 proof-of-concept trial of oral tofacitinib in adult patients with discoid lupus erythematosus (DLE) lesions and systemic lupus erythematosus (SLE).

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Lyme Disease


Xenodiagnosis after Antibiotic 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 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


Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

This is an open-label, dose-escalation Phase 1/2 Study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regiment, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available. 

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Medulloblastoma


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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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 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low- Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 mAb

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

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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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Myocardial Heart Disease


Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator

The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.

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Nephropathy


A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

ARTEMIS – IGaN is a maximum 160 week a Phase 3 trial evaluating the Safety and Efficacy of OMS721 in patients with Immunoglobulin A (IgA) Nephropathy

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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


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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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


Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) 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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Non-Hodgkin Lymphoma


A Pharmacodynamically-guided, Dose-escalation, Phase I Study to Assess the Safety of AFM11 (Recombinant Antibody Construct Against Human CD19 and CD3) in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL.

Determine whether AFM11 is safe and active in the treatment of relapsed and/or non-responsive Non-Hodgkin Lymphoma (NHL).

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A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen

The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.

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Obesity


Lifestyle Intervention in Preparation for Pregnancy (LIPP)

The aim of this study is to improve the metabolic health of overweight and obese women prior to a planned pregnancy. 

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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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Osteoarthritis


A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo and NSAID-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain due to Osteoarthritis of the Knee or Hip

This study evaluates the efficacy and safety of fasinumab compared to placebo, diclofenac, and celecoxib (diclofenac and celecoxib are standard-of-care non-steroidal anti-inflammatory drugs, NSAIDs, used for moderate-to-severe pain due to OA). The study drug will be administered for up to 24 weeks in patients with OA of the knee or hip. Fasinumab aims to selectively block nerve growth factor (NGF), a protein that causes pain. Blocking NGF may reduce pain due to OA of the hip and knee. Fasinumab is being test and is not approved for use in pain management by the United States Food and Drug Administration (FDA).

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A Cross-sectional Observational Study Evaluating the Effect of intra-Articular Steroids or Placebo Previously Injected in the target Knee Joint of Subjects on structural Progression of Knee Osteoarthritis.

The purpose of the study is to evaluate for long term changes in pain and function in knee osteoarthritis and also to ascertain differences in health care utilization among subjects who participated in the randomized controlled trial on effect of intra-articular steroids on structural progression of knee osteoarthritis (IACS)

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A prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator

The purpose of this research study is to determine the safety and effectiveness of a new treatment for osteoarthritis of the first carpomeetacarpal joint (base of your thumb). The new treatment uses the Cartiva Synthetic Cartilage Implant (Cartiva implant) to replace damaged cartilage in your thumb joint. The most common treatment is called ligament reconstruction tendon interposition (LRTI), where the bone is surgically removed and the joint us stabilized using the surrounding tendons. 

You will need to have the following exam, tests, and procedures to find out if you can be in the study. The exam, tests, and procedures are part of your regular thumb arthritis care and may be done even if you do not join the study. If you have had some of these done recently, they may not need to be repeated. This will be up to your study doctor. 

After surgery you will need to come back for follow up visits. These follow up visits will happen at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and each year up to 5 years after your hand surgery. The procedures performed during these visits are part of your regular thumb arthritis care. 

 

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A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis as Compared to a Ligament Reconstruction Tendon Interposition (LRTI) Comparator

The purpose of this research study is to determine the safety and effectiveness of a new treatment for osteoarthritis of the first carpometacarpal joint (the base of your thumb). The new treatment uses the Cartiva Synthetic Cartilage Implant (Cartiva implant) to replace the damaged cartilage in your thumb joint. The most common treatment is called ligament reconstruction tendon interposition (LRTI), where the bone is surgically removed and the joint is stabilized using surrounding tendons.

You will need to have the following exam, tests, and procedures to find out if you can be in the study. The exam, tests, and procedures are part of your regular thumb arthritis care and may be done even if you do not join the study. If you have had some of these done recently, they may not need to be repeated. This will be up to your study doctor.

After surgery you will need to come back for follow up visits. These visits will happen at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and each year up to 5 years after your hand surgery. The procedures performed during these visits are part of regular thumb arthritis care.

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A Randomized, Double-Blind, Placebo-Controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects with Chronic, Moderate-to severe Osteoarthritis Knee Pain

The study evaluates the analgesic efficacy on pain with walking of a one-time knee injection for patients with moderate to severe knee osteoarthritis. CNTX-4975-05 is the investigational drug that has not been approved by the FDA. The study drug is a long-acting, non-opioid analgesic drug candidate designed to provide pain relieve. Subjects will be randomly assigned to one of two groups: study drug group, or a placebo group.

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Ovarian Cancer


A Phase III, Multicenter, Randomized, Study of Atezolizumab versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to patients with Newly Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In this study, subjects will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy based treatments are standard for patients with ovarian, fallopian tube, or primary peritoneal cancer. In addition to these standard treatments, subjects will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

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Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer

The purpose of this study is to test the effectiveness of the combination of niraparib and pembrolizumab in patients with triple negative breast cancer or ovarian cancer.

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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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Peritoneal Cancer


A Phase III, Multicenter, Randomized, Study of Atezolizumab versus Placebo Administered in Combination with Paclitaxel, Carboplatin, and Bevacizumab to patients with Newly Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In this study, subjects will also receive treatment with paclitaxel, carboplatin, and bevacizumab. These chemotherapy based treatments are standard for patients with ovarian, fallopian tube, or primary peritoneal cancer. In addition to these standard treatments, subjects will receive either atezolizumab or a placebo (in other words, an inactive substance that looks like atezolizumab).

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Pregnancy


Lifestyle Intervention in Preparation for Pregnancy (LIPP)

The aim of this study is to improve the metabolic health of overweight and obese women prior to a planned pregnancy. 

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Maternal lipid metabolism and placental function in early pregnancy

The purpose of this study is to measure the effect of maternal metabolism (how your body uses food for energy) on the growth of the placenta (afterbirth), and how the placenta uses lipids.

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Maternal Metabolic Mediators of infant Adiposity (MaMMA)

The purpose of this study is to measure the effect of maternal diet and metabolism (how your body uses food for energy) on the growth of the baby, and how the placenta uses lipids.

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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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Prostate Cancer


A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients with Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistance prostate cancer (mCRPC)

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative To Placebo Plus Abiraterone Plus Prednisone/Prednisolone In Adult Male Patients With Asymptomatic Or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

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A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

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Psoriatic Arthritis


A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1

This study evaluates the safety and efficacy of the study drug ABT-494 as compared to a current FDA-approved drug, adalimumab, as well as a placebo. ABT-494 aims to inhibit the JAK1, which is partially responsible for inflammation associated with psoriatic arthritis. Although ABT-494 is not FDA approved, it has seen success in the first 2 phases of trials.

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Tufts Spondyloarthritis Registry

This is an observational study of people who have spondyloarthritis. This includes diseases such as ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease associated arthritis. Those in the registry must be patients of providers in the Tufts rheumatology clinic. 

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Pulmonary Hypertension


206246 : An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension

The purpose of this study is to test the safety of different doses of the study drug (GSK2586881) to find out if it causes any changes to the pressures inside the heart and lungs of patients who have Pulmonary Arterial Hypertension (PAH).

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A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Arterial Hypertension

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 16 weeks of study participation.

This is a two-part study.

Part 1: Part 1 of the study will include both dose-escalation and expansion cohorts.

Part 2 (extension period): All patients from Part 1 who complete the 16-week treatment period as planned will be eligible to continue directly into the extension period to evaluate the intermediate and long-term safety and efficacy of bardoxolone methyl.

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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


A Phase 2/3 Trial of the Efficacy and Safety of Bardolxolone Methyl in Patients with Alports Syndrome

CARDINAL is a Phase 2/3 clinical study evaluating the safety and effectiveness of bardoxolone methyl (an oral investigational drug) for the treatment of Alport syndrome

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Seizures


A Phase 2a, Safety, Tolerability, Pharmacokinetics and Quantitative EEG Study of CX-8998 in Adolescents and Young Adults with Generalized Epileptic Syndromes with Absence Seizures

This is a 9-week, phase 2a, multicenter, double-blind, placebo-controlled, parallel-group study in young adults with generalized epileptic syndromes with absence seizures. The primary objective of the study is to determine the safety and tolerability of the study drug, CX-8998.

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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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Sickle Cell Disease


Abatacept for Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease: A Sickle Transplant Alliance for Research Trial

To assess the tolerability of the costimulation blocking agent abatacept (CTLA4-lg) when added to the standard graft versus host disease (GVHD) prophylaxis regimen of a calcineurin inhibitor and methotrexate in patients receiving early alemtuzumab followed by fludarabine, thiotepa, melphalan, and alemtuzumab for conditioning. 

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Solid Tumors


Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

This is an open-label, dose-escalation Phase 1/2 Study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regiment, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available. 

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Squamous Cell Carcinoma


A Randomized Double-blind Phase 3 Study of Avelumab In Combination With Standard of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard of Care Chemoradiotherapy in the Front-line Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

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A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

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Strabismus


Do Strabismus Measurements Change After Pupil Dilation and Cycloplegia in Children

The aim of our investigation is to determine whether strabismus measurements change significantly after dilation whit cyclopentolate ophthalmic drops in children. The impetus for this study is a recent report published in the American Journal of Ophthalmology, which concluded that in adults, strabismus measurements do not significantly change after dilation with tropicamide and phenylephrine. We would like to replicate this study in a pediatric population with cyclopentolate.

In a hospital or clinical learning institution, there may be multiple clinicians who evaluate a pediatric patient. Because so much of strabismus management is predicated upon the results of cover testing, it is common to ask the attending to repeat the measurement, based on the belief that strabismus measurements can change after dilation. If the results of the aforementioned report were applied to the pediatric population, it could dramatically affect the current standard of care. We want to ensure providers are using the most accurate measurements in their treatment of eye turn.

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Stroke


AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

Abbott developed the AMPLATZER™  PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain. 

The safety and effectiveness of the AMPLATZER PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER PFO Occluder received market approval by FDA on October 28, 2016.

The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER PFO Occluder in a post approval setting. 

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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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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


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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Vitamin D Deficiency


Vitamin D to Improve Outcomes by Leveraging Early Treatment

A randomized, double-blinded, placebo-controlled, phase III trial (up to maximum n=3000) of early vitamin D3 in vitamin D deficient patients at high risk of ARDS and mortality

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