Clinical Trials at Tufts MC and Floating Hospital

211 result(s) found

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.

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.

Abdominal Infection

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.

Abdominal Infection

Acute Myeloid Leukemia

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

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

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

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.

Amyloidosis

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.

Amyloidosis

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

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

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

Amyloidosis

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.

Anesthesia

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.

Ankylosing Spondylitis

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.

An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

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

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

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

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

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

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

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

Asthma

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.

Atopic Dermatitis

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.

Atrial Fibrillation

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.

Autism

Blood Stream Infection

Neonatal Salivary Transcriptomics

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

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

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

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

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

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

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

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.

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.

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.

Brain Tumors

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

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)

Mammography - Accuracy Using Optical Mammography

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

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.

Preventing Anthracycline Cardiovascular Toxicity with Statins

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

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.

Evaluating Neuropsychological and Psychological Screening in Cancer Survivors

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

Cancer

Cardiac Failure

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

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

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

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

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

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

Characterizing HIV-related Diastolic Dysfunction

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

Entresto^tm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

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

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.

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

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

Subcutaneous Furosemide in Acute Decompensated Heart Failure

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

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

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

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

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

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

Characterizing HIV-related Diastolic Dysfunction

Entresto^tm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

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

Subcutaneous Furosemide in Acute Decompensated Heart Failure

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.

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

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

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

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

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

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

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.

Cardiovascular Disease

Characterizing HIV-related Diastolic Dysfunction

Entresto^tm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

Subcutaneous Furosemide in Acute Decompensated Heart Failure

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

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.

Cesarean Section

Childbirth

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

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

Childbirth

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).

Chronic Kidney Disease

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

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

Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

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

Preventing Anthracycline Cardiovascular Toxicity with Statins

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.

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.

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

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

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.

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.

Crohn's Disease (Floating)

Cystic Fibrosis

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

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

Cystic Fibrosis

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)

Cystoid Macular Edema

Developmental Disabilities

A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

Neonatal Salivary Transcriptomics

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

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

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

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.

Dislocations

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.

Eosinophilic Disorders

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.

Eosinophilic Esophagitis

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.

Epilepsy

Cognitive Debriefing and Usability Testing of an Epilepsy Seizure Diary

Evaluation of a seizure diary.

Epilepsy

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).

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

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

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

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.

Growth problems (Floating)

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.

GVHD

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.

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.

Head and Neck Cancer

Healthy Volunteers

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

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.

Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

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.

Healthy Volunteers

Safe and effective delivery of supplemental iron to healthy volunteers

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

Healthy Volunteers

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

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

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

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

Our hypothesis is adolescents who engage in NSSI behaviors and/or sharing of sexually explicit material spend greater amounts of time on social media than adolescents who do not engage in NSSI behaviors and/or sharing of sexually explicit materials

Healthy Volunteers

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.

Healthy Volunteers

Heart Diseases

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

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.

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

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

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

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

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

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.

Heart Failure

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

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

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

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

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

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.

Heart Failure

Characterizing HIV-related Diastolic Dysfunction

Entresto^tm (LCZ696) In Advanced Heart Failure (LIFE Study) (HFN-LIFE)

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

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

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

Subcutaneous Furosemide in Acute Decompensated Heart Failure

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

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.

Heart Transplantation

High Blood Pressure

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

Development of Blood Pressure Imager

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

Characterizing HIV-related Diastolic Dysfunction

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

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

Hodgkin Lymphoma

Hypertension

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

Development of Blood Pressure Imager

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).

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)

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.

Metabolic Signature of Colonic Migcroorganisms in Inflammatory Bowel Disease

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

Inflammatory Bowel Disease

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.

Intensive Care

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.

Intracranial Pressure

Juvenile Idiopathic Arthritis

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

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

Juvenile Idiopathic Arthritis (Floating)

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).

Keratitis

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.

Kidney Diseases

Kidney Failure

The Dialysate Sodium Lowering Trial (DeSaLT)

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

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

Knee Injuries and Disorders

Labor and Delivery

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

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

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

Leptomeningeal Metastases

Leukemia

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

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.

Leukemias (Pediatric)

Liver Diseases

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

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)

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

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

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

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).

Lupus Erythematosus

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.

Lyme Disease

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.

Preventing Anthracycline Cardiovascular Toxicity with Statins

Mammography - Accuracy Using Optical Mammography

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

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

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.

Mild Cognitive Impairment

Mood Disorders

An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

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

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).

Multiple Myeloma

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

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

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

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

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

Multiple Myeloma

Characterization of T Cell Distribution in Stem Cell Mobilization

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).

Myelodysplastic Syndromes

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.

Myocardial Heart Disease

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.

Nephrotic Syndrome (Floating)

Neuroblastoma

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

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.

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)

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).

Non-Hodgkin 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

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.

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.

Obesity

Obstetric Anesthesia

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

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

Obstetric Anesthesia

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).

Osteoarthritis

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)

Osteoarthritis

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.

Osteoarthritis

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.

Osteoarthritis

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

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

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

Ovarian 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.

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

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

Pancreatic Cancer

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.

Parkinson's Disease

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

The purpose of this study is:

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

Parkinson's Disease

Pelvic Pain

Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

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

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

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

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

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

Polycystic Kidney Disease

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

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

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

What is the Open Label study?

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

Who can participate?

You may be able to join the study if you:

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

What is the investigational medication?

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

What are the potential risks and benefits?

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

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

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

Polycystic Kidney Disease

Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease

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

Polycystic Kidney Disease

Post-Operative Pain

Postoperative Pain Management in Minimally Invasive Gynecologic Surgery

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

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.

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.

Pregnancy

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.

Pregnancy

Premature Babies

Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

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

Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

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.

Premature Birth (Floating)

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)

Prostate Cancer

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

Prostate Cancer

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.

Prostate Cancer

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.

Psoriatic Arthritis

Tufts Spondyloarthritis Registry

An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

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).

Pulmonary Hypertension

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.

Pulmonary Hypertension

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

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

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

Pulmonary Hypertension

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.

Pulmonary Vascular Resistance

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

Biological Determinants of Peritoneal Dialysis

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

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

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

Renal Disease

Coherent Hemodynamics Spectroscopy

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

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

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

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

Renal Disease

Rheumatoid Arthritis

Pathogenic role of autoreactive anergic B cells in Rheumatoid Arthritis

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

Rheumatoid Arthritis

Rheumatologic Conditions

Observational Study for Pediatric Rheumatic Disease: The CARRA Registry Study

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

Rheumatologic Conditions

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.

Seizures

A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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.

Sickle Cell Disease

Solid Tumors

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

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

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

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

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.

Strabismus

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.

Stroke

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

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

Stroke

Ulnar Neuropathy

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

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

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

Vitamin D Deficiency

Wound Care

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

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

Wound Care

Search Clinical Trials

211 result(s) found

Abdominal Aortic Aneurysm

Abdominal Infection

Acute Myeloid Leukemia

Alports Syndrome

Amyloidosis

Anesthesia

Ankylosing Spondylitis

Anxiety

Asthma

Atopic Dermatitis

Atrial Fibrillation

Autism

Blood Stream Infection

Brain Cancer

Brain Malformations

Brain Tumors

Breast Cancer

Burkitt Lymphoma

Cancer

Cardiac Failure

Cardiomyopathy

Cardiovascular Disease

Cesarean Section

Childbirth

Chronic Kidney Disease

Chronic Pain

Congestive Heart Failure

Constipation

Contact Lens Discomfort

Corneal Pain

Coronary Artery Disease

Crohn's Disease

Cystic Fibrosis

Cystoid Macular Edema

Developmental Disabilities

Diabetes Type 2

Dislocations

Eosinophilic Disorders

Eosinophilic Esophagitis

Epilepsy

Fallopian Tube Cancer

Fractures

Growth problems

GVHD

Head and Neck Cancer

Healthy Volunteers

Heart Diseases

Heart Failure