Search Clinical Trials

202 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.

• Aortic Aneurysm
• Abdominal Aortic Aneurysm
• Healthy Volunteers

Abdominal Infection

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

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

• 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 intra abdominal infections.

• Abdominal Infection

Acute Lymphocytic Leukemia

A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Acute Lymphoblastic Leukemia

The purpose of this study is to evaluate whether structured social interaction and rewards increases the effects of a web-based physical activity intervention among children and adolescents following treatment for Acute Lymphoblastic Leukemia (ALL)

• Acute Lymphocytic Leukemia

Anesthesia

A Prospective Randomized Trial of Durapore vs. Hy-Tape to secure the Endotracheal Tube During Anesthesia

Protective tape is used during general anesthesia in order to secure the endotracheal tube with no preference for one or the other. In this study, we will compare two tapes, Durapore™ and Hy-Tape® to determine if one is less likely to cause skin 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. 

• Ankylosing Spondylitis
• Psoriatic Arthritis

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.

• Aortic Aneurysm
• Abdominal Aortic Aneurysm
• Healthy Volunteers

Arthritis

Neurobiological Mechanisms of Mind-body Therapy for Knee Osteoarthritis

This study aims to provide crucial knowledge about the neurobiological mechanisms underlying mind-body therapy for knee osteoarthritis (OA). We will investigate the central mechanism of knee OA pain using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time.

Participants will be randomized to either a Tai Chi or Wellness Education class and asked to come to Tufts Medical Center twice a week for 12 weeks, along with a baseline and follow-up visit (26 study visits). The findings will lead to the establishment of a new treatment paradigm in OA and have broad application to the management of chronic musculoskeletal pain.

• Arthritis
• Osteoarthritis

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

Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation

The primary aim of the study is to determine if patients with permanent AF who meet conventional criteria for CRT and undergo AVJ ablation have reduced ventricular remodeling (i.e. echocardardiographic improvement of LV end systolic volume), a potent marker of subsequent clinical deterioration, compared to patients who do not undergo AVJ ablation. This study is designed to test feasibility of enrollment and short-term improvement in surrogate endpoints, with anticipation of a full-scale large randomized clinical trial using hard outcome events if this phase is promising. 

• Atrial Fibrillation
• Cardiac Arrhythmia

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

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 fullv considers the preferences, values, and treatment goals of families, regardless of their racial/ethnic background. 

• Autism

Bone Marrow Transplantation

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES)

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

• Bone Marrow Transplantation

Brain Malformations

A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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

• Seizures (Floating)
• Brain Malformations (Floating)
• Developmental Disabilities (Floating)

Brain Tumors

A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

• Brain Tumors
• Breast Cancer

Breast Cancer

A Phase III Trial Of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) For 5-15 Brain Metastases

This is an international multi-centre, open-label, randomized phase III trial comparing stereotactic radiosurgery (SRS) to whole brain radiotherapy (WBRT) in patients with 5 to 15 brain metastases.

Primary Objectives

• To compare the overall survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

• To compare the neurocognitive progression-free survival in patients with five to fifteen brain metastases who receive SRS compared to patients who receive WBRT.

Secondary Objectives

Patient/treatment Related Secondary Outcomes

• To compare time to central nervous system (CNS) failure (local, distant, and leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate if there is any difference in CNS failure patterns (local, distant, or leptomeningeal) in patients who receive SRS compared to patients who receive WBRT.

• To evaluate number of salvage procedures following SRS in comparison to WBRT.

• To evaluate the individual cognitive test results following SRS in comparison to WBRT.

• To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.

• To evaluate the time delay to (re-)initiation of systemic therapy in patients receiving SRS in comparison to WBRT.

• To prospectively validate a predictive nomogram for distant brain failure [Ayala-Peacock 2014].

Economic Endpoints

• To compare the estimated cost of brain-related therapies in patients who receive SRS compared to patients who receive WBRT:

- Comparison based on payer rates (Medicare for US / provincial heath authorities in Canadian jurisdictions with activity-based funding).

Quality of Life Endpoints

• To evaluate patient’s quality of life, as assessed by the EORTC QLQ-C30 + BN20, EQ-5D, ECOG performance status, for those who receive SRS compared to those who receive WBRT.

Translational Endpoints

• Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.

• Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes.

Imaging/Dosimetric Endpoints

• Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis (hippocampal dosimetry will be retrospectively assessed).

• Collect imaging parameters and workflow details relating to the radiosurgery planning MRIs (including timing of MR prior to radiosurgery, magnet field strength, contrast type/dose/timing, use of image post-processing, and formal reviewed by radiology) to be prospectively correlated with tumour control outcomes (local control, intracranial control).

• Evaluate serial changes in imaging features found in routine MRI images (T2w changes, morphometry) that may predict tumour control and/or neurocognitive outcomes

• Brain Tumors
• Breast Cancer

Cancer

A Pilot Study to Assess an Oral Anti-Cancer Medication Initiative

The use of oral anti-cancer medication to treat cancer has been increasing over time and is expected to continue to increase in the future. The use of these medicines can be challenging for patients and their families, their clinical team, and health care systems. Because these medications are administered at home, patients and their families are responsible for taking the medicines when they are supposed to, safely handling and storing the medicines, and knowing how to check for side effects. This study will ask questions to understand more about patient experiences with oral anti-cancer medication so we can develop programs to improve our support and education of patients in the future.

• Cancer

Evaluating Neuropsychological and Psychological Screening in Cancer Survivors

The overall aim of this research project is to assess the feasibility and performance of neuropsychological and psychological screening measures completed by adolescents and young adults (AYA), and adults, who receive care at the Reid R. Sacco A YA 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 impairment and (2) the Brief Symptom lnventory-18 (BSI), a screener for psychological distress. The results from these well-validated screeners will guide future care for these participants at Tufts MC and beyond. 

• Cancer

Cancer in Children

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

The Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) directly addresses the need for the next generation of clinical trials for hepatic malignancies, incorporating rational reductions in therapy that ameliorate both short and long-term side effects for patients with good prognoses while simultaneously optimizing curative potential with intensification and new agent integration to improve outcomes for those with poor prognoses. This trial is the first international cooperative liver tumors trial in which a consensus approach was established by investigators representing Children's Oncology Group (COG), Societe Internationale d'Oncologie Pediatrique - Epithelial Liver Tumor Study Group (SIOPEL) and the Japanese Children's Cancer Group (JCCG). The study builds on treatment strategies established by the most recent trials from each of the individual consortia - COG (AHEP0731 ), SIOPEL (SIOPEL 3 and 4) and Japanese Pediatric Liver Tumor study group (JPLT2), but provides new approaches to all stages of HB and HCC patients keeping the aforementioned goals in focus. A critical aspect of this trial is the opportunity to correlate histologic and biologic heterogeneity with response and outcomes in all risk categories, providing promise for future refinement to the newly proposed risk stratification schema. 

• Hepatoblastoma (Floating)
• Cancer in Children (Floating)

Cardiac Arrest

Acute Hemodynamics in Patients on AMCS

This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock. 

• Cardiac Failure
• Cardiac Arrest

Cardiac Arrhythmia

Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation

The primary aim of the study is to determine if patients with permanent AF who meet conventional criteria for CRT and undergo AVJ ablation have reduced ventricular remodeling (i.e. echocardardiographic improvement of LV end systolic volume), a potent marker of subsequent clinical deterioration, compared to patients who do not undergo AVJ ablation. This study is designed to test feasibility of enrollment and short-term improvement in surrogate endpoints, with anticipation of a full-scale large randomized clinical trial using hard outcome events if this phase is promising. 

• Atrial Fibrillation
• Cardiac Arrhythmia

Cardiac Failure

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

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

• Heart Failure
• Cardiovascular Disease
• Cardiac Failure

A 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 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.

• Cardiomyopathy
• Cardiac Failure
• Heart Failure
• Cardiovascular Disease

Acute Hemodynamics in Patients on AMCS

This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock. 

• Cardiac Failure
• Cardiac Arrest

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 being 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 failure and 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.

• Cardiac Failure
• Cardiovascular Disease
• Heart Failure
• Cardiomyopathy

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

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

• Cardiac Failure
• Cardiomyopathy
• Cardiovascular Disease
• Heart Failure

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.

• Heart Failure
• Cardiomyopathy
• Cardiac Failure

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

• Cardiovascular Disease
• Cardiac Failure
• Heart Diseases
• Valvular Heart Disease
• Heart Failure

Cardiomyopathy

A 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 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.

• Cardiomyopathy
• Cardiac Failure
• Heart Failure
• Cardiovascular Disease

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 being 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 failure and 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.

• Cardiac Failure
• Cardiovascular Disease
• Heart Failure
• Cardiomyopathy

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

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

• Cardiac Failure
• Cardiomyopathy
• Cardiovascular Disease
• Heart Failure

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.

• Heart Failure
• Cardiomyopathy
• Cardiac Failure

Cardiovascular Disease

HeartMate PHP™ Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

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

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

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

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

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

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

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

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

• Cardiovascular Disease
• Coronary Artery Disease
• Heart Diseases

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

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

• Heart Failure
• Cardiovascular Disease
• Cardiac Failure

A 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 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.

• Cardiomyopathy
• Cardiac Failure
• Heart Failure
• Cardiovascular Disease

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

Connected Insights

Prospective observational study to assess association between time in target Flowtrac/EV1000 data with clinical outcomes in cardiac surgery patients (Connected Insights). The new study application will investigate a minimally invasive device (Flotrac sensor with EV1000 clinical platform) from Edwards Life Science in cardiac surgery patients.  The EV1000 device is already being used at Tufts Medical Center in the operating rooms and ICUs to guide fluid resuscitation and medicine administration in critically ill patients.

• Cardiovascular Disease

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 being 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 failure and 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.

• Cardiac Failure
• Cardiovascular Disease
• Heart Failure
• Cardiomyopathy

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

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

• Cardiac Failure
• Cardiomyopathy
• Cardiovascular Disease
• Heart Failure

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

• Cardiovascular Disease
• Cardiac Failure
• Heart Diseases
• Valvular Heart Disease
• Heart Failure

Cesarean Section

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

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

• Cesarean Section

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.

• Chronic Kidney Disease
• Diabetes Type 2

Development of a Serum Quality Control Pool for Kidney Function Biomarkers

The main aim of this research study is to create materials to make sure that one of the blood
tests we use to measure kidney function are correct. The College of American Pathologists (CAP) surveys
laboratories as part of their proficiency testing program. This survey involves sending out quality control (QC)
samples to clinical laboratories who measure this in patient to make sure that their results are accurate.

• Chronic Kidney Disease

Clostridium Difficile Infection

ECOSPOR Ill: A Phase 2 Multicenter, RandomizeEd, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of SER-109 vs. Placebo to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adults Who Have Received Antibacterial Drug Treatment for Recurrent CDI (RCDI) 

ECOSPOR Ill is a Phase 3, multicenter, randomized, double-blind, placebo- controlled, parallel-group study of the safety, tolerability, and efficacy of SER-109 versus placebo in adult subjects 18 years of age or older with recurrent CDI, defined as: a history of;:: 3 CDI episodes within 12 months, inclusive of the current episode. This study is designed to demonstrate the superiority of SER-109 versus placebo to reduce recurrence of Clostridium difficile infection (CDI) in adults who have received antibacterial drug treatment for recurrent CDI (RCDI), based on the proportion of subjects experiencing a CDI recurrence requiring antibiotic treatment up to 8 weeks after initiation of treatment. 

• Clostridium Difficile Infection

ECOSPOR IV: An Open-Label Extension of Study SERES-012 Evaluating SER-109 in Adult Subjects with Recurrent Clostridium difficile Infection (RCDI) 

ECOSPOR IV is an open-label extension of Study SERES-012. This study is designed to evaluate the safety, tolerability, and efficacy of a SER-109 treatment regimen in adult subjects 18 years of age or older with recurrent Clostridium difficile infection (RCDI), who received a SER-109 or placebo treatment regimen in Study SERES-012. 

• Clostridium Difficile Infection

Constipation

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

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

• Constipation
• Lower GI Tract Paralysis

Contact Lens Discomfort

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

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

• Contact Lens Discomfort
• Corneal Pain

Corneal Disorders

Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain 

Patients that suffered from neuropathic pain or photoallodynia, reported immediate relief of pain after use of TrueTear® intranasal neurostimulator (ITN). We propose a pilot study for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims: 

• To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal patients.
• To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal patients during a 90-day period with daily use.
• o assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.

• Corneal Pain
• Corneal Disorders

Corneal Pain

Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain 

Patients that suffered from neuropathic pain or photoallodynia, reported immediate relief of pain after use of TrueTear® intranasal neurostimulator (ITN). We propose a pilot study for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims: 

• To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal patients.
• To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal patients during a 90-day period with daily use.
• o assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.

• Corneal Pain
• Corneal Disorders

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.

• Contact Lens Discomfort
• Corneal Pain

The Utility of In-Office Pain Tests to Distinguish Patients with Neuropathic Corneal Pain from Patients with Dry Eye Disease 

We propose to develop an economic in-office pain tests that may help screen and differentiate patients with neuropathic corneal pain (NCP) that could be used at any ophthalmic office. These five in-office pain tests include response with filter glasses, moisture googles, cold saline, hypertonic saline and topical proparcaine. The current study will serve as validation for clinical diagnosis of NCP among dry eye disease (DED) patients and will subsequently be conducted in larger population studies. Identification of patients with NCP would prevent unnecessary drug treatment failures and improved response rate of DED patients to therapies, such as Lifitigrast.

• Dry Eye
• Corneal Pain

Coronary Artery Disease

HeartMate PHP™ Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

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

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

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

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

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

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

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

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

• Cardiovascular Disease
• Coronary Artery Disease
• Heart Diseases

Covid-19

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

The purpose of this study is to provide Remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens compared to standard of care (SOC), with respect to the proportion of participants discharged on or before Day 14

• Covid-19

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19

The purpose of this study is to provide remdesivir (RDV) to participants with severe COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to the normalization of temperature and oxygen saturation through Day 14.

• Covid-19

An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients with COVID-19

This study is an adaptive Phase 2/3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of sarilumab in hospitalized adults with severe or critical COVID-19. The study will be conducted in the United States (US) in up to 50 sites. Patients will be randomized in a 2:2:1 ratio to sarilumab 400 mg IV, 200 mg IV, or placebo in a stratified manner. Randomization will be stratified by severity of illness (severe, critical, multi-system organ dysfunction) and use of systemic corticosteroids for COVID-19

• Covid-19

A Phase 2 Trial Of Infliximab In Coronavirus Disease 2019 (Covid-19)

This study is a prospective, single center, phase 2 trial to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

• Covid-19

National Registry of COVID-19 Convalescent Patients

This patient registry aims to recruit people who have recovered following infection with SARS-CoV-2 / COVID-19 for the purpose of connecting them with researchers in the United States who are conducting research to learn about the survivor experience, and develop new treatments for patients currently with the illness.

• Covid-19

Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide

The purpose of this study is to investigate the potential for inhaled NO to reduce clinical worsening of hospitalized, high-risk patients with early COVID-19 to progressive systemic de-oxygenation, intubation, and death. This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in hospitalized patients with COVID-19 at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age  60 years, type II DM, hypertension, and obesity.

• Covid-19

Crohn's Disease

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

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

• Crohn's Disease (Floating)

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

Depression

Generating Evidence to Inform a Value Framework for Major Depression

The goal of this study is to understand what people with depression value from their medication and what they consider when making treatment decisions.  We will interview patients about what improvement with medication means for them and how they decide what treatment to use.

• Depression
• Major Depression

Dermatomyositis

Prospective, Double-Blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients with Dermatomyositis 

This study evaluates the beneficial effect of Octagam 10% given every 4 weeks compared to placebo in subjects with active dermatomyositis. Octagam 10% is an immune globlulin that is administered intravenously. Subjects will be randomly assigned to one of two groups: study drug group that will receive Octagam 10%, or a placebo group that will receive saline solution.

• Dermatomyositis

Developmental Disabilities

A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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

• Seizures (Floating)
• Brain Malformations (Floating)
• Developmental Disabilities (Floating)

Diabetes Type 2

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

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

• Chronic Kidney Disease
• Diabetes Type 2

Diabetic Eye Problems

A Phase Ill, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients with Diabetic Macular Edema (RHINE) 

This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 when dosed every 8 weeks (Q8W) and with a personalized treatment interval (PTI) regimen compared with aflibercept (Eylea®) monotherapy in patients with diabetic macular edema (DME).

• Diabetic Eye Problems

Dislocations

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

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

• Dislocations

Dry Eye

A Single-Center,  Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

The IMPERIAL Study is a Phase 2, single-center, randomized, controlled, masked study including 45 subjects with Dry Eye Disease (DED). The purpose of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED. The OC-01 Nasal Spray (varenicline tartrate) is an investigational drug intended to treat Dry Eye Disease. 

• Dry Eye

The Utility of In-Office Pain Tests to Distinguish Patients with Neuropathic Corneal Pain from Patients with Dry Eye Disease 

We propose to develop an economic in-office pain tests that may help screen and differentiate patients with neuropathic corneal pain (NCP) that could be used at any ophthalmic office. These five in-office pain tests include response with filter glasses, moisture googles, cold saline, hypertonic saline and topical proparcaine. The current study will serve as validation for clinical diagnosis of NCP among dry eye disease (DED) patients and will subsequently be conducted in larger population studies. Identification of patients with NCP would prevent unnecessary drug treatment failures and improved response rate of DED patients to therapies, such as Lifitigrast.

• Dry Eye
• Corneal Pain

Emergency Services

Analyzing the Experiences of Frequent Emergency Department Utilizers and Emergency Department Providers 

A mixed methods study entailing quantitative analysis of a survey distributed among 100 providers in the Tufts Medical Center Emergency Department, defined as Physicians (MD/DO), Physician Assistants (PA), Registered Nurses (RN), Social Workers (SW), and Patient Care Technicians (PCT). Additionally, there will be concurrent qualitative analysis of semi-structured, in-depth interviews with frequent emergency department utilizers, defined as greater-than-or-equal-to 4 ED visits in the past year. 

• The first aim is to characterize and examine the lived experience of frequent emergency department utilizers. This will help to understand and analyze the barriers and underlying determinants to overutilization.
• The second aim is to characterize and examine the relationship of emergency department personnel to frequent emergency department utilizers. This will help identify discrepancies in perceived appropriate use between ED personnel and frequent ED utilizers, while also identifying potential precipitants to burnout.

• Emergency Services

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

FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo- controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis 

FLUTE is a randomized, double-blind, placebo-controlled dose-ranging study of 4 total dailydoses of APT-1011 versus placebo in 100 adult subjects (at least 18 years of age) diagnosed with EoE. During the single-blind run-in/baseline symptom assessment, the subjects will receive placebo 30 minutes after breakfast and HS (at bedtime). APT-1011 will be administered in 4 doses: Placebo 30 minutes after breakfast and 1.5 mg HS (at bedtime), 1.5 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 3 mg), 3 mg HS (at bedtime), and 3 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 6 mg), compared with matching placebo administered 30 minutes after breakfast and HS (at bedtime). The randomization scheme is discussed in Section 4.1.5.2. Efficacy (histological response), safety, and PK of APT-1011 will be examined. 
FLUTE will enroll around 100 adult (at least 18 years of age) subjects (see Section 8.1 for a discussion of the potential number of subjects to participate in each part). 
FLUTE is planned to be performed at approximately 60 active sites in North America (US and Canada) and Western Europe (Belgium, Germany and Spain). The study will be conducted in several parts (Screening, 4-week single-blind placebo run-in and Baseline Symptom Assessment, and 2 treatment parts [Part 1 and Part 21) with a Follow-up Visit to occur 2 weeks after the final dose of study drug. Subjects who enter and complete FLUTE will be in the study for up to 62 weeks until the last subject completes Week 28. 

• Eosinophilic Esophagitis
• 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 solely 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

FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo- controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis 

FLUTE is a randomized, double-blind, placebo-controlled dose-ranging study of 4 total dailydoses of APT-1011 versus placebo in 100 adult subjects (at least 18 years of age) diagnosed with EoE. During the single-blind run-in/baseline symptom assessment, the subjects will receive placebo 30 minutes after breakfast and HS (at bedtime). APT-1011 will be administered in 4 doses: Placebo 30 minutes after breakfast and 1.5 mg HS (at bedtime), 1.5 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 3 mg), 3 mg HS (at bedtime), and 3 mg BID (30 minutes after breakfast and at bedtime; total daily dose of 6 mg), compared with matching placebo administered 30 minutes after breakfast and HS (at bedtime). The randomization scheme is discussed in Section 4.1.5.2. Efficacy (histological response), safety, and PK of APT-1011 will be examined. 
FLUTE will enroll around 100 adult (at least 18 years of age) subjects (see Section 8.1 for a discussion of the potential number of subjects to participate in each part). 
FLUTE is planned to be performed at approximately 60 active sites in North America (US and Canada) and Western Europe (Belgium, Germany and Spain). The study will be conducted in several parts (Screening, 4-week single-blind placebo run-in and Baseline Symptom Assessment, and 2 treatment parts [Part 1 and Part 21) with a Follow-up Visit to occur 2 weeks after the final dose of study drug. Subjects who enter and complete FLUTE will be in the study for up to 62 weeks until the last subject completes Week 28. 

• Eosinophilic Esophagitis
• Eosinophilic Disorders

Epidermolysis Bullosa

Epithelial thickness mapping with anterior segment optical coherence tomography (AS-OCT) in patients with epidermolysis bullosa 

Recessive dystrophic epidermolysis bullosa (RDEB) causes recurrent corneal abrasions, scarring and vision loss in the majority of patients. Treatment is supportive and there is no cure. One major limitation of therapeutic testing is the lack of established clinical tools for quantifying the severity of corneal disease. Clinicians rely solely on slit lamp exams and subjective reports of frequency and duration of symptoms. These parameters have not been correlated with visual outcomes or any other objective metrics. In the RDEB mouse model, the corneal epithelium is thickened (hypertrophied) in areas of prior injury, blistering or abrasion. It stands to reason that patients with EB may also show epithelial hyperplasia if the ocular surface was recently injured, blistered or abraded. New technology that measures epithelial thickness with anterior segment OCT (AS- OCT) may offer a no-risk, clinically viable tool to quantify severity of disease. Development of this powerful non-invasive tool would allow clinicians to monitor epithelial changes in response to treatments. It could have widespread application for assessment of other diseases of the corneal surface including aniridic pannus and chemical injury. 

• Epidermolysis Bullosa

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

Fetal Abnormalities

Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test

The objective of this specimen collection protocol is to obtain whole blood specimens from women with viable pregnancies of at least 10 weeks pregnancy (at any 
risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs).

• Fetal Abnormalities

Glaucoma

Discovery Approach to Ocular Hypertension

Eligible subjects are selected from a registry maintained by the Clinical Site: Cornea Research Foundation of America (CRFA) In Indianapolis. Registry patients are individuals who underwent corneal surgery at the Price Vision Group and whose intraocular pressure was tracked over at least a 6-month period following their surgery and follow-up treatment with steroids. The patients" clinical data resides in the registry. Thus, ONLY CRFA registry patients are eligible for recruitment to the study. Selected registry patients that meet all inclusion/exclusion criteria are phoned, the study is explained, and if they agree to participate they are mailed a consent form. The signed form is returned to CRFA by mail. Enrolled subjects are then mailed a saliva collection kit. Patients mail their filled kits to the Laboratory Site, previously USC, now Tufts Medical Center. DNA will be prepared, and DNA analysis will be performed at Tufts Medical Center. DNA will be stored at Tufts Medical Center. Statistical analysis to associate patient clinical data to DNA genotype will be performed at the Statistical Site: the University of Illinois Chicago. 

• Glaucoma

Growth problems

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

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

• Growth problems (Floating)

Hand Osteoarthritis

Cross-Sectional Observational Study Evaluating the Use of Ultrasound to Evaluate the Hands of People with and without Symptomatic Hand Osteoarthritis to Examine the Extent and Severity of US-Detected Synovitis and the Relationship Between Symptoms and Structural Abnormalities. 

The purpose of this study is to learn more about the relationship between synovitis (swelling and inflammation of the joint lining) and pain in persons with symptomatic and non-symptomatic hand osteoarthritis by using ultrasonography (US). 

• Hand Osteoarthritis

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.

• Head and Neck Cancer
• Squamous Cell Carcinoma

Healthy Volunteers

Development of Blood Pressure Imager

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

• Healthy Volunteers
• High Blood Pressure
• Hypertension

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.

• Aortic Aneurysm
• Abdominal Aortic Aneurysm
• Healthy Volunteers

Examining Teacher and Student Ratings of Student Behavior

The purpose of this study is to investigate the treatment sensitivity of the multi-item DBR scales (a hybrid between rating scales and direct observation) (henceforth referred to as "DBR-MIS'') through a series of single-case intervention studies. That is, we wish to examine whether the DBR-MIS measures are sensitive to changes in student behavior. The single-case studies will use an A-B design across subjects to evaluate the effects of medication intervention on internalizing behaviors ( e.g., worries, sad), social behaviors (e.g., reluctant to join others, avoidant), and externalizing behaviors (e.g., disruptive, oppositional). It is hypothesized that changes in these behaviors will be reflected in the DBR-MIS ratings completed by classroom teachers and the students themselves (if age 8 and above). Secondary aims include looking at teacher and student concordance on the DBR-MIS measures in the instances when both the teacher and the student ( of appropriately determined age) will be completing the brief rating scales. 

• Healthy Volunteers

Pilot study of virtual reality device to test distance visual acuity in children and adults

This study aims to test the ability of a virtual reality device to measure distance vision compared to the vision testing systems currently used at the Pediatric Ophthalmology clinic at Tufts Floating Hospital for Children. 

• Healthy Volunteers

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

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)

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.

• Cardiovascular Disease
• Coronary Artery Disease
• Heart Diseases

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).

• Heart Diseases
• Heart Failure
• Pulmonary Hypertension

Evaluation of Time to detection of Hyperglycemia And of Nursing Ease of use (ETHANE) 

The OptiScanner® 5000 Glucose Monitoring System from OptiScan Biomedical Corporation is an automated, bedside glucose monitoring system designed to quantitatively measure the concentration of venous blood glucose. The objective of this study is to evaluate the performance of the OptiScanner 5000 Glucose Monitoring System, a continuous, automated glucose monitor for the Surgical ICU. The OptiScanner 5000 Glucose Monitoring System (OptiScanner) will decrease time spent obtaining glucose values, improve efficiency and increase nursing satisfaction in the Surgical ICU, specifically in administering care to patients who require frequent bedside glucose monitoring. The OptiScanner will allow for earlier detection of hyperglycemia follow cardiac surgeries which require cardiopulmonary bypass by automating glucose measurement collection and displaying trending data. 

• Heart Diseases

Global cVAD Registry

The Global cVAD Registry collects data retrospectively from hospital medical records for patients, who received one or multiple Impella devices during routine care. This registry is an observational, multicenter, retrospective records review. The purpose of this registry is to capture data that reflects 'real world' use of Impella devices in clinical practice and provide insight into patient characteristics, overall health, patterns of care, quality of care and performance during the hospital stay. 

• Heart Diseases

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

• Cardiovascular Disease
• Cardiac Failure
• Heart Diseases
• Valvular Heart Disease
• Heart Failure

Heart Failure

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

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

• Heart Failure
• Cardiovascular Disease
• Cardiac Failure

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

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

• Heart Failure

A 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 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.

• Cardiomyopathy
• Cardiac Failure
• Heart Failure
• Cardiovascular Disease

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).

• Heart Diseases
• Heart Failure
• Pulmonary Hypertension

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

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 being 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 failure and 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.

• Cardiac Failure
• Cardiovascular Disease
• Heart Failure
• Cardiomyopathy

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

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

• Cardiac Failure
• Cardiomyopathy
• Cardiovascular Disease
• Heart Failure

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.

• Heart Failure
• Cardiomyopathy
• Cardiac Failure

Renal Hemodynamics in Patients on AMCS

This study explores changes in blood flow in the kidney before and after activation of Impella or ECMO devices, used to support subjects in cardiogenic shock. 

• Heart Failure
• Hematologic Disorders

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

• Cardiovascular Disease
• Cardiac Failure
• Heart Diseases
• Valvular Heart Disease
• Heart Failure

Heart Transplantation

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

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

• Heart Transplantation

Hematologic Disorders

Renal Hemodynamics in Patients on AMCS

This study explores changes in blood flow in the kidney before and after activation of Impella or ECMO devices, used to support subjects in cardiogenic shock. 

• Heart Failure
• Hematologic Disorders

Hepatitis C

Unlocking Access to HCV Testing in Jails: Stakeholder Engagement is the Key: Qualitative Research Portion (Part I)

With the advent of well-tolerated highly-curative treatment, eradication of hepatitis C virus (HCV) from the United States is possible. Despite guidelines, high HCV prevalence (18-85%, depending on the state) and modeling demonstrating cost-effectiveness, HCV care in corrections’ systems is infrequent. Racial and ethnic minorities comprise the majority (>60%) of HCV cases in US correctional settings. Overlaid on health disparities imposed by incarceration, there are racial disparities in corrections’ settings as evidenced by higher rates of HCV-related morbidity and mortality in incarcerated Non-Whites than Whites.

Increasing access to HCV testing during incarceration with linkage to HCV treatment in the community following release is a feasible approach to decrease health disparities. Recognizing the gaps in knowledge about HCV testing and opportunities for improvement, I have partnered with key stakeholders along the HCV care pathway to evaluate the current state of HCV testing in MA jails. My goal is to interview inmates and other stakeholders (including people who work and people in the community who help deliver care to people who are in jail) to betterat the jail understand barriers and facilitators to testing and treatment in the jails. Examples of important stakeholders include anyone who makes decisions about Hep C testing and treatment for people in jail. This included sheriffs, clinicians, public health specialists, pharmacists, industry representatives.

• Hepatitis C

Hepatoblastoma

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

The Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) directly addresses the need for the next generation of clinical trials for hepatic malignancies, incorporating rational reductions in therapy that ameliorate both short and long-term side effects for patients with good prognoses while simultaneously optimizing curative potential with intensification and new agent integration to improve outcomes for those with poor prognoses. This trial is the first international cooperative liver tumors trial in which a consensus approach was established by investigators representing Children's Oncology Group (COG), Societe Internationale d'Oncologie Pediatrique - Epithelial Liver Tumor Study Group (SIOPEL) and the Japanese Children's Cancer Group (JCCG). The study builds on treatment strategies established by the most recent trials from each of the individual consortia - COG (AHEP0731 ), SIOPEL (SIOPEL 3 and 4) and Japanese Pediatric Liver Tumor study group (JPLT2), but provides new approaches to all stages of HB and HCC patients keeping the aforementioned goals in focus. A critical aspect of this trial is the opportunity to correlate histologic and biologic heterogeneity with response and outcomes in all risk categories, providing promise for future refinement to the newly proposed risk stratification schema. 

• Hepatoblastoma (Floating)
• Cancer in Children (Floating)

High Blood Pressure

Development of Blood Pressure Imager

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

• Healthy Volunteers
• High Blood Pressure
• Hypertension

High Blood Pressure in Pregnancy

Role of decidual leukocytes and placental trophoblasts in the development of spontaneous preterm birth and preeclampsia 

Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions 

• High Blood Pressure in Pregnancy
• Preterm Birth
• Preeclampsia

Hypertension

Development of Blood Pressure Imager

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

• Healthy Volunteers
• High Blood Pressure
• Hypertension

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).

• Kidney Failure
• Hypertension

Hypertrophic Cardiomyopathy

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

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

• Hypertrophic Cardiomyopathy
• Long QT Syndrome

Induced Labor

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

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

• Labor and Delivery
• Induced Labor

Inflammatory Bowel Disease

Metabolic Signature of Colonic Microorganisms in Inflammatory Bowel Disease

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

• Inflammatory Bowel Disease

Intensive Care

Family Factors in PICU Hospitalization: Secondary Stressor Inventory

This is a survey of parents whose children are admitted to the PICU, investigating how life stressors impact the time they spendin the hospital during their child's PICU stay.  To the best of our knowledge, no previous research has assessed the vovariance of parental stressors within and outside the hospital environment with the amount of time parents spend within the PICU.   We hypothesize that secondary stressors such as work obligations, child care needs, financial stress, family medical needs, and distance from home, as well as comfort within the hospital will show correlation with time spent within the PICU for parents.

• 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

Intraabdominal Infections

IT001-303: A prospective Phase 3, double-blind, multicenter, randomized study of the efficacy and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus ertapenem followed by ciprofloxacin and metronidazole or amoxicillin-clavulanate for treatment of complicated intra-abdominal infections in adults. 

The purpose of this research study is to determine if IV sulopenem followed by oral sulopenem-etzadroxil/probenecid is safe and at least as effective as standard treatment for complicated intra-abdominal infections 

• Intraabdominal Infections

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

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)

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).

• Kidney Failure
• Hypertension

Labor and Delivery

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

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

• Labor and Delivery
• Induced Labor

Leukemia

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

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

• Leukemias (Pediatric)

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 imatihib 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 enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

• Leukemias (Pediatric)

Long QT Syndrome

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

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

• Hypertrophic Cardiomyopathy
• Long QT Syndrome

Low Blood Pressure

A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy

This is a 36 week. multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention of droxidopa study in adult patients with symptomatic NOH associated with primary autonomic failure including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), or Pre Autonomic Failure (PAF), or Non-diabetic autonomic Neuropathy (NDAN) or dopamine beta hydroxylase (NBH) deficiency. The primary objective is to evaluate the time to treatment intervention.  The secondary objective is to determine the long-term efficacy of droxidopa in this patient population. 

• Low Blood Pressure
• Neurogenic Orthostatic Hypotension

Lower GI Tract Paralysis

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

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

• Constipation
• Lower GI Tract Paralysis

Lupus Erythematosus

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

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

• 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

Macular Degeneration

A biomarker evaluation study in patients with geographic atrophy secondary to age-related macular degeneration (AMD) evaluating the use of microperimetry (fundus-controlled perimetry) and Swept Source-OCT in assessing changes in retinal sensitivity and anatomy over time. 

This study is being done to see if some eye tests could be useful in finding the natural changes that happen over time in the retina (the back part of the eye) of patients with GA secondary to AMD.

• Macular Degeneration

A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy. Safe and Pharmacokinetics of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration

This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered with the PDS Implant compared with ranibizumab delivered as a monthly intravitreal injection in patients with neovascular age-related macular degeneration (nAMD). 

• Macular Degeneration

Major Depression

Generating Evidence to Inform a Value Framework for Major Depression

The goal of this study is to understand what people with depression value from their medication and what they consider when making treatment decisions.  We will interview patients about what improvement with medication means for them and how they decide what treatment to use.

• Depression
• Major Depression

Menstruation

Gene expression patterns of endometrial decidual cells during menses among women with a history of preterm labor or early-onset preeclampsia versus term delivery

This is a research study to find out more about preterm labor and preeclampsia during pregnancy. We would like to study the uterine lining and monthly cycles to find out if they have any role to play in preterm labor or preeclampsia. 

• Preeclampsia
• Pregnancy
• Preterm Birth
• Menstruation

Mild Cognitive Impairment

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

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

• Mild Cognitive Impairment

Long-Term Nicotine Treatment of Mild Cognitive Impairment - the MIND study

This is a phase 2, multi-center, randomized double-blind, placebo-controlled study to assess the efficacy and safety the nicotine patch to alleviate symptoms of mild cognitive impairment (MCI). Those who meet the study qualifications will be placed on either daily nicotine or placebo patches to be worn for 16 hours a day for the next 2 years accompanied by visits to the clinic. Participants must also have a study partner willing to participate who spends at least 10 hours a week with the participant. 

• Mild Cognitive Impairment

Multiple Myeloma

Long-Term Follow-Up Study Of Subjects Treated With An Autologous T Cell Product Expressing An Antibody Coupled T Cell Receptor (ACTR) 

The study objectives are to evaluate long-term safety and ACTR T cell persistence in subjects previously treated with an ACTR T cell product. 

• Multiple Myeloma

A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination with SEA-BCM, a Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma 

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma. 

• Multiple Myeloma

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

Neonatal Care

National Action Partnership to Promote Safe Sleep - Improvement Innovation Network Collaborative

The main aim of this project is to test the effectiveness of infant safe sleep methods and breastfeeding rates among mothers who were followed for their pregnancy at Tufts Medical Center. We will survey mothers in the Mother Infant Unit after delivery to find out about their knowledge and understanding of safe sleep methods and breastfeeding. We will also be following up mothers 2 weeks after discharge from the hospital to ask questions about their practice at home for infant's safe sleep.

• Neonatal Care

Nephropathy

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

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

• Nephropathy

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 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

This partially randomized phase III trial studies iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma.

• Neuroblastoma

NMTT: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

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

• Neuroblastoma (pediatric)

Neurogenic Orthostatic Hypotension

A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy

This is a 36 week. multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention of droxidopa study in adult patients with symptomatic NOH associated with primary autonomic failure including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), or Pre Autonomic Failure (PAF), or Non-diabetic autonomic Neuropathy (NDAN) or dopamine beta hydroxylase (NBH) deficiency. The primary objective is to evaluate the time to treatment intervention.  The secondary objective is to determine the long-term efficacy of droxidopa in this patient population. 

• Low Blood Pressure
• Neurogenic Orthostatic Hypotension

Neurologic Diseases

Developing an activity-dependent marker of upper motor neuron dysfunction in motor neuron disorders.

This study is evaluating the potential to use transcranial magnetic stimulation in diagnosis of diagnosis of neurologic conditions that effect movement. We are seeking healthy volunteers and participants with a neurologic condition that affects the ability to move parts of your body.

• Neurologic Diseases

Neuromuscular Disorders

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

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

• Ulnar Neuropathy
• Neuromuscular Disorders

Neurotrauma

 Evolution of Cerebral Development in Twin-Twin Transfusion Syndrome (TITS).

This research uses safe and highly sensitive fetal brain magnetic resonance imaging (MRI) to understand how the disease affects on twin fetuses' brain development in Twin Twin Transfusion Syndrome (TTTS). 

• Twin Pregnancy
• Neurotrauma

Obesity

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

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

• Pregnancy
• Obesity

Orthopaedic Surgery

Orthopaedic Sports Medicine, Arthoscopy, and Related Surgery Registry Using the Web-Based Surgical Outcomes System

The purpose of this study is to establish a large, international, web based registry, using the Surgical Outcomes System (SOS), to collect baseline characteristics of patients undergoing orthopaedic and sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and costs-effectiveness associated with the surgical procedures. Additionally, baseline and outcome data for non-operative treatment procedures will b collected using the same measures in order to compare to surgical outcomes.

Health care providers participate in the SOS registry for the primary purpose of tracking their patient's outcomes and evaluating the global outcomes of various standard of care orthopaedic and sports medicine medical procedures, in order to develop evidence based protocols fo the best methods for treating patients with different conditions. The sponsor, Arthrex, uses the protected health information submitted from the health care providers to create aggregated healthcare provider and de-identified global averages. The de-identified global data is shared with all participants. Healthcare providers use this information to perform healthcare operations including outcomes evaluation and development of clinical guidelines. The aggregated data provide orthopaedic and sport medicine healthcare providers' feedback on their patient's outcomes relative to global benchmarks.

Secondarily, healthcare providers participate in the SOS registry for the purposes of analyzing and publishing outcomes of specific standards of care procedures, techniques, devices/biologics (i.e."research"), as well as to utilize the de-identified data for patient education of expected outcomes and to provide evidence of successful surgical/treatment outcomes to their peers and future patients. Except for technical and system functionality purposes (for example, registry maintenance, data aggregation, and de-identification), the sponsor only views and uses the global de-identified global dataset. Arthrex uses the global de-identified data for the purposes of international product approval, internal research and product develop, and marketing. healthcare providers participating in the SOS registry for primary and secondary research purposes are designated as study doctors in this protocol.

Only data associated with labeled indications of approved or cleared orthopedic devices and/or biologics are intended to be collected. Data will be collected from the subject and study doctor, who is the same person as the subjection's treating physician, by completing data fields and surveys on a web based secure site, which is maintained by the sponsor. From the information collected and analyzed in this study the study doctors and study sponsor hope to learn more about the cost-effectiveness of surgical and non-operative interventions and subjects' pain, function and well-being before and after treatment. The sponsor, Arthrex Inc., manufactures medical devices for orthopedic sports medicine and arthroscopy that may be used in the subjects' surgery. Arthrex does not participate in the study doctor's selection or provision of treatment for any specific subject, including the selection medical device.

• Orthopaedic Surgery

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

Neurobiological Mechanisms of Mind-body Therapy for Knee Osteoarthritis

This study aims to provide crucial knowledge about the neurobiological mechanisms underlying mind-body therapy for knee osteoarthritis (OA). We will investigate the central mechanism of knee OA pain using brain imaging technology to evaluate how brain function and structure change in response to mind-body exercise over time.

Participants will be randomized to either a Tai Chi or Wellness Education class and asked to come to Tufts Medical Center twice a week for 12 weeks, along with a baseline and follow-up visit (26 study visits). The findings will lead to the establishment of a new treatment paradigm in OA and have broad application to the management of chronic musculoskeletal pain.

• Arthritis
• 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 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 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

Efficacy and safety of 3 doses of S201086/GLPG1972 administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study (ROCCELLA Study) 

The main purpose of this study is to evaluate safety and efficacy of three doses of the study drug, GLPG1972 compared to placebo. The study drug will be administered as an oral pill daily. This drug aims to reduce the cartilate breakdown in patients with knee osteoarthritis (OA). GLPG1972 is being tested and is not approved for use for patients with knee OA by the United States Food and Drug Administration (FDA). 

• Osteoarthritis

MRI Qualification for Imaging Facility Sites, participating in the Galapagos NV / "Efficacy and safety of 3 doses of S201086/GLPG1972 administered orally once daily in patients with knee osteoarthritis. A 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study." 

You are invited to take part in an assessment of MRI (Magnetic Resonance Imaging) equipment. The MRI examination will be one study visit that will take place at Tufts Medical Center and will take up to 1 hour. It is important to be aware that the images will only be analyzed for evaluating the quality of the images. The images will not be evaluated for any diseases. 

• Osteoarthritis

Parkinson's Disease

A Non-Invasive Technique for the Detection of CSF-Derived Exosomal PD Biomarkers in Olfactory Mucus

We are collecting olfactory mucus in order to determine if we can isolate exosomes and identify PD biomarkers.

• 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

PKD

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
• PKD

Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is an international, multicenter, randomized, double-blind, placebo-controlled two stage study in adult patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) aged 18 to 50 years.

• Polycystic Kidney Disease
• PKD

Polycystic Kidney Disease

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

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

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

• Polycystic Kidney Disease
• PKD

Multicenter, randomized, double-blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is an international, multicenter, randomized, double-blind, placebo-controlled two stage study in adult patients at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) aged 18 to 50 years.

• Polycystic Kidney Disease
• PKD

Preeclampsia

Gene expression patterns of endometrial decidual cells during menses among women with a history of preterm labor or early-onset preeclampsia versus term delivery

This is a research study to find out more about preterm labor and preeclampsia during pregnancy. We would like to study the uterine lining and monthly cycles to find out if they have any role to play in preterm labor or preeclampsia. 

• Preeclampsia
• Pregnancy
• Preterm Birth
• Menstruation

Role of decidual leukocytes and placental trophoblasts in the development of spontaneous preterm birth and preeclampsia 

Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions 

• High Blood Pressure in Pregnancy
• Preterm Birth
• Preeclampsia

Pregnancy

Gene expression patterns of endometrial decidual cells during menses among women with a history of preterm labor or early-onset preeclampsia versus term delivery

This is a research study to find out more about preterm labor and preeclampsia during pregnancy. We would like to study the uterine lining and monthly cycles to find out if they have any role to play in preterm labor or preeclampsia. 

• Preeclampsia
• Pregnancy
• Preterm Birth
• Menstruation

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. 

• Pregnancy
• Obesity

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

Prospective Collection of Whole Blood Specimens in Pregnant Women

To collect blood from pregnant women (should be at least 10 weeks pregnant) who are scheduled for an invasive prenatal diagnostic procedure. Specimens will be used for future testing with an investigational test.

• Pregnancy

Premature Birth

Molecular Assessment of the Consequences of Preterm Birth

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

• Premature Birth (Floating)

Preterm Birth

Gene expression patterns of endometrial decidual cells during menses among women with a history of preterm labor or early-onset preeclampsia versus term delivery

This is a research study to find out more about preterm labor and preeclampsia during pregnancy. We would like to study the uterine lining and monthly cycles to find out if they have any role to play in preterm labor or preeclampsia. 

• Preeclampsia
• Pregnancy
• Preterm Birth
• Menstruation

Role of decidual leukocytes and placental trophoblasts in the development of spontaneous preterm birth and preeclampsia 

Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions 

• High Blood Pressure in Pregnancy
• Preterm Birth
• Preeclampsia

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

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. 

• Ankylosing Spondylitis
• Psoriatic Arthritis

Pulmonary Hypertension

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

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

• Pulmonary Hypertension

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

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

• Heart Diseases
• Heart Failure
• Pulmonary Hypertension

An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

Multi-center, open-label study for eligible patients who completed Study TDE-HF-301. The primary objective of this study is to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The secondary objective of this study is to assess the effect of continued long-term therapy with oral treprostinil on the following:

• 6-Minute Walk Distance (6MWD)
• Borg dyspnea score
• World Health Organization (WHO) Functional Class
• N-Terminal pro-brain natriuretic peptide (NT-proBNP) at Weeks 24 and 48.

• Pulmonary Hypertension

TDE-HF-301: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF) 

A multicenter, randomized, double-blind, placebo-controlled, 24-week, parallel-group study. Approximately 310 subjects will be enrolled and randomly allocated (1:1) to receive oral treprostinil or placebo, stratified by Baseline 6MWD. The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6-Minute Walk Distance (6MWD) from Baseline to Week 24 in subjects with PH associated with HFpEF. The secondary objective of this study is to assess the effect of oral treprostinil compared with placebo on the following: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from Baseline to Week 24 Time to clinical worsening where clinical worsening is defined by at least 1 
of the following: oospitalization due to a cardiopulmonary indication, Outpatient administration of 1 intravenous (IV) diuretics, Decrease in 6MWD > 15% from Baseline (or too ill to walk) directly related 
to disease under study, at 2 consecutive visits on different days, or Death (all causes) Change in World Health Organization (WHO) Functional Class from Baseline to Week 24.

• 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

Sclerosing Cholangitis

Clinical Outcomes Of Primary Sclerosing Cholangitis In North America

This is a 10-year, longitudinal, observational study of patients with PSC to address knowledge gaps in the clinical presentation, natural history, epidemiology, progression, and outcomes of PSC. In addition, the study will address prognostic models and biomarker development. There will be an option to participate in specimen repository at each site for translational studies of genomics and novel biomarkers discovery.

• Sclerosing Cholangitis

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

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.

• Seizures (Floating)
• Brain Malformations (Floating)
• Developmental Disabilities (Floating)

Sickle Cell Disease

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

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

• Sickle Cell Disease

Solid Tumors

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

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

• Solid Tumors

Squamous Cell Carcinoma

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

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

• Squamous Cell Carcinoma

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

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

• Head and Neck Cancer
• Squamous Cell Carcinoma

Strabismus

Do Strabismus Measurements Change After Pupil Dilation and Cycloplegia in Children

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

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

• Strabismus

Stroke

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects

The main purpose of this study is to learn the how safe the study drug, n-butylphthalide (NBP) is when added to your routine care. Other purposes of the study are to determine how the study drug is absorbed, distributed, broken down, and removed from the body, how well it works compared to placebo as measured by improvement of disability, recovery, and physical function after a stroke. Patients are randomized to either the study drug or a placebo and take pills twice daily for a month starting 12 hours from last-known well after stroke.

• 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

AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NIH StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

• Stroke

Cyberphysical Therapy for Enhanced Neuromotor Recovery in Stroke Survivor

The proposed research aims to combine the advantages of human and robotic post-stroke gait rehabilitation in a new approach called cyberphysical therapy (CBT). This paradigm allows therapists to remain actively involved in gait training while removing barriers limiting the effectiveness of traditional human-provided therapy: high effort and poor real-time feedback. In this innovative approach a therapist interacts with patients through coupled robotic arms that act as an extension of the therapist’s arm; this rehabilitative collaboration can take place either face-to-face or remotely by teleoperation. The central hypothesis is that combining the advantages of human and robotic gait rehabilitation approaches in CBT will significantly improve patient learning outcomes compared to traditional therapist-only and automated robotic gait training.

• Stroke
• Stroke Rehabilitation

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

Stroke Rehabilitation

Cyberphysical Therapy for Enhanced Neuromotor Recovery in Stroke Survivor

The proposed research aims to combine the advantages of human and robotic post-stroke gait rehabilitation in a new approach called cyberphysical therapy (CBT). This paradigm allows therapists to remain actively involved in gait training while removing barriers limiting the effectiveness of traditional human-provided therapy: high effort and poor real-time feedback. In this innovative approach a therapist interacts with patients through coupled robotic arms that act as an extension of the therapist’s arm; this rehabilitative collaboration can take place either face-to-face or remotely by teleoperation. The central hypothesis is that combining the advantages of human and robotic gait rehabilitation approaches in CBT will significantly improve patient learning outcomes compared to traditional therapist-only and automated robotic gait training.

• Stroke
• Stroke Rehabilitation

Twin Pregnancy

 Evolution of Cerebral Development in Twin-Twin Transfusion Syndrome (TITS).

This research uses safe and highly sensitive fetal brain magnetic resonance imaging (MRI) to understand how the disease affects on twin fetuses' brain development in Twin Twin Transfusion Syndrome (TTTS). 

• Twin Pregnancy
• Neurotrauma

Ulnar Neuropathy

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

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

• Ulnar Neuropathy
• Neuromuscular Disorders

Urinary Tract Infections

A Randomized, Controlled, Evaluator-blinded, Multi-center, study to evaluate LYS228 pharmacokinetics, clinical response, safety and tolerability in patients with complicated urinary tract infection 

The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections 

• Urinary Tract Infections

IT00l-302: A prospective, phase 3, randomized, multi-center, double-blind, double-dummy study of the efficacy, tolerability, and safety of intravenous sulopenem followed by oral sulopenem­etzadroxil with probenecid versus intravenous ertapenem followed by oral ciprofloxacin or amoxicill clavulanate for treatment of complicated urinary tract infections in adults 

The purpose of this research study is to determine if IV sulopenem followed by oral sulopenem-etzadroxil/probenecid is safe and at least as effective as standard treatment for urinary tract infections 

• Urinary Tract Infections

Valvular Heart Disease

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

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

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

• Cardiovascular Disease
• Cardiac Failure
• Heart Diseases
• Valvular Heart Disease
• Heart Failure

Vitamin D Deficiency

Vitamin D to Improve Outcomes by Leveraging Early Treatment

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

• Vitamin D Deficiency