306 result(s) found
Abdominal Aortic Aneurysm
This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.
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Abdominal Infection
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.
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Acromegaly
The MACRO registry will collect data prospectively on patients with active acromegaly, defined operationally as an adult patient with a confirmed diagnosis of acromegaly being treated with medical therapy; or eligible to be treated with medical therapy, e.g., having an elevated IGF-1. This is an observational study; therefore, no additional visits or laboratory tests will be required outside of local routine clinical practice. Dosing and duration of medical therapies is at the discretion of the treating physician, in accordance with local labeling.
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Acute Lung Injury
Part 2 is a randomized, double-blind, parallel-group study evaluating efficacy and safety of one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo in hospitalized subjects with confirmed symptomatic COVID-19 who require supplemental oxygen. Approximately 99 subjects per group (198 subjects total) will be enrolled in Part 2.
Eligible subjects will be stratified by baseline age (≤ 60 vs > 60 years) and concurrent use of antiviral medications (yes or no) (e.g., remdesivir) at baseline. Within each stratum, subjects will be randomized 1:1 to receive placebo or TD-0903. Approximately 20% of participants will be enrolled with a baseline clinical status score of six (NIPPV or high flow oxygen device) based on the 8-point ordinal scale (Table 3). The study drug will be administered once-daily or twice daily in divided doses (as determined by results from Study TD-0903-0183 and from Part 1 of this study) for up to 7 days or until discharge from the hospital, whichever is earlier. Subjects will be followed for up to 28 days or until death, whichever is earlier.
Sparse sampling for assessment of TD-0903 plasma concentrations will be collected for population PK analysis.
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Acute Lymphocytic 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)
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Amyloidosis
This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with standard of care plasma cell dyscrasia (PCD) treatment versus placebo combined with standard of care PCD treatment in Mayo stage IIIb PCD treatment-naïve AL amyloidosis patients. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient’s death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event-driven study, the study will continue, and all patients will continue to receive study treatment until at least 54 deaths have been observed. Approximately 111 patients will be enrolled using a 2:1 randomization ratio. Stratification will be based on geographic region across approximately 70 investigator sites.
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This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with standard of care plasma cell dyscrasia (PCD) treatment versus placebo combined with standard of care PCD treatment in Mayo stage IIIa PCD treatment-naïve AL amyloidosis patients. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient’s death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment. As this is an event-driven study, the study will continue, and all patients will continue to receive study treatment until at least 77 deaths have been observed. Approximately 267 patients will be enrolled using a 2:1 randomization ratio. Stratification will be based on geographic region across approximately 70 investigator sites.
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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.
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Aneurysms
The objective of this study is to evaluate the safety and effectiveness of the Surpass Evolve Flow Diverter System in the treatment of unruptured intracranial (brain) aneurysms. If you choose to participate in this study, you will receive intervention with the Surpass Evolve Flow Diverter implant. There will be no randomization or blinding.
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Ankylosing Spondylitis
This is an observational study of people who have spondyloarthritis. This includes diseases such as ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease associated arthritis. Those in the registry must be patients of providers in the Tufts rheumatology clinic.
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Aortic Aneurysm
This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.
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Aortic Stenosis
This is a Prospective, multi‐center, international, randomized controlled, post‐market trial. To enroll subjects with symptomatic heart disease due to severe native calcific aortic stenosis and a small annulus appropriate for transcatheter heart valvereplacement therapy. The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Devices used in this trial must be commercially approved by the local regulatory agencies in the geography they are used. The devices will be used within the localcommercially approved indication in the geographies in which each device is approved. Subjects will be randomized on a 1:1 basis to receive transcatheter aortic valve replacement (TAVR) with either a Medtronic SE or an Edwards BE TAV. Randomization will be stratified by site and sex. Approximately 700 treated subjects at approximately 90 sites in Canada, EMEA and the United States.
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Arthritis
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.
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Juvenile idiopathic arthritis (JIA) is an exclusion diagnosis that encompasses all forms of otherwise unexplained chronic non-infectious arthritis occurring under the age of 16. Various attempts have been made to classify this heterogeneous group of diseases with the aim of identifying mutually exclusive categories suitable for etiopathogenetic studies. Since then increasing evidence has accumulated suggesting that some of these categories are heterogeneous. Therefore, there is a need to revise the criteria in order to identify more homogeneous entities and to try to distinguish those diseases. The main reason for this research study is to learn more about the diagnosis of Juvenile Idiopathic Arthritis (JIA) according to the ILAR (International League of Associations for Rheumatology) criteria and investigate a new classification criteria proposed by the international research organization Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG).
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Atopic Dermatitis
Study I4V-MC-JAHN (JAHN) is a Phase 3, multicenter, double-blind study to evaluate the long-term safety and efficacy of baricitnib (1-mg once daily, 2-mg once daily and 4-mg once daily) in adult patients with AD for approximately 2 years.
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Phase 3, randomized, double-blind, placebo-controlled study to assess the impact of lebrikizumab on vaccine immune responses in adult patients with moderate-to-severe atopic dermatitis (AD). This study will evaluate the effect of lebrikizumab treatment on 2 vaccines commonly used in adults with moderate to severe AD
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This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab.
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Atrial Fibrillation
This clinical investigation is intended to evaluate the safety and effectiveness of Abbott’s AmplatzerTM AmuletTM Left Atrial Appendage (LAA) occluder device (“Amulet device”) compared to commercially available non-vitamin K antagonist oral anticoagulant (NOAC) drugs in patients with non-valvular atrial fibrillation (AF) who are at increased risk for ischemic stroke and who are tolerant of long-term NOAC therapy. The Amulet device is intended to reduce the risk of thromboembolism from the LAA in patients with non-valvular AF who are at increased risk for ischemic stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, and offers an alternative to oral anticoagulants (OAC) for patients recommended for anticoagulation therapy.
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Autism
Racial and ethnic minority families receive less family-centered care than their majority counterparts, resulting in disparities in treatment engagement and adverse child outcomes among children diagnosed with Autism Spectrum Disorder (Autism). Shared-decision making (SDM) increases family-centered care by identifying treatments that meet the needs and goals of the family, and increases engagement, adherence and outcomes. In the context of Autism, a valuable opportunity to engage families in SDM occurs at their first diagnostic encounter, where treatment options are initially discussed. The proposed stakeholder engaged T2 pilot project, draws upon qualitative and quantitative mixed methods to produce objective information about SDM in the context of Autism diagnosis and treatment. This innovative project will aim to identify key elements of SDM during initial diagnostic encounters, explore patient perspectives and the role of race/ethnicity, and investigate provider perspectives in their use of SDM with families. Through direct observation, measurement scales, and qualitative interviews, we will identify the frequency of SDM elements used between 30 parent-provider dyads, as well as information about family preferences, values, and treatment goals for children with Autism, and particularly how they vary by race/ethnicity. Knowledge gained from this foundational research will result in several translational funding opportunities for future SDM interventions: decision aids, provider/parent training, and care system redesign. Our ultimate goal is to increase the use of SDM in clinical practice to provide a system of care for Autism that more fully considers the preferences, values, and treatment goals of families, regardless of their racial/ethnic background.
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Bone Marrow Transplantation
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.
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Brain Cancer
This study is being done to answer the following question: Can a patient’s life be extended by adding a type of radiation therapy called whole-brain radiation therapy that avoids the hippocampus to preserve memory plus the medication memantine that is FDA approved to treat dementia to the usual treatment?
This study aims to find out if adding Hippocampal-Avoidant Whole Brain Radiotherapy and memantine is better or worse than the usual approach for your brain cancer.
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Brain Contusion
The primary objective of this study is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. Secondary objectives and endpoints for the study are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.
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Brain Malformations
Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.
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Brain Tumors
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
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Breast Cancer
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
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This study is being done to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing human epidermal growth factor receptor 2 (HER2)-positive breast cancer from returning?
This study aims to find out if this approach is better or worse than the usual approach for human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
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Bullous Pemphigoid
To demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP)
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Cancer
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.
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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.
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Cancer in Children
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.
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Cardiac Arrest
This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock.
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Cardiac Failure
The purpose of this study is to determine the relationship between levels of metabolites, such as lactate in the sweat of the skinm, and the severity of heart failure. We hope to determine whether the levels of lactate and other metabolites on the skin change as heart failure severity improves during a hospitalization. This information oculd also be used to develop ways to detect worsening heart failure severity using a sweat-based test. The study seeks to recruit patients admitted to Tufts Medical Center due to decompensated heart failure. There are 2 study visits which each require the collection of 15ml of fasted venous blood, a completed KCCQ, and holding a damped gauze between the palms for 2 minutes. The baseline study visit takes place within 72 hour of admission and the second study visit takes place within 3 and 60 days of the baseline visit when the patient meets criteria for clinical stability.
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This is a pilot/feasibility study on the accuracy of HRV measured by the Apple Watch on the clinical status of patients admitted for acute heart failure decompnsation. We hypothesize that there will be a statistically significant improvement in the HRV that correlates clinically over the course of hospitalization. Meaningful findings from this study will strengthen the potential for a telemonitoring system where HRV measured remotely from home using wearable devices like Apple Watch can help physicians monitoring their health and intervene accordingly.
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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.
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This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.
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This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock.
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At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.
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The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.
Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis
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Cardiomyopathy
Hypertrophic Cardiomyopathy (HCM) is a genetic disease where the heart muscles become thicker because of the disease. We use electrocardiogram, echocardiogram or cardiac magnetic resonance imaging (CMR) tests to see if someone might have HCM. Another disease, transthyretin cardiac amyloidosis (ATTR-CM) can also cause the heart to become thick and look similar to HCM on these tests (usually in patients who are over 60 years old).
Recent research suggests that up to 10% of patients ≥ 60 years of age who have been diagnosed with HCM, may actually have ATTR-CM. However, no formal research study has been done to confirm if this is what is happening. Standard practice at Tufts is that patients ≥ 60 years of age have routine testing for HCM (including electrocardiogram, echocardiogram, and CMR) and a special test (called a pryophosphate scan) specifically to evaluate for ATTR-CM. This is important as ATTR-CM is treated differently than HCM.
The research team is inviting participants to be included in a registry in order to look at the difference between the two diseases and how they are diagnosed. This study's registry is a compilation of various cardiac images, lab tests, and medical histories of patients with HCM and ATTR-CM. If they choose to participate, they will be included in a registry using the following information: clinical history, lab tests, echocardiogram, cardiac magnetic resonance imaging (CMR), and pyrophosphate scan. We will look at this information to understand how often patients originally diagnosed with HCM were later diagnosed with ATTR-CM instead.
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This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.
More
At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.
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Cardiovascular Disease
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.
Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.
Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,
hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.
Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.
All patients will have a follow-up visit at 90 days post-device removal.
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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.
More
This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.
More
Collecting and storing heart tissue and blood samples from consented Tufts Medical Center patients for the purpose of cardiovascular research.
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The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.
Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis
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Celiac Disease
The purpose of this study is to learn about the safety and effectiveness of an investigational study drug called PRV-015.
PRV 015 is an antibody designed to block an immune system protein called interleukin-15 (IL 15). IL 15 is made in the small intestine and is one trigger that causes intestinal inflammation followed by death of the intestinal cells. This immune response can be caused by eating gluten. In previous studies, PRV 015 has been shown to reduce inflammation in the intestine and improve the symptoms of celiac disease when used together with a GFD.
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Cervical Cancer
This study is evaluating a newly developed test which will help in detecting a virus that causes cervical cancer for example- high risk human papillomavirus (HR HPV). This test is called Alinity m HR HPV
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Cervix Disorders
The purpose of the study is to measure the softness of the cervix. The softness of the cervix will be compared in two groups of pregnant women. One group is women who will be having a surgery to strengthen the cervix (a cerclage surgery). The second group is normal women in the prenatal clinic. We anticipate recruiting 140 patients total (60 cases and 80 control patients.)
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Chronic Kidney Disease
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.
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Chronic Myeloid Leukemia
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
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Chronic Pain
The purpose of this study is to assess how Immersive Virtual Reality effects the intensity of (pain, tiredness, mood and sensory responses) in people with chronic back pain
- Study participants will complete two Immersive Virtual Reality experiences over two visits to the Virtual Reality Lab at Tufts University
- Study participants will receive up to $80 if all study activities are completed.In addition, participants will be reimbursed up to $40 to cover travel costs.
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Chronic Tympanic Membrane Perforation
This study is for people who have a tear in their ear drum that has lasted longer than 3 months (chronic tympanic membrane perforation, or CTMP). It is looking at the ability of an investigational drug, ASP0598 Otic Solution, to close ear drum tears when given as ear drops. This study will consist of multiple arms, in which study participants will be randomly placed. Some participants will receive one dose of the study drug, some will receive multiple doses, and some will receive a placebo. Neither the participant nor the study team will know what was received.
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Cirrhosis
You are being invited to consider participation in a clinical research study for patients with cirrhosis caused by nonalcoholic steatohepatitis (NASH) This study involves research and is conducted to determine the safety and efficacy of a new investigational drug called aldafermin (previously known as NGM282
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Clostridium Difficile Infection
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.
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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.
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Colorectal Cancer
This is a Phase II to Phase III randomized, double-blind, placebo-controlled design to determine if duloxetine can prevent oxaliplatin-induced peripheral neuropathy (OPIN). Initially, we will screen two duloxetine doses, 30 mg and 60 mg daily, using a 3-arm Phase II study design. The most promising dose will then be tested in a 2-arm Phase III study. The primary hypothesis in the Phase III study is that the most promising duloxetine dose will be more effective than placebo to prevent 1) sensory OIPN (N, T, & pain) during treatment and 2) chronic OIPN pain 1 month after the last planned oxaliplatin treatment.
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Congenital Adrenal Hyperplasia
Spruce Biosciences, Inc. is doing a research study to see if an investigational drug (tildacerfont) can reduce the amount of glucocorticoids (GCs) (e.g., hydrocortisone) patients need to take and reduce the level of certain hormones in your body in patients diagnosed with congenital adrenal hyperplasia (CAH).
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Spruce Biosciences, Inc. is doing a research study to determine the safety and effects of tildacerfont, an investigational drug that may be used to treat congenital adrenal hyperplasia (CAH). Tildacerfont aims to treat the disease by improving the control of adrenal steroid hormones, possibly reducing the likelihood of long-term effects of the disease.
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Constipation
Among the more than 5 million adults who are admitted to the ICU each year in the USA, most have pain and thus receive a pain (analgesic) medication called an opioid. Opioid use in critically ill adults continues to increase given the greater awareness of untreated pain in the ICU population and a recent strong recommendation in the Society of Critical Care Medicine’s Pain, Agitation, and Delirium Guidelines for Critically Ill Adults that an opioid-first approach be used to optimize patient safety and comfort and improve tolerance with breathing machines (i.e. mechanical ventilation). Similar to constipation, paralysis of the lower gastrointestinal (GI) tract is defined as the inability to pass stool due to impaired gut movements, and is a common effect of opioid use in the critically ill. Lower GI tract paralysis will often lead to nausea, vomiting, aspiration, compromise the ability to administer tube feeds (enteral nutrition), increases abdominal pain, and has been shown to delay getting off mechanical ventilation. One recent randomized study found that aggressive use of laxatives to prevent lower GI tract paralysis in critically ill adults was associated with lower daily organ dysfunction [as measured by the Sequential Organ Failure Assessment (SOFA) score]. The lower GI tract paralysis that occurs in the critically ill often responds poorly to laxative medication therapy (e.g., senna, bisacodyl, lactulose). While stool softener medications like docusateare routinely administered to patients on opioids, laxative-based protocols are frequently not initiated in the ICU until signs of lower GI tract paralysis start to appear. There is therefore an important and unmet need for a safe and efficacious medication to prevent lower GI tract paralysis in critically ill adults who are initiated on opioid therapy. Naloxegol (Movantik) is a naloxone-like drug that blocks the effect of opioids on the opioid µ receptor in the gut. Naloxegol is currently approved by the Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in non-ICU patients receiving scheduled moderate to high dose opioids for the treatment of chronic non-cancer pain. Naloxegol has a mechanism of action, efficacy, convenience of administration, and safety profile that make it an ideal candidate for use as a preventative medication for lower GI tract paralysis in critically ill adults receiving opioid therapy through the vein [intravenous (IV)]. We therefore propose a pilot study in which we will test the hypothesis that naloxegol (versus placebo) will reduce the time to the first spontaneous bowel movement (SBM) that the ICU patient has, that it will prevent lower GI tract paralysis in critically ill adults initiated on scheduled IV opioid therapy, and its use will not result in side effects that are concerning to doctors or patients. We will randomize 36 critically ill ICU patients (18 in each arm) to receive naloxegol [25mg or 12.5mg (in patients with kidney problems] or placebo. This pilot study will provide valuable information to help guide future, larger studies of naloxegol in ICU patients.
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Corneal Disorders
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.
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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.
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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.
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Coronary Artery Disease
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.
Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.
Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,
hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.
Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.
All patients will have a follow-up visit at 90 days post-device removal.
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Covid-19
A multicenter, two arm, randomized, single-blind clinical trial to determine if receiving one dose of convalescent plasma (CP) for mild COVID-19 illness prevents illness progression.
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This study is being conducted in healthy children from age 6 months to age 12 years. The study is looking at how well the Moderna mRNA vaccine works when given to healthy children for the prevention of COVID-19.
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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.
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The purpose of this study is to see if remdesivir (RDV) given into a vein in an outpatient setting is safe and is an effective treatment in participants with confirmed COVID-19 who are at risk for disease progression.
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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
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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.
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This study is being conducted in patients with reduced immunity who have a high risk of being infected with COVID-19. The study is looking at a new experimental drug to prevent COVID-19 in these patients.
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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.
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This research study is looking at experimental drugs to prevent the COVID-19 disease from occurring in people who have been exposed to the SARS-CoV-2 virus. The goals of the study include seeing whether the study drugs lower infection by the virus, whether they reduce the need for medical visits and the amount of time you spend away from your day-to-day activities (i.e., work, school, caring for others) due to COVID-19, and whether they can cause side effects.
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This study is being done to see if a vaccine that is being developed to prevent people from getting sick with COVID-19 is safe and effective and also to see how well it is tolerated. It involves both vaccine and a placebo (which looks like the vaccine but does not contain any actual vaccine).
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While much has been learned about the acute phase of Coronavirus disease 2019 (COVID-19) in the last year, little is known about the recovery phase. There have recently been several reports in the news and in the medical literature about a prolonged recovery phase after developing acute COVID-19 in some individuals who may have persistent symptoms many months after infection, developing the so called “long COVID”. The goal of the proposed study is to determine the underlying cause of impairment in patients who have recovered from COVID-19 but who continue to have symptoms at least 3 months after infection.
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Participation in this study can be done remotely, from your home. No in-person interactions with the researchers will be needed, and no travel will be required.
To be eligible, contact with the study team needs to be made within 3 days of the time you were tested for COVID-19.
What is the purpose of the study? Coronavirus disease 2019 (COVID-19) is a public health emergency for which there is no known effective treatment. This study will evaluate the study drug, Niclosamide, as a potential treatment for mild to moderate COVID-19 to find out if it is effective in shortening the time that COVID-19 is contagious. This research study will also evaluate if Niclosamide works to shorten the time of symptoms related to COVID-19.
Background: Niclosamide has been widely used in humans to treat tapeworm infections for several decades and is currently listed on the World Health Organization’s List of Essential Medicines, the safest and most effective medicines needed in a health system.
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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.
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ACTIV-1 IM is a master protocol designed to evaluate immune modulators for the treatment of moderately or severely ill hospitalized patients infected with COVID-19. Trial participants will be assessed daily while hospitalized. If the participants are discharged from the hospital prior to Day 29, they will have follow-up study visits at Days 8, 11, 15, 22, and 29. For discharged participants, it is preferred that the Day 8, 11, 15, and 29 visits are in person to obtain safety laboratory tests and blood (serum/plasma) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the participant to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The Day 60 assessment will be conducted by phone.
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Part 2 is a randomized, double-blind, parallel-group study evaluating efficacy and safety of one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo in hospitalized subjects with confirmed symptomatic COVID-19 who require supplemental oxygen. Approximately 99 subjects per group (198 subjects total) will be enrolled in Part 2.
Eligible subjects will be stratified by baseline age (≤ 60 vs > 60 years) and concurrent use of antiviral medications (yes or no) (e.g., remdesivir) at baseline. Within each stratum, subjects will be randomized 1:1 to receive placebo or TD-0903. Approximately 20% of participants will be enrolled with a baseline clinical status score of six (NIPPV or high flow oxygen device) based on the 8-point ordinal scale (Table 3). The study drug will be administered once-daily or twice daily in divided doses (as determined by results from Study TD-0903-0183 and from Part 1 of this study) for up to 7 days or until discharge from the hospital, whichever is earlier. Subjects will be followed for up to 28 days or until death, whichever is earlier.
Sparse sampling for assessment of TD-0903 plasma concentrations will be collected for population PK analysis.
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Craniopharyngioma
This phase II trial studies how well vemurafenib and cobimetinib work in treating patients with BRAF V600E mutation positive craniopharyngioma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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Crohn's Disease
To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.
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Cytomegalovirus Infection
Open label trial of letermovir prophylaxis for those heart transplant recipients at risk of cytomegalovirus infection and disease
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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.
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Developmental Disabilities
Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.
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Diabetes in Children and Teens
In children and adolescents (>10 to <18 years) with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control (ie, hemoglobin A1c [HbA1c] of >6.5% to <10.5%), either on diet and exercise only, or on diet and exercise and metformin monotherapy, or on diet and exercise and insulin monotherapy, or on diet and exercise and combination therapy with metformin and insulin.
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Diabetes Mellitus
In children and adolescents (>10 to <18 years) with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control (ie, hemoglobin A1c [HbA1c] of >6.5% to <10.5%), either on diet and exercise only, or on diet and exercise and metformin monotherapy, or on diet and exercise and insulin monotherapy, or on diet and exercise and combination therapy with metformin and insulin.
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Diabetic Eye Problems
Microperimetry allows for precise structure-function correlation studies to be performed on the retina. By creating a map of retinal sensitivity and overlaying it onto images of the retina, structure-function correlation can be determined. Already used in common retinal diseases like diabetic retinopathy, microperimetry has proven useful as a diagnostic tool. Studies have shown early changes in retinal sensitivity associated with disease even before there are major clinically apparent changes in the eye. This suggests that there may be subtle changes to eye structure and function before vision is noticeably impaired—better understanding these changes could provide rationale for earlier intervention to prevent deterioration in patient vision. This study seeks to assess possible structural and functional changes over the course of the disease progression in a variety of retinal disorders by using microperimetry in combination with optical coherence tomography imaging. This could allow for
earlier detection of diseases, provide rationale for earlier intervention, and provide a means of tracking and managing disease progression.
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This is a 12 month prospective observational study using OCT angiography to visualize retinal ischemia in greater detail in patients with diabetic retinopathy.
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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).
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Diabetic Foot Ulcers
This study will follow a superiority design that will test whether the treatment group (NuShield plus SOC) compared to the control group (SOC alone) demonstrates statistically significant differences for time to and frequency of complete wound closure in patients with diabetic foot ulcers. Subjects in the study will be randomized 1:1 to either: Group 1, NuShield plus SOC weekly for up to 24 weeks, or Group 2, SOC (control) weekly for up to 24 weeks.
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Diabetic Nephropathy
This study looks at a new medicine to help kidneys in people who have protein in their urine due to either diabetic kidney disease or two other diseases that specifically impact the kidneys, called focal segmental glomerulosclerosis and treatment resistant minimal change disease. It looks at the safety of a new medicine, GFB-887, which blocks a channel called TRPC-5. Existing studies suggest that blocking the TRPC-5 channel can help lower urine protein levels and preserve kidney function in people with these diseases. The drug is a tablet taken once a day; depending on your doseage level, you may take up to 4 tablets once a day. Some participants will get the medications while others will get a placebo (also in tablet form); this will be decided randomly by chance. We will look at protein loss in the urine as the main outcome and also look at safety and kidney function.
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Dry Eye
This prospective, single center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of IDI on ameliorating the signs and symptoms of dry eye disease. The study aims to enroll 54 patients (36 Dextenza commercial formulation, 18 Collagen Plug) with DED.
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- To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.
- To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive.
- To establish the prevalence of subtypes of patients with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort.
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This clinical research study is divided into two parts. The purpose of Part 1 is to compare the safety and efficacy of the study drug (ECF843) to a placebo (also referred to as vehicle) for the relief of signs and symptoms associated with moderate to severe DED. The purpose of Part 2 is to compare the safety and efficacy of the study drug (ECF843) to a prescription eye drop medication called Xiidra®.
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This study aims to correlate pediatric dry eye symptomology with electronic device screen time (iPhones, iPads, video games, etc). This study will utilize a modified version of the SPEED questionnaire - a short self-reported survey that asks questions about the way your eyes are feeling and the severity. This questionnaire has been modified to include a section on electronic device screen time usage, to determine if the amount of daily screen time plays a role in the clinical symptomology of dry eye disease.
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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.
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Emergency Services
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.
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Eosinophilic Disorders
This study is being conducted to test the efficacy and safety of AK002 in patients with Eosinophilic Gastritis with or without Eosinophilic Gastroenteritis and requires nine study visits over the course of 24 weeks. Participants will receive study drug or placebo via infusion during four of these visits.
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Eosinophilic Esophagitis
The purpose of this study is to assess an investigational drug called etrasimod in the treatment of eosinophilic esophagitis (EoE). This study is being done to find out which dose of etrasimod works best and which is the safest dose for people with EoE. The study will also look at how etrasimod works, and whether it will reduce the number of eosinophils in the esophagus and help improve the pain or difficulty of swallowing in people with EoE.
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Participation during screening will last no less than 2 weeks and no more than 4 weeks. If you qualify for the study, you will participate for 7 additional months if you participate in only the randomized, double-blind, placebo-controlled part of the study or 13 additional months (if you complete the randomized, double-blind, placebo-controlled part of the study and decide to participate in an extended dosing period during which all participants receive 6 doses of AK002. Therefore, the total period of participation is approximately 8 months or 14 months.
If you are eligible and choose to participate in the OLE Period of the study, you will participate in the randomized, double-blind, placebo-controlled part of the study for approximately 24 weeks and will complete study visits through the Day 155 visit. You will begin following the OLE Period schedule and extended dosing at the Day 169 visit.
Overall, approximately 300 men and women 12 to 80 years of age are expected to be enrolled in this study which is being conducted at approximately 60 sites.
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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.
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This study has 3 treatment periods: A 24-week double-blind treatment period, a 28-week open-label treatment period, and an open-label extension. Subjects that complete the 52-week treatment period, double blind and open label on investigational product will be eligible to continue into a 52-week open label extension period on benralizumab 30 mg every 4 weeks (Q4W). The open label extension period is intended to allow each patient 1 year of treatment with open label benralizumab after completion of the 52-week double blind and open label treatment periods. All eligible subjects will be invited to participate in the open label extension. Patients who do not enroll in the open label extension will have a follow-up visit 12 weeks after their last dose of IP.
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Eosinophilic Gastrointestinal Disorders
Open label extension study to the AK002-016 study where eligible participants who have completed the AK002-016 study can enroll into the AK002-016X extension study and receive additional doses of AK002.
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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.
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Esophageal Cancer
This study is being done to answer the following questions:
- What are the good and bad effects of using usual chemotherapy and radiation plus the immunotherapy, nivolumab, before standard surgery for your condition?
- What are the good and bad effects of adding the immunotherapy nivolumab versus adding nivolumab and ipilimumab after standard surgery for your condition?
This study is being done to find out if these approaches are better or worse than the usual approach for locoregional esophageal or gastroesophageal junction adenocarcinoma.
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Fatty Liver
This study evaluates the efficacy and safety of the investigational treatment Aramchol as compared to placebo in subjects with Nonalcoholic Steatohepatitis (also known as NASH or Fatty Liver)
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Focal Semental Glomeroulsclerosis
This study looks at a new medicine to help kidneys in people who have protein in their urine due to either diabetic kidney disease or two other diseases that specifically impact the kidneys, called focal segmental glomerulosclerosis and treatment resistant minimal change disease. It looks at the safety of a new medicine, GFB-887, which blocks a channel called TRPC-5. Existing studies suggest that blocking the TRPC-5 channel can help lower urine protein levels and preserve kidney function in people with these diseases. The drug is a tablet taken once a day; depending on your doseage level, you may take up to 4 tablets once a day. Some participants will get the medications while others will get a placebo (also in tablet form); this will be decided randomly by chance. We will look at protein loss in the urine as the main outcome and also look at safety and kidney function.
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Glaucoma
Microperimetry allows for precise structure-function correlation studies to be performed on the retina. By creating a map of retinal sensitivity and overlaying it onto images of the retina, structure-function correlation can be determined. Already used in common retinal diseases like diabetic retinopathy, microperimetry has proven useful as a diagnostic tool. Studies have shown early changes in retinal sensitivity associated with disease even before there are major clinically apparent changes in the eye. This suggests that there may be subtle changes to eye structure and function before vision is noticeably impaired—better understanding these changes could provide rationale for earlier intervention to prevent deterioration in patient vision. This study seeks to assess possible structural and functional changes over the course of the disease progression in a variety of retinal disorders by using microperimetry in combination with optical coherence tomography imaging. This could allow for
earlier detection of diseases, provide rationale for earlier intervention, and provide a means of tracking and managing disease progression.
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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.
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Glioblastoma
This trial is to test the effectiveness and safety of Optune® given with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
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tilize fresh tumor tissue to aid the development of future therapies for brain cancer.
Briefly, a cell immunotherapy consisting of a patient’s autologous glioblastoma tumor cells, called ‘IGV-001’, is being tested in clinical trials. In order to advance clinical and product development of IGV-001, Imvax is seeking access to patient material to test key product parameters in a laboratory setting.
The device used to collect the tissue, the Myriad multifunctional device enabling suction, resection, and collection of tumor tissue (see NICO Myriad Use Manual) is an FDA-approved device that is safe
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This is a phase 2, multicenter, open-label study. Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin 1% and triamcinolone 0.1%. This study was designed to test the efficacy of topical clindamycin and triamcinolone for the prevention of moderate to severe skin toxicity from TTFields.
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Glioblastoma Multiforme
This is a phase 2, multicenter, open-label study. Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin 1% and triamcinolone 0.1%. This study was designed to test the efficacy of topical clindamycin and triamcinolone for the prevention of moderate to severe skin toxicity from TTFields.
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Growth problems
The purpose of this study is to compare the effectiveness, safety and handling of the investigational drug MOD-4023 (weekly injections, dose of 0.66 mg/kg/week) to standard of care treatment with Genotropin (daily injections, dose of 0.034 mg/kg/day over one year. The study will include approximately 220 children worldwide.
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Head and Neck Cancer
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
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This trial will help to determine if either the experimental arm (adjuvant reirradiation plus pembrolizumab, followed by pembrolizumab to complete 12 months total of pembrolizumab and/or pembrolizumab alone for 12 months) significantly improves Overall Survival (OS) compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk patients.
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Healthy Volunteers
This study will compare an automated wrist blood pressure device (Omron 3 Series Wrist Blood Pressure Monitor) with both an automated arm blood pressure device (Welch Allyn ProBP 3400 series) and a manual aneroid blood pressure device. The goal is to assess correlation of wrist blood pressure readings to manual and automated arm readings, and to determine the utility of wrist monitors in both clinic and home ambulatory blood pressure monitoring in the pediatric population.
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Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.
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This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.
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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.
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This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.
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Perform a pilot study to establish the average and standard deviations from experimental readouts reflective of TLR function in human alveolar macrophages (AM) collected from healthy young and old people.
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Heart Diseases
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.
Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.
Proposed Indications The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent,
hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.
Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.
All patients will have a follow-up visit at 90 days post-device removal.
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This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).
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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.
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The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.
Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis
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The primary objective for this early feasibility study is to assess safety and feasibility of the Impella ECP device in adult patients undergoing an elective high-risk percutaneous coronary intervention. To assess safety, special attention is being paid to the effect of the pump on the aortic valve
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Heart Failure
The purpose of this study is to determine the relationship between levels of metabolites, such as lactate in the sweat of the skinm, and the severity of heart failure. We hope to determine whether the levels of lactate and other metabolites on the skin change as heart failure severity improves during a hospitalization. This information oculd also be used to develop ways to detect worsening heart failure severity using a sweat-based test. The study seeks to recruit patients admitted to Tufts Medical Center due to decompensated heart failure. There are 2 study visits which each require the collection of 15ml of fasted venous blood, a completed KCCQ, and holding a damped gauze between the palms for 2 minutes. The baseline study visit takes place within 72 hour of admission and the second study visit takes place within 3 and 60 days of the baseline visit when the patient meets criteria for clinical stability.
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This is a pilot/feasibility study on the accuracy of HRV measured by the Apple Watch on the clinical status of patients admitted for acute heart failure decompnsation. We hypothesize that there will be a statistically significant improvement in the HRV that correlates clinically over the course of hospitalization. Meaningful findings from this study will strengthen the potential for a telemonitoring system where HRV measured remotely from home using wearable devices like Apple Watch can help physicians monitoring their health and intervene accordingly.
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This study will examine how effective the SyncAV feature of Abbott’s cardiac resynchronization therapy device is in treating heart failure.
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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.
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This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.
The objective is to demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI or hospitalization for cardiovascular causes at 3-year follow-up.
All subjects will have follow-up for 3 years after randomization. The primary endpoint will be assessed after the last randomized patient reaches 1-year follow-up.
Eligible subjects are those with a chronic coronary syndrome (CCS) or NSTEMI with LVEF 40% or STEMI ≥24 hours and <30 days after symptom onset with LVEF 30% in whom complex PCI is planned after heart team discussion, without any study Exclusion Criteria and who provide informed written consent for participation in the Trial. Prior to randomization, all subjects will undergo baseline transthoracic echocardiography, QoL assessment, 6MWD testing (if able to ambulate). Randomization will take place in the Cardiac Catheterization Lab. Prior to randomization in the Cath Lab, the PCI operator will declare 1) the intended revascularization plan regardless of the use of hemodynamic support (including vessels/lesion, staging and intended IABP use); 2) the intent to use (or not use) IABP if randomized to the Control arm; 3) the planned use of right heart catheterization either within or not within a formal sub-study or not at all. Patients will then be randomized to PCI with Impella CP or standard of care PCI (± IABP),treatment of patients and discontinuation of hemodynamic support will be based on Protocol recommendations and standard of care at the hospital site, but Impella removal in the Cath lab is mandated.
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This study is looking at patients who will be receiving the HeartMate3 Left ventricular assist device and its insertion based off of an incision technique aside from full median sternotomy.
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The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.
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The proposed dyadic intervention will be one of the first to target the outcomes of both the HF patient and their spouse care partner simultaneously through a team-based intervention centered on shared appraisal, collaboration, communication and confidence to promote optimal dyadic health. The proposed study is, therefore, significant in addressing an important gap. Our study will determine the feasibility, acceptability and clinical meaningfulness of the Taking Care of Us program, providing vital information needed to move closer to our long-term goal to successfully translate this program into multiple delivery modalities (for maximum reach) and inform clinical practice. Results of this study will provide vital information to move us closer to translating successful programs into clinical practice and shed important light on whether, for whom, and how the Taking Care of Us program benefits both members of the HF care dyad
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This is a prospective, multicenter, phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure (HF) with reduced Ejection Fraction (HFrEF). The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF ≤40%) under stable treatment of HF symptoms. Empagliflozin is an orally available, potent, and selective inhibitor of the renal SGLT-2. Its selective inhibition reduces renal reabsorption of sodium and glucose. This leads to both increased urinary sodium and glucose excretion. While the urinary sodium excretion returns to normal within few days of empagliflozin administration, the effect on urinary glucose continues. The study treatment period will run for approximately 20- 38 months, until the required number of adjudicated primary events are reached. In Addition to the treatment period there is a 4-21 day screening period and a 30 day follow up visit.
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This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).
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Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of ‘food as medicine’ to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). We plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) to patients with HFrEF and malnutrition. We hypothesize that home delivery of MTMs will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The first phase of the proposed pilot study will asssign participants to a 12-week MTM phase only. The second phase is a randomized crossover trial, in which each subject receives a 12-week standard of care phase with self-directed dietary intake and a 12-week MTM dietary intervention phase, with a 4-week washout period between the two phases. Meals will be designed, prepared and delivered by our community based organized partner, Community Servings. We will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of MTM for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
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At Tufts Medical Center, we are continually evaluating different approaches to monitor and improve the care of our patients with advanced systolic heart failure. We are currently partnering with a company that has developed a non-invasive probe that measures capillary oxygenation through the skin. The probe attaches to the skin with a temporary adhesive and records the amount of oxygen in the blood cells passing through the skin. This technology may help us to detect when patients with abnormal heart pumping function (heart failure) are not circulating enough blood to their body. We have designed a study using this non-invasive probe to measure capillary oxygenation during exercise stress tests in patients with systolic heart failure and without systolic heart failure. Both groups of patients will have already been scheduled to undergo a treadmill exercise tests for standard clinical indications at Tufts Medical Center. We attach the adhesive probe to the skin on the base of the thumb and on the forearm during the exercise test. Study participation ends at the conclusion of the stress test, and the adhesive probe is removed. We hope to identify the differences between blood supply to the skin during exercise in patients with normal heart function versus those with systolic heart failure.
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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.
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The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.
Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis
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Heart Transplantation
This study is designed to find out whether there is a difference between how men and women respond to infections or vaccines following heart transplantation. We are recruiting men and women undergoing heart transplantation to participate by providing three blood samples over the course of about six months (taken in the same time and place as usual blood draws used for clinical purposes). We will use these samples to test levels of cells and proteins that are used fight infection and will compare these levels between male and female patients. In addition, we will gather information over the course of the first six post-transplant months about any infections or episodes of heart transplant rejection that you may experience. The point of the study is to identify if there could be different strategies used to prevent or treat infection in male versus female transplant recipients.
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Hematologic Disorders
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.
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Hepatitis C
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.
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Hepatoblastoma
This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.
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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.
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Hidradenitis Suppurativa
4 year long term extension study for subject who participated in previous HS study
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High Blood Pressure
Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.
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High Blood Pressure in Pregnancy
Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions
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Hypertension
Accurate resting blood pressure plays an important role in the accurate calculation of flow-dependent valvular indices used to grade the severity of valvular disease using echocardiograph images. If resting blood pressure is over-estimated there is a potential for error in the diagnosis of valvulopathies and by extension, an over or under treatment of valvular disease. Therefore, there is a need to improve concordance between various non-flow dependent indices, such as AVA and Dimensionless Index (DI), and flow dependent indices by using the patient’s average resting BP or trough BP. It is still not known at what time point during the course of the study the patient achieves their resting BP. This research study hopes to investigate that.
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Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals at their own homes or regional care settings to measure blood pressure. In this study, blood pressure will be measured with BPI and blood pressure readings will be compared with a commercially available cuff-based BP measuring device.The BPI will be placed at the wrist of healthy volunteers or persons with history of high blood pressure with the help of a wrist strap- similar to the current heart-rate monitoring devices in the market, such as the Fitbit- and three sets of readings will be obtained.
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Hypertrophic Cardiomyopathy
This will be a double-blinded, placebo-controlled study, aiming to assess the safety and tolerability of CT-G20 in subjects with obstructive hypertrophic cardiomyopathy (oHCM).
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This study is a double-blinded phase 2 clinical trial for a medication dedicated to treating patients with non-obstructive hypertrophic cardiomyopathy.
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The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)
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Intensive Care
A randomized, controlled, open-label, multi-center adaptive clinical trial to investigate the safe and effective performance of the Lungpacer Diaphragm Pacing Therapy System in patients who have failed to wean from mechanical ventilation
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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.
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The objective of this study is to demonstrate that the OptiScanner® can identify elevated and changing blood lactate levels in surgical ICU subjects.
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Intraabdominal Infections
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
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Intracerebral Hemorrhage
SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period.
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Intracranial Hemorrhage
The class of Novel Oral Anticoagulants (NOACs) known as direct Factor Xa (FXa) inhibitors has consistently demonstrated comparable or superior efficacy and/or safety relative to its predecessors, Vitamin K Antagonists (VKAs) and Low Molecular Weight Heparins (LMWHs). These agents (apixaban [Eliquis®], betrixaban [BevyxXa®], edoxaban [Savaysa®], rivaroxaban [Xarelto®]) are approved for the prevention of serious thromboembolic outcomes (e.g., stroke, deep vein thrombosis, pulmonary embolism) and have become widely used in the United States (US) and worldwide. One limitation to the use of FXa inhibitors has been the lack of an antidote to be used in cases of severe and/or life-threatening bleeding events. Acute major bleeding occurs at observed rates of 2-4% in pivotal stroke prevention trials in patients with nonvalvular atrial fibrillation [1-3], and such events are often catastrophic. Given the wide adoption and increasing use of FXa inhibitors, the prospect of major bleeding, especially in Intracranial Hemorrhage (ICrH) patients, has become a significant unmet medical need.
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Intracranial Pressure
This study is being done to find out if an external and painless method of measuring and monitoring the health of blood vessels within the head and the blood that flows in them is possible. This may be useful to clinicians as changes in cerebral blood flow are a frequent complication of neurological and neurosurgical disease and frequently need to be treated and monitored. Our goal is to show that this simple external monitor can improve the information that standard monitors provide, including surgically-implanted monitors. The way in which intracranial pressure (ICP) is monitored is by using a catheter inserted through the skull into the brain though a small incision made under local anesthesia at the bedside in the Intensive Care Unit (ICU) where you are staying. In contrast, our method of monitoring uses a small optical probe taped temporarily to the skin of your forehead. By comparing the data we will get from this study monitor to the standard monitors you already have, we hope to prove that this technology can be used to replace invasive procedures for these measurements.
The Near Infrared Spectroscopy (NIRS) device which will be taped to your forehead (ISS OxiplexTS), uses low energy light to measure oxygen levels in your blood. It is similar to the probe that is placed on your finger to measure your oxygen levels. The ISS OxiplexTX has been approved by the FDA to obtain NIRS measurements, but it has not been used in this way before.
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Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.
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Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) is an exclusion diagnosis that encompasses all forms of otherwise unexplained chronic non-infectious arthritis occurring under the age of 16. Various attempts have been made to classify this heterogeneous group of diseases with the aim of identifying mutually exclusive categories suitable for etiopathogenetic studies. Since then increasing evidence has accumulated suggesting that some of these categories are heterogeneous. Therefore, there is a need to revise the criteria in order to identify more homogeneous entities and to try to distinguish those diseases. The main reason for this research study is to learn more about the diagnosis of Juvenile Idiopathic Arthritis (JIA) according to the ILAR (International League of Associations for Rheumatology) criteria and investigate a new classification criteria proposed by the international research organization Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG).
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Kidney Diseases
This is the first study to look at a new medicine to help kidneys in people with diabetes who have protein in their urine. It looks at the safety and the effect on the amount of protein in the urine of a blocker of ‘Vascular Endothelial Growth Factor (VEGF)-B’. Information from animal studies suggests that blocking VEGF-B could help protect cells in the kidney from the damaging effects of diabetes. The drug is given either through the vein or under the skin by research nurses under the supervision of a research doctor. Some participants will get the medications while others will get a placebo (salt water); this will be decided randomly by chance.
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Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, we are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.
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Kidney Transplantation
This study is designed to find out whether there is a difference between how men and women respond to infections or vaccines following heart transplantation. We are recruiting men and women undergoing heart transplantation to participate by providing three blood samples over the course of about six months (taken in the same time and place as usual blood draws used for clinical purposes). We will use these samples to test levels of cells and proteins that are used fight infection and will compare these levels between male and female patients. In addition, we will gather information over the course of the first six post-transplant months about any infections or episodes of heart transplant rejection that you may experience. The point of the study is to identify if there could be different strategies used to prevent or treat infection in male versus female transplant recipients.
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This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have TRAC™ testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
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Laryngoscopy
This study will look at how accurate physician recall is compared to video review for laryngoscopies, which are throat examinations and a standard part of the otolaryngology visit. The hypothesis is that there may be a significant difference in accuracy, creating reason to standardize video recording of the laryngoscopy exam for improved patient outcomes.
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Leukemia
This is a randomized Phase 3 trial that will compare efficacy of CPX-351 during Induction 1 and Induction 2 versus standard chemotherapy for children with do novo, non FLT3-mutant AML.
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This phase III trial studies how well inotuzumab ozogamicin and post-induction chemotherapy work in treating patients with high-risk B-cell lymphoblastic lymphoma (B-ALL), mixed phenotype acute leukemia, and B-lymphoblastic lymphoma (B-LLy). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, cytarabine, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, thioguanine, vincristine, and pegaspargase, 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.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.
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This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with or without Down syndrome and newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.
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This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax 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 ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
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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 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.
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The overall goals of this study are to:
- To find out if subjects with down syndrome and standard risk acute myeloid leukemia can be treated with less treatment and still have successful outcomes.
- To find out if subjects with down syndrome and high risk acute myeloid leukemia can be successfully treated with stronger chemotherapy.
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This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzyme needed for cell growth. Drugs used in chemotherapy, work in different ways to stop growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinin mesylate and combination chemotherapy may work better in treating patients with Philadelphia positive acute lymphoblastic leukemia.
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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.
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Long QT Syndrome
The goal is to determine how lifestyle and exercise impact the well-being of individuals with hypertrophic cardiomyopathy (HCM and long QT syndrome (LQTS)
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Low Blood Pressure
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.
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Lower GI Tract Paralysis
Among the more than 5 million adults who are admitted to the ICU each year in the USA, most have pain and thus receive a pain (analgesic) medication called an opioid. Opioid use in critically ill adults continues to increase given the greater awareness of untreated pain in the ICU population and a recent strong recommendation in the Society of Critical Care Medicine’s Pain, Agitation, and Delirium Guidelines for Critically Ill Adults that an opioid-first approach be used to optimize patient safety and comfort and improve tolerance with breathing machines (i.e. mechanical ventilation). Similar to constipation, paralysis of the lower gastrointestinal (GI) tract is defined as the inability to pass stool due to impaired gut movements, and is a common effect of opioid use in the critically ill. Lower GI tract paralysis will often lead to nausea, vomiting, aspiration, compromise the ability to administer tube feeds (enteral nutrition), increases abdominal pain, and has been shown to delay getting off mechanical ventilation. One recent randomized study found that aggressive use of laxatives to prevent lower GI tract paralysis in critically ill adults was associated with lower daily organ dysfunction [as measured by the Sequential Organ Failure Assessment (SOFA) score]. The lower GI tract paralysis that occurs in the critically ill often responds poorly to laxative medication therapy (e.g., senna, bisacodyl, lactulose). While stool softener medications like docusateare routinely administered to patients on opioids, laxative-based protocols are frequently not initiated in the ICU until signs of lower GI tract paralysis start to appear. There is therefore an important and unmet need for a safe and efficacious medication to prevent lower GI tract paralysis in critically ill adults who are initiated on opioid therapy. Naloxegol (Movantik) is a naloxone-like drug that blocks the effect of opioids on the opioid µ receptor in the gut. Naloxegol is currently approved by the Food and Drug Administration (FDA) for the treatment of opioid-induced constipation (OIC) in non-ICU patients receiving scheduled moderate to high dose opioids for the treatment of chronic non-cancer pain. Naloxegol has a mechanism of action, efficacy, convenience of administration, and safety profile that make it an ideal candidate for use as a preventative medication for lower GI tract paralysis in critically ill adults receiving opioid therapy through the vein [intravenous (IV)]. We therefore propose a pilot study in which we will test the hypothesis that naloxegol (versus placebo) will reduce the time to the first spontaneous bowel movement (SBM) that the ICU patient has, that it will prevent lower GI tract paralysis in critically ill adults initiated on scheduled IV opioid therapy, and its use will not result in side effects that are concerning to doctors or patients. We will randomize 36 critically ill ICU patients (18 in each arm) to receive naloxegol [25mg or 12.5mg (in patients with kidney problems] or placebo. This pilot study will provide valuable information to help guide future, larger studies of naloxegol in ICU patients.
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Lupus
The purpose of the study is to evaluate the ability and safety of subcutaneous secukinumab 300 mg plus standard of care, compared to placebo plus standard of care, in treating subjects with active Lupus Nephritis.
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Lupus Erythematosus
Open label phase 2 proof-of-concept trial of oral tofacitinib in adult patients with discoid lupus erythematosus (DLE) lesions and systemic lupus erythematosus (SLE).
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Lyme Disease
Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease.
Our objectives include: (1) assessing the link between the detection of B. burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans.
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Lymphomas
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with or without Down syndrome and newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.
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This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL).
Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread.
Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
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Macular Degeneration
Microperimetry allows for precise structure-function correlation studies to be performed on the retina. By creating a map of retinal sensitivity and overlaying it onto images of the retina, structure-function correlation can be determined. Already used in common retinal diseases like diabetic retinopathy, microperimetry has proven useful as a diagnostic tool. Studies have shown early changes in retinal sensitivity associated with disease even before there are major clinically apparent changes in the eye. This suggests that there may be subtle changes to eye structure and function before vision is noticeably impaired—better understanding these changes could provide rationale for earlier intervention to prevent deterioration in patient vision. This study seeks to assess possible structural and functional changes over the course of the disease progression in a variety of retinal disorders by using microperimetry in combination with optical coherence tomography imaging. This could allow for
earlier detection of diseases, provide rationale for earlier intervention, and provide a means of tracking and managing disease progression.
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This long-term extension (LTE) study will evaluate the long-term safety, tolerability, and efficacy of intravitreal (IVT) faricimab in patients with diabetic macular edema who have completed either of the Phase III GR40306 (TENAYA) study. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed.
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This is a Phase 3, multicenter, 36-month, open-label extension study to assess the safety and efficacy of long-term IVT injections of pegcetacoplan in subjects with GA secondary to age-related macular degeneration (AMD).
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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).
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Macular Edema
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24.
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Medulloblastoma
This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.
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Meningiomas
The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.
The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK22560
98, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.
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Menstruation
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.
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Multiple Myeloma
The present study is evaluating whether the combined activity of belantamab mafodotin
at 2.5 mg/kg in Cycle 1 (C1) and 1.9 mg/kg in Cycle 2 onwards (C2+) when administered in combination with Pd could potentially translate into clinically meaningful benefits compared to PVd in RRMM participants who are progressing on or after treatment with a lenalidomide-containing regimen.
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To determine if bortezomib, daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab-hyaluronidase SC and lenalidomide (DR) maintenance after standard induction therapy with daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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Multiple Sclerosis
The purpose of this study is to assess early phase safety and tolerability of transitioning patients from approved oral and injectable RMS DMTs to siponimod. The results of this study will guide clinically relevant decisions related to the transition from frequently used RMS DMTs to siponimod and provide clinically relevant data on safety and tolerability for healthcare providers who are considering transitioning patients from currently approved RMS DMT to siponimod. The primary objective is to evaluate overall safety and tolerability profile of siponimod in advancing RMS patients (including a broader population that had not been previously studied with siponimod who are converting from currently approved oral or injectable RMS DMT).
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The purpose of the study is to assess the efficacy and safety of SAR442168 compared with teriflunomide (Aubagio) in participants with relapsing multiple sclerosis (RMS).
The experimental drug works in the blood and in the brain where it blocks a molecule called “Bruton's tyrosine kinase (BTK)”, which is present in some cells involved in multiple sclerosis (immune cells known as B-cells and microglial cells). This mechanism of action may help stop the formation of new brain lesions in MS.
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The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with NRSPMS compared to placebo and has an acceptable safety profile.
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The purpose of the study is to see if the study drug, SAR442168, works to delay the progression of disability in people with PPMS compared to placebo and has an acceptable safety profile.
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This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.
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Myasthenia Gravis
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluates using ravulizumab infusions as treatment for patients with generalized Myasthenia Gravis. Participants will receive either ravulizumab for the duration of the study or placebo during the 26-week randomized-controlled period of the stufy and then enter the open-label extension period where they will receive ravulizumab. The main outcome will look at the change from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at week 26 (end of randomized period).
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Myeloma
The goal of this study is to determine whether escalating maintenance therapy with the addition of ixazomib to lenalidomide improves overall survival among patients who are minimal residual disease (MRD) positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (≤ 12 months from diagnosis).
This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.
This study involves pre-registration (Step 0) and randomization (Step 1). Bone marrow specimen must be submitted for central MRD assessment and results will determine step 1 eligibility.
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Myocardial Heart Disease
The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.
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Myopia
This study will last approximately 4 years. Screening will last for approximately 2 weeks. Stage 1, where subjects will be randomized in a 2:1 ratio to OT-101 Ophthalmic Solution or placebo, will last approximately 3 years. Stage 2, where subjects previously assigned to OT-101 Ophthalmic Solution will be re-randomized to either continue with OT-101 Ophthalmic Solution or switch to placebo and subjects previously assigned to placebo will continue with placebo, will last approximately 1 year. Subjects will be asked to undergo visual acuity testing and intraocular examinations at visits every 6 months. Ocular imaging will be performed on a yearly basis.
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Neonatal Necrotizing Enterocolitis
We will collect salivary and stool samples from newborns born in our NICU and obtain mRNA sequencing to identify microbial colonization. We will attempt to correlate aberrant colonization with adverse outcomes of newborn mortality and morbidities such as NEC and sepsis.
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Neonatal Care
Low IGF-1 levels in extremely preterm infants (gestational age [GA] of 23 weeks +0 days to 27 weeks +6 days) are a risk factor for CLD and other complications of extreme prematurity. An increase of serum IGF-1 levels provided by SHP607 administration may reduce the incidence of CLD and other complications of extreme prematurity. This would be the only available preventive pharmacological therapy leading to an absolute decrease in the incidence of moderate or severe BPD and an absolute decrease in the incidence of IVH for extremely premature babies translating to an improvement in long-term pulmonary and neurodevelopmental outcomes which are key drivers for short- and long-term use of resources. Subjects will be randomly assigned on a per site basis to treatment either with SHP607 (250 μg/kg/24 hours or 400 μg/kg/24 hours) or to receive standard neonatal care in a 1:1:1 ratio. Standard neonatal care is determined based upon the individual premature infant’s condition and clinical judgment of the treating physician and may include interventions for thermoregulation, blood pressure support, respiratory/ventilatory support, nutritional support, treatment for infections, etc. Recognizing that medical care required for each premature infant may vary, other than those specific parameters outlined in the protocol, local neonatal intensive care unit (NICU) practices and investigator’s judgment for care decisions are to be followed. Subjects randomly assigned to treatment with SHP607 will receive continuous IV infusion of study drug commencing within 24 hours of birth, once all baseline assessments have been completed. The infusion of study drug will continue to PMA 29 weeks +6 days, when the subjects’ endogenous production of IGF-1 is considered sufficient to maintain physiologic serum IGF-1 levels for corresponding GA. Infusion of study drug may be discontinued before PMA 29 weeks +6 days if IV access is not possible according to the clinical judgment of the investigator or when the responsible physician, for other medical reasons, decides that infusion of study drug should be discontinued. Initially, enrollment will be restricted to subjects of GA ≥26 weeks (26 weeks +0 days to 27 weeks +6 days). After approximately 75 subjects (approximately 25 subjects in each treatment group) have completed the PMA 40 weeks visit, the DMC will assess safety and preliminary efficacy data, where preliminary efficacy assessments would include review of imbalances in BPD and IVH incidence between study groups. Based on the outcomes of these assessments, the DMC may authorize enrollment of subjects of GA between 23 weeks +0 days and 27 weeks +6
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Neonatal Sepsis
We will collect salivary and stool samples from newborns born in our NICU and obtain mRNA sequencing to identify microbial colonization. We will attempt to correlate aberrant colonization with adverse outcomes of newborn mortality and morbidities such as NEC and sepsis.
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Nephropathy
Additional development of an enzyme called IgA protease as a means to remove IgA (a protein) from the kidney.
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ARTEMIS – IGaN is a maximum 160 week a Phase 3 trial evaluating the Safety and Efficacy of OMS721 in patients with Immunoglobulin A (IgA) Nephropathy
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Neuroblastoma
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.
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Neurogenic Orthostatic Hypotension
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.
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Neurologic Diseases
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.
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Neuromuscular Disorders
The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.
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Neurotrauma
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).
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Neurotrophic Keratitis
This clinical study will be a multi-center, open label, prospective study of 8 weeks of treatment with 24 weeks of follow-up to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks in patients with Stage 1 Neurotrophic Keratitis (NK).
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Non-Alcoholic steatohepatitis
You are being invited to consider participation in a clinical research study for patients with cirrhosis caused by nonalcoholic steatohepatitis (NASH) This study involves research and is conducted to determine the safety and efficacy of a new investigational drug called aldafermin (previously known as NGM282
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The purpose of this study is to find out about the safety and efficacy of VK2809 for the treatment of non-alcoholic steatohepatitis (NASH).
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Obesity
The aim of this study is to improve the metabolic health of overweight and obese women prior to a planned pregnancy.
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Optic Neuritis
This study focuses on developing a new portable noninvasive system to aid in the diagnosis of the vision disorders Multiple Sclerosis and Optic Neuritis. This device combines images and patterns using a Head Mounted Display, similar to a virtual reality headset. The system measures brain responses to these images using a form of electroencephalography (EEG), which will give us information about how the brain and eyes communicate and how this may be affected by a vision disorder.
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Oropharyngeal Cancer
This study is being done to answer the following question:
Does maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (OS) (time being alive) for patients with your type of cancer (intermediate risk HPV positive oropharynx cancer).
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your HPV positive oropharynx cancer. The usual approach is defined as care most people get for HPV positive oropharynx cancer.
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Orthopaedic Surgery
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.
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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.
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This study will evaluate the potential usefulness and effectiveness of Virtual Reality (VR) in reducing pain for adults with chronic knee osteoarthritis (OA).
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The purpose of the study is to evaluate for long term changes in pain and function in knee osteoarthritis and also to ascertain differences in health care utilization among subjects who participated in the randomized controlled trial on effect of intra-articular steroids on structural progression of knee osteoarthritis (IACS)
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The purpose of this clinical research study is to learn more about the use of the study drug, amnion suspension allograft (written as ‘ASA’ in this form), for the potential treatment of osteoarthritis (OA) of the knee. The ASA injection is being studied to see if it improves the knee pain and function in people with knee OA
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This study evaluates the efficacy and safety of fasinumab compared to placebo, diclofenac, and celecoxib (diclofenac and celecoxib are standard-of-care non-steroidal anti- inflammatory drugs, NSAIDs, used for moderate-to-severe pain due to OA). The study drug will be administered for up to 24 weeks in patients with OA of the knee or hip. Fasinumab aims to selectively block nerve growth factor (NGF), a protein that causes pain. Blocking NGF may reduce pain due to OA of the hip and knee. Fasinumab is being test and is not approved for use in pain management by the United States Food and Drug Administration (FDA).
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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.
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Pancreatic Cancer
The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy
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The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy.
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This study is being done to answer the following question:
Which of two treatment combinations, Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan, is more effective at lengthening the period of time that less fit patients over the age of 70 years with metastatic pancreatic cancer (mPCA) live?
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Parkinson's Disease
The aim of this study is to test the safety and efficacy of IPX203 compared to IR CD-LD in participants with Parkinson’s disease. IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth).
IPX203 is being investigated to determine whether the drug is safe and potentially has a better effect than currently approved IR CD-LD. If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson’s disease.
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Polycystic Kidney Disease
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.
The primary objectives of this study is assess the off-treatment change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 or following a 4-week drug treatment withdrawal period in the first year of treatment and to assess safety and tolerability.
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The project is focused on understanding the underlying biology in kidney cells, with the goal of developing drug to treat kidney diseases, in particular Autosomal Dominant Polycystic Kidney Disease
(ADPKD). Following the elective removal of a polycystic kidney, otherwise normally discarded kidneys will be sent to Vertex Pharmaceuticals, Inc. to be analyzed.
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Post-Operative Pain
The purpose of this research is to find out if a local administration of liposomal bupivacaine works as well, or better, than our standard of care medication solution when administered in the same way to manage pain after surgery.
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Preeclampsia
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.
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Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions
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Pregnancy
The FEED study will focus on maternal feeding styles and practices. Feeding styles refers to the attitudes, emotional climate, and quality of the interaction that parents maintain with their child during feeding. Feeding practices refer to specific strategies that parents use to feed their children. Research studies have shown that feeding styles and practices can interact to influence a child’s food preferences, dietary intake and weight status. Less is known about how feeding styles and practices track in early life. This research study will investigate these relationships and look at the relationship between feeding and infant adiposity.
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GO MOMS is a study that tracks maternal blood sugar levels in pregnancy and how the levels may predict the development of gestational diabetes (pregnancy-related high blood sugar) or relate to the size of a baby at birth. As not enough is known about who will get gestational diabetes and because treatment of gestational diabetes in later pregnancy does not make all of the complications go away, learning about the early pregnancy blood sugars may help us learn how to improve prenatal care in the future for healthier families.
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The purpose of the study is to measure the softness of the cervix. The softness of the cervix will be compared in two groups of pregnant women. One group is women who will be having a surgery to strengthen the cervix (a cerclage surgery). The second group is normal women in the prenatal clinic. We anticipate recruiting 140 patients total (60 cases and 80 control patients.)
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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.
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The aim of this study is to improve the metabolic health of overweight and obese women prior to a planned pregnancy.
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The purpose of this study is to measure the effect of maternal metabolism (how your body uses food for energy) on the growth of the placenta (afterbirth), and how the placenta uses lipids.
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The purpose of this study is to measure the effect of maternal diet and metabolism (how your body uses food for energy) on the growth of the baby, and how the placenta uses lipids.
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This study is being done to learn more about the placenta’s rich blood supply and the relation between the placenta and family history of heart health. The researchers would also like to find out if this information can be used to help guide long term heart health care. To study this, we would like to collect and compare placentas from subjects who have a family history of heart disease to those who do not have a family history of heart disease.
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Premature Babies
Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC. Infants with NEC are usually treated with bowel rest (stopping feeding by mouth), antibiotic medicines, and in some cases with surgery where the affected bowel needs to be removed.
Some studies have shown that live bacteria given to the intestine of premature infants as early as possible in their life might be able to prevent NEC. Researchers want to find out if an investigational drug called “IBP-9414”, which is made of living bacteria, can help prevent NEC in prematurely born infants. An investigational drug is a drug that is being tested and is not approved for use and sale by any authorities (like the U.S Food and Drug Administration [FDA], the European Medicines Agency [EMA], or the authority in your country
All infants in the study will receive “standard-of-care” treatment, which means they will receive the same medical treatment they would receive if they were not in the study. In addition to the standard-of-care treatment that all infants will receive, half of the infants in the study will receive the investigational drug (IBP-9414) and half will receive an inactive substance (contains no medicine) called “placebo”. Receiving placebo is the same as not receiving any medication other than the standard-of-care treatment. The reason placebo is used in this study is to help the researchers know if any effects they see in the study are because of the investigational drug rather than the researchers’ expectations about the effects of the study drug. Neither you nor the study doctor/staff will be able to choose or to know whether your child receives IBP 9414 or placebo. This is why the study is called “double blind”. Your child will be assigned at random (like flipping a coin) to receive IBP 9414 or placebo. Your child’s chances of receiving IBP 9414 or placebo are the same (50 50 chance). In case of medical need, the study doctor will be able to find out whether your child is receiving IBP 9414 or placebo. In this study, the placebo will be sterile water. Please ask the study doctor or study staff if you have any questions about your child receiving placebo.
The main purpose of this study is to see if IBP-9414 can prevent NEC and if it is safe and tolerable. The unit that doses of live bacterial drugs are measured in is called “colony forming units” or CFUs. The dose of IBP-9414 to be tested is 1x109 CFU, which means it contains 1 billion live bacteria. This dose has been tested previously in a smaller study of IBP-9414 and was found to be safe and tolerable. In order to see if this dose actually can prevent NEC, a much larger study involving more infants is needed.
It is planned that 2158 premature infants will be included in this study, who will be less than 48 hours old at the time they begin taking part. At the end of the study, the researchers will compare the infants who received IBP 9414 with those who received placebo, to help decide if receiving IBP 9414 can prevent NEC and if it is safe for premature infants.
While the study doctor responsible for your child will monitor the safety of your individual infant, the safety of all infants in the study, as well as the effect of IBP 9414, will also be monitored on an ongoing basis throughout the study by a so-called Data Monitoring Committee (DMC). A DMC is a panel of experts who are independent from the study team and the pharmaceutical company developing IBP 9414.
Most of the infants (1942) in the study will weigh up to 1000 grams birth weight (about 2 lbs) and the rest (216) will weigh 1001 to 1500 grams (about 2 lbs to about 3 lbs).
The study will start with a group of 300 infants, all of whom will be in the intermediate weight category (750-1000 grams category). After 300 infants have completed treatment, a panel of experts (called a Data Monitoring Committee or DMC), who know which treatment each infant received, will determine if IBP-9414 appears to be safe and well tolerated. Enrollment in the study will continue during this review.
Based on the DMC recommendation, enrollment will open to infants from the lower weight category (500 749 grams), alongside the intermediate weight category (750 1000 grams).
A second DMC safety review will occur after the first 600 infants have completed treatment. Enrollment in the study will continue during this review.
A third DMC safety review will be performed after 1400 infants have completed treatment. Enrollment in the study will continue during this review.
After 1400 infants, the plan is to open recruitment to infants in the higher birth weight category (1001 1500 grams). The study will continue with all 3 birth weight categories until 2158 infants have been enrolled
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The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.
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Premature Birth
Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC. Infants with NEC are usually treated with bowel rest (stopping feeding by mouth), antibiotic medicines, and in some cases with surgery where the affected bowel needs to be removed.
Some studies have shown that live bacteria given to the intestine of premature infants as early as possible in their life might be able to prevent NEC. Researchers want to find out if an investigational drug called “IBP-9414”, which is made of living bacteria, can help prevent NEC in prematurely born infants. An investigational drug is a drug that is being tested and is not approved for use and sale by any authorities (like the U.S Food and Drug Administration [FDA], the European Medicines Agency [EMA], or the authority in your country
All infants in the study will receive “standard-of-care” treatment, which means they will receive the same medical treatment they would receive if they were not in the study. In addition to the standard-of-care treatment that all infants will receive, half of the infants in the study will receive the investigational drug (IBP-9414) and half will receive an inactive substance (contains no medicine) called “placebo”. Receiving placebo is the same as not receiving any medication other than the standard-of-care treatment. The reason placebo is used in this study is to help the researchers know if any effects they see in the study are because of the investigational drug rather than the researchers’ expectations about the effects of the study drug. Neither you nor the study doctor/staff will be able to choose or to know whether your child receives IBP 9414 or placebo. This is why the study is called “double blind”. Your child will be assigned at random (like flipping a coin) to receive IBP 9414 or placebo. Your child’s chances of receiving IBP 9414 or placebo are the same (50 50 chance). In case of medical need, the study doctor will be able to find out whether your child is receiving IBP 9414 or placebo. In this study, the placebo will be sterile water. Please ask the study doctor or study staff if you have any questions about your child receiving placebo.
The main purpose of this study is to see if IBP-9414 can prevent NEC and if it is safe and tolerable. The unit that doses of live bacterial drugs are measured in is called “colony forming units” or CFUs. The dose of IBP-9414 to be tested is 1x109 CFU, which means it contains 1 billion live bacteria. This dose has been tested previously in a smaller study of IBP-9414 and was found to be safe and tolerable. In order to see if this dose actually can prevent NEC, a much larger study involving more infants is needed.
It is planned that 2158 premature infants will be included in this study, who will be less than 48 hours old at the time they begin taking part. At the end of the study, the researchers will compare the infants who received IBP 9414 with those who received placebo, to help decide if receiving IBP 9414 can prevent NEC and if it is safe for premature infants.
While the study doctor responsible for your child will monitor the safety of your individual infant, the safety of all infants in the study, as well as the effect of IBP 9414, will also be monitored on an ongoing basis throughout the study by a so-called Data Monitoring Committee (DMC). A DMC is a panel of experts who are independent from the study team and the pharmaceutical company developing IBP 9414.
Most of the infants (1942) in the study will weigh up to 1000 grams birth weight (about 2 lbs) and the rest (216) will weigh 1001 to 1500 grams (about 2 lbs to about 3 lbs).
The study will start with a group of 300 infants, all of whom will be in the intermediate weight category (750-1000 grams category). After 300 infants have completed treatment, a panel of experts (called a Data Monitoring Committee or DMC), who know which treatment each infant received, will determine if IBP-9414 appears to be safe and well tolerated. Enrollment in the study will continue during this review.
Based on the DMC recommendation, enrollment will open to infants from the lower weight category (500 749 grams), alongside the intermediate weight category (750 1000 grams).
A second DMC safety review will occur after the first 600 infants have completed treatment. Enrollment in the study will continue during this review.
A third DMC safety review will be performed after 1400 infants have completed treatment. Enrollment in the study will continue during this review.
After 1400 infants, the plan is to open recruitment to infants in the higher birth weight category (1001 1500 grams). The study will continue with all 3 birth weight categories until 2158 infants have been enrolled
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The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.
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This study is being conducted to find out what genes are turned on or off (called "gene expression") in babies born preterm and how that may be related to complications of prematurity or other health conditions they may experience during or after their initial hospitalizations.
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Preterm Birth
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.
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Understanding the etiology of preeclampsia and spontaneous preterm delivery through the characterization of placental trophoblasts and maternal decidual leukocytes as well as their interactions
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Primary Sclerosing Cholangitis
The purpose of this study is to create a research tissue bank to collect, process, and store samples until researchers need them to do research. Tissue samples in this bank will be used mainly for research on primary sclerosing cholangitis (PSC). You have been asked to take part of this study because you have PSC, another related disease, or are a healthy person.
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Proteinuria
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Prurigo Nodularis
Evaluate Safety and Efficacy of Nemolizumab in subject with Prurigo Nodularis
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Psoriatic Arthritis
This study evaluates the safety and efficacy of the study drug ABT-494 as compared to a current FDA-approved drug, adalimumab, as well as a placebo. ABT-494 aims to inhibit the JAK1, which is partially responsible for inflammation associated with psoriatic arthritis. Although ABT-494 is not FDA approved, it has seen success in the first 2 phases of trials.
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This is an observational study of people who have spondyloarthritis. This includes diseases such as ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease associated arthritis. Those in the registry must be patients of providers in the Tufts rheumatology clinic.
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Pulmonary Fibrosis
The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. This study hypothesizes that inhaled treprostinil will have a positive effect on absolute FVC after 52 weeks of therapy as compared with placebo when administered to subjects with IPF. This is a Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of subjects with IPF treated with inhaled treprostinil over a 52-week period.Approximately 396 eligible subjects study-wide will be randomly assigned 1:1 to inhaled treprostinil or placebo at Baseline. Randomization will be stratified by IPF background therapy (nintedanib or pirfenidone vs no background therapy). All subjects will initiate inhaled treprostinil (6 mcg/breath) or placebo at a dose of 3 breaths (18 mcg) administered QID (during waking hours) and will titrate to a target dosing regimen of 12 breaths (72 mcg) QID.
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Pulmonary Hypertension
This is a Phase 3, randomized, double-blinded, placebo-controlled study to compare the efficacy and safety of sotatercept versus placebo when added to background pulmonary arterial hypertension (PAH) therapy for the treatment of PAH. The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. Participants enrolled in the study will have a diagnosis of PAH (Pulmonary Hypertension WHO Group 1) associated with idiopathic/heritable, drug-induced, connective tissue diseases (CTD),or post shunt correction PAH, within WHO FC II or III. Approximately 284 participants will be randomly assigned in a 1:1 ratio to the two study treatment groups (142 participants per arm).
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This is a research study involving an investigational drug called PB1046. The word “investigational” means this drug is still being tested in a research setting and is not approved by the U.S. Food and Drug Administration (FDA). Throughout the remainder of this consent form the investigational drug, PB1046 will be referred to as the “study drug”.
The active ingredient in the study drug is a slightly changed form of a protein called vasoactive intestinal peptide (VIP). The VIP protein is normally found in the body. The change made to the natural protein helps to protect the protein from breaking down too quickly. It has been reported in scientific sources that the amount of VIP may be lower in people with Pulmonary Arterial Hypertension (PAH).
This study is being done for multiple reasons. One reason is to see how well participants with PAH tolerate the study drug long term by checking bloodwork periodically and checking for side effects. The study will also see whether your body makes antibodies against the study drug. Antibodies are proteins produced by the body's immune system that are usually found in the blood that help protect our bodies from harm by finding and destroying invaders, like bacteria and viruses. They can also cause harm when they find other proteins that are not normally in the body like the study drug, and these antibodies can make the study drug, or the natural VIP found in our bodies, not work as well or not at all.
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ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Study visits will occur at Day 1 and every 4 weeks through Week 28, with weekly titration phone calls during the first 16 weeks. Approximately 193 subjects with WHO Group 1 PH and on stable background therapy are planned to be enrolled. Subjects who meet entry criteria will be randomly allocated (2:1 ratio) to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who complete the study on study drug through Week 28 will have the option to receive ralinepag in an open-label extension (OLE) study.
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This is a double-blind, placebo-controlled, randomized Phase 2 study. This study will evaluate the oral inhalation of GB002 in adult subjects with WHO Group 1 PAH who are WHO FC II and III and have a PVR of ≥ 400 dyne•s/cm5. After signing an informed consent form (ICF), subjects will be screened for study eligibility for up to a 5-week screening period. Subjects must continue on stable doses of background PAH medications from 4 weeks before consent and throughout the treatment period. Dose modification of background PAH medications will not be allowed during the screening period. On Day 1 (Baseline visit), eligible subjects will be randomized 1:1 to 1 of 2 treatment groups to receive GB002 twice per day (BID) or placebo. Initially subjects will receive 60 mg BID (4 inhalations BID) for 1 week, after which, subjects will increase the dose to 90 mg BID (6 inhalations BID). Investigational product (IP) dose may be reduced due to tolerability or AEs. Randomization will be stratified by PVR. Subjects will receive IP, BID, over 24 weeks inhaled orally with a dry powder inhaler (DPI). Following initiation of IP in the clinic on Day 1, subjects will return to the clinic every 4 weeks through Week 28 (24 weeks of treatment + 4 weeks of follow-up). Subjects will also be contacted by phone at Week 1 and attend a Week 28 Follow-up visit at the clinic.
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This double-blind study will compare the efficacy, safety, and tolerability of 2 doses of rodatristat ethyl to placebo in patients with PAH. Eligible patients will be stratified during the randomization process based on the number of background PAH therapies they are receiving (1, 2 or 3) and use of selexipag (yes/no). The number of patients who are receiving a prostanoid infusion will be capped at 50% of the total number of patients enrolled. The number of patients who are receiving selexipag will be capped at 20% of the total enrolled. Patients will be randomized 1:1:1 to placebo, 300 mg BID, or 600 mg BID of rodatristat ethyl. Patients who complete the Main Study will have the option to enroll into the OLE and continue to receive rodatristat ethyl (those randomized to placebo will be re-randomized 1:1 to receive rodatristat ethyl 300 mg BID or 600 mg BID) until the Investigator or patient chooses to stop the investigational product (IP), any stopping criterion in the Main Study is met, IP becomes commercially available, or the Sponsor stops the study for lack of efficacy or a safety signal. Approximately 90 patients with PAH are expected to be enrolled at approximately 45 to 50 study sites in the U.S., Canada, and Rest of World (ROW). This is a parallel group treatment study with 3 arms that is participant, Sponsor, and Investigator blinded. The objective of the OLE is to evaluate the long-term safety, tolerability, and efficacy of rodatristat ethyl in patients with PAH.
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This is a prospective, multicenter study in patients with PH to discover, design and develop blood biomarker signatures. The study population will include prevalent (previously diagnosed) and incident (newly diagnosed) patients who have RHC grouped according to the following subgroups: prevalent non-PH (RHC within 6 months), or incident non-PH (RHC within 6 weeks), or incident PH (RHC within 6 weeks), or prevalent PH without or with PAH therapy (RHC within 18 months). At the time of enrollment in the study, blood samples will be taken and a TTE will be performed for each participant. All TTE will be centrally read in a blinded manner according to the ESC/ERS Guidelines. TTE readings will be used to compare the diagnostic performance of the biomarker signature(s) in identifying the presence of PH to the current best practice for non-invasive diagnosis of PH. No genomic profiling analysis is planned in this study, however, as stated above, blood samples containing white blood cells will be collected and stored to enable future analysis using the most appropriate genomic analysis platform to allow for genomic research, as necessary where local regulations permit. Results of such analysis will be reported separately if done. Participation in the genomic research is optional. Any genomic analysis will be included in a separate report.
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This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).
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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.
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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.
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Pulmonary Vascular Resistance
Collection of TRV and RVOT VTI from TEE and right heart pressures and CO from PA catheter.
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Respiratory Infections
We intend to use the measurement of three host-related, serum-based, protein biomarkers using a previously validated score to determine whether a patient with a suspected respiratory illness has a bacterial or viral immune response (or equivocal). These results will then be compared to the decision of the clinical provider to prescribe antibiotics as documented in the patient chart and allow for calculation of potential antibiotic use reduction.
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Respiratory Syncytial Virus Infections
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, interventional study in infants and children (≥28 days to ≤5 years of age) and subsequently in neonates (<28 days of age), hospitalized (refers to having planned at least 24 hours with an overnight stay in the hospital) with RSV infection. Rilematovir is an investigational, potent small-molecule RSV-specific fusion inhibitor belonging to the indole chemical class. Rilematovir targets the RSV F protein and prevents the conformational changes of the F protein required for fusion of the viral envelope with the host cell membrane and for cell-to-cell fusion, thereby inhibiting viral replication and syncytia formation. Study participants with signs/symptoms of an acute respiratory illness supporting a diagnosis of RSV infection will be identified and tested for RSV infection when they are hospitalized or present to the ER/clinic and are expected to be hospitalized. Participants should only be screened if they are expected to be randomized within ≤3 days of RSV sign/symptom onset.
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Retinal Disorders
Adaptive optics (AO) is a non-invasive imaging technology of the eye that allows for precise and detailed observations of neuroretinal structures in vivo. By counteracting optical aberrations using a deformable mirror, AO provides higher resolution and contrast en face retinal imaging than any other imaging technology, resulting in visualization of the microscopic structures of the retina. AO has already been used in the diagnosis and monitoring of common retinal diseases like diabetic retinopathy, age-related macular degeneration (AMD) and macular telangiectasia. Because of the increased quality in AO images, it can show subtle changes to eye structure and function before vision is noticeably impaired. Better understanding these changes could provide rational for earlier intervention to prevent deterioration in patient vision due to retinal diseases. This study seeks to assess possible structural and functional changes over the course of the disease progression in a variety of retinal disorders by using AO in combination with optical coherence tomography imaging and microperimetry. This could allow for earlier detection of diseases, provide rationale for earlier intervention, and provide a means of tracking and managing disease progression.
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Rhabdomyosarcoma
This phase III trial compares the effect of vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide for the treatment of high risk rhabdomyosarcoma.
Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Giving vinorelbine and VAC may kill more tumor cells. Adding maintenance therapy (vinorelbine and cyclophosphamide) after VAC therapy, with or without vinorelbine, may help get rid of the cancer and/or lower the chance that the cancer comes back.
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Rheumatoid Arthritis
The purpose of the study is to assess whether the addition of a TNFi-biologic (tumor necrosis factor inhibitor) medication to methotrexate (MTX) is superior to adding a targeted synthetic DMARD (disease-modifying anti-rheumatic) medication to MTX for people with active RA despite current MTX treatment.
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Sclerosing Cholangitis
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.
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Seizures
Neonatal seizures have developmentally unique and heterogeneous disease mechanisms that differ from epilepsies seen in older populations. Anti-seizure drug discovery has had limited success over the decades to improve treatment of neonatal seizures. A knowledge gap exists in the molecular mechanisms responsible for neonatal seizures, limiting anti-seizure therapeutic targets unique to this population. Our study goal is to identify unique molecular networks and pathways responsible for neonatal seizures by salivary gene expression analyses, so that we may identify novel drug therapies to improve outcomes in this vulnerable population.
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Solid Tumors
The purpose of this study is to describe, under real-world conditions, the safety and effectiveness of larotrectinib in patients with locally advanced or metastatic TRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment.
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Squamous Cell Carcinoma
This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
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Status Epilepticus
Status Epilepticus(SE) is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. The purpose of this research is to find out if ganaxolone can stop or decrease the seizure activity in participants who have SE and if ganaxolone is safe compared to placebo when given to participants who are on other anti-seizure medications.
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Stent Restenosis
A prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. Up to 40 sites in the United States, at least 480 subjects will be enrolled in the trial. An interim analysis will be performed prior to the end of the initial enrollment of 480 patients. The final sample size may be increased up to a maximum of 600 subjects enrolled in the trial.
The objective of this study is to assess the safety and effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
The AgentTM Paclitaxel Coated balloon catheter is indicated for percutaneous transluminal coronary angioplasty (PTCA) in coronary arteries 2.0 mm to 4.0 mm in diameter and up to 26mm in length, for the purpose of improving myocardial perfusion to treat in-stent restenosis (ISR).
Clinical follow-up: in hospital, 30 days, 6 months, 12 months, then annually through 5 years post index procedure.
The study will be considered complete with regard to the primary endpoint after all subjects have completed the 12-month follow-up period. Subjects who are enrolled but who do not receive a study/ control device will be followed through 12 months only.
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Strabismus
The aim of our investigation is to determine whether strabismus measurements change significantly after dilation whit cyclopentolate ophthalmic drops in children. The impetus for this study is a recent report published in the American Journal of Ophthalmology, which concluded that in adults, strabismus measurements do not significantly change after dilation with tropicamide and phenylephrine. We would like to replicate this study in a pediatric population with cyclopentolate.
In a hospital or clinical learning institution, there may be multiple clinicians who evaluate a pediatric patient. Because so much of strabismus management is predicated upon the results of cover testing, it is common to ask the attending to repeat the measurement, based on the belief that strabismus measurements can change after dilation. If the results of the aforementioned report were applied to the pediatric population, it could dramatically affect the current standard of care. We want to ensure providers are using the most accurate measurements in their treatment of eye turn.
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This study aims to determine whether strabismus measurements change significantly after dilation with cyclopentolate ophthalmic drops in children. The impetus for this study is a 2018 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 the standard of care dilating agent: cyclopentolate.
In a hospital or clinical learning institution, there may be multiple clinicians who evaluate the 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 of their treatment of eye turn.
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Stress
The goal of this research project is to test the hypothesis that the effects of both positive and negative lifetime experiences of men can be transmitted to their offspring through a specific biochemical change in their sperm, that may also be detectable in their saliva. Thus, we will ask you and your father to fill out a set of short surveys about your positive (resilience building) and negative (early life and adult exposures to severe stress) experiences. We will also ask you to fill out a set of short surveys on your recent mental health, and we will perform biochemical tests on samples of your sperm and saliva. Finally, because there is some evidence that female offspring are affected differently than their male siblings by their father’s experiences, if you have a sister willing to participate, we will ask her to fill out a similar set of short surveys.
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Stroke
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.
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The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.
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The purpose of this research is to enhance and support our understanding and evaluating actual response behaviors of cognitive disability in realistic tasks. We hope to obtain more information about the response behaviors to stimuli during simulated driving of a typical cohort compared to post-stroke cohorts.
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The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
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Abbott developed the AMPLATZER™ PFO Occluder as a minimally invasive, transcatheter PFO closure treatment to further reduce the risk of recurrent stroke among patients with PFO and cryptogenic stroke beyond that achieved with medical management. This additional risk reduction is achieved by blocking the pathway for a venous embolism from reaching the body's arterial system and the brain.
The safety and effectiveness of the AMPLATZER™ PFO Occluder was evaluated in RESPECT, a randomized controlled clinical trial conducted under an investigational device exemption (IDE), which was the largest trial of a transcatheter PFO closure device, with the longest follow-up. RESPECT demonstrated that the AMPLATZER™ PFO Occluder is effective in reducing recurrent ischemic stroke in subjects implanted with the device and can be implanted safely. The AMPLATZER™ PFO Occluder received market approval by FDA on October 28, 2016.
The purpose of this study is the continued evaluation of the long-term safety and effectiveness of the AMPLATZER™ PFO Occluder in a post approval setting.
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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.
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The purpose of this research study is to explore the challenges of recognizing stroke in young adults, the process of making treatment decisions, and the patient’s understanding of the risk of recurrence and long term consequences of stroke. This study consists of a 30 to 60 minute interview of patients with prior stroke (ischemic stroke, transient ischemic attack, or intracerebral hemorrhage) who were 18-50 years of age at the time of stroke onset.
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Structural Heart Disease
Using conductance catheters the study will assess the change in invasively determined cardiac mechanics prior to and following structural heart procedures
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Surgical Infections
The aim of this study is to assess the anti‐infective efficacy of D‐PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection in the target incision, compared to the SoC treated control arm, while assessing the safety of D‐PLEX administered concomitantly with the Standard of Care (SoC).
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Thrombotic Microangiopathy (TMA)
This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.
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Transplant
To determine if bortezomib, daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab-hyaluronidase SC and lenalidomide (DR) maintenance after standard induction therapy with daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.
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A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (SOC1 and SOC2 - from both randomized and concurrent control groups), adjusting for differences in risk factors.
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Transthyretin Cardiac Amyloidosis
Hypertrophic Cardiomyopathy (HCM) is a genetic disease where the heart muscles become thicker because of the disease. We use electrocardiogram, echocardiogram or cardiac magnetic resonance imaging (CMR) tests to see if someone might have HCM. Another disease, transthyretin cardiac amyloidosis (ATTR-CM) can also cause the heart to become thick and look similar to HCM on these tests (usually in patients who are over 60 years old).
Recent research suggests that up to 10% of patients ≥ 60 years of age who have been diagnosed with HCM, may actually have ATTR-CM. However, no formal research study has been done to confirm if this is what is happening. Standard practice at Tufts is that patients ≥ 60 years of age have routine testing for HCM (including electrocardiogram, echocardiogram, and CMR) and a special test (called a pryophosphate scan) specifically to evaluate for ATTR-CM. This is important as ATTR-CM is treated differently than HCM.
The research team is inviting participants to be included in a registry in order to look at the difference between the two diseases and how they are diagnosed. This study's registry is a compilation of various cardiac images, lab tests, and medical histories of patients with HCM and ATTR-CM. If they choose to participate, they will be included in a registry using the following information: clinical history, lab tests, echocardiogram, cardiac magnetic resonance imaging (CMR), and pyrophosphate scan. We will look at this information to understand how often patients originally diagnosed with HCM were later diagnosed with ATTR-CM instead.
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Trauma
In patients requiring urgent surgery who are being treated with a direct or indirect Factor Xa (FXa) inhibitor, the objectives of this study are as follows:
Primary Objective:
• To evaluate hemostatic efficacy following andexanet alfa (andexanet) treatment.
Secondary Efficacy Objective:
• To evaluate the effect of andexanet on anti-fXa activity.
Exploratory Efficacy Objectives:
• To evaluate the effect of andexanet on thrombin generation (TG).
• To evaluate the use of red blood cell (RBC) transfusions.
• To evaluate the use of non-RBC, non-platelet blood products and hemostatic agents.
• To evaluate the transfusion-corrected change in hemoglobin from baseline to the nadir.
• To evaluate the time from obtaining informed consent (study consent) to the start of surgery.
• To evaluate observed intraoperative blood loss and the difference between predicted versus observed blood loss.
• To evaluate the length of index hospitalization, intensive care unit (ICU) stay, time in a post-anesthesia care unit (PACU), time in the operating room (OR), and length of surgery.
• To evaluate the occurrence of re-hospitalization.
• To evaluate the occurrence of post-surgical major bleeding.
• To evaluate the occurrence of re-operations for bleeding.
• To evaluate the effect of andexanet on tissue factor pathway inhibitor (TFPI) activity.
• In patients receiving enoxaparin, to evaluate the effect of andexanet on anti-IIa activity.
Safety Objective:
• To evaluate the overall safety of andexanet.
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Twin Pregnancy
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).
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Type II Diabetes
In children and adolescents (>10 to <18 years) with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control (ie, hemoglobin A1c [HbA1c] of >6.5% to <10.5%), either on diet and exercise only, or on diet and exercise and metformin monotherapy, or on diet and exercise and insulin monotherapy, or on diet and exercise and combination therapy with metformin and insulin.
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This is the first study to look at a new medicine to help kidneys in people with diabetes who have protein in their urine. It looks at the safety and the effect on the amount of protein in the urine of a blocker of ‘Vascular Endothelial Growth Factor (VEGF)-B’. Information from animal studies suggests that blocking VEGF-B could help protect cells in the kidney from the damaging effects of diabetes. The drug is given either through the vein or under the skin by research nurses under the supervision of a research doctor. Some participants will get the medications while others will get a placebo (salt water); this will be decided randomly by chance.
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Ulnar Neuropathy
The purpose of this study is to understand why some patients with nerve entrapment at the elbow do better than others. This study is investigational because it attempts to address the problem comprehensively, using different techniques, something that is not usually done for routine diagnostic purposes.
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Urinary Tract Infections
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
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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
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Valvular Heart Disease
The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy ( OHFT ) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis ( AS). OHFT is defined as guideline-directed medical therapy. It can be medication only or a combination of medical therapy and approved HF devices.
Clinical efficacy of TAVR is assessed after 1 year of follow-up in all 600 patients. All patients are followed for 2 years to evaluate the value of the study device in to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 Valve has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis
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Vascular Diseases
To determine whether these contributions of the Mineralocorticoid Receptor to vascular function and disease determined in animal models are also implicated in human vessels and to address the impact of sex, age, cardiovascular risk factors, and potentially race, which cannot be completely recapitulated in vitro or in mouse models.
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Vision Health
This study will evaluate infant vision health based on the history of prenatal drug exposure. Data from this study will be used to create a new process which will include vision health as part of the discharge planning for infants with prenatal drug exposure admitted to Tufts Children’s Hospital
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Vitamin D Deficiency
A randomized, double-blinded, placebo-controlled, phase III trial (up to maximum n=3000) of early vitamin D3 in vitamin D deficient patients at high risk of ARDS and mortality
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Vitiligo
The purpose of this study is to continue to assess the effect and safety of ruxolitinib cream on people and their vitiligo with long-term use and also to assess how long the effect lasts on people who stop using ruxolitinib cream.
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