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Abdominal Aortic Aneurysm


Post-Approval Study of the TREO Abdominal Stent-Graft System in Patients with Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

This is a prospective, multi-center, non-randomized, single arm, post-approval study. The main objective of this study is collection of the real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of abdominal aortic aneurysm (AAA) in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

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Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Abdominal Infection


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

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

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Acromegaly


The Management of Acromegaly (MACRO) Registry

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 Myeloid Leukemia


ASTX727-07 - A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination with Venetoclax in Adult Patients with Acute Myeloid Leukemia

This study aims to learn more about the investigational drug, ASTX727, and another drug, venetoclax, when given in combination. It also aims to evaluate potential pharmocokinetics (PK) interactions for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy.

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Alcohol Liver Disease


A Randomized, Double-Blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Alcoholic Hepatitis

This study is being conducted in patients who are hospitalized due to liver damage from alcohol abuse (Alcoholic Hepatitis AH). The purpose of this study is to see if the study drug, DUR-928 given in inpatient seeting is safe and effective in this group of patients. 

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Amyloidosis


A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL 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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CAEL 101-302: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell DyscrasiaTreatment-Naïve Patients with Mayo Stage IIIa AL 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 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


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

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

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Aneurysms


EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System

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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The Intra-arterial Vasospasm Trial - A Multicenter Randomized Study

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.

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Ankylosing Spondylitis


Tufts Spondyloarthritis Registry

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

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Aortic Aneurysm


Post-Approval Study of the TREO Abdominal Stent-Graft System in Patients with Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

This is a prospective, multi-center, non-randomized, single arm, post-approval study. The main objective of this study is collection of the real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of abdominal aortic aneurysm (AAA) in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

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Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Aortic Stenosis


SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART Trial)

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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Appendicitis


Fetal outcomes among pregnant emergency general surgery patients. A prospective multi-center evaluation of pregnant patients undergoing emergency general surgery

Approximately 1/500 pregnant require non-obstetric surgery. Surgical care for the pregnant women raises concern for complications adversely pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Some studies have investigated the impact of a subset of emergency general surgery on maternal outcomes during pregnancy but none have looked at the array of emergency general surgery operations on fetal outcome. In recent decades, the advent of laparoscopic techniques has improved recovery time in the general population and has become the standard of care for some disease processes. Studies have reported safe maternal outcomes for laparoscopic interventions. Despite the common incidence of non-obstetric surgery among pregnant women little is known regarding fetal outcome and the impact of laparoscopic interventions vs. traditional open procedures. Even less is known about the role of nonoperative management of general surgical disease in the pregnant population.   

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Arthritis


Neurobiological Mechanisms of Mind-body Therapy for Knee Osteoarthritis

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

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

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The PRINTO Evidence-based Revision of the International League Against Rheumatism (ILAR) Classification criteria for 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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Atopic Dermatitis


A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients with Moderate-to-Severe Atopic Dermatitis

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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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis

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


Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants

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


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

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

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Bone Marrow Transplantation


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

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

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Brain Cancer


Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity ≥4 Brain Metastases/Year

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


A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients with 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


A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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

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Brain Tumors


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

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

Primary Objectives

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

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

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

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

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

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

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

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

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

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

Economic Endpoints

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

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

Quality of Life Endpoints

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

Translational Endpoints

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

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

Imaging/Dosimetric Endpoints

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

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

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

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Breast Cancer


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

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

Primary Objectives

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

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

 

Secondary Objectives

Patient/treatment Related Secondary Outcomes

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

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

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

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

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

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

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

Economic Endpoints

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

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

Quality of Life Endpoints

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

Translational Endpoints

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

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

Imaging/Dosimetric Endpoints

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

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

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

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A011801: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

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


A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Dupilumab In Adult Patients With 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


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

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

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Evaluating Neuropsychological and Psychological Screening in Cancer Survivors

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

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Cancer in Children


Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

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

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Cardiac Arrest


Acute Hemodynamics in Patients on AMCS

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

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Cardiac Failure


Epidermal Metabolomic Changes in Patients with Cardiogenic Shock

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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Monitoring Heart Failure Patients using Heart Rate Variability measured by the Apple Watch

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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Factors Associated with Response to Cardiac Resynchronization Therapy in Heart Failure Patients with Non-LBBB ECG Pattern

Heart failure is a harmful disease that is associated with high avoidable moribidity that can be treated with a cardiac resynchronization therapy device (CRT-D). Previous studies have shown links between CRT-D implants and reduced rates of morbidity in patients with heart failure with left bundle branch blockages (LBBB). However, there is limited amounts of evidence for the success of heart failure patients with non-LBBB. This prospective, multi-center study is looking at heart failure patients with non-LBBB that are implanted with CRT-D. 

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

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart 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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Acute Hemodynamics in Patients on AMCS

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

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

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

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

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

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

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Cardiomyopathy


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

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

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Cardiovascular Disease


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

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

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Cardiovascular Tissue and DNA Banking Study

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

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

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

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

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Cervical Cancer


Alinity m HR HPV Specimen Collection Study from Women Referred to Colposcopy

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


Cervical Stiffness Measurement in Cervical Insufficiency

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


Development of a Serum Quality Control Pool for Kidney Function Biomarkers

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

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The AFFINITY Study: A trial for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A (IgA) Nephropathy, Diabetic Kidney Diseases (DKD), or Alport Syndrome. 

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome. 

The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year. 

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The ALIGN Study: A study for patients with the kidney disease Immunoglobulin A (IgA) Nephropathy.

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN. We will look at whether the drug decreases the protein levels in your urine.

The study is comprised of an optional pre-screening period, a screening period, a treatment period and a follow-up period. If you qualify, you will receive either the study drug Atrasenten or placebo for up to 2.5 years. 

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The FIND-CKD Study: a trial for patients with non-diabetic chronic kidney disease.

The purpose of this clinical trial is to see if the drug Finerenone is safe and effective in patients with in participants with non-diabetic chronic kidney disease. Additionally, while finerenone has been approved for other patient populations, this study will collect additional safety information about finerenone to determine how it affects the body.

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The TRACTION Study: A study for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS) and Treatment-Resistant Minimal Change Disease

This study looks at whether the drug  GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug. 

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Chronic Pain


The Feasibility of Immersive Virtual Reality as a treatment for Chronic Back 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


A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical application into the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

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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Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical application into the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

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


Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

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

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

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

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

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Colorectal Cancer


Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study

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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Constipation


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

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

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Corneal Disorders


A phase 2B, multi-center, randomized, double-blind, placebo-controlled study with Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects

The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.

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A 12-week parallel group, randomized, placebo-controlled, double-blinded, multi-center study to evaluate efficacy and safety of 2 concentrations of SAF312 eye drops (5mg/ml and 15mg/ml) used twice-daily in the treatment of post-operative corneal induced chronic pain (CICP) following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) surgeries

The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 [5 mg/ml] and dose 2 [15 mg/ml]) in subjects with chronic induced corneal pain (CICP) persisting at least for 4 months after refractive surgery and chronicity confirmed during the observational period. The study will also determine the optimal dose to carry forward for further development.

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A Multi-center, Randomized, Double-masked, Vehicle-controlled, Parallel-group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

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

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

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

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Corneal Pain


A 12-week parallel group, randomized, placebo-controlled, double-blinded, multi-center study to evaluate efficacy and safety of 2 concentrations of SAF312 eye drops (5mg/ml and 15mg/ml) used twice-daily in the treatment of post-operative corneal induced chronic pain (CICP) following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) surgeries

The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 [5 mg/ml] and dose 2 [15 mg/ml]) in subjects with chronic induced corneal pain (CICP) persisting at least for 4 months after refractive surgery and chronicity confirmed during the observational period. The study will also determine the optimal dose to carry forward for further development.

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

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

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

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

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

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Covid-19


Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO)

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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A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

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

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

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National COVID-19 Survivors Registry

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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The Utility of X-Ray Velocimetry Analysis in Assessing the Ventilatory Limitations in Individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

The purpose of the study is to learn about the problems that some individuals who recover from a COVID-19 infection continue to have months after they recover from the initial phase of the infection. We will be performing specific type of imaging called x-ray velocimetry. This allows us to understand regional lung ventilation. We will be examining if the measures of regional lung ventilation are more abnormal in participants who have previously had COVID-19 compared to those who have not previously acquired this infection. We will also investigate if the measurements obtained from x-ray velocimetry correlate with ratings of certain symptoms, quality of life ratings, and results of pulmonary function test and a walking test. 

The study includes 1 study visit and will be performed at Tufts Medical Center in Boston, MA.

We expect up to 48 participants will be enrolled in this study at Tufts Medical Center in order to have 40 participants complete the study.  

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

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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A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

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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Exercise Limitations and Biomarkers of Cardiopulmonary Injury in Individuals with Persistent Symptoms after Recovery from COVID-19 Infection: The COVID-19 Recovery Study (CORS)

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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Niclosamide for Patients with Mild to Moderate Disease from Novel Coronavirus (COVID-19)

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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Randomized Master Protocol for Immune Modulators for Treating COVID-19

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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Craniopharyngioma


Phase II Trial of BRAF/MEK Inhibitors in Papillary Craniopharyngiomas

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


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

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

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Cytomegalovirus Infection


Evaluation of the tolerability and clinical effectiveness of letermovir in heart transplant recipients

Open label trial of letermovir prophylaxis for those heart transplant recipients at risk of cytomegalovirus infection and disease

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Dermatomyositis


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

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

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Developmental Disabilities


A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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

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Diabetic Eye Problems


Epidemiological Study to Evaluate the Prevalence and Progression of Diabetic Macular Ischemia in Patients with Diabetic Retinopathy Treated with Panretinal Photocoagulation

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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Diabetic Foot Ulcers


A Prospective, Multicenter, Randomized, Controlled Clinical Study of NuShiled and Standard of Card (SOC) Compared to SOC Alone for the Management of 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 Kidney Problems


The AFFINITY Study: A trial for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A (IgA) Nephropathy, Diabetic Kidney Diseases (DKD), or Alport Syndrome. 

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome. 

The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year. 

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The MANEUVER Study: a study for patients with Diabetic Kidney Disease. 

The purpose of this clincial trial is to see if the drug CSL346 (developed by CSL Behring) is safe and effective in treating type II diabetic kidney disease.  We will look at whether the drug decreases the amount of protein in your urine. The drug is given through the vein and under the skin by research nurses under the supervision of the research doctor. This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug.

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Diabetic Nephropathy


The MANEUVER Study: a study for patients with Diabetic Kidney Disease. 

The purpose of this clincial trial is to see if the drug CSL346 (developed by CSL Behring) is safe and effective in treating type II diabetic kidney disease.  We will look at whether the drug decreases the amount of protein in your urine. The drug is given through the vein and under the skin by research nurses under the supervision of the research doctor. This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug.

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The TRACTION Study: A study for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS) and Treatment-Resistant Minimal Change Disease

This study looks at whether the drug  GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug. 

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Dry Eye


A 4 week, Phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of Oxervate® (cenegermin) 20 mcg/ml ophthalmic solution versus vehicle, in patients with severe Sjogren’s dry eye disease

The purpose of this research study is to find out more about the study drug, cenegermin 20mcg/mL ophthalmic solution, in people with severe Sjogren’s dry eye disease. The study will see if cenegermin can safely and effectively relieve the signs and symptoms of this condition, and whether it causes side effects. You will be in this research study for 25 weeks (6 months). If you are eligible to participate in the study, you will be asked to self-administer the study eye drops (cenegermin or placebo) 3 times per day (one drop in both eyes every 6-8 hours) for 4 weeks. Once you have finished 4 weeks of using the study eye drops, you will continue in the study for an additional 20 weeks, so your study doctor can monitor your eyes and health for any side effects. 
You will also be asked to attend the eye clinic for 8 visits. These visits can take up to two hours. At each visit, the study team will ask you about your medical history, symptoms and medications. Your study doctor will also conduct an eye examination. All of the eye examination procedures are considered routine for people with severe Sjogren’s DED.

 

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Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease

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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Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

  • 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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Predicting the Success of Dry Eye Disease Treatment Using Hyperosmolarity Drops

This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: HS non-responders (33 subjects) and HS responders (33 subjects). After completion of questionnaires, the subjects will undergo DED testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the DED tests and functional nerve tests will be repeated.

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Efficacy of the SPEED Questionnaire in Correlating Electronic Device Screen time and Pediatric Dry Eye Symptomology

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

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

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Emergency Services


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

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

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

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Eosinophilic Disorders


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

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

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Eosinophilic Esophagitis


Development, Validation, and Evaluation of an Adult and Eosinophilic Esophagitis Activity Index: A Prospective Multicenter Study

Eosinophilic Esophagitis (EoE) is a swallowing disorder which is caused by an allergy-like inflammation of the esophagus. It is diagnosed by esophageal biopsies and can be treated with anti-inflammatory medicines. There are cases of EoE in children and adults and the symptoms primarily present with difficulty swallowing or the feeling of food being stuck in the esophagus. Currently there is no exact way to define the activity of Eosinophilic Esophagitis. An activity index for measuring the disease severity has not been developed so there is difficulty in measuring the treatment responses in clinical studies. The creation of an Activity Index (or a score) for EoE will allow the objective measurement of patient symptoms.

The aim of the current multi-center study is to develop, validate and evaluate an EoE activity index for pediatric and adult patients. Our site at Tufts will 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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Epidermolysis Bullosa


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

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

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Esophageal Cancer


A Phase II/III Study of Peri-operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

This study is being done to answer the following questions:

  1. What are the good and bad effects of using usual chemotherapy and radiation plus the immunotherapy, nivolumab, before standard surgery for your condition?
  2. 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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Fallopian Tube Cancer


IMGN853-0419: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO)

PICCOLO is a Phase 2, multicenter, open label study designed to evaluate the safety and efficacy of MIRV in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.

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Focal Semental Glomeroulsclerosis


The TRACTION Study: A study for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS) and Treatment-Resistant Minimal Change Disease

This study looks at whether the drug  GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug. 

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Gallstones


Fetal outcomes among pregnant emergency general surgery patients. A prospective multi-center evaluation of pregnant patients undergoing emergency general surgery

Approximately 1/500 pregnant require non-obstetric surgery. Surgical care for the pregnant women raises concern for complications adversely pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Some studies have investigated the impact of a subset of emergency general surgery on maternal outcomes during pregnancy but none have looked at the array of emergency general surgery operations on fetal outcome. In recent decades, the advent of laparoscopic techniques has improved recovery time in the general population and has become the standard of care for some disease processes. Studies have reported safe maternal outcomes for laparoscopic interventions. Despite the common incidence of non-obstetric surgery among pregnant women little is known regarding fetal outcome and the impact of laparoscopic interventions vs. traditional open procedures. Even less is known about the role of nonoperative management of general surgical disease in the pregnant population.   

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Glaucoma


Discovery Approach to Ocular Hypertension

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

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Glioblastoma


A Pivotal Randomized, Open-Label Study of Optube (TTFields, 100KHZ) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed 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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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma – The ImmuneSense Study

This is a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study, with the objective of comparing Progression-Free Survival (PFS) in newly diagnosed GBM patients treated with IGV-001 with patients treated with placebo.

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Analysis Of Cell Count, Viability, And Of Fresh Newly Diagnosed Glioblastoma Tissue

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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A Modified Ketogenic, Anti-Inflammatory Diet for Patients with High-Grade Gliomas

This is a phase I trial to see whether patients are able to adhere to a modified, high fat/low carbohydrate diet (the sHFLC + KetoPhyt Diet) with a supplement named KetoPhyt that includes ketones and anti-inflammatory properties.

The classic ketogenic diet (KD) is difficult for patients to adhere to due to its stringent nature. A modified KD has been developed that mimics the glucose lowering, ketone raising effects and the anti-cancer outcomes of the KD.

The sHFLC + KetoPhyt diet will be implemented in a cohort of 10 Glioblastoma patients, who will be trained and provided with sample meal plans so as to maintain their carbohydrate levels up to 33% of total caloric intake. The study will determine whether participants can maintain the diet and the ketogenic state.

This study will also conduct molecular analyses to determine the effect of the diet on the microbiome, inflammatory cytokines, and extracellular vesicle content.

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MSK 19-342 PROTECT: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

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


CNS201: Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Approximately 210 patients with Glioblastoma Multiforme (GBM) after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of overall survival

In this research study, an investigational medication named berubicin is being compared to lomustine (an approved chemotherapy medication) for the treatment of recurrent GBM. 

The main purpose of this study is to investigate how effective berubicin is in treating GBM that has recurred after initial standard therapy, and comparing this with lomustine.  The study also aims to assess the safety of berubicin and how it is absorbed by and cleared from the body.  Both medications are designed to slow or stop the growth of cancer cells.

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MSK 19-342 PROTECT: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

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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Glomerular Disease


A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK)

Primary Objectives:

• Evaluate the safety and tolerability of sparsentan oral suspension

• Assess changes in proteinuria after once-daily dosing of sparsentan oral suspension over the 108-week treatment period

 

Secondary Objectives:

• Assess the pharmacokinetics (PK) of sparsentan oral suspension in a pediatric population

• Assess changes in estimated glomerular filtration rate (eGFR) after once-daily dosing of sparsentan oral suspension over the 108-week treatment period

 

Exploratory Objective:

• Assess the palatability and acceptability of sparsentan oral suspension

 

Primary Endpoints:

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to treatment discontinuation, and adverse events of interest (AEOIs)

• Change from baseline in urine protein/creatinine ratio (UP/C) over the 108-week treatment period

Secondary Endpoints:

• Observed plasma PK concentrations at scheduled timepoints and visits

• Steady-state PK parameters (area under the plasma concentration-time curve during a dosing interval [AUCτ], maximum steady-state plasma drug concentration during a dosage interval [Cmax_ss], and minimum steady-state plasma drug concentration [Cmin_ss]) derived from population PK analysis

• Change from baseline in urine albumin/creatinine ratio (UA/C) over the 108-week treatment period

• Change from baseline in eGFR over the 108-week treatment period

• The proportion of subjects with focal segmental glomerulosclerosis (FSGS) and/or minimal change disease (MCD) histological patterns achieving partial remission, defined as UP/C ≤1.5 g/g and >40% reduction in UP/C over the 108-week treatment period

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The AFFINITY Study: A trial for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A (IgA) Nephropathy, Diabetic Kidney Diseases (DKD), or Alport Syndrome. 

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome. 

The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year. 

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Growth problems


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

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

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Head and Neck Cancer


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

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

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EA3191 - A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab after Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features

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


Correlation of Automated Wrist Blood Pressure Measurements to Automated Arm and Manual Arm Measurements

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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Development of Blood Pressure Imager

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

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Diameter Variation of Aortic Aneurysms Over the Cardiac Cycle

This project involves a study of the diameter variation of abdominal aortic aneurysms (AAAs) over the cardiac cycle in vivo, a measure of the in vivo mechanical properties of AAA walls. Patient aneurysms are imaged non-invasively by ECG-gated MR Imaging, then mechanical properties of the aneurysms are determined from computational analysis of the imaging.

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Examining Teacher and Student Ratings of Student Behavior

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

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Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

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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Heart Diseases


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

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

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Global cVAD Registry

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

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

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

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

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Use of the Impella ECPTM in Patients Undergoing an Elective High-Risk Percutaneous Coronary Intervention: An Early Feasibility Study

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


Epidermal Metabolomic Changes in Patients with Cardiogenic Shock

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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Monitoring Heart Failure Patients using Heart Rate Variability measured by the Apple Watch

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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CRD_973 SyncAV Post-Market Trial

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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Factors Associated with Response to Cardiac Resynchronization Therapy in Heart Failure Patients with Non-LBBB ECG Pattern

Heart failure is a harmful disease that is associated with high avoidable moribidity that can be treated with a cardiac resynchronization therapy device (CRT-D). Previous studies have shown links between CRT-D implants and reduced rates of morbidity in patients with heart failure with left bundle branch blockages (LBBB). However, there is limited amounts of evidence for the success of heart failure patients with non-LBBB. This prospective, multi-center study is looking at heart failure patients with non-LBBB that are implanted with CRT-D. 

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

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart 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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Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial

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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Implantation of the HeartMate 3 in Subjects with Heart Failure using  Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT)

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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Prospective Multi-Center Randomized Study for Evaluating the EVAHEART2 Left Ventricular Assist System: the COMPETENCE Trial

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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Pulmonary vascular impedance as a novel tool to understand right ventricular afterload in cardiogenic shock

Cardiogenic shock (CS) is a dangerous clinical condition where the heart’s ability to pump blood is so compromised that it cannot support the vital functions of the rest of the body. CS has an increased risk of death of 50-60%, and despite tremendous research effort over the last decade, survival outcomes have not changed over this period. Current treatment for CS often involves mechanical circulatory support (MCS) devices, which are mechanical pumps that help support blood flow to the body. These devices primarily support left ventricular (LV) heart function (the function of the main chamber of your heart). However, many patients with CS have right ventricular (RV) dysfunction as well, which is difficult to manage and associated with shortened lifespan. Better recognition and management of right ventricular (RV) failure is therefore critical for improving clinical outcomes in CS. This research will use a new way to measure RV afterload, which is the force resisting the ejection of blood from the RV. We hope that by using this new method, we can better understand how to treat future patients with CS.

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Taking Care of Us: A dyadic intervention for heart failure

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

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

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Food As Medicine in Heart Failure

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

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

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Renal Hemodynamics in Patients on AMCS

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

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

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

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

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Heart Transplantation


Sex-based differences in immune response in solid organ transplant recipients

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


Renal Hemodynamics in Patients on AMCS

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

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Hematologic Malignancies


A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients with Advanced Hematologic Malignancies

This is an open-label, multi-center Phase 1 study of LOXO-338 in patients with advanced hematologic malignancies who have received standard therapy. This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, Part 2 will evaluate the combination of LOXO-338 with LOXO-305.

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Hepatitis C


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

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

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

 

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Hepatoblastoma


AHEP1531: Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

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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Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

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

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Hepatology


A Randomized, Double-Blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Alcoholic Hepatitis

This study is being conducted in patients who are hospitalized due to liver damage from alcohol abuse (Alcoholic Hepatitis AH). The purpose of this study is to see if the study drug, DUR-928 given in inpatient seeting is safe and effective in this group of patients. 

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Herpes Zoster


Long-term Suppressive Valacyclovir Treatment for Herpes Zoster Ophthalmicus

This study is a double-masked, placebo controlled randomized clinical trial looking to find out whether one year of a low dose of the medicine valacyclovir reduces complications of shingles affecting the eye.

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Hidradenitis Suppurativa


Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa.

4 year long term extension study for subject who participated in previous HS study

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High Blood Pressure


Development of Blood Pressure Imager

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

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High Blood Pressure in Pregnancy


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

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

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Hypertension


Blood Pressure Changes During Transthoracic Echocardiogram Study

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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Development of Blood Pressure Imager

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

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Hypertrophic Cardiomyopathy


A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-G20 in Subjects with Hypertrophic Obstructive 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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A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients with Non-obstructive Hypertrophic Cardiomyopathy

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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Intensive Care


A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning from Mechanical Ventilation in ICU Patients (RESCUE 3)

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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Family Factors in PICU Hospitalization: Secondary Stressor Inventory

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

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GLO: Glucose and Lactate OptiScanner Study

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

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Intraabdominal Infections


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

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

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Intracerebral Hemorrhage


Statins Use In Intracerebral Hemorrhage Patients

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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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.

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Statins Use in Intracerebral Hemorrhage Patients

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


A Randomized Clinical Trial Of Andexanet Alfa In Acute Intracranial Hemorrhage In Patients Receiving An Oral Factor Xa Inhibitor

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


A pilot study to assess non-invasive near-infrared spectroscopy measurements of Coherent Hemodynamics Spectroscopy for the assessment of cerebral autoregulation and blood flow

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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Prospective evaluation of non-invasive intracranial pressure monitoring

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded. Patients vital signs including heart rate, blood pressure, and SpO2 will also be routinely recorded. Once the patient is felt to no longer require the ICP monitor and it is removed, the IPASS device will also be removed.

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Joint Disorders


Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance

This is an NIH-funded clinical trial investigating ease of use and patient compliance with an alternative Intermittent Pneumatic Compression (IPC) device created by Recovery Force. This new product, the Recovery Force Movement and Compression (MAC) device, is a walking boot that is designed to increase mobility after a total joint replacement surgery, while also decreasing the risk of Deep Vein Thrombosis (DVT). Subjects will be randomly assigned either the standard of care IPC device or the Recovery Force MAC system. If randomly assigned the Recovery Force MAC device, subjects will wear the device home and return it at their two week post-operative appointment with their surgeon. Subjects will complete four separate 4-meter walk tests before and after surgery to track their mobility. Subjects will also record their mobility daily during their two-week post-operative period, using the provided mobility tracker and journals. This study has many goals, but one is to test how comfortable and easy to use this device is. This will be tested by a series of studies once the subject has returned the device.

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Juvenile Idiopathic Arthritis


The PRINTO Evidence-based Revision of the International League Against Rheumatism (ILAR) Classification criteria for 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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Keratitis


A Multi-center, Randomized, Double-masked, Vehicle-controlled, Parallel-group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

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Kidney Diseases


A study to evaluate the efficacy and safety of Ravulizumab (ALXN1210) in patients with Thrombotic Microangiopathy (TMA) associated with a trigger 

The purpose of this trial is to see if the drug ravulizumab  is safe and effective in patients with thrombotic microangiopathy (TMA). This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug. You will recieve the drug or placebo for about 6 months and then have follow-up appoinments for about 6 months. 

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

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

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The FIND-CKD Study: a trial for patients with non-diabetic chronic kidney disease.

The purpose of this clinical trial is to see if the drug Finerenone is safe and effective in patients with in participants with non-diabetic chronic kidney disease. Additionally, while finerenone has been approved for other patient populations, this study will collect additional safety information about finerenone to determine how it affects the body.

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The MANEUVER Study: a study for patients with Diabetic Kidney Disease. 

The purpose of this clincial trial is to see if the drug CSL346 (developed by CSL Behring) is safe and effective in treating type II diabetic kidney disease.  We will look at whether the drug decreases the amount of protein in your urine. The drug is given through the vein and under the skin by research nurses under the supervision of the research doctor. This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug.

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The TRACTION Study: A study for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS) and Treatment-Resistant Minimal Change Disease

This study looks at whether the drug  GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug. 

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Kidney Transplantation


Sex-based differences in immune response in solid organ transplant recipients

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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TruGraf® Long-term Clinical Outcomes Study

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


Laryngoscopy Accuracy: Physician Recall vs. Video Review

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


A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

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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A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

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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A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

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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A041702: A Randomized Phase III Study of Ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (> 70 years of age) with Chronic Lymphocytic Leukemia

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

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the 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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International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones. 

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

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Lower GI Tract Paralysis


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

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

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Lupus


A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis

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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Lyme Disease


Xenodiagnosis after Antibiotic for Lyme Disease - Phase 2 Study

Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease. 

Our objectives include: (1) assessing the link between the detection of B. burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans. 

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Lymphomas


A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

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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An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, An Anti-CD20 X Anti-CD3 Bispecific Antibody, In Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

This is a phase 2, open-label, multi-cohort, multi-center study of REGN1979 administered as an IV infusion in patients with B-NHL that has relapsed after or is refractory to prior systemic therapy. This study consists of 5 disease specific cohorts, each with independent parallel enrollment. 

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Macular Degeneration


Non Exudative Age-Related Macular Degeneration Imaged with Swept Source Optical Coherence Tomography

This is a longitudinal observational study that will look at 300 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 100 subjects with nGA or GA in at least one eye.

 

The target population is all subjects who are at least 50 years of age and have a clinical diagnosis of non-exudative AMD in at least one eye.

Subjects who convert to exudative AMD during the study will be treated as per the enrolling physician’s standard of care and will continue to be scanned per protocol, allowing for a wider interval of +/- 30 days around the standard timing of scanning to avoid excessively frequent visits.

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Medulloblastoma


ACNS1422: Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven 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


A071401: Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

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


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

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

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Migraine


preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems

The purpose of this study is to collect information about treatment patterns, effects, and outcomes in patients with migraines who are switching or initiating a pharmacologic treatment for migraine prevention. This is an observational study which means there will be no treatment added or taken away.

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Mouth Disorders


Validation of Elastic Scattering Spectroscopy for Intra-operative Margin Guidance during Oral Cancer Resection

We are doing a research study to test a technology called spectroscopy that uses a special light and computer to better “see” where cancer is during surgery. We want to see if it can make surgery for mouth and throat cancer more effective by letting the doctor know if there are any cancer cells left behind during surgery. 

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Multiple Myeloma


A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory 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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EAA181: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

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


A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis

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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A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis

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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A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants with Primary Progressive Multiple Sclerosis

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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Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

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


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized 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


EAA171: Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)

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


Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator

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

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Myopia


A phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine Sulfate 0.01%) in treating the progression of myopia in pediatric subjects

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


Chronicling the Development of the Neonatal Microbiome through Salivary and Stool Analyses

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


A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants

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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A Prospective Study to Evaluate the Safety and Effectiveness of the BoppliTM in Measuring Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) as Compared to an Invasive Arterial Reference

This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. This study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP, DBP, and MAP against the reference methodology in pediatric and neonatal populations.

Primary Effectiveness Endpoint: Mean and standard deviation of the difference of the paired measurements between the device and arterial line reference for systolic, diastolic and mean pressures treated separately.

Safety endpoint: Device related adverse events

To assess the accuracy of the test device, a mean average difference of +/- 5 mmHg with a standard deviation of 8 mmHg of difference between the test device and the intra-arterial reference method will be considered as the upper limits of clinically acceptable disagreement. These parameters are in accordance with ISO 81060-2 and ANSI/AAMI SP10 for neonatal/infant populations using an intra-arterial method as the reference standard.

In addition to the test of accuracy, the stability test will be used to assess the accuracy over the duration of use of the device.

The change test will be used to demonstrate that the Boppli device will measure clinically relevant changes in BP measurements.

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Neonatal Sepsis


Chronicling the Development of the Neonatal Microbiome through Salivary and Stool Analyses

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


IgA Protease Treatment for IgA Nephropathy

Additional development of an enzyme called IgA protease as a means to remove IgA (a protein) from the kidney.

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

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

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The TRACTION Study: A study for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS) and Treatment-Resistant Minimal Change Disease

This study looks at whether the drug  GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug. 

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Neuroblastoma


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

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

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Neurologic Diseases


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

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

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Neurotrauma


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

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

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Neurotrophic Keratitis


A Multi-center, Randomized, Double-masked, Vehicle-controlled, Parallel-group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

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Non Small Cell Lung Cancer


Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

This is a multisite, placebo-controlled, randomized, double-blind study designed to compare the efficacy and safety of SBRT + pembrolizumab versus SBRT + placebo in participants with unresected Stage I or IIA NSCLC. Eligible patients must have histologically or cytologically confirmed Stage I or IIA NSCLC that has not been previously treated.

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Non-Alcoholic steatohepatitis


Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

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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VK2809 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Efficacy, Safety, And Tolerability Of VK2809 Administered For 52 Weeks Followed By A 4-Week Off-Drug Phase In Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

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


Lifestyle Intervention in Preparation for Pregnancy (LIPP)

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

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Optic Neuritis


Objective Portable Diagnostics of Neurological Disorders using Visual Evoked Potentials

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


EA3161: A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Rsik HPV Positive OPSCC

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


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

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

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

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

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

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Osteoarthritis


Neurobiological Mechanisms of Mind-body Therapy for Knee Osteoarthritis

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

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

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The Feasibility and Effectiveness of Virtual Reality in Reducing Pain for Older Adults with Knee Osteoarthritis

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

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

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A Phase 3 Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee

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

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

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

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

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Tai Chi and Gut Microbiota in Metabolic Osteoarthritis

 

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Pancreatic Cancer


A phase III trial of perioperative versus adjuvant chemotherapy for resectable 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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A021806, A phase III trial of perioperative versus adjuvant chemotherapy for resectable 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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EA2186 - A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

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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Peritoneal Cancer


IMGN853-0419: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO)

PICCOLO is a Phase 2, multicenter, open label study designed to evaluate the safety and efficacy of MIRV in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed for the treatment of subjects with recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.

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Polycystic Kidney Disease


A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-Label Phase: The ACTION Study

This is a Phase 3 trial consisting of a 2-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm open-label phase (Part 2) to demonstrate the efficacy and safety of lixivaptan in participants with ADPKD. Part 1 of the trial is designed to demonstrate the efficacy of lixivaptan in slowing the decline in kidney function as measured by the difference in change from baseline of eGFR between the lixivaptan-treated and placebo-treated participants. Part 2 of the study is designed to provide confirmation of the durability of this effect. 

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A Phase 3 Trial Of The Efficacy And Safety Of Bardoxolone Methyl In Patients With Autosomal Dominant 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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PKD Biomaterials

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


An Investigator-Initiated, Double-Blind, Patient-Controlled, Randomized Control Trial Comparing the Effectiveness of Liposomal Bupivacaine to a Solution of Bupivacaine, Epinephrine, Clonidine, and Dexamethasone in Bilateral, Single Shot, Erector Spinae Plane Blocks during Oncoplastic Breast Surgery

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


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

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

More

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

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

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Pregnancy


Following Early Eating in Dyads

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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Glycemic Outcomes and Metabolic Observations in Mothers and Offspring

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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Cervical Stiffness Measurement in Cervical Insufficiency

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

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

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Lifestyle Intervention in Preparation for Pregnancy (LIPP)

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

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Maternal lipid metabolism and placental function in early pregnancy

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

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Maternal Metabolic Mediators of infant Adiposity (MaMMA)

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

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The Tree of Life: Harnessing Placenta Biology for Cardiovascular Disease Research

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


A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of  necrotizing enterocolitis

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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Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

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

More

Premature Birth


A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of  necrotizing enterocolitis

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

More

Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

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

More

Molecular Assessment of the Consequences of Preterm Birth

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

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Preterm Birth


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

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

More

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

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

More

Primary Sclerosing Cholangitis


Boston Primary Sclerosing Cholangitis Consortium

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


A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK)

Primary Objectives:

• Evaluate the safety and tolerability of sparsentan oral suspension

• Assess changes in proteinuria after once-daily dosing of sparsentan oral suspension over the 108-week treatment period

 

Secondary Objectives:

• Assess the pharmacokinetics (PK) of sparsentan oral suspension in a pediatric population

• Assess changes in estimated glomerular filtration rate (eGFR) after once-daily dosing of sparsentan oral suspension over the 108-week treatment period

 

Exploratory Objective:

• Assess the palatability and acceptability of sparsentan oral suspension

 

Primary Endpoints:

• Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to treatment discontinuation, and adverse events of interest (AEOIs)

• Change from baseline in urine protein/creatinine ratio (UP/C) over the 108-week treatment period

Secondary Endpoints:

• Observed plasma PK concentrations at scheduled timepoints and visits

• Steady-state PK parameters (area under the plasma concentration-time curve during a dosing interval [AUCτ], maximum steady-state plasma drug concentration during a dosage interval [Cmax_ss], and minimum steady-state plasma drug concentration [Cmin_ss]) derived from population PK analysis

• Change from baseline in urine albumin/creatinine ratio (UA/C) over the 108-week treatment period

• Change from baseline in eGFR over the 108-week treatment period

• The proportion of subjects with focal segmental glomerulosclerosis (FSGS) and/or minimal change disease (MCD) histological patterns achieving partial remission, defined as UP/C ≤1.5 g/g and >40% reduction in UP/C over the 108-week treatment period

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The AFFINITY Study: A trial for patients with kidney disease caused by Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A (IgA) Nephropathy, Diabetic Kidney Diseases (DKD), or Alport Syndrome. 

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN, FSGS, DKD, and Alport Syndrome. 

The study is comprised of an optional pre-screening period, screening, treatment, and follow-up periods. If you qualify, you will receive the study drug Atrasentan for up to 1 year. 

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The ALIGN Study: A study for patients with the kidney disease Immunoglobulin A (IgA) Nephropathy.

The purpose of this clinical trial is to see if the drug atrasentan is safe and effective in treating IgAN. We will look at whether the drug decreases the protein levels in your urine.

The study is comprised of an optional pre-screening period, a screening period, a treatment period and a follow-up period. If you qualify, you will receive either the study drug Atrasenten or placebo for up to 2.5 years. 

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The FIND-CKD Study: a trial for patients with non-diabetic chronic kidney disease.

The purpose of this clinical trial is to see if the drug Finerenone is safe and effective in patients with in participants with non-diabetic chronic kidney disease. Additionally, while finerenone has been approved for other patient populations, this study will collect additional safety information about finerenone to determine how it affects the body.

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Prurigo Nodularis


A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis

Evaluate Safety and Efficacy of Nemolizumab in subject with Prurigo Nodularis

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Psoriatic Arthritis


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

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

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Tufts Spondyloarthritis Registry

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

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Pulmonary Fibrosis


A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of of Inhaled Treprostinil in Subjects with Idiopathic 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


A Phase 3, Randomized, Double-Blind, 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

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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A Long-Term, Open label Extension Study of PB1046 Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004

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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A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy

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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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality. Maximum study duration for a given participant in this study will be up to approximately 49 months as follows:

Screening Period (up to 4 weeks)

DBPC Treatment Period (until event occurrence, up to approximately 46 months)

Follow-up Period (up to 8 weeks)

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An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

This is a Phase 3, open-label, follow-up study to evaluate the long-term safety and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the PAH sotatercept clinical studies. Participants who have discontinued from a previous PAH sotatercept clinical study will not be eligible to enroll in this LTFU study.

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

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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A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension

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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A Prospective, Multicenter Study for the Identification of Biomarker Signatures for early detection of of Pulmonary Hypertension (PH)

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

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

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

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

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

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

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

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Pulmonary Vascular Resistance


Transesophageal Echocardiographic Assessment of Pulmonary Vascular Resistance

Collection of TRV and RVOT VTI from TEE and right heart pressures and CO from PA catheter.

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Respiratory Infections


The Impact of a Novel Host-Protein Assay on Antibiotic Use in Acute Respiratory Illness

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


A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)

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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Rheumatoid Arthritis


A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients with 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


Clinical Outcomes Of Primary Sclerosing Cholangitis In North America

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

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Seizures


A Salivary Transcriptomic Approach to Drug Discovery for Neonatal Seizures

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

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Shock


Pulmonary vascular impedance as a novel tool to understand right ventricular afterload in cardiogenic shock

Cardiogenic shock (CS) is a dangerous clinical condition where the heart’s ability to pump blood is so compromised that it cannot support the vital functions of the rest of the body. CS has an increased risk of death of 50-60%, and despite tremendous research effort over the last decade, survival outcomes have not changed over this period. Current treatment for CS often involves mechanical circulatory support (MCS) devices, which are mechanical pumps that help support blood flow to the body. These devices primarily support left ventricular (LV) heart function (the function of the main chamber of your heart). However, many patients with CS have right ventricular (RV) dysfunction as well, which is difficult to manage and associated with shortened lifespan. Better recognition and management of right ventricular (RV) failure is therefore critical for improving clinical outcomes in CS. This research will use a new way to measure RV afterload, which is the force resisting the ejection of blood from the RV. We hope that by using this new method, we can better understand how to treat future patients with CS.

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Sjogren's Syndrome


A 4 week, Phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of Oxervate® (cenegermin) 20 mcg/ml ophthalmic solution versus vehicle, in patients with severe Sjogren’s dry eye disease

The purpose of this research study is to find out more about the study drug, cenegermin 20mcg/mL ophthalmic solution, in people with severe Sjogren’s dry eye disease. The study will see if cenegermin can safely and effectively relieve the signs and symptoms of this condition, and whether it causes side effects. You will be in this research study for 25 weeks (6 months). If you are eligible to participate in the study, you will be asked to self-administer the study eye drops (cenegermin or placebo) 3 times per day (one drop in both eyes every 6-8 hours) for 4 weeks. Once you have finished 4 weeks of using the study eye drops, you will continue in the study for an additional 20 weeks, so your study doctor can monitor your eyes and health for any side effects. 
You will also be asked to attend the eye clinic for 8 visits. These visits can take up to two hours. At each visit, the study team will ask you about your medical history, symptoms and medications. Your study doctor will also conduct an eye examination. All of the eye examination procedures are considered routine for people with severe Sjogren’s DED.

 

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Solid Tumors


PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib

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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Spine Injuries and Disorders


A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).  

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Squamous Cell Carcinoma


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

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

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Status Epilepticus


A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous Ganaxolone in 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, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR)

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


Do Strabismus Measurements Change After Pupil Dilation and Cycloplegia in Children

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

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

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Do strabismus measurements change after pupil dilation and cycloplegia in children?

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


Detection of sperm biochemical changes involved in transmitting effects of positive and negative experiences across generations.

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


A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients

The objective of this study is to compare the safety and effectiveness of the Route 92 Medical Reperfusion System to predicate AXS Vecta Aspiration System.

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A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

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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Driving Ability Tests for Cognitive and Sensorimotor Function Assessment

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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Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE)

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Sleep for Stroke Management And Recovery Trial

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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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

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

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

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

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AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke

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

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

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

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Structural Heart Disease


Assessment of Invasive Hemodynamics in patients undergoing structural heart procedures

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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Subarachnoid Hemorrhage


The Intra-arterial Vasospasm Trial - A Multicenter Randomized Study

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.

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Surgical Infections


Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection

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)


A study to evaluate the efficacy and safety of Ravulizumab (ALXN1210) in patients with Thrombotic Microangiopathy (TMA) associated with a trigger 

The purpose of this trial is to see if the drug ravulizumab  is safe and effective in patients with thrombotic microangiopathy (TMA). This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug. You will recieve the drug or placebo for about 6 months and then have follow-up appoinments for about 6 months. 

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Transplant


EAA181: Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

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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Trauma


PROSPECTIVE, OPEN-LABEL STUDY OF ANDEXANET ALFA IN PATIENTS RECEIVING A FACTOR XA INHIBITOR WHO REQUIRE URGENT SURGERY (ANNEXA-S)

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


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

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

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Type II Diabetes


The MANEUVER Study: a study for patients with Diabetic Kidney Disease. 

The purpose of this clincial trial is to see if the drug CSL346 (developed by CSL Behring) is safe and effective in treating type II diabetic kidney disease.  We will look at whether the drug decreases the amount of protein in your urine. The drug is given through the vein and under the skin by research nurses under the supervision of the research doctor. This study is double-blind and placebo-controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a saline solution. There is a 50% chance that you will recieve the drug.

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Urinary Tract Infections


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

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

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

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

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Valvular Heart Disease


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

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

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

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Vascular Diseases


Exploring the Role of the Mineralocorticoid Receptor in Human Vascular Disease

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


Single-Center Baseline Data on Vision Health in Infants with History of Prenatal Drug Exposure

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


Vitamin D to Improve Outcomes by Leveraging Early Treatment

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

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Vitiligo


A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Non-Segmental Vitiligo

The primary objective of this study is to evaluate the safety and efficacy of upadacitinib for the treatment of adult subjects with NSV.

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A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants with Vitiligo (TRuE LTE)

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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A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action Ruxolitinib Cream for Vitiligo (TRuE-V MOA)

To evaluate the change in immune biomarkers in participants with vitiligo

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