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Acute Lymphocytic Leukemia


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

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

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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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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 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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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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Covid-19


A Phase 3, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting

The purpose of this study is to see if remdesivir (RDV) given into a vein in an outpatient setting is safe and is an effective treatment in participants with confirmed COVID-19 who are at risk for disease progression.

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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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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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Eosinophilic Esophagitis


Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA)

This study has 3 treatment periods: A 24-week double-blind treatment period, a 28-week open-label treatment period, and an open-label extension. Subjects that complete the 52-week treatment period, double blind and open label on investigational product will be eligible to continue into a 52-week open label extension period on benralizumab 30 mg every 4 weeks (Q4W). The open label extension period is intended to allow each patient 1 year of treatment with open label benralizumab after completion of the 52-week double blind and open label treatment periods. All eligible subjects will be invited to participate in the open label extension. Patients who do not enroll in the open label extension will have a follow-up visit 12 weeks after their last dose of IP.

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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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Healthy Volunteers


Examining Teacher and Student Ratings of Student Behavior

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

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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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Intensive Care


Family Factors in PICU Hospitalization: Secondary Stressor Inventory

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

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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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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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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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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

The overall goals of this study are to:

  • To find out if subjects with down syndrome and standard risk acute myeloid leukemia can be treated with less treatment and still have successful outcomes.
  • To find out if subjects with down syndrome and high risk acute myeloid leukemia can be successfully treated with stronger chemotherapy.

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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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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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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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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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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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Premature Babies


Environment, Epigenetics, Neurodevelopment and Health of Extremely Preterm Children

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

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Premature Birth


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.

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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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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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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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