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23 result(s) found

Amblyopia


Structural Changes on Ocular Coherence Tomography Angiography (OCTA) in Amblyopic Eyes

Amblyopia is a disorder of the visual developmental system in which visual acuity is decreased in the absence of clinically visible anatomic pathology. It can be caused by visual deprivation (i.e. ptosis, cataract), strabismus, and/or anisometropic refractive error and is one of the most prevalent and treatable eye diseases in children. Children who have a delay in treatment may have lifelong visual impairments. Though previous understanding of amblyopia precluded any structural ocular anomaly and was largely attributed to abnormalities of the visual cortex, recent studies have suggested otherwise. Sub-clinical changes noted in amblyopic eyes by optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) imaging that have been reported in the literature include optic nerve hypoplasia1, increased choroidal thickness2, decreased retinal outer segment layer thickness3, attenuation of the ellipsoid zone4, increased foveal thickness5, and decreased retinal capillary density6. With appropriate treatment of amblyopia, some studies have reported a measurable structural change in retinal anatomy, such as an increase in outer segment length, based on OCT imaging3.

The ability to objectively quantify structural ocular changes correlating with improvement in visual acuity in amblyopia treatment would shed light on underlying etiologies of amblyopia. Furthermore, examining the absence of structural changes or improvements on OCTA despite appropriate amblyopia treatment could potentially answer the question of why certain amblyopic children are refractory to standard-of-care treatment regimens despite good compliance.

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Blood Stream Infection


Neonatal Salivary Transcriptomics

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

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Bone Marrow Transplant


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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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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Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

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Developmental Disabilities


Neonatal Salivary Transcriptomics

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

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GVHD


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.

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Hodgkin Lymphoma


A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

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Inflammatory Bowel Disease


Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

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Juvenile Idiopathic Arthritis


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

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

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Leukemia


AALL0932:  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

This is a protocol for people with newly diagnosed Standard Risk Acute Lymphoblastic Leukemia. The study is broken up into parts. Each part of the study will be exploring different phases of chemotherapy such as Induction, Post-Induction, and Maintenance. In each phase of the study, researchers will be testing different experimental drug regimens versus standard treatments to see which one works better. Additionally, participants will be grouped based on their risk level and may receive different  chemotherapy regimens based on their risk.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Lymphomas


A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Neuroblastoma


ANBL1232: Utilizing Response and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma: A Groupwide Historically Controlled Phase III Study

In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.

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NMTT: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

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

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Premature Birth


Molecular Assessment of the Consequences of Preterm Birth

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

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Preterm Birth


Molecular Assessment of the Consequences of Preterm Birth

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

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Pulmonary Hypertension


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

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

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Rheumatologic Conditions


Observational Study for Pediatric Rheumatic Disease: The CARRA Registry Study

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

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Twin-Twin Transfusion Syndrome


Evolution of Cerebral Development in Twin-Twin Transfusion Syndrome (TTTS)

The study includes 30 pregnant women with twin pregnancy - 15 carrying twin fetuses that have been prenatally diagnosed with twin-twin transfusion syndrome (TTTS), and 15 carrying healthy twin fetuses. These women may be offered a fetal MRI scan at no cost to the women. Dr. Tarui will look for differences and changes in the fetal brains with TTTS compared to unaffected twin fetuses.

The study also includes children of women who participate in the study. Children will be followed up after the birth and their neurodevelopmental outcome will be precisely recorded by battery of neurodevelopmental testing at 18 month of age.

The study’s goal is to establish anatomical landmarks for fetal brain development in TTTS that can subsequently predict future neurodevelopmental outcome of affected children.

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Ulcerative Colitis


Using patient data to transform care and improve outcomes for children, adolescents and young adults with inflammatory bowel disease.

Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease

More