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29 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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Anxiety


An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

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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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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 II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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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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Cystic Fibrosis


A Long Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis (CF) Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors

This is a prospective observational study to determine the incidence of fibrosing colonpathy in patients with CF.

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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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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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Healthy Volunteers


Social Media as a Vehicle for Expression of Self-Harm and Risk-Taking Behavior in Adolescents

The primary objective of this study is to develop and administer a survey tool based on previously validated survey measures to identify adolescents who engage in non-suicidal self-injury (NSSI) and/or sharing of sexually explicit material.

A secondary objective of the study will be to determine if any correlation exists between adolescents self-reporting to engage in NSSI behaviors and/or sharing of sexually explicit messages and socio-demographic variables, substance use, academic performance and bullying.

  1. Determine percentage of the adolescents who engage in NSSI, what percentage use social media to express intent to engage in NSSI and/or connect with other adolescents who engage in NSSI;
  2. Determine percentage of the adolescents who engage in sharing of sexually explicit material, what percentage use social media as the platform to share sexually explicit materials; and
  3. Determine how much time adolescents who engage in self-harm behaviors and/or sharing of sexually explicit messages spend on social media compared to adolescents who do not engage in self-harm behaviors and/or sharing of explicit messages
Our hypothesis is adolescents who engage in NSSI behaviors and/or sharing of sexually explicit material spend greater amounts of time on social media than adolescents who do not engage in NSSI behaviors and/or sharing of sexually explicit materials

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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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Medulloblastoma


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

More

Mood Disorders


An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

More

Nephrotic Syndrome


Practice patterns and outcomes of ACTHar use in children with nephrotic syndrome

This is a registry study which will collect safety health information from children 6 months to 21 years of age with nephrotic syndrome of any cause, and treated with ACTHar therapy. All the data collection will take place during the routine hospital visits. There is no additional visits and invasive procedures for this study.

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Neuroblastoma


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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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 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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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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Psychotic Disorders


An Innovative Model to Address Shortage of Child and Adolescent Psychiatry

Our study will help us learn the amount of time our clinic takes to see referred patients. The goal is to see patients as soon as possible from time of referral to help decrease the wait time for a provider. Our study will also help us see how well our treatment model is working.

More

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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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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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