Clinical trials

The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across \~3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~Day 21; TLFB interview, urine test, oral fluid test, survey, interview).

The goal of this clinical trial is to learn more about anterior leg compartment pressures in adolescents who have sustained tibia fractures. It will also examine whether measuring anterior compartment pressure helps physicians diagnose acute compartment syndrome (ACS), a rare but dangerous complication that can develop following surgical treatment of a tibia fracture. The main questions it aims to answer are: 1. Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS? 2. Does compartment pressure monitoring aid physicians in accurately diagnosing ACS? Participants will have a continuous pressure monitoring sensor placed in their knee anterior knee compartment during their surgery. This sensor will record pressure data following a patient's surgical treatment for 18+ hours.

The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.

This study is a single-center, prospective, and non-randomized feasibility study designed to evaluate the practicality, tolerability, and data quality of short-duration continuous fetal monitoring using a wireless bioadhesive ultrasound device. The study involves a single visit per participant and does not include any therapeutic intervention. Eligible participants will undergo placement of a wireless bioadhesive ultrasound (ABAUS) device on the maternal abdomen for a short-duration monitoring session. The device will acquire continuous or semi-continuous ultrasound data for a total of 10-30 minutes per participant, without altering standard clinical care. The study is observational and is intended to assess the technical feasibility of device placement, the stability of the coupling during routine maternal movement, image quality over time, and the ability to monitor fetal motion, heart rate, and uterine activity using the investigational device under controlled yet realistic clinical conditions. The study is non-interventional. No diagnostic or therapeutic decisions will be made based on the ultrasound data collected as part of this research protocol, and all standard prenatal care will proceed independently of participation in this study.

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, \>50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result. This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines. 220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications \>6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before. Study Participation Includes: 1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher. 2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication. 3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects. 4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week. 5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects. 6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits. 7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy. 8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic or passed down (inherited) from one generation to the next. In this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP/CPPS. We will be collecting DNA (from Blood/Saliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. Individuals and families with CP/CPPS will be enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also experience CP/CPPS symptoms.

Doctors use patterns on heart rhythm tracings (ECGs) to predict where abnormal heart rhythms originate, but these prediction methods were developed in people with normal heart structure. Patients with repaired Tetralogy of Fallot have hearts that developed differently, and cardiologists do not know if these prediction methods work accurately for them. In this study, the investigators will test whether three commonly used prediction methods work in Tetralogy of Fallot patients by pacing the heart from known locations during an already-scheduled heart procedure and comparing the predicted location to the actual location. Participation adds approximately 15 minutes to the procedure and does not require additional visits. The results will help cardiologists understand whether current methods can be trusted when planning treatments for abnormal heart rhythms in this patient population, or whether new prediction methods need to be developed.

The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties. The study will measure if everolimus can safely improve social abilities and functioning in this study population. PTEN Hamartoma Tumor Syndrome (PHTS) is a genetic condition that results from alteration (germline variant) to the PTEN gene. It is associated with a wide range of symptoms and characteristics, which vary from individual to individual. These include symptoms such as harmatomas (non-cancerous lesions), an increased risk of certain types of cancer, having a larger than average head, and abnormalities in blood vessels. Some people also have neurobehavioral problems including social difficulties. It is estimated approximately 25% (1 in 4) of people with PHTS meet the criteria for an autism diagnosis. The study lasts for one year. In the first 6 months half of participants will receive everolimus as a once daily oral tablet, and half will receive placebo tablets. For the second 6 months all participants will receive everolimus. Visits to the study clinic are required at the start, month 3, month 6, month 9 and month 12, with phone calls or virtual visits in between. Assessments include questionnaires, blood tests and urine tests, physical and neurological exams, and vital signs. Everolimus is an existing FDA approved medication used to treat other conditions, including a genetic condition called tuberous sclerosis complex which has some similarities to PHTS, and several types of cancer.

The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction/feedback with implementation of these guidelines.

The most common imaging procedure requiring sedation/anesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic/sedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol. A concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg/kg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg/kg and an infusion of propofol of 100 mcg/kg/min provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times. Finally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.

The pediatric cardiac surgery patient endures a tremendous number of physiologic alterations during surgery and cardiopulmonary bypass (CPB) that lasts well into the recovery period. Most of the hemodynamic data are assessed and treated with macrovascular assessment tools such as blood pressure and central venous line measures. Studies show there may be an incoherence of macrovascular to microvascular assessment; i.e. a patient with a stable macrovascular status may not be in the state of microvascular stability. The use of a handheld device called Cytocam incident dark-field (IDF) microcirculatory camera (Braedius Medical, Huizen, Netherlands) gives real-time video screening and data feedback to assess the microvasculature in the hemodynamically labile patient.

The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are: 1. Does the device improve the appearance of striae distensae? 2. Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device. Participants will: 1. Undergo treatment with the device in the clinic 2. Visit the clinic 1 week, 3 months, and 1 year for checkups and tests

This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.

Central line-associated bloodstream infections (CLABSIs) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. This study will attempt to identify the source of bloodstream infections (BSIs) in children with CLABSI because we hypothesize that many of the BSIs that are currently classified as CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will isolate bacteria from multiple body sites of children that have BSI in order to compare these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also evaluate biomarkers of MBI of the respiratory tract and GI tract.

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is: -What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients? Participants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.

This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.

This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.

Adolescents and young adults with sickle cell disease (SCD) face challenges managing their illness and maintaining their well-being. This study proposes to test the feasibility and acceptability of a resilience-promoting intervention through a Collaborative Care Model. The primary goal is to determine with the resilience intervention (PRISM) is feasible and acceptable for adolescents and young adults with SCD. Exploratory outcomes include whether this intervention improves depression, anxiety, and pain interference.

Esophageal atresia (EA) is one of the most common gastrointestinal congenital anomalies that affects 1 in 2500 to 1 in 4000 live births. It is characterized by abnormal development of the esophagus, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated with risk of developing esophageal strictures or narrowing, which nearly affects 40% of cases. Strictures can be treated using endoscopic balloon dilation, which consists of introducing a catheter with a balloon into the esophagus via endoscopy and positioning it across stricture followed by balloon inflation. The inflated balloon is held in position for a set amount of time with the goal to dilate the narrowed area. At this time there are no pediatric studies comparing difference balloon dilation times and outcomes. Our study's goal is to evaluate balloon dilation inflation time in treating esophageal anastomotic strictures to understand if inflation time is associated with outcome.

95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a comparison group that receives the intervention after a delay. Before and after intervention, electroencephalography (EEG) will be used to examine engagement of the target neural responses.

The goal of this study is to discover new genetic causes of infantile epilepsies and evaluate the impact of these discoveries on infants with epilepsy and their families.

The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships. The main goals of the project are to: * Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition. * Initial exploration of how the CRUSH curriculum works and whether it is helpful. Participants will complete: * A screening call. * Confirmation of clinical characteristics (autism features, language ability, cognitive ability). * 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing). * 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.

According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake. This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure. The investigators believe that the information from this study will help establish a comprehensive NPO guideline.