Healthy Clinical Trials in New York, NY

Background: During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more. Objective: To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children. Eligibility: Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study. Design: Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample. Some participants will have 1 study visit that lasts 2 days. Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years. Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study. Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible. Read Less

The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. The purpose of this stage of the project is to evaluate the safety and tolerability of tIS administration in healthy volunteers. This study involves 30 healthy participants without known psychiatric illness, who will participate in groups of 10. The dose of tIS will be escalated progressively across doses. Functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS) and side effect checklists will be used to assess tIS safety/tolerability at each dose. In addition, electroencephalogram (EEG) will be collected simultaneously with tIS and used to assess target engagement. Face emotion recognition (FER) data will also be collected, but will be used for feasibility assessment only. If successful, these studies will form the basis for future studies in schizophrenia. Read Less

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Parkinson's disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for Parkinson's disease. Read Less

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Charcot-Marie-Tooth disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for Charcot-Marie-Tooth disease. Read Less

This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied. Arms will consist of 21-day treatment periods and be separated by 8-week washout periods. Subjects will receive, in random order: i) GH alone, ii) GH with liraglutide, iii) liraglutide alone and iv) placebo. Each phase of the study will consist of a 7-day baseline period including 2 days of testing and 21 days on therapy with visits on days 2, 7, 14 and 21. Testing before, during and at the completion of each arm will include blood sampling and assessments of insulin resistance, energy expenditure and body composition. Read Less

The purpose of the study is to: * Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors * Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis * Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients * Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors Read Less

Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 14 community sites will be randomized into the intervention (Sleep2BWell) or control (BWell4Life) group, enrolling an average of 15 participants per site for an expected sample of 210. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline, 10 weeks (primary endpoint), and 24 weeks (long-term follow-up to assess sustainability of the intervention's effect). The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes), as well as better glycemic control and inflammatory and allostatic load indicators (exploratory outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions. Read Less

The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement of insulin at two different levels (low and high), with or without replacement of glucagon, and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes. Read Less

The goal of this clinical trial is to test whether the Food FARMacia intervention to reduce food insecurity is feasible and accepted among families with an infant age 6 to less than 18 months receiving pediatric primary care. All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care. Read Less

This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health equity, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are: 1. Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs? 2. Is the MTM program coupled with the Cardiovascular Health (CVH) curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated blood pressure who do not currently quality for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs? To answer question 1, 100 participants with type 2 diabetes and elevated blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum. To answer question 2, 100 participants with type 2 diabetes and elevated blood pressure who do not currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months. (Objectives) Read Less

The primary goal of this interventional study is to explore whether 3 months of arts-based digital interventions can change the way in which teenagers (13-16 years of age) use social media and are affected by them. The main questions it aims to answer are: Can we give teenagers new, stimulating, and more goal-oriented ways of using social media through arts-based digital trainings and active discussions around social media? Can these arts-based digital interventions also help teenagers to overcome the negative consequences of social media overuse (such as depression, anxiety, and reduced attention and cognitive performance)? Secondarily, this study also aims to explore the brain and behavioral traits associated with these arts-based interventions to better understand how they work. Researchers will compare a music composition intervention with two other interventions: an active control intervention based on visual-arts instead of music (i.e., photography), and a passive approach to control for the mere pass of time. Participants will: Complete a baseline and a post-intervention evaluation where researchers will obtain measures of cognitive performance (attention and executive functions, mainly), mood, mental health, brain structure and function, and social media usage and attitudes towards these platforms. Complete weekly measures regarding their use of social media platforms and their mood. Complete 3-month arts-based composition / edition intervention (based on music or visual-arts/photography), or the equivalent time with no intervention (passive control group). The motivation of this study was driven by the observation that, in recent years, there has been an increasing use of social media and digital devices in teenagers, while the scientific community still does not fully understand the effects of the overuse of these digital means and platforms. Moreover, some of the negative effects described to be associated with the passive overuse of social media tap on the same brain structures that are benefited by musical and artistic trainings. Hence, we thought it could be worth trying to use arts-based training to help teenagers compensate for or overcome the negative effects of social media at the neural, cognitive, mood and mental health levels. This study introduces novelty through three main aspects. Firstly, it employs a digital art creation approach that requires no classical art training, making it more accessible and less intimidating. Secondly, it incorporates commonly used digital devices (e.g., phones/tablets) and motivating environments into the learning process, integrating the development of new digital skills and the practice of critical thinking around the use of SM into normal classroom activities. Finally, the study employs a multi-methodological approach to explore the brain mechanisms underlying mental-health and cognitive changes resulting from arts-based interventions. Finally, we believe that conclusions from SMART will: set the basis for developing preventive and therapeutic interventions for depression and anxiety in teenagers, promote educational programs that provide optimal tools for adolescents to navigate social media in a healthy manner, and inspire educational policy. Read Less

Groups of unimpaired participants will all receive speech motor training of nonwords, and six tDCS conditions will be compared: anodal tDCS over speech motor regions; cathodal tDCS over speech motor regions; anodal tDCS over left frontal regions; cathodal tDCS over left frontal regions; cathodal stimulation over non-speech motor regions (anodal already collected);and sham tDCS (no stimulation). This will address a basic science question about whether the mechanism underlying speech motor learning requires premotor and motor cortical regions to be stimulated, which has implications for treatment of acquired speech impairment. The primary outcome measure will be the difference in production accuracy and changes in motor acuity (measured with duration) of novel consonant cluster production. Read Less