New York Paid Clinical Trials

The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and/or matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology. The goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases. Read Less

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy. This is currently not available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED. Read Less

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. Participation may last up to 18 weeks. Study procedures for this research are: * Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent * Let the research team record information from your medical record related to your condition and the treatment you receive. * Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery. Read Less

The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms. Read Less

This research project aims to understand the brain mechanisms behind the manifestation of psychotic symptoms in Alzheimer´s disease (AD), and nature of the unique relationship with tau pathology. Amongst the cognitive manifestations of psychosis are impairments related to frontal circuits (social cognition, working memory and executive function deficits). The investigator's previous work suggests a role of tau pathology (one of the hallmarks of AD neuropathology) in the manifestation of psychosis in AD. However, the cerebral mechanisms that underly this association remain poorly understood. The overarching aim of the study is is to investigate the mechanisms by which tau network pathology may promote the presentation of psychosis in AD. Read Less

Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care. By using a DBS device called the Percept PC (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS. The study team will recruit 10 patients with TRD and implant them with the Percept PC system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and movement, voice, and video recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study. Read Less

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control. Read Less

This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention. Read Less

The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines. Primary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine: 1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition. 1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control. Secondary Aim: It is also critical to public health strategy to assess the acceptability/feasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical/psychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion/fatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where \<20% of participants exhibit an adverse outcome. Read Less

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression. The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC. This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block. Read Less

This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery. Read Less

The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life. Read Less