Boston, MA Paid Clinical Trials

One method of breast cancer screening involves radiologists reading digital tomosynthesis (DBT) images. DBT consists of a 3D stack of x-ray "slices" through the breast. The exam is accompanied by a 2D image like a standard mammogram, a single x-ray of the breast. In a screening setting, most cases are normal. Sometimes it is obvious that a case is normal from a quick look at the 2D image. It would speed up the process of screening if readers could dismiss a clearly normal case on the basis of the 2D image, alone, without looking at the DBT images. Obviously, the investigators would only want to "triage" cases in this way if the investigators were almost perfectly sure that no cancers would be missed. In this study, the investigators look at radiologist's willingness to triage cases and on the accuracy of their answers. In addition, the investigators ask about the impact of an Artificial Intelligence (AI) opinion. Would it be possible to triage an image on the basis of the AI opinion, alone? Radiologists will look at each case for up to five seconds and offer an opinion (on a 1-10 scale) about how sure they are that a case is normal. Next, they will see the opinion of the AI. Finally, they will say (using a 1-10) scale, how willing they would be for the AI to triage this case without human intervention. This study is the start of an effort to understand the conditions under which radiologists might be willing to declare a case "normal" with little or no human examination. Read Less

Background \& Significance. Children with congenital heart disease (CHD) have experienced improved postoperative survival shifting the focus away from minimizing mortality to curtailing morbidities. Critical illness following cardiac surgery induces catabolism which may impact functional status. Catabolism, a state in which protein breakdown exceeds protein synthesis, can lead to lean body mass (LBM) breakdown. LBM loss has been associated with poor clinical outcomes. Muscle ultrasound (mUS) has been utilized to measure LBM changes and the functional status score (FSS) was developed to assess functional status changes in children following hospitalization. The ability to identify LBM loss acutely and its association with FSS changes may lead to earlier interventions to preserve LBM and aid in outcome prediction. Specific Aims \& Hypotheses. Specific Aim 1 is to identify the percent change in LBM by mUS during the first postoperative week in children following complex cardiac surgery. Specific Aim 2 is to evaluate the relationship between percent change in LBM during the first postoperative week and the FSS at discharge and 6 and 12-month follow-up in children with CHD following complex cardiac surgery. The investigators hypothesize children with CHD following complex cardiac surgery will experience a decline in LBM and that there is a direct relationship between the change in LBM and postoperative FSS follow-up. Study Design \& Methods. The investigators are conducting a single-center, prospective, observational cohort study. Consecutive children (\> 3 months and \< 18 years of age) with CHD undergoing biventricular conversion will be enrolled. Patients will undergo a baseline mUS and FSS at the time of the index operation. Interval mUS will be obtained on the third and seventh postoperative day. Discharge mUS and FSS will be obtained and a remote FSS will be requested by the family at 6 and 12-months postoperatively. Demographics, pertinent laboratory, concomitant medications, nutrition and ultrasound variables will be collected. Outcomes. The primary outcomes will be change in LBM during the first postoperative week and change in FSS at 6 and 12-month follow-up in children following complex cardiac surgery. Change in LBM will be defined as a percent change in cross-sectional area of the quadriceps muscle layer thickness (QMLT). Change in FSS will be significant if the score drops 3 points or more from baseline at postoperative follow-up. Read Less

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. In previous research atomoxetine and oxybutynin showed promising effect at reducing OSA severity, however they reduced arousal threshold, one of the key traits responsible for OSA. Since oxybutynin was used mainly as a hypnotic, but it is burdened by several anti-cholinergic side effects, DAW2020, a hypnotic which prolonged the total sleep time in a previous trial in OSA patients, could be a better candidate to associate with atomoxetine. Read Less

This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years. Read Less

This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC). The name of the intervention(s) involved in this study are: * Implantable Microdevice (IMD) * Surgery (excision of tumor) * Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC) Read Less

Physical activity is important to maintain health, fitness, and function in people with spinal cord injury (SCI) and social support is one of the most effective ways to increase physical activity participation. However, a large proportion of people with SCI are physically inactive and do not engage in recreational activities due to environmental and physical challenges. Many people with SCI also experience challenges with social connection, which may make engaging in physical activities more difficult. The investigators are offering a new online application designed specifically for people with SCI. The purpose of the research is to develop and evaluate a new online app, called SCI-Lynx, that would allow people with SCI to connect with other people and support each other in their physical activity, exercise, or other health or personal goals over a one-month period. This research will also evaluate how SCI-Lynx affects self-efficacy and social support for exercise and provide new information on changing physical activity participation and social connection in people with SCI. Read Less

An observational study of electronic patient data to compare diabetes medications and to determine which ones offer the best balance of risks and benefits. Read Less

This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation. Read Less

While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values. Read Less

The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis. Read Less

This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy. Read Less

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits. Read Less