There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction. Research participants will undergo reconstruction either using the AuryzoN device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.
This study tests a memory-based account of atypical speech perception in adults with language-based learning disability (also known as developmental language impairment [LI]). One perspective regarding the its etiology considers impoverished speech sound representations to be central to the linguistic symptoms observed in LI. This project examines a potential abnormality in the process of building speech sound representations in LI. Previous work by the PI has found that sleep is important for learning speech sounds. Furthermore, different measures of speech perception (identification and discrimination), reveal distinct patterns of learning that are consistent with that of declarative and procedural memory consolidation. A division of labor by declarative and procedural memory systems in the building of speech representations may imply that problems with phonology may stem from selective weaknesses in declarative or procedural memory in predictive ways. The first project Aim is to identify the memory substrates of novel phonetic category formation. In Experiment 1, the investigators will obtain behavioral measures of declarative, procedural, and speech sound learning before and after post-training sleep in 40 typical adults and 20 adults with LI. Among typical adults, a double dissociation is predicted in which speech identification will be predicted by individual differences in declarative memory, and speech discrimination will be predicted by individual differences in procedural memory. Moreover, adults with LI are predicted to demonstrate consolidation deficits across memory types. The second project Aim is to identify the neural substrates of phonetic category formation. In Experiment 2, the investigators will obtain functional magnetic resonance (fMRI) recordings of 20 TD and 20 LI adults performing post-training identification and discrimination tasks on a trained speech contrast before and after sleep. In typical adults, a Time by Speech-task interaction is predicted. Speech identification will recruit episodic (hippocampal) information on Day 1 relative to classic regions for phonological processing on Day 2. Speech discrimination will result in a change in magnitude of activation from Days 1 and 2 in the left inferior frontal gyrus (IFG), reflecting an overnight decrease in effort. LI (n=20) is predicted to demonstrate reduced overnight change in neural activation relative to TD in both tasks.
This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
Human beings react differently to changes in diet, exercise, and sleep patterns. The goal of this study is to (1) learn how individuals react to lifestyle choices and suggestions by examining a small group of people with similar health and lifestyle profiles; and (2) to develop algorithmic policies (male/female) that will help people optimize their health through lifestyle interventions and supplementation with prebiotics.
The mission is to develop novel interventions to improve cognitive function, and thereby reducing delirium in hospitalized patients to improve perioperative outcomes. Delirium affects up to 42% of hospitalized patients and disproportionately increases morbidity and mortality in older adults, especially after surgical procedures. Current approaches prevent only 30-40% of delirium cases. The goal is to use prehabilitation (an individualized exercise regimen performed in the 2-4 weeks prior to admission) to improve peri-operative cognitive status, mobility and recovery. Based on preliminary data, the investigators propose to deeply phenotype patients, meaning to study the patient, the disease and surgery in a very detailed fashion, with elective knee or hip replacement surgery and use a personalized prehabilitation intervention compared to standard pre-operative care. To facilitate data collection over the course of the study, the investigators use wearable devices and mobile phone applications.
This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma. The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administration of both EDP1503 (twice daily) and pembrolizumab (every 3 weeks). Mandatory biopsies are required before starting study treatment and after 2 weeks of EDP1503 dosing.
The investigators propose to create e-Connect, a new service delivery model that will enable real time identification and targeted, county-specific referral and linkage of participants with suicidal behavior (SB) and related behavioral health (BH) problems. e-Connect will: (i) establish and formalize interagency referral decisions based on clinical need, jointly derived by JJ (juvenile justice) and BH agencies; (ii) train probation staff to increase BH/SB understanding; (iii) utilize an existing evidence-based (EB) BH/SB screen; and (iv) develop a mobile application to seamlessly integrate screening, classification of clinical need and development of a related referral plan. There are 4 project phases: Development, Baseline, Implementation, and Sustainment/Evaluation. After development, activities take place in 10 NY (New York) counties and all study counties will begin the intervention at the same time. The investigators will examine changes in outcomes (e.g., service use) relative to baseline in (i) identification of participants service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) participants BH service use (access and engagement). Analyses will further consider contributions of multi-level factors (e.g., staff, organizational, family, and community) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases). The investigators will consider the role of mediating elements (e.g., probation practices) in explaining the association between e-Connect and identification, referral, and service use.
This phase II trial studies how well stereotactic body radiation therapy works in treating patients with kidney cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
The goal of this study is to determine whether metabolic control centers in the brain can be activated in patients with type 2 diabetes as compared to non-diabetic individuals. This is important since people with diabetes have inappropriately high production of glucose, which could be at least in part due to impaired activation of important brain centers.
This is a single arm phase II study of neoadjuvant chemotherapy followed by local excision and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma. After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is mandatory at baseline and other imaging is encouraged) and confirmation of eligibility, systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy (Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response to chemotherapy to allow local excision will continue with evaluation and treatment per the current standard of care (chemoradiation followed by TME). These patients will be considered failures for the primary endpoint of the study. Patients who respond to the neoadjuvant chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks after local excision. Patients with positive margins at the time of local excision will also be treated as per standard of care and will be considered as failures. Number of patients who can undergo successful local excision with this approach will define the success of the strategy. After chemoradiation therapy post local excision, patients will be followed closely every 3 months for the first 3 years and then every 2 months for the next 2 years (history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary end-point will be followed as per standard of care, off-study.