All Clinical Trials

Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy. Read Less

The Managed Problem Solving (MAPS) behavioral intervention is an EBP for behavior change in people living with HIV (PLWH). The investigators propose that MAPS can be delivered by trained Community Health Workers (CHWs). The use of CHWs to deliver MAPS is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. In order to also address retention in care, the investigators will adapt MAPS to also focus on problem solving activities tailored toward retention in care (now termed MAPS+). CHWs will be located in clinics to implement MAPS+ to improve viral suppression and care retention in PLWH. Data-to-care allows for identification of people who are lost to care and link these patients back to care. Currently, medication adherence and retention in HIV care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of PLWH who are out of care and not virally suppressed to offer them MAPS+. The set of implementation strategies include task-shifting the delivery of MAPS+ to CHWs, providing the CHWs training and ongoing support, and increasing communication between the CHWs and medical care team via standardized protocols. The investigators will conduct a hybrid type II effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test MAPS+ compared to usual care using a set of implementation strategies that will best support implementation. Each clinic will be randomized to one of three implementation start times. Baseline (usual care) data will be collected from each clinic for 6 months, followed by MAPS+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. Aim 1 will test the effectiveness of MAPS+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). Aim 2 will examine the effect of the package of implementation strategies on reach. Implementation cost will also be measured. Aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. The results will guide future efforts to implement behavioral EBPs across the HIV care continuum, consistent with the "treat" pillar of EHE, and move the science of implementation services, consistent with NIH strategic priorities. Read Less

The overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Recent studies highlight significant promise for multi-parametric magnetic resonance imaging of the prostate (MRI) and Genomic Prostate Score assay (GPS) as tools to help risk stratify men on active surveillance to identify men likely to harbor undetected aggressive disease in their prostate. Given the risk data provided by these modalities and the low adherence with monitoring common in men served in public hospitals, both tools may improve safety via improved patient selection and patient adherence with monitoring. The downside is that excessive testing may lead to too many false positives and unnecessary treatment. Two hundred men with very low to intermediate risk prostate cancer were randomized into the 2-arm ENACT Clinical trial from 2016-2019 to study the impact of the GPS assay on treatment choice. Overall, 104 men received GPS assay and 96 controls did not receive the assay (a confirmatory test) right after being newly diagnosed with favorable risk prostate cancer. For Aim 1, 222 men will be recruited into the MRI And GPS Informing Choices for prostate cancer treatment (MAGIC) study and they will be given the GPS assay and multi-parametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Between the ENACT and MAGIC study, there will be 3 groups of men who will have received both GPS \& MRI, GPS alone, or neither test and can compare the impact of having 0,1 or 2 confirmatory tests on patient's adherence to active surveillance monitoring protocols over 18 months. The analyses will elucidate whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death. In Aim 2, the MAGIC study cohort will be leveraged to determine the accuracy of the Genomic Prostate Score assay and the prostate imaging- reporting and data system (PIRADS) score from the MRI in predicting which tumors will progress in 18 months. Progression is defined as increased Gleason grade group (GG) or change in prostate digital rectal examination findings. This serves two purposes. It will allow doctors and patients to categorize the patient as safe or risky for active surveillance. Secondly, it will allow doctors to identify which men on active surveillance need to be followed with annual prostate biopsies and which men can have their biopsies deferred for 3-5 years to reduce the number of prostate biopsies and their morbidities. Lastly in Aim 3, the participants will rank the importance of these tests among a multitude of clinical, social, financial and interpersonal influences on their cancer treatment choice. By tallying the patient rankings, one can identify the most critical decision making factors that can be used to encourage increased selection of active surveillance. Read Less

A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems Read Less

The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care. Read Less

The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with: * Mild Cognitive Impairment * Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties * Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties * Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties * The investigators are also enrolling older adults with normal visual, language, and memory function. Read Less

This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss. Read Less

In this study, the researchers are trying to learn more about the relationship between Polycystic Ovary Syndrome and Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is a sleep-related breathing disorder that involves a decrease or complete stop in airflow. The purpose of this study is to find out why some people with obstructive sleep apnea have higher levels of insulin resistance, and the investigators will study the role of hypoxia (low levels of oxygen in the blood at night) in insulin resistance and see if insulin resistance improves during your treatment with CPAP. Read Less

Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events. Read Less

This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption. Read Less

The goal of this study is to investigate the role of social factors on speech learning, including production and perception, in infants ranging in age from \~7-18 months. Infants have either typical hearing or sensorineural hearing loss. The main prediction of the study is that social reinforcement will engender improvements in vocal learning above and beyond gains in hearing in infants with hearing loss. As part of this study: * The parent and infant engage in a free play session in the playroom while the investigator cues the parent to say simple nonsense words; * Infants hear playback of the same words during a second phase. Read Less

This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes. Read Less