All Clinical Trials

Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable reproducible measurements of emphysema metrics (e.g., Perc15, LAA-950, HU accuracy) and airways (Pi10, WA%) in the lungs. Study activities and population group: The study will recruit subjects from a current study at Duke (COPDGene Phase 4, Pro00113442). Here are the aims: * The research team will request consent from participants to acquire PCCT scans at their Phase 4 COPDGene visit. Scans will be performed using a PCCT-specific protocol. * Reconstruct the PCCT images with multiple post-acquisition parameter settings. Apply harmonization techniques that are recently developed by the investigators of this study. Data analysis: * Identify the reconstruction and harmonization conditions that enable reproducible measurements of emphysema metrics (perc15, LAA-950, HU accuracy) and airways (Pi10, WA%), when compared to the counterpart EICT scans. * Demonstrate the non-inferiority and potentially improved capabilities of PCCT scans in cross-sectional and longitudinal studies. Risk/safety issues: The participants are asked to get an additional CT scan with a PCCT scanner at their COPDGene Phase 4 visit. This additional CT scan will be done using an inspiratory chest protocol with a total of 3 mGy (\~1.5 mSv) radiation dose. This is roughly equivalent of 6 month of background radiation. Women who are pregnant will not have a chest CT scan done until they are confirmed to be not pregnant. Read Less

Military suicide is an ongoing public health concern, particularly within the Army National Guard (ARNG), with longstanding effects on fellow soldiers, family, and friends. The straddling of military and civilian worlds for ARNG can worsen risk factors for suicide, including increased social isolation, disruption to family life, and employment difficulties. One promising framework that addresses both unit cohesion and social support is the First Line Leaders (FLL) program, recently designated by ARNG for nation-wide dissemination. The program is centered on enhancing the relationship between junior enlisted soldiers (JES) and their assigned non-commissioned officer (NCO). The Investigators propose to study an augmented FLL program that includes templated guides developed in collaboration with Idaho ARNG stakeholders. The guides, referred to as TAP (Total Health Action Plan), were adapted from two empirically based interventions, Crisis Response Planning and Problem-Solving Therapy, and consist of prompts for open communication and effective engagement and guidelines for responding to impending or current behavioral distress. Given their elevated suicide risk, the Idaho ARNG is a crucial setting to develop this upstream intervention. In this study, the Investigators propose to compare the augmented FLL + TAP program to FLL only, and training as usual (n= 50 NCOs and 100 JES per group) with quarterly assessments for up to one year. The Investigators will examine a random selection of deidentified counseling templates to examine the type and frequency of counseling sessions involving acute crisis and behavioral health difficulties, and online ratings from a random selection of JES using validated instruments to assess upstream indicators of behavioral distress and suicide risk and resilience. The Investigators will also conduct qualitative interviews with a random selection of 20% of the NCOs (n = 30) and JES (n = 60) enrolled in the project to provide personalized perspectives of program experiences. The Investigators propose three aims to guide this research. (1) Collaborate with Idaho ARNG stakeholders to integrate TAP into FLL programming via: a) development and refinement of TAP training materials, b) building templated counseling statements that align with FLL and TAP, and c) education of Idaho ARNG training cadre in the delivery of TAP. (2) Evaluate fidelity, feasibility, and acceptability of FLL and FLL + TAP through a mixed methods approach of qualitative interviews with FLLs and JESs and evaluation of data from templated counseling sessions. (3) Examine the impact of FLL+TAP versus FLL versus training as usual on unit morale, cohesion, and general functioning. Read Less

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors. Read Less

This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications. There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids. This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period. Read Less

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception. Read Less

This project will examine how multiple biological measures from the brain and the body's stress response system contribute to anhedonia (the loss of pleasure) in adolescence. The goal of this project is to see if it is possible to combine these biological measures to describe different patterns of activity in the brain and body that adolescents may have in response to stress. The main question this study aims to answer is whether different patterns of activity in the brain and body are related to whether adolescents develop anhedonia and how high or low levels of anhedonia are over time. This study will enroll 192 adolescents who are between 13 and 15 years. Adolescents will complete tasks three times: at the beginning of the study, 10 months after that, and then 10 months after that. In total, they will be part of the study for 20 months. At each time, adolescents will complete surveys, provide samples of spit to measure hormones and provide pictures of their brain to measure brain activity, participate in mildly stressful tasks, and complete different activities that measure how they think. The investigators will also ask each adolescent's parent or legal guardian to answer some surveys about themselves and their child. Read Less

The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair. The main questions this trial aims to answer are: * to confirm using photograph analytics, how much hair growth has increased in a marked area when using active treatment versus inactive treatment, and * participants assessment and satisfaction with the hair growth using scaled assessments. Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months of the study. Read Less

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB. Read Less

Patients with a total hip replacement may require early revision surgery due to an adverse local tissue reaction or bone resorption that occurs due to wear debris released from the implant. MRI provides a non-invasive biomarker for clinicians and surgeons to detect early adverse synovial reactions which may exist in the absence of clinical symptoms, thus imparting essential information for clinical management. This study will address two of the most commons causes of hip implant failure, including adverse local tissue reaction in implants not traditionally associated with adverse tissue reactions, as well as the presence of aseptic loosening and loss of implant-bone integration. Read Less

The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD). Read Less

Differentiating between septic arthritis and other causes of joint inflammation in pediatric patients is challenging and of the utmost importance because septic arthritis requires surgical debridement as part of the treatment regimen. The current gold standard to diagnose septic arthritis in children is a positive synovial fluid culture; however, joint cultures may take several days to return. If a bacterial infection is present, it requires immediate surgical intervention in order to prevent lasting articular cartilage damage. Frequently surgeons must decide whether to surgically debride a joint before culture results are available. There is no single lab test or clinical feature that reliably indicates bacterial infection over other causes of joint inflammation. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this study is to determine the sensitivity and specificity of several synovial biomarkers for diagnosing pediatric septic arthritis. Read Less

Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period. Read Less