All Clinical Trials

The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function. The main questions that the study aims to answer are: 1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN? 2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels? 3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN? In this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years. Read Less

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor. Read Less

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection. Read Less

Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow. Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image. This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments. The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan. Read Less

This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema. Read Less

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs. Read Less

This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease. Read Less

Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease Read Less

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health. Read Less

The investigators will follow probability-based cohorts of adult non-medical marijuana users (N=1,500; ages 21+) and susceptible adolescents and young adults (AYA) users (N=1,000; ages 15-20) over four years. The investigators will use a prospective survey to collect marijuana use information and will conduct volumetric choice experiments (VCEs) where participants choose quantities to purchase among three legal product prototypes: flower, edible, and concentrate; and one illegal flower product, under simulated retail marijuana tax structures. The presentation of edibles and concentrates will change over time to capture the range of product varieties in the market and to accommodate new products and characteristics as they evolve. Choice experiments including VCEs use a series of manipulations as a measurement device to elicit preferences for products and consumption. Therefore, the experimental design is within-subjects with repeated measures, which allow for causal identifications of the impact of design attributes (e.g., tax bases and rates) on preference and consumption outcomes. The attributes and levels are selected to reflect THC levels in the market, existing (weight, price, tiered price by forms) and novel (potency) tax bases, existing (10%-40% of retail price or equivalent in other bases) and potential (high 60% and 80% of retail prices or equivalent) tax rates, and price distribution for each product. Price distribution levels (5 to 95 percentiles) will come from our price data collection and will be updated over time and vary by participants' state and locality of residence. Before the experiment, study personnel will instruct participants 1) how to answer the choice experiment question, including considering their weekly expenditures when answering VCE questions; 2) that there is no access to other products, no stockpiling, no selling or giving away products to others, etc., to ensure that participants choose products that reflect their usual purchase patterns for self-use; 3) that there are no right or wrong responses. Study personnel will instruct participants to answer all questions honestly, thoughtfully, and to the best of their understanding as if they were actually in this situation, to reduce hypothetical bias; 4) that there may be potential costs or issues associated with purchasing illegal products, including risks of penalties, undefined potency, possible contamination, and inconsistent product quality; and 5) that participants should keep their weekly budget in mind when making purchase choices of the products. In VCEs, the investigators will manipulate THC levels, tax rates and bases, and price levels. Participants will be asked to answer the following: "Imagine these are the marijuana products that you (participants) can purchase for non-medical use, how many of each product would you (participants) most likely buy next time?" Participants can choose more than one product, and as they choose quantities, the total balance will be displayed. To make the tasks easier, study personnel will 1) set a warning to inform participants if their reported budget exceeds their weekly budget for spending; 2) provide a dropdown list for quantities or, if they would like more units than the listed, they can fill in a number; and 3) all products are described as high-quality to allow for a comparison of prices. Half of the participants will be randomized to see itemized pre-tax tag price, excise taxes, and sales taxes, as requested in some states (e.g., Illinois); the other half will be randomized to see only prices that are inclusive of excise taxes. This will allow us to whether excise taxes are more effective when applied at checkout compared to hidden in the tag prices. Read Less

This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells. Read Less

This phase Ib trial seeks to find out the best dose and possible side effects and/or benefits of zanubrutinib in combination with the R-PolaCHP in treating patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Zanubrutinib is designed to block a protein called Bruton Tyrosine Kinase in order to stop cancer growth. R-CHOP is the acronym for the combination of five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. It is the most widely used chemoimmunotherapy regimen for DLBCL and is considered the standard-of-care treatment for patients with DLBCL. Three of the drugs in R-CHOP (cyclophosphamide, doxorubicin and vincristine) are chemotherapy drugs. Rituximab is a type of immunotherapy and prednisone is a type of steroids. Read Less