All Clinical Trials

We have developed a questionnaire to elucidate the dosing, frequency and indication for the use of emicizumab in patients with Hemophilia A (mild, moderate or severe) ages 0-3 years. We are also collecting data on any pre-, peri and post surgical practices while on emicizumab. More importantly, we are asking if pediatricians are planning to introduce factor 8 to children who are already on emicizumab for primary prophylaxis as well as how and when they are planning to do so. We hope that this data will help inform understanding of current use of emicizumab in infants and young children as a form of primary prophylaxis, especially when venous access has historically been a limiting factor. Read Less

This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia. Read Less

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period. Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B. Read Less

The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom? Read Less

This study aims to culturally adapt an existing American Diabetes Association (ADA)-recognized diabetes self-management and support or DSMES (Diabetes Self Management Education Support) program (Project Dulce) and integrate an evidence-based text messaging program (Dulce Digital) for implementation in Filipino Americans (FAs) with type 2 diabetes mellitus (T2DM). Cultural adaptations aims to facilitate and enhance patient centered approaches and increase participant engagement by addressing barriers to DSMES unique to FAs, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, this study aims to examine the effectiveness of the culturally and digitally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, belief, attitudes, hemoglobin A1C (glycosylated hemoglobin), and self-management behaviors at baseline to 3 months and 6 months. The unprecedented increase of T2DM prevalence among racial and ethnic minority populations including FAs in recent decades demands for effective strategies to meet the needs in DSMES in this population. The outcomes of the current study will demonstrate that the culturally adapted Project Dulce and integration of Dulce Digital is effective in addressing the needs FAs, an underserved racial and ethnic minority group in high need of culturally appropriate DSMES. Read Less

Background: Alcohol use disorder (AUD) is the most common substance use disorder in the world. Long-term AUD can affect a person s sense of taste and smell. This natural history study will compare alcohol drinking behaviors and measures of taste and smell in people with and without AUD. Objective: To understand how alcohol use changes the senses of taste and smell. Eligibility: People aged 18 to 65 years with or without AUD. Design: Participants will be screened. They will have several tests to assess their smell and taste functions. They will answer questions about their eating, alcohol use, and smoking or vaping habits. Participants will have 2 study visits. They will give samples of blood, nasal mucous, saliva, stool, and urine. Their bodies will be measured. They will undergo a type of scan that uses X-rays to measure their body composition. They will complete taste measurements. They will taste liquids by swishing them in their mouth, without swallowing. Then, they will be asked what they can detect and which flavors they preferred. They will also complete smell measurements. They will be asked if they can identify strong odors on a metal wand. They will be asked to rate the intensity and pleasantness of odors. Their brain activity in the frontal regions will be measured while they smell various odors. For this, we will use a brain imaging tool called functional near infrared spectroscopy. They will have sensory testing. Sensations such as pressure, pinpricks, heat, or vibrations will be applied to their skin. Then, they will be asked what they felt. They will keep diaries. They will write down what they eat (for 3 days), the alcohol they drink (3 days), and how much they sleep (14 days). They will wear a wristwatch-like device that records their activity for 14 days. Read Less

The goal of this clinical trial is to determine the impact of omega-3 fatty acids on the production of anti-inflammatory effects and clinical improvement in people with depression who have not responded well to standard antidepressant treatment. The main questions it seeks to answer are: 1. Do omega-3 fatty acids added to ineffective antidepressant treatment increase production of compounds that reduce inflammation? 2. Is the increase in these anti-inflammatory compounds associated with a stronger antidepressant effect? Participants taking antidepressants that have not worked completely will be assigned at random for a 12-week period to one of the following: 1. an omega-3 preparation 2. an inactive placebo During the course of the study, blood tests will be obtained for compounds associated with inflammation, and questionnaires to measure clinical improvement in depressive symptoms will be administered. Read Less

A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease. Read Less

This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep. Read Less

The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow. Read Less

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms. Read Less

Young children rely on their foods and drinks for the nutrients they need to grow, like energy, protein, vitamins, and minerals. In addition to nutrients, there are substances in fruits, vegetables, milk and formula, called phytochemicals, that can support health. While researchers know more about the role of phytochemicals in adult health, researchers know surprisingly little about how phytochemicals can support health in young children. One group of phytochemicals are called the carotenoids. Carotenoids are responsible for the red, orange, and yellow colors in some fruits and vegetables. In adults, carotenoids can support visual function. Researchers also know that measuring levels of carotenoids in the blood or optically in the skin, can serve as an indirect measurement of what child and adults eat. The purpose of this study is to determine how a child's usual intake of carotenoids is related to their visual development and their blood and skin levels of carotenoids. The study involves 6 visits. For each visit, we will ask about the child's recent diet, will measure their body size, collect a blood sample, collect optical measurements of their skin, and will test how sharp their vision is. Read Less