45 Clinical Trials for Various Conditions
This research study is designed to answer the question: How does professional coaching impact early career academic emergency medicine physician goal attainment, leadership strengths, well-being, and burnout?
Studies have shown that choline is a necessary part of the human diet. Choline is important in making membranes for all the cells in the body, and for making chemicals that are responsible for nerve function. Studies have also shown that choline improves memory of rats when they are given choline at early stages in their lives. The purpose of this study is to find out whether choline supplementation (provided as a choline dietary supplement) in pregnant women will improve memory function of their babies after they are born. In this study, we hypothesize that high dietary choline consumption during pregnancy and lactation will: 1. Increase maternal choline concentration in plasma 2. Increase breast milk choline concentration 3. Enhance memory performance in the children born of supplemented mothers
To study of classical conditioning mechanisms associated with arousal, craving and cocaine use.
The purpose of this study is to assess the development of human laboratory study model of cocaine relapse prevention.
The major goal of this project is to characterize the structural and functional development of cortical plate and white matter of the human neonatal brain from the equivalent 30 gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535. Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921) with at least 36 million funding also sponsored by niH. Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain not only aids in understanding this highly ordered process, but also provides clues to detect abnormalities caused by genetic or environmental factors. Cerebral vascular measurements offer important information on cerebral metabolism. However, either anatomical or functional studies of human brain development during this period are surprisingly scarce. Diffusion tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is capable of noninvasively delineating macroscopic anatomical components with high contrast and revealing structures at the microscopic level. Cerebral vascular quantification including cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and no sedation will be applied during MRi. The resultant database will provide reference standards for diagnostic radiology of premature newborns and reveal the vascular activities of these newborn brains. Specifically, three aims will be achieved: 1. To delineate the anatomical development of complex structure in the cerebral wall and white matter tracts of neonatal brains at different equivalent gestational ages. 2. To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain. 3. To correlate the structural and functional measurements with the gene transcriptome results.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.
Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.
There is currently no experimental model that accurately represents sarcoidosis. The lack of a useful research model significantly slows progress towards developing new treatments for sarcoidosis. The investigators plan to develop a new model for sarcoidosis research and will test the model to see if it helps us understand how sarcoidosis develops and if it is useful for testing new treatments.
Dr. Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins. We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 (KSHV, the etiologic agents of Kaposi's sarcoma, an AIDS-defining condition). We initially plan to examine samples from patients with Kaposi's sarcoma, since all those patients are almost certainly infected with HHV-8. We are thus using samples from patients with previously diagnosed Kaposi's sarcoma. The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville, MD.
The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. Eighty-eight breastfeeding dyads, 3m postnatal, will participate in this study designed to: 1. To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks. 2. To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado. 3. To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group. To this end, healthy, lactating women who are 13 weeks postpartum and their infants will be enrolled. Mothers will be provided avocados on a bi-weekly basis and will be asked to consume an avocado a day. Infant cognition will be tested when the infants are 4.5 and 6 months of age. Milk samples and diet data will be collected and assayed on a bi-weekly basis.
To develop a test to measure small bowel and colonic permeability.
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question\[s\] it aims to answer are: * Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * Will early introduction interventions prevent the development of these food allergies? Participants will * provide breast milk sample (s) for testing for food allergens * Infants will be tested for sensitization via skin prick and blood testing * Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures
More than 60,000 infants are born between 22 to 32 weeks gestation age annually in the US. Approximately 11% of them develop comorbidities. During NICU hospitalization, preterm infants inevitably endure early life toxic stress without adequate protective buffers. Early life toxic stress results in adverse epigenetic modifications of glucocorticoid-related genes and dysbiosis, impairing neurodevelopment. These adversities further exacerbate the risk of comorbidities and inappropriate brain development during sensitive periods of neuroplasticity. Adverse epigenetic modifications and dysbiosis may set a life-long trajectory of risk for chronic health conditions. It is a clinical and scientific priority to test an early NICU intervention to attenuate stress-related adverse epigenetic modifications and dysbiosis. Human milk influences the structure and relative abundance of healthy gut bacteria and neurodevelopment. Maternal nurturing, e.g., licking and grooming (in rodents), and breastfeeding and touch (in humans), promotes neurodevelopment, reduces stress, and reverses stress-related epigenetic modifications. The multisensory early oral administration of human milk (M-MILK) intervention is designed to provide an enjoyable and nurturing experience for infants, through a safe and consistent infant-guided provision of human milk droplets, given orally as early as 22 weeks postmenstrual age. M-MILK is implemented from day 3 of life, after every hands-on care, and during the beginning of a full gavage feeding. We propose the M-MILK pilot randomized controlled trial (RCT): a 2-group (N = 12, 6 per group), parallel, and longitudinal design in preterm infants who are born between 22 to 28 weeks gestational age. The aims of this pilot are to determine the feasibility and acceptability of the M-MILK intervention, recruitment, retention, and obtain data for sample size estimation. This study will advance nursing science and practice because it will inform our R01 RCT to examine the efficacy of M-MILK to attenuate adverse effects of early life toxic stress in preterm infants.
Evaluation of a novel self-collection device for cervical cancer screening.
The overall purpose of this study is to determine feasibility and preliminary efficacy of pet therapy, or human-animal interactions (HAI), for children (5-12 years of age) with or at risk for LD. Children among 4 reading groups will be randomly assigned to a HAI intervention or control group. The 2 HAI intervention reading groups will receive visits from a registered canine team during children's small group reading sessions twice a week over 12 weeks. The 2 control reading groups will receive care as usual and offered a 1-time visit from the dog at the end of the study (after T3 completed). Two weeks of initial work will focus on preliminary modifications to the protocol. Parents will complete electronic measures of psychological outcomes (child depression, anxiety, QOL) via REDCap at baseline (T1), 2 weeks post-baseline (T2), and 12 weeks post-baseline (T3). The investigators will obtain copies of reading assessments already conducted by the teachers at T1 and T3. Children's salivary cortisol will be obtained from participants in the intervention groups at T1, T2, and T3. Children and their parents will complete concluding interviews at study end (T3) to further inform what they liked and did not like about the intervention. Results of the proposed study will provide critical data for a future full-scale randomized clinical trial (R01) to examine the impact of HAI on psychological, physiological, and reading outcomes in children with or at risk for LD.
This study will determine whether the ratio between 24h C-peptide urinary excretion rate and average 24h circulating glucose represent a good correlate of what is measured by the gold standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp
Youth living with HIV are at high risk of falling out of care when they transition from pediatric to adult care. The investigators are proposing to develop a mobile app to help both clinical providers and patients navigate this process.
The overarching goal of this project is to implement Boot Camp Translation (BCT) methodology to translate the guidelines and evidence for human papillomavirus (HPV) vaccine into a practice and provider level intervention designed to improve its acceptability and uptake.
This trial develops a health-related symptom index for participants with and either treated or monitored for anal high-grade squamous intraepithelial lesions. The health-related quality of life index may help to capture the symptoms and related experiences of living with or being treated for high-grade squamous intraepithelial lesions.
This study design consists of a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID). A total of 108 men and women with current AUD (moderate or severe) and reporting intrinsic motivation to change their drinking, will be randomly assigned to receive naltrexone (50 mg QD), varenicline (1 mg BID) or matched placebo. Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. After a week-long medication titration period, participants will be asked to complete a 7-day practice quit attempt, during which they will have daily virtual visits (phone and online) where they will report on their alcohol use. Additionally, a second cue-reactivity paradigm will be conducted 90 minutes following study drug administration on final day of the practice quit attempt (Day 14).
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values \< 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes. The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day. The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age. Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
Background: Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people. Objective: To collect samples to use for research on blood disorders. Eligibility: People ages 18-70 who have blood disorders. Healthy volunteers without blood disorders are also needed. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will give one or more samples. They will give them over 5 years. They can choose not to give any of the samples: Saliva: Participants will spit into a tube. They may also have the inside of their mouth swabbed. Urine: Participants will urinate into a cup. Blood and blood waste products: Blood will be taken through a needle in the participant s arm. Fat samples: An area on the participant s belly or buttock will be numbed. A small cut will be made into the skin and a small piece of fat removed. Mucus and cells from the lungs: The participant will be sedated. A flexible tube will be inserted through the nose or mouth into the lung airways. These participants will also have a physical exam, chest x-ray, and heart tests after the procedure.
Background: This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples. Objective: To collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine. Eligibility: Healthy volunteers and patients ages 18 and older Design: First-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes. Participants will undergo a limited history and physical exam. Participants may have routine blood and urine tests. If participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research. Participants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes. Participants may be asked to provide urine in an appropriate container...
Background: The Human Brain Collection Core (HBCC) collects brain and other tissues. They get these from deceased people who may or may not have had psychiatric disorders. The next of kin gives permission for researchers to get the tissues. Researchers want to collect medical details of people whose brains are donated. They also want to use the donated tissue to study brain chemistry and structure. This could lead to better treatments for mental illness. Objective: To create a collection of human brain tissue to learn about the causes and mechanisms of mental disorders. Eligibility: People willing to donate their deceased relative s brain tissue. The deceased person could not have had any of the following: Severe mental retardation Long-lasting seizure disorder Infections that affect the brain Decomposition Brain damage Being on a respirator for more than 12 hours Major sepsis Serious renal or hepatic disease Certain dementias and degenerative diseases Design: Medical Examiner s Offices will screen donors who have recently died. Some others will be screened by hospitals or funeral homes. Participants will be the next of kin. They will give consent for HBCC to obtain brain tissue from the deceased person. The tissue will be frozen for future research. Participants will have a 30-minute phone call. They will answer questions about the deceased person s medical and psychiatric conditions. They will answer questions about the person s use of medicines and drugs. Participants will be contacted by a social worker. They will be asked for permission to access the deceased person s medical records.
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection.
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enriched in the corresponding fatty acid. Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be characterized by similar transport, higher conversion, and similar oxidation rates..