The overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. Using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fMRI) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. Stroke patients will practice modulating their own brain activity using fMRI neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.

Type: Interventional

Start Date: Apr 2023

open study

A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.

Type: Interventional

Start Date: Nov 2019

open study

A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of the strongest identified predictors of an improved antidepressant response to ketamine. Like ketamine, alcohol is a functional NMDA receptor antagonist. FHP is associated with differential response to ketamine, e.g. blunted psychotomimetic side effects. One of the primary mechanistic hypotheses for ketamine's antidepressant action is the acute intrasynaptic release of glutamate from major output neurons, e.g. cortical pyramidal cells. Preliminary clinical studies have demonstrated this acute glutamate "surge" in response to subanesthetic dose ketamine. Based on these findings, the investigators hypothesize that ketamine's enhanced antidepressant efficacy in FHP TRD subjects is, at least in part, attributable to increased glutamate release relative to TRD subjects without a family history of alcohol use disorder (Family History Negative, FHN). To test this hypothesis, the investigators have designed a now two-site, open-label study of 18-55-year-old medically and neurologically healthy, currently moderately-to-severely depressed TRD patients. In total, the investigators plan to recruit 25 FHP and 25 FHN TRD subjects. All subjects must not have a current substance use disorder (except nicotine or caffeine). The experimental portion consists of two phases. The preliminary first phase is a medication taper (if needed) and psychotropic medication-free period. The experimental second phase comprises one subanesthetic dose (0.5mg/kg x 40 minute) ketamine infusion. The ketamine infusion will occur during 7T-magnetic resonance imaging (MRI), both resting-state functional MRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) to detect glutamate in the ventromedial prefrontal cortex/ventral anterior cingulate cortex (vmPFC/vACC). The primary outcome measure is group mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from pre-ketamine infusion (baseline) to one-week post-infusion, where the investigators observed ketamine's greatest antidepressant effect in FHP TRD. Additional outcome measures are vmPFC/vACC glutamate change in response to ketamine based on family history status. In summary, this study will provide key mechanistic information on ketamine's improved antidepressant efficacy in a biologically-enriched subgroup. This will contribute to the systematic development of more efficacious, personalized treatments for major depression in an effort to reduce its enormous public health burden.

Type: Interventional

Start Date: Apr 2014

open study

The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.

Type: Interventional

Start Date: Aug 2023

open study

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.

Type: Interventional

Start Date: Oct 2022

open study

The purpose of this study is to develop, evaluate the acceptability/feasibility (Phase IA), and test (Phase IB) the effectiveness of a brief, integrated, single-session, computer-based, culturally adapted personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with anxiety.

Type: Interventional

Start Date: Sep 2022

open study

To evaluate the impact of an adapted online, self-help relationship intervention (supplemented with brief coach calls) for survivors of breast cancer and their partners. Couples will be randomized to receive either the online intervention (Together after Cancer) or usual care (UC) and assessed at baseline, end of the program, and 3 months after randomization.

Type: Interventional

Start Date: Jan 2023

open study

The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions. However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.

Type: Interventional

Start Date: May 2021

open study

This study meets the NIH definition of a clinical trial, but is not a treatment study. Instead, the goal of this study is to investigate how hearing ourselves speak affects the planning and execution of speech movements. The study investigates this topic in both typical speakers and in patients with Deep Brain Stimulation (DBS) implants. The main questions it aims to answer are: - Does the way we hear our own speech while talking affect future speech movements? - Can the speech of DBS patients reveal which brain areas are involved in adjusting speech movements? Participants will read words, sentences, or series of random syllables from a computer monitor while their speech is being recorded. For some participants, an electrode cap is also used to record brain activity during these tasks. And for DBS patients, the tasks will be performed with the stimulator ON and with the stimulator OFF.

Type: Interventional

Start Date: Jan 2023

open study

This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'. The purpose of this study is to find out more about how exposures during pregnancy, such as having an infection, diet and growth may impact later risk of type 1 diabetes (TID) and islet autoimmunity in the child. We are also interested in finding out more about why having a father or sibling with T1D increases risk of autoimmunity in the child more than having a mother with T1D. We are enrolling women who are pregnant and either have T1D or another first degree relative (father or full sibling) of the baby has T1D. The biological father is also invited to enroll in study, as it is important to understand how the father's health and genetics may contribute to the child's risk of developing T1D. The study procedures for the mother, father and baby are explained below. Mother: Pregnant women will be asked to complete a visit once per trimester (3 visits) during pregnancy and one visit up to 12 weeks after delivery. At each visit, mothers will consent to a blood draw, collection of biological samples and the completion of questionnaires. . Mothers who have T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Father: The (biological) father will be invited to enroll in a single visit. He will consent to a blood draw and completion of questionnaires. Fathers with T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Baby: The baby will have blood collected at birth to determine the genetic risk for T1D. Families will consent to the completion of questionnaires about growth, health and diet at 6, 12, 18 and 24 months of age and between 5-7 years of age, and to complete blood testing for islet autoantibodies at 24 months and between 5-7 years of age. For those children with a high genetic risk score, we will also collect blood for autoantibody testing at 6, 12, and 18 months of age.

Type: Observational

Start Date: Dec 2022

open study

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

Type: Interventional

Start Date: Apr 2023

open study

This study aims to better understand how people with Parkinson's control reaching movements. Specifically, we are asking how these individuals respond to different environmental perturbations. Testing includes reaching movements made within a virtual reality set-up.

Type: Interventional

Start Date: Dec 2018

open study

Background: - Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: - To understand how genes and environment influence eating behavior and health over time. Eligibility: - Children ages 8-17 in good general health. Design: - Screening visit 1: Medical history, physical exam, body measurements, and questions. - 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample. - Screening visit 2: - Body measurements. - Saliva, urine, and blood samples. - Heart tests. - Meals provided (after fasting overnight). - Questionnaires and interview. - Behavior, thinking, and exercise tests. - X-ray of left wrist and full body.<TAB> - Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits. - Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours. - Participants may choose to participate in other studies: - Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task. - Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood. - Experiment 3 (sleep/fatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task/movie, they will answer questions and be provided with food. Participants will be compensated for the time and inconvenience involved with completing study procedures.

Type: Observational

Start Date: Apr 2015

open study

Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide. The purpose of this trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in reducing the occurrence, severity, and/or the duration of illness resulting from respiratory virus infections. The trial will enroll generally healthy adults (age 18 - 45 years) who are at risk for exposure to viral respiratory infection, for example, due to living conditions or occupation. Participants will be treated with INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.

Type: Interventional

Start Date: Dec 2025

open study

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)

Type: Interventional

Start Date: Feb 2025

open study

In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Type: Interventional

Start Date: Sep 2024

open study

This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.

Type: Interventional

Start Date: Mar 2024

open study

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence. This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA).

Type: Interventional

Start Date: Mar 2024

open study

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans. The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy. This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual (TAU), (in this case B-FIT+ Cognitive Behavioral Therapy treatment) as compared to TAU alone (CBT treatment).Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 & 6 month follow-up assessments, all via telehealth.

Type: Interventional

Start Date: Mar 2023

open study

The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study

Type: Interventional

Start Date: Sep 2024

open study

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Type: Interventional

Start Date: Apr 2023

open study

Background: Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies. Objective: To identify and understand how environmental exposures contribute to human disease. Eligibility: Healthy adults ages 18 and older Design: Participants will be screened with questions about their health history, demographics, and medicines they take. Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath. Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup. Participants may have their nasal passages brushed, scraped, or washed. Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup. Participants who produce sperm may give samples. Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung. Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests. Participants may collect household dust, urine, or stool at home. Participants will complete surveys about their health, diet, and exposures. Participation will last for one or more study visits. Participants may be contacted in the future to take part in other studies.

Type: Observational

Start Date: Nov 2021

open study

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time. Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds. Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly. After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS. ...

Type: Interventional

Start Date: Jan 2009

open study

This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.

Type: Interventional

Start Date: Oct 2025

open study