The goal of this project is to address the urgent need for effective, scalable adult literacy interventions by integrating breakthroughs in two separate fields: 1.) the brain network science of resilience to reading disorders and 2.) high-definition non-invasive brain network stimulation. This study will first establish the efficacy of a novel, noninvasive stimulation protocol on reading behavior and brain metrics; then will determine how stimulation-induced effects interact with baseline reading comprehension ability; and lastly, will identify whether stimulation-induced effects are more clinically-beneficial than canonical behavioral interventions. Results may change the foundation for how we treat low adult literacy, and have the potential for wider reaching impacts on non-invasive stimulation protocols for other clinical disorders.

Type: Interventional

Start Date: Nov 2022

open study

Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.

Type: Observational

Start Date: May 2018

open study

Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants.

Type: Observational

Start Date: Dec 2023

open study

The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.

Type: Interventional

Start Date: Jul 2021

open study

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).

Type: Interventional

Start Date: Apr 2022

open study

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

Type: Interventional

Start Date: Feb 2022

open study

The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles.

Type: Observational

Start Date: Aug 2010

open study

The purpose of this study is three-fold. First, researchers will assess whether subjects who have clinically abnormal reactions to sunlight (photosensitivity) have increased levels of microvesicle particles (MVP) following ultraviolet B (UVB) treatment to localized area of skin. Second, researchers will assess if topical application of the medicine imipramine will block UVB-induced MVP release. Third, researchers will assess if the topical cream will block UVB-induced increased erythema reactions (reddening of the skin).

Type: Interventional

Start Date: Jun 2022

open study

This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.

Type: Interventional

Start Date: May 2023

open study

Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to epilepsy and related disorders. These findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.

Type: Observational

Start Date: Nov 2010

open study

The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).

Type: Interventional

Start Date: Jul 2023

open study

This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.

Type: Interventional

Start Date: May 2024

open study

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

Type: Interventional

Start Date: Feb 2023

open study

The objective of this pilot study is to determine whether obesity and metabolic syndrome are in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the investigators want to determine how obesity and the metabolic syndrome relate to metabolism in bronchial airway epithelial cells and the nasal epithelium.

Type: Interventional

Start Date: Aug 2017

open study

Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat. Objective: To see if stable isotopes can help scientists identify things people eat. Eligibility: Healthy adults ages 18 to 65 Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study. Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks. For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda. Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays. Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours. Participants will give hair and stool samples. Participants will complete a diet questionnaire. It assesses their food intake over 24 hours. Participants will complete behavioral questionnaires and computer performance tests. Participants will have fat biopsies taken from their stomach and thigh. Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.

Type: Interventional

Start Date: Feb 2022

open study

Background: - The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work. Objectives: - To screen healthy volunteers for clinical trials at the NIAID VRC. Eligibility: - Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies. Design: - Screening for healthy volunteers to participate in clinical trials is an ongoing process. - Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed. - Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status. - Volunteers will not receive any investigational product in this screening protocol....

Type: Observational

Start Date: Aug 2011

open study

Background: People with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant. Researchers want to learn how and why this happens. Objective: To study the benefits of treatments that are intended to cure SCD. Eligibility: People aged 18 and older with SCD who are either receiving curative therapy in the next 3 months or don t have any plans to receive a curative therapy in the next 2 years. Design: At their first visit, participants will be screened with their medical history and a physical exam. Participants will then have a baseline visit. This will take about a week to complete and will include: Blood and heart tests MRI of the brain, heart, and lungs. Participants will lie on a bed that will move into the MRI scanner. Special padding may be placed around their head to keep it still. Interactive games. Participants will complete computer games that test memory, attention, problem solving, language, spatial orientation, processing speed, and emotion. Questionnaire rating quality of life Iothalamate test. An IV catheter will be placed into a vein. A contrast agent will be injected through the IV. Blood will then be collected at different time points. Lung function tests and a 6-minute walk test Vibration controlled transient elastography. A probe placed on the abdomen will measure liver scarring. DOS test. A light attached to the finger or toe will measure blood oxygen. Participants will have an end-of-study visit about 2 years after their baseline visit. This will include repeats of the baseline visit tests.

Type: Observational

Start Date: Mar 2022

open study

Background: Researchers developed [11C]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group. Objective: To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE). Eligibility: People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years. Design: Group A: MDD participants will be studied with the same dose of [11C]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with [11C]PS13 and compared to healthy volunteers.. https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988

Type: Interventional

Start Date: Jul 2021

open study

The purpose of this study is to establish differences in the primary outcome of walking dysfunction using the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) and to establish differences in the secondary outcome of HRQoL using the 29-Item Multiple Sclerosis Walking Scale (MSWS-29) between the exercise training intervention condition and the waitlist control condition following the 16-week intervention period.

Type: Interventional

Start Date: Sep 2026

open study

The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Type: Interventional

Start Date: Dec 2025

open study

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Type: Interventional

Start Date: Aug 2025

open study

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Type: Interventional

Start Date: Jul 2024

open study

The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.

Type: Interventional

Start Date: Feb 2025

open study

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.

Type: Interventional

Start Date: Dec 2023

open study

The prevalence of autonomic dysfunction and sleep disordered breathing (SDB) is increased in individuals with spinal cord injury (SCI). The loss of autonomic control results in autonomic dysreflexia (AD) and orthostatic hypotension (OH) which explains the increase in cardiovascular related mortality in these Veterans. There is no effective prophylaxis for autonomic dysfunction. The lack of prophylactic treatment for autonomic dysfunction, and no best clinical practices for SDB in SCI, are significant health concerns for Veterans with SCI. Therefore, the investigators will investigate the effectiveness of mild intermittent hypoxia (MIH) as a prophylactic for autonomic dysfunction in patients with SCI. The investigators propose that MIH targets several mechanisms associated with autonomic control and the co-morbidities associated with SDB. Specifically, exposure to MIH will promote restoration of homeostatic BP control, which would be beneficial to participation in daily activities and independence in those with SCI.

Type: Interventional

Start Date: Oct 2022

open study