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NCT ID: NCT05003791 Completed - Clinical trials for Ischemic Heart Disease

Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease

Hope Beats
Start date: September 1, 2021
Phase:
Study type: Observational

Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability between normal successive heart beats, is a biomarker of both adaptive and maladaptive reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is associated with poor mental health outcomes in persons with IHD. As stated by polyvagal theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in persons with IHD. Decreased PSS has been associated with hopelessness in patients with cancer, but this relationship has not been studied in IHD beyond the applicant's small pilot study of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness about the future, is present in 27-52% of patients with IHD. This is of grave concern, because hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial infarction in patients with IHD, independent of depression. This research focuses on understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-term goal of developing and testing novel interventions to reduce the adverse effects of hopelessness and improve health outcomes in patients with IHD. Participants for this cross-sectional study will be recruited while hospitalized for an IHD event. Participants will include patients who report moderate to severe hopelessness from the sponsor's NIH-funded study (n = 225); additional patients with minimal to no hopelessness will be recruited and enrolled by the applicant (n = 45). Data collection will take place remotely two weeks after hospital discharge. Specific aims include: Aim 1) Evaluate the relationship between HRV and hopelessness in patients with IHD; Aim 2) Determine the relationship between PSS and hopelessness in patients with IHD; and Aim 3) Explore the possible mediating effect of HRV on the relationship between PSS and hopelessness in patients with IHD.

NCT ID: NCT05003778 Completed - Healthy Clinical Trials

Minimal Equipment Training Approach to Improve Warfighter Performance

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

The purpose of this project is to compare a minimal equipment training program with and without blood flow restriction (BFR) training to periodized concurrent resistance and endurance training. The outcomes of interest are Army Combat Fitness Test (ACFT) performance along with laboratory measures of performance, which include body composition, power, strength, and maximal aerobic capacity (VO2max). Additionally, based on the role of mechanical tension in connective tissue adaptation and the importance for chronic musculoskeletal health, tendon architecture will be assessed as well. Lastly, specific blood-based biomarkers will be analyzed in conjunction with questionnaires to determine the systemic physiological and psychological responses to training. Participants will be randomized into one of three training groups and will follow their respective program for 6 weeks. The three groups are traditional concurrent resistance and endurance training, minimal equipment training, and minimal equipment training with blood flow restriction (BFR).

NCT ID: NCT05003687 Completed - Healthy Clinical Trials

Safety and Tolerability of Lu AG06474 in Healthy Young Men

Start date: August 4, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.

NCT ID: NCT05003362 Completed - Migraine Clinical Trials

ACT for High Frequency Migraine; A Virtual Mindfulness Intervention

Start date: October 25, 2020
Phase: N/A
Study type: Interventional

Mindfulness Training specifically for pain to be offered to migraine patients

NCT ID: NCT05003323 Completed - Chronic Pain Clinical Trials

Brain Biomarker of Endogenous Analgesia in Patients With Chronic Knee Pain

Start date: November 18, 2021
Phase:
Study type: Observational

This case-control study in patients with knee osteoarthritis and pain-free control individuals aims to develop a brain biomarker of endogenous analgesia that may be used in subsequent clinical trials. Deficits in central nervous system (CNS) pain inhibition may contribute to chronic pain intensity, but quantitative sensory testing (QST) methods are limited. Incorporating brain imaging to assessments of CNS pain inhibition, by examining activity in relevant brain networks, would allow for an objective, physiologic measure of CNS pain inhibition. Preliminary data in pain-free volunteers implicate cortical activity measured with functional near-infrared spectroscopy (fNIRS) during CNS pain inhibition. Broadly, the investigators hypothesize that variability in CNS pain inhibition contributes to variability in clinical pain intensity.

NCT ID: NCT05003167 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.

NCT ID: NCT05003115 Completed - Clinical trials for End Stage Renal Disease on Dialysis

Motivational Strategies To Empower African Americans To Improve Dialysis Adherence

MoVE
Start date: June 6, 2022
Phase: N/A
Study type: Interventional

This study addresses the need to rigorously advance the science and understanding of the development, feasibility, acceptability and adoption of novel culturally-sensitive motivational strategies to improve dialysis treatment adherence among African Americans with end-stage kidney disease (ESKD). This study specifically aims to: 1. Gain advanced skills in the development and implementation of novel culturally sensitive motivational strategies 2. Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these motivational strategies to improve dialysis treatment adherence.

NCT ID: NCT05003076 Completed - Healthy Clinical Trials

Brain Function and EEG

DEG
Start date: July 1, 2021
Phase: Early Phase 1
Study type: Interventional

In this project, we will examine effects of MA on reward function using electroencephalograms (EEG), which will complement our ongoing study with MA and fMRI. We will determine how MA alters reward-related neural activity and how this is related to its subjective rewarding effects. The effects of MA on reward function will be examined using both reward-task-related activation and resting state activity. We will examine the effects of MA on ratings of drug liking and euphoria, as well as on EEG measures sensitivity to reward. Healthy young adults will undergo three EEG sessions with placebo and MA (10 and 20 mg), while performing the Monetary Incentive Delay task and the Stop Task, as a measure of inhibition. We will examine correlations between the neural responses and subjective responses to MA. Our central hypotheses are 1) that MA will increase feelings of alertness and well-being, and 2) that MA will increase neural responses to anticipation and receipt of reward, and 3) that the effects of MA on mood will be correlated with its effects on neural responses to reward.

NCT ID: NCT05003063 Completed - Attention Clinical Trials

Effects of Acetylcholine and Attention on Visual Spatial Representations in the Brain

Start date: February 4, 2021
Phase: Early Phase 1
Study type: Interventional

This study in, healthy human subjects using fMRI and MRS (magnetic resonance spectroscopy) characterizes, how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Levels of acetylcholine in the cerebral cortex will be enhanced by administration of donepezil, an inhibitor of acetylcholinesterase. Half the subjects will receive donepezil and other half will receive placebo.

NCT ID: NCT05002985 Completed - Dietary Habits Clinical Trials

Tanglewood Trail Walking Program in Rural Kentucky 2020

Start date: May 17, 2020
Phase: N/A
Study type: Interventional

The Tanglewood Trail Walking Program is a well established community health initiative that encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Saturday. The study aims to determine if walking to the market with a community health coach results in healthier options being selected at the market when compared to the driving group.