40 Clinical Trials for Various Conditions
Over recent years, military service women have shown increasing interest in utilizing long-acting reversible contraceptives (LARCs; i.e., implants or intrauterine devices, IUDs). While clinically, LARC have been proven safe and effective at preventing pregnancy \& decreasing menstrual symptoms, it is unclear what impact this type of contraceptive may have on physiological responses to extreme environments (heat, cold and high altitude). Additionally, iron deficiency and iron deficiency anemia are prevalent in U.S. military women which likely affect health and performance. There is evidence to suggest that the prevalence of iron deficiency and iron deficiency anemia is lower in women utilizing LARCs, which preserve iron stores, likely due to reduced menstrual blood loss that compounds with each cycle over the course of months. Due to the increasing interest in the utilization of LARCs it is important to understand what, if any, impact these methods of contraception may have on a female Soldier's physiological responses. The overall goal of the present study is to characterize iron status and physiological responses (including but not limited to sweating, skin blood flow, ventilation, and heart rate) to extreme environmental stressors of heat, cold and high altitude (i.e. hypobaric hypoxia) in women utilizing LARCs. Up to thirty-three individuals (n=18 LARCs, n=15 monophasic oral contraceptives) will complete testing visits separated by at least 48 hours for environmental testing visits. During heat stress testing, measures of core body temperature, skin temperature, and sweat rate will be measured during a standardized protocol in hot, humid conditions. During cold stress, measures of body core temperature, metabolic heat production, skin blood flow and temperature (at both distal extremity and proximal body sites) will be assessed in order to better quantify the impact of exogenous sex hormones via LARCs and OCs in volunteers exposed to the cold. Measurements will be obtained during a standardized protocol in cold air (\~90 min; 10°C). For altitude, cardiopulmonary responses will be assessed during rest and exercise during an acute altitude exposure (4300m). Blood samples will be collected throughout the investigation in order to quantify sex hormone concentrations, iron status, and inflammatory biomarkers in response to environmental stressors. The investigators will also utilize laboratory tests (i.e., carbon monoxide (CO) rebreathing technique) and collect blood samples to quantity iron stores in these groups of women. To characterize iron status, the Soldier Performance Health and Readiness (SPHERE) epidemiological data repository will be utilized to quantify the prevalence of iron deficiency and iron deficient anemia diagnoses between women using LARCs and women not utilizing LARCs.
Exertional heat stroke (EHS) affects \~500 Military Personnel and over 100 Soldiers every year, and it is believed that these numbers are underreported. EHS is the most severe form of exertional heat illness (EHI) and can result in substantial, long-lasting organ damage, and even death in severe cases. Based on current knowledge and training needs, it is impossible to prevent every EHS - which shifts the focus from exclusively prevention to a combination of prevention, treatment, and enhancing recovery as much as possible. While many risk factors have been identified and there are adequate treatments available, biomarkers associated with heat stroke risk, recovery, and return-to-duty (RTD) remain largely unclear. The purpose of the proposed study is to enhance knowledge surrounding biomarkers of EHS and long-term health consequences that result from EHS. The investigators will recruit research volunteers for a field study in order to collect pre-, post-, and follow-up measures from a high-risk EHS event (i.e. ruck marches, timed runs) this will allow us to have a basis for comparison between Soldiers who collapse with EHS (from previously collected data) and those that complete high-risk events, but do not collapse. This will allow for comparison between the groups to identify EHS-specific biomarkers that could aid in recovery and RTD decisions for Soldiers.
The goal of this pilot study is to test the feasibility of assessing how biological factors and chemical properties of sugars may influence metabolism and food reward in humans. The main questions it aims to answer are: * Can differences in appetitive responses and neural activations to sucrose (table sugar) and its chemical components (glucose and fructose) be measured and quantified? * Are there detectable differences in how combinations of sugars and non-nutritive sweeteners commonly found in our food supply influence appetitive responses and neural activation? This study is a crossover design, meaning every participant will complete every condition. Participants will consume beverages containing sucrose, glucose, or fructose, which are each novelly flavored, 6 times within a week. During one of the consumption times, energy expenditure, carbohydrate oxidation, and blood glucose will be measured in the lab before and for 2 hours after consumption. After participants have consumed each condition, they will undergo a tasting task in the MRI scanner, neural responses to receipt of the beverages are measured. Another group of participants will undergo the same study design but with sucrose, high fructose corn syrup, or sucrose + non-nutritive sweetener as the conditions.
The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.
The optimal recovery duration depends on the intensity of exercise and in the present study the intensity was maximal power for 4-s while cycling an 'Inertial Load' ergometer (ILE). Recovery duration of 15, 30 and 45-s were given between 30 successive sprints.
The study design is to assess the between groups factor (controls, chronic pain, addicted individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a longitudinal component to assess stress, pain and addictive behaviors in daily life.
This device-study includes a pilot, physiological investigation of normal human subjects. The aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry as measured by EEG recording. Currently, the application of non-invasive neuromodulation is rarely guided by detailed knowledge of how neural activity is altered in the brain circuits that are targeted for intervention. This gap in knowledge is problematic for interpreting response variability, which is common. To address this gap, the current proposal aims to combine two forms of neuromodulation sequentially, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at different frequencies of rTMS. Homeostatic plasticity, the initial activation state of a targeted circuit, is a key determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD) Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. We aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The protocol included an exploratory aim to examine physiological changes in patients with tinnitus but this aim was not part of the pilot physiological investigation and it could not be completed due to funding limitations.
This study will evaluate the effects of Mindfulness-Based Stress Reduction (MBSR) on physiological reactivity. This study will focus on individuals with anxiety who will participate in an 8-week MBSR class. The investigators will test participants' reactivity to both predictable and unpredictable stimuli before and after the class to understand the physiological changes that may occur after to the intervention. Secondary measures include psychometric instruments and a delay discounting task.
Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests. ...
A variety of medications have been used to treat the anxiety, discomfort, and fear associated with continuous and sudden episodic breathlessness in patients with advanced respiratory disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed for this distressing symptom. Clinicians are concerned about the adverse effects of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines. Recent studies have shown that benzodiazepine use is associated with adverse respiratory outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD). Dexmedetomidine may be an alternative to current drug therapies for breathlessness. Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive dysfunction. The drug can be administered intranasally (IN-DEX) to induce light to moderate sedation of several hours duration. The objective of the research is to assess the dose dependent safety and efficacy of intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable patients with severe COPD. This will be accomplished in a staffed acute care setting with routine vital signs monitoring and continuous pulse oximetry. Patients will be assessed objectively and subjectively for their level of sedation by validated sedation scales. The study is an extension of a similarly designed pilot study which did not include a placebo comparison. Results of the study will be helpful to design additional trials with intranasal dexmedetomidine in acutely symptomatic COPD patients, exertional dyspnea and exercise performance, and dyspnea treatment comparisons.
Cortisol is essential for survival. The importance of cortisol response is most apparent in patients with partial or complete deficiency of glucocorticoids during stressful events such as illness or surgery.
UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with internet access, are not pregnant, planning to become pregnant, or currently breastfeeding (if female), to participate in a study investigating whether real-world experiences alter the brain and body. This study takes place over an eight week period and involves providing the names of 8 close friends or family members, completing a neuroimaging session, providing blood and saliva (for genetic analysis), and a 6-week period in which participants login twice a week to complete online questionnaires. Compensation is up to $210 for those who complete all aspects of the study. Please email realworld.ucla@gmail.com for more information.
This study is ancillary. Participants will be recruited as part of a separate clinical trial on effects of two intensive behavioral training programs that evaluates feasibility and efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to compare the effect of MT to that of traditional CBT on a physiological marker of stress, salivary cortisol concentration, and physiological responses to smoking cues in tobacco smokers. The investigators will use electrophysiological reactivity to smoking cues in the form of audio recordings of personalized scripts describing the scenarios associated with the strongest urges to smoke that will provide a physiological validation to a behavioral intervention. The investigators will also explore correlations between these biological markers and self report of stress, craving and negative affect to supplement self report and behavioral outcome measures with biological and physiological markers to represent improvement attributed to the intervention.
This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.
Assessment of sensor parameter in patients with heart failure.
Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Little is known regarding the relationship between perceived and physiological exertion in adolescents. The purpose of this study is to investigate the association between physiological and perceptual markers of effort during exercise and the relationship of these markers to other health-related behaviors in healthy weight and obese adolescents.
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high fat/carbohydrate meal.
The purpose of this research is to study the efficacy of an intervention that could interrupt the cycle of emotion dysregulation as it relates to cravings and negative emotions for those with problematic substance use behaviors. This will be a quantitative randomized control trial study with data collection at three points: pre-intervention, post-intervention, and same-day follow up. This study will be conducted at the Inova Behavioral Health Merrifield Center. Inova's addictions services program is the CATS program (formerly comprehensive addiction treatment services), which provides therapeutic interventions for those managing substance use disorders. The focus of measurement will be about the current state of the participant, and not a cumulative status. This one-session intervention. The goal is to have 96 participants in the study, 48 in each of the two groups.
The purpose of this study is to examine the effect of a moderately low blood sugar stress on the nervous system. The investigators hope that information obtained from completing this study will help to reveal information about how a non-psychological stress impacts the parts of the brain that react to stress and the autonomic nervous system. The autonomic nervous system is the part of the nervous system that provides the body with involuntary or automatic control of heart rate, blood pressure, and breathing.
The proposed study aims to investigate experimentally anxiety sensitivity and physiologic sensations associated with anxiety using a paradigm combining hydrocortisone, caffeine, and a set of social stress challenges. Following informed consent, participants will be instructed to ingest either 400 milligrams of caffeine (an amount of caffeine roughly equivalent to that in two 8 oz. cups of brewed coffee from Starbucks), and 20 milligrams of hydrocortisone or two placebo capsules via stratified, random assignment. Physiologic and self-reported measures of stress and anxiety will be taken.
The purpose of this study is to investigate the acute effects of different intensities (i.e., 50, 75, and 100% of maximal anaerobic power) of 4-s sprint interval exercise on physiological responses. Secondly, it will determine the relationship between intensity and recovery duration (i.e., 15, 30, or 45-s) that will stimulate the cardiovascular and metabolic systems.
The purpose of this study is to determine if drinking proprietary water (PW) during a standardized daily plan as compared to distilled water (control) and carbohydrate-electrolyte (CE) drink can improve hydration status over time. Another purpose is to determine if PW, as compared to control and CE, can improve hydration status, perceptual responses, physiological responses, and cognition measures in a heat stressful environment. Healthy, physically active males and females aged 18 to 50y will be recruited for the study. Participants will be randomized into one of three groups: PW, CE, or Control. The participant will be given a daily standardized plan integrating their assigned fluid into daily hydration habits for five days. Participants will provide their first-morning urine sample, keep a daily food log, and answer questions about their perceptions of hydration. After the five days, they will participate in a treadmill exercise protocol within a warm environment (heat chamber). Multiple physiological, perceptual, and cognitive measures will be obtained while participants exercise and then recover.
BHSAI is developing a computational system that provides early alerts of a rise in core body temperature to help reduce the risk of heat injury in the field and during training. The goal of the body temperature alerting system is to use it during rest, exercise in the heat and during body cooling. Using this system during cooling will allow healthcare professionals and military personnel monitor core temperature to ensure cooling is effective (and prevent hypothermia). Therefore, the primary purpose of this investigation is to validate a body temperature alerting system using physiological responses that occur during rest, exercise in the heat and during body cooling. Multiple cooling modalities will be validated. This study is expanding on a previous intervention IRB#H20-0010 (BHSAI Cooling Study), but will examine body cooling during more intense exercise and while cycling. We will also examine the effectiveness of each cooling modality (passive cooling, mist-fan cooling, hand/forearm immersion, ice towel) on physiological variables after exercise in the heat.
This randomized cross-over study compares two identical cardiorespiratory exercise bouts, differing only in the inclusion or exclusion of a dynamic period of increasing exercise intensity prior to the exercise bout. Planned comparisons include physiological responses and perceived effort during exercise, leukocyte mobilization, and mood between the two exercise sessions.
This study is a randomized controlled trial designed to evaluate changes in reaction times (RTs) and response times (RespTs) following chiropractic treatment compared to controls in the Special Forces Qualified (SFQ) population, including Special Operation Forces who are part of the 160th SOAR regiment on flight status.
To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.
The purpose of this study is to assess the health and performance outcomes associated with supplementation of Veillonella atypica.
The objective of this study, named THRIVE (The Research In Virtual Environments Study), is to test hypotheses for how neighborhood environments influence stress and emotion, as a mechanism by which they may influence health. Neighborhood environments may have both acute influences on stress-related processes, but also may have lifespan effects due to the chronic, cumulative effects of repeated exposures and the long-term toll of adapting to adverse neighborhood environments. However, assessing neighborhood influences on stress and emotion is methodologically challenging. This study develops such a novel, alternative approach to address these questions by deploying a virtual reality (VR) based model of neighborhood disadvantage and affluence that creates an immersive experience approximating the experience of being in different neighborhoods. In this study, this model will be applied to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range of disadvantaged and affluent neighborhoods. The proposed study will employ a randomized experiment (n = 65 per condition), with online questionnaires and a single study session, to determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in habituation or sensitization to different neighborhood characteristics; and (3) if chronic stress results in habituation or sensitization to different neighborhood characteristics. This research will develop an innovative methodology that will help establish the role that neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic stress and chronic neighborhood exposures. In addition, it will help establish a method that can be utilized more broadly to study contextual and social environmental influences on psychological and biological risk in adolescence.
To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.