21 Clinical Trials for Various Conditions
The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.
The overall objective for this clinical trial is to provide evidence for internal and external cueing for physical therapists and other rehabilitation clinicians to optimize resistance training within rehabilitation for older adults. The main questions it aims to answer are: * What is the impact of external focus (providing velocity of movement for each repetition) compared to internal focus (i.e., no cues, control group) on physical percent velocity loss and neuromuscular activation in older adults with sarcopenia? * Does internal and external focus influence motivation and perceptual workload following resistance training in older adults with sarcopenia? Researchers will compare external focus to internal focus to see if external focus impacts percent velocity loss, motivation, and perceived workload. Participants will: * Visit the lab once per week for 3 weeks * Perform exercise testing using a leg press * Answer questionnaires regarding perceived workload and motivation before and after exercise
The purpose of this community-engaged project is to examine how taking part in different arts (dance \& music), compared to control (no arts) affects older adults' Health-Related Quality of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social engagement (National Social Life, Health, \& Aging Project-NSHAP survey), and perceptions of self (focus interviews).
The goal of this application is to test whether menthol and fruit flavors impact e-cigarette use through dissociable mechanisms and exert their effects differentially across nicotine doses.
The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.
To evaluate the effects of exam preparation on anxiety level, self perception, ocular symptoms and oculomotor responses in myopes
This study will use functional magnetic resonance imaging (MRI) to examine loss of balance in the elderly. Falls due to balance problems are a major health issue in older people, often resulting in bone fractures and other bodily injuries, and in functional decline. Risk factors for falling in the elderly include some standing positions in which older people usually experience balance problems, such as leaning forwards or backwards. Functional MRI records brain function while the subject performs a task, such as moving a limb or speaking, and detects changes in the brain regions involved in those tasks. This study will look at different brain areas to see which areas might control what people see around them while they are standing. Healthy normal volunteers between 20 and 90 years of age may be eligible for this study. Candidates must be in good health, have no difficulties in performing activities of daily living, and be able to walk for at least 400 meters (1/4 mile). They will be screened with a medical history and physical examination. Participants will undergo functional MRI while performing visual recognition tasks in two experiments, described below. For the MRI procedure, the subject lies in the MRI scanner, a narrow metal cylinder containing a strong magnet, for 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. The experiments are as follows: Experiment 1 During MRI scanning, the subject watches computer-generated movies of a person leaning forwards and backwards. When the subject recognizes an unstable body position in the movements, he or she presses a computer mouse. Experiment 2 During MRI scanning, the subject watches still pictures of people leaning in stable and unstable postures and presses a button as soon as he or she recognizes that the posture is unstable.
Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.
The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx/Hispanic families. The main questions it aims to answer are: * Does this enhanced intervention change children's diet quality? * Does this enhanced intervention change parental feeding practices? * Does this enhanced intervention change the availability of healthy foods in the home? Participants will: * Work with a support coach * Have a home visit with a support coach once a month, for three months * Have a phone call with a support coach once a month, for three months * Receive written materials and text messages over the six months Researchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.
The purpose of this study is to evaluate the efficacy of three, brief (10-minute) theory-guided video chats for increasing self-efficacy for lifestyle physical activity versus a time-matched video chat comparison group designed to increase self-efficacy for work-life balance. Participants will include individuals who are low-active, full-time (\>35 hours/week) working adults.
This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products.
One method of breast cancer screening involves radiologists reading digital tomosynthesis (DBT) images. DBT consists of a 3D stack of x-ray "slices" through the breast. The exam is accompanied by a 2D image like a standard mammogram, a single x-ray of the breast. In a screening setting, most cases are normal. Sometimes it is obvious that a case is normal from a quick look at the 2D image. It would speed up the process of screening if readers could dismiss a clearly normal case on the basis of the 2D image, alone, without looking at the DBT images. Obviously, the investigators would only want to "triage" cases in this way if the investigators were almost perfectly sure that no cancers would be missed. In this study, the investigators look at radiologist's willingness to triage cases and on the accuracy of their answers. In addition, the investigators ask about the impact of an Artificial Intelligence (AI) opinion. Would it be possible to triage an image on the basis of the AI opinion, alone? Radiologists will look at each case for up to five seconds and offer an opinion (on a 1-10 scale) about how sure they are that a case is normal. Next, they will see the opinion of the AI. Finally, they will say (using a 1-10) scale, how willing they would be for the AI to triage this case without human intervention. This study is the start of an effort to understand the conditions under which radiologists might be willing to declare a case "normal" with little or no human examination.
Self-production facilitates acquisition of spoken words, signs, and characters from an unfamiliar second language. The proposed work investigates how motor cortex, a key part of the brain enabling body action, supports their acquisition via production as well as perception, providing insight into whether they are learned via mental simulation of the body actions used to produce them. It is hypothesized that activity in motor cortex will differ based on the body part used to produce lexical items (e.g., mouth vs. hands), will be greater for lexical items learned via production than observation, and will differentiate lexical items recognized successfully vs. unsuccessfully.
Older asthmatics have considerably worse outcomes than younger patients with asthma. In this study, the investigators will evaluate the role of symptom perception as a key determinant of poorer outcomes and lower adherence to asthma self-management behaviors among older asthmatics. The proposed study is significant for its potential to greatly advance understanding of the mechanisms related to worse outcomes in older adults, and it will provide actionable data for new interventions to improve self-management.
Pain is a predominant disruption of well-being among humans. Feeling pain is a multimodal sensory experience where information is collected and processed from various senses such as sight and touch. Because pain is complex, variable, and experienced differently by each individual, finding more accessible and practical treatments for pain are necessary. Mindfulness meditation (MM) aims to reduce pain by directing focus to perceive thoughts through non-judgmental awareness. Positive reappraisal (PR) is a possible cognitive pain treatment that focuses on changing the meaning of stressful or negative events into positive, benign, valuable, or beneficial. When a stressful event, such as experiencing pain, is positively reappraised, the individual recognizes and engages with the feeling of stress produced by the event and intentionally looks for benefits that change the feeling from negative to positive. The focus of this study is to examine the effect of different cognitive techniques on multimodal innocuous and noxious stimuli. Visual and tactile noxious stimuli will be administered to determine how visual cue integrate to form and modulate the subjective experience of pain. The study team postulates that mindfulness meditation and positive reappraisal will significantly reduce pain in response to multimodal stimulus (visual cue + noxious heat) when compared to a non-manipulation control condition. These findings will be utilized to better understand the multidimensional mechanisms supporting nociception and the cognitive modulation of pain.
Many children (age 3-6) living in the Mountain West (MW) region face unique challenges that can affect their health and welfare, such as lower socioeconomic status, and limited access to healthcare and education. The proposed project aims to address those health and education gaps by improving children's self-regulation (i.e., the ability to control emotional and behavioral impulses), a critical cognitive skill that underpins future mental health and academic achievement. The project will test the effectiveness of an innovative intervention mechanism, the Emotive Intelligent Space (EIS). The EIS consists of two adjacent 3 x 5 sq. ft. wooden wall panels with colored LED lights, creating a 90-degree semi-private space. The adaptable colored lightings are controlled by a machine learning algorithm that is developed based on a co-investigator's prior study. The EIS harnesses the power of artificial intelligence to detect children's emotions from physiological data in real-time and to translate physiological signals into environmental changes (i.e., adaptable colored lighting) that adequately respond to children's emotions, resulting in improved self-regulation, physiological stress responses, and cognitive performance. The objective of this proposal is to determine the effect of EIS on children's (age 3-6) self-regulation, physiological, and cognitive outcomes by employing a repeated ABAB experimental design (A = no intervention, B = EIS intervention). The hypothesis is that EIS will positively impact children's self-regulation, physiological stress response, and cognitive performance. Based on a priori power analysis, 40 preschool and kindergarten children will be recruited from early childhood programs in the rural areas near Moscow, ID. During the experiment, children will be assessed under a combination of A and B conditions. A digital wristband will capture children's real-time physiological responses (i.e., Galvanic skin response, body temperature, and blood volume pulse). A machine learning algorithm will immediately translate the physiological data into three basic emotions (i.e., happy, angry/fearful, sad) represented by children's choice of colors on the EIS. A series of ANCOVA analyses will be used to determine the mean differences in self-regulation, physiological, and cognitive scores under baseline and treatment conditions.
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.
The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents. A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor. Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results. The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.
The study is a multi-site, double blind, parallel arm, community-based randomized controlled trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase receipt of dental care among inner-city urban and rural elementary school children who were screened at school and have restorative treatment needs. The study has 5 arms: The experimental intervention is the use of a theoretically driven CSM referral letter alone, the letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a reduced CSM referral letter plus a reduced Dental Information Guide. The control strategy is the use of a standard referral letter. All participating K-4 grade children will receive a screening at the beginning of the school year and at the study end point 7 months later to determine if the child received dental care. Due to lower than expected enrollment in both the Ohio and Washington sites, a second year of recruitment was added to include Bedford School District and East Cleveland School District (only KG and other grades if they did not enroll in the first year). The same study procedures, schedule and design was utilized for the second year of recruitment. The primary aim is to evaluate the effectiveness of experimental (new) versus standard referral approach given to parents/caregivers in increasing receipt of dental care among their children in grades K-4. The secondary aim is to assess changes in parent/caregiver illness representation/perception and behavioral intention between enrollment (beginning of school year) and follow-up (end of school year) to understand the underlying mechanisms of the new vs. standard referral approach that result in receipt of dental care. The hypothesis is that CSM-based interventions will increase receipt of dental care compared to the standard referral letter.
Aims of this study are: 1. To determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma. 2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy, perception of barriers, and self-management behaviors, asthma control and quality of life over time among peer leaders. 3. To test the following hypothesis: * Adolescents participating in a peer-assisted asthma camp program will report improved knowledge, attitudes toward asthma, self-efficacy, and self-management behaviors, decreased perception of barriers, and increased asthma control and quality of life at 3-, 6- and 9-months post-intervention compared with the adult-led camp group. 4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic status, race, illness status, family support) on intervention outcomes such as self-management behaviors, asthma control and quality of life in adolescents with asthma. 5. To examine the effect of the peer-assisted camp program on self-reported health care utilization including emergency department visits, days of hospitalization, outpatient visits by comparing between baseline and 9-months post-camp data and between the peer-led camp and the adult-camp programs.