Clinical Research Directory

Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults

This study is being conducted to assess the effects of the Feel Free® Classic Tonic on stress in healthy adults. The goal is to see whether the tonic can help reduce self-perceived and physiological stress and provide information on how its ingredients are processed in the body.

Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults

This randomized, double-blind, placebo-controlled clinical trial evaluates whether 70 days of daily cranberry juice consumption improves cognitive performance and motor accuracy and reduces psychological and physiological stress responses during a motor-cognitive dual-task multitasking challenge in healthy adults aged 30-55 (Aim 1). It is hypothesized that chronic cranberry juice intake will enhance dual-task performance and attenuate stress reactivity (Hypothesis 1). It is further hypothesized that cranberry juice will mitigate multitasking-related fatigue, mood fluctuations, and cognitive impairment, accompanied by favorable changes in circulating stress biomarkers and stress-regulatory neurochemical pathways (Aim 2/Hypothesis 2). Finally, the study incorporates gut analysis to determine whether cranberry juice induces beneficial shifts in the gut microbiota and microbial metabolites (e.g., SCFAs) and whether these changes are associated with improved cognitive and stress-related outcomes, consistent with a microbiome-gut-brain axis mechanism (Aim 3/Hypothesis 3).

Impact of Indoor Overheating on Physiological Strain in Children

Communities worldwide are experiencing increasing heat extremes that challenge the limits of human thermoregulation, particularly among vulnerable populations such as children. Compared with adults, children are more susceptible to heat related illness due to less efficient thermoregulatory systems and difficulty recognizing early signs of heat stress. In addition, prolonged heat exposure can adversely affect their mental health, contributing to cognitive decline, heightened anxiety, and irritability. As children spend substantial time in hot environments at school and at home, and as these conditions intensify with climate change, actions to safeguard their health are essential. Yet our understanding of heat exposure effects in children remains incomplete, hindering the development of evidence based strategies to protect them. To address this gap, the investigators aim to evaluate whether an indoor temperature limit of 26 °C (45 percent relative humidity), the upper threshold recommended to protect older adults, can effectively prevent dangerous increases in physiological strain and declines in cognitive function in children during a simulated daylong heatwave. The preliminary study will assess physiological and cognitive responses in children aged 10 to 15 years during a 6 hour exposure (approximating a typical school day) to two conditions: (1) the recommended indoor temperature upper limit (26 °C) and (2) a high heat condition representative of homes and schools without air conditioning during extreme heat events (36 °C). In both conditions, children will remain seated at rest while wearing light clothing (t shirt and shorts), with the exception of performing 15 minutes of stepping exercise (6-6.5 METS) each hour (excluding the lunch period) to reflect typical daily activity in a school setting. This experimental design will allow investigators to determine whether maintaining indoor temperatures at the recommended upper limit for older adults sufficiently mitigates physiological strain in children.

Heat Stress in Individuals With Schizophrenia

Schizophrenia is a severe mental illness affecting approximately 24 million people worldwide and is associated with more than double the all cause mortality risk of the general population. Emerging evidence demonstrates that elevated temperatures acutely worsen mental health symptoms and significantly increase the risk of heat related morbidity and mortality. For people living with schizophrenia, prolonged exposure to heat can exacerbate psychiatric symptoms, impair judgment and decision making, and reduce the ability to engage in protective behaviors such as increasing hydration, reducing clothing, improving ventilation, or seeking cooler environments. As a result, individuals with schizophrenia may experience higher rates of heat related illness. To date our understanding of heat exposure effects in individuals with schizophrenia remains incomplete, hindering the development of evidence-based strategies to protect them. Thus, the primary objective of this exploratory study is to gather preliminary data on the effects of indoor overheating on physiological responses (core body temperature and cardiovascular function), cognitive performance (attention, working memory, and reaction time), and mood in adults with schizophrenia. Specifically, we will assess whether maintaining indoor conditions at the upper recommended temperature limit for older adults (26°C, 45% relative humidity \[RH\]; PMID: 38329752) is sufficient to mitigate physiological strain compared with exposure to a hot indoor environment (36°C, 45% RH) representative of non-air-conditioned homes during extreme heat events in individuals with schizophrenia. In both conditions, the individual will remain seated at rest while wearing light clothing (t shirt and shorts), with the exception of performing 15 minutes of stepping exercise (4-4.5 METS) each hour (excluding the lunch period) to reflect typical daily activities of daily living.

Suitability of a 26 °C Indoor Environment for Mitigating Heat Strain in Young Adults

While an indoor upper temperature limit of 26 °C has been shown to protect heat-vulnerable older adults (DOI: 10.1289/EHP11651), this guideline has not been verified in young, habitually active adults. Public health recommendations during hot weather typically emphasize staying in cool environments, avoiding strenuous activity, wearing lightweight clothing, and maintaining adequate hydration. However, young adults may be less likely to follow these guidelines. They often do not reduce their physical activity during extreme heat events and may overdress for fashion, cultural, or religious reasons. These behaviors can impose an additional thermoregulatory burden and lead to greater physiological strain during heat exposure, even though young adults generally have a higher capacity for heat dissipation than older individuals. Accordingly, it is important to evaluate whether an indoor temperature limit of 26 °C is sufficient to protect young, habitually active adults. To address this gap, the investigators aim to assess changes in body temperature and cardiovascular strain in young, habitually active adults (18-29 years) during an 8-hour exposure to the recommended indoor upper temperature limit of 26 °C and 45% relative humidity (humidex of 29, considered comfortable). Participants will complete two conditions: A) seated rest while dressed in light clothing (T-shirt, shorts, and socks), and B) light exercise (stepping to simulate activities of daily living, 4-4.5 METs) performed once per hour (except for the lunch hour) while dressed in light clothing plus an additional insulating layer (sweatshirt and sweatpants). This experimental design will allow investigators to determine the effects of added clothing insulation and light activity-representative of typical daily behaviors-on physiological strain in young adults, and to assess whether refinements to the recommended 26 °C indoor temperature limit are warranted for this population.

Suitability of the 26 °C Indoor Temperature Upper Limit for Older Adults: Impacts of Clothing and Daily Activity

While an upper limit of 26°C has been shown to be protective for heat-vulnerable older occupants (DOI: 10.1289/EHP11651), this recommendation did not consider the added heat burden associated with increases in internal heat production accompanying activities of daily living or the restriction to heat loss caused by clothing insulation. To safeguard the health of older adults, health agencies worldwide recommend the remain in cool space indoors, avoid strenuous activity, wear lightweight clothing, and drink cool water regularly throughout the day. However, older adults do not sense heat as well as their younger counterparts. Consequently, they may not take appropriate countermeasures to mitigate physiological strain from indoor overheating. This may include overdressing despite high indoor temperatures. In other cases, individuals may wear insulated clothing in hot weather to observe cultural or religious modesty requirements, which serve as expressions of faith and identity rather than a tool for thermoregulation. Further, individuals may be unaware of the consequences of increases in physical activity on heat gain and may therefore not adjust their normal day-to-day activity levels to prevent potentially dangerous rises in body temperature. Consequently, this may necessitate a lowering of recommended upper indoor temperature limit during hot weather. To address these important considerations, on separate occasions the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 8 hours to the recommended indoor temperature upper limit of 26°C and 45% relative humidity equivalent humidex of 29 (considered comfortable) while they A) perform seated rest dressed in light clothing (t-shirt, shorts and socks), B) perform light exercise (stepping exercise to simulate activities of daily living, 4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing, C) perform light exercise (4-4.5 METS) every hour (except during lunch hour period) dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants) and D) perform seated rest dressed in light clothing (t-shirt, shorts and socks) and an added clothing layer (sweatshirt and sweatpants). With this experimental design, investigators will assess the effects of added clothing insulation and light activity, representative in activities of daily living on physiological strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required.

Physiologic Burden to the Surgeon During Orthopaedic Surgery

The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.

Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial

Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test an intervention for weight stigma and WBI combined with an evidence-based adolescent weight management program. Eligible adolescents (13-17) will be assigned by chance to one of two groups: 1) a 4-week intervention focused on weight stigma and WBI followed by a 16-week behavioral weight management program; or 2) a 4-week health information control (to include non-weight-related health promotion topics such as smoking and skin cancer prevention) followed by the same 16-week weight management program but without the WBI and weight stigma content. Study outcomes will be assessed at the 4-week and post-treatment (20 week) timepoints.

Influence of Indoor Humidity on Physiological Strain in Older Adults During a Simulated Heat Wave

Laboratory-based studies show that exposure to high humidity can worsen the effects of heat stress in young and older adults by impeding sweat evaporation - the main mechanism by which the human body cools itself. At high levels of humidity, the efficiency of sweating decreases causing a greater rise core temperature and burden on the cardiovascular system. In this context, increasing temperatures and humidity with climate change thus pose a potential compound risk for human health. While humidity's role in heat-health outcomes could substantially alter projections of health burdens from climate change, the impact of humidity on physiological strain in vulnerable people in relation to the indoor environment has yet to be evaluated. In a recent study delineating the physiological effects of the proposed 26°C indoor upper limit (PMID: 38329752), relative humidity was set to 45% in all conditions based on indoor humidity standards by the American Society of Heating and Air-Conditioning Engineers. However, it is unknown whether a refinement of the recommended indoor temperature limit of 26°C is required in situations where humidity cannot be maintained at this level. On separate occasions, the investigators will assess the change in body temperature and cardiovascular strain in older adults (65-85 years) exposed for 10 hours at the recommended indoor temperature limit of 26°C and 45% relative humidity (equivalent humidex of 29 (considered comfortable)) (experimental condition A), to 26°C with a relative humidity of 15% (equivalent humidex of 23 (considered comfortable); humidex is used to measure the perceived temperature taking into account the humidity)) (experimental condition B), to 26°C with a relative humidity of 85% (equivalent humidex of 37 (considered somewhat uncomfortable)) (experimental condition C), and to 31°C and 45% relative humidity with an equivalent humidex of 37 (considered somewhat uncomfortable) that is similar to experimental condition C. With this experimental design, investigators will assess the effects of indoor humidity in driving human heat strain and identify whether refinements in the recommended 26°C indoor temperature limit may be required. Further, by evaluating changes in relation to ambient conditions with a similar humidex, the investigators can assess how individuals perceive and respond to both heat and humidity.

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Parental Stress and Attachment in Preterm Infants

Introduction: Advances in neonatology mean a significant reduction in mortality in premature infants as well as an increase in the risk of morbidity in the medium, short and long term. Furthermore, previous studies have linked prematurity, as an associated risk factor, with possible alterations in the bonding between the child and his or her mother in the first years of life. The possible impact that the stay in the neonatal unit may have on the mental health of the parents is noted. In fact, several studies have shown that the hospital environment of neonatal units may contribute to increased stress and anxiety in mothers. On the other hand, prematurity is one of the causes of referral to Child Development and Early Care Centres, to address their development in the first years of life, as well as for family support. One of the functions of early childhood professionals is to guarantee the development of a secure attachment between the child and his or her caregivers. Little is known about whether maternal stress levels can influence mother-child interactions and thus influence the attachment relationship in the early years of life. Objective: to analyse the association between mothers' stress level due to preterm birth and attendance at a Child Development and Early Care Centre and child development and patterns of mother-child interactions.

Integrated Learning Support System Based on Immersive Simulated Training for Nursing Students

This study aims to evaluate the effectiveness of an Integrated Learning Support System (ILSS) in preparing undergraduate nursing students for immersive simulated training in managing drug-induced nephrotoxicity. The study hypothesizes that the ILSS, which accommodates different learning styles, will be more effective in reducing stress and anxiety compared to the standard learning model (SLM). The research will involve a parallel randomized controlled trial with 96 students from two Brazilian institutions. The students will be divided into control and experimental groups, with the latter using the ILSS in addition to SLM during preparation. The study will assess outcomes such as knowledge acquisition, skill development, and stress reduction using various instruments, including the Lasater Clinical Judgment Rubric and DASS-21. The study's findings aim to validate the ILSS as a tool to enhance learning outcomes and reduce stress and anxiety, thereby promoting better professional development and patient safety in nursing practice.

Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening Programs

The communication of an altered Pap smear or positive HPV test has a strong impact on patients on a psychological level. HPV positive women are more likely to have higher level of stress, anxiety, depression and impaired sexual life. The examiner want to establish this impact through different surveys (DASS-21 (Depression Anxiety Stress Scales); PCL-5 (Posttraumatic Stress Disorder Checklist); DTS (Dyadic Trust Scale), CDDQ (Cervical Dysplasia Distress Questionnaire) and MPI (Match Patient Inventory) from the moment the patient receives the news until after completing treatment for her intraepithelial neoplasia.

A Health Apps for Post-Pandemic Years for People With Physiological and Psychosocial Distress

The negative impacts on physical and psychological health brought by COVID-19 seem to perpetuate in the post-pandemic era. It is estimated that there will be an impending mental health crisis in the general population in the aftermath of the pandemic due to the delayed negative impacts of COVID-19 and the associated non-pharmaceutical public health interventions such as social distancing, quarantining, and lockdown. Smart Health, defined as the provision of medical and public healthcare services by using mobile technologies, is a cost-effective and easily operated intervention that can provide various functions and can bring significant changes in people's health behaviour, such as prompting them to adopt a physically active lifestyle. Despite the rapid growth of digital health technology, most of them were developed during pandemic with a focus on delivering non-systematic, general virtual healthcare to people. The aim of this study is 1) to develop a Health Apps for Post-Pandemic Years (HAPPY) driven by the Transactional Model of Stress and Coping Theory, and 2) to evaluate its efficacy of alleviating people's physiological and psychosocial distress during post-pandemic era. A total of 814 eligible participants, both COVID-19 victims and non-COVID-19 victims exhibiting physiological and/or psychosocial distress during post-pandemic era, will be recruited and randomized to either the experimental or the waitlist control group. The experimental group will receive a 24-week intervention combined with an 8-week regular supervision phase plus a 16-week self-help phase. Participants will receive different coping strategies, namely physical training, energy conservation techniques and mindfulness-based coping in the intervention hub at Level 2 based on participants' assessments at Level 1, and enhance self-management at Level 3. Participants' physical activity levels will be measured using commercial wearable sensors. The waitlist control group will receive materials on the promotion of physical and psychological health during waiting period and receive the same intervention as the experimental group in week 25. It is hypothesized that the experimental group will exhibit milder symptoms of physiological and psychosocial distress, and have a more positive appraisal mindset, greater self-efficacy, and more sustainable self-management ability than participants in the waitlist control group.