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37,469 result(s) for "pilot study"
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Efficacy and safety of intranasal insulin on postoperative cognitive dysfunction in elderly patients after laparoscopic radical resection of colorectal cancer: a double-blind pilot study
To evaluate the efficacy and safety of intranasal insulin on postoperative cognitive dysfunction (POCD) in elderly patients after laparoscopic radical resection of colorectal cancer. Older patients scheduled for laparoscopic radical resection of colorectal cancer at Beijing Luhe Hospital, Capital Medical University, between August 2023 and November 2023, were enrolled in this double-blind pilot study. Patients were randomized to the control and insulin groups at a 1:1 ratio. The primary outcome was the rate of POCD at postoperative 7 days. A total of 61 patients (30 in the insulin group) were analyzed. The insulin group had a significantly lower POCD rate compared with the control group at postoperative day 7 [4(13.3%) vs. 12 (38.7%),  = 0.024]. The serum levels of IL-6, TNF-α and S100β at T in the insulin group were significantly lower than those of the control group (IL-6: mean difference at T , -4.14,  = 0.036; T , -3.84,  = 0.039; T , -3.37,  = 0.013; T , -2.57,  = 0.042; TNF-α: mean difference at T , -3.19,  = 0.002; T , -2.35,  = 0.028; T , -2.30,  = 0.019; T , -1.96,  = 0.0181; S100β: mean difference at T , -8.30,  = 0.019; T , -23.95,  = 0.020; T , -20.01,  = 0.023; T , -17.67,  = 0.010). No insulin allergic reactions, nasal irritation, or hypoglycemic reactions were observed in either of the groups. Intranasal insulin may decrease the risk of POCD and inhibit the elevated serum IL-6, TNF-α, and S100β levels in elderly patients after laparoscopic radical resection of colorectal cancer, which proves that intranasal insulin may be a promising therapeutic option for POCD. Identifier, ChiCTR2300074423.
A Pilot Study Evaluating the Feasibility and Efficacy of an In-Home Resonance-Based Electromagnetic Field Protection Device on Improving Markers of Health and Cognitive Function Among a Sample of Healthy Adults
The dramatic increase in exposure to non-native sources of electromagnetic fields (EMF) in recent years has given rise to numerous human health concerns. The near pervasive exposure to radiofrequency (RF) emanating from wireless technologies inside the home (e.g., cell phones, wireless routers, \"Smart\" devices) and outside of the home (e.g., cell towers, automobiles, computers at work, tablets at school) is particularly troubling. While epidemiological studies are somewhat conflicting to date, RF exposure is currently classified by the World Health Organization as a Class 2B carcinogen. Mechanisms of activity of the deleterious effects of RF exposure on human health include the generation of excessive oxidative stress, chronic inflammation, and disruption of the production of melatonin and other hormones, all of which are believed to be due largely to the activation of voltage-gated calcium channels (VGCC). Mitigation strategies are currently generally limited to wireless device hygiene (e.g., hard-wired ethernet, turning off wireless routers at night, keeping cellphones away from the body) and metal-based shielding in the home, which can be expensive and not feasible for many. The goal of this pilot and feasibility trial was to evaluate the feasibility and preliminary signs of efficacy of an in-home resonance-based electromagnetic field protection device (BluShield) on various physiological and patient-reported outcomes commonly affected by excessive RF exposure. A sample of relatively healthy adults was enrolled in a single arm, 12-week pilot and feasibility study. The intervention consisted of plugging in the BluShield device at home or at the participant's residence when traveling. Outcomes included laboratory panels assessing overall physiological health (CBC & CMP), blood markers related to inflammation, oxidative stress, DNA damage, and cellular senescence (Jinfiniti), a high-resolution genome-wide assessment of DNA methylation (TruDiagnostic), a validated questionnaire to assess cognitive function (CNS - Vital Signs), a wearable device to assess sleep and other physiological parameters (Oura ring), and a single-item assessment of overall health. Outcomes were compared before and after the intervention with paired tests or Wilcoxon signed rank tests, depending upon the distribution of data. 25 participants enrolled in the study. All participants reported compliance with the EMF mitigation device throughout the course of the study, and no adverse events were reported. There were limited changes in conventional labs (decrease in glucose, increase in monocytes; < .04]), but modest improvement in self-reported health ( = .02), improvements on numerous domains of the CNS - Vital Signs questionnaire (Composite Memory, Cognitive Flexibility, Executive Function, and Processing Speed; < .02), wearable device parameters (deep sleep, heart rate variability, resting heart rate, and body temperature; < .04), and perhaps most interestingly, hypermethylation of genes involved in RF exposure (including a key VGCC gene [ ]; = .000045). The use of the BluShield is feasible and revealed improvements in some markers of sleep, cognitive function, and overall health. These improvements may be due in part to suppression of VGCC activity, which previous literature has demonstrated is activated by RF exposure and can generate oxidative stress and inflammation. An RF mitigation strategy should focus primarily on limiting modifiable exposures within the home, and the device appears to be a promising component of a comprehensive approach.. Controlled studies are needed to mitigate potential sources of confounding in this single-arm pilot study. A specific focus among populations with excessive RF exposures that are not modifiable within the home, such as those living in high-density urban settings, in close proximity to cell towers, or certain occupational hazards, also appears warranted.
Comparative evaluation of intubation performances using two different barrier devices used in the COVID-19 era: A manikin based pilot study
Background and Aims: Protection of anaesthesiologists from contaminated aerosols of COVID 19 patients during endotracheal intubation has spurred the development of barrier devices like aerosol boxes and clear transparent plastic sheets and usage of videolaryngoscopes in COVID 19 patients. However, the efficiency, feasibility and difficulties faced by anaesthesiologist while performing endotracheal intubations under barrier devices require scientific validation. This manikin-based pilot study aims to assess the laryngoscopic performances of experienced anaesthesiologists under two different barrier enclosures. Methods and Materials: 53 anaesthesiologists (14 Consultants and 39 Senior Residents) who were undergoing an airway training module as a part of preparedness for handling the COVID 19 pandemic were recruited. Using an aerosol box over a manikin, the participants attempted intubation using a Glidescope Videolaryngoscope and Macintosh laryngoscopes (GA and MA Groups). Subsequently, intubation was attempted under a transparent plastic sheet using both laryngoscopes (GP and MP groups). Time required for intubation, first pass success rates, subjective ease of intubation and the feedback obtained from the participants were recorded and analysed. Results: Time required for accomplishing successful intubation was 38.55 ± 12.16 seconds, 26.58 ± 5.73 seconds, 46.89 ± 15.23 seconds and 37.26 ± 8.71 seconds for GA, MA, GP and MP groups respectively. Time for intubation and difficulty (VAS) was least for Macintosh group with aerosol box (MA) and maximum time was taken in Glidescope group with transparent polythene drape (GP). First attempt success rate for Glidescope groups (GP and GA) were 100% and in MA and MP group was 98% and 96% respectively. Restriction in hand movement and stylet removal were the major difficulties reported Conclusion: Longer intubation times were observed while using Glidescope Videolaryngoscopes with either of the two barrier devices in place compared to Macintosh laryngoscopes.
Feasibility and acceptability of design and conduct of a registry-based randomised clinical trial evaluating eVIS as a digital support for physical activity in interdisciplinary pain rehabilitation programs: A randomised pilot study
Background Patients with chronic pain often struggle to engage in physical activity despite its health benefits. The eVISualisation of physical activity and pain intervention (eVIS) was developed to support adherence to physical activity plans in Interdisciplinary Pain Rehabilitation Programs (IPRPs) by visualising activity, pain levels, pain interference, and pharmacological use. This pilot study assesses the feasibility and acceptability of trial design and trial conduct of a registry-based randomised clinical trial (R-RCT). Method This randomised clinical pilot study included the first 10% (n = 39, mean age 43.5, 74.4% females) of the R-RCT sample (n≈400). Participants with non-cancer chronic pain from six IPRP units were randomly assigned to either the intervention group (IPRP + eVIS, n = 19) or the control group (IPRP, n = 20). Feasibility and acceptability were evaluated using pre-defined criteria on recruitment- and data collection procedures (e.g., inclusion rates, representativeness, adverse events), physiotherapists’ ratings of trial design and conduct (e.g., acceptability, feasibility), and outcome data characteristics and completeness (e.g., adherence, data accessibility). Results Recruitment was largely feasible, though attrition differences and the need for refined eligibility screening were noted. Physiotherapists cited time and implementation challenges. Both groups had satisfactory data completeness, but the control group showed lower adherence to daily reporting in the final third of the study. The intervention group had greater improvements in physical health, with 19.5% more participants achieving the minimum clinically important difference (≥3) on the physical component summary scale (PCS). No adverse events occurred. Conclusion With minor adjustments, the R-RCT design is mostly feasible, though some challenges to feasibility were identified and addressed.
On the Consistency of 360 Video Quality Assessment in Repeated Subjective Tests: A Pilot Study
Immersive media such as virtual reality, augmented reality, and 360◦ video have seen tremendous technological developments in recent years. Furthermore, the advances in head-mounted displays (HMDs) offer the users increased immersive experiences compared to conventional displays. To develop novel immersive media systems and services that satisfy the expectations of the users, it is essential to conduct subjective tests revealing users’ perceived quality of immersive media. However, due to the new viewing dimensions provided by HMDs and the potential of interacting with the content, a wide range of subjective tests are required to understand the many aspects of user behavior in and quality perception of immersive media. The ground truth obtained by such subjective tests enable the development of optimized immersive media systems that fulfill the expectations of the users. This article focuses on the consistency of 360◦ video quality assessment to reveal whether users’ subjective quality assessment of such immersive visual stimuli changes fundamentally over time or is kept consistent with each user having their own behavior signature. A pilot study was conducted under pandemic conditions with participants given the task of rating the quality of 360◦ video stimuli on an HMD in standing and seated viewing. The choice of conducting a pilot study is motivated by the fact that immersive media impose high cognitive load on the participants and the need to keep the number of participants under pandemic conditions as low as possible. To gain insight into the consistency of the participants’ 360◦ video assessment over time, three sessions were held for each participant and each viewing condition with long and short breaks between sessions. In particular, the opinion scores and head movements were recorded for each participant and each session in standing and seated viewing. The statistical analysis of this data leads to the conjecture that the quality rating stays consistent throughout these sessions with each participant having their own quality assessment signature. The head movements, indicating the participants’ scene exploration during the quality assessment task, also remain consistent for each participant according their individual narrower or wider scene exploration signature. These findings are more pronounced for standing viewing than for seated viewing. This work supports the role of pilot studies being a useful approach of conducting pre-tests on immersive media quality under opportunity-limited conditions and for the planning of subsequent full subjective tests with a large panel of participants. The annotated RQA360 dataset containing the data recorded in the repeated subjective tests is made publicly available to the research community.
Effect of Immersive Virtual Reality Teamwork Training on Safety Behaviors During Surgical Cases: Nonrandomized Intervention Versus Controlled Pilot Study
Approximately 4000 preventable surgical errors occur per year in the US operating rooms, many due to suboptimal teamwork and safety behaviors. Such errors can result in temporary or permanent harm to patients, including physical injury, emotional distress, or even death, and can also adversely affect care providers, often referred to as the \"second victim.\" Given the persistence of adverse events in the operating rooms, the objective of this study was to quantify the effect of an innovative and immersive virtual reality (VR)-based educational intervention on (1) safety behaviors of surgeons in the operating rooms and (2) sense-making regarding the overall training experience. This mixed methods pre- versus postintervention pilot study was conducted in a large academic medical center with 55 operating rooms. Safety behaviors were observed and quantified using validated Teamwork Evaluation of Non-Technical Skills instrument during surgical cases at baseline (101 observations; 83 surgeons) and postimmersive VR based intervention (postintervention: 24 observations within each group; intervention group [with VR training; 10 surgeons] and control [no VR training; 10 surgeons]). VR intervention included a 45-minute immersive VR-based training incorporating a pre- and postdebriefing based on Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) principles to improve safety behaviors. A 2-tailed, 2-sample t-test with adjustments for multiplicity of the tests was used to test for significance in observable safety behaviors between the groupings. The debriefing data underwent analysis through the phenomenological analysis method to gain insights into how participants interpreted the training. Preintervention, all safety behaviors averaged slightly above \"acceptable\" scores, with an overall average of 2.2 (range 2-2.3; 0-3 scale). The 10 surgeons that underwent our intervention showed statistically significant (P<.05) improvements in 90% (18/20) of safety behaviors when compared to the 10 surgeons that did not receive the intervention (overall average 2.5, range 2.3-2.7 vs overall average 2.1, range 1.9-2.2). Our qualitative analysis based on 492 quotes from participants suggests that the observed behavioral changes are a result of an immersive experience and sense-making of key TeamSTEPPS training concepts. VR-based immersive training intervention focused on TeamSTEPPS principles seems effective in improving safety behaviors in the operating rooms as quantified via observations using the Teamwork Evaluation of Non-Technical Skills instrument. Further research with larger, more diverse sample sizes is needed to confirm the generalizability of these findings.
A Brief Cognitive Behavioral Therapy–Based Digital Intervention for Reducing Hazardous Alcohol Use in South Korea: Development and Prospective Pilot Study
Alcohol consumption is a leading cause of death and disability worldwide, associated with numerous acute and chronic medical conditions. Digital health interventions offer a promising solution to overcome barriers associated with traditional treatment methods, providing accessible, scalable, and cost-effective means to support individuals in reducing hazardous drinking. This pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the Sober smartphone app in individuals with hazardous alcohol use. This single-group, pre- and postpilot study included 20 participants with risky alcohol use, identified using the Alcohol Use Disorder Identification Test. Participants used the Sober app for 4 weeks, incorporating cognitive behavioral therapy-based interventions. Feasibility was assessed by study and session completion rates, acceptability by participant satisfaction and perceived usefulness, and preliminary efficacy by changes in alcohol consumption and psychiatric symptoms. Semistructured interviews with participants and clinicians provided qualitative perspectives on the app's usability, efficacy, and areas for improvement. Of the 20 enrolled participants, 17 completed the study. The app demonstrated high feasibility with an 85% (17/20) study completion rate, and 59% (10/17) completed all cognitive behavioral therapy sessions. Participants reported positive acceptability, with average satisfaction and usefulness ratings of 3.8 and 3.7 of 5, respectively. Preliminary efficacy outcomes showed significant improvements: abstinence days increased from 67% to 85% (z=-3.17; P=.002), heavy drinking episodes decreased from 3.3 to 1.9 (t16=-2.97; P=.003), and total alcohol consumption reduced from 456.8 to 195.9 mL (t16=3.16; P=.002). Alcohol Use Disorder Identification Test scores dropped from 17.5 to 10.7 (t16=4.51; P<.001). Additionally, depression (Patient Health Questionnaire-9) scores decreased from 5.8 to 4.4 (t16=2.91; P=.01), and anxiety (Generalized Anxiety Disorder-7) scores from 3.4 to 2.1 (z=-2.80; P=.005). No adverse events were reported. Qualitative analysis found participants valued daily logging but noted usability issues, while clinicians called for tailored goals, enhanced communication features, and age-specific content. The mobile app Sober shows promise as an effective tool for reducing hazardous alcohol consumption and improving related psychiatric symptoms. The study demonstrated high feasibility and positive acceptability, with significant preliminary efficacy in reducing alcohol use. Qualitative findings provided actionable evidence for refining the app's usability and clinical integration. Further research through a randomized controlled trial is warranted to confirm these findings and optimize the app's features and content.
Performance of a Pilot-Scale Continuous Flow Ozone-Based Hospital Wastewater Treatment System
Antimicrobial resistance (AMR) is becoming a global concern. Recently, research has emerged to evaluate the human and environmental health implications of wastewater from medical facilities and to identify acceptable wastewater treatment methods. In this study, a disinfection wastewater treatment system using an ozone-based continuous flow system was installed in a general hospital located in Japan. The effectiveness of antimicrobial-resistant bacteria (ARB) and antimicrobials in mitigating the environmental impact of hospital wastewater was evaluated. Metagenomic analysis was conducted to characterize the microorganisms in the wastewater before and after treatment. The results demonstrated that ozone treatment enables effective inactivation of general gut bacteria, including Bacteroides, Prevotella, Escherichia coli, Klebsiella, DNA molecules, and ARGs, as well as antimicrobials. Azithromycin and doxycycline removal rates were >99% immediately after treatment, and levofloxacin and vancomycin removal rates remained between 90% and 97% for approximately one month. Clarithromycin was more readily removed than the other antimicrobials (81–91%), and no clear removal trend was observed for ampicillin. Our findings provide a better understanding of the environmental management of hospital wastewater and enhance the effectiveness of disinfection wastewater treatment systems at medical facilities for mitigating the discharge of pollutants into aquatic environments.
Culturally Adapted STAR-Caregivers Virtual Training and Follow-Up for Latino Caregivers of People Living With Dementia: Single-Arm Pre-Post Mixed Methods Study
Latino caregivers are at an increased risk of negative health outcomes due to the responsibilities of caring for someone with dementia. Although interventions exist to address caregiver burden, they often do not meet the cultural needs of Latino caregivers. This study aimed to pilot test the cultural adaptation of the STAR-Caregivers Virtual Training and Follow-Up (STAR-VTF) intervention. The intervention is an evidence-based training program designed to teach family caregivers strategies to manage behavioral and psychological symptoms of dementia (BPSD). Our research team has conducted past studies to identify and perform culturally relevant adaptations to the training modules of STAR-VTF, and this study aimed to pilot these culturally adapted modules with a sample of Latino caregivers. Data on feasibility, usability, and acceptability were collected from a pilot test in which Latino caregivers (n=16) used the training modules of the STAR-VTF intervention over a 7-week period. Participants completed usability surveys following the completion of each module, and acceptability was assessed through semistructured interviews (n=14) postintervention. Preliminary outcome measures were also collected, and a descriptive analysis was conducted. The primary outcomes were the Revised Memory and Behavior Problem Checklist (RMBPC) and the Preparedness for Caregiving Scale. The pilot study results suggest that it is feasible to deliver the culturally adapted STAR-VTF intervention to Latino caregivers, with 94% (15/16) of participants maintaining enrollment through intervention completion. The intervention's usability was found to be \"good\" based on an average System Usability Score of 76.7 out of 100 across all training modules. Caregivers were generally satisfied with the training modules. In addition, preliminary outcome results demonstrated a trend of decreased BPSD pre- versus postintervention (RMBPC subscale score: 28.24 to 21.34). Findings also demonstrated decreased caregiver reaction to BPSD pre- versus postintervention (RMBPC subscale score: 40.40 to 37.21) and increased caregiver preparedness based on pre- and postintervention (Preparedness Caregiving Scale score: 1.98 to 2.43). The pilot study demonstrated that the culturally adapted STAR-VTF intervention is feasible and perceived as easy to use by a small sample of Latino caregivers. We aim to refine the cultural adaptations of the STAR-VTF intervention further based on feedback from study participants. Future studies are necessary to test the efficacy of the intervention and support the broad dissemination of the culturally adapted intervention.
Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults
Probiotics are among the most commonly used dietary supplements and evidence of their efficacy is increasing. Despite the long historical use of probiotics, some experts suggest that additional research is necessary to understand their potential risks. Main aims of this study were to assess short-term tolerability and safety of a new, high colony-forming unit count, multi-strain probiotic supplement. Exploratory objectives included evaluating effects on gut microbial composition. Ten healthy adults were enrolled in a single-arm, open-label study. Over a 10-day period, participants consumed a once daily probiotic capsule (2.1 x 10 CFU) containing NCFM, Lpc-37, Lp-115, GG, HN001, Bi-07, Bl-04, and HN019. The primary measure of tolerability pertained to whether or not participants completed the study. Secondary safety measures included clinical biomarkers from a routine metabolic panel and a complete blood count. Exploratory measures included stool microbiota counts. All participants completed the study and there were no serious adverse events. All documented adverse events were prompted by the investigators and the most commonly reported symptoms were gastrointestinal. There was a single instance of a biomarker abnormality in one individual. Overall, decreases in total bilirubin and aspartate aminotransferase, and increases in stool levels of species, , and ( < .05) were observed over the course of the study. The findings of this study suggest the multi-strain probiotic supplement was well-tolerated and most likely safe. Changes in liver function measures suggest the probiotics could potentially impact liver health. Stool microbiota changes suggest the probiotic could potentially impact gut health by affecting levels of intestinal microbiota that have been described as bioindicators of health and potential keystone species. However, additional research is necessary to follow up on the exploratory findings of this preliminary work.