Feasibility and Acceptability of a Mobile App-Based TEAM-CBT (Testing Empathy Assessment Methods-Cognitive Behavioral Therapy) Intervention (Feeling Good) for Depression: Secondary Data Analysis.

BACKGROUND: The Feeling Good App is an automated stand-alone digital mobile mental health tool currently undergoing beta testing with the goal of providing evidence-informed self-help lessons and exercises to help individuals reduce depressive symptoms without guidance from a mental health provider. Users work through intensive basic training (IBT) and ongoing training models that provide education regarding cognitive behavioral therapy principles from a smartphone. OBJECTIVE: The key objective of this study was to perform a nonsponsored third-party academic assessment of an industry-generated data set; this data set focused on the safety, feasibility, and accessibility of a commercial automated digital mobile mental health app that was developed to reduce feelings associated with depression. METHODS: The Feeling Good App development team created a waitlist cohort crossover design and measured symptoms of depression and anxiety using the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and an app-specific measure of negative feelings called the 7 Dimension Emotion Slider (7-DES). The waitlist cohort crossover design divided the participants into 2 groups, where 48.6% (141/290) of the participants were given immediate access to the apps, while 51.4% (149/290) were placed on a 2-week waitlist before being given access to the app. Data collected by the Feeling Good App development team were deidentified and provided to the authors of this paper for analysis through a nonsponsored university data use agreement. All quantitative data were analyzed using SPSS Statistics (version 28.0; IBM Corp). Descriptive statistics were calculated for demographic variables. Feasibility and acceptability were descriptively assessed. All participants included in the quantitative data were given access to the Feeling Good App; this study did not include a control group. RESULTS: In terms of safety, there was no statistically significant change in suicidality from preintervention to postintervention time points (t288=0.0; P>.99), and there was a statistically significant decrease in hopelessness from preintervention to postintervention time points (F289=30.16; P<.01). In terms of acceptability, 72.2% (166/230) of the users who started the initial 2-day IBT went on to complete it, while 34.8% (80/230) of the users who started IBT completed the entirety of the apps' 4-week protocol (150/230, 65.22% dropout rate over 4 weeks). CONCLUSIONS: This study is the first reported proof-of-concept evaluation of the Feeling Good App in terms of safety, feasibility, and statistical trends within the data set. It demonstrates a feasible and novel approach to industry and academic collaboration in the process of developing a digital mental health technology translated from an existing evidence-informed treatment. The results support the prototype app as safe for a select nonclinical population. The app had acceptable levels of engagement and dropouts throughout the intervention. Those who stay engaged showed reductions in symptom severity of depression warranting further investigation of the app's efficacy.

Comparison of a portable, pneumotach flow-sensor-based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients-a randomized, crossover study.

BACKGROUND: Spirofy™ is India's first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices. METHODS: In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV1/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers. RESULTS: Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV1 values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV1 values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV1/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices. CONCLUSION: Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma. TRIAL REGISTRATION: CTRI/2021/09/036492 (Clinical Trials Registry - India).

Competency-Based Medication Administration and Error Reporting.

BACKGROUND: Accuracy is needed with medication administration, a skill that involves rule-based habits and clinical reasoning. This pilot study investigated the use of an evidence-based checklist for accuracy with oral medication administration and error reporting among prelicensure nursing students. Checklist items were anchored in the mnemonic C-MATCH-REASON© (Client, Medication, ADRs, Time, Client History, Route, Expiration date, Amount, Site, Outcomes, Notation). METHOD: Nineteen participants randomly assigned to crossover sequence AB or BA (A: checklist; B: no checklist) practiced simulation scenarios with embedded errors. Nursing faculty used an observation form to track error data. RESULTS: Using the C-MATCH-REASON© checklist compared with not using the checklist supported rule adherence (p = .005), knowledge-based error reduction (p = .011), and total error reduction (p = .010). The null hypothesis was not rejected for errors found (p = .061) nor reported (p = .144), possibly due to sample size. CONCLUSION: C-MATCH-REASON© was effective for error reduction. Study replication with a larger sample is warranted. [J Nurs Educ. 2024;63(5):320-327.].

Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged ≥6 to <12 years, using matching placebo tablets: A randomized study.

BACKGROUND: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) was developed as a once-daily, complete antiretroviral (ARV) regimen therapy to address the need for simplified protease inhibitor-based ARV regimens. This study assessed the swallowability and acceptability for long-term use of scored placebo tablets matching the D/C/F/TAF FDC tablets in children living with HIV-1. METHODS: This study (NCT04006704) was a Phase 1, open-label, randomized, single-dose, 2-period, 2-sequence crossover study in children living with HIV-1, aged ≥6 to <12 years and weighing ≥25 to <40 kg, on a stable ARV regimen for ≥3 months. Participants were asked to swallow whole (size, 21 × 11 × 7 mm) and split matching placebo D/C/F/TAF tablets. Swallowability of the matching placebo D/C/F/TAF tablets (primary endpoint) was assessed by observers. Acceptability of taking matching placebo D/C/F/TAF tablets and current ARVs was evaluated by participants using a 3-point questionnaire. Participants rated the acceptability for long-term daily use of the placebo D/C/F/TAF tablets, and observers assessed how easily caregivers could split a scored tablet by hand, using 3-point questionnaires. RESULTS: Among the 24 participants who enrolled and completed the study, 95.8% (23/24) were able to swallow the whole and split matching placebo D/C/F/TAF tablets after 1 or 2 attempts. Most participants (>70%) rated the acceptability of tablets for long-term daily use as acceptable or good to take. Breaking the tablets was considered easy or OK by 79.2% (19/24) of caregivers. CONCLUSION: Scored D/C/F/TAF FDC tablets are swallowable - with whole favoured over split - and considered at least acceptable for long-term daily intake in children living with HIV-1 aged ≥6 to <12 years. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04006704.

Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males.

Fexuprazan, a novel potassium-competitive acid blocker, is expected to be used for the prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) induced ulcer. This study aimed to evaluate pharmacokinetic (PK) interactions between fexuprazan and NSAIDs in healthy subjects. A randomized, open-label, multicenter, six-sequence, one-way crossover study was conducted in healthy male subjects. Subjects randomly received one of the study drugs (fexuprazan 40 mg BID, celecoxib 200 mg BID, naproxen 500 mg BID, or meloxicam 15 mg QD) for 5 or 7 days in the first period followed by the combination of fexuprazan and one of NSAIDs for the same days and the perpetrator additionally administered for 1-2 days in the second period. Serial blood samples for PK analysis were collected until 48- or 72-h post-dose at steady state. PK parameters including maximum plasma concentration at steady state (Cmax,ss) and area under plasma concentration-time curve over dosing interval at steady state (AUCτ,ss) were compared between monotherapy and combination therapy. The PKs of NSAIDs were not significantly altered by fexuprazan. For fexuprazan, differences in PK parameters (22% in Cmax, 19% in AUCτ,ss) were observed when co-administered with naproxen, but not clinically significant. The geometric mean ratio (90% confidence interval) of combination therapy to monotherapy for Cmax,ss and AUCτ,ss was 1.22 (1.02-1.46) and 1.19 (1.00-1.43), respectively. There were no significant changes in the systemic exposure of fexuprazan by celecoxib and meloxicam. Fexuprazan and NSAIDs did not show clinically meaningful PK interactions.

Effectiveness of digital and analog learning methods for learning anatomical structures in physiotherapy education.

BACKGROUND: According to the German Physiotherapy Education and Qualification Regulations, teaching of anatomical structures is one of the fundamental subjects of physiotherapy education. Besides exhibits and models, anatomy atlases are usually used as teaching and learning tools. These are available in both analog form such as printed books or in digital form as a mobile application. Furthermore, the use of digital teaching and learning tools is steadily increasing within the education of health professionals. AIM: To assess the efficacy of a digital educational tool in contrast to an analog anatomical atlas in acquiring knowledge about anatomical structures. MATERIAL AND METHOD: The data collection took place in the context of an anatomy tutorial for students of the bachelor's degree program in physiotherapy. In a cross-over design, the students completed two learning assignments, each, with different learning materials provided, either with an anatomy app on a tablet or with an anatomy atlas as a book. The tests to assess the newly acquired knowledge immediately after the task, consisted of questions about the anatomical structures of the knee as well as the shoulder. In addition, the students' satisfaction with the learning materials provided was surveyed using a questionnaire. The survey assessed their satisfaction, their assessment of learning success, and their affinity to digital learning materials. This was done using a 5-point Likert scale and a free-text field. The data was analyzed descriptively, and group differences were calculated using a t-tests. RESULTS: Thirty students participated. The group comparison showed a significantly better outcome for the group that prepared with the analog anatomy atlas for the questions on the knee than the comparison group that used the anatomy app (t(28) = 2.6; p = 0.007). For the questions concerning the shoulder, there was no significant difference between the digital and analog groups (t(28) = 1.14; p = 0.26). The questionnaire revealed that satisfaction with the analog anatomy atlas was significantly higher than with the anatomy app. A total of 93.34% rated their experience with the analog learning tool at least "somewhat satisfied". In contrast, 72.67% of students partially or fully agreed that they "enjoyed learning with digital learning tools". DISCUSSION: Learning anatomical structures with the Human Anatomy Atlas 2023 + app did not show a clear advantage when compared to an anatomy book in these two cohorts of physiotherapy students. The results of the questionnaire also showed greater satisfaction with the analog anatomy atlas than with the anatomy app, whereas most students stated that they frequently use digital learning tools, including some for anatomical structures. Satisfaction with the learning tool seems to play a central role in their effectiveness. In addition, sufficient time must be provided for users to familiarize themselves with the user interface of digital applications to use them effectively. REGISTRATION: Diese klinische Studie wurde nicht in einem Studienregister registriert.

The Effects of Displaying the Time Targets of the Manchester Triage System to Emergency Department Personnel: Prospective Crossover Study.

BACKGROUND: The use of triage systems such as the Manchester Triage System (MTS) is a standard procedure to determine the sequence of treatment in emergency departments (EDs). When using the MTS, time targets for treatment are determined. These are commonly displayed in the ED information system (EDIS) to ED staff. Using measurements as targets has been associated with a decline in meeting those targets. OBJECTIVE: This study investigated the impact of displaying time targets for treatment to physicians on processing times in the ED. METHODS: We analyzed the effects of displaying time targets to ED staff on waiting times in a prospective crossover study, during the introduction of a new EDIS in a large regional hospital in Germany. The old information system version used a module that showed the time target determined by the MTS, while the new system version used a priority list instead. Evaluation was based on 35,167 routinely collected electronic health records from the preintervention period and 10,655 records from the postintervention period. Electronic health records were extracted from the EDIS, and data were analyzed using descriptive statistics and generalized additive models. We evaluated the effects of the intervention on waiting times and the odds of achieving timely treatment according to the time targets set by the MTS. RESULTS: The average ED length of stay and waiting times increased when the EDIS that did not display time targets was used (average time from admission to treatment: preintervention phase=median 15, IQR 6-39 min; postintervention phase=median 11, IQR 5-23 min). However, severe cases with high acuity (as indicated by the triage score) benefited from lower waiting times (0.15 times as high as in the preintervention period for MTS1, only 0.49 as high for MTS2). Furthermore, these patients were less likely to receive delayed treatment, and we observed reduced odds of late treatment when crowding occurred. CONCLUSIONS: Our results suggest that it is beneficial to use a priority list instead of displaying time targets to ED personnel. These time targets may lead to false incentives. Our work highlights that working better is not the same as working faster.

Paraxanthine provides greater improvement in cognitive function than caffeine after performing a 10-km run.

RATIONALE: Intense exercise promotes fatigue and can impair cognitive function, particularly toward the end of competition when decision-making is often critical for success. For this reason, athletes often ingest caffeinated energy drinks prior to or during exercise to help them maintain focus, reaction time, and cognitive function during competition. However, caffeine habituation and genetic sensitivity to caffeine (CA) limit efficacy. Paraxanthine (PX) is a metabolite of caffeine reported to possess nootropic properties. This study examined whether ingestion of PX with and without CA affects pre- or post-exercise cognitive function. METHODS: 12 trained runners were randomly assigned to consume in a double-blind, randomized, and crossover manner 400 mg of a placebo (PL); 200 mg of PL + 200 mg of CA; 200 mg of PL + 200 mg of PX (ENFINITY®, Ingenious Ingredients); or 200 mg PX + 200 mg of CA (PX+CA) with a 7-14-day washout between treatments. Participants donated fasting blood samples and completed pre-supplementation (PRE) side effects questionnaires, the Berg-Wisconsin Card Sorting Test (BCST), and the Psychomotor Vigilance Task Test (PVTT). Participants then ingested the assigned treatment and rested for 60 minutes, repeated tests (PRE-EX), performed a 10-km run on a treadmill at a competition pace, and then repeated tests (POST-EX). Data were analyzed using General Linear Model (GLM) univariate analyses with repeated measures and percent changes from baseline with 95% confidence intervals. RESULTS: BCST correct responses in the PX treatment increased from PRE-EX to POST-EX (6.8% [1.5, 12.1], p = 0.012). The error rate in the PL (23.5 [-2.8, 49.8] %, p = 0.078) and CA treatment (31.5 [5.2, 57.8] %, p = 0.02) increased from PRE-EX values with POST-EX errors tending to be lower with PX treatment compared to CA (-35.7 [-72.9, 1.4] %, p = 0.059). POST-EX perseverative errors with PAR rules were significantly lower with PX treatment than with CA (-26.9 [-50.5, -3.4] %, p = 0.026). Vigilance analysis revealed a significant interaction effect in Trial #2 mean reaction time values (p = 0.049, ηp2 = 0.134, moderate to large effect) with POST-EX reaction times tending to be faster with PX and CA treatment. POST-EX mean reaction time of all trials with PX treatment was significantly faster than PL (-23.2 [-43.4, -2.4] %, p = 0.029) and PX+CA (-29.6 [-50.3, -8.80] %, p = 0.006) treatments. There was no evidence that PX ingestion adversely affected ratings of side effects associated with stimulant intake or clinical blood markers. CONCLUSIONS: Results provide some evidence that pre-exercise PX ingestion improves prefrontal cortex function, attenuates attentional decline, mitigates cognitive fatigue, and improves reaction time and vigilance. Adding CA to PX did not provide additional benefits. Therefore, PX ingestion may serve as a nootropic alternative to CA.

Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal regimes.

The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may represent a barrier for some patients. Therefore, the aim of this study was to evaluate innovative rivaroxaban-containing formulations designed to eliminate the food effect to ensure reliable absorption and thus to improve patient adherence with the treatment. Three prototypes (Cocrystal, HPMCP and Kollidon) with rivaroxaban were developed and their bioavailability and food effect in comparison to the reference product was tested in open label, randomized, single oral dose, crossover studies, where test products were administered under fasting and fed conditions and the reference product was administered under fed conditions. Comparable bioavailability for all tested prototypes both under fed and fasting conditions was demonstrated as the 90% confidence intervals of the geometric mean ratios for area under the concentration-time curve remained within the standard acceptance range of 80.00%-125.00%. An innovative immediate release form of rivaroxaban with no food effect on drug bioavailability has been developed, which may represent an important step toward increasing adherence, improving treatment outcome and reducing health care costs.

Clinical trial evaluating apomorphine oromucosal solution in Parkinson's disease patients.

Apomorphine, used to treat OFF episodes in patients with Parkinson's disease (PD), is typically administered via subcutaneous injections. Administration of an oromucosal solution could offer a non-invasive and user-friendly alternative. This two-part clinical study evaluated the safety, tolerability, pharmacokinetics (PK), and dose proportionality of a novel apomorphine hydrochloride oromucosal solution, as well as its relative bioavailability to subcutaneous apomorphine injection and apomorphine sublingual film. In part A of the study, 12 patients with PD received 2 mg oromucosal apomorphine (4% weight/volume) and 2 mg subcutaneous apomorphine in a randomized order, followed by 4 and 8 mg oromucosal apomorphine. In part B of the study, 13 patients with PD received 7 mg oromucosal apomorphine (7% weight/volume) and 30 mg sublingual apomorphine in a randomized order, followed by 14 mg oromucosal apomorphine. Washout between dose administrations in both study parts was at least 2 days. Safety, tolerability, and PK were assessed pre- and post-dose. Both study parts showed that oromucosal apomorphine was generally well-tolerated. Observed side effects were typical for apomorphine administration and included asymptomatic orthostatic hypotension, yawning, fatigue, and somnolence. Oromucosal apomorphine exposure increased with dose, although less than dose proportional. The mean (SD) maximum exposure reached with 14 mg oromucosal apomorphine was 753.0 (298.6) ng*min/mL (area under the plasma concentration-time curve from zero to infinity) and 8.0 (3.3) ng/mL (maximum plasma concentration). This was comparable to exposure reached after 2 mg subcutaneous apomorphine and approximately half of the exposure observed with 30 mg sublingual apomorphine. In summary, clinically relevant plasma concentrations could be reached in PD patients without tolerability issues.

The effects of ambient temperature on road traffic injuries in Jinan city: a time-stratified case-crossover study based on distributed lag nonlinear model.

Objectives: The impact of climate change, especially extreme temperatures, on health outcomes has become a global public health concern. Most previous studies focused on the impact of disease incidence or mortality, whereas much less has been done on road traffic injuries (RTIs). This study aimed to explore the effects of ambient temperature, particularly extreme temperature, on road traffic deaths in Jinan city. Methods: Daily data on road traffic deaths and meteorological factors were collected among all residents in Jinan city during 2011-2020. We used a time-stratified case-crossover design with distributed lag nonlinear model to evaluate the association between daily mean temperature, especially extreme temperature and road traffic deaths, and its variation in different subgroups of transportation mode, adjusting for meteorological confounders. Results: A total of 9,794 road traffic deaths were collected in our study. The results showed that extreme temperatures were associated with increased risks of deaths from road traffic injuries and four main subtypes of transportation mode, including walking, Bicycle, Motorcycle and Motor vehicle (except motorcycles), with obviously lag effects. Meanwhile, the negative effects of extreme high temperatures were significantly higher than those of extreme low temperatures. Under low-temperature exposure, the highest cumulative lag effect of 1.355 (95% CI, 1.054, 1.742) for pedal cyclists when cumulated over lag 0 to 6 day, and those for pedestrians, motorcycles and motor vehicle occupants all persisted until 14 days, with ORs of 1.227 (95% CI, 1.102, 1.367), 1.453 (95% CI, 1.214, 1.740) and 1.202 (95% CI, 1.005, 1.438), respectively. Under high-temperature exposure, the highest cumulative lag effect of 3.106 (95% CI, 1.646, 5.861) for motorcycle occupants when cumulated over lag 0 to 12 day, and those for pedestrian, pedal cyclists, and motor vehicle accidents all peaked when persisted until 14 days, with OR values of 1.638 (95% CI, 1.281, 2.094), 2.603 (95% CI, 1.695, 3.997) and 1.603 (95% CI, 1.066, 2.411), respectively. Conclusion: This study provides evidence that ambient temperature is significantly associated with the risk of road traffic injuries accompanied by obvious lag effect, and the associations differ by the mode of transportation. Our findings help to promote a more comprehensive understanding of the relationship between temperature and road traffic injuries, which can be used to establish appropriate public health policies and targeted interventions.

Practical cooling interventions for preventing heat strain in indoor factory workers in Thailand.

BACKGROUND: Occupational heat stress, exacerbated by factors such as climate change and insufficient cooling solutions, endangers the health and productivity of workers, especially in low-resource workplaces. OBJECTIVE: To evaluate the effectiveness of two cooling strategies in reducing physiological strain and productivity of piece-rate workers over a 9-h work shift in a southern Thailand sawmill. METHODS: In a crossover randomized control trial design, 12 (33 ± 7 y; 1.58 ± 0.05 m; 51 ± 9 kg; n = 5 females) medically screened sawmill workers were randomly allocated into three groups comprising an established phase change material vest (VEST), an on-site combination cooling oasis (OASIS) (i.e., hydration, cold towels, fans, water dousing), and no cooling (CON) across 3 consecutive workdays. Physiological strain was measured via core temperature telemetry and heart rate monitoring. Productivity was determined by counting the number of pallets of wood sorted, stacked, and stowed each day. RESULTS: Relative to CON, OASIS lowered core temperature by 0.25°C [95% confidence interval = 0.24, 0.25] and heart rate by 7 bpm [6, 9] bpm, compared to 0.17°C [0.17, 0.18] and 10 [9,12] bpm reductions with VEST. It was inconclusive whether productivity was statistically lower in OASIS compared to CON (mean difference [MD] = 2.5 [-0.2, 5.2]), and was not statistically different between VEST and CON (MD = 1.4 [-1.3, 4.1]). CONCLUSIONS: Both OASIS and VEST were effective in reducing physiological strain compared to no cooling. Their effect on productivity requires further investigation, as even small differences between interventions could lead to meaningful disparities in piece-rate worker earnings over time.

Prefrontal tDCS modulates risk-taking in male violent offenders.

Detrimental decision-making is a major problem among violent offenders. Non-invasive brain stimulation offers a promising method to directly influence decision-making and has already been shown to modulate risk-taking in non-violent controls. We hypothesize that anodal transcranial direct current stimulation (tDCS) over the right dorsolateral prefrontal cortex beneficially modulates the neural and behavioral correlates of risk-taking in a sample of violent offenders. We expect offenders to show more risky decision-making than non-violent controls and that prefrontal tDCS will induce stronger changes in the offender group. In the current study, 22 male violent offenders and 24 male non-violent controls took part in a randomized double-blind sham-controlled cross-over study applying tDCS over the right dorsolateral prefrontal cortex. Subsequently, participants performed the Balloon Analogue Risk Task (BART) during functional magnetic resonance imaging (fMRI). Violent offenders showed significantly less optimal decision-making compared to non-violent controls. Active tDCS increased prefrontal activity and improved decision-making only in violent offenders but not in the control group. Also, in offenders only, prefrontal tDCS influenced functional connectivity between the stimulated area and other brain regions such as the thalamus. These results suggest baseline dependent effects of tDCS and pave the way for treatment options of disadvantageous decision-making behavior in this population.

Effects of sleep deprivation on food-related Pavlovian-instrumental transfer: a randomized crossover experiment.

Recent research suggests that insufficient sleep elevates the risk of obesity. Although the mechanisms underlying the relationship between insufficient sleep and obesity are not fully understood, preliminary evidence suggests that insufficient sleep may intensify habitual control of behavior, leading to greater cue-elicited food-seeking behavior that is insensitive to satiation. The present study tested this hypothesis using a within-individual, randomized, crossover experiment. Ninety-six adults underwent a one-night normal sleep duration (NSD) condition and a one-night total sleep deprivation (TSD) condition. They also completed the Pavlovian-instrumental transfer paradigm in which their instrumental responses for food in the presence and absence of conditioned cues were recorded. The sleep × cue × satiation interaction was significant, indicating that the enhancing effect of conditioned cues on food-seeking responses significantly differed across sleep × satiation conditions. However, this effect was observed in NSD but not TSD, and it disappeared after satiation. This finding contradicted the hypothesis but aligned with previous literature on the effect of sleep disruption on appetitive conditioning in animals-sleep disruption following learning impaired the expression of appetitive behavior. The present finding is the first evidence for the role of sleep in Pavlovian-instrumental transfer effects. Future research is needed to further disentangle how sleep influences motivational mechanisms underlying eating.

The effects of real-time waveform analysis software on patient ventilator synchronization during pressure support ventilation: a randomized crossover physiological study.

BACKGROUND: Patient-ventilator asynchrony commonly occurs during pressure support ventilation (PSV). IntelliSync + software (Hamilton Medical AG, Bonaduz, Switzerland) is a new ventilation technology that continuously analyzes ventilator waveforms to detect the beginning and end of patient inspiration in real time. This study aimed to evaluate the physiological effect of IntelliSync + software on inspiratory trigger delay time, delta airway (Paw) and esophageal (Pes) pressure drop during the trigger phase, airway occlusion pressure at 0.1 s (P0.1), and hemodynamic variables. METHODS: A randomized crossover physiologic study was conducted in 14 mechanically ventilated patients under PSV. Patients were randomly assigned to receive conventional flow trigger and cycling, inspiratory trigger synchronization (I-sync), cycle synchronization (C-sync), and inspiratory trigger and cycle synchronization (I/C-sync) for 15 min at each step. Other ventilator settings were kept constant. Paw, Pes, airflow, P0.1, respiratory rate, SpO2, and hemodynamic variables were recorded. The primary outcome was inspiratory trigger and cycle delay time between each intervention. Secondary outcomes were delta Paw and Pes drop during the trigger phase, P0.1, SpO2, and hemodynamic variables. RESULTS: The time to initiate the trigger was significantly shorter with I-sync compared to baseline (208.9±91.7 vs. 301.4±131.7 msec; P = 0.002) and I/C-sync compared to baseline (222.8±94.0 vs. 301.4±131.7 msec; P = 0.005). The I/C-sync group had significantly lower delta Paw and Pes drop during the trigger phase compared to C-sync group (-0.7±0.4 vs. -1.2±0.8 cmH2O; P = 0.028 and - 1.8±2.2 vs. -2.8±3.2 cmH2O; P = 0.011, respectively). No statistically significant differences were found in cycle delay time, P0.1 and other physiological variables between the groups. CONCLUSIONS: IntelliSync + software reduced inspiratory trigger delay time compared to the conventional flow trigger system during PSV mode. However, no significant improvements in cycle delay time and other physiological variables were observed with IntelliSync + software. TRIAL REGISTRATION: This study was registered in the Thai Clinical Trial Registry (TCTR20200528003; date of registration 28/05/2020).

A patient-centered 'test-drive' strategy for ankle-foot orthosis prescription: Protocol for a randomized participant-blinded trial.

BACKGROUND: Ankle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized 'test-drive' strategy using a robotic exoskeleton ('AFO emulator') to emulate commercial AFO mechanical properties (i.e., stiffness). The study will determine if brief, in-lab trials (with emulated or actual AFOs) can predict longer term preference, satisfaction, and mobility outcomes after community trials (with the actual AFOs). Secondarily, it will compare the in-lab experience of walking between actual vs. emulated AFOs. METHODS AND ANALYSIS: In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the "in-lab" assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs). TRIAL REGISTRATION: The study was prospectively registered at www.clininicaltrials.gov (Clinical Trials Study ID: NCT06113159). Date: November 1st 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06113159.

Anodal transcranial direct current stimulation enhances response inhibition and attention allocation in fencers.

Background: The aim of this study is to investigate the acute effects of anodal transcranial direct current stimulation (tDCS) on reaction time, response inhibition and attention in fencers. Methods: Sixteen professional female fencers were recruited, and subjected to anodal tDCS and sham stimulation in the primary motor area (M1) one week apart in a randomized, crossover, single-blind design. A two-factor analysis of variance with repeated measures was used to analyze the effects of stimulation conditions (anodal stimulation, sham stimulation) and time (pre-stimulation, post-stimulation) on reaction time, response inhibition, and attention in fencers. Results: The study found a significant improvement in response inhibition and attention allocation from pre-stimulation to post-stimulation following anodal tDCS but not after sham stimulation. There was no statistically significant improvement in reaction time and selective attention. Conclusions: A single session of anodal tDCS could improve response inhibition, attention allocation in female fencers. This shows that tDCS has potential to improve aspects of an athlete's cognitive performance, although we do not know if such improvements would transfer to improved performance in competition. However, more studies involving all genders, large samples, and different sports groups are needed in the future to further validate the effect of tDCS in improving the cognitive performance of athletes.

Comparative analysis of pulmonary ventilation distribution between low-cost and branded incentive spirometers using electrical impedance tomography in healthy adults: Study protocol.

BACKGROUND: The Incentive Spirometer (IS) increases lung volume and improves gas exchange by visually stimulating patients to take slow, deep breaths. It prevents respiratory complications and treats postoperative atelectasis in patients undergoing abdominal, thoracic, and neurosurgical procedures. Its effectiveness has been validated in studies that support improved lung capacities and volumes in individuals with respiratory complications, postoperative thoracic surgery, upper abdominal surgery, and bariatric surgery. The modified Pachón incentive spirometer (MPIS) is a cost-effective alternative to branded IS. It is crucial to validate whether the MPIS distributes ventilation as effectively as commercial devices do. Ventilation distribution will be measured using electrical impedance tomography. OBJECTIVE: The aim is to compare the distribution of pulmonary ventilation between the MPIS and another commercial IS in healthy adults using electrical impedance tomography. METHODS: A crossover clinical trial is proposed to evaluate the measurement of pulmonary ventilation distribution using EIT in a sample of healthy adults. All participants will use a commercial flow IS and the MPIS, with the order of assignment randomized. This research will use electrical impedance tomography to validate the operation of the MPIS. CONCLUSIONS: This study protocol will compare two incentive spirometers' impact on pulmonary ventilation, potentially endorsing the adoption of a cost-effective device to enhance accessibility for targeted populations. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NTC05532748).

Recombinant ADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura.

BACKGROUND: Congenital thrombotic thrombocytopenic purpura (TTP) results from severe hereditary deficiency of ADAMTS13. The efficacy and safety of recombinant ADAMTS13 and standard therapy (plasma-derived products) administered as routine prophylaxis or on-demand treatment in patients with congenital TTP is not known. METHODS: In this phase 3, open-label, crossover trial, we randomly assigned patients in a 1:1 ratio to two 6-month periods of prophylaxis with recombinant ADAMTS13 (40 IU per kilogram of body weight, administered intravenously) or standard therapy, followed by the alternate treatment; thereafter, all the patients received recombinant ADAMTS13 for an additional 6 months. The trigger for this interim analysis was trial completion by at least 30 patients. The primary outcome was acute TTP events. Manifestations of TTP, safety, and pharmacokinetics were assessed. Patients who had an acute TTP event could receive on-demand treatment. RESULTS: A total of 48 patients underwent randomization; 32 completed the trial. No acute TTP event occurred during prophylaxis with recombinant ADAMTS13, whereas 1 patient had an acute TTP event during prophylaxis with standard therapy (mean annualized event rate, 0.05). Thrombocytopenia was the most frequent TTP manifestation (annualized event rate, 0.74 with recombinant ADAMTS13 and 1.73 with standard therapy). Adverse events occurred in 71% of the patients with recombinant ADAMTS13 and in 84% with standard therapy. Adverse events that were considered by investigators to be related to the trial drug occurred in 9% of the patients with recombinant ADAMTS13 and in 48% with standard therapy. Trial-drug interruption or discontinuation due to adverse events occurred in no patients with recombinant ADAMTS13 and in 8 patients with standard therapy. No neutralizing antibodies developed during recombinant ADAMTS13 treatment. The mean maximum ADAMTS13 activity after recombinant ADAMTS13 treatment was 101%, as compared with 19% after standard therapy. CONCLUSIONS: During prophylaxis with recombinant ADAMTS13 in patients with congenital TTP, ADAMTS13 activity reached approximately 100% of normal levels, adverse events were generally mild or moderate in severity, and TTP events and manifestations were rare. (Funded by Takeda Development Center Americas and Baxalta Innovations; ClinicalTrials.gov number, NCT03393975.).

Effect of video angle on detection of induced front limb lameness in horses.

BACKGROUND: Lameness examinations are commonly performed in equine medicine. Advancements in digital technology have increased the use of video recordings for lameness assessment, however, standardization of ideal video angle is not available yielding videos of poor diagnostic quality. The objective of this study was to evaluate the effect of video angle on the subjective assessment of front limb lameness. A randomized, blinded, crossover study was performed. Six horses with and without mechanically induced forelimb solar pain were recorded using 9 video angles including horses trotting directly away and towards the video camera, horses trotting away and towards a video camera placed to the left and right side of midline, and horses trotting in a circle with the video camera placed on the inside and outside of the circle. Videos were randomized and assessed by three expert equine veterinarians using a 0-5 point scoring system. Objective lameness parameters were collected using a body-mounted inertial sensor system (Lameness Locator®, Equinosis LLC). Interobserver agreement for subjective lameness scores and ease of grading scores were determined. RESULTS: Induction of lameness was successful in all horses. There was excellent agreement between objective lameness parameters and subjective lameness scores (AUC of the ROC = 0.87). For horses in the "lame" trials, interobserver agreement was moderate for video angle 2 when degree of lameness was considered and perfect for video angle 2 and 9 when lameness was considered as a binary outcome. All other angles had no to fair agreement. For horses in the "sound" trials, interobserver agreement was perfect for video angle 5. All other video angles had slight to moderate agreement. CONCLUSIONS: When video assessment of forelimb lameness is required, a video of the horse trotting directly towards the video camera at a minimum is recommended. Other video angles may provide supportive information regarding lameness characteristics.