Contemporary Clinical Trials Communications

Exercise training is a cornerstone of Cardiovascular Rehabilitation (CR) and, as of now, moderate-to-vigorous continuous exercise training (MICT) is the standard. New exercise modalities in the context of CR are constantly being explored to improve patient outcomes. These Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) exercise training recommendations provide a synthesis of evidence-informed recommendations from existing documents, including recommendations around High-Intensity Interval training (HIIT). CACPR created a pan-Canadian Exercise Working Group with various knowledge users (e.g., kinesiologists/exercise physiologists, physiotherapists, cardiologists, and patients) with expertise in CR-based exercise, who developed knowledge gap questions related to exercise training based on a literature review and synthesis of all available recommendations. An independent evidence-synthesis team performed a rapid review and meta-analyses to address the questions. The working group used this data to develop relevant recommendations. The final guidelines include 12 recommendations for CR exercise, including nine from previous documents and three new recommendations based on HIIT. The previous recommendations address exercise assessments and prescriptions for CR for various patient profiles. The new recommendations suggest that HIIT can be used to improve exercise capacity in patients with coronary artery disease (CAD), heart failure (HF) or atrial fibrillation. They also state that HIIT is superior to MICT in patients with CAD, that patients with HF should be considered for either HIIT or MICT and that any HIIT interval duration can be used as part of CR. Overall, these recommendations provide guidance for exercise in Canadian CR programs.

BackgroundSedentary behavior is highly prevalent following traumatic brain injury (TBI) and compounds existing risks for cardiovascular, neurodegenerative, and affective disorders. The cognitive and behavioral sequelae of TBI, including impaired decision-making, blunted reward processing, and cognitive fatigue, create particular barriers to adopting and maintaining an active lifestyle. Despite this, effective behavior change interventions targeting physical activity in community-dwelling TBI survivors remain scarce. Here, we evaluated the feasibility, compliance, and preliminary efficacy of a 12-week remotely delivered walking intervention combining planning, behavioral reminders, and monetary micro-incentives. MethodsFifty-six adults aged 40-80 years with a mild-to-moderate TBI diagnosed between 3 months and 15 years prior were randomized to either a planning, reminders, and micro-incentives intervention (n=23) or a health advice control condition (n=25). Participants wore a Fitbit Inspire 3 continuously throughout the study. Intervention participants completed weekly phone calls to plan five 30-minute walks for the following week, received daily text message or email reminders on planned walk days, and earned small monetary incentives upon walk completion. Control participants received weekly health education calls. Feasibility was assessed through recruitment, retention, and adverse event rates. Compliance was assessed via phone call completion rates and Fitbit wear time. Efficacy outcomes included weekly walk counts, walking duration, and step counts, modeled using Poisson generalized linear mixed models and linear mixed-effects models over 12 weeks. ResultsForty-eight participants completed the study (retention rate: 84.2%), with high phone call compliance in both groups (intervention: 98.4%; control: 98.1%). Intervention participants completed significantly more walks than controls from week 1 onward (aIRR = 5.33, 95% CI: 2.27-12.5, p < 0.001), with the group difference growing over time (interaction aIRR = 1.09 per week, 95% CI: 1.01-1.17, p = 0.029). Estimated marginal means indicated that intervention participants completed 5.5 times more walks than controls at week 1, increasing to 15.5 times more by week 12. The intervention group also walked significantly longer at week 1 (b = 62.14 min, 95% CI: 1.05-123.23, p = .046), with the advantage growing over time; by week 12, intervention participants walked 5.3 times longer than controls. Similarly, the intervention group accumulated significantly more steps during walks at week 1 (b = 4,779 steps, 95% CI: 45.50-9,513.00, p = .048), accumulating 3.1 times more steps than controls by week 12. ConclusionsA remotely delivered, multicomponent walking intervention targeting planning, behavioral reminders, and micro-incentives was feasible, well-tolerated, and produced meaningful increases in walking activity in community-dwelling adults with TBI. With high retention and compliance, and consistent effects on walk counts, duration, and steps across the intervention period, these findings provide compelling support for a larger, fully powered trial.

BackgroundAdapted dance is a promising rehabilitation intervention for physical and psychosocial impairments in people with chronic stroke. However, in-person attendance is hindered by limited community ambulation, transportation, and schedule conflicts. At-home participation with a live-streamed dance program could address these issues, but psychosocial benefits may be diminished because of reduced social interactions. The primary objective of this study was to assess the feasibility and safety of a live-streamed dance program for chronic stroke. Secondary objectives were to characterize participants who choose live-stream vs in-person options and quantify pre-post changes in balance, gait and social connection. MethodPeople with chronic stroke were given the choice of attending a live-streamed adapted dance program either in-person or at home twice a week for 4 weeks. A priori feasibility criteria were tracked, and participants were characterized with self-report (Center for Epidemiologic Studies Depression Scale; CES-D) and performance-based measures (e.g., Montreal Cognitive Assessment, Chedoke McMaster Assessment) at baseline. Pre-post measures of secondary outcomes included gait speed, Mini Balance Evaluation Systems Test (Mini-BESTest), Activities of Balance Confidence Scale (ABC), and Inclusion of Community in Self scale (ICS). Unpaired median/mean differences in baseline clinical presentation were used to compare in-person and live-stream participants. Paired median/mean differences were used to examine change in secondary outcomes with dance. ResultsInterest and enrollment rates for both groups combined were 87% and 38% respectively. Of the 13 people who enrolled, 8 chose in-person and 5 chose live-stream. In-person and live-stream attendance rates were 83% and 89% respectively, and retention rates were 80% and 75% respectively. At baseline, the in-person group had greater depressive symptoms (CES-D score, median [IQR] difference: 11.5 [-21.5, -5]), and faster mean gait speed (-25.8cm/s [-50.98, 0.006]) than the live-stream group. There were no pre-post changes in secondary outcome measures. ConclusionsA live-streamed dance intervention featuring in-class and at-home participation is safe and feasible for people with chronic stroke. These results will inform a future randomized controlled trial to investigate the effects of a live-stream dance program with a longer duration while considering how factors such as gait function and mood may relate to the choice between in-person and at-home attendance.

ImportanceCurrent guidelines from the World Health Organization, Centers for Disease Control and Prevention, and Academy of Breastfeeding Medicine recommend discarding all milk remaining in bottles immediately after infant feeding. However, these recommendations lack supporting microbiological evidence from studies of actual infant feeding, imposing substantial financial and emotional burden on the 78 million families worldwide who bottle-feed their infants. ObjectiveTo determine (1) the financial, emotional, and time burden associated with bottle feeding and parental milk disposal practices, and (2) bacterial growth in leftover human milk and formula under different storage conditions. Design(1) Cross-sectional online survey (January 2023-February 2024) and (2) prospective microbiological cohort study. Setting(1) Online survey, (2) infants recruited in Hannover, Germany Participants(1) Survey respondents (n=1056; 99% mothers) and (2) healthy, full-term, bottle-fed infants (n=44; 17 humanmilk, 27 formula) aged 0-12 months. Main Outcomes and MeasuresParental burden scores, milk disposal frequency, and bacterial colony-forming units (CFU)/ml in milk samples before feeding, immediately after feeding, and at 4, 8, and 24 hours post-feeding at 4{degrees}C and 20{degrees}C. ResultsAmong surveyed parents, 46% discarded leftover milk daily, yet 84% reported they would keep milk longer if deemed safe. In microbiological testing, median bacterial burden in humanmilk increased from 4200 CFU/ml (range 300-350,000) pre-feeding to 24,600 CFU/ml (range 1900-29,004,400) post-feeding, but showed no significant further increase at 4 hours (p=0.82) or 8 hours (p=0.64) when stored at either 4{degrees}C or 20{degrees}C. Formula showed similar stability: median CFU/ml increased from 0 (range 0-10,700) to 11,700 (range 1900-630,000) post-feeding, with no significant change at 4 hours (p=0.91) or 8 hours (p=0.73) at either temperature. Significant bacterial growth occurred only after 24 hours at 20{degrees}C (p<0.001). Conclusions and RelevanceBacterial burden in leftover infant milk remained stable below concerning thresholds for 8 hours when refrigerated and 4-8 hours at room temperature, challenging current guidelines that mandate immediate disposal. Evidence-based guideline revision could reduce financial burden and milk waste for families around the globe without compromising infant safety. Key PointsO_ST_ABSQuestionC_ST_ABSHow long is it safe to offer leftover milk in a bottle to an infant that has previously drunk from it? FindingsThe number of bacteria in leftover human milk or formula did not significantly increase from 0 to 8h post-feeding in milk bottles sampled from 44 infants, regardless of whether the milk was kept at room temperature or refrigerated. MeaningLeftover milk may be safely reoffered beyond the limits of the current guidelines.

BackgroundThoracic spine mobilization (TSM) has been proposed to influence autonomic nervous system (ANS) activity, yet evidence remains inconsistent and feasibility of standardised protocols is unclear. This study aimed to evaluate whether a randomized TSM protocol can be implemented successfully in healthy participants and to provide preliminary estimates of its effects on heart rate variability (HRV) and heart rate (HR). MethodsA randomized feasibility trial was conducted with healthy young adults receiving six manual therapy sessions consisting of rotational mobilizations above Th5 over 14 days. Feasibility outcomes included adherence, absence of unexpected adverse events (UAE), and practicality of autonomic data acquisition. Physiological outcomes comprised HRV parameters, high-frequency (HF), low-frequency/high-frequency ratio (LF/HF) and HR, analyzed using autoregressive (AR) and fast Fourier transform (FFT) methods. ResultsProcedural safety and methodological integrity were confirmed (no UAE; complete datasets), but feasibility was only partially achieved due to adherence shortfalls, higher attrition, and device-related delays. Physiologically, large effect sizes were observed in the intervention group: at evening assessment, HF_AR showed ES = 0.80 (p = .008); at morning assessment, HF_FFT ES = 0.72 (p = .016), HF_AR ES = 0.78 (p = .010), and LF/HF_AR ES = 0.70 (p = .021). HR remained unchanged. These findings suggest repeated TSM may modulate HRV, primarily through HF-related changes associated with vagal activity, while LF/HF interpretation remains controversial. ConclusionA randomized TSM protocol is safe and methodologically viable with logistical refinements. Preliminary evidence indicates potential vagal modulation, warranting larger trials with respiratory control, ECG-based HRV, multimodal ANS measures, and clinical populations to confirm efficacy and translational relevance.

Introduction Vonoprazan, a new oral potassium-competitive acid blocker (PCAB), has shown promise in terms of superior acid suppression when compared to Proton pump inhibitors (PPIs). We evaluated the efficacy of PCABs versus PPIs in preventing rebleeding in high-risk peptic ulcer patients after endoscopic hemostasis. Methods Following the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines, we conducted a comprehensive search for relevant studies across Medline, Embase, Web of Science, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov, from inception till March 25, 2025. The primary outcome of interest was peptic ulcer rebleeding rate. Pooled risk ratios (RR) and mean difference (MD) with the corresponding 95% confidence intervals (CIs) were calculated. Results Three studies with 54,410 patients receiving endoscopic hemostasis for peptic ulcer bleeding were included in our analysis. The mean age of included participants was 71 years. There was no significant difference in rebleeding rates between patients receiving PPIs and PCABs (RR 0.827; 95 % CI: 0.5 to 1.3). We observed a significant reduction in length of hospital stay in the PCAB group when compared to the PPI group (MD: -0.44, 95% CI: -0.72 to -0.17), but no significant difference in all-cause mortality between both groups (RR: 0.90, 95% CI: 0.79 to 1.04). Conclusions Our study demonstrates comparable efficacy of PPIs and PCABs in preventing rebleeding in patients with high-risk peptic ulcers after successful endoscopic hemostasis. However, there was a significant reduction in hospital length of stay favoring PCABs. Keywords: Vonoprazan, Proton Pump inhibitors, peptic ulcer bleeding, Endoscopy

BackgroundGLP-1 receptor agonists (GLP-1RAs) and SGLT2 inhibitors (SGLT2Is) have established cardiovascular benefits for patients with type 2 diabetes mellitus (T2DM), with similar class-level effectiveness found in previous studies. However, real-world comparative effectiveness assessments of individual agents remain limited. ObjectivesTo compare the cardiovascular effectiveness of individual GLP-1RAs and SGLT2Is. MethodsWe conducted a multi-national, retrospective, new-user active-comparator cohort study using 10 US and non-US administrative claims and electronic health record databases. The study included 1,245,211 adults with T2DM receiving metformin who initiated second-line therapy with one of six GLP-1RAs (albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide) or one of four SGLT2Is (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin). Empagliflozin (393,499; 31.6%), semaglutide (235,585; 18.9%), dapagliflozin (208,666; 16.8%), and dulaglutide (207,348; 16.8%) were most commonly used. A secondary subgroup analysis included 316,242 patients with established cardiovascular diseases (CVD). Primary outcomes were 3-point major adverse cardiovascular events (MACE: acute myocardial infarction, stroke, sudden cardiac death) and 4-point MACE (adding hospitalization/ER visit with heart failure). Secondary outcomes included the individual components. Hazard ratios (HRs) were estimated for pairwise agent comparisons while on-treatment (per-protocol) and over total follow-up using Cox proportional hazards models, with propensity score adjustments, negative control calibration, and pre-specified study diagnostics to guard against potential confounding. Random-effects meta-analysis produced summary HR estimates across data sources that passed diagnostics. ResultsAcross the study cohort, individual GLP-1RAs and SGLT2Is demonstrated broadly similar cardiovascular effectiveness, both within and across drug classes. For example, semaglutide and empagliflozin showed comparable risks for 3-point MACE (meta-analytic HR 1.05; 95% CI 0.79-1.39) and 4-point MACE (meta-analytic HR 0.95; 95% CI 0.81-1.12), with consistent findings in the CVD subgroup. Study diagnostics confirmed adequate equipoise, covariate balance and statistical power to detect similarity in HRs between 0.8 and 1.2 for commonly used agents. ConclusionsIn this large-scale real-world study, individual GLP-1RAs and SGLT2Is exhibited largely comparable cardiovascular benefits, including in patients with established CVD. These findings align with network meta-analytic estimates from major cardiovascular outcome trials and broadly support current treatment guidelines. Clinical choices should be guided by relevant factors such as safety, adherence, tolerability, cost, and patient preference, where further work is needed.

Societies are aging rapidly in parallel with the increasingly earlier onset of serious diseases in younger populations. These and other factors are creating a substantial disparity between healthspan, the period of life where an individual is free from serious chronic disease or disability, and lifespan -- expanding the morbidity span. Extending healthspan has thus become a major priority. To pursue an integrated strategy toward healthspan support, we launched DELTA, a prospective, open-label, interventional, and participatory N=1 study (NCT06630637) conducted on a healthy individual (DELTA001, author D.H.). The study was conducted with methodological rigor to support repeatability, transparency, and balanced reporting. The core focus of the DELTA protocol was to assess and enhance human biological resilience. This was demonstrated through the subjects adaptive capacity, revealed through changes and trajectories in cardiometabolic and pleiotropic biomarker levels based upon systematically administered challenges (e.g., fasting). Specifically, the interventional DELTA protocol integrates time-restricted eating (TRE, fasting), strength and cardiovascular fitness regimens, a Mediterranean-inspired dietary protocol, and supplementation alongside an analytics and reporting framework comprised of artificial intelligence (AI), digital health, and wearables-based sleep performance monitoring, microbiome assessment, and longitudinal tracking of biomarker dynamics and performance outcomes. This study introduces new methods and metrics for assessing these biomarker dynamics, including the development of digital biomarkers that reflect dynamic human functional resilience. Findings from DELTA may actionably guide the design of larger participatory human trials to monitor biomarker resilience, design appropriate interventions for dynamic administration, and subsequently fortify healthspan at a population level.

We performed a systematic review and meta-analysis of randomized controlled trials evaluating glucagon-like peptide-1 receptor agonists (GLP-1 RAs) versus placebo in adults with heart failure (HF), searching PubMed, Cochrane CENTRAL, and ClinicalTrials.gov through February 2026. The primary outcome was the composite of cardiovascular death and first HF hospitalization. Random-effects meta-analysis used restricted maximum likelihood estimation with Hartung-Knapp-Sidik-Jonkman adjustment. We included 14 studies (6 dedicated HF trials and 8 cardiovascular outcomes trial HF subgroup analyses) encompassing 18,558 patients, of whom 2,499 were randomized in dedicated HF trials. The primary composite did not reach statistical significance (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.73-1.01; P=0.067; I2=47%). GLP-1 RAs significantly reduced all-cause mortality (HR 0.87, 95% CI 0.81-0.93; P<0.001; I2=0%), major adverse cardiovascular events (HR 0.83, 95% CI 0.73-0.95; P=0.019), and improved Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (+7.4 points, 95% CI 6.3-8.5) and 6-minute walk distance (+17.6 m, 95% CI 13.4-21.7). Excluding the FIGHT trial (acute HFrEF) yielded a significant primary composite (HR 0.83, P=0.011). The mortality signal was driven primarily by CVOT subgroups; the largest dedicated HFpEF trial (SUMMIT) showed numerically higher mortality (HR 1.25). The strongest evidence supports GLP-1 RAs in HFpEF with obesity. HighlightsO_LIPrimary composite of CV death + HHF was not significant (HR 0.86, P=0.067) C_LIO_LIGLP-1 RAs reduced all-cause mortality (HR 0.87) with no heterogeneity C_LIO_LIKCCQ-CSS improved by 7.4 points and 6MWD by 17.6 m in HFpEF trials C_LIO_LIMortality benefit driven by CVOT subgroups, not dedicated HF trials C_LIO_LIStrongest evidence supports GLP-1 RAs in HFpEF with obesity C_LI

Purpose: Human anatomy remains foundational to clinical practice, yet reduced instructional hours raise concerns about graduate competence and preparedness for patient care. Although trainees often report confidence, supervisors may perceive deficiencies, creating a gap between self-assessment and external evaluation. This study examined stakeholder perspectives on anatomical competence within physical therapy education to identify areas of discordance in perceived capability. Methods: A cross-sectional web-based survey collected responses from 165 stakeholders associated with an entry-level Doctor of Physical Therapy program featuring a 16-week dissection curriculum. Participants rated four domains of anatomical competence using a 5-point ordinal scale. Group differences were analyzed with the Kruskal-Wallis test appropriate for ordinal data. This methodology ensured robust assessment of stakeholder perceptions and comparative analysis. Results: Median ratings of preparedness and capability were 4 of 5 (quite prepared). Significant discordance emerged in three domains: recent graduates rated their foundational knowledge and ability to explain complex concepts to lay audiences higher than faculty or clinical instructors, whereas faculty expressed lower confidence in graduates' ability to explain patient symptoms using anatomical principles. No significant differences were observed in the ability to describe structures by location, suggesting shared perceptions of basic anatomical understanding despite variation in applied reasoning. Conclusions: Stakeholders generally viewed graduates as well prepared, yet disagreement persisted regarding clinical application of anatomical knowledge. Faculty skepticism about symptom explanation indicates that mastery of anatomy alone does not guarantee clinical reasoning. Curricular strategies emphasizing vertical integration and explicit connections between anatomical science and patient-centered reasoning may help bridge perception gaps and enhance professional competence.

Background and ObjectivesDecision-making about resuscitating a critically ill child is complex yet common. We aimed to study the survival thresholds at which physicians, compared to parents, decide to treat or withhold resuscitating a child. Moreover, we aimed to compare physicians survival estimates with those from a nationwide registry. MethodsWe conducted a cross-sectional survey-based study in the United States. Clinical vignettes based on hypothetical survival probabilities were used to study and compare the decision thresholds for parents and physicians. Vignettes developed using the Get-With-The-Guidelines-Resuscitation registry were used to explore physicians decision thresholds and compare their survival estimates with those from the data. Thresholds were determined using mixed-effect logistic regression models. ResultsWe had decisions for 501 and 257 vignettes from 167 parents and 43 physicians, respectively. The decision threshold for survival to discharge was 5.3% (95% CI: 3.7 to 7.0) for physicians and 1.2% (95% CI: -0.8 to 3.0) for parents. Whereas the decision threshold for survival to discharge with PCPC 1 or 2 was 3.5% (95% CI: 1.1 to 7.1) for physicians and 0.6% (95% CI: -1.2 to 1.8) for parents. About 58% of the physicians overestimated the likelihood of survival. ConclusionsThe study found that the decision threshold for the physicians was higher than that for the parents (5.3% vs. 1.2%). This illustrates that parents still want to attempt resuscitation at a survival probability where physicians would recommend withholding resuscitation. These findings have implications for clinical practice and counseling the parents of critically ill hospitalized children.

Background Older adults' walking has so far been evaluated using standardised assessments of walking capacity within a clinical setting. By taking the evaluation out of the laboratory into the real world, this study provides first evidence of the ability of Digital Mobility Outcomes (DMOs) to detect changes over time and the Minimal Important Difference (MID) in patients after proximal femoral fracture (PFF). This will guide the implementation of DMOs in research and clinical care. Methods For this multicenter prospective cohort study, 381 community-dwelling older adults were included within one year after sustaining a PFF and assessed at two time points, separated by six months. Walking activity and gait DMOs were measured using a single wearable device worn on the lower back for up to seven days. A global impression of change question and three mobility-related outcome measures (Late-Life Function and Disability Instrument; Short Physical Performance Battery; 4m gait speed) were used as anchor variables. To assess each DMOs ability to detect changes, we calculated the standardized mean change as effect size. For estimating MIDs, both distribution-based and anchor-based methods were applied, followed by triangulation by experts if at least three anchor-based estimates were available per DMO, resulting in single-point estimates. Results All three anchor variables demonstrated substantial changes. Overall, 10 out of 24 available DMOs showed large and 7 DMOs moderate positive effects in the expected direction of the respective anchors. Seven DMOs showed no or only small effects. For 12 DMOs, at least three anchor-based estimates were available, enabling MID triangulation. MIDs for walking activity DMOs per day were: a walking duration of 10 minutes, a step count of 1,000 steps, 50 walking bouts (WB), and 15 WBs in WBs over 10 seconds. For gait DMOs, depending on the walking bout length, MIDs for walking speed were between 0.04 m/s and 0.08 m/s, and MIDs for cadence between 4 and 6 steps/minute. Almost all DMOs showed a strong ability to detect improvement in mobility, but rarely in detecting decline. Conclusions For the first time, MIDs are presented for real-world DMOs in PFF patients. These MIDs inform sample size requirements and interpretation of intervention effects for clinical trials, thereby providing guidance and reassurance for clinicians and regulatory bodies.

BackgroundReactive balance training using repeated perturbations may reduce falls, however, training methods are not easily replicated or translatable to clinical settings. This study aimed to examine the effects of a novel reactive balance training program on balance recovery from laboratory induced trips and slips and fall risk factors in older people using simple and low-cost equipment. MethodsWe conducted a randomised controlled trial involving 88 older people. An intervention group (n = 43) received the ReacStep program which involved tether-release reactive stepping and intentional slips once a week for 6 weeks. Both the intervention and control (n = 45) groups received home-based strength training for 8 weeks. Blinded staff assessed reactive balance (laboratory induced falls), physical functions at baseline (week 1) and post intervention (week 8). Weekly SMS surveys ascertained falls in daily life over 12 months. ResultsBoth groups were comparable in demographics, with a mean age of 72 years (SD = 5.6). Adherence to ReacStep sessions was high (90%). There were no significant differences between groups in laboratory-assessed reactive balance falls at post-test or daily-life falls over one year (P =.19). However, at post-test, the intervention group demonstrated significant improvements in usual gait speed, maximum step length, and choice stepping reaction time compared to controls (P <.05). ConclusionsThe ReacStep program demonstrated excellent adherence, was well tolerated, and improved gait parameters required for balance recovery following postural perturbations in older people. Nevertheless, it appears this program is not sufficient to improve reactive balance against unexpected trips and slips. Key pointsO_LIThe ReacStep program is acceptable, demonstrates excellent adherence and improves gait measures in older people, potentially reducing fall risk. C_LIO_LIThe generalisability against unexpected trips, and slips, and falls in daily life may be limited. C_LIO_LIFuture research should explore more ecological perturbations while maintaining its accessibility and acceptability. C_LI

BackgroundOrganization, time management, and planning (OTMP) difficulties are associated with academic underachievement. OTMP skills training programs are effective in reducing OTMP deficits and improving academic performance. A randomized controlled trial of Homework, Organization, and Planning Skills (HOPS) for students ages 11-14 (1) found it to be effective with medium to large effects. In that study, HOPS was provided by counselors employed by the research team. This study is a replication examining HOPS under more authentic conditions when providers are employed by schools serving enrolled students. The primary aim is to evaluate HOPS offered by school providers in relation to treatment-as-usual/waitlist (TAU/WL). To respond to limited school resources post-COVID-19, HOPS is also provided by research team members, creating the opportunity to replicate the findings from the prior trial (1) and explore differential effectiveness when HOPS is implemented by school vs. research providers. MethodsStudents in about 30 schools serving students ages 11-14 will be enrolled. Schools are randomly assigned to HOPS vs. TAU/WL on a 2:1 ratio. Students assigned to HOPS schools are randomly assigned to a school vs. research provider on a 1:1 basis. Providers receive two hours of training and additional assistance on request. Child outcomes related to OTMP skills, homework, and academic performance are assessed at post-treatment, 6-month (from baseline) follow-up, and 12-month follow-up. HOPS sessions are video recorded for fidelity coding. Potential effect modifiers include student ADHD, oppositional defiant, and internalizing symptoms, and family socioeconomic level. Analyses will use mixed effects modeling. The goal of the study is to enroll 135 participants, yielding a minimal detectable effect size of 0.50, within the expected range based on prior research. DiscussionThe study is unique in examining intervention implementation and effectiveness when intervention is provided under authentic practice conditions. Trial RegistrationThis study was registered with clinicaltrials.gov (NCT04465708).

This study aimed to evaluate the prognostic value of quantitative analysis of {superscript 1}F-FDG positron emission tomography (PET)/computed tomography (CT) metabolic parameters in patients with pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant chemotherapy (NACT). A retrospective analysis was conducted on the clinical and imaging data of 44 patients with pathologically confirmed PDAC who received NACT. All patients completed standard chemotherapy regimens and underwent {superscript 1}F-FDG PET/CT examinations within 2 weeks before and after chemotherapy. Multiple metabolic parameters of lesions were extracted, their percentage changes were calculated, and the optimal cut-off values for each parameter were determined. Kaplan-Meier survival analysis and Cox proportional hazards regression analysis were applied to explore the prognostic value of the metabolic parameters, and the prognostic stratification performance of PET Response Criteria in Solid Tumors (PERCIST) 1.0 was compared with that of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. PERCIST 1.0 demonstrated significantly superior prognostic stratification compared with RECIST 1.1. A peak standardized uptake value corrected for lean body mass (SULpeak2) > 3.07 and a percentage change in SULpeak between pre- and post-treatment scans ({Delta}SULpeak%) [&le;] 37.66% were identified as independent risk factors for poor prognosis. Furthermore, SUL-related parameters exhibited markedly better predictive efficacy than traditional metabolic parameters such as the standardized uptake value and metabolic tumor volume. Quantitative analysis of {superscript 1}F-FDG PET/CT metabolic parameters can effectively predict prognosis in PDAC after NACT, and PERCIST 1.0 is a more optimal criterion for efficacy and prognostic assessment. A post-NACT SULpeak > 3.07 and {Delta}SULpeak% [&le;] 37.66% were core independent indicators for predicting poor prognosis in these patients.

IntroductionThis clinical trial investigates the efficacy and safety of a personalized 15-day accelerated intermittent theta-burst stimulation (aiTBS) protocol, targeted at either the default mode network (DMN) or the fronto-parietal network (FPN), in individuals with mild Alzheimers disease (AD). Methods45 patients with mild AD were randomized 1:1:1 to receive 15 consecutive days of high-dose aiTBS (7200 pulses/day) targeting the DMN or FPN, or sham. The primary outcome was the change in ADAS-Cog after 15 days of treatment. ResultsBoth active aiTBS groups demonstrated significantly greater ADAS-Cog improvement than sham at the primary endpoint. Response rates for a clinically meaningful improvement ([&ge;]3-points on ADAS-Cog) were significantly higher in the active groups (DMN: 38%; FPN: 47%) than in the sham group (0%). The improvement in active groups was sustained at 3-month follow-up. DiscussionPersonalized aiTBS targeting the DMN or FPN produced clinically meaningful cognitive benefits in mild AD and was safe.

Iron deficiency (ID) is the most common nutritional deficiency worldwide, often caused by insufficient dietary intakes. Oral supplementation is one of the means to improve iron status. This study evaluated the efficacy and safety of two low-dose iron supplements - >Your< Iron Forte Capsules (YIFC) and Ferrous Sulfate Capsules (FSC) - in individuals with dietary ID. One hundred and one participants (mean age 30.6 years; 98% women) with low iron stores (mean serum ferritin 16.1 {micro}g/L) were randomized to receive either YIFC or FSC once daily for 12 weeks. Changes in blood indices and iron-related parameters were assessed at four and 12 weeks of intervention relative to baseline. The primary outcome was the change in hemoglobin (Hb) after 12 weeks. Eighty-seven participants completed the study. Both supplements significantly increased Hb at 12 weeks (YIFC: mean 6.52 g/L, p<0.001; FSC: mean 5.71 g/L, p<0.001). Product-related adverse events (AEs) were few (17% of all AEs) and of mild to moderate intensity only. One participant receiving FSC withdrew due to a probable product-related AE. The frequencies of product-related AEs were similar between study arms, however, statistically significantly more AEs judged to be definitely related to the product occurred in in the FSC arm. While product-related AEs were confined to the gastrointestinal tract in the YIFC arm, they affected multiple organ systems in the FSC arm. Supplementation with either YIFC or FSC proved as an effective, well-tolerated, and safe strategy for improving iron status in non-anemic dietary iron deficiency. In terms of the AE profile, supplementation with YIFC may offer advantages over supplementation with FSC.

BackgroundIndividuals with severe mobility impairments (SMI) often experience significant psychological distress and chronic pain. Virtual walking (VW) presents an innovative rehabilitation approach to improve mood and alleviate pain. This study aimed to develop a home-based VW system with integrated mood and symptom tracking and to report on its feasibility and usability in a user study with individuals with SMI. MethodsA multidisciplinary, iterative frame-work guided the systems development. Following initial contextual research and design iterations, a user study was conducted with 11 participants with SMI. A repeated measures pre-post design was employed. Feasibility and usability were primarily assessed through post-study qualitative interviews, analyzed via content analysis. Changes in mood and symptoms were measured immediately before and after each session. Momentary mood was captured using an in-virtual reality (in-VR) two-dimensional (2D) affect grid, while embedded single-item state ratings were used to track anxiety, depressed mood, and pain. Daily mood changes and symptom trajectories were analyzed using logistic regression and generalized estimating equations (GEE), respectively. ResultsContextual research guided the system design towards enhancing accessibility, ergonomics, and therapeutic engagement. The final VW system featured three core modules: locomotion, multi-sensory feedback, and mood/symptom tracking. Qualitative analysis of the user study revealed high acceptance for the VW system, alongside challenges related to content variety and hardware ergonomics. Each intervention session was significantly associated with an immediate positive mood shift (odds ratio (OR) = 1.83), as measured by the affect grid. Furthermore, GEE models revealed a significant reduction in self-reported depression and anxiety symptoms over the intervention period (all P < 0.01). ConclusionsThis study confirms the feasibility and acceptability of the novel VW system for home-based use by individuals with SMI. The preliminary evidence suggests the system has high potential as a tool for improving mood and alleviating psychological distress. Future large-scale randomized controlled trials are warranted to establish its clinical efficacy. Trial registration numberNCT07073144-07/17/2025.

Abstract/SummaryFinancial exploitation of older adults is an increasingly prevalent public health concern, yet few have characterized fraud prevalence longitudinally or evaluated whether financial exploitation vulnerability measures prospectively predict fraud outcomes. Using data from the Health and Retirement Study, we examined fraud prevalence across a 14-year period and tested whether the Perceived Financial Vulnerability Scale (PFVS) predicts subsequent fraud victimization among older adults. Fraud prevalence increased steadily over time, rising from 5.0% in 2008 (347 of N=6,920) to a peak of 10.2% in 2022 (448 of N=4,380). Higher PFVS scores measured in 2018 were associated with greater odds of fraud victimization reported in 2022 (OR=1.62, 95% CI [1.25-2.15], p<.001). Most individuals who later reported fraud fell within the highest group of PFVS scores up to five years earlier. Together, these findings highlight financial exploitation as an emerging aging-related vulnerability and support the PFVS as a brief indicator of future fraud risk.

Background and ObjectiveThe dysbiosis of human gut microbiome has been increasingly seen to have a relation in the development of autoimmune diseases, with specific microbial signatures having causative association with specific conditions. Inflammatory bowel disease (IBD) is one such autoimmune ailment. This paper proposes a predictive tool that can identify the IBD status of an individual based on the composition of the gut microbiome using machine learning and AI agents driven techniques. The technology can strengthen the suspicion of a potential IBD diagnosis a patient may have based on their gut microbiome profile. MethodsThe tool processes patient gut metagenome using integrated Kneaddata and MetaPhlAn to generate taxonomic profiles. These are fed into an XGBoost classifier to predict IBD or healthy status. Dysbiotic taxa are identified via Z-score and fold change. CrewAI delivers personalized probiotic recommendations based on diagnosis and dysbiosis. ResultsThe tuned XGBoost model achieved 86.6% accuracy. On validation using single ulcerative colitis sample, the tool correctly predicted IBD status but misclassified it as Crohns disease(possibly due to overlapping microbial signatures), identifying Faecalibacterium and Flavonifractor as dysbiotic taxa.The probiotic recommended was Faecalibacterium prausnitzii, backed with reasoning basedon scientific literature. ConclusionsDespite limited validation sample size, the high accuracy, correct IBD detection, dysbiosis analysis and elaborate probiotic recommendation suggest promising potential; further validation needed