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PubMed2026

Effect of brewers' yeast or beta-glucan derived from Saccharomyces cerevisiae on breast milk supply following preterm birth: the BLOOM randomised controlled trial.

OBJECTIVE: Breast milk is the optimal source of nutrition for preterm infants; however, low breast milk production is common following a preterm birth. This study aimed to determine if taking brewers' yeast or beta-glucan improves daily expressed breast milk volume. DESIGN: Randomised, blinded, parallel, placebo-controlled trial. SETTING: Three Australian tertiary-level neonatal units. PATIENTS: Mothers with a singleton or twin pregnancy who gave birth at <34 weeks' gestation. INTERVENTIONS: Mothers were randomised within 72 hours of birth into three parallel groups in a 1:1:1 ratio to receive either brewers' yeast, beta-glucan or placebo capsules for 7 days. MAIN OUTCOME MEASURE: Total expressed breast milk volume over a 24-hour period on day 7 of intervention. RESULTS: A total of 105 mothers underwent randomisation between August 2022 and April 2024 (36 brewers' yeast, 35 beta-glucan and 34 placebo). The adjusted mean difference in daily expressed breast milk volume was 94 mL/day (95% CI -51 mL/day to 239 mL/day) between the brewers' yeast and placebo groups and -25 mL/day (95% CI -173 mL/day to 123 mL/day) between the beta-glucan and placebo groups. Maternal side effects were similar across groups. CONCLUSION: We found no clear effect of short-term administration of brewers' yeast or beta-glucan on breast-milk production following preterm birth; both interventions were well tolerated. Given the small sample size, these findings do not rule out the possibility of a clinically meaningful benefit of brewers' yeast and suggest further research with a larger sample size may be warranted to clarify the potential clinical impact. TRIAL REGISTRATION NUMBER: ACTRN12622000968774.

Intensive Care Units, Neonatal↗

PubMed2026

Effects of Digital Mental Health Screening Alone and With the Online MINDBODYSTRONG CBT-Based Program on Burnout, Depression, Anxiety, Healthy Behaviors, and Suicidal Ideation in at-Risk Nurses at 3- and 6-Months Post-Intervention: An RCT.

BACKGROUND: Burnout and mental distress among nurses are global public health epidemics that adversely affect nurse well-being and healthcare quality. Evidence-based, scalable mental health interventions are urgently needed. AIMS: To evaluate the 3- and 6-month outcomes of a randomized controlled trial (RCT) comparing a psychologically safe, digital mental health screening and referral program alone versus the same screening and referral program combined with the video-based online MINDBODYSTRONG (MBS) cognitive behavioral therapy (CBT)-based skills-building program among nurses at risk for mental distress. METHODS: 501 nurses were recruited from professional organizations and healthcare systems across the United States by email and randomized to either mental health screening and referral (standard care) or standard care plus the MBS cognitive behavioral skills-building intervention (the intervention). All study activities were conducted remotely. Follow-up surveys administered at 3- and 6-months assessed anxiety, depression, suicidal ideation, burnout, healthy lifestyle beliefs, and healthy lifestyle behaviors using valid and reliable scales. RESULTS: Compared with the screening and referral only group, participants in the intervention group had greater reductions in anxiety and depression and significantly greater increases in healthy lifestyle beliefs and behaviors at 3 and 6 months post-intervention. After controlling baseline risk, the intervention group had a lower risk of suicidal ideation than the screening and referral group at 3 months (relative risk ratio [RRR] = 0.717; 95% CI: 0.320-1.606) and 6 months (RRR = 0.329; 95% CI: 0.101-1.072). The intervention group also had a significantly lower risk of burnout at 6 months (RRR: 0.698, 95% CI: 0.528, 0.929, p = 0.012). Nurses who completed more MBS sessions had less suicidal ideation at 6 months and those who completed more MBS skills-building activities had less burnout at 3 and 6 months. LINKING ACTION TO EVIDENCE: Integrating psychologically safe mental health screening combined with the scalable online CBT-based intervention, MBS, can produce sustained improvements in burnout, mental health symptoms, including suicidality, and healthy lifestyle beliefs and behaviors among nurses experiencing mental distress.

Humans↗

PubMed2026

Dissociating behavioral, neural and experiential effects of prefrontal HD-tDCS during conflict resolution.

Inconsistent evidence regarding the cognitive effects of transcranial direct current stimulation (tDCS) highlights the need for more comprehensive approaches to assess its impact. This study aimed to investigate the effects of high-definition tDCS (HD-tDCS) on conflict resolution by combining behavioral, neural, and subjective experience measures. Sixty participants were randomly assigned to anodal, cathodal, or sham HD-tDCS groups and completed a 30-min flanker task. EEG was recorded during the first and last blocks (without stimulation), while stimulation was applied during the intermediate blocks of the task. Using a multidimensional methodological approach including Drift-Diffusion Modeling (DDM), EEG spectral analysis, Lempel-Ziv complexity, and Temporal Experience Tracing (TET), we assessed the cognitive, neural, and phenomenological effects of stimulation. Behavioral results indicated no significant improvements in reaction times or accuracy across the stimulation groups. Similarly, DDM parameters showed no effect of HD-tDCS on latent cognitive processes. However, EEG data revealed a significant reduction in neural complexity in the anodal group during resting-state, suggesting a stabilization or reorganization of neural dynamics. Subjective experience analysis identified two distinct clusters of task-related feelings, though time spent in these experiential states did not differ between groups. Interestingly, sensation of stimulation was significantly higher for anodal stimulation than sham when analyzed as a single dimension. Despite null behavioral effects, this study provides important insights into the neural and subjective responses to HD-tDCS and highlights the value of integrating complementary multidimensional approaches to better characterize brain stimulation effects. These findings contribute to the ongoing debate about the efficacy of tDCS in cognitive enhancement.

Humans↗

PubMed2026

Symptom Burden After Dialysis Initiation and Its Association With Hospitalization.

RATIONALE & OBJECTIVE: Symptom burden is distressing for patients living with kidney failure, but there is limited information about the combination of symptoms and individual symptoms that most strongly predict health care use in this group. We classified and summarized patients' symptom burden levels and changes over time and estimated associations with hospitalizations among patients receiving incident hemodialysis. STUDY DESIGN: Longitudinal, observational. SETTING & PARTICIPANTS: Individuals initiating dialysis in the United States. EXPOSURE: Kidney Disease Quality of Life-36 (KDQOL-36) measure. OUTCOME: First hospitalization after dialysis initiation. ANALYTICAL APPROACH: Latent transition analysis was used to identify symptom burden classes using the KDQOL-36. Cox regression models were used to assess whether individual KDQOL-36 symptoms and symptom burden groups were associated with hospitalization risk after dialysis initiation, independent of demographics and comorbid conditions. RESULTS: 1,818 participants were Black (29%), were aged >65 years (59%), were women (42%), had diabetes (49%), and had hypertension (74%). Latent transition analysis identified the following 3 symptom burden groups: (1) low (low severity of all symptoms and kidney disease impacts), (2) moderate (high physical health impact and overall burden of kidney disease), and (3) high (high levels of all symptoms and kidney disease impact). After adjusting for patient characteristics, all KDQOL-36 scales except the Effects of Kidney Disease scale were associated with a higher hazard of hospitalization. Using the symptom burden groups, a high symptom burden was associated with a 20% increase in the hazard of hospitalization. A 1-category worsening in pain interference and in fatigue was associated with a 12% and an 8% increased hazard of hospitalization, respectively. LIMITATIONS: Findings may not generalize outside the United States. CONCLUSIONS: Pain interference and fatigue, as well as an overall symptom burden, are useful prognostic indicators in patients receiving in-center hemodialysis. Symptom burden should remain a treatment target in hemodialysis.

Hemodialysis↗

PubMed2026

Latent profile analysis of pregnant exercise adherence and the relationship with demographic and socio-psychological factors: a multicentre cross-sectional study.

BACKGROUND: Pregnancy physical activity (PA) and exercise benefits both mothers and babies, but requires sustained adherence. Many pregnant women fail to meet recommended levels. The reasons for low adherence comprised fluctuating physiological and environmental factors. This study aims to identify discrete profiles of pregnant women based on exercise adherence and to examine differences in demographic and socio-psychological factors across these profiles. METHODS: A survey was conducted among 1,255 pregnant women in three hospitals in Shenzhen, Dongguan, and Shunde, China, using the Exercise Adherence Rating Scale (EARS), the Pregnancy Exercise Self-Efficacy Scale (P-ESES), and the Pregnancy Physical Activity Social Support Scale (P-PASSS). In the analysis, EARS items were scored higher, indicating a healthier state (e.g., sufficient time and energy). Latent profile analysis (LPA) was employed to classify adherence profiles, and multinomial logistic regression was used to examine differences in demographic, self-efficacy, and social support across four groups. RESULTS: Four profiles of exercise adherence were identified: (1) Profile 1 (16.97%), characterized by deficits in time and energy, (2) Profile 2 (15.22%), a group with sufficient time resources but the lowest self-efficacy, (3) Profile 3 (43.98%), characterized by high adherence despite moderate barriers, and (4) Profile 4 (23.83%), a group with optimal exercise adherence, confidence, and resources. Women with higher P-ESES (OR: 1.14-1.38) and P-PASSS (OR: 1.04-1.06) scores were more likely to be in Profiles 3 and 4. Additionally, women's partners who never or occasionally exercise were significantly more likely to be categorized into Profile 1 (OR = 0.18 for Profile 4 vs. Profile 1). Furthermore, the first trimester emerged as a significant risk period for lower exercise adherence, whereas overweight/obesity was independently associated with higher odds of membership in Profile 4. CONCLUSION: The study identified four distinct profiles of exercise adherence among pregnant women. 32.19% of participants were in the two lower exercise-adherence groups. Pregnant women in Profile 1 were characterized by challenges related to a lack of time and knowledge. Participants in Profile 2 showed the lowest exercise self-efficacy and social support among the four profiles. Furthermore, women in early pregnancy were more likely to have lower adherence profiles. Hence, targeted interventions addressing these specific groups are warranted to improve exercise adherence during pregnancy.

Humans↗

PubMed2026

Artificial intelligence-assisted detection and optical differentiation of colorectal lesions in Lynch syndrome surveillance (CADLY2): a multicentre, open-label, randomised controlled superiority trial.

BACKGROUND: Artificial intelligence (AI)-based computer-aided detection (CADe) systems improve adenoma detection in average-risk colorectal cancer screening. Meanwhile, evidence in Lynch syndrome surveillance is sparse and inconsistent. We assessed the effect of CADe on adenoma detection during Lynch syndrome surveillance. Computer-aided optical diagnosis (CADx) performance for optical differentiation of colorectal lesions was evaluated as a secondary aim. METHODS: CADLY2 was an international, multicentre, open-label, randomised controlled superiority trial at nine specialised hereditary cancer surveillance centres in Belgium, Germany, the Netherlands, and Spain. Adults aged 18 years or older with genetically confirmed Lynch syndrome scheduled for surveillance colonoscopy were randomly assigned (1:1) to high-definition white-light (HD-WL) colonoscopy alone or to HD-WL colonoscopy with computer-aided assistance from CAD EYE (Fujifilm, Tokyo, Japan). CAD EYE was used for CADe during withdrawal and for CADx after lesion detection. Randomisation was done centrally through a secure web-based system using Pocock's minimisation algorithm with a stochastic component and was stratified by centre, sex, previous colorectal cancer, underlying pathogenic variant, and interval since previous colonoscopy. Allocation concealment was ensured through the centralised web-based system. Patients were masked to group allocation until the start of withdrawal in procedures with mild sedation, or until completion of the procedure in procedures with propofol-based sedation. Endoscopists were not masked. The primary outcome was adenoma detection rate, defined as the proportion of patients with at least one histopathologically confirmed adenoma, analysed in the full analysis set (defined as all randomly allocated patients with available data for the primary outcome). The diagnostic performance of the CADx system was evaluated as a secondary outcome. The safety analysis set comprised all randomly allocated patients who underwent a study colonoscopy. This study is registered with the German Clinical Trials Register, DRKS00030695, and is completed. FINDINGS: Between May 9, 2023, and Oct 30, 2025, 757 patients were randomly allocated to HD-WL colonoscopy (377 patients) or to AI-assisted colonoscopy (380 patients); 733 patients were included in the full analysis set (369 HD-WL and 364 AI-assisted). The median age was 49 years (IQR 38-59) in the HD-WL group and 50 years (38-59) in the AI-assisted group; 213 (58%) were female and 156 (42%) male in the HD-WL group, and 207 (57%) were female and 157 (43%) male in the AI-assisted group. The adenoma detection rate was 30·9% (114 of 369 patients) with HD-WL versus 33·8% (123 of 364 patients) with CADe assistance (odds ratio 1·14 [95% CI 0·83-1·57], p=0·41). For CADx differentiation of neoplastic versus non-neoplastic lesions in the paired lesion-level analysis, with histopathology as the reference standard and sessile serrated lesions and traditional serrated adenomas classified as non-neoplastic, CADx sensitivity was 85·9% (95% CI 82·0-89·1) and specificity was 91·4% (89·4-93·0). Three adverse events occurred in the AI-assisted group: two mild post-polypectomy bleedings and one serious pulmonary embolism or deep venous thrombosis unrelated to the procedure. No adverse events occurred in the HD-WL group. INTERPRETATION: CADe-assisted colonoscopy did not show the absolute improvement in adenoma detection rate that was assumed in the prespecified sample-size calculation. CADx did not clearly improve lesion differentiation beyond expert optical diagnosis in expert Lynch syndrome surveillance settings. FUNDING: Third-party research funding of the National Center for Hereditary Tumor Syndromes, University Hospital Bonn.

Humans↗

PubMed2025

Preoperative Patient Education on Opioid Use and Pain After Surgery: A Randomized Trial.

OBJECTIVE: To evaluate the impact of preoperative analgesic education on postoperative opioid consumption, pain scores, and patient satisfaction with analgesia. BACKGROUND: Effective postoperative pain management is crucial for patient recovery and satisfaction, yet opioid use poses risks of tolerance and addiction. Preoperative patient education offers a potential avenue to mitigate opioid reliance and improve pain management outcomes. METHODS: This single-center randomized trial was conducted at the Cleveland Clinic Main Campus between October 2021 and October 2023. Adult patients scheduled for hip arthroplasty or laparoscopic-assisted abdominal surgery with an ASA physical status of 1 to 4 were eligible. Patients with a history of prolonged opioid use, planned regional block or epidural analgesia, or limited English fluency were excluded. Participants were randomized 1:1 to receive either an analgesic educational video or a generic video about surgery and hospitalization. The primary outcome was opioid consumption during the initial 72 postoperative hours. Secondary outcomes included time-weighted average pain scores and patient satisfaction with analgesia. RESULTS: Among 957 analyzed patients, preoperative analgesic education did not significantly reduce opioid consumption (adjusted ratio of geometric means, 1.01; 95% CI, 0.86-1.18; P =0.890) or improve pain scores (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P =0.617). Patient satisfaction scores also did not differ significantly between groups (adjusted mean difference, -0.1; 95% CI, -0.3 to 0.2; P = 0.611). CONCLUSIONS: Preoperative analgesic education did not result in clinically meaningful reductions in opioid consumption or improvements in pain management outcomes. Further research may explore more intensive educational interventions to optimize postoperative pain management strategies.

Humans↗

PubMed2026

Comparative Efficacy and Safety of Adjunctive 0.015% Triamcinolone Acetonide Topical Spray With Lokivetmab Versus Lokivetmab Monotherapy as 'Reactive Therapy' for Canine Atopic Dermatitis: A Randomised, Single-Blinded, Controlled Preliminary Trial.

BACKGROUND: Lokivetmab is considered an effective systemic therapy for dogs with atopic dermatitis (AD); however, utilisation of lokivetmab with adjunctive topical anti-inflammatory glucocorticoids has not been investigated in canine AD. OBJECTIVES: To evaluate the efficacy and safety of the combination therapy of lokivetmab and 0.015% triamcinolone acetonide (TCA) spray in dogs with AD. ANIMALS: Twenty dogs with nonseasonal AD. MATERIALS AND METHODS: This study was a randomised, single-blinded (investigators only) 4-week controlled trial. Dogs were randomised to receive lokivetmab monotherapy or lokivetmab-TCA spray per manufacturer instructions. Clinical assessments included the Canine Atopic Dermatitis Extent and Severity Index, 4th iteration (CADESI-04), CADESI-04E (i.e., extracted erythema grade alone) and the 10-grade pruritus Visual Analog Scale (PVAS10) at Day (D)0, D14 and D28. Complete blood count and serum biochemical analysis were performed on D0 and D28. RESULTS: The median CADESI-04 and CADESI-04E scores in the lokivetmab-TCA group were significantly reduced on D14 (p < 0.05 for both) and D28 (p < 0.01 for both) compared to baseline; there were no significant differences in lesional scores at any time point for the lokivetmab monotherapy group. Lokivetmab-TCA significantly reduced CADESI-04E values compared to the lokivetmab monotherapy group on D28 (p = 0.04). Both interventions significantly reduced PVAS10 scores on D14 and D28 compared to D0 (p < 0.05 for both groups). CONCLUSIONS AND CLINICAL RELEVANCE: Topical application of TCA spray may be a useful and safe adjunctive therapy for systemic lokivetmab to alleviate pruritus and clinical lesions in the initial management of canine AD patients.

Animals↗

PubMed2026

Insights into specific and nonspecific butyrate-producing pathways during the in vitro fecal fermentation of butyrylated starch.

Butyrylated starch is a special type-4 resistant starch with butyrate-carrying attribute. In this study, the unique butyrate-producing capability of butyrylated starch was deeply investigated by focusing on its specific and nonspecific butyrate-producing pathways, respectively, using specially designed substrates as controls. In vitro fermentation studies revealed that butyrylated and isobutyrylated starches generated high levels of butyrate and isobutyrate, respectively, highlighting the role of butyryl group metabolism in the specificity of butyrate production. Carboxylesterase assays have demonstrated that butyryl group metabolism is primarily facilitated by carbohydrate esterases expressed in the gut microbiota. Combined with 16S rRNA sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis, it was found that butyrylated starch fermentation did not significantly enhance traditional butyrate synthesis pathways but modified the balance between the butyryl-CoA:acetyl-CoA transferase and butyrate kinase pathways by altering the gut microbiota composition, specifically by upregulating the relative abundance of indicator species such as Bacteroides, the Lachnospiraceae_NK4A136_group, and Parabacteroides. These insights offer theoretical guidance for designing butyrylated starch structures and regulating intestinal health.

Starch↗

PubMed2026

Mealtime satisfaction in public nursing homes: Associations with sensory, foodservice, and dining-room environment factors.

Satisfaction with meals is commonly used to assess how meals are experienced in nursing homes (NH), although limited evidence compares breakfast, lunch, and dinner within a unified analytical framework. This study examined the sensory and contextual factors associated with satisfaction across meals in public NH. A cross-sectional observational study was conducted using structured interviews with 290 residents aged ≥60 years (median 85 years; Q1-Q3: 81-88; 63.1% women) from 19 facilities in Galicia, Spain. Overall satisfaction and 12 factors related to sensory attributes of the food, foodservice characteristics, and dining-room environment were assessed using a 5-point Likert scale. Descriptive analyses used medians and quartiles, and group comparisons were performed using nonparametric tests. Three multivariable linear regression models, one per meal, were estimated including all factors simultaneously. In adjusted models, the largest standardized coefficients were observed for taste (lunch: β = 0.366; P < 0.001), food temperature at serving (dinner: β = 0.319; P < 0.001), and menu variety (breakfast: β = 0.301; P < 0.001). Taste, food temperature at serving, menu variety, and meal schedule showed statistically significant coefficients in all models. Overall satisfaction was lower at dinner (29.0% ≥ 4) than at breakfast (34.8%) and lunch (34.5%) (P = 0.003). Selected dining-room environment factors showed significant coefficients in meal-specific models. Mealtime satisfaction was mainly associated with sensory and contextual factors related to how meals are perceived. Lower satisfaction at dinner suggests this mealtime as a relevant context for understanding variations in meal perception in NH residents.

Humans↗

PubMed2025

Improving Community-Based Care for Adolescents with ADHD: a Randomized Controlled Trial of Artificial Intelligence-Assisted Fidelity Supports.

Cognitive-behavioral treatments (CBTs) for adolescents with ADHD demonstrate promise of long-term effects on outcome. However, their implementation in routine care community clinics faces barriers that impact quantity, efficiency, and quality of delivery, as well as client outcomes. This study is a randomized controlled trial designed to evaluate the impact of an AI-assisted service delivery model on therapist implementation of Supporting Teens' Autonomy Daily (STAND), a CBT blended with Motivational Interviewing (MI) for adolescents with ADHD. Adolescents with ADHD (N = 51), who were clients at three community mental health agencies, received treatment from 23 therapists. There was randomization of adolescents and therapists to AI-assisted or standard implementation supports. In addition to standard supports (i.e., training, standard facilitation resources, technical assistance, case supervision), AI-assisted support package included digitized facilitation resources housed in a clinical dashboard (Care4), feedback on content fidelity, and AI-generated feedback on MI implementation quality. The AI-assisted group was associated with more efficient treatment delivery and lower number of appointments attended by the adolescent. There was also a significant decrement in MI quality over time in the AI-assisted group compared to the standard support group. Feedback in focus groups indicated that therapists perceived a task-oriented mindset to be associated with receipt of the AI-assisted support package, leading therapists to prioritize efficiency over relational aspects of therapy. Following the results of this trial, a future, larger RCT should examine the impact of the AI-assisted implementation model on mental health outcomes and cost savings to organizations, third party payers, and clients. Trial registration number: NCT05135065; https://www.clinicaltrials.gov ; Registered September 2021.

Humans↗

PubMed2026

A 7-mm Covered TIPS Reduces Hepatic Encephalopathy Without Increasing Rebleeding in Cirrhotic Patients With Small Liver: A Randomized Study.

BACKGROUND/AIMS: International guidelines recommend initiating transjugular intrahepatic portosystemic shunt (TIPS) placement with an 8-mm stent. However, there is an evident lack of randomized controlled trials evaluating TIPS diameters < 8 mm in cirrhotic patients with a relatively small liver. The aim of this study was to determine whether 7 mm-covered TIPS, compared with 8-mm stents, could achieve comparable shunt function with a lower incidence of hepatic encephalopathy (HE). METHODS: In this multicenter randomized controlled trial, patients with cirrhosis and relatively small liver were randomized 1:1 to receive TIPS with a 7-mm (n = 92) or 8-mm (n = 92) covered stent to prevent variceal rebleeding. The primary endpoint was the incidence of overt HE after randomization. All-cause rebleeding, orthotopic liver transplantation (OLT)-free survival and a composite of these outcomes, were designated as secondary endpoints. RESULTS: Among the 184 enrolled patients, the predominant etiologies of liver cirrhosis were hepatitis B virus infection (56.0%) and alcohol-related liver disease (20.7%). Over a median follow-up of 26.5 months, overt HE occurred in 19 patients (20.7%) in the 7-mm group and 33 patients (35.9%) in the 8-mm group. The 2-year cumulative incidence of overt HE was significantly lower in the 7-mm group than in the 8-mm group (21.4% vs. 37.2%, p = 0.02). Stent diameter, post-TIPS portosystemic pressure gradient, pre-covert HE and MELD-Na score were identified as independent risk factors for overt HE. The rates of shunt dysfunction were statistically similar between groups (8.7% vs. 8.7%, p = 1.0), as were 2-year rebleeding rates (10.9% vs. 9.8%, p = 0.81) and OLT-free survival rates (91.3% vs. 88.0%, p = 0.82). CONCLUSIONS: A 7-mm covered TIPS demonstrated comparable shunt function to an 8-mm covered stents, with a significantly lower risk of overt HE. These findings support consideration of 7-mm TIPS stents for preventing variceal rebleeding in cirrhotic patients with a small liver who are undergoing TIPS. TRAIL REGISTRATION: ClinicalTrials.gov, NCT02541825.

Humans↗

PubMed2026

Impact of a thermal care bundle on peri-operative hypothermia, surgical site infection, and readmissions in osteosynthesis patients: A randomised controlled trial.

BACKGROUND: Maintaining normothermia throughout the peri-operative period prevents the occurrence of complications related to hypothermia. OBJECTIVE: To determine the effect of a thermal care bundle with a short prewarming period on inadvertent peri-operative hypothermia (IPH), surgical site infection (SSI), and unplanned readmission among osteosynthesis patients, and to identify associated variables. DESIGN: Open-label, randomised controlled trial. SETTING: University hospital. PATIENTS: One hundred and forty-eight patients who underwent osteosynthesis surgery. INTERVENTION: The intervention group received the thermal care bundle, which consisted in prewarming patients 10 min before anaesthesia delivery and maintaining body temperature with a forced air device during surgery and the immediate postoperative period; in addition, the operating room environmental temperature was kept at 21 °C, and fluids were warmed to 38 °C. MAIN OUTCOME MEASURES: For the primary objective, hypothermia was defined as core body temperature below 36 °C and measured using the 3M Spot On zero heat flux sensor. Core temperature was recorded upon admission to the pre-operative holding area and subsequently every 30 min until postanaesthesia care unit (PACU) discharge. Secondary objectives were SSI and readmissions: a follow-up at 30 to 60 and 90 days was performed by the principal investigator. RESULTS: All 148 patients completed the study, and there were no significant differences between the groups at baseline. At the start of surgery, the incidence of hypothermia was significantly lower in the bundle group (1.3 vs. 9.9% among controls; odds ratio = 7.59, P  = 0.021). A significantly lower incidence of hypothermia was also observed at admission to the PACU (14.3% in the bundle group vs. 29.6% among controls; odds ratio = 2.07; P  = 0.024). Application of the bundle increased patients' core body temperature by 0.13 °C (95% confidence interval (CI), 0.003 to 0.254; P  = 0.045). Patients in the bundle group had a slightly lower observed incidence of wound infections requiring readmission (odds ratio = 0.35; 95% CI, 0.04 to 2.92), although this difference was not statistically significant ( P  = 0.332). CONCLUSIONS: The bundle reduces peri-operative hypothermia by up to 59%, but does not affect on SSI; factors like presurgery hospital stay, operating room and PACU occupancy were identified as risk factors for SSI. REGISTRATION: 21 July 2022: NCT05469958 (Clinical Trials.gov), first recruitment 15 August 2022.

Adult↗

PubMed2026

Efficacy and safety of microwave ablation for the treatment of pulmonary osteosarcoma oligometastases.

PURPOSE: Evaluate efficacy and safety of microwave ablation (MWA) for pulmonary osteosarcoma oligometastases. METHODS: Twenty-two patients (median age, 16 years [range, 9-41 years]; 15 male) with pulmonary osteosarcoma oligometastases who underwent MWA from January 2018 to December 2023 were included, with 27 MWA sessions for 36 lung metastases. Technical success and complications were evaluated in all 22 patients, while efficacy and survival were evaluated in 19 patients with 24 MWA sessions in treatment of 32 tumors. Technical success was assessed for each tumor. Local tumor control, progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan-Meier method. Complications were classified using Common Terminology Criteria for Adverse Events version 5.0. RESULTS: Technical success was achieved in all 36 tumors (100.0%). Local tumor progression occurred in five of 32 tumors (15.6%). The estimated local tumor control rates at 12, 24 and 36 months were 96.9%, 86.1% and 81.5%, respectively. No significant difference in local control was found between tumors ≤ 10 mm and > 10 mm (p = .470). Twelve of 19 patients (63.2%) developed new lung metastases outside the ablation area, including one with concurrent newly developed bone metastases and one with recurrence of primary osteosarcoma. The median PFS was 21.5 months. The estimated OS rates at 12, 24 and 60 months were 100.0%, 94.4% and 94.4%, respectively. Major complications occurred in five of 27 sessions (18.5%). CONCLUSIONS: MWA preliminarily demonstrates a high technical success rate, notable local tumor control, promising overall survival and acceptable safety for pulmonary osteosarcoma oligometastases.

Adolescent↗

PubMed2026

Feasibility and efficacy of left bundle branch area pacing guided by modified chest lead 1.

BACKGROUND: Left bundle branch area pacing (LBBAP) typically requires 12‑lead electrocardiogram (ECG) measurements using an electrophysiology (EP) recording system. However, a simplified approach using modified chest lead 1 (MCL1) is potentially feasible. This study aimed to compare the success rate and pacing outcomes of LBBAP guided by MCL1 with those guided by the 12‑lead ECG using an EP recording system. METHODS: This retrospective, single-center study included patients with preserved left ventricular ejection fraction who underwent LBBAP for bradyarrhythmia. LBBAP was either guided by 12‑lead ECG using an EP recording system or by MCL1. In the MCL1 group, a follow-up examination with a 12‑lead ECG using an EP recording system was conducted within one week postoperatively. RESULTS: A total of 65 patients underwent LBBAP (EP recording system group: n = 35; MCL1 group: n = 30). The overall success rate of LBBAP was 84.6%, with no significant difference between groups (88.5% vs. 80.0%, p = 0.49). No significant differences were observed in the paced QRS duration (140.4 ± 8.0 vs. 141.9 ± 13.1 ms, p = 0.54), V6-V1 interpeak interval (39.7 ± 16.5 vs. 38.3 ± 15.6 ms, p = 0.79), or V6 R-wave peak time (69.8 ± 12.3 vs. 71.5 ± 12.1 ms, p = 0.68). CONCLUSIONS: MCL1-guided LBBAP was feasible and achieved a high success rate, with outcomes comparable to those of conventional EP recording system-guided implantation. This simplified approach may reduce procedural complexity and may allow LBBAP implantation without the routine use of an EP recording system.

Humans↗

PubMed2026

Effect of self-activating phthalocyanine gel on palatal donor site healing, inflammatory biomarkers, somatosensory and patient-centered outcomes: a randomized split-mouth clinical trial.

OBJECTIVES: To evaluate effects of self-activating phthalocyanine (PHY) gel on palatal donor site after subepithelial connective tissue graft (SCTG) harvesting, considering clinical outcomes, inflammatory biomarkers, patient-centered outcomes, and quantitative somatosensory changes. MATERIALS AND METHODS: Twenty participants were included in this randomized, crossover, split-mouth clinical trial. Donor sites received topical PHY gel (PHY group-PHYG) and placebo gel (control group-CG). Clinical parameters (residual wound area-RWA, wound epithelialization-WE, residual remodeling area-RRA and tissue thickness-TM) were assessed at baseline, 7, 14, 30, and 60 days. Patient-centered outcomes were recorded during 14 postoperative days and inflammatory biomarkers at 3 and 7 days postoperatively. Mechanical detection threshold (MDT) and mechanical pain threshold (MPT) were evaluated at baseline, 2 months, and 6 months. RESULTS: PHYG and CG exhibited similar clinical outcomes, but PHYG demonstrated superior performance in reducing RRA. Both groups presented positive postoperative progression of patient-centered outcomes. IL-10 levels showed a significant increase in PHYG, suggesting a more favorable anti-inflammatory response. MDT remained stable but, donor sites exhibited transient hypersensitivity (MPT) at 2 months. CONCLUSIONS: PHYG and CG protocols promoted satisfactory healing of palatal donor sites. Most clinical parameters and patient-centered outcomes were similar between groups. The PHYG presented reduced RRA and increased IL-10 levels. Donor sites exhibited transient hypersensitivity, which tended to resolve over time. CLINICAL RELEVANCE: Both postoperative protocols resulted in favorable healing of palatal donor sites following SCTG harvesting, with comparable clinical and patient-centered outcomes. Quantitative sensory testing indicates that hypersensitivity may occur during healing, but sensory function tends to recover progressively.

Humans↗

PubMed2026

Cognitive-behavioral therapy for post COVID-19 condition: A pilot randomized controlled trial.

BACKGROUND: The post COVID-19 condition (PCC) is a disabling condition with urgent need for effective treatments. This pilot randomized controlled trial examined the feasibility and efficacy of a cognitive-behavioral therapy (CBT) for PCC in a parallel-group design. METHODS: N = 53 individuals with PCC were randomized to CBT (n = 27) or 16-week wait-list control (WLC) condition (n = 26). One participant allocated to WLC was excluded after randomization, resulting in an intention-to-treat (ITT) sample of N = 52 participants (CBT: n = 27, age: M = 48.59, SD = 11.52, 77.8% female; WLC: n = 25, Age: M = 48.44, SD = 9.81, 60% female). CBT comprised eight group and five individual sessions addressing cognitive and behavioral factors of symptom maintenance (treatment duration if completed: M = 14 weeks, SD = 1 week). Primary outcomes included fatigue (FSS), overall somatic symptom burden (PHQ-15), and respiratory and cardiovascular symptoms (SBQ™-LC "Breathing" and "Circulation"), assessed at pre-, post-assessment, and follow-up. RESULTS: Participants receiving CBT showed a significant medium-sized reduction in fatigue directly after treatment compared to the WLC condition (d = -0.58, p = .045), whereas the WLC group showed a significant increase in overall somatic symptoms (d = 0.60, p = .027). Results for respiratory symptoms were mixed, showing inconsistent patterns across analyses. Retrospectively assessed feasibility and treatment satisfaction were good, with few adverse effects reported. CONCLUSIONS: This pilot trial suggests the feasibility and preliminary efficacy of CBT for PCC. Larger RCTs with active control groups should confirm these findings.

Humans↗

PubMed2026

Durability and Safety of Imeglimin as an Add-On to DPP-4 Inhibitors in Japanese Type 2 Diabetes: The 104-Week FAMILIAR Trial.

AIMS: To evaluate the long-term efficacy and safety of imeglimin added to dipeptidyl peptidase-4 (DPP-4) inhibitors in Japanese patients with type 2 diabetes, focusing on glycemic durability and safety in elderly patients over 104 weeks. MATERIALS AND METHODS: This multicenter, randomized, placebo-controlled trial comprised a 24-week double-blind phase (imeglimin 1000 mg or placebo twice daily) followed by an 80-week open-label extension in which all patients received imeglimin. Eligible patients had inadequate glycemic control despite DPP-4 inhibitor monotherapy. The main assessment measured HbA1c changes from baseline to week 104. Secondary assessments included meal tolerance tests (MTT) for evaluating physiological changes in β-cell function and insulin resistance and safety monitoring. RESULTS: Of 117 randomized patients, 81 completed 104 weeks. In the early-start group that received imeglimin from week 0, the significant HbA1c reduction observed at week 24 (-0.65%) was maintained through week 104 (-0.55%; p < 0.001 vs. baseline). The delayed-start group that switched to imeglimin at week 24 achieved similar glycemic control thereafter. Elderly patients (≥ 65 years) in the early-start group maintained stable HbA1c reduction (-0.58%) without hypoglycemic events over 2 years. MTT analysis in the early-start group showed sustained improvements in glucose AUC and insulin sensitivity without unnecessary insulin secretion over time. CONCLUSIONS: Imeglimin added to DPP-4 inhibitors appeared to improve glycemic control for 104 weeks, without clear attenuation. The combination was well-tolerated with a low risk of hypoglycemia even in elderly patients. The long-term effect may be associated with improvements in insulin sensitivity. TRIAL REGISTRATION: jRCTs061210082.

Humans↗