Changes of gut microbiota, hormone and glycolipid metabolism by dietary fiber (oat bran) supplementation in patients with laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass: A randomized controlled study.

Disruption and restoration of the self are theorized to be central to bereavement adjustment, yet previous interventions rarely address self-disruption directly. This study examined whether an online expressive writing intervention targeting self-disruption could alleviate grief symptoms in bereaved adults. In a two-arm randomized controlled trial, 66 bereaved participants were randomly assigned to an intervention group (n = 35) or a waitlist control group (n = 31). The intervention consisted of six sessions (one psychoeducational session and five structured expressive writing sessions) over three weeks, focusing on four aspects of self-disruption, namely: Loss of Self-Direction, Self-Derailment, Self-Devaluation, and Disconnection of Relational-Self. Grief severity was assessed using the PG-13-R at baseline and post-intervention, with a six-month follow-up for the intervention group. Compared with the waitlist control group, the intervention group showed a significantly greater reduction in grief severity (Cohen's d = - 0.93). Within the intervention group, the improvement remained stable at the six-month follow-up. Online expressive writing targeting self-disruption in bereaved adults may provide an effective, low-cost, and scalable intervention for grief. However, in the absence of a validated measure of self-disruption, whether the intervention exerts its effects through changes in the self remains untested. This trial was retrospectively registered with the Chinese Clinical Trial Registry (Registration Number ChiCTR2600120661, Date 18.03.2026).

Accommodation in myopic children wearing individualized ocular refraction customization spectacle lenses: Results from a randomized clinical trial.

Bladder outlet obstruction (BOO) is diagnosed through clinical urodynamics, an invasive method with many limitations, including side effects or surgical complications. This study introduces evaluation strategies for BOO recognition based on uroflowmetry test. In this study, a catheter-free male lower urinary tract (LUT) model was developed for hydrodynamics simulation. The pressure and velocity distributions in urethras with different obstruction degrees were analyzed under a fixed vesical pressure, and the effect of obstruction on urine flow under transient vesical pressure input was investigated. Dynamic analysis revealed that the assignments of urethral pressure and velocity were substantially influenced by the extent and location of obstruction. The global maximum pressure and velocity differences between obstructed and healthy urethra models reached 28.8 cm H2O and 2.41 m/s, respectively, at a constant bladder pressure input of 50 cm H2O. Vortices emerged at different segments along the obstruction, resulting in energy loss in the urine stream. Based on uroflowmetry data from 300 subjects, four dimensionless evaluation parameters were designed to distinguish healthy individuals from those with BOO, with p-values of < 0.001, 0.05, 0.001, and 0.02, respectively. The distributions of pressure, velocity, and vortex provide significant guidance for customized BOO surgery. In addition, the means and indicators of dimensionless evaluation have a crucial contribution to identify male BOO by uroflowmetry examination. Trial Registration: This experiment was certified by the Chinese Clinical Trial Registry (ChiCTR2200063467).

College students are vulnerable to depressive symptoms, suicidal ideation, sleep disturbance, and stress-related psychological problems. Aerobic exercise and repetitive transcranial magnetic stimulation (rTMS) have each shown therapeutic potential in affective disorders, but evidence on their combined application in college students at suicide risk remains limited, particularly when neurophysiological outcomes are considered. To evaluate the feasibility, safety, and preliminary effects of aerobic exercise combined with rTMS on suicidal ideation, depressive symptoms, sleep, and prefrontal functional activation in college students at suicide risk. This prospective single-centre non-randomised controlled pilot study will enrol students aged 18-21years who are identified as being at suicide risk by the Xinhai University Crisis Intervention System. At-risk participants will enter one of three groups: active rTMS plus aerobic exercise, sham rTMS plus aerobic exercise, or standardised group psychological intervention/usual support. A separately recruited healthy reference cohort will complete the same assessment schedule without active treatment. Active rTMS will be delivered over the left dorsolateral prefrontal cortex at 10Hz and 120% of the individual motor threshold once daily for 2weeks. Aerobic exercise will be prescribed at a target heart-rate zone of 135-164 beats/min for 30-60min per session every 2days for 2weeks, with heart rate and adherence objectively monitored. The primary outcomes are changes in the Self-rating Idea of Suicide Scale (SIOSS) total score and Self-rating Depression Scale (SDS) standard score from baseline to week 4. Secondary outcomes include SIOSS and SDS dimensions, total sleep time, task-related and resting-state functional near-infrared spectroscopy (fNIRS) measures, adherence, concomitant care, and adverse events. The study was approved by the Ethical Review Committee of Yancheng First People's Hospital (Approval No. 2023-K-230) and the Ethics Committee of INTI International University (Approval No. INTI-IU/FHLS-RC/BTCMI/AUGUST2022/003). Findings will be disseminated through peer-reviewed publications and academic conferences. Chinese Clinical Trial Registry, ChiCTR2400079723.

Pre-pregnancy overweight or obesity delays the onset of lactogenesis II, posing an early barrier to achieving optimal infant nutrition and long-term health. However, the underlying pathophysiological mechanisms remain incompletely elucidated. This prospective cohort study conducted in China aimed to delineate the distinct pathways through which pre-pregnancy overweight/obesity, compared to normal body mass index (BMI), leads to delayed lactogenesis II. Guided by an expanded biopsychosocial framework, we enrolled and stratified 296 primiparous women into pre-pregnancy overweight/obese (n = 146) and normal BMI (n = 150) groups. Data on biological, psychological, social, and infant-related factors were collected prospectively at prenatal, delivery, and one-week postpartum stages. Structural equation modeling was used to identify and compare the mediating pathways between the two groups. Results demonstrated that the association between pre-pregnancy overweight/obesity and delayed lactogenesis II was primarily mediated through four distinct pathways: biological (e.g., breastfeeding difficulties: β = 0.203, 95% CI: 0.144-0.265, p < 0.001), psychological (e.g., internalized weight stigma: β = 0.095, 95% CI: 0.016-0.181, p = 0.026), social (e.g., reduced pro-breastfeeding practices: β = 0.076, 95% CI: 0.017-0.144, p = 0.019), and infant-related (e.g., higher formula intake: β = 0.114, 95% CI: 0.047-0.195, p = 0.003). This study validates the expanded biopsychosocial model by elucidating the distinct pathways through which pre-pregnancy overweight/obesity contributes to delayed lactogenesis II. These findings underscore the necessity for clinical practice to move beyond a purely biological focus and advocate for a paradigm shift in clinical support towards integrated, multi-faceted interventions tailored to this vulnerable population. TRIAL REGISTRATION: This study was registered at the Chinese Clinical Trial Registry (registry number: ChiCTR2200057038). The trial was registered on February 26, 2022.

Prurigo nodularis (PN) is a chronic inflammatory dermatosis with severe, persistent pruritus and limited effective therapies. Janus kinase (JAK) inhibition has emerged as a targeted strategy for PN. This phaseI/II, randomized, double-blind, vehicle-controlled, multicenter clinical trial was conducted in China to evaluate the safety, pharmacokinetics, and efficacy of topical 1.5% ruxolitinib gel (HDM3010) in adults with PN. Adult patients with PN were randomized 2:1 to receive HDM3010 or vehicle, administered once daily (QD) or twice daily (BID), during a 4-week double-blind treatment period. Forty-nine patients were randomized. HDM3010 demonstrated a safety profile characterized by treatment-emergent adverse events in 18.8% of QD and 25.0% of BID patients, compared with 12.5% of vehicle QD and 55.6% of vehicle BID patients. Treatment-related adverse events were infrequent (4.1%) and limited to mild-to-moderate severity. Pharmacokinetic analyses showed low systemic exposure, with mean peak plasma concentrations below 7ng/mL at steady state. Compared with vehicle, HDM3010 was associated with higher proportions of ≥ 4-point Worst Itch Numerical Rating Scale (WI-NRS) responders and greater improvements in WI-NRS, Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA PN-S), and Investigator's Global Assessment for Prurigo Nodularis-Activity (IGA PN-A) scores. HDM3010 demonstrated a favorable safety profile, minimal systemic exposure, and positive trends in reducing pruritus and lesions in adults with PN. Chinese Clinical Trial Registry ( http://www.chictr.org.cn ): ChiCTR2500096434 (registered January 23, 2025).

Development and validation of an eye-tracking-based cognitive impairment screening system for older adults in China: a cross-sectional study.

To investigate 6-month changes in accommodation and vergence in juvenile myopes wearing multifocal soft contact lenses (MFSCLs) versus single-vision spectacles (SVLs). A prospective, matched cohort study was conducted involving 49 myopic children aged 8 to 14 years. Participants were divided into two groups: those fitted with MFSCLs (n=26) and those with SVLs (n=23). Measurements of accommodation (e.g., lag, microfluctuations, facility, relative accommodation) and vergence (e.g., phoria, vergence range, accommodative convergence/accommodation [AC/A] ratio) were taken at baseline, 1, and 6 month. Multifocal soft contact lenses significantly reduced accommodative lag (F=13.75) and increased microfluctuations (F=30.93; both P <0.001) compared with SVLs throughout the study. Initial exophoric shift and decreased AC/A ratio at baseline (both P <0.001) were transient and not sustained at 1- or 6-month follow-ups. Over 6 months, the MFSCLs showed significant changes in accommodative lag, amplitude, facility, phoria, and AC/A ratio (all P <0.05). Notably, accommodative lag, phoria, and AC/A ratio changed from baseline to 1 month, then stabilized with continued wear. These findings demonstrate rapid binocular adaptation to MFSCL in juvenile myopes, with key parameters stabilizing within the first month despite sustained effects on accommodative lag and microfluctuations over 6 months. Chinese Clinical Trial Registry: ChiCTR-OOC-17012103. Registered July 23, 2017, http://www.chictr.org.cn/showproj.aspx?proj=20622 .

Effects of crutch-assisted walking on pain, gait, and hip function in early and middle-stage osteonecrosis: a randomized trial.

Efficacy of Erector Spinae Plane Block in Preventing Chronic Pain After Breast Cancer Surgery: A Randomized Controlled Trial.

Effect of high positive end-expiratory pressure on perioperative atelectasis in neonates and small infants (0-6 months) with healthy lungs: A randomized controlled trial.

Sepsis is a clinical syndrome marked by a dysregulated host response to infection, impairing oxygen delivery and utilization and causing organ dysfunction. Hypoxemia, which can cause significant tissue and organ damage, commonly occurs in sepsis. Thus, oxygen therapy is essential in patients with sepsis. However, the optimal oxygenation target for these patients remains controversial. To evaluate the effects of different oxygenation targets on short- and medium-term outcomes in patients with sepsis. A prospective, single-center, randomized controlled trial was conducted. The primary outcome was 28-day mortality. Secondary outcomes included 90-day mortality and intergroup comparisons of mechanical ventilation and vasopressor use during hospitalization. In total, 270 patients were randomly assigned to the conservative oxygenation, conventional oxygenation, and hyperoxygenation target groups (n = 86, 93, and 91), of whom 35 (40.7%), 32 (34.4%), and 17 (18.7%) died by day 28, respectively. The 28-day mortality significantly differed between these groups ( P = 0.005). Pairwise comparison revealed a significant difference between the conservative oxygenation and hyperoxygenation target groups (χ 2 = 10.132, P = 0.001). Kaplan-Meier analysis showed significant differences in survival distributions among the groups (χ 2 = 10.340, P = 0.006). The 90-day mortality rates were 50.0%, 41.9%, and 36.3% in the conservative oxygenation, conventional oxygenation, and hyperoxygenation target groups, respectively, exhibiting no significant difference. Compared with conservative oxygen therapy, hyperoxygenation (PaO 2 : 100-150 mmHg) reduced 28-day mortality in patients with sepsis. However, no significant differences were observed among oxygenation targets regarding 90-day outcomes.

To evaluate the effects of adding repetitive transcranial magnetic stimulation (rTMS) to dorsolateral prefrontal cortex(DLPFC) with dual-task (DT) exercise on DT mobility, balance and cognitive performance in individuals with sub-acute stroke. Thirty sub-acute stroke patients [age, mean (SD)=59.2 (7.9) years] were randomly assigned to the experimental group (N=15), or the sham stimulation group (N=15). 5Hz rTMS (90% resting motor threshold, 1200 pulses/session) or sham stimulation was applied to the ipsilesional DLPFC, 1 session/day, 5days/week for 2weeks, followed by dual-task training. Two mobility tests [10m walking and timed-up-and-go (TUG) test] and two cognitive tasks (serial 3 subtractions and verbal fluency) were assessed separately [that is, single-task (ST) condition] and concurrently (i.e., DT condition) before and after the intervention. The experimental group had greater improvement in TUG time under both ST and DT conditions (p<0.05), while the step length of the paretic leg during the 10m walking test of the experimental group only showed better improvement under ST condition and in DT condition when performed with serial 3 subtractions task. Cadence changes did not reach significance in any DT condition. Greater increment in the DT cognitive performance was observed only when verbal fluency task performed with 10m walking test in the experimental group. The experimental group had better gain in Montreal cognitive assessment, Mini balance evaluation systems test, and Activities-specific balance confidence scores than controls. The 2-week rTMS to DLPFC combined with DT training augments DT walking performance, and improves balance and cognitive function in mild to moderate motor and cognitive impairment individuals with sub-acute stroke. This combined intervention is a feasible, effective strategy to improve real-world mobility in sub-acute stroke rehabilitation. Chinese Clinical Trial Registry platform (www.chictr.org.cn), with the registration number ChiCTR2200066237.

Patients with unmethylated O6-methylguanine-DNA methyltransferase (MGMT) glioblastoma derive minimal benefit from the standard temozolomide chemoradiotherapy, leaving an urgent need for more effective therapies. The objective of this phase 2 study was to evaluate the efficacy of anlotinib plus radiotherapy in this disease. In this single-arm, phase 2 study, patients with newly diagnosed, unmethylated MGMT glioblastoma were recruited after surgical resection. Patients received standard radiotherapy (60.0 grays) and concomitant with anlotinib (12 mg once daily, 2 weeks on/1 week off), followed by six cycles of anlotinib maintenance. The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), OS rates at 12 and 24 months, PFS rates at 6 and 12 months, and safety. Between October 12, 2020, and August 1, 2022, 32 patients were enrolled and received protocol therapy, and all were evaluable for efficacy and safety analyses. At a median follow-up of 18.6 months (range, 8.3-50.3 months), the median OS was 19.1 months (95% confidence interval, 14.4-22.4 months), with 12-month and 24-month OS rates of 90.6% and 30.0%, respectively. The median OS did not reach the prespecified threshold of 20.1 months. The median PFS was 11.1 months (95% confidence interval, 9.6-12.9 months), with 6-month and 12-month PFS rates of 96.9% and 37.5%, respectively. Four patients (12.5%) experienced grade 3 or worse treatment-related adverse events, two of which (6.3%) were serious. No treatment-related deaths occurred. Postoperative anlotinib plus radiotherapy demonstrated clinically meaningful activity with a manageable safety profile in patients with unmethylated MGMT glioblastoma (Chinese Clinical Trials Registry identifier: ChiCTR2000040116).

Refractory sudden sensorineural hearing loss (RSSNHL) remains a therapeutic challenge with limited effective treatment options. Human umbilical cord mesenchymal stem cell-derived small extracellular vesicles (hucMSC-sEVs) have demonstrated otoprotective and regenerative potential in preclinical studies. This Phase 1 trial evaluated the safety of intratympanic hucMSC-sEVs in patients with RSSNHL. This single-center, open-label, single-arm clinical study enrolled RSSNHL patients between June and September 2025 (ChiCTR2500103765). Participants received intratympanic hucMSC-sEVs for five consecutive days across four dose cohorts, ranging from 8 × 10⁸ to 1 × 10¹¹ particles/mL. Follow-up assessments were conducted at 1, 2, 4, and 8 weeks after treatment, during which adverse events (AEs) were recorded, and hearing outcomes were evaluated. Twelve of the thirteen enrolled patients completed the 8-week follow-up. Intratympanic administration of hucMSC-sEVs was well tolerated across all dose levels, with no dose-limited toxicity or serious AEs. The most common AEs were ear pain (5/12), ear fullness (3/12), and transient dizziness (2/12), all characteristic of intratympanic injection and resolving without intervention. In this Phase 1 study, intratympanic hucMSC-sEVs were well tolerated and showed preliminary signals of hearing improvement. Responses were observed only in patients receiving lower dose levels (8 × 10⁸ and 4 × 10⁹ particles/mL) and in those treated within a shorter disease window (≤ 22 days). These exploratory findings require confirmation in larger controlled trials. Trial Registration This study was registered on June 5,2025, at Chinese Clinical Trial Registry (ChiCTR2500103765).

Adolescent idiopathic scoliosis (AIS) features structural spinal deformity and impaired postural control, which may be associated with altered vestibular function and multisensory integration. Neuromodulatory approaches such as noisy galvanic vestibular stimulation (nGVS) and high-definition transcranial direct current stimulation (HD-tDCS) have shown promise in enhancing balance in healthy and older populations. However, whether peripheral and cortical vestibular neuromodulation exert distinct or combined effects on postural control in AIS remains unknown. This study aimed to compare the immediate post-stimulation effects of peripheral (nGVS), central (HD-tDCS), and combined (nGVS + HD-tDCS) vestibular modulation on postural control in AIS and explore their neuromuscular and cortical correlates. Forty adolescents with AIS were randomly assigned to sham, nGVS, HD-tDCS (anodal CP6), or nGVS+tDCS groups. Center of pressure (COP), surface electromyography (EMG) for bilateral gastrocnemius (GM), tibialis anterior (TA), and erector spinae (ES), and functional near-infrared spectroscopy (fNIRS) for bilateral inferior parietal lobule (IPL), superior parietal lobule (SPL), supplementary motor area (SMA), and primary motor cortex (M1) were simultaneously recorded during an eyes-closed foam-standing Romberg task to evaluate behavior, muscular and cortical responses before and after a single-session neuromodulation intervention. Active interventions (nGVS, HD-tDCS, and combined nGVS + HD-tDCS) significantly reduced COP path length and sway area versus sham, with the combined nGVS + HD-tDCS demonstrating the greatest reduction in path length. EMG analysis showed reduced gastrocnemius exertion following nGVS (right side) and combined stimulation (both sides). fNIRS revealed no hemodynamic changes after nGVS, while HD-tDCS increased activation in the right IPL, and enhanced functional connectivity (FC) between the right IPL and right SMA. Combined nGVS + HD-tDCS further amplified right IPL and right SPL activity, and strengthened connectivity within bilateral SMA and between the right IPL and right SMA. nGVS, HD-tDCS, and their combination improve postural control in AIS through distinct neuromodulation mechanisms. Combined stimulation was associated with the largest improvement in COP path length and broader cortical network modulation. Trial registration Registered at Chinese Clinical Trial Registry (ChiCTR2500110347) on July 25, 2025.

Miscarriage is a common complication of pregnancy, and it is defined as spontaneous pregnancy loss before the fetus reaches viability. However, there are no clear pathological factors identified as causes of recurrent miscarriage in some cases. Preimplantation genetic testing for aneuploidy (PGT-A) has been shown to have some advantages in the live birth rate in limited populations with a favorable prognosis. Hence, we investigated whether PGT-A improves pregnancy outcomes in patients with recurrent pregnancy loss. We conducted a retrospective study including patients with a history of recurrent pregnancy loss from December 2021 to June 2022 receiving assisted reproduction therapy in the first medical center of the Chinese PLA General Hospital. The patients were divided into PGT-A and non-PGT-A groups, and we compared the pregnancy outcomes between the PGT-A and non-PGT-A groups. PGT-A significantly increased the clinical pregnancy rate per embryo transfer (ET) (58.7 vs. 32.3%, p = 0.023) and live birth rate per ET (50.0 vs. 25.8%, p = 0.034). However, there were no differences in biochemical pregnancy rates per ET (69.6 vs. 51.6%, P = 0.111), biochemical pregnancy loss rates (15.6 vs. 37.5%, p = 0.089), and miscarriage rate per clinical pregnancy (11.5 vs. 20.0%, p = 0.511) between the PGT-A and non-PGT-A groups. PGT-A was associated with significant improvements in clinical pregnancy and live birth rates in patients with recurrent pregnancy loss. This study was registered at the Chinese Clinical Trial Registry (ChiCTR2200056991 http//www.chictr.org.cn/). Registration Date 20,220,225.

In-stent restenosis (ISR) remains a significant complication after percutaneous coronary intervention. Identifying patients at high risk for ISR from visually patent post-procedural angiograms is challenging. We developed and validated deep learning models using routine post-procedural digital subtraction angiography (DSA) to predict future ISR risk, emphasizing the role of mask-guided spatial attention. We retrospectively enrolled 237 patients with 1-year angiographic follow-up across three centers. Immediate post-procedural DSA frames were used as inputs, with 1-year outcomes as ground truth. Deep learning architectures were trained using full-image and mask-guided strategies. On the independent external test set, the mask-guided DenseNet-121 achieved the highest predictive performance (AUC: 0.885, AUPRC: 0.912). Crucially, models trained on full images exhibited severe shortcut learning, erroneously focusing on task-irrelevant background noise. The mask-guided strategy successfully corrected this, demonstrating excellent calibration and robust clinical net benefit. Grad-CAM visualization confirmed precise attention on stented vessel regions associated with future restenosis. In conclusion, mask-guided deep learning analysis of post-procedural DSA provides an accurate, interpretable, and automated prognostic tool. By overcoming shortcut learning, this approach effectively stratifies future ISR risk, holding potential to guide personalized post-procedural surveillance and optimize secondary prevention.Trial registration: This study was registered with the Chinese Clinical Trial Registry (ChiCTR) under the registration number ChiCTR2500115474 on December 26, 2025.

The relationship between remimazolam administration and early neurological complications, particularly postoperative delirium (POD), in elderly patients undergoing major non-cardiac surgery remains unclear. Plasma neurofilament light chain (NfL) is a potential biomarker for central nervous injury. This study aims to compare the effects of remimazolam and propofol on postoperative plasma NfL concentrations and the incidence of POD in frail elderly patients undergoing major non-cardiac surgery. This was a single-center randomized controlled trial on frail patients who underwent non-cardiac surgery. Participants were randomized to receive either Remimazolam (Group R) or Propofol (Group P) for induction and maintenance of general anesthesia, with all other anesthetic management standardized. The primary outcome was plasma NfL concentration on postoperative day 1, and the incidence of POD was assessed as a key clinical secondary endpoint. The secondary endpoint encompassed the incidence of hypotension during the anesthesia induction, as well as the time-weighted average of the area under the curve below the baseline for mean arterial pressure (AUB-MAP). A total of 123 patients were enrolled. No significant differences were observed in plasma NfL concentrations on postoperative day 1 between Group R and Group P (123.3[83.6-198.2] vs. 149.0[102.0-226.6], pg/ml, P = 0.186, respectively); and similarly, no differences in POD were found between Group R and Group P (6/62[9.7%] vs. 7/61[11.5%], unadjusted odds ratio 0.827, 95% CI 0.261-2.62, P = 0.746). In the secondary outcomes, the incidence of hypotension during the anesthesia induction in Group R was significantly decreased (3[4.8%] vs. 19[31.3%], P < 0.001). And the time-weighted average of AUB-MAP in Group R was higher than Group P (-21.3 ± 10.7 vs. -25.4 ± 9.6, mmHg, P = 0.03). In frail elderly patients undergoing major non-cardiac surgery, remimazolam group shows no significant difference from propofol in plasma NfL levels or POD incidence on the first day. Due to its advantage in maintaining hemodynamic stability, remimazolam may be a safer anesthetic option for frail patients sensitive to hemodynamic changes. Chinese Clinical Trials Registry, ChiCTR2400093862.