Lung-protective ventilation is a cornerstone of modern mechanical ventilation, yet real-world adherence to lung-protective targets remains suboptimal. While previous studies have established the physiological benefits of low tidal volume and driving pressure, clinical implementation is hindered by limited monitoring granularity and lack of real-time actionable feedback. This trial aims to evaluate whether a real-time, cloud-based algorithmic feedback platform can improve lung-protective ventilation delivery and contribute to better clinical outcomes in mechanically ventilated patients with ARDS. This multicentre, parallel-group, open-label randomised controlled trial will enrol 208 adult mechanically ventilated ICU patients with ARDS from nine adult ICUs across tertiary academic hospitals and regional referral centres in multiple provinces and municipalities in mainland China. Participants will be randomly assigned in blocks to receive either standard monitoring (Control group) or real-time respiratory mechanics feedback through a cloud-based platform (Intervention group). The intervention group will receive real-time alerts for lasting 72 h and ventilator reports every 24 h, integrating tidal volume, plateau pressure, driving pressure, mechanical power, and detected patient-ventilator asynchrony events. The primary outcome is the lung-protective ventilation achievement rate, defined as compliance with VT < 8 mL/kg predicted body weight, driving pressure < 15 cmH₂O, plateau pressure < 30 cmH₂O, and mechanical power < 17 J/min during the first 72 h after randomisation. Secondary outcomes include ventilator-free days at day 28, ICU length of stay, ventilator-associated complications, inflammatory biomarkers, clinician satisfaction, and predefined safety outcomes, including severe hypoxemia, severe hypercapnia/acidemia, barotrauma, and hemodynamic instability temporally associated with ventilator adjustments. This study is, to our knowledge, among the first multicentre randomised controlled trials to evaluate a real-time algorithmic feedback platform designed to enhance lung-protective ventilation. The intervention is designed to provide continuous bedside feedback on ventilation mechanics and may enable more timely and standardised clinical adjustments, with the potential to facilitate lung-protective ventilation delivery. Triaiontl registration ClinicalTrials.gov Identifier NCT07307066 (Registration Date: 2025/12/02).
The direct anterior approach (DAA) and the posterolateral approach (PLA) are commonly used surgical techniques in total hip arthroplasty (THA). However, whether DAA is associated with different wound complication rates compared with PLA remains controversial. This meta-analysis aimed to compare wound complications and clinical outcomes between DAA and PLA in THA based on randomized controlled trials. A comprehensive search was conducted across six major electronic databases: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), and Chongqing VIP Information (CQVIP). The search strategy encompassed studies indexed from database inception to 31 December 2025. The primary outcomes were wound complications, including incisional infection, hematoma, and delayed wound healing. Predefined eligibility criteria were applied during study screening. The risk of bias of the included studies was assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2). The PLA group was used as the control group. Data were extracted from the included randomized controlled trials (RCTs). A pooled statistical analysis was performed to estimate the rate of wound complications and to compare the clinical effects of DAA and PLA. The meta-analysis was conducted with Review Manager 5.3 and Stata 15. A total of 18 eligible RCTs, comprising 1,485 patients, were included. Compared with PLA, DAA was associated with decreased rates of incisional infection (RR = 0.48, P = 0.03, I2 = 0%) and a lower overall rate of wound complications (RR = 0.58, P = 0.04, I2 = 0%). No evidence of a significant difference between groups was observed for hematoma incidence, poor wound healing, or overall surgical complications. Regarding perioperative indicators, DAA demonstrated several advantages. DAA was associated with a shorter incision length (MD = -3.44, P < 0.001, I2 = 97%), less intraoperative blood loss (MD = -76.74, P < 0.001, I2 = 97%), and a shorter hospital stay (MD = -2.15, P < 0.001, I2 = 95%). In terms of functional recovery, DAA demonstrated better early postoperative function. The DAA group had higher HHS at 1 month (MD = 5.87, P < 0.001, I2 = 15%), 3 months (MD = 5.10, P < 0.001, I2 = 95%), and 6 months (MD = 2.94, P < 0.001, I2 = 92%). No significant difference was observed at 12 months. For pain outcomes, DAA was associated with lower VAS scores in the postoperative period, including at 1 day (MD = -0.84, P < 0.001, I2 = 59%), 3 days (MD = -0.77, P < 0.001, I2 = 76%), 7 days (MD = -0.85, P < 0.001, I2 = 88%), 1 month (MD = -0.49, P = 0.002, I2 = 90%), 3 month (MD = -0.67, P = 0.02, I2 = 96%), and 6 month (MD = -0.12, P = 0.04, I2 = 75%). Compared with the PLA, the DAA is associated with improved perioperative outcomes following THA. Specifically, the DAA demonstrates a lower incidence of incision infection, fewer overall wound complications, shorter incision length, reduced intraoperative blood loss, and a shorter length of hospital stay. Early postoperative functional outcomes and pain, assessed by HHS and VAS, are also superior with the DAA. However, owing to heterogeneity and limited robustness of certain outcomes, these findings should be interpreted with caution. Further high-quality randomized controlled trials are warranted to confirm these results.
To characterize harms specification, harms reporting, concordance between specified and reported harms, transparency about harms reporting criteria, and equity-related harms reporting in randomized controlled trials (RCTs) of biomedical interventions. We conducted a meta-epidemiological study of 200 randomly sampled biomedical RCTs indexed in PubMed in 2023. Using publicly available protocols, trial registries, and publications, we assessed harms specification, harms reporting, concordance between specified and reported harms, transparency about harms reporting criteria, and whether trials had considered PROGRESS-Plus equity-related factors when reporting harms. Sixty-four percent (128/200) of trials were registered, and 15.5% (31/200) had an accessible protocol. Harms were specified in 64.0% (128/200) across publicly available protocols, registry study details, or method section, and reported in 69.5% (139/200). Across the 200 RCTs, 120 trials (60.0%) both specified and reported harms, 8 (4.0%) specified harms but reported none, 19 (9.5%) reported harms without prior specification, and 53 (26.5%) neither specified nor reported harms. Among the 120 trials that both specified and reported harms, concordance was complete in 87 trials (72.5%), partial in 29 trials (23.2%), and absent in 4 trials (3.3%). Only 1.0% (2/200) clearly specified harms reporting criteria, and 7.0% (14/200) indicated using criteria when reporting. Trials with a registry listing or an identified protocol had higher odds of specifying harms compared with trials without (OR = 2.1 [1.2, 3.8] and OR = 5.6 [1.8, 18.1], respectively). Compared with behavioral or physical therapy interventions, pharmacological trials had higher odds of harms specification (OR = 3.5 [1.9, 6.5]) and harms reporting (OR = 3.3 [1.7, 6.2]). No trials reported harms stratified by PROGRESS-Plus equity-related factors. In a contemporary sample of biomedical RCTs, harms were frequently specified and reported, but concordance between planned and reported harms and transparency about reporting criteria remain deficient. Trialists should pre-specify harms outcomes in protocols/registrations and report harms comprehensively and consistently across all public sources; when counts and collected participant characteristics support it, descriptive harms summaries by key equity-related factors may help identify potential vulnerability, with cautious interpretation for rare harms. Randomized trials are often used to understand how biomedical interventions work, but they should also be used to identify potential harms. In this study of 200 randomized trials published in 2023, most trials specified or reported at least one harm, but the harms planned in protocols, registries, or methods sections often did not fully match those reported in the results. Trials that were registered or had a study protocol were more likely to specify potential harms than trials without them. Drug, surgery, and medical device trials were also more likely than behavioral or physical therapy trials to both specify and report harms. Very few trials explained the criteria used to decide which harms were reported, and none reported harms by equity-related participant characteristics. Better planning for and more complete reporting of harms would help clinicians, patients, reviewers, and policymakers better judge the balance between the benefits and harms of a health intervention.
Functional dissociative seizures (FDS) are paroxysmal seizure-like events with no electrographic abnormalities. Structured psychoeducation is considered a standard component of FDS management. Yoga Nidra (YN) is a guided meditative relaxation technique that has shown benefit in other neuropsychiatric conditions, but its adjunctive role in FDS has not been studied. To evaluate whether adjunctive YN provides additional benefit over structured brief psychoeducation alone in reducing monthly FDS frequency. This open-label, randomised controlled pilot trial enrolled 50 FDS patients aged ≥13 years, randomised 1:1 to receive brief psychoeducation plus YN (n = 25) or brief psychoeducation plus sham YN (n = 25). All participants received structured psychoeducation; the intervention group additionally practised standardised audio-guided YN. The primary outcome was the change in monthly FDS frequency. Secondary outcomes included 6-month FDS episode count, seizure freedom duration, HAM-A, HAM-D, WSAS, and QOLIE-31 scores. Outcomes were assessed at 6 months by a blinded evaluator. Between January 2021 and February 2022, 72 patients were screened, and 22 were excluded. Fifty patients were randomly assigned to receive brief psychoeducation plus YN (n = 25) or brief psychoeducation plus sham YN (n = 25), of whom primary outcome data were available for 48 patients at 6 months (23 patients in the brief psychoeducation plus YN group and 25 in the brief psychoeducation plus sham YN group). Median monthly FDS frequency reduced from 6 (IQR 2.5-45) to 0.5 (0-1) in the brief psychoeducation plus YN group and from 7 (3.5-45) to 0.5 (01.7) in the sham group; between-group difference was not statistically significant (p = 0.88). Both groups demonstrated substantial clinical improvement during follow-up in seizure frequency, mood symptoms, functioning and quality of life; however, adjunctive YN did not provide measurable additional benefit over the control condition. Larger studies are needed to clarify the role of adjunctive YN in the management of functional dissociative seizures.
Early identification and timely intervention of radiotherapy‑related toxicities are crucial for maintaining treatment adherence and improving quality of life in patients with head and neck cancer (HNC) undergoing concurrent chemoradiotherapy (CCRT). To address this clinical need, a nurse‑led smartphone application, Sun Yat-sen Symptom Management (SYS-SM), was developed to integrate patient‑reported outcome (PRO) assessments with personalized self‑management guidance tailored to individual symptom profiles. The feasibility and preliminary efficacy of this application were evaluated in a randomized controlled trial (RCT). Eligible patients were randomly assigned to an intervention group or a control group. During the 3-month intervention period, the intervention group received standard care combined with nurse-led personalized mobile symptom management, whereas the control group received standard care alone. The intervention included in-person discharge education, structured instruction on application use, and automated push notifications delivering individualized health management recommendations based on PRO data. When symptom scores exceeded predefined thresholds, alerts were automatically generated for nursing staff. Clinical outcomes were assessed at baseline (T0), 1 month (T1), and 3 months (T2). A total of 136 patients were enrolled (107 [78.7%] men; mean [SD] age, 50.88 [12.6] years), including 67 participants in the intervention group and 69 in the control group, with no significant differences in baseline characteristics. For health-related quality of life (HRQOL), the primary summary scores showed no significant overall group × time interaction (P = 0.108; T2: mean difference [MD] = 4.61; 95% CI, -1.02-10.24; effect size [ES] = 0.23). In the physical functioning domain demonstrated a significant interaction effect (P = 0.048; T2: MD = 8.25; 95% CI, 1.15-15.35), its effect size (ES = 0.35) remained below the clinical threshold (ES ≥ 0.40). Notably, significant improvements were observed in several secondary domains, specifically appetite loss (interaction P = 0.001; ES = -0.56) and global health status (interaction P = 0.009; ES = 0.46). Improvements in self-efficacy (SUPPH interaction P = 0.012) and psychological status (IDA interaction P < 0.01) were significantly greater in the intervention group. The SYS-SM application demonstrated high feasibility and acceptability. A nurse-led personalized mobile health symptom management intervention did not significantly improve primary overall HRQOL summary scores, but it demonstrated targeted benefits in reducing specific symptoms (particularly appetite loss), enhancing self-management capacity, and alleviating negative affect in patients with HNC undergoing concurrent chemoradiotherapy. The application shows potential for broader clinical implementation. The study was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2300072314) on June 9, 2023.
Paclitaxel is an effective chemotherapeutic agent for breast cancer, but its use is often limited by cumulative toxicities linked to mitochondrial dysfunction and oxidative stress. This study investigated whether Coenzyme Q10 (CoQ10) could mitigate paclitaxel-induced adverse events and improve treatment tolerability. In this open label randomized controlled trial, 60 patients with breast cancer were randomized (1:1) receive weekly paclitaxel (80 mg/m²) for 12 weeks either alone (control group, n = 30) or in combination with oral CoQ10. The primary outcome was the cumulative incidence of grade ≥ 2 peripheral neuropathy. Secondary endpoints included time-to-onset of grade ≥ 2 neuropathy; fatigue, headache, insomnia, musculoskeletal, gastrointestinal, and hematological adverse events; and left ventricular ejection fraction. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. CoQ10 supplementation was associated with a lower incidence of clinically relevant neuropathy, with grade ≥ 2 events occurring in 68% of the CoQ10 group versus 96% of controls (p = 0.01) with delayed onset of neuropathy (30.0 vs. 20.0 days; log-rank p = 0.005). Significant reductions in severity were also observed for fatigue and insomnia from week 9, and for mucositis, diarrhea, arthralgia, and myalgia from week 11 (p < 0.05). Hemoglobin levels were higher at week 12 (p = 0.009). CoQ10 was associated with preservation of left ventricular ejection fraction (p = 0.005). CoQ10 supplementation during paclitaxel therapy was associated with reduced treatment-related toxicities, preservation of hematologic parameters, and favorable changes in left ventricular ejection fraction, with favorable tolerability. ClinicalTrials.gov (NCT06570811) on August 26, 2024. Available at: https://clinicaltrials.gov/study/NCT06570811.
Total knee arthroplasty (TKA) has become a common surgical procedure for alleviating pain caused by end-stage osteoarthritis and improving joint dysfunction, but the optimal postoperative analgesic regimen remains controversial. This study aimed to evaluate the efficacy and safety of liposomal bupivacaine(LB) for peri-articular injection (PAI) in TKA, focusing on its impact on early postoperative outcomes, and comparing it with traditional ropivacaine hydrochloride (RH). From February to June 2025, 121 patients undergoing total knee arthroplasty at Qingdao University Affiliated Hospital were enrolled. This single-center, parallel-group, double-blind study randomly assigned patients in a 1:1 ratio using a random number table to the LB or RH group. Prime outcomes include the visual analogue scale (VAS) within 72 h after surgery and the consumption of opioid drugs. Secondary outcomes comprised postoperative knee range of motion (ROM), time to first ambulation (TFA), Timed Up-and-Go (TUG) test, 2-minute walk test(2MWT), length of hospital stay (LHT), and postoperative adverse events. Demographic and clinical characteristics were comparable between groups. The LB group demonstrated lower postoperative pain scores and opioid consumption. Additionally, LB group patients exhibited markedly greater joint range of motion and earlier time to first ambulation compared to the RH group. The incidence of adverse events was similar between groups. One patient in the LB group and two in the RH group experienced early postoperative complications, none of which were considered related to analgesic selection. This study demonstrates that LB may alleviate postoperative knee pain, reduce the consumption of opioid drugs, and thereby facilitate recovery. Clinicaltrials.gov. Identifier ChiCTR2400082998, 12/04/2024.
This study aimed to evaluate the impact of perioperative respiratory muscle training on respiratory muscle strength, pulmonary function, functional capacity and prognostic outcomes in patients undergoing surgery. A randomized controlled trial. Cardiac surgery ward and cardiac surgery intensive care unit of a tertiary Grade A hospital in Fuzhou, China. Eighty-two participants. Perioperative respiratory muscle exercise. Eighty-two patients were randomly assigned to either the intervention group (n = 42), who performed perioperative respiratory muscle training, or the control group (n = 40). Patients completed one session per day from admission to discharge (except during mechanical ventilation). Respiratory muscle strength was assessed upon admission, the day before surgery, on the third day post-intensive care unit transfer, and at discharge. Each patient underwent a lung function test, six-minute walk test, self-efficacy for exercise scale, anxiety and depression test, and quality of life questionnaire, before and after intervention. The intervention group showed significantly greater improvements in maximal inspiratory pressure (57.69 ± 10.85 cmH2O vs. 48.28 ± 10.30 cmH2O), pulmonary function, functional capacity, postoperative pulmonary complications (38.1% vs. 65.0%), inspiratory muscle weakness (42.9% vs. 85.0%), duration of mechanical ventilation and intensive care unit stay, level of anxiety and depression, quality of life, and length of post-operative hospitalization. Additionally, the incidence of postoperative pulmonary (9.5% vs. 22.5%) and re-hospitalization within six months (9.5% vs. 17.5%) was reduced, though not statistically significant. Perioperative respiratory muscle training could contribute to improved respiratory muscle strength, pulmonary function, functional capacity, prognostic outcome, and quality of life in elderly cardiac surgery patients. Continuous activation of the respiratory muscles could provide multiple benefits for these individuals.
To assess whether a lower maximum dose of soybean oil lipid emulsion reduces bilirubin neurotoxicity measured by brainstem auditory evoked response (BAER) wave V latency. Single-center Bayesian randomized trial (NCT04584983; January 2021-January 2024) in a level IV neonatal intensive care unit. Infants born at <27 weeks or ≤750 grams were stratified by phototherapy regimen, randomized to 1.5 vs 3.0 g/kg/day maximum soybean oil lipid emulsion (Intralipid) doses through day 14. Of 143 eligible infants, 134 were enrolled (67 lower dose, 65 higher dose). Mean [SD] daily lipid administration was 1.1 [0.3] vs 1.96 [0.58] g/kg/day. Unbound bilirubin levels were similar between groups although values ≥30 and ≥40 nM occurred more often in the higher dose group (14.5% vs 28.6% and 6.5% vs 16.1%), even at low total serum bilirubin levels (3-8 mg/dL). Adjusted wave V latency did not differ between groups (7.36 ms [0.53] vs 7.22 ms [0.57], aMD: -0.14 [95% CrI -0.34, 0.06]), with no interaction with phototherapy dose. Clinical outcomes and growth were comparable. The lower maximum lipid dose did not reduce BAER wave V latency. Elevated unbound bilirubin levels occurred at the higher dose, suggesting the need for a multicenter safety trial in extremely preterm infants.
Limited research exists on the effects of OsteoStrong on physical function in older women. This randomized controlled trial aimed to evaluate and compare the effects of OsteoStrong (OS) and dynamic multicomponent exercise (DME) on functional outcomes in older women with osteopenia or osteoporosis. A total of 194 women aged 65-79 years with a T-score of ≤-1.0 at the hip and/or spine were randomized to nine months of either OS (once weekly, 20 min) or DME (twice weekly, 60 min). Outcomes included measures of muscle strength (hand grip and back strength), back and trunk endurance, mobility (sit-to-stand tests, gait speed, Timed Up and Go), and balance (one-leg standing time, tandem standing, tandem walking). Measurements were conducted at baseline and again at nine months. Both OS and DME showed significant improvements in grip strength, back strength, isometric trunk flexion endurance, gait speed 30 m (m/sec), 5 sit-to-stand (sec) and 50 sit-to-stand speed (n/sec) with no significant between-group differences. DME resulted in greater improvements in gait speed 30 m (+ 7.1% vs. +3.2%, p = 0.001), isometric trunk extension (+ 27.6% vs. +4.4%, p = 0.007), and one-leg standing balance (right leg: +13.1% vs. -2.1%, p = 0.001; left leg: +13.3% vs. -2.4%, p = 0.001) compared to OS. These findings suggest that while both OS and DME improve physical function in older women with osteopenia or osteoporosis, DME provides superior benefits in gait speed, back muscle endurance, and balance. These findings should be interpreted with caution, as they are based on secondary outcomes.
Postoperative stroke can undermine the benefits of endovascular stenting for cerebrovascular stenosis. This trial investigated whether adjunctive remote ischemic conditioning (RIC) improves cerebral blood flow (CBF) regulation and reduces the risk of postoperative stroke. A total of 104 patients with intracranial or extracranial cerebrovascular stenosis who underwent endovascular stenting were enrolled and randomized to receive either RIC or sham-RIC (1:1). The intervention was administered twice daily for 7 consecutive days postoperatively. CBF regulation was assessed bilaterally using transfer function analysis of spontaneous blood pressure and CBF oscillations at baseline and on day 7 or at discharge. The primary outcomes were phase difference (PD) and gain, whereas the secondary outcomes were 90-day stroke incidence and safety. Significantly higher PD values were observed in the RIC group than in the sham-RIC group on the affected side (40.67° [26.76°-58.28°] vs. 20.51° [10.90°-41.73°], P < 0.001) and the unaffected side (36.04° [21.66°-54.53°] vs. 26.80° [11.94°-44.83°], P = 0.022), indicating improved CBF regulation. Intragroup comparisons revealed significant PD improvement from baseline to day 7 or discharge in the RIC group (affected side: 20.57° [8.70°-34.24°] vs. 40.67° [26.76°-58.28°], P < 0.001; unaffected side: 26.06° [8.70°-44.37°] vs. 36.04° [27.66°-54.53°], P = 0.001). The 90-day stroke incidence was significantly lower in the RIC group (0.00% vs. 9.62%, P = 0.022). Adjunctive RIC safely enhanced CBF regulation and substantially reduced postoperative stroke in patients after cerebrovascular stenting, suggesting a promising non-pharmacological strategy to improve outcomes. This trial was registered at ClinicalTrials.gov (NCT05970653).
Submental fat (SMF) is commonly treated with liposuction, surgery, or injectable drugs. Cholic acid, a primary bile acid, can induce lipolysis. To evaluate the efficacy and safety of MT921, an injectable cholic acid formulation, for reducing moderate to severe SMF. Subjects with moderate to severe SMF were randomized to receive MT921 1.0%/1.0 cm, MT921 1.5%/1.0 cm, MT921 1.5%/1.25 cm, or placebo. Primary endpoints were ≥1- and ≥2-grade improvements in clinician- and patient-assessed SMF Rating Scales at 4 weeks after the final treatment. Secondary endpoints included changes in SMFRS, patient satisfaction, Patient-Assessed Submental Fat Impact Scale, and SMF volume or thickness measured by MRI or calipers. Safety was assessed by adverse events, laboratory tests, and vital signs. In groups 1, 2, 3, and 4, respectively, ≥1-grade improvement in clinician-assessed SMFRS was achieved by 72.73%, 88.64%, 79.07%, and 48.78% of subjects, and ≥1-grade improvement in patient-assessed SMFRS by 77.27%, 88.64%, 79.07%, and 46.34%. Compared with placebo, MT921 showed favorable improvements in SMFRS responses, patient satisfaction, PA-SMFIS, and caliper-measured SMF thickness. MRI-measured SMF volume decreased in MT921-treated groups but not in the placebo group. Adverse events were more frequent with MT921 but were mostly mild or moderate. MT921 showed favorable efficacy signals for reducing moderate to severe SMF and was generally well tolerated. These findings support further evaluation of MT921, particularly the 1.5% formulation, in larger phase 3 trials with longer follow-up.
Postoperative nausea and vomiting (PONV) is a common surgical complication, especially in breast and gynecologic surgery, with a high incidence despite prophylactic treatment. There is uncertainty about the effective dose and therapeutic effect of drug therapy, leading to unsatisfactory results. This study aims to investigate the effect of preoperative whey protein (WP) supplementation on postoperative recovery and PONV in gynecologic tumor patients with good nutritional status, so as to optimize postoperative rehabilitation strategies. This study was a randomized, double-blind, placebo-controlled, prospective trial involving 52 patients undergoing gynecologic tumor surgery. The experimental group received WP liquid daily for 3 days before surgery, while the R-M group received rice-milk (R-M) liquid daily. The primary endpoint was incidence of PONV and the secondary endpoints included postoperative recovery indicators such as length of hospital stay, time to first flatus and defecation, time to first ambulation, and nutritional indicators such as hemoglobin, total protein, albumin and prealbumin. Statistical analysis was performed using Python, and a P-value less than 0.05 was considered statistically significant. The results of the study showed that preoperative WP supplementation reduced the incidence of PONV within 24 h after surgery, and accelerated postoperative recovery, including shorter hospital stay and early exhaust, defecation, and ambulation time (P < 0.05). Preoperative WP supplementation reduced the incidence of PONV in the first 24 h after surgery and was associated with accelerated early postoperative recovery. This intervention may have clinical relevance in improving postoperative recovery.Clinical trial registration: Clinical trial registration number: ChiCTR2200059673; Clinical trial registration time: 06/05/2022.
Cardiac resynchronization therapy (CRT) with biventricular (BiV) pacing is non-physiological, and a third of patients do not respond. This study aimed to compare conduction system pacing (CSP) with BiV. Systematic searching of databases was conducted to include RCTs and comparative propensity-matched studies. CSP includes left bundle branch pacing (LBBP), his bundle pacing (HBP), and HOT/ LOT CRT (optimized HBP/ LBBP). Frequentist and Bayesian meta-analyses were performed. Twenty-eight studies (13 RCTs) with 5524 patients were included. CSP was associated with better CRT response (OR 1.69, CI: 1.20-2.39; p = 0.0027) and better clinical response (OR 1.83, CI: 1.12-2.99; p = 0.01). CSP was associated with lower odds of composite outcomes (OR 0.51, CI: 0.30-0.88, p = 0.01), HF hospitalization (OR 0.58, CI: 0.35-0.96; p = 0.0347), and all-cause mortality (OR 0.67, CI: 0.46-0.97, p = 0.0340). CSP was also associated with significantly higher improvement in QRS duration, LVEF, LVESD, NT-pro BNP, NYHA, and 6MWD (all p < 0.05). Bayesian meta-analysis consistently favoured CSP across all clinical outcomes, with probability of meaningful benefit exceeding 90% for CRT response, super-response, composite outcome, and HF hospitalization. However, RCT-only analysis yielded inconsistent results across most outcomes, with only clinical response remaining statistically significant. In subgroup analyses, LBBP appears to have the most benefit across CRT response and HF hospitalization outcomes. CSP may offer potential advantages over BiV pacing in patients indicated for CRT; however, confirmation in larger randomized clinical trials is required.
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To develop and internally validate a radiology-centered machine-learning model using preoperative MRI and clinical characteristics to predict arthroscopic meniscal repairability. A retrospective cohort of 491 patients who underwent knee MRI followed by arthroscopy between 2018 and 2023 was analyzed. Preoperative predictors included demographic variables, injury mechanism, and a comprehensive set of MRI-derived features. Meniscal morphology, bone marrow edema, joint effusion, cruciate ligament integrity, cartilage degeneration, tear displacement, ramp lesion, and extrusion distance were systematically assessed by two musculoskeletal radiologists. Interobserver agreement was evaluated using Cohen's kappa and intraclass correlation coefficients (ICCs). Least absolute shrinkage and selection operator (LASSO) regression was used to identify the most informative predictors. Logistic regression, random forest, gradient boosting machine (GBM), and support vector machine (SVM) models were trained using five-fold stratified cross-validation with hyperparameter tuning via grid search. Model performance was evaluated using area under the receiver operating characteristic curve (AUC) with 95% confidence intervals, calibration metrics (calibration slope, intercept, and Brier score), and decision curve analysis (DCA). LASSO selected 13 preoperative predictors spanning eight clinically relevant domains. Logistic regression achieved the highest cross-validated performance (AUC = 0.777, 95% CI 0.735-0.819), followed by SVM (AUC = 0.771), random forest (AUC = 0.770), and GBM (AUC = 0.755). Multivariable logistic regression identified ACL injury (OR 0.38, 95% CI 0.25-0.57, p < 0.001), high-grade cartilage degeneration (OR 0.42, 95% CI 0.28-0.63, p < 0.001), greater BMI (OR 1.08 per kg/m2, 95% CI 1.03-1.13, p = 0.002), male sex (OR 0.51, 95% CI 0.33-0.78, p = 0.002), and ≥ 3 mm tear displacement (OR 0.44, 95% CI 0.29-0.67, p < 0.001) as independent predictors of non-repairability. Calibration analysis demonstrated good agreement between predicted and observed probabilities (calibration slope 0.95, intercept -0.08, Brier score 0.21). DCA demonstrated that logistic regression and random forest provided the greatest clinical net benefit across practical threshold probabilities. A radiology-based machine-learning model integrating detailed preoperative MRI features can accurately predict meniscal repairability with internally validated performance and may assist surgeons in optimizing arthroscopic decision-making and surgical planning pending prospective external validation.
Lucchesi, VH, Giorgetti, APO, Corrêa, MG. et al. Impact of systemic resveratrol on non-surgical periodontal treatment of smokers: A 12-month randomized clinical trial. Clin Oral Invest 2025;29:428. https://doi.org/10.1007/s00784-025-06517-9 DESIGN: This double-blind, placebo-controlled randomized clinical trial evaluated whether systemic resveratrol (500 mg/day for 180 days) improves outcomes of non-surgical periodontal therapy in smokers with Stage III or IV, Grade C periodontitis. Thirty-eight adult smokers were recruited from a university periodontal clinic and randomly assigned to receive full-mouth ultrasonic debridement combined with either systemic resveratrol or placebo (n = 19 per group). Eligible participants had at least 20 teeth, smoked a minimum of 10 cigarettes daily for at least five years, and presented with multiple periodontal sites exhibiting probing depth (PD) and clinical attachment loss ≥5 mm; patients with recent periodontal therapy, systemic diseases, pregnancy, or recent use of antibiotics or anti-inflammatory medications were excluded. Clinical parameters, including PD, clinical attachment level (CAL), position of gingival margin (PGM), full-mouth plaque score (FMPS), and full-mouth bleeding score (FMBS), were assessed at baseline and at 3-, 6-, and 12-month follow-up, alongside microbiological and immunoinflammatory markers. The primary outcome was CAL, while secondary outcomes included PD, PGM, FMPS, subgingival microbiological profiles, and inflammatory cytokine concentrations. Data distribution was assessed using exploratory and normality testing, with appropriate transformations applied where necessary. Repeated clinical measures were analyzed using restricted maximum likelihood models and generalized estimating equations, while microbiological and immunological outcomes were compared using non-parametric tests. Missing data were addressed using multiple imputation, and statistical significance was set at p < 0.05. Compared with placebo, the resveratrol group demonstrated significantly lower PD and improved CAL throughout follow-up. At 12 months, PD was 2.80 mm in the resveratrol group versus 3.02 mm in controls, while CAL was 3.87 mm versus 4.39 mm, respectively. Resveratrol was also associated with lower levels of Aggregatibacter actinomycetemcomitans, reduced IL-1β at 3 months, and reduced IL-6 at 3 and 12 months. Both groups showed substantial improvements following therapy, and no major adverse effects were reported. Systemic resveratrol may improve clinical, microbiological, and inflammatory outcomes when used as an adjunct to non-surgical periodontal therapy in smokers with Stage III or IV, Grade C periodontitis.
Sudden arrhythmic death remains a major clinical risk in ischemic heart disease (IHD), underscoring the need for improved risk stratification. Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) provides measures of scar burden and heterogeneity, but its incremental prognostic value beyond conventional markers such as left ventricular ejection fraction remains uncertain. We analysed two independent IHD cohorts (Dataset 1: n = 399, 54 events; National Research Ethics Service approvals 07/H0708/83 and 09/H0504/104+5; Dataset 2: n = 424, 50 events; derived from the prospectively registered REVIVED-BCIS2 trial, ISRCTN45979711, registered 20 November 2012)using clinical and LGE-CMR-derived variables to evaluate the contribution of LGE-CMR features, and compare machine learning-based survival modelling approaches. A brute-force feature-selection strategy identified optimal predictor subsets for Cox proportional hazards models, Random Survival Forests, and DeepSurv, evaluated using cross-cohort and pooled validation strategies. Scar entropy consistently emerged as a strong predictor of major arrhythmic events. Non-linear approaches outperformed Cox regression, with DeepSurv demonstrating superior generalization across cohorts and Random Survival Forests showing robust performance in pooled analyses. These findings support scar heterogeneity as an important prognostic marker and suggest that machine-learning survival models may improve arrhythmic risk prediction in patients with IHD.
Reconstruction of segment 5 and/or segment 8 anterior sector veins ≥ 5 mm is widely recommended in adult right lobe living donor liver transplantation (LDLT) to prevent venous congestion. Whether this approach is universally required, or whether selective ligation guided by intraoperative findings is acceptable in lower-risk recipients, remains unresolved. This single-centre retrospective cohort study included adult recipients who underwent right lobe LDLT without inclusion of the middle hepatic vein at a high-volume transplant centre (approximately 150 adult LDLTs per year) between November 2021 and May 2025. Eligible patients had intraoperatively measured segment 5 and/or segment 8 veins ≥ 5 mm. Venous management was determined intraoperatively and was not randomized: reconstruction was preferred in recipients judged at higher risk of congestion, and all recipients with graft-to-recipient weight ratio (GRWR) < 0.8 were managed in the reconstruction group. The primary endpoints were postoperative day 7 (POD7) international normalized ratio (INR), total bilirubin, and ascites volume. Multivariable adjustment was prespecified for postoperative ascites only, adjusting for ligation status, MELD score, and GRWR. Prespecified sensitivity analysis restricted to GRWR ≥ 0.8 was performed. Partial Olthoff early allograft dysfunction (EAD) and approximate ILTS-iLDLT small-for-size syndrome (SFSS) were assessed as secondary analyses. A total of 170 recipients were included (16 selective ligation; 154 reconstruction). Baseline variables did not differ statistically, but all 20 recipients with GRWR < 0.8 were in the reconstruction group. POD7 outcomes were comparable: INR 1.24 vs. 1.27 (p = 0.80), bilirubin 1.46 vs. 1.70 mg/dL (p = 0.35), ascites 1100 vs. 1250 mL (p = 0.89). In multivariable analysis (n = 91), selective ligation was not independently associated with ascites (β = 0.202; 95% CI - 0.359 to + 0.764; p = 0.476); MELD was the only significant predictor (p = 0.024). The GRWR ≥ 0.8 sensitivity analysis confirmed these findings. Partial Olthoff EAD was 25.0% vs. 15.7% (p = 0.42); approximate SFSS was 27.3% vs. 24.7% (p = 1.00). Post-hoc power for the ascites comparison was 80% only for Cohen's d ≥ 0.90, far larger than the observed d = 0.02. In carefully selected recipients with adequate graft volume and favourable intraoperative findings, selective ligation of segment 5 and/or 8 veins ≥ 5 mm was not associated with worse early graft function in this cohort. Given the small ligation group, non-randomized allocation, and substantial missing data, these preliminary results are consistent with the feasibility of selective ligation in a selected lower-risk subgroup but cannot establish its safety, clinical applicability, or equivalence to reconstruction. Prospective, adequately powered, multicentre validation is required before any change in current clinical practice can be considered. not applicable.
Clear aligner therapy has expanded substantially in mixed dentition, yet the boundaries of clinical predictability across indications, movement types, and growth stages remain incompletely defined. The aim of this review was to synthesize evidence on clear aligner therapy in mixed dentition, describe indication-specific performance patterns, and identify evidence gaps that limit clinical confidence. This scoping review was reported in accordance with PRISMA-ScR. PubMed/MEDLINE, Embase, and Scopus were systematically searched for studies published from 2000 to 2025. Additional records were identified through Google Scholar and reference list searching. Randomized controlled trials, prospective and retrospective cohorts, and cross-sectional studies were eligible. Data were charted and synthesized descriptively. Fifty-nine studies were included (8 randomized controlled trials, 11 prospective cohorts, 38 retrospective cohorts, 2 cross-sectional), most involving children aged 7 to 12 years. Achieved transverse dentoalveolar expansion with clear aligners was lower than planned, particularly posteriorly and at gingival levels. Comparative studies suggested greater posterior and palatal changes with rapid maxillary expansion. Mandibular advancement aligners were associated with Class II sagittal improvement, with responses varying by skeletal maturity and dentoskeletal pattern. Evidence for incisor correction, molar movement, vertical outcomes, airway, oral health, patient-reported outcomes, and smile esthetics remained limited. Clear aligners in mixed dentition demonstrate indication-dependent predictability influenced by movement type, anatomical region, and growth stage. Clinical confidence remains limited by retrospective evidence, heterogeneous outcome measures, and insufficient standardized reporting of post-treatment stability.