Inguinal hernia repair is one of the most common surgical procedures worldwide and is frequently performed as day-case surgery. Postoperative pain may delay recovery and occasionally necessitate unplanned hospital admission. Regional anesthesia techniques, including transversus abdominis plane (TAP) and rectus sheath (RS) blocks, have shown promise in improving analgesia. However, their combined efficacy in open inguinal hernia repair has not been established in randomized trials. The PRO-RSTAP trial is a prospective, double-blind, four-arm randomized controlled trial conducted at three hospitals in Finland. The study evaluates the individual and combined effects of TAP and RS blocks in adults undergoing elective open inguinal hernia repair. Two hundred patients are randomized equally into four groups: (1) placebo TAP + placebo RS, (2) active TAP + placebo RS, (3) active RS + placebo TAP, and (4) active TAP + active RS. All patients receive standardized sedation and multimodal analgesia, including paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and rescue opioids. The primary outcome is cumulative perioperative opioid consumption from block administration until hospital discharge, expressed as intravenous morphine equivalents. Secondary outcomes include pain scores, conversion to general anesthesia, postoperative nausea and vomiting, time to discharge, and unplanned admissions or emergency visits within 7 days. The planned sample size provides 80% power to detect a clinically meaningful reduction in opioid use (two-sided α = 0.05). Analyses follow the intention-to-treat principle. The first participant was enrolled in September 2025, and the trial is ongoing. No interim efficacy analysis is planned. Safety is monitored continuously throughout the study. This randomized controlled trial is designed to determine whether combining TAP and RS blocks improves postoperative analgesia and recovery after open inguinal hernia repair. The results will contribute to evidence-based optimization of regional anesthesia strategies in ambulatory surgery. EU Clinical Trials Information System (CTIS): 2024-513406-59-00; ClinicalTrials.gov identifier: NCT07423910.
Informed consent forms (ICFs) for clinical trials are often written above the recommended eighth-grade level. We aimed to compare the readability of original ICFs used for National Institutes of Health-funded stroke-related clinical trials with ICFs edited for readability using artificial intelligence. Publicly available ICFs associated with National Institutes of Health-funded stroke-related clinical trials were accessed through ClinicalTrials.gov (search period: inception to August 12, 2025). Using ChatGPT-4o, we created a customized Generative Pre-Trained Transformer (GPT) designed to lower the reading level to eighth grade or below while maintaining ICF content. We processed each ICF using this GPT to create edited ICFs. Standard readability metrics, including the Flesch-Kincaid grade level (primary outcome), were compared between original and edited ICFs using paired t tests or the McNemar test (cross-sectional design). We also assessed semantic similarity using the MPNet language model, which produced continuous scores from 0 (no similarity) to 1 (perfect similarity). ICFs were available for 46 stroke trials, including behavioral (n=21), device (n=15), drug (n=5), and other (n=5) intervention types. Mean reading levels were 11.52 for the original and 9.47 for the GPT-edited ICFs using the Flesch-Kincaid grade level (P<0.001). Only 1 (2%) of the original ICFs and 18 (39%) of the GPT-edited ICFs had a Flesch-Kincaid reading level at or below eighth grade (P<0.001). Both the Simple Measure of Gobbledygook and Gunning Fog Index favored the GPT-edited ICFs by 1 to 2 grade levels. The Flesch Reading Ease score favored the GPT-edited ICFs by about 8 points. The mean similarity score was 0.85 (SD=0.04). GPT-edited ICFs achieved a readability reduction of approximately 2 grade levels compared with the original ICFs while preserving high semantic similarity. Customized GPTs may be a useful tool to improve the readability of clinical trial ICFs.
In competitive sports, minor performance enhancements can significantly impact outcomes, driving athletes to utilize nutritional supplements, though many lack robust scientific evidence. Inorganic nitrate (NO₃⁻) stands out as a well-supported ergogenic aid, particularly for high-intensity activities, enhancing both performance metrics and psychological factors like perceived exertion. Wrestling, characterized by short, intense bursts of activity, necessitates efficient energy metabolism and recovery strategies. This protocol describes a trial to evaluate the acute effects of vitamin C-enriched beetroot supplementation on the performance of semi-professional wrestlers, assessed through upper and lower body Wingate tests. This study will conduct a double-blind, randomized, placebo-controlled crossover trial involving 28 semi-professional wrestlers. Participants will be assigned to receive either a beetroot juice containing 8.4 mmol of nitrate and 90 mg of vitamin C or a placebo. Randomization will be facilitated through a web-based tool, ensuring blinding with placebo drinks. The primary outcome will be maximal anaerobic power, while secondary outcomes will include mean anaerobic power, fatigue index, time to exhaustion, and metabolic markers associated with muscle damage, such as creatine kinase and lactate dehydrogenase. The trial is registered at IRCT20240407061440N1. Not applicable (study protocol). This protocol describes a rigorous trial to evaluate potential ergogenic and recovery benefits of vitamin C-enriched beetroot in wrestling-specific anaerobic performance, addressing gaps in multi-muscle group testing.
The ISCHEMIA-CKD trial showed similar outcomes with an initial conservative vs invasive approach to chronic coronary syndrome in patients with advanced chronic kidney disease. Guideline-directed medical therapy (GDMT) was recommended regardless of the randomized strategy assignment. To describe GDMT attainment in ISCHEMIA-CKD participants in Poland compared to other world regions. Among 777 trial participants, 105 were randomized in Poland. Patients were followed for a median of 2.2 years with the following GDMT recommendations: not smoking, systolic blood pressure (SBP) < 140/ diastolic blood pressure (DBP) < 90 mm Hg, high/moderate-intensity statin, antiplatelet/anticoagulant, angiotensin-converting-enzyme inhibitors (ACE-I)/angiotensin receptor blockers (ARB) and b-blocker therapy, glycated hemoglobin (HbA1c) < 8% when indicated. Participants in Poland vs other regions of the world (age 67 [60, 76] vs. 63 [55, 70] years, p < 0.001, 32% vs. 31% females, p = 0.86) had higher incidence of prior myocardial infarction (25% vs. 16%, p = 0.04), peripheral vascular disease (12% vs. 5%, p = 0.009), atrial fibrillation (23% vs. 7%, p < 0.001), and less frequently diabetes (44% vs. 59%, p = 0.004). At baseline, Polish participants were more often on antiplatelets/anticoagulants (91% vs. 83%, p = 0.04), b-blockers (95% vs. 72%, p < 0.001), and ACE-I/ARBs (62% vs. 45%, p = 0.002), with better attainment of SBP < 140 (73% vs. 53%, p < 0.001), and HbA1c < 8% (86% vs. 56%, p = 0.003) and similar smoking and high-/moderate-intensity statin treatment frequencies. This degree of GDMT goal attainment was maintained at the last follow-up visit. In Polish patients with advanced kidney disease, high GDMT goal attainment was observed and maintained until the last follow-up visit under trial-specific, strict medical surveillance. The impact of GDMT on long-term outcomes remains to be studied in this patient population.
Poststroke fatigue (PSF) affects nearly half of all stroke survivors and significantly hinders rehabilitation and daily functioning. There is no established treatment. Low cardiorespiratory fitness may contribute to PSF, suggesting aerobic training as a potential intervention. In this 2-center, randomized, open-label, blinded end point trial, we evaluated a home-based, supervised cardiorespiratory interval training program (HS-CITP) in individuals with PSF (Swedish Fatigue Assessment Scale score ≥28) 1 to 7 months poststroke. Participants were randomized (1:1) to either HS-CITP or usual care with self-directed activity after early supported discharge. The intervention consisted of 35-minute cycling sessions performed 3 times per week at 70% to 80% of maximum heart rate for 8 weeks. The study was powered to detect a 9-point between-group difference on the Swedish Fatigue Assessment Scale. The primary outcome was self-reported fatigue (Swedish Fatigue Assessment Scale score) at 8 weeks (postintervention), and the secondary outcome was peak oxygen uptake (mL/kg per minute) at 8 weeks. Analyses were performed according to the intention-to-treat principle using adjusted between-group comparisons. Forty-five participants were randomized; the mean age was 64 years, and 56% were women. Forty-three participants completed the postintervention assessment (HS-CITP: n=22; control: n=21). Adherence to HS-CITP was 92%, and no adverse events were reported. In adjusted analyses, compared with the control group, HS-CITP significantly reduced fatigue (between-group mean difference -5.35 Swedish Fatigue Assessment Scale score points [95% CI -9.03 to -3.67]; P<0.001) and improved cardiorespiratory fitness (+4.48 mL/kg per minute [95% CI, 3.41-5.54]; P<0.001). No significant group-by sex interaction was observed. Supervised home-based interval training significantly reduced PSF and improved cardiorespiratory fitness, with good adherence and no safety concerns. These findings support integrating structured aerobic exercise into stroke rehabilitation. Larger, longer-term trials are needed to confirm durability, determine the optimal timing poststroke, and evaluate other exercise modalities. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03458884.
The effects of intravenous thrombolytic agents on fibrinogen differ due to structural differences among the agents. Using data from the RAISE (Reteplase Versus Alteplase for Acute Ischemic Stroke) trial, we aimed to investigate the impact of differences in baseline plasma fibrinogen levels on the efficacy and safety of reteplase versus alteplase within 4.5 hours of acute ischemic stroke symptom onset. This post hoc subgroup analysis of the multicenter RAISE trial categorized participants by baseline fibrinogen levels: low (<2 g/L), normal (2-4 g/L), and high (>4 g/L). The primary efficacy outcome was excellent functional outcome at 90 days (modified Rankin scale score of 0 or 1). The primary safety outcome was symptomatic intracranial hemorrhage within 36 hours. A total of 1373 patients with acute ischemic stroke were included. Ninety-two in the low fibrinogen group (<2 g/L), 1178 in the normal fibrinogen group (2-4 g/L), and 103 in the high fibrinogen group (>4 g/L). Adjusted risk ratios of primary efficacy outcome were 1.13 (95% CI, 0.97-1.32) for the low fibrinogen group, 1.13 (95% CI, 1.04-1.23) for the normal fibrinogen group, and 1.09 (95% CI, 0.84-1.42) for the high fibrinogen group. The primary safety outcome showed no difference between reteplase and alteplase in the 3 fibrinogen subgroups. Among patients with acute ischemic stroke who were treated with either reteplase or alteplase within 4.5 hours after symptom onset, there was no difference observed in the relative efficacy and safety between the 2 groups across the 3 fibrinogen subgroups. However, these findings should be interpreted cautiously and require validation in larger, adequately powered prospective studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05295173.
Binge eating in adolescents and young adults is a clinically significant concern due to its risk of progression to full-syndrome eating disorders and functional impairment. Digital guided self-help (GSH) based on enhanced cognitive behavioral therapy (CBT-E) is a scalable intervention, but implementing individualized approaches within digital platforms remains challenging. This pilot randomized controlled trial used a 2-arm waitlist-controlled crossover design to evaluate the feasibility and preliminary efficacy of PlanEat, a developmentally and symptom-tailored digital CBT-E-based GSH program. Participants aged 13-22 years (N = 64) reporting binge-eating symptoms were randomized to intervention or waitlist control. Assessments were conducted at baseline, post-intervention, and 16-week follow-up, and analyzed using linear mixed-effects models. In intention-to-treat analyses, feasibility was supported by high usability and acceptable retention. At post-intervention, the intervention group showed significantly greater reductions in eating disorder symptoms than the waitlist group, with improvements in self-esteem and psychosocial functioning. These effects were maintained at follow-up. The waitlist group showed nonsignificant changes following crossover. This pilot study supports the feasibility and preliminary effectiveness of a developmentally and symptomatically tailored digital CBT-E intervention. A fully powered trial with extended follow-up is warranted. Trial Registration:ClinicalTrials.gov Identifier: NCT05615090.
Guideline-directed medical therapy during the transitional period is crucial for improving outcomes in heart failure with reduced ejection fraction. We investigated whether a simplified transitional care intervention could increase guideline-directed medical therapy adherence in patients with acute heart failure (HF). This multicenter, open-label randomized trial enrolled 982 patients with acute HF. The transitional care intervention included a discharge checklist, HF education, and telephone monitoring. The primary outcome was achievement of high guideline adherence indicator, defined as the prescription of all 3 guideline-directed medical therapy drugs (renin-angiotensin system blockades, beta blockers, and mineralocorticoid receptor antagonists) at 6 months. Both modified intention-to-treat and per-intervention analyses were conducted to evaluate the effectiveness of intervention components. Among 982 participants (mean age, 62.4±15.5 years; 64.5% male), there was no statistical difference in the proportion achieving a high guideline adherence indicator between the intervention and control groups (49.6% versus 44.6%; OR, 1.12; 95% CI, 0.86-1.45; P=0.37). No significant differences were observed in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score or clinical outcomes. In the per-intervention analysis, patients who received all components showed significantly higher guideline adherence indicator achievement compared with those who received no components (adjusted odds ratio [OR], 1.56 [95% CI, 1.07-2.27], P=0.02). In this randomized trial of patients with acute HF, although the simplified transitional care intervention did not increase high guideline adherence indicator achievement, implementation of all intervention components was associated with improved guideline adherence. Our findings emphasize that implementation fidelity is the key challenge in optimizing transitional care for HF management. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04900584.
Recurrent glioblastoma (GBM) remains a therapeutic challenge with poor prognosis and limited treatment options. This phase I, open-label, dose-escalation trial investigates the safety and tolerability of combining sulfasalazine, a cystine/glutamate antiporter-inhibitor, with gamma knife radiosurgery (GKRS) for patients with recurrent GBM. Sulfasalazine is hypothesized to potentiate radiotherapy by depleting tumor cells of glutathione (GSH), thereby enhancing susceptibility to reactive oxygen species generated during irradiation. The study aims to establish the maximum tolerated dose (MTD) of sulfasalazine in combination with GKRS and explore preliminary efficacy signals through imaging and clinical endpoints.•Primary objective: Determine the MTD of sulfasalazine combined with GKRS and recommend a dose for future•phase II trials using the common toxicity criteria for adverse events v4.0.•Secondary objectives: Assess changes in intratumoral GSH via GSH‑edited Magnetic Resonance Spectroscopy, tumor response by Response Assessment in Neuro‑Oncology criteria, metabolic response on Carbon-11 methionine positron emission tomography, quality of life, progression free and overall survival.•Design: Open-label, dose-escalation study enrolling 12-24 patients with recurrent GBM eligible for GKRS.Patients receive sulfasalazine for 3 days prior to GKRS, followed by 12 months of monitoring for adverse events, imaging biomarkers, radiological and survival outcomes. This trial will provide safety data and inform the potential of sulfasalazine as a radiosensitizer in GBM treatment.
To assess the efficacy of whole-body vibration (WBV) on hand grip strength, muscular activity, and upper limb function in young females with smartphone addiction. This is a single-blinded randomized controlled trial. 66 females aged 18-25 years with smartphone addiction were randomly distributed into two equal groups; WBV group: It received WBV with strengthening exercises, and Sham WBV group: that received Sham WBV plus strengthening exercises. All participants received two sessions per week for four consecutive weeks. The primary outcome was hand grip strength. Secondary outcomes included pinch strength, muscle activity, and upper limb function. Evaluation was performed at baseline and after 4 weeks. Post-treatment, there were significantly greater improvement in all variables with more favor to WBV group (p < 0.001) compared to the Sham WBV group. Mean differences (95% CI) between both groups were 9.48 [7.07, 11.88] for hand grip strength, which is the primary outcome. WBV combined with hand strengthening exercises might have a positive effect in enhancing hand grip strength, pinch strength, muscle activity, and upper limb function among young females with smartphone addiction. WBV could be a valuable adjunct to traditional rehabilitation programs targeting musculoskeletal effects of smartphone overuse. ClinicalTrials.gov, identifier: NCT06849687.
COVID-19 and other respiratory viral infections can cause cardiovascular complications. SARS-CoV-2 virions are found in the blood, and circulating viral RNA levels are associated with death. We hypothesized that viremia can induce thrombotic endotheliopathy that contributes to death and studied this relationship in patients hospitalized for COVID-19 and enrolled in the ACTIV-4a (Accelerating COVID-19 Therapeutic Interventions and Vaccines) randomized trial of antithrombotic therapy. We quantified SARS-CoV-2 nucleocapsid RNA and protein in plasma and measured their associations with clinical outcomes and biomarkers of thromboinflammation and endotheliopathy. We used Cox regression and Fine-Gray competing risk models to analyze survival and thrombosis. We conducted causal mediation analysis to explore whether thrombotic endotheliopathy mediates the relationship between viral RNA and death. In 93 patients, SARS-CoV-2 RNA and N-antigen were higher in nonsurvivors. Baseline viral RNA levels were associated with increased 90-day death (hazard ratio [HR], 1.31 [95% CI, 1.17-1.46]) and thrombosis (HR, 1.35 [95% CI, 1.24-1.47]). Viral RNA more effectively predicted survivorship than N-antigen levels. Soluble thrombomodulin, a biomarker of thrombotic endotheliopathy, positively correlated with viral RNA levels. Mediation analysis revealed that soluble thrombomodulin accounts for 12.2% (95% CI, 0.1%-32.3%; P=0.048) after adjustment for age and sex of the relationship between viral RNA and the 90-day mortality rate. Elevated plasma SARS-CoV-2 RNA levels are associated with death in ACTIV-4a, which is causally mediated in part by soluble thrombomodulin. We propose that lung-blood viral dissemination is a potential mechanism for cardiovascular complications of respiratory viruses. URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04505774.
Robotic-assisted total knee arthroplasty (RATKA) has garnered attention in the field of orthopedic surgery. It has been developed to improve surgical precision and prosthesis alignment in comparison to conventional total knee arthroplasty (CTKA). It utilizes advanced robotic workflow systems as opposed to manual jig-based techniques. This review evaluated perioperative and radiographic outcomes to assess the overall safety and effectiveness of RATKA with CTKA. A comprehensive search for randomized and quasi-randomized control trials was conducted across 3 databases, PubMed/MEDLINE, Cochrane Library and Embase, from 1st January 2021 to 1st January 2026. Studies were chosen that compared RATKA to CTKA, where the primary indication was knee osteoarthritis. The primary objectives were operative time, length of stay, adverse events and blood loss. The secondary objectives were hip-knee-ankle (HKA) angle and absolute deviation of HKA angle from 180° (ΔHKA). The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA). Risk of bias was assessed using the Cochrane risk of bias tool (RoB 2). Quantitative analysis performed using the RevMan 5.4 software package. Results were presented using mean difference (MD), 95% confidence interval (CI), and risk ratio (RR). A total of 12 controlled trials were identified that met the inclusion criteria, with a total of 2269 participants. Meta-analysis revealed a statistically significant difference in operative duration, with RATKA taking longer than CTKA (MD = 23.81, 95% CI = 13.39 to 34.24, P <0.00001). There were no statistically significant differences in hospital stay (MD = 0.11, 95% CI = -0.19 to 0.42, P = 0.47), intraoperative blood loss (MD = 9.00, 95% CI = -9.46 to 27.46, P = 0.34) and adverse events (RR = 0.80, 95% CI = 0.54 to 1.18, P = 0.28). However, a statistically significant difference was identified in postoperative mechanical alignment, favoring RATKA. Postoperative HKA angle (MD: 0.71°, 95% CI: 0.43 to 1.00, P <0.00001) and absolute deviation from 180° ΔHKA (MD = -1.33, 95% CI -2.12 to -0.55, P = 0.009). RATKA is associated with longer operating times but is associated with improved mechanical alignment. The intraoperative blood loss, length of hospitalization and complications were comparable to CTKA. Considering these findings, further studies are required to assess the long-term implications and clinical benefits of RATKA.
The incidence of neuropathic pain following spinal cord injury (SCI-NP) is increasing, and current pharmacological treatments are often limited by severe side effects and diminishing efficacy. This study aims to systematically evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on SCI-NP and its frequently comorbid emotional disorders. We conducted a comprehensive search across five databases (PubMed, Embase, Cochrane Library, Web of Science, and Pedro) up to April 13, 2025. Randomized controlled trials (RCTs) investigating the impact of rTMS on SCI-NP against sham stimulation were included. Pain was the primary outcome, while changes in anxiety and depressive symptoms were secondary outcomes. Data were pooled using standardized mean differences (SMDs) and 95% confidence intervals (CIs). A total of 131 studies were retrieved from the five databases, and 7 RCTs involving 159 SCI patients were ultimately included. The results indicated that, compared to the control group (sham stimulation), rTMS effectively improved SCI-NP (SMD = -1.41; 95% CI = -2.44 to -0.59; p = 0.0007, I 2 = 78%). However, rTMS did not have a significant impact on anxiety (SMD = -0.67; 95% CI = -1.82 to 0.48; p = 0.25, I 2 = 66%) or depressive symptoms (SMD = -1.04; 95% CI = -2.26 to 0.19; p = 0.1, I 2 = 74%) compared to the control group. rTMS demonstrates promising potential in alleviating the severity of SCI-NP. However, current evidence does not support a significant therapeutic effect on comorbid emotional states. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251074707, identifier PROSPERO (CRD420251074707).
Postoperative recovery quality is a key concern for elderly patients undergoing spinal surgery, yet evidence comparing different anesthetic techniques in this population remain limited. This study aimed to compare the quality of recovery between desflurane-based inhalational anesthesia and propofol-based total intravenous anesthesia in this population. This randomized non-inferiority trial was conducted from July 1 to October 31, 2025. A total of 109 elderly patients scheduled for spinal surgery were randomly assigned to two groups: the desflurane group (group D), which received desflurane at a maintenance dose of 0.7 to 1.0 MAC, and the propofol group (group P), which received propofol at 4 to 6 mg/kg/h. Both groups received standard monitoring and invasive arterial blood pressure measurement. The primary outcome was the quality of recovery (QoR-15) scores on postoperative day 1 (POD1). Secondary outcomes include intraoperative remifentanil and vasopressors requirements, fluid volume, hemodynamic parameters, emergence profiles, duration of post-anesthesia care unit (PACU) stay, postoperative hospital length of stay, Activities of Daily Living (ADL) scale, Mini Montreal Cognitive Assessment (Mini-MoCA), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), incidence of postoperative nausea and vomiting (PONV), Numeric Rating Scale (NRS) of postoperative pain and subjective sleep quality on POD1 and POD2. The total QoR-15 score on POD1 in group D was non-inferior to that in group P (117.0 ± 10.6 vs. 118.4 ± 12.0; mean difference: -1.4; 95% CI: -5.6-2.4; one-sided P=0.017 for non-inferiority). Compared with group P, group D had significantly shorter times to extubation, eye opening, limb movement, orientation recovery, and ability to state one's name, as well as significantly higher Riker Sedation-Agitation Scale scores. Intraoperative phenylephrine consumption and fluid volume were lower in group D than in group P. No significant differences were observed between the two groups in PACU stay duration, postoperative hospital length of stay, ADL scale, Mini-MoCA, CAM-ICU, PONV incidence, NRS pain scores, or subjective sleep quality. Desflurane-based inhalational anesthesia provided a non-inferior quality of recovery compared with propofol. Additionally, desflurane was associated with faster emergence and lower vasopressor requirements. Desflurane and propofol can be considered interchangeable for general anesthesia in elderly patients undergoing spinal surgery.
Manual therapy is widely applied for musculoskeletal dysfunction and pain, yet the mechanisms underlying its effects remain incompletely understood. Local biomechanical and central neurophysiological processes are considered relevant, while contextual factors such as patient expectations and therapist beliefs may further influence treatment outcomes. This study investigated whether suggestions regarding the mechanisms of manual therapy modulate treatment effects on range of motion (ROM) and pressure pain threshold (PPT), both locally and at a remote site. Ninety-three healthy participants were randomized, in a university campus laboratory, to one of three groups, each receiving a distinct mechanistic suggestion (biomechanical, neurophysiological, or none) prior to a standardized lumbar manual therapy intervention. The outcomes comprised lumbar ROM, PPT, and movement-related pain, assessed before and after the intervention at the treated site and at a remote site, and analyzed using a general linear model (GLM). All groups showed significant improvements in ROM over time (p = 0.01, η²p = 0.07) and between assessment areas (p = 0.006, η²p = 0.08). However, no main effect of group was detected (p = 0.40), and no significant two-way or three-way interactions emerged (all p > 0.05). Similarly, no between-group differences were observed for PPT or movement-related pain. Suggestions regarding the mechanisms of manual therapy did not influence treatment outcomes in healthy individuals. Cognitive modulation through mechanistic suggestions failed to alter ROM, PPT, or movement-related pain.
An infant's unique scent can significantly foster a deep emotional connection between mother and baby. This study aimed to determine the effect of watching infant video with or without smelling an infant-scented hat on anxiety and breast milk volume (primary outcomes), stress and mother-infant attachment (secondary outcomes) in mothers with hospitalized infants in the neonatal intensive care unit (NICU). In this randomized controlled trial, 78 mothers were allocated to three groups using block randomization: intervention group 1 (infant-scented hat plus video), intervention group 2 (video only), and a control group (plain hat). The intervention lasted 5 days. All mothers received training on breast pumping and recording their milk volume. Data were analyzed using analysis of covariance. Compared with the control group, both interventions led to significant improvements in state anxiety (Group 1: adjusted mean difference [AMD] = -16.40, 95%CI: -24.56 to -8.24, p < 0.001; Group 2: AMD = -13.83, 95%CI: -21.26 to -6.40, p < 0.001), trait anxiety (Group 1: AMD = -11.54, 95%CI: -16.29 to -6.80, p < 0.001; Group 2: AMD = -11.57, 95%CI: -15.87 to -7.26, p < 0.001), and perceived stress (Group 1: AMD = -2.11, 95%CI: -3.67 to -0.56, p = 0.004; Group 2: AMD = -1.86, 95%CI: -3.39 to -0.33, p = 0.001). Milk volume (mL) in Group 1 was significantly higher than in the control group (Day 3: MD = 37.85, 95%CI: 4.13 to 71.56, p = 0.023; Day 4: MD = 49.13, 95%CI: 9.73 to 88.53, p = 0.010; Day 5: MD = 80.55, 95%CI: 34.85 to 126.26, p = 0.001). On Day 5, milk volume in Group 2 was significantly higher than in the control group (MD = 51.05, 95%CI: 5.17 to 96.93, p = 0.024). Mother-infant attachment scores were significantly higher in Group 1 compared with the control group (MD = 3.56, 95%CI: 0.93 to 6.19, p = 0.004). Scent-infused materials and infant video exposure during NICU hospitalization may reduce maternal anxiety and stress, enhance milk production, and improve attachment, supporting development of targeted NICU interventions.
The optimal radiotherapy strategy for prostate cancer (PC) patients with high nodal risk remains debated. This prospective phase II study reports long‑term clinical outcomes, toxicity, and patient‑reported outcomes in men with PC treated with whole‑pelvis radiotherapy and dose escalation to MRI‑identified intraprostatic lesions and PET‑positive pelvic lymph nodes. Eighty‑five PC patients with high nodal risk or up to three pelvic nodal metastases were enrolled between 2013 and 2017. Radiotherapy delivered 77 Gy to the prostate and 56 Gy to pelvic nodes in 35 fractions, with escalation to 70 Gy for PET‑positive nodes and 84 Gy for MRI‑defined intraprostatic lesions when feasible. Endpoints included biochemical progression‑free survival, overall survival, toxicity, and longitudinal patient‑reported outcomes. Seventy-eight patients underwent radiotherapy. Of these, 42 received an intraprostatic boost and were classified as the per-protocol population. Median follow‑up was 7.8 years, and 26% had N1 disease. For the full cohort, five‑year biochemical progression‑free survival was 76%, with poorer results among patients with RECIST‑positive nodal involvement. Five‑year overall survival was 95%. Acute grade ≥ 2 genitourinary and gastrointestinal toxicities occurred in 33 and 23%, respectively, and decreased over time. No grade ≥ 3 gastrointestinal toxicity was observed. Patient‑reported outcomes showed low long‑term urinary and bowel bother. Whole‑pelvis radiotherapy with targeted dose escalation was well tolerated. The high proportion of patients not receiving an intraprostatic boost underscores methodological challenges and emphasises the need for standardised imaging interpretation and delineation guidelines.
Aging is characterized by a decline in functional abilities, strength, balance, flexibility, agility, and coordination due to neurological and muscular changes. Hippotherapy (HPOT) has been recognized for its physical and psychological benefits for older adults. Hence, this study aimed to investigate the effects of hippotherapy on balance in elderly individuals. The novelty lies in using the Biodex Balance System SD for dynamic balance assessment in healthy elderly without neurological disorders. We recruited elderly men aged 60 to 70 who had independent mobility and medical clearance for hippotherapy, ensuring they met criteria such as consistent participation and the absence of pertinent diseases, orthopedic issues, recent surgeries, or medications that could influence outcomes. The dependent variables measured with the Biodex Balance System SD included (I) fall risk, (II) stability index, (III) balance index, (IV) anterior-posterior deviation, and (V) mediolateral deviation. The intervention consisted of 16 sessions of hippotherapy over 8 weeks, with two 30-min sessions each week, during which participants rode a horse. The main findings derived from this study indicate that the intervention significantly reduced Fall Risk in the training group compared to the control (p = 0.000, η = 0.77). Hippotherapy also significantly improved Stability index (p = 0.041, η = 0.15), Anterior-Posterior Sway (p = 0.013, η = 0.39), mediolateral sway (p = 0.002, η = 0.54), and Balance index (p = 0.008, η = 0.43). This suggests a noteworthy distinction across all measured variables. The findings demonstrate that hippotherapy significantly enhances balance in physically active elderly individuals, potentially improving their quality of life. These results will inform professionals working with this population.
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Acute ischemic stroke (AIS) triggers a complex systemic immune-inflammatory response. While proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide significant lipid-lowering and pleiotropic anti-inflammatory effects, their impact on early peripheral inflammatory and immune responses in AIS patients due to large artery atherosclerosis (LAA) remains underexplored. A total of 72 AIS patients attributed to LAA were included in the final analysis of this prospective study (the standard treatment group, n = 24; the intensive treatment group, n = 48). Fasting blood samples were obtained at admission and the 2-week follow-up. A comprehensive panel of laboratory parameters was assessed at baseline and the 2-week follow-up, encompassing lipid profiles, a spectrum of inflammatory biomarkers (including but not limited to high-sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α)), and lymphocyte subsets. The intensive treatment group achieved a significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) compared to the standard treatment group (P < 0.001). Notably, the intensive treatment group also showed significant reductions in key pro-inflammatory cytokines IL-6 (P = 0.024) and TNF-α (P = 0.041). However, no significant between-group differences were observed in the changes of peripheral blood lymphocyte subsets (P > 0.050). In AIS patients, early adjunctive PCSK9 inhibitor therapy provides superior lipid-lowering and may modulate specific pro-inflammatory cytokines compared to statin monotherapy, without significantly altering peripheral lymphocyte subset distributions within 2 weeks. Further large-scale studies are warranted to validate its immunomodulatory role and long-term clinical outcomes. ClinicalTrials.gov NCT05410457. Registered May 24, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05410457; ClinicalTrials.gov NCT05397405. Registered May 23, 2022. https://www.clinicaltrials.gov/ct2/show/NCT05397405. Acute ischemic stroke (AIS) triggers a complex systemic immune-inflammatory response. While proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide significant lipid-lowering and pleiotropic anti-inflammatory effects, their impact on early peripheral inflammatory and immune responses in AIS patients due to large artery atherosclerosis (LAA) remains underexplored. Our study evaluated the early immunomodulatory effects of PCSK9 inhibitor add-on therapy versus statin monotherapy in acute ischemic stroke patients. The combination therapy achieved superior LDL-C reduction and significantly decreased key pro-inflammatory cytokines (IL-6 and TNF-α), while no significant impact on peripheral lymphocyte subset distributions was observed within 2 weeks.