Tag: nevin manimala

Trials. 2025 Sep 24;26(1):345. doi: 10.1186/s13063-025-09079-z.

ABSTRACT

OBJECTIVE: The study attempted to explore the postoperative pain control of ultrasound-guided iliac fascia and trigeminus block anesthesia among patients undergoing free flap reconstruction for head-and-neck tumors.

METHODS: This research implemented a prospective, double-blinded, randomized, and placebo-controlled clinical trial. Patients between 18 and 85 years who had accepted a radical head-and-neck tumor resection while simultaneously undergoing the vascularized anterolateral femoral free flap reconstruction for the surgical coloboma were recruited. The subjects were randomly divided into nerve block and blank groups. Faciocervical pain while speaking was the primary outcome variable. It was measured using the visual analog scale (VAS) during the perioperative period up to postoperative 7 days. Descriptive statistics and logistic regression analysis were performed. The data were analyzed using the Mann-Whitney U test, linear mixed-effects model, chi-square test, and Fisher’s exact test. The statistically significant level was set at P < 0.05.

RESULTS: The sample comprised 145 subjects with a mean age of 58.4 (SD = 12.7), 102 (70.3%) males. There were 71 (49.0%) and 74 (51.0%) participants in the nerve block and blank groups. Nerve block anesthesia reduced postoperative pain, depicted by VASS (0.99 ± 1.72 P < 0.0001). The out-of-bed mobilization started before within the nerve block group (47.45 ± 19.68 P = 0.017). The high expression of IL-6 could decrease the efficacy of this protocol (P = 0.0176).

CONCLUSION: Ultrasound-guided iliac fascia combined with trigeminus block anesthesia is an effective method for pain management in patients who underwent head-and-neck tumor surgery in conjunction with the simultaneous repair using the vascularized anterolateral femoral free flap.

TRIAL REGISTRATION: The Institutional Ethics Review Board approved the study and retrospectively registered it with the Chinese Clinical Trial Registry at January 10, 2024 (ChiCTR2400079720).

PMID:40993773 | DOI:10.1186/s13063-025-09079-z

Diabetol Metab Syndr. 2025 Sep 24;17(1):370. doi: 10.1186/s13098-025-01931-1.

ABSTRACT

BACKGROUND: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a prevalent metabolic condition lacking sensitive and accessible biomarkers for early detection and risk stratification.

OBJECTIVE: To investigate the association between serum alpha-1-acid glycoprotein (AGP) levels and MAFLD prevalence among young and middle-aged women, and to evaluate the dose-response relationship and diagnostic performance of AGP.

METHODS: Data were obtained from 2,003 female participants aged 20-49 years in the NHANES 2017-2020 cycles. Weighted multivariable logistic regression models assessed the association between AGP and MAFLD, with adjustments for demographic, metabolic, and inflammatory covariates. Restricted cubic spline (RCS) regression evaluated nonlinear trends, and ROC analysis assessed predictive accuracy.

RESULTS: Higher AGP levels were significantly associated with increased MAFLD risk. In the fully adjusted model, the highest AGP tertile had an odds ratio of 2.63 (95% CI: 1.65-4.19) compared to the lowest. RCS analysis showed a nonlinear, biphasic relationship with an inflection point around 0.9 g/L. ROC analysis indicated moderate discriminatory ability (AUC = 0.734), with AGP outperforming traditional liver enzymes. Subgroup analyses confirmed consistency across metabolic risk strata.

CONCLUSION: AGP is independently and nonlinearly associated with MAFLD and may serve as a non-invasive biomarker for early identification of at-risk individuals. These findings support the potential clinical utility of AGP in MAFLD screening and risk assessment.

PMID:40993765 | DOI:10.1186/s13098-025-01931-1

Parasit Vectors. 2025 Sep 24;18(1):375. doi: 10.1186/s13071-025-06844-6.

ABSTRACT

BACKGROUND: Taenia solium cysticercosis is a zoonotic parasitic disease with significant public health implications, particularly in endemic regions of low- and middle-income countries. In pigs, cyst burden varies widely, with most harboring fewer than 10 cysts and only a small fraction carrying high cyst loads. Age has been identified as a key factor influencing infection susceptibility. However, inconsistencies in previous studies have hindered clear characterization of infection patterns and immunity. In this study, we conducted controlled experiments involving the infection of pigs with T. solium eggs to evaluate the relationship between pig age and susceptibility to infection.

METHODS: A total of 52 pigs from northern Peru, aged 4 to 22 weeks, were experimentally infected with T. solium eggs to examine age-related differences in cyst burden. Pigs were housed individually under controlled conditions and fed commercial pig diets. Infections were administered using an esophageal catheter, delivering 20,000 T. solium eggs in gelatin capsules. Six age groups were studied using a standardized egg pool to ensure consistency across infection rounds. After 10 weeks, necropsies were performed to count cysts in all muscles, the brain, and other organs. Weekly serological tests monitored seroconversion. Statistical models were used to analyze cyst counts and assess the effects of age and other predictors.

RESULTS: The number of live, degenerated, and total cysts was overdispersed, making a negative binomial model the most suitable choice to represent the data and their dependence on age at infection. Younger pigs showed low median live cyst count, similar to older pigs, while median cyst burden increased in pigs infected at intermediate ages, around natural weaning age. The negative binomial regression showed that age and a covariate inversely related to age at infection were significantly associated with cyst count at necropsy. Other covariates such as egg pool viability and sex did not significantly affect model performance. Serological tests confirmed seroconversion in all pigs.

CONCLUSIONS: Our results show that younger pigs display partial protection against the development of cysticerci compared to those infected at the natural weaning age (around 9 to 12 weeks of age). Additionally, infection susceptibility then decreases with age in a way that is consistent with previous literature.

PMID:40993763 | DOI:10.1186/s13071-025-06844-6

BMC Public Health. 2025 Sep 24;25(1):3065. doi: 10.1186/s12889-025-24272-0.

ABSTRACT

Diabetic kidney disease (DKD) is a severe and prevalent complication of diabetes. Social contexts have been increasingly recognized as critical factors in the escalation and ongoing management of chronic diseases, including DKD. This study aimed to evaluate the connection between social risk profile (SRP) and DKD in United States. METHODS: Data were sourced from the National Health and Nutrition Examination Survey (1999-2018). DKD was defined as the coexistence of diabetes and chronic kidney disease (CKD). SRP scores, based on the number of positive measures, were categorized into four quartiles: low (0-2), lower-middle (3-4), upper-middle (5-6), and high (7-8). The associations of SRP with the prevalence and mortality of DKD were assessed. RESULTS: A total of 6,464 participants were included in the study, among them, 2,668 had DKD, and 1,153 died during a mean follow-up of 143 months. SRP scores were associated with the prevalence and mortality of DKD. Compared with high SRP scores, low SRP levels were related with a higher risk of DKD (OR, 1.86; 95% CI, 1.54 to 2.26, P < 0.0001). Higher SRP scores were associated with lower risks of mortality, including all-cause (HR, 0.84; 95% CI, 0.81-0.88; P < 0.0001), cardiovascular disease (HR, 0.85; 95% CI, 0.80-0.91; P < 0.0001), and diabetes-related mortality (HR, 0.86; 95% CI, 0.76-0.96; P = 0.009). CONCLUSION: Lower SRP scores showed a connection to higher DKD prevalence and worse outcomes, highlighting the potential importance of social risk screening and targeted interventions.

PMID:40993757 | DOI:10.1186/s12889-025-24272-0

Trials. 2025 Sep 24;26(1):348. doi: 10.1186/s13063-025-09068-2.

ABSTRACT

BACKGROUND: The Estimands framework, introduced in the Addendum to ICH E9, provides a structured method to define treatment effects in clinical trials. The main novelty of the framework is the discussion of intercurrent events as part of the treatment effect definition. It is widely believed that the application of the framework to non-inferiority and equivalence trials deserves specific consideration.

METHODS: To examine the current practices of using the estimand framework in non-inferiority and equivalence trials, we reviewed the scientific advice provided by the European Medicines Agency to drug developers in 2022. This review aimed to determine how often the estimands framework is used by drug developers and/or recommended by EMA and to describe what intercurrent events and handling strategies are being proposed by drug developers and recommended by EMA.

RESULTS: The use of the framework varied substantially by clinical development phases. While it was used for phase 3 trials in 47% (25/53) by developers, it was used in 5% (1/19) of the phase 1 trials. For 39% (11/28) of the trials where developers did not use the estimands framework in phase 3, there was no regulatory recommendation to adopt the framework in the response. The most discussed intercurrent event in our sample was ‘treatment discontinuation’ (n = 47), for which developers most often proposed either a treatment policy strategy (17/47, 36%) or a hypothetical strategy (11/47, 23%). In contrast, EMA most often recommended the use of two co-primary estimands with two different strategies (22/47, 47%).

CONCLUSIONS: Generally, the proposed and recommended strategies depend on the clinical setting and the respective intercurrent event. Developers almost always proposed a single primary estimand, whereas EMA often recommended two co-primary estimands differing in the strategies used to handle some or all the intercurrent events. Further interaction between academia, industry and regulators is necessary to progress the implementation process of the estimands framework for non-inferiority and equivalence trials.

PMID:40993752 | DOI:10.1186/s13063-025-09068-2

Orphanet J Rare Dis. 2025 Sep 24;20(1):481. doi: 10.1186/s13023-025-04007-5.

ABSTRACT

BACKGROUND: Spasticity is a hallmark of hereditary spastic paraplegia (HSP) and contributes to gait impairment. Alpinia zerumbet oil (Ziclague^®) is a topical anti-spastic agent approved in Brazil, but not yet explored in HSP. Then, it was designed a randomized, placebo-controlled, double-blind, crossover trial to evaluate the efficacy and safety of Ziclague^® in patients with HSP: the ZISPAST trial.

METHODS: Each participant was randomly assigned to receive 0.8 mL of Ziclague^® dermal applications (0.064 mL of Alpinia Zerumbet equally divided in each adductor magnus and each triceps surae) or placebo 0.9%. The primary endpoint was change from baseline in self-selected gait velocity and secondary endpoints included changes in maximal gait velocity, walking endurance, spasticity, muscle strength, Spastic Paraplegia Rating Scale, pain, fatigue, quality of life and post-treatment perceived change and general impression. Adverse events (AE) were also recorded.

RESULTS: Fifty-seven patients were enrolled, 37 (64.9%) of whom were men and 50 (87.7%) with pure phenotype. Mean age was 44 (± 11.6; range, 22 to 74), mean age of onset 23 (± 16.6; range, < 1 to 62) and mean disease duration 21 (± 13.1; range, 2 to 54) years. Compared to baseline, there were no significant between-group differences in primary and secondary outcomes. There were few AEs, all of them mild. Incidence of AE was similar between treatment arms (p = 0.56).

CONCLUSIONS: Ziclague^® was safe in patients with HSP, but it was not able to improve gait velocity considering methods and protocol used.

TRIAL REGISTRATION NUMBER: U1111-1218-2539. Registered 28 August 2018, https://ensaiosclinicos.gov.br/rg/RBR-83xh37 .

PMID:40993748 | DOI:10.1186/s13023-025-04007-5

BMC Public Health. 2025 Sep 24;25(1):3052. doi: 10.1186/s12889-025-24735-4.

NO ABSTRACT

PMID:40993739 | DOI:10.1186/s12889-025-24735-4

Orphanet J Rare Dis. 2025 Sep 24;20(1):483. doi: 10.1186/s13023-025-04019-1.

ABSTRACT

BACKGROUND: Fragile X syndrome (FXS) is the most common cause of inherited intellectual disability (ID) with comorbid autism and several support requirements. Challenging behaviors are frequently reported as a main concern for parents and caregivers, who also experience increased stress levels. There is little evidence of telehealth parent-implemented intervention (PII) for this population. Our study focused on describing the impact that brief telehealth parent-implemented interventions had on the parental stress levels and challenging behaviors of children with FXS in a Latin American country.

METHODS: Thirteen caregivers were assessed pre- and postintervention with the Parenting Stress Index short form (PSI-SF), Motivation Assessment Scale (MAS), and Fragile-X-specific adaptation of the Aberrant Behavior Checklist-Community questionnaire (ABC-C_FX). Four telehealth sessions were developed with each participant to guide their intervention with their children with FXS. Statistical analysis was performed using paired t tests or Wilcoxon matched-pairs tests, and Pearson’s and Spearman’s correlations were used for comparisons. All the statistical analyses were performed using GraphPad Prism v8.3.0, and a two-tailed p value < 0.05 was considered to indicate statistical significance.

RESULTS: PSI-SF (TS_initial=85(52.5-97) vs. TS_final=55(27.5-90), p = 0.0117) and two MAS subscale frequencies of occurrence (scape_initial=10(4-12.5) vs. scape_final=3(0.5-8.5), p = 0.0146; tangible_initial =11.69 ± 8.27 vs. tangible_final=7.154 ± 6.56, p = 0.0146) significantly decreased. ABC-C_FX did not significantly differ. The LSI-SF was positively correlated with three ABC-C_FX subindexes (lethargy/withdrawal s = 0.719, p = 0.007; hyperactivity r = 0.682, p = 0.01; and irritability s = 0.69, p = 0.011).

CONCLUSIONS: Telehealth parent-implemented interventions decreased parental stress and challenging behavior perception and increased feelings of parental competence. The PII benefits interventions for children with FXS and is a key aspect to consider in situations where movement, transfer and access to specialized professionals are difficult or interfered with in a particular region or because of a major sanitary alert.

PMID:40993733 | DOI:10.1186/s13023-025-04019-1

Parasit Vectors. 2025 Sep 24;18(1):376. doi: 10.1186/s13071-025-07043-z.

ABSTRACT

BACKGROUND: Intestinal protozoa and helminths remain an under‑recognized cause of gastrointestinal morbidity in China. Molecular high‑throughput tools offer the chance to survey their diversity comprehensively, yet their application in clinical settings has been limited.

METHODS: We pooled leftover fecal samples from 360 hospital patients in Changchun (36 pools; 12 demographic/seasonal groups) and enriched them by sucrose flotation. Three primer pairs targeting 18S V4‑V5, 18S V9 and 28S D3‑D4 rRNA regions were amplified, and paired‑end libraries (100-140 k reads per amplicon) were sequenced on Illumina platforms. Taxa were assigned with QIIME2 against SILVA, and true prevalences were estimated from pooled‑sample data using a binomial model with profile‑likelihood confidential intervals. Selected positives were confirmed by qPCR, nested PCR, gp60 subtyping and immunofluorescence assay.

RESULTS: From 6.1 million quality‑filtered reads, only 1.65% mapped to parasites; fungal reads dominated (98.35%), underscoring primer bias. Four eukaryotic parasites were detected across 12/36 pools. Cryptosporidium parvum was most frequent (7 pools, true prevalence = 2.14%, 95% CI 0.92-4.10), and all gp60‑typed isolates belonged to subtype IIdA19G1. Blastocystis hominis occurred in five pools (1.48%, 0.53-3.17), predominantly ST1, with single detections of ST3 and ST6. Entamoeba hartmanni appeared in one pool (0.28%, 0.02-1.23). Reads assignable only to Opisthorchiidae suggested liver‑fluke carriage in four adult pools (1.17%, 0.36-2.70). No statistically significant associations were found between infection status and age, sex, season or diarrhea. Amplification success differed markedly between primer sets, limiting quantitative comparisons.

CONCLUSIONS: Metabarcoding of rDNA amplicons provides a feasible snapshot of human intestinal‑parasite communities in Northeast China, revealing C. parvum IIdA19G1 as an emerging zoonotic threat and highlighting ongoing food‑borne trematodiasis. However, the overwhelming amplification of fungal templates and inter‑primer bias call for primer redesign and complementary diagnostics before routine clinical adoption.

PMID:40993720 | DOI:10.1186/s13071-025-07043-z

BMC Sports Sci Med Rehabil. 2025 Sep 24;17(1):266. doi: 10.1186/s13102-025-01329-6.

ABSTRACT

OBJECTIVE: The aim is to elucidate the effects of mental fatigue (MF) on lower limb biomechanics during stop-jump maneuver in healthy male college students and to evaluate its potential contribution to the heightened risk of noncontact anterior cruciate ligament injury (NC-ACLI).

METHODS: Using a within-subject experimental design, MF was induced with a 45-minute Stroop task. The visual analogue scale for mental fatigue (VAS-MF), an infrared motion capture system, a three-dimensional force platform, and surface electromyography (sEMG) were employed to collect data on VAS-MF scores, as well as lower limb kinematics, kinetics, and electromyographic activity pertinent to NC-ACLI risk in 36 participants, before and after the MF induction. Paired t-tests and non-parametric statistical analyses were used for evaluation.

RESULTS: VAS-MF scores increased significantly following MF induction (P < 0.001). After induction, participants demonstrated significant reductions in ankle dorsiflexion and knee flexion angle at the moment of peak vertical ground reaction force during stop-jump (P < 0.05). Conversely, peak vertical ground reaction force, knee extension moment, and knee abduction moment increased significantly (P < 0.05), while knee abduction and hip flexion angles remained unchanged (P > 0.05). Regarding muscle activation, rectus femoris sEMG parameters-including median frequency, mean power frequency, mean absolute value amplitude, and root mean square amplitude-were significantly elevated (P < 0.05), whereas tibialis anterior sEMG exhibited significant decreases in median frequency and mean power frequency (P < 0.05). No significant changes were observed in the sEMG signals of the biceps femoris or lateral gastrocnemius (P > 0.05).

CONCLUSION: MF significantly modulates certain biomechanical characteristics of the lower limb during stop-jump maneuver, potentially exacerbating the risk of NC-ACLI in healthy male college students. Targeted intervention strategies are recommended to mitigate ACL injury risks under mentally fatigued conditions.

TRIAL REGISTRATION: This study was registered with the China Clinical Trial Registry (Registration No. ChiCTR2400093367, 2024/12/03), a WHO Level 1 registry.

PMID:40993717 | DOI:10.1186/s13102-025-01329-6