Category: Statistics

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

Allergy Asthma Clin Immunol. 2025 Sep 24;21(1):41. doi: 10.1186/s13223-025-00981-4.

ABSTRACT

BACKGROUND: Unverified drug allergy labels are common and associated with significant patient harm, yet infrastructure and testing practices vary across clinical settings in Canada.

OBJECTIVE: To characterize variability in drug allergy management among allergists in Canada and identify setting-specific barriers to drug allergy testing and desensitization.

METHODS: We developed a peer-reviewed 40-item survey, distributed via the Canadian Society of Allergy and Clinical Immunology, to assess practice patterns, testing modalities, and perceived barriers among allergists. Descriptive statistics and Fisher’s exact test were used to evaluate responses by practice setting.

RESULTS: Sixty-six allergists responded (30% estimated response rate), with 48.4% solely practicing in community clinics and 21.9% solely in hospital-based clinics. While 87.9% performed some form of drug allergy testing, hospital-based allergists were significantly more likely to perform intradermal (81.1% vs. 48.7%, p = 0.004) and patch testing (38.2% vs. 8.8%, p = 0.009), as well as non-oral drug challenges (63.6% vs. 20.0%, p = 0.0005). Common barriers included a lack of nursing support and inadequate reimbursement.

CONCLUSION: Drug allergy management practices vary substantially across Canada, with drug allergy testing being more frequently performed by allergists practicing in hospital-based clinics than by those in community-based clinics. Findings support the need for equitable access to testing infrastructure and system-level investments in improving drug allergy testing services.

PMID:40993713 | DOI:10.1186/s13223-025-00981-4

Cardiovasc Diabetol. 2025 Sep 24;24(1):367. doi: 10.1186/s12933-025-02826-1.

ABSTRACT

OBJECTIVES: The triglyceride-glucose index (TyG) is an emerging marker of metabolic health, yet its association with mortality across different glucose metabolism statuses remains unclear. This study aimed to investigate the relationship between the TyG and the risk of all-cause and cardiovascular mortality among individuals with normoglycemia, dysglycemia, and diabetes mellitus.

METHODS: Participants from nine cycles of the National Health and Nutrition Examination Survey (NHANES) were included and categorized into three groups: normoglycemia, dysglycemia, and diabetes. Cox regression and restricted cubic spline (RCS) analyses were performed to evaluate the linear and nonlinear associations between TyG and mortality. To assess the predictive power of TyG and the atherogenic index of plasma (AIP) for mortality, time-dependent receiver operating characteristic (ROC) curves were constructed. Subgroup analyses were conducted based on age, sex, and blood pressure status.

RESULTS: During a median follow-up of 9.2 years, a total of 2199 all-cause deaths and 606 cardiovascular deaths were documented. In the normoglycemic group, a single standard unit increase in TyG was associated with a 35% higher risk of all-cause mortality and a 38% higher risk of cardiovascular mortality (HR: 1.35, 95% CI 1.17-1.56; HR: 1.38, 95% CI 1.04-1.84, respectively). Among participants with diabetes, RCS analysis revealed a U-shaped association between TyG and all-cause/cardiovascular mortality, with an inflection point at 9.1. No significant associations were observed in the dysglycemia group. TyG demonstrated superior predictive performance compared to the AIP for 3-year mortality in both normoglycemic and diabetic individuals. Subgroup analyses identified significant interaction effects of age and sex on the association between TyG and mortality.

CONCLUSION: TyG was associated with an increased risk of all-cause and cardiovascular death in the normoglycemic subgroup, but not in the dysglycemic subgroup. In the diabetes subgroup, the association between the TyG and mortality was nonlinear. The predictive value of TyG across different glucose metabolism statuses provides new evidence for medical practice.

PMID:40993712 | DOI:10.1186/s12933-025-02826-1

Eat Behav. 2025 Sep 11;59:102031. doi: 10.1016/j.eatbeh.2025.102031. Online ahead of print.

ABSTRACT

This study aimed to compare eating pathology between heterosexual and sexual minority (SM) undergraduate women and explore the relation between eating pathology and minority stress in SM undergraduate women. Undergraduate women at a Southeastern university (N = 547; 38 % SM, 62 % heterosexual) completed a one-time online survey (2023-2024) measuring eating pathology, internalized stigma, and stigma concealment. We analyzed descriptive statistics and Analyses of Covariance (ANCOVAS). SM undergraduate women reported more body dissatisfaction and shape/weight overvaluation (p < .001) and no difference in dietary restraint (p = .78) compared with their heterosexual counterparts. For SM undergraduate women, dietary restraint was linked to stigma concealment (p < .05). These findings suggest that although SM undergraduate women experience unique stressors related to eating pathology, they are at similar risk of restrictive eating pathology to heterosexual undergraduate women. In addition to typical university life stressors, providers should be aware of the potential impact of stigma on SM female students’ eating behaviors/cognitions.

PMID:40992020 | DOI:10.1016/j.eatbeh.2025.102031

Arch Oral Biol. 2025 Sep 19;180:106400. doi: 10.1016/j.archoralbio.2025.106400. Online ahead of print.

ABSTRACT

OBJECTIVE: This project aimed to evaluate the immunoexpression pattern of murine double minute 2 (MDM2) in solid ameloblastomas compared to unicystic ameloblastomas.

METHODS: The review followed PRISMA guidelines and was registered in the PROSPERO database. PubMed, Scopus, ScienceDirect, Web of Science, and Google Scholar were comprehensively searched. Original cross-sectional studies were included. The meta-analysis was performed using STATA V15 and RevMan. Positivity rates were pooled using a random-effects model (REM), the labeling index was analyzed using mean difference under a REM, and expression intensity (moderate-strong) was assessed as categorical data using a REM with Hartung-Knapp adjustment. Heterogeneity was evaluated with the Chi² test and I² statistic. The methodological quality and certainty of the evidence were assessed using the Joanna Briggs Institute items and the GRADE system.

RESULTS: Nine studies (n = 438 specimens) were analyzed, of which 325/438 (74.2 %) were ameloblastoma biopsies. MDM2 positivity was detected in 403/438 cases (92 %). A statistically significant association in favor of solid ameloblastoma was observed (RR = 2.08; 95 %CI [1.66-2.60]; p = 0.005), indicating a twofold probability of finding high MDM2 expression in solid compared to unicystic ameloblastomas. Four of the nine studies (44.4 %) were considered to be of low quality, and the certainty of evidence was low to very low.

CONCLUSIONS: MDM2 expression was prevalent in both types of ameloblastomas, with a higher intensity of expression observed in solid cases. However, due to study heterogeneity, further investigations with more robust methodological designs are recommended to assess the diagnostic potential of MDM2 in ameloblastomas.

PMID:40992015 | DOI:10.1016/j.archoralbio.2025.106400

Biomed Pharmacother. 2025 Sep 23;192:118598. doi: 10.1016/j.biopha.2025.118598. Online ahead of print.

ABSTRACT

Alzheimer’s disease (AD) is a neurodegenerative disorder characterized by a complex pathobiology that includes neuroinflammation, the accumulation of extracellular amyloid-beta (Aβ) plaque, and intracellular neurofibrillary tangles comprising tau. Increasing evidence suggests that the aberrant activation of glial cells, including microglia and astrocytes, is a significant early characteristic that accelerates neuroinflammatory processes in the development of AD. Protocatechuic acid (PCA), a natural phenolic compound, has been investigated for its anti-inflammatory properties in various pathological conditions. Here, we demonstrated that administration of PCA significantly ameliorated neuroinflammation as well as cognitive deficits in the 5 ×FAD mouse model of AD, which overexpresses human amyloid precursor protein (APP) and presenilin-1 (PSEN1) genes carrying five familial Alzheimer’s disease (FAD) mutations, leading to accelerated Aβ deposition. We further confirmed that PCA treatment significantly reduced microglial activation and downregulated the production of pro-inflammatory cytokines, astrogliosis, and tau hyperphosphorylation, thereby preserved the integrity of hippocampal neurons. Our RNA sequencing analysis revealed that PCA treatment restored the transcriptomic profile of hippocampal tissues in 5 ×FAD mice, particularly by downregulating genes associated with innate immune and inflammatory responses. Moreover, PCA alleviated gut dysbiosis and enhanced the integrity of the intestinal barrier. The findings suggest that PCA may serve as a promising therapeutic agent for early intervention in AD to mitigate its progression.

PMID:40991989 | DOI:10.1016/j.biopha.2025.118598