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Aim: To investigate the prevalence and clinical manifestations of reading, writing, and mathematics disorders in children with cerebral palsy (CP). We explored how the clinical profile of these children differed from those with specific learning disorders (SLDs), taking into account several factors, particularly IQ scores, neuropsychological aspects, and the presence of a visual impairment. Method: A prospective cross‐sectional study was conducted in 42 children with CP (mean age 9 years 8 months; SD = 2 years 2 months) and 60 children with SLDs (mean age 10 years; SD = 1 year 7 months). Clinical characteristics, neuromotor and cognitive profiles, neuropsychological aspects (speech performance, academic skills, visual attention, phonological awareness, working memory), and signs of visual impairment (visual acuity, contrast sensitivity, visual field, oculomotor functions) were assessed. A machine learning approach consisting of a random forest algorithm, where the outcome was the diagnosis and the covariates were the clinical variables collected in the sample, was used for the analyses. Results: About 59% of the children with CP had reading, writing, or mathematics disorders. Children with CP with learning disorders had a low performance IQ, normal phonological awareness, and working memory difficulties, whereas children with SLDs had normal performance IQ, impaired phonological awareness, and mild working memory difficulties. There were no differences in verbal IQ between the two groups. Interpretation: Learning disorders are frequently associated with CP, with different clinical characteristics, compared with SLDs. Assessment of academic skills is mandatory in these children, even if the IQ is normal. At school age, specific interventions to promote academic skills in children with CP could be a major rehabilitative goal. What this paper adds: Reading, writing, and mathematics disorders in cerebral palsy have specific clinical characteristics.Their underlying mechanisms differ from those described in specific learning disorders.Working memory impairment can be considered a hallmark of learning disorders in children with cerebral palsy. [ABSTRACT FROM AUTHOR]

Objective: This retrospective review documents the experience of ipratropium bromide use among pediatric patients with sialorrhea at our multidisciplinary sialorrhea clinic at Children's Hospital at London Health Sciences Centre (LHSC). Methods: A retrospective chart review of patients diagnosed with sialorrhea at our multidisciplinary clinic between January 2015 and June 2021 was completed. Data on patient demographics, comorbidities, clinical presentation, previous interventions, quality of life, and medication adverse side effects was collected. Drooling Frequency and Severity Scale (DFSS) scores were reviewed to compare sialorrhea management pre- and post-treatment with topical 0.03% ipratropium bromide nasal solution. A descriptive analysis and Wilcoxon signed rank tests were conducted to compare pre- versus post-treatment DFSS scores. Results: A total of 12 patients presented for follow-up and were included in the final analysis. At the pre-treatment visit, the median DFSS score was 4 for frequency and 5 for severity. Post-treatment, median DFSS score was 3 for frequency and 4.5 for severity, (P =.020 and.129, respectively). Minimal adverse effects were encountered. Conclusions: Ipratropium bromide provided a statistically significant benefit for drooling frequency in the patients studied and may present an additional topical medical option for pediatric sialorrhea with limited adverse effects. [ABSTRACT FROM AUTHOR]

Primary symptoms of cerebral palsy (CP), such as spasm and weakness, can lead to secondary musculoskeletal problems. Exploring the interplay and impact of secondary symptoms is essential in CP management. A total of 56 children (32 males and 24 females) aged eight to 12 years in level I to III of Gross Motor Function Classification System (GMFCS) completed The Pediatric Balance Scale and Wong-Baker Faces Scale and the Posture and Postural Ability Scale. Relationships between the three groups were examined using the Kruskal-Wallis test, Tukey test, gamma coefficient, De Somers D, phi coefficient, Cramér V, and one-way analysis of variance. There was a significant correlation between balance and postural asymmetry (P < 0.001), and no significant difference in balance was there between the severe and moderate asymmetry groups (P = 0.759) and between the mild asymmetry and no asymmetry groups (P = 0.374). Furthermore, there was a significant relationship between postural asymmetry and each of the variables of pain (P < 0.001) and gross motor function (P = 0.002). Although a meaningful correlation was identified between balance and gross motor function (P < 0.001), the relationship between postural asymmetry and balance in GMFCS levels was not found (P = 0.052, P = 0.052, P = 0.233). Conversely, no significant relationship was detected between pain and gross motor function (P = 0.072). Postural asymmetry negatively impacts balance and correlates with pain intensity. Addressing postural problems can contribute to pain management and improved balance. [ABSTRACT FROM AUTHOR]

The majority of the estimated 50 to 100 million children living with disability worldwide reside in low- or middle-income countries. As families migrate to avoid humanitarian crises, children with developmental disability and delay warrant particular attention in refugee and international health settings. During transitions, medical documentation may be lost and diagnoses may not be fully understood, contributing to the challenges of determining etiologies of motor impairment. Of the first 100 refugee children who were referred to the Child Development Clinic, we identified a subset of children referred for motor impairment or cerebral palsy. Data on their presentation, diagnoses following evaluation, and therapeutic services required was collected by retrospective chart review. Twenty children were referred for motor impairment and cerebral palsy. Average age was 8.9 years; 45% were female. Eight children were eventually diagnosed with cerebral palsy, and 12 had alternate or inconclusive diagnoses. Microcephaly was more common in children diagnosed with cerebral palsy. The frequent differences between referral and final diagnoses in refugee children referred for cerebral palsy highlights the need for pediatricians' careful examination and diagnostic reasoning upon initial presentation. [ABSTRACT FROM AUTHOR]

This article presents a study that investigated the effects of using the Innowalk Pro robotic rehabilitation trainer on the quality of life of children with severe cerebral palsy. The study found that the use of this trainer had positive impacts on the children's quality of life, range of movement, and functional goals. The article also provides summaries of various research studies on cerebral palsy, covering topics such as interventions, cognitive functioning, visual impairments, school readiness, parenting experiences, urinary incontinence, assessment tools, motor function, and participation. The findings emphasize the importance of early intervention, understanding diverse needs, and providing support for individuals with cerebral palsy and their families. However, further research is needed to fully apply these findings in clinical practice. [Extracted from the article]

Aim: This study describes the process of updating the cerebral palsy (CP) common data elements (CDEs), specifically identifying tools that capture the impact of chronic pain on children's functioning. Method: Through a partnership between the American Academy for Cerebral Palsy and Developmental Medicine and the National Institute of Neurological Disorders and Stroke (NINDS), the CP CDEs were developed as data standards for clinical research in neuroscience. Chronic pain was underrepresented in the NINDS CP CDEs version 1.0. A multi‐step methodology was applied by an interdisciplinary professional team. Following an adapted CP chronic pain tools' rating system, and a review of psychometric properties, clinical utility, and compliance with inclusion/exclusion criteria, a set of recommended pain tools was posted online for external public comment in May 2022. Results: Fifteen chronic pain tools met inclusion criteria, representing constructs across all components of the International Classification of Functioning, Disability and Health. Interpretation: This paper describes the first condition‐specific pain CDEs for a pediatric population. The proposed set of chronic pain tools complement and enhance the applicability of the existing pediatric CP CDEs. The novel CP CDE pain tools harmonize the assessment of chronic pain, addressing not only intensity of chronic pain, but also the functional impact of experiencing it in everyday activities. [ABSTRACT FROM AUTHOR]

Background: Pitt–Hopkins syndrome (PTHS) is a rare genetic disorder affecting psychomotor, social, and intellectual development, caused by a mutation in the TCF4 gene. The study aims to gather the phenotype and genotype data of PTHS patients from Poland and to assess the quality of life (QoL) and the impact of the disorders on the family. Methods: Eight families with PTHS participated in the study. To obtain data, the following standardized questionnaires were used: Questionnaire on Clinical Problems (QCP), the PedsQL™ Family Impact Module, and the QL-Disability Questionnaire. Additionally, a retrospective analysis of clinical examination, genetic consult, medical history, and genotype of each individual was performed. Results: All of the examined children exhibited a mutation in the TCF4 gene and typical features of PTHS. The most prevalent clinical symptoms in the study group included typical PTHS appearance, intellectual disability (n = 5; as the rest of the patients were too young to be assessed), abnormal speech development (n = 8), reduced pain response (n = 7), constipation (n = 7), drooling (n = 7), cold extremities (n = 7), and disturbances in sensory integration processes (n = 7). The QL-Disability Questionnaire revealed a total QoL score of 67.7/100 for children with PTHS, while the QoL for their families in the PedsQL Family Impact Module was 53.82/100. The highest-rated domain was cognitive functioning (Median (Me) = 67.50; Standard Deviation (SD) = 21.95), while the lowest was daily activities (Me = 25.00; SD = 29.86). Conclusions: The study allowed the collection of data on the phenotype and genotype of children with PTHS living in Poland. Overall, our study showed that the QoL of children with PTHS is impaired. [ABSTRACT FROM AUTHOR]

Background: Chewing difficulty, poor oral health, inadequate and imbalanced nutrition are serious health problems in individuals with intellectual disabilities. The participants' chewing abilities, oral health and nutritional status were analysed in this study. Methods: Forty‐five adult participants with intellectual disabilities were included. Anthropometric measurements, oral health assessments, chewing ability evaluations and dietary intake analyses were conducted. Results: A 56.8% of the participants were classified as overweight or obese. Teeth grinding was reported in 33.3% of the participants, while 40.0% experienced drooling. All participants with Down syndrome and 58.6% of the participants with developmental delay had chewing difficulties. Inadequate nutrient intake was observed and the fibre, vitamins B1, B3, B9, sodium, phosphorus and iron intakes were significantly lower than reference values in those with chewing difficulty (p <.05). Conclusions: Chewing difficulties were associated with lower intake of certain nutrients, highlighting the importance of addressing oral health and dietary counselling in this population. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of COVID-19 preventive mouthwashes on the surface hardness, surface roughness (Ra), and color change (ΔE) of three different polymer-based composite CAD/CAM materials (Vita Enamic (ENA), Grandio Block (GB), Lava Ultimate (LU)). Methods: A total of 100 rectangular-shaped specimens with dimensions of 2 mm × 7 mm × 12 mm were obtained by sectioning three different CAD/CAM blocks and randomly divided into five subgroups according to the 30 days of mouthwash immersion protocol as follows: Control: artificial saliva, PVP-I: 1% povidone-iodine, HP: 1.5% hydrogen peroxide, CPC: mouthwash containing 0.075% cetylpyridinium chloride, EO: mouthwash containing essential oils. Microhardness, Ra, and ΔE values were measured at baseline and after 30 days of immersion protocols. Data were analyzed using the Wald Chi-square, two-way ANOVA, and post hoc Tukey tests. Results: The independent factors (materials and solutions) significantly influenced the microhardness and color (p < 0.001). Ra of the materials was not affected by any of the mouthwashes (p > 0.05). The microhardness and color of each material varied significantly after immersion in PvP-I and HP (p < 0.05). The highest percentage change in microhardness, Ra, and ΔE was found in LU immersed in PvP-I and HP mouthwashes, while the lowest change was found in ENA groups (p < 0.05). Conclusion: Within the limitations of this study, it was found that the surface hardness and color of tested polymer-based composite CAD/CAM materials are susceptible to degradation and change after 30 days of immersion in 1% PvP-I and 1.5% HP mouthwashes. [ABSTRACT FROM AUTHOR]

Cervical perivascular sympathectomy (CPVS) can improve communication disorders in children with cerebral palsy (CP); however, there are no research reports on the factors affecting surgical efficacy. This study aimed to establish a nomogram for poor prognosis after CPVS. We collected data from 313 CP patients who underwent CPVS at the Neurosurgery Cerebral Palsy Center of the Second Affiliated Hospital of Xinjiang Medical University from January 2019 to January 2023. Among them, 70% (n = 216) formed the training cohort and 30% (n = 97) the validation cohort. The general data and laboratory examination data of both groups were analyzed. In training cohort, 82 (37.96%) showed improved postoperative communication function. Logistic analysis identified motor function, serum alkaline phosphatase, serum albumin, and prothrombin activity as the prognostic factors. Using these four factors, a prediction model was constructed with an area under the curve (AUC) of 0.807 (95% confidence interval [CI], 0.743–0.870), indicating its ability to predict adverse outcomes after CPVS. The validation cohort results showed an AUC of 0.76 (95% CI, 0.650–0.869). The consistency curve and Hosmer–Lemeshow test (χ2 = 10.988 and p = 0.202, respectively) demonstrated good consistency between the model-predicted incidence and the actual incidence of poor prognosis. Motor function, serum alkaline phosphatase, serum albumin, and prothrombin activity are independent risk factors associated with the prognosis of communication disorders after CPVS. The combined prediction model has a good clinical prediction effect and has promising potential to be used for early prediction of prognosis of CPVS. [ABSTRACT FROM AUTHOR]

Introduction: In the treatment of deep throat infections, it is necessary to make a correct decision about surgical treatment. The aim was to observe trends and characteristics of patients requiring surgical treatment and to identify factors that predict the type of treatment. Materials and methods: This is a retrospective study including pediatric patients hospitalized in the Children's Hospital of The University Hospital Brno with deep throat infections between 2010–2019. Studied parameters: age, sex, duration of problems before hospitalization, presence of dysphagia, odynophagia, impaired neck mobility, bulging of the pharyngeal wall, ankylostomia, respiratory problems, dysphonia, drooling, cervical lymphadenitis, sore throat, length of hospitalization, conservative or surgical approach, and well-being day. Laboratory investigations included CRP, neutrophil granulocyte count, and microbiological findings. Imaging examinations monitored the presence of phlegm or abscess, side, position relative to the great vessels and oppression of the great vessels, and size of abscess. Results: This study presents the clinical characteristics of 78 deep throat infections. Observed trends: patients with abscesses were younger, had higher CRP, and were hospitalized longer. Larger abscess statistically resulted in surgical treatment. Patients with phlegm had a shorter time to achieve comprehensive improvement. The incidence of an abscess is not related to gender. Boys had statistically significantly higher CRP and neutrophil granulocyte counts. The most common microbiological finding was Streptococcus pyogenes. Conclusion: Patients with abscesses were younger, had longer hospital stays, and had higher CRP. [ABSTRACT FROM AUTHOR]

Objective: Intraglandular injection of botulinum toxin type A (BoNT/A) effectively treats sialorrhea. Myoepithelial cells (MECs) are essential for salivary secretion. The role of MECs in BoNT/A‐inhibited salivary secretion, and its underlying mechanisms remain unknown. Materials and Methods: BoNT/A was injected into rat submandibular glands (SMGs). At 1, 2, 4, 8, and 12 weeks postinjection, salivary flow rate of SMGs was measured. Electron microscopy, immunohistochemistry, immunofluorescence, and Western blot analysis were used to detect morphological and functional changes in MECs and chemical denervation in SMGs. Results: BoNT/A temporarily decreased salivary secretion in rat SMGs and this inhibitory effect lasted 4 weeks. During the inhibitory period, MECs atrophied and expressed reduced α‐smooth muscle actin (α‐SMA), vimentin, and phosphorylated myosin light chain 2 (p‐MLC2), suggesting that BoNT/A attenuated MEC contractility. Furthermore, BoNT/A cleaved synaptosome‐associated protein 25 (SNAP‐25) and decreased the expression and activity of acetylcholinesterase (AChE), indicating that BoNT/A‐induced chemical parasympathetic denervation of SMGs by cleaving SNAP‐25. Conclusions: BoNT/A temporarily caused MEC atrophy and decreased MEC contractility in rat SMGs, which contributed to reversible inhibition of salivary secretion. The underlying mechanisms involved temporary parasympathetic denervation caused by SNAP‐25 cleavage. These findings provide new insights into the mechanisms of BoNT/A‐inhibited salivary secretion. [ABSTRACT FROM AUTHOR]

The objective of this study was to clarify whether there are sex‐specific differences in salivary α‐amylase and immunoglobulin A responses following acute endurance exercise in adolescent males and females with equivalent cardiorespiratory fitness levels. Twenty‐six aerobically trained adolescent males and females with similar training status were enrolled in this study. Each individual executed a 1‐h prolonged cycling exercise corresponding to a constant power output at 65% of peak oxygen uptake. Unstimulated whole salivary samples were taken with the passive drooling method at the 10‐min period before and after exercise for the determination of salivary responses [α‐amylase, immunoglobulin A, total protein and flow rate]. Salivary α‐amylase activity, immunoglobulin A concentration and total protein concentration were significantly augmented immediately after acute endurance exercise. Regarding sex differences, only the salivary flow rate was significantly lower in females than in males. The findings of the present study imply that adolescent males and females appear to have similar salivary responses after acute endurance exercise, as represented by salivary α‐amylase activity and immunoglobulin A concentration in connection with total protein concentration and salivary flow rate, when they are matched for peak oxygen uptake relative to fat‐free body mass. [ABSTRACT FROM AUTHOR]

Aim: To identify, map, and describe outcome measurement domains and instruments used within a community setting to assess respiratory health in children and young people aged 1 to 18 years, diagnosed with cerebral palsy (CP). Method: A scoping review methodology informed structured searches in nine databases, grey literature, and registries, conducted in August 2021 (updated in February 2023). Articles were screened for eligibility by two independent researchers. Any outcome measurement instruments used to assess respiratory health or associated impact were extracted, categorized, and mapped to health and health‐related domains of the International Classification of Functioning, Disability, and Health. Results: Seventy‐six outcome measurement instruments were identified across 78 articles worldwide between 1970 and 2023. These were categorized into 'Body functions and structures' (n = 20), 'Activity and performance' (n = 22), and 'Participation and quality of life' (n = 19), with a further 15 mapped to 'Health care resources use'. Interpretation: No consensus of 'what' to measure and 'how' to measure respiratory health in children and young people with CP was found. Moreover, many measures were not replicable in individuals with more severe forms of CP, excluding those at increased risk of respiratory‐related morbidity and mortality. Further research is required to agree important outcome domains and associated measures in research and clinical practice. What this paper adds: A limited number and size of experimental designs were found.Seventy‐six measures were identified to assess respiratory health in cerebral palsy.No consensus was found in 'what' or 'how' to measure respiratory health.Many measures were not replicable in children and young people at risk of poorer respiratory health outcomes.Children and young people with comorbidities and learning disability were frequently excluded from studies. [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy, safety, and impact on quality of life (QoL) of an oral formulation of 320 μg/mL glycopyrronium designed for children. Method: A double‐blind, placebo‐controlled SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial was conducted. Children (3–17 years) with neurodisabilities and severe sialorrhoea (modified Teachers Drooling Scale ≥6) were randomized to 320 μg/mL glycopyrronium or placebo, in addition to non‐pharmacological standard care. Results: Of 87 participants, 44 were aged 10 years or under and 43 had cerebral palsy. The primary endpoint, change in total Drooling Impact Scale (DIS) score from baseline to day 84, was significantly greater (improved) with 320 μg/mL glycopyrronium versus placebo (median [quartile 1, quartile 3] –29.5 [−44.5, 0] vs −1 [−16, 5]; p < 0.001), an effect also observed at day 28 (median − 25 vs −2; p < 0.01). Significant reduction in bibs/clothes used per day was seen with glycopyrronium versus placebo at day 84 (median − 2 vs 0; p < 0.01). Glycopyrronium significantly improved DIS items 9 and 10 related to the extent that drooling affects the child's and family's life (p ≤ 0.03). Adverse events were reported by 77.3% and 69.8% of children with glycopyrronium and placebo respectively; the most common treatment‐related adverse event was constipation (20.5% and 16.3%). Interpretation: The formulation of 320 μg/mL glycopyrronium significantly improved drooling and reduced its impact on QoL, with good tolerability in children with neurodisabilities. What this paper adds: The formulation of 320 μg/mL glycopyrronium significantly improved Drooling Impact Scale score versus placebo at day 84.The formulation reduced the impact of drooling on the child's and family's quality of life.There were no safety or tolerability concerns with this specific formulation. [ABSTRACT FROM AUTHOR]

Aim: To develop robust multivariable prediction models for non‐response to (1) submandibular botulinum neurotoxin A (BoNT‐A) injections and (2) concurrent submandibular and parotid (four‐gland) injections, to guide treatment decisions for drooling in children with neurodevelopmental disabilities, including cerebral palsy. Method: This was a retrospective cohort study including 262 children (155 males/107 females, median age 7 years 11 months [IQR 5 years 1 month], range 4 years 0 months – 17 years 11 months) receiving submandibular injections and 74 children (52 males/22 females, median age 7 years 7 months [IQR 4 years 3 months], range 4 years 9 months – 18 years 8 months) receiving four‐gland injections. Multivariable logistic regression analyses were used to estimate associations between candidate predictors and non‐response 8 weeks after injection. Results: Ninety‐six children (37%) were non‐responders to submandibular injections, for which developmental age was the strongest predictor (adjusted odds ratio [aOR] 2.13; 95% confidence interval [CI] 1.02–4.45 for developmental age <4 years or 4–6 years with IQ <70). Other characteristics that showed a trend towards an increased risk of non‐response were diagnosis, sex, and head position. Thirty‐four children (46%) were non‐responders to four‐gland injections, for which tongue protrusion (aOR 3.10; 95% CI 1.14–8.43) seemed most predictive, whereas multiple preceding submandibular injections (aOR 0.34; 95% CI 0.10–1.16) showed a trend towards being protective. Predictors were, however, unstable across different definitions of non‐response and both models (i.e. submandibular and four‐gland) had insufficient discriminative ability. Interpretation: Potential predictors of non‐response to BoNT‐A injections were identified. Nevertheless, the developed prediction models seemed inadequate for guidance of treatment decisions. What this paper adds: Developmental age seemed most predictive of non‐response to submandibular botulinum neurotoxin A injections.Non‐response to concurrent submandibular and parotid injections was best predicted by tongue protrusion and number of previous injections.Multivariable prediction models including these clinical characteristics were unable to discriminate well.Predictors differed when non‐response was defined using alternative outcome measures. [ABSTRACT FROM AUTHOR]

Background: The aim was to analyse whether scoliosis or windswept hip deformity (WSH) occurs first for children with cerebral palsy (CP). Methods: This longitudinal cohort study using data from 1994 − 2020 (26 years) involved 41,600 measurements of 4148 children (2419 [58.3%] boys) with CP born 1990 − 2018 and registered into the Swedish CP follow-up program. Children were followed from a mean age of 2.8 [SD 1.4] years, until they developed either scoliosis or WSH or were removed at surgery. Results: WSH developed first in 16.6% of the children (mean age 8.1 [SD 5.0] years), and scoliosis in 8.1% (mean age 8.1 [SD 4.9] years). The incidence of WSH was higher than scoliosis across all levels I–V of the Gross Motor Function Classification System (GMFCS), both sexes, and for those with dyskinetic (20.0%) or spastic (17.0%) CP. The incidence of scoliosis was highest (19.8%) and developed earliest in children with GMFCS level V (mean age 5.5 [SD 3.5] years), and in children with dyskinetic (17.9%) CP (mean age 7.0 [SD 4.7] years). Conclusions: WSH presents earlier than scoliosis in most children with CP. Children with higher GMFCS level or dyskinetic CP are more likely to develop these deformities at a younger age. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Virtual height exposure coupled with motion capture is feasible to elicit changes in spatiotemporal, kinematic, and kinetic gait parameters in a child with cerebral palsy and should be considered when investigating gait in real‐world‐scenarios. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to evaluate local and systemic photobiomodulation (PBM) in patients with COVID-19-related dysgeusia, with the expectation of improving taste dysfunction. Background: PBM has garnered attention as a potential therapy in long COVID, a condition characterized by many persistent symptoms following the acute phase of COVID-19. Among these symptoms, dysgeusia, or altered taste perception, can significantly affect patients' quality of life. Emerging research suggests that PBM may hold promise in ameliorating dysgeusia by modulating cellular processes and reducing inflammation. Further clinical studies and randomized controlled trials are essential to establish the efficacy and safety of PBM for the treatment of dysgeusia in long COVID, but initial evidence suggests that this noninvasive modality may offer a novel avenue for symptom management. Methods: Seventy patients experiencing dysgeusia were randomly assigned to receive active local and systemic PBM (n = 34) or simulated PBM (n = 36). Low-power laser (red wavelength) was used at 18 spots on the lateral borders of the tongue (3 J per spot), salivary glands (parotid, sublingual, and submandibular glands-3 J per spot), and over the carotid artery for 10 min (60 J). Alongside laser therapy, all patients in both groups received weekly olfactory therapy for up to 8 weeks. Results: Dysgeusia improved in both groups. At weeks 7 and 8, improvement scores were significantly higher in the PBM group than in the sham group (p = 0.048). Conclusions: Combined local and systemic PBM, as applied in this study, proved effective and could serve as a viable treatment option for alleviating dysgeusia in long-COVID patients. Clinical Trial Registration: RBR-2mfbkkk. [ABSTRACT FROM AUTHOR]

PURPOSE: Infants can have muscle hypertonia due to cerebral palsy, muscle strength imbalances due to brachial plexus palsy, refractory clubfoot, and torticollis. These muscle problems can cause significant development impairments. A child with severe sialorrhea and dysphagia from leukodystrophy can aspirate, causing respiratory problems. Botulinum toxin (BoNT) injections can improve these conditions but may lead to adverse effects from the toxin spreading to non-targeted muscles, potentially impacting breathing, swallowing, and overall strength. This is particularly concerning in infants. This study assessed the safety of BoNT injections in children less than one year of age. METHODS: This was a retrospective cohort study. RESULTS: Forty-seven patients (22 male, 25 female) received BoNT injections before one year of age (three to 12 months). Thirty-seven received one round of injections and 10 were injected on multiple occasions. Forty-five received onabotulinumtoxinA (15–100 units [U], 1.9–15.2 U/kg), one received abobotulinumtoxinA (70 U, 9.0 U/kg), and one received incobotulinumtoxinA (25 U, 3.5 U/kg). Lower extremities were treated in 15 patients, upper extremities in 38, the sternocleidomastoid in two, and the salivary glands in one. Forty-five patients had no reported complications. One experienced transient fever, vomiting, and diarrhea. The parent of another reported subjective weakness in one muscle. CONCLUSION: BoNT injections in children less than one year of age appear to be safe. [ABSTRACT FROM AUTHOR]

Aim: To compare muscle mass in the upper and lower extremities between ambulatory children with cerebral palsy (CP) and typically developing (TD) children. Materials and Methods: A total of 21 children aged 2 to 12 years with CP and a Gross Motor Function Classification System (GMFCS) level of I, II, or III were matched with 21 TD children for age, sex, and body mass index. The lean body mass (LBM) of each extremity was calculated from whole-body dual-energy X-ray absorptiometry. Results: The LBM of the upper extremities was greater in children with CP compared to TD children, and the difference was significant in the GMFCS level II group (1340.6 g vs. 1004.2 g, p = 0.027). There was no significant difference in the LBM of the lower extremities between the CP and TD groups (p = 0.190). The ratio of lower extremity LBM to total extremity LBM was lower in children with CP, while the ratio of upper extremity LBM to total extremity LBM was higher in children with CP (73.2% vs. 78.5% [p < 0.001] and 26.7% vs. 21.5% [p < 0.001], respectively). Conclusions: Ambulatory children with CP, especially in the GMFCS level II group, exhibit greater muscle mass in the upper extremities compared to TD children. [ABSTRACT FROM AUTHOR]

Despite the rising incidence, currently, there are no early detection methods for HPV-driven HNC (HPV-HNC). Cervical cancer studies suggest that HPV DNA methylation changes can be used as a biomarker to discriminate cancer patients from HPV-infected individuals. As such, this study was designed to establish a protocol to evaluate DNA methylation changes in HPV late genes and long control region (LCR) in saliva samples of HPV-HNC patients and HPV-positive controls. Higher methylation levels were detected in HPV late genes (L1 and L2) in both tumour and saliva samples of HPV-HNC patients compared with HPV-positive controls. Moreover, methylation patterns between tumours and corresponding saliva samples were observed to have a strong correlation (Passing-Bablok regression analysis; τ = 0.7483, P  < 0.0001). Considering the differences between HNC and controls in methylation levels in late genes, and considering primer amplification efficiencies, 13 CpG sites located at L1 and L2 genes were selected for further evaluation. A total of 18 HNC saliva samples and 10 control saliva samples were assessed for the methylation levels in the selected sites. From the CpG sites evaluated statistically significant differences were identified for CpG sites at L2—CpG 6 (P  = 0.0004), L1—CpG 3 (P  = 0.0144), L1—CpG 2 (P  = 0.0395) and L2—CpG 19 (P  = 0.0455). Our pilot data indicate that higher levels of DNA methylation in HPV late genes are indicative of HPV-HNC risk, and it is a potential supplementary biomarker for salivary HPV detection-based HPV-HNC screening. [ABSTRACT FROM AUTHOR]

This article explores the challenges of managing nonmotor symptoms (NMS) in individuals with Parkinson's disease (PD) in low-resourced settings. It highlights the lack of specialized healthcare professionals and limited access to diagnosis and treatment as major obstacles. However, there are strategies available to manage NMS in PD, including nonpharmacological interventions like diet, exercise, cognitive training, and alternative therapies. Repurposing existing drugs for nonmotor diseases is another approach. The article emphasizes the importance of addressing inequities and disparities in managing NMSs in PD, and suggests raising public awareness, providing education to healthcare professionals, and implementing nonpharmacological interventions as potential solutions. [Extracted from the article]

Aim: To find out the utility of the island nasolabial flap in patients with oral cavity malignancy. Materials and methods: This was an observational study conducted at a super-specialty hospital in Maharashtra from October 2019 to December 2021. Patients with oral malignancy planned for island nasolabial flaps were only considered. Results: A total of 20 patients were operated on, out of which 16 were males and 4 were females. All the patients were followed up for a minimum period of 6 months. The hospital's online reporting system is used for the data collection including the post-operative assessment. Out of the 20 patients, 10 patients were suffering from tongue carcinoma, 6 patients from buccal mucosal carcinoma, two from hard palate carcinoma and one patient each from the floor of the mouth and lip carcinoma. The mean age of the series was 52.3 years, the average duration of the surgery is 169.4 min and the average hospital stay in the series was 4.35 days. The Ryle's tube was removed on an average of 4.35 days. No flap-related complications were noted during the series, and healing of the donor site was uneventful. The functional outcomes after the reconstruction are acceptable in all the cases except in the lip reconstruction patient where there was post-operative drooling. Conclusion: The island nasolabial flap is relatively easy to harvest and less time-consuming. The other advantages include the post-operative surgical scar falls along the nasolabial fold, long pedicle length with preservation of the facial pedicle for future microvascular use, early transfer to the oral feed from the nasogastric feed, and early de-cannulation. In our small study, we observed that the island nasolabial flap is a very useful flap for the small to moderate-sized defects of the oral cavity. We feel, one of the disadvantages of this flap is that it is not an ideal flap for lip reconstruction. [ABSTRACT FROM AUTHOR]

During mastication, food undergoes state and texture changes influenced by various mechanical properties, including compression and fracturing of the molar teeth, mixing with saliva, and oral temperature. Prior studies have explored mastication simulators, however, no studies have assessed the forces and duration applied to the molars by the food during bolus formation. In this study, we developed a novel system that integrates a masticatory simulator and analysis method to evaluate mechanical properties. We developed ORAL‐MAPS which is equipped with 6‐axis force sensor, pneumatic pressure control mechanism, vertical movement, molar‐like module, artificial saliva injection unit, and temperature control apparatus. A gap exists between the upper and lower unit at the closest point, allowing the sensor to measure vertical upward force and duration from food, while compressed air provides constant downward pressure. We hypothesized a correlation between the total integrated muscle activity ratio obtained from the human masseter muscle electromyography (iEMG). We compared the normalized impulse obtained from ORAL‐MAPS with the normalized total iEMG obtained from human studies with four different types of gummy candies. As a result, the normalized total impulse of gummy candies A, B, C, and D were 1.00 ± 0.00, 1.29 ± 0.06, 0.95 ± 0.00, and 0.39 ± 0.0, respectively. The normalized total iEMG of the same gummy candies were 1.00 ± 0.00, 1.23 ± 0.15, 0.98 ± 0.09, and 0.45 ± 0.07, respectively. Thus, no significant difference was observed between the normalized total impulse obtained in vitro and the normalized total iEMG values for masticating the gummy candies B, C, and D (p >.05). [ABSTRACT FROM AUTHOR]

This article, titled "Infratentorial Hemangioblastoma in Pregnancy: A Systematic Review and Case Report," explores the diagnosis and treatment options for hemangioblastoma, a benign vascular tumor of the central nervous system, in pregnant women. The study found that prompt surgical treatment is crucial for the safety of both the mother and fetus, with surgery leading to neurological improvement in all patients. The article includes a case report of a 37-year-old woman who successfully underwent surgery and delivered her baby via cesarean section. The authors emphasize the importance of thorough evaluation in pregnant women with von Hippel-Lindau disease to rule out potentially life-threatening cerebral masses. [Extracted from the article]

Recent literature suggests that service dogs may be a valuable complementary intervention option for posttraumatic stress disorder (PTSD) among military veterans due to the potential influence on stress response dysregulation. The aim of this short-term longitudinal study was to quantify the impact of service dogs in US military veterans with PTSD with particular attention to the cortisol awakening response. A sub aim of the study was to empirically evaluate the physiological effects of PTSD service dogs on veteran partners. We conducted a clinical trial (ID: NCT03245814) that assessed the cortisol awakening response for 245 participants at baseline and 3 months follow-up across an intervention group (service dog: veterans n = 88, partners n = 46) and control group (usual care: n = 73, partners n = 38). A total of N = 161 veterans and N = 84 partners collected whole saliva samples via a passive drool collection immediately upon waking, 30 min after waking, and 45 min after waking on three consecutive weekdays at baseline and again at follow-up. Mixed model repeated measures (MMRM) with a fixed effect of the intervention group (service dog or control) were utilized. Covariates considered for the model included time of awakening, sleep duration, sleep efficiency, prior day experiences (measured via ecological momentary assessment), traumatic brain injury, age, gender, race, ethnicity, socioeconomic status, smoking status, alcohol use, physical health, and body mass index. A total of 3951 salivary samples were collected (veterans: 2613, partners: 1338). MMRM results demonstrated that veterans with a service dog had a statistically significant higher cortisol awakening response, including the area under the curve with respect to both increase (AUCi, β = 1.46, p = 0.046) and absolute increase (AINC, β = 0.05, p = 0.035). Results were not statistically significant for partners. Findings suggest that veterans with service dogs have a higher, less blunted CAR in comparison to veterans receiving usual care alone. In veterans with a blunted morning cortisol response, service dog placement could help boost their morning cortisol response. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Unilateral opercular lesions can result in Foix–Chavany–Marie syndrome, which is marked by acute anarthria, automatic‐voluntary movement dissociation—most notably the absence of voluntary facial and tongue movements—and a generally better prognosis. Better patient outcomes are mostly dependent on early detection, management, and rehabilitation. Opercular syndrome is a rare neurological disorder caused by bilateral or unilateral lesions of the operculum that result in symptoms related to speech and swallowing difficulties with dissociation of automatic‐voluntary movements in affected muscles. 78‐year‐old female presented with acute onset dysarthria, left sided facial deviation and difficulties in chewing, speaking, and swallowing. CT head revealed ischemic changes in left frontal operculum and was diagnosed with the unilateral opercular syndrome. The case was managed according to ischemic stroke protocol. The patient was discharged after 7 days of hospital stay, with MRS 2, NIHSS 9 and secondary stroke preventive measures. At 4 months follow‐up, her MRS was 1, with mild dysarthria, that could be understood, and her swallowing improved to some amount of drooling while feeding. Early recognition, treatment, and rehabilitation play important role in prompt improvement of symptoms. [ABSTRACT FROM AUTHOR]

Objective: Saliva can be used for screening and diagnostic purposes. Although multiple saliva collection methods are available, their use in children can be limited due to lack of cooperation, developmental stage, and age. The aim of this scoping review was to comprehensively appraise the different methods of saliva collection among both children and adolescents by assessing the available scientific literature. Methods: A literature search was performed using the databases PubMed, Embase, and Web of Science. Eligible studies on saliva collection methods among children and adolescents were included for this review. Results: The literature search identified 249 eligible articles, of which 205 had a cross-sectional study design. Four distinct saliva collection methods have surfaced: the drooling method, the absorption method, the spitting method, and the suction method. Among infants or children under the age of 6 years, the suction and absorption methods were most preferred. The drooling and spitting methods were only applicable among children above the age of 3 years. When children were not willing to cooperate, the absorption method was most feasible. In adolescents and older children, no specific method was found to be preferred over another method. Conclusion: Overall, saliva collection is well tolerated by children and adolescents, with the absorption and suction methods being preferred with young and uncooperative children. [ABSTRACT FROM AUTHOR]

There is a growing trend in using saliva for SARS-CoV-2 detection with reasonable accuracy. We have studied the responses of IgA, IgG, and IgM in human saliva by directly comparing disease with control analyzing two-trace two-dimensional correlation spectra (2T2D-COS) employing Fourier transform infrared (FTIR) spectra. It explores the molecular-level variation between control and COVID-19 saliva samples. The advantage of 2T2D spectra is that it helps in discriminating remarkably subtle features between two simple pairs of spectra. It gives spectral information from highly overlapped bands associated with different systems. The clinical findings from 2T2D show the decrease of IgG and IgM salivary antibodies in the 50, 60, 65, and 75-years COVID-19 samples. Among the various COVID-19 populations studied the female 30-years group reveals defense mechanisms exhibited by IgM and IgA. Lipids and fatty acids decrease, resulting in lipid oxidation due to the SARS-CoV-2 in the samples studied. Study shows salivary thiocyanate plays defense against SARS-CoV-2 in the male population in 25 and 35 age groups. The receiver operation characteristics statistical method shows a sensitivity of 98% and a specificity of 94% for the samples studied. The measure of accuracy computed as F score and G score has a high value, supporting our study's validation. Thus, 2T2D-COS analysis can potentially monitor the progression of immunoglobulin's response function to COVID-19 with reasonable accuracy, which could help diagnose clinical trials. Key messages: The molecular profile of salivary antibodies is well resolved and identified from 2T2D-COS FTIR spectra. The IgG antibody plays a significant role in the defense mechanism against SARS-CoV-2 in 25–40 years. 2T2D-COS reveals the absence of salivary thiocyanate in the 40–75 years COVID-19 population. The receiver operation characteristic (ROC) analysis validates our study with high sensitivity and specificity. [ABSTRACT FROM AUTHOR]

Paediatric anterior drooling has a major impact on the daily lives of children and caregivers. Intraglandular botulinum neurotoxin type-A (BoNT-A) injections are considered an effective treatment to diminish drooling. However, there is no international consensus on which major salivary glands should be injected to obtain optimal treatment effect while minimizing the risk of side effects. This scoping review aimed to explore the evidence for submandibular BoNT-A injections and concurrent submandibular and parotid (i.e. four-gland) injections, respectively, and assess whether outcomes could be compared across studies to improve decision making regarding the optimal initial BoNT-A treatment approach for paediatric anterior drooling. PubMed, Embase, and Web of Science were searched to identify relevant studies (until October 1, 2023) on submandibular or four-gland BoNT-A injections for the treatment of anterior drooling in children with neurodevelopmental disabilities. Similarities and differences in treatment, patient, outcome, and follow-up characteristics were assessed. Twenty-eight papers were identified; 7 reporting on submandibular injections and 21 on four-gland injections. No major differences in treatment procedures or timing of follow-up were found. However, patient characteristics were poorly reported, there was great variety in outcome measurement, and the assessment of side effects was not clearly described. Conclusion: This review highlights heterogeneity in outcome measures and patient population descriptors among studies on paediatric BoNT-A injections, limiting the ability to compare treatment effectiveness between submandibular and four-gland injections. These findings emphasize the need for more extensive and uniform reporting of patient characteristics and the implementation of a core outcome measurement set to allow for comparison of results between studies and facilitate the optimization of clinical practice guidelines. What is Known: • There is no international consensus on which salivary glands to initially inject with BoNT-A to treat paediatric drooling. What is New: • Concluding on the optimal initial BoNT-A treatment based on literature is currently infeasible. There is considerable heterogeneity in outcome measures used to quantify anterior drooling.and clinical characteristics of children treated with intraglandular BoNT-A are generally insufficiently reported. • Consensus-based sets of outcome measures and patient characteristics should be developed and implemented. [ABSTRACT FROM AUTHOR]

Immunoglobulin G4‐related disease (IgG4‐RD)‐associated hypercalcemia has rarely been reported. We report a case of IgG4‐RD that presented as severe symptomatic hypercalcemia. A 50‐year‐old woman with a history of sustained bilateral periorbital swelling and proptosis for more than 5 years presented to our hospital complaining of a 3‐day history of significant and progressive nausea, vomiting, loss of appetite, fatigue, and pruritus. She denied a long history of medication. On admission, laboratory tests showed severe hypercalcemia with serum adjusted calcium elevated to 4.34 mmol/L and renal dysfunction with serum creatinine elevated to 206 μmol/L. Urinary calcium excretion was increased. The serum IgG4 subclass was markedly elevated to 22.4 g/L with polyclonal hypergammaglobulinemia. Tests of autoantibodies were all negative. Bone metabolism markers that reflect the activity of osteoblasts and osteoclasts were all significantly elevated. However, the levels of intact parathyroid hormone and 25(OH) vitamin D3 were decreased. B‐ultrasonography showed chronic inflammation of bilateral submandibular glands. Neither bone marrow biopsy nor positron emission tomography – computed tomography examination showed evidence of neoplastic diseases. The patient was treated with intravenous saline infusion, loop diuretics, salmon calcitonin, glucocorticoids, and hemodialysis with a good response. [ABSTRACT FROM AUTHOR]

Objectives: To study the differences in side effects of clozapine between older adults aged ≥55 years and younger adults aged 18–55 years with treatment‐resistant schizophrenia. Methods: A retrospective cohort study in a large mental health institute in the Netherlands. All patients diagnosed with treatment‐resistant schizophrenia who started with clozapine between 2011 and 2020 (N = 284) were included. We compared the number and type of side effects reported in the electronic patient files as well as the number of treatment discontinuations and the time until discontinuation, both due to side effects, of older adults versus younger adults. Results: In the younger age group (N = 183), the number of reported side effects was significantly higher in the first 3 months of treatment (Mann–Whitney U = 7341.5, p = 0.004) and after those 3 months (Mann–Whitney U = 5668.5, p < 0.001) compared with the number reported in the older age group (N = 101). Sedation, hypersalivation, dizziness, tachycardia, heartburn, nausea, weight gain, and constipation were reported significantly more often in the younger age group, and only extrapyramidal symptoms were reported significantly more often in the older age group. There was no significant difference in the number of treatment discontinuations due to side effects (23% vs. 21.8%, Chi‐2 = 0.051, df = 1, p = 0.821) and time until discontinuation due to side effects (b = 0.091, SE = 0.335, p = 0.798) between younger and older adults. Conclusions: Side effects of clozapine were reported significantly less often in older patients compared with younger patients. Older patients did not discontinue treatment due to side effects more often or earlier than younger patients. Older patients with schizophrenia may not be more vulnerable to side effects than younger adults. Key points: Only a few studies are published on the use of clozapine in older patients with treatment‐resistant schizophrenia.Contrary to our expectations, side effects of clozapine were reported significantly less often in older patients compared with younger patients and discontinuation rates did not differ significantly.This study suggest that older patients with treatment‐resistant schizophrenia may not be more vulnerable, and perhaps are even less vulnerable, to side effects than younger adults. [ABSTRACT FROM AUTHOR]

Sialorrhea, defined as an excess flow of saliva or excessive secretions, is common in patients with cerebral palsy and other neurologic disorders and is associated with clinical complications such as increased risk of local skin reactions, infections, aspiration, pneumonia, and dehydration. Upon failure of non-pharmacologic measures, clinicians have several noninvasive pharmacologic options available to manage sialorrhea. This review of the literature provides detailed descriptions of medications used, efficacy, safety, and practical considerations for use of non-injectable pharmacologic agents. The literature search included published human studies in the English language in PubMed and Google Scholar from 1997 to 2022. Relevant citations within articles were also screened. A total of 15 studies representing 719 pediatric patients were included. Glycopyrrolate, atropine, scopolamine, and trihexyphenidyl all have a potential role for sialorrhea management in children; however, glycopyrrolate remains the most studied option with 374 (n = 52.0%) of the 719 patients included in the systematic review receiving this medication. Overall, glycopyrrolate showed similar efficacy but higher tolerability than its comparators in 2 comparative studies and is often considered the first-line agent. Patient-specific (age, route of administration) and medication-specific (dosage formulation, medication strength) considerations must be weighed when initiating a new therapy or switching to another medication upon treatment failure. Owing to the high propensity of adverse events with all agents, clinicians should consider initiating doses at the lower end of the dosage range, as previous studies have noted a dose-dependent relationship. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of ultrasound‐guided injection of botulinum toxin type A (BTX‐A) in treating sialorrhea. Methods: We recruited 32 sialorrhea subjects and they received an ultrasound‐guided injection of BTX‐A. The extent of salivation was evaluated according to the Visual Analog Scale (VAS), Drooling Severity and Frequency Scale (DSFS), and Saliva Flow Rate (SFR). Laryngeal secretions were evaluated based on Fiberoptic Endoscopic Evaluation of Swallowing (FEES) rated according to the Murray Secretion Scale (MSS). We assessed the extent of salivation and laryngeal secretions before injection and at 1, 2, and 4 weeks after injection. Results: The scores for the VAS, DSFS‐S, DSFS‐F, and DSFS‐T decreased significantly at 1, 2, and 4 weeks after injection compared with before injection (p <.05). Based on VAS, the efficacy was substantially higher at 2 and 4 weeks after injection than at 1 week after injection (p <.05). According to DSFS‐S and DSFS‐T, the efficacy was significantly higher at 4 weeks than at 1 week after injection (p <.05). The SFR and MSS scores at 1 and 2 weeks after injection were superior to those before injection (p <.05). Meanwhile, the SFR score 2 weeks after injection was superior to that 1 week after injection (p <.05). Conclusion: The ultrasound‐guided injection of BTX‐A can effectively reduce saliva secretion in patients with neurogenic dysphagia. Furthermore, it has the advantages of early onset time and lasting curative effects, which indicates that clinical promotion and application of this technique are justified. Level of Evidence: Level 3. [ABSTRACT FROM AUTHOR]

Lip and oral cavity SCC account for 2nd highest incidence of cancers and 3rd most common cause of mortality from cancer in India. Reconstruction of defects of central arch invading cancers results in poor cosmetic and functional outcomes if free flaps are not used. 30 patients with Oral SCC in the age group 20–75 years requiring central arch segmental mandibulectomy were included. Reconstruction was done with pedicled bipaddled PMMC flap with 'AJ's orbicularis oris stitch' using Fiber wire. Patients were divided into 4 groups according to extent of lip and skin loss post excision of primary tumour. Patients were evaluated with subjective scores for drooling, oral competence and cosmesis. There were 4, 12, 9 and 5 patients in Group A, B, C and D respectively. Mean subjective scores using our technique for drooling, oral competence and cosmesis were 3.75/4,3.75/4 and 3.5/4 for group A, 3.45/4, 3.36/4 and 3.09/4 for group B, 2.8/4, 2.6/4 and 2.3/4 for group C defects and 2.5/4, 3/4 and 2.5/4 for group D defects respectively. Over all scores for all patients were 3.2/4, 3.14/4 and 2.84/4 for drooling, oral competence and cosmesis. This simple, quick and inexpensive technique of reconstruction of central mandibular arch defects can drastically improve cosmetic and functional outcomes in a resource restrained set up. However, long term results and comparison studies are required for standardisation of the technique. [ABSTRACT FROM AUTHOR]

Background: Individuals with spastic cerebral palsy are more predisposed to parafunctional oral activities and oral motor problems because of spasticity. Objectives: The aim of the study was to evaluate the relationship between the gross motor function classification system score (GMFCS), age, bruxism, parafunctional oral habits and oral motor problems in children with cerebral palsy. Methods: This cross‐sectional study included 63 children with spastic cerebral palsy, aged 3–18 years, with developmental disabilities. The relationship between parentally reported bruxism, parafunctional oral activity rates, oral motor problems, and GMFCS was analysed. Results: The prevalence of bruxism was 52.4%, and the rate decreased as age increased. There was a greater likelihood of bruxism in individuals with tongue thrust (OR [95% CI] = 8.15 [1.4–47.3]) and swallowing problems (OR [95% CI] = 5.78 [1.3–24.68]). Conclusion: In children with spastic cerebral palsy, bruxism and the rate of parafunctional oral habits were high, thus affecting oral motor activities. A relationship was found between oral motor problems and increased GMFCS levels, but no relationship was found between bruxism and GMFCS levels. Children with spastic cerebral palsy who display tongue thrust or swallowing problems have an increased likelihood of presenting with bruxism. The study found that the prevalence of bruxism was 52.4% among 63 children with spastic cerebral palsy, ranging in age from 3 to 18 years, and the incidence of bruxism decreased as age increased. Individuals with tongue thrust (OR [95% CI] = 8.15 [1.4–47.3]) and swallowing problems (OR [95% CI] = 5.78 [1.3–24.68]) had a significantly higher likelihood of experiencing bruxism. In children with spastic cerebral palsy, both bruxism and the frequency of parafunctional oral habits were notably high, thereby influencing oral motor activities. [ABSTRACT FROM AUTHOR]

Chronic kidney disease is classified as a civilization disease and is being diagnosed in an increasing number of patients. Hypertension and diabetes mellitus often coexist in hemodialyzed patients. The aim of the present study was to identify publications on the oral cavity status of multimorbid hemodialyzed adult patients additionally diagnosed with hypertension and/or diabetes mellitus, published between 2012 and 2022 to establish evidence of the impact of hypertension and diabetes mellitus on the oral status of hemodialyzed patients. Scopus and Web of Science databases were searched. Eight articles were included in the review. In total, 3 articles discussed oral hygiene in hemodialyzed patients, 4 discussed periodontal status, 3 discussed mucosa condition and saliva parameters, and 3 discussed the problem of Candidiasis infections. The conclusions were as follows: there is still a limited number of publications discussing the oral status of hemodialyzed patients diagnosed with hypertension; involved articles have proven that coexisting diseases can influence the oral cavity status of hemodialyzed patients and cause periodontal disorders, lower hygiene status, saliva parameters and make the risk of Candida infections higher. [ABSTRACT FROM AUTHOR]

Introduction: The aim was to investigate the risk, prevalence, and clinical characteristics of cerebral palsy among children born after assisted reproductive technology (ART) in Norway. Material and methods: All liveborn children from 2002 to 2015 were included. Information was collected from the Medical Birth Registry of Norway, linked to the Norwegian Quality and Surveillance Registry for Cerebral Palsy as of December 31, 2022. Logistic regression analyses were used to calculate the prevalence of cerebral palsy per 1000 live births after ART and natural conception with birth year as covariate, crude odds ratios (OR) for cerebral palsy among children born after ART using children born after natural conception as reference, and OR adjusted for potential confounders, with 95% confidence intervals (CI). Potential mediators of the association were studied in stratified analyses. Descriptive statistics were used to compare proportions in clinical characteristics among children with cerebral palsy born after ART and natural conception. Results: Among 833 645 livebirths, 23 645 children were born after ART and of the latter 97 were diagnosed with cerebral palsy. The overall prevalence of cerebral palsy after ART was 4.10 per 1000 live births (95% CI 3.36–5.00), decreasing from 7.79 per 1000 in 2002 to 3.55 in 2015. Compared with children born after natural conception, the OR for cerebral palsy was 2.01 (95% CI 1.63–2.47) adjusted for mother's age at birth, parity, and pre‐pregnancy health. When restricted to singletons born at term, the adjusted OR for cerebral palsy was 1.13 (95% CI 0.76–1.69). The distribution of cerebral palsy subtypes and the severity of gross and fine motor function and associated impairments did not differ significantly between children with cerebral palsy born after ART and natural conception. Conclusions: Children born after ART had a risk of cerebral palsy that was twice that of children born after natural conception. The increased risk of cerebral palsy after ART is likely attributed to multiple pregnancies and preterm births. The prevalence of cerebral palsy after ART decreased significantly during the study period, despite an increased use of ART in the population. The distribution of clinical characteristics did not differ between children with cerebral palsy born after ART and those born after a natural conception, suggesting that the risk factors for, and causes of cerebral palsy were similar. [ABSTRACT FROM AUTHOR]

Background. National as well as international Parkinson's disease (PD) treatment guidelines are available to guide clinicians. Previous research has shown that nonmotor symptoms (NMS) are pronounced in late-stage PD and has suggested that current treatment is insufficient and could be improved. Objectives. The aim of this study was to investigate to which degree the national and international treatment guidelines are followed in the treatment of NMS in late-stage PD. Methods. This Swedish cohort was part of the Care of Late-Stage Parkinsonism (CLaSP) study. Late-stage PD was defined as Hoehn and Yahr stages IV-V in "on" and/or ≤50% on the Schwab and England Activities of Daily Living (ADL) scale. NMS were assessed with the NMS scale (NMSS), cognition with the Mini-Mental State Examination (MMSE), and depressive symptoms with the Geriatric Depression Scale (GDS-30). Symptomatic individuals were defined as ≥ 6 on an item of the NMSS; for dementia, a cutoff of ≤18 on the MMSE; for depression, a cutoff of ≥10 on the GDS. Results. All 107 participants exhibited NMS to various degrees and severities; the median NMSS score was 91. Among symptomatic individuals, for depressive symptoms, 37/63 (59%) were treated with antidepressants; for hallucinations and delusions, 9/18 (50%) and 5/13 (38%) were treated with antipsychotics; and for dementia, 9/27 (33%) were treated with rivastigmine and 1 (4%) was treated with donepezil. For orthostatic hypotension, 11/19 (58%) with lightheadedness and 7/8 (88%) with fainting were treated with antihypotensives; for sialorrhea, 2/42 (5%) were treated with botulinum toxin; and for constipation, 19/35 (54%) were treated with laxatives. For insomnia, 4/16 (25%) were treated with hypnotics, and for daytime sleepiness, 1/29 (3%) was treated with psychostimulants. Conclusions. The present analyses suggest a need for clinicians to further screen for and treat NMS. Optimizing treatment of NMS according to the national and international treatment guidelines may improve symptomatology and enhance quality of life in late-stage PD. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to investigate the causal interaction between significant sensorimotor network (SMN) regions and other brain regions in Parkinson's disease patients with drooling (droolers). Methods: Twenty‐one droolers, 22 PD patients without drooling (non‐droolers), and 22 matched healthy controls underwent 3T‐MRI resting‐state scans. We performed independent component analysis and Granger causality analysis to determine whether significant SMN regions help predict other brain areas. Pearson's correlation was computed between imaging characteristics and clinical characteristics. ROC curves were plotted to assess the diagnostic performance of effective connectivity (EC). Results: Compared with non‐droolers and healthy controls, droolers showed abnormal EC of the right caudate nucleus (CAU.R) and right postcentral gyrus to extensive brain regions. In droolers, increased EC from the CAU.R to the right middle temporal gyrus was positively correlated with MDS‐UPDRS, MDS‐UPDRS II, NMSS, and HAMD scores; increased EC from the right inferior parietal lobe to CAU.R was positively correlated with MDS‐UPDRS score. ROC curve analysis showed that these abnormal ECs are of great significance in diagnosing drooling in PD. Conclusion: This study identified that PD patients with drooling have abnormal EC in the cortico‐limbic‐striatal‐cerebellar and cortio‐cortical networks, which could be potential biomarkers for drooling in PD. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Esophagogastroduodenoscopy is considered the gold standard in assessing the severity of injury to the gastrointestinal tract following corrosive ingestion. Zargar's endoscopic grading of injury helps in prognostication as well as guiding management. Since the major burden of cases lies in resource-limited settings, the availability of endoscopic evaluation is a limiting factor. Hence, it is prudent to develop bedside tools that can be used as screening tools to identify patients at high risk of mortality and complications so that timely referrals and judicious utilization of resources can be made. Literature in this regard is limited and published studies have shown that clinical features fail to predict the severity of injury. We aimed our study to find the role of Drooling, Reluctance, Oropharynx, Others, and Leukocytosis (DROOL) score as a predictor of mortality and complications following acute corrosive ingestion. METHODS: This was a diagnostic accuracy study conducted in the emergency department (ED) of a tertiary care hospital in North India. We screened all cases of acute corrosive ingestion presented to our ED. We collected the data on demographic profile, clinical features, investigations, endoscopy findings, treatment, and DROOL score. We followed patients for up to 12 weeks for outcomes including mortality and complications. RESULTS: We studied 79 patients of acute corrosive ingestion. The median age was 26 years with a female predominance. Nausea, vomiting, and pain abdomen were the common symptoms. The median DROOL score was 4. The majority of our patients had normal to Zargar grade 1 injury to the stomach and esophagus. Out of 79 patients, 27 patients developed some complications. The overall mortality up to 12 weeks was 10%. The receiver operating characteristics (ROC) analysis was performed, and the area under the ROC (AUROC) curve of Zargar classification in predicting overall complications was 0.909 (96% confidence interval [CI]: 0.842-0.975) and it was 0.775 (95% CI: 0.553-1.000) in predicting mortality. The AUROC of DROOL score in predicting overall complications was 0.932 (95% CI: 0.877-0.987) and the AUROC of DROOL score in predicting mortality was 0.864 (95% CI: 0.758-0.970). The ROC analysis showed that a DROOL score =4 has a sensitivity of 96.2% and a specificity of 77.8% in predicting overall complications. Similarly, DROOL score =5 has a sensitivity of 81.7% and a specificity of 62.5% in predicting the development of mortality. Delong test showed that there was no statistically significant difference in Zargar versus DROOL score in terms of prediction of mortality and overall complications (P > 0.05). CONCLUSION: DROOL score is comparable to Zargar score in identifying patients at high risk of mortality and complications. Hence, DROOL score can be used for risk stratification of patients presenting with corrosive ingestion. [ABSTRACT FROM AUTHOR]

Excessive copper accumulation in various body organs is due to mutations of alleles located on the ATP7B gene on chromosome 13. The presence of musculoskeletal symptoms, neurological symptoms, and psychiatric symptoms individually promotes misdiagnosis. Complete knowledge of Wilson's disease (WD) promotes early resolution of the case. This study presents a case of WD and reviews literature published in India. A 15-year-old boy from a non-consanguineous family presented with tremors, dysphagia, drooling of saliva, emotional tantrums, and Kayser-Fleischer rings. Magnetic resonance imaging shows hyperintensity in the basal ganglia; the Leipzig score was 6. Based on the score the patient was diagnosed with WD. The patient was treated with zinc sulfate 50 mg, twice daily. Significant improvement was observed in neurological symptoms after 30 days. Early condition assessment avoids complications and promotes improvement of the patient's condition. Regular monitoring of therapy reduces the occurrence of adverse drug reactions. Counseling minimizes the possibility of events in the next generation and promotes early diagnosis of late-onset WD among family members. [ABSTRACT FROM AUTHOR]

ENGLISH SUMMARY: Dry eye disease (DED) is characterized by ocular dryness, irritation and blurred vision and has a significant impact on the patient's quality of life. This condition can be particularly severe in patients with aqueous deficient dry eye disease (ADDE) due to Sjögren's syndrome (SS), an autoimmune disease that affects the lacrimal and salivary glands. Current treatments for ADDE are often limited to symptomatic relief. A literature review was conducted to explore the current surgical interventions used or tested in humans with ADDE (I). These interventions include procedures involving the eyelids and tear ducts, transplantation of amniotic membrane or salivary glands, injections around the tear ducts and cell‐based injections into the lacrimal gland (LG). Each treatment has its advantages and disadvantages; however, treating dry eyes in patients with SS presents a particular challenge due to the systemic nature of the disease. Moreover, there is a need for new therapeutic options. Mesenchymal stem cells (MSCs) are a type of stem cell that have shown promise in regenerating damaged tissue and reducing inflammation in various diseases. Previous studies in animal models have suggested that MSCs could be effective in treating ADDE. Thus, this thesis aims to investigate the safety and efficacy of injecting MSCs into the LG as a treatment option for patients with ADDE secondary to SS. The study also aims to see this treatment in light of existing and novel investigational treatment options. The clinical studies conducted for this thesis are the first of their kind in humans. MSCs derived from healthy donors' adipose tissue (ASCs) were cultured in a laboratory, frozen and thawed ready for use. In the safety study, we performed the first human trial involving the administration of a single injection of ASCs into the LG of one eye in seven patients suffering from severe ADDE (II). The primary objective was to test the safety of this treatment, while the secondary objective was to assess improvements in subjective and objective signs of dry eye. The results of the trial showed no serious side effects within 4 months of follow‐up after treatment. On average, there was a 40% reduction in dry eye symptoms assessed with the Ocular Surface Disease Index (OSDI) questionnaire. Additionally, in the treated eye, there was a significant decrease in tear osmolarity, an increase in tear film stability and an increase in tear production. To further investigate the efficacy of this treatment, our research group performed a clinical, randomized study aiming to compare the ASC injection into the LG with the injection of a vehicle (the excipient in which the ASCs are dissolved) and observation (no intervention) (III). The study involved 20 subjects receiving ASC injection, 20 subjects receiving vehicle injection and 14 patients being observed without intervention. The subjects were examined to assess the outcomes with a 12‐month follow‐up after treatment. Both intervention groups showed a significant reduction in subjective dry eye symptoms of approximately 40%. This improvement was evident at the 1‐week follow‐up and persisted until the 12‐month follow‐up. The observation group did not experience any change in OSDI score. The ASCs group exhibited a significant mean increase in non‐invasive tear break‐up time (NIKBUT) of 6.48 s (149%) at the four‐week follow‐up, which was significantly higher than that in the vehicle group (p = 0.04). Moreover, the ASCs group showed a significant increase in NIKBUT compared to that in the observation group at the 12‐month follow‐up (p = 0.004). In both the ASCs and vehicle group, a significant increase in Schirmer test scores at the 4‐month follow‐up and the 12‐month follow‐up was observed. In conclusion, this thesis contributes valuable findings with a new treatment option for patients with dry eye disease. Injection of ASCs into the LG was shown to be safe and to improve subjective dry eye symptoms and specifically the tear film stability in patients with ADDE due to SS. Compared to other treatment modalities of ADDE, this treatment has greater potential, as ASCs could potentially be used as an anti‐inflammatory therapeutic option for managing DED of other causes as well. RESUMÉ (DANISH SUMMARY): Tørre øjne, karakteriseret ved tørhedsfornemmelse og irritation af øjnene samt sløret syn, har en betydelig indvirkning på patientens livskvalitet. Denne tilstand kan være særligt alvorlig hos patienter med nedsat tåreproduktion (ADDE) som følge af Sjögrens syndrom (SS), en autoimmun sygdom, der påvirker tårekirtlerne og spytkirtlerne. Nuværende behandlinger for ADDE er ofte begrænset til symptomlindring. Vi gennemførte en litteraturgennemgang for at undersøge, hvilke nuværende kirurgiske behandlingsmetoder, der anvendes eller testes hos patienter med ADDE (I). Disse interventioner inkluderer procedurer, der involverer øjenlåg og tårekanaler, transplantation af amnionhinde eller spytkirtler, injektioner omkring tårekanalerne samt cellebaserede injektioner i tårekirtlen. Hver behandling har sine fordele og ulemper, men behandling af tørre øjne hos patienter med SS udgør en særlig udfordring på grund af sygdommens systemiske udbredning, og der er behov for nye behandlingsmuligheder. Mesenkymale stamceller (MSCs) er en type stamcelle, der har vist lovende resultater med hensyn til at regenerere beskadiget væv og reducere inflammation i forskellige sygdomme. Tidligere undersøgelser i dyremodeller har indikeret, at MSCs kan være en effektiv behandling af ADDE. Denne afhandling har til formål at undersøge sikkerheden og effekten af injektion af MSCs i tårekirtlen som en mulig behandling til patienter med ADDE som følge af SS. Afhandlingen sigter også mod at sammenligne denne behandling med andre eksisterende, kirurgiske behandlingsmuligheder af ADDE. Som led i dette projekt udførte vi de første kliniske forsøg af sin art i mennesker. MSCs fra raske donorers fedtvæv (ASCs) blev dyrket i et laboratorium, frosset ned og er optøet klar til brug. Det første mål var at teste sikkerheden ved denne behandling og sekundært at undersøge behandlingens effekt. For at undersøge dette modtog syv forsøgspersoner med svær ADDE én injektion med ASCs i tårekirtlen på det ene øje (II). Resultaterne af forsøget viste ingen alvorlige bivirkninger inden for fire måneders opfølgning efter behandlingen. I gennemsnit fandt vi yderligere en 40% reduktion i symptomer på tørre øjne vurderet med et spørgeskema, og en markant stigning i tåreproduktionen og af tårefilmens stabilitet i det behandlede øje. For yderligere at undersøge effekten af denne behandling udførte vi et klinisk, randomiseret forsøg med det formål at sammenligne injektion af ASCs i tårekirtlen med injektion af en kontrolopløsning (væsken, hvor stamcellerne var opløst) og observation (ingen intervention) (III). Studiet omfattede 20 forsøgspersoner, der modtog ASC‐injektion, 20 forsøgspersoner, der modtog injektion af kontrolopløsningen, og 14 forsøgspersoner i observationsgruppen. Forsøgspersonerne blev undersøgt med en opfølgningstid på 12 måneder efter behandling. Begge interventionsgrupper viste en betydelig reduktion på ca. 40% i subjektive symptomer på tørre øjne. Denne forbedring var betydelig allerede ved opfølgning efter en uge og varede ved 12 måneder efter behandling. Observationsgruppen oplevede ingen betydelig ændring i symptomer. ASCs gruppen viste desuden en signifikant stigning i tårefilmsstabiliteten (NIKBUT) på 6,48 sekunder (149%) ved opfølgning efter fire uger, hvilket var markant højere end efter injektion af kontrolopløsning (p = 0,04). Desuden viste ASCs gruppen en betydelig stigning i NIKBUT sammenlignet med observationsgruppen ved opfølgning efter 12 måneder (p = 0,004). Både injektion af ASCs og kontrolopløsning medførte en betydelig stigning i tåreproduktionen ved opfølgning fire måneder og 12 måneder efter behandling. Denne afhandling bidrager med vigtige resultater inden for en ny behandlingsmulighed af tørre øjne. Injektion af ASCs i tårekirtlen viste sig at være sikker, forbedrede subjektive symptomer på tørre øjne og øgede særligt tårfilmens stabilitet hos patienter med ADDE på grund af SS. Sammenlignet med andre behandlingsmuligheder for ADDE har denne behandling vist et stort potentiale. ASCs kan muligvis også bruges som en anti‐inflammatorisk behandling af tørre øjne af andre årsager i fremtiden. [ABSTRACT FROM AUTHOR]

Background: Xerostomia and sialorrhea often accompany Burning Mouth Syndrome (BMS) despite no change in saliva quantity. This study analyzed BMS patients with different symptom combinations: burning only (B), burning and xerostomia (BX), burning and sialorrhea (BS), and burning with xerostomia and sialorrhea (BXS), using a large sample of 500 patients from the University of Naples Federico II. Methods: After a medical evaluation, patients were divided into four groups based on their reported symptoms: B (140), BX (253), BS (49), and BXS (58). Patient data on education, BMI, smoking/alcohol habits, comorbidities, medication use, pain intensity, quality, and psychological profile were collected. Results: The BX group showed a higher prevalence of patients taking blood thinners. Additional symptoms varied among groups, with the BX group experiencing more dysgeusia and globus, and the BS group reporting more tingling. Multivariate analysis identified BMI, dysgeusia, globus, and blood thinner use as significant factors in the B and BX groups, while male gender, tingling, alcohol use, and pain quality were significant in the BS and BXS groups. Conclusions: Overall, BMS patients display a complex range of symptoms, with xerostomia being the most frequent additional symptom. Sociodemographic, psychological, and medical factors cannot fully explain the variations in symptomatology among different patient subgroups. Further research is needed to understand the underlying causes and develop tailored treatment approaches. [ABSTRACT FROM AUTHOR]

Paediatric pharyngeal trauma is common and frequently occurs after falls or other accidents. Children with these injuries typically present to emergency departments with drooling, respiratory distress, stridor and hematemesis. Although most cases of pharyngeal trauma are minor, some can have rare, life‐threatening complications. [ABSTRACT FROM AUTHOR]

Introduction: Clozapine-induced sialorrhea (CIS) is one of the most common side effects of clozapine use, while the mechanism remains unclear. Methods: A total of 51 schizophrenia patients taking clozapine were selected. Among them, 32 had sialorrhea, and 19 had no sialorrhea. Saliva metabolites were identified using ultra-high-performance liquid chromatography-MS/MS (UHPLC-MS/MS), and the differences in saliva metabolites in each group were analyzed through qualitatively searching HMDB, KEGG, and self-built databases, combined with multivariate statistics. After further evaluation by receiver-operating characteristic curve (ROC) analysis, the screened differential metabolites were enriched and topologically analyzed. Results: The biomarkers potentially related to CIS included 37 differential metabolites involving 17 metabolic pathways, mainly histidine metabolism (p < 0.05, impact = 0.50), pyrimidine metabolism (p < 0.05, impact = 0.08), and β-alanine metabolism (p < 0.05, impact = 0.06). Conclusion: Our study indicates that histidine metabolic pathway may contribute to the mechanism of CIS. [ABSTRACT FROM AUTHOR]

This study was performed to evaluate the effect of different decontamination protocols applied to contaminated surfaces on the recovery of adhesion. Different decontamination protocols were applied to molar teeth contaminated with blood and saliva except the control group. 40 third molar teeth were divided into groups according to the applied decontamination protocols: Group 1(control), Group 2 (water rinse), Group 3 (15-sec re-etch), Group 4 (10-sec re-etch), Group 5 (5-sec re-etch), Group 6 (5% NaOCl), Group 7 (2% chlorhexidine gluconate), Group 8 (ozonated water). Universal adhesive resin (Gluma Universal, Heraus Kulzer) was used in the etch and rinse mode according to the manufacturer's instructions. Nanohybrid composite material was placed in all groups. Then the Shear Bond strengths of all groups were evaluated after applying 5000 thermal cycles (5–55 °C) to each sample. In the limitation of this in vitro study, it has been shown that rinsing with ozonated water of contaminated surfaces with blood and saliva after etching, has increased the micro-shear bond strength (μSBS) values more than that of in control group values. Also, the application of NaOCl, re-etching with 37% phosphoric acid for 15 seconds, and cleaning with CHX, significantly increase the bonding potential. [ABSTRACT FROM AUTHOR]

Sialorrhea is common in children with neurodevelopmental disabilities (NDD) and is reported in >40% of children with cerebral palsy (CP). It causes a range of complications, including significant respiratory morbidity. This single-center retrospective chart review aims to document sublingual atropine (SLA) utilization to guide further study in establishing its role in secretion management for children with NDD. A chart review was completed for patients with NDD ≤ 22 years of age treated with SLA at a free-standing children's hospital between 1 January 2016 and 1 June 2021. Descriptive statistics were generated to summarize findings. In total, 190 patients were identified, of which 178 met inclusion criteria. The average starting dose for SLA was 1.5 mg/day, or 0.09 mg/kg/day when adjusted for patient weight. Eighty-nine (50%) patients were prescribed SLA first line for secretion management while 85 (48%) patients tried glycopyrrolate prior to SLA. SLA was used after salivary Botox, ablation, and/or surgery in 16 (9%) patients. This study investigates SLA as a potential pharmacologic agent to treat sialorrhea in children with NDD. We identify a range of prescribing patterns regarding dosing, schedule, and place in therapy, highlighting the need for further evidence to support and guide its safe and efficacious use. [ABSTRACT FROM AUTHOR]

Cerebral palsy (CP) is a condition characterized by abnormal pronunciation, posture, and movement, particularly spastic CP, which involves Gross motor dysfunction due to increased muscle tone and stiffness. This monocentric clinical study aims to evaluate the effectiveness of acupuncture and tuina (AT) in improving gross motor function and alleviating associated symptoms in children diagnosed with spastic CP.Methods: A total of 83 eligible patients received AT treatment, while 85 patients received conventional rehabilitation treatment. Both groups underwent a 12-week treatment period following the research protocol. Pre- and post-treatment assessments included the Modified Ashworth Muscle Tension Scale (MAS), Gross Motor Function Measure (GMFM-D and GMFM-E), 6-min walking distance measurement (6MWD), and Modified Children's Functional Independence Rating Scale (WeeFIM).Results: After 12 weeks of treatment, when compared with baseline, the scores of MAS in both AT group and control group are decreased (p< 0.01, p< 0.01), the scores of GMFM-D, GMFME, 6MWD, WeeFIM in both group are increased (p< 0.01 in all indicators). When compared with control group, AT group had significantly lower MAS scores compared to the control group (p< 0.01), indicating reduced muscle tension. Moreover, AT group showed significantly higher scores in GMFM-D, GMFM-E, 6MWD, and WeeFIM compared to the control group (p< 0.01 in all indicators), indicating improved gross motor function and functional independence. The study also revealed an inverse correlation between the children's age and treatment efficacy (r= − 0.496, p< 0.01 in AT group, r=− 0.540, p< 0.01 in control group), highlighting the importance of early intervention in the management of CP in children.Conclusion: These findings suggest that AT may effectively enhance gross motor function and alleviate associated symptoms in children diagnosed with spastic CP. Moreover, early initiation of treatment is crucial to maximize therapeutic efficacy in children with spastic CP.Trial Registration: Chinese Clinical Trial Registry, ChiCTR2200059823. Registered on 12 May 2022. [ABSTRACT FROM AUTHOR]