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Limitations | co-occurring intellectual disabilities, autism | Future studies using larger cohorts and more explicitly controlled concurrent psychosocial trainings are warranted to further explore the preliminary moderator effects, also including understudied populations within the autism spectrum, such as children with co-occurring intellectual disabilities. | PMC10117268 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13229-023-00546-5. | PMC10117268 | ||
Keywords | PMC10117268 | |||
Background | ASD, impairments in social communication, Autism spectrum disorder, early-onset neurodevelopmental condition, repetitive behaviors, autism | Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by impairments in social communication and interaction, combined with restricted and repetitive behaviors and interests [Following a myriad of single-dose proof-of-principle studies [Given that autism is an early-onset neurodevelopmental con... | PMC10117268 | |
Methods | PMC10117268 | |||
General study design | The RCT with a parallel design assessing the effect of multiple-dose OT administration in children with ASD was performed at the Leuven University Hospital (Belgium). The double-blind phase (phase I) was followed by a 4-week single-blind phase (phase II) during which all participants received intranasal OT. In both pha... | PMC10117268 | ||
Data analysis | Analyses were performed using a modified intention-to-treat approach that included all randomized participants who completed the baseline session and at least one post or follow-up session (Fig. First, possible baseline differences on the questionnaires were assessed between randomized nasal spray groups, indicating no... | PMC10117268 | ||
Results | PMC10117268 | |||
Double-blind phase (phase I) | No significant effect of ‘nasal spray’ was revealed on parent-reported social responsiveness (SRS-2), neither at the T1 assessment session, immediately after the 4-week nasal spray administration period ( | PMC10117268 | ||
Single-blind phase (phase II) | To examine whether the change from placebo to OT administration (in the placebo-first group) or a continuation of OT administration for another 4 weeks (in the OT-first group) may have induced differential changes in SRS-2 scores during phase II, change scores (from T2, the last session of phase I) were calculated and ... | PMC10117268 | ||
Exploratory moderator analyses | For the moderator variable ‘psychosocial training’, a significant interaction with ‘nasal spray’ was identified (Change in treatment responses according to the presence of concomitant psychosocial training. Visualization of changes from baseline in parent-reported social responsiveness (SRS-2 raw total scores) of the d... | PMC10117268 | ||
Discussion | ASD | SECONDARY | The current pediatric trial demonstrated no significant treatment-specific effects of a 4-week OT administration period on social responsiveness (SRS-2), nor on the secondary outcomes. Both the OT and the placebo groups displayed similar improvements, both immediately after the multiple-dose nasal spray administration ... | PMC10117268 |
Limitations | intellectual disabilities | While the study provides novel insights into the effects of OT administration in school-aged children with ASD, the following limitations are noted. First, the current study included a relatively strict age range of pre-pubertal, school-aged children with ASD limiting generalizability to other age ranges. Future studie... | PMC10117268 | |
Conclusions | To conclude, while the current study showed no overall treatment-specific improvements, exploratory moderator effects were identified, providing preliminary evidence that clinical efficacy can be augmented when OT administration is paired with targeted concurrent behavioral interventions.
| PMC10117268 | ||
Acknowledgements | Autism | The authors would like to express their gratitude to the participants and parents for taking part in this study. Additionally, they would like to thank colleagues of the Leuven Autism Research Consortium (LAuRes), the reviewers for their constructive feedback which has helped improve the manuscript's quality, and the s... | PMC10117268 | |
Authors' contributions | MM | ND performed investigation, project administration, formal analysis, and writing—original draft. JS done conceptualization, resources, writing—review & editing. AB contributed to project administration and resources. ED was involved in investigation, resources, writing—review & editing. JP, SVD, MM and TT did investiga... | PMC10117268 | |
Funding | JP, MM | This research was supported by an internal C1 fund of the KU Leuven (ELG-D2857-C14/17/102), a Doctor Gustave Delport fund of the King Baudouin Foundation (2019-J1811190-212989), the Branco Weiss fellowship of the Society in Science—ETH Zurich granted to KA and the Excellence of Science grant granted to BB (EOS; G0E8718... | PMC10117268 | |
Availability of data and materials | The data that support the findings of this study are available on request from the corresponding author, KA. The data are not publicly available due to privacy restrictions. | PMC10117268 | ||
Declarations | PMC10117268 | |||
Ethics approval and consent to participate | This study protocol was reviewed and approved by the Ethics Committee for Biomedical Research at the University of Leuven, approval number [S61358]. Written informed consent from the parents and assent from the child were obtained prior to the study. | PMC10117268 | ||
Consent for publication | Not applicable. | PMC10117268 | ||
Competing interests | The authors declare no conflicts of interest. | PMC10117268 | ||
References | PMC10117268 | |||
1. Introduction | inflammation, atopic skin diseases, eczema, psoriasis | ROSACEA, METABOLIC DISORDER, INFLAMMATION, PSORIASIS, PALMOPLANTAR KERATODERMA, SKIN CONDITION, SKIN DISORDERS, ECZEMA | We examined the effect of a dietary seaweed extract—sulfated xylorhamnoglucuronan (SXRG84)—on individuals with inflammatory skin conditions. A subgroup analysis of a larger trial was undertaken, where 44 participants with skin conditions were enrolled in a double-blind placebo-controlled crossover design. Subjects inge... | PMC10381427 |
2. Results | PMC10381427 | |||
2.1. Participants | SKIN CONDITION | For the subset of participants with inflammatory skin conditions, a total of 50 participants were randomised to either regime. The reasons for participant withdrawal are summarized in | PMC10381427 | |
2.2. Differences in Gut Microbiome between the Subsets of Skin Cohort and Non-Skin Cohort from the Original Clinical Trial | SKIN CONDITION | At baseline, a PERMANOVA determined that the cohort with inflammatory skin conditions used for this trial had a gut microbiome that differed in composition and abundance when compared to a cohort without inflammatory skin conditions (taken from the larger clinical trial [ | PMC10381427 | |
2.3. Baseline Characteristics of Participants with Inflammatory Skin Conditions | There were no significant differences between the two regime groups at baseline for any of the outcome variables, except for BMI ( | PMC10381427 | ||
2.4. Changes in Outcome Variables | When examining the changes in outcome variables at six weeks or twelve weeks, there were no significant changes for BMI, the skin measures (PASI, VAS and DQLI), CRP, IL-6 and IL-8. There were significant differences detected for IFNγ ( | PMC10381427 | ||
2.5. Changes in Gut Microbiota | To assess changes in the gut microbiota, a PERMANOVA was used to test for differences between the six and twelve week timepoints following either the placebo or SXRG84 treatment. There were no significant differences between gut microbiota composition and abundance for any timepoint ( | PMC10381427 | ||
2.6. Skin Responders and Non-Responders to the Intervention | SKIN CONDITION | Although there were no significant differences between the treatments and timepoints for the skin measures for the group as a whole, a subset of participants reported improvements in their skin condition. Ten participants reported noticeable improvements in their skin directly following the SXRG84 treatment (However, s... | PMC10381427 | |
2.7. Dietary Intake | SKIN CONDITION | At baseline, the dietary intake of servings of food differed between the skin cohort and the non-skin cohort from the larger clinical trial. At baseline, those with a skin condition consumed fewer servings of yoghurt, soy products and milk alternatives compared to the those without a skin condition ( | PMC10381427 | |
3. Discussion | TNF-α, eczema, psoriasis | SKIN CONDITION, PATHOGENESIS, ECZEMA, PSORIASIS | This study investigated the effect of SXRG84 treatment on a range of inflammatory skin conditions. Although there were no significant skin improvements across the whole cohort, there were significant results for inflammatory cytokine reduction. A subset of participants experienced improvements in skin outcome measures.... | PMC10381427 |
4. Materials and Methods | PMC10381427 | |||
4.1. Ethics and Clinical Trial Registration | This trial was approved by the University of Wollongong Human Research Ethics Committee, approval no. 2017/101, and was registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12617001010381). The research was conducted according to the guidelines of the Declaration of Helsinki [ | PMC10381427 | ||
4.2. Participants and Study Design | Participants were enrolled in a larger, randomized, double-blind placebo crossover trial, assessing the effect of a seaweed SXRG84 extract on metabolic and inflammatory markers (Bio-Belly 2 trial [ | PMC10381427 | ||
4.3. Clinic Visits | Participants attended clinic visits at the Illawarra Health and Medical Research Institute (IHMRI), Wollongong, Australia, between August and December 2017. Visits occurred at baseline; at week six, at the end of the first treatment arm, which coincided with the commenced of the second treatment arm; and at week 12, fo... | PMC10381427 | ||
4.4. Blood and Faecal Sample Analysis | BLOOD | Blood samples were analysed for inflammatory cytokines using an immunoassay high sensitivity Luminex Panel by Crux Biolab, Melbourne, Australia ( | PMC10381427 | |
4.5. Dietary Intake | SKIN CONDITION | Participants’ dietary intake was assessed by three 24 h recalls at baseline, which included one weekend day and two weekdays of intake. These were entered into Foodworks nutrient analysis software (Version 8, Xyris Software, Pty Ltd. (Xyris Pty Ltd., Brisbane, Australia). The databases AusBrands 2017 and AusFoods 2017 ... | PMC10381427 | |
4.6. Statistics | Data were analysed with SPSS Statistics version 21 (IBM Corporation, Armonk, NY, USA). Researchers were blinded to the treatment allocation during data analysis. Data were tested for normality using the Shapiro–Wilk test, and data that were not normally distributed are presented as median (25th, 75th percentile). The t... | PMC10381427 | ||
5. Conclusions | inflammation, psoriasis | PATHOLOGY, INFLAMMATION, SKIN CONDITION, PSORIASIS | In conclusion, SXRG84 ingestion has the potential to improve a subset of inflammatory skin conditions, potentially through the reduction of pro-inflammatory cytokines. However, the effect was not seen across all participants, and further work is required to determine the optimal dose, the duration of the trial and the ... | PMC10381427 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10381427 | ||
Author Contributions | Conceptualization, L.A.R., B.J.M. and P.W.; methodology, L.A.R.; formal analysis, L.A.R.; investigation, B.J.M. and P.W.; resources, B.J.M. and P.W.; data curation, L.A.R.; writing—original draft preparation, L.A.R. and J.H.F.; writing—review and editing, L.A.R., B.J.M., J.H.F. and P.W.; supervision, B.J.M. and P.W.; p... | PMC10381427 | ||
Institutional Review Board Statement | MAY | All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the University of Wollongong Human Research Ethics Committee, approval no. 2017/101, approved on 16 May 2017, and was register... | PMC10381427 | |
Data Availability Statement | Data are not publicly available due to participant confidentiality as defined by the ethics committee. De-identified data are available on request from the corresponding author. | PMC10381427 | ||
Conflicts of Interest | P.W. is the CEO of Venus Shell Systems, which provided the extract for this research. | PMC10381427 | ||
References | Dermatitis, psoriasis, keratoderma, non-skin, DSAP | DERMATITIS, DISSEMINATED SUPERFICIAL ACTINIC POROKERATOSIS, PSORIASIS, SKIN CONDITION, SKIN CONDITIONS | CONSORT flow diagram of participants with inflammatory skin conditions.Dietary differences observed at baseline between participants with a skin condition (Differences in dietary intake observed at T2 between those with skin conditions (Differences in dietary intake observed at T3 between those with skin conditions (Di... | PMC10381427 |
Background | postoperative sore throat, postoperative sleep disturbance, sleep disturbance, Postoperative sore throat | Postoperative sore throat and sleep disturbance are prevalent among patients undergoing spinal surgery, and these conditions can substantially impact their postoperative satisfaction and quality of life. The present study aimed to examine the impact of ultrasound-guided stellate ganglion block (SGB) on the occurrence o... | PMC10576298 | |
Methods | Sixty patients were randomly assigned to either the experimental group (SGB group) or the control group (CG). Both groups received the same induction and maintenance drugs. However, the SGB group received a right SGB under ultrasound guidance 15 min before anesthesia induction, while the CG did not receive any block an... | PMC10576298 | ||
Results | The incidence of POST at 1 h and 6 h after surgery was significantly lower in the SGB group (10.0% and 13.3%) than in the CG (43.3% and 36.7%) ( | PMC10576298 | ||
Conclusion | Ultrasound-guided SGB can reduce the incidence and severity of POST and improve PSD in patients undergoing lumbar spine surgery. | PMC10576298 | ||
Trial registration | This study was registered on Chinese Clinical Trial Registry, (ChiCTR2200065279) on 01/11/2022. | PMC10576298 | ||
Keywords | PMC10576298 | |||
Introduction | postoperative pain, postoperative sleep disorders, During lumbar spine surgery, pain, psychiatric, vasospastic syndromes, postoperative sore throat, arrhythmias | DISORDERS, ARRHYTHMIAS, ADVERSE REACTIONS, DYSFUNCTION | Stellate ganglion block (SGB) is a reversible technique that involves blocking the sympathetic nerves in the neck and their distribution area. Clinical research has shown that SGB is effective in pain suppression, regulation of autonomic nervous system dysfunction, and reduction of the adverse stress response caused by... | PMC10576298 |
Materials and methods | PMC10576298 | |||
General information | abnormal coagulation, mental illness, hoarseness, throat pain, upper respiratory tract infection, allergy, lumbar spondylosis, cognitive dysfunction, psychiatric | ABNORMAL COAGULATION, UPPER RESPIRATORY TRACT INFECTIONS, ALLERGY, LUMBAR SPONDYLOSIS, DISORDERS, FUNCTIONAL DISORDERS, HEARING IMPAIRMENT, PUNCTURE SITE INFECTION | This study was a prospective, randomized controlled trial that received approval from the Ethics Committee of the Affiliated Hospital of North Sichuan Medical College (Approval No: 2022ER403-1) on 14/10/2022 and was registered in the Chinese Clinical Trial Registry (ChiCTR2200065279) on 01/11/2022. Prior to the experim... | PMC10576298 |
Treatment regimen | MUSCLE RELAXATION | Both groups of patients underwent intravenous inhalation compound general anesthesia for surgery, and the administration of medication and endotracheal intubation were both performed by the same anesthesiologist. Upon entering the operating room, routine tests were conducted, including heart rate (HR), mean arterial pr... | PMC10576298 | |
Analgesic regimen | postoperative pain | Both patient groups were provided intravenous patient-controlled analgesia (PCA) for postoperative pain management. The analgesic regimen was comprised 150 µg sufentanil, 200 mg flurbiprofen ester, and 5 mg tropisetron, which were diluted to 150 mL with normal saline. The PCA parameters were established as follows: a b... | PMC10576298 | |
Observation indicators | postoperative sore throat, postoperative throat pain | (1) The incidence and severity of postoperative sore throat (POST) were embodied in the postoperative sore throat score, a four-level rating scale used to assess the severity of postoperative throat pain [ | PMC10576298 | |
Sample size calculation | Assuming that a 20% decrease in POST incidence is clinically significant, experimental results from 20 lumbar spine surgery patients were used to estimate the sample size using PASS software. A type I error rate of α = 0.05 and a test power of β = 90% were set, and at least 26 samples were needed in each group. Taking ... | PMC10576298 | ||
Data analysis | Data analysis was performed using SPSS 26.0 statistical software. Continuous data are expressed as the mean ± standard deviation (x ± s), and intergroup comparisons were performed using t tests. Within-group comparisons at different time points were performed using repeated measures analysis of variance. Categorical da... | PMC10576298 | ||
Results | PMC10576298 | |||
Demographic profile | The experimental study included a total of 60 patients, none of whom withdrew from the study (the study flow diagram is displayed in Fig. Technology roadmapDemographic profile of two groupsThe SGB group refers to the stellate ganglion block group; The CG refers to the control group; The symbol ∗ represents the comparis... | PMC10576298 | ||
Comparison of postoperative sore throat | postoperative sore throat | SORE THROAT | The incidence of POST in the SGB group was significantly lower than that in the CG at 1 h and 6 h after general anesthesia (10.0% and 13.3%, respectively, compared to 43.3% and 36.7%, respectively). The mean postoperative sore throat scores of the SGB group (0.10 ± 0.31 and 0.17 ± 0.46, respectively) were lower than th... | PMC10576298 |
Comparison of postoperative throat complications | postoperative hoarseness, postoperative nausea and vomiting, postoperative cough | Table Comparison of incidence of postoperative hoarseness among two groups [n(%)]The SGB group refers to the stellate ganglion block group; The CG refers to the control group; The symbol ∗ represents the comparison between the SGB group and the CG, with Comparison of incidence of postoperative cough among two groups [n... | PMC10576298 | |
Comparison of deep sleep quality scores | Table Comparison of incidence of deep sleep quality score among two groupsThe SGB group refers to the stellate ganglion block group; The CG refers to the control group; The symbol ∗ represents the comparison between the SGB group and the CG, with | PMC10576298 | ||
Comparison of intraoperative hemodynamics | There was no significant difference in MAP or HR between the SGB group and the CG at T0, T1, or T7 (Comparison of hemodynamics among two groupsThe SGB group refers to the stellate ganglion block group; The CG refers to the control group; The symbol ∗ represents the comparison between the SGB group and the CG, with | PMC10576298 | ||
Comparison of other data | Table Comparison of other data among two groupsThe SGB group refers to the stellate ganglion block group; The CG refers to the control group; The symbol ∗ represents the comparison between the SGB group and the CG, with | PMC10576298 | ||
Discussion | postoperative sleep disorders, postoperative incisional pain, postoperative cough, tissue injury, postoperative hoarseness, inflammation, throat, pain, intermittent claudication, PONV, Lumbar spine diseases, trauma | INFLAMMATION, COMPLICATION, DYSFUNCTION, INTERMITTENT CLAUDICATION, OXIDATIVE STRESS, INFLAMMATORY RESPONSE | Lumbar spine diseases are prevalent among middle-aged and elderly individuals in China. The primary symptoms include intermittent claudication and pain in the legs and lower back. In severe cases, these symptoms can significantly impact daily life. In clinical practice, when conservative treatments prove ineffective, s... | PMC10576298 |
Conclusion | postoperative sore throat, postoperative sleep disturbances | Ultrasound-guided SGB is an effective intervention to reduce the incidence and severity of postoperative sore throat in lumbar surgery patients. It also alleviates postoperative sleep disturbances by inhibiting the excitation of the autonomic nervous system. Therefore, ultrasound-guided SGB can improve patient comfort ... | PMC10576298 | |
Acknowledgements | Not applicable. | PMC10576298 | ||
Authors’ contributions | DL: Conceptualization, methodology, investigation, formal analysis, writing – original draft, review, and editing. YS: Conceptualization, methodology, formal analysis, writing – review and editing. YP: Conceptualization, methodology, investigation, formal analysis, writing – review and editing, supervision.All the auth... | PMC10576298 | ||
Funding | This study did not receive any funding. | PMC10576298 | ||
Availability of data and materials | The datasets generated and/or analyzed during this study are not publicly available due to institutional policy on data confidentiality but are available from the corresponding author on reasonable request. | PMC10576298 | ||
Declarations | PMC10576298 | |||
Ethics approval and consent to participate | This study received approval by the Medical Ethics Committee of the Affiliated Hospital of North Sichuan Medical College (2022ER403-1) on 04/10/2022, with registration on ClinicalTrials. gov and the Chinese Clinical Trial Registry (ChiCTR2200065279) on 01/11/2022. Written informed consent was obtained from every patien... | PMC10576298 | ||
Consent for publication | Not applicable. | PMC10576298 | ||
Competing interests | The authors declare no competing interests. | PMC10576298 | ||
References | PMC10576298 | |||
Key Points | PMC10199342 | |||
Question | Does higher daily vitamin D | PMC10199342 | ||
Findings | SECONDARY | In this secondary analysis of a randomized clinical trial including 346 children, those randomized to higher vitamin D | PMC10199342 | |
Meaning | This study found that higher than standard vitamin D | PMC10199342 | ||
Importance | Vitamin D is associated with neurodevelopment, but causality, critical windows, and potentials for modification remain unknown. | PMC10199342 | ||
Objective | To determine the impact of high-dose (1200 IU) vs standard-dose (400 IU) vitamin D | PMC10199342 | ||
Design, Setting, and Participants | psychiatric, term-born | RECRUITMENT, SECONDARY | This study was a long-term follow-up of the double-blind randomized clinical trial (RCT) Vitamin D Intervention in Infants (VIDI) conducted at a single center in Helsinki, Finland, at 60 degrees north latitude. Recruitment for VIDI took place in 2013 to 2014. Follow-up data for secondary data analysis were collected 20... | PMC10199342 |
Interventions | There were 169 infants randomized to receive 400-IU and 177 infants randomized to receive 1200-IU oral vitamin D | PMC10199342 | ||
Main Outcomes and Measures | Primary outcomes were internalizing, externalizing, and total problems scores, with clinically significant problems defined as | PMC10199342 | ||
Results | Among 346 participants (164 females [47.4%]; mean [SD] age, 7.1 [0.4] years), the vitamin D | PMC10199342 | ||
Conclusions and Relevance | This randomized clinical trial found that higher-than-standard vitamin D | PMC10199342 | ||
Trial Registration | ClinicalTrials.gov Identifiers: | PMC10199342 | ||
Introduction | DISORDERS | Vitamin D insufficiency and deficiency are estimated to occur among almost half and more than one-tenth of the global population, respectively, across all ages.Approximately one-eighth of children in high-income countries have mental disorders,Lower 25(OH)D levels in pregnancy have been associated with unfavorable neur... | PMC10199342 | |
Methods | SECONDARY, RECRUITMENT | Participating children’s parents signed informed consent forms at recruitment and at the 6 to 8–year follow-up for this RCT secondary analysis. Children gave written consent to participate at the 6 to 8–year follow-up. The study was approved by the ethics committee at the Hospital District of Helsinki and Uusimaa and r... | PMC10199342 | |
Study Design and Participants | The VIDI study (see trial protocol in | PMC10199342 | ||
Flowchart of Study Enrollment, Allocation, and Follow-up | CBCL indicates Childhood Behavior Checklist. | PMC10199342 | ||
Follow-up at 6 to 8 Years | MAY, GENETIC DISORDER | The follow-up study was initiated in November 2019; we invited 817 families who remained in the original VIDI study until completion of the intervention at age 2 years of the child and had available home address info to participate. Of 546 families who participated in the follow-up study (55.3% of the original study po... | PMC10199342 | |
Biochemical Analysis | Serum 25(OH)D concentrations were analyzed at the Pediatric Research Centre, University of Helsinki, using a fully automated IDS-iSYS immunoassay system with chemiluminescence detection (Immunodiagnostics System). Biochemical analyses are described in detail in the eAppendix in | PMC10199342 | ||
Outcome Measures | psychiatric | Childhood psychiatric symptoms were assessed at a mean (SD; range) age of 7.1 years (0.4; 6.3-8.2) years using CBCL, a standardized questionnaire comprising 113 items scored using a 3-point Likert scale (0 = absent; 1 = occurs sometimes; 2 = occurs often). | PMC10199342 | |
Covariates | Potential covariates were assessed based on known association with childhood neurodevelopment or vitamin D | PMC10199342 | ||
Statistical Analysis | SECONDARY | Longitudinal secondary data analyses followed the intention-to-treat principle; 2-tailed independent-sample To test the potential interaction between prenatal 25(OH)D level and supplementation degree, children were grouped by maternal pregnancy 25(OH)D level. A 30-ng/mL cutoff point was selected a priori based on previ... | PMC10199342 |
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