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BMJ Open Jun 2024Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we... (Comparative Study)
Comparative Study Randomized Controlled Trial
INTRODUCTION
Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) as Software as a Medical Device for insomnia. This paper describes the study protocol for an exploratory randomised controlled trial (RCT) to evaluate effectiveness and safety of our developed digital CBT (dCBT) for 5 weeks compared with zolpidem tartrate for patients with insomnia disorder.
METHODS AND ANALYSIS
This proposed multicentre exploratory RCT will be conducted at the outpatient clinic of Chiba University Hospital, Akita University Hospital and Yoyogi Sleep Disorder Center, Japan. The study population comprises two parallel groups (dCBT and zolpidem) consisting of 15 participants each (n=30 in total) diagnosed with insomnia disorder who remain symptomatic at 4 weeks after sleep hygiene education. We will evaluate the effectiveness at baseline, week 5 (post-intervention) and week 10 (follow-up). The primary outcome will be the change of subjective sleep onset latency at week 5 from baseline. Secondary outcomes include sleep-related outcomes, such as objective sleep onset latency measured by mobile electroencephalography, functional improvement during the daytime and quality of life.
ETHICS AND DISSEMINATION
Ethics approval was granted by the Institutional Review Board of Chiba University Hospital (K2023001). All participants will be required to provide written informed consent. Results will be published in international journals.
TRIAL REGISTRATION NUMBER
jRCT2032230353.
Topics: Humans; Sleep Initiation and Maintenance Disorders; Zolpidem; Cognitive Behavioral Therapy; Hypnotics and Sedatives; Adult; Randomized Controlled Trials as Topic; Female; Male; Treatment Outcome; Japan; Middle Aged
PubMed: 38925698
DOI: 10.1136/bmjopen-2023-081205 -
BMJ Open Jun 2024Children with atopic dermatitis (AD) are more at risk for the neurodevelopmental disorders attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder...
INTRODUCTION
Children with atopic dermatitis (AD) are more at risk for the neurodevelopmental disorders attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) with parallel increases in global prevalences. Children afflicted with these conditions appear to share similar problems in sensory modulation but investigational studies on the underlying aetiology are scarce. This scoping review aims to find knowledge gaps, collate hypotheses and to summarise available evidence on the shared pathophysiology of AD, ADHD and ASD in children.
METHODS AND ANALYSIS
Our study will follow the methodological manual published by the Joanna Briggs Methodology for Scoping Reviews and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews. The following electronic databases will be searched for studies focused on children with AD and symptoms of ADHD and/or ASD: Medline ALL via Ovid, Embase, Web of Science Core Collection and the Cochrane Central Register of Controlled Trials via Wiley.
ETHICS AND DISSEMINATION
This review does not require ethics approval as it will not be conducted with human participants. We will only use published data. Our dissemination strategy includes peer review publication and conference reports.
Topics: Humans; Dermatitis, Atopic; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Systematic Reviews as Topic; Child; Research Design
PubMed: 38925697
DOI: 10.1136/bmjopen-2023-081280 -
PloS One 2024Dissolved organic matter (DOM) influences the bioavailability and behavior of trace metals and other pollutants in landfill leachate. This research characterized...
Characterization and spatiotemporal variations of fluorescent dissolved organic matter in leachate from old landfill-derived incineration residues and incombustible waste.
Dissolved organic matter (DOM) influences the bioavailability and behavior of trace metals and other pollutants in landfill leachate. This research characterized fluorescent dissolved organic matter (FDOM) in leachate from an old landfill in Japan during a 13-month investigation. We employed excitation-emission matrix (EEM) fluorescence spectroscopy with parallel factor analysis (PARAFAC) to deconvolute the FDOM complex mixture into three fluorophores: microbial humic-like (C1), terrestrial humic-like (C2), and tryptophan-like fluorophores (C3). These FDOM components were compared with findings from other studies of leachate in landfills with different waste compositions. The correlations among EEM-PARAFAC components, dissolved organic carbon (DOC) concentration, and ultraviolet-visible and fluorescence indices were evaluated. The FDOM in leachate varied spatially among old and extended leachate collected in the landfill and leachate treatment facility. The FDOM changed temporally and decreased markedly in August 2019, November 2019, and April 2020. The strong positive correlation between HIX and %C2 (r = 0.87, ρ = 0.91, p < 0.001)) implies that HIX may indicate the relative contribution of terrestrial humic-like components in landfill leachate. The Fmax of C1, C2, and C3 and the DOC concentration showed strong correlations among each other (r > 0.72, ρ > 0.78, p < 0.001) and positive correlations with leachate level (r > 0.41, p < 0.001), suggesting the importance of hydrological effects and leachate pump operation on FDOM.
Topics: Water Pollutants, Chemical; Waste Disposal Facilities; Spectrometry, Fluorescence; Incineration; Japan; Humic Substances; Fluorescence; Environmental Monitoring
PubMed: 38924014
DOI: 10.1371/journal.pone.0304188 -
PloS One 2024Myopia, characterized by excessive axial elongation of the eyeball, increases risks of having sight-threatening diseases and impose a financial burden to healthcare... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Myopia, characterized by excessive axial elongation of the eyeball, increases risks of having sight-threatening diseases and impose a financial burden to healthcare system. Although myopic control interventions showed their effectiveness in slowing progression, the efficacy varies between individuals and does not completely halt progression. The study aims to investigate the efficacy of combining 0.01% atropine administered twice daily with optical defocus for myopia control in schoolchildren.
METHODS AND DESIGN
This is a prospective, parallel-group, single-blinded, randomized, active-control trial (ClinicalTrials.gov identifier: NCT06358755). Myopic schoolchildren with no previous myopic control interventions aged between 7 to 12 years will be recruited. They will be randomly allocated into two groups (n = 56 per group) after baseline measurement. Both groups will receive 0.01% atropine twice per day for 18 months (one drop in the morning and the other drop at night before bedtime). Defocus incorporated multiple segments (DIMS) spectacle lenses will be prescribed in atropine plus optical defocus (ATD) treatment group while single vision spectacle lenses will be given in atropine only (AT) group. Cycloplegic refraction and axial lengths will be monitored every 6 months over 18-month study period. The primary outcomes are changes in cycloplegic refraction and axial lengths relative to the baseline over the study period.
DISCUSSION
The result will examine the combination effect of low dose atropine and myopic defocus on myopia control in a randomized controlled study. The findings will also explore the potential benefits of applying 0.01% atropine twice per day on myopic control and its potential side effects.
Topics: Humans; Atropine; Myopia; Child; Prospective Studies; Male; Female; Refraction, Ocular; Eyeglasses; Single-Blind Method; Ophthalmic Solutions; Mydriatics; Treatment Outcome
PubMed: 38923965
DOI: 10.1371/journal.pone.0306050 -
Cancer Medicine Jun 2024Neurosurgery is considered the mainstay of treatment for pediatric low-grade glioma (LGG); the extent of resection determines subsequent stratification in current...
INTRODUCTION
Neurosurgery is considered the mainstay of treatment for pediatric low-grade glioma (LGG); the extent of resection determines subsequent stratification in current treatment protocols. Yet, surgical radicality must be balanced against the risks of complications that may affect long-term quality of life. We investigated whether this consideration impacted surgical resection patterns over time for patients of the German LGG studies.
PATIENTS AND METHODS
Four thousand two hundred and seventy pediatric patients from three successive LGG studies (median age at diagnosis 7.6 years, neurofibromatosis (NF1) 14.7%) were grouped into 5 consecutive time intervals (TI1-5) for date of diagnosis and analyzed for timing and extent of first surgery with respect to tumor site, histology, NF1-status, sex, and age.
RESULTS
The fraction of radiological LGG diagnoses increased over time (TI1 12.6%; TI5 21.7%), while the extent of the first neurosurgical intervention (3440/4270) showed a reduced fraction of complete/subtotal and an increase of partial resections from TI1 to TI5. Binary logistic regression analysis for the first intervention within the first year following diagnosis confirmed the temporal trends (p < 0.001) and the link with tumor site for each extent of resection (p < 0.001). Higher age is related to more complete resections in the cerebellum and cerebral hemispheres.
CONCLUSIONS
The declining extent of surgical resections over time was unrelated to patient characteristics. It paralleled the evolution of comprehensive treatment algorithms; thus, it may reflect alignment of surgical practice to recommendations in respect to age, tumor site, and NF1-status integrated as such into current treatment guidelines. Further investigations are needed to understand how planning, performance, or tumor characteristics impact achieving surgical goals.
Topics: Humans; Child; Glioma; Female; Male; Neurosurgical Procedures; Germany; Brain Neoplasms; Adolescent; Child, Preschool; Infant; Neoplasm Grading
PubMed: 38923198
DOI: 10.1002/cam4.7417 -
Journal of Vector Borne Diseases Apr 2024The range of Aedes albopictus, the most important vector mosquito in Western Eurasia is growing due to climate change. However, it is not known how it will influence the...
BACKGROUND OBJECTIVES
The range of Aedes albopictus, the most important vector mosquito in Western Eurasia is growing due to climate change. However, it is not known how it will influence the habitats occupied by the species and its environmental fitness within its future range.
METHODS
To study this question, the habitat characteristic of the mosquito was investigated for 2081-2100.
RESULTS
The models suggest a notable future spread of the mosquito in the direction of Northern Europe and the parallel northward and westward shift of the southern and eastern potential occurrences of the mosquito. The models suggest a notable increase in generation numbers in the warmest quarter, which can reach 4-5 generations in the peri-Mediterranean region. However, both the joint survival rate of larvae and pupae and the number of survival days of adults in the warmest quarter exhibit decreasing values, as does the potential disappearance of the mosquito in the southern regions of Europe and Asia Minor, along with the growing atmospheric CO2 concentration-based scenarios.
INTERPRETATION CONCLUSION
While in 1970-2000 Aedes albopictus mainly occupied the hot and warm summer temperate regions of Europe, the species will inhabit dominantly the cool summer temperate (oceanic) and the humid continental climate territories of North and North-Eastern Europe in 2081-2100.
Topics: Aedes; Animals; Ecosystem; Europe; Climate Change; Asia; Mosquito Vectors; Larva; Pupa; Seasons
PubMed: 38922659
DOI: 10.4103/jvbd.jvbd_143_23 -
Online Journal of Public Health... Jun 2024The World Health Organization has recommended digital adherence tools (DATs) as a promising intervention to improve antituberculosis drug adherence. However, the...
BACKGROUND
The World Health Organization has recommended digital adherence tools (DATs) as a promising intervention to improve antituberculosis drug adherence. However, the acceptability of DATs in resource-limited settings is not adequately studied.
OBJECTIVE
We investigated the acceptability of a DAT among patients with tuberculosis (TB) and TB care providers in Kilimanjaro, Tanzania.
METHODS
We conducted a convergent parallel mixed methods study among patients with TB and TB care providers participating in our 2-arm cluster randomized trial (REMIND-TB). The trial aimed to investigate whether the evriMED pillbox with reminder cues and adherence feedback effectively improves adherence to anti-TB treatment among patients with TB in Kilimanjaro, Tanzania. We conducted exit and in-depth interviews among patients as well as in-depth interviews among TB care providers in the intervention arm. We conducted a descriptive analysis of the quantitative data from exit interviews. Translated transcripts and memos were organized using NVivo software. We employed inductive and deductive thematic framework analysis, guided by Sekhon's theoretical framework of acceptability.
RESULTS
Out of the 245 patients who completed treatment, 100 (40.8%) were interviewed during exit interviews, and 18 patients and 15 TB care providers were interviewed in-depth. Our findings showed that the DAT was highly accepted: 83% (83/100) expressed satisfaction, 98% (98/100) reported positive experiences with DAT use, 78% (78/100) understood how the intervention works, and 92% (92/100) successfully used the pillbox. Good perceived effectiveness was reported by 84% (84/100) of the participants who noticed improved adherence, and many preferred continuing receiving reminders through SMS text messages, indicating high levels of self-efficacy. Ethical concerns were minimal, as 85 (85%) participants did not worry about remote monitoring. However, some participants felt burdened using DATs; 9 (9%) faced difficulties keeping the device at home, 12 (12%) were not pleased with receiving daily reminder SMS text messages, and 30 (30%) reported challenges related to mobile network connectivity issues. TB care providers accepted the intervention due to its perceived impact on treatment outcomes and behavior change in adherence counseling, and they demonstrated high level of intervention coherence.
CONCLUSIONS
DATs are highly acceptable in Tanzania. However, some barriers such as TB-related stigma and mobile network connectivity issues may limit acceptance.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1186/s13063-019-3483-4.
PubMed: 38922643
DOI: 10.2196/51662 -
Brazilian Dental Journal 2024The aim of this clinical, prospective, randomized, and parallel study was to evaluate different in-office treatments for dentin hypersensitivity (DH). One hundred... (Randomized Controlled Trial)
Randomized Controlled Trial
The aim of this clinical, prospective, randomized, and parallel study was to evaluate different in-office treatments for dentin hypersensitivity (DH). One hundred ninety-two teeth with non-cavitated root exposures were treated using different desensitizers: fluoride varnish (Duraphat - FLU); bioactive ceramic solution (Biosilicate - BIOS); universal self-etching adhesive (Single Bond Universal - SBU); bioactive photoactivated varnish (PRG filler - SPRG). The degree of DH was analyzed using a visual analog scale (VAS) and computerized visual scale (CoVAS), before treatments and after 7, 15, and 30 days from the first session. Comparisons among desensitizers were performed using the Kruskal-Wallis and Dunn's tests. Friedman test was used to compare between times (p ≤ 0.05). Comparing desensitizers FLU presented a higher value of DH than BIOS using VAS at 7 days, however, no differences were found using CoVAS analysis. Comparing times, BIOS and SBU showed a reduction in DH after 7 days and SBU showed a reduction at 30 days compared to 7 days using VAS. FLU and SPRG groups reduced DH from 15 days to 30 days using VAS. There was a reduction in DH for FLU, BIOS, and SBU after 7 days and for BIOS this reduction also occurred at 30 days when compared to 15 days using CoVAS. SPRG group showed a reduction from 15 to 30 days. All desensitizers tested were able to reduce the initial sensitivity. The bioactive ceramic solution reduced the DH gradually after 30 days using computerized analysis.
Topics: Humans; Dentin Sensitivity; Dentin Desensitizing Agents; Male; Female; Prospective Studies; Adult; Treatment Outcome; Middle Aged; Fluorides, Topical
PubMed: 38922247
DOI: 10.1590/0103-6440202405487 -
Revista Gaucha de Enfermagem 2024To analyze the effectiveness of Bach flower therapy compared to placebo in reducing perceived stress levels in primary health care nursing professionals. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To analyze the effectiveness of Bach flower therapy compared to placebo in reducing perceived stress levels in primary health care nursing professionals.
METHOD
Pragmatic, parallel randomized clinical trial conducted with 87 primary care nursing professionals with self-identified stress, from October 2021 to June 2022, in the cities of Osasco and São Paulo, Brazil. The intervention group (n=43) received the collective flower formula, and the placebo group (n=44) received only the diluent. Data analysis was performed using the linear mixed model, and effect size was measured by partial Eta squared, significance level 5%.
RESULTS
Data analysis showed a significant reduction in perceived stress levels within groups (p=0.038). However, there was no significant difference between the study groups (p=0.750). Participants in the intervention group reported a greater perception of changes than participants in the placebo group, but without statistical significance (p=0,089).
CONCLUSION
The floral formula was not more effective than the placebo formula in reducing perceived stress. There was a significant stress reduction among nursing professionals in both study groups, although with a small effect size.
Topics: Humans; Female; Male; Adult; Flowers; Primary Care Nursing; Middle Aged; Occupational Stress; Phytotherapy; Stress, Psychological; Brazil
PubMed: 38922232
DOI: 10.1590/1983-1447.2024.20230132.en -
Veterinary Sciences Jun 2024Raw milk and dairy products can serve as potential vectors for transmissible bacterial, viral and protozoal diseases, alongside harboring antimicrobial-resistance genes....
Raw milk and dairy products can serve as potential vectors for transmissible bacterial, viral and protozoal diseases, alongside harboring antimicrobial-resistance genes. This study monitors the changes in the antimicrobial-resistance gene pool in raw milk and cheese, from farm to consumer, utilizing next-generation sequencing. Five parallel sampling runs were conducted to assess the resistance gene pool, as well as phage or plasmid carriage and potential mobility. In terms of taxonomic composition, in raw milk the Firmicutes phylum made up 41%, while the Proteobacteria phylum accounted for 58%. In fresh cheese, this ratio shifted to 93% Firmicutes and 7% Proteobacteria. In matured cheese, the composition was 79% Firmicutes and 21% Proteobacteria. In total, 112 antimicrobial-resistance genes were identified. While a notable reduction in the resistance gene pool was observed in the freshly made raw cheese compared to the raw milk samples, a significant growth in the resistance gene pool occurred after one month of maturation, surpassing the initial gene frequency. Notably, the presence of extended-spectrum beta-lactamase (ESBL) genes, such as (100% coverage, 99.3% identity) and (97.1% coverage, 96.2% identity), raised concerns; these genes have a major public health relevance. In total, nineteen such genes belonging to nine gene families (, , , , , , , , ) have been identified. The largest number of resistance genes were identified against fluoroquinolone drugs, which determined efflux pumps predominantly. Our findings underscore the importance of monitoring gene pool variations throughout the product pathway and the potential for horizontal gene transfer in raw products. We advocate the adoption of a new approach to food safety investigations, incorporating next-generation sequencing techniques.
PubMed: 38922012
DOI: 10.3390/vetsci11060265