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Summary of adverse events (AEs) by safety analysis set.
diarrhoea, myalgia, fatigue, headache, arthralgia
ADVERSE EVENT
AE, adverse event.For AEs at the indicated severity with two numbers, n represents the number of participants per category/number of AEs as one participant experienced several cases of the same AE during the study.The most commonly reported reactions in the Ad5-nCoV group included increase in body temperature (20.2%), ...
PMC9994755
Injection site reactions
swelling, pain
INDURATION, INJECTION SITE REACTION, INJECTION SITE REACTIONS
Injection site reactions occurred in 106 participants (28.5%) who received the Ad5-nCoV vaccine. By comparison, only 2 participants in the Placebo group (1.6%) experienced an injection site reaction including swelling and pain or induration (
PMC9994755
Other adverse events (excluding immunisation reactions)
SAEs
EVENTS, INJECTION SITE REACTION
As listed in For most participants, AEs were mild, reported in 28.5% of the Ad5-nCoV group and 16.1% of the Placebo group. Moderate events were registered in 5.6% of participants who received the Ad5-nCoV vaccine and 4.0% who received the placebo. By comparison, SAEs occurred in 0.8% of participants in the Ad5-nCoV gro...
PMC9994755
Discussion
RBD, headache, pain
ADVERSE REACTIONS, SECONDARY, ADENOVIRUS
In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial including 500 adult participants aged 18–85 years (mean age: 41.2 years), the immunogenicity, efficacy and safety of the Ad5-nCoV COVID-19 vaccine was assessed up to 6 months after vaccination. Both study groups (Ad5-nCoV and Placebo) had ...
PMC9994755
Conclusions
infections
VIRUS, INFECTIONS
Analysis of data from this phase 3 trial demonstrated the immunogenicity and safety of this Ad5-vector based COVID-19 vaccine. More data are required to determine whether this vaccine reduces infections and transmission. Overall, this stable, single-dose vaccine could contribute to the global fight against the evolving...
PMC9994755
Supporting information
PMC9994755
CONSORT checklist.
(DOC)Click here for additional data file.
PMC9994755
Study protocol.
(DOCX)Click here for additional data file.
PMC9994755
Additional details of statistical analysis.
(DOCX)Click here for additional data file.
PMC9994755
Summary of geometric mean titres and seroconversion rates post-vaccination with Ad5-nCoV or placebo (full analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Systemic (general) post-vaccination reactions (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Systemic (general) post-vaccination reactions by severity (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Summary of all severe adverse events that led to hospitalisation or prolonged hospitalisation (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Local post-vaccination reactions (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Local post-vaccination reactions by severity (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Other adverse events unrelated to vaccination reactions (safety analysis set).
(DOCX)Click here for additional data file.
PMC9994755
Background
neck pain
The advancement of technology has contributed to a more sedentary lifestyle, and the extensive use of handheld devices among adolescents may potentially result in neck pain. This study aimed to assess the association between exposure to common technology devices and self-reported neck pain in Iranian school-age adolesc...
PMC10644474
Methods
pain
This cross-sectional study was conducted between June and October 2021, employing a randomized multi-stage cluster sampling approach. We enrolled 808 adolescent students aged 11 to 19 years old. We asked participants about any neck pain they experienced in the week leading up to the study. Additionally, we gathered dem...
PMC10644474
Results
neck pain
REGRESSION
Our study comprised 73.5% female participants with an average age of 15.1 ± 1.7 years and 26.5% male participants with an average age of 14.5 ± 1.5 years. In the regression model, the female gender (p = 0.038), using mobile for more than 6 h (p = 0.04), and using electronic devices while sitting on the floor (p = 0.02)...
PMC10644474
Conclusion
neck pain
In our study, we observed a relatively high prevalence of neck pain, which was linked to extended daily mobile phone usage and body posture during electronic device use. Policymakers may consider interventions aimed at reducing mobile phone usage and promoting proper body posture while using electronic devices as poten...
PMC10644474
Keywords
PMC10644474
Background
neck pain, Musculoskeletal pain
Musculoskeletal pain (MSKP) is a global health concern that affects individuals of all ages and genders, presenting with diverse manifestations [Information and Communication Technology (ICT) comprises a wide range of devices, including mobile phones, tablets, gaming consoles, televisions, computers, and laptops. [Stud...
PMC10644474
Method and materials
PMC10644474
Design
This cross-sectional study was conducted from June to October 2021. The ethics committee of Tehran University of Medical Sciences approved the study (ethics code: IR.TUMS.IKHC.REC.1400.320). The ethics committee waived the parental consent for this study as this was an observational study with no intervention.
PMC10644474
Participants & setting
We calculated the sample size using G*Power 3.1.9.7. Employing the Exact test family and a binomial statistical test, with a small effect size of 0.05, α = 0.05, and power = 0.8, we determined a sample size of 786 participants. To accommodate an anticipated dropout rate of 5%, we enrolled 808 individuals in our study [...
PMC10644474
Measurements
Our questionnaire evaluated three groups of variables, including basic and demographic variables, exposures, and outcomes.The demographic variables included age (years), gender (male or female), educational level (level one high school or level two high school), body mass index (BMI), and family structure (living with ...
PMC10644474
Statistical analysis
neck pain
REGRESSION
Mean and standard deviation (SD) were calculated for continuous variables. Number and percentage were calculated for categorical variables. We used the Fisher exact or Chi-square tests to compare the categorical variables across groups. We used a binary logistic regression model to determine the factors independently a...
PMC10644474
Results
neck pain
REGRESSION
Eight hundred-eight adolescents aged 11 to 19 were included in our study. Our sample included 73.5% female participants, with a mean age of 15.1 ± 1.7 years, and 26.5% male participants, with an average age of 14.5 ± 1.5 years. Among all participants, 95.2% lived with both parents, while 3.3% lived with their mother, 0...
PMC10644474
Discussion
neck pain, fatigue, pain
REGRESSION, MUSCULOSKELETAL DISORDERS
MSKPs often lack definitive treatments and may require prolonged therapeutic interventions, resulting in significant adverse consequences affecting healthcare demands, daily functional abilities, and adolescent social engagement [Among the devices we examined in our study, mobile phones emerged as the most commonly use...
PMC10644474
Limitations
neck pain
This study had a cross-sectional design, which is inappropriate for evaluating causal relationships between variables, and there is a need for future longitudinal studies to determine the risk factors of neck pain among Iranian adolescents. Furthermore, as this study was limited to Qazvin province, we may not generaliz...
PMC10644474
Conclusion
neck pain
The prevalence of neck pain was relatively high in our study and was associated with using mobile phones for more than six hours a day and the body position while using electronic devices. Considering that mobile phones are widely used electronic devices among adolescents, they could be a possible target for future int...
PMC10644474
Acknowledgements
N/A.
PMC10644474
Authors’ contributions
MA designed the study. SR and AY collected the data. MA supervised the study. AB analyzed the data. AH, MS, and ANA wrote the initial draft of the manuscript. All authors read and approved the final manuscript.
PMC10644474
Funding
This study was not funded.
PMC10644474
Data Availability
The datasets generated and/or analysed during the current study are not publicly available to keep the confidentiality of data and privacy of participants, but are available from the corresponding author on reasonable request.
PMC10644474
Declarations
PMC10644474
Ethics approval and consent to participate
We declare that all methods were performed in accordance with the relevant guidelines and regulations.The ethics committee of Tehran University of Medical Sciences approved the study (ethics code: IR.TUMS.IKHC.REC.1400.320). Also, participants provided informed consent prior to their participation in the study.
PMC10644474
Consent for publication
N/A.
PMC10644474
Competing interests
The authors declare no competing interests.
PMC10644474
References
PMC10644474
2. Materials and Methods
PMC10744600
2.1. Trial Design and Participants
dentine lesions, Caries, caries
DENTAL CARIES, SYSTEMIC DISEASE, CARIES, CARIES, MOTOR DISORDERS
This study was designed as a double-blind three-parallel-group randomized controlled trial, in which the subject, operator, and evaluator were masked to the group assignment. It was accepted by the Comisión de Ética, Facultad de Odontología, Universidad de Buenos Aires No. FOUBA 29/05/2013-52.A sample size calculation ...
PMC10744600
2.2. Intervention
calculus, Caries lesions, caries, primary dentition
CARIES
As described above, the children were randomly divided into three different groups according to the mode of treatment:NaF varnish group (NaFV) APF in tray group (APFt) APF in toothbrush group (APFtbru) Three-row children’s brushes with soft, rounded nylon bristles, a compact head and a straight handle were used for all...
PMC10744600
2.3. Dental Examination and Monitoring
caries lesions
Observations and clinical examinations were conducted at schools. After 12 and 24 months, the clinical examination was repeated to assess the dental status of schoolchildren following the same criteria described. The presence of new caries lesions was taken as a dependent variable. So, sound surfaces on baseline were o...
PMC10744600
2.4. Statistical Analysis
caries’
All the data were input into a spreadsheet (Microsoft Excel 2021 for Mac, version 16.4.8). A chi-square test was performed for CTNI changes between experimental groups and follow-up examinations; moreover, tests for trends across ordered experimental groups were tested using the Cuzick’s test trends.Cox Proportional Ha...
PMC10744600
3. Results
caries lesions, caries
CARIES
Overall, 16,719 dental surfaces from 180 kids were included in this study. The CONSORT flow-chart is displayed in The calibration procedure was successfully performed. The level of agreement overall ranged from 90.44% for caries lesions at enamel level (ICDAS 2) to 94.50% for caries lesions at deep dentinal level (ICDA...
PMC10744600
4. Discussion
caries
DENTAL CARIES, CARIES
In this study, the use of an alternative application technique for the application of (APF) has been shown to be effective in maintaining healthy surfaces over 24 months.Different caries preventive program strategies were carried out in many countries to decrease caries prevalence and incidence [Fluoride varnishes stan...
PMC10744600
Author Contributions
Conceptualization, A.L.S., A.F.S. and G.K.; methodology and data collection, A.L.S., S.F. and R.L.; formal analysis, P.S. and G.C.; investigation, A.L.S., S.F., R.L. and A.F.S.; resources, A.F.S.; data curation, A.L.S.; writing—original draft preparation, A.L.S. and G.C.; writing—review and editing, A.F.S. and G.C.; su...
PMC10744600
Institutional Review Board Statement
The study protocol was approved by the Research Ethics Committee of the University of Buenos Aires, UBACYT 20020120100324BA (13 December 2016) and registered at
PMC10744600
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10744600
Data Availability Statement
The data presented in this study are available on request from the corresponding author.
PMC10744600
Conflicts of Interest
The authors declare no conflict of interest.
PMC10744600
Background
mucocutaneous, OLP
ORAL LICHEN PLANUS, ADVERSE EFFECT
Oral lichen planus (OLP) is a chronic mucocutaneous immunologically mediated condition that has a great adverse effect on oral functions. Corticosteroids are still the first drugs of choice used in the treatment of OLP; however, they have extensive medical side effects. The present study was carried out to assess the c...
PMC10360223
Subjects and methods
pain
We performed a randomized, double blinded controlled trial at the Faculty of Dentistry, Cairo University, Egypt. The study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups: intervention group (I),who received topical CoQ10 in the form of mucoadhesive tablets (4...
PMC10360223
Results
pain
Both groups showed a significant reduction in pain and the size of the lesions (
PMC10360223
Conclusions
The topical use of CoQ10 mucoadhesive tablets was as effective as the topical use of triamcinolone acetonide, and its clinical effect was associated with a reduction in the salivary level of MDA.
PMC10360223
Trial registration
The study protocol was registered at
PMC10360223
Keywords
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC10360223
Introduction
immune-mediated disease of the oral mucosa, tumor necrosis, OLLs, TNF-α, GVHD, OLP
TUMOR NECROSIS, GRAFT VERSUS HOST DISEASE, ORAL LICHEN PLANUS, LYMPHOCYTIC INFILTRATION, GVHD
Oral lichen planus (OLP) is a relatively common chronic mucocutaneous inflammatory immune-mediated disease of the oral mucosa [On the other hand, oral lichenoid lesions (OLLs) are a term used to identify conditions that are clinically and histopathologically similar to OLP but with identifiable, either local or systemi...
PMC10360223
Subjects and methods
PMC10360223
Study design
The present study is a randomized controlled clinical trial (two parallel groups) with an allocation ratio of 1:1. The number of patients was equal in each group. The study was conducted following the principles of the Helsinki Declaration and was approved by the Research Ethics Committee of the Faculty of Dentistry, C...
PMC10360223
Study participants
The patients were recruited from the Diagnostic Center, as well as the Clinics of the Oral Medicine and Periodontology Department, at the Faculty of Dentistry, Cairo University, during the period from September 2019 to February 2022. According to specific inclusion and exclusion criteria
PMC10360223
Inclusion criteria
OLP
SYSTEMIC DISEASE
Patients were more than 18 years old.Patients were free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index [Patients clinically diagnosed by a dermatologist and oral medicine specialist as suffering from OLP.Patients who agreed to the biopsy in undiagnosed casesClin...
PMC10360223
Exclusion criteria
LICHENOID REACTION
Patients taking systemic drugs such as systemic steroids, or other immunosuppressive therapies for at least 8 weeks prior to the study.Patients treated with any oral topical medications for at least four weeks prior to the study.Patients receiving any medication either topical or systemic that could cause lichenoid re...
PMC10360223
Study interventions
The present study was conducted on 34 patients suffering from symptomatic OLP. Patients were randomly divided into two groups and received both treatments in the form of opaque sealed jars (Jar A) for adhesive tablets (Fig. Opaque sealed jar containing mucoadhesive CoQ10 tablets
PMC10360223
Group I (intervention group)
Seventeen participants received topical coenzyme Q10 (ubiquinol) in the form of mucoadhesive tablets, (Fig. 
PMC10360223
CoQ10 mucoadhesive tablet preparation
The tablets were prepared using 120 mg coQ10 powder (in reduced form which is the antioxidant form) [Mucoadhesive CoQ10 tablets
PMC10360223
Group II (control group)
Seventeen participants received topical corticosteroid (kenacorte in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste – dermapharm), (Fig. Opaque sealed jar containing triamcinolone acetonide paste
PMC10360223
Study outcomes
erosion, Pain, pain
CAVITY, EROSION, ATROPHIC
Primary outcome1.1. Pain measurement using the Visual Analogue Scale: according to Maxwell [All patients were asked to define their level of pain and discomfort by using a numerical rating from 0 to 10 (11-points), with 0 indicating "no pain", 1 to 3 indicating mild pain, 4 to 6 indicating moderate pain, 7 to 9 indica...
PMC10360223
Saliva sample collection
Whole unstimulated saliva (WUS) was collected between 8 am to 1 pm using standard techniques according to Navazesh [
PMC10360223
Determination of human malondialdehyde (MDA) in saliva using an ELISA kit (prepared by Prof. OS)
Saliva samples were centrifuged for 10 min at 4000 xg. The supernatant was separated and used for determination of MDA levels using ELISA Kit Cat No. MBS263626 provided by My BioSource (USA, NY). This kit employs the “Double Antibody Sandwich” technique. The principle of double antibody sandwich is based on the charact...
PMC10360223
Sample size calculation
Thomas
An interventional study by Thomas et al. [
PMC10360223
Randomization and allocation concealment
Simple randomization was generated using
PMC10360223
Masking/blinding
Neither the statistician nor clinical outcome assessor (associate prof. AH) were aware of which medication was being administered, thus yielding a double-blind controlled study.
PMC10360223
Data collection and statistical analysis
All data collected from patients using clinical parameters were recorded electronically for statistical analysis. Categorical data are presented as frequencies (n), and percentages (%), and the chi square test was used for the analysis. Quantitative data were explored for normality using Kolmogorov–Smirnov and Shapiro–...
PMC10360223
Results
thirty-four, OLP
ADVERSE EFFECTS, SYSTEMIC DISEASE, RECRUITMENT
During the recruitment phase, 36 patients were assessed for eligibility from September 2019 to February 2022. Two patients did not meet the inclusion criteria due to their chronic systemic diseases. Only thirty-four participants were eligible for inclusion. All patients gave written informed consent and were randomly a...
PMC10360223
Discussion
pain, OLP
ADHESION, ADVERSE DRUG EFFECTS, OXIDATIVE STRESS
The chronic nature of OLP, prolonged course of treatment, and frequent exacerbation of the condition increase the incidence of steroid side effects [In addition to the antioxidant and anti-inflammatory effects of CoQ10, its topical use in the form of mucoadhesive tablets in the present study has many advantages includi...
PMC10360223
Conclusions
pain
OXIDATIVE STRESS
Topical application of mucoadhesive CoQ10 tablets on symptomatic OLP lesions leads to significant pain relief and clinical improvement of the condition in addition to decreasing the salivary levels of one of the markers of oxidative stress (MDA).CoQ10 in a mucoadhesive formula is as effective as the standard treatment...
PMC10360223
Recommendations
OLP
REMISSION
Studies with larger sample sizes are needed to conclude the effective role of CoQ10 in the management of symptomatic OLP.Different concentrations of CoQ10 need to be used to reach the optimum dose required to achieve optimum management of OLP with no side effects.The period between lesion remission and exacerbation fo...
PMC10360223
Acknowledgements
The authors of the study would like to express the greatest thanks to all the staff members of the Oral Medicine Department, Faculty of Dentistry, and Cairo University for their cooperation, kind feelings and for sparing no effort in helping us, as well as many thanks to Mepaco_Arab Co. For Pharmaceuticals and Medicine...
PMC10360223
Authors’ contributions
A.H.
M.A. responsible for the funding and undergoing the clinical and theoretical work of the trial, collecting data, clarification, conclusions and drafting the manuscript. F.Z. responsible for patients’ randomization, providing guidance through the clinical work, revising the theoretical part and help with the conclusions...
PMC10360223
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). Self-funded.
PMC10360223
Availability of data and materials
The datasets used and/or analyzed during the current study are not publicly available due [for better patient data confidentiality] but are available from the corresponding author on reasonable request.
PMC10360223
Declarations
PMC10360223
Ethics approval and consent to participate
The study was conducted following the principles of the Helsinki Declaration and was approved by the Research Ethics Committee of the Faculty of Dentistry, Cairo University (code: 19923). All patients were informed about the nature and objectives of the study. All participants read, approved, and signed a written infor...
PMC10360223
Consent for publication
Not applicable.
PMC10360223
Competing interests
The authors declare no competing interests.
PMC10360223
References
PMC10360223
Background
Social media has emerged as an effective tool to mitigate preventable and costly health issues with social network interventions (SNIs), but a precision public health approach is still lacking to improve health equity and account for population disparities.
PMC10267788
Objective
This study aimed to (1) develop an SNI framework for precision public health using control systems engineering to improve the delivery of digital educational interventions for health behavior change and (2) validate the SNI framework to increase organ donation awareness in California, taking into account underlying pop...
PMC10267788
Methods
PID
This study developed and tested an SNI framework that uses publicly available data at the ZIP Code Tabulation Area (ZCTA) level to uncover demographic environments using clustering analysis, which is then used to guide digital health interventions using the Meta business platform. The SNI delivered 5 tailored organ don...
PMC10267788
Results
Four main clusters with distinctive sociodemographic characteristics were identified for the state of California. The ACT mechanism significantly increased the overall click rate per 1000 impressions (β=.2187;
PMC10267788
Conclusions
The proposed SNI framework, with its ACT mechanism, learns and delivers, in real time, for each distinct subpopulation, the most tailored educational content and establishes a new standard for precision public health to design novel health interventions with the use of social media, automation, and machine learning in ...
PMC10267788
Trial Registration
ClinicalTrials.gov NTC04850287; https://clinicaltrials.gov/ct2/show/NCT04850287
PMC10267788
Introduction
PID
Health care expenditures, especially in the United States, continue to rise [Social network interventions (SNIs) enable the development of large-scale and tailored educational interventions but also need to account for population disparities. SNIs have been increasingly adopted for health behavior change [The design of...
PMC10267788
Methods
PMC10267788
Overview
The SNI framework is a precision digital education approach developed to enable, test, and improve large-scale and equitable access to health literacy by automating four components: (1) population stratification into demographic environments, (2) cluster-randomized assignment, (3) personalized digital content delivery,...
PMC10267788
Study Design, Study Setting, and Participants
This was a 3-month, prospective, cluster randomized trial (CRT) to evaluate the engagement performance of optimal and nonoptimal SNIs on health educational content delivered as ads using Meta’s Business Platform (Facebook) [The study setting was the Meta Business Platform [
PMC10267788
Study Outcome
The main study outcome was the number of link clicks per 1000 impressions (C/I) on the health educational content, which is a measure of social media engagement retrieved from Facebook and used as a surrogate marker of awareness [
PMC10267788
Study Variables
The study variables were the use of ACT mechanism optimization (optimal and nonoptimal) and the type of demographic environment (4 uncovered clusters). The ACT mechanism was applied to the optimal group, and the demographic environments are defined at the ZCTA level.
PMC10267788