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Introduction
reduced psychological distress, depression, meaningfulness, ’
DISORDERS
Health-promoting lifestyle is a multidimensional model of perceptions and activities that begin with personal motivation and help to improve and promote health and self-care [The culture that dominates the society is one of the factors that can affect people's behavior and lifestyle [Lifestyle and HPL usually develop d...
PMC10198750
Methods
PMC10198750
Design
This single-blind randomized clinical trial was conducted in Iran.
PMC10198750
Participants and setting
DISEASES, DISORDERS
Study setting was the support organization for vulnerable individuals in Tehran, Iran, and study population consisted of all single-parent adolescent girls who referred to the study setting. Participants were 88 girls who were willing to participate in the study and met the following eligibility criteria: age 13–18 yea...
PMC10198750
Instruments
disability or problems such as parent loss
Data were collected using a demographic questionnaire and the Adolescent Health Promotion Short-Form. The demographic questionnaire had ten items on age, educational year, weight, height, family size, birth rank, parent (father or mother), adequacy of monthly family income, and parent’s educational level and occupation...
PMC10198750
Data analysis
Data were analyzed using the SPSS software (v. 26.0). Pretest and posttest data were described using the measures of descriptive statistics (namely mean, median, standard deviation, and interquartile range) and analyzed using the independent-sample
PMC10198750
Discussion
anxiety, HPL behaviors, frustration, nutritional behaviors, depression, Logotherapy
SAID
The aim of this study was to investigate the effects of VL on HPL among single-parent adolescent girls during the COVID-19 pandemic. Findings showed that VL significantly improved HPL among these girls. This is in agreement with the findings of previous studies [The findings of the present study revealed that VL had si...
PMC10198750
Limitations
Although participants were randomly allocated to the study groups, there were between-groups differences respecting some of the demographic characteristics of participants. Moreover, the non-normal distribution of some study variables necessitated the use of non-parametric methods for data analysis.In addition, the ina...
PMC10198750
Conclusion
DISEASES
VL is effective in significantly improving all aspects of HPL, namely nutrition, physical activity, life appreciation, social support, health responsibility, and stress management among single-parent adolescent girls. Therefore, healthcare authorities are recommended to use VL to promote health and prevent illnesses am...
PMC10198750
Acknowledgements
This study was a master’s thesis approved by the Tehran University of Medical Sciences, Tehran, Iran. We would like to thank the Research Administration of this university and the authorities of comprehensive healthcare centers in the south of Tehran, Iran.
PMC10198750
Authors’ contributions
FH, AS and ShP: design of study and acquisition of data; FH, ShP and RN: drafting the manuscript. RN: data analysis; All authors assisted in revising the text and approved the final manuscript.
PMC10198750
Funding
This study was funded and supported by Tehran University of Medical Sciences (TUMS).
PMC10198750
Availability of data and materials
The datasets generated and/or analysed during the current study are not publicly available due [We do not have consent from all patients to publish this data] but are available from the corresponding author on reasonable request.
PMC10198750
Declarations
PMC10198750
Ethics approval and consent to participate
Ethical considerationsThis research was performed in accordance with the Declaration of Helsinki. This study has the approval of the ethics committee of Tehran University of Medical Sciences (code: IR.TUMS.FNM.REC.1398.181), and was registered in the Thailand Clinical Trials Registry (code: TCTR20200517001). We provide...
PMC10198750
Consent for publication
Not applicable.
PMC10198750
Competing interests
The authors declare no competing interests.
PMC10198750
References
PMC10198750
Objective
To determine whether the blood lipidomic response to supplementation with two rTG supplements, varying by degree of re-esterification, would differ between treatments.
PMC9882700
Design
®
This was a double-blind, parallel-design, single-center, 128-day study with sixty young, healthy subjects randomized into two groups. One group received a >95% rTG (Ultimate Omega®), as 1,000 mg capsules containing 325 mg eicosapentaenoic acid (EPA) and 225 mg docosahexaenoic acid (DHA), and the other received a <70% r...
PMC9882700
Results
For erythrocyte PLFA profiles, EPA, docosapentaenoic acid (DPA) and DHA percentage of total erythrocyte PLFA were significantly greater for the Ultimate Omega® group than for the MEG-3 group, at week 16 (
PMC9882700
Conclusions
These data suggest that the percentage of rTG in rTG fish oil preparations may evolve as a new chemoprofile/quality control marker that can influence its lipidomic pharmacodynamics. Additional investigations to assess the physiologic/vascular and metabolic/inflammasome responses to concentrated fish oil preparations di...
PMC9882700
Data Availability
All relevant data are within the paper and its
PMC9882700
Introduction
hypertriglyceridemia, TG
HYPERTRIGLYCERIDEMIA
The use of supplements with high concentrations of omega-3 polyunsaturated fatty acids (N3PUFA) has become increasingly popular, delivering greater than 90% N3PUFA, most commonly as free fatty acids (FFA), ethyl esters (EE), or re-esterified triglycerides (rTG). The re-esterification process involves the transfer of N3...
PMC9882700
Subjects and methods
PMC9882700
Study design
RECRUITMENT
This study was a randomized, double-blind, parallel-design, single-center study conducted in accordance with local regulations, the International Conference on Harmonization E6 Guideline for Good Clinical Practice (GCP), and the Declaration of Helsinki. The study was sponsored by Nordic Naturals (Watsonville, CA) and c...
PMC9882700
Fish oil products
UO bulk oil was manufactured and provided by Nordic Naturals; M3 bulk oil was manufactured by and purchased directly from DSM (Dartmouth, Nova Scotia, Canada) by a soft-gel dosage form manufacturer (Select Supplements, Carlsbad, California, USA). Percent TGs (%TGs) in the bulk oils were initially evaluated by each supp...
PMC9882700
Subjects
The study enrolled healthy, non-smoking, normolipidemic adults, aged 18–35 years, with a body mass index (BMI) of 18.5 through 24.9 kg per mThe following were the main exclusion criteria for this study: BMI ≥ 25 kg/m
PMC9882700
Randomization and blinding
The subjects were randomly assigned 1:1 to either the UO or M3 group. The principal investigator, co-investigators, study personnel, and study participants were blinded to the treatment through the completion of the study. Blinding was maintained by labeling both products in a similar manner, differentiated only by the...
PMC9882700
Study interventions
UO was provided as 1,000 mg soft-gel capsules (Batch 141179), each containing 325 mg EPA and 225 mg DHA, along with 90 mg of other FA, in a 90% re-esterified TG form. M3 was provided as 1,000 mg soft-gel capsules (Batch153143), each containing 300 mg EPA and 200 mg DHA, along with 90 mg of other FA in a 70% re-esterifi...
PMC9882700
Outcome measurements
TG, Diteba
ADVERSE EVENTS, SECONDARY
The primary outcome measures were the intergroup comparisons of the ERC phospholipid fatty acid (PLFA) profiles at week 16 and the serum PLFA profiles at week 4. The secondary outcome measures were the comparisons of the ERC PLFA profiles at weeks 12 and 24, and blood lipids (i.e. TG, total cholesterol [TC], low-densit...
PMC9882700
Sample size estimation
Based on many previous omega-3 studies by the CRO, it was estimated that twenty-four (24) subjects per group would be required for acceptable statistical analysis. With an expected attrition rate of twenty-five (25) %, 30 subjects per group were required for enrollment. However, a formal sample size or power calculatio...
PMC9882700
Statistical analyses
All calculations and statistical analyses were performed using SAS® (version 9.2 or later; SAS Institute, Cary, NC). Numerical efficacy endpoints were tested for significance by analysis of covariance (ANCOVA). The dependent variable was the post-baseline variable; the factor of interest was the UO group, and the value...
PMC9882700
Results
The Consolidated Standards for Reporting of Trials (CONSORT) flow diagram shows the progress of the study subjects in
PMC9882700
Adverse events suspected of being related to a product, by group.
PMC9882700
Discussion
A variety of N3PUFA preparations are marketed internationally, varying in biomass source, e.g. fish liver or body oil, krill, or microalgal extracts and concentrates. Among FBO N3PUFA dosage forms displaying high percentages of EPA and DHA, the process of enrichment and concentration often employs transesterification a...
PMC9882700
Conclusion
We observed greater increases in EPA- and DHA-containing lipidomic species after 1 and 4 months of supplementation from a higher % rTG FO preparation (UO) containing a very similar amount of EPA and DHA, in young, normolipidemic subjects, in comparison to a lower %rTG FO preparation (Meg-3®). These data suggest that, l...
PMC9882700
Supporting information
PMC9882700
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.
PMC9882700
Certificate of analysis for Ultimate Omega®.
(PDF)Click here for additional data file.
PMC9882700
Certificate of analysis for Meg-3®.
(PDF)Click here for additional data file.
PMC9882700
Individual red blood cell fatty acid raw data.
(XLSX)Click here for additional data file.
PMC9882700
Individual serum fatty acid raw data.
(XLSX)Click here for additional data file.
PMC9882700
Protocol.
(PDF)Click here for additional data file.SM was the primary author, and the person responsible for final content.ALA was a co-author and reviewer of the manuscript.JLE was a co-author and reviewer of the manuscript.ML was a co-author and reviewer of the manuscript.JO was a reviewer and provided all essential materials ...
PMC9882700
References
PMC9882700
Subject terms
anxiety, pain
Many patients are frightened of or anxious about dental treatment. We have recently reported our use of virtual reality (VR) to alleviate the fear and anxiety experienced during oral surgical procedures However, the effectiveness of VR in alleviating anxiety varies greatly between individuals. We therefore investigated...
PMC10665549
Introduction
ADVERSE DRUG EVENTS, COMPLICATIONS
During oral surgery, patients are required to keep their mouths open for a certain period, and the metallic screech of the surgical drill and the unpleasant smell generated by the drilling of hard tissue such as teeth and bone all contribute to a high level of stressVR refers to the techniques and systems used to creat...
PMC10665549
Results
Anxiety, anxiety, pain
Table The results of the satisfaction questionnaire are illustrated in Table A comparison of the results of the decreased anxiety questionnaire between the natural landscape VR and video game VR groups showed high rates of decrease in both groups, with 80% of those in the natural landscape VR group and 84% of those in ...
PMC10665549
Discussion
heaviness, anxiety, pain
Many patients are frightened of or anxious about dental treatmentIn a previous study, we demonstrated that the use of VR decreased anxiety and fear of surgical treatment under local anesthesia both subjectively and objectivelyVR is currently in use in several medical fieldsOne point that warrants attention in the exper...
PMC10665549
Subjects and methods
PMC10665549
Subjects
vertigo
HEART DISEASE
The study population comprised patients who required impacted mandibular third molar extraction in the Department of Oral Surgery of Saga University Hospital between April 2020 and March 2021. For sample size calculation, we used G*Power software (ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany...
PMC10665549
Evaluation method
Anxiety, anxiety, pain
As a subjective evaluation, preoperative and postoperative fear and anxiety were evaluated by a questionnaire that included a visual analog scale (VAS). Anxiety was scored on a scale from “Completely relaxed” at 0 mm to “The most anxious state imaginable” at 100 mm. The post-treatment questionnaire asked patients to ev...
PMC10665549
Surgical technique
tooth
LOCAL INFILTRATION
After local infiltration anesthesia, the patients were placed in a supine position and were fitted with a patient monitor and a head-mounted display (Oculus Go 32 GB, Oculus VR, Menlo Park, CA). Before the impacted third molar extraction started, they experienced a VR presentation for a short period and were asked to c...
PMC10665549
VR presentations
All prototype VR software we used for this study was specially developed by the company PR NETWORK Co. (Fukuoka, Japan). The author (YY) owns the copyright of this software. The natural landscape presentation was the presentation used in our previous study. Specifically, the VR reproduced a large film screen either in ...
PMC10665549
Pain threshold measurement
pain
This experiment was conducted on 46 healthy volunteers (9 men and 37 women; mean age 27.0 years). They experienced the VR presentations while lying flat in the same position as the patients who underwent the surgical procedure. Their pain thresholds were measured using a PainVision PS-2100 (Nipro Corporation, Osaka, Ja...
PMC10665549
Analysis method
The data obtained were examined with respect to their variability and showed a normal distribution curve. A
PMC10665549
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-023-47764-8.
PMC10665549
Acknowledgements
The author kindly appreciates the precious work of PR NETWORK Co. (Fukuoka, Japan) for VR production.
PMC10665549
Author contributions
Y.Y. designed the study. All authors performed all surgical treatment. R.A. contributed to the statistical analysis. All the authors interpreted data. Y.Y. wrote the manuscript, all authors reviewed the manuscript.
PMC10665549
Data availability
All data generated or analysed during this study are included in this published article and its supplementary information files.
PMC10665549
Competing interests
The authors declare no competing interests.
PMC10665549
References
PMC10665549
Background
lenses, keratoconus
CORNEAL ECTASIA, DISEASE, LENS, KERATOCONUS
Transepithelial corneal crosslinking (CXL) is a novel surgical approach for the treatment of keratoconus, which is a bilateral asymmetrical ophthalmological disease accompanied by progressive corneal ectasia. Silicon hydrogel (SiH) contact lenses have been extensively used in clinical ophthalmologic medicine, as a post...
PMC10662168
Methods
blurred vision, dry, stinging, tearing, pain, corneal edema, conjunctival congestion, keratoconus, photophobia
CORNEAL EDEMA, KERATOCONUS
In this prospective study, 60 patients with keratoconus who underwent transepithelial CXL treatment were enrolled from September 2021 to January 2023 with a male:female ratio of 39:21, and an average age of 25.42 ± 5.47 years. The patients were divided randomly into two groups: group A contained 30 patients wearing sil...
PMC10662168
Results
COMPLICATIONS
Each surgical procedure was readily performed without complications, and both groups postoperative day 7 (
PMC10662168
Conclusions
postoperative ocular distress
Immediate use of silicone hydrogel corneal lenses after transepithelial CXL effectively alleviates postoperative ocular distress, particularly with a three-day use period as the ideal duration.
PMC10662168
Keywords
PMC10662168
Background
postoperative pain, astigmatism, Keratoconus, Corneal crosslinking, lens, keratoconus, photophobia
CORNEAL ECTASIA, DISEASE PROGRESSION, INFILTRATION, ASTIGMATISM, DISEASE, KERATOCONUS, CORNEA, LENS, KERATOCONUS
Keratoconus is a bilateral asymmetrical ophthalmological disease accompanied by progressive corneal ectasia. The major clinical characteristics are substantial thinning and bulging of the cornea, as well as astigmatism to various extents, resulting in a rapid reduction in visual acuity.The prevalence and incidence rate...
PMC10662168
Methods
PMC10662168
Study protocol
LENS, GROUP B
After a routine preoperative examination, each surgery was performed by the same experienced senior physician.The surgical procedure was the same as that used in our previous study [Once the surgical procedure was completed, both groups were immediately fixed with AcuVue Oasys SiH contact lenses (Johnson&Johnson, ACUVU...
PMC10662168
Postoperative observation
PMC10662168
Subjective symptoms of the operative eye
PMC10662168
Postoperative comfortability
blurred vision, tearing, edema, pain, photophobia
EDEMA
A standard self-administered questionnaire was adopted for both groups to record the postoperative comfort of the ocular area, which was administered on postoperative days 1, 3, 5, and 7. The questionnaire assessed 10 symptoms, including photophobia, tearing, burning, pain, foreign body sensation, blurred vision, diffi...
PMC10662168
Severity of postoperative ocular pain
postoperative ocular pain, pain
The visual analogue scale (VAS) is used to assess the severity of postoperative ocular pain. The VAS for pain is composed of a 10 cm straight line, which is marked with 0 at one end and 10 at the other. A score of 0 represents “no pain,” score 1–3 represents “mild pain,” which does not affect sleeping; score 4–6 is def...
PMC10662168
Objective signs of the operative eye
conjunctival congestion, corneal edema
EDEMATOUS, CORNEAL EDEMA, CORNEA, LENS
A single blinded test was applied for corneal edema assessment, where one senior ophthalmologist masked the allocation of the participant’s group while examining the ocular condition of each participant using slit-lamp microscopy. The resulting ocular status was recorded using a score range between 0–3. A higher score...
PMC10662168
Statistical analysis
The database was established in Excel using SPSS 20.0 statistical software. All the data were tested for homogeneity of variance and sphericity. Further, analysis of variance (ANOVA) and chi-square tests were used for comparison of preoperative basic condition in the two groups, and repeated measures analysis of varian...
PMC10662168
Results
LENS, COMPLICATIONS
All surgical procedures were performed smoothly without any complications. In total, 60 patients in groups A and B completed the entire period of lens wearing and observation.
PMC10662168
Adaptability of the Acuvue Oasys contact lens
lens detachment, lens
LENS, CORNEA
The center of the lens was well accommodated as it evenly covered the entire cornea. The degree of horizontal and vertical displacement of the lens center was within 1 mm, and the necessary mobility for lens in situ and upward gazing positions was sufficient, which were 0.61 ± 0.38 mm and 0.88 ± 0.12 mm, respectively. ...
PMC10662168
Patient ocular subjective symptom score
PMC10662168
Discussion
ocular pain, corneal dehydration, corneal crosslinking, pain, haze, lens, keratoconus, postoperative corneal edema, dry eye symptoms
INFILTRATION, EPITHELIALIZATION, ADVERSE EFFECTS, LENS, MEIBOMIAN GLAND DYSFUNCTION, KERATOCONUS, DRY EYES SYNDROME
Ensuring patient comfort and satisfaction is a top priority in healthcare systems. Application of bandage contact lens could effectively promote epithelialization and ease the postoperative symptoms after corneal crosslinking [Through rigorous observation, we discovered that it was feasible for patients to remove their...
PMC10662168
Acknowledgements
The funders had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation.
PMC10662168
Authors’ contributions
LL, JFW, XTZ, Study concept and design; LL, LJ, YLD, data collection; ZZ, JFW, data analysis and interpretation; LL, TF, drafting of the manuscript; XTZ, JFW, TH,critical revision of the manuscript; JFW, XTZ, supervision. All authors read and approved the final manuscript.
PMC10662168
Funding
Not pplicable.
PMC10662168
Availability of data and materials
The data used in this study are available from the corresponding author upon request.
PMC10662168
Declarations
PMC10662168
Ethics approval and consent to participate
EYE
This prospective randomized controlled study was approved by the ethics committee of the Eye and ENT Hospital affiliated with the Fudan Institutional Review Board (ethical code KJ2010-18). This study was conducted according to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all par...
PMC10662168
Consent for publication
Not applicable.
PMC10662168
Competing interests
The authors declare no competing interests.
PMC10662168
References
PMC10662168
Study:
This 16-week trial was performed using a double-blind, placebo-controlled, parallel group design. We aimed to establish whether
PMC10637569
Results:
cedar pollinosis, nasal blockage
All subjects completed the trial. It was conducted during the season when Japanese cedar pollen is most scattered. Serum concentration of Japanese cedar pollen-specific IgE was > 2.0 UA/mL in patients with Japanese cedar pollinosis. The amount of s-IgA in saliva was not increased by NTM048 in overall subjects, and Japa...
PMC10637569
Conclusion:
nasal blockage
The amount of s-IgA in saliva was not increased by NTM048, but nasal blockage was improved by it. Psychological status might be improved if dosage of NTM048 is raised to the degree that NTM048 might be increased in the intestinal tract.
PMC10637569
2. Materials and methods
PMC10637569
2.1. Participants
cedar pollinosis, pollinosis
HYPERSENSITIVITY SYMPTOMS, POLLINOSIS
We recruited Japanese adult men and women between 20 and 60 years old who could take capsules between November 20, 2017 and December 31, 2017 via Wakayama Medical University. Their eligibility was assessed according to the following exclusion criteria:1) Symptoms of pollinosis other than cedar pollinosis at the time of...
PMC10637569
2.2. Study design
This sixteen-week trial was performed using a double-blind, placebo-controlled, parallel group design. Participants were asked to take 2 capsules per day as test foods for 16 weeks. The trial was started between January 25, 2018 and February 1, 2018. Participants visited Wakayama Medical University every 4 weeks (0, 4,...
PMC10637569
2.3. Sample size
Sample size was computed based on the primary end-point measurement of s-IgA level on the last day of trial. In a previous report, the difference of mean of s-IgA level between the start and end of trial was 52.2 in a
PMC10637569
2.4. Measurement in blood and stool samples
BLOOD
Blood samples were centrifuged at 1500 g for 10 minutes, and concentrations of JCP-specific IgE in collected serum samples were measured by fluorescence enzyme immune assay (SRL, Tokyo, Japan). Stool samples were collected in spoon-type collection tubes and frozen at −80°C. Concentration of organic anions and short-cha...
PMC10637569
2.4.1. Test foods.
The test foods were capsules containing starch, calcium stearate and microcrystalline cellulose. Probiotic capsules also contained the viable cell count of
PMC10637569
2.4.2. Randomization and masking.
cedar pollinosis
After obtaining written informed consent, we collected the age and sex of the participants. When the number of eligible participants reached 40 in both the healthy subjects and the patients with Japanese cedar pollinosis, these participants were enrolled.In this study, a static allocation table adjusting sex and age (2...
PMC10637569
2.4.3. Statistical analysis.
SECONDARY
Primary outcome was the difference of s-IgA in saliva from start to end of the study (16 weeks after the start). Secondary outcomes were increase in s-IgA in saliva from the start to 4, 8, and 12 weeks after the start, increase in JCP-specific IgE in serum, each POMS2 score and the score of nasal symptoms 4, 8, 12, and...
PMC10637569