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Statistical analysis | Based on the results from a pilot study, the PASS software was used for sample size calculation. With α = 0.05 and β = 0.2, it was determined that 54 cases in each group were needed. Considering a 20% potential loss to follow-up, a total of 195 patients were required for this study.The normal distribution was assessed ... | PMC10426143 | ||
Results | PMC10426143 | |||
General information | Out of the 195 children initially recruited, 14 were excluded due to their inability to cooperate with the measurement of IOP under topical anesthesia before induction. Ultimately, 181 children (59 cases in the NS group, 62 cases in the EL group, and 60 cases in the EH group) were included for analysis (Fig. | PMC10426143 | ||
Comparison of IOP | Figure | PMC10426143 | ||
Comparison of hemodynamic parameters | HR at TSBP at T | PMC10426143 | ||
Discussion | extraocular muscle | AQUEOUS HUMOR | IOP refers to the pressure exerted by the ocular contents on the walls of the eyeball, typically ranging from 11 to 21 mmHg. Various factors influence IOP, including demographic factors such as age and gender and individual physiological factors such as aqueous humor circulation, extraocular muscle tension, and respira... | PMC10426143 |
Acknowledgements | Not applicable. | PMC10426143 | ||
Author contributions | Jun Luo and Kuoqi Yin contributed to the conception and design of the study and manuscript drafting. Dinghuan Zhao and Zhao Zhang were involved in data acquisition, analysis, and interpretation. Jun Luo and Kuoqi Yin contributed equally to this work and shared the co-first authorship. All authors have given approval fo... | PMC10426143 | ||
Funding | This work has been funded by Tianjin Health Research Project (Approval No. RC20062). | PMC10426143 | ||
Availability of data and material | The datasets used and analyzed in the current study are available from the corresponding author on reasonable request. | PMC10426143 | ||
Declarations | PMC10426143 | |||
Competing interests | The authors declare no competing interests. | PMC10426143 | ||
Ethics approval and consent to participate | EYE | This study was approved by the Ethical Committee of Tianjin Eye Hospital and registered at the Chinese Clinical Trial Registry with a registration number ChiCTR2200066586. All the experiment protocol for involving humans was in accordance to the guiding principles of the Helsinki declaration. All parents of the include... | PMC10426143 | |
Consent for publication | Not applicable. | PMC10426143 | ||
References | PMC10426143 | |||
Subject terms | Anxiety, anxiety | ADVERSE EFFECTS, SECONDARY | We aimed to evaluate the potential anxiolytic effects of premedication with pregabalin, compared with diazepam and placebo. We conducted this non-inferiority, double-blind, randomized controlled trial in ASA classification I-II patients aged 18–70 years, scheduled for elective surgery under general anesthesia. They wer... | PMC10272144 |
Introduction | anxiety | ADVERSE EVENTS, SECONDARY | Preoperative anxiety is common and remains an important problem for individuals scheduled for major surgeryPremedication with benzodiazepines has been in used for decades to ease anxiety and promote sleep in patients scheduled for surgeryPregabalin (S-[+]-3-isobutylgaba) is a lipophilic GABA analogPregabalin is also us... | PMC10272144 |
Methods | PMC10272144 | |||
Ethics | RECRUITMENT | This study was approved by the Ethics Committee of the Faculty of Medicine, Prince of Songkla University, Thailand: REC Number 62-080-8-1 (19/07/2019) and registered with Thai Clinical Trials Registry TCTR20190424001 (24/04/2019). All participants provided written informed consent. Study recruitment began on 29 August,... | PMC10272144 | |
Study design and patient selection | allergy | ALLERGY | This is a randomized, double-blind, placebo-controlled trial. In order to be eligible to participate, potential participants needed to be aged 18 to 70 years old, be scheduled for an elective surgery under general anesthesia, and be rated as having American Society of Anesthesiologists (ASA) physical status I or II.Exc... | PMC10272144 |
Measures | PMC10272144 | |||
Descriptive measures | pain | Demographic data (sex, age, weight, height, body mass index (BMI), ASA classification and history of previous surgery), baseline clinical variables (vital signs and preoperative pain), and postoperative clinical variables (vital signs) were recorded. | PMC10272144 | |
Primary outcomes | Anxiety, anxiety | We evaluated anxiety before and after receiving 2 doses the study medications prior to surgery using 2 co-primary outcome measures: (1) an 11-point Verbal Numerical Rating Scale (VNRS) with 0 = “Very calm” and 10 = “Very anxious”; and (2) the Amsterdam Preoperative Anxiety and Information Scale (APAIS) Thai version | PMC10272144 | |
Secondary outcomes | Anxiety, anxiety | We assessed preoperative anxiety before receiving the study medications by State Trait Anxiety Inventory (STAI-state) form Y Thai version | PMC10272144 | |
Study population size | This is a non-inferiority trial which hypothesized that the difference in the APAIS scores between participants who received pregabalin and diazepam would be 0. The standard deviation of the APAIS reported in a previous study with a proportional comparison of a visual analog scale of 2.6 was used | PMC10272144 | ||
Statistical analysis | anxiety | REGRESSION, SECONDARY | We first computed descriptive statistics to describe the sample and compare the participants assigned to the 3 treatment conditions [using a Fisher’s exact test or Chi-square test as appropriate for the categorical variables, and analysis of variance (ANOVA) F-test or Kruskal–Wallis test as appropriate for the continuo... | PMC10272144 |
Discussion | anxiety | The purpose of this study was to determine if patients premedicated with pregabalin would report similar improvements (decreases) in anxiety as those who received the standard treatment, diazepam, for anxiety in this population. The findings indicated that the patients who received the 2 medications evidenced similar i... | PMC10272144 | |
Acknowledgements | The authors would like to thank Ms. Walailuk Jitpiboon for her assistance in the statistical analyses for this paper. | PMC10272144 | ||
Author contributions | S.N.: This author helped doing study design, proposal writing, Ethics Committee application, data collection, data analysis, manuscript writing and submission for publication. B.C.: This author helped doing study design, proposal writing, Ethics Committee application, data collection, data analysis and manuscript writi... | PMC10272144 | ||
Funding | Supported by Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand. Grant no. 62-080-8-1. | PMC10272144 | ||
Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10272144 | ||
Competing interests | The authors declare no competing interests. | PMC10272144 | ||
References | PMC10272144 | |||
Background | PERIODONTITIS | The aim of this work was to evaluate the efficacy of proanthocyanidins (PACNs) as an adjunctive periodontal therapy in patients with periodontitis. | PMC10023589 | |
Methods | MINST, periodontitis, bleeding | PERIODONTITIS, BLEEDING, PLAQUE | Patients with periodontitis (stage III–IV) were included in this randomised clinical study. Patients with periodontitis received 2 different treatment modalities: minimally invasive nonsurgical therapy only (MINST group) or minimally invasive nonsurgical therapy and subgingival application of collagen hydrogels with PA... | PMC10023589 |
Results | MINST, periodontitis | PERIODONTITIS | Forty-six patients diagnosed with periodontitis were randomised into 2 groups: 23 patients in the MINST group and 23 patients in the MINST + PACNs group received the intended treatment. PACNs combined with MINST resulted in additional statistically significant PPD reduction and CAL gain in moderate periodontal pockets ... | PMC10023589 |
Conclusions | MINST | Adjunctive use of PACNs in MINST resulted in better clinical outcomes for moderate pockets. Additional use of PACNs improved MMP-3 concentration in saliva more than MINST alone. Biochemical analysis revealed that MMP-3 concentration in saliva reflected the periodontal health state. | PMC10023589 | |
Key words | PMC10023589 | |||
Introduction | MINST, tooth loss, Periodontitis | CHRONIC INFECTION, INFLAMMATION, PERIODONTITIS, ALVEOLAR BONE RESORPTION, PERIODONTITIS | Periodontitis is a chronic infection that leads to gingival inflammation, alveolar bone resorption, gingival attachment loss, and tooth loss.Different variations of nonsurgical periodontal therapy, such as minimally invasive nonsurgical therapy (MINST), conventional one-stage or partial quadrant scaling and root planin... | PMC10023589 |
Materials and methods | PMC10023589 | |||
Trial design | periodontitis | MAY, PERIODONTITIS | We conducted a randomised clinical trial in the Department of Dental and Oral Pathology at the Lithuanian University of Health Sciences in Kaunas, Lithuania, from January to May 2019. Systemically healthy individuals with periodontitis were involved in the study. All included patients must have signed an informed conse... | PMC10023589 |
Participants | periodontitis, allergic, tooth loss, bone loss | PERIODONTITIS, DISEASES, HIV PERIODONTITIS, BONE LOSS | Male and female patients visiting the Department of Dental and Oral Pathology at the Lithuanian University of Health Sciences in Kaunas, Lithuania, were considered for enrollment.Patients with periodontitis (stage III–IV) were included in the study according to the 2017 World Workshop on the Classification of Periodont... | PMC10023589 |
Intervention | MINST | STERILE, CAVITY, HIV PERIODONTITIS | Patients with stage III and IV periodontitis were allocated by the same examiner (RP) to 2 groups: The first group received MINST only (MINST group), and the second group received MINST and single-time subgingival application of collagen hydrogels with PACNs (MINST + PACNs group). Non–commercially available type I coll... | PMC10023589 |
Outcomes | For data analysis, pockets were assigned into 2 categories: moderate (PPD, 4–6 mm) and deep (PPD ≥7 mm).Examiner calibration was performed with the use of the Cohen's kappa coefficient (≥0.85). Ten patients with more than 5 teeth with PPD and CAL | PMC10023589 | ||
Immunologic investigation | MINST | The relationship of clinical periodontal parameters and MMP-3 and TIMP-1 levels was analysed to assess the efficacy of PACNs in periodontal therapy. Concentrations of immunologic markers, MMP-3, and TIMP-1 in saliva were assessed at baseline and at 8 weeks following therapy.For MMP-3/TIMP-1 detection, unstimulated sali... | PMC10023589 | |
Sample size | A sample size of 46 patients, 23 in each group (control and test), was sufficient to detect a clinically important difference in the mean PPD change from baseline in moderate sites at 8 weeks between the control and test groups using a 2-tailed | PMC10023589 | ||
Randomisation | MINST, periodontitis, RP | PERIODONTITIS | A total of 46 patients with periodontitis were randomised into 2 groups. RP performed the coding and randomisation of the participants in the treatment groups with a computer-generated randomisation table. At first, the patients were issued unique numbers from 1 to 46. After the coding procedure, a simple randomisation... | PMC10023589 |
Blinding | MINST | STERILE | During the MINST procedure, the clinician (periodontist EA) was not informed about the patients’ group allocation (MINST or MINST + PACNs). After the MINST procedure, the patients’ group assignments were revealed to the clinician by the examiner (RP), and accordingly the patients received the intended treatment.From th... | PMC10023589 |
Statistical methods | CALs, tooth | PLAQUE | The effect of periodontal treatment was reflected by clinical periodontal measures (PPD, CAL, BOP, and PI) and 2 biochemical measures (MMP-3 and TIMP-1 concentrations in saliva). PPD, BOP, CAL, and PI were measured at 6 sites per tooth: mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual. The clin... | PMC10023589 |
Results | PMC10023589 | |||
Participant flow | MINST, periodontitis | PERIODONTITIS, RECRUITMENT | Forty-six patients (stage of periodontitis III–IV) completed the study. Each treatment group (MINST or MINST +PACNs) consisted of 23 randomly selected patients. The number of participants is shown in the CONSORT flow diagram (CONSORT flow diagram of participant recruitment. | PMC10023589 |
Effect on clinical parameters | PMC10023589 | |||
Effect on probing depth | MINST, bleeding, SD | BLEEDING, PLAQUE | The mean per-patient PPD dynamics in moderate (baseline PPD 4–6 mm) and deep (baseline PPD ≥7 mm) pockets are presented in Clinical characteristics of sample population at the baseline and after 8 weeks.Significance level is .05 are shown in bold.Paired-samples Related-samples Wilcoxon signed rank test (α=0.05).One-sam... | PMC10023589 |
Effect on BOP | The BOP dynamics in moderate and deep pockets are presented in | PMC10023589 | ||
Effect on salivary biomarkers | MINST, periodontitis | PERIODONTITIS, ADVERSE EFFECTS | A goal of this study was to determine whether MMP-3 might be considered as a biomarker of periodontitis. A total of 46 individuals with periodontitis were included in the study. The effects of MINST and MINST + PACNs treatment on MMP-3 and TIMP-1 levels in saliva are presented in Effect of specific periodontal treatmen... | PMC10023589 |
Discussion | MINST | PERIODONTITIS, GENERALISED PERIODONTITIS | The current study estimated the effects of PACNs on the treatment of generalised periodontitis by analysing clinical and immunologic parameters. The results showed that adjunctive use of PACNs combined with MINST promoted additional beneficial effects on clinical and immunologic parameters. Adjunctive use of PACNs show... | PMC10023589 |
Conclusions | MINST | Within the limits of this study, adjunctive use of PACNs with MINST has been shown to result in additional PPD reduction and CAL gain in moderate periodontal pockets compared to MINST alone. Immunologic investigation showed that additional use of PACNs in MINST reduced MMP-3 concentrations in saliva more than MINST alo... | PMC10023589 | |
Author contributions | All authors collaborated to generate a plan and perform all the necessary experimental procedures. Rasa Pušinskaitė performed the statistical analysis. Rasa Banienė, Evelina Alkimavičienė, and Rasa Pušinskaitė analysed and summarised the experimental results. Evelina Alkimavičienė and Rasa Pušinskaitė wrote the paper. ... | PMC10023589 | ||
Conflict of interest | None disclosed. | PMC10023589 | ||
REFERENCES | PMC10023589 | |||
Funding | This study is a part of project (“Engineering and Functionalization of Delivery System With | PMC10023589 | ||
Background | cardiotoxicity | There is rekindled interest in the cardiotoxicity of antimalarial medicines. Halofantrine is associated with QT interval prolongation. Fluconazole and kolanut alter the pharmacokinetics of halofantrine. | PMC10398509 | |
Objectives | The study assessed the electrocardiographic changes of concomitant administration of kolanut or fluconazole with halofantrine and the effects on the QTc interval. | PMC10398509 | ||
Methods | Eighteen healthy volunteers received a single oral dose of halofantrine, halofantrine with kolanut or halofantrine with fluconazole in a crossover study. Twelve lead electrocardiography (ECG) was performed to measure the PR and QT interval (QTc). Statistical analysis was with SPSS at 5% level of significance. | PMC10398509 | ||
Results | PR intervals were shortened by halofantrine alone and halofantrine with kolanut (169.29 28.67 to 165.29 28.007 and 172.73 29.843 to 163.00 18.336ms) but was prolonged by halofantrine with fluconazole (177.70 27.394 to 186.59 44.434ms). There was prolongation of QTc (384.76 21.727 to 394.12 21.525; 381.36 22.29 to 388.3... | PMC10398509 | ||
Conclusion | Concomitant intake of kolanut with halofantrine was significantly decrease cardiac effect of halofantrine. | PMC10398509 | ||
Introduction | corona virus disease-19, cardiotoxic, infections, Malaria | PARASITIC INFECTION, MALARIA, INFECTIONS | Malaria is the most important parasitic infection affecting man and may coexist with other infections including HIV. Malaria is a close differential diagnosis of corona virus disease-19 (COVID-19) in this current pandemic. Halofantrine is a synthetic phenanthrene-methanol antimalarial which is chemically related to qui... | PMC10398509 |
Objectives | The study assessed the electrocardiographic changes of concomitant administration of kolanut or fluconazole with halofantrine to determine the effects on the QTc and PR intervals. The study also evaluated the influence of serum potassium on the electrocardiographic findings. | PMC10398509 | ||
Materials and methods | heart disease | HEART, HEART DISEASE | The study is part of a larger study conducted between September 2003 and January 2004 for which joint University of Ibadan/University College Hospital (UI/IRC/02/0041) ethical approval was obtainedClinical information including family history of heart disease was obtained. Physical examination included blood pressure m... | PMC10398509 |
Results | HEART | The baseline clinico-electrocardiographic characteristics of healthy volunteers administered halofantrine alone or with either fluconazole or kolanut as shown in Baseline clinico-electrocardiographic characteristics of healthy volunteers administered halofantrine alone or with either fluconazole or kolanutP < 0.05 for ... | PMC10398509 | |
Discussions | In this study, baseline electrocardiographic intervals significantly correlated with 6-hour values. QT and QTc at 6 hrs and 336 hrs (Day 14) correlated well with pre-treatment value. Electrocardiographic monitoring at 6 hours may be a most important single point measurement of assessment of the electrocardiographic cha... | PMC10398509 | ||
Conclusion | In conclusion we found halofantrine alone or in concomitant use with fluconazole caused prolonged QT interval which correlated with the baseline, whereas use of kolanut with halofantrine caused reduced PR interval. Further studies are however needed to determine if such QT prolongation is accentuated by presence of bac... | PMC10398509 | ||
Acknowledgement | Abstract of this study was accepted for presentation at the IX | PMC10398509 | ||
Conflict of interest | Nil | PMC10398509 | ||
Introduction | depression, coronavirus disease 2019, anxiety | CORONAVIRUS DISEASE 2019, POLAND | With the spread of the coronavirus disease 2019 (COVID-19) pandemic, people have been recommended to wear masks in various settings around the world [A recent study revealed notable disparities between Poland and China in mask-wearing and associated health outcomes. Specifically, far fewer Poles (35.0%) wore masks comp... | PMC10653515 |
Methods | PMC10653515 | |||
Study design | In this study, a double-blind, randomized controlled trial was conducted to assess the effects of aroma seals on adult participants. The study was conducted between November 11, 2021, and December 20, 2021. The participants were informed in advance about the study’s objectives and methods, and written informed consent ... | PMC10653515 | ||
Participants | mental illness, epilepsy, chronic diseases, allergies, hypertension, allergic reactions | ALLERGIC REACTION, EPILEPSY, CHRONIC DISEASES, ALLERGIES, HYPERTENSION | In this study, we recruited 67 healthy university students aged 18 years or older who understood the study’s purpose and content, provided written consent, and volunteered to participate. Eligible participants were those who, to the extent that it did not impede the conduct of the study, had the ability to comprehend t... | PMC10653515 |
Randomization and masking | Participants were randomly assigned to one of the two groups (intervention or control) in a 1:1 ratio, and were double-blinded to ensure that the participants and data analysts in the study could not discriminate between the groups of participants. The permuted block method with block sizes of 2 and 4 was used for rand... | PMC10653515 | ||
Procedures | skin allergy, aromas, allergic reactions | SKIN ALLERGY, RECRUITMENT, ALLERGIC REACTION | The baseline period in our study refers to the two-week period immediately preceding the intervention period, during which participants applied the seals to their masks. The baseline values used in our analysis were obtained from the questionnaire responses collected on the day before the intervention started.All enrol... | PMC10653515 |
Study outcomes | Anxiety, anxiety, breathlessness, depression, Depression | The primary outcome was the Depression, Anxiety, and Stress Scale-21 (DASS-21) [The DASS-21 is a 21-question rating scale comprising a three-factor construct of depression, anxiety, and stress. The responses to the questions were scored as 0 (did not apply to me at all), 1 (applied to me to some degree or some of the t... | PMC10653515 | |
Statistical analysis | depression | ADVERSE EVENTS | Descriptive statistics were used to present the demographic characteristics of the participants. Numerical data (age, number of outings per week, and outcome measures) were presented as means and standard deviations, whereas categorical data (sex, stress, and favorite aroma) were presented as frequencies and ratio. To ... | PMC10653515 |
Results | PMC10653515 | |||
Participants’ information | In this study, 67 participants were screened, and 62 were included and randomly assigned to one of two groups: an aroma-seal use group ( | PMC10653515 | ||
Flow chart of participant allocation. | The participants’ demographics and baseline characteristics were comparable between the groups ( | PMC10653515 | ||
Demographic and baseline characteristics of study participants in the aroma- and placebo-seal use groups. | The values in | PMC10653515 | ||
Assessment of depression, anxiety, and stress using the DASS-21 | depression, anxiety | DASS-21, which assesses depression, anxiety, and stress, was utilized in our study. In its evaluations at baseline, 1 week, and 2 week, the scores for the Aroma-Seal Use Group appeared to show a decreasing trend ( | PMC10653515 | |
Comparison of DASS-21 score changes from baseline in the aroma- and placebo-seal use groups. | LSMD, least squares mean difference | PMC10653515 | ||
Improvement in discomfort associated with wearing masks | breathlessness | The aroma-seal use group had mean breathlessness scores of 2.48 ± 1.09, 1.74 ± 0.89, and 1.84 ± 0.86 at baseline, first week, and second week of the intervention, respectively, indicating that the scores changed from “it’s rather breathlessness” to “it’s not very breathlessness” in many patients. Conversely, the placeb... | PMC10653515 | |
Comparison of mask-breathlessness score change from baseline in the aroma- and placebo-seal use groups. | LSMD, least squares mean difference | PMC10653515 | ||
Assessment of mental well-being using the WHO-5 rating scale | The average score for each item of the WHO-5 was observed to be higher in the intervention group compared to the placebo group ( | PMC10653515 | ||
Comparison of WHO-5 score changes from baseline at the end of the two-week intervention in the aroma- and placebo-seal groups. | LSMD, least squares mean difference | PMC10653515 | ||
Adverse event reporting | ADVERSE EVENT | Safety was assessed for the 61 participants. The number of days of seal use during the intervention period was 5.6 ± 1.2 and 5.4 ± 1.3 days per week in the aroma- and placebo-seal use groups, respectively, and all 61 participants completed the two weeks of the intervention period. One adverse event (3.2%) each was repo... | PMC10653515 | |
A summary of adverse events in the aroma- and placebo-seal use groups. | ADVERSE EVENT | Adverse events were defined as those occurring between the time the seal was applied and 14 days after the last use of the mask seal. | PMC10653515 | |
Discussion | depression, breathlessness | INFLUENZA | This study investigated whether mask seals containing orange–lime essential oils could alleviate stress and breathlessness while wearing a mask and improve mental well-being. The findings revealed a significant improvement in stress and depression, as determined by the DASS-21 scores, in the aroma-seal use group compar... | PMC10653515 |
Conclusion | This study demonstrated the efficacy of aroma seals containing orange–lime essential oils in relieving mental stress and improving the comfort of breathing while wearing a mask. Therefore, using aroma seals while wearing masks can be expected to improve mental health and alleviate discomfort in breathing, improving the... | PMC10653515 | ||
Supporting information | PMC10653515 | |||
DASS-21 scores in the aroma-seal use group and placebo-seal use group at baseline, 1 week, and 2 week. | (DOCX)Click here for additional data file. | PMC10653515 | ||
WHO-5 scores in aroma seal and placebo groups at baseline and 2 week. | (DOCX)Click here for additional data file. | PMC10653515 | ||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(DOC)Click here for additional data file.(DOC)Click here for additional data file.(XLS)Click here for additional data file.(XLS)Click here for additional data file.(XLS)Click here for additional data file.The authors would like to thank all the students who participated in this ... | PMC10653515 |
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