Liquid-Liquid Dispersion Performance Prediction and Uncertainty Quantification Using Recurrent Neural Networks.

We demonstrate the application of a recurrent neural network (RNN) to perform multistep and multivariate time-series performance predictions for stirred and static mixers as exemplars of complex multiphase systems. We employ two network architectures in this study, fitted with either long short-term memory and gated recurrent unit cells, which are trained on high-fidelity, three-dimensional, computational fluid dynamics simulations of the mixer performance, in the presence and absence of surfactants, in terms of drop size distributions and interfacial areas as a function of system parameters; these include physicochemical properties, mixer geometry, and operating conditions. Our results demonstrate that while it is possible to train RNNs with a single fully connected layer more efficiently than with an encoder-decoder structure, the latter is shown to be more capable of learning long-term dynamics underlying dispersion metrics. Details of the methodology are presented, which include data preprocessing, RNN model exploration, and methods for model performance visualization; an ensemble-based procedure is also introduced to provide a measure of the model uncertainty. The workflow is designed to be generic and can be deployed to make predictions in other industrial applications with similar time-series data.

Trends of Surgical Service Utilization for Lumbar Spinal Stenosis in South Korea: A 10-Year (2010-2019) Cross-Sectional Analysis of the Health Insurance Review and Assessment Service-National Patient Sample Data.

Background and Objectives: This retrospective, cross-sectional, and descriptive study used claims data from the Korean Health Insurance Review and Assessment Service (HIRA) between 2010 and 2019 to analyze the trend of surgical service utilization in patients with lumbar spinal stenosis (LSS). Materials and Methods: The national patient sample data provided by the HIRA, which consisted of a 2% sample of the entire Korean population, was used to assess all patients who underwent decompression or fusion surgery at least once in Korea, with LSS as the main diagnosis from January 2010 to December 2019. An in-depth analysis was conducted to examine the utilization of surgical services, taking into account various demographic characteristics of patients, the frequency of claims for different types of surgeries, reoperation rates, the specific types of inpatient care associated with each surgery type, prescribed medications, and the overall expense of healthcare services. Results: A total of 6194 claims and 6074 patients were analyzed. The number of HIRA claims for patients increased from 393 (2010) to 417 (2019) for decompression, and from 230 (2010) to 244 (2019) for fusion. As for the medical expenses of surgery, there was an increase from United States dollar (USD) 867,549.31 (2010) to USD 1,153,078.94 (2019) for decompression and from USD 1,330,440.37 (2010) to USD 1,780,026.48 (2019) for fusion. Decompression accounted for the highest proportion (65.8%) of the first surgeries, but more patients underwent fusion (50.6%) than decompression (49.4%) in the second surgery. Across all sex and age groups, patients who underwent fusion procedures experienced longer hospital stays and incurred higher medical expenses for their inpatient care. Conclusion: The surgical service utilization of patients with LSS and the prescribing rate of opioids and non-opioid analgesics for surgical patients increased in 2019 compared to 2010. From mid-2010 onward, claims for fusion showed a gradual decrease, whereas those for decompression showed a continuously increasing trend. The findings of this study are expected to provide basic research data for clinicians, researchers, and policymakers.

National Health Insurance Data Analysis for the Second-Wave Development of Korean Medicine Clinical Practice Guidelines in South Korea.

Objectives: After the evidence-based Korean medicine clinical practice guidelines (KM-CPGs) for 30 targeted diseases were developed in 2021, 34 diseases have been proposed for the second-wave development of the KM-CPGs. The purpose of this study was to investigate the development priorities of the candidate diseases into the second-wave development of KM-CPGs in south Korea. Methods: In this study, we analyzed the Health Insurance Review and Assessment Service National Patient Sample data from 2017 to 2018 to determine the demand and economic importance of the candidates for the second-wave development of KM-CPGs in real-world clinical settings in Korea. Results: The annual number of visits and patients, annual healthcare expenditure per patient, and healthcare expenditure per institution were analyzed. Musculoskeletal disorders, including sciatica and adhesive capsulitis of the shoulder, were the most important topics regarding the number of visits and patients and annual healthcare expenditure per institution. Specifically, sciatica (52.05% of the total number of visits, 48.34% of the total number of patients, and 42.12% of the total treatment expenditure per institution) showed overwhelmingly high proportions. However, cerebral palsy (36.03% of the total number of inpatient visits and 24.55% of the total number of inpatient patients) was a more important topic in inpatient clinical settings than musculoskeletal conditions or cancer, and healthcare expenditure per patient in this topic had the highest ranking. Furthermore, fractures were found to be highly important in inpatient clinical settings. No patients had influenza A virus infection or posttraumatic stress disorders who visited the KM medical institution of interest. Conclusion: This study highlights the gap between the real-world clinical setting and the research field in some topics. The results of this study can provide guidance for the second-wave development of KM-CPGs in the future.

Development of clinical practice guidelines for Korean medicine: Towards evidence-based complementary and alternative medicine.

Background: Since evidence-based medicine has been pursued in complementary and alternative medicine, the clinical practice guideline (CPG) has become a key factor in providing standardized and validated practices in Korean Medicine (KM). We aimed to review the current status and characteristics of the development, dissemination, and implementation of KM-CPGs. Methods: We searched KM-CPGs and relevant publication via web-based databases. We organized the searching results focused on the year of publications and the development programs to show which and how KM-CPGs have been development. We also reviewed the manuals for KM-CPG development to introduce concise characteristics of the KM-CPGs published in Korea. Results: The KM-CPGs have been developed according to manuals and standard templates for developing evidence-based KM-CPGs. First, CPG developers reviews the previously published CPGs for a clinical condition of interest and plans the CPG development. After finalizing the key clinical questions, the evidence is searched, selected, appraised, and analyzed following the internationally standardized methods. The quality of the KM-CPGs is controlled by a tri-step appraisal process. Second, the CPGs were submitted for the appraisal of the KM-CPG Review and Evaluation Committee. The committee evaluates the CPGs according to the AGREE II tool. Finally, the Steering Committee of the KoMIT project reviews the entire process of developing the CPGs and confirms it for public disclosure and dissemination. Conclusion: Evidence-based KM from research to practice can be achieved with the attention and effort of multidisciplinary entities such as clinicians, practitioners, researchers, and policymakers for the CPGs.

Bee Venom Acupuncture for Neck Pain: A Review of the Korean Literature.

Bee venom is a natural toxin that is effective in treating various types of pain. The purpose of this paper was to review all the features of clinical studies conducted on bee venom acupuncture (BVA) for the treatment of neck pain in Korean publications. Six Korean databases and 16 Korean journals were searched in August 2022 for clinical studies on BVA for neck pain. We identified 24 trials that met our inclusion criteria, of which 316 patients with neck pain were treated with BVA. The most common diagnosis in the patients with neck pain was herniated intervertebral discs (HIVDs) of the cervical spine (C-spine) (29.2%), and the concentration and dosage per session were 0.05-0.5 mg/mL and 0.1-1.5 mL, respectively. The visual analog scale was most often measured for neck pain severity (62.5%), and all clinical research reported improvements in 16 outcome measures. This study shows that BVA could be recommended for the treatment of neck pain, especially HIVD of the C-spine; however, the adverse effects of BVA must be examined in future studies.

The effect of cancer on traditional, complementary and alternative medicine utilization in Korea: a fixed effect analysis using Korea Health Panel data.

BACKGROUND: Cancer-related incidence and mortality rates are rapidly increasing worldwide. However, no studies have examined the effect of cancer as a single factor on the use of traditional, complementary, and alternative medicine (T&CAM). We aimed to determine the effect of cancer occurrence on T&CAM utilization using Korea Health Panel (KHP) data. METHODS: We analyzed longitudinal data (49,380 observations) derived from 12,975 Korean adult participants with complete KHP data from 2011 to 2014 and 2016, and divided them into two groups based on cancer diagnosis. A panel multinomial logit model was used to assess whether the participants used T&CAM or conventional medicine or both in outpatient settings. Additionally, a negative binomial regression model was used to examine the effect of cancer on the number of outpatient visits for T&CAM. RESULTS: In total, 25.54% of the study participants in the cancer group used T&CAM, which was higher than that in the non-cancer group (18.37%, p < 0.0001). A panel multinomial logistic regression analysis using KHP data showed that cancer occurrence was significantly more likely to be associated with 'Using both Korean medicine and conventional medicine' (Coef. = 0.80, p = 0.017) and 'Not using Korean medicine but using conventional medicine' (Coef. = 0.85, p = 0.008) than 'Not using Korean medicine and conventional medicine.' A panel negative binomial regression showed a significant effect of cancer on increasing the number of T&CAM outpatient visits (Coef. = 0.11, p = 0.040). CONCLUSIONS: Our findings showed that cancer occurrence within an individual led to the simultaneous use of conventional medicine and T&CAM. In addition, the occurrence of cancer significantly increased the number of T&CAM outpatient visits among participants already using T&CAM. It was also found that T&CAM has been utilized more often by the most vulnerable people, such as medical beneficiaries and those with a low level of education.

Cascade reaction networks within audible sound induced transient domains in a solution.

Spatiotemporal control of chemical cascade reactions within compartmentalized domains is one of the difficult challenges to achieve. To implement such control, scientists have been working on the development of various artificial compartmentalized systems such as liposomes, vesicles, polymersomes, etc. Although a considerable amount of progress has been made in this direction, one still needs to develop alternative strategies for controlling cascade reaction networks within spatiotemporally controlled domains in a solution, which remains a non-trivial issue. Herein, we present the utilization of audible sound induced liquid vibrations for the generation of transient domains in an aqueous medium, which can be used for the control of cascade chemical reactions in a spatiotemporal fashion. This approach gives us access to highly reproducible spatiotemporal chemical gradients and patterns, in situ growth and aggregation of gold nanoparticles at predetermined locations or domains formed in a solution. Our strategy also gives us access to nanoparticle patterned hydrogels and their applications for region specific cell growth.

Chinese Herbal Medicine for Cervicogenic Dizziness: A Systematic Review and Meta-Analysis.

Background: Chinese herbal medicines (CHMs) have been widely used in the treatment of cervicogenic dizziness (CGD) based on their empirical effectiveness and safety. Herein, we reviewed and evaluated the clinical evidence of the efficacy and safety of CHMs for CGD. Methods: Among the relevant studies published in 11 electronic databases up to December 2021, only randomised controlled trials were included. Methodological quality was assessed using the revised Cochrane risk-of-bias tool for randomised trials, and the strength of evidence for the main outcomes was evaluated using the grading of recommendations assessment, development, and evaluation system. Results: All 35 included randomised controlled trials with 3,862 participants were conducted with six types of modified CHM and four types of active controls. More than half of the included studies were of low quality because of the high risk of bias due to deviations from intended interventions. CHM plus active control was more effective in the treatment of CGD than active control alone. CHM plus anti-vertigo drugs, CHM plus manual therapy, CHM plus acupuncture therapy, and CHM plus manual and acupuncture therapy were all effective in treating CGD, with CHM plus manual and acupuncture therapy showing the most reliable effect. All CHMs were effective for specific patterns of CGD when administered with active controls, with Dingxuan Tang and Yiqi Congming Tang demonstrating the most reliable effects. No serious adverse events were reported in any of the included studies. Conclusion: The current evidence suggests that CHM may enhance the treatment of CGD when combined with other treatments without serious adverse events. Further high-quality evidence is needed to draw definitive conclusions.

Effectiveness a herbal medicine (Sipjeondaebo-tang) on adults with chronic fatigue syndrome: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Sipjeondaebo-tang (SJDBT, Shi-quan-da-bu-tang in Chinese) is a widely prescribed herbal medicine in traditional Korean medicine. This study aimed to evaluate the effectiveness and safety of SJDBT for treating chronic fatigue syndrome (CFS). METHODS: Ninety-six eligible participants were randomly allocated to either the SJDBT or placebo groups in a 1:1 ratio. Nine grams of SJDBT or placebo granules were administered to the patients for 8 weeks. The primary outcome was the response rate, defined as the proportion of participants with a score of 76 or higher in the Checklist Individual Strength assessment. Other measurements for fatigue severity, quality of life, and qi/blood/yin/yang deficiency were included. Safety was assessed throughout the trial. RESULTS: At week 8, the response rate did not significantly differ between the groups (SJDBT: 35.4%; placebo: 54.2%; P =  0.101, effect size [95% confidence interval] = 0.021 [-0.177, 0.218]). However, the scores of the visual analogue scale (P =  0.001, -0.327 [-0.506, -0.128]), Fatigue Severity Scale (P =  0.020, 0.480 [0.066, 0.889]), and Chalder fatigue scale (P =  0.004, -0.292 [-0.479, -0.101]) for the SJDBT group showed significant improvements in fatigue severity at the endpoint. Quality of life was not significantly different. Furthermore, SJDBT significantly ameliorated the severity of qi deficiency compared to that in the placebo group. No serious adverse events were observed. CONCLUSION: This trial failed to show a significant improvement in fatigue severity, as assessed by the CIS-deprived response rate. It merely showed that SJDBT could alleviate the severity of fatigue and qi deficiency in patients with CFS. However, the further study is needed to confirm the details.

Herbal medicine for cervicogenic dizziness: A protocol for a systematic review and meta-analysis.

BACKGROUND: Herbal medicines are empirically used to treat cervicogenic dizziness. However, till date there have been no systematic review to evaluate the efficacy and safety of these medicines. Therefore, this study protocol describes the methods for evaluating the efficacy and safety of herbal medicine for cervicogenic dizziness. METHODS AND ANALYSIS: The following electronic academic databases will be searched up to December 2019 without language or publication status restrictions: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL), together with Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for cervicogenic dizziness will be included. The functional outcomes and the vertebrobasilar artery hemodynamic states will be evaluated as primary outcomes. The total effective rate, hematological conditions, and adverse events will be assessed as secondary outcomes. Study selection, data extraction, quality assessment of studies, and qualitative evaluation of clinical evidence will be performed by 2 independent reviewers. The methodological quality of the included studies will be evaluated using a revised Cochrane risk-of-bias tool for randomized trials. The strength of evidence from the included data will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Data synthesis will be performed as either a fixed-effects or a random-effects model using Review Manager software version 5.3. The results will be reported as a risk ratio for dichotomous outcomes and as a mean difference or standardized mean difference for continuous outcomes. ETHICS AND DISSEMINATION: No ethical approval is required since the individual clinical information of the patient is not used. The findings of this systematic review will be disseminated through the peer-reviewed publications or conference presentations. REVIEW REGISTRY UNIQUE IDENTIFYING NUMBER: reviewregistry1036.

Efficacy and safety of thread embedding acupuncture combined with acupuncture for chronic low back pain: A randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Low back pain is a very common disease. Many patients with chronic low back pain (CLBP) have been treated by complementary and alternative medicine such as acupuncture (AT) treatment. A type of AT, thread embedding acupuncture (TEA), consists of a thread that can continually stimulate at the AT points and has mechanical and chemical effects. Although TEA was widely used in clinical practice, there was little evidence of its efficacy and safety for CLBP. METHODS: This clinical trial was randomized, controlled, assessor-blinded, two-armed, parallel, and conducted in multiple centers. Four Korean medical institutions recruited 38 outpatients with CLBP. The participants were randomly allocated to a treatment group (TEA combined with AT) or a control group (only AT) in a 1:1 ratio. All participants received conventional AT twice a week for 8 weeks (16 sessions) at 15 AT points (GV3 and bilateral BL23, BL24, BL25, BL26, BL40, BL60, and EX-B5) and the treatment group participants additionally received TEA once a week for 8 weeks (8 sessions) on 10 AT points in the multifidus, spinal erector, and lumbar quadrate muscles. The primary outcome measure of this study was the change of visual analog scale (VAS) from baseline (0 week) to the end of intervention (8 weeks). Secondary outcome measures included clinically relevant improvement (minimal clinically important difference) and 3% to 50% decrease on VAS, disability level (Korean version of Roland and Morris disability questionnaire), quality of life (Korean version of European quality of life 5dimension), global assessment (patient global impression of change), economic analysis, credibility test, and safety assessment. RESULTS: The treatment group showed a significant reduction in VAS scores when compared with the control group (-33.7 ±â€Š25.1 vs -15.6 ±â€Š17.0, P = .013). As for the secondary outcome measures, the treatment group showed significant difference in 50% decrease on VAS and patient global impression of change. There was no serious adverse event associated with TEA and AT. CONCLUSION: This clinical trial documents the efficacy and safety of TEA combined with AT for the management of CLBP.

Contact time on curved superhydrophobic surfaces.

When a water drop impinges on a flat superhydrophobic surface, it bounces off the surface after a certain dwelling time, which is determined by the Rayleigh inertial-capillary timescale. Recent works have demonstrated that this dwelling time (i.e., contact time) is modified on curved superhydrophobic surfaces, as the drop asymmetrically spreads over the surface. However, the contact time on the curved surfaces still remains poorly understood, while no successful physical model for the contact time has been proposed. Here, we propose that the asymmetric spreading on the curved surface is driven by either the Coanda effect or inertia depending on the ratio of the drop diameter to the curvature diameter. Then, based on scaling analysis, we develop the contact time model that successfully predicts the contact time measured under a wide range of experiment conditions such as different impact velocities and curvature diameters. We believe that our results illuminate the underlying mechanism for the asymmetric spreading over the curved surface, while the proposed contact time model can be utilized for the design of superhydrophobic surfaces for various thermal applications, where the thermal exchange between the surface and the water drop occurs via a direct physical contact.

Development of an Automated Image Analyzer for Microvessel Density Measurement in Bone Marrow Biopsies.

Angiogenesis is important for the proliferation and survival of multiple myeloma (MM) cells. Bone marrow (BM) microvessel density (MVD) is a useful marker of angiogenesis and an increase in MVD can be used as a marker of poor prognosis in MM patients. We developed an automated image analyzer to assess MVD from images of BM biopsies stained with anti-CD34 antibodies using two color models. MVD was calculated by merging images from the red and hue channels after eliminating non-microvessels. The analyzer results were compared with those obtained by two experienced hematopathologists in a blinded manner using the 84 BM samples of MM patients. Manual assessment of the MVD by two hematopathologists yielded mean±SD values of 19.4±11.8 and 20.0±11.8. The analyzer generated a mean±SD of 19.5±11.2. The intraclass correlation coefficient (ICC) and Bland-Altman plot of the MVD results demonstrated very good agreement between the automated image analyzer and both hematopathologists (ICC=0.893 [0.840-0.929] and ICC=0.906 [0.859-0.938]). This automated analyzer can provide time- and labor-saving benefits with more objective results in hematology laboratories.

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. METHODS: This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed. DISCUSSION: The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.

Heart rate variability in middle-aged adults: Use of Sasang typology to distinguish individuals susceptible to stress.

While stress is known to cause many diseases, there is no established method to determine individuals vulnerable to stress. Sasang typology categorizes humans into four Sasang types (So-Eum, Tae-Eum, So-Yang, and Tae-Yang), which have unique pathophysiologies because of their differential susceptibilities to specific stimuli, including stress. The purpose of this study was to determine if Sasang typology can be used identify individuals who are vulnerable to stress by evaluation of heart rate variability (HRV).This was a cross-sectional study. A total of 399 healthy men and women aged 30 to 49 years were recruited. Physical examinations for stress included HRV measurement and blood tests. The subjects also completed questionnaires about psychological stress, self-awareness, and lifestyle. HRV was analyzed using frequency-domain analysis. Subjects were divided into So-Eum (SE) and non-So-Eum (non-SE) groups according to their diagnosis.The weight and body mass index in the SE group were significantly lower than those in the non-SE group (both, P = .000). There were no significant between-group differences in any other demographic variables. In HRV analysis, the normalized high frequency (nHF) was higher (P = .008) while the normalized low frequency (nLF; P = .008) and LF:HF ratio (LF/HF; P = .002) were lower in the SE group than in the non-SE group.Although there was no difference in variables affecting HRV, HRV values were significantly different between groups. The LF/HF value for the SE group was at the lower limit of the normal range, although there were no associated clinical problems. These findings suggest that individuals with the SE type are more susceptible to stress than those with the other types. Thus, middle-aged individuals who are vulnerable to stress can be identified using Sasang typology.

Effectiveness, safety, and economic evaluation of adjuvant moxibustion therapy for aromatase inhibitor-induced arthralgia of postmenopausal breast cancer stage I to III patients: Study protocol for a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial.

INTRODUCTION: This study is a prospective, assessor-blinded, parallel-group, randomized controlled pilot trial to explore the effectiveness of 12-week adjuvant moxibustion therapy for arthralgia in menopausal females at stage I to III breast cancer on aromatase inhibitor (AI) administration, compared with those receiving usual care. METHODS/DESIGN: Forty-six menopausal female patients with breast cancer who completed cancer therapy will be randomly allocated to either adjuvant moxibustion or usual care groups with a 1:1 allocation ratio. The intervention group will undergo 24 sessions of adjuvant moxibustion therapy with usual care for 12 weeks, whereas the control group will receive only usual care during the same period. The usual care consists of acetaminophen administration on demand and self-directed exercise education to manage AI-related joint pain. The primary outcome is the mean change of the worst pain level according to the Brief Pain Inventory-Short Form between the initial visit and the endpoint. The mean changes in depression, fatigue, and quality of life will also be compared between groups. Safety and pharmacoeconomic evaluations will also be included. DISCUSSION: Continuous variables will be compared by an independent t test or Wilcoxon rank-sum test between the adjuvant moxibustion and usual care groups. Adverse events will be analyzed using the chi-square or Fisher exact test. The statistical analysis will be performed by a 2-tailed test at a significance level of .05.

Safety, effectiveness, and economic evaluation of an herbal medicine, Ukgansangajinpibanha granule, in children with autism spectrum disorder: a study protocol for a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial.

BACKGROUND: Autism spectrum disorder (ASD) is characterized by continuous impairment in communication and social interaction and by limited and repetitive behaviors, interests, or activities. Behavioral, educational, and pharmaceutical interventions have been shown to reduce behavioral disabilities, improve verbal/non-verbal communication, and help patients acquire self-reliance skills. However, there has been a lack of systematic verification and consensus regarding the treatment of the core symptoms of ASD because of its unclear etiology. Ukgansangajinpibanha (UGSJB), a legitimately prescribed herbal medicine for nervousness, insomnia, night crying, and malnutrition in South Korea and Japan, has been used for angry, sensitive, nervous, and unsettled children with ASD. METHODS/DESIGN: This trial is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial. The 4- to 6-year-old children with ASD will be randomly assigned to following groups: 1. A UGSJB granule with acupuncture, twice daily (n = 120) 2. A placebo group with acupuncture, twice daily (n = 120). The following outcome measures will be used: behavior by the Childhood Autism Rating Scale, Autism Behavior Checklist, and Aberrant Behavior Checklist; social maturity by the Social Maturity Scale; quality of life by the Child Health Questionnaire and EuroQoL Five-dimension Five-level Youth; and parental stress by the Parenting Stress Index at baseline and at 6, 12, and 24 weeks after the beginning of treatment. In addition, to evaluate safety, we will investigate the adverse reactions that may be caused by UGSJB granule. Finally, we will make an economic evaluation of UGSJB for the treatment of ASD. DISCUSSION: We prepared a well-designed clinical trial to investigate the safety and effectiveness of UGSJB on ASD symptoms compared with placebo treatment. The results from this study will provide clinical evidence on the safety, effectiveness, and economic value of UGSJB combined with acupuncture in children with ASD. TRIAL REGISTRATION: Clinical Research Information Service: KCT0003007 (registered on April 5, 2018).

Feasibility and effectiveness assessment of a mobile application for subhealth management: Study protocol for a randomized controlled trial.

INTRODUCTION: Mibyeongbogam (MBBG) is a mobile application developed for subhealth status self-management in the Republic of Korea. It aims to assess a user's subhealth status, and then to recommend relevant traditional Korean medicine (TKM)-based health-promoting strategies. The purpose of this study is to evaluate the feasibility and effectiveness of MBBG's employment for the subhealth management of general healthy adults. METHODS: This is a prospective, open-label, parallel group, randomized controlled trial that will seek to enroll 150 healthy adults, aged 30 to 49 years old, from 2 hospitals in the Republic of Korea. The eligible participants will then be randomly allocated to either the MBBG or control group, at a 1:1 allocation ratio. The MBBG group will use the application for 12 weeks, while the control group will undergo no intervention. The awareness of subhealth status will be primarily assessed. Health promoting behaviors, quality of life, TKM-based health questionnaires, and physical examination results will be assessed as secondary outcomes. DISCUSSION: The primary endpoint will be tested with a 2-sample t test, or a Wilcoxon rank sum test. Any other continuous variables will be tested via an analysis of covariance, while categorical variables will be tested by a Chi-squared or Fisher exact test. Repeated measure analysis of variance will be performed to explore any in-group differences. The results will be addressed with a 95% confidence interval. We expect that MBBG will be the 1st TKM-based mobile application to be feasible for primary care in subhealth management. TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003488, February 11, 2019.

Effectiveness, safety, and economic evaluation of topical application of a herbal ointment, Jaungo, for radiation dermatitis after breast conserving surgery in patients with breast cancer (GREEN study): Study protocol for a randomized controlled trial.

INTRODUCTION: This is a prospective, open-label, parallel-group, randomized controlled trial that evaluates the effectiveness and safety of adjuvant application of Jaungo (JUG) for radiation-induced dermatitis (RD) in breast cancer patients undergoing radiation therapy, in comparison with general supportive care (GSC). METHODS/DESIGN: Eighty female patients, who have been diagnosed with unilateral breast cancer, will be allocated to either the JUG or GSC group with an allocation ratio of 1:1 after breast conservation surgery, in the Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea. Both the groups will be subjected to GSC, but only the JUG group participants will apply adjuvant JUG ointment on the irradiated skin for 6 weeks, twice a day. The primary outcome of this study is the assessment of incidence rate of RD using the Radiation Therapy Oncology Group (RTOG) for toxicity gradation of 2 or more. Maximum pain level, quality of life, adverse reactions, and pharmacoeconomic evaluations will also be included. DISCUSSION: The primary outcome will be statistically compared using the logrank test after estimating the survival curve using the Kaplan-Meier method. Continuous variables will be tested using independent t test or Mann-Whitney U test. The adverse events will be evaluated with Chi-square or Fisher exact test. All the data will be analyzed at a significance level of 0.05 (two-sided) with R software (The R Foundation). TRIAL REGISTRATION: CRIS (Clinical Research Information Service), KCT0003506, 14 February 2019.