BACKGROUND: Breast cancer patients suffer from lowered quality of life (QoL) after surgery. Breast conservancy surgery (BCS) such as partial mastectomy is being practiced and studied as an alternative to solve this problem. This study confirmed breast tissue reconstruction in a pig model by fabricating a 3-dimensional (3D) printed Polycaprolactone spherical scaffold (PCL ball) to fit the tissue resected after partial mastectomy. METHODS: A 3D printed Polycaprolactone spherical scaffold with a structure that can help adipose tissue regeneration was produced using computer-aided design (CAD). A physical property test was conducted for optimization. In order to enhance biocompatibility, collagen coating was applied and a comparative study was conducted for 3 months in a partial mastectomy pig model. RESULTS: In order to identify adipose tissue and fibroglandular tissue, which mainly constitute breast tissue, the degree of adipose tissue and collagen regeneration was confirmed in a pig model after 3 months. As a result, it was confirmed that a lot of adipose tissue was regenerated in the PCL ball, whereas more collagen was regenerated in the collagen-coated Polycaprolactone spherical scaffold (PCL–COL ball). In addition, as a result of confirming the expression levels of TNF-a and IL-6, it was confirmed that PCL ball showed higher levels than PCL–COL ball. CONCLUSION Through this study, we were able to confirm the regeneration of adipose tissue through a 3-dimensional structure in a pig model. Studies were conducted on medium and large-sized animal models for the final purpose of clinical use and reconstruction of human breast tissue, and the possibility was confirmed.

Purpose: The aim of this study is to evaluate bone change around the implant in patients who underwent alveolar ridge preservation for implantation in the posterior teeth using radiographic data measuring changes of mesial, distal crestal bone level according to post-implantation, post-final prosthesis delivery and follow-up periods. Materials and methods: In total, 36 implants were placed in 32 patients. The mesial and distal crestal bone level of all the areas where alveolar ridge preservation was performed uses panoramic images taken post-implantation, post-final prosthesis delivery, and follow-up period each was measured and evaluated as a vertical value. The following factors were analyzed: associations between changes of crestal bone level and factors (e.g., age, sex, systemic diseases, dentist, implant location, tooth, bone type, membrane). The statistical analysis was performed using the mean, standard deviation and independent t-test, paired t-test (P < .05). Results: Analysis of crestal bone level differences between periods shows statistically significant differences (P < .05). There was no statistically significant difference when the changes of crestal bone level between post-implantation, post-final prosthesis delivery and follow-up periods were correlated with each factors. Conclusion After alveolar ridge preservation, bone around the implant remained stable during the maintenance period without being affected by the patient and surgical factors, and alveolar ridge preservation is considered a clinically usable procedure.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Purpose: The aim of this study is to evaluate bone change around the implant in patients who underwent alveolar ridge preservation for implantation in the posterior teeth using radiographic data measuring changes of mesial, distal crestal bone level according to post-implantation, post-final prosthesis delivery and follow-up periods. Materials and methods: In total, 36 implants were placed in 32 patients. The mesial and distal crestal bone level of all the areas where alveolar ridge preservation was performed uses panoramic images taken post-implantation, post-final prosthesis delivery, and follow-up period each was measured and evaluated as a vertical value. The following factors were analyzed: associations between changes of crestal bone level and factors (e.g., age, sex, systemic diseases, dentist, implant location, tooth, bone type, membrane). The statistical analysis was performed using the mean, standard deviation and independent t-test, paired t-test (P < .05). Results: Analysis of crestal bone level differences between periods shows statistically significant differences (P < .05). There was no statistically significant difference when the changes of crestal bone level between post-implantation, post-final prosthesis delivery and follow-up periods were correlated with each factors. Conclusion After alveolar ridge preservation, bone around the implant remained stable during the maintenance period without being affected by the patient and surgical factors, and alveolar ridge preservation is considered a clinically usable procedure.

OBJECTIVES: Vitamin D is regarded as one of the major nutrients that significantly influence bone metabolism. This study aims to look at the effect of supplementary vitamin D on bone mineral density (BMD) in female osteoporosis patients. METHODS: The retrospective hospital record review was performed on 282 patients who were diagnosed with osteoporosis and treated with selective estrogen receptor modulators (SERMs) between January 2015 and December 2016. Of these patients, 151 were treated with SERMs only while 131 were treated using both SERMs and vitamin D supplements. The BMD and any occurrence of osteoporotic fracture episode were investigated after one year. The result of two groups was compared to find the significance of vitamin D. RESULTS: Overall, improvement in BMD score was observed in 76% of the patients. The BMD of the SERMs only group improved by 3% in spine and 1% in the hip while that of the SERMs with vitamin D group improved by 6% and 1% respectively. Statistical significance was noticed in the spine only. One distal radius fracture and one single level vertebral fracture occurred in patients of SERMs group while two distal radius fractures occurred in SERMs with vitamin D group. There was no occurrence of around hip fracture in both groups. CONCLUSION: The result of the current study suggests that additional vitamin D may have some additive effect on improving BMD of the spine. Further study with the larger study population and the extended study period is recommended.
Bone Density ; Female ; Hip ; Hospital Records ; Humans ; Metabolism ; Osteoporosis ; Osteoporotic Fractures ; Radius Fractures ; Retrospective Studies ; Selective Estrogen Receptor Modulators ; Spine ; Vitamin D ; Vitamins

OBJECTIVES: Insomnia is one of the major concerns in the elderly population. Cognitive behavioral treatment for insomnia is the first line treatment option, but there are some limitations including time and cost burdens and the requirement for sufficient cognitive resources to obtain a proper treatment effect. The Brief intervention for insomnia (BII) is a treatment that focuses on behavioral aspects of insomnia in primary care practices. The purpose of this study was to evaluate the effects of BII in community-dwelling older adults. METHODS: A total of 47 older adults with insomnia were enrolled from community centers between May 2016 and January 2018. They participated in the BII program for three weeks. We gathered sleep-related participant information with using the Pittsburgh sleep quality index (PSQI), the Sleep hygiene index, and a sleep diary. Clinical efficacy was evaluated by comparing total sleep time (TST), sleep latency (SL), waking after sleep onset (WASO), and sleep efficiency (SE) before and after the treatment. RESULTS: There was significant improvement in sleep-related features after BII. Global score and sleep quality from the PSQI, freshness, and WASO from the sleep diary showed statistically significant improvement. CONCLUSION: We found BII showed positive clinical efficacy in community dwelling older adults, especially from the perspective of subjective sleep quality and WASO. This finding implies that BII can be effectively applied for the managment of elderly insomnia patients in a community setting.
Adult ; Aged ; Humans ; Hygiene ; Independent Living ; Primary Health Care ; Sleep Initiation and Maintenance Disorders ; Treatment Outcome

BACKGROUND/OBJECTIVES: Easy access to intervention and support for certain behaviors is important for obesity prevention and management. The available technology such as smartphone applications can be used for intervention regarding healthy food choices for obesity prevention and management in elementary-school students. The transtheoretical model (TTM) is comprised of stages and processes of change and can be adopted to tailored education for behavioral change. This study aims to develop TTM-based nutrition contents for mobile applications intended to change eating behaviors related to weight gain in young children. SUBJECTS/METHODS: A synthesized algorithm for tailored nutrition messages was developed according to the intake status of six food groups (vegetables, fruits, sugar-sweetened beverages, fast food and instant food, snacks, and late-night snacks), decision to make dietary behavioral changes, and self-confidence in dietary behavioral changes. The messages in this study were developed from December 2014 to April 2015. After the validity evaluation of the contents through expert consultation, tailored nutrition information messages and educational contents were developed based on the TTM. RESULTS: Based on the TTM, stages of subjects are determined by their current intake status, decision to make dietary behavioral changes, and self-confidence in dietary behavioral changes. Three versions of tailored nutrition messages at each TTM stage were developed so as to not send the same messages for three weeks at most, and visual materials such as figures and tables were developed to provide additional nutritional information. Finally, 3,276 tailored nutrition messages and 60 nutrition contents for applications were developed. CONCLUSIONS: Smartphone applications may be an innovative medium to deliver interventions for eating behavior changes directly to individuals with favorable cost-effectiveness. In addition, using the TTM for tailored nutrition education for healthy eating is an effective approach.
Beverages ; Child ; Eating ; Education ; Fast Foods ; Feeding Behavior ; Fruit ; Health Behavior ; Humans ; Mobile Applications ; Nutritional Status ; Obesity* ; Pediatric Obesity ; Preventive Health Services ; Smartphone* ; Snacks ; Weight Gain

Eosinophilic gastroenteritis is a rare disease characterized by prominent eosinophilic tissue infiltration of the gastrointestinal tract. Here, we report a case of eosinophilic gastroenteritis in an 18-year-old patient with prolonged nephrotic syndrome who presented with abdominal pain and peripheral hypereosinophilia. During the previous 2 years, he had visited local Emergency Department several times because of epigastric pain and nausea. He had been treated with steroid-dependent nephrotic syndrome since 3 years of age. Tests ruled out allergic and parasitic disease etiologies. Gastroduodenoscopy with biopsy revealed marked eosinophilic infiltration in the duodenum. Renal biopsy findings indicated minimal change disease spectrum without eosinophilic infiltration. The oral deflazacort dosage was increased, and the patient was discharged after abdominal pain resolved. To our knowledge, this is the first report of eosinophilic gastroenteritis in a patient with minimal change disease.
Abdominal Pain ; Adolescent* ; Biopsy ; Duodenum ; Emergency Service, Hospital ; Eosinophilia ; Eosinophils* ; Gastroenteritis* ; Gastrointestinal Tract ; Humans ; Male* ; Nausea ; Nephrosis, Lipoid ; Nephrotic Syndrome* ; Parasitic Diseases ; Rare Diseases

Gastroesophageal reflux disorder (GERD) is the most common esophageal disorder in children. Achalasia occurs less commonly but has similar symptoms to GERD. A nine-year old boy presented with vomiting, heartburn, and nocturnal cough. The esophageal impedance-pH monitor revealed nonacidic GERD (all-refluxate clearance percent time of 20.9%). His symptoms persisted despite medical treatment for GERD, and he was lost to follow up. Four years later, he presented with heartburn, solid-food dysphagia, daily post-prandial vomiting, and failure to thrive. Endoscopy showed a severely dilated esophagus with candidiasis. High-resolution manometry was performed, and he was diagnosed with classic achalasia (also known as type I). His symptoms resolved after two pneumatic dilatation procedures, and his weight and height began to catch up to his peers. Clinicians might consider using high-resolution manometry in children with atypical GERD even after evaluation with an impedance-pH monitor.
Candidiasis ; Child* ; Cough ; Deglutition Disorders ; Dilatation ; Electric Impedance ; Endoscopy ; Esophageal Achalasia* ; Esophageal pH Monitoring ; Esophagus ; Failure to Thrive ; Gastroesophageal Reflux* ; Heartburn ; Humans ; Lost to Follow-Up ; Male ; Manometry* ; Vomiting