Novel clinical trial designs are conducted in the precision medicine era. This study aimed to evaluate biomarker-driven, adaptive phase II trials in precision oncology, focusing on infrastructure, efficacy, and safety. We systematically reviewed and analyzed the target studies. EMBASE and PubMed searches from 2015 to 2023 generated 29 eligible trials. Data extraction included infrastructure, biomarker screening methodologies, efficacy, and safety profiles. Government agencies, cancer hospitals, and academic societies with accumulated experiences led investigator-initiated precision oncology clinical trials (IIPOCTs), which later guided sponsor-initiated precision oncology clinical trials (SIPOCTs). Most SIPOCTs were international studies with basket design. IIPOCTs primarily used the central laboratory for biomarker screening, but SIPOCTs used both central and local laboratories. Most of the studies adapted next-generation sequencing and/or immunohistochemistry for biomarker screening. Fifteen studies included an independent central review committee for outcome investigation. Efficacy assessments predominantly featured objective response rate as the primary endpoint, with varying results. Nine eligible studies contributed to the United States Food and Drug Administration’s marketing authorization. Safety monitoring was rigorous, but reporting formats lacked uniformity. Health-related quality of life and patient-reported outcomes were described in some protocols but rarely reported. Our results reveal that precision oncology trials with adaptive design rapidly and efficiently evaluate anticancer drugs’ efficacy and safety, particularly in specified biomarker-driven cohorts. The evolution from IIPOCT to SIPOCT has facilitated fast regulatory approval, providing valuable insights into the precision oncology landscape.

Coronavirus disease 2019 (COVID-19), a multi-organ disease impacting the respiratory system and various organs, has recently been linked to diverse cutaneous manifestations. COVID toes, a cutaneous sign of COVID-19 infection, is relatively common in children and young adults, although its clear association with COVID-19 has not been widely reported. This report presents the case of a 1-year-old infant with COVID toes. The patient exhibited violaceous discoloration in the distal toes. Further, the patient exhibited no symptoms of COVID-19 infection and the enzyme-linked immunosorbent assay was negative for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2); therefore, the patient was initially diagnosed with frostbite. However, the infant’s condition deteriorated despite treatment with nonsteroidal anti-inflammatory drugs and a warm-water bath. After a skin biopsy and serum SARS-CoV-2 test, the patient was diagnosed with COVID toes and treated with systemic steroids, photobiomodulation therapy, and dressing. This case underscores the importance of recognizing chilblain-like lesions in pediatric patients during the COVID-19 pandemic, emphasizing the need for awareness of COVID toes among healthcare professionals.

Purpose: Concomitant ankle injuries associated with tibial shaft fractures can affect postoperative ankle joint pain and various postoperative ankle complications. This study compared the clinical outcomes between surgical treatment and conservative treatment of concomitant ankle injuries associated with tibial shaft fractures. Materials and Methods: From January 2015 to June 2020, a retrospective study was conducted on 118 tibia shaft fractures at the orthopedics department of the hospital. Associated ankle injuries were analyzed using plain radiographs, computed tomography (CT), magnetic resonance imaging (MRI), and intraoperative stress exams. The clinical outcomes were compared using the pain visual analog scale (pain VAS), American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score (AOFAS score), and Karlsson–Peterson ankle score (KP score). Results: Seventy-two (61.02%) of the 118 cases were diagnosed with associated ankle injuries. Fifty-six cases underwent surgery for the ankle injury, and 16 cases underwent conservative treatment. The clinical results (according to the pain VAS score, AOFAS score, the KP score) were 1.79±1.26, 94.48±4.03, and 94.57±3.60, respectively, in the surgical treatment group, and 3.00±1.03, 91.06±3.02, and 91.25±3.31, respectively, in the conservative treatment group. Conclusion Surgical treatment showed better clinical outcomes than conservative treatment in concomitant ankle injury in tibia fractures. Therefore, surgical treatment produces better clinical outcomes than conservative treatment in concomitant ankle injuries in tibia fractures. Hence to improve the clinical outcomes, more attention is needed on ankle joint injury in tibial shaft fractures for selecting suitable surgical treatments for those patients.

Background: The coronavirus disease 2019 (COVID-19) pandemic has caused the death of thousands of patients worldwide. Although age is known to be a risk factor for morbidity and mortality in COVID-19 patients, critical illness or death is occurring even in the younger age group as the epidemic spreads. In early 2022, omicron became the dominant variant of the COVID-19 virus in South Korea, and the epidemic proceeded on a large scale. Accordingly, this study aimed to determine whether young adults (aged ≤ 50 years) with critical COVID-19 infection during the omicron period had different characteristics from older patients and to determine the risk factors for mortality in this specific age group. Methods: We evaluated 213 critical adult patients (high flow nasal cannula or higher respiratory support) hospitalized for polymerase chain reaction-confirmed COVID-19 in nine hospitals in South Korea between February 1, 2022 and April 30, 2022. Demographic characteristics, including body mass index (BMI) and vaccination status; underlying diseases; clinical features and laboratory findings; clinical course; treatment received; and outcomes were collected from electronic medical records (EMRs) and analyzed according to age and mortality. Results: Overall, 71 critically ill patients aged ≤ 50 years were enrolled, and 142 critically ill patients aged over 50 years were selected through 1:2 matching based on the date of diagnosis. The most frequent underlying diseases among those aged ≤ 50 years were diabetes and hypertension, and all 14 patients who died had either a BMI ≥ 25 kg/m 2 or an underlying disease. The total case fatality rate among severe patients (S-CFR) was 31.0%, and the S-CFR differed according to age and was higher than that during the delta period. The S-CFR was 19.7% for those aged ≤ 50 years, 36.6% for those aged > 50 years, and 38.1% for those aged ≥ 65 years. In multivariate analysis, age (odds ratio [OR], 1.084; 95% confidence interval [CI], 1.043–1.127), initial low-density lipoprotein > 600 IU/L (OR, 4.782; 95% CI, 1.584–14.434), initial C-reactive protein > 8 mg/dL (OR, 2.940; 95% CI, 1.042–8.293), highest aspartate aminotransferase > 200 IU/L (OR, 12.931; 95% CI, 1.691–98.908), and mechanical ventilation implementation (OR, 3.671; 95% CI, 1.294–10.420) were significant independent predictors of mortality in critical COVID-19 patients during the omicron wave. A similar pattern was shown when analyzing the data by age group, but most had no statistical significance owing to the small number of deaths in the young critical group. Although the vaccination completion rate of all the patients (31.0%) was higher than that in the delta wave period (13.6%), it was still lower than that of the general population. Further, only 15 (21.1%) critically ill patients aged ≤ 50 years were fully vaccinated. Overall, the severity of hospitalized critical patients was significantly higher than that in the delta period, indicating that it was difficult to find common risk factors in the two periods only with a simple comparison. Conclusion Overall, the S-CFR of critically ill COVID-19 patients in the omicron period was higher than that in the delta period, especially in those aged ≤ 50 years. All of the patients who died had an underlying disease or obesity. In the same population, the vaccination rate was very low compared to that in the delta wave, indicating that non-vaccination significantly affected the progression to critical illness. Notably, there was a lack of prescription for Paxlovid for these patients although they satisfied the prescription criteria. Early diagnosis and active initial treatment was necessary, along with the proven methods of vaccination and personal hygiene. Further studies are needed to determine how each variant affects critically ill patients.

OBJECTIVES: In July 2019, there were multiple reports on patients with hepatitis A among the visitors of a restaurant in Busan. The current study presents the results of an epidemiological investigation and outlines the supplementary measures that would help with hepatitis A control. METHODS: A cohort study was conducted for all 2,865 customers who visited restaurant A from June to July. Using a standardized questionnaire, participants reported the presence of hepatitis A symptoms and whether they had consumed any of 19 food items. As for participants who had visited public health centers, their specimens were collected. RESULTS: From the study cohort, 155 participants (5.4%) had confirmed hepatitis A. The epidemic curve was unimodal, and the median number of days from the restaurant visit to symptom onset was 31 days. A genotype analysis indicated that 89 of 90 tested patients had hepatitis A virus (HAV) genotype 1A. The results of a multivariate logistic regression analysis indicated that the ingestion of salted clams increased the risk of hepatitis A by 68.12 times (95% confidence interval [CI], 9.22 to 510.87). In an unopened package of salted clams found and secured through traceback investigation, HAV genotype 1A was detected. CONCLUSIONS To prevent people from ingesting uncooked clams, there needs to be more efforts to publicize the dangers of uncooked clams; the food sampling test standards for salted clams should also be expanded. Furthermore, a laboratory surveillance system based on molecular genetics should be established to detect outbreaks earlier.

Background: As society becomes more complex, the incidence of mandibular fractures is increasing. This study aimed to analyze the incidence and type and identify etiological factors of mandibular fractures to use them in future treatments.Material and methodsData were collected from 224 patients who visited the department of oral and maxillofacial surgery at the Kyung Hee Medical Center dental hospital during a 6-year period (2016 to 2021). A logistic regression model was used for data analysis. Results: In a total of 224 patients, 362 fractures were appeared. The average age of the patients was 34.1 years, with the highest incidence in the 20s. And the ratio between male and female was 4.09:1. Symphysis fractures were the most prevalent of all patients (52.7%), followed by unilateral condyle (37.1%), angle (36.2%), bilateral condyle (9.4%), body (8%), and coronoid (2.2%). The most common cause of fracture was daily-life activity (57.6%), followed by violence (30.4%), traffic accidents (8.5%), and syncope (3.6%). Patients with symphysis fracture were at low risk (OR < 1) of angle, body, and unilateral condyle fractures. Similarly, patients with unilateral fracture were at low risk (OR < 1) of symphysis, angle, body, and others site fractures. In contrast, patient with bilateral condyle fracture were at high risk (OR > 1) of coronoid fractures. And younger patients were high risk of mandibular angle fractures. Conclusion Through this study, it was confirmed that etiological factors of mandibular fractures were like those of previous studies.

Background: This study aimed to describe the maternal, obstetrical, and neonatal outcomes in pregnant women with coronavirus disease 2019 (COVID-19) and identify the predictors associated with the severity of COVID-19. Methods: This multicenter observational study included consecutive pregnant women admitted because of COVID-19 confirmed using reverse transcriptase-polymerase chain reaction (RT-PCR) test at 15 hospitals in the Republic of Korea between January 2020 and December 2021. Results: A total of 257 women with COVID-19 and 62 newborns were included in this study. Most of the patients developed this disease during the third trimester. Nine patients (7.4%) developed pregnancy-related complications. All pregnant women received inpatient treatment, of whom 9 (3.5%) required intensive care, but none of them died. The gestational age at COVID-19 diagnosis (odds ratio [OR], 1.096, 95% confidence interval [CI], 1.04–1.15) and parity (OR, 1.703, 95% CI, 1.13–2.57) were identified as significant risk factors of severe diseases. Among women who delivered, 78.5% underwent cesarean section. Preterm birth (38.5%), premature rupture of membranes (7.7%), and miscarriage (4.6%) occurred, but there was no stillbirth or neonatal death. The RT-PCR test of newborns’ amniotic fluid and umbilical cord blood samples was negative for severe acute respiratory syndrome coronavirus 2. Conclusion At the time of COVID-19 diagnosis, gestational age and parity of pregnant women were the risk factors of disease severity. Vertical transmission of COVID-19 was not observed, and maternal severity did not significantly affect the neonatal prognosis.

Systemic lupus erythematosus (SLE) may occur in any organ. In patients with SLE, myocarditis is extremely rare and potentially life-threatening. Herein, we report on a patient with lupus myocarditis, diagnosed by myocardial biopsy, immunologic tests, and clinical manifestations. Our findings suggest that securing time for diagnosis via extracorporeal membrane oxygenation and other intensive care is helpful for obtaining a good prognosis.

Systemic lupus erythematosus (SLE) may occur in any organ. In patients with SLE, myocarditis is extremely rare and potentially life-threatening. Herein, we report on a patient with lupus myocarditis, diagnosed by myocardial biopsy, immunologic tests, and clinical manifestations. Our findings suggest that securing time for diagnosis via extracorporeal membrane oxygenation and other intensive care is helpful for obtaining a good prognosis.

Objectives: To describe and evaluate epidemiological investigation results and containment measures implemented in Busan, where 108 cases were confirmed with coronavirus disease 2019 (COVID-19) between February 21, 2020 and March 24, 2020. Methods: Any individual who tested positive for COVID-19 was classified as a confirmed case. Measures were taken to identify the source of infection and trace and quarantine contacts. Serial intervals were estimated and the effective reproduction number was computed. Results: Of the total 18,303 COVID-19 tests performed between January 16, 2020 and March 24, 2020 in Busan, 108 yielded positive results (positive test rate, 0.6%). All confirmed cases were placed in isolation at hospitals. Of the 108 confirmed cases, 59 (54.6%) were female. The most common age group was 20-29 years with 37 cases (34.3%). Regarding symptoms at the time of diagnosis, cough (n=38, 35.2%) and fever (n=34, 31.5%) were most common; 12 cases (11.1%) were asymptomatic. The source of infection was identified in 99 cases (91.7%). A total of 3,223 contacts were identified and quarantined. Household contacts accounted for 196, and the household secondary attack rate was 8.2% (95% confidence interval [CI], 4.7 to 12.9). The mean serial interval was estimated to be 5.54 days (95% CI, 4.08 to 7.01). After February 26, (Rt) remained below 1 in Busan. Conclusions The early containment strategy implemented in Busan shows that control is possible if outbreaks are of limited scope. In preparation for future outbreaks, public health and healthcare systems should be re-examined and put in a ready state.