• Communications for Statistical Applications and Methods
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• v.25 no.5
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• pp.501-512
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• 2018

We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.

• Journal of Periodontal and Implant Science
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• v.41 no.3
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• pp.143-148
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• 2011

Purpose: Few epidemiologic studies have investigated aggressive periodontitis in Koreans, but such studies of disease prevalence and other clinical characteristics would be invaluable in providing proper treatment. The aim of this study was to assess the prevalence of aggressive periodontitis and to measure the extent of associated periodontal breakdown. Methods: The study population consisted of 1,692 patients who visited the Department of Periodontology, Wonkwang Daejeon Dental Hospital from January to December, 2010. Clinical parameters (probing depth, gingival recession, periodontal attachment loss) were measured by a single examiner, and radiographic examination was performed at the baseline. Results: Twenty-eight (1.65%) patients showed clinical features of aggressive periodontitis, of which 27 patients exhibited the generalized form, and 1 exhibited the localized form. There was no significant difference between the percentage of male and female patients. The probing pocket depth of the maxillary first molar was deeper than that of the other teeth and gingival recession was also the most serious at the maxillary first molar. The periodontal attachment loss was the highest at the maxillary first molar. The average number of missing teeth was 1.29 per subject. Loss of the second molar was prominent. Conclusions: Within the limitations of this study, the periodontal breakdown evaluated by attachment loss was found to be most severe at the first molars of aggressive periodontitis patients. However, further large scale multicenter studies are necessary to access more precise data, including prevalence.

• Clinical and Experimental Pediatrics
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• v.54 no.3
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• pp.106-110
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• 2011

In pediatric patients with acute lymphoblastic leukemia (ALL), the Philadelphia chromosome translocation is uncommon, with a frequency of less than 5%. However, it is classified as a high or very high risk, and only 20-30% of Philadelphia chromosome-positive (Ph+) children with ALL are cured with chemotherapy alone. Allogeneic hematopoietic stem cell transplantation from a closely matched donor cures 60% of patients in first complete remission. Recent data suggest that chemotherapy plus tyrosine kinase inhibitors (TKIs) may be the initial treatment of choice for Ph+ ALL in children. However, longer observation is required to determine whether long-term outcome with intensive imatinib and chemotherapy is indeed equivalent to that with allogeneic related or alternative donor hematopoietic stem cell transplantation (HSCT). Reports on the use of second-generation TKIs in children with Ph+ ALL are limited. A few case reports have indicated the feasibility and clinical benefit of using dasatinib as salvage therapy enabling HSCT. However, more extensive data from clinical trials are needed to determine whether the administration of second-generation TKIs in children is comparable to that in adults. Because Ph+ ALL is rare in children, the question of whether HSCT could be a dispensable part of their therapy may not be answered for some time. An international multicenter study is needed to answer the question of whether imatinib plus chemotherapy could replace sibling allogeneic HSCT in children with Ph+ ALL.

• Bulletin of the Korean Chemical Society
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• v.30 no.11
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• pp.2617-2620
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• 2009

Using Coulomb-Yukawa like correlated interaction potentials of integer and noninteger indices the series expansion formulae in terms of multicenter overlap integrals of three complete orthonormal sets of ${\psi}^{\alpha}$‒exponential type orbitals and linear combination coefficients of molecular orbitals are established for the potential of electrostatic field produced by the charges of molecule, where $\alpha$ = 1, 0, ‒1, ‒2,${\cdots}$. The formulae obtained can be useful for the study of interaction between atomic--molecular systems containing any number of closed and open shells when the ${\psi}^{\alpha}$‒exponential type basis functions and Coulomb-Yukawa like correlated interaction potentials are used in the Hartree-Fock-Roothaan and explicitly correlated approximations. The final results are valid for the arbitrary values of parameters of correlated interaction potentials and orbitals. As an example of application, the calculations have been performed for the potential energy of interaction between electron and molecule $H_2O$ using combined Hartree-Fock-Roothaan equations suggested by the author.

• Journal of Sasang Constitutional Medicine
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• v.26 no.3
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• pp.295-303
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• 2014

Objectives It is very important to diagnose Sasang Constitution (SC) correctly. The aim of this study was to reveal the concordance and validity of the specialists in Sasang Constitutional Medicine (SCM). Methods Three experts who had more than 5 years of experience and used more than 90% of Sasang Constitutional prescription in clinical practice of SCM participated in this study. The data composed of body shape, face, voice, temperament and physio-pathological symptoms were collected in the Korea Constitutional Multicenter Bank and 81 subjects' data were extracted randomly. The experts reviewed all 81 subjects data independently. Kappa analysis was conducted. Results 1) The concordance is from 52.5% to 68.4% among three experts. 2) The validity between individual expert and gold standard is from 54.3% to 63% and Kappa's coefficients are from 0.283 to 0.421. 3) The validity is from 68.5% to 70.7% when two or three experts agree the Sasang constitution independently and 75.7% when all of experts agree it. Conclusions The concordance and validity of experts in SCM seems to be moderate. We think further study is needed.

• Clinical and Experimental Pediatrics
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• v.62 no.5
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• pp.155-161
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• 2019

Following the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were designed to overcome limitations of natural surfactants such as cost, immune reactions, and infections elicited by animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove their superiority over natural surfactants because they lack surfactant protein (SP). Lucinactant, a second-generation synthetic surfactant containing the SP-B analog, was better or at least as effective as the natural surfactant, suggesting that lucinactant could act an alternative to natural surfactants. Lucinactant was approved by the U. S. Food and Drug Administration in March 2012 as the fifth surfactant to treat neonatal RDS. CHF5633, a second-generation synthetic surfactant containing SP-B and SP-C analogs, was effective and safe in a human multicenter cohort study for preterm infants. Many comparative studies of natural surfactants used worldwide have reported different efficacies for different preparations. However, these differences are believed to due to site variations, not actual differences. The more important thing than the composition of the surfactant in improving outcome is the timing and mode of administration of the surfactant. Novel synthetic surfactants containing synthetic phospholipid incorporated with SP-B and SP-C analogs will potentially represent alternatives to natural surfactants in the future, while improvement of treatment modalities with less-invasive or noninvasive methods of surfactant administration will be the most important task to be resolved.

• Tuberculosis and Respiratory Diseases
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• v.82 no.1
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• pp.6-14
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• 2019

Sepsis is a life-threatening condition caused by infection and represents a substantial global health burden. Recent epidemiological studies showed that sepsis mortality rates have decreased, but that the incidence has continued to increase. Although a mortality benefit from early-goal directed therapy (EGDT) in patients with severe sepsis or septic shock was reported in 2001, three subsequent multicenter randomized studies showed no benefits of EGDT versus usual care. Nonetheless, the early administration of antibiotics and intravenous fluids is considered crucial for the treatment of sepsis. In 2016, new sepsis definitions (Sepsis-3) were issued, in which organ failure was emphasized and use of the terms "systemic inflammatory response syndrome" and "severe sepsis" was discouraged. However, early detection of sepsis with timely, appropriate interventions increases the likelihood of survival for patients with sepsis. Also, performance improvement programs have been associated with a significant increase in compliance with the sepsis bundles and a reduction in mortality. To improve sepsis management and reduce its burden, in 2017, the World Health Assembly and World Health Organization adopted a resolution that urged governments and healthcare workers to implement appropriate measures to address sepsis. Sepsis should be considered a medical emergency, and increasing the level of awareness of sepsis is essential.

• Infection and chemotherapy
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• v.50 no.4
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• pp.301-310
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• 2018

Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

• Clinical Endoscopy
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• v.57 no.3
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• pp.302-308
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• 2024

With incessant advances in information technology and its implications in all domains of our lives, artificial intelligence (AI) has emerged as a requirement for improved machine performance. This brings forth the query of how this can benefit endoscopists and improve both diagnostic and therapeutic endoscopy in each part of the gastrointestinal tract. Additionally, it also raises the question of the recent benefits and clinical usefulness of this new technology in daily endoscopic practice. There are two main categories of AI systems: computer-assisted detection (CADe) for lesion detection and computer-assisted diagnosis (CADx) for optical biopsy and lesion characterization. Quality assurance is the next step in the complete monitoring of high-quality colonoscopies. In all cases, computer-aided endoscopy is used, as the overall results rely on the physician. Video capsule endoscopy is a unique example in which a computer operates a device, stores multiple images, and performs an accurate diagnosis. While there are many expectations, we need to standardize and assess various software packages. It is important for healthcare providers to support this new development and make its use an obligation in daily clinical practice. In summary, AI represents a breakthrough in digestive endoscopy. Screening for gastric and colonic cancer detection should be improved, particularly outside expert centers. Prospective and multicenter trials are mandatory before introducing new software into clinical practice.

• Clinical and Experimental Pediatrics
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• v.57 no.10
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• pp.434-439
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• 2014

Treatment outcomes of pediatric cancers have improved greatly with the development of improved treatment protocols, new drugs, and better supportive measures, resulting in overall survival rates greater than 70%. Survival rates are highest in acute lymphoblastic leukemia, reaching more than 90%, owing to risk-based treatment through multicenter clinical trials and protocols developed to prevent central nervous system relapse and testicular relapse in boys. New drugs including clofarabine and nelarabine are currently being evaluated in clinical trials, and other targeted agents are continuously being developed. Chimeric antigen receptor-modified T cells are now attracting interest for the treatment of recurrent or refractory disease. Stem cell transplantation is still the most effective treatment for pediatric acute myeloid leukemia (AML). However, in order to reduce treatment-related death after stem cell transplantation, there is need for improved treatments. New drugs and targeted agents are also needed for improved outcome of AML. Surgery and radiation therapy have been the mainstay for brain tumor treatment. However, chemotherapy is becoming more important for patients who are not eligible for radiotherapy owing to age. Stem cell transplant as a means of high dose chemotherapy and stem cell rescue is a new treatment modality and is often repeated for improved survival. Drugs such as temozolomide are new chemotherapeutic options. In order to achieve 100% cure in children with pediatric cancer, every possible treatment modality and effort should be considered.