• Title/Summary/Keyword: e-clinical data

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Domestic development situation of precision nutrition healthcare (PNH) system based on direct-to-consumer (DTC) obese genes (소비자대상 직접 (DTC) 비만유전자 기반 정밀영양 (PNH)의 국내 현황)

  • Oh Yoen Kim;Myoungsook Lee;Jounghee Lee;Cheongmin Sohn;Mi Ock Yoon
    • Journal of Nutrition and Health
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    • v.55 no.6
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    • pp.601-616
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    • 2022
  • In the era of the fourth industrial revolution technology, the inclusion of personalized nutrition for healthcare (PNH), when establishing a healthcare platform to prevent chronic diseases such as obesity, diabetes, cerebrovascular and cardiovascular disease, pulmonary disease, and inflammatory diseases, enhances the national competitiveness of global healthcare markets. Furthermore, since the government experienced COVID-19 and the population dead cross in 2020, as well as numerous health problems due to an increasing super-aged Korean society, there is an urgent need to secure, develop, and utilize PNH-related technologies. Three conditions are essential for the development of PNH technologies. These include the establishment of causality between obesity genome (genotype) and prevalence (phenotype) in Koreans, validation of clinical intervention research, and securing PNH-utilization technology (i.e., algorithm development, artificial intelligence-based platform, direct-to-customer [DTC]-based PNH, etc.). Therefore, a national control tower is required to establish appropriate PNH infrastructure (basic and clinical research, cultivation of PNH-related experts, etc.). The post-corona era will be aggressive in sharing data knowledge and developing related technologies, and Korea needs to actively participate in the large-scale global healthcare markets. This review provides the importance of scientific evidence based on a huge dataset, which is the primary prerequisite for the DTC obesity gene-based PNH technologies to be competitive in the healthcare market. Furthermore, based on comparing domestic and internationally approved DTC obese genes and the current status of Korean obesity genome-based PNH research, we intend to provide a direction to PNH planners (individuals and industries) for establishing scientific PNH guidelines for the prevention of obesity.

Chylous Ascites After Gastric Cancer Surgery: Risk Factors and Treatment Results

  • Sung Hyun Park;Ki-Yoon Kim;Minah Cho;Hyoung-Il Kim;Woo Jin Hyung;Yoo Min Kim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.253-263
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    • 2023
  • Purpose: Although chylous ascites is a frequent complication of radical gastrectomy for gastric cancer, proper diagnostic criteria and optimal treatment strategies have not been established. This study aimed to identify the clinical features of chylous ascites and evaluate the treatment outcomes. Materials and Methods: We retrospectively analyzed the data of patients who underwent radical gastrectomy between 2013 and 2019. Diagnosis was made when milky fluid or elevated triglyceride levels (≥100 mg/dL) appeared in the drains without a preceding infection. The clinical features, risk factors, and treatment outcomes were assessed according to the initial treatment modalities for fasting and non-fasting groups. Results: Among the 7,388 patients who underwent radical gastrectomy for gastric cancer, 156 (2.1%) experienced chylous ascites. The median length of hospital stay was longer in patients with chylous ascites than in those without (median [interquartile range]: 8.0 [6.0-12.0] vs. 6.0 [5.0-8.0], P<0.001). Low body mass index (adjusted odds ratio [aOR]=0.9; P<0.001), advanced gastric cancer (aOR=1.51, P=0.024), open surgery (reference: laparoscopic surgery; aOR=1.87, P=0.003), and extent of surgical resection (reference: subtotal gastrectomy, total gastrectomy, aOR=1.5, P=0.029; proximal gastrectomy, aOR=2.93, P=0.002) were associated with the occurrence of chylous ascites. The fasting group (n=12) was hospitalized for a longer period than the non-fasting group (n=144) (15.0 [12.5-19.5] vs. 8.0 [6.0-10.0], P<0.001). There was no difference in grade III complication rate (16.7% vs. 4.2%, P=0.117) or readmission rate (16.7% vs. 11.1%, P=0.632) between the groups. Conclusions: A fat-controlled diet and medication without fasting provided adequate initial treatment for chylous ascites after radical gastrectomy for gastric cancer.

Epigallocatechin-3-gallate prior to composite resin in abfraction lesions: a split-mouth randomized clinical trial

  • Luisa Valente Gotardo Lara Alves;Lisiane Martins Fracasso;Thiago Vinicius Cortez;Aline Evangelista Souza-Gabriel;Silmara Aparecida Milori Corona
    • Restorative Dentistry and Endodontics
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    • v.48 no.2
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    • pp.13.1-13.11
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    • 2023
  • Objectives: Natural extracts have been investigated as a biomimetic strategy to mechanically strengthen the collagen network and control the biodegradation of extracellular matrix. This study evaluated the effect of epigallocatechin-3-gallate (EGCG) on abfraction lesions prior to the composite resin. Materials and Methods: The sample consisted of 30 patients (aged between 28 and 60 years) with abfraction lesions located in 2 homologous premolars. The teeth were randomly assigned according to dentin treatment: 0.02% EGCG solution or distilled water (control). After enamel acid etching, the solutions were applied immediately for 1 minute. The teeth were restored with Universal Adhesive (3M) and Filtek Z350 XT (3M). Analyzes were done by 2 independent examiners using modified USPHS (retention, secondary caries, marginal adaptation, and postoperative sensitivity) and photographic (color, marginal pigmentation, and anatomical form) criteria at baseline (7 days) and final (18 months). The data analysis used Friedman and Wilcoxon signed-rank tests (α = 0.05). Results: At baseline, all restorations were evaluated as alpha for all criteria. After 18 months, restorations were evaluated as alpha for secondary caries, color, and marginal pigmentation. There was significant difference between baseline and 18 months (p = 0.009) for marginal adaptation and postoperative sensitivity (p = 0.029), but no significant difference were verified between treatments (p = 0.433). The EGCG group had a restoration retention rate of 93.3%, while the control group had 96.7%. Conclusions: The application of EGCG solution on abfraction lesions did not significantly influence the survival of the restorations based on clinical and photographic criteria.

Evaluation of at-home bleaching protocol with application on different surfaces: bleaching efficacy and hydrogen peroxide permeability

  • Heloisa Forville;Michael Willian Favoreto;Michel Wendlinger;Roberta Micheten Dias;Christiane Philippini Ferreira Borges;Alessandra Reis;Alessandro D. Loguercio
    • Restorative Dentistry and Endodontics
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    • v.48 no.4
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    • pp.33.1-33.12
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    • 2023
  • Objectives: This study aimed to evaluate the bleaching efficacy and hydrogen peroxide permeability in the pulp chamber by the at-home bleaching gel in protocols applied on different dental surfaces. Materials and Methods: Forty premolars were randomly into 4 groups: control group no bleaching, only application on the buccal surface (OB), only application on the lingual surface (OL) and application in buccal and lingual surfaces, simultaneously (BL). At-home bleaching gel (White Class 7.5%) was used for the procedure. The bleaching efficacy was evaluated with a digital spectrophotometer (color change in CIELAB [ΔEab] and CIEDE 2000 [ΔE00] systems and Whitening Index for Dentistry [ΔWID]). The hydrogen peroxide permeability in the pulp chamber (㎍/mL) was assessed using UV-Vis spectrophotometry and data were analyzed for a 1-way analysis of variance and Tukey's test (α = 0.05). Results: All groups submitted to bleaching procedure showed bleaching efficacy when measured with ΔEab and ΔE00 (p > 0.05). Therefore, when analyzed by ΔWID, a higher bleaching efficacy were observed for the application on the groups OB and BL (p = 0.00003). Similar hydrogen peroxide permeability was found in the pulp chambers of the teeth undergoing different protocols (p > 0.05). Conclusions: The application of bleaching gel exclusively on the OB is sufficient to achieve bleaching efficacy, when compared to BL. Although the OL protocol demonstrated lower bleaching efficacy based on the ΔWID values, it may still be of interest and relevant in certain clinical scenarios based on individual needs, requiring clinical trials to better understand its specificities.

Endoscopic ultrasound-guided coiling and glue is safe and superior to endoscopic glue injection in gastric varices with severe liver disease: a retrospective case control study

  • Kapil D. Jamwal;Rajesh K. Padhan;Atul Sharma;Manoj K. Sharma
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.65-74
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    • 2023
  • Background/Aims: Gastric varices (GV) are present in 25% of cirrhotic patients with high rates of rebleeding and mortality. Data on endoscopic ultrasound (EUS)-guided treatment in severe liver disease (model for end stage liver disease sodium [MELD-Na] >18 and Child-Turcotte-Pugh [CTP] C with GV) are scarce. Thus, we performed a retrospective comparison of endoscopic glue injection with EUS-guided therapy in cirrhotic patients with large GV. Methods: A retrospective study was performed in the tertiary hospitals of India. A total of 80 patients were recruited. The inclusion criteria were gastroesophageal varices type 2, isolated gastric varices type 1, bleeding within 6 weeks, size of GV >10 mm, and a MELD-Na >18. Treatment outcomes and complications of endoscopic glue injection and EUS-guided GV therapy were compared. Results: In this study, the patients' age, sex, liver disease severity (CTP, MELD-Na) and clinical parameters were comparable. The median number of procedures, injected glue volume, complications, and GV obturation were better in the EUS group, respectively. On subgroup analysis of the EUS method (e.g., direct gastric fundus vs. paragastric collateral [PGC] coil placement), PGC coil placement showed decreased coil requirement, less injected glue volume, decreased luminal coil extrusion, and increased successful GV obturation. Conclusions: EUS-guided treatment is more efficient and safer, and requires a smaller number of treatment sessions, as compared to endoscopic treatment in severe liver disease patients with large GV. Furthermore, PGC coil placement increases the complete obliteration of GV.

Adverse Events in Total Artificial Heart for End-Stage Heart Failure: Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)

  • Min Choon Tan;Yong Hao Yeo;Jia Wei Tham;Jian Liang Tan;Hee Kong Fong;Bryan E-Xin Tan;Kwan S Lee;Justin Z Lee
    • International Journal of Heart Failure
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    • v.6 no.2
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    • pp.76-81
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    • 2024
  • Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

Clinical Feasibility of Vascular Navigation System During Laparoscopic Gastrectomy for Gastric Cancer: A Retrospective Comparison With Propensity-Score Matching

  • Ji Eun Jung;Jeong Ho Song;Seyeol Oh;Sang-Yong Son;Hoon Hur;In Gyu Kwon;Sang-Uk Han
    • Journal of Gastric Cancer
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    • v.24 no.4
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    • pp.356-366
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    • 2024
  • Purpose: The usability of a new surgical navigation system that provides patient-specific vascular information for robotic gastrectomy in gastric cancer remains unexplored for laparoscopic gastrectomy owing to differences in surgical environments. This study aimed to evaluate the applicability and safety of this navigation system in laparoscopic gastrectomy and to compare the post-operative outcomes between procedures with and without its use. Materials and Methods: Between June 2022 and July 2023, 38 patients across 2 institutions underwent laparoscopic gastrectomy using a navigation system (navigation group). The technical feasibility, safety, and accuracy of detecting variations in vascular anatomy were measured. The perioperative outcomes were compared with 114 patients who underwent laparoscopic gastrectomy without a navigation system (non-navigation group) using 1:3 propensity score matching during the same study period. Results: In all patients in the navigation group, no adverse events associated with the navigation system occurred during surgery in any patient in the navigation group. No accidental vessel injuries necessitate auxiliary procedures. All vessels encountered during the gastrectomy were successfully reconstructed and visualized. Patient demographics and operative data were comparable between the 2 groups. The navigation group exhibited a significantly lower overall complication rate (10.5%) than the non-navigation group (26.3%, P=0.043). Notably, pancreas-related complications were absent in the navigation group but occurred in eight cases in the non-navigation group (7.0%, P=0.093), although the difference was not statistically significant. Conclusions: The patient-specific surgical navigation system demonstrated clinical feasibility and safety for laparoscopic gastrectomy for gastric cancer, potentially reducing complication rates compared with laparoscopic gastrectomy without its use.

Microsurgical treatment of distal middle cerebral artery aneurysm: A single-center review

  • Taehoon Jang;Sung-Tae Kim;Jin Lee;Won-Hee Lee;Keun-Soo Lee;Se-Young Pyo;Junghae Ko;Hangwoo Lee;Yeong Gyun Jeong
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.26 no.1
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    • pp.37-45
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    • 2024
  • Objective: To review the characteristics of distal middle cerebral artery (MCA) aneurysm treated by microsurgery, the detailed surgical options, and the clinical result. Methods: We retrospectively reviewed cerebral aneurysm in the M2 and M3 segments of the MCA surgically treated between January 2015 and December 2022. The demographic data, aneurysm-related findings, type of surgical approach, surgical technique, and clinical outcomes of the enrolled patients were analyzed. Results: Sixteen distal MCA aneurysms were treated with microneurosurgery (incidence, 1.0%; female, 12; mean age, 58.1 years; ruptured, three). Twelve aneurysms were in the M2 segment (insular segment), two aneurysms at the M2-M3 junction, and two aneurysms in the M3 segment (opercular segment). Twelve aneurysms were saccular (average size, 4.9 mm; multiplicity, 50%; average aneurysms, 3.0; partially thrombosed, 1; sidewall aneurysm, 2). Three aneurysms were fusiform, of which two were ruptured. Of the ruptured aneurysms, one was a ruptured dissecting aneurysm. The trans-sylvian and trans-sulcal approaches were used in fourteen and two patients, respectively. Neck clipping, wrap clipping, and surgical trapping were performed in twelve, one, and one patient, respectively. Proximal occlusion was performed in one patient. Bypass technique was required in two patients (neck clipping and proximal occlusion). The modified Rankin Score was 6 in the two patients with ruptured aneurysms. The remaining patients did not show further neurological deterioration after microneurosurgery. Conclusions: Distal MCA aneurysms had a high incidence of being diagnosed with multiple other aneurysms and were relatively non-saccular.

Acoustic differences according to the epileptic focus in benign partial epilepsy with centrotemporal spikes patients (양성 부분 간질 환아에서 간질 발생 위치에 따른 음성언어 분석)

  • Kim, Jung Tae;Choi, Sang Hoon;Kim, Sun Jun
    • Clinical and Experimental Pediatrics
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    • v.50 no.9
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    • pp.896-900
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    • 2007
  • Purpose : The aim of this study was to investigate the speech problems in benign rolandic epilepsy (BRE) according to the seizure focus in EEG and semiology. Methods : Twenty three patients [right origin (13 patients) or left side (10 patients)] who met the BRE criteria by International League Against Epilepsy (ILAE) were prospectively enrolled. We excluded the patients who had abnormal MRI or showed both side spikes in EEG. Computerized Speech Lab was used to assess the speech characteristics of the patients. Results : The error pattern of laryngeal articulation in BRE was exclusively substitution of stop consonants, these errors showed more frequent in the left group (16.0% vs 25.5%). Voice onset time (VOT) of stop consonants and Total duration (TD) of word in both groups were prolonged than normal control group, especially in left group (P<0.05). The first formant of vowel /o/ and second formant of /e/ were significantly decreased in left group (P<0.05). The right group scored wider on pitch range ($192.9{\pm}54.0Hz$) and energy range in spontaneous speech ($14.2{\pm}6.4db$) than the left group ($233.3{\pm}12.5Hz$, $19.4{\pm}9.3db$, respectively, P>0.05). Duration of counting (5 to 9) in left group slower than right group ($8.6{\pm}1.7$ vs $7.9{\pm}1.8sec$). Conclusion : Our data suggested that interictal spikes and seizures in either centrotemporal sides, especially left side group, may induce speech problems. We recommend the logopedic and phoniatric evaluations of speech in BRE patients.

Bioequivalence of Kuhnil GabapentinTM Capsule 300 mg to NeurontinTM Capsule 300 mg (Gabapentin 300 mg) (뉴론틴 캡슐 300밀리그람(가바펜틴 300 mg)에 대한 건일가바펜틴 캡슐 300밀리그람의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Eun-Ja;Oh, Se-Won;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.193-199
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    • 2005
  • Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.