• Title/Summary/Keyword: Imaging endpoint

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Trends in Artificial Intelligence Applications in Clinical Trials: An analysis of ClinicalTrials.gov (임상시험에서 인공지능의 활용에 대한 분석 및 고찰: ClinicalTrials.gov 분석)

  • Jeong Min Go;Ji Yeon Lee;Yun-Kyoung Song;Jae Hyun Kim
    • Korean Journal of Clinical Pharmacy
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    • v.34 no.2
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    • pp.134-139
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    • 2024
  • Background: Increasing numbers of studies and research about artificial intelligence (AI) and machine learning (ML) have led to their application in clinical trials. The purpose of this study is to analyze computer-based new technologies (AI/ML) applied on clinical trials registered on ClinicalTrials.gov to elucidate current usage of these technologies. Methods: As of March 1st, 2023, protocols listed on ClinicalTrials.gov that claimed to use AI/ML and included at least one of the following interventions-Drug, Biological, Dietary Supplement, or Combination Product-were selected. The selected protocols were classified according to their context of use: 1) drug discovery; 2) toxicity prediction; 3) enrichment; 4) risk stratification/management; 5) dose selection/optimization; 6) adherence; 7) synthetic control; 8) endpoint assessment; 9) postmarketing surveillance; and 10) drug selection. Results: The applications of AI/ML were explored in 131 clinical trial protocols. The areas where AI/ML was most frequently utilized in clinical trials included endpoint assessment (n=80), followed by dose selection/optimization (n=15), risk stratification/management (n=13), drug discovery (n=4), adherence (n=4), drug selection (n=1) and enrichment (n=1). Conclusion: The most frequent application of AI/ML in clinical trials is in the fields of endpoint assessment, where the utilization is primarily focuses on the diagnosis of disease by imaging or video analyses. The number of clinical trials using artificial intelligence will increase as the technology continues to develop rapidly, making it necessary for regulatory associates to establish proper regulations for these clinical trials.

A Study on Automatic Modeling of Pipelines Connection Using Point Cloud (포인트 클라우드를 이용한 파이프라인 연결 자동 모델링에 관한 연구)

  • Lee, Jae Won;Patil, Ashok Kumar;Holi, Pavitra;Chai, Young Ho
    • Korean Journal of Computational Design and Engineering
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    • v.21 no.3
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    • pp.341-352
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    • 2016
  • Manual 3D pipeline modeling from LiDAR scanned point cloud data is laborious and time-consuming process. This paper presents a method to extract the pipe, elbow and branch information which is essential to the automatic modeling of the pipeline connection. The pipe geometry is estimated from the point cloud data through the Hough transform and the elbow position is calculated by the medial axis intersection for assembling the nearest pair of pipes. The branch is also created for a pair of pipe segments by estimating the virtual points on one pipe segment and checking for any feasible intersection with the other pipe's endpoint within the pre-defined range of distance. As a result of the automatic modeling, a complete 3D pipeline model is generated by connecting the extracted information of pipes, elbows and branches.

Endovascular Treatment of Congenital Portosystemic Shunt: A Single-Center Prospective Study

  • Ponce-Dorrego, Maria-Dolores;Hernandez-Cabrero, Teresa;Garzon-Moll, Gonzalo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.25 no.2
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    • pp.147-162
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    • 2022
  • Purpose: To design a prospective study on endovascular closure of congenital portosystemic shunts. The primary endpoint was to assess the safety of endovascular closure. The secondary endpoint was to evaluate the clinical, analytical and imaging outcomes of treatment. Methods: Fifteen patients (age range: 2 days to 21 years; 10 male) were referred to our center due to congenital portosystemic shunts. The following data were collected prior to treatment: age, sex, medical history, clinical and analytical data, urine trimethylaminuria, abdominal-US, and body-CT. The following data were collected at the time of intervention: anatomical and hemodynamic characteristics of the shunts, device used, and closure success. The following data were collected at various post-intervention time points: during hospital stay (to confirm shunt closure and detect complications) and at one year after (for clinical, analytical, and imaging purposes). Results: The treatment was successful in 12 participants, migration of the device was observed in two, while acute splanchnic thrombosis was observed in one. Off-label devices were used in attempting to close the side-to-side shunts, and success was achieved using Amplatzer™ Ductus-Occluder and Amplatzer™ Muscular-Vascular-Septal-Defect-Occluder. The main changes were: increased prothrombin activity (p=0.043); decreased AST, ALT, GGT, and bilirubin (p=0.007, p=0.056, p=0.036, p=0.013); thrombocytopenia resolution (p=0.131); expansion of portal veins (p=0.005); normalization of Doppler portal flow (100%); regression of liver nodules (p=0.001); ammonia normalization (p=0.003); and disappearance of trimethylaminuria (p=0.285). Conclusion: Endovascular closure is effective. Our results support the indication of endovascular closure for side-to-side shunts and for cases of congenital absence of portal vein.

Usefulness of Endoscopic Imaging to Visualize Regional Alterations in Acid Secretion of Noncancerous Gastric Mucosa after Helicobacter pylori Eradication

  • Uno, Kaname;Iijima, Katsunori;Abe, Yasuhiko;Koike, Tomoyuki;Takahashi, Yasushi;Ara, Nobuyuki;Shimosegawa, Tooru
    • Journal of Gastric Cancer
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    • v.16 no.3
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    • pp.152-160
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    • 2016
  • Purpose: Endoscopic diagnosis of gastric cancer (GC) that emerges after eradication of Helicobacter pylori may be affected by unique morphological changes. Using comprehensive endoscopic imaging, which can reveal biological alterations in gastric mucosa after eradication, previous studies demonstrated that Congo red chromoendoscopy (CRE) might clearly show an acid non-secretory area (ANA) with malignant potential, while autofluorescence imaging (AFI) without drug injection or dyeing may achieve early detection or prediction of GC. We aimed to determine whether AFI might be an alternative to CRE for identification of high-risk areas of gastric carcinogenesis after eradication. Materials and Methods: We included 27 sequential patients with metachronous GC detected during endoscopic surveillance for a mean of 82.8 months after curative endoscopic resection for primary GC and eradication. After their H. pylori infection status was evaluated by clinical interviews and $^{13}C$-urea breath tests, the consistency in the extension of corpus atrophy (e.g., open-type or closed-type atrophy) between AFI and CRE was investigated as a primary endpoint. Results: Inconsistencies in atrophic extension between AFI and CRE were observed in 6 of 27 patients, although CRE revealed all GC cases in the ANA. Interobserver and intraobserver agreements in the evaluation of atrophic extension by AFI were significantly less than those for CRE. Conclusions: We demonstrated that AFI findings might be less reliable for the evaluation of gastric mucosa with malignant potential after eradication than CRE findings. Therefore, special attention should be paid when we clinically evaluate AFI findings of background gastric mucosa after eradication (University Hospital Medical Information Network Center registration number: UMIN000020849).

Carbon-ion radiotherapy in osteosarcoma of the mandible: a case report

  • Ha, Tae-Wook;Park, Slmaro;Youn, Min Yeong;Kim, Dong Wook;Kim, Hyung Jun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.4
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    • pp.315-320
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    • 2021
  • Carbon-ion radiotherapy (CIRT) is on the rise as a treatment choice for malignant tumor. Compared to conventional radiotherapy, particle beams have different physical and biological properties. Particle beam provides a low entry dose, deposits most of the energy at the endpoint of the flight path, and forms an asymptotic dose peak (the "Bragg peak"). Compared to protons, carbon with its larger mass decreases beam scattering, resulting in a sharper dose distribution border. We report a 50-year-old male who underwent CIRT without surgical resection on osteosarcoma of the mandible. After CIRT, the patient's pain was gone, and the malignant mass remained stable with accompanying necrosis. Nine months later, however, magnetic resonance imaging demonstrated progression of the left mandibular osteosarcoma with pulmonary metastases. After multidisciplinary discussion, concurrent chemoradiotherapy was conducted. While necrotic bone segments came out of the mandible during subsequent periodic outpatient visits, the tumor itself was stable. Thirty months after his first visit and diagnosis, the patient is waiting for chemotherapy. Although CIRT is superior in treating radioresistant hypoxic disease, CIRT is in its infancy, so care must be taken for its indications and complications.

Role of Adjunctive Tranexamic Acid in Facilitating Resolution of Chronic Subdural Hematoma after Surgery

  • Kiyoon Yang;Kyung Hwan Kim;Han-Joo Lee;Eun-Oh Jeong;Hyon-Jo Kwon;Seon-Hwan Kim
    • Journal of Korean Neurosurgical Society
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    • v.66 no.4
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    • pp.446-455
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    • 2023
  • Objective : Chronic subdural hematoma (CSDH) is a common neurosurgical disease and generally treated with burr-hole surgery alone. Tranexamic acid (TXA) is an antifibrinolytic agent that potentially reduces recurrence rates and the residual hematoma volume. However, the role of postoperative TXA medication remains unclear to date. This study aimed to verify the effectiveness of adjunctive TXA in the view of early hematoma resolution. Methods : Between January 2018 and September 2021, patients with CSDH who underwent burr-hole trephination in a single tertiary institute were reviewed. The study population was divided into three groups, TXA, non-TXA, and antithrombotics (AT) groups, according to the medical history of cardio-cerebrovascular disease and TXA administration. The primary endpoint was CSDH recurrence, defined as re-appearance or re-accumulation of CSDH requiring neurosurgical interventions. The secondary outcome was CSDH resolution, defined as complete or near-complete resorption of the CSDH. The CSDH resolution time and serial changes of hematoma thickness were also investigated. Results : A total of 240 patients was included in the analysis consisting of 185 male and 55 female, with a median age of 74 years. During the median imaging follow-up period of 75 days, 222 patients were reached to the primary or secondary endpoint. TXA was administered as an adjunctive therapy in 41 patients (TXA group, 16.9%) while 114 patients were included in the non-TXA group (47.9%) and 85 were in the AT group. The recurrence rate was the lowest in the TXA group (2.4%), followed by non-TXA (7.0%) and AT (8.2%) groups. However, there was no statistical significance due to the small number of patients with recurrence. CSDH resolution was achieved in 206 patients, and the median estimated time to resolution was significantly faster in the TXA group (p<0.001). Adjunctive TXA administration was a significant positive factor for achieving CSDH resolution (p<0.001). The hematoma thickness was comparable among the three groups at the initial time and after surgery. However, CSDH thickness in the TXA group decreased abruptly in a month and showed a significant difference from that in the other groups (p<0.001). There was no TXA-related adverse event. Conclusion : The adjunctive use of TXA after CSDH surgery significantly facilitated the resorption of residual CSDH and resulted in the early CSDH resolution. Adjunctive TXA may be an effective treatment option to reduce recurrence by enhancing CSDH resolution in the selective patients.

Effects of the Combination Herbal Extract on Working Memory and White Matter Integrity in Healthy Individuals with Subjective Memory Complaints : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

  • Kwon, Oran;Lee, Sunho;Ban, Soonhyun;Im, Jooyeon J.;Lee, Doo Suk;Lee, Eun Hee;Kim, Joohee;Lim, Soo Mee;Lee, Sang Gon;Kang, Ilhyang;Kim, Kyung-Hee;Yoon, Sujung;Lee, Sun Hea
    • Korean Journal of Biological Psychiatry
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    • v.22 no.2
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    • pp.63-77
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    • 2015
  • Objectives The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. Methods Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. Results The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. Conclusions Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool;Yoon, Hong Man;Min, Jae Seok;Cho, In;Park, Ji-Ho;Jung, Mi Ran;Hur, Hoon;Kim, Young-Woo;Park, Young Kyu;Nam, Byung-Ho;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.157-164
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    • 2019
  • Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Cardiac diastolic dysfunction predicts poor prognosis in patients with decompensated liver cirrhosis

  • Lee, Soon Kyu;Song, Myeong Jun;Kim, Seok Hwan;Ahn, Hyo Jun
    • Clinical and Molecular Hepatology
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    • v.24 no.4
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    • pp.409-416
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    • 2018
  • Background/Aims: Left ventricular diastolic dysfunction (LVDD) is an early manifestation of cardiac dysfunction in patients with liver cirrhosis (LC). However, the effect of LVDD on survival has not been clarified, especially in decompensated LC. Methods: We prospectively enrolled 70 patients with decompensated LC, including ascites or variceal bleeding, at Daejeon St. Mary's Hospital from April 2013 to April 2015. The cardiac function of these patients was evaluated using 2D echocardiography with tissue Doppler imaging. The diagnosis of LVDD was based on the American Society of Echocardiography guidelines. The primary endpoint was overall survival. Results: Forty-four patients (62.9%) had LVDD. During follow-up (22.3 months), 18 patients died (16 with LVDD and 2 without LVDD). The survival rate was significantly lower in patients with LVDD than in those without LVDD (31.1 months vs. 42.6 months, P=0.01). In a multivariate analysis, the Child-Pugh score and LVDD were independent predictors of survival. Moreover, patients with a ratio of early filling velocity to early diastolic mitral annular velocity (E/e') ${\geq}10$ (LVDD grade 2) had lower survival than patients with E/e' ratio < 10. Conclusions: The presence of LVDD is associated with poor survival in patients with decompensated LC. Therefore, it may be important to monitor and closely follow LVDD patients.