• Title/Summary/Keyword: Multicenter

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The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Prediction of lifespan and assessing risk factors of large-sample implant prostheses: a multicenter study

  • Jeong Hoon Kim;Joon-Ho Yoon;Hae-In Jeon;Dong-Wook Kim;Young-Bum Park;Namsik Oh
    • The Journal of Advanced Prosthodontics
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    • v.16 no.3
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    • pp.151-162
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    • 2024
  • PURPOSE. This study aimed to analyze factors influencing the success and failure of implant prostheses and to estimate the lifespan of prostheses using standardized evaluation criteria. An online survey platform was utilized to efficiently gather large samples from multiple institutions. MATERIALS AND METHODS. During the one-year period, patients visiting 16 institutions were assessed using standardized evaluation criteria (KAP criteria). Data from these institutions were collected through an online platform, and various statistical analyses were conducted. Risk factors were assessed using both the Cox proportional hazard model and Cox regression analysis. Survival analysis was conducted using Kaplan-Meier analysis and nomogram, and lifespan prediction was performed using principal component analysis. RESULTS. The number of patients involved in this study was 485, with a total of 841 prostheses evaluated. The median survival was estimated to be 16 years with a 95% confidence interval. Factors found to be significantly associated with implant prosthesis failure, characterized by higher hazard ratios, included the 'type of clinic', 'type of antagonist', and 'plaque index'. The lifespan of implant prostheses that did not fail was estimated to exceed the projected lifespan by approximately 1.34 years. CONCLUSION. To ensure the success of implant prostheses, maintaining good oral hygiene is crucial. The estimated lifespan of implant prostheses is often underestimated by approximately 1.34 years. Furthermore, standardized form, online platform, and visualization tool, such as nomogram, can be effectively utilized in future follow-up studies.

The Dome Technique for Managing Massive Anterosuperior Medial Acetabular Bone Loss in Revision Total Hip Arthroplasty: Short-Term Outcomes

  • Tyler J. Humphrey;Colin M. Baker;Paul M. Courtney;Wayne G. Paprosky;Hany S. Bedair;Neil P. Sheth;Christopher M. Melnic
    • Hip & pelvis
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    • v.35 no.2
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    • pp.122-132
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    • 2023
  • Purpose: The dome technique is a technique used in performance of revision total hip arthroplasty (THA) involving intraoperative joining of two porous metal acetabular augments to fill a massive anterosuperior medial acetabular bone defect. While excellent outcomes were achieved using this surgical technique in a series of three cases, short-term results have not been reported. We hypothesized that excellent short-term clinical and patient reported outcomes could be achieved with use of the dome technique. Materials and Methods: A multicenter case series was conducted for evaluation of patients who underwent revision THA using the dome technique for management of Paprosky 3B anterosuperior medial acetabular bone loss from 2013-2019 with a minimum clinical follow-up period of two years. Twelve cases in 12 patients were identified. Baseline demographics, intraoperative variables, surgical outcomes, and patient reported outcomes were acquired. Results: The implant survivorship was 91% with component failure requiring re-revision in only one patient at a mean follow-up period of 36.2 months (range, 24-72 months). Three patients (25.0%) experienced complications, including re-revision for component failure, inter-prosthetic dual-mobility dissociation, and periprosthetic joint infection. Of seven patients who completed the HOOS, JR (hip disability and osteoarthritis outcome score, joint replacement) survey, five patients showed improvement. Conclusion: Excellent outcomes can be achieved using the dome technique for management of massive anterosuperior medial acetabular defects in revision THA with survivorship of 91% at a mean follow-up period of three years. Conduct of future studies will be required in order to evaluate mid- to long-term outcomes for this technique.

Diffusion-Weighted Imaging as a Stand-Alone Breast Imaging Modality (독립적 검사 방법으로서의 확산강조 자기공명영상검사)

  • Hee Jung Shin;Su Hyun Lee;Woo Kyung Moon
    • Journal of the Korean Society of Radiology
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    • v.82 no.1
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    • pp.29-48
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    • 2021
  • Diffusion-weighted magnetic resonance imaging (DW MRI) is a fast unenhanced technique that shows promise as a stand-alone modality for cancer screening and characterization. Currently, DW MRI may have lower sensitivity than that of dynamic contrast-enhanced MRI as a standalone modality for breast cancer detection but superior to that of mammography, which may provide a useful alternative for supplemental screening. Standardized acquisition and interpretation of DW MRI can improve the image quality and reduce the variability of the results. Furthermore, high-resolution DW MRI, with advanced techniques and postprocessing, will facilitate better detection and characterization of subcentimeter cancers and reduce false-negatives and false-positives. Future results from ongoing prospective multicenter clinical trials using standardized and optimized protocols will facilitate the use of DW MRI as a stand-alone modality.

A Multicenter Pilot Study of Biliary Atresia Screening Using Digital Stool Color Imaging

  • Kannamon Waitayagitgumjon;Wannisa Poocharoen;Suchin Trirongjitmoah;Kriengsak Treeprapin;Arada Suttiwongsing;Thetiya Wirifai;Chira Trirongchitmoh;Pitiporn Tangkabuanbutr
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.3
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    • pp.168-175
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    • 2024
  • Purpose: The presence of alcoholic stool in biliary atresia (BA) patients is the basis of a stool color card (SCC), a screening tool that has led to more patients receiving Kasai portoenterostomy earlier. This study aimed to evaluate the color image processing of stool images captured using smartphones. We propose that measuring digital color parameters is a more objective method for identifying BA stools and may improve the sensitivity of BA screening. Methods: A prospective study was conducted in five hospitals in Thailand between October 1, 2020, and December 31, 2021. Stools from infants presenting with jaundice, acholic stool, or dark-colored urine were photographed. Digital image color analysis was performed, and software was developed based on the color on the original SCC. Sensitivity and specificity for predicting BA stools were compared between the SCC and the software. Results: Of 33 infants eligible for data collection, 19 were diagnosed with BA. Saturation and blue were two potential digital color parameters used to differentiate BA stools. The receiver operating characteristic curve was used to determine the optimum cutoff point of both values, and when saturation ≤56 or blue ≥61 was set as a threshold for detecting BA stool, high accuracy was achieved at 81.8% and 78.8%, respectively. Conclusion: Digital image processing is a promising technology. With appropriate cutoff values of saturation in hue, saturation, value and blue in red, green, blue color models, BA stools can be identified, and equivocal-colored stools of non-BA patients can be differentiated with acceptable accuracy in infants presenting with jaundice.

Non-atrophic gastric mucosa is an independently associated factor for superficial non-ampullary duodenal epithelial tumors: a multicenter, matched, case-control study

  • Azusa Kawasaki;Kunihiro Tsuji;Noriya Uedo;Takashi Kanesaka;Hideaki Miyamoto;Ryosuke Gushima;Yosuke Minoda;Eikichi Ihara;Ryosuke Amano;Kenshi Yao;Yoshihide Naito;Hiroyuki Aoyagi;Takehiro Iwasaki;Kunihisa Uchita;Hisatomi Arima;Hisashi Doyama
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.75-82
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    • 2023
  • Background/Aims: The etiology of superficial non-ampullary duodenal epithelial tumors (SNADETs) remains unclear. Recent studies have reported conflicting associations between duodenal tumor development and Helicobacter pylori infection or endoscopic gastric mucosal atrophy. As such, the present study aimed to clarify the relationship between SNADETs and H. pylori infection and/or endoscopic gastric mucosal atrophy. Methods: This retrospective case-control study reviewed data from 177 consecutive patients with SNADETs who underwent endoscopic or surgical resection at seven institutions in Japan over a three-year period. The prevalence of endoscopic gastric mucosal atrophy and the status of H. pylori infection were compared in 531 sex- and age-matched controls selected from screening endoscopies at two of the seven participating institutions. Results: For H. pylori infection, 85 of 177 (48.0%) patients exhibited SNADETs and 112 of 531 (21.1%) control patients were non-infected (p<0.001). Non-atrophic mucosa (C0 to C1) was observed in 96 of 177 (54.2%) patients with SNADETs and 112 of 531 (21.1%) control patients (p<0.001). Conditional logistic regression analysis revealed that non-atrophic gastric mucosa was an independent risk factor for SNADETs (odds ratio, 5.10; 95% confidence interval, 2.44-8.40; p<0.001). Conclusions: Non-atrophic gastric mucosa, regardless of H. pylori infection status, was a factor independently associated with SNADETs.

Detection of Malignant Primary Hepatic Neoplasms with Gadobenate Dimeglumine (Gd-BOPTA) Enhanced T1-Weighted Hepatocyte Phase MR Imaging: Results of Off-site Blinded Review in a Phase-II Multicenter Trial

  • Constantino S. Pena;Sanjay Saini;Richard L. Baron;Bernd A. Hamm;Giovanni Morana;Roberto Caudana;Andrea Giovagnoni;Andrea Villa;Alessandro Carriero;Didier Mathieu;Michael W. Bourne;Miles A. Kirchin;Gianpaolo Pirovano;Alberto Spinazzi
    • Korean Journal of Radiology
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    • v.2 no.4
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    • pp.210-215
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    • 2001
  • Objective: To investigate the efficacy of gadobenate dimeglumine (GdBOPTA) enhanced MR imaging for the detection of liver lesions in patients with primary malignant hepatic neoplasms. Materials and Methods: Thirty-one patients with histologically proven primary malignancy of the liver were evaluated before and after administration of GdBOPTA at dose 0.05 or 0.10 mmol/kg. T1-weighted spin echo (T1W-SE) and gradient echo (T1W-GRE) images were evaluated for lesion number, location, size and confidence by three off-site independent reviewers and the findings were compared to reference standard imaging (intraoperative ultrasound, computed tomography during arterial portography or lipiodol computed tomography). Results were analyzed for significance using a two-sided McNemar's test. Results: More lesions were identified on Gd-BOPTA enhanced images than on unenhanced images and there was no significant difference in lesion detection between either concentration. The largest benefit was in detection of lesions under 1 cm in size (7 to 21, 9 to 15, 16 to 18 for reviewers A, B, C respectively). In 68% of the patients with more than one lesion, Gd-BOPTA increased the number of lesions detected. Conclusion: Liver MR imaging after Gd-BOPTA increases the detection of liver lesions in patients with primary malignant hepatic neoplasm.

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Covered self-expandable metallic stents versus plastic stents for endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction

  • Taro Shibuki;Kei Okumura;Masanari Sekine;Ikuhiro Kobori;Aki Miyagaki;Yoshihiro Sasaki;Yuichi Takano;Yusuke Hashimoto
    • Clinical Endoscopy
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    • v.56 no.6
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    • pp.802-811
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    • 2023
  • Background/Aims: Covered self-expandable metallic stents (cSEMS) have become popular for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting (EUS-HGS). We compared the time to recurrent biliary obstruction (TRBO), complications, and reintervention rates between EUS-HGS using plastic stent (PS) and cSEMS in patients with unresectable malignancies at multicenter institutions in Japan. Methods: Patients with unresectable malignant biliary obstruction who underwent EUS-HGS between April 2015 and July 2020 at any of the six participating facilities were enrolled. Primary endpoint: TRBO; secondary endpoints: rate of complications other than recurrent biliary obstruction and technical success rate of reintervention were evaluated. Results: PS and cSEMS were used for EUS-HGS in 109 and 43 patients, respectively. The TRBO was significantly longer in the cSEMS group than in the PS group (646 vs. 202 days). Multivariate analysis identified two independent factors associated with a favorable TRBO: combined EUS-guided antegrade stenting with EUS-HGS and the use of cSEMS. No significant difference was observed in the rate of complications other than recurrent biliary obstruction between the two groups. The technical success rate of reintervention was 85.7% for PS and 100% for cSEMS (p=0.309). Conclusions: cSEMS might be a better option for EUS-HGS in patients with unresectable malignancies, given the longer TRBO.

Role of the Gastrocnemius Musculocutaneous with a Propeller Style Skin Flap in Knee Region Reconstruction: Indications and Pitfalls

  • Gianluca Sapino;Rik Osinga;Michele Maruccia;Martino Guiotto;Martin Clauss;Olivier Borens;David Guillier;Pietro Giovanni di Summa
    • Archives of Plastic Surgery
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    • v.50 no.6
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    • pp.593-600
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    • 2023
  • Background Soft tissue reconstruction around the knee area is still an open question, particularly in persistent infections and multiple reoperations scenario. Flap coverage should guarantee jointmobility and protection, even when foreign materials are implanted. The chimeric harvesting of the musculocutaneous gastrocnemius flap, based on the sural artery perforators, can extend its applicability in soft tissue reconstruction of the upper leg, overcoming the drawbacks of the alternative pedicled flaps. Methods A multicenter retrospective study was conducted enrolling patients who underwent to a pedicled, chimeric gastrocnemius musculocutaneous-medial sural artery perforator (GM-MSAP) or lateral sural artery perforator (GM-LSAP) flap for knee coverage in total knee arthroplasty (TKA) recurrent infections and oncological or traumatic defects of the upper leg from 2018 to 2021. Outcomes evaluated were the successful soft tissue reconstruction and flap complications. Surgical timing, reconstruction planning, technique, and rehabilitation protocols were discussed. Results Twenty-one patients were included in the study. Nineteen GM-MSAPs and 2 GM-LSAPs were performed (soft tissue reconstruction in infected TKA [12], in infected hardware [4], and in oncological patients [5]). Donor site was closed primarily in 9 cases, whereas a skin graft was required in 12. Flap wound dehiscence (1), distal flap necrosis (1), distal necrosis of the skin paddle (1), and donor site infection (1) were the encountered complications. Flap reraise associated to implant exchange or extensive debridement was successful without requiring any further flap surgery. Conclusion The propeller-perforator GM-MSAP offers qualitative defect coverage and easiness of multiple flap reraise due to skin availability and its laxity.

Current practices of cervical epidural block for cervical radicular pain: a multicenter survey conducted by the Korean Pain Society

  • Chan-Sik Kim;Hyun-Jung Kwon;Sugeun Nam;Heeyoon Jang;Yeon-Dong Kim;Seong-Soo Choi
    • The Korean Journal of Pain
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    • v.37 no.3
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    • pp.256-263
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    • 2024
  • Background: Cervical epidural block (CEB) is an effective intervention for managing cervical radicular pain. This study aimed to investigate the current status of performing CEB in South Korea. Methods: Pain physicians affiliated with the Korean Pain Society were asked to complete anonymous questionnaires regarding CEB between September and October 2022. The questionnaire consisted of 24 questions assessing the current status and methods of CEB in detail. Results: Of the 198 surveys collected, 171 physicians (86.4%) reported performing CEB. Among those, the majority (94.7%) used fluoroscopy during the procedure. The paramedian interlaminar (IL) approach was the most preferred method (50.3%). Respondents performing fluoroscopic-guided IL CEB were categorized into two groups based on clinical experience: those with ≤10 years of experience (≤10-year group, n = 91) and those with >10 years of experience (>10-year group, n = 71). The proportion of physicians obtaining informed consent in the ≤10-year group and >10-year group was 50.5% and 56.3%, respectively. When entering the epidural space during IL CEB, the contralateral oblique view was the second most frequently used in both groups (≤10-year group, 42.9%; >10-year group, 29.6%). In targeting the upper cervical lesions (C3-4), the proportion of respondents who used an IL space higher than C6-7 was 17.6% in the ≤10-year group and 29.5% in the >10-year experience group. Conclusions: This study demonstrated variability in the CEB technique used by pain physicians in South Korea. The findings highlight the need for education on informed consent and techniques to enhance safety.