• Title/Summary/Keyword: Multicenter

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Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

Pediatric Inflammatory Bowel Disease: A Multicenter Study of Changing Trends in Argentina Over the Past 30 Years

  • Arcucci, Maria Soledad;Contreras, Monica Beatriz;Gallo, Julieta;Antoniska, Mariela Andrea;Busoni, Veronica;Tennina, Cecilia;D’Agostino, Daniel;Kakisu, Maria Hisae;Weyersberg, Christian;Orsi, Marina
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.25 no.3
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    • pp.218-227
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    • 2022
  • Purpose: To analyze the characteristics of pediatric inflammatory bowel disease (IBD) over the past three decades in Argentina and determine if there are differences between the first two decades and the past decade. Methods: We conducted a retrospective multicenter analytical study in children with IBD between 0 and 18 years of age diagnosed between 1987 and 2017 in three tertiary health centers in Argentina. The evaluation included clinical characterization, endoscopy, histology, and imaging data together with therapeutic strategies. The patients were divided into two groups: Group 1, diagnosed between 1987 and 2007, and Group 2, diagnosed between 2008 and 2017. Results: Of the 756 patients included, 409 (54%) had ulcerative colitis (UC), 250 (33%) had Crohn's disease (CD), and 97 (13%) had IBD-unclassified (IBD-U). The positive family history was 3.8%, which was more frequent among children under two years of age (6.7%). There were no significant differences in clinical presentation and extraintestinal manifestations between periods, with hepatic manifestations being the most frequent. In the last decade, we found an upward trend in CD, a downward trend in UC/IBD-U, even after adjustment for socioeconomic status, and a decrease of 50% in surgical treatments coinciding with the advent of biological therapy. Conclusion: This is the first multicenter cohort study in a Latin American country to describe clinical, endoscopic, and therapeutic data across the past 30-year period. Although CD was responsible for the overall increase in incidence, UC was still prevalent in this region.

MULTICENTER RETROSPECTIVE STUDY OF IMMEDIATE TWO DIFFERENT RBM SURFACED IMPLANT SYSTEMS AFTER EXTRACTION (발치 후 즉시 매식된 서로 다른 두종의 RBM표면 처리된 임플란트에 대한 다기관 후향적 임상연구)

  • Park, Hong-Ju;Kook, Min-Suk;Kim, Su-Gwan;Kim, Young-Kyun;Cho, Yong-Seok;Choi, Gab-Lim;Oh, Young-Hak;Oh, Hee-Kyun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.30 no.3
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    • pp.258-265
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    • 2008
  • Purpose. This multicenter retrospective study was performed to evaluate the survival and success rates of immediate placement of USII and SSII Osstem implant (Osstem implant Co, Korea) on the maxillary and mandibular anterior and premolar areas. Materials and methods. Dental records were obtained in 37 patients who were treated with immediate implantation on the maxillary and mandibular anterior and premolar areas in 6 different clinics. The 98 implants were evaluated both clinically and radiographically using predefined success criteria. Results. There was no failed implant in all patients. The mean follow up period was 24.7 months (ranged from 12 to 58 months), and 25.1 months (ranged from 16 to 35 months) in USII and SSII implants, respectively. The crestal bone loss was 3 mm in 3 USII implants during 41 months, and in 1 SSII implant during 22 months. The overall success rate was 94.2% and 97.7% in USII and SSII implants, respectively. The age, gender, diameter, or length of implants, and type of surgery were not influenced to the success rate of immediate implantation. Conclusion. These results suggest that USII and SSII Osstem implant can be used successfully in immediate implantation on the maxillary and mandibular anterior and premolar areas.

Radiosurgery Compared with External Radiation Therapy as a Primary Treatment in Spine Metastasis from Hepatocellular Carcinoma : A Multicenter, Matched-Pair Study

  • Sohn, Seil;Chung, Chun Kee;Sohn, Moon Jun;Kim, Sung Hwan;Kim, Jinhee;Park, Eunjung
    • Journal of Korean Neurosurgical Society
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    • v.59 no.1
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    • pp.37-43
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    • 2016
  • Objective : The aim of this multicenter, matched-pair study was to compare the outcomes of stereotactic radiosurgery (SRS) and conventional external radiation therapy (RT) when used as a primary treatment in spine metastasis from hepatocellular carcinoma (HCC). Methods : From 2005 to 2012, 28 patients underwent SRS as the primary treatment in spine metastasis from HCC. Based on sex, age, number of spine metastasis, Child-Pugh classification, interval from original tumor to spine metastasis, and year of treatment, 28 patients who underwent RT were paired. Outcomes of interest were pain relief, progression free survival, toxicities, and further treatment. Results : The perioperative visual analog scale (VAS) decrease was larger in SRS group than in RT group, but the difference was not significant (3.7 vs. 2.8, p=0.13). When pain medication was adjusted, the number of patients with complete (n=6 vs.3) or partial (n=12 vs.13) relief was larger in SRS group than in RT group; however, the difference was not significant (p=0.83). There was no significant difference in progression free survival (p=0.48). In SRS group, 32.1% of patients had 1 or more toxicities whereas the percentage in RT group was 63.0%, a significant difference (p=0.04). Six SRS patients and 7 RT patients received further intervention at the treated segment. Conclusion : Clinical and radiological outcome were not significantly different between the two treatments. Toxicities, however, were more prevalent in the RT group.

Survival of 352 titanium implants placed in 181 patients: a 4-year multicenter field study

  • Shin, Seung-Il;Yun, Jeong-Ho;Kim, Sung-Geun;Park, Byoungkyou;Herr, Yeek;Chung, Jong-Hyuk
    • Journal of Periodontal and Implant Science
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    • v.44 no.1
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    • pp.8-12
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    • 2014
  • Purpose: The aim of this retrospective chart review was to evaluate the four-year survival rate of a titanium implant system. Methods: A total of 352 sand-blasted, thermally acid-etched titanium implants were inserted into 181 partially or completely edentulous patients. Their cumulative survival rate was evaluated retrospectively. Associated factors, such as the implant distribution and treatment type were included in the evaluation. Results: The implants were equally distributed between the maxilla (52.3%) and the mandible (47.7%). 48 implants (13.6%) were placed in the anterior region and 304 implants (86.4%) in the posterior region. The majority of the implants were inserted into bone of type II and III quality (89.8%) and volume (quantity B and C, 87.2%). Most of the implants (70.7%) were restored as single crowns; 28.7% supported a bridge construction and 0.6% a full denture. Only one implant failed, resulting in a four-year cumulative survival rate of 99.7%. Conclusions: The implant system showed an excellent four-year survival rate. It proved to be a safe and predictable means for restoration of the dentition in partially or completely edentulous patients.

Efficacy Profile of Cisapride in Laryngopharyngeal Reflux(LPR)-Related Symptoms(Open Multicenter Case Study & Open Multicenter Case Study between Cisapride & Ranitidine) (인후두위산역류증(Laryngopharyngeal Reflux : LPR) 관련 증상에 대한 시사프리드(Cisapride)의 효과)

  • 최홍식;고중화;김광문;김광현;김민식;김영모;김찬우;김춘동;김형태
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.9 no.2
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    • pp.115-127
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    • 1998
  • Laryngopharyngeal reflux(LPR) is one firm of the gastroesophageal reflux diseases(GERD). It is known to cause various kinds of otolaryngologic symptoms such as hoarseness, foreign body sensation in throat, chronic throat clearing, chronic cough, etc. Disease entities diagnosed by otolaryngologists as posterior laryngitis, globus pharyngeus should be suspected as LPR-related diseases. In this multi-center trial, we tried to evaluate the effect of cisapride(10mg tid) on LPR-related symptoms as the part I study(CIS-KOR-051) in 19 centers, and as the part II study(CIS-KOR-052) comparative evaluation of effect between cisapride(10mg tid) and ranitidine(150mg bid) on LPR-related symptoms in 4 centers. In part I study, efficacy of cisapride on LPR-related symptoms after 4 weeks was 53.5% and that of after 8weeks was 77.9% in per protocol(PPA) analysis group. In part II study, efficacy of the cisapride was much better than that of ranitidine not only from 8 weeks trial(p<0.001) but also from 4 weeks trial(p<0.021) in PPA group. In the multiple logistic regression analysis among the parameters which affect the efficacy of the treatment, cisapride prescribed group showed 10 times greater than that of ranitidine prescribed group(p<0.0001, Odds ratio : 10) in PPA group. LPR was proved by 24Hr double probe pHmetry in 13 patients out of 19 patients tested(68.4%). Thus these results indicated that inducing the improvement of motility functions could affect the amelioration of the LPR-related symptoms much better than reducing acid secretion from the stomach. And maybe it suggests that LPR-related symptoms mainly developed by the reduced motility functions of the esophagus and/or delayed gastric emptying.

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131I-Labeled-Metuximab Plus Transarterial Chemoembolization in Combination Therapy for Unresectable Hepatocellular Carcinoma: Results from a Multicenter Phase IV Clinical Study

  • Ma, Jun;Wang, Jian-Hua
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7441-7447
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    • 2015
  • Objective: This study evaluated the safety and objective response of combining $^{131}I$-labeled-metuximab (Licartin) with transarterial chemoembolization (TACE) in the treatment of unresectable hepatocellular carcinoma (HCC). Materials and Methods: In a multicenter open-label clinical trial, 341 enrolled patients with stage III/IV HCC according to TNM criteria were nonrandomly assigned to a trial group (n=167) and a control group (n=174), undergoing TACE following hepatic intra-arterial injection of licartin or TACE alone from July 2007 to July 2009. Radiopharmaceutical distribution was evaluated. The primary endpoint was overall survival; secondary endpoints included time-to-progression (TTP), toxicity and adverse events (AEs). Results: The radiobiological distribution demonstrated better localization of licartin in liver tumors than other tissues (P<0.01). The organ absorbed doses to liver and red marrow were $3.19{\pm}1.01Gy$ and $0.55{\pm}0.22Gy$, respectively. The 1-year survival rate was significantly higher [79.47% vs. 65.59%, hazard ratio (HR), 0.598, P=0.041] and TTP significantly improved ($6.82{\pm}1.28$ vs. $4.7{\pm}1.14months$, P=0.037) compared with the control group. Patients at stage III achieved more benefit of one year survival than stage IV in the trial group (86.9% vs. 53.8%, P<0.001). There were significant different toxicities in leukocytopenia, thrombocytopenia and increased total bilirubin level [P<0.001, P=0.013, P<0.01, relative risk (RR) 1.63, 1.33, 1.43], but no differences in severe AEs of upper GI hemorrhage and severe liver dysfunction between the groups (5.39% vs. 2.3%, P=0.136). Conclusions: Owing to excellent tumor-targeting, promised efficacy and favourable toxicity profile, the novel combination therapy of licartin and TACE could be applied in patients with unresectable HCC.

Multicenter Retrospective Analysis of Intraperitoneal Paclitaxel and Systemic Chemotherapy for Advanced Gastric Cancer with Peritoneal Metastasis

  • Kim, Dong-Wook;Jee, Ye Seob;Kim, Chang Hyun;Kim, Jin-Jo;Park, Sungsoo;Choi, Sung Il;Park, Joong-Min;Kim, Jong-Han
    • Journal of Gastric Cancer
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    • v.20 no.1
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    • pp.50-59
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    • 2020
  • Purpose: The objective of the present retrospective analysis was to describe the experience of intraperitoneal (IP) paclitaxel and systemic chemotherapy in patients with peritoneal metastasis (PM) of advanced gastric cancer (AGC) in a multicenter setting in Korea. Materials and Methods: The medical records of patients with AGC, who were diagnosed with PM between January 2015 and December 2018, were reviewed. IP catheter was placed in the pouch of Douglas and was used for the administration of IP paclitaxel chemotherapy. Results: We reviewed the clinical outcomes of IP paclitaxel and systemic chemotherapy administration in 82 patients at six institutions in Korea. Mean number of IP chemotherapy cycles was 6.6. The mean peritoneal cancer index (PCI) was 21.9. Postoperative complications related to IP catheter and port were observed in 15 patients. The overall median survival was 20.0 months. A significant difference was observed in the survival rate according to the ascites grade (grade I and II, 24.1 months; grade III and IV, 15.3 months; P=0.014) and PCI grade (grade I, 25.6 months; grade II and III, 16.3 months; P=0.023). Conclusions: The feasibility of IP paclitaxel and systemic chemotherapy administration was demonstrated in this experience-based retrospective analysis suggesting that the procedure is beneficial in patients with PM of AGC.

Acute lymphoblastic leukemia in children: past, present and future (소아 급성 림프모구 백혈병: 과거, 현재, 미래)

  • Kang, Hyoung Jin;Shin, Hee Young;Ahn, Hyo Seop
    • Clinical and Experimental Pediatrics
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    • v.50 no.7
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    • pp.601-605
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    • 2007
  • The cure rate of acute lymphoblastic leukemia (ALL) in children dramatically improved over past 5 decades from zero to about 80%. The main cause of improvement is owing to the development of chemotherapy by multicenter clinical trial of large study groups with the understanding of leukemia biology. Recently, pediatric ALL protocols were applied to the treatment of adolescent and even adult ALL patients. For nearly 30 years, clinical factors have been used to risk-stratify therapy for children with ALL, so that the most intensive therapies are reserved for those patients at the highest risk of relapse. The risk groups of ALL are divided as standard- (low- plus intermediate-), high- and very high-risk group according to the prognostic factors, and treatment results improved by this risk based treatment. The factors used to risk-stratify therapy include age, gender, presenting leukocyte count, immunophenotype, cytogenetic aberrations including ploidy and translocations, and initial response after 1 to 2 weeks of therapy. But treatment efficacy is the most important determinant and can abolish the clinical significance of most, if at all, prognostic factors. Today, in the era of intensive, multiagent regimens, there is increasing evidence that we have reached the limits of prognostic significance of currently applied clinical risk factors in childhood ALL. As the cure rate of ALL is about 80%, introducing new prognostic factors such as new molecular prognostic markers, new methods of assessment about minimal residual disease, and pharmacogenetic study, with the development of stem cell transplantation and molecular targeted therapy are needed to cure residual 20% of childhood ALL patients without short and long term complications.