• Title/Summary/Keyword: Multicenter studies

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Clinicopathological Features of Patients with Malignant Mesothelioma in a Multicenter, Case-Control Study: No Role for ABO-Rh Blood Groups

  • Utkan, Gungor;Urun, Yuksel;Cangir, Ayten Kayi;Kilic, Dalokay;Ozdemir, Nuriye Yildirim;Oztuna, Derya Gokmen;Bulut, Erhan;Arslan, Ulku Yalcintas;Kocer, Murat;Kavukcu, Sevket;Icli, Fikri
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.249-253
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    • 2013
  • Background: Malignant mesothelioma (MM) is an aggressive tumor of mesothelial surfaces. Previous studies have observed an association between ABO blood groups and risk of certain malignancies, including pancreatic and gastric cancer; however, no information on any association with MM risk is available. The aim of this study was to investigate possible associations amoong MM clinicopathological features and ABO blood groups and Rh factor. Materials and Methods: In 252 patients with MM, the ABO blood group and Rh factor were examined and compared with the control group of 3,022,883 healthy volunteer blood donors of Turkish Red Crescent between 2004 and 2011. The relationship of blood groups with various clinicopathological features were also evaluated in the patient group. Results: The median age was 55 (range: 27-86) and 61.5% of patients were male. While 82.8% of patients had a history of exposure to asbestos, 60.7% of patients had a smoking history. Epithelioid (65.1%) was the most common histology and 18.7% of patients had mixed histology. Overall, the ABO blood group distribution of the 252 patients with MM was comparable with the general population. The median overall survival (OS) was 14 months (95% confidence interval, 11.3-16.6 months). The median OS for A, B, AB, and O were 11, 15, 16, and 15 months respectively (p=0.396). First line chemotherapy was administered to 118 patients. The median OS of patients on pemetrexed or gemcitabine was longer than patient who was not administered chemotherapy [17 months (95%CI, 11.7-22.2) vs. 9 months (95%CI, 6.9-11.0); p<0.001]. Conclusions: The results of this study suggest that patients with MM can benefit from treatment with pemetrexed or gemcitabine in combination with cisplatin. We did not observe a statistically significant association between ABO blood group and risk of MM.

Effectiveness of alendronate as an adjunct to scaling and root planing in the treatment of periodontitis: a meta-analysis of randomized controlled clinical trials

  • Chen, Jin;Chen, Qian;Hu, Bo;Wang, Yunji;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.46 no.6
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    • pp.382-395
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    • 2016
  • Purpose: Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods: Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane ${\chi}^2$ and $I^2$ tests. Results: After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05%-43.45%; P<0.001; $I^2=94.0%$), 2.29 mm for PD reduction (95% CI=2.07-2.52 mm; P<0.001; $I^2=0.0%$) and 1.92 mm for CAL gain (95% CI=1.55-2.30 mm; P<0.001; $I^2=66.0%$). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18-0.55 mm; P<0.001; $I^2=0.0%$) and increased CAL by 0.39 mm (95% CI=0.11-0.68 mm; P=0.006; $I^2=6.0%$). Conclusions: The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out.

Does Immunohistochemistry Provide Additional Prognostic Data in Gastrointestinal Stromal Tumors?

  • Demir, Lutfiye;Ekinci, Nese;Erten, Cigdem;Kucukzeybek, Yuksel;Alacacioglu, Ahmet;Somali, Isil;Can, Alper;Dirican, Ahmet;Bayoglu, Vedat;Akyol, Murat;Cakalagaoglu, Fulya;Tarhan, Mustafa Oktay
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.8
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    • pp.4751-4758
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    • 2013
  • Background: To investigate the predictive and prognostic effects of clinicopathologic and immunohistochemical (IHC) features in patients with gastrointestinal stromal tumours (GISTs). Materials and Methods: Fifty-six patients who were diagnosed with GIST between 2002 and 2012 were retrospectively evaluated. Relationships between clinicopathologic/immunohistochemical factors and prognosis were investigated. Results: Median overall survival (OS) of the whole study group was 74.9 months (42.8-107.1 months), while it was 95.2 months in resectable and 44.7 months in metastatic patients respectively (p=0.007). Epitheliolid tumor morphology was significantly associated with shortened OS as compared to other histologies (p=0.001). SMA(+) tumours were significantly correlated with low (<10/50HPF) mitotic activity (p=0.034). Moreover, SMA(+) patients tended to survive longer and had significantly longer disease-free survival (DFS) times than SMA (-) patients (37.7 months vs 15.9 months; p=0.002). High Ki-67 level (${\geq}30%$) was significantly associated with shorter OS (34 vs 95.2 months; 95%CI; p=0.001). CD34 (-) tumours were significantly associated with low proliferative tumours (Ki-67<%10) (p=0.026). Median PFS (progression-free survival) of the patients who received imatinib was 36 months (27.7-44.2 months). CD34 (-) patients had significantly longer PFS times than that of negative tumours; (50.8 vs 29.8 months; p=0.045). S100 and desmin expression did not play any role in predicting the prognosis of GISTs. Multivariate analysis demonstrated that ${\geq}10/50HPF$ mitotic activity/HPF was the only independent factor for risk of death in GIST patients. Conclusions: Despite the negative prognostic and predictive effect of high Ki-67 and CD34 expression, mitotic activity remains the strongest prognostic factor in GIST patients. SMA positivity seems to affect GIST prognosis positively. However, large-scale, multicenter studies are required to provide supportive data for these findings.

ADPRT Val762Ala and XRCC1 Arg194Trp Polymorphisms and Risk of Gastric Cancer in Sichuan of China

  • Wen, Yuan-Yuan;Pan, Xiong-Fei;Loh, Marie;Tian, Zhi;Yang, Shu-Juan;Lv, Si-Han;Huang, Wen-Zhi;Huang, He;Xie, Yao;Soong, Richie;Yang, Chun-Xia
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.5
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    • pp.2139-2144
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    • 2012
  • Objective: Gastric cancer remains a major health problem in China. We hypothesized that XRCC1 Arg194Trp and ADPRT Val762Ala may be associated with risk. Methods: We designed a multicenter 1:1 matched case-control study of 307 pairs of gastric cancers and controls between October 2010 and August 2011. XRCC1 Arg194Trp and ADPRT Val762Ala were sequenced, and demographic data as well as lifestyle factors were collected using a self-designed questionnaire. Results: Individuals carrying XRCC1 Trp/Trp or Arg/Trp variant genotype had a significantly increased risk of gastric cancer (OR, 1.718; 95% CI, 1.190-2.479), while the OR for ADPRT Val762Ala variant genotype (Ala/Ala or Val/Ala) was 1.175 (95% CI, 0.796-1.737). No gene-gene or gene-environment interactions were found. In addition, family history of cancer and drinkers proportion were higher among cases than among controls (P<0.05). Conclusions: XRCC1 194 Arg/Trp or Trp/Trp genotype, family history of cancer, and drinking are suspected risk factors of gastric cancer from our study. Our findings may offer insight into further similar large gene-environment and gene-gene studies in this region.

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial

  • Song, Sang-Wook;Kim, Ha-Na;Shim, Jae-Yong;Yoo, Byeong-Yeon;Kim, Dae-Hyun;Lee, Sang-Hyun;Park, Joo-Sung;Kim, Moon-Jong;Yoo, Jun-Hyun;Cho, BeLong;Kang, Hee-Cheol;Kim, Kwang-Min;Kim, Sung-Soo;Kim, Kyung-Soo
    • Journal of Ginseng Research
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    • v.42 no.4
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    • pp.571-576
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    • 2018
  • Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

Prospective Multicenter Study of the Challenges Inherent in Using Large Cell-Type Stents for Bilateral Stent-in-Stent Placement in Patients with Inoperable Malignant Hilar Biliary Obstruction

  • Yang, Min Jae;Kim, Jin Hong;Hwang, Jae Chul;Yoo, Byung Moo;Lee, Sang Hyub;Ryu, Ji Kon;Kim, Yong-Tae;Woo, Sang Myung;Lee, Woo Jin;Jeong, Seok;Lee, Don Haeng
    • Gut and Liver
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    • v.12 no.6
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    • pp.722-727
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    • 2018
  • Background/Aims: Although endoscopic bilateral stent-instent placement is challenging, many recent studies have reported promising outcomes regarding technical success and endoscopic re-intervention. This study aimed to evaluate the technical accessibility of stent-in-stent placement using large cell-type stents in patients with inoperable malignant hilar biliary obstruction. Methods: Forty-three patients with inoperable malignant hilar biliary obstruction from four academic centers were prospectively enrolled from March 2013 to June 2015. Results: Bilateral stent-in-stent placement using two large cell-type stents was successfully performed in 88.4% of the patients (38/43). In four of the five cases with technical failure, the delivery sheath of the second stent became caught in the hook-cross-type vertex of the large cell of the first stent, and subsequent attempts to pass a guidewire and stent assembly through the mesh failed. Functional success was achieved in all cases of technical success. Stent occlusion occurred in 63.2% of the patients (24/38), with a median patient survival of 300 days. The median stent patency was 198 days. The stent patency rate was 82.9%, 63.1%, and 32.1% at 3, 6, and 12 months postoperatively, respectively. Endoscopic re-intervention was performed in 14 patients, whereas 10 underwent percutaneous drainage. Conclusions: Large cell-type stents for endoscopic bilateral stent-in-stent placement had acceptable functional success and stent patency when technically successful. However, the technical difficulty associated with the entanglement of the second stent delivery sheath in the hook-cross-type vertex of the first stent may preclude large cell-type stents from being considered as a dedicated standard tool for stent-in-stent placement.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

Effect of Non-contact Korean Medical Treatment for Patients Recovering at Home with Positive Coronavirus Disease 2019 Diagnostic Test Results at a Local Public Health Center: A Retrospective Chart Review (지역 보건소에서 시행한 코로나 바이러스 감염증-19 진단 검사상 양성인 재택치료 환자의 비대면 한의진료 효과: 후향적 차트 리뷰)

  • Jeon, Chaeheun;Choi, Daejun;Kim, Gyeongmuk;Kim, Hyejin;Leem, Jungtae;Chi, Gyoo-yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.36 no.4
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    • pp.130-137
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    • 2022
  • Due to the coronavirus disease 2019 (COVID-19) pandemic, appropriate management of sequelae and treatment of infectious symptoms became increasingly important healthcare issues. Although the practice guidelines and treatment cases based on the East Asian traditional medicine have been reported, there are rare studies on the use of Korean medicine in Korea. Therefore, this study aimed to present the progress of non-contact Korean medical treatment for infected patients at a local public health center using retrospective chart review. A total of 18 patients were prescribed with 5 days of herbal decoction and medicine extract covered by the national health insurance. With the questionnaire form, the progression and improvement of symptoms before and after treatment were evaluated using the numerical rating scale (NRS), and the treatment satisfaction and opinions were obtained. The symptoms such as cough (5.56±2.23 to 2.89±2.14), sputum (6.11±1,75 to 3.28±2.47), sore throat (6.06±2.70 to 1.47±1.62), anorexia (5.56±2.63 to 1.94±2.21), nausea (3.75±1.71 to 1.17±1.11), diarrhea (3.40±2.63 to 1.50±1.51), chest tightness (4.93±2.46 to 2.29±2.30) and fatigue (6.44±1.79 to 2.67±1.88) all improved according to the NRS, and the satisfaction with herbal medicine treatment on a 5-point Likert scale was 4.24±0.90. No side effects and adverse reactions were reported. Thereupon non-contact Korean medical treatment can be concluded that it effectively reduces the COVID-19 infection mild symptoms in restrictive extent. Since the retrospective data does not include a control group, the more confirmative data is needed by multicenter and large-scale controlled clinical study afterwards.

A prospective multicenter clinical study on the efficiency of detachable ball- and spring-retained implant prosthesis

  • Min-Jung Kim;Won-Tak Cho;Su-Hyun Hwang;Ji-Hyeon Bae;Eun-Bin Bae;June-Sung Shim;Jong-Eun Kim;Chang-Mo Jeong;Jung-Bo Huh
    • The Journal of Advanced Prosthodontics
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    • v.15 no.4
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    • pp.202-213
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    • 2023
  • PURPOSE. This prospective clinical study was conducted to evaluate the clinical usefulness of the freely detachable zirconia ball- and spring-retained implant prosthesis (BSRP) through a comparative analysis of screw- and cement-retained implant prosthesis (SCRP). MATERIALS AND METHODS. A multi-center, randomized, prospective clinical study evaluating the clinical usefulness of the detachable zirconia ball- and spring-retained implant prostheses was conducted. Sixty-four implant prostheses in 64 patients were examined. Periodic observational studies were conducted at 0, 3, 6, and 12 months after delivery of the implant prosthesis. Factors such as implant success rate, marginal bone resorption, periodontal pocket depth, plaque and bleeding index, and prosthetic complications were evaluated, respectively. RESULTS. During the 1-year observation period, all implants survived without functional problems and clinical mobility, showing a 100% implant success rate. Marginal bone resorption was significantly higher in the SCRP group than in the BSRP group only at the time of implant prosthesis delivery (P = .043). In all observation periods, periodontal pocket depth was slightly higher in the BSRP group than in the SCRP group, but there was no significant difference (P > .05). The modified plaque index (mPI) scores of both groups were moderate. Higher ratio of a score 2 in modified sulcus bleeding index (mBI) was observed in the BSRP group in the 6- and 12-months observation. CONCLUSION. Within the limitations of this study, the newly developed zirconia ball- and spring-retained implant prosthesis could be considered as an applicable and predictable treatment method along with the existing screw- and cement-retained prosthesis.

Development and Validation of AI Image Segmentation Model for CT Image-Based Sarcopenia Diagnosis (CT 영상 기반 근감소증 진단을 위한 AI 영상분할 모델 개발 및 검증)

  • Lee Chung-Sub;Lim Dong-Wook;Noh Si-Hyeong;Kim Tae-Hoon;Ko Yousun;Kim Kyung Won;Jeong Chang-Won
    • KIPS Transactions on Computer and Communication Systems
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    • v.12 no.3
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    • pp.119-126
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    • 2023
  • Sarcopenia is not well known enough to be classified as a disease in 2021 in Korea, but it is recognized as a social problem in developed countries that have entered an aging society. The diagnosis of sarcopenia follows the international standard guidelines presented by the European Working Group for Sarcopenia in Older People (EWGSOP) and the d Asian Working Group for Sarcopenia (AWGS). Recently, it is recommended to evaluate muscle function by using physical performance evaluation, walking speed measurement, and standing test in addition to absolute muscle mass as a diagnostic method. As a representative method for measuring muscle mass, the body composition analysis method using DEXA has been formally implemented in clinical practice. In addition, various studies for measuring muscle mass using abdominal images of MRI or CT are being actively conducted. In this paper, we develop an AI image segmentation model based on abdominal images of CT with a relatively short imaging time for the diagnosis of sarcopenia and describe the multicenter validation. We developed an artificial intelligence model using U-Net that can automatically segment muscle, subcutaneous fat, and visceral fat by selecting the L3 region from the CT image. Also, to evaluate the performance of the model, internal verification was performed by calculating the intersection over union (IOU) of the partitioned area, and the results of external verification using data from other hospitals are shown. Based on the verification results, we tried to review and supplement the problems and solutions.