• 제목/요약/키워드: Multicenter clinical study

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중풍환자의 변증에 따른 맥상의 분포 (Study on the Pulse Diagnosis for Pattern Identifications in Stroke Patients)

  • 이정섭;강병갑;고미미;김보영;김정철;이인;김윤식;조기호;최선미;방옥선
    • 동의생리병리학회지
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    • 제22권6호
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    • pp.1378-1382
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    • 2008
  • This study is aim to evaluate pulse diagnosis as indicators for classification of the pattern identifications in stroke patients. To get the clinical information, we recruited the onset 1 month stroke patients through the multicenter network which consists of 13 oriental hospitals. The clinical informations about three pairs of pulse wave form and levels of their significancy based on the case report form (CRF) were collected and their distribution in each pattern identification were analyzed. The results are as follows Fire-Heat group shows high portions of floating pulse, rapid pulse and solid pulse. Qi Defficiency group has a greater portion of deep pulse, slow pulse, deficient pulse. The well-defined character of Phlegm-Retained Fluid, Yin Defficiency, Static Blood groups cannot be explained by pulse wave form. These results show a rough relationship between the pulse diagnosis and pattern identifications of stroke therefore, further studies are required to determine the pulse diagnosis as significant indicators of stroke pattern identification.

Liver Involvement in Children with Alpha-1 Antitrypsin Deficiency: A Multicenter Study

  • Cakir, Murat;Sag, Elif;Islek, Ali;Baran, Masallah;Tumgor, Gokhan;Aydogdu, Sema
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제23권2호
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    • pp.146-153
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    • 2020
  • Purpose: Alpha-1 antitrypsin deficiency (A1ATD) in one of the most common genetic causes of liver disease in children. We aimed to analyze the clinical characteristics and outcomes of patients with A1ATD. Methods: This study included patients with A1ATD from five pediatric hepatology units. Demographics, clinical findings, genetics, and outcome of the patients were recorded (n=25). Results: Eight patients (32.0%) had homozygous PiZZ genotype while 17 (68.0%) had heterozygous genotype. Patients with PiZZ genotype had lower alpha-1 antitrypsin levels than patients with PiMZ genotype (37.6±7.7 mg/dL vs. 66.5±22.7 mg/dL, p=0.0001). Patients with PiZZ genotype were diagnosed earlier than patients with PiMZ genotype, but this was not significant (13±6.8 months vs. 23.7±30.1 months, p=0.192). Follow-up revealed the death of one patient (12.5%) with a homozygous mutation, and revealed that one patient had child A cirrhosis, five patients (62.5%) had chronic hepatitis, and one patient (12.5%) was asymptomatic. Nine of the 17 patients with a heterozygous mutation had chronic hepatitis (52.9%), two (11.7%) had child A cirrhosis, and six (35.2%) were asymptomatic. Overall, 18 (72%) of the 25 children had liver pathology in the long-term. Conclusion: Although prevalence is rare, patients with liver disorders should be checked for alpha-1 antitrypsin levels. Moreover, long-term follow-up is essential because most patients have a liver pathology.

Docetaxel and Cisplatin in First Line Treatment of Patients with Unknown Primary Cancer: A Multicenter Study of the Anatolian Society of Medical Oncology

  • Demirci, Umut;Coskun, Ugur;Karaca, Halit;Dane, Faysal;Ozdemir, Nuriye Yildirim;Ulas, Arife;Baykara, Meltem;Benekli, Mustafa;Ozkan, Metin;Buyukberber, Suleyman
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권4호
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    • pp.1581-1584
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    • 2014
  • Background: The overall prognosis for cancers of unknown primary (CUP) is poor, median overall survival (OS) being 6-12 months. We evaluated our multicentric retrospective experience for CUP administered docetaxel and cisplatin combination therapy. Materials and Methods: A total of 29 patients that were pathologically confirmed subtypes of CUP were included in the study. The combination of docetaxel ($75mg/m^2$, day 1) and cisplatin ($75mg/m^2$, day 1) was performed as a first line regimen every 21 days. Results: The median age was 51 (range: 27-68). Some 17 patients had multimetastatic disease on the inital diagnosis. Histopathological diagnoses were well-moderate differentiated adenocarcinoma (51.7%), undifferentiated carcinoma (27.6%), squamous cell cancer (13.8%), mucoepidermoid carcinoma (3.4%) and neuroendocrine differentiated carcinoma (3.4%). Median number of cycles was 3 (range: 1-6). Objective response rate was 37.9% and clinical benefit was 58.6%. Median progression free survival (PFS) and overall survival (OS) were 6 months (range: 4.3-7.7 months) and 16 months (range: 8.1-30.9 months), respectively. Fourteen patients (60.8%) were treated in a second line setting. There was no treatment related death. Most common toxicities were nausia-vomiting (44.6%) and fatigue (34.7%), serious cases (grade 3/4) suffering nausia-vomiting (10.3%), neutropenia (13.8%) and febrile neutropenia (n=1). Conclusion: The combination of cisplatin and docetaxel is an effective regimen for selected patients with CUP.

Endoscopic Resection of Undifferentiated Early Gastric Cancer

  • Yuichiro Hirai;Seiichiro Abe;Mai Ego Makiguchi;Masau Sekiguchi;Satoru Nonaka;Haruhisa Suzuki;Shigetaka Yoshinaga;Yutaka Saito
    • Journal of Gastric Cancer
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    • 제23권1호
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    • pp.146-158
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    • 2023
  • Endoscopic resection (ER) is widely performed for early gastric cancer (EGC) with a negligible risk of lymph node metastasis (LNM) in Eastern Asian countries. In particular, endoscopic submucosal dissection (ESD) leads to a high en bloc resection rate, enabling accurate pathological evaluation. As undifferentiated EGC (UD-EGC) is known to result in a higher incidence of LNM and infiltrative growth than differentiated EGC (D-EGC), the indications for ER are limited compared with those for D-EGC. Previously, clinical staging as intramucosal UD-EGC ≤2 cm, without ulceration, was presented as 'weakly recommended' or 'expanded indications' for ER in the guidelines of the United States, Europe, Korea, and Japan. Based on promising long-term outcomes from a prospective multicenter study by the Japan Clinical Oncology Group (JCOG) 1009/1010, the status of this indication has expanded and is now considered 'absolute indications' in the latest Japanese guidelines published in 2021. In this study, which comprised 275 patients with UD-EGC (cT1a, ≤2 cm, without ulceration) treated with ESD, the 5-year overall survival (OS) was 99.3% (95% confidence interval, 97.1%-99.8%), which was higher than the threshold 5-year OS (89.9%). Currently, the levels of evidence grades and recommendations for ER of UD-EGC differ among Japan, Korea, and Western countries. Therefore, a further discussion is warranted to generalize the indications for ER of UD-EGC in countries besides Japan.

기능성 소화불량 환자의 간 기능에 대한 한약 투여의 안전성: 단일 센터 후향적 연구 (Safety of Herbal Medicines on Liver Function in Functional Dyspepsia Patients: A Single-Center Retrospective Study)

  • 한아람;금창열;윤채림;최수현;정다희;정나현;정해인;하나연;김진성
    • 대한한방내과학회지
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    • 제44권4호
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    • pp.635-644
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    • 2023
  • Objectives: This study analyzed laboratory serum data results before and after patients took herbal medicine to confirm the clinical safety of herbal medicine. In addition, in the event of liver damage, the case was analyzed to confirm the characteristics of liver damage and the possibility of liver damage caused by herbal medicine. Methods: A retrospective chart review of the effects of herbal medicine on liver function in patients diagnosed with functional dyspepsia was conducted. The electronic medical records of 128 patients in a single hospital were reviewed. Results: The statistical analysis revealed a statistically significant decrease in liver function-related laboratory serum data after taking herbal medicine (p<0.05). In addition, among 128 patients, there were two cases of drug-induced liver injury (DILI) (1.56%). Conclusion: Taking herbal medicine prescribed by experts does not significantly affect liver function in patients with functional dyspepsia. Rather, the liver levels of the subjects showed a significant decrease after taking herbal medicine. To support these results, further large-scale multicenter prospective studies are necessary.

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • 제27권2호
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

  • Tae Won Choi;Je Hwan Won;Hwan Jun Jae;Yong Sun Jeon;Sang Woo Park;Gi-Young Ko;Nam Yeol Yim;Jong Yun Won;Chang Won Kim;Jinoo Kim
    • Korean Journal of Radiology
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    • 제25권6호
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    • pp.565-574
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    • 2024
  • Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

A multicenter comparative study of endoscopic ultrasound-guided fine-needle biopsy using a Franseen needle versus conventional endoscopic ultrasound-guided fine-needle aspiration to evaluate microsatellite instability in patients with unresectable pancreatic cancer

  • Tadayuki Takagi;Mitsuru Sugimoto;Hidemichi Imamura;Yosuke Takahata;Yuki Nakajima;Rei Suzuki;Naoki Konno;Hiroyuki Asama;Yuki Sato;Hiroki Irie;Jun Nakamura;Mika Takasumi;Minami Hashimoto;Tsunetaka Kato;Ryoichiro Kobashi;Yuko Hashimoto;Goro Shibukawa;Shigeru Marubashi;Takuto Hikichi;Hiromasa Ohira
    • Clinical Endoscopy
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    • 제56권1호
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    • pp.107-113
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    • 2023
  • Background/Aims: Immune checkpoint blockade has recently been reported to be effective in treating microsatellite instability (MSI)-high tumors. Therefore, sufficient sampling of histological specimens is necessary in cases of unresectable pancreatic cancer (UR-PC). This multicenter study investigated the efficacy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) using a Franseen needle for MSI evaluation in patients with UR-PC. Methods: A total of 89 patients with UR-PC who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or EUS-FNB using 22-G needles at three hospitals in Japan (2018-2021) were enrolled. Fifty-six of these patients (FNB 23 and FNA 33) were followed up or evaluated for MSI. Patient characteristics, UR-PC data, and procedural outcomes were compared between patients who underwent EUS-FNB and those who underwent EUS-FNA. Results: No significant difference in terms of sufficient tissue acquisition for histology was observed between patients who underwent EUS-FNB and those who underwent EUS-FNA. MSI evaluation was possible significantly more with tissue samples obtained using EUS-FNB than with tissue samples obtained using EUS-FNA (82.6% [19/23] vs. 45.5% [15/33], respectively; p<0.01). In the multivariate analysis, EUS-FNB was the only significant factor influencing the possibility of MSI evaluation. Conclusions: EUS-FNB using a Franseen needle is desirable for ensuring sufficient tissue acquisition for MSI evaluation.

소아 기형종의 임상적 고찰 및 PCNA 발현율에 관한 연구 (Clinical Review and PCNA Expressions of Teratomas in Pediatric Patients)

  • 주재환;최수진나;정상영;김신곤
    • Advances in pediatric surgery
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    • 제1권2호
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    • pp.122-132
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    • 1995
  • Teratoma contains elements derived from all three embryonic germ layers and mature teratomas are entirely composed of mature differentiated tissues, while immature types always contain additional embryonic tissues of variable degree of immaturity, especially neuroepithelial elements. Twenty cases of teratoma in infancy and childhood were reviewed and the clinical features and pathologic findings including PCNA expression were studied. Sacrococcygeal teratomas were the most common type(45%), followed by retroperitoneal and ovarian teratomas. There was a predilection of females in a ratio of 4:1 and age distribution was most prevalent below the first year of age(45%). But in ovarian teratomas, the age at diagnosis was above 4 years of age in all cases. Serum alpha-fetoprotein levels were checked in 18 cases. In all mature teratomas and 1 of 5 immature teratomas, the levels were normal. But in 4 of 5 immature teratomas, the serum levels were elevated and progressively declined to normal range after mass excision. Radiologically, calcifications in tumor were found in 60.0% of teratomas and was higher in mature teratomas(69.2%) than immature teratomas(42.9%). Immunohistochemical staining for PCNA(proliferating cell nuclear antigen) was done in 16 cases and PCNA expression was higher in grade III immature teratomas than grade I and II. The operative modes were complete mass excisions. Five immature teratomas were treated with multiagent PEB(Bleomycin, Etoposide, Cisplatin) adjuvant chemotherapy, 3 tolerated well without significant complications, but in one case, severe bone marrow suppression was developed and died of sepsis. In conclusion, grade III immature teratoma showed higher PCNA expression than mature or lower grade immature teratoma, which suggests that chemotherapy after surgical excision may be effective modality for grade III immature teratoma. We think, however, multicenter study is necessary because of low incidence of immature teratoma.

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우황청심원 관련 최근 연구 동향 : 국내 논문에 대한 고찰 (The Latest Research Trends on Woohwangchungsim-won : A Review in Korean Articles)

  • 이제원;백경민;백영두;임은영;장우석;전우현;정인권
    • 대한한방내과학회지
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    • 제31권4호
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    • pp.775-791
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    • 2010
  • Objectives : Woohwangchungsim-won has been used for acute diseases such as cerebrovascular disease (stroke), heart disease. The aim of this study was to determine the effects, significance & necessity of Woohwangchungsim-won in acute stages of these disease by reviewing Korean articles about Woohwangchungsim-won. Methods : Article searches were performed on 8 major Korean web article search engine from January 1980 to August 2010. There were no restrictions on the types of publication, including grey articles. Results : Forty-three articles were included. Twenty one were efficacy tests, thirteen were comparative efficacy tests, eight were toxicity tests, and one was new method development. Eighteen articles were multicenter studies and twenty five were single center studies. Thirty two articles were animal testing, only ten articles were clinical articles. Thirty seven articles presented the composition and quantity of Woohwangchungsim-won, but six did not. Conclusions : The results of Korean articles about Woohwangchungsim-won can not strongly support the effects, significance & necessity of Woohwangchungsim-won. More rigorous studies are required for determination of the effects of Woohwangchungsim-won.