• Title/Summary/Keyword: Multicenter clinical studies

Search Result 56, Processing Time 0.026 seconds

Literature Review of Studies Related with Injinho in Korea (인진호(茵蔯蒿) 관련 국내 연구 동향 고찰)

  • Na, Ran-Hee;Bang, Chang-Ho;Jang, Seok-Oh;Choi, Ji-Hye;Ko, Ha-Neul;Kim, Lae-Hee;Rhee, Yun-Jin;Kim, Kang-San
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.24 no.3
    • /
    • pp.361-366
    • /
    • 2010
  • This study was practiced to investigate the existing study trends for Injinho that is numerously used for hepatobiliary diseases in oriental medicine. The studies selected from the domestic academic database included the following keywords in the title or abstract; 'Artemisia capillaris', 'Artemisia iwayomogi', 'Artemisia scoparia'. The studies considered were those published from January 1990 to May 2009. 198 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts, and 104 studies among them were finally selected as subjects for this study. 81 studies among 104 studies(78%) were published between 2000 and 2009, while 23 studies(22%) were published between 1990 and 1999. Classification was proceeded according to study subjects as followed; 23 studies confirming hepatoprotective effect after artificial liver damage in a number of cells or the organ itself, 18 studies on anti-tumor effect, 12 studies on hyperlipidemia and fatty liver disease, and 4 studies on liver cirrhosis and hepatocyte regeneration. Furthermore, classification was conducted according to study methods as followed; 56 studies practicing in vitro, 33 studies practicing in vivo, 11 studies practicing both in vitro and in vivo. 2 studies on specific cases and 1 study on documentary records. The majority of studies report the affirmative effects of Injinho. However most study methods were restricted to in vitro and in vivo. Hereafter, case reports on various fields and multicenter clinical trials on Injinho is necessary.

Determining Optimal Cut-off Score for the Braden Scale on Assessment of Pressure Injury for Tertiary Hospital Inpatients (상급종합병원 입원환자의 욕창발생 위험예측을 위한 Braden Scale의 타당도 검증)

  • Park, Sook Hyun;Choi, hyeyeon;Son, Youn-Jung
    • Journal of Korean Critical Care Nursing
    • /
    • v.16 no.3
    • /
    • pp.24-33
    • /
    • 2023
  • Purpose : This study aims to establish an optimal cut-off score on the Braden scale for the assessment of pressure injury to detect pressure injury risks among inpatients in a South Korean tertiary hospital. Methods : This retrospective study used electronic medical records, from January to December 2022. A total of 654 patients were included in the study. Of these, 218 inpatients with pressure injuries and 436 without pressure injuries were classified and analyzed using 1:2 Propensity Score Matching (PSM), and the generalized estimating equation was performed using SPSS Version 26 and the R Machlt package program. Results : The cut-off value on the Braden scale for distinguishing pressure injury was 17 points, and the AUC (area under the ROC curve) was 0.531 (0.484-0.579). The sensitivity was 56.6% (45.5-67.7%) and the specificity was 69.7% (66.0-73.4%). With 17 points, the Braden scale cut-off distinguished those who had pressure injuries from those who did not at the time of admission (p < .03). In the pressure injury group, the Braden score on the day of the pressure injury was 14, with significant results in all subcategories except the moisture category. Conclusion : Our findings revealed that a cut-off value of 17 was optimal for predicting the risk of pressure injuries among tertiary hospital inpatients. Future studies should evaluate the optimal cut-off values in different clinical environments. Additionally, it is necessary to conduct multicenter large sample studies to verify the effectiveness of a 17 value in PI risk assessments.

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
    • /
    • v.15 no.4
    • /
    • pp.202-213
    • /
    • 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.

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
    • /
    • v.27 no.2
    • /
    • pp.97-104
    • /
    • 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
    • /
    • v.25 no.6
    • /
    • pp.565-574
    • /
    • 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.

Functional Aspects of the Obesity Paradox in Patients with Severe Coronavirus Disease-2019: A Retrospective, Multicenter Study

  • Jeongsu Kim;Jin Ho Jang;Kipoong Kim;Sunghoon Park;Su Hwan Lee;Onyu Park;Tae Hwa Kim;Hye Ju Yeo;Woo Hyun Cho
    • Tuberculosis and Respiratory Diseases
    • /
    • v.87 no.2
    • /
    • pp.176-184
    • /
    • 2024
  • Background: Results of studies investigating the association between body mass index (BMI) and mortality in patients with coronavirus disease-2019 (COVID-19) have been conflicting. Methods: This multicenter, retrospective observational study, conducted between January 2020 and August 2021, evaluated the impact of obesity on outcomes in patients with severe COVID-19 in a Korean national cohort. A total of 1,114 patients were enrolled from 22 tertiary referral hospitals or university-affiliated hospitals, of whom 1,099 were included in the analysis, excluding 15 with unavailable height and weight information. The effect(s) of BMI on patients with severe COVID-19 were analyzed. Results: According to the World Health Organization BMI classification, 59 patients were underweight, 541 were normal, 389 were overweight, and 110 were obese. The overall 28-day mortality rate was 15.3%, and there was no significant difference according to BMI. Univariate Cox analysis revealed that BMI was associated with 28-day mortality (hazard ratio, 0.96; p=0.045), but not in the multivariate analysis. Additionally, patients were divided into two groups based on BMI ≥25 kg/m2 and underwent propensity score matching analysis, in which the two groups exhibited no significant difference in mortality at 28 days. The median (interquartile range) clinical frailty scale score at discharge was higher in nonobese patients (3 [3 to 5] vs. 4 [3 to 6], p<0.001). The proportion of frail patients at discharge was significantly higher in the nonobese group (28.1% vs. 46.8%, p<0.001). Conclusion: The obesity paradox was not evident in this cohort of patients with severe COVID-19. However, functional outcomes at discharge were better in the obese group.

Prediction of Residual Axillary Nodal Metastasis Following Neoadjuvant Chemotherapy for Breast Cancer: Radiomics Analysis Based on Chest Computed Tomography

  • Hyo-jae Lee;Anh-Tien Nguyen;Myung Won Song;Jong Eun Lee;Seol Bin Park;Won Gi Jeong;Min Ho Park;Ji Shin Lee;Ilwoo Park;Hyo Soon Lim
    • Korean Journal of Radiology
    • /
    • v.24 no.6
    • /
    • pp.498-511
    • /
    • 2023
  • Objective: To evaluate the diagnostic performance of chest computed tomography (CT)-based qualitative and radiomics models for predicting residual axillary nodal metastasis after neoadjuvant chemotherapy (NAC) for patients with clinically node-positive breast cancer. Materials and Methods: This retrospective study included 226 women (mean age, 51.4 years) with clinically node-positive breast cancer treated with NAC followed by surgery between January 2015 and July 2021. Patients were randomly divided into the training and test sets (4:1 ratio). The following predictive models were built: a qualitative CT feature model using logistic regression based on qualitative imaging features of axillary nodes from the pooled data obtained using the visual interpretations of three radiologists; three radiomics models using radiomics features from three (intranodal, perinodal, and combined) different regions of interest (ROIs) delineated on pre-NAC CT and post-NAC CT using a gradient-boosting classifier; and fusion models integrating clinicopathologic factors with the qualitative CT feature model (referred to as clinical-qualitative CT feature models) or with the combined ROI radiomics model (referred to as clinical-radiomics models). The area under the curve (AUC) was used to assess and compare the model performance. Results: Clinical N stage, biological subtype, and primary tumor response indicated by imaging were associated with residual nodal metastasis during the multivariable analysis (all P < 0.05). The AUCs of the qualitative CT feature model and radiomics models (intranodal, perinodal, and combined ROI models) according to post-NAC CT were 0.642, 0.812, 0.762, and 0.832, respectively. The AUCs of the clinical-qualitative CT feature model and clinical-radiomics model according to post-NAC CT were 0.740 and 0.866, respectively. Conclusion: CT-based predictive models showed good diagnostic performance for predicting residual nodal metastasis after NAC. Quantitative radiomics analysis may provide a higher level of performance than qualitative CT features models. Larger multicenter studies should be conducted to confirm their performance.

Flumazenil administration in suspected patients with acute hypnotics and sedatives poisoning: risk-benefit re-evaluation (급성 진정제 중독 추정 환자에서 플루마제닐의 투여: 위험도/이익 재평가)

  • Huh, Jae Hong;Choi, Sang Chun;Lim, Yong Gyun;Lampotang, Samsun;Park, Eung Jung
    • Journal of The Korean Society of Clinical Toxicology
    • /
    • v.14 no.2
    • /
    • pp.92-99
    • /
    • 2016
  • Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

Multicenter Evaluation of Patients with Cutaneous Malignant Melanoma in Turkey: MELAS Study

  • Uysal-Sonmez, Ozlem;Tanriverdi, Ozgur;Esbah, Onur;Uyeturk, Ummugul;Helvaci, Kaan;Bal, Oznur;Yalcintas-Arslan, Ulku;Budakoglu, Burcin;Oksuzoglu, Berna
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.14 no.1
    • /
    • pp.533-537
    • /
    • 2013
  • Background: Malignant melanoma is a cancer that demonstrates rapid progression and atypical clinically features with a poor prognosis. Aim: This study was performed to determine the clinical characteristics and treatment outcomes of patients with malignant melanoma in Turkey. Methods: The medical records of 98 patients between 2007-2012 at our centers were retrieved from the patient registry. Overall survival (OS) was calculated using the Kaplan-Meier method. Results: In our study, with the median follow-up of all patients with cutaneous MM of 46.3 months, the median OS rate of all cases was 43.6 months and 5-year OS was 48.6%. However, five-year OS rates of patients with localized disease (stage I-II) and node involvement (stage III) were 60.3% and 39.6%, respectively. The median OS of stage IV patients was 8.7 months and 1-year OS rate was 26.2%. We showed that advanced stage, male gender, and advanced age in all patients with MM were significant prognostic factors of OS. Conclusions: Compared with the results of current studies from Western countries, we found similar findings concerning demographical features, histological variables and survival analyses for our patients with cutaneous MM in Turkey.

Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
    • /
    • v.15 no.6
    • /
    • pp.703-714
    • /
    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.