• Title/Summary/Keyword: multicentre

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An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients

  • Eun-Yeong Cho;Jung-Eun Cho;Eun-Bin Lee;Seung Soo Yoo;Jung Hyun Chang
    • Tuberculosis and Respiratory Diseases
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    • v.86 no.1
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    • pp.33-46
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    • 2023
  • Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

The Treatment of Adult Respiratory Distress Syndrome (ARDS) Using Extracorporeal Membrane Oxygenation (ECMO) (성인 호흡곤란 증후군에 있어 체외막 산소화 장치를 이용한 치료)

  • Kim, Go-Woon;Choi, Eun-Young;Hong, Sang-Bum
    • Tuberculosis and Respiratory Diseases
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    • v.72 no.1
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    • pp.1-7
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    • 2012
  • Extracorporeal Membrane Oxygenation (ECMO) support to tissue oxygenation has been shown to improve survival in patients with life threatening respiratory distress syndrome or cardiac failure. Extracorporeal life support such as ECMO, including extracorporeal $CO_2$ removal ($ECCO_2R$), is used as temporary support until successful recovery of organs. A recently published multicentre randomized controlled trial, known as the CESAR (conventional ventilation or extracorporeal membrane oxygenation for severe adult respiratory failure) trial, was the first trial to demonstrate the utility of ECMO in acute respiratory distress syndrome (ARDS). During the 2009 influenza A (H1N1) pandemic, there were many reports of patients with severe ARDS related to H1N1 infection treated with ECMO. These reports revealed a high survival rate and effectiveness of ECMO. In this review, we explain the indication of ECMO clinical application, the practical types of ECMO, and complications associated with ECMO. In addition, we explain recent new ECMO technology and management of patients during ECMO support.

Antifungal Susceptibility Tests and the cyp51 Mutant Strains among Clinical Aspergillus fumigatus Isolates from Korean Multicenters

  • Won, Eun Jeong;Joo, Min Young;Lee, Dain;Kim, Mi-Na;Park, Yeon-Joon;Kim, Soo Hyun;Shin, Myung Geun;Shin, Jong Hee
    • Mycobiology
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    • v.48 no.2
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    • pp.148-152
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    • 2020
  • We investigated the antifungal susceptibilities and the cyp51 mutant strains among Aspergillus fumigatus clinical isolates obtained from 10 university hospitals in Korea. Of the 84 isolates examined, two itraconazole-resistant isolates were found with no amino acid substitution in the cyp51A/cyp51B genes. However, 19 (23.2%) azole-susceptible isolates harbored amino acid substitutions: Nine isolates harbored one to five mutations in cyp51A with high polymorphism, and 11 isolates exhibited the same Q42L mutation in cyp51B. Overall, a low azole resistance rate and high frequency of cyp51A/cyp51B amino acid substitutions were observed in the azole-susceptible A. fumigatus isolates in Korea.

Prognostic Factors and Adjuvant Treatments for Surgically Treated Cancers of the Biliary Tract: A Multicentre Study of the Anatolian Society of Medical Oncology (ASMO)

  • Unal, Olcun Umit;Oztop, Ilhan;Assoc, Tugba Kos;Turan, Nedim;Kucukoner, Mehmet;Helvaci, Kaan;Berk, Veli;Sevinc, Alper;Yildiz, Ramazan;Cinkir, Havva yesil;Tonyali, Onder;Demirci, Umut;Aktas, Bilge;Balakan, Ozan;Yilmaz, Ahmet Ugur
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.22
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    • pp.9687-9692
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    • 2014
  • Background: Biliary tract cancers are rare, and surgical resection is the standard treatment at early stages. However, reports on the benefits of adjuvant treatment following surgical resection are conflicting. This study aimed to evaluate the factors affecting survival and adjuvant treatments in patients with surgically treated biliary tract cancers. Materials and Methods: Patient clinical features, adjuvant treatments, and efficacy and prognostic factor data were evaluated. Survival analyses were performed using SPSS 15.0. Results: The median overall survival was 30.7 months (95% confidence interval [CI], 18.4-42.9 months). Median survival was 19 months (95% CI, 6-33) for patients treated with fluorouracil based chemotherapy and 53 months (95% CI, 33.2-78.8) with gemcitabine based chemotherapy(p=0.033). On univariate analysis, poor prognostic factors for survival were galbladder localization, perineural invasion, hepatic invasion, a lack of adjuvant chemoradiotherapy treatment, and a lack of lymph node dissection. On multivariate analysis, perineural invasion was a poor prognostic factor (p=0.008). Conclusions: Biliary tract cancers generally have poor prognoses. The main factors affecting survival are tumour localization, perineural invasion, hepatic invasion, adjuvant chemoradiotherapy, and lymph node dissection. Gemcitabine-based adjuvant chemotherapy is more effective than 5-fluorouracil-based chemotherapy.

Clinical Prognostic Factors and Survival Outcome in Renal Cell Carcinoma Patients - A Malaysian Single Centre Perspective

  • Yap, Ning Yi;Ng, Keng Lim;Ong, Teng Aik;Pailoor, Jayalakshmi;Gobe, Glenda Carolyn;Ooi, Chong Chien;Razack, Azed Hassan;Dublin, Norman;Morais, Christudas;Rajandram, Retnagowri
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7497-7500
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    • 2013
  • Background: This study concerns clinical characteristics and survival of renal cell carcinoma (RCC) patients in University Malaya Medical Centre (UMMC), as well as the prognostic significance of presenting symptoms. Materials and Methods: The clinical characteristics, presenting symptoms and survival of RCC patients (n=151) treated at UMMC from 2003-2012 were analysed. Symptoms evaluated were macrohaematuria, flank pain, palpable abdominal mass, fever, lethargy, loss of weight, anaemia, elevated ALP, hypoalbuminemia and thrombocytosis. Univariate and multivariate Cox regression analyses were performed to determine the prognostic significance of these presenting symptoms. Kaplan Meier and log rank tests were employed for survival analysis. Results: The 2002 TNM staging was a prognostic factor (p<0.001) but Fuhrman grading was not significantly correlated with survival (p=0.088). At presentation, 76.8% of the patients were symptomatic. Generally, symptomatic tumours had a worse survival prognosis compared to asymptomatic cases (p=0.009; HR 4.74). All symptoms significantly affect disease specific survival except frank haematuria and loin pain on univariate Cox regression analysis. On multivariate analysis adjusted for stage, only clinically palpable abdominal mass remained statistically significant (p=0.027). The mean tumour size of palpable abdominal masses, $9.5{\pm}4.3cm$, was larger than non palpable masses, $5.3{\pm}2.7cm$ (p<0.001). Conclusions: This is the first report which includes survival information of RCC patients from Malaysia. Here the TNM stage and a palpable abdominal mass were independent predictors for survival. Further investigations using a multicentre cohort to analyse mortality and survival rates may aid in improving management of these patients.

Multicentre Hospital-based Case-control Study of Diffuse Large B-cell Lymphoma in Shanghai, China

  • Fan, Rong;Zhang, Lu-Yao;Wang, Hong;Yang, Bo;Han, Tao;Zhao, Xiao-Li;Wang, Wei;Wang, Xiao-Qin;Lin, Guo-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.7
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    • pp.3329-3334
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    • 2012
  • Background: Several potential risk factors have been identified for diffuse large B-cell lymphoma (DLBCL); however, epidemiological studies investigating the association between these risk factors and DLBCL have yielded inconsistent results. Objectives: To investigate potential medical, lifestyle, and environmental risk factors of DLBCL in Shanghai, China through a hospital-based case-control study. Method: One-hundred-and-forty-seven newly diagnosed DLBCL patients and 294 sex- and age-matched controls were recruited from 11 hospitals in Shanghai between 2003 and 2007. A standardized structured questionnaire was used to obtain patient data on demographics, medical history, family history, lifestyle, and environmental exposures. Conditional logistic regression models were used to estimate odds ratios (ORs), with 95% confidence intervals (CIs), for risk associated with each data category. Results: History of tuberculosis (TB) infection and "living on a farm" were positively associated with DLBCL (TB: OR=3.05, 95% CI: 1.19-7.80; farm: OR=1.82, 95% CI: 1.21-2.73). In contrast, taking traditional Chinese medicine was negatively associated with DLBCL (OR=0.36, 95% CI: 0.14-0.89). No significant correlation with DLBCL risk was found for any of the other potential risk factors (p>0.05), including but not limited to hair dyes, alcohol drinking, smoking, and home/workplace renovation within one year. Conclusions: Consistent with results from previous studies in other DLBCL case populations, traditional Chinese medicine appeared to have a direct or indirect protective effect against DLBCL. However, this study also identified a possible predisposition for DLBCL in TB sufferers and farmers.

The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP - (소아 청소년 만성기침 환자를 대상으로 한 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Jun-Hwan;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.3
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    • pp.75-93
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    • 2023
  • Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

The single-stage management of bile duct stones is underutilised: A prospective multicentre cohort study with a literature review

  • Andrei Tanase;Thomas Brendon Russell;Timothy Platt;Ewen Alexander Griffiths;Somaiah Aroori;CholeS study group, West Midlands Research Collaborative
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.26 no.4
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    • pp.333-338
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    • 2022
  • Backgrounds/Aims: Bile duct stones (BDS) can be managed either prior to laparoscopic cholecystectomy (LC) using endoscopic retrograde cholangiopancreatography (ERCP) or with laparoscopic bile duct exploration (LBDE) at the time of LC. The latter is underutilised. The aim of this study was to use the dataset of the previously performed CholeS study to investigate LBDE hospital volumes, LBDE-to-LC rates, and LBDE outcomes. Methods: Data from 166 United Kingdom/Republic of Ireland hospitals were used to study the utilisation of LBDE in LC patients. Results: Of 8,820 LCs performed, 932 patients (10.6%) underwent preoperative ERCP and 256 patients (2.9%) underwent LBDE. Of the 256 patients who underwent LBDE, 73 patients (28.5%) had undergone prior ERCP and 112 patients (43.8%) had undergone prior magnetic resonance cholangiopancreatography. Fifteen (9.0%) of the 166 included hospitals performed less than five LBDEs in the two-month study period. LBDEs were mainly performed by upper gastrointestinal surgeons (84.4%) and colorectal surgeons (10.0%). Eighty-seven percent of the LBDEs were performed by consultants and 13.0% were performed by trainees. The laparoscopic-to-open conversion rate was 12.5%. The median operation time was 111 minutes (range: 75-155 minutes). Median hospital stay was 6 days (range: 4-11 days) for emergency LBDEs and 1 day (range: 1-4 days) for elective LBDEs. Overall morbidity was 21.5%. Bile leak rate was 5.3%. Thirty-day readmission and mortality rates were 12.1% and 0.4%, respectively. Conclusions: The single-stage approach to managing BDS was underutilised. An additional prospective study with a longer study period is needed to verify this finding.

Does an extensive diagnostic workup for upfront resectable pancreatic cancer result in a delay which affects survival? Results from an international multicentre study

  • Thomas B. Russell;Peter L. Labib;Jemimah Denson;Fabio Ausania;Elizabeth Pando;Keith J. Roberts;Ambareen Kausar;Vasileios K. Mavroeidis;Gabriele Marangoni;Sarah C. Thomasset;Adam E. Frampton;Pavlos Lykoudis;Manuel Maglione;Nassir Alhaboob;Hassaan Bari;Andrew M. Smith;Duncan Spalding;Parthi Srinivasan;Brian R. Davidson;Ricky H. Bhogal;Daniel Croagh;Ashray Rajagopalan;Ismael Dominguez;Rohan Thakkar;Dhanny Gomez;Michael A. Silva;Pierfrancesco Lapolla;Andrea Mingoli;Alberto Porcu;Teresa Perra;Nehal S. Shah;Zaed Z. R. Hamady;Bilal Al-Sarrieh;Alejandro Serrablo;Somaiah Aroori
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.27 no.4
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    • pp.403-414
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    • 2023
  • Backgrounds/Aims: Pancreatoduodenectomy (PD) is recommended in fit patients with a carcinoma (PDAC) of the pancreatic head, and a delayed resection may affect survival. This study aimed to correlate the time from staging to PD with long-term survival, and study the impact of preoperative investigations (if any) on the timing of surgery. Methods: Data were extracted from the Recurrence After Whipple's (RAW) study, a multicentre retrospective study of PD outcomes. Only PDAC patients who underwent an upfront resection were included. Patients who received neoadjuvant chemo-/radiotherapy were excluded. Group A (PD within 28 days of most recent preoperative computed tomography [CT]) was compared to group B (> 28 days). Results: A total of 595 patents were included. Compared to group A (median CT-PD time: 12.5 days, interquartile range: 6-21), group B (49 days, 39-64.5) had similar one-year survival (73% vs. 75%, p = 0.6), five-year survival (23% vs. 21%, p = 0.6) and median time-to-death (17 vs. 18 months, p = 0.8). Staging laparoscopy (43 vs. 29.5 days, p = 0.009) and preoperative biliary stenting (39 vs. 20 days, p < 0.001) were associated with a delay to PD, but magnetic resonance imaging (32 vs. 32 days, p = 0.5), positron emission tomography (40 vs. 31 days, p > 0.99) and endoscopic ultrasonography (28 vs. 32 days, p > 0.99) were not. Conclusions: Although a treatment delay may give rise to patient anxiety, our findings would suggest this does not correlate with worse survival. A delay may be necessary to obtain further information and minimize the number of PD patients diagnosed with early disease recurrence.