1.Detection of Leptospiral DNA from Field Rodents by PCR.
Eun Kyoung YIM ; Yoon Won KIM ; Jin Sang LEE ; In Ae CHANG ; Luck Ju BAEK ; Jin Won SONG ; Anthony SCHUSTER ; Hee Choon S LEE ; Terry A KLEIN ; Min Kee CHO
Journal of Bacteriology and Virology 2003;33(3):177-181
Leptospirosis has been one of important epidemic diseases in Korea since 1984. Wild rodents, mostly Apodemus agrarius, served the important source of infection especially in harvest season in rural areas of Korea. Prevalence of Leptospira spp. infection in field rodents were investigated by detecting leptospiral DNA from rodent kidney. Among 108 rodents collected from various areas in 1998, leptospiral DNA were detected from 7 rodents (6.48%). Among 104 rodents, Apodemus agrarius, captured from Yeonchon and Paju area in 2001 and 2002, leptospiral DNA were detected from 6 rodents (5.76%). No leptospiral DNA was detected from 23 rodonts (Apodemus peninsulae 16, Apodemus agrarius 2 and Eothenomys regulus 5) captured in Odae mountain area in 1998.
Animals
;
DNA*
;
Kidney
;
Korea
;
Leptospira
;
Leptospirosis
;
Murinae
;
Polymerase Chain Reaction*
;
Prevalence
;
Rodentia*
;
Seasons
2.Adverse Events in Total Artificial Heart for End-Stage Heart Failure:Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
Background and Objectives:
Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database.
Methods:
We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians.
Results:
A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453).The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%).
Conclusions
Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.
3.Adverse Events in Total Artificial Heart for End-Stage Heart Failure:Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
Background and Objectives:
Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database.
Methods:
We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians.
Results:
A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453).The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%).
Conclusions
Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.
4.Adverse Events in Total Artificial Heart for End-Stage Heart Failure:Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
Background and Objectives:
Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database.
Methods:
We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians.
Results:
A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453).The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%).
Conclusions
Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.
5.Adverse Events in Total Artificial Heart for End-Stage Heart Failure:Insight From the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE)
Min Choon TAN ; Yong Hao YEO ; Jia Wei THAM ; Jian Liang TAN ; Hee Kong FONG ; Bryan E-Xin TAN ; Kwan S LEE ; Justin Z LEE
International Journal of Heart Failure 2024;6(2):76-81
Background and Objectives:
Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)’s Manufacturers and User Defined Experience (MAUDE) database.
Methods:
We reviewed the FDA’s MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians.
Results:
A total of 1,512 adverse events were identified in 453 “injury and death” reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453).The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%).
Conclusions
Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.
6.Risk of Vertebral Artery Injury: A Comparison between C2 Subarticular Segmental and C1-2 Transarticular Screws.
Seong Wan KIM ; Jin S YEOM ; Yoon Ju KWON ; Seung Min YOU ; Young Hee AN ; Kun Woo PARK ; Bong Soon CHANG ; Choon Ki LEE
The Journal of the Korean Orthopaedic Association 2008;43(5):572-578
PURPOSE: We compared the risk of vertebral artery injury associated with the insertion of C1-2 transarticular screws and C2 subarticular segmental screws using a computer simulation of computed tomography (CT) scans. MATERIALS AND METHODS: We simulated the placement of C1-2 transarticular screws and C2 subarticular segmental screws using 1-mm interval CT scan images in 166 patients, along with simulation software. We then determined the incidence of violation of the C2 vertebral artery groove. The same determination was performed for high-riding vertebral arteries found among those patients. RESULTS: Among the 332 C2 vertebral artery grooves (166 patients), C1-2 transarticular screws violated the groove in 33 (9.9%) instances, while C2 subarticular segmental screws violated the groove in 19 (5.7%) instances. The difference in incidence between the two screw types was statistically significant (p=0.001, McNemar test). In the 48 high-riding vertebral arteries, C1-2 transarticular screws led to violation of the C2 vertebral artery groove in 30 (62.5%) instances, while C2 subarticular segmental screws led to violation of the groove in 18 (37.5%) instances. The difference in incidence between the two screw types was statistically significant (p=0.002, McNemar test). CONCLUSION: Use of C2 subarticular segmental screws is associated with a lower risk of vertebral artery injury than is the use of C1-2 transarticular screws, even for high-riding vertebral arteries.
Computer Simulation
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Humans
;
Incidence
;
Vertebral Artery
7.Academy of Medicine-Ministry of Health clinical practice guidelines: attention deficit hyperactivity disorder.
Daniel S S FUNG ; Choon Guan LIM ; John Chee Meng WONG ; Koon Hock NG ; Christopher Cheng Soon CHEOK ; Jennifer Sie Hee KIING ; Shang Chee CHONG ; June LOU ; Mary Lourdes DANIEL ; Desmond ONG ; Charity LOW ; Sharifah Mariam ALJUNIED ; Pui Meng CHOI ; Kala MEHROTRA ; Carolyn KEE ; Ivy LEUNG ; Lee Chen YEN ; Geraldine WONG ; Poh Yin LEE ; Bella CHIN ; Hwee Chien NG
Singapore medical journal 2014;55(8):411-quiz 415
The Academy of Medicine (AMS) and the Ministry of Health (MOH) have developed the clinical practice guidelines on Attention Deficit Hyperactivity Disorder (ADHD) to provide doctors and patients in Singapore with evidence-based treatment for ADHD. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on ADHD, for the information of SMJ readers. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html.The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.
Attention Deficit Disorder with Hyperactivity
;
diagnosis
;
drug therapy
;
therapy
;
Caregivers
;
Child
;
Evidence-Based Medicine
;
Humans
;
Methylphenidate
;
therapeutic use
;
Parents
;
Psychiatry
;
methods
;
standards
;
Singapore
;
Societies, Medical
8.Validation of the Korean Version of the DN4 Diagnostic Questionnaire for Neuropathic Pain in Patients with Lumbar or Lumbar-Radicular Pain.
Ho Joong KIM ; Joon Hee PARK ; Didier BOUHASSIRA ; Jae Hoon SHIN ; Bong Soon CHANG ; Choon Ki LEE ; Chang Hyun BAEK ; Jin S YEOM
Yonsei Medical Journal 2016;57(2):449-454
PURPOSE: To evaluate the diagnostic value of the Korean version of the Douleur Neuropathique 4 (DN4) questionnaire and to validate this questionnaire in terms of psychometric properties in patients with chronic pain due to degenerative spinal disease. MATERIALS AND METHODS: The Korean version of the DN4 questionnaire, which was translated and linguistically validated by the MAPI Research Group, was tested on 83 patients with lumbar or lumbar-radicular pain. Test-retest reliability was evaluated in a subsample of 40 patients who completed two assessments with an interval of 2 weeks. Nociceptive pain and neuropathic component pain were diagnosed in 40 and 43 patients, respectively. RESULTS: The Cronbach's alpha coefficient of internal consistency was 0.819, and the test-retest intraclass correlation coefficient (3, 1) (95% confidence interval) was 0.813 (0.776-0.847) (n=40). The area under the receiver-operator characteristics curve was 0.953 (p<0.001), with 95% confidence interval between 0.869 and 0.990. The Korean version of the DN4 questionnaire showed a sensitivity of 100% and 87.1%, and a specificity of 88.2% and 94.1% at the cutoff value of 3/10 and 4/10, respectively, for discriminating neuropathic component pain. CONCLUSION: The present study demonstrated the good discriminatory power of DN4 between nociceptive pain and neuropathic component pain in patients with lumbar or lumbar-radicular pain.
Adult
;
Aged
;
Aged, 80 and over
;
Chronic Pain/*diagnosis
;
Female
;
Humans
;
Male
;
Middle Aged
;
Neuralgia/*diagnosis
;
Pain Measurement/*methods
;
Psychometrics
;
Reproducibility of Results
;
Sensitivity and Specificity
;
Surveys and Questionnaires/*standards
;
Translating
9.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(4):1001-1013
Background/Aims:
Omalizumab is the first biologic known to be effective in patients with severe allergic asthma.
Methods:
This study was conducted as a multicenter, single-group, open trial to evaluate the improvement in the quality of life with the additional administration of omalizumab for 24 weeks in Korean patients with severe persistent allergic asthma.
Results:
Of the 44 patients, 31.8% were men and the mean age was 49.8 ± 11.8 years. A score improvement of 0.5 points or more in the Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) was noted in 50.0% (22/44) of the patinets. In the improved group, the baseline total immunoglobulin E (IgE) level and the amount of omalizumab used were higher, and the day and night asthma symptoms were more severe, compared to those in the non-improved group. According to the Global Evaluation of Treatment Effectiveness, favorable outcomes were found in 78.6% of patients. The Korean asthma control test (p < 0.005) and forced expiratory volume in 1 second % predicted (FEV1%; p < 0.01) improved significantly in patients who received omalizumab treatment, compared to that at week 0, and the total dose of rescue systemic corticosteroids significantly decreased (p < 0.05). The improved group on KAQLQ showed a significant improvement in FEV1% (p < 0.001).
Conclusions
Omalizumab can be considered a biological treatment for Korean patients with severe allergic asthma. It is recommended to consider omalizumab as add-on therapy in patients with high baseline total IgE levels and severe asthma symptoms.
10.Effect of omalizumab as add-on therapy to Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) in Korean patients with severe persistent allergic asthma
Jae-Woo JUNG ; Hae-Sim PARK ; Choon-Sik PARK ; Sang-Heon CHO ; Inseon S. CHOI ; Hee-Bom MOON ; Soon Seog KWON ; Ho Joo YOON ; Jung Won PARK ; Jong-Myung LEE ; Dong-Chull CHOI ; Byoung Whui CHOI
The Korean Journal of Internal Medicine 2021;36(4):1001-1013
Background/Aims:
Omalizumab is the first biologic known to be effective in patients with severe allergic asthma.
Methods:
This study was conducted as a multicenter, single-group, open trial to evaluate the improvement in the quality of life with the additional administration of omalizumab for 24 weeks in Korean patients with severe persistent allergic asthma.
Results:
Of the 44 patients, 31.8% were men and the mean age was 49.8 ± 11.8 years. A score improvement of 0.5 points or more in the Quality of Life Questionnaire for Korean Asthmatics (KAQLQ) was noted in 50.0% (22/44) of the patinets. In the improved group, the baseline total immunoglobulin E (IgE) level and the amount of omalizumab used were higher, and the day and night asthma symptoms were more severe, compared to those in the non-improved group. According to the Global Evaluation of Treatment Effectiveness, favorable outcomes were found in 78.6% of patients. The Korean asthma control test (p < 0.005) and forced expiratory volume in 1 second % predicted (FEV1%; p < 0.01) improved significantly in patients who received omalizumab treatment, compared to that at week 0, and the total dose of rescue systemic corticosteroids significantly decreased (p < 0.05). The improved group on KAQLQ showed a significant improvement in FEV1% (p < 0.001).
Conclusions
Omalizumab can be considered a biological treatment for Korean patients with severe allergic asthma. It is recommended to consider omalizumab as add-on therapy in patients with high baseline total IgE levels and severe asthma symptoms.