• Title/Summary/Keyword: observational clinical study

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Thyroid-Stimulating Hormone Reference Ranges in the First Trimester of Pregnancy in an Iodine-Sufficient Country

  • Castillo, Carmen;Lustig, Nicole;Margozzini, Paula;Gomez, Andrea;Rojas, MarIa Paulina;Muzzo, Santiago;Mosso, Lorena
    • Endocrinology and Metabolism
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    • v.33 no.4
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    • pp.466-472
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    • 2018
  • Background: Thyroid dysfunction is associated with negative neonatal and obstetric outcomes. Large differences in thyroid function reference intervals exist across different populations. These differences can be explained by population-specific factors, such as iodine status. Many countries in Latin America report iodine sufficiency, but relatively few countries have published up-to-date data on iodine levels and thyroid function in the overall population, and especially in pregnant women. We evaluated the iodine status of pregnant women in Chile and determined thyroid hormone reference ranges in this population. Methods: This was a prospective observational study of healthy Chilean women at their first prenatal visit before week 14. Thyroid-stimulating hormone (TSH), total thyroxine ($T_4$), free $T_4$, antithyroid peroxidase antibody (TPOAb), and iodine levels from spot urine samples were measured. Iodine status and the reference ranges for TSH were calculated. Results: A total of 1,022 pregnant women in the first trimester were selected. Urinary iodine levels were measured in 302 randomly-selected women. The median urinary iodine concentration was $173.45{\mu}g/L$ (interquartile range, 108.11 to 249.35).The reference ranges of TSH were calculated in 670 patients selected according to the National Academy of Clinical Biochemistry guidelines. The median TSH level was $1.88{\mu}IU/mL$ (2.5th percentile: 0.13 to 97.5th percentile: 5.37). Using the reference range in the 1,022 women, the prevalence of clinical hypothyroidism was 1.76%, and that of subclinical hypothyroidism was 3.92%. TPOAb positivity was more common in women with TSH levels above $3.5{\mu}IU/mL$. Conclusion: We found adequate iodine intake and a right-shifted distribution of serum TSH levels in pregnant women in Chile. The prevalence of hypothyroidism in our sample of pregnant women was higher than has been described in the literature.

Rationale, Design, and Interim Observations of the Steady Movement With Innovating Leadership for Heart Failure (SMILE HF) Registry: A Multicenter Prospective Cohort Registry for Patients With Acute Heart Failure

  • Jah Yeon Choi;Mi-Na Kim;Seongwoo Han;Sunki Lee;Myung Soo Park;Min Gyu Kong;Sung-Hea Kim;Yong-Hyun Kim;Sang-Ho Jo;Sungeun Kim;Seonghoon Choi;Jinsung Jeon;Jieun Lee;Byambakhand Battumur;Seong-Mi Park;Eung Ju Kim;SMILE HF Investigators
    • International Journal of Heart Failure
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    • v.6 no.3
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    • pp.129-136
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    • 2024
  • Background and Objectives: Heart failure (HF) is a leading cause of hospitalization and death worldwide. The Steady Movement with Innovating Leadership for Heart Failure (SMILE HF) aims to evaluate the clinical characteristics, management, hospital course, and long-term outcomes of patients hospitalized for acute HF in South Korea. Methods: This prospective, observational multicenter cohort study was conducted on consecutive patients hospitalized for acute HF in nine university hospitals since September 2019. Enrolment of 2000 patients should be completed in 2024, and follow-up is planned through 2025. Results: Interim analysis of 1,052 consecutive patients was performed to understand the baseline characteristics. The mean age was 69±15 years; 57.6% were male. The mean left ventricular ejection fraction was 39±15%. The prevalences of HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction were 50.9%, 15.3%, and 29.2%. Ischemic cardiomyopathy (CMP) was the most common etiology (32%), followed by tachycardia-induced CMP (12.8%) and idiopathic dilated CMP (9.5%). The prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers/angiotensin receptor/neprilysin inhibitor, beta-blockers, spironolactone, and sodium-glucose cotransporter-2 inhibitors at discharge were 76.8%, 66.5%, 50.0%, and 17.5%, respectively. The post-discharge 90-day mortality and readmission rates due to HF aggravation were 2.0% and 6.4%, respectively. Our analysis reveals the current state of acute HF in South Korea. Conclusions: Our interim analysis provides valuable insights into the clinical characteristics, management, and early outcomes of acute HF patients in South Korea, highlighting the current state and treatment patterns in this population.

Comparison of Statin With Ezetimibe Combination Therapy Versus Statin Monotherapy for Primary Prevention in Middle-Aged Adults

  • Jung-Joon Cha;Soon Jun Hong;Subin Lim;Ju Hyeon Kim;Hyung Joon Joo;Jae Hyoung Park;Cheol Woong Yu;Do-Sun Lim;Jang Young Kim;Jin-Ok Jeong;Jeong-Hun Shin;Chi Young Shim;Jong-Young Lee;Young-Hyo Lim;Sung Ha Park;Eun Joo Cho;Hasung Kim;Jungkuk Lee;Ki-Chul Sung;Korean Vascular Society
    • Korean Circulation Journal
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    • v.54 no.9
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    • pp.534-544
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    • 2024
  • Background and Objectives: Lipid lowering therapy is essential to reduce the risk of major cardiovascular events; however, limited evidence exists regarding the use of statin with ezetimibe as primary prevention strategy for middle-aged adults. We aimed to investigate the impact of single pill combination therapy on clinical outcomes in relatively healthy middle-aged patients when compared with statin monotherapy. Methods: Using the Korean National Health Insurance Service database, a propensity score match analysis was performed for baseline characteristics of 92,156 patients categorized into combination therapy (n=46,078) and statin monotherapy (n=46,078) groups. Primary outcome was composite outcomes, including death, coronary artery disease, and ischemic stroke. And secondary outcome was all-cause death. The mean follow-up duration was 2.9±0.3 years. Results: The 3-year composite outcomes of all-cause death, coronary artery disease, and ischemic stroke demonstrated no significant difference between the 2 groups (10.3% vs. 10.1%; hazard ratio [HR], 1.022; 95% confidence interval [CI], 0.980-1.064; p=0.309). Meanwhile, the 3-year all-cause death rate was lower in the combination therapy group than in the statin monotherapy group (0.2% vs. 0.4%; p<0.001), with a significant HR of 0.595 (95% CI, 0.460-0.769; p<0.001). Single pill combination therapy exhibited consistently lower mortality rates across various subgroups. Conclusions: Compared to the statin monotherapy, the combination therapy for primary prevention showed no difference in composite outcomes but may reduce mortality risk in relatively healthy middle-aged patients. However, since the study was observational, further randomized clinical trials are needed to confirm these findings.

Clinical Spectrum and Short-term Effects of Enzyme Replacement Therapy for Mucopolysaccharidosis Type II (제2형 뮤코다당증의 임상적 스펙트럼과 효소대치요법의 단기간 효과)

  • Cheon, Chong Kun;Hwu, Wuh-Liang
    • Journal of The Korean Society of Inherited Metabolic disease
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    • v.18 no.3
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    • pp.78-86
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    • 2018
  • Purpose: We aimed to delineate clinical spectrum and short-term effects after enzyme replacement therapy (ERT) for 5 mucopolysaccharidosis type II (MPS II). Methods: Five patients were diagnosed with MPS II by clinical findings, enzyme activity, and genetic testing. Idursulfase was administered by intravenous infusion at a dose of 0.5 mg/kg every week. Observational chart analysis of patients, who underwent systematic investigations more than 12 months after initiation of ERT was done retrospectively. Results: Three patients were classified as having the attenuated type, and 2 patients were classified as having the severe type. The median age at the diagnosis was 9.6 years (range 3.4-26 years). Four different mutations in 5 Korean patients (4 families) with MPS II were identified, among which two were novel mutations (1 small insertion mutation: p.Thr409Hisfs*22, and 1 missense mutation: p.Gly134Glu). Two severe type sibling patients with the same mutation had different clinical manifestation. Urinary glycosaminoglycan excretion decreased within the twelve months of ERT (P=0.043). Liver and spleen volumes showed reductions that were maintained in all patients (P=0.043 and P=0.043, respectively). Improvements were also noted in left ventricular mass index (P=0.042), shoulder flexion (P=0.043), shoulder abduction (P=0.039), knee flexion (P=0.043), elbow flexion (P=0.042), and respiratory distress index (P=0.041). Conclusion: This study demonstrates that Korean patients with MPS II are clinically heterogeneous and indicates that idursulfase is relatively effective in several clinical parameters including heart size and respiratory distress index without infusion-related reactions in patients with MPS II.

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AN OBSERVATIONAL MULTI-CENTER STUDY FOR EVALUATION OF EFFICACY, SAFETY AND PARENTAL SATISFACTION OF METHYLPHENIDATE-OROS IN CHILDREN WITH ADHD (주의력결핍과잉운동장애 아동에게 Methylphenidate-OROS 투여시 효용성과 안전성 및 부모 만족도를 평가하기 위한 다기관관찰연구)

  • Kim, Bong-Seog;Park, Eun-Jin
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.16 no.2
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    • pp.279-285
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    • 2005
  • Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

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Does Process Quality of Inpatient Care Serve as a Guide to Reduce Potentially Preventable Readmission (PPR)? (의료서비스의 과정적 질과 잠재적으로 예방 가능한 재입원율과의 관계)

  • Choi, Jae-Young
    • Korea Journal of Hospital Management
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    • v.23 no.1
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    • pp.87-106
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    • 2018
  • Objective: The objective of this study is to examine the association between process quality of inpatient care and risk-adjusted, thirty-day potentially preventable hospital readmission (PPR) rates. Data Sources/Study Setting: This was an observational cross-sectional study of nonfederal acute-care hospitals located in two states California and Florida, discharging Medicare patients with a principal discharge diagnosis of heart failure, acute myocardial infarction, or pneumonia January through December 31, 2007. Data were obtained from the Healthcare Cost and Utilization Project State Inpatient Database of the Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services Hospital Compare database, and the American Hospital Association Annual Survey of Hospitals. Study Design: The dependent variable of this study is condition-specific, risk-adjusted, thirty-day potentially preventable hospital readmission (PPR). 3M's PPR software was utilized to determine whether a readmission was potentially preventable. The independent variable of this study is hospital performance for process quality of inpatient care, measured by hospital adherence to recommended processes of care. We used multivariate hierarchical logistic models, clustered by hospitals, to examine the relationship between condition-specific, risk-adjusted, thirty-day PPR rates and process quality of inpatient care, after taking clinical and socio-demographic characteristics of patients and structural and operational characteristics of hospitals into account. Findings: Better performance on the process quality metrics was associated with better patient outcome (i.e., low thirty-day PPR rates) in pneumonia, but not generally in two cardiovascular conditions (i.e., heart failure and acute myocardial infarction). Practical Implication: Adherence to the process quality metrics currently in use by CMS is associated with risk-adjusted, thirty-day PPR rates for patients with pneumonia, but not with cardiovascular conditions. More evidence-based process quality metrics closely linked to 30-day PPR rates, particularly for cardiovascular conditions, need to be developed to serve as a guideline to reduce potentially preventable readmissions.

Effect of Self-gravity Acupressure on Varus Knee Correction: Retrospective Observational Study (자가 중력 지압에 의한 내반슬 교정 효과: 후향적 관찰 연구)

  • Sung Kwon Park;Seong Chan Kim;Geum Na Hong;Min Joo Choi
    • Journal of Naturopathy
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    • v.12 no.1
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    • pp.1-6
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    • 2023
  • Background: Despite the positive effects of the self-gravity acupressure program on genu varum correction, no systematic observation has yet to be made. Purpose: In this study, the effect of the self-gravity acupressure program on varus knee correction was confirmed retrospectively by comparing the medial angle of the knee before and after the self-gravity acupressure program. Methods: Fifty people with varus knees were subjected to a 75-minute acupressure program while lying on an acupressure tool, and then the medial knee angles were compared before and after the program. Results: The average angle of the inside of the knee of the study subjects increased by 7.29±3.85° (p<.000) on the left side and 7.08±3.86° (p<.000) on the right side after the acupressure program was implemented, indicating that the study subject's varus knee significantly improved even after applying for a short period time. It was confirmed. Conclusion: This study confirmed that the self-gravity acupressure is a valuable program for correcting the genus varus. However, to use the results of this study clinically in the future, further studies are required to optimize the mechanism and clinical effects of the self-gravity acupressure program on the improvement of the genu varus knee.

Observational Study of Glossodynia (설통에 대한 관찰연구)

  • Shim, So-Ra;Kim, Min-Kyung;Lee, Ji-Hyun;Lu, Hsu-Yuan;Cho, Seung-Yeon;Park, Seong-Uk;Park, Jung-Mi;Bae, Hyung-Sup;Ko, Chang-Nam
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.476-484
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    • 2012
  • Objectives : The purpose of this study was to report the clinical characteristics of glossodynia patients and effects of traditional Korean treatment on glossodynia and to gather data in order to carry out future study. Methods : We surveyed 40 glossodynia patients visiting the Department of Korean Internal Medicine of Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong and analyzed their glossodynia questionnaires, examination results, and progression of symptoms. Results : In Glossodynia patients the average age was 62.4 years old. Glossodynia was more prevalent in females than males (5.67:1). Red tongue color, white fur, and fissured tongue were observed most often. The average glossodynia duration was 36.1 months and the average glossodynia degree was VAS 5.6. The most commonly appearing symptom was burning sense, and dryness of tongue. In Korean medicine diagnosis, Yin, deficiency, Tae-eum was most commonly diagnosed. In herbal medicine, Gamichungsim-tang was the most frequently prescribed. In laboratory tests, zinc deficiency was the most common result. In heart rate variability (HRV), average SDNN was 34.03 and average LF/HF ratio was 2.11. Of 40 patients, 23 completed treatment and their pain was relieved from average VAS 5.52 to VAS 3.63. Pre-and post-treatment results showed a significant difference. The average duration of treatment was 34.91 days. Conclusions : The results of this study suggest that Korean medical approach and treatment for glossodynia could be effective. Further study should be conducted for more valuable information.

Recovery of lingual nerve injury: retrospective observational study (설신경 손상 환자의 회복에 대한 후향적 연구)

  • Hong, Dong-Hwan;Lim, Ho-Kyung;Kim, Soung-Min;Kim, Myung-Jin;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.37 no.5
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    • pp.355-364
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    • 2011
  • Introduction: This study evaluated nerve recovery through retrospective study of patients with lingual nerve damage. Patients and Methods: The patients who visited Seoul National University Dental Hospital for an injury to the lingual nerve from April 1988 to August 2009 were enrolled in this study (n=41). The relevance of various factors including the causes of damage, age, etc. was analyzed by the subjective improvement based upon questionnaires and the clinical records. The evaluation variants were a subjective assessment and neurosensory examination composed of the direction, contact threshold, two-point discrimination, pin prick, thermal discrimination and current perception threshold. Results: The causes of lingual nerve damage were an extraction of the lower third molar (75.6%), local anesthesia (9.7%), incision and drainage (4.88%), trauma (2.44%). The evaluation of subjective prognosis exhibited no difference in sensory improvement depending on the cause, age and gender. Based upon the subjective evaluation, 44.7% of patients showed sensory improvement. The first hospital visit from injury was shorter in the group showing subjective improvement (3.41 months) than those showing no improvement (5.24 months) (P=0.301). Thirty six out of 41 patients were treated with only conservative therapy and 5 patients were treated by surgical intervention. Neurosensory examinations revealed improvement, although not statistically significant, and the degree was higher in the subjectively improved group. The contact threshold discrimination showed the highest correlation with subjective improvement (P=0.069). Most of the sensory recovery was gained within 12 months and the degree of improvement at the tip of the tongue was higher than that of the dorsum (P<0.001). Conclusion: The damaged lingual nerve improved at a rate of 44.7% and mostly within 12 months after the incident. There was no difference between the subjective prognosis and neurosensory examination depending on the cause of damage, age and gender, whereas the contact threshold discrimination was the best variant that reflected the subjective prognosis statistically.

Strategic Direction and Road Map of Expanding Prevention of Winter Disease in the Summer (동병하치 확산을 위한 전략적 방향과 이행방안)

  • Song, Ho-Sueb
    • Journal of Acupuncture Research
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    • v.27 no.3
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    • pp.147-157
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    • 2010
  • Objectives : The purpose of this study was to propose appropriate strategic directions and road maps for successful achievement of programs preventing winter disease in the summer. Methods : Details on programs preventing winter disease in the summer such as clear concept, theoretical basis, current status, intervention or available prescriptions and indication/contraindication/caution were prepared through the related journal review, upon which an observational study was devised and done for simulation to find out even a trivial problem and to guarantee the safety beforehand. The experimental group was divided into 5 groups by the size of pill and the way ginger is treated; 1cm pill with ginger group, 3cm pill group without ginger, 3cm pill group dipped into ginger, 3cm pill group applying ginger to acupoints and 3cm pill group with ginger Results 1. program preventing winter disease in the summer was defined as representative winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis and rheumatoid arthritis, and preventive care in the summer, reinforcing deficient yang qi of five viscera by using exuberant yang qi from summer heat. 2. It was based upon historically established theories which is 'nourishing yang qi in the spring and summer', 'long summer, namely rainy spell in the summer overwhelms the winter, because of earth winning water according to the five phases theory' and 'To replenish yang qi is major principle to treat winter diseases, which can be most appropriately and timely applied to the patient with deficient yang qi of five viscera inherently, especially in the three dog days of the summer, because of exuberant exterior yang qi and deficient interior yang qi in the five viscera'. 3. In the adjacent China and Taiwan, acupoint applying method in the three dog days named 'San Fu Tie' have been stirring a boom throughout the nation, in which Xiaochuan Gao was used as a basic prescription and it mainly was applied at bilateral $BL_{13}$, $_{15}$ and $_{17}$ for about 4 hours. As far as domestic current status, the necessity of adopting the above method prior to Herbal formula was also recognised, because not a few koreans have apprehension for the safety of it including medicinal herbs and are reluctant to take it any more due to negative advertisement of narrow minded doctors' association. 4. Indication of acupoint applying method in the three dog days included most of winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis. contraindication was pregnant woman and the weak such as infants and the old. More attention was paid to grasp firmly the normal reaction following the treatment for preventing side effect and teasing blister. recommendation was also given to abstain from food inducing phlegm and dampness such as meat, shrimp and crab as well as cold drinks and foods 5. In the simulation observational study based upon the above findings following review the related articles, no blister was shown on the acupoints icluding bilateral $BL_{13}$, $_{15}$ and $_{17}$ in every experimental group during 24hr observation following the acupoint applying treatment with pills made by modified and devised prescription. At 4 hr, the effectiveness of it reached a peak showing redness and mild tenderness and there is little difference between groups 3cm pills groups regardless of the way ginger was treated. abdominal distention and growling was found in all the volunteers during the treatment at CV 8. Strategic directions and road maps : Through successful fulfillment of the program preventing winter disease in the summer, Korean traditional medicine should be integrated into mainstream national health care services. Cultural access was thought to be as important as Scientific EBM approach. First of all, To evoke potential cultural homogeneity from campaigns and press advertisement was needed for promoting public awareness about preventing winter disease in the summer by enhancing immunity via acupoint applying treatment in the three dog days, and then indigenous name as Sambokcheop, protocol, Clinical Research Form for data collection of it should be developed and prepared. Once the first step was taken this summer, through a thorough data collection and scrutinized scientific evaluation, drawbacks should be compensted for and the efficacy and safety should be substantiated.