• Title/Summary/Keyword: screening trial

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An Analysis of Clinical Research Trends on Interventions of Oriental Medicine for Postpartum Disease and Postpartum Care (산후병 및 산후관리에 대한 국내 한의학 임상 연구 동향 분석)

  • Kim, Nu-Ree;Lee, Eun-Hee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.1
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    • pp.34-58
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    • 2022
  • Objectives: This study was performed to analyze the interventions of Oriental Medicine which had been commonly used for postpartum disease and postpartum care. Methods: We searched research on the interventions for postpartum disease and postpartum care in 4 domestic search engines. After that, we conducted eligibility screening based on inclusion and exclusion criteria. Results: 1. We selected total 50 studies. There were 2 randomized controlled trial (RCT), 5 non-RCT, 35 case reports, 8 case series within the 6~8 weeks after childbirth. 2. Of the 35 case reports, several interventions were used : acupuncture (22), moxibustion (11), cupping therapy (7), pharmacopuncture (5), chuna manipulation (4), herbal medicine (34). The most common symptoms were musculoskeletal symptoms (8), followed by postpartum depression (7). Various prescriptions and acupoints of oriental medicine were used depending on the diseases or symptoms. 3. Of the 8 case series, 382 subjects in 5 case series had taken Saenghwa-tang-gagam. And Acupuncture, moxibustion, cupping therapy (5), pharmacopuncture (1) were used as an intervention. 4. The most commonly used acupoint is 腎兪 (BL23) in the pain including postpartum back pain and 三陰交 (SP6), 關元 (CV4) in the postpartum care. 關元 (CV4) is the most commomly used moxibustion point not only the postpartum disease but also the postpartum care. Conclusions: In clinical studies of oriental medicine related to postpartum disease and postpartum care, pain-related clinical studies that belong to or progress to Sanhupung were the most common (30%), and among them, postpartum low back pain studies were the most common (20%). Based on this, we believe that large-scale clinical studies with high quality using oriental interventions including chuna and pharmacopuncture are needed to establish guidelines for the management of pain treatment including postpartum back pain.

A study on the Correlation between Primary dysmenorrhea and Blood stasis (원발성(原發性) 월경곤난증(月經困難症)과 어혈(瘀血)의 상관성 연구)

  • Yoon, Young-Jin;Cho, Jung-Hoon;Jang, Jun-Bock;Lee, Jin-Moo;Lee, Chang-Hoon;Lee, Kyung-Sub
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.1
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    • pp.148-160
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    • 2009
  • Purpose: We intended to observe the correlations between Primary dysmenorrhea severity and Questionnaires for Blood Stasis Pattern. Methods: After initial approval by Kyung-Hee University Oriental Medical Hospital Institutional Review Board of Clinical Trials, volunteers for the clinical trial were recruited. We selected the 52 primary dysmenorrhea patients by the screening tests (clinical examination and inquiry). The severity of dysmenorrhea was evaluated by VAS (Visual Analog Scale), VRS (Verbal Rating Scale) & MVRS (Multidimensional Verbal Rating Scale). The severity of Blood Stasis was evaluated by Questionnaires for Blood Stasis Pattern. For statistics, we used Spearman's rho correlations, SPSS 13.0 for windows. Results: In case of VAS, though two items (眼瞼下靑紫, 便黑) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. In case of VRS, though two items (小腹痛, 夜間痛) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. In case of MVRS, though one items (久痺症) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. Conclusion: Though the results showed partial correlation of Primary dysmenorrhea severity and Questionnaires for Blood Stasis Pattern, we need further study after improvement and complementation of Questionnaires for Blood Stasis Pattern.

A Review of Anticancer Efficacy Outcome Measures in Clinical Trials of Herbal Medicine for Cancer Patients (한약을 사용한 암환자 대상 임상시험에서의 항암 효능 평가변수 고찰)

  • Chunhoo Cheon;Min Jun Kang;Wonbin Shin;;Hyunsuk Park;Unho Yang;Unseog Yeo
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.1
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    • pp.119-130
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    • 2024
  • Objectives : The objective of this review is to examine the variety of evaluation parameters utilized in clinical trials that assess the anticancer efficacy of herbal medicine, focusing on the importance of including both symptomatic management and direct anticancer effectiveness. Methods : A detailed literature review was conducted across PubMed, Embase, and the Cochrane Library to identify clinical trials investigating the antitumor efficacy of herbal medicine. The search was performed on February 22, 2024. This review specifically examined the employed outcome measures, which were then categorized and analyzed to understand their relevance and application in evaluating the anticancer properties of herbal medicine. Results : From an initial search of 900 records, 15 clinical trials were selected for in-depth analysis after deduplication and screening. These studies evaluated the efficacy of herbal medicine across various cancers, including hepatocellular carcinoma, colorectal cancer, and breast cancer, using outcome measures such as survival rates, disease control rates, and quality of life improvements. The research spanned multiple countries, primarily in East Asia and the United States, reflecting a global interest in herbal medicine as a complementary approach to cancer treatment. The present study demonstrated that herbal medicine, especially when used alongside standard treatments, potentially improved clinical outcomes and patient well-being. Conclusions : The findings of this review highlight the need for a broader focus on the full range of therapeutic capabilities of herbal medicine, including its direct anticancer effects, in the management of cancer patients. Future oncology research involving herbal medicine should integrate a wide spectrum of clinical endpoints to fully ascertain its impact on cancer treatment and patient health.

A Single Center Study on the Evaluation of Safety after Single Oral Administration of Peony Root Extract Tablets (작약엑스정 1회 경구 투여의 안전성 평가에 관한 연구)

  • Su-Hak Kim;Jeong-Su Park;Tae-Seong Jeong;Seung-Hyun Oh;Young-Dal Kwon
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.3
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    • pp.89-96
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    • 2024
  • Objectives This study is designed to evaluated the safety of peony root extract tablet in healthy male volunteers. Methods 12 healthy male volunteers were recruited, and this study was conducted by a single center. The safety was evaluated by collecting laboratory test and vital signs of volunteers. As the registration process, 12 subjects were assigned by serial number. To evaluate safety, vital signs were checked and blood samples were collected 4 times during the screening period, pre & post-administration (after 8 hours) and post-administration (after 7 days). The difference in variables was summarized by the mean±standard deviation. The normality test was carried out using the Shapiro-Wilk test and Kolmogorov-Smirnov test. When normality is fulfilled, a paired t-test is applied and the significance level was p<0.05. And the incidence of all adverse effects and serious adverse effects are shown in percentage. Results In the case of vital sign, body temperature (BT) (℃) was 0.06±0.05 ℃ (p=0.008), and there was a statistically significant difference in before and after administration. However, clinical symptoms were not occurred and BT (℃) of all subjects before and after administration showed values within the normal reference value. There was no significant difference from the control group in all other vital signs and laboratory test data. And no side-effects associated to clinical trial drugs were followed. Conclusions The peony root extract tablet was considered to be safe for healthy male volunteers.

Mitral Annulus Calcification and Cardiac Conduction Disturbances: A DANCAVAS Sub-study

  • Jeppe Holm Rasmussen;Maise Hoeigaard Fredgart;Jes Sanddal Lindholt;Jens Brock Johansen;Niels Sandgaard;Abdulrahman Haj Yousef;Selma Hasific;Pernille Sonderskov;Flemming Hald Steffensen;Lars Frost;Jess Lambrechtsen;Marek Karon;Martin Busk;Grazina Urbonaviciene;Kenneth Egstrup;Axel Cosmus Pyndt Diederichsen
    • Journal of Cardiovascular Imaging
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    • v.30 no.1
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    • pp.62-75
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    • 2022
  • BACKGROUND: Due to its location very close to the bundle of His, mitral annulus calcification (MAC) might be associated with the development of atrioventricular (AV) conduction disturbances. This study assessed the association between MAC and AV conduction disturbances identified by cardiac implantable electronic device (CIED) use and electrocardiographic parameters. The association between MAC and traditional cardiovascular risk factors was also assessed. METHODS: This cross-sectional study analyzed 14,771 participants, predominantly men aged 60-75 years, from the population-based Danish Cardiovascular Screening trial. Traditional cardiovascular risk factors were obtained. Using cardiac non-contrast computed tomography imaging, MAC scores were measured using the Agatston method and divided into absent versus present and score categories. CIED implantation data were obtained from the Danish Pacemaker and Implantable Cardioverter Defibrillator Register. A 12-lead electrocardiogram was available for 2,107 participants. Associations between MAC scores and AV conduction disturbances were assessed using multivariate regression analyses. RESULTS: MAC was present in 22.4% of the study subjects. Participants with pacemakers for an AV conduction disturbance had significantly higher MAC scores (odds ratio [OR], 1.11; 95% confidence interval [CI], 1.01-1.23) than participants without a CIED, whereas participants with a CIED for other reasons did not. Prolonged QRS-interval was significantly associated with the presence of MAC (OR, 1.45; 95% CI, 1.04-2.04), whereas prolonged PQ-interval was not. Female sex and most traditional cardiovascular risk factors were significantly associated with high MAC scores. CONCLUSIONS: MAC was associated with AV conduction disturbances, which could improve our understanding of the development of AV conduction disturbances.

Near Infrared Spectroscopy for Diagnosis: Influence of Mammary Gland Inflammation on Cow´s Milk Composition Measurement

  • Roumiana Tsenkova;Stefka Atanassova;Kiyohiko Toyoda
    • Near Infrared Analysis
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    • v.2 no.1
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    • pp.59-66
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    • 2001
  • Nowadays, medical diagnostics is efficiently supported by clinical chemistry and near infrared spectroscopy is becoming a new dimension, which has shown high potential to provide valuable information for diagnosis. The investigation was carried out to study the influence of mammary gland inflammation, called mastitis, on cow´s milk spectra and milk composition measured by near infrared spectroscopy (NIRS). Milk somatic cell counts (SCC) in milk were used as a measure of mammary gland inflammation. Naturally occurred variations with milk composition within lactation and in the process of milking were included in the experimental design of this study. Time series of unhomogenized, raw milk spectral data were collected from 3 cow along morning and evening milking, for 5 consecutive months, within their second lactation. In the time of the trial, the investigated cows had periods with mammary gland inflammation. Transmittance spectra of 258 milk samples were obtained by NIRSystem 6500 spectrophotometer in 1100-2400 nm region. Calibration equations for the examined milk components were developed by PLS regression using 3 different sets of samples: samples with low somatic cell count (SCC), samples with high SCC and combined data set. The NIR calibration and prediction of individual cow´s milk fat, protein, and lactose were highly influenced by the presence of mil samples from animals with mammary gland inflammation in the data set. The best accuracy of prediction (i.e. the lower SEP and the higher correlation coefficient) for fat, protein and lactose was obtained for equations, developed when using only “healthy” samples, with low SCC. The standard error of prediction increased and correlation coefficient decreased significantly when equations for low SCC milk were used to predict examined components in “mastitis” samples with high SCC, and vice versa. Combined data set that included samples from healthy and mastitis animals could be used to build up regression models for screening. Further use of separate model for healthy samples improved milk composition measurement. Regression vectors for NIR mild protein measurement obtained for “healthy” and “mastitic” group were compared and revealed differences in 1390-1450 nm, 1500-1740 nm and 1900-2200 nm regions and thus illustrated post-secretory breakdown of milk proteins by hydrolytic enzymes that occurred with mastitis. For the first time it has been found that monitoring the spectral differences in water bands at 1440 nm and 1912 nm could provide valuable information for inflammation diagnosis.

Breeding of Pleurotus eryngii with a high temperature tolerance trait (고온적응성 큰느타리(새송이)버섯 품종육성)

  • Im, Chak Han;Kim, Min-Keun;Kim, Kyung-Hee;Cho, Soo Jeong;Lee, Jong Jin;Joung, Wan-Kyu;Lee, Sang Dae;Choi, Young Jo;Ali, Asjad;Ryu, Jae-San
    • Journal of Mushroom
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    • v.12 no.3
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    • pp.187-192
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    • 2014
  • In order to breed a new P. eryngii cultivar with high temperature tolerance trait to cope with climate change, strains and cultivars were characterized at $20^{\circ}C$ that is $5^{\circ}C$ higher than normal condition followed by screening for the characteristics such as required days to harvest, quality and yield. Monokaryons from the selected strains were crossed. $Da-32{\times}KNR2322-15$ derived from the crosses between KNR2322 having characteristics of short growing day and Da($Ga5Na5-4{\times}KNR2312-7$) having charateristics of high guality and yield at $20^{\circ}C$, showed 14.9 days for harvest, 120.6 g yield, and 7.0 quality in the first trial. The strains were named as Taeyangsongi and cultivated on a large scale to compare with Kenneutari No. 2 at a mushroom farm. Yield of Taeyangsongi (109 g) was significantly different(P=0.001) from Kenneutari No.2. Quality of the new (6.6) and the reference cultivar (3.5) was also statistically different (P=0.001) The brightness of pileus of Taeyangsongi (59.5) was 10 points less than the reference cultivar due to which it has an inability to bear high temperature stress. Thus, PCR reactions with URP2 discriminated between Taeyansongi and reference cultivars (Keneutari No. 2 and Aeryni).

A Review of Acupuncture and Moxibustion for the Treatment of Parkinson's Disease (파킨슨병의 침구치료 동향에 대한 고찰)

  • Lee, Eun;Kang, Ki-Wan;Kim, Lak-Hyung;Kang, Sei-Young;Sun, Seung-Ho;Han, Chang-Ho;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.35 no.1
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    • pp.12-23
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    • 2014
  • Objectives : The purpose of this study was to report possibility of acupuncture or moxibustion for the treatment of Parkinson's disease (PD) by reviewing literature about its effectiveness. Methods : In this review, PubMed, SCOPUS, Science Direct and CINAHL of EBSCOhost were used to search medical journals, using keywords "Parkinson's disease and acupuncture" and "Parkinson's disease and moxibustion". The search range included randomized controlled trials (RCT) about Parkinson's disease combined with another disease and other treatments with acupuncture or moxibustion. Non-randomized controlled trial (nRCT), case study, animal experiment, human experiment, review, survey, essay, letter, and protocol for review were excluded. Results : From 311 studies, 111 were selected during the title and the screening. Finally, 16 RCTs (15 for acupuncture research and one for moxibustion) were included in this review, after scanning and matching the inclusion and exclusion criteria. The number of patients varied between 5 and 88. A total of 12 studies using electroacupuncture (EA) were classified into acupuncture studies. The body acupuncture studies numbered 4, scalp acupuncture 4, body and scarp acupuncture mixed studies 4, and bee venom, ear and abdomen acupuncture were each one study. In evaluation methods, total effective rate method was used in 9 studies, the Unified Parkinson's Disease Rating Scale (UPDRS) was used in 8, and the Webster score in 2. In addition, the Berg balance scale (BBS), 30 m walking time, steps to walk 30 m, PD motor function score, and Motor Performance Series by Schoppe (MLS) method were used for evaluation. In 15 of the 16 studies, the verum acupuncture group showed significant improvement compared with the control. In 9 studies using total effective rate method, the effective rate was reported as 80.0-97.3% in verum acupuncture groups and 52.6-86.4% in controls. Conclusions : Acupuncture may be a plausible alternative method to care for the long term symptoms and treat movement impairment of Parkinson's disease. However, to confirm this result, high quality studies including randomized, placebo-controlled double-blind trials are warranted.

Mini-Array of Multiple Tumor-associated Antigens (TAAs) in the Immunodiagnosis of Esophageal Cancer

  • Qin, Jie-Jie;Wang, Xiao-Rui;Wang, Peng;Ren, Peng-Fei;Shi, Jian-Xiang;Zhang, Hong-Fei;Xia, Jun-Fen;Wang, Kai-Juan;Song, Chun-Hua;Dai, Li-Ping;Zhang, Jian-Ying
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.6
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    • pp.2635-2640
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    • 2014
  • Sera of cancer patients may contain antibodies that react with a unique group of autologous cellular antigens called tumor-associated antigens (TAAs). The present study aimed to determine whether a mini-array of multiple TAAs would enhance antibody detection and be a useful approach in esophageal cancer detection and diagnosis. Our mini-array of multiple TAAs consisted of eleven antigens, p53, pl6, Impl, CyclinB1, C-myc, RalA, p62, Survivin, Koc, CyclinD1 and CyclinE full-length recombinant proteins. Enzyme-linked immunosorbent assays (ELISA) were used to detect autoantibodies against eleven selected TAAs in 174 sera from patients with esophageal cancer, as well as 242 sera from normal individuals. In addition, positive results of ELISA were confirmed by Western blotting. In a parallel screening trial, with the successive addition of antigen to a final total of eleven TAAs, there was a stepwise increase in positive antibody reactions. The eleven TAAs were the best parallel combination, and the sensitivity and specificity in diagnosing esophageal cancer was 75.3% and 81.0%, respectively. The positive and negative predictive values were 74.0% and 82.0%, respectively, indicating that the parallel assay of eleven TAAs raised the diagnostic precision significantly. In addition, the levels of antibodies to seven antigens, comprising p53, Impl, C-myc, RalA, p62, Survivin, and CyclinD1, were significantly different in various stages of esophageal cancer, which showed that autoantibodies may be involved in the pathogenesis and progression of esophageal cancer. All in all, this study further supports our previous hypothesis that a combination of antibodies might acquire higher sensitivity for the diagnosis of certain types of cancer. A customized mini-array of multiple carefully-selected TAAs is able to enhance autoantibody detection in the immunodiagnosis of esophageal cancer and autoantibodies to TAAs might be reference indicators of clinical stage.

Efficacy of a Training Program for Long-Term Disease-Free Cancer Survivors as Health Partners: A Randomized Controlled Trial in Korea

  • Yun, Young Ho;Lee, Myung Kyung;Bae, Yeonmin;Shon, Eun-Jung;Shin, Bo-Ram;Ko, Hyonsook;Lee, Eun Sook;Noh, Dong-Young;Lim, Jae-Young;Kim, Sung;Kim, Si-Young;Cho, Chi-Heum;Jung, Kyung Hae;Chun, Mison;Lee, Soon Nam;Park, Kyong Hwa;Chang, Yoon Jung
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7229-7235
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    • 2013
  • Background: To determine whether the Health Partner Program is effective in training long-term cancer survivors to be health coaches. Materials and Methods: We randomly assigned cancer survivors who were selected through a rigorous screening process to either the Health Partner Program or the waiting-list control group. The program consisted of 8 weeks of training in health management, leadership, and coaching. At baseline, 8, and 16 weeks, we measured primary outcomes using the Seven Habit Profile (SHP), the Korean Leadership Coaching Competency Inventory (KCCI), Ed Diner's Satisfaction with Life Scale (SWLS), and the Posttraumatic Growth inventory (PTGI) and secondary outcomes using the Hospital Anxiety and Depression Scale (HADS), the Impact of Event Scale-Revised (IES-R), and the Medical Outcomes Study (MOS) short form 36-item questionnaire (SF-36). Results: We recruited 70 subjects and randomly assigned 34 to the intervention group. The Sharpen the Saw habit of the SHP increased significantly more in intervention group than in the control group (p=0.049), as did most PTGI factors. The intervention group also showed a significantly greater enhancement of vitality (p=0.015) and mental health (p=0.049) SF-36 scores but no improvement in KCCI, SWLS, HADS, or IES-R scores. The intervention group also showed a greater clinically meaningful improvement in the "Think Win-Win" of SHP (p=0.043) and in the personal strength score (p=0.025) and total score (p=0.015) of the PTGI. Conclusions: Long-term cancer survivors can benefit from the Health Partner Program to become health coaches.