• Title/Summary/Keyword: Non-clinical trial

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Analytical Evaluation of PPG Blood Glucose Monitoring System - researcher clinical trial (PPG 혈당 모니터링 시스템의 분석적 평가 - 연구자 임상)

  • Cheol-Gu Park;Sang-Ki Choi;Seong-Geun Jo;Kwon-Min Kim
    • Journal of Digital Convergence
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    • v.21 no.3
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    • pp.33-39
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    • 2023
  • This study is a performance evaluation of a blood sugar monitoring system that combines a PPG sensor, which is an evaluation device for blood glucose monitoring, and a DNN algorithm when monitoring capillary blood glucose. The study is a researcher-led clinical trial conducted on participants from September 2023 to November 2023. PPG-BGMS compared predicted blood sugar levels for evaluation using 1-minute heart rate and heart rate variability information and the DNN prediction algorithm with capillary blood glucose levels measured with a blood glucose meter of the standard personal blood sugar management system. Of the 100 participants, 50 had type 2 diabetes (T2DM), and the average age was 67 years (range, 28 to 89 years). It was found that 100% of the predicted blood sugar level of PPG-BGMS was distributed in the A+B area of the Clarke error grid and Parker(Consensus) error grid. The MARD value of PPG-BGMS predicted blood glucose is 5.3 ± 4.0%. Consequentially, the non-blood-based PPG-BGMS was found to be non-inferior to the instantaneous blood sugar level of the clinical standard blood-based personal blood glucose measurement system.

Limited Impact of Music Therapy on Patient Anxiety with the Large Loop Excision of Transformation Zone Procedure - a Randomized Controlled Trial

  • Kongsawatvorakul, Chompunoot;Charakorn, Chuenkamon;Paiwattananupant, Krissada;Lekskul, Navamol;Rattanasiri, Sasivimol;Lertkhachonsuk, Arb-Aroon
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.6
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    • pp.2853-2856
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    • 2016
  • Background: Many studies have pointed to strategies to cope with patient anxiety in colposcopy. Evidence shows that patients experienced considerable distress with the large loop excision of transformation zone (LLETZ) procedure and suitable interventions should be introduced to reduce anxiety. This study aimed to investigate the effects of music therapy in patients undergoing LLETZ. Materials and Methods: A randomized controlled trial was conducted with patients undergoing LLETZ performed under local anesthesia in an out patient setting at Ramathibodi Hospital, Bangkok, Thailand, from February 2015 to January 2016. After informed consent and demographic data were obtained, we assessed the anxiety level using State Anxiety Inventory pre and post procedures. Music group patients listened to classical songs through headphones, while the control group received the standard care. Pain score was evaluated with a visual analog scale (VAS). Statistical analysis was conducted using Pearson Chi-square, Fisher's Exact test and T-Test and p-values less than 0.05 were considered statistically significant. Results: A total of 73 patients were enrolled and randomized, resulting in 36 women in the music group and 37 women in the non-music control group. The preoperative mean anxiety score was higher in the music group (46.8 VS 45.8 points). The postoperative mean anxiety scores in the music and the non-music groups were 38.7 and 41.3 points, respectively. VAS was lower in music group (2.55 VS 3.33). The percent change of anxiety was greater in the music group, although there was no significant difference between two groups. Conclusions: Music therapy did not significantly reduce anxiety in patients undergoing the LLETZ procedure. However, different interventions should be developed to ease the patients' apprehension during this procedure.

DEVELOPMENT OF THREE DIMENSIONAL MEASURING PROGRAM WITH FRONTAL AND LATERAL CEPHALOMETRIC RADIOGRAPHS -PART 1. COMPUTATION OF THE THREE-DIMENSIONAL COORDINATES BY COMPENSATION OF THE ERROR OF THE HEAD POSITION IN ORDINARY NON-BIPLANAR CEPHALOSTAT- (정모 및 측모 두부 방사선 규격사진을 이용한 3차원 계측 프로그램의 개발 -1. 단일 방사선원으로 촬영된 두부 방사선사진의 두부 위치 보정을 이용한 3차원 좌표의 산출-)

  • Lee, Geun-Ho;Lee, Sang-Han;Jang, Hyon-Joong;Kwon, Tae-Geon
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.27 no.3
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    • pp.214-220
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    • 2001
  • The clinical application of the three-dimensional radiographic technique had been limited to standard Broadbent-Bolton cephalometer with biplanar stereoradiography. We developed a new method for compensating the error of head position in ordinary non-biplanar cephalostat. It became to possible to use the three dimensional cephalogram commonly in clinical bases. 1. The method of methemetical compensation of head positioning error in non-biplanar condition was evaluated with dry skull. The error of the method of first and the second trial was $0.46{\pm}1.21$, $0.33{\pm}0.90mm$, which means the error of the head positioning correction in conventional cephalogram was within clinical acceptance. 2. The reproducibility of this system for clinical application was 0.54 mm ($-2.99{\sim}2.26mm$) which defines the absolute mean difference of the first and second trial. Compare to the The landmark identification error $1.2{\pm}1.6mm$, the error of the measurement was within the range of landmark identification error. The result indicates the adequate clinical accuracy of the computation of three-dimensional coordinates by compensation of the error of the head position in ordinary non-biplanar cephalostat.

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Clonazepam Treatment of Pathologic Aerophagia in Children with Mental Retardation

  • Lee, Ga-Hyun;Jang, Hyo-Jeong;Hwang, Jin-Bok
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.17 no.4
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    • pp.209-213
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    • 2014
  • Purpose: Pathologic aerophagia (PA) may lead to bowel perforation or volvulus in mentally retarded patients. The authors investigated the effects of clonazepam on the management of PA in children with severe to profound mental retardation (MR). Methods: This study was undertaken as a retrospective case analysis of 21 PA patients with MR who were followed for over 12 months and diagnosed as having PA. Patients were assigned to two management groups, that is, to a clonazepam randomized open-labeled, treatment group or a reassurance group. The following were recorded and analyzed; age, response, remission rate to clonazepam treatment, and the side effect of clonazepam. It was defined positive response (response+) as being symptom-free for a whole week within 1 month of commencing treatment and remission(+) as being symptom-free for a whole month within 6 months of treatment. Results: The average age of the 21 PA children with MR was 10 years and 13 patients were female. Symptom duration before diagnosis of PA was 7 months. Clinical features of the clonazepam-trial group (n=11) and the reassurance group (n=10) were non-significantly different. Response(+) was achieved by 2 patients (18.2%) in the clonazepamtrial group and by no patient in the reassurance group. Remission(+) was achieved by 6 patients (54.5%) in the clonazepam-trial group and by one patient (10%) in the reassurance group (p=0.040). Conclusion: When PA children with MR with severe bowel distention are considered for surgical treatment to prevent acute abdomen, a trial of clonazepam could be recommended.

Peptides in Obesity Treatment (비만의 펩타이드 치료제)

  • Kim, Kyoung-Kon
    • Archives of Obesity and Metabolism
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    • v.1 no.1
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    • pp.4-13
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    • 2022
  • Currently, pharmacotherapy is becoming essential for obesity, owing to its expanding and increasing epidemiology. In this review, novel peptide-based drugs of four classes are covered: GLP-1 receptor agonist, GIP/GLP-1 receptor dual agonist, glucagon/GLP-1 receptor dual agonist, and a combination of amylin receptor agonist/GLP-1 receptor agonist. Semaglutide is a next-generation GLP-1 receptor agonist with a longer duration and stronger weight and glucose reduction effects than liraglutide and dulaglutide. In the STEP1 trial, semaglutide 2.4 mg reduced body weight by approximately 15% in people with obesity with similar or milder adverse events than liraglutide 3.0 mg. Tirzepatide, a GIP/GLP-1 receptor dual agonist, also has a long duration and strong weight- and glucose-lowering effect. According to SURPASS-2, 3, and 4, in patients with BMI≥25 kg/m2 and type 2 diabetes mellitus (T2DM), tirzepatide 15 mg reduced the initial body weight by >13%. Cotadutide, a glucagon/GLP-1 receptor dual agonist, showed weaker weight-lowering effects than semaglutide and tirzepatide, while it was comparable to that of liraglutide in a phase 2 clinical trial for non-alcoholic fatty liver disease in patients with BMI≥25 kg/m2 and T2DM. Additionally, its effect on the liver was noticeable. The long-acting amylin receptor agonist cargrilintide combined with semaglutide can be another effective option for obesity treatment. Even in a small phase 1 trial with a short study period of 20 weeks, cargrilintide 2.4 mg/semaglutide 2.4 mg reduced by 17% of initial body weight in people with BMI 27-39.9 kg/m2. In coming several years, semaglutide, tirzepatide, and cargrilintide/semaglutide will become available for obesity treatment in Korea.

The Clinical Trial of Quicure Vaginal Irrigation on Cenvico-Vaginitis (Quicure Vaginal Irrigation에 의한 자궁경부염 및 질염치료에 관한 임상적 연구(예보))

  • Whang, Dong-Hoon;Cho, Joo-Youn;Kwak, Hyun-Mo
    • Clinical and Experimental Reproductive Medicine
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    • v.10 no.1
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    • pp.45-55
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    • 1983
  • This study was intended to investigate the effectiveness of Quicure vaginal irrigaticn for treatment of cervico-vaginitis. 53 patients who visited to severance hospital during July to December 1982 were included in this study. Antiseptics used for irrigation were 1% KMnO4, 10% Betadine and Albright solution, each solution was prepared for warm ($37^{\circ}C$) and cold ($15^{\circ}C$) form respectively, Acridine Orange immunofluorescent stainiry of cervico-vaginal smear was used for assessment of effectivenese. The results were as followed. 1. On unitial examination 62%s of patients had trichomonas infection, 19% had moniliasis infection, 19% had non specific infection. 2. Smear findings of patients~who had trichomonas infection or moniliasis infection, treated with cold 1% KMnO4 or Albright solution, became>negative except case of on each group. But the findings of all patients treated with warm solution became negative. Changes of findings of patients who had non specific infection showed similar result. This results indicated that warm solution would be better than cold solution. 3. The findings of all patients treated with Betadine solution became negative except, patient who had non specific infection, showed that Betadine solution would be better than 1% KMnO4 or Albright salution. 4. Patients' feeling of using warm saline was more satisfactory than that of cold solution

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Short-term Benefits of Mobilization for Patients with Non-Specific Neck Pains: Executive Function and Neck Pain Intensity

  • Choi, Wansuk;Heo, Seoyoon
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.2
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    • pp.1803-1809
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    • 2019
  • Background: Cervical mobilization has been applied mainly for the improvement of arm and neck movements and pain reduction, and little research has been done to improve the executive function. Since this kind of so-called mechanical neck pain is one of most common symptoms, there are controversial issues about this with spine alignment. Posteroanterior (PA) mobilization from the Maitland concept is a process of examination, assessment, and treatment of neuromusculoskeletal disorder by manipulative physical therapy. Objective: To examine the short-term benefits of mobilization for patients with non-specific neck pain. Design: Dual-group Pretest-Posttest Design from the Quasi-Experimental research Methods: Fourteen participants (male 8, female 6; 20's of their age) with non-specific neck pains which are distributed all the unilateral or bilateral body side were recruited. Participants were categorized to Neck Pain with Movement Coordination Impairments (NPMCI) and Neck Pain with Mobility Deficits (NPMD) groups according to the results of physical examination. Professional physical therapist who has over 15-years-of clinical experience applicated manipulative therapy for the neck pain, an occupational therapist only conducted evaluations; K-NDI (Korean version of the Neck Disability Index), VAS (Visual Analog Scale), BDS-K (Korean version of Behavioral Dyscontrol Scale) for decreasing possible adverse effects; there were no person who reported other symptoms followed 4 weeks from the trial. Results: In the NPMCI group, data analysis indicated statistical differences between the PA mobilization interventions in NDI and BDS-K; even though, pain was reduced in VAS, this is not a significantly differ. In the NPMD group, data analysis represented statistical differences between the PA mobilization interventions in NDI, VAS and BDS-K; the scores were represented to be increased or the pain got relief. Conclusions: PA mobilization techniques according to Maitland concept have beneficial effects in patients with neck pain and other clinical positive effects which included neck disability, pain itself and motor function of upper extremity.

The Safety and Pharmacokinetics of Cyanidin-3-Glucoside after 2-Week Administration of Black Bean Seed Coat Extract in Healthy Subjects

  • Jeon, Sang-Il;Han, Seung-Hoon;Lee, Jong-Tae;Hong, Tae-Gon;Yim, Dong-Seok
    • The Korean Journal of Physiology and Pharmacology
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    • v.16 no.4
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    • pp.249-253
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    • 2012
  • We analyzed the pharmacokinetics of C3G on data from twelve subjects, after 2-week multiple dosing of black bean (Phaseolus vulgaris, Cheongjakong-3-ho) seed coat extract, using the mixed effect analysis method (NONMEM, Ver. 6.2), as well as the conventional non-compartmental method. We also examined the safety and tolerability. The PK analysis used plasma concentrations of the C3G on day 1 and 14. There was no observed accumulation of C3G after 2-week multiple dosing of black bean seed coat extract. The typical point estimates of PK were CL (clearance)=3,420 l/h, V (volume)=7,280 L, Ka (absorption constant)=9.94 $h^{-1}$, ALAG (lag time)=0.217 h. The black bean seed coat extract was well tolerated and there were no serious adverse events. In this study, we confirmed that a significant amount of C3G was absorbed in human after given the black bean seed coat extract.

A Systematic Review of Placenta Pharmacopuncture for Neuropsychiatric Diseases in Practice (자하거 약침의 신경정신과 임상 응용에 관한 체계적 문헌 고찰)

  • Shin, Haegue;Lee, Jae-Hyok;Kang, Hyung Won
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.2
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    • pp.157-180
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    • 2022
  • Objectives: To perform a systematic review of placenta pharmacopuncture for treating neuropsychiatric diseases, focusing on its efficacy and the safety so that evidence on its clinical use could be obtained, thus contributing to further studies. Methods: Through Korean, English, and Chinese databases (OASIS, Korean TK, KISS, RISS, ScienceON, Pubmed, Cochrane, EMBASE, CINAHL, AMED, CNKI, and Wanfang), combinations of keywords (placenta, pharmacopuncture, etc.) were used to select clinical studies published until January 2021 about placenta pharmacopuncture for neuropsychiatric diseases. Interventions included combined treatments. Study design included cases studies, series, and clinical trials. Cohort studies, literature reviews, in vitro and animal experiments were excluded. The primary outcomes involved measurements of symptoms, Visual Analogue Scale, or questionnaires. Data extracted from databases were imported to Endnote X7 to remove duplicates. The quality of the literature was assessed based on CAse REports Guidelines and Cochrane's Risk of Bias (ROB). Results: Twenty-one studies were selected, including ten case reports, three case series, two one-armed clinical trials, one non-randomized clinical trial, and five randomized clinical trials. There were six studies on sleep disorders, five studies on stroke sequela, two on mood disorders, two on enuresis, two on Guillain-Barré syndrome, two on multiple sclerosis, one on neurocognitive disorder, and one on vertigo. The most frequent combined treatment was acupuncture in both the experimental group (n=10) and the control group (n=3). Acupoints were ST36, SP6, BL23, CV4, GB20, GV20, N-HN54, and so on. All studies reported improvement of symptoms. The quality of case studies was relatively high. Assessment of ROBs resulted in low risks. Conclusions: Placenta pharmacopuncture is effective for neuropsychiatric diseases such as sleep disorders, mood disorders, enuresis, and neurocognitive disorders. Regarding insomnia, several studies have reported significant improvements with placenta pharmacopuncture. There was no adverse event associated with placenta pharmacopuncture.

Survey of Conflict of Interest in the Clinical Research for IRB Members and Researchers (임상시험심사위원회 위원과 연구자를 대상으로 임상연구에서 이해상충에 대한 설문조사연구)

  • Maeng, Chi Hoon;Kang, Su Jin;Lee, Sun Ju;Yim, Hyeon Woo;Choe, Byung-in;Shin, Im Hee;Huh, Jung-Sik;Kwon, Ivo;Yoo, Soyoung;Lee, Mi-Kyung;Shin, Hee-Young;Kim, Duck-An
    • The Journal of KAIRB
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    • v.2 no.1
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    • pp.23-31
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    • 2020
  • Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

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