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Analysis of Existing Guidelines and Controlled Clinical Trials for Development of [Guideline of Clinical Trials with Herbal Medicinal Products for Colorectal Cancer] (결장직장암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 대조군 임상시험 고찰)

  • Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo;Ko, Seok-Jae;Han, Gajin
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.124-152
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

Characteristics of Clinical Trials in Korea for Atopic Dermatitis - Focus on ClinicalTrials.gov Registered Clinical Trials - (식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-)

  • Hwang, Mi-Lee;Ahn, Jae-Hyun;Jea, Ha-Kyung;Kim, Soo-Young;Jung, Hyun-A
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.2
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    • pp.68-93
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    • 2019
  • Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

Induction of fertile estrus without the use of steroid hormones in seasonally anestrous Suffolk ewes

  • Miguel-Cruz, Erika Elizabeth;Mejia-Villanueva, Octavio;Zarco, Luis
    • Asian-Australasian Journal of Animal Sciences
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    • v.32 no.11
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    • pp.1673-1685
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    • 2019
  • Objective: To evaluate the efficacy of treatments based on gonadotrophin-releasing hormone (GnRH), GnRH-prostaglandin $F2{\alpha}$ ($PGF2{\alpha}$), and/or intense exposure to novel rams to induce fertile estrus without the use of steroid hormones in seasonally anestrous Suffolk ewes. Methods: In the first experiment, ewes were treated with one injection of GnRH, two injections of GnRH administered 7 days apart, or a sequence of GnRH-$PGF2{\alpha}$-GnRH (GPG). In the second experiment anestrous ewes were exposed, for 36 days starting on the day of weaning, to groups of four rams of three different breeds that were alternated every day. Besides exposure to the male effect (ME), the ewes were injected with saline solution (ME group, n = 20), with GnRH (ME-GnRH group, n = 20) or with a sequence of GnRH-$PGF2{\alpha}$-GnRH (ME-GPG group, n = 20). The rams used for male-effect were fitted with aprons to prevent mating, and ewes detected in estrus were bred to selected fertile rams. Ovarian activity was monitored by progesterone determinations in both experiments. Results: In the first experiment sustained induction of ovarian activity was not achieved and no ewe was detected in estrus. In the second experiment induction of sustained ovarian activity was achieved in all groups. Most of the ewes were detected in estrus, 76.7% of the ewes were mated during a 36-d breeding period and 71.7% of all the ewes became pregnant during that period. No significant differences between groups were found for any of these variables. However, estrus detection efficiency was higher in the ME-GnRH group than in the ME group (p<0.05). Conclusion: An intense male-effect, that included the continuous presence and frequent alternation of several rams of different breeds, was sufficient to induce ovarian activity and fertile estrus in Suffolk ewes during the period of deep anestrus without the use of hormones, although addition of GnRH improved the efficiency of estrus detection.

A Substorm Injection Event and the Radiation Belt Structure Observed by Space Radiation Detectors onboard Next Generation Small Satellite-1 (NEXTSat-1)

  • Yoo, Ji-Hyeon;Lee, Dae-Young;Kim, Eojin;Seo, Hoonkyu;Ryu, Kwangsun;Kim, Kyung-Chan;Min, Kyoungwook;Sohn, Jongdae;Lee, Junchan;Seon, Jongho;Kang, Kyung-In;Lee, Seunguk;Park, Jaeheung;Shin, Goo-Hwan;Park, SungOg
    • Journal of Astronomy and Space Sciences
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    • v.38 no.1
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    • pp.31-38
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    • 2021
  • In this paper, we present observations of the Space Radiation Detectors (SRDs) onboard the Next Generation Small Satellite-1 (NEXTSat-1) satellite. The SRDs, which are a part of the Instruments for the study of Stable/Storm-time Space (ISSS), consist of the Medium-Energy Particle Detector (MEPD) and the High-Energy Particle Detector (HEPD). The MEPD can detect electrons, ions, and neutrals with energies ranging from 20 to 400 keV, and the HEPD can detect electrons over an energy range from 0.35 to 2 MeV. In this paper, we report an event where particle flux enhancements due to substorm injections are clearly identified in the MEPD A observations at energies of tens of keV. Additionally, we report a specific example observation of the electron distributions over a wide energy range in which we identify electron spatial distributions with energies of tens to hundreds of keV from the MEPD and with energy ranging up to a few MeV from the HEPD in the slot region and outer radiation belts. In addition, for an ~1.5-year period, we confirm that the HEPD successfully observed the well-known outer radiation belt electron flux distributions and their variations in time and L shell in a way consistent with the geomagnetic disturbance levels. Last, we find that the inner edge of the outer radiation belt is mostly coincident with the plasmapause locations in L, somewhat more consistent at subrelativistic energies than at relativistic energies. Based on these example events, we conclude that the SRD observations are of reliable quality, so they are useful for understanding the dynamics of the inner magnetosphere, including substorms and radiation belt variations.

Treatment Results of Vocal Process Granuloma: Intubation Versus Contact Granuloma (삽관성 육아종과 접촉성 육아종에 대한 치료 결과 분석)

  • Jeong, Jin Uk;Oh, Jae Hwan;Kim, Seul;Kim, Dong Young;Woo, Joo Hyun
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.32 no.3
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    • pp.135-141
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    • 2021
  • Background and Objectives Vocal process granulomas (VPGs) are benign lesions of the larynx, typically contact granulomas (CG) and intubation granulomas (IG). The two diseases are known to have different clinical manifestations despite having the same pathological features. The purpose of this study was to analyze the treatment results for CG and IG and to obtain clinical information. Materials and Method We retrospectively reviewed the medical records of patients diagnosed with VPG between January 2015 and December 2018. The patient's age, sex, medical history, lesion size, lesion type, reflux finding score, response to treatment, duration of treatment, and follow-up period were compared. Results In total, 32 patients were included in the study, of which 18 were CG and 14 were IG. In the CG group, males were dominant (n=15, 83.3%), whereas in the IG group, females were dominant (n=11, 78.6%) (p=0.0009). The response to medical treatment using proton pump inhibitor and steroid inhaler was better in the IG group (11/14, 78.6%) than in the CG group (7/18, 38.9%) (p=0.036). Of the 14 patients who did not respond to medical treatment, 5 received botulium toxin injections, and all 5 had complete remission. The duration of medical treatment was significantly longer in the IG group (p=0.0029). Conclusion IG was more common in female, and CG was more dominant in male. IG had better response to medical treatment using proton pump inhibitor and steroid inhaler than CG.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

  • Aggarwal, Vivek;Ahmad, Tanveer;Singla, Mamta;Gupta, Alpa;Saatchi, Masoud;Hasija, Mukesh;Meena, Babita;Kumar, Umesh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.305-314
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    • 2022
  • Introduction: This clinical trial aimed to evaluate the anesthetic effect of the addition of 2 mg (4 mg/ml) of dexamethasone to 2% lidocaine (plain or with 1:80,000 epinephrine). The solutions were injected for a primary inferior alveolar nerve block (IANB) to provide mandibular anesthesia for the endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. Methods: In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as "failed" anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as "no pain or faint/weak/mild pain" during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. Results: The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, 𝛘2 = 9.07, df = 2). Conclusions: The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

Anesthetic efficacy of primary and supplemental buccal/lingual infiltration in patients with irreversible pulpitis in human mandibular molars: a systematic review and meta-analysis

  • Gupta, Alpa;Sahai, Aarushi;Aggarwal, Vivek;Mehta, Namrata;Abraham, Dax;Jala, Sucheta;Singh, Arundeep
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.4
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    • pp.283-309
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    • 2021
  • Achieving profound anesthesia in mandibular molars with irreversible pulpitis is a tedious task. This review aimed at evaluating the success of buccal/lingual infiltrations administered with a primary inferior alveolar nerve block (IANB) injection or as a supplemental injection after the failure of the primary injection in symptomatic and asymptomatic patients with irreversible pulpitis in human mandibular molars. The review question was "What will be the success of primary and supplemental infiltration injection in the endodontic treatment of patients with irreversible pulpitis in human mandibular molars?" We searched electronic databases, including Pubmed, Scopus, and Ebsco host and we did a comprehensive manual search. The review protocol was framed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) checklist. We included clinical studies that evaluated and compared the anesthetic outcomes of primary IANB with primary and/or supplementary infiltration injections. Standard evaluation of the included studies was performed and suitable data and inferences were assessed. Twenty-six studies were included, of which 13 were selected for the meta-analysis. In the forest plot representation of the studies evaluating infiltrations, the combined risk ratio (RR) was 1.88 (95% CI: 1.49, 2.37), in favor of the secondary infiltrations with a statistical heterogeneity of 77%. The forest plot analysis for studies comparing primary IANB + infiltration versus primary IANB alone showed a low heterogeneity (0%). The included studies had similar RRs and the combined RR was 1.84 (95% CI: 1.44, 2.34). These findings suggest that supplemental infiltrations given along with a primary IANB provide a better success rate. L'Abbe plots were generated to measure the statistical heterogeneity among the studies. Trial sequential analysis suggested that the number of patients included in the analysis was adequate. Based on the qualitative and quantitative analyses, we concluded that the infiltration technique, either as a primary injection or as a supplementary injection, given after the failure of primary IANB, increases the overall anesthetic efficacy.

Withdrawal time study of lincomycin administered intramuscularly to olive flounder Paralichthys olivaceus, and in vitro efficacy evaluation against Gram-negative bacterial pathogens (넙치에서 lincomycin 근육투여에 따른 휴약기간 도출 및 병원성 그람음성 세균에 대한 약효 평가)

  • Eun Ha, Jeong;Keun-Taek, Kim;Dong Hun, Shin;Jun Sung, Bae;Kang Uk, Lee;Chae Won, Lee;Chan Yeong, Yang;Areum, Kim;Ji-Hoon, Lee;Su-Jin, Bak;Kwan Ha, Park
    • Journal of fish pathology
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    • v.35 no.2
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    • pp.195-203
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    • 2022
  • This study was performed to delineate pharmacokinetic residue characteristics of lincomycin (LM) in olive flounder at low water temperature (13℃), and to examine whether LM is effective against main Gram-negative pathogens. It was observed that the times for residue declined below the maximal residue limit (0.1 mg/kg) in the muscle was, respectively, 32, 33 and 55 days following 10, 20 and 40 mg/kg intramuscular LM injections. The in vitro MIC value of LM against Edwardsiella piscida was higher than 256 ㎍/mL and against Vibrio harveyi 32 ㎍/mL when examined with several clinical isolates. These results suggest that the withdrawal time of LM should be more than 30 days in consideration of the 10 mg/kg employed as the regular clinical dose. It was also found that LM administered to treat streptococosis in olive flounder is not likely to be effective against some pathogenic Gram-negative bacteria.

A Study on the Implementation and Development of Image Processing Algorithms for Vibes Detection Equipment (정맥 검출 장비 구현 및 영상처리 알고리즘 개발에 대한 연구)

  • Jin-Hyoung, Jeong;Jae-Hyun, Jo;Jee-Hun, Jang;Sang-Sik, Lee
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.15 no.6
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    • pp.463-470
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    • 2022
  • Intravenous injection is widely used for patient treatment, including injection drugs, fluids, parenteral nutrition, and blood products, and is the most frequently performed invasive treatment for inpatients, including blood collection, peripheral catheter insertion, and other IV therapy, and more than 1 billion cases per year. Intravenous injection is one of the difficult procedures performed only by experienced nurses who have been trained in intravenous injection, and failure can lead to thrombosis and hematoma or nerve damage to the vein. Nurses who frequently perform intravenous injections may also make mistakes because it is not easy to detect veins due to factors such as obesity, skin color, and age. Accordingly, studies on auxiliary equipment capable of visualizing the venous structure of the back of the hand or arm have been published to reduce mistakes during intravenous injection. This paper is about the development of venous detection equipment that visualizes venous structure during intravenous injection, and the optimal combination was selected by comparing the brightness of acquired images according to the combination of near-infrared (NIR) LED and Filter with different wavelength bands. In addition, an image processing algorithm was derived to threshehold and making blood vessel part to green through grayscale conversion, histogram equilzation, and sharpening filters for clarity of vein images obtained through the implemented venous detection experimental module.

Comparison of the effectiveness of extensor muscle strengthening exercise by itself, exercise with polydeoxyribonucleotide injection, and exercise with extracorporeal shockwave therapy in lateral epicondylitis: a randomized controlled trial

  • Shim, Bum Jin;Seo, Eun-Min;Hwang, Jung-Taek;Kim, Do-Young;Yang, Jae-Shin;Seo, Su-Jung;Hong, Myung Sun
    • Clinics in Shoulder and Elbow
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    • v.24 no.4
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    • pp.231-238
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    • 2021
  • Background: Extensor muscle strengthening exercises with counterforce braces (EX) is a conventional conservative treatment for lateral epicondylitis (LE) of the elbow. In addition, polydeoxyribonucleotide (PDRN) or extracorporeal shockwave therapy (ESWT) has been recently used for LE. Methods: Sixty-three patients with chronic LE participated in this study and randomly allocated in three groups (G1: EX, G2: EX+PDRN injection, and G3: EX+ESWT). All of the three groups were taught to perform EX at the first out-patient department (OPD) visit. Group 2 was injected with 3 mL PDRN (5.625 mg/3 mL), while group 3 received ESWT at the first OPD visit. Visual analog scale pain score, Mayo elbow performance score (MEPS), and ultrasonographic examination were checked before, 6 weeks, and 12 weeks after the treatments. Results: Overall functional scores and ultrasonographic findings in all three groups improved after treatment. The mean MEPS in group 2 improved more than groups 1 and 3 at 6 weeks (G1, 56.9>62.4; G2, 54.3>65.0; G3, 55.7>62.6), and more than group 1 at 12 weeks (G1, 56.9>67.9; G2, 54.3>73.6). The mean common extensor tendon depth (CETD) on ultrasonography in group 2 increased more than groups 1 and 3 at 6 and 12 weeks (6 weeks: G1, 0.385>0.386; G2, 0.332>0.392; G3, 0.334>0.357; 12 weeks: G1, 0.385>0.409; G2, 0.332>0.438; G3, 0.334>0.405 [cm]). Conclusions: PDRN injections combined with EX exhibited a greater improvement in mean MEPS and mean CETD compared to EX only or EX combined with ESWT for LE within the 12 weeks follow-up.