• 제목/요약/키워드: Pilot protocol study

검색결과 61건 처리시간 0.027초

본 임상시험을 대비한 천식 침치료 무작위 대조군 예비 임상시험 프로토콜 (Acupuncture, an Adjunct Therapy for Asthma: a Pilot Study Protocol of Randomized Controlled Trial)

  • 최준용;오달석;노영래;정희재;정승기;최선미
    • Korean Journal of Acupuncture
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    • 제25권3호
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    • pp.43-51
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    • 2008
  • 배경 : 최근까지 이루어진 천식의 침치료 무작위 대조군 연구들에 의한 결과는 뚜렷한 효과를 보여주지 못하고 있다. 이러한 요인의 하나로 적절한 피험자 수를 정하기 위한 예비 임상시험의 부재가 거론되고 있다. 따라서 천식에 대한 침치료의 본 임상시험에 앞서 이의 실행 가능성 및 규모를 예측하는 예비임상시험이 필요한 상황이다. 목적 : 예비임상시험을 통해 서양의학적 치료를 받고 있는 천식환자들에 대한 침치료의 부가적 효과를 검증하기 위한 본 임상시험의 실현 가능성을 예측하기 위함. 방법 : 본 시험은 무작위 단일 맹검 대조군 평행 설계 예비 임상시험이다. 1차 평가변수는 최대 호기량 검사기로 집에서 아침, 저녁으로 매일 측정한 수치로 구해진 최대 호기 유속 일중 변동률의 1주간 평균치 변화이며 2차 평가변수는 의료기관에서 시행하는 폐기능 검사, 기준시점 호흡곤란 지수, 호흡곤란 변화에 대한 지수, 천식환자들의 삶의 질 평가를 위한 설문 등이다. 피험자 수는 총 45명으로 선정 및 제외기준을 통해서 참여하게 되며 1주간의 최대 호기 유속 기저치 평가 기간을 거친 후 진짜침 처치 군, 가짜침 처치 군, 대기군 세 군에 각각 무작위로 15명씩 할당된다. 모든 피험자에게 기존의 천식관련 약물의 사용을 허용하며, 진짜침 처치군 및 가짜침 처치군은 주 3회 4주간 해당 처치를 받고 2주 후에 각 평가 항목에 대하여 추적, 관찰하게 된다. 대기군은 기존의 천식관리를 유지하면서 2주마다 방문하여 총 6주간 평가를 받고 진짜침 처치를 4주간 받게 된다. 고찰 : 본 연구는 국내에서 최초로 이루어지는 천식에 대한 침 무작위 대조군 예비 임상시험으로 향후 적절한 피험자 수와 실행가능성을 예측할 수 있으리라 기대된다.

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Therapeutic Potential of Atopy-camp: A pilot study

  • Lee, Nam-Ryul;Kim, Hyung-Geug;Seo, Kyoung-Suk;Son, Chang-Gue
    • 대한한의학회지
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    • 제31권6호
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    • pp.40-46
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    • 2010
  • Objective: This study investigated the therapeutic possibility of natural therapy in atopy-camp for children with atopic dermatitis. Methods: 30 children (19 boys and 11 girls, median age 11.5 years, ranging from 9 to 15) participated in natural environment-based activities in a camp-village located in Geumsan-gun for five days. Assessment of symptom change was conducted by self-reporting numeric scale (NRS) for pruritus and sleeping difficulty, investigator global assessment (IGA), eczema area and severity index (EASI score), serum histamine and IgE concentration before and after the camp period. Statistical significance was analyzed by paired t-test. Results: NRS for pruritus ($4.7{\pm}2.0$ into $4.3{\pm}2.1$), sleeping difficulty ($3.1{\pm}2.1$ into $2.9{\pm}2.0$), and serum histamine concentration ($4.27{\pm}7.39$ mol / L into $3.21{\pm}6.08$ mol / L) showed positive changes but didn't reach statistical significance (p > 0.05). IGA ($3.8{\pm}0.9$ into $4.13{\pm}1.0$), while EASI score ($10.8{\pm}9.7$ into $9.1{\pm}9.2$) and IgE ($408{\pm}320$ IU / mL into $385{\pm}3.8$ IU / mL) were significantly improved (p < 0.01). Conclusions: In spite of the limitation of the clinical trial protocol, this study may provide the possibility of natural environment-based therapy for children with atopic dermatitis.

Safety and Effectiveness of Fluoroscopy-Guided Acupotomy for Carpal Tunnel Syndrome: Protocol for a Pilot Randomized, Patient-Assessor Blind, Parallel Clinical Trial

  • Yang, Muhack;Kim, Jae Kyoun;Park, Gun Woo;Cha, Eunhye;Jang, Jongwon;Seo, Jihye;Lee, Sangkwan;Kim, Sungchul
    • Journal of Acupuncture Research
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    • 제36권2호
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    • pp.100-106
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    • 2019
  • Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

생물학 가설의 생성에서 나타난 과학적 감성의 생성 과정 (The Generating Processes of Scientific Emotion in the Generation of Biological Hypotheses)

  • 권용주;신동훈;박지영
    • 한국과학교육학회지
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    • 제25권4호
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    • pp.503-513
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    • 2005
  • 본 연구의 목적은 생물학 가설 생성 중에 나타나는 과학적 감성 생성 과정을 밝히는 것이다. 먼저 예비연구를 통해 잠정적 모형을 구성하고, 사고 발성법 훈련 계획을 확정하고, 표준화된 면접지 개발하였다. 본 연구에서는 8명의 대학생을 대상으로 사고 발성법과 회상적 면접법, 심층 면접을 이용한 삼각측정법으로 언어적 프로토콜과 행동 프로토콜을 수집하였다. 잠정적 모형을 근거를 선언적 지식과 절차적 지식의 분석틀을 개발하였고, 이 분석틀을 이용하여 부호화 프로토콜을 개발하였다. 부호화 프로토콜을 분석한 결과 과학적 감성 생성의 4가지 유형을 개발하였다. 첫 번째 생성 유형은 기본 과정으로서 인식하기 전에 먼저 느끼는 과정을 설명한다. 두 번째 생성 유형은 회상적 과정으로서 과거의 감성기억이 되살아나는 과정을 설명한다. 세 번째 생성 유형은 인지적 과정으로서 인지적 목표를 달성하기 위해 일어나는 일련의 사고 과정에서 생성되는 감성을 설명한다. 네 번째 생성 유형은 귀인 과정으로서 인지적 목표의 달성 여부에 대한 귀인평가 과정에서 생성되는 감성을 설명한다. 기본 과정에서 생성한 감성은 기본 감성이라 하고, 회상 과정에서 생성한 감성은 회상 감성이라 하고, 인지적 과정에서 생성한 감성은 인지적 감성이라 하고, 귀인 과정에서 생성한 감성은 귀인감성이라 한다. 개발된 과학적 감성 생성 과정 유형은 감성 생성 과정 모형 개발과 감성적 두뇌 기반 학습 전략 수립의 기초가 될 것으로 기대한다.

Familial Breast Cancer Registry Program in Patients Referred to the Cancer Institute of Iran

  • Sabokbar, Tayebeh;Khajeh, Elias;Taghdiri, Foad;Peyghambari, Vahideh;Shirkoohi, Reza
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권6호
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    • pp.2675-2679
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    • 2012
  • Introduction: Annually a considerable number of people die because of breast cancer, a common disease among women also in Iran. Identifying risk factors and susceptible people can lead to prevention or at least early diagnosis. Among susceptibility risks, 5-10% of patients have a family history predisposing factor which can influence the risk of incidence among the family. Having a registry program can be a more practical way to screen high risk families for preventive planning. Method: Based on inclusion criteria, a questionnaire was prepared and after a pilot study on a small number of patients, actual data were collected on 400 patients and processed in SPSS 16.0. Results: Totally, 28.2%of the patients were younger than 40 years old and 36.8% had the included criteria for familial breast cancer (FBC). 102 patient's samples could be compared for receptor presentation. Similar to other studies, the number of triple negative breast cancers increased as the age decreased. Conclusion: The high percentage of patients with FBC among 400 cases in this study demonstrates that in order to design an infrastructural diagnostic protocol and screening of patients with FBC, a precise survey related to frequency and founder mutations of FBC is needed nationwide.

이중맹검용 피내침을 이용한 단순성 비만여성의 사암침 치료효과에 관한 임상선행연구 (A Pilot Study of Sa-am Acupuncture Treatment Used by Sham Acupuncture for the Simple Obesity)

  • 김성철;장은하;나원민;이성용;이종덕;문형철;최선미;정영해
    • Journal of Acupuncture Research
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    • 제24권5호
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    • pp.67-88
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    • 2007
  • Objectives : To present proper protocol as global standard- clinical study about acupuncture treatment, and to demonstrate effectiveness of Sa-am Acupuncture treatment for obesity. Methods : We randomly allocated participants to treatment group 1 and 2. The group 1 is treated by real acupuncture and the group 2 is treated by Kim Sham Acupuncture. We treated Bi-jang seung-gyeok (脾臟勝格) ; Daedon(LR1), EunBaek(SP1) Gyoung-geo(LU8) Sang-gu(SP5), to both group. Primary outcomes were measured by the Body Composition Analysis(Inbody. Korea). Secondary outcomes were measured by Blood Cholesterol, Triglyceride, HDL, LDL Cholesterol. Results : After treatment, the group 1 shown significant weight loss that analysed by Kruskal-Wallis certification, but didn't show notable change in body fat, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol. Group 2 didn't show significant change in body weight, body fat, triglyceride, HDL cholesterol, LDL cholesterol, but total cholesterol was notably decreased. Controled group was not changed in body weight, body fat. Aftter treatment, 3 groups didn't show significant change in body weight, body fat, triglyceride, HDL cholesterol, LDL cholesterol, total cholesterol.

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Socket preservation using eggshell-derived nanohydroxyapatite with platelet-rich fibrin as a barrier membrane: a new technique

  • Kattimani, Vivekanand Sabanna;Lingamaneni, Krishna Prasad;Kreedapathi, Girija Easwaradas;Kattappagari, Kiran Kumar
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제45권6호
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    • pp.332-342
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    • 2019
  • Objectives: Socket grafting is vital to prevent bone resorption after tooth extraction. Several techniques to prevent resorption have been described, and various bone graft substitutes have been developed and used with varying success. We conducted this pilot study to evaluate the performance of nanohydroxyapatite (nHA) derived from chicken eggshells in socket preservation. Materials and Methods: This was a prospective, single center, outcome assessor-blinded evaluation of 23 sockets (11 patients) grafted with nHA and covered with platelet-rich fibrin (PRF) membrane as a barrier. Bone width and radiographic bone density were measured using digital radiographs at 1, 12, and 24 weeks post-procedure. Postoperative histomorphometric and micro-computed tomography (CT) evaluation were performed. The study protocol was approved by the Institutional Ethics Committee. Results: All patients had uneventful wound healing without graft material displacement or leaching despite partial exposure of the grafted socket. Tissue re-epithelialized with thick gingival biotype (>3 mm). Width of the bone was maintained and radiographic density increased significantly with a trabecular pattern (73.91% of sockets) within 12 weeks. Histomorphometric analysis showed 56.52% Grade 3 bone formation and micro-CT analysis revealed newly formed bone with interconnecting trabeculae. Conclusion: Use of a PRF membrane with nHA resulted in good bone regeneration in sockets. Use of a PRF membrane prevents periosteal-releasing incisions for primary closure, thereby facilitating the preservation of keratinized mucosa and gingival architecture. This technique, which uses eggshell-derived nHA and PRF membrane from the patient's own blood, is innovative and is free of disease transfer risks. nHA is a promising economic bone graft substitute for bone regeneration and reconstruction because of the abundant availability of eggshell waste as a raw material.

Intraovarian platelet-rich plasma administration could improve blastocyst euploidy rates in women undergoing in vitro fertilization

  • Merhi, Zaher;Seckin, Serin;Mouanness, Marco
    • Clinical and Experimental Reproductive Medicine
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    • 제49권3호
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    • pp.210-214
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    • 2022
  • Objective: Platelet-rich plasma (PRP) therapy has received a considerable attention as an adjunct to fertility treatments, especially in women with very low ovarian reserve and premature ovarian insufficiency. Although recent studies have demonstrated that PRP led to improvements in folliculogenesis and biomarkers of ovarian reserve, the effect of intraovarian PRP administration on embryo genetics has not been studied. Methods: We report a pilot study of patients who had preimplantation genetic testing for aneuploidy (PGT-A) before and then within 3 months following PRP administration. Twelve infertile women with at least one prior failed in vitro fertilization (IVF) cycle underwent ovarian stimulation (cycle 1) with a gentle stimulation protocol and PGT-A performed at the blastocyst stage. Following cycle 1, autologous intraovarian PRP administration was performed. Within 3 months following PRP administration, the patients underwent cycle 2 and produced blastocysts for PGT-A. The percentage of euploid embryos between both cycles was compared. Results: The mean age of all participants was 40.08±1.46 years, and their mean body mass index was 26.18±1.18 kg/m2. The number of good-quality embryos formed at the blastocyst stage was similar between cycle 1 and cycle 2 (3.08±0.88 vs. 2.17±0.49, respectively; p=0.11). Among all patients in cycle 1, 3 of 37 embryos were euploid (8.11%) while in cycle 2, 11 out of 28 embryos were euploid (39.28%, p=0.002). Three clinical pregnancies were noted among this patient group. Conclusion: This novel study is the first to present an improvement in the embryo euploidy rate following intraovarian PRP application in infertile women with prior failed IVF cycles. The growth factors present in PRP may exhibit a local paracrine effect that could improve meiotic aberrations in human oocytes and thus improve euploidy rates. Whether PRP improves live birth rates and lowers miscarriage rates remains to be determined in large trials.

만성통증을 지닌 노인의 자기효능과 삶의 질에 관한 연구 (A Study on Self-Efficacy and Quality of Life in the Elderly Patients with Chronic Pain)

  • 김경희;정혜경;최미혜;권혜진
    • 기본간호학회지
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    • 제7권2호
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    • pp.332-344
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    • 2000
  • The subjects of this study were 100 elderly people who were over 60 years of age and had chronic pain. The study examined the matter of quality of life and self-efficacy of elderly patients with chronic pain including the influence of related factors on these variables. Also, by examining their relation, it provides basic data for the development of efficient nursing interventions for the elderly patients with chronic pain. The tools were the general self-efficacy scale by Sherer & Maddux(1982) and a specific self-efficacy Scale(Lorig et al, 1989) modified to better suit the subjects of this study. The quality of life scale by You-Ja Ro(1988) modified to better suit the subjects of this study was used. The data were collected from August to October 1999. Four researchers and two research assistants developed a data collection protocol subjected to a pilot study for confirmation of validity. In this study, the research assistants read the questionaire to the subjects and recorded the responses themselves. The interviews lasted 40-50 minutes on an average. The data thus collected were analyzed in terms of t-test, ANOVA, Pearson's correlation coefficient, using the SAS PC program. The major findings are as follows: 1) For self-efficacy it was found that males had higher self-efficacy than females for specific self-efficacy. But for general efficacy, males and females showed similar results. The the quality of life was found to be higher for males than females. 2) A positive correlation was identified between the specific self-efficacy, general self-efficacy and quality of life. 3) The general characteristics affecting the self-efficacy of elderly patients with chronic pain were employment, age, level of education, spouse, economic status and income. Self-efficacy was higher among those who were employed, aged between 66-70, well-educated, married and rich or having their own income. 4) The general characteristics affecting the quality of life of elderly patients with chronic pain were lodging with children, religion, level of education and economic status. The quality of life was higher among those who lived with their children and were Buddhists, were well-educated and rich.

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환자와 의사의 의료에 대한 태도 차이 -한 중소도시의 대학병원과 한의과대학 부속 한방병원을 중심으로- (The Difference in Attitude toward Medical Care between Patients and Physicians)

  • 강명근;박종구;김한중;손명세;김달래
    • Journal of Preventive Medicine and Public Health
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    • 제31권3호
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    • pp.516-539
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    • 1998
  • The objective of this study is to identify the difference in attitude toward medical care between patients who visited a university hospital or an oriental medical hospital of oriental medical college, and physicians who engaged in the same hospitals. The subjects of this study were 397 cases who agreed to respond the prepared questionnaire, including 288 patients(146 university hospital utilizers and 142 utilzers for an oriental medical hospital) and 109 physicians(76 physicians and 33 oriental medical doctors). The attitude toward medical care was measured by the structured questionnaire developed for this study, which had high validity and reliability according to factor analysis, item discriminant validity, and Cronbach's $\alpha$ coefficients. On the criteria of mean value of care and cure score, the attitude toward medical care was classified into 4 groups encompassing a group with dependent attitude on medical care, a group with skeptical attitude toward it, a group with cure-oriented attitude, and a group with care-preferred attitude. The results of chi-square test, discriminant analysis, and logistic regression analysis were as follows; patients who visited a univisity hospital, patients who visited an oriental hospital, physicians, and oriental medical doctors included in the group with dependent attitude, the group with cure-oriented attitude, the group with skeptical attitude, and the group with care-preferred attitude, retrospectively. Among the subdomains of care and cure domains, which classified in reference to the result of factor analysis on pilot study, those that patients ranked more importantly than physicians were 'the importance of medical equipment for diagnosis and treatment', 'authority of physician, 'aggressiveness of treatment', 'information giving', 'personal interest' in the case of western medicine. In the case of oriental medicine, those were 'the importance of equipment for diagnosis and treatment', 'aggressiveness of treatment', 'amenities and accessibility', 'coordination of medical staff'. Both physicans and patients put the subdomain, 'physicians' medical knowledge and skillfulness' on the highest rank. The differences in ranking the important attributes of medical care between patients and physicians were apparent in the area of an 'importance of medical equipment for diagnosis and treatment' and so on. It meant that patient had over-expectation on medical care and suggested that the policy on demanad side such as the developement and dissemination of an evidence-based recommendation protocol for health care consumers might be important in Korea. In addition, regarding the attitude of physicians, during the medical education and training it may be neccessary to emphasize the aspect of 'care' of medical care rather than 'cure'. In planning on heath care delivery system, it should be considered that there is a difference in the attitude toward medical care between western medicine and oriental medicine as well as between health care providers and consumers. We expect that more valid measurement tool be developed in this area, which may be major limitation of this study and that this kind of research be expanded into the non-academic settings.

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