• 제목/요약/키워드: screening trial

검색결과 104건 처리시간 0.025초

허리 불안정성이 있는 허리통증 환자에게 실시한 자가-복합 운동프로그램이 통증과 기능, 심리사회적, 균형 능력 그리고 배가로근에 미치는 효과 (Effect of Self-Complex Exercise Program on Pain, Function, Psychosocial, Balance Ability, and TrA Muscle in Patients with Lumbar Instability: A Randomized Controlled Trial)

  • 윤종혁;정대근;박삼호
    • 대한통합의학회지
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    • 제10권2호
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    • pp.73-83
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    • 2022
  • Purpose : Low back pain (LBP) is reported as a risk of experiencing musculoskeletal disorders due to muscle stiffness and hypokinetics. The lumbar spine in an unstable state causes imbalance and lumbar instability. Therefore, This study examined the effects of lumbar stabilization exercise and self-complex exercise program on pain, function, psychosocial level, static balance ability, and transverse abdominal muscle (TrA) thickness and contraction ratio in patients with lumbar instability. Methods : The design of this is a randomized controlled trial (RCT). Twenty-six LBP patients participated in this study. Screening tests were performed and assigned to the experimental group (n=13) and control group (n=13) using a random allocation program. Both groups underwent a lumbar stabilization exercise program. In addition, the experimental group implemented the self-complex exercise program. All interventions were applied three times per week for four weeks. The quadruple visual analog (QVAS), the Korean version of the Oswestry disability index (K-ODI), Korean version of fear-avoidance belief questionnaire (FABQ), static balance ability, TrA thickness, and contraction ratio were compared to evaluate the effect on intervention. Statistical significance was set at 𝛼=.05. Results : Both groups showed significant differences before and after the intervention in QVAS, K-ODI, FABQ, static balance ability, and TrA thickness in contraction (p<.05). In addition, significant differences in K-ODI and FABQ were observed between the experimental group and control group (p<.05). Conclusion : A lumbar stabilization exercise and self-complex exercise program resulted in reduced dysfunctions, psychosocial stability in patients with lumbar instability. Therefore, Lumbar stabilization exercise and self-complex exercise program for patients with lumbar instability are effective method with clinical significance in improving the function and psychosocial stability.

팔물탕연조엑스의 단회 경구 투여 안전성 평가에 관한 연구 (Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 정영진;김수학;임지성;권영달
    • 한방재활의학과학회지
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    • 제33권1호
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    • pp.77-85
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    • 2023
  • Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.

전문가 설문조사에 기반한 재난 경험자에 대한 침치료 임상연구 프로토콜 개발 (Clinical Trial Protocol Development of Acupuncture for Disaster Survivors: Results from an Expert Survey)

  • 곽희용;권찬영;임정태;김상호
    • 동의신경정신과학회지
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    • 제35권1호
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    • pp.15-26
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    • 2024
  • Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

Socio Demographic and Reproductive Risk Factors for Cervical Cancer - a Large Prospective Cohort Study from Rural India

  • Thulaseedharan, Jissa V.;Malila, Nea;Hakama, Matti;Esmy, Pulikottil O.;Cheriyan, Mary;Swaminathan, Rajaraman;Muwonge, Richard;Sankaranarayanan, Rengaswami
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권6호
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    • pp.2991-2995
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    • 2012
  • Background: India shows some of the highest rates of cervical cancer worldwide, and more than 70% of the population is living in rural villages. Prospective cohort studies to determine the risk factors for cervical cancer are very rare from low and medium resource countries. The aim of this study was to quantify the effect of risk factors related to cervical cancer in a rural setting in South India. Material and methods: Sociodemographic and reproductive potential risk factors for cervical cancer were studied using the data from a cohort of 30,958 women who constituted the unscreened control group in a randomised screening trial in Dindigul district, Tamilnadu, India. The analysis was accomplished with the Cox proportional hazard regression model. Results: Women of increasing age (HR=2.4; 95% CI: 1.6, 3.8 in 50-59 vs 30-39), having many pregnancies (HR=7.1; 1.0, 52 in 4+ vs 0) and no education (HR=0.6; 0.2, 0.7 in high vs none) were found to be at significantly increased risk of cervical cancer. Conclusion: This cohort study gives very strong evidence to say that education is the fundamental factor among the sociodemographic and reproductive determinants of cervical cancer in low resource settings. Public awareness through education and improvements in living standards can play an important role in reducing the high incidence of cervical cancer in India. These findings further stress the importance of formulating public health policies aimed at increasing awareness and implementation of cervical cancer screening programmes.

Hereditary Tyrosinemia Type I 환아의 NTBC 치료 경험 (Hereditary Tyrosinemia Type I)

  • 강현영;김숙자;송웅주;장미영
    • 대한유전성대사질환학회지
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    • 제4권1호
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    • pp.13-17
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    • 2004
  • 저자들은 생후 28일된 발열, 간종대, 출혈성 경향, 구토, 잦은 보챔, 전신의 황달 증상을 보이던 환아를 MS-MS 이용한 신생아 대사 이상 검사와 혈중 아미노산 분석, 뇨중 유기산 분석을 통하여 hereditary tyrosinemia type I으로 진단하였다. 저 페닐알라닌/타이로신 식이와 NTBC 사용으로 국내 첫 타이로신혈증 I 치료 성공례를 경험하였다.

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A Case of Cyclosporine Treatment in Cat with Allergic Dermatitis, Nonresponsive to Prednisolone Treatment

  • Ryu, Dongwook;Kang, Jooyeon;Ko, Minho;Cho, Hyunkee;Han, Jeong-Hee;Chung, Jin-Young
    • 한국임상수의학회지
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    • 제33권6호
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    • pp.392-394
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    • 2016
  • A 2-year-old spayed female Persian cat presented to Kangwon National University Veterinary Medical Teaching Hospital with pruritus and erythema on the tips of both ears, around the eyes, and in the caudal abdomen. This patient had previously been prescribed prednisolone, but did not respond positively to the treatment. A skin screening test revealed that there were no fleas or fungi, and that only cocci were present. Blood testing revealed no remarkable findings. The patient was prescribed antibiotics (amoxicillin-clavulanic acid 25 mg/kg for 2 weeks) with no prednisolone. After 2 weeks, clinical signs were alleviated and the skin screening test showed no signs of cocci. However, clinical signs recurred even with the prescription of antibiotics. Four weeks after the steroid-free interval, Malassezia spp. hypersensitivity was detected upon a serum allergy test, and pathological analysis confirmed eosinophilic and mastocytic superficial dermatitis in the caudal abdomen. Based on these results, we suspected allergic dermatitis and prescribed 7 mg/kg cyclosporine A once a day. After 3 weeks, clinical signs were resolved. Seven weeks after the first trial with cyclosporine A, we reduced the cyclosporine A dose to 7 mg/kg every other day. The patient's symptoms have since been well controlled for 6 months. This study suggests that cyclosporine A can be a good choice for treating cats with suspected allergic dermatitis that has not responded positively to steroid treatment.

Effects of Pain Neuroscience Education on Pain, Body Function, Activity Disorders, and Depression in Patients with Chronic low back Pain: Randomized Controlled Trail

  • Kyoung-Gon Oh;Min-Ji Lee;Byoung-Hee Lee
    • 대한물리치료과학회지
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    • 제31권2호
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    • pp.1-14
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    • 2024
  • Background: Many patients with chronic low back pain have reduced movement due to pain. For that reason, muscle strength weakens, which leads to pain again. The pain caused by such a vicious circle is not only caused by structural problems, but also by physical function, activity disorder, or psychological depression due to biopsychosocial approaches and pain neuroscience education was applied as an intervention to find out its effect. Therefore, this study was experimented with to find out the effects of pain neuroscience education on pain, physical function, activity disorder, and depression in patients with chronic low back pain. Design: Randomized control trial Method: The study subjects were 39 patients with chronic low back pain, and the study subjects were randomized through computers to the experimental group applying pain neuroscience education and the control group applying only general physical therapy and myofascial release techniques, and the experiment was conducted for 4 weeks. Pressure Pain Threshold , Schober test, Korean Roland-Morris Disability Questionnaire, Korean Oswestry Disability Index, and Korean Depression Screening Assessment were measured. Results: As a result of the study, there was no significant difference in pain neuroscience education compared to the group that applied only general physical therapy and myofascial release techniques in both lumbar pressure pain thresholds, Schober test, Korean Roland-Morris disability questionnaire, and Korean Oswestry disability questionnaire. However, the Korean Depression Screening Assessment which is the result of measuring depression, showed significant results(p<0.05). Conclusion: Therefore, it is believed that it can be a way to mediate the psychological part through pain neuroscience education for patients with chronic low back pain in the future.

최근 일본의 의학계 연구규율의 특색 (The Characteristic of Research Regulation in Recent Japanese Medical World)

  • 송영민
    • 의료법학
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    • 제20권2호
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    • pp.173-206
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    • 2019
  • 본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구·치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구 (Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 안성후;신희라;박경태;이윤승;김종규;염승룡;권영달;조혜영
    • 한방재활의학과학회지
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    • 제29권4호
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    • pp.101-108
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    • 2019
  • Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers.

보중익기탕연조엑스의 1회 경구투여 후 안전성 평가에 관한 단일기관 연구 (Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 안성후;정영진;김종규;신혜령;권영달
    • 한방재활의학과학회지
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    • 제31권4호
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    • pp.157-166
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    • 2021
  • Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.