• 제목/요약/키워드: Clinical trial center

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곡지혈 매선침 시술이 경피수분 손실량에 미치는 영향 (Pilot Clinical Trial to Evaluate the Efficacy of Needle-Embedding Acupuncture Therapy at Gokji(LI11) on TEWL)

  • 이호찬;정미영;최정화;정민영;박수연
    • 동의생리병리학회지
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    • 제32권4호
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    • pp.291-297
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    • 2018
  • The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

전이성 거세 저항성 전립선암의 치료 반응 평가를 위한 뼈스캔 기반의 전이성 골병변 반응 평가 지침: Prostate Cancer Clinical Trial Working Group 3 권장사항 (Guidelines for Evaluating Treatment Response Based on Bone Scan for Metastatic Castration-Resistant Prostate Cancer: Prostate Cancer Clinical Trial Working Group 3 Recommendations)

  • 장지성;이정현;박계진;김경원;박효정
    • 대한영상의학회지
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    • 제84권6호
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    • pp.1244-1256
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    • 2023
  • 전립선암에서 뼈는 가장 흔한 전이병소이며, 전립선암의 질병 상태를 파악하고 치료 반응을 평가하기 위해서는 전이성 골병변의 평가가 필수적이다. 거세 저항성 전립선암은 남성호르몬을 거세 수치로 떨어뜨렸음에도 불구하고 암이 진행하는 상태를 의미하며, 이 상태에서는 원격 전이가 빈번하게 발생한다. 거세 저항성 전립선암의 치료 반응을 객관적으로 평가하기 위해 뼈스캔을 기반으로 한 Prostate Cancer Working Group 3 (이하 PCWG3) 가이드라인이 발표되었으나 실제 이를 쉽게 숙지하여 적용하기에는 어려운 점이 있다. 본 종설에서 PCWG3 가이드라인에 준한 거세 저항성 전립선암의 뼈스캔 기반 골병변 반응 평가를 위한 구체적인 영상 획득 방법 및 치료 반응 평가법을 소개하고자 한다.

성조숙증 소아 대상 중재 임상시험의 등록 현황 보고 -Clinicaltrial.gov, WHO ICTPR, CRIS를 중심으로- (The Current State of Registration of Interventional Clinical Trials for Children and Adolescents with Precocious Puberty)

  • 심수보;서현식;이현희;이혜림
    • 대한한방소아과학회지
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    • 제36권3호
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    • pp.1-18
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    • 2022
  • Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

소변검사의 검체 채취 방법에 관한 임상실험연구 (A Clinical Trial on the Method of Urine Sampling for Urinalysis)

  • 안혜성;이성은;박현옥
    • 기본간호학회지
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    • 제2권2호
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    • pp.131-137
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    • 1995
  • Improving validity and reliability is the important components of clinical laboratory tests. And the quality control of the test should be started with the accurate collection of specimen. Urinalysis is one of the useful and common tests in diseases diagnosis and determining the process of medical treatment. Since urinalysis is requested routinely in hospital setting, the importance of the quality control for urine specimen is often ignored. To improve the validity of urinalysis, a clinical trial was done on the method of collecting urine specimen. The result was as follows : 1. The rate of presumtive UTI(urinary tract infection) was decreased in 21.6% with experiment method for collecting urine specimen. 2. The rate of presumtive UTI in female patients was decreased in 43.2% with the experiment method. 3. The rate of negative urine culture was decreased in 6.6% with the experiment method.

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A Randomized single blind controlled clinical trial on safety and efficacy of a Unani formulation (Itrifal-e-Sagheer) in dyslipidemia

  • Alam, Sazid;Alam, MD Anzar;Quamri, MA;Sofi, Ghulamuddin;Khan, Mohd. Qudratullah;Ansari, Shabnam
    • 셀메드
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    • 제10권1호
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    • pp.8.1-8.7
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    • 2020
  • Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.

요추 수술 후 급성기 통증 환자에 대한 통합의학 표준임상경로 임상시험 프로토콜 (An Integrative Care Model of Clinical Pathway Approach for Acute Pain after Back Surgery: A Protocol for Clinical Trial)

  • 김병준;신병철;황만석;신경민;허인;임경태;박인화;손동욱;황의형
    • 한방재활의학과학회지
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    • 제27권4호
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    • pp.111-119
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    • 2017
  • Objectives Clinical pathway (CP), is management plans that display goals for patients and have led to improve outcomes for many diseases. In Korea, Interest in Korean medicine's stabilization (Clinical pathway, Clinical Practice Guideline) is increasing, But the number of studies is scare. Method and Analysis This trials composes nonequivalent control group pretest-posttest design to conduct clincal pathway trial for the acute pain after back surgery. The subjects were 10 control patients with back surgery, and 10 experimental patients with application of integrative CP. Each group patient will observed 6 weeks. We check validation of CP. Also we compared the patient's status using the pain, function, Quality of life index between the two groups. Discussion This trial is the first CP for the acute pain after back surgery using integrative medicine concepts. Aim of this trial is to find the effectiveness and validity of clincal pathway for acute pain after back surgery.

퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석 (Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method)

  • 임회정;김윤이;정영복;성상철;안진환;노권재;김정만;박병주
    • Journal of Preventive Medicine and Public Health
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    • 제37권4호
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    • pp.381-389
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    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.