• 제목/요약/키워드: Clinical trial center

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

  • Lee, Ho Chan;Jung, Mi Young;Choi, Jung Hwa;Jeong, Min Yeong;Park, Soo Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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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.

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

  • Ji Sung Jang;Amy Junghyun Lee;Kye Jin Park;Kyung Won Kim;Hyo Jung Park
    • Journal of the Korean Society of Radiology
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    • 제84권6호
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    • pp.1244-1256
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    • 2023
  • In prostate cancer, the bone is the most common site of metastasis, and it is essential to evaluate metastatic bone lesions to assess the tumor burden and treatment response. Castration-resistant prostate cancer refers to the state wherein the cancer continues to progress despite a significant reduction of the sex hormone level and is associated with frequent distant metastasis. The Prostate Cancer Working Group 3 (PCWG3) released guidelines that aimed to standardize the assessment of treatment effects in castration-resistant prostate cancer using bone scintigraphy. However, these guidelines can be challenging to comprehend and implement in practical settings. The purpose of this review was to provide an overview of a specific image acquisition method and treatment response assessment for bone scintigraphy-based evaluation of bone lesions in metastatic castration-resistant prostate cancer, in accordance with the PCWG3 guidelines.

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

  • Shim, Soo Bo;Seo, Hyun Sik;Lee, Hyun Hee;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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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.

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

  • An Hae-Sung;Lee Sung-Eun;Park Hyun-Ok
    • Journal of Korean Academy of Fundamentals of Nursing
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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
    • CELLMED
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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.

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

  • Kim, Byung-Jun;Shin, Byung-Cheul;Hwang, Man-suk;Shin, Kyung-Min;Heo, In;Lim, Kyeong-Tae;Park, In-Hwa;Son, Dong-Wuk;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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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.

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

  • Lim, Hoi-Jeong;Kim, Yoon-I;Jung, Young-Bok;Seong, Sang-Cheol;Ahn, Jin-Hwan;Roh, Kwon-Jae;Kim, Jung-Man;Park, Byung-Joo
    • 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.