• 제목/요약/키워드: Clinical trial center

검색결과 697건 처리시간 0.026초

한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰 (Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients)

  • 박봉기;왕경화;조정효;손창규
    • 대한한의학회지
    • /
    • 제31권5호
    • /
    • pp.12-32
    • /
    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

Short-course versus long-course neoadjuvant chemoradiotherapy in patients with rectal cancer: preliminary results of a randomized controlled trial

  • Aghili, Mahdi;Khalili, Nastaran;Khalili, Neda;Babaei, Mohammad;Farhan, Farshid;Haddad, Peiman;Salarvand, Samaneh;Keshvari, Amir;Fazeli, Mohammad Sadegh;Mohammadi, Negin;Ghalehtaki, Reza
    • Radiation Oncology Journal
    • /
    • 제38권2호
    • /
    • pp.119-128
    • /
    • 2020
  • Purpose: Colorectal cancer is becoming an increasing concern in the middle-aged population of Iran. This study aimed to compare the preliminary results of short-course and long-course neoadjuvant chemoradiotherapy treatment for rectal cancer patients. Materials and Methods: In this clinical trial we recruited patients with rectal adenocarcinoma located from 5 cm to 15 cm above the anal verge. Patients in group I (short-course) received three-dimensional conformational radiotherapy with a dose of 25 Gy/5 fractions in 1 week plus concurrent XELOX regimen (capecitabine 625 mg/㎡ from day 1-5 twice daily and oxaliplatin 50 mg/㎡ on day 1 once daily). Patients in group II (long-course) received a total dose of 50-50.4 Gy/25-28 fractions for 5 to 5.5 weeks plus capecitabine 825 mg/㎡ twice daily. Both groups underwent consolidation chemotherapy followed by delayed surgery at least 8 weeks after radiotherapy completion. The pathological response was assessed with tumor regression grade. Results: In this preliminary report on complications and pathological response, 66 patients were randomized into two study groups. Mean duration of radiotherapy in the group II (long-course) was 5 ± 1 days (range, 5 to 8 days) and 38 ± 6 days (range, 30 to 58 days). The median follow-up was 18 months. Pathological complete response was achieved in 32.3% and 23.1% of patients in the shortcourse and long-course groups, respectively (p = 0.558). Overall, acute grade 3 or higher treatment-related toxicities occurred in 24.2% and 22.2% of patients in group I and II, respectively (p = 0.551). No acute grade 4 or 5 adverse events were observed in either group except one grade 4 hematologic toxicity that was seen in group II. Within one month of surgery, no significant difference was seen regarding grade ≥3 postoperative complications (p = 0.333). Conclusion: For patients with rectal cancer located at least 5 cm above the anal verge, short-course radiotherapy with concurrent and consolidation chemotherapy and delayed surgery is not different in terms of acute toxicity, postoperative morbidity, complete resection, and pathological response compared to long-course chemoradiotherapy.

다목적 안과용 레이저 시스템 안전성 성능평가 및 임상적 유효성평가 가이드라인 수립을 위한 연구 (A Study on Safety, Performance and Clinical effectiveness Test Guideline of Versatile Ophthalmic Laser System)

  • 김유림;유우진;박호준;장원석
    • 대한의용생체공학회:의공학회지
    • /
    • 제40권6호
    • /
    • pp.250-259
    • /
    • 2019
  • Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

양돈 임상 연구에 의한 천연물 오배자 추출물의 항균.항바이러스 효과 규명 (Antimicrobial Effects of the Extract of Galla rhois on the Long-term Swine Clinical Trial)

  • 이현아;홍선화;한상준;김옥진
    • 한국임상수의학회지
    • /
    • 제28권1호
    • /
    • pp.1-6
    • /
    • 2011
  • 천연물 오배자 추출물은 in vitro 선행 연구를 통하여 병원성 세균과 바이러스에 대한 강력한 항균 항바이러스 효과를 확인하였다. 본 연구는 양돈 농장에서 130일간의 장기 임상시험을 통하여 효능평가를 통한 천연물 오배자 추출물의 항균 항바이러스 효과를 규명하고자 수행되었다. 200 마리의 돼지를 천연물 오배자 추출물 투여군과 비투여군으로 2 그룹으로 나누어 130일 동안 양돈농장에서 연구가 수행되었다. 천연물 오배자 추출물 투여군에는 항생제가 없는 사료에 천연물 오배자 추출물을 0.2% 배합하여 급여하였고 비투여군은 항생제가 포함된 일반 사료를 급여하였다. 연구기간 동안 사료섭취량, 체중, 임상증상을 분석하고 시험종료일에 부검하여 육안검사와 미생물학적 검사 및 병리조직학적 검사를 수행하였다. 연구결과 천연물 오배자 추출물은 양돈 산업에서 심각한 문제가 되고 있는 병원성 세균과 바이러스에 대한 강력한 항균 항바이러스 효과를 가지고 있는 것을 확인할 수 있었다.

Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste

  • Cha, Youn-Soo;Yang, Ji-Ae;Back, Hyang-Im;Kim, Soo-Ran;Kim, Min-Gul;Jung, Su-Jin;Song, Won O;Chae, Soo-Wan
    • Nutrition Research and Practice
    • /
    • 제6권6호
    • /
    • pp.520-526
    • /
    • 2012
  • Various forms of fermented soybean products are well documented for their health benefits. The efficacy of anti-obesogenic effect of Doenjang, one of the most commonly used seasonings in Korean cuisine, has been reported only in animal models; thus, an evaluation of Doenjang needs to be conducted in human studies. We aimed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults. A total of 51 overweight adults participated in this study. A group of males with BMI ${\geq}23kg/m^2$ and waist to hip ratio (WHR) ${\geq}$ 0.90, and a group of females with BMI ${\geq}23kg/m^2$ and WHR ${\geq}$ 0.85 were randomly assigned to either a Doenjang supplement (9.9 g dry/day) group or a placebo group for a 12-week randomized, double-blind and placebo-controlled study. Anthropometric parameters, abdominal fat distribution by computerized tomography (CT) and blood components were measured before and after the intervention period. After the 12-week study, the Doenjang supplementation group had significant reductions in body weight (kg), body fat mass (kg) and body fat (%) compared to the placebo group, the supplementation of Doenjang resulted in a significant reduction in visceral fat ($cm^2$), although no changes were observed in total and subcutaneous fat are as ($cm^2$), serum lipid profiles and dietary intakes. The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults.

Sequential patient recruitment monitoring in multi-center clinical trials

  • Kim, Dong-Yun;Han, Sung-Min;Youngblood, Marston Jr.
    • Communications for Statistical Applications and Methods
    • /
    • 제25권5호
    • /
    • pp.501-512
    • /
    • 2018
  • We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.

침 및 운동 치료로 호전된 파킨슨병 환자 1례에 대한 증례보고 (A Case Report of a Patient with Parkinson's Disease Treated with Acupuncture and Exercise Therapy)

  • 박미소;박상수;이승현;허왕정;유호룡
    • 대한한방내과학회지
    • /
    • 제43권5호
    • /
    • pp.1018-1028
    • /
    • 2022
  • Objectives: Parkinson's disease is characterized by progressive, irreversible damage to dopamine neurons in the substantia nigra pars compacta, as well as motor and non-motor symptoms. This disease currently has no dependable disease-modifying treatment. In this paper, we describe the treatment of a 67-year-old female with Parkinson's disease using acupuncture and exercise therapy. Case Presentation: Clinical symptoms and the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria were used to diagnose the patient with Parkinson's disease. Over a 12-week period, the patient visited a Korean medicine hospital 18 times and was treated with acupuncture and exercise therapy in addition to anti-Parkinson's drugs. Before and after treatment, clinical examinations were performed using tools such as the Unified Parkinson's Disease Rating Scale, Fall Efficacy Scale, Parkinson's Disease Questionnaire, Berg Balance Scale, and Non-Motor Symptoms Scale. Furthermore, functional near-infrared spectroscopy was used to assess cortical hemodynamics. All clinical examination results improved after 12 weeks of intervention. In particular, improvements on the Total Unified Parkinson's Disease Rating Scale and Part III of this scale demonstrated large, clinically important differences. Conclusion: This case suggests that combining acupuncture and exercise therapy could produce an effective treatment for Parkinson's disease patients.