• 대한기관윤리심의기구협의회지
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• 제3권1호
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• pp.1-10
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• 2021

In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants' civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.

• 한국발생생물학회:학술대회논문집
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• 한국발생생물학회 2009년도 특별 Symposium
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• pp.34-34
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• 2009

• Clinics in Shoulder and Elbow
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• 제27권2호
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• pp.237-246
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• 2024

Proximal humeral fractures (PHFs) are a common injury among the older population. An ideal therapeutic protocol has yet to be developed, and numerous clinical trials are being conducted to find the best therapeutic approach. The purpose of this study is to evaluate the current body of knowledge available via interventional clinical trials. In December 2022, interventional clinical trials relating to PHFs on Clinicaltrials.gov were screened. Trial characteristics included duration, status, intervention, phase, outcomes, location, and study design. Publications associated with each trial were searched on PubMed/Medline using the ClinicalTrials.gov registry number. The final dataset comprised 64 trials. The most common trial status was completed (36%). The majority did not have a Food and Drug Administration-defined phase (67%), was randomized (81%), involved a single facility (72%), used a parallel assignment intervention model (80%), and used an open-label approach (45%). Eleven trials were associated with a publication, and the publication rate was 17%. Average enrollment was 86 participants, and mean trial duration was 51.4 months. Europe/UK/Russia/Turkey participated in the most trials (70%). Most of the trials were initiated after 2010 (87.5%). Procedure-related interventions (55%) were most common. Disability/function was the most common primary outcome assessed (61%). The low publication rate and the multitude of trials conducted after 2010 highlight the urgency and need for trial results to be published to establish an ideal therapeutic protocol. Since the majority of the trials involved a single institution and an open-label approach, reinforcing blinding and establishing multi-centered trials can improve the validity of the clinical trial results.

• 사상체질의학회지
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• 제26권3호
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• pp.241-250
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soyangin Disease of Sasang Constitutional Medicine(SCM): Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related to clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, 1 articles were selected and included in CPG for Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology of Spleen Cold-based Exterior Cold (Bisuhan-pyohan) disease in Soyangin Disease. Results & Conclusions The CPG of Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology in Soyangin Disease include classification, definition and standard symptoms of each pattern. Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology is classified into mild and moderate pattern by severity. Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology mild pattern is classified into initial pattern and advanced pattern. Lesser-Yang Wind-Injury (Soyang-sangpung) symptomatology moderate pattern is classified into Chest-binding (Gyeolhyoong) pattern and Chest-binding (Gyeolhyoong) advanced pattern.

• 한방재활의학과학회지
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• 제28권2호
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• pp.73-82
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• 2018

Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

• Journal of Acupuncture Research
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• 제27권4호
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• pp.127-135
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• 2010

Objectives : The main purpose of this study is to evaluate effects of acupuncture at Fengchi($GB_{20}$) and Houxi($SI_3$) for acute headache due to whiplash injury. Methods : This study was observed among 50 patients with acute headache due to whiplash injury who admitted to Bundang oriental medicine hospital of Dongguk University from June 16, 2009 to January 31, 2010. These patients were divided into two groups; One was control group that was acupunctured at general acupuncture points except Fengchi($GB_{20}$), Houxi($SI_3$)(Control group) and the other was acupunctured at Fengchi($GB_{20}$), Houxi($SI_3$) with general acupuncture points(Experimental group). Each patient was acupunctured once a day. The effect was assessed through self-rating headache index. Results & Conclusions : As a result of evaluation by using self-rating headache index, pain score at 8th day declined in both groups. But they were not difference between two groups at 8th day.

• 동의생리병리학회지
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• 제20권6호
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• 대한핵의학회:학술대회논문집
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• 대한핵의학회 1999년도 제38차 춘계학술대회
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• pp.228-241
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• 1999

Percutaneous coronary angioplasty is well established therapeutic modality in the management of coronary artery disease. However, the high restenosis rate of 30 to 50% limits its usefulness. The principal mechanism of restenosis, intimal hyperplasia, is the proliferative response of vessel wall to injury, which consists largely of smooth muscle cells. A large body of animal investigations and a limited number of clinical studies have established the ability of ionizing radiation to reduce neointimal proliferation and restenosis rate significantly. Human studies have been reported that intravascular radiation after first restenosis inhibits a second restenosis. Encouraged by these reports, we are also conducting a double blind, placebo-controlled, randomized trial to evaluate this new therapeutic modality in patients with coronary artery stenosis. The objective of our trial is to determine the safety and efficacy of catheter-based solutional beta emitting radioisotope system in preventing restenosis after angioplasty. This review describes the vascular brachytherapy systems and isotopes that have been utilized in the initial clinical trials performed in this area of post PTCA coronary restenosis. The results of many worldwide ongoing clinical trials will determine whether this new technology will change the future practice of vascular intervention.

• 식품보건융합연구
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• 제5권4호
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• pp.25-28
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• 2019

Now a days problem in health has become common. So, instead of curing them, prevention through dietary supplements has proven to be useful. In the case of patients who have already developed the disease atleast relieving pain and suffer is a challenging thing. In this context L- arginine is doing better compared to other essential aminoacids up to some extent. Arginine was found to reduce the pain associated with pulmonary hypertension foun to be associated with sickle cell anaemia. It also reduces the reperfusion injury after ischemia, trauma and shock. Some of the drugs with L-arginine as component are under clinical trials and hope to be available in the market soon. Severe preeclampsia is characterised by headaches, blurred vision, and inability to have high photovision, nausea and vomiting. L-Arginine along with Vit C and E are given as medical food to the patients and decrease in condition symptoms is the project now under phase II clinical trial. However the role of arginine in ameolirating preeclampsia symptoms is uncertain except with that of hypertension. Arginine is used to treat pain in sickle cell anaemia, lung damage, reperfusion injury, Trauma and shock but should be excluded during sepsis.

• 한방재활의학과학회지
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• 제31권3호
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• pp.73-84
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• 2021

Objectives The objective of the study is to review the Korean traditional medicine treatment used in cruciate ligament injury. Methods According to patients, treatment methods, research design, evaluation tools, outcome, we searched for studies which performed Korean traditional medical treatment on patient with cruciate ligament injury. Results In 11 studies, total number of patents were 78. Patients were conducted with 11 kinds of treatment, which is acupuncture, herbal medicine, pharmacopuncture, electro-acupuncture, burning acupuncture, moxibustion, physiotherapy, exercise, Chuna and cupping. The most commonly used measurement was visual analog scale. Conclusions Throughout the study, we could organize Korean traditional medicine treatment for patient with cruciate ligament injury. However it is difficult to figure out among the 11 intervention which interventions were effective in improving symptom. Therefore, further researches like randomized clinical trial and systematic review is needed in order to enhance the evidence of the Korean traditional medicine.