• Title/Summary/Keyword: observational clinical study

Search Result 308, Processing Time 0.031 seconds

Korean Medicine with Self-monitoring for Weight Control and Factors Associated with Weight Loss: a Retrospective Observational Study (자기감시를 병행한 한의비만치료에서 체중감량 및 감량에 영향을 미치는 요인 분석: 후향적 관찰연구)

  • Jang, In-Yeong;Yim, Ju-Hyuk;Park, Ji-Seon;Kim, Ji-Seong;Kim, Tae-Hun
    • The Journal of Korean Medicine
    • /
    • v.43 no.1
    • /
    • pp.87-98
    • /
    • 2022
  • Objectives: The purpose of this study was to investigate the effect of weight loss in Korean Medicine (KM) obesity treatment combined with self-monitoring and to identify the relevant factors which are related to successful weight loss. In addition to this, adverse events reported by the patients were analyzed to assess the safety of KM treatments for obesity Methods: This was a retrospective observational study that analyzed the medical records of the patients that participated in the 10-week of KM treatment. All patients took herbal medicine for weight loss and were instructed to reduce calorie intake and adhere to self-monitoring. Clinical data including body weight were collected for evaluating the effect of the treatments. Behavior factors affecting weight loss were collected. The correlation between each factor and weight loss was analyzed. Adverse events (AEs) were collected at each time to evaluate the safety of the intervention. Results: One hundred eighteen patients' records were included in this study. The average weight loss was 7.64kg(74.59kg to 66.95kg). 94.9% of patients lost 5% or more of their initial weight. The degree of weight loss was identified to be related to self-assessment of diet control and self-assessment of appetite control. The average self-weighing frequency significantly increased(2.45 times/week before treatment and 4.70 times/weeks during treatment). Constipation, insomnia, and dizziness were found to be the most frequent AEs, and except for one case, most AEs were mild cases. Conclusion: From this study, we found that KM obesity treatment combined with self-monitoring showed significant weight loss without serious AE.

Comparison of the effect of Action Observational training and Task-oriented training on Upper Limb Function and activities of daily living in People with Chronic stroke (만성 뇌졸중환자의 상지 기능 및 일상생활동작에 동작관찰훈련과 과제지향훈련의 효과 비교)

  • Bang, Dae-Hyouk;Kang, Tae-Woo;Oh, Duck-Won
    • Journal of Digital Convergence
    • /
    • v.10 no.9
    • /
    • pp.409-416
    • /
    • 2012
  • This study aimed to compare the effectiveness of action-observational training and task-oriented training on upper limb function and activities of daily living in patients with post-stroke hemiparesis. This study included 12 voluntary participants with post-stroke hemiparesis. Subjects were randomly assigned to either group 1 or group 2, with 6 in each group. Each subject completed the crossover experiment that comprised of action-observational training (A) and task-oriented training (B). The intervention sequence was A-B for the group 1 and B-A for the group 2. Each training was performed for 30 min a day, 5 times a week for 2 weeks (total experimental period of 4 weeks). Assessments were made using the Wolf Motor Function Test (WMFT) and Modified Barthel Index (MBI) thrice: at baseline, after 2 weeks of intervention, and after 4 weeks of intervention. The results showed that the WMFT and MBI scores significantly improved after the completion of each training (p<.05). Therefore, a determination of the superior training method was difficult. The effect sizes of both groups were greater when performed the action-observational training. The findings suggest that both the action-observational training and task-oriented training may be helpful in improving the upper limb function and activities of daily living for patients with post-stroke hemiparesis, and support the clinical feasibility of the action-observational training.

Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy (Statin 계열 약물의 제네릭 및 브랜드 제품 간 임상 치료결과 비교를 위한 체계적 문헌 고찰)

  • Shim, Haeri;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
    • /
    • v.27 no.2
    • /
    • pp.105-112
    • /
    • 2017
  • Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

Literature Review and suggestions : dementia clinical studies in Korean Oriental Medicine (한의학의 치매관련 임상연구 동향분석과 제안)

  • Kim, Wu-Young;Jeon, Won-Kyung;Heo, Eun-Jung;Park, Sang-Young;Han, Chang-Hyun
    • Korean Journal of Oriental Medicine
    • /
    • v.17 no.2
    • /
    • pp.39-46
    • /
    • 2011
  • Objectives : This study was aimed to review the trend of dementia clinical studies in Korean Oriental Medicine and to suggest better clinical studies. Method : We collected 26 papers on dementia clinical studies in the internet site OASIS using the keyword 'Dementia'. Then we analyzed them. Results : There were 26 clinical study papers that were published between 1996 and 2010. Observational studies account for 61% of total clinical studies, whereas experimental studies account for only 31%. Effects of treatment in experimental studies was evaluated mainly by MMSE-K and K-DRS. Treatment period of experimental studies was longer than 100days. Conclusions : High quality experimental studies like randomized clinical trial(RCT) and intervention studies which use syndrome differentiation(辨證) have not yet been published. It is necessary to research and develop duration of treatment effect and tools for evaluating treatment effects.

A Study on the Application of Standard Korean Medicine Clinical Pathway for Dysmenorrhea (월경통 한의표준임상경로 적용 가능성 및 유효성 평가 연구 프로토콜)

  • Choi, Su-Ji;Kim, Dong-Il;Noh, Eun-Ji
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.35 no.1
    • /
    • pp.75-90
    • /
    • 2022
  • Objectives: The purpose of this study protocol is firstly to investigate the status of Korean medical treatment of dysmenorrhea, and secondly to investigate effectiveness of the Clinical Pathway (CP) of dysmenorrhea and review the applicability. Methods: This is a multi-center observational study. The data will be prospectively collected from 14 Korean medicine clinics. 45 patients for each of the CP-applied and non-applied groups will be recruited to compare the degree of improvement in menstrual pain. All the diagnosis records, treatment methods, treatment results, adverse events, and medical expenses of patients with dysmenorrhea will be collected. We will investigate the proportion of patients who could be applied with CP, and the actual number of CP applications, and CP completion rate to evaluate the applicability. Additionally, the satisfaction survey will be used to collect feedback from medical staff members and patients. Results: The results of this study will be disseminated through peer-reviewed publications and scientific presentations. Conclusions: This study is expected to provide valuable data for application of standard Korean medicine clinical pathway for dysmenorrhea.

Anti-Diabetic Medications Do Not Influence Risk of Lung Cancer in Patients with Diabetes Mellitus: a Systematic Review and Meta-analysis

  • Nie, Shu-Ping;Chen, Hui;Zhuang, Mao-Qiang;Lu, Ming
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.15 no.16
    • /
    • pp.6863-6869
    • /
    • 2014
  • Objectives: Several preclinical and observational studies have shown that anti-diabetic medications (ADMs) may modify the risk of lung cancer. We performed a systematic review and meta-analysis evaluating the effect of metformin, sulfonylureas (SUs), thiazolidinediones (TZDs), and insulin on the risk of lung cancer in patients with diabetes mellitus (DM). Materials and Methods: We conducted a systematic search of Pubmed and Web of Science, up to August 20, 2013. We also searched the Conference Proceedings Citation Index (CPCI) and China National Knowledge Infrastructure (CNKI) for abstracts from major meetings. Fixed or random effect pooled measures were selected based on heterogeneity among studies, which was evaluated using Q test and the I2 of Higgins and Thompson. Meta-regression was used to explore the sources of between-study heterogeneity. Publication bias was analyzed by Begg's funnel plot and Egger's regression test. Associations were assessed by odds ratios (ORs) with 95% confidence intervals (CIs). Results: A total of 15 studies (11 cohort, 4 case-control) were included in this meta-analysis. In observational studies no significant association between metformin (n=11 studies; adjusted OR=0.99, 95%CI: 0.87-1.12), SUs (n=5 studies; adjusted OR=0.98, 95%CI: 0.79-1.22), or TZDs (n=7 studies; adjusted OR=0.92, 95%CI: 0.75-1.13), insulin (n=6 studies; adjusted OR=1.13, 95%CI: 0.79-1.62) use and risk of developing lung cancer was noted. There was considerable inherent heterogeneity between studies not explained by study design, setting, or location. Conclusions: Meta-analysis of existing studies does not support a protective or harmful association between ADMs use and risk of lung cancer in patients with DM. There was considerable heterogeneity across studies, and future, well-designed, prospective studies would be required for better understanding of any association.

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon;Choi, Hongjo;Jeon, Doosoo;Jhun, Byung Woo;Jo, Kyung-Wook;Kang, Young Ae;Kwon, Yong-Soo;Lee, Myungsun;Mok, Jeongha;Shim, Tae-Sun;Shin, Hong-Joon;Whang, Jake;Yim, Jae-Joon
    • Tuberculosis and Respiratory Diseases
    • /
    • v.83 no.2
    • /
    • pp.141-146
    • /
    • 2020
  • Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.

Clinical outcome of perioperative airway and ventilatory management in patients undergoing surgery for oral cavity cancer: a prospective observational study

  • Souvik Mukherjee;Anuj Jain;Seema S;Vaishali Waindeskar
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
    • /
    • v.50 no.3
    • /
    • pp.146-152
    • /
    • 2024
  • Objectives: This prospective observational study aimed to assess the clinical outcomes of perioperative airway and ventilatory management in patients undergoing surgery for oral cavity cancer. The study described the frequencies and types of procedures for securing the airway and the duration and types of postoperative ventilatory support. We compared the findings with those of the TRACHY study. Patients and Methods: One hundred patients undergoing oral cavity oncological surgeries were included. Airway assessment included inter-incisor gap, Mallampati class, neck movements, and radiological features. Surgical parameters, postoperative ventilatory support, and complications were documented. Results: The buccal mucosa was the most common cancer site (48.0%), and direct laryngoscopy was deemed difficult in 58.0% of patients. Awake fibreoptic intubation or elective tracheostomy was required in 43.0% of cases. Thirty-three patients were extubated on the table, and 34 patients were successfully managed with a delayed extubation strategy. In comparison with the TRACHY study, variations were observed in demographic parameters, tumour characteristics, and surgical interventions. Our mean TRACHY score was 1.38, and only five patients had a score ≥4. Prophylactic tracheostomy was performed in 2.0% of cases, in contrast to the TRACHY study in which 42.0% of patients underwent the procedure. Conclusion: The study emphasizes the challenges in airway management for oral cavity cancer surgery. While prophylactic tracheostomy may be necessary in specific cases, individualized approaches, including delayed extubation, are preferrable to maximize safety. Our findings contribute to better understanding and managing perioperative challenges in oral cancer patients and highlight the need for personalized strategies. Scoring systems like TRACHY should not be accepted as universally applicable.

A Study on the Clinical Study of Periodic Treatment of Endometriosis (자궁내막증의 주기요법 임상 연구에 대한 고찰)

  • Park, Jang-Kyung
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.33 no.2
    • /
    • pp.112-123
    • /
    • 2020
  • Objectives: The purpose of this study is to review the research in the cyclic treatment of endometriosis in traditional Korean medicine. Methods: By October 2019, the relevant studies on the periodic therapy of endometriosis were searched using the Chinese National Knowledge Infrastructure Database (CNKI) and Oriental Medicine Advanced Searching Integrated System (OASIS). Results: Finally, three Randomized controlled trials, one case study, two clinical observational studies were selected. In all studies, herbal medicine periodic therapy has been effective in improving symptoms of endometriosis. Blood-activating and stasis-dispelling medicinal were the most commonly used before menstruation and during menstruation, and tonifying and replenishing medicinal were the most commonly used after menstruation. According to the one study, which reported safety, herbal medicine was safe. Conclusions: Although limited due to a lack of literature, periodic therapy is effective in improving endometriosis related symptoms and preventing recurrence. A well-designed study and experimental studies for the identification of the mechanism are needed.

Evaluation of Clinical Alarms and Alarm Management in Intensive Care Units (중환자실에서 사용되는 의료장비의 경보음 발생과 관리 현황)

  • Jeong, Yu Jin;Kim, Hyunjung
    • Journal of Korean Biological Nursing Science
    • /
    • v.20 no.4
    • /
    • pp.228-235
    • /
    • 2018
  • Purpose: This study aimed to investigate the clinical alarm occurrence and management of nurses toward clinical alarms in the intensive care unit (ICU). Methods: This observational study was conducted with 40 patients and nurses cases in two ICUs of a university hospital. This study divided 24 hours into the unit of an hour and conducted two times of direct observation per unit hour for 48 hours targeting the medical devices applied to 40 patients. Data were analyzed using IBM SPSS Statistics 23. Results: On average, 3.8 units of medical devices were applied for each patient and the ranges of alarm settings were wide. During 48 hours, 184 cases of clinical alarm were occurred by four types of medical devices including physiological monitors, mechanical ventilators, infusion pumps, and continuous renal replacement therapy. Among them, false alarm was 110 cases (59.8%). As for the alarm management by ICU nurses, two-minute alarm mute took up most at 38.0% (70 cases), and no response was second most at 32.6% (60 cases). When valid alarm sounded, nurses showed no response at 43.2%. Conclusion: The findings suggest that a standard protocol for alarm management should be developed for Korean ICU settings. Based on the protocol, continuous training and education should be provided to nurses for appropriate alarm management.