• Title/Summary/Keyword: Clinical trial registration

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Manual Therapy in the Treatment of Temporomandibular Disorders: A Protocol for a Systematic Review (측두하악 장애 치료를 위한 수기치료에 대한 체계적 고찰의 프로토콜)

  • Kim, Hyungsuk;Jung, Jae-Young;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.41-46
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    • 2015
  • Objectives This systematic review will analyse randomised controlled trials (RCTs) of manual therapy in patients with temporomandibular disorders (TMDs) to evaluate the efficacy of this approach. Methods RCTs will be identified in the following ten databases based on searches starting with their inception: MEDLINE, EMBASE, CENTRAL, four Korean databases as KoreaMed, DBPIA, NDSL, and RISS and three Chinese databases as CNKI, VIP and Wanfang. The quality of these studies will be analysed using the Cochrane risk of bias. A meta-analysis will be conducted, and subgroup analysis will be considered if comparatively large heterogeneity is detected. Conclusions We plan to publish this systematic review in a peer-reviewed journal. Findings from this review may contribute to the treatment process in clinical situations. Trial registration number: PROSPERO 2015: CRD42015024090

The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

A Single Center Study on the Evaluation of Safety after Single Oral Administration of Peony Root Extract Tablets (작약엑스정 1회 경구 투여의 안전성 평가에 관한 연구)

  • Su-Hak Kim;Jeong-Su Park;Tae-Seong Jeong;Seung-Hyun Oh;Young-Dal Kwon
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.3
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    • pp.89-96
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    • 2024
  • Objectives This study is designed to evaluated the safety of peony root extract tablet in healthy male volunteers. Methods 12 healthy male volunteers were recruited, and this study was conducted by a single center. The safety was evaluated by collecting laboratory test and vital signs of volunteers. As the registration process, 12 subjects were assigned by serial number. To evaluate safety, vital signs were checked and blood samples were collected 4 times during the screening period, pre & post-administration (after 8 hours) and post-administration (after 7 days). The difference in variables was summarized by the mean±standard deviation. The normality test was carried out using the Shapiro-Wilk test and Kolmogorov-Smirnov test. When normality is fulfilled, a paired t-test is applied and the significance level was p<0.05. And the incidence of all adverse effects and serious adverse effects are shown in percentage. Results In the case of vital sign, body temperature (BT) (℃) was 0.06±0.05 ℃ (p=0.008), and there was a statistically significant difference in before and after administration. However, clinical symptoms were not occurred and BT (℃) of all subjects before and after administration showed values within the normal reference value. There was no significant difference from the control group in all other vital signs and laboratory test data. And no side-effects associated to clinical trial drugs were followed. Conclusions The peony root extract tablet was considered to be safe for healthy male volunteers.

Design and Development of Middleware for Clinical Trial System based on Brain MR Image (뇌 MR 영상기반 임상연구 시스템을 위한 미들웨어 설계 및 개발)

  • Jeon, Woong-Gi;Park, Kyoung-Jong;Lee, Young-Seung;Choi, Hyun-Ju;Jeong, Sang-Wook;Kim, Dong-Eog;Choi, Heung-Kook
    • Journal of Korea Multimedia Society
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    • v.15 no.6
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    • pp.805-813
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    • 2012
  • In this paper, we have designed and developed a middleware for an effectively approaching database to the existed brain disease clinical research system. The brain disease clinical research system was consisted of two parts i.e., a register and an analyzer. Since the register collects the registration data the analyzer yields a statistical data which based on the diverse variables. The middleware has designed to database management and a large data query processing of clients. By separating the function of each feature as a module, the module which was weakened connectivity between functionalities has been implemented the re-use module. And image data module used a new compression method from image to text for an effective management and storage in database. We tested the middleware system using 700 actual clinical medical data. As a result, the total data transmission time was improved maximum 115 times faster than the existing one. Through the improved module structures, it is possible to provide a robust and reliable system operation and enhanced security functionality. In the future, these middleware importances should be increased to the large medical database constructions.

Optimal Timing of Zoster Vaccination After Shingles: A Prospective Study of the Immunogenicity and Safety of Live Zoster Vaccine

  • Lee, Eunyoung;Chun, June Young;Song, Kyoung-Ho;Choe, Pyoeng Gyun;Bang, Ji Hwan;Kim, Eu Suk;Kim, Hong Bin;Park, Sang Won;Kim, Nam Joong;Park, Wan Beom;Oh, Myoung-don
    • Infection and chemotherapy
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    • v.50 no.4
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    • pp.311-318
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    • 2018
  • Background: Zoster vaccination is recommended for people with a history of herpes zoster (HZ), but the most effective timing of vaccine administration after zoster illness is unresolved. This prospective observational study compared the immunogenicity and safety of administering HZ vaccine at 6-12 months and 1-5 years after zoster illness. Materials and Methods: Blood samples were collected before the administration of live zoster vaccine and 6 weeks after vaccination. Varicella-zoster virus (VZV) IgG concentrations and T-cell responses were assessed by glycoprotein enzyme-linked immunosorbent assay and interferon-${\gamma}$ enzyme-linked immunospot assay (ELISPOT), respectively. Results: The baseline geometric mean value (GMV) of VZV IgG was higher in the 6-12 months group than in the 1-5 years group (245.5 IU/mL vs. 125.9 IU/mL; P = 0.021). However, the GMV increased significantly in both groups (P = 0.002 in the 6-12 months group; P <0.001 in the 1-5 years group). The results of the ELISPOT assay were not significant for differences of the GMV between baseline and 6-week post-vaccination groups, while the GMV increased significantly in both groups (P = 0.001 in the 6-12 months group; P <0.001 in the 1-5 years group). Conclusion: The immunogenicity of zoster vaccine may be similar whether administered 6-12 months, or >1 year after zoster illness. Trial Registration: ClinicalTrials.gov Identifier: NCT02704572

Effects of LI11 Acupuncture on CO2 reactivity in the anterior and middle cerebral arteries during hyperventilation-induced hypocapnia in normal subjects: A before and after study.

  • Kim, Gyeong-muk;Jung, Woo-Sang;Kwon, Seungwon;Jin, Chul;Cho, Seung-Yeon;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho
    • The Journal of Korean Medicine
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    • v.42 no.4
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    • pp.164-175
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    • 2021
  • Objectives: The LI11 (Quchi) acupuncture point has always been included in the Seven acupoints for stroke; however, additional LI11 acupuncture research is needed. In this study, the effect of LI11 acupuncture on cerebral blood flow of the anterior cerebral arteries (ACA) and middle cerebral arteries (MCA) was investigated. Method: This study included 10 healthy young male subjects. Cerebral blood flow velocity and cerebrovascular reactivity were measured using transcranial Doppler sonography. Changes in hyperventilation-induced carbon dioxide (CO2) reactivity and modified ACA and MCA blood flow velocity at 40 mmHg (CV40), blood pressure, and heart rate were observed before and after LI11 acupuncture treatment. Results: A statistically significant increase in contralateral anterior cerebral artery CO2 reactivity (p=0.036) and decrease in contralateral middle cerebral artery CV40 (p=0.047) were observed. No significant difference in mean blood pressure was shown. A statistically significant increase in heart rate occurred after LI11 acupuncture; however, it was not clinically significant as there were negligible changes in the heart rhythm. Conclusions: LI11 acupuncture treatment could improve cerebral blood flow velocity. These results might be explained by regulating endothelium-dependent vessel dilation in the anterior cerebral artery region. Trial registration: This trial has been registered with Clinical Research Information Service, a service of the Korea Centers for Disease Control and Prevention: KCT0004494 (retrospectively registered). https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=15359

Late-term effects of hypofractionated chest wall and regional nodal radiotherapy with two-dimensional technique in patients with breast cancer

  • Yadav, Budhi Singh;Bansal, Anshuma;Kuttikat, Philip George;Das, Deepak;Gupta, Ankita;Dahiya, Divya
    • Radiation Oncology Journal
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    • v.38 no.2
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    • pp.109-118
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    • 2020
  • Purpose: Hypofractionated radiotherapy (RT) is becoming a new standard in postoperative treatment of patients with early stage breast cancer after breast conservation surgery. However, data on hypofractionation in patients with advanced stage disease who undergo mastectomy followed by local and regional nodal irradiation (RNI) is lacking. In this retrospective study, we report late-term effects of 3 weeks post-mastectomy hypofractionated local and RNI with two-dimensional (2D) technique in patients with stage II and III breast cancer. Methods: Between January 1990 and December 2007, 1,770 women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. RT dose was 35 Gy/15 fractions/3 weeks to chest wall by two tangential fields and 40 Gy in same fractions to supraclavicular fossa (SCF) and internal mammary nodes (IMNs). SCF and IMNs dose was prescribed at dmax and 3 cm depth, respectively. Chemotherapy and hormonal therapy was given in 64% and 74% patients, respectively. Late-term toxicities were assessed with the Radiation Therapy Oncology Group (RTOG) scores and LENT-SOMA scales (the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales). Results: Mean age was 48 years (range, 19 to 75 years). Median follow-up was 12 years (range, 10 to 27 years). Moderate/marked arm/shoulder pain was reported by 254 (14.3%) patients. Moderate/marked shoulder stiffness was reported by 219 (12.3%) patients. Moderate/marked arm edema was seen in 131 (7.4%) patients. Brachial plexopathy was not seen in any patient. Rib fractures were noted in 6 (0.3%) patients. Late cardiac and lung toxicity was seen in 29 (1.6%) and 23 (1.3%) patients, respectively. Second malignancy developed in 105 (5.9%) patients. Conclusion: RNI with 40 Gy/15 fractions/3 weeks hypofractionation with 2D technique seems safe and comparable to historical data of conventional fractionation (ClinicalTrial.gov Registration No. NCT04175821).

Efficacy and safety of losartan in childhood immunoglobulin A nephropathy: a prospective multicenter study

  • Hyesun Hyun;Yo Han Ahn;Eujin Park;Hyun Jin Choi;Kyoung Hee Han;Jung Won Lee;Su Young Kim;Eun Mi Yang;Jin Soon Suh;Jae Il Shin;Min Hyun Cho;Ja Wook Koo;Kee Hyuck Kim;Hye Won Park;Il Soo Ha;Hae Il Cheong;Hee Gyung Kang;Seong Heon Kim
    • Childhood Kidney Diseases
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    • v.27 no.2
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    • pp.97-104
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    • 2023
  • Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)