• Title/Summary/Keyword: Clinical trial center

Search Result 704, Processing Time 0.025 seconds

The Impact of Fractional Flow Reserve on Clinical Outcomes after Coronary Artery Bypass Grafting: A Meta-analysis

  • Yoonjin, Kang;Heeju, Hong;Suk Ho, Sohn;Myoung-jin, Jang;Ho Young, Hwang
    • Journal of Chest Surgery
    • /
    • v.55 no.6
    • /
    • pp.442-451
    • /
    • 2022
  • Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG). Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis. MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization. The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes. Publication bias was assessed using a funnel plot and the Egger test. Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected. MACE data were extracted from 4 studies. The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12). However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94). The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG. Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.

A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients (중풍후우울증 환자에 대한 향기침요법의 임상적 연구)

  • Chung, Sae-Yun;Hwang, Jae-Woong;Kim, Seok-Min;Jung, Jae-Han;Choi, Chang-Min;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Young-Suk;Sun, Jong-Joo
    • The Journal of Internal Korean Medicine
    • /
    • v.27 no.2
    • /
    • pp.480-487
    • /
    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

  • PDF

$H_2$ Receptor Antagonists and Gastric Cancer in the Elderly: A Nested Case-Control Study (노인 인구에서 $H_2$ Receptor Antagonist와 위암과의 관련성: 코호트 내 환자-대조군 연구)

  • Kim, Yoon-I;Heo, Dae-Seog;Lee, Seung-Mi;Youn, Kyoung-Eun;Koo, Hye-Won;Bae, Jong-Myon;Park, Byoung-Joo
    • Journal of Preventive Medicine and Public Health
    • /
    • v.35 no.3
    • /
    • pp.245-254
    • /
    • 2002
  • Objective : To test if the intake of $H_2$ receptor antagonists ($H_2$-RAs) increases the risk of gastric cancer in the elderly. Methods : The source population for this study was drawn from the responders to a questionnaire survey administered to the Korea Elderly Pharmacoepidemiological Cohort (KEPEC), who were beneficiaries of the Korean Medical Insurance Corporation, were at least 65 years old, and residing in Busan in 1999. The information on $H_2$-RAs exposure was obtained from a drug prescription database compiled between inn. 1993 and Dec. 1994. The cases consisted of 76 gastric cancer patients, as confirmed from the KMIC claims data, the National Cancer Registry and the Busan Cancer Registry. The follow-up period was from Jan. 1993 to Dec. 1998. Cancer free controls were randomly selected by 1:4 individual matching, which took in to consideration the year of birth and gender. Information on confounders was collected by a mail questionnaire survey. The odds ratios, and their 95% confidence intervals, were calculated using a conditional logistic regression model. Results : After adjusting for a history of gastric ulcer symptoms, medication history, and body mass index, the adjusted OR (aOR) was 4.6 (95% CI=1.72-12.49). The odds ratio of long term use (more than 7 days) was 2.3 (95% CI=1.07-4.82). The odds ratio of short term use was 4.6 (95% CI=1.26-16.50). The odds ratio of parenteral use was 4.4 195% CI=1.16-17.05) and combination use between the oral and parenteral routes (aOR, 16.8; 95% CI=1.21-233.24) had the high risk of gastric cancer. The aOR of cimetidine was 1.7 (95% CI=1.04-2.95). The aOR of ranitidine was 2.0 (95% CI=1.21-3.40). The aOR of famotidine was 1.7 (95% CI=0.98-2.80). Conclusion : The intake of $H_2$-RAs might increase the risk of gastric cancer through achlorhydria in the elderly.

An Analysis of Clinical Prognosis Factors of Peripheral Facial Palsy and the Effects of Electrodiagnostic Test (말초성 안면신경마비 경과에 대한 임상적 예후인자 및 신경생리검사의 유용성 분석)

  • Ahn, Chang-Beohm;Yoon, Hyun-Min;Jang, Kyung-Jun;Kim, Cheol-Hong;Jung, Kyoung-Keun;Min, Young-Kwang;Kim, Soo-Min;Kim, Jeong-Eun;Cho, Beohm-Gyu
    • Journal of Acupuncture Research
    • /
    • v.24 no.4
    • /
    • pp.209-223
    • /
    • 2007
  • Objectives : Facial Nerve Paralysis is one kind of common diseases and it can be treated by natural therapy and the efficiency of treatment is relatively high. In clinical trial, it is not difficult to find patients who were not completely recovered from Facial Nerve Paralysis, so the symptoms are fixed permanently. This leads many doctors and patients to have interests in the progress and prognosis of the disease, so this study was to analyze clinical prognosis factors and verify the effects of Electrodiagnostic Test. Methods : The 378 subjects were chosen from 987 patients who were suffering from Peripheral Facial Palsy, diagnosed with Bell's palsy and Ramsay Hunt Syndrome and had admission treatment. They got Oriental-Western Medicine Treatment within two weeks after outbreaks of the disease and treated at least over 3 weeks using Oriental-Western Medicine Treatment. Results : 1. There was a significant difference in the results of treatment according to gender, age, types of Facial Palsy, existence of Post Auricular Pain, existence of Labyrinth Symptom, HBGS, and existence of onsets of recovery as clinical prognosis factors of Peripheral Facial Palsy, However, a statistically significant difference was not shown in the results of treatment according to the position of Facial Palsy(left or right), existence of a relapse, and diabetes, hypertension. 2. As a result of overall treatment, 77.2% of patients were recovered almost entirely and 22.8% were not, and the quelae of incomplete recovery were Synkinesis, facial contracture, facial spasm, crocodile tears and scheroma in order of frequency. 3. The results of electrodiagnostic test represented useful correlation to predict the final effects of treatment. Conclusion : Based on the above results, the prognosis factors, the degree of recovery, and the sequelae of incomplete recovery were analysed and the effects of electrodiagnostic test was verified.

  • PDF

Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results

  • Aghili, Mahdi;Sotoudeh, Sarvazad;Ghalehtaki, Reza;Babaei, Mohammad;Farazmand, Borna;Fazeli, Mohammad-Sadegh;Keshvari, Amir;Haddad, Peiman;Farhan, Farshid
    • Radiation Oncology Journal
    • /
    • v.36 no.1
    • /
    • pp.17-24
    • /
    • 2018
  • Purpose: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. Materials and Methods: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. Results: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. Conclusion: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

A Comparison Study of Postural Control Measures Between Before and After Applying Temporomandibular Joint Balance Appliance-Golf (TBA-G) Using Balance Master System (Balance Master를 이용한 TBA-G 착용 전후 균형능력 평가 비교 연구)

  • Doo, Kyeong-Hee;Lee, Ji-Hyun;Lee, Dong-Hyuk;Kim, Soo-Kyung;Cho, Seung-Yeon;Park, Jung-Mi;Ko, Chang-Nam;Bae, Hyung-Sup;Park, Seong-Uk
    • The Journal of Korean Medicine
    • /
    • v.35 no.1
    • /
    • pp.50-57
    • /
    • 2014
  • Objectives: The purpose of this study was to examine whether Temporomandibular Joint Balance Appliance-Golf (TBA-G) can improve postural control ability of healthy adults. Methods: Twenty participants (10 male, 10 female) aged 20 to 39 years were involved. Postural control ability of all participants was assessed before and after applying TBA-G with Balance $Master^{(R)}$ system. Modified clinical test sensory interaction on balance (mCTSIB), unilateral stance, weight bearing and rhythmic weight shift were used to evaluate postural control ability. Results: After applying TBA-G, mCTSIB on a firm plate with eyes open increased from 0.2 to 0.23 (p<0.05) but directional control was improved in slow and moderate velocity of front/back rhythmic weight shift test (P<0.05). In two cases with postural imbalance, most of the postural control measures improved after applying TBA-G. Conclusions: The results suggest that TBA-G could improve balance control ability. A larger controlled trial is needed to determine more accurately the effect of TBA-G on balance control ability.

The anti-hypertensive effect of ginseng in patients with mild hypertension

  • Kim, Young-Suk;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Bae, Hyung-Sup
    • Advances in Traditional Medicine
    • /
    • v.7 no.5
    • /
    • pp.494-500
    • /
    • 2008
  • Ginseng has been traditionally used to recover vital energy from Qi deficiency in oriental countries. Recent reports suggested that ginseng could regulate blood pressure (BP), but much controversy still remain. Therefore, we intended to assess the anti-hypertensive effect of some ginseng species on Koreans and Chinese. This is a randomized, double blinded controlled clinical trial. The study subjects were recruited from the mild hypertensive patients who belonged prehypertension(120/80 to 139/89 mmHg) and stage I hypertension (140/90 to 159/99 mmHg) in Korea and China. After assigning the subjects into a Korean, a Chinese, and an American ginseng group by randomization, we prescribed ginseng with the dose of 4.5 g per a day for 4 w. To assess the anti-hypertensive effect, we compared the mean of systolic and diastolic BP between before and after ginseng medication by 24 h Ambulatory Blood Pressure Monitor (24 h ABPM). We also monitored adverse effect and laboratory findings to secure the subjects' safety. There were 64 subjects treated with Korean ginseng, 58 treated with Chinese ginseng, and 64 treated with American ginseng. All of the ginseng species reduced subjects' BP. Especially, Korean and Chinese ginseng showed more excellent effects. The secondary analysis on the subjects' nationality revealed that all of the ginseng species showed more significant anti-hypertensive effect in Chinese than in Koreans. We suggest ginseng could be useful for mild hypertension regardless of its species. And it would be safe within the dosage of 4.5 g per a day.

Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6-10 weeks: a randomized double-blind active-controlled trial

  • Shin, Jonghoon;Teeratakulpisarn, Jamaree;Puthanakit, Thanyawee;Theerawit, Tuangtip;Ryu, Ji Hwa;Shin, Jinhwan;Lee, Seulgi;Lee, Hayoung;An, Kyungjun;Kim, Hun
    • Clinical and Experimental Pediatrics
    • /
    • v.63 no.7
    • /
    • pp.265-271
    • /
    • 2020
  • Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates. Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants. Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group. Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 ㎍/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 ㎍/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
    • /
    • v.15 no.2
    • /
    • pp.37-42
    • /
    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
    • /
    • v.44 no.4
    • /
    • pp.104-120
    • /
    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.