• Title/Summary/Keyword: Add-on trials

Search Result 20, Processing Time 0.022 seconds

Designing Clinical Studies and Keeping Research Ethics (임상연구의 설계 및 연구윤리)

  • Chang, Jae Seung;Lee, Sunny;Ha, Tae Hyon;Yoon, In-Young;Ha, Kyooseob
    • Korean Journal of Biological Psychiatry
    • /
    • v.19 no.4
    • /
    • pp.172-178
    • /
    • 2012
  • Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

Effects of probiotic, prebiotic, and synbiotic with and without feed restriction on performance, hematological indices and carcass characteristics of broiler chickens

  • Abdel-Hafeez, Hassan M.;Saleh, Elham S.E.;Tawfeek, Samar S.;Youssef, Ibrahim M.I.;Abdel-Daim, Asmaa S.A.
    • Asian-Australasian Journal of Animal Sciences
    • /
    • v.30 no.5
    • /
    • pp.672-682
    • /
    • 2017
  • Objective: This study was conducted to investigate the effects of probiotic, prebiotic and synbiotic with and without feed restriction on broilers performance, blood parameters, carcass characteristics, and feed cost of production from 1 to 56 days of age. Methods: Two hundred and forty unsexed one day-old chicks of Arbor Acres breed were used. Two trials, I and II, were conducted, with 120 birds in both. Each trial was divided into 4 equal groups. The birds in trial I were fed ad libitum throughout the experiment, while the chicks in trial II were fed ad libitum during the first week of age, then subjected to 5 hours/d of feed restriction from the beginning of the second week up to the end of the experiment. In both trials, the birds in group 1 were fed on a control diet while the other groups were given the same control diet supplemented either with a probiotic in group 2, prebiotic in group 3, or synbiotic in group 4. Results: It was found that chicks fed diets supplemented with probiotic, prebiotic and synbiotic (with and without feed restriction) exhibited higher body weight and feed efficiency than chicks fed the control diets. The feed additives in both trials did not affect hemoglobin, serum total protein, albumin, globulin, glucose, and total cholesterol, except the packed cell volume which was increased in the additive treatments with restriction at the end of the experiment. Moreover, the dietary treatments did not influence the carcass yield. However, the relative weights of liver, gizzard and proventriculus, small intestine and bursa of fabricius were found to be increased. The additives decreased the visible fat in the carcass, with more decreasing effect in the additive groups with restriction. The lowest feed cost per kg of weight gain was observed in the birds fed diets supplemented with synbiotic, probiotic and prebiotic. Feed restriction improved the feed conversion ratio, economic return, but decreased the feed intake, serum total cholesterol and visible fat in comparison with non-restricted groups. Conclusion: The biological feed additives could be routinely added to broiler diets, especially when a feed restriction program is followed. Finally, it can be recommended to restrict feed, and add probiotic or synbiotic to increase weight, improve feed conversion rate and reduce feed cost of production.

Development of Big Data-based Cardiovascular Disease Prediction Analysis Algorithm

  • Kyung-A KIM;Dong-Hun HAN;Myung-Ae CHUNG
    • Korean Journal of Artificial Intelligence
    • /
    • v.11 no.3
    • /
    • pp.29-34
    • /
    • 2023
  • Recently, the rapid development of artificial intelligence technology, many studies are being conducted to predict the risk of heart disease in order to lower the mortality rate of cardiovascular diseases worldwide. This study presents exercise or dietary improvement contents in the form of a software app or web to patients with cardiovascular disease, and cardiovascular disease through digital devices such as mobile phones and PCs. LR, LDA, SVM, XGBoost for the purpose of developing "Life style Improvement Contents (Digital Therapy)" for cardiovascular disease care to help with management or treatment We compared and analyzed cardiovascular disease prediction models using machine learning algorithms. Research Results XGBoost. The algorithm model showed the best predictive model performance with overall accuracy of 80% before and after. Overall, accuracy was 80.0%, F1 Score was 0.77~0.79, and ROC-AUC was 80%~84%, resulting in predictive model performance. Therefore, it was found that the algorithm used in this study can be used as a reference model necessary to verify the validity and accuracy of cardiovascular disease prediction. A cardiovascular disease prediction analysis algorithm that can enter accurate biometric data collected in future clinical trials, add lifestyle management (exercise, eating habits, etc.) elements, and verify the effect and efficacy on cardiovascular-related bio-signals and disease risk. development, ultimately suggesting that it is possible to develop lifestyle improvement contents (Digital Therapy).

Arthroscopic remplissage: history, indications, and clinical outcomes

  • Mohamad Y. Fares;Mohammad Daher;Peter Boufadel;Emil R. Haikal;Jonathan Koa;Jaspal Singh;Joseph A. Abboud
    • Clinics in Shoulder and Elbow
    • /
    • v.27 no.2
    • /
    • pp.254-262
    • /
    • 2024
  • Several surgical procedures have been proposed to address anterior glenohumeral instability, which is one of the most common complaints in the general population. The remplissage, first described in early 2000s, is a procedure performed simultaneously with the arthroscopic Bankart repair to correct large, engaging Hill-Sachs lesions (HSLs). This procedure stabilizes the joint by tenodesing the infraspinatus tendon into the HSL to fill and disengage the defect. This procedure gained popularity because it has relatively low risk and is able to improve shoulder stability while being less invasive than other bone-blocking procedures. The remplissage has become a valuable add-on technique that can substantially improve outcomes in unstable patients undergoing arthroscopic Bankart repair. Nevertheless, several studies in the literature have raised concerns regarding its efficacy in critically unstable patients and the potential range of motion limitations that can arise postoperatively. Additional comparative studies and trials should be conducted to appropriately establish the role of remplissage in treating anterior instability, especially in patients with critical bone loss.

Montelukast as an add-on therapy in bronchopulmonary dysplasia (기관지폐 이형성증의 추가 치료제로서의 Montelukast)

  • Kim, He Min;Song, Ji Eun;Lee, Soon Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
    • /
    • v.52 no.2
    • /
    • pp.181-186
    • /
    • 2009
  • Purpose : Inflammation plays a potential role in the pathogenesis of bronchopulmonary dysplasia (BPD). Strategies for preventing BPD include respiratory management, antioxidants, nutritional treatment, and others such as anti-inflammatory agents. We aimed to assess the safety, tolerability, and efficacy of montelukast (MK), a cysteinyl leukotriene 1 receptor antagonist, as an add-on therapy in BPD. Methods : In addition to currently available standard measures such as oxygen supplementation, bronchodilators, nutritional support, and/or diuretics, montelukast was administered to 15 preterm infants with BPD. MK was given orally (1 mg/kg/d) for a mean period of 12 weeks. We compared safety and efficacy parameters with historical controls. Results : All 15 patients survived, and no differences were found in the incidence of adverse reactions between the 2 groups. The ventilation index was significantly improved after 2 weeks in MK group compared with historical controls. There were no significant differences in other respiratory parameters (MAP, oxygen dependency, and ventilator dependency) between the groups, but the MK group showed trends of greater improvement. Conclusion : Administration of MK 1 mg/kg/d was well tolerated in preterm BPD patients as an add-on therapy. We demonstrated that after 2 weeks of MK administration of 1 mg/kg/d, MK had beneficial therapeutic effects on BPD patients as an add-on to the standard therapy. Further multicenter randomized controlled clinical trials are needed to confirm the efficacy and safety of MK as a useful supplement to standard therapy for BPD patients.

Scientific Study of Magnetic Acu-point Therapy on Eight Extraordinary Meridian for Lowering Blood Pressure (기경팔맥 자석침의 혈압 강하 효과에 대한 과학적 검증 연구)

  • Yoo, Ho-Rhyong;Lee, Jae-Hwi;Kang, Ji-Sun;Moon, Seung-Hee;Kang, Byung-Gab;Lim, Seung-Min;An, Joung-Jo;Jo, Hyun-Kyung;Kim, Yoon-Sik;Seol, In-Chan
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.24 no.1
    • /
    • pp.165-170
    • /
    • 2010
  • This study assessed effects of magnetic acu-point therapy as an add-on to conventional antihypertensive managements such as medication or lifestyle modification for hypertensive or pre-hypertensive subjects. This study was conducted with the purpose to evaluate the decreasing effect of the blood pressure on the hypertensive patients who were given to magnetic acu-point therapy. A single-blind, placebo-controlled trial by cross matching was conducted at Daejeon University Oriental Hospital. The washout periods of cross matching are 10 days. 22 hypertensive (systolic BP>140 mmHg or diastolic BP>90 mmHg) volunteers were recruited and treatments were donemagnetic acu-points on Oegwan(TE 5), Jogimeup(GB 41), Naegwan(PC 6), Gongson(SP 4), Hugye(SI 3), Sinmaek(BL 62). The treated group was statistically significant decrease of the blood pressure, while control group show no statistically significant difference of BP. From the results, magnetic acu-point therapy seems to offer a benefit to the treatment of hypertensive patients.

A COMPARISON OF THE SHEAR BOND STRENGTHS BETWEEN CONVENTIONAL COMPOSITE SEALANTS AND FLUORIDE-RELEASING SEALANTS (불소유리 전색재와 일반 레진계 전색재의 전단결합강도에 관한 비교연구)

  • Kim, Shin;Jeong, Tae-Sung
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.27 no.1
    • /
    • pp.85-89
    • /
    • 2000
  • There has recently been some trials to add the fluoride-releasing property to existing fissure sealants and some of them are already commercially available. But, some questions mat naturally be arisen regarding the potential decrease of physical properties by adding the fluoride despite its new caries-inhibiting abilities. This study was performed for the purpose of comparing the shear bond strengths of conventional composite sealant, Fluoride-releasing sealant and glass ionomer sealant, and obtained the results as fellows. 1. Two kinds of composite sealants (Helioseal and Teethmate-A) showed slightly higher bond strength than Fluoride-releasing sealant(Teethmate-F) without any significance(p>0.05). 2. Class ionomer sealant (Fuji III) was much lower than composite sealant in shear bond strength(p<0.05). 3. With the result of this study, it was found that there is little effect on retentive properties of sealants by adding fluoride to amplify the caries-inhibiting properties.

  • PDF

Recent Evolution of Surgical Treatment for Gastric Cancer in Korea

  • An, Ji-Yeong;Cheong, Jae-Ho;Hyung, Woo-Jin;Noh, Sung-Hoon
    • Journal of Gastric Cancer
    • /
    • v.11 no.1
    • /
    • pp.1-6
    • /
    • 2011
  • Gastric cancer is the most common malignancy and the incidence is steadily increasing in Korea. The principal treatment modality for gastric cancer is surgical extirpation of tumor along with draining lymph nodes. Gastrectomy with D2 lymph node dissection has been well established as a standard of surgery and improved the survival of gastric cancer patients. Recently, technological advances are drastically reshaping the landscape of surgical treatment of gastric cancer. One of the most notable trends is that minimal access surgery becomes dominating the treatment of early stage diseases. For advanced diseases, the standard access surgery is considered a reference treatment. Although there is a pilot study underway to evaluate the feasibility of the application of minimal access surgery to advanced gastric cancer (AGC), the evidence for oncological safety is not yet provided sufficiently. Based on the recent randomized controlled trials, the extent of surgery for AGC has re-defined as para-aortic lymph node dissection dose not add any survival benefit while increasing surgery-related morbidities. In addition, it is now accepted as a standard operation omitting unnecessary procedures such as splenectomy and/or distal pancreatectomy for prophylactic lymph node dissection. Conceptual and technical innovation has contributed to decreasing morbidity and mortality without impairing oncological safety. All these recent advances in the field of gastric cancer surgery would be concluded in maximizing therapeutic index for gastric cancer while improving quality of life.

A Study on Secure Encoding for Visible Light Communication Without Performance Degradation (가시광 통신에서 성능 저하 없는 보안 인코딩 연구)

  • Kim, Minchul;Suh, Taeweon
    • KIPS Transactions on Computer and Communication Systems
    • /
    • v.11 no.1
    • /
    • pp.35-42
    • /
    • 2022
  • Visible light communication (VLC) is a method of transmitting data through LED blinking and is vulnerable to eavesdropping because the illumination affects the wide range of area. IEEE standard 802.15.7 defines On-Off Keying (OOK), Variable Pulse Position Modulation (VPPM), and Color Shift Keying (CSK) as modulation. In this paper, we propose an encryption method in VPPM for secure communication. The VPPM uses an encoding method called 4B6B where 16 different outputs are represented with 6-bit. This paper extends the number of outputs to 20, to add complexity while not violating the 4B6B generation conditions. Then each entry in the extended 4B6B table is scrambled using vigenère cipher. The probability of decrypting each 6-bit data is $\frac{1}{20}$. Eavesdropper should perform $\sum\limits_{k=1}^{n}20^k$ number of different trials to decrypt the message if the number of keys is n. The proposed method can be applied to OOK of PHY II and CSK of PHY III. We further discuss the secure encoding that can be used in OOK and CSK without performance degradation.

Adjuvant Radiotherapy for Gastric Carcinoma: 10 years Follow-up of 244 cases from a Single Institution

  • Misirlioglu, Hasan Cem;Coskun-Breuneval, Mehtap;Kucukpilakci, Bulent;Ugur, Vahide Isil;Elgin, Yesim;Demirkasimoglu, Taciser;Kara, Sakire Pinar;Ozgen, Aytul;Sanri, Ergun;Guney, Yildiz
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.15 no.20
    • /
    • pp.8871-8876
    • /
    • 2014
  • Background: Postoperative chemoradiotherapy (CRT) of gastric carcinoma improves survival among high-risk patients. This study was undertaken to analyse long-term survival probability and the impact of certain covariates on the survival outcome in affected individuals. Materials and Methods: Between January 2000 and December 2005, 244 patients with gastric cancer underwent adjuvant radiotherapy (RT) in our institution. Data were retrieved retrospectively from patient files and analysed with SPSS version 21.0. Results: A total of 244 cases, with a male to female ratio of 2.2:1, were enrolled in the study. The median age of the patients was 52 years (range, 20-78 years). Surgical margin status was positive or close in 72 (33%) out of 220 patients. Postoperative adjuvant RT dose was 46 Gy. Median follow-up was 99 months (range, 79-132 months) and 23 months (range, 2-155 months) for surviving patients and all patients, respectively. Actuarial overall survival (OS) probability for 1-, 3-, 5- and 10-year was 79%, 37%, 24% and 16%, respectively. Actuarial progression free survival (PFS) probability was 69%, 34%, 23% and 16% in the same consecutive order. AJCC Stage I-II disease, subtotal gastrectomy and adjuvant CRT were significantly associated with improved OS and PFS in multivariate analyses. Surgical margin status or lymph node dissection type were not prognostic for survival. Conclusions: Postoperative CRT should be considered for all patients with high risk of recurrence after gastrectomy. Beside well-known prognostic factors such as stage, lymph node status and concurrent chemotherapy, the type of gastrectomy was an important prognostic factor in our series. With our findings we add to the discussion on the definition of required surgical margin for subtotal gastrectomy. We consider that our observations in gastric cancer patients in our clinic can be useful in the future randomised trials to point the way to improved outcomes.