• Title/Summary/Keyword: e-Clinical Trials

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Survey on the Need to Develop Training Educational Program for Oriental Medical Clinical Trial (한의약 임상시험 전문인력양성 교육프로그램 개발의 필요성에 대한 설문조사)

  • Shin, Seon-Hwa;Oh, Dal-Seok;Kim, Bo-Young;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.13 no.2 s.20
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    • pp.127-133
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    • 2007
  • Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

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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
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    • v.30 no.5
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    • pp.672-682
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    • 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.

Influence of the root canal filling technique on the success rate of primary endodontic treatments: a systematic review

  • Daniel Feijolo Marconi ;Giovana Siocheta da Silva ;Theodoro Weissheimer;Isadora Ames Silva ;Gabriel Barcelos So;Leonardo Thomasi Jahnke ;Jovito Adiel Skupien ; Marcus Vinicius Reis So ; Ricardo Abreu da Rosa
    • Restorative Dentistry and Endodontics
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    • v.47 no.4
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    • pp.40.1-40.18
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    • 2022
  • Objectives: This study aimed to investigate the influence of different obturation techniques compared to cold lateral compaction on the success rate of primary non-surgical endodontic treatments. Materials and Methods: Systematic searches were performed for studies published up to May 17th, 2022 in MEDLINE/PubMed, Cochrane Library, Web of Science, Scopus, EMBASE, and Grey Literature Reports. Randomized clinical trials and nonrandomized (nonrandomized clinical trials, prospective or retrospective) studies that evaluated the success rate of primary non-surgical endodontic treatments obturated with the cold lateral compaction (control) and other obturation techniques were included. The revised Cochrane risk of bias tools for randomized trials (RoB 2) and nonrandomized studies of interventions (ROBINS-I) were used to evaluate the risk of bias. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool was used to evaluate the certainty of evidence. Results: Eleven studies (4 randomized clinical trials (RCTs), 4 prospective, and 3 retrospectives) were included. Two RCTs were classified as having some concerns risk of bias and 2 as a low risk of bias. Two nonrandomized studies were classified as having a critical risk of bias and 5 as having a moderate risk of bias. The GRADE analysis demonstrated a very low to moderate certainty of evidence. Conclusions: This systematic review generally evidenced no differences in the success rate of primary non-surgical endodontic treatments when the cold lateral compaction technique and other obturation techniques are performed. Further well-designed studies are still necessary.

Neoadjuvant Chemotherapy in Asian Patients With Locally Advanced Gastric Cancer

  • Xie Tong;Peng Zhi;Shen Lin
    • Journal of Gastric Cancer
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    • v.23 no.1
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    • pp.182-193
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    • 2023
  • Presently, surgery is the only treatment approach for gastric cancer and improving the prognosis of locally advanced gastric cancer is one of the key factors in promoting gastric cancer survival benefit. The MAGIC study was the first to demonstrate the efficacy of neoadjuvant chemotherapy (NAC) in European countries. In recent years, several clinical trials have provided evidence for the use of NAC in Asian patients with locally advanced gastric cancer. However, clinical practice guidelines vary between Asian and non-Asian populations. Optimal NAC regimens, proper target populations, and predictors of NAC outcomes in Asian patients are still under investigation. Herein, we summarized the current progress in the administration of NAC in Asian patients with gastric cancer.

Immunotherapy of Autoimmune Diseases with Nonantibiotic Properties of Tetracyclines

  • Chan-Su Park;Sang-Hyun Kim;Chong-Kil Lee
    • IMMUNE NETWORK
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    • v.20 no.6
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    • pp.47.1-47.13
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    • 2020
  • Tetracyclines, which have long been used as broad-spectrum antibiotics, also exhibit a variety of nonantibiotic activities including anti-inflammatory and immunomodulatory properties. Tetracyclines bind to the 30S ribosome of the bacteria and inhibit protein synthesis. Unlike antimicrobial activity, the primary molecular target for the nonantibiotic activity of tetracycline remains to be clarified. Nonetheless, the therapeutic efficacies of tetracyclines, particularly minocycline and doxycycline, have been demonstrated in various animal models of autoimmune disorders, such as multiple sclerosis, rheumatoid arthritis, and asthma. In this study, we summarized the anti-inflammatory and immunomodulatory activities of tetracyclines, focusing on the mechanisms underlying these activities. In addition, we highlighted the on-going or completed clinical trials with reported outcomes.

Selenium and Vitamin E for Prostate Cancer - Justifications for the SELECT Study

  • Ramamoorthy, Venkataraghavan;Rubens, Muni;Saxena, Anshul;Shehadeh, Nancy
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.7
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    • pp.2619-2627
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    • 2015
  • There are several studies that relate oxidative damage as possible mechanism for many cancers. Many studies have also shown that anti-oxidants like selenium and vitamin E decrease the risk for prostate cancer. The main objective of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) study was to look for the benefits of selenium and vitamin E supplementation on prostate cancer. The study had a large sample size, stringent experimental conditions, very long duration, standardized laboratories for biochemical analyses and other factors that contribute to high external validity. The SELECT study failed to show any significant risk reduction for prostate cancers ascribable to selenium and vitamin E supplementations. Because of these conflicting results, many researchers argue about the methods used, supplementations administered (selenium and vitamin E) and indicators used for assessing levels of supplementations. We reviewed many epidemiological studies, clinical trials, and pre-clinical studies. With corroborative evidences we justify that SELECT study has a sound methodology and rationale. In lieu of the contrary results of the select study, researchers should focus on the probable mechanisms for these contrary findings and continue their search for newer and effective agents for prevention of prostate cancer.

Immune Checkpoint Inhibitors in 10 Years: Contribution of Basic Research and Clinical Application in Cancer Immunotherapy

  • Jii Bum Lee;Hye Ryun Kim;Sang-Jun Ha
    • IMMUNE NETWORK
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    • v.22 no.1
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    • pp.2.1-2.22
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    • 2022
  • Targeting immune evasion via immune checkpoint pathways has changed the treatment paradigm in cancer. Since CTLA-4 antibody was first approved in 2011 for treatment of metastatic melanoma, eight immune checkpoint inhibitors (ICIs) centered on PD-1 pathway blockade are approved and currently administered to treat 18 different types of cancers. The first part of the review focuses on the history of CTLA-4 and PD-1 discovery and the preclinical experiments that demonstrated the possibility of anti-CTLA-4 and anti-PD-1 as anti-cancer therapeutics. The approval process of clinical trials and clinical utility of ICIs are described, specifically focusing on non-small cell lung cancer (NSCLC), in which immunotherapies are most actively applied. Additionally, this review covers the combination therapy and novel ICIs currently under investigation in NSCLC. Although ICIs are now key pivotal cancer therapy option in clinical settings, they show inconsistent therapeutic efficacy and limited responsiveness. Thus, newly proposed action mechanism to overcome the limitations of ICIs in a near future are also discussed.

Proof-of-concept study of the caninized anti-canine programmed death 1 antibody in dogs with advanced non-oral malignant melanoma solid tumors

  • Masaya Igase;Sakuya Inanaga;Shoma Nishibori;Kazuhito Itamoto;Hiroshi Sunahara;Yuki Nemoto;Kenji Tani;Hiro Horikirizono;Munekazu Nakaichi;Kenji Baba;Satoshi Kambayashi;Masaru Okuda;Yusuke Sakai;Masashi Sakurai;Masahiro Kato;Toshihiro Tsukui;Takuya Mizuno
    • Journal of Veterinary Science
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    • v.25 no.1
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    • pp.15.1-15.15
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    • 2024
  • Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%). Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions: The present study demonstrated that ca-4F12-E6 was well-tolerated in non-OMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

[ $\b{S}afety\;\b{A}nd\;\b{E}fficacy$ ] of $\b{K}orean$ red ginseng Intervention (SAEKI) Trial: Rationale, Design, and Expected Findings

  • Sievenpiper John L;Buono Marco Di;Stavro P. Mark;Jenkins Alexandra L;Nam Ki Yeul;Choi Melody;Naeem Asima;Leiter Lawrence A;Sung Mi-Kyung;Vuksan Vladimir
    • Proceedings of the Ginseng society Conference
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    • 2002.10a
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    • pp.424-455
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    • 2002
  • Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

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Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery: Taking Lessons from the Past to Inform the Future

  • Jung, Na Young;Chang, Jin Woo
    • Journal of Korean Medical Science
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    • v.33 no.44
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    • pp.279.1-279.16
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    • 2018
  • Magnetic resonance-guided focused ultrasound (MRgFUS) is a new emerging neurosurgical procedure applied in a wide range of clinical fields. It can generate high-intensity energy at the focal zone in deep body areas without requiring incision of soft tissues. Although the effectiveness of the focused ultrasound technique had not been recognized because of the skull being a main barrier in the transmission of acoustic energy, the development of hemispheric distribution of ultrasound transducer phased arrays has solved this issue and enabled the performance of true transcranial procedures. Advanced imaging technologies such as magnetic resonance thermometry could enhance the safety of MRgFUS. The current clinical applications of MRgFUS in neurosurgery involve stereotactic ablative treatments for patients with essential tremor, Parkinson's disease, obsessive-compulsive disorder, major depressive disorder, or neuropathic pain. Other potential treatment candidates being examined in ongoing clinical trials include brain tumors, Alzheimer's disease, and epilepsy, based on MRgFUS abilities of thermal ablation and opening the blood-brain barrier. With the development of ultrasound technology to overcome the limitations, MRgFUS is gradually expanding the therapeutic field for intractable neurological disorders and serving as a trail for a promising future in noninvasive and safe neurosurgical care.