• Title/Summary/Keyword: screening trial

Search Result 104, Processing Time 0.026 seconds

Screening of Inhibition Activity of LPS-induced NO Production by Ethanol Extracts from Jeju Island Native Plants and Algae

  • Go, Boram;Hyun, Ho Bong;Yoon, Seon-A;Oh, Dae-ju;Yoon, Weon-Jong;Ham, Young-Min
    • Proceedings of the Plant Resources Society of Korea Conference
    • /
    • 2019.10a
    • /
    • pp.77-77
    • /
    • 2019
  • Herbal medicines have been used as a basic means of clinical trial throughout history, and traditional medicines are targeted to seek functional components. To discover new cosmetic or food ingredients among numerous natural resources from Jeju island, we screened for inhibition activity against nitric oxide (NO) production in lipopolysaccharide (LPS)-stimulated RAW 264.7 cells. Although NO formation plays an important role to relax vascular muscles or eliminate tumors, NO produced excessively in inflammatory condition can cause metabolic diseases or inflammatory dysfunctions. Among 52 natural resources ethanol extracts, 5 extracts inhibited NO production over 25% compared to only LPS-treated control at the concentration of $100{\mu}g/mL$. In further study, we try to investigate other bio-activities and the phytochemicals of 5 different extracts as useful ingredients for cosmetics or functional foods.

  • PDF

Current status and prospects of organoid-based regenerative medicine

  • Woo Hee Choi;Dong Hyuck Bae;Jongman Yoo
    • BMB Reports
    • /
    • v.56 no.1
    • /
    • pp.10-14
    • /
    • 2023
  • Organoids derived from stem cells or organ-specific progenitors are self-organizable, self-renewable, and multicellular three-dimensional (3D) structures that can mimic the function and structure of the derived tissue. Due to such characteristics, organoids are attracting attention as an excellent ex vivo model for drug screening at the stage of drug development. In addition, since the applicability of organoids as therapeutics for tissue regeneration has been embossed, the development of various organoids-based regenerative medicine has been rapidly progressing, reaching the clinical trial stage. In this review, we give a general overview of organoids and describe current status and prospects of organoid-based regenerative medicine, focusing on organoid-based regenerative therapeutics currently under development including clinical trials.

Radiology for Ductal Carcinoma In Situ of the Breast: Updates on Invasive Cancer Progression and Active Monitoring

  • Lars J Grimm
    • Korean Journal of Radiology
    • /
    • v.25 no.8
    • /
    • pp.698-705
    • /
    • 2024
  • Ductal carcinoma in situ (DCIS) accounts for approximately 30% of new breast cancer diagnoses. However, our understanding of how normal breast tissue evolves into DCIS and invasive cancers remains insufficient. Further, conclusions regarding the mechanisms of disease progression in terms of histopathology, genetics, and radiology are often conflicting and have implications for treatment planning. Moreover, the increase in DCIS diagnoses since the adoption of organized breast cancer screening programs has raised concerns about overdiagnosis and subsequent overtreatment. Active monitoring, a nonsurgical management strategy for DCIS, avoids surgery in favor of close imaging follow-up to de-escalate therapy and provides more treatment options. However, the two major challenges in active monitoring are identifying occult invasive cancer and patients at risk of invasive cancer progression. Subsequently, four prospective active monitoring trials are ongoing to determine the feasibility of active monitoring and refine the patient eligibility criteria and follow-up intervals. Radiologists play a major role in determining eligibility for active monitoring and reviewing surveillance images for disease progression. Trial results published over the next few years would support a new era of multidisciplinary DCIS care.

Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • Genomics & Informatics
    • /
    • v.16 no.3
    • /
    • pp.52-58
    • /
    • 2018
  • In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting 68Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer

  • Minseok Suh;Hyun Gee Ryoo;Keon Wook Kang;Jae Min Jeong;Chang Wook Jeong;Cheol Kwak;Gi Jeong Cheon
    • Korean Journal of Radiology
    • /
    • v.23 no.9
    • /
    • pp.911-920
    • /
    • 2022
  • Objective: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N',N''-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.

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
    • /
    • v.41 no.3
    • /
    • pp.326-338
    • /
    • 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).

Development of Korean Medical Psychotherapy and Preliminary Clinical Trial for Post Traumatic Stress Disorder (외상 후 스트레스 장애에 대한 한방정신요법 기반 심리치료 개발 및 예비적 임상시험)

  • Kim, Jin-Hyung;Sue, Joo-Hee;Lee, Go-Eun;Kim, Nam-Kwen;Choi, Sung-Youl;Lyu, Yeoung-Su;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
    • /
    • v.26 no.1
    • /
    • pp.49-61
    • /
    • 2015
  • Post traumatic stress disorder (PTSD) is an anxiety disorder that usually occurs after suffering from a psychological trauma that can not threatening events, which is one of the individual's subjective pain and their families and the larger society due to the chronic disease burden results. Treatment with a medication, as well as cognitive behavioral therapy (CBT), exposure therapy, prolonged exposure therapy (PE), eye-movement desensitizing, and reprocessing (EMDR) are preferentially performed, including psychotherapy. Korean medical psychotherapy consists of a wide range of manual therapy, but it does not have systematically screening limits. This study was developed by Korean medical psychotherapy program for PTSD, and it was carried out as a preliminary clinical trial for validity. The Korean medical psychotherapy program for PTSD consists of four stages as follows: building chapter of safety, flow and send, accept, and integration. Based on this preliminary clinical study of PTSD, seven patients were treated for 2 hours per week for 5 weeks. We report the meaningful results gained by observing the changes in IES-RK points, questionnaire on five-faceted mindfulness, quality of life, anxiety, depression, insomnia, hwabyung scale, HRV, and EEG, before and after the Korean medical psychotherapy program.

Acupuncture for the Treatment of Burns: A Systematic Review of Randomized Controlled Trials and Case Controlled Trials (화상의 침 치료에 대한 체계적 문헌고찰)

  • Lee, Jieun;Jeong, Seoyoon;Choi, Yoomin;Jeong, Minjeong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.31 no.4
    • /
    • pp.19-30
    • /
    • 2017
  • Objectives The study was conducted to evaluate the acupuncture treatment for burns by reviewing international randomized controlled studies and case controlled studies. Methods In the review, ten academic literature archives; NDSL, OASIS, PubMed, Cochrane library, CNKI, WANFANG, CINAHL, J-STAGE, CiNii, and EMBASE were used as the main databases to search for the randomized controlled trials or the case controlled trials about acupuncture treatment of burns using the keywords "burns AND acupuncture", "burn AND acupuncture", and "scald AND acupuncture". Results Initially, a total of 852 studies were founded except duplicate studies. 801 studies were excluded after screening of title and abstract. After reviewing 51 papers, a total of four randomized controlled trials and two case controlled trials were selected. These studies were analyzed by year, subjects, treatment intervention, evaluation criteria, treatment effect, adverse events, and 'Risk of Bias' assessment for randomized studies and non-randomized studies. From the six papers out of 51 papers those were reviewed, patients with burns were divided into two groups. The experimental group received acupuncture treatment, while the control group did not. The results of the completed studies have shown that the experimental group receiving acupuncture treatment demonstrated significant improvement compared to the control group, and there was no serious adverse events. Conclusions According to some of the studies, acupuncture in burn treatment is worth to try. However, additional well-designed randomized controlled studies will be required to justify the effectiveness of acupuncture treatment of burns.

Pathogenicity Screening of Entomopathogenic Fungus, Beauveria bassiana against Paratlanticus ussuriensis (갈색여치에 대한 백강균의 병원력 검증)

  • Bang, Hea-Son;Jung, Myung-Pyo;Kim, Myung-Hyun;Han, Min-Su;Kang, Kee-Kyung;Lee, Deog-Bae;Nam, Sung-Hee
    • Korean Journal of Environmental Agriculture
    • /
    • v.29 no.3
    • /
    • pp.300-303
    • /
    • 2010
  • Laboratory trial on the control effect of Beauveria bassiana against Paratlanticus ussuriensis was carried out with fungi collected from South Korea, China and Peru. All B. bassiana species from collected at each site had a strong fungicidal activity against P. ussuriensis. The Abbott's formula was the highest showing 100% mortality and the others also showed over 60% mortality. It took 3 to 6 days until katydid attained to death after inoculation with all B. bassiana treatments. From this trial, B. bassiana fungus was found to have some effects as pathogenicity of entomopathogenic activity against P. ussuriensis. So B. bassiana could be considered as one of the environment-friendly and effective pesticides for the control of P. ussuriensis.

Review of Clinical Research about the Treatment of Aphasia after Cerebrovascular Disease (뇌혈관질환 후 실어증의 한의학적 치료에 대한 국내 임상연구에 대한 고찰)

  • Koh, Ji-yoon;Son, Ah-hyun;Shin, Hyeon-su
    • The Journal of Internal Korean Medicine
    • /
    • v.39 no.6
    • /
    • pp.1105-1115
    • /
    • 2018
  • Objectives: The aim of this review is to investigate clinical studies on Oriental medicine treatment for aphasia after cerebrovascular disease. Methods: Using the keywords 'Aphasia', 'Oriental medicine', 'Stroke' 'Cerebral infarction', 'Cerebral hemorrhage', and 'Clinic', we searched domestic databases, including "NDSL (National Discovery for Science Leaders)", "Korean Traditional Knowledge Portal", "OASIS (Oriental Medicine Advanced Searching Integrated System)", and "RISS (Research Information Sharing Service)". Each keyword was not searched individually, but combined in various ways. To investigate recent trends, we limited our search to papers published after 2000. Papers that did not include a specific treatment method or did not match the subject "Aphasia after stroke" were excluded. Results: Using the searching method, 13 studies were found. Of these, 12 studies were in the form of case reports, while one was in the form of a non-randomized controlled trial. These studies showed positive results for the use of Oriental medicine in terms of the Korean version of the Western Aphasia Battery (K-WAB), the evaluation form on functional performance capability and accuracy of articulatory organs developed by Lee, aphasia screening test refered in 'Assessment in Speech-Language Pathology' and adapted properly to Korean, the Communicative Ability in Daily Living Test (CADLT), the Korean Version-Boston Naming Test (K-BNT), and language assessment items included in CNS, and NIHSS. Conclusions: Of the 12 case reports, 11 studies showed positive results of the use of Oriental medicine for treatment of aphasia after cerebrovascular disease. However, more sophisticated and large-scale clinical research on aphasia should be conducted.