• Title/Summary/Keyword: Human trials

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Progress in human ovarian rejuvenation: Current platelet-rich plasma and condensed cytokine research activity by scope and international origin

  • Sills, E. Scott;Wood, Samuel H.
    • Clinical and Experimental Reproductive Medicine
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    • 제48권4호
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    • pp.311-315
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    • 2021
  • Objective: As clinicians and patients await consensus on intraovarian platelet-rich plasma (PRP) treatment, this project evaluated contemporary research trends in the literature. Methods: A PubMed/NLM search aggregated all ovarian PRP-related publications (n=54) to evaluate their scope, abstract utility, submission-to-publication interval, journal selected, article processing charge (APC), free reader access to full-text manuscripts, number and nationality of authors, and inclusion of international collaborators. The NIH Clinical Trials database was also audited. Results: Published output on intraovarian PRP has increased consistently since 2016, especially among investigators in Greece, Iran, USA, and Turkey. Between 2013 and 2021, 42 articles met the relevancy criteria, of which 40.5% reported clinical studies, small series, or case reports, 33% described experimental animal models, and 23.8% were opinion/review papers. Only two works included a placebo control group. The submission-to-publication interval (mean±standard deviation) was 130±96 days, there were 5.9±3.2 authors per project, and journals invoiced US $1,613±1,466 (range, $0-$3,860) for APCs. Conclusion: There was no correlation between APC and time to publish (Pearson's r=-0.01). Abstract content was inconsistent; sample size and patient age were often missing, yet free full-text "open access" was available for most publications (59.5%). The NIH Clinical Trials portal lists eight registered studies on "ovarian rejuvenation," of which two are actively recruiting patients, while four have been terminated or have an uncertain status. Two studies have concluded, with results from one posted to the NIH website. PRP and its derivatives for ovarian treatment show early promise, but require further investigation. Research is accelerating and should be encouraged, particularly placebo-controlled randomized clinical trials.

Clinical and preclinical tolerance protocols for vascularized composite allograft transplantation

  • Yang, Jerry Huanda;Johnson, Ariel C.;Colakoglu, Salih;Huang, Christene A.;Mathes, David Woodbridge
    • Archives of Plastic Surgery
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    • 제48권6호
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    • pp.703-713
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    • 2021
  • The field of vascularized composite allografts (VCAs) has undergone significant advancement in recent decades, and VCAs are increasingly common and accepted in the clinical setting, bringing hope of functional recovery to patients with debilitating injuries. A major obstacle facing the widespread application of VCAs is the side effect profile associated with the current immunosuppressive regimen, which can cause a wide array of complications such as infection, malignancy, and even death. Significant concerns remain regarding whether the treatment outweighs the risk. The potential solution to this dilemma would be achieving VCA tolerance, which would allow recipients to receive allografts without significant immunosuppression and its sequelae. Promising tolerance protocols are being studied in kidney transplantation; four major trials have attempted to withdraw immunosuppressive treatment with various successes. The common theme in all four trials is the use of radiation treatment and donor cell transplantation. The knowledge gained from these trials can provide valuable insight into the development of a VCA tolerance protocol. Despite similarities, VCAs present additional barriers compared to kidney allografts regarding tolerance induction. VCA donors are likely to be deceased, which limits the time for significant pre-conditioning. VCA donors are also more likely to be human leukocyte antigen-mismatched, which means that tolerance must be induced across major immunological barriers. This review also explores adjunct therapies studied in large animal models that could be the missing element in establishing a safe and stable tolerance induction method.

Breakthroughs in the Systemic Treatment of HER2-Positive Advanced/Metastatic Gastric Cancer: From Singlet Chemotherapy to Triple Combination

  • Sun Young Rha;Hyun Cheol Chung
    • Journal of Gastric Cancer
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    • 제23권1호
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    • pp.224-249
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    • 2023
  • Gastric cancer is heterogeneous in morphology, biology, genomics, and treatment response. Alterations in human epidermal growth factor receptor 2 (HER2) overexpression, microsatellite instability (MSI) status, programmed death-ligand 1 (PD-L1) levels, and fibroblast growth factor receptor 2 (FGFR2) can be used as biomarkers. Since the combination of fluoropyrimidine/platinum plus trastuzumab that was investigated in the ToGA trial was approved as a standard of care in HER2-positive patients in 2010, no other agents showed efficacy in the first- (HELOISE, LOGiC, JACOB trials) and second- (TyTAN, GATSBY, T-ACT trials) line treatments. Despite the success in treating breast cancer, various anti-HER2 agents, including a monoclonal antibody (pertuzumab), an antibody-drug conjugate (ADC; trastuzumab emtansine [T-DM1]), and a small molecule (lapatinib) failed to translate into clinical benefits until the KEYNOTE-811 (first-line) and DESTINY-Gastri01 (≥second-line) trials were conducted. The incorporation of HER2-directed treatment with immune checkpoint inhibitors in the form of a monoclonal antibody or ADC is now approved as a standard treatment. Despite the promising results of new agents (engineered monoclonal antibodies, bi-specific antibodies, fusion proteins, and small molecules) in the early phase of development, the management of HER2-positive gastric cancer requires further optimization to achieve precision medicine with a chemotherapeutic backbone. Treatment resistance is a complex process that can be overcome using a combination of chemotherapy, targeted agents, and immune checkpoint inhibitors, including novel agents. HER2 status must be reassessed in patients undergoing anti-HER2 treatment with disease progression after the first-line treatment. As a general guideline, patients who need systemic treatment should receive chemotherapy plus targeted agents, anti-angiogenic agents, immune checkpoint inhibitors, or their combinations.

Ongoing Clinical Trials of Vaccines to Fight against COVID-19 Pandemic

  • Chiranjib Chakraborty;Ashish Ranjan Sharma;Manojit Bhattacharya;Garima Sharma;Rudra P. Saha;Sang-Soo Lee
    • IMMUNE NETWORK
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    • 제21권1호
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    • pp.5.1-5.22
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    • 2021
  • Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.

Antibody Engineering

  • Hong, Hyo-Jeong;Kim, Sun-Taek
    • Biotechnology and Bioprocess Engineering:BBE
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    • 제7권3호
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    • pp.150-154
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    • 2002
  • Monoclonal antibodies (Mabs) have been used as diagnostic and analytical reagents since hybridoma technology was invented in 1975. In recent years, antibodies have become increasingly accepted as therapeutics for human diseases, particularly for cancer, viral infection and autoimmune disorders. An indication of the emerging significance of antibody-based therapeutics is that over a third of the proteins currently undergoing clinical trials in the United States are antibodies. Until the late 1980's, antibody technology relied primarily on animal immunization and the expression of engineered antibodies. However, the development of methods for the expression of antibody fragments in bacteria and powerful techniques for screening combinatorial libraries, together with the accumulating structure-function data base of antibodies, have opened unlimited opportunities for the engineering of antibodies with tailor-made properties for specific applications. Antibodies of low immunogenicity, suitable for human therapy and in vivo diagnosis, can now be developed with relative ease. Here, antibody structure-function and antibody engineering technologies are described.

iPSC technology-Powerful hand for disease modeling and therapeutic screen

  • Kim, Changsung
    • BMB Reports
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    • 제48권5호
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    • pp.256-265
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    • 2015
  • Cardiovascular and neurodegenerative diseases are major health threats in many developed countries. Recently, target tissues derived from human embryonic stem (hES) cells and induced pluripotent stem cells (iPSCs), such as cardiomyocytes (CMs) or neurons, have been actively mobilized for drug screening. Knowledge of drug toxicity and efficacy obtained using stem cell-derived tissues could parallel that obtained from human trials. Furthermore, iPSC disease models could be advantageous in the development of personalized medicine in various parts of disease sectors. To obtain the maximum benefit from iPSCs in disease modeling, researchers are now focusing on aging, maturation, and metabolism to recapitulate the pathological features seen in patients. Compared to pediatric disease modeling, adult-onset disease modeling with iPSCs requires proper maturation for full manifestation of pathological features. Herein, the success of iPSC technology, focusing on patient-specific drug treatment, maturation-based disease modeling, and alternative approaches to compensate for the current limitations of patient iPSC modeling, will be further discussed. [BMB Reports 2015; 48(5): 256-265]

아동상담자의 변화에 관한 질적 연구 (A qualitative study of process of the child counselor's change)

  • 신현정
    • 한국생활과학회지
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    • 제18권1호
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    • pp.41-53
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    • 2009
  • The purposes of this study are to search for counselor's change process and factors in Theraplay, and to explore how they are changed into experts. This study used a method of qualitative study to reveal a concrete context of child counseling. The results are as follows. Therapist or counselor subjects realized that therapy(counseling) was not focusing on activities, but on meanings. In the beginning, therapist subjects acted according to the situation rather than according to the child's reactions and their own strategy. It was expressed into long and boring explanations, trials to flatter a child. Therapist subjects were often depressed because of their incompetence, they even did overpraise for the undistinguished behavior of children, but gradually they have changed into expert therapists through ceaseless interaction with Theraplay community, reflection, trial and practice.

Analysis of The Lateral Motion of Tractor-Trailer Combination (I) Operator/Vehicle System Model for Forward Maneuver

  • Torisu, R.;Mugucia, S.W.;Takeda, J.
    • 한국농업기계학회:학술대회논문집
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    • 한국농업기계학회 1993년도 Proceedings of International Conference for Agricultural Machinery and Process Engineering
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    • pp.1137-1146
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    • 1993
  • In order to analyze lateral control in the forward manuever of a tractor- trailer combination , a human operator model and a kinematic vehicle model were utilized for the operator/vehicle system. By combining the vehicle and operator models, a mathematical model of the closed-loop operator/vehicle system was formulated. A computer program was developed so as to simulate the motion of the tractor-trailer combination . In order to verify the operator/vehicle system model, the results of the field trials were compared with the simulated results. There was found to be reasonably good agreement between the two.

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Thermal Comfort Aspects of Pesticide-protective Clothing Made with Nonwoven Fabrics

  • Choi Jong-Myoung;Tanabe Shin-Ichi
    • International Journal of Human Ecology
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    • 제3권1호
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    • pp.55-72
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    • 2002
  • The purpose of this study was to evaluate the thermal resistance of pesticideprotective clothing and to investigate its subjective wear performance. Three different nonwoven fabrics, which provide barrier properties against water and pesticide, were used to manufacture the experimental clothing: spunbonded nonwoven (SB), spunbonded/meltblown/spunbonded nonwoven (SM), and spunlaced nonwoven (SL). The thermal insulation values of the experimental clothing were measured with a thermal manikin, and other wear trials were performed on human subjects in a climate chamber at $28^{\circ}C$, with 70% R.H. and air movement at less than 0.15m/s. Our results found that the thermal resistance was lower in the SB experimental clothing than in the others; that the mean skin temperature of subjects who wore the experimental clothing made with SL was significantly lower than that of subjects who wore the SB and SM clothing; and that the microclimate temperature and humidity with SB were significantly higher than that of the others. Overall, the experimental clothing made with SL was more comfortable than the others in terms of subjective wear sensations.

진화적 알고리즘을 이용한 자율적 2족 보행생성 (Autonomous Bipedal Locomotion with Evolutionary Algorithm)

  • 옥수열
    • 한국지능시스템학회:학술대회논문집
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    • 한국퍼지및지능시스템학회 2004년도 춘계학술대회 학술발표 논문집 제14권 제1호
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    • pp.277-280
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    • 2004
  • In the research of biomechanical engineering, robotics and neurophysiology, to clarify the mechanism of human bipedal walking is of major interest. It serves as a basis of developing several applications such as rehabilitation tools and humanoid robots Nevertheless, because of complexity of the neuronal system that Interacts with the body dynamics system to make walking movements, much is left unknown about the details of locomotion mechanism. Researchers were looking for the optimal model of the neuronal system by trials and errors. In this paper, we applied Genetic Programming to induce the model of the nervous system automatically and showed its effectiveness by simulating a human bipedal walking with the obtained model.

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