• Title/Summary/Keyword: e-Clinical 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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    • v.48 no.4
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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.

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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    • v.21 no.1
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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.

Multimodal Treatment Strategies in Esophagogastric Junction Cancer: a Western Perspective

  • Goetze, Thorsten Oliver;Al-Batran, Salah-Eddin;Berlth, Felix;Hoelscher, Arnulf Heinrich
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.148-156
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    • 2019
  • Esophagogastric junction (EGJ) cancer is a solid tumor entity with rapidly increasing incidence in the Western countries. Given the high proportion of advanced cancers in the West, treatment strategies routinely employed include surgery and chemotherapy perioperatively, and chemoradiation in neoadjuvant settings. Neoadjuvant chemoradiation and perioperative chemotherapy are mostly performed in esophageal cancer that extends to the EGJ and gastric as well as EGJ cancers, respectively. Recent trials have tried to combine both strategies in a perioperative context, which might have beneficial outcomes, especially in patients with EGJ cancer. However, it is difficult to recruit patients for trials, exclusively for EGJ cancers; therefore, the results have to be carefully reviewed before establishing a standard protocol. Trastuzumab was the first drug for targeted therapy that was positively evaluated for this tumor entity, and there are several ongoing trials investigating more targeted drugs in order to customize effective therapies based on tissue characteristics. The current study reviews the multimodal treatment concept for EGJ cancers in the West and summarizes the latest reports.

Research on Outcome Indicators in Clinical Trials of Asthma, Cough, and Sputum by Reviewing Papers Searched from PubMed (해외논문고찰을 통한 천식 및 기침${\cdot}$가래 치료제의 유효성 평가지표 개발연구)

  • Oh, Mi-Hyune;Lee, Ji-Hyung;Jang, Bo-Hyoung;Jung, Sung-Ki;Sun, Seung-Ho;Ko, Ho-Yeon;Jun, Chan-Yong;Park, Jong-Hyeong;Ko, Seong-Gyu
    • The Journal of Internal Korean Medicine
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    • v.28 no.3
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    • pp.519-530
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    • 2007
  • Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

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A Nordoff-Robbins Music Therapy Case with a Child with Chromosome 15q Duplication Syndrome: The Therapist's Changes and Growth (15q 염색체중복 증후군 아동과의 놀도프-로빈스 음악치료 임상사례 - 치료사의 변화와 성장을 중심으로)

  • Kwak, Hee Jung;Kim, Dong Min
    • Journal of Music and Human Behavior
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    • v.5 no.1
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    • pp.47-65
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    • 2008
  • This case study is on the course of therapy with a client named E with Chromosome 15q Duplications Syndrome during the therapist's level 1 training, which offers a certification of Nordoff-Robbins Music Therapist(NRMT), at the Nordoff-Robbins Music therapy Center at New York University. This study gives an overview of the clinical process with E as well as the Nordoff-Robbins approach. Yet it is also focused on the therapist's personal and clinical experience and growth throughout the course of therapy. It shows how the therapist experienced various challenging situations and obstacles in the clinical process. There were consistent and diverse trials and mistakes. Throughout the process, therapist could learn more deeply about E's physical, psychological and emotional needsand have new perspectives on how to be a music therapist. The therapist applied 'Qualities of Clinical-Musical Interaction', one of the concepts in Nordoff-Robbins Music therapy, to organize the work with E.

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Incretin-based Treatment for Type 2 Diabetes Mellitus (제2형 당뇨병 환자에게 인크레틴 기반 약물치료요법)

  • Kim, Hyun-Ah;Kim, Hun-Sung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.57-65
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    • 2011
  • Incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide delay gastric emptying, increasing satiety, and enhance insulin secretion. Two new classes of treatments related to incretin hormones for the management of type 2 diabetes mellitus have emerged: GLP-1 receptor agonists (e.g., exenatide, liraglutide) and the dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin, saxagliptin, vildagliptin, alogliptin), which prevent the degradation of GLP-1. A MEDLINE search was conducted in order to evaluate the efficacy and safety of incretin-based therapies and publications were reviewed. Data from clinical trials indicated incretin-based treatment showed clinically significant reductions in hemoglobin A1c with low risk of hypoglycemia. Weight reductions were observed with GLP-1 receptor agonists where as DPP-4 inhibitors are weight neutral.

Intranasal Insulin for Alzheimer's Disease and Amnestic Mild Cognitive Impairment: Systematic Review and Meta-analysis (알츠하이머병 및 건망증 경도 인지장애의 인슐린 비강투여: 체계적 문헌 고찰 및 메타분석)

  • Alnajjar, Sarah;Jin, Hye Kyung;Kang, Ji Eun;Park, So Hyun;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.3
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    • pp.161-170
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    • 2017
  • Background: There is recent evidence that insulin resistance is responsible for increasing the risk of developing cognitive dysfunction. To systematically review the influence of intranasal insulin treatment on the cognitive function in Alzheimer's disease patients. Methods: Randomized controlled trials comparing the cognitive effects of intranasal insulin therapy in Alzheimer's disease patients with controlled interventions were retrieved from Pubmed, Medline, Embase and Cochrane library. Meta-analysis was conducted on the cognitive measurements with a subgroup analysis by dose, gender and apolipoprotein E allele 4 (ApoE ${\varepsilon}4$) status. Results: Seven randomized controlled trials were eligible for inclusion. Intranasal insulin had a positive influence on the cognitive function as compared to placebo without a statistical significance (standardized mean difference; SMD = 0.109; 95% confidence interval; CI -0.04 to 0.26; P=0.14). In subgroup analysis, a 20 IU dose of intranasal insulin induced a significant improvement in cognitive function (SMD = 0.14; 95% CI 0.05 to 0.24; P=0.004), but 40 IU did not show this effect (SMD = -0.01; 95% CI -0.11 to 0.09; P=0.82). ApoE ${\varepsilon}4$ positive patients showed a significant decline in cognitive function as compared to ApoE ${\varepsilon}4$ positive patients in the control group (SMD = -0.213; 95% CI -0.38 to -0.04; P=0.015). Such an effect was not apparent in ApoE ${\varepsilon}4$ negative patients. Gender had no influence on the cognitive outcomes. Conclusion: The results indicate that intranasal insulin may have beneficial effect in improving the cognitive function in Alzheimer's disease patients.

Challenges of stem cell therapies in companion animal practice

  • Kang, Min-Hee;Park, Hee-Myung
    • Journal of Veterinary Science
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    • v.21 no.3
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    • pp.42.1-42.22
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    • 2020
  • Regenerative medicine using stem cells from various sources are emerging treatment modality in several refractory diseases in veterinary medicine. It is well-known that stem cells can differentiate into specific cell types, self-renew, and regenerate. In addition, the unique immunomodulatory effects of stem cells have made stem cell transplantation a promising option for treating a wide range of disease and injuries. Recently, the medical demands for companion animals have been rapidly increasing, and certain disease conditions require alternative treatment options. In this review, we focused on stem cell application research in companion animals including experimental models, case reports and clinical trials in dogs and cats. The clinical studies and therapeutic protocols were categorized, evaluated and summarized according to the organ systems involved. The results indicate that evidence for the effectiveness of cell-based treatment in specific diseases or organ systems is not yet conclusive. Nonetheless, stem cell therapy may be a realistic treatment option in the near future, therefore, considerable efforts are needed to find optimized cell sources, cell numbers and delivery methods in order to standardize treatment methods and evaluation processes.

Recent Clinical Research on Effect of Acupuncture for Urticaria (두드러기의 침치료에 대한 최근 임상 연구 동향)

  • Han, Ye ji;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.1
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    • pp.22-31
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on the effect of acupuncture for urticaria worldwide. Methods Based on the PubMed search with the key search terms of 'urticaria, acupuncture', dated between 2002 to 2015, a total of 9 randomized controlled trials (RCTs), 3 case series, and 2 case reports have been found, and were analyzed. Results and conclusions 1. The most commonly used acupoints were Quchi (LI 11), Xuehai (SP 10), Zusanli (ST 36), Sanyinjiao (SP 6), Dazhui (GV 14). 2. The most commonly used meridians were The Ren Channel, The Du Channel and The Gall Bladder Meridian of Foot-Shaoyang. 3. The treatment period varied from 12 days to 3 months. 4. Acupuncture treatment found to be significantly more or equally effective than the western medicine. 5. More clinical studies are needed to prove a true effectiveness of the acupuncture for urticaria. In case of laboratory tests, serum immunoglobulin E (IgE), interleukin 4 (IL-4) and Helicobacter pylori negative rate might be helpful.