Journal of clinical trials最新文献

{"title":"Clinical Trials and Its Role in the Drug Discovery","authors":"R. Davey","doi":"10.35248/2167-0870.20.S7.E003","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S7.E003","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"43 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82111429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Rational for a Prospective Randomized Study of Safety Outcomes Treated with Edoxaban in Patients with Stable Coronary Artery Disease and Atrial Fibrillation (PRAEDO AF Study)","authors":"D. Fukamachi, Y. Okumura, N. Matsumoto, E. Tachibana, K. Oiwa, M. Ichikawa, K. Nomoto, H. Haruta, K. Arima, A. Hirayama","doi":"10.35248/2167-0870.20.10.405","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.405","url":null,"abstract":"Background: In non-valvular atrial fibrillation (NVAF) patients with coronary artery disease (CAD), using antiplatelet drugs in addition to anticoagulants for stroke prevention may further increase the bleeding risk. Several guidelines have recommended an oral anticoagulant (OAC) monotherapy in patients with stable CAD one year after percutaneous coronary intervention (PCI). When considering early neointima healing of current 3rd generation drug-eluting stents (DESs), the duration of the de-escalation from a single antiplatelet drug plus an OAC to an OAC alone therapy can be shortened by less than one year after PCI. The data on the clinical acceptability of short durations for de-escalation to an edoxaban monotherapy in those patients are still lacking. Methods: A multicenter, prospective, randomized, open-label, parallel group study has been established to investigate the safety outcomes of an edoxaban monotherapy in NVAF patients with stable CAD for over at least 6 months after PCI (PRAEDO AF study). From 7 institutions in Japan, approximately 200 participants will be randomized to receive either edoxaban monotherapy or edoxaban plus clopidogrel. All patients will be followed-up at least 1 year after enrollment. The primary endpoint is the percentage of serious bleeding complications and clinically significant bleeding combined events according to the ISTH criteria for edoxaban alone and edoxaban plus an antiplatelet agent. Conclusions: This will be the first study to assess the safety of edoxaban monotherapy in NVAF patients with stable CAD over 6 months after the 3rd generation DES and over 12 months after 1st or 2nd DES implantations.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76228386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inhibitory Effect of Calcium Alginate on Postprandial Blood Glucose Elevation: Basic and Clinical Studies","authors":"Kazuyo Shiragami, N. Obara, T. Ogihara","doi":"10.35248/2167-0870.20.10.411","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.411","url":null,"abstract":"Diabetes is known to increase the risk of myocardial and cerebral infarction, as well as complications such as retinopathy, nephropathy and neuropathy. It is important for diabetics to improve their eating habits, for example, by eating slowly, avoiding overeating, and increasing their intake of vegetables, in order to suppress sudden rises in blood glucose (Glu) levels. On the other hand, alginic acid (Alg), which is a polysaccharide derived from brown algae, is used as a food and medicinal additive, a health food and a pharmaceutical, based on its blood cholesterol-lowering effect and protective effect on the gastric mucosa. It was recently reported that calcium alginate (Ca-Alg) has the pharmacological effect of suppressing blood Glu elevation. We investigated the mechanism of this effect and found that Ca-Alg inhibits the metabolism of starch in the gastrointestinal tract by inhibiting the activity of α-glucosidase, which degrades maltose into Glu.We also examined the influence of the amount of Ca-Alg added to the diet and the particle size of the Ca-Alg on postprandial blood Glu elevation in rats. Subsequently, we conducted several clinical trials. We asked healthy adults to eat udon noodles, soba (buckwheat noodles), and Chinese noodles containing CaAlg, and measured the blood Glu levels after consumption. In each case, Ca-Alg decreased blood Glu levels and suppressed total absorption of Glu. This review summarizes the results of our basic and clinical studies on the effects of Ca-Alg on postprandial blood Glu elevation.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"8 2","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91502910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strict Gluten-Restricted Diet Reduces Disease Activity of Rheumatoid Arthritis with Low Anti-Cyclic Citrullinated Peptide Antibodies","authors":"Kenji Tani, Yoshihiro Okura, Shingo Kawaminami, Keisuke Kawahito, Keisuke Kondo, R. Takahashi, R. Tabata, Teruki Shimizu, Harutaka Yamaguchi","doi":"10.35248/2167-0870.10.7.441","DOIUrl":"https://doi.org/10.35248/2167-0870.10.7.441","url":null,"abstract":"Objective: To investigate the efficacy of gluten-restricted diet for the disease activity of Rheumatoid Arthritis (RA) and clinical factors corresponding to the response. Methods: Sixty three patients with active RA were included in this study. At baseline, we gave the patients the information about gluten-free and-contained foods, and asked them to refrain from the daily gluten consumption during the experimental period. Results: The 16-week gluten-restricted diet significantly improved DAS28-CRP and CDAI scores. The percentages of patients achieving DAS28-CRP- and CDAI-defined remission or LDA were significantly increased at Week 16. When the self-reported levels about adherence to the gluten-restricted diet were divided into two categories, a significant improvement in DAS28- CRP, CDAI, and EULAR treatment response after 16 weeks was detected only in the patient group with the strict adherence to gluten-restriction. Significantly lower levels of Anti-Cyclic Citrullinated Peptide Antibodies (ACPA) were detected in responders to the gluten-restriction than in non-responders. Conclusion: This study demonstrates that strict adherence to gluten-restricted diet results in decreased disease activity of RA patients with low ACPA.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":" 38","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91415230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-Invasive Strategies for Nose-to-Brain Drug Delivery.","authors":"J T Trevino,&nbsp;R C Quispe,&nbsp;F Khan,&nbsp;V Novak","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Intranasal drug administration is a promising method for delivering drugs directly to the brain. Animal studies have described pathways and potential brain targets, but nose-to-brain delivery and treatment efficacy in humans remains debated. We describe the proposed pathways and barriers for nose-to-brain drug delivery in humans, drug properties that influence central nervous system delivery, clinically tested methods to enhance absorption, and the devices used in clinical trials. This review compiles the available evidence for nose-to-brain drug delivery in humans and summarizes the factors involved in nose-to-brain drug delivery.</p>","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"10 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38867921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of Severe Chronic Urticaria: Current and Future Therapies","authors":"M. Sánchez-Borges, R. González-Díaz, J. Martell, I. Rojo, I. A. Zubeldia","doi":"10.35248/2167-0870.20.10.437","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.437","url":null,"abstract":"Chronic urticaria is highly prevalent in the population and a major motive for consultation in general practice as well as in allergology and dermatology services. It represents a heavy burden on patient’s quality of life and results in significant costs. This review article presents a comprehensive analysis of available literature on the definition, classification, pathogenesis, diagnosis and management of patients suffering chronic urticaria and angioedema and provides clues for clinicians taking care of them. Recommendations to utilize the management strategies contained in the guidelines and the instruments to assess severity, control and quality of life are strongly encouraged.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"86 3-4 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77849048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intestinal Dysbiosis and Probiotics in COVID-19","authors":"Y. Kageyama, T. Akiyama, Tsutomu Nakamura","doi":"10.35248/2167-0870.20.10.421","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.421","url":null,"abstract":"The COVID-19 pandemic has been an emerging threat to global public health. Several lines of evidence suggest that the causative virus SARS-CoV-2 infects the human intestinal epithelial cells as well as airway epithelial cells, suggesting that the enteric infection of SARS-CoV-2 has destructive effects on the intestinal microbiota and subsequently airway physiology and immunity through the gut-lung axis. Despite the important roles of the gut-lung axis in the antiviral immunity, only limited information is currently available concerning COVID-19-specific changes in the gut microbiome. This review summarizes recent knowledge of intestinal dysbiosis associated with COVID-19 patients and its potential contribution to the respiratory symptoms through the gut-lung axis. We also discuss the possibility of prophylactic and therapeutic use of probiotics in COVID-19, including our ongoing trial using Lactobacillus plantarum, which is known to have a wide variety of immunomodulatory activity against respiratory viral infections.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"12 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78313298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulation of Bile Acids by an NTCP Inhibitor is Promising for the Treatment of Nonalcoholic Steatohepatitis","authors":"Cui-li Fan, Hong-Li Liu, Jian Wu","doi":"10.35248/2167-0870.20.10.420","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.420","url":null,"abstract":"The beneficial effects of Hepalatide, an inhibitor of sodium taurocholate cotransporting polypeptide (NTCP), on the progression of nonalcoholic steato hepatitis was previously validated in mice. The underlying mechanismsare presumably associated with the profile changes of bile acids, which are natural agonistsfor FXR and TGR5receptors. In this short communication, the profile of bile acids and the metabolic changes in the liver or peripheral tissues were analyzed. It is our anticipation that using NTCP inhibitors, such as Hepalatide for the nonalcoholic steatohepatitis would be a clinically-applicable strategy","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"9 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85258427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Video-Assisted Thoracoscopic Lung Resection Following Video-AssistedMediastinoscopic Lymphadenectomy in the Cure of Non-Small Cell LungCancer","authors":"Ahmed A. H. Abdellatif, A. Allam, Samir Keshk, Abdel-maguid Ramadan, Walid Abuarab, R. Marasco, A. D. Morte, G. Giudice, C. Lequaglie","doi":"10.35248/2167-0870.20.10.416","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.416","url":null,"abstract":"Aim: The aim of this study was to evaluate the technical feasibility and limitations of video-assisted mediastinoscopic lymphadenectomy (VAMLA) followed by video-assisted thoracoscopic surgery (VATS) lobectomy and video-assisted thoracoscopic surgery (VATS) lobectomy alone in treating patients with non-small cell lung cancer. VATS lobectomy alone or following VAMLA is feasible and can be done with an acceptable safety profile under the hands of specialized, highly trained and cooperating team working in a high volume center treating patients with lung cancer. VAMLA followed by VATS lobectomy allowed the excision of more lymph nodes compared to the VATS approach alone, suggesting that VAMLA is a good adjuvant to VATS lobectomy for complete radical mediastinal lymphadenectomy for the surgical cure of non-small cell lung cancer patients. Over the last decade we witnessed significant change of practice in many thoracic units within the hands of a new generation of young minimally invasive thoracic Surgeons. The goal of our research was to evaluate the technical feasibility and limitations of video-assisted mediastinoscopic lymphadenectomy (VAMLA) followed by video-assisted thoracoscopic surgery (VATS) lobectomy and video-assisted thoracoscopic surgery (VATS) lobectomy alone in treating patients with non-small cell lung cancer. A prospective study from September 2015 to September 2016 involving 22 non-small cell lung cancer patients admitted to the Department of Thoracic Surgery of the Referral Oncologic Center of Basilicata (IRCCS-CROB), Italy, was done. Six patients underwent a combination of subsequent VAMLA and VATS lobectomy (Group A), whereas sixteen patients underwent lobectomy and mediastinal lymphadenectomy using thoracoscopy only (Group B). Comparison between the two studied groups was done regarding the baseline characteristics, operative profiles and complications. Males were more than females (17 patients vs. 5 patients) respectively. The most common tumour was T1 (18 patients). And, the most common encountered tumour was adenocarcinoma (17 Patients). Our results highlighted that the lobectomy operative time was shorter in (Group A), (117 minutes) compared to (Group B), (157.5 minutes). The total number of mediastinal lymph nodes excised in (Group A), (18 lymph nodes) was more than (Group B), (12.5 lymph nodes). VATS lobectomy alone or following VAMLA is feasible and can be done safely under the hands of specialized, highly trained and cooperating team working in a high volume center treating lung cancer patients.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"117 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80619851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ongoing Trials of Low Dose Radiation Therapy for Covid-19 Pneumonia: Studying the Past to Define the Future?","authors":"Á. Montero, M. Algara, M. Arenas","doi":"10.35248/2167-0870.20.S3.005","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S3.005","url":null,"abstract":"The current COVID-19 pandemic, caused by the infection by the SARS-CoV-2 virus, is a disease with great contagiousness, a non-negligible morbidity rate and a very important consumption of health resources, which is leading to a blockade of practically the entire world health system. The main complication is pneumonia, which has an important inflammatory component and for which there is still no definitive treatment. The absence of a standardized treatment coupled with the possible failure in the supply of drugs due to the great existing demand makes it necessary to investigate new anti-inflammatory therapeutics. The anti-inflammatory efficacy of Low-Dose Radio Therapy (LD-RT) has been confirmed in several experimental models, both in vitro and in vivo, as well as in different clinical studies. The radiobiological mechanisms that confirm this claim are becoming increasingly well known. Unlike high-dose radiotherapy that induces the production of pro-inflammatory cytokines in immune and endothelial cells, low doses of radiotherapy (0.5-1.5 Gy) act on the cells that participate in the inflammatory response, producing anti-inflammatory effects. At this time, there are different clinical studies underway that seek to demonstrate the usefulness of LD-RT against COVID19 pneumonia and open the possibility of offering an effective and widely affordable therapeutic alternative for this infection. Perhaps, as Confucius wrote, it is necessary to “study the past if you would define the future”","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"4 1","pages":"13-17"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89329819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}