Journal of clinical trials最新文献

{"title":"Frailty Raises as a New Target in Patients with Chronic Hemodialysis in Any Country and the Problem We Should Solve","authors":"Hidemi Takeuchi, H. Uchida, J. Wada","doi":"10.35248/2167-0870.20.10.414","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.414","url":null,"abstract":"The population undergoing dialysis is aging and increasing around the world. A particularly problematic issue plaguing the elderly population is the frailty. Frailty is usually defined as “a state of increased vulnerability to stressors resulting from a decrease in physiologic reserves in multiple organ systems causing limited capacity to maintain homeostasis” [1]. There are two major approaches to assess frailty: one is frailty phenotype model developed by Fried et al. and the other is accumulated deficit model by Rockwood et al. While the most widely used assessment of frailty is Fried’s phenotype model, regardless of assessment method, frailty remains highly associated with an increased risk of several deleterious outcomes including disability, falls, hospitalization, institutionalization, and death [2].","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"81 3 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88010910","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":"Efficacy of Early Adalimumab or Immunomodulator on Postoperative Remission Maintenance in Patients with Crohn's Disease: Randomized study","authors":"A. Yamada, H. Iwashita, S. Okazumi, H. Kikuchi, Yasuo Suzuki, K. Matsuoka","doi":"10.35248/2167-0870.20.10.401","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.401","url":null,"abstract":"Background and Aim: This study aim was to clarify the efficacy of early adalimumab (ADA) and azathioprine (AZA) in Postoperative recurrence of Crohn’s disease (CD). Methods: In a 78-week single-center prospective study, patients with bowel resection were randomly assigned to ADA 160-80-40 mg subcutaneously (SC) or AZA 0.5-1.5 mg/kg/day. The primary endpoint was endoscopic remission at 18 months (Rutgeerts i0, i1 and Simple endoscopic score for CD (SES-CD) ≤ 4). Results: A total of 47 patients (median age 39.0 years, disease duration 9.5 years, 19.1% smokers, 44.6% previous resections) were recruited, 39 patients were received the study drugs. Endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group (p=0.17). Re-surgery rate was trend to higher in the AZA group (21.1%) than in the ADA group (0%) (p=0.10). Treatment was discontinued due to adverse events in 6 patients (15.3%), severe adverse events were significantly more frequent in the AZA group than in the ADA group (AZA, 25.0% vs ADA, 0%; p=0.04). Conclusions: Early ADA did not show statistically better efficacy than AZA for postoperative CD recurrence in this study, although safety profile of ADA is better. (UMIN000032485).","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"30 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":"85222237","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":"A Randomized, Comparative Clinical Study to Evaluate the Activity of CureqovitaaTM Formulation for Management of SARS-COV-2 Infection(COVID-19)","authors":"Y. Dound, M. Sagar, Lik, S. Suryavanshi, R. Sehgal, A. Naik","doi":"10.35248/2167-0870.20.S3.004","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S3.004","url":null,"abstract":"COVID-19 outbreak has put forward a huge challenge in front of researchers across the globe. Non availability of any vaccine or drug has worsened the situation and it has become a worst pandemic of modern times. Keeping scientific rationale and results of in silico studies, Researchers at Shreepad Shree Vallabh SSV Phytopharmaceuticals (SSV) have developed formulation containing natural ingredients viz Curcumin, Vitamin C, Vitamin K2-7 and L-Selenomethionine. Objective: To evaluate role of CureqovitaaTM in the management of COVID-19 and its tolerability in comparison with standard treatment available from Ministry of Health and Family Welfare (MOHFW). Study design and methodology: In a randomized, two arm, comparative study, COVID-19 positive patients (n=200) were enrolled during the month of August and September 2020 from Radiant Plus Hospital, Nashik, Maharashtra, India. The enrolled patients were administered either CureqovitaaTM 500 mg tablets twice daily or given standard treatment protocol designed by MOHFW for 10 days. The patients were evaluated for decrease in oral temperature; SpO2 and VAS score for cough and respiratory distress. The underlying mechanism was assessed by evaluating markers such as Interleukin-6, Homocysteine, D-dimer, Ferritin and C Reactive Protein. Results: In the CureqovitaaTM group, within two days, temperature reduced considerably to afebrile level in all the subjects and remained afebrile till end of study. While in the standard treatment group, temperature reduced to afebrile stage in all the subjects by 4 days and there after remained afebrile till end of study. The elevated levels of serum Interleukin-6, Homocysteine, Di-dimer, Ferritin and C-Reactive Protein at baseline dropped considerably within normal limits within 10 days in the CureqovitaaTM group in comparison to standard treatment group. Conclusion: CureqovitaaTM has shown for the first time to be useful in management of COVID-19 positive patients along with improvement in the immunity, within 48 hours of starting treatment. CureqovitaaTM was well tolerated without any side effects in any of the patients treated.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"21 1","pages":"6-12"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81217758","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":"Roles of Complement and Extracellular Histones in Infectious Sepsis","authors":"F. Zetoune, P. Ward","doi":"10.35248/2167-0870.20.10.418","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.418","url":null,"abstract":"In North America, infectious sepsis is associated with bacteria, fungi, protozoa and viruses. It has been well established that age is an important factor. Septic patients of 60 years of age, or greater, are much more susceptible to lethality as compared to patients whose age is around 40 years of age. Recently, there is also evidence that sepsis associated with non-penetrating trauma, drug toxicity of liver, or hemorrhagic shock are associated with similar responses developing in infectious sepsis. Following onset of sepsis (infectious or non-infectious), during the first 2-3 days there is a “cytokine storm,” also involving proinflammatorychemokines.Typically, IL-1β, IL-6, TNF and IL-17A and F rapidly rise in plasma. After day 3-4, this inflammatory cascade related to the innate immune system (involving neutrophils, macrophages and an array of proinflammatory mediators) results in reduced responsiveness of the innate immune system, followed by development of immune suppression. The precise molecular mechanisms for these outcomes are poorly understood. It is well known that sepsis activates the following complement activation pathways: classical, alternative and lectin pathways, resulting in release of two powerful anaphylatoxins: C3a and C5a. Each anaphylatoxin has powerful proinflammatory functions. In the setting of sepsis, C5a reacts with its high affinity receptors (C5aR1, C5aR2), especially on phagocytes (neutrophils, macrophages), resulting in release of proinflammatory factors (proteases, oxygen-derived free-radicals, extracellular histones, etc.). C5a has a molecular weight of approximately 12 kDa and is freely diffusable locally. Histones have only recently been shown to be released with a variety of inflammatory products from phagocytic cells activated by C5a. There is a great deal of work going on to define precisely how histones contribute to the adverse outcomes of sepsis.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"23 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89558740","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":"Mini Review: Update on Polycystic Ovarian syndrome","authors":"A. Dwivedi, S. Dwivedi, Muhammad Tariq, Suzhen Hong, Yu Xin, Xiaoming Qiu","doi":"10.35248/2167-0870.20.10.393","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.393","url":null,"abstract":"Polycystic ovarian Syndrome is one of the most common disorders among the women of reproductive age. Women suffering from PCOS present with menstrual disturbances and excess of androgens which may affect their reproductive life and quality of life at the same time. women with PCOS may be at increased risk of having multiple morbidities, which include obesity, type II Diabetes mellitus, cancer, cardiovascular disease, infertility and psychological disorders. The pathogenesis of PCOS still remains unclear. More and more supplementary studies needed to make a correlation between several factors that might play an active role in the pathogenesis of PCOS.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"84 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73432340","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":"Coronavirus Pandemic (COVID-19) -Clinical Trials Advice","authors":"D. Novara","doi":"10.35248/2167-0870.20.10.407","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.407","url":null,"abstract":"There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally. COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. Due to the Coronavirus situation most of European Regulatory Authority (Italy, Spain, UK, Finland, Denmark, etc.) and FDA provided some advice regarding the clinical trials during the pandemic. In this article I want to provide a summary of advises provided by the Regulatory Authority. These measures are intended to preserve the activities of the trial as far as possible, guaranteeing the health care of the patients, protecting their safety and well-being and preserving the traceability of the actions implemented in this health emergency situation. It is expected that the sponsor performs a thorough risk assessment of each individual ongoing trial and implements measures which priorities patient safety and data validity. In case these two conflicts, patient safety should take priority. These risk assessments should be based on relevant parties’ input and should be documented on an ongoing basis. The Sponsor should reassess risk as the situation develops. This reassessment should also be documented.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"16 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":"81718085","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":"Importance and Scope of Pharmacovigilance","authors":"P. Zeng","doi":"10.35248/2167-0870.20.S7.E002","DOIUrl":"https://doi.org/10.35248/2167-0870.20.S7.E002","url":null,"abstract":"","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 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":"85585800","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":"Optimising Health Literacy in the Modern Era: A Readability Approach","authors":"Tiarnán Ó. Doinn, J. Broderick","doi":"10.35248/2167-0870.20.10.431","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.431","url":null,"abstract":"Worldwide internet use has increased more than eleven -fold over the past 20 years [1]. The increased availability of the Internet has provided patients with unprecedented access to health information and patients are increasingly turning to the internet for health education materials [2]. However, despite widespread Internet use among patients for health education, the majority of patients do not discuss this information with their healthcare provider [3]. This is concerning given that not only do patients commonly find online health information confusing, it also influences their decision regarding treatment options [4]. As a result, an increasing emphasis has been placed on health literacy. Health literacy is defined as the \"capacity to obtain, interpret, and understand basic health information and services and the competence to use such information and services to enhance health [5].\" Recently, it estimated that 36% of US adults [6] or roughly 90 million Americans [7] have basic or below basic health literacy.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"50 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":"80997809","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":"Symptomatic Encapsulated Fat Necrosis: Unusual Cause of Abdominal Pain","authors":"B. G. A. Dieu, S. Cimpean, Imorou Yacobou, Kamga Felix, Gbessi Gaspard","doi":"10.35248/2167-0870.20.10.417","DOIUrl":"https://doi.org/10.35248/2167-0870.20.10.417","url":null,"abstract":"Encapsulated fat necrosis can be can be found in the abdominal cavity and other parts of the body. It can be the cause of abdominal pain. We present a case of a patient with two encapsulated fat necrosis intra-abdominal in a patient with a history of three caesarean sections who consulted for abdominal pain. Encapsulated fat necrosis intraabdominal is thought to result from a traumatic or ischemic insult that causes degeneration of intra-abdominal fat tissues; in turn, the necrotic fatty tissue organizes within a thin or thick fibrous capsule. Encapsulated fat necrosis is most often follows exploratory laparotomies can be discovered by incidentally or during an exploratory laparoscopy.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"1 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":"83689902","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":"Early Sequential Risk Stratification Assessment to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children with Acute Kidney Injury: Taking Focus 2 Process Article.","authors":"Jean-Philippe Roy,&nbsp;Kelli A Krallman,&nbsp;Rajit K Basu,&nbsp;Ranjit S Chima,&nbsp;Lin Fei,&nbsp;Sarah Wilder,&nbsp;Alexandra Schmerge,&nbsp;Bradley Gerhardt,&nbsp;Kaylee Fox,&nbsp;Cassie Kirby,&nbsp;Stuart L Goldstein","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Acute Kidney Injury (AKI) is common in critically ill children and is associated with increased morbidity and mortality. Recognition and management of AKI is often delayed, predisposing patients to risk of clinically significant fluid accumulation (Fluid Overload (FO)). Early recognition and intervention in high risk patients could decrease fluid associated morbidity. We aim to assess an AKI Clinical Decision Algorithm (CDA) using a sequential risk stratification strategy integrating the Renal Angina Index (RAI), urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) and the Furosemide Stress Test (FST) to optimize AKI and FO prediction and management in critically ill children.</p><p><strong>Methods/design: </strong>This single center prospective observational cohort study evaluates the AKI CDA in a Pediatric Intensive Care Unit (PICU). Every patient ≥ 3 months old has the risk score RAI calculated automatically at 12 hours of admission. Patients with a RAI ≥ 8 (fulfilling renal angina) have risk further stratified with a urine NGAL and, if positive (NGAL ≥ 150ng/mL), subsequently by their response to a standardized dose of furosemide (namely FST). RAI negative or NGAL negative patients are treated per usual care. FST-responders are managed conservatively, while non-responders receive fluid restrictive strategy and/or continuous renal replacement therapy (CRRT) at 10%-15% of FO. 2100 patients over 3 years will be evaluated to capture 210 patients with severe AKI (KDIGO Stage 2 or 3 AKI), 100 patients with >10% FO, and 50 requiring CRRT. Primary analyses: Standardizing a pediatric FST and assessing prediction accuracy of CDA for severe AKI, FO>10% and CRRT requirement in children. Secondary analyses in patients with AKI: Renal function return to baseline, RRT and mortality within 28 days.</p><p><strong>Discussion: </strong>This will be the first prospective evaluation of feasibility of AKI CDA, integrating individual prediction tools in one cohesive and comprehensive approach, and its prediction of FO>10% and AKI, as well as the first to standardize the FST in the pediatric population. This will increase knowledge on current AKI prediction tools and provide actionable insight for early interventions in critically ill children based on their level of risk.</p>","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"10 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8409431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39382089","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}