Open Access Journal of Clinical Trials最新文献

{"title":"Clinical Efficacy of an Osmotic, Antiviral and Anti-Inflammatory Polymeric Nasal Film to Treat Covid-19 Early-Phase Respiratory Symptoms","authors":"R. Shrivastava, Megha Vijay, Nathalie Maneby, R. Shrivastava","doi":"10.2147/OAJCT.S307144","DOIUrl":"https://doi.org/10.2147/OAJCT.S307144","url":null,"abstract":"Background: Covid-19 infection is a multifactorial disease where the virus mainly enters through the nasal cavity, grows, triggers inflammation, and destroys nasal mucosa cells, allowing systemic virus entry and infection of other organs. When symptoms appear, the disease physiopathology is already established. The immune system tries to control the infection but if the infection persists, it gets tired, fatigued, stressed, and finally, there is burnout. Therefore, an effective treatment should be multi-targeted and should not focus only on one parameter. Minimizing virus concentration, reducing nasal mucosa inflammation, and keeping the nasal surface clean should lessen systemic infection and the probability of developing severe respiratory distress. We evaluated clinical efficacy and safety of an osmotic nasal surface cleaning, virus and cytokine trapping polymeric film, in early-stage Covid-19 positive symptomatic patients. Methods: A randomized, multicentric, observational study was performed to evaluate the efficacy and safety of the osmotic film in 213 patients, randomized in 2 equal arms, and confined for 14-days just after the RT-PCR+ test. Due to ethical reasons, all patients received symptomatic treatments (ST). In addition, the patients in Arm-1 received the test product (ST+TP, 2-3 sprays, 4-5 times/ day) for 14-days. Leicester Cough Questionnaire, Visual Analogue Scale, and Covid-19-associated symptoms such as fever, pain, taste, smell, and headache were evaluated daily. Home-confined patients were immediately hospitalized in case of aggravation of any life-threatening clinical sign. Results: Among 213 patients, 98 in the ST and 102 in the ST+TP group completed the study. Thirteen patients did not complete the study as 8 in the ST group and 5 in the ST+TP group were hospitalized during the study due to low blood oxygen levels or sudden health deterioration and were excluded from the study. In the remaining control standard treatment group (n=98), clinical signs sharply aggravated on day 1-2 followed by stabilisation between days 3-6 and progressive reduction thereafter. In the test product group (n=102), symptoms were stabilized just after the first application and improved progressively. Only 42/102 patients in the test product group presented nasal discharge or irritation due to the osmotic properties of the product. Conclusion: The continuous multi-target approach of detaching and neutralizing virus particles and pro-inflammatory cytokines from the nasal surface to minimize systemic virus exposure is a very logical and efficient approach to avoid Covid-19-induced systemic pathology.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2021-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45582810","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":"Effectiveness of a Structured Nutrition Education Course for Caregivers of Children and Adolescents with Type 1 Diabetes in Improving Glycemic and Dietary Outcomes: A Cluster-Randomized Controlled Trial Protocol","authors":"N. B. Ndahura, J. Munga, J. Kimiywe, E. Mupere","doi":"10.2147/OAJCT.S304290","DOIUrl":"https://doi.org/10.2147/OAJCT.S304290","url":null,"abstract":"Purpose: This study will aim to evaluate whether the provision of a structured nutrition education course to caregivers of children and adolescents with type 1 diabetes mellitus (T1DM) will help improve their children’s glycemic control, dietary intake, and diversity. Research Design and Methods: The study will be a cluster randomized controlled trial conducted at 10 health facilities with established T1DM clinics in Uganda. The facilities will include: Mulago National Referral Hospital, St. Francis Hospital, Lubaga Hospital, Mbale Regional Referral Hospital, Soroti Regional Referral Hospital, Holy innocents’ Hospital, Virika Hospital, Kagando Hospital, Nyakibale Hospital, and Wakiso Health Centre IV. The facilities will be randomized to control or intervention at a ratio of 1:1. A total of 100 caregiver-child pairs will be recruited. The participants in the control group will continue to receive routine medical care, while those in the intervention group will receive routine medical care and attend a structured group nutrition education course. The course will be delivered over 3 months, it will consist of a total of 8 face-to-face sessions lasting 45 minutes each. A two-member team of a diabetes specialist nurse and dietician will conduct the sessions. Each session will be conducted once a week and a question-and-answer session held every after 2 sessions. The primary outcome which is a change in glycated hemoglobin (HbA1c) and secondary outcomes (caregivers’ level of knowledge on general and diabetes-specific nutrition knowledge, children’s dietary diversity score, and children’s mean intake of energy, protein, and fat) will be assessed at baseline, 3, and 6 months. Intention-to-treat analysis will be conducted. Data will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for cluster-randomized trials. The trial is registered with the Pan African Clinical Trials Registry (PACTR201902548129842).","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44859718","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":"Terminated Interventional Trials in the Clinical Trial Registry of India Database: An Analysis to Evaluate the Reasons for Termination","authors":"S. Dutta, Rimplejeet Kaur, M. Haque, P. Bhardwaj, D. Saxena, N. Rahman, H. Lugova, Dilshad Jahan, Salequl Islam, T. Chowdhury, J. Charan","doi":"10.2147/oajct.s285177","DOIUrl":"https://doi.org/10.2147/oajct.s285177","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2020-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41290378","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":"The Use of Gabapentin for the Treatment of Alcohol and Tobacco Use Disorders: A Review","authors":"Gabriel C Quintero Garzola","doi":"10.2147/OAJCT.S257556","DOIUrl":"https://doi.org/10.2147/OAJCT.S257556","url":null,"abstract":"Background: Alcohol and tobacco use disorders are pervasive health problems without adequate treatment. Gabapentin has been used for different psychiatric disorders, including addiction. Methods: In this article, the use of gabapentin for the treatment of alcohol and tobacco use disorders is reviewed. Accordingly, a database search of PubMed was performed (January 1, 1983–August 31, 2017), using the search terms “gabapentin” AND “alcohol” OR “tobacco”. Animal and human studies written in English were included. A total of 426 records were identified, and 40 articles met eligibility criteria and were included in this review. The main reasons for exclusion were gabapentin was not the intervention of interest or the study population did not have alcohol/tobacco abuse issues. Additionally, 28 references were included in the Introduction, for a total of 68 references. The success of gabapentin for treating alcohol/tobacco use problems was determined by calculating the success rate across studies: the total number of investigations with favorable results was divided by the total numbers of investigations for each specific disorder (eg, alcohol or tobacco dependence, or other). Results and Discussion: The available evidence on gabapentin for alcohol use disorder suggests that this treatment successfully alleviates problems related to alcohol abuse, including withdrawal symptoms, dependence, and cravings. However, more research is needed to determine the effectiveness of gabapentin for preventing relapse. Further, more data are required before a conclusion regarding gabapentin’s effectiveness for treating tobacco dependence.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2020-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43086063","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":"Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design.","authors":"Michael White, Michael Mackay, Roger Whittaker","doi":"10.2147/OAJCT.S259702","DOIUrl":"10.2147/OAJCT.S259702","url":null,"abstract":"<p><p>Optogenetics, the use of light to control the activity of suitably sensitized cells, has led to major advances in the field of basic neuroscience since it first emerged in 2005. Already, the technique has entered clinical trials for conditions such as Retinitis Pigmentosa. A major focus of interest is the use of optogenetics within the brain, where the ability to precisely control the activity of specific subsets of neurons could lead to novel treatments for a wide range of disorders from epilepsy to schizophrenia. However, since any therapy would require both the use of gene therapy techniques to introduce non-human proteins, and implantable electronic devices to provide optical stimulation, applying this technique in the brain presents a unique set of obstacles and challenges. This review looks at the reasons why researchers are exploring the use of optogenetics within the brain. It then explores the challenges facing scientists, engineers and clinicians wanting to take this technology from the lab into the first human brain, discussing different possibilities for a first-in-human clinical trial from a sponsor, patient and regulatory perspective.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2020-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7611592/pdf/EMS133514.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39377087","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":"Effectiveness of Body Awareness Therapy in Stroke Survivors: A Systematic Review of Randomized Controlled Trials","authors":"Abayneh Alamer, Kefale Getie, Haimanot Melese, Habtamu Mazea","doi":"10.2147/oajct.s260476","DOIUrl":"https://doi.org/10.2147/oajct.s260476","url":null,"abstract":": Body awareness therapy has been hypothesized as an effective program for maintaining balance and improving gait function in patients with neurological diseases. Nevertheless, there is a dearth of recent studies in a systematic way to confirm its efficacy on stroke survivors. The objective of this review was to synthesize the current evidence on the effectiveness of body awareness therapy on balance and gait function in stroke survivors. A comprehensive search of PubMed, CINAHL, AMED, PEDro, EMBASE, REHABDATA Database, and Scopus was done to identify randomized controlled trials of body awareness therapy in individuals with stroke. The PEDro scale was used to evaluate the methodological quality of included trials. The primary outcome measures of this review were the 10-Meter Walk Test (10MWT) and Berg Balance Scale (BBS). Due to varying included trials, meta-analysis was not carried out. Nine randomized controlled trials with 332 patients were analyzed. Body awareness therapy exhibited a moderate confirmation to better balance and gait function of stroke survivors. Body awareness therapy could be a well-founded rehabilitative intervention and might support enhanced balance and gait function of individuals with stroke.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2020-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s260476","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48298515","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":"Remdesivir is Effective for Moderately Severe Patients: A Re-Analysis of the First Double-Blind, Placebo-Controlled, Randomized Trial on Remdesivir for Treatment of Severe COVID-19 Patients Conducted in Wuhan City","authors":"W. Shih, Xin Shen, Peng Zhang, Tai Xie","doi":"10.2147/oajct.s262606","DOIUrl":"https://doi.org/10.2147/oajct.s262606","url":null,"abstract":"Introduction: The first clinical trial on remdesivir for treatment of severe COVID-19 conducted in China was terminated prematurely due to limited patient enrollment, which rendered the findings inconclusive. We re-analyzed the efficacy with a statistically more powerful and clinically meaningful method based on published data using the 6-point ordinal scale of patient’s disease severity. Methods: We defined response as patient’s point reached, either 2 (hospitalized, no require-ment for supplementary oxygen therapy) or 1 (discharged or met discharge criterion), and then analyzed with logistic regression with baseline score, day of assessment, treatment group, baseline by treatment interaction, and day by treatment interaction as covariates. The binary endpoint was supported by the recent FDA’s guidance on COVID-19. Results: Eighty-two percent (82%) of the patients were in the disease severity point=3 (hospitalized, required supplemental oxygen (but not NIV/HFNC)) – the moderately severe category. The response rate was 85% for remdesivir-treated patients with baseline disease point=3 versus 70% response rate for likewise placebo-treated patients on Day 28 (OR=2.38, P=0.0012). On Day 14, the response rate for these patients was 43% for remdesivir versus 33% for placebo (OR=1.53, P=0.0022). For patients with baseline disease point=4 (critically severe category), no similar comparisons were statistically significant. Conclusion and Discussion: The Chinese trial was not really under-powered as previously perceived or portrayed by many opinions. This result supports the preliminary findings of ACTT that remdesivir is effective for patients who were not critically severe. This result also suggests that remdesivir should be given to hospitalized COVID-19 patients as soon as possible. There is no race difference in the treatment effect.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2020-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s262606","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43654704","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":"MCLENA-1: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Lenalidomide in Patients with Mild Cognitive Impairment Due to Alzheimer's Disease.","authors":"Boris Decourt, Jeffrey Wilson, Aaron Ritter, Christopher Dardis, Frank P DiFilippo, Xiaowei Zhuang, Dietmar Cordes, Garam Lee, Nadia D Fulkerson, Tessa St Rose, Katurah Hartley, Marwan N Sabbagh","doi":"10.2147/oajct.s221914","DOIUrl":"10.2147/oajct.s221914","url":null,"abstract":"<p><p>With the general population reaching higher ages, a surge in Alzheimer's disease (AD) incidence will happen in the coming decades, putting a heavy burden on families and healthcare systems Worldwide. This emphasizes the pressing need for AD therapeutic interventions. Accumulating evidence indicates that inflammation is prominent both in the blood and central nervous system of AD sufferers. These data suggest that systemic inflammation plays a crucial role in the cause and effects of AD neuropathology. Capitalizing on our experience from a previous clinical trial with thalidomide, we hypothesize that modulating inflammation via the pleiotropic immunomodulator lenalidomide may alter AD if administered during a proper time window in the course of the disease. Thus, in this Phase II, proof-of mechanism study, 30 amnestic mild cognitive impairment (aMCI) subjects will be treated with lenalidomide at 10 mg/day for 12 months on a 1:1 ratio, followed by a 6 months washout period. The primary objective of this study is to investigate the effect of lenalidomide on cognition, which is assessed at regular intervals. The secondary objective is to assess the safety and tolerability of lenalidomide in aMCI patients evaluated through adverse events, vital signs, clinical biochemistry, and physical and neurological examinations. Tertiary objectives are to analyze the effects of lenalidomide on brain amyloid loads (Florbetapir PET imaging) and neurodegeneration (volumetric MRI) by comparing pre- and post-dosing data. Finally, exploratory objectives will investigate whether blood inflammatory markers can serve as surrogate markers of therapeutic efficacy. Our study should determine whether lenalidomide is safe in AD subjects and whether it can alter the clinical progression of AD when administered before dementia onset. If effective, lenalidomide would become the first drug capable of delaying the trajectory of AD, which could lead the way to find additional, less toxic treatments in the near future.</p>","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/27/4b/nihms-1067860.PMC7051033.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37699039","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":"The Challenges In Conducting Research Studies In Arabic Countries","authors":"N. Sheblaq, Amal Al Najjar","doi":"10.2147/oajct.s215738","DOIUrl":"https://doi.org/10.2147/oajct.s215738","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s215738","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47965001","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":"Verified Hepatorenal Syndrome Reversal As A Robust Multi-Component Primary End Point: The CONFIRM Study Trial Design","authors":"K. Jamil, S. Pappas, F. Wong, A. Sanyal","doi":"10.2147/oajct.s224974","DOIUrl":"https://doi.org/10.2147/oajct.s224974","url":null,"abstract":"Background: Hepatorenal syndrome type 1 (HRS-1) is an uncommon, rapidly progressing, potentially fatal renal failure if left untreated. Terlipressin is a vasopressin analog that is fi rst-line therapy in combination with albumin for treatment of HRS-1 in countries outside of North America. In two previous Phase III clinical trials, terlipressin showed favorable effects on improvement in renal function compared with placebo; however, neither study showed a signi fi cant between-group difference in the primary end point. CONFIRM (NCT02770716) is an ongoing clinical trial designed to address operational challenges observed in the previous studies by using a novel, more clinically relevant primary end point than the previous studies. Methods: This Phase III, randomized, double-blind, multicenter study is expected to enroll about 300 patients at approximately 70 sites in the US and Canada. Patients with cirrhosis and ascites demonstrating renal impairment via rapidly progressive worsening of serum creatinine (SCr) level ( ≥ 199 μ mol/L [ ≥ 2.25 mg/dL] with a trajectory of SCr doubling over 2 weeks) are randomized 2:1 to receive either terlipressin 1 mg every 6 hrs as an IV bolus injection or placebo. The design of the study is generally similar to previous terlipressin prospective studies in the setting of HRS-1. A key feature differentiating this study from the previous ones centers around a novel, multi-component ef fi cacy variable that extends beyond the traditional outcome of improvement in renal function to include durability of treatment-related effects on renal replacement therapy (RRT) requirements and survival. To meet criteria for the primary ef fi cacy end point in CONFIRM, patients must show not only HRS reversal con fi rmed by two SCr values ≤ 1.5 mg/dL, but also survive, without RRT, for at least 10 days after achieving it. Conclusion: Data from this pivotal study will demonstrate whether terlipressin treatment is effective as measured by a new, clinically meaningful, multi-component primary ef fi cacy end point.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2019-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/oajct.s224974","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45255010","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}