Open Access Journal of Clinical Trials最新文献

Evaluation of a Newly Developed Transdiagnostic Cognitive Behavioral Therapy Group to Promote Healthy Aging Among Older People with HIV: Study Protocol for a Pilot Randomized Controlled Trial 评估新开发的跨诊断认知行为疗法小组，以促进感染艾滋病毒的老年人健康老龄化：试点随机对照试验的研究方案

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2024-06-01 DOI: 10.2147/oajct.s451233

Jacklyn Foley, Lauren Bernier, Stephanie Schiavo, Madison Davis, Abigail Batchelder

引用次数: 0

Center with or Without a Coordinator? The Coordinator as an Integral Part of a Research Team 中心有无协调员？作为研究团队重要组成部分的协调员

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2024-05-01 DOI: 10.2147/oajct.s462674

Izabela Gudewicz, Justyna Hajtuch, Renata Zaucha

{"title":"Center with or Without a Coordinator? The Coordinator as an Integral Part of a Research Team","authors":"Izabela Gudewicz, Justyna Hajtuch, Renata Zaucha","doi":"10.2147/oajct.s462674","DOIUrl":"https://doi.org/10.2147/oajct.s462674","url":null,"abstract":": The entire clinical trial process is a perfectly orchestrated team. It took many years before centers started hiring clinical trial coordinators. The centers that decided to do so noted not only positive aspects from the technical side of the study, but also from the side of the participants - which are the patients. The aim of the publication was to collect literature data showing the work of the coordinator in the centers and its impact on increasing the effectiveness of the study. The comparison additionally included the importance of the coordinator’s role on patient recruitment and perceptions. The centers analyzed, showed the impact of the coordinator on their center’s research at approximately: 99.1% in China (knowledge of patient rights), 80% in Italy (increasing the quality of the clinical trial conducted) and 70% in South Korea (impact on reducing patient withdrawal of consent). Those teams that worked without the support of a coordinator gained less trust among patients, which affected recruitment and retention of participants. The coordinator’s influence on study management resulted in better organization of the study. Conclusions reached can support the development of centers and thus clinical trials around the world. Hiring a coordinator not only has an impact on improving the management of the study, but also on increasing the number of patients included, and thus increasing the therapeutic options in medicine. This paper aims to compile existing literature concerning the responsibilities of clinical trial coordinators and subsequently advocate for the value they bring to enhancing the efficacy and efficiency of clinical trials.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141132350","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}

引用次数: 0

A Multidomain Intervention Program for Older People with Dementia: A Pilot Study 一项针对老年痴呆症患者的多领域干预计划：一项试点研究

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2023-04-01 DOI: 10.2147/oajct.s403282

Thanh Xuan Nguyen, Huyen Thi Thanh Vu, T. Nguyen, A. Esterman, Luc Viet Tran, Janani Thillainadesan, V. Naganathan, H. Brodaty, Anh Trung Nguyen

引用次数: 0

Randomized Clinical Trial Comparing Insulin Fast Dissolving Films versus Control Group for Anosmic Patients for Improving Their Health and Social Qualities of Life 比较胰岛素快速溶解膜与对照组对嗅觉丧失患者改善其健康和社会生活质量的随机临床试验

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2022-12-01 DOI: 10.2147/oajct.s389489

Soad A Mohamad, S. M. Sayed, A. A. Sadek, A. Badawi

{"title":"Randomized Clinical Trial Comparing Insulin Fast Dissolving Films versus Control Group for Anosmic Patients for Improving Their Health and Social Qualities of Life","authors":"Soad A Mohamad, S. M. Sayed, A. A. Sadek, A. Badawi","doi":"10.2147/oajct.s389489","DOIUrl":"https://doi.org/10.2147/oajct.s389489","url":null,"abstract":"Background: Olfactory anomalies are the most common diseases among post-COVID-19 disorders. Only 15% of patients completed their prescribed treatment plans, even though several different treatment strategies were recommended;this had a detrimental effect on the patients' physical, social, and emotional wellbeing.Purpose: The aim of this study was approving intranasal fast-dissolving insulin films as the treatment of choice for anosmia in comparison to the control group, and the innovative treatment for anosmic post-COVID-19 is assessed in terms of the patients' health-related quality of life (HRQoL).Methods: For therapy and evaluation, a randomized clinical trial with forty adult anosmic post-viral patients was performed. The recruited participants were recruited between October 1 and March 8 of 2021 based on predetermined criteria. A validated smell assessment questionnaire concerning the participants' olfactory, physical, and psychological outcomes was given to them. Recruited patients were randomly subdivided into two groups: intervention and control group. Intervention was treated with insulin intranasal films, while control group took plain films (placebo).Results: The physical, emotional, and social health quality of life were significantly (p-value <0.0001) improved after 4 consecutive weeks of treatment with the intervention group compared to the control group. The data were analyzed statistically with the aid of GraphPad Prism 9.1.0.Conclusion: The lowest HRQoLs, which significantly impact their quality of life, are found in post-COVID-19 anosmic patients treated with insulin films. It is advised to employ this new intervention (insulin films) as the main therapy approach and to gather additional industry data for its development and dissemination. Problems with self-hygiene, eating, sense of danger and emotional satisfaction were significantly enhanced with insulin intervention versus placebo.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413732","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}

引用次数: 0

Treatment of Oropharyngeal Symptoms: A Prospective, Single-Dose, Placebo-Controlled, Randomized Clinical Trial 口咽症状的治疗:一项前瞻性、单剂量、安慰剂对照、随机临床试验

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2022-03-01 DOI: 10.2147/oajct.s331883

Katharina Kapoor, D. Wilhelm, C. Neumeister, M. R. Götz, U. Schwantes, G. Bleckert, Lilli Gerstenmaier, A. Jambrecina

引用次数: 0

Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain 人脑早期光遗传学试验的试验后考虑因素

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2022-02-01 DOI: 10.2147/oajct.s345482

Michael White, R. Whittaker

{"title":"Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain","authors":"Michael White, R. Whittaker","doi":"10.2147/oajct.s345482","DOIUrl":"https://doi.org/10.2147/oajct.s345482","url":null,"abstract":": For many clinical trials, the issue of post-trial access to research treatments is straightforward. Sponsors offer a range of follow-on studies, compassionate use programs or expanded access programs to allow participants to continue accessing beneficial experimental treatments. But there are times when this is not always the case and participants are required to stop beneficial treatments and return to standard care. Guidance states that post-trial access should be made available for “those participants who still need an intervention identified as beneficial”. This broad statement has allowed sponsors to make their own interpretation of when an intervention is still “needed” and when it is “beneficial”. As a result, there have been a number of situations where participants of clinical trials have been left afterwards with feelings of abandonment. Participants involved in studies with long-term, invasive treatments can be seen as being particularly vulnerable. Optogenetic technology has the potential to offer hope to people with neurological conditions, especially people who may not respond to current approved treatments. Optogenetics typically involves two components: a gene therapy medicinal product (GTMP) that induces long-term expression of light-reactive proteins within cells, and an active implantable device to stimulate the light-sensitised cells. Neither works without the other, hence for long-term patient benefit, both must remain active and may therefore require maintenance or replacement. With the potential life-long consequences of both components and the difficulty of accessing the brain, there is a need to reconsider post-trial guidelines and whether they are suitable to support early phase optogenetic trial participants. This paper considers the ethical and regulatory requirements in place for post-trial access and care in relation to optogenetic treatments of neurological conditions. We propose that a new perspective with wider responsibilities for sponsors is required when it comes to these types of novel therapies.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48850333","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}

引用次数: 5

Reviewing Treatments for Cocaine Consume Problems: The Gabapentinoid Alternative 回顾可卡因消费问题的治疗:加巴喷丁类药物的替代品

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2021-09-23 DOI: 10.2147/OAJCT.S327934

Gabriel C Quintero Garzola

{"title":"Reviewing Treatments for Cocaine Consume Problems: The Gabapentinoid Alternative","authors":"Gabriel C Quintero Garzola","doi":"10.2147/OAJCT.S327934","DOIUrl":"https://doi.org/10.2147/OAJCT.S327934","url":null,"abstract":"Background: Cocaine use disorder is a worldwide problem. Presently, however, no adequate treatments exist. Gabapentin has been explored recently as an alternative for treating different substance use disorders, including cocaine. Methods: The aim of the present paper is to assess the effectiveness of gabapentin for treating cocaine use disorders. For this purpose, a systematic review of the literature was performed using the publication database, PubMed, with search limits from January 1, 1983 to February 28, 2018. The search terms used were combined as follows: “gabapentin” AND “cocaine”. Initially, 41 articles were identified, with additional 23 articles identified through reference exploration or web search. These 23 complementary articles relate mainly to the general description of gabapentin and discussion. After the analysis of the titles and abstracts, 18 references were removed, resulting in 46 articles for further analysis. Results and Discussion: Gabapentin is inadequate for treating cocaine dependence and relapse, and alleviating the subjective effects of cocaine. More research is necessary for exploring gabapentin alleviation of cocaine intoxication, and further investigation is required for confirming the gabapentin’s utility for treating cocaine addiction.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2021-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46645587","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}

引用次数: 0

Social Support Intervention for Self-Management of Type 2 Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial 社会支持干预对2型糖尿病自我管理的作用:一项随机对照试验的研究方案

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2021-07-26 DOI: 10.2147/OAJCT.S314030

Claudia Milena Garizábalo-Dávila, Alba Luz Rodríguez-Acelas, R. Mattiello, Wilson Cañón-Montañez

引用次数: 3

Impacts of Research Staff Burnout for a National Large Scale Pragmatic Clinical Trial 研究人员职业倦怠对国家大型实用临床试验的影响

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2021-07-01 DOI: 10.2147/OAJCT.S312365

Alison Majkut Klint, Jacob I. McPherson, Abhinav Tella, W. Vang, Srihari I Raju, Rebecca Windschitl, A. Ishani

{"title":"Impacts of Research Staff Burnout for a National Large Scale Pragmatic Clinical Trial","authors":"Alison Majkut Klint, Jacob I. McPherson, Abhinav Tella, W. Vang, Srihari I Raju, Rebecca Windschitl, A. Ishani","doi":"10.2147/OAJCT.S312365","DOIUrl":"https://doi.org/10.2147/OAJCT.S312365","url":null,"abstract":"Introduction: Burnout can have a negative impact on job satisfaction and productivity. Antecedents to burnout include workload, control, values, fairness, reward, community and job-person incongruency. Purpose: To better understand the impact of burnout in research staff, these seven antecedents to burnout were analyzed retrospectively within the call centers for the Diuretic Comparison Project. Methods: Two call centers were analyzed with respect to these antecedents to burnout. Consent rates and employee turnover of the two call centers were compared as a means of comparing productivity and job satisfaction, respectively. Results: An odds ratio of 0.13 (95% CI=[0.0164, 1.0853]) indicates that an employee at the Minneapolis call center had lower odds of leaving than an employee at the Canandaigua call center. The call center in Canandaigua had a consent rate of 2.7% (Figure 2). The consent rate for the same months of the following year in Minneapolis came out to 14.6%. Conclusion: A higher consent rate and lower turnover rate of the call center in Minneapolis could be a result of lower levels of burnout among callers. The confidence interval of the odds ratio calculated for turnover indicates that the result is not statistically significant. Due to the retrospective nature of the analysis, extraneous variables were not controlled for analyzing this data. The protocol of the Minneapolis call center appears to take into consideration the antecedents to burnout more than that of the Canandaigua call center. Further studies on burnout prevention methods for clinical research are needed. Research staff could benefit from strategies to help reduce burnout. Organizations should provide proper protocols and training concerning stress and burnout to improve the well-being of employees and, in turn, their productivity.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":1.2,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48741420","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}

引用次数: 0

Intensive Home Blood Pressure Lowering in Advanced Chronic Kidney Disease: A Pilot Randomized Controlled Trial Protocol 强化家庭降压治疗晚期慢性肾病:一项试点随机对照试验方案

IF 1.2

Open Access Journal of Clinical Trials Pub Date : 2021-06-24 DOI: 10.2147/oajct.s311821

S. Bae, C. McCulloch, Raymond K. Hsu, E. Ku

引用次数: 0