Clinical Trials and Practice – Open Journal最新文献

{"title":"Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need","authors":"Nathalie Vives","doi":"10.17140/ctpoj-1-112","DOIUrl":"https://doi.org/10.17140/ctpoj-1-112","url":null,"abstract":"Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension, diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication, community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial. Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics, benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient recruitment strategies that would mitigate the current lack of diversity","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133218376","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 Role of Negative Pressure Wound Therapy with Instillation and Dwell Time in the Preparation of Wound Bed","authors":"Nishad Kerakad, R. Chittoria, S. Gupta, C. Reddy, P. Mohan, I. Pathan, S. Koliyath, N. Thomas","doi":"10.17140/ctpoj-3-115","DOIUrl":"https://doi.org/10.17140/ctpoj-3-115","url":null,"abstract":"Introduction Although the negative pressure wound therapy (NPWT) is a time tested method of wound preparation, the role of NPWT with instillation and dwell time (NPWTi-d) in decreasing the downtime of wound preparation needs to be evaluated. Objective The objective of this study is assess the role of NPWTi-d in wound bed preparation. Materials and Methods This study was conducted in a tertiary care center, after getting informed consent and ethical clearance. NPWTi-d was done on a 36-years-old female with no known co-morbidities admitted with infected raw area over the right below knee amputation stump and exposed bone who was not responding well to conventional wound dressing. NPWT was applied with the help of sterile polyurethane sponge and two tubes. The antimicrobial solution used was ionic silver solution, just enough to wet the sponge completely and up to the point when the transparent occlusive covering begins to lift. Negative pressure was applied at 125 mmHg. The wound was bathed with ionic silver solution and it was allowed to stay in the wound for 10-minutes, after every 2-hours of negative pressure application. This was continued for 1-week. The dressing was opened at the end of 1-week, wound irrigated with normal saline, exudate swabs for culture taken and debrided, following which fresh NPWTi-d was applied. This was repeated for the next 3-weeks. Result By the end of third week, the wound became clean, fully covered with healthy granulation and the wound bed was ready to undergo the definitive wound cover procedure.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"55 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129213008","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":"How a Network Came Together to Manage a Large Research Program During the Pandemic","authors":"Tamara Friedman, E. G. Paleoudis, Avery Freed, Susan Adler, Cheryl Fittizzi","doi":"10.17140/ctpoj-3-114","DOIUrl":"https://doi.org/10.17140/ctpoj-3-114","url":null,"abstract":"Hackensack Meridian Health, a large New Jersey network comprised of 17 hospitals, a medical school, and 200 ambulatory care centers, executes a large research program with approximately 1000 active human subjects studies. With the arrival of the coronavirus disease-2019 (COVID-19) pandemic, the Office of Research Administration was confronted with a series of challenges. These included minimizing face-to-face contact among research participants and staff, allocating limited resources to handle the influx of COVID-19 related proposals, providing human subjects protection training to the physicians and staff who were needed to run the clinical trials, adjusting bio-repository activities to meet the increased demand for samples, and disseminating all of the new regulatory and operational information to the thousands of researchers in the network. The network’s success in modifying its research program quickly and effectively to adapt to the changing landscape can be attributed, in large part, to the centralized nature of the research administration.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"110 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126790710","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":"Role of Low-Level Laser Therapy as an Adjunct in the Management of Diabetic Ulcer","authors":"S. Koliyath, R. Chittoria, C. Reddy, P. Mohan, I. Pathan, N. Thomas, N. Kerakada","doi":"10.17140/ctpoj-3-116","DOIUrl":"https://doi.org/10.17140/ctpoj-3-116","url":null,"abstract":"Diabetes mellitus (DM) is a chronic debilitating condition affecting people worldwide and diabetic foot ulcers are also a common problem. The treatment of diabetic ulcers requires a multimodal approach. Adjuvant low-level laser therapy (LLLT) may be useful in lesions with protracted healing course but the evidence is still limited. In this study, we share our experience regarding the use of low-level laser therapy as an adjuvant treatment modality in a patient with diabetic foot ulcer.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"45 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134427071","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":"Innovation in Clinical Trials is Possible: The Hidden Opportunity in the Coronavirus Disease-2019 Emergency","authors":"V. Scarano, David A. Smaldone","doi":"10.17140/ctpoj-3-113","DOIUrl":"https://doi.org/10.17140/ctpoj-3-113","url":null,"abstract":"The coronavirus disease-2019 (COVID-19) emergency has clearly shown the need to discover, test and produce a new vaccine but also in general the fragility of the current chain of clinical trials. Through this emergency, is it possible to look at the current clinical trial processes with new eyes? Is it possible to seize the opportunity for change and to have confidence in the possibility of their improvement? In this short article the authors wanted to give an optimistic answer to this question by pushing on the possibilities of innovation nowadays.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124796415","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 Digital Stethoscope in Telemedicine: A Health Camp Study","authors":"I. Pathan, R. Chittoria, S. Gupta, C. Reddy, P. Mohan, S. Koliyath, Nishad K, Mohamed Ishaq Z","doi":"10.17140/ctpoj-3-111","DOIUrl":"https://doi.org/10.17140/ctpoj-3-111","url":null,"abstract":"India is a vast country with limited human resources. People living in remote areas often have limited access to healthcare facilities. To address this need and to increase healthcare awareness, health camps have been established. These camps are often supervised by junior physicians. Telemedicine, and in particular use of a digital stethoscope may provide better diagnosis and better consultation to the patient by senior physicians located remotely. This article highlights the clinical use of a digital stethoscope in such a health camp.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"68 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133860090","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":"Role of Sound Enhancer Device in Teleconsultation","authors":"S. Koliyath, R. Chittoria, V. Chavan, Abhinav Aggarwal, S. Gupta, C. Reddy, P. Mohan, I. Pathan","doi":"10.17140/ctpoj-2-106","DOIUrl":"https://doi.org/10.17140/ctpoj-2-106","url":null,"abstract":"Aim To study the role of sound enhancer device in teleconsultation. Methods This study was conducted in the plastic surgery department in a tertiary care centre in the month of May-June 2019. A sound enhancer device was used with mobile phone for videoconferencing as form of teleconsultation by plastic surgery trainees in operation theatre and outpatient department. At the end of the study feedbacks were taken from the trainees. Results It was found that on using the sound enhancer device, the sound quality improved and it was helpful in the teleconsultation sessions using videoconferencing. Conclusion The use of sound enhancer is a simple, cost-effective, innovative method of using a simple technology to aid in utilisation of teleconsultation facilities in a very non-sophisticated way.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131319594","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":"Remote Consent Clinical Research","authors":"P. Sriram","doi":"10.17140/ctpoj-2-109","DOIUrl":"https://doi.org/10.17140/ctpoj-2-109","url":null,"abstract":"Recruitment in clinical research trials can be challenging in trials that are time-sensitive and/or are rare disease and critical care trials. One of the hurdles for recruitment in these types of clinical trials is due to the consent process, and the need to have consent of the patient within a certain timeframe, or the patient unable to consent for themselves. This paper will discuss the usage of the utilization of remote consent options for these trials.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127565481","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 Effectiveness of Transcutaneous Electrical Nerve Stimulation Versus Carbamazepine in Trigeminal Neuralgia: A Randomized Controlled Trial","authors":"R. Millán-Guerrero, R. Isais-Millán, G. Castillo-Varela, Gabriel Ceja-Espíritu, M. A. Higareda-Almaraz","doi":"10.17140/ctpoj-2-104","DOIUrl":"https://doi.org/10.17140/ctpoj-2-104","url":null,"abstract":"Objectives To determine if the treatment of refractory trigeminal neuralgia (TN) with transcutaneous electrical nerve stimulation (TENS) could lead to improved pain control. Materials and Methods We enrolled 20 patients with refractory TN in a double blinded, randomized, placebo-controlled clinical trial. Patients received either TENS for group 1 (n=10) or carbamazepine (CBZ) for group 2 (n=10). The visual analog pain scale (VAS) and the barrow neurological institute (BNI) pain scale, the number and duration of pain episodes and daily analgesic intake were analyzed for each group at 1 month, 2 months, 3 months, 1 year, 3 years and 5 years. Results The TENS group achieved better pain control than the CBZ group (p<0.05). Pain-free patients accounted for 60% in the TENS group and 50% in the CBZ group 1 month after initiating treatment, 100% and 77.77% at 3 months, 100% and 62.5% at 1 year, 100% and 50% at 3 years, respectively. The TENS group remained pain free for 3 years. At the 5-year mark, all members of the TENS group and the CBZ group presented pain recurrence. Conclusion TENS group scored significantly lower in pain scales compared with the CBZ group. TENS group was pain free for a longer period of time compared with the CBZ group. Significant differences between both groups favored TENS therapy, however the small sample size remains an important limitation of this study.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116786188","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":"Role of Bactiguard Infection Technology in Preventing Catheter-Associated Urinary Tract Infections","authors":"S. Koliyath, R. Chittoria, Abhinav Aggarwal, S. Gupta, C. Reddy, P. Mohan, I. Pathan","doi":"10.17140/ctpoj-2-108","DOIUrl":"https://doi.org/10.17140/ctpoj-2-108","url":null,"abstract":"To study the role of bactiguard infection technology (BIP) in preventing Catheter-associated urinary tract infections. This study was conducted in a tertiary care centre in the Department of Plastic Surgery, JIPMER, Pondicherry, India in the month of August 2019. The study subject was a 55-year-old gentleman with Fournier’s gangrene and type 2 diabetes mellitus (DM). The Foley’s catheter with BIP technology was used and its role in preventing urinary tract infections (UTI) was studied over a period of 10-days. During the period of the catheter use in our subject, patient did not develop features of urinary tract infections. BIP technology is claimed to be effective in preventing Catheter-associated urinary tract infections but further studies in more individuals is required to validate the same.","PeriodicalId":259842,"journal":{"name":"Clinical Trials and Practice – Open Journal","volume":"22 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131805250","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}