Principles and practice of clinical research (2015)最新文献

{"title":"Weight loss and mortality in people living with HIV: Systematic Review Protocol and Meta-analysis","authors":"S. A. Cordeiro, T. Lopes, R. L. Gonçalves","doi":"10.21801/ppcrj.2021.73.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.73.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42982115","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":"Neuromodulatory effects of Transcranial Pulsed Current Stimulation (tPCS) in Fibromyalgia: protocol for a double-blinded, sham-controlled, randomized clinical trial","authors":"M. Castro, J. Fortes, L. Medeiros, A. de Souza","doi":"10.21801/ppcrj.2021.73.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.73.4","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68355838","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":"Development of a distance education course on Skills and Strategies in Veterinary Communication (SSVC): a contribution to clinical research and evidence-based practice","authors":"Paul A. Tilley","doi":"10.21801/ppcrj.2021.73.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.73.3","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49090572","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 WIRED Trial - Wii Sports™ as a virtual Reality Exercise Experience to improve Depression in healthcare workers during the COVID-19 Pandemic: A Multicenter, Prospective, Randomized, Controlled, Superiority Phase II Trial.","authors":"Julia De Conti Pelanda, A. M. Cabal Herrera, Irene de Torres García, Karen Burken Burgess, Flavia Engel Aduan, A. Koo, Afaf Khaled Hamze, Andreza Lamônica, Bruno Leonardo Duarte Pereira, Camila Sirieiro Abreu, Daniel Sebastian Bustamante Soliz, David Estiven Arboleda Prado, Felipe Alves Vione, H. Theyra-Enias, Huascar Alexander Rodriguez Cuello, Luiza Fonseca Sales de Medeiros, Mirian Antonieta Cardenas Vargas, Mohammed Ali Al-Hamzi, Naglaa Mohammed Ahmed Abdelrahim Omer, Phool Iqbal, Ricardo Virgínio dos Santos, Tiago Ernesto Reyes Castro, Y. C. Cornelio Puello, Juan Manuel Linares, Ahmed Fouad Algendy","doi":"10.21801/ppcrj.2021.73.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.73.1","url":null,"abstract":": Background: Due to the coronavirus pandemic, the number of hospitalized individuals increased exponentially. The sudden increase in workload, the social isolation, and the fear of COVID-19 contributed to a remarkable increase of depression cases (from 20.9% to 43.2%) among healthcare workers. Although many treatments are available for depression, including pharmacotherapy, exercise, and virtual reality, response varies widely, from complete recovery to non-responders and relapsing cases. In this sense, Wii Sports™ may serve as an alternative to improve response to standard first-line therapy, since it provides an interactive environment, physical activity and incorporates playfulness. Objective: Evaluate the effect of Wii Sports™ in treating mild and moderate cases of major depressive disorder in healthcare professionals who developed depression during the COVID-19 pandemic. Methods: The WIRED trial is a phase II, multicenter, randomized, active-controlled, single-blinded, superiority trial with two parallel groups. The intervention group will be composed of Wii Sports™ in addition to a first -line antidepressant, while the con trol group will be composed of Wii™ games that do not involve physical activity in addition to a first -line antidepressant. The primary outcome is to detect a group mean difference in the 17-item Hamilton Depression Rating Scale (HAM-D17) at week twelve, while secondary outcomes include participant adherence and comparison of HAM-D17 scores at different time points. Conclusion: To our knowledge, there is no previous literature published that targets the same population, tests the same intervention, and evaluates the same outcomes, highlighting the possible impact of the study on the psychological and psychiatric fields, regardless of its results.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48080904","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":"Protocol for a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of gamification using Nintendo Switch Ring Fit Adventure game versus standard exercise in the treatment of fibromyalgia","authors":"Sofia Leonardo, Katharina Requião Barretto Bezerra, T. Grigio, Carla Darrás Ismael, Letícia Araujo Pinholato, Antonino Pugliesi, Romelia A. Barba Bernal, Manasa Kotte, C. Furia, N. P. Boris, S. Mohamed, V. Amaral, L. F. Botelho, Franciely Jesus Guedes, M. M. Miyake, María Fe Velarde-Álvarez, A. Azambuja, Antonio Vaz de Macedo","doi":"10.21801/ppcrj.2021.72.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.72.4","url":null,"abstract":"Background: Fibromyalgia (FM) is a chronic condition related to dysfunctional central pain processing mechanisms, which affects 3-6% of the world population, leading to widespread pain, stiffness, and tenderness of the muscles, tendons, and joints, as well as restless sleep, fatigue, depression, and anxiety. Exercise is the most effective way of reducing pain and improving global well-being in people with FM, but such patients present an important limitation to exercise adherence.\u0000Objective: We aim to evaluate whether a home-based gamification strategy will improve the Fibromyalgia Impact Questionnaire Revised (FIQR) scores in female patients aged 18-60 years old as an alternative to traditional exercise.\u0000Methods: The proposed trial is a multicenter, phase II, open-label, parallel, randomized, superiority trial. Female patients ranging from 18 to 60 years old with a diagnosis of FM will be randomized to the intervention group, designed to play the Nintendo Switch Ring Fit Adventure game on three home-based weekly sessions, or to the control group, which will receive general educational guidance through videos and pamphlets provided by the study staff for a total of 12 weeks. The primary outcome will be the mean change in FIQR score results.\u0000Discussion: The development of new strategies to increase exercise adherence can enhance the control of symptoms such as pain, depression, low quality of sleep, and physical limitation in FM patients, thereby improving their quality of life. We believe that gamification strategies such as the one used here can make physical activity more playful, accessible, and dynamic, motivating patients and increasing their physical function compared to those seeking center-based or conventional exercises.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45925093","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 NEAT Study (Novel ElectroAcupuncture) - Electroacupuncture After Laparoscopic Colon Cancer Resection: Thinking Outside The Box. Study Protocol.","authors":"C. Vigna, María-Paz Orellana, Ingrid Sanchez, Natanael Pietroski, R. F. Vieira, Rinaldy Radhames Capellan, Nesiya Hassan, Roberto Rodríguez-Rivas, N. Mohammed, Almudena Fernández-Bravo, C. P. Ordonez, Maiara Cristina de Cesaro, Andy Silva-Santisteban","doi":"10.21801/PPCRJ.2021.72.2","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.72.2","url":null,"abstract":"Introduction: Colorectal cancer is the second leading cause of cancer-related death in the US; complete surgical resection is the only curative treatment for non-metastatic colorectal cancer (NMCC). Postoperative ileus (POI) frequently increases patient morbidity and healthcare costs. Enhanced recovery after surgery (ERAS) protocol is the standard of care in most institutions and has been shown to reduce postoperative complications, but there is no a completely effective treatment for this condition. Studies suggest that electroacupuncture (EA) can improve gastrointestinal tract function after surgery.\u0000Objective: We aim to determine if including EA in the standard treatment of POI decreases the time to the first defecation, enhancing the return of normal bowel function after colon resection for NMCC.\u0000Methods: We propose a phase II, single-center, randomized, triple-blinded, sham-controlled trial with two parallel arms and a 1:1 allocation ratio. Patients 40-80 years of age diagnosed with NMCC scheduled to undergo laparoscopic surgery for colon cancer resection will be included. The arms will be EA + standard treatment and sham EA + standard treatment. The standard treatment will follow the ERAS protocol.\u0000Discussion: This will be the first randomized clinical trial to evaluate the impact of using EA along with the ERAS protocol for POI. This intervention may reduce patient morbidity and improve healthcare costs associated with the disease.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45686476","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":"Effect of kinesio taping on improving pain in patients with patellofemoral pain syndrome: a meta-analysis","authors":"Muneera Al-Muhannadi, K. AlKarbi, K. Al-Khelaifi, Hamda Al-Qaatri, M. Mahmoud, Fawzyia Al-Hor, M. Aseel","doi":"10.21801/ppcrj.2021.72.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.72.6","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41375839","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":"Costs and economic impacts of type-1 diabetes from the Dominican patient perspective","authors":"A. Martinez, Coral Naomi Vargas Peña, Daniela Crespo Almonte, Nancy Esther Romero Castro, Franklyn Augustín Colón Arias, Sergio Gresse Júnior","doi":"10.21801/PPCRJ.2021.72.1","DOIUrl":"https://doi.org/10.21801/PPCRJ.2021.72.1","url":null,"abstract":"Objective: Estimate the economic burden of type 1 diabetes (T1D) in the Dominican Republic and its impact on treatment adherence and patients’ quality of life (QoL).\u0000Materials and Methods: Cross-sectional observational study about T1D treatment cost and adherence plus patients QoL. The total monthly cost of treatment regimes was calculated through microcosting analysis and correlated with a national minimum wage (NMW) and average household income. Sociodemographic, clinical, treatment adherence, and QoL data were obtained through an online questionnaire. In an exploratory approach, all variables were compared with the categorization of household income.\u0000Results: Fixed doses (FD) regime has the lowest cost (46% of the NMW) and continuous subcutaneous insulin infusion (CSII) the highest (540% of the NMW). The lower household income group had less insurance coverage (P= 0.034), purchased fewer diabetes management supplies for cost-related reasons (P= 0.014), performed less glycemic monitoring (P= 0.016), and had more cost-related factors limiting appropriate treatment and follow-up (P= 0.030). Also, the FD treatment modality predominated in this group, while Multiple Daily Injections and constant subcutaneous insulin injection prevailed in the higher income group (P= 0.005). The QoL mean scores were 31.63 (SD 8.02) in the lower-income group and 32.52 (SD 8.81) in the higher-income one.\u0000Conclusions: T1D has a high monthly economic impact, potentially worsening treatment adherence and QoL, especially in the lower socioeconomic status population. Efforts must be made by the healthcare system to enhance the economic support and management of this disease.\u0000KEYWORDS: Type 1 diabetes, Microcosting, Dominican Republic, Public Health, Treatment adherence.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48696380","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":"Scientist at School: Connecting Elementary Students to University Clinical Research Scientists Through Live Streams During a Pandemic in Southern Brazil","authors":"Raul M Rodrigues, C. A. J. O. Agani, Andreia Luciana Bard, S. R. B. Fonseca, Jhoana Uribe Ramos, N. M. Soares, Ândrea Celestino de Souza, Aline Weyh, J. Saute","doi":"10.21801/ppcrj.2021.72.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.72.5","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42323377","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":"Addressing the critical role of gender identity and sex in the planning, analysis, and conduct of clinical trials.","authors":"Karen Vasquez-Avila, Kevin Pacheco-Barrios, Paulo Sampaio de Melo, Felipe Fregni","doi":"10.21801/ppcrj.2021.72.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2021.72.7","url":null,"abstract":"population considering differences in each population’s biological and psychosocial","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":"7 2","pages":"59-62"},"PeriodicalIF":0.0,"publicationDate":"2021-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443128/pdf/nihms-1736673.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39424707","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}