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

{"title":"The Impact of the COVID-19 Pandemic on Healthcare Costs: A Descriptive Cross-Sectional Study","authors":"Joel De La Cruz-Oller, A. Ojeda-Castro, Mustafa Reha Dodurgali, J. Valera-Marquez","doi":"10.21801/ppcrj.2022.84.8","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.8","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41381230","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":"Prevalence of pharmacological control of arterial hypertension by ambulatory blood pressure measurement (ABPM) findings","authors":"J. Abreu, Ramón Romano, L. Reyes, Sharon Calderato, Oscar Vasquez, Pedro Peguero, I. Gutiérrez, Yaris Feliz","doi":"10.21801/ppcrj.2022.84.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.5","url":null,"abstract":"Introduction: Arterial hypertension (AHT) is one of the most prevalent chronic non-transmittable diseases and the main cause of cardiovascular death worldwide (World Health Organization, 2021). Adequate control of blood pressure levels is the best therapeutic measure to manage and prevent hypertension-related complications. In the Dominican Republic, there is insufficient and unreliable data related to pharmacological control through ambulatory blood pressure measurement (ABPM). Methods: Cross-sectional and retrospective study, in which the results of 380 patients, who underwent an ABPM, were analyzed to determine if their blood pressure levels were within therapeutic control. The study was conducted between March 2022 and May 2022. The diagnostic criteria to determine blood pressure control were used from the guidelines of the Specialized Diagnostic Center (CEDISA), and included being older than 18 and having a study duration longer than 18 hours. Likewise, we excluded pregnant patients, patients diagnosed with heart failure, or patients taking triple antihypertensive therapy. For the data summary, we used mean and standard deviation. For statistical testing, we performed a Shapiro-Wilk normality test, and a two-tailed Student's t-test was used to assess the mean difference for which a value of p<0.05 was chosen to demonstrate significance. We performed a Bonferroni correction to adjust the significance value using the mean blood pressure in the repeated measures for the t-test, which reduced the significance from 0.05 to 0.016. Results: The point prevalence of adequate pharmacological control was 44.2% (95% CI 39.21% to 49.19%). The mean systolic blood pressure of controlled patients was 117.8 (±7.5), while that of un-controlled patients was 140.8 (±14.5). Between controlled and uncontrolled patients, the drugs most frequently used for managing hypertension were angiotensin II, receptor antagonists. There is a statistically significant difference between the mean 24-hour and daytime systolic blood pressure between males and females (p. 0.0016 and p. 0.0007, respectively) and 24-hour, daytime, and nighttime systolic blood pressure between controlled and uncontrolled patients (p. 0.000, p. 0.000, p 0.000, respectively) Discussion: The prevalence of adequate pharmacological control in patients suffering from arterial hypertension encompasses 168 patients of the 380 studied, so it is evident that the remaining 212 patients, even when diagnosed, have not managed to obtain controlled blood pressure levels. The study was limited by not being able to investigate the treatment specifications and other risk factors. Regardless of these issues, the study obtained the desired sample size; therefore, it can establish the study’s reported AHT control prevalence as a direct measure of hypertensive patients in the Dominican Republic not being adequately controlled.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42782185","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 effects of aquatic exercises on body functions, activity and participation in children and adolescents with cerebral palsy: a systematic review","authors":"Jorge Franklin Mansur Rodrigues Filho, Jeane Assunção, A. Carvalho","doi":"10.21801/ppcrj.2022.84.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.7","url":null,"abstract":"Introduction: Aquatic exercises may benefit children and adolescents with cerebral palsy (CP). Nevertheless, there are few studies about the efficacy and safety of those interventions for this population. Therefore, the objective of this study was to perform a systematic review of the effects of aquatic interventions in children and adolescents with CP, considering outcomes related to the body structure, function, activity, and participation; based on the World Health Organization International Classification of Functioning, Disability and Health framework (ICF). Methods: We searched for experimental or quasi-experimental studies about aquatic exercises’ effects on children and adolescents with CP. We used the databases PubMed/MEDLINE, CINAHL, Scielo, LILACS, SPORTDiscus, Cochrane Reviews, Trials, and PEDro, from January 1st, 2011, to December 31st, 2020. In addition, the risk of bias was assessed with the PEDro tool. Results: 10 randomized clinical trials and five quasi-experimental studies were included. The focus was on aerobic activities in children with spastic CP, mainly classified as levels I to III in the Gross Motor Function Classification System (GMFCS), outcomes related to structure and function, and activity. Thirteen studies reported positive effects, but the methodological quality was low. Discussion: Aquatic exercise programs are feasible and demonstrate a positive effect on this population. There is a need for studies of better methodological quality, including children classified as GMFCS V and outcomes based on the domain of participation.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49020439","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":"Lack of Clinical Research and Evidence Based Medicine during COVID-19 pandemic in Peru","authors":"Adriano Huaroc-Revollar, Enrique O. Bedoya-Ismodes","doi":"10.21801/ppcrj.2022.84.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.2","url":null,"abstract":"Dear editor, One of the biggest advances facing the COVID-19 pandemic was the development and application of vaccines around the world. Different studies worldwide have found and concluded that the best way to prevent complications and reduce the incidence rates of this disease, is by implementing preventive measures through the application of vaccines. (Thompson et al., 2021). In Perú, the mortality and hospitaliztion rates have decreased since the vaccine application, but the main public health problem emerges when ministers, leaders and medical profesionals that are selected without implementing the proper criteria, do not consider the vaccination as an important way for preventing the disease and prefer the use of medicine that does not have enough evidence. The application and the objective of reaching the minimum coverage of vaccinated population depends on the Ministry of Health and on the intensive work of the health personnel at sites of application, even at places that would be otherwise not used for this purpose. Unfortunately, as previously mentioned, some of these professionals used and prescribed drugs without evidence to treat COVID-19, such as ivermectin, hydroxychloroquine, azithromycin and many others for all patients and without clinical criteria. The investment and expenses that public Peruvian economy used for COVID19 treatment, left without supply of medicines for diseases that should be used as the first line of treatment as hydroxychloroquine for malaria or ivermectin for strongyloidiasis and many other examples. By this, the individual decisions of treating a disease without the correct evidence, generates that people who require this medication are left without availability and increase the symptoms and complications of other disease that are present. Instead, a better strategy that should be done was the implementation of oxygen plants, due is demonstrated that early application of oxygen in appropriate cases is critical improving mortality rate and is necessary for many other respiratory diseases. (COVID-19 Treatment Guidelines Panel., 2022) Why is this important? Because of the number of people that died because of COVID-19, not only due to a complication of the disease itself, but also due to Academic Editor: Felipe Fregni Peer-reviewers: Nicole Sanchez, Leandra Ramin, Niels Pacheco.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47276249","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 Efficacy of Creatine Supplementation in Improving Cognitive Performance in Adolescents: A Phase-II, Triple-Blind, Randomized Study Protocol","authors":"Salma K Ahmed, Gauruv Bose, A. Adenuga, Carlos E. Insfrán, Carolina Ashihara, Daniel Sacoto, Delaney Orbaugh, Isra Ahmed, Javiera Vargas, Jefferson Luiz Gross, July N Alves, M. Moreno, Mariana Turza, M. Lôbo, Olivier Forian Clerc, Pablo Morejon-Jaramillo, Patricia Lora, R. Cordeiro, Rodrigo Niño, Samah N Gashey, Sara Hayder Ahmed, S. Salameh, Yuri Chemale, Thais G. Moreira","doi":"10.21801/ppcrj.2022.84.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.4","url":null,"abstract":"Background/Aims: Creatine supplementation has demonstrated cognitive benefits in neurodegenerative conditions, having a protective effect in the brain's function in stressful situations, with excellent safety (Watanabe et al., 2002). However, any beneficial effects on the cognitive performance of healthy adolescents underperforming in school is unknown. Our objective is to assess whether creatine supplementation improves cognitive performance in 15- to 17-year-old students with an average school grade below the 50th percentile. Methods: This will be a phase-II, triple-blinded, randomized, parallel-group, superiority, single-center trial. Students with grades below the 50th percentile in the prior semester will be enrolled and randomized to receive juice packages containing either creatine monohydrate supplementation (0.1 mg/kg/day), or placebo, for 12 weeks. The primary outcome will be the mean difference in change of Raven’s Standard Progressive Matrices (RSPM) scores from baseline to week 12 between groups. To achieve a 90% power for detecting a 3-point difference in change in the RSPM score, and accounting for drop-out, 116 participants will be included. Secondary outcomes will include the difference in processing speed (SpaceCode), working memory (SpaceMatrix), non-visual memory (backward digit span), percentage change in lean mass, and any safety events. Conclusion: To our knowledge, this will be the most comprehensive study assessing creatine supple-mentation in adolescents. This is a low-risk intervention that has been shown to improve cognitive function in other populations. This study will potentially support the widespread use of creatine supplementation in adolescents with low school performance, while having a positive impact on this population.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49372275","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":"Editorial: Enrollment and Adherence of Minorities in Clinical Trials for Chronic Pain","authors":"Lucas Camargo, A. Cardenas-Rojas, Daniela Martinez-Magallanes, Caroline Araujo, F. Fregni","doi":"10.21801/ppcrj.2022.84.9","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.84.9","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42800228","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, double-blind, placebo-controlled, Phase 1/2a trial protocol to assess the safety and efficacy of TAK-101 administered by microneedles in patients with celiac disease","authors":"Jwn Corrêa","doi":"10.21801/ppcrj.2022.83.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.5","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48905649","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 ExCITE-BA Trial: Effects of physical activity plus behavioral activation on preserving cognitive function in elderly patients with mild cognitive im-pairment Protocol for a randomized, controlled, phase II, parallel, single-blinded, superiority trial","authors":"E. Suriano","doi":"10.21801/ppcrj.2022.83.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48525503","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 HABIT: Heparin and Aspirin on Birth in Inherited Thrombophilia, an International Multicenter Phase IIb Randomized Triple Blinded Clinical Trial","authors":"Alessandra Carvalho","doi":"10.21801/ppcrj.2022.83.8","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.8","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47940387","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 an mHealth App as an add-on for Smoking Cessation in One year: A multicenter and randomized Trial (The MASCOT study)","authors":"Tatiana Gomez Gomez","doi":"10.21801/ppcrj.2022.83.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.6","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42805511","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}