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

{"title":"Digital Interventions in Type 2 Diabetes Mellitus","authors":"Lucía Salgueiro, Keiry Pereyra-Bencosme, Cristian Vargas-Martínez, Jorge Ortega-Márquez, Santiago Callegari-Osorio, Amanda Robasini-dos Santos, Alberto Castro Molina, Allan Vásquez-Bolaños, Diego Olavarría-Bernal, Gabriel Soares-de Sousa, Elaine Cristina Marqueze, Cecília Mendes-de Sousa","doi":"10.21801/ppcrj.2023.92.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.5","url":null,"abstract":"Introduction: Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with an increasing mortality rate over the last decade. Diabetes self-management education (DSME) programs have been reported as essential to improve survival; however, patient adherence rates are very low. Therefore, digital devices have been created to deliver DSME at a distance and enhance program attendance. This study aims to assess the effects of digitally delivered DSME programs on the glycosylated hemoglobin (HbA1C) of patients with prediabetes and T2DM. Methods: We researched PUBMED databases for randomized controlled trials (RCT) and observational studies (OS) published between 2012-2022 in English, Portuguese, or Spanish. The selected articles tested digital DSME interventions against treatment as usual (TAU) on adults (>18 years) previously diagnosed with T2DM or prediabetes. The result was measured by determining the HbA1c levels. Results: Out of 261 articles, 14 RCTs were selected based on eligibility criteria. Digital DSME technologies have different objectives, including monitoring glycemic fluctuation, insulin titration, nutritional guidance, sleeping assessment, enhancement of physical activity, control of comorbidities, relevant task notifications, personalized treatment recommendations, educational content, and patient/medical staff remote interaction. Some of the technologies combined machine learning techniques for different functions, including detecting adverse glycemic events, physical activity, and blood pressure, among others. Although the level of adherence varied among the various trials, 4 of the 14 RCTs analyzed reported a significant reduction of HbA1c levels using these digital devices compared to TAU. Discussion: Programs providing digital DSME education is a potentially cost-effective tool to improve diabetes care worldwide by overcoming distance barriers, facilitating physician-patient communication, and reducing HbA1c levels. Future improvements in implementing these technologies could enhance user compliance and contribute effectively to diabetes management.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48736148","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":"Effects of Neuromuscular Electrical Stimulation in Patients with Post-Stroke Related Dysarthria: A Double-Blinded, Phase-II Randomized Sham-Controlled Trial Protocol - ULYSSES Trial","authors":"Mustafa Reha Dodurgali, Roser Coll-Fernández, Fernanda Queiroz Petrus, Márcio Kawano, Franziska Schreiber, Nayara de Lima Froio, Guilherme Jose Machado Lacerda, Edilin Lopez, Adrielly Martins, Angélica Flores- Flores, Belen Machado, Bethânia Soares dos Santos, Bianca Parron, Christiany Marilinn Tapia Argudo, Claudia Renata dos Santos Barros, Cristina Stephan, Daniela Bouzas Rodeiro, Gustavo Mucci, James Alfonso Carvajal Acosta, Larrie Rabelo Laporte, Laura De Leon Benedetti, Luis Morales Ojeda, Paula Raso Bastos, Regina Villalobos, Vinicius Trindade Gomes da Silva, Abdul Haseeb, Mariana Gasparoto Pereira Valério, Renata Junqueira Moll-Bernardes, Roseanne Ferreira de Freitas Euzébio, Gabriel Rangel Olivera, Caio Cesar dos Santos Kasai, Fathima Minisha, Juan Carlos Silva Godinez","doi":"10.21801/ppcrj.2023.92.9","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.9","url":null,"abstract":"Introduction: Post-stroke individuals with dysarthria experience difficulties in producing speech due to muscle dysfunction. Neuromuscular electrical stimulation (NMES) can stimulate motor units and enhance their functionality. The objective of this study is to investigate the effects of NMES on speech intelligibility in patients with persistent dysarthria 3-6 months post-ischemic stroke. Methods: This study will be designed as a phase II, double-blinded, randomized, two-arm, parallel-group, superiority trial conducted at a single center. The target population will consist of post-stroke individuals with dysarthria, who will undergo randomization to receive either neuromuscular electrical stimulation (NMES) or sham-NMES. Both intervention groups will receive treatment sessions 5 days a week over a 4-week period. The sample size for this study will be 154 patients, recruited exclusively from a Rehabilitation Unit located in the United States. The primary outcome measure will focus on determining the mean difference in the FDA-2 intelligibility score between the two treatment groups. Secondary outcomes will involve evaluating the mean difference in the full FDA-2 score, as well as various subsets of the score, alongside an assessment of the participants’ health-related quality of life, utilizing the Stroke Impact Scale (SIS). Conclusion: To the best of our knowledge, this will be a comprehensive assessment of the potential benefits of NMES for post- stroke patients with dysarthria. Considering the positive impact of NMES on enhancing muscle functionality, it is plausible to anticipate its potential benefits in improving speech outcomes as well. Despite early studies indicating the safety and tolerability of NMES for various motor muscle conditions, there is limited data on its use in patients with dysarthria.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136079347","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":"From Referee to Reviewer: The Evolution and Impact of Peer Review in Scientific Publications","authors":"Mustafa Reha Dodurgali, K. Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2023.92.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.1","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42952088","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":"Umbilical Cord-Mesenchymal Stem Cell Therapy for COVID-19 Related Acute Respiratory Distress Syndrome: A Mini-Review","authors":"Bryan Monterroso Yancor, Roselyn Lemus Martin, Daniela Alonso-Ruiz, Nicole A. Sanchez-Iriarte, Lucas Maffioletti Gonçalves, Mónica Rosales-Salán, J. Bustos, Aisha Aladab, Dahiana Garcia De La Rosa, Emilio Israel Wong-Valenzuela, Krista Cano","doi":"10.21801/ppcrj.2023.92.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.6","url":null,"abstract":"Introduction: Acute respiratory distress syndrome (ARDS) is the leading cause of death among coronavirus disease 2019 (COVID-19) patients, mainly due to the cytokine storm and the rearrangements in coagulation and immune responses. Accordingly, the immunomodulatory and regenerative properties of umbilical mesenchymal stem cells (UC-MSCs) have been studied for the treatment of COVID-19. Methods: This mini-review evaluated adults with moderate-severe COVID-19 infection and compared the results of placebo plus standard of care (SOC) therapy with those obtained from the administration of umbilical cord mesenchymal cells (UC-MSCs). We searched the following databases: Cochrane, Central Register of Controlled Trials, and PubMed; subsequently, 8 clinical trials were included in this mini-review. Some statistically significant difference was found in the levels of clinical and inflammatory markers between the intervention and the control groups. Conclusion: Early phase trials have shown the promising efficacy and safety of UC-MSC therapy for COVID-19-associated moderate-to-severe ARDS. Large multicenter phase III randomized controlled clinical trials will further confirm these findings.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42142798","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 - The Secret Life of Retractions in Scientific Publications.","authors":"Bianca Barros Parron Fernandes, Mustafa Reha Dodurgali, Carlos Augusto Rossetti, Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2023.91.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10485848/pdf/nihms-1920378.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10605707","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":"N-acetylcysteine Effects on Inflammatory Markers in Animal Models Exposed to Air Pollutants","authors":"Maria Jose Hernandez Woodbine, Daniel Romero, Cristal Roman, Juan Rene Delgado Cornejo, Richard Vaca, Francisca Jaime, Donghyun Ko, Pragati Sureka, Erica V. Stelmaszewski, Maria Simon, Lucero G. Flores","doi":"10.21801/ppcrj.2023.91.9","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.9","url":null,"abstract":"Introduction: Air pollution (AP) significantly contributes to morbidity and mortality worldwide. N-acetylcysteine (NAC) is a potent antioxidant with potential health benefits to people residing in poor air quality areas. Our study aimed to analyze animal studies conducted on rats and mice to assess the anti-inflammatory effects of NAC during exposure to air pollutants. Methods: A systematic search on two large databases was performed. Nineteen studies were included in this review following a screening of duplicates and a full-text review. Results: We found that NAC successfully ameliorates some pollution-associated inflammatory pathways. Discussion: NAC is a potential therapeutic drug against inflammatory pathologies caused by AP, although its role in human models requires further studies.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47848717","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 Deep Breathing Techniques in Patients with Elevated Blood Pressure and Hypertension: A Review of the Literature","authors":"Kelsie Lizbeth Pereyra-Bencosme, Diana Arango, Flavio Lichtenstein, Gabriela Alexandra Mateo, Alonso S Gormaz-Bravo, Ángel Jael Acosta, Bruno Antonio de Oliveira, Temidayo Olasinbo Avwioro, Adriano Fernandes Teixeira, G. Guinto-Nishimura, Laura Marie Bourget, Marta Figueral, Rodrigo Uribe-Pacheco","doi":"10.21801/ppcrj.2023.91.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.5","url":null,"abstract":"Introduction: Increased blood pressure (BP) is among the top modifiable causes of cardiovascular disease risk. Non- pharmacological interventions in the prevention and management of elevated BP and hypertension have increased in popularity in recent years. Deep breathing techniques (DBT) are mindfulness stress reduction strategies that target the autonomous nervous system, increase vagal tone, and reduce BP levels. Inconsistent evidence exists in the efficacy of DB techniques in BP control. This review of the literature aims to assess the overall BP lowering efficacy of DBT in hypertension, compare the efficacy of device-guided versus non-device-guided DBT, and assess the safety and adherence rate of DBT, through systematic search and review of randomized controlled trials. Methods: We searched Randomized clinical trials (RCT) in PubMed and Cochrane databases. The search terms were divided into three-term groups: a) hypertension, b) deep breathing techniques, and c) trials. Then, the list of articles was divided into five groups, each with two to three reviewers, to verify every study met the inclusion and exclusion criteria by reading the title and the abstract. Whenever necessary, we downloaded articles to verify adherence by reading the methods, results, and discussions. Studies having two or more votes were selected. Next, all selected articles were downloaded and read to analyze findings and effect sizes and to confirm a correct methodology and statistical analysis. Results: We selected 4 of 119 articles. There is a conflict in the literature; one study affirms no overall difference between DBT and control, two studies affirm that there are statistically significant differences, and one study reports no difference in office BP but statistical difference in “awake, at home” monitoring in the control group. Thus large-scale, high-quality clinical trials are needed to critically assess the effectiveness of long-term DBT in the management of HTN.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45510698","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 - The Use of Large Language Models in Science: Opportunities and Challenges.","authors":"Bassel Almarie, Paulo E P Teixeira, Kevin Pacheco-Barrios, Carlos Augusto Rossetti, Felipe Fregni","doi":"10.21801/ppcrj.2023.91.1","DOIUrl":"10.21801/ppcrj.2023.91.1","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10485814/pdf/nihms-1918127.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10588054","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 Benefits of Probiotics on Depression: A Systematic Mini-Review","authors":"R. Caruso, Jose Luis Chamba Rospigliosi, Mariana Checo, Lilia Maria Lima de Oliveira, Giovani Schulte Farina, Karen Barros Parron Fernandes, Angelica Valeria Jaldin-Pinto, Naira Link, Aimee Mercado Dominguez, Joyce Meza-Venegas, I. Mohamed, Lauren Nirta, T. Nishizawa, Ibrahim Antonio Radi-Zahran, P. Urja, Celso Francisco Pimentel Vespasiano, Arturo Tamayo","doi":"10.21801/ppcrj.2023.91.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.6","url":null,"abstract":"Introduction: Evidence from randomized controlled trials investigating the effects of probiotics on depression published in the last four years has not yet been synthesized. The current systematic mini-review aimed to summarize the impact of probiotics in adults diagnosed with major depression with mild, moderate, or severe symptoms using studies published after May 2018. Methods: A systematic literature search was conducted in PubMed, Web of Science, and Embase databases to identify randomized controlled trials that investigated the effect of any strain of probiotics alone or as an add-on therapy for the treatment of adult patients with mild, moderate, or severe symptoms of major depression and without other neurological and/or psychiatric disorders, published between May 2018 and August 2022. Data were extracted and qualitatively reviewed to determine the treatment effect. In addition, the quality of the methodology and risk of bias was assessed using the Cochrane risk-of-bias tool (RoB 2). Results: Five studies met the inclusion criteria. All were randomized, parallel-group, placebo-controlled, double-anonymized trials with probiotics administered as an add-on therapy for treating mild and moderate symptoms of major depression only. In total, 303 patients (18–65 years) were randomized and treated with probiotics for 1–3 months. Four studies showed positive treatment effects, while one showed no difference between groups. Discussion: There is encouraging evidence showing the potential beneficial effect of probiotics as an add-on treatment for patients with major depression with mild-to-moderate symptoms. However, future phase III trials are required to corroborate these results.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46924304","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":"Anti-inflammatory Effects of Topical Hypericum perforatum: A Systematic Review","authors":"Mónica M. Estrada, R. Chávez-Nomberto, A. Crestani, Ana Paula Tsuneto, C. Awad, Carlos Takahiro Chone, D. Kimura, Devy Quiroz, Erivelton de Azevedo Lopes, Habiba Ibrahim Abdullah, Jacob Eli García Torres, J. Díaz-Schmidt, Levi H Jales Neto, Luís Fernando López, Maria Bazan, Matteo Guidetti, Piero Larco-Castilla, Santiago Sucre, S. Bola-Oyebamiji, Jimena Vizarreta Rosas, Alessandra Carvalho","doi":"10.21801/ppcrj.2023.91.8","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.91.8","url":null,"abstract":"Introduction: Many inflammatory conditions directly impact the skin through different pathways, the understanding of which should be a priority to develop new medications to treat patients suffering from these conditions. Some studies have demonstrated the anti-inflammatory properties of Hypericum perforatum (HP), but no previous systematic reviews have described all the mechanisms by which topical HP may act on inflammation. Therefore, the purpose of this review was to assess the effects of topical HP on inflammatory markers in inflammatory skin conditions or models involving epithelial cells that have been described so far. Methods: The databases PubMed, Scopus, Research4Life (HINARI), and SciELO were used to retrieve experimental and observational studies, from inception to September 25, 2022, reporting the effects of HP on inflammatory markers in inflammatory skin conditions or models involving epithelial cells. We used the following keywords: Hypericum perforatum, H. perforatum, Saint John’s wort, hypericin, hyperforin, inflammation, pro-inflammatory, inflammatory, inflammatory biomarkers, chemokine, prostaglandin, inflammation mediators, TNF, and tumor necrosis factor. Results: From 348 articles screened, 11 were selected based on inclusion and exclusion criteria: two in vitro studies, eight animal studies, and one human pilot trial. A reduction in proliferation and proinflammatory pathways, IL-8 modulation, and a decrease in TNF expression were the main findings reported in the included studies. Discussion: HP has shown promising effects in reducing inflammatory biomarkers in inflammatory skin diseases and experimental models of epithelial cells. Further studies should confirm this herb’s clinical significance and future applications.","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48169525","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}