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

{"title":"Neuromuscular Electrical Stimulation (NMES) as an Add-on Therapy for the Improvement of Dyspnea in Patients with Post-Covid Syndrome: a Protocol for a Phase II Randomized, Non-Pharmacological Intervention-Controlled, Double-Blind Study.","authors":"Anusree Anil Kumar","doi":"10.21801/ppcrj.2022.83.1","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.1","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":"41536297","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":"Efficacy of Cannabidiol Versus Ibuprofen in the Relief of Menstrual Pain in Females Living with Primary Dysmenorrhea A phase II, Non-Inferiority trial","authors":"Haneesha Mohan","doi":"10.21801/ppcrj.2022.83.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.7","url":null,"abstract":"Introduction: Pain is the cardinal symptom in women living with primary dysmenorrhea (PDM), resulting in a relentless negative effect on their quality of life. Women with PDM have higher levels of prostaglandin in their endometrial fluid, which correlates with the degree of pain. The standard of care treatment for pain associated with PDM starts with nonsteroidal anti-inflammatory drugs (NSAIDs) that block prostaglandin-triggering enzymes. Although NSAIDs are a feasible option, they are also associated with a significant risk of side effects. Around 20 to 25% of patients will experience pain refractory to NSAIDs and seek alternative therapies. Cannabidiol (CBD) is a well-tolerated potential therapy for several chronic diseases, including pain, and acts by blocking prostaglandin-triggering enzymes, similar to NSAIDs. The safety of CBD is well established, with the advantage of acting via central and peripheral mechanisms. To date, no previous trials assessing CBD alone for dysmenorrhea have been conducted. Objective: To evaluate the effect of CBD alone in reducing acute menstrual pain compared to ibuprofen, as assessed by the total pain relief (TOTPAR) scale. Design: Randomized (with random block sizes), triple-blinded, multicenter, parallel-group, non-inferiority clinical trial. Participants: PDM patients aged 18 to 40 years, with regular menstrual cycles (ranging from 21 to 35 days) and a visual analog scale (VAS) score of ≥ 5. Academic Editor: Felipe Fregni Peer-reviewers: Natalia Suarez; Giovani Farina; Magali Andrea Pestana; Luis Morales Ojeda. Copyright: © 2022 by the authors. Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).","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":"48093128","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":"Clinical and hemodynamic phenotype of BMPR2 variation carriers with pulmonary arterial hypertension: A systematic review and a call to action","authors":"David Rodríguez, Miguel A. Floran-Bautista, B. Illigens, Tiago Lemos Cerqueira, A. Ramírez-Rivera, C. Jerjes-Sánchez","doi":"10.21801/ppcrj.2022.83.9","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.9","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":"42825400","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":"Efficacy and safety of over-the-scope clips® com-pared to through-the-scope clips for initial bleeding control in non-variceal upper gastrointestinal bleeding: a multicenter randomized clinical trial","authors":"F. Lopes","doi":"10.21801/ppcrj.2022.83.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.3","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":"48986672","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":"Protective Effect of Surgical Masks versus N95 Respirator in Prevention of SARS-CoV-2 Contami-nation in Healthcare Professionals: Systematic Re-view Protocol","authors":"R. L. Gonçalves","doi":"10.21801/ppcrj.2022.83.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.4","url":null,"abstract":": Introduction","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":"44130533","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 KDEP Trial: Protocol for a phase II, multicenter, open label, randomized controlled trial to evaluate the efficacy of ketogenic diet for symptomatic improvement of moderate to severe Major Depressive Disorder","authors":"Gargi Kakani","doi":"10.21801/ppcrj.2022.83.10","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.10","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":"43787877","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: Bench to Bedside - the translation of intracortical inhibition marker to clinical practice.","authors":"Danielle Carolina Pimenta, Daniel Lima, Eric Slawka, Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2022.83.11","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.83.11","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10343941/pdf/nihms-1863078.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9823803","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":"Telehealth usability evaluation by healthcare professionals in post-pandemic treatment of non-communicable diseases (hypertension and diabetes): Systematic Review Protocol","authors":"R. L. Gonçalves, A. Pagano, Z. Reis, Seth Kwaku Afagbedzi, Michael Head, K. Brackstone, M. Marcolino, T. Lopes, S. A. Cordeiro, J. M. Nunes, James Batchelor, A. L. P. Ribeiro","doi":"10.21801/ppcrj.2022.82.6","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.6","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42350326","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":"Neurofeedback for Attention Deficit Disorder in preschoolers (NeFAP): A randomized, sham-controlled, efficacy study protocol of a novel non-pharmacological therapy","authors":"A. Pugliesi, Niraj A. Mehta, Daniel Guimarães Silva, Jennifer P. Khouri López, Cornelis Anibal Luna Fuerte, Nicolas Nuñez-Ordonez, Suzy Krimon, Omar Kotb, Sahilly Adelina Rodríguez-Martínez, Janaina Lima, Douaa Omer Mohamed, Cristiane Paulain David, Nathalia Satoo Demian F., Joyce Macedo da Silva, A. Yock-Corrales","doi":"10.21801/ppcrj.2022.82.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.7","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46656977","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":"Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for Guiding Decisions on the Addition of a Run-In Period.","authors":"Haley Rafferty,&nbsp;Elisa Rocha,&nbsp;Paola Gonzalez-Mego,&nbsp;Clara L Ramos,&nbsp;Mirret M El-Hagrassy,&nbsp;Muhammed E Gunduz,&nbsp;Elif Uygur-Kucukseymen,&nbsp;Hanan Zehry,&nbsp;Swapnali S Chaudhari,&nbsp;Paulo Ep Teixeira,&nbsp;Gleysson R Rosa,&nbsp;Ana L Zaninotto,&nbsp;Christopher Connor,&nbsp;Uri Eden,&nbsp;Ciro Ramos-Estebanez,&nbsp;Felipe Fregni,&nbsp;Laura Dipietro,&nbsp;Timothy Wagner","doi":"10.21801/ppcrj.2022.82.5","DOIUrl":"https://doi.org/10.21801/ppcrj.2022.82.5","url":null,"abstract":"<p><strong>Introduction: </strong>Run-In (RI) periods can be used to improve the validity of randomized controlled trials (RCTs), but their utility in Chronic Pain (CP) RCTs is debated. Cost-effectiveness analysis (CEA) methods are commonly used in evaluating the results of RCTs, but they are seldom used for designing RCTs. We present a step-by-step overview to objectively design RCTs via CEA methods and specifically determine the cost effectiveness of a RI period in a CP RCT.</p><p><strong>Methods: </strong>We applied the CEA methodology to data obtained from several noninvasive brain stimulation CP RCTs, specifically focusing on (1) defining the CEA research question, (2) identifying RCT phases and cost ingredients, (3) discounting, (4) modeling the stochastic nature of the RCT, and (5) performing sensitivity analyses. We assessed the average cost-effectiveness ratios and incremental cost effectiveness ratios of varied RCT designs and the impact on cost-effectiveness by the inclusion of a RI period vs. No-Run-In (NRI) period.</p><p><strong>Results: </strong>We demonstrated the potential impact of varying the number of institutions, number of patients that could be accommodated per institution, cost and effectiveness discounts, RCT component costs, and patient adherence characteristics on varied RI and NRI RCT designs. In the specific CP RCT designs that we analyzed, we demonstrated that lower patient adherence, lower baseline assessment costs, and higher treatment costs all necessitated the inclusion of an RI period to be cost-effective compared to NRI RCT designs.</p><p><strong>Conclusions: </strong>Clinical trialists can optimize CP RCT study designs and make informed decisions regarding RI period inclusion/exclusion via CEA methods.</p>","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769699/pdf/nihms-1831819.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9861773","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}