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

{"title":"Developing transcranial direct current stimulation as a treatment for phantom limb pain: from pilot mechanistic studies to large clinical studies.","authors":"Xinyi Christine Zhang, Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2024.101.10","DOIUrl":"10.21801/ppcrj.2024.101.10","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11185833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141422171","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":"Enhancing Dissemination and Understanding in Clinical Research Protocols: Optimizing Visual Communication in a Phantom Limb Pain Clinical Trial.","authors":"Xinyi Christine Zhang, Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2024.101.8","DOIUrl":"10.21801/ppcrj.2024.101.8","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11185834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141422172","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":"Physical Conditioning, Obesity and Fibromyalgia: Causal Relationship or Confounding?","authors":"Valton Costa, Anna Carolyna Gianlorenço, Marianna Daibes, Fernanda Queiroz, Guilherme Lacerda, Daniela Martinez-Magallanes, Lucas Camargo, Luana Gola Alves, Maria Fernanda Andrade, Mustafa Reha Dodurgali, Kevin Pacheco-Barrios, Felipe Fregni","doi":"10.21801/ppcrj.2023.93.2","DOIUrl":"10.21801/ppcrj.2023.93.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10906936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023966","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":"Editorial - Seeking Brain Homeostatic Compensatory Mechanisms for Pain Control.","authors":"Kevin Pacheco-Barrios, Lucas M Marques, Mustafa Reha Dodurgali, Daniela Martinez-Magallanes, Sara P Barbosa, Marianna De Andrade, Jorge Ortega Márquez, Paulo S de Melo, Marcel Simis, Wolnei Caumo, Felipe Fregni","doi":"10.21801/ppcrj.2023.92.2","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.2","url":null,"abstract":"","PeriodicalId":74496,"journal":{"name":"Principles and practice of clinical research (2015)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10500629/pdf/nihms-1929561.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10309547","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":"Curcumin for Aromatase Inhibitor-Induced Joint Pain in Breast Cancer Survivors - The CurPain Trial: A Randomized, Double-Blind, Phase III, Multicenter Clinical Trial","authors":"Michael Apostolou, T. Méry, I. Aivasovsky, Milena Akamatsu, Marianna Daibes, Winifer Araujo, Maria Burgos, Victor Capellan, F. Cerulli, Vitor Costa, W. Fandino, Igor Farias, Vivian Gagliardi, Maria Gomez, David Guardamino, Andreina Guzman, Karla L. Loss, S. Mohamed, V. Montero, J. Obeso, Alicia Rosell, Jorge Sakon, Erik Simon, Rene Tovar, S. Afonseca, Katarzyna Kresse-Walczak","doi":"10.21801/ppcrj.2023.92.10","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.10","url":null,"abstract":"Introduction: Adjuvant treatment with aromatase inhibitors (AIs) is extremely important in hormone-positive breast cancer survivors, reducing the early recurrence of the disease. Arthralgia and musculoskeletal symptoms resulting from AIs-toxicity can be observed in approximately one-third of the treated patients and are the leading cause of AIs-treatment discontinuation. However, there is no sufficient standard treatment. Analgesic and anti-inflammatory effects of curcumin in chronic joint pain are reported. This study protocol will determine whether curcumin supplementation reduces joint pain in breast cancer survivors under AIs therapy. Methods: This study protocol is a phase III, randomized, blinded, placebo-controlled, multicentric, parallel arm design. The study population targets post-menopause women with stage I, luminal, unilateral, non-metastatic, receptor-positive breast cancer after breast-conserving surgery healed per primary intention. 160 participants will be enrolled. Daily curcumin supplementation (500 mg thrice daily) for twelve weeks is planned. Brief Pain Inventory-Worst Pain (Δ BPI-WP) will assess joint pain change after twelve weeks of follow-up as the primary outcome. Secondary outcomes include Quality of Life assessed by Functional Assessment of Cancer Therapy-Breast, further Brief Pain Inventory-Short Form items, Patient Health Questionnaire-8, and Quantitative Analgesic Questionnaire at six and twelve weeks. Discussion: We present a randomized clinical trial to provide scientific evidence that supports the efficacy of curcumin supplementation on joint pain alleviation, pain-relieving medication reduction, and AIs-treatment adherence improvement in a predefined breast cancer survivor population.","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":"46054007","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":"XIV International Symposium of Neuromodulation: Conference Abstracts","authors":"Sara Barbosa, Lucas Marques, International Symposium of Neuromodulation Scientific Team","doi":"10.21801/ppcrj.2023.92.11","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.11","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":"41807515","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 Occupational Therapy on Cognition in Patients with Mild Alzheimer’s Disease: A Systematized Literature Review","authors":"Leandra Ramin-Wright, N. Pacheco-Barrios, Sandra Zhong, Marion Stokvis-Blok, A. Barrios-Ruiz, Aala F Elhadi, Stefany Alfaro-Amez, Deborah Estrella, João P. G. Kasakewitch, Cecilia Plaza, Renata Medeiros, Nayara Rutes, Guilherme Areas","doi":"10.21801/ppcrj.2023.92.8","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.8","url":null,"abstract":"Introduction: Mild Alzheimer’s Disease (AD), the most prevalent form of dementia, substantially burdens patients and caregivers. With only symptomatic treatments currently available, the potential of Occupational Therapy (OT) in aiding mild AD patients is increasingly recognized. This review evaluates OT’s role in preserving cognitive function in mild AD. Methods: We used PubMed and HINARI platforms to explore the effect of OT on mild AD. Studies in English, with observational or clinical trial designs involving patients with AD, were included. Case studies and literature reviews were excluded. Two authors independently selected the study, with a third resolving disputes. Results: 43 studies were initially retrieved. Post-duplicate removal, 34 abstracts were screened, 21 were selected for full review, and five met the inclusion criteria. Of these, three reported positive results, and two reported adverse effects. Those with positive results are observational studies with a low risk of bias and one RCT with a high risk of bias. The two remaining RCTs with negative consequences showed a low risk of bias. Discussion: Our review suggests no benefit on cognition in mild AD from OT, although methodological variability led to inconsistent findings. Certain OT interventions, like Recollection-Based and Group Cognitive Therapy, showed promise in cognitive improvement for mild AD. Future research should include larger samples, extended interventions, and follow-up periods for a more comprehensive insight into OT’s effects on cognition in mild AD patients.","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":"42191117","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":"Transcranial Direct Current Stimulation in Opioid Use Disorder: A Systematic Review of the Literature","authors":"Victor Anculle-Arauco, Mohammed S Alnafisah, Karen Czischke L, Ángel L. Rodríguez Lockward, Murilo Simão Cenovicz, Nassima Allouche Colak, Alexandra Frealdo Dumont Alves, Emilia Kvasnicka, Rafael A F Barros, Juliana A M Couto Magalhães, Fernando Zanela da Silva Arêas, Rabia Islam, Beatrice Nyawira, Pedro Lança Gomes, Ana Victoria P. Vigano, Sorivel Sosa, Sara Pinto Barbosa, Flávia Regina Bueno","doi":"10.21801/ppcrj.2023.92.4","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.4","url":null,"abstract":"Introduction: Opioid use disorder burdens healthcare facilities and causes significant annual mortality and healthcare costs. Its current management focuses on biopsychosocial interactions; however, a high relapse rate prompts the search for new treatment strategies, such as Transcranial Direct Current stimulation. Methods: A systematic literature search of PubMed, MEDLINE, and clinicaltrials.gov databases was performed. The search terms reflected the conditions and treatment modalities of interest. Trials reporting transcranial direct current stimulation in opioid use disorders were eligible. The primary outcome was craving reduction, measured using different questionnaires. According to the PRISMA guidelines, three research members independently performed article selection and data extraction. Also, was performed Cochrane risk-of-bias tool for each article. Results: Seven articles were selected from the 16 eligible papers. In total, 233 patients were included in this study. All studies were conducted in Asian countries and included only male subjects, and the follow-up time was limited to less than six months. Most studies (6/7) reported a significant improvement in craving reduction in the active transcranial direct current stimulation group. Discussion: Most studies concluded that active transcranial stimulation significantly reduced craving scores; however, the studies had high variability in frequency, intensity, and stimulation site. The limited locations of the trials and small sample sizes represent a threat to the external validity of the studies, which emphasizes the need for further large multicenter randomized trials with adequate follow-up periods to test the efficacy of transcranial direct current stimulation in treating opioid use disorder.","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":"136080619","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":"Inflammasomes as a Prognostic Marker and Possible Therapeutic Target in Multiple Sclerosis: A Rapid Review of the Literature","authors":"Nury Tatiana Rincón Cuenca, Daniela Pereira Lamas, Rosa Fernández Hawa, Ketty Quezada, L. Garcia, Pamela Baez, Assma A. Althobaity, N. Dim","doi":"10.21801/ppcrj.2023.92.7","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.7","url":null,"abstract":"Introduction: Inflammasomes are multiprotein complexes innate to the immune system that, upon activation, initiate a chain reaction culminating in the production of cytokines IL-1 and IL-18. Recent studies have suggested a connection between inflammasome activation and neurological diseases such as multiple sclerosis (MS). In this review, we aimed to evaluate the role of inflammasomes as potential therapeutic agents and prognostic markers of MS. Methods: Through a database search, 156 articles were identified. Of these, we selected articles focusing on observational and interventional studies that either directly measured the expression of inflammasomes or the levels of cytokines or interleukin as outcomes. After applying a snowball sampling strategy, this review ultimately included nine studies. Results: Our search yielded nine studies published between 2010 and 2022—9 observational studies included case-control and cohort designs. All studies comprised adult populations, 20–72 years of age. All studies incorporated a control group. We selected studies that utilized surrogate measures to evaluate outcomes such as inflammasome expression of NLRP3 or similar genes and assess cytokine levels such as IL-1β, IL-18, IL-23, and TNF. Discussion: Overall, the revised studies suggest a possible role for inflammasomes components, including ASC and caspase-1, which have been evaluated as potential prognostic markers in MS. Therapeutic strategies have focused on the inhibition of NLRP3, which is one of the most prominent and studied inflammasomes, by IFN-β.","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":"44344050","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":"Pursuing Dementia in People Living with HIV: Prevalence and Associated Factors","authors":"Daniela Pereira Lamas, Simone Barros Tenore, David Salomao Lewi, Paulo Abrao Ferreira","doi":"10.21801/ppcrj.2023.92.3","DOIUrl":"https://doi.org/10.21801/ppcrj.2023.92.3","url":null,"abstract":"Introduction: The human immunodeficiency virus (HIV) is the leading cause of neurocognitive impairment in people over 40. The development of highly active antiretroviral therapy (HAART), the comprehension of disease pathogenesis, and the constant search for better life quality in people living with HIV have led to the HIV disease chronic evolution. Hence, it has been common to observe chronic diseases such as HIV-associated neurocognitive disorder (HAND). Unfortunately, the practitioner’s unfamiliarity with HAND screening and treatment has contributed to poor patient care. Methods: We evaluated 134 patients living with HIV and performed two tracking tests, the Mini-mental, which evaluates cortical dementia, and the International HIV Dementia Scale, which evaluates subcortical dementia. Results: We observed dementia associated with HIV (HAD) in 29 patients (prevalence of 21.6%; CI 95%: 15.0 – 29.6). The independent factors related to HAD in this study, with statistical significance, were age (RPaj 1.05; CI 1.00 – 1.09; p=0.033), TCD4+ nadir (RPaj 0.998; CI 95% 0.996 – 0.999; p=0.03), and more than two years of detectable HIV viral load (RPaj 2.35; CI 95% 1.27 – 4.33; p=0.006). Discussion: The prevalence of dementia related to HIV in our study was similar to the Brazilian and International data. Early diagnosis and treatment are fundamental for preventing HAND development, especially in older patients.","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":"42573633","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}