Baylor University Medical Center Proceedings最新文献

{"title":"Early termination and nonpublication of phase III/IV melanoma clinical trials: a cross-sectional study.","authors":"Abdulrahman Nasir Al Khatib, Rama Al Masri, Sa'ed Al Hayek, Sameer Yaser, Omar Jaber, Yacob Saleh","doi":"10.1080/08998280.2024.2439771","DOIUrl":"10.1080/08998280.2024.2439771","url":null,"abstract":"<p><strong>Introduction: </strong>Melanoma is a common cancer worldwide. Introduction of new treatments through clinical trials is essential to reduce the global burden from melanoma; however, it is estimated that 22% of oncological clinical trials are terminated early. We conducted the first cross-sectional study to assess melanoma clinical trial termination and nonpublication with an aim to guide scientists conducting such trials.</p><p><strong>Methods: </strong>We identified all phase III/IV clinical trials evaluating melanoma therapies in the ClinicalTrials.gov database between 2010 and 2024. For each trial, we extracted data on the trial's status, melanoma stage, melanoma subtype, included age, funding sources, trial locations, publication status, and reasons for termination. A descriptive and frequency analysis was performed in JASP 0.19 software.</p><p><strong>Results: </strong>A total of 108 trials were analyzed; the majority of trials included stage III/IV melanoma (n = 95), and cutaneous melanoma was the most common subtype. Only 15 trials included pediatric patients. Industrial funding accounted for 74% (n = 80) of trials' financing. Most of the trials were conducted internationally in North America, Europe, Australia, and New Zealand, with a few trials conducted in South Africa (n = 1), South America (n = 1), or China (n = 5). Early termination was observed in 21% (n = 23) of trials, with no association between early termination and melanoma stage, subtype, age, funding source, or trial locations. Notably, the most common reason for early termination was publication of interim efficacy and safety results (n = 14/23).</p><p><strong>Conclusion: </strong>Our study confirms that early termination of phase III and IV melanoma trials doesn't raise a significant concern; however, diversified funding and broader geographic representation are needed to create more equitable and inclusive trials. We also suggest conducting further cross-sectional studies on phase I/II melanoma trials.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 2","pages":"179-182"},"PeriodicalIF":0.0,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845047/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482217","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":"Shoulder synovial sarcoma radical excision with pedicled inverted pectoralis major flap.","authors":"Luke Mascarenhas, Luke Villamaria, Rashmi Agarwal, Russell Ward","doi":"10.1080/08998280.2024.2435777","DOIUrl":"https://doi.org/10.1080/08998280.2024.2435777","url":null,"abstract":"<p><p>Synovial sarcoma, a rare soft tissue malignancy, predominantly affects adolescents and young adults, with a predilection for extremities. We present the case of a 19-year-old woman with a rapidly growing left shoulder synovial sarcoma, initially managed with neoadjuvant chemotherapy to reduce tumor size. Subsequently, she underwent radical surgical resection, necessitating complex anatomical dissection due to tumor involvement extending into the coracoid and deltoid. Given limitations in current literature regarding reconstructive options for shoulder defects following sarcoma resection, the use of a pedicled pectoralis major flap demonstrates feasibility and functional outcomes.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 3","pages":"346-349"},"PeriodicalIF":0.0,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960562","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":"Effect of intracervical block on self-reported intrauterine device insertion pain: a single-center prospective survey study.","authors":"Micah Clay, Joyce Ku, Krystal N Fett, Michael P Hofkamp, Joanna K Stacey","doi":"10.1080/08998280.2024.2440285","DOIUrl":"10.1080/08998280.2024.2440285","url":null,"abstract":"<p><strong>Objective: </strong>The study aimed to determine the incidence of self-reported pain during office-based intrauterine device (IUD) placement.</p><p><strong>Methods: </strong>The study included patients who had IUD placement at our clinic from April 1, 2023, to March 31, 2024 with no prior history of vaginal delivery, who were between the ages of 14 and 48 years, did not have cervicitis, and were not pregnant. Informed consent was obtained, a prequestionnaire was completed, the IUD was placed in accordance with clinician preference, and a postquestionnaire was administered.</p><p><strong>Results: </strong>Thirty-seven patients answered the question about expected pain. Two (5%) reported that their pain during IUD placement was none, 22 (59%) reported that pain was better than expected, 10 (27%) reported that pain was just as bad as expected, two (5%) reported pain was worse than expected, and one (3%) indicated that their pain during IUD placement was much worse than expected. Thirty-three patients received an intracervical or paracervical block, and five patients did not receive an intracervical or paracervical block; these groups reported visual analog pain scores of 35 ± 25 mm and 58 ± 14 mm, respectively (<i>P</i> = 0.22).</p><p><strong>Conclusion: </strong>Approximately 8% of patients in our study reported worse or much worse than expected pain with IUD placement. Patients who received an intracervical or paracervical block reported less pain, but this difference was not statistically significant. Paracervical or intracervical blocks can decrease perceived pain with IUD insertion, increasing contraceptive options for those who are concerned about painful insertions; however larger studies are needed.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 2","pages":"155-158"},"PeriodicalIF":0.0,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482222","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":"Safety information and adverse event profiles of ultraviolet nail lamps: a commercial website analysis.","authors":"Kritin K Verma, Melissa Marchan-Martinez, Daniel P Friedmann, Michelle B Tarbox, Ida F Orengo","doi":"10.1080/08998280.2024.2435760","DOIUrl":"10.1080/08998280.2024.2435760","url":null,"abstract":"","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 2","pages":"209"},"PeriodicalIF":0.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844919/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482169","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":"Herpes zoster ophthalmicus temporally after COVID-19 vaccination: a systematic review of uncontrolled case reports and case series.","authors":"Jawad Muayad, Hamza Masood, Zaryab Alam, Asad Loya, Andrew G Lee","doi":"10.1080/08998280.2024.2426439","DOIUrl":"10.1080/08998280.2024.2426439","url":null,"abstract":"<p><strong>Purpose: </strong>Herpes zoster ophthalmicus (HZO) following COVID-19 vaccination has been reported previously but the clinical characteristics, onset, treatment, and outcomes of these cases have not been previously systematically reviewed.</p><p><strong>Methods: </strong>A systematic review, guided by PRISMA guidelines, surveyed PubMed and Embase databases from April 2021 to June 2023 for case reports and series detailing HZO following COVID-19 vaccination. Studies excluded were abstracts, reviews, and clinical trials. A subsequent descriptive analysis was performed, focusing on patient demographics, clinical characteristics, and outcomes.</p><p><strong>Results: </strong>Sixteen publications involving 27 participants who developed HZO post-COVID-19 vaccination met the inclusion criteria. The onset of HZO averaged 13 days (SD 12) postvaccination, predominantly after the first dose (n = 20/27 HZO cases, 74%). Most patients (70%) had preexisting medical conditions. Antiherpetic antiviral therapy was utilized in all cases, with the majority achieving resolution of cutaneous and ocular symptoms. Long-term sequelae included postherpetic neuralgia in 7.4% of patients.</p><p><strong>Conclusion: </strong>Cases of HZO following COVID-19 vaccination generally mirror the clinical trajectory of HZO in general. This review focused on case reports describing HZO occurring in an interval postvaccination; neither association nor causation can be addressed methodologically.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 1","pages":"69-75"},"PeriodicalIF":0.0,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11657098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142875523","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":"Solitary erythematous round nodule with a hemorrhagic crust on the posterior shoulder.","authors":"Promise Ufomadu, Soo Jung Kim, Hafeez Diwan","doi":"10.1080/08998280.2024.2429969","DOIUrl":"https://doi.org/10.1080/08998280.2024.2429969","url":null,"abstract":"<p><p>Primary cutaneous CD4⁺ small/medium-sized pleomorphic T-cell lymphoproliferative disorder (PCMS-TCL) is a rare skin condition. We present a 67-year-old patient with a growing lesion on the shoulder that was diagnosed as PCMS-TCL. The patient was otherwise healthy without systemic involvement. The lesion was surgically excised, and no recurrence occurred. PCMS-TCL has an excellent prognosis, unlike other cutaneous lymphomas. This case highlights the importance of crafting a comprehensive differential diagnosis that incorporates any possibilities of rare disorders like PCMS-TCL to avoid unnecessary treatment.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 3","pages":"336-338"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12026230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967866","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":"Current approaches for management of gastric varices in the United States: a survey of providers' attitudes and practices.","authors":"Mahmoud A Hashim, Khaled Elfert, Ahmed M Afifi, Manal Hassan, Ahmed Elkheshen, Harish Gagneja, Kalpesh Patel, Sanjaya Satapathy, Kris Kowdley, Prasun K Jalal","doi":"10.1080/08998280.2024.2430153","DOIUrl":"10.1080/08998280.2024.2430153","url":null,"abstract":"<p><strong>Introduction: </strong>Bleeding from gastric varices (GV) is more drastic and associated with higher mortality than that from esophageal varices. There are multiple therapeutic approaches for GV bleeding. Although endoscopic cyanoacrylate glue injection (ECGI) is recommended as the first-line management for GV bleeding worldwide, its implementation in the US is limited. We conducted a survey among health care providers to examine attitudes and practice related to GV management.</p><p><strong>Methods: </strong>Collected data were cleaned using SPSS V24. Summary statistics and graphical analyses for continuous and categorical variables were used to describe the data. Continuous variables with a normal distribution are presented as mean ± standard deviation.</p><p><strong>Results: </strong>A total of 339 providers completed the survey, for a response rate of 16.95%. Nearly a quarter of respondents reported performing ECGI in patients with GV bleeding. Male healthcare providers (odds ratio [OR]: 2.1, 95% confidence interval [CI] = 1.22-3.75, <i>P</i> = 0.006), transplant hepatologists (OR: 2.6, 95% CI = 1.25-4.87, <i>P</i> = 0.019), and those working in hospitals with liver transplantation centers (OR: 2.5, 95% CI = 1.35-4.62, <i>P</i> = 0.002) were more likely to perform ECGI in GV bleeding cases. However, only gender was significant in the multivariate model.</p><p><strong>Conclusions: </strong>Our results indicate the underutilization of ECGI in GV patients among US endoscopists. Key hurdles are lack of training and approval from the US Food and Drug Administration.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 2","pages":"127-134"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482207","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":"Recombinant von Willebrand factor use in obstetric anesthesia.","authors":"Emily E Sharpe, Rochelle J Pompeian, Ariela L Marshall","doi":"10.1080/08998280.2024.2430141","DOIUrl":"10.1080/08998280.2024.2430141","url":null,"abstract":"<p><strong>Background: </strong>In pregnant patients with von Willebrand disease who have reduced von Willebrand factor (VWF) activity but normal factor VIII activity, recombinant VWF may be considered to supplement VWF.</p><p><strong>Methods: </strong>All patients with known diagnosis of von Willebrand disease who were admitted for delivery and received recombinant VWF between October 2019 and March 2023 were included. Demographic data, peripartum course, laboratory data, neuraxial use, and bleeding complications were reviewed.</p><p><strong>Results: </strong>There were 8 deliveries in 6 patients who had von Willebrand disease and received recombinant VWF during the study period. All patients received neuraxial analgesia or anesthesia after administration of recombinant VWF without complications. No patient required additional recombinant VWF supplementation at delivery.</p><p><strong>Conclusion: </strong>Recombinant VWF may be an option for peripartum management in parturients with selective reduction in VWF activity and normal factor VIII activity.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 2","pages":"142-147"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482165","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":"Institution of a formal multidisciplinary heart team for high-risk coronary revascularization.","authors":"Srinivasa Potluri, Rahul Sawhney, Cody Dorton, Kyle McCullough, Ghadi Moubarak, Emily Shih, Jared Christensen, J Michael DiMaio, Karim Al-Azizi, Chadi Dib, Sameh Sayfo, Molly Szerlip, Sibi Thomas, Alfred Levy, Kelly Hutcheson, Melissa Carranza, Samantha Douthit, Trent Pettijohn, William Ryan, Michael Mack","doi":"10.1080/08998280.2024.2426925","DOIUrl":"10.1080/08998280.2024.2426925","url":null,"abstract":"<p><strong>Introduction: </strong>The heart team approach is now the standard of care for patients with complex coronary artery disease; however, the definition of a heart team is variable. We embarked on a project to create an extended, multidisciplinary heart team to evaluate patients we deemed high risk for coronary revascularization. In doing so, we created a new service, workflow, and paradigm.</p><p><strong>Methods: </strong>Herein, we describe the process through which we created our high-risk percutaneous coronary intervention team, our criteria for determining risk, our process for evaluating these patients, and quality assurance. Additionally, we describe the design of our prospective study assessing 200 patients with complex coronary artery disease. The primary outcomes include the final heart team revascularization decision, all-cause mortality, major adverse cardiac events, acute kidney injury, postintervention bleeding, and length of stay.</p><p><strong>Conclusion: </strong>Establishing a multidisciplinary heart team may help with complex and high-risk patient and family scenarios and potentially improve patient outcomes. A study has been initiated to test this hypothesis formally.</p>","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 1","pages":"28-33"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11657062/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142875611","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":"Barriers to guideline implementation.","authors":"Jennifer Freeman","doi":"10.1080/08998280.2024.2429285","DOIUrl":"10.1080/08998280.2024.2429285","url":null,"abstract":"","PeriodicalId":8828,"journal":{"name":"Baylor University Medical Center Proceedings","volume":"38 1","pages":"47"},"PeriodicalIF":0.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11657056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876153","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}