bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data
Authors: Wallace Daniel J , Atsumi Tatsuya , Daniels Mark , Hammer Anne , Meizlik Paige , Quasny Holly , Schwarting Andreas , Zhang Fengchun , Roth David A 
Published: October 2022

Objectives Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that affects multiple organ systems. Belimumab, a targeted human monoclonal antibody, binds to and inhibits soluble B-lymphocyte stimulator. The safety and efficacy of belimumab has consistently been demonstrated in multiple clinical trials for the treatment of patients with active SLE. Integration of these data provides an additional opportunity to explore the safety of belimumab in a larger and more diverse population. This post hoc pooled analysis of clinical studies evaluated the safety profile of belimumab versus placebo in adults with SLE. Methods This was a pooled post hoc analysis of 52-week safety data from one Phase 2 and five Phase 3 belimumab trials in adult patients with SLE. Patients received ≥1 dose of placebo or belimumab (1, 4, or 10 mg/kg intravenous or 200 mg subcutaneous), plus standard therapy. Outcomes included the incidence of adverse events (AEs), serious AEs (SAEs), severe AEs, AEs of special interest (AESI), and mortality. Results Across 4170 patients (placebo: N = 1355; belimumab: N = 2815), baseline demographics, disease characteristics, and treatment exposure were similar for placebo and belimumab. Most patients (placebo: 76.6%; belimumab: 81.0%) completed the protocol Week 52 visit. Overall, incidence of AEs, SAEs, severe AEs, AESI, and mortality were similar between groups. In both groups, the most commonly reported SAEs by system organ class were infections and infestations (placebo: 5.9%; belimumab: 5.4%) and renal and urinary disorders (placebo: 2.2%; belimumab: 1.7%). Additionally, a greater proportion of patients experienced AESI with belimumab versus placebo for post-infusion/injection systemic reactions (placebo: 8.1%; belimumab: 10.2%). Mortality rates were similar between groups (placebo: 0.4%; belimumab: 0.6%). Conclusions These results are consistent with those of the individual studies, BASE, BLISS-LN, and long-term extension studies, making belimumab one of the most studied SLE treatments for safety. Collectively, this evidence continues to support a positive benefit–risk profile of belimumab in the treatment of adult patients with SLE.
Clinical Outcomes in Orthognathic Surgery for Craniofacial Microsomia Following Mandibular Distraction Using CBCT Analysis: A Retrospective Study
Authors: DeMitchell-Rodriguez Evellyn M. , Mittermiller Paul A. , Avinoam Shayna P. , Staffenberg David A. , Rodriguez Eduardo D. , Shetye Pradip R. , Flores Roberto L. 
Published: October 2022

Objective The aim of this study was to evaluate the outcomes of orthognathic surgery (OGS) in patients with craniofacial microsomia (CFM) who had previously undergone mandibular distraction osteogenesis (MDO). Design A retrospective cohort study was performed including all patients with CFM who were treated with OGS at a single institution between 1996 and 2019. The clinical records, operative reports, and cone beam computed tomography (CBCT) scans were reviewed. CBCT data before OGS (T1), immediately after OGS (T2), and at long-term follow-up (T3) were analyzed using Dolphin three-dimensional software to measure the occlusal cant and chin point deviation. Results The study included 12 patients with CFM who underwent OGS (6 underwent OGS without MDO and 6 underwent OGS after MDO). There was a statistically significant improvement in occlusal cant and chin point deviation in both groups postoperatively. Occlusal cant relapsed by a mean of 0.6° (standard deviation [SD] 1.1°) in the patients who had OGS alone compared with 0.7° (SD 1.2°) in the patients who had OGS after MDO ( P  =  .745) between T2 and T3. There was no statistically significant difference in chin point relapse between patients who had OGS alone compared with those who had OGS after MDO (0.1 mm [SD 2.5mm] vs 0.7mm [SD 2.2mm]; P  =  .808). Conclusions Within the limitations of this study, these findings suggest that OGS after MDO in patients with CFM can produce stable results.
Implementation of an Integrated Lung Cancer Prevention and Screening Program Using a Mobile Computed Tomography (CT) Unit in Brazil
Authors: Chiarantano Rodrigo Sampaio , Vazquez Fabiana Lima , Franco Alexander , Ferreira Larissa Cristina , Cristina da Costa Maraísa , Talarico Thais , Oliveira Ângela Neves , Miziara José Elias , Mauad Edmundo Carvalho , Caetano da Silva Eduardo , Ventura Luis Marcelo , Junior Raphael Haikel , Leal Letícia Ferro , Reis Rui Manuel 
Published: October 2022

Introduction Lung cancer is the deadliest cancer worldwide and in Brazil. Despite strong evidence, lung cancer screening by low-dose computed tomography (LDCT) in high-risk individuals is far from a reality in many countries, particularly in Brazil. Brazil has a universal public health system marked with important inequalities. One affordable strategy to increase the coverage of resources is to use mobile units. Objectives To describe the implementation and results of an innovative lung cancer prevention program that integrates tobacco cessation and lung cancer screening using a mobile CT unit. Methodology From May 2019 to Dec 2020, health professionals from 18 public primary health care units in Barretos, Brazil, were trained to offer smoking cessation counseling and treatment. Eligible high-risk participants of this program were also invited to perform lung cancer screening in a mobile LDCT unit that was specially conceived to be dispatched to the community. A detailed epidemiological questionnaire was administered to the LDCT participants. Results Among the 233 screened participants, the majority were women (54.9%), and the average age was 62 years old. A total of 52.8% of participants showed high or very high nicotine dependence. After 1 year, 27.8% of participants who were involved in smoking cessation groups had quit smoking. The first LDCT round revealed that the majority of participants (83.7%) exhibited lung-Rads 1 or 2; 7.3% exhibited lung-Rads 3; 7.7% exhibited lung-Rads 4a; and 3% exhibited lung-Rads 4b or 4x. The three participants with lung-Rads 4b were further confirmed, and their surgery led to the diagnosis of early-stage cancer (1 case of adenocarcinoma and two cases of squamous cell carcinoma), leading to a cancer diagnosis rate of 12.8/1000. Conclusion Our results indicate promising outcomes for an onsite integrative program enrolling high-risk individuals in a middle-income country. Evidence barriers and challenges remain to be overcome.
Identifying Children at Risk for Maltreatment Using Emergency Medical Services’ Data: An Exploratory Study
Authors: Bressler Colleen J. , Malthaner Lauren , Pondel Nicholas , Letson Megan M. , Kline David , Leonard Julie C. 
Published: October 2022

The objective of this study was to use natural language processing to query Emergency Medical Services (EMS) electronic health records (EHRs) to identify variables associated with child maltreatment. We hypothesized the variables identified would show an association between the Emergency Medical Services encounter and risk of a children maltreatment report. This study is a retrospective cohort study of children with an EMS encounter from 1/1/11–12/31/18. NLP of EMS EHRs was conducted to generate single words, bigrams and trigrams. Clinically plausible risk factors for child maltreatment were established, where presence of the word(s) indicated presence of the hypothesized risk factor. The EMS encounters were probabilistically linked to child maltreatment reports. Univariable associations were assessed, and a multivariable logistic regression was conducted to determine a final set of predictors. 11 variables showed an association in the multivariable modeling. Sexual, abuse, chronic condition, developmental delay, unconscious on arrival, criminal activity/police, ingestion/inhalation/exposure, and <2 years old showed positive associations with child maltreatment reports. Refusal and DOA/PEA/asystole held negative associations. This study demonstrated that through EMS EHRs, risk factors for child maltreatment can be identified. A future direction of this work include developing a tool that screens EMS EHRs for households at risk for maltreatment.
Pentoxifylline decreases the activity of the nucleotide-binding oligomerization domain-like receptor protein 3 pathway: potential role for preventing arteriovenous fistula stenosis
Authors: Feng Tao , Ma Zejun , Pan Congqing , Yu Pei 
Published: October 2022

Purpose: This study aimed to determine the effect of pentoxifylline (PTX) on the nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) inflammasome pathway and its role in preventing arteriovenous fistula (AVF) failure. Methods: Vein samples were collected from AVF failure patients and from patients who underwent surgical AVF as a control. The expressions of CD34 and NLRP3 in AVF tissues were detected by immunohistochemistry and Western blotting. Arteriovenous fistula rat models were established by the end-to-end anastomosis of the common carotid artery and external jugular vein. The AVF models were divided into the following groups: AVF, AVF + PTX, AVF + uraemia and AVF + uraemia + PTX. Six weeks after surgery, the AVF tissues in each group were collected to detect the expressions of CD34, NLRP3, caspase-1 and interleukin (IL)-1β by immunohistochemistry, Western blotting and real-time polymerase chain reaction. Results: The expressions of NLRP3 and CD34 in human AVF failure tissues were significantly higher than those in normal veins ( p < 0.001), indicating that NLRP3 was upregulated in patients with AVF failure. In our animal study, the veins in the AVF + uraemia group exhibited heavy hyperplasia, and the boundary between the media and the adventitia was not clear. However, PTX alleviated this hyperplasia. Compared with the AVF models, the AVF + uraemia models had much higher expressions of NLRP3, caspase-1, IL-1β and CD34 ( p < 0.001). However, PTX had the opposite effect against uraemia on the NLRP3 inflammasome pathway at both the gene and protein levels. Conclusions: Our findings provide new insights that show that PTX can decrease the activity of the NLRP3 inflammasome pathway in AVF models. Pentoxifylline has the potential as a drug for preventing intimal hyperplasia and AVF failure.
A comparison between two radiological criteria for verifying tip location of central venous catheters
Authors: Pittiruti Mauro , Bilancia Andrea , Ortiz Miluy Gloria , D’Arrigo Sonia 
Published: October 2022

Introduction: Current guidelines recommend intraprocedural methods—such as Intra-Cavitary ECG (IC-ECG) and echocardiography—for verifying the location of the tip of central venous catheters. Nonetheless, there are clinical conditions which may require to verify tip location by less accurate methods such as Chest X-Ray (CXR). We have compared the feasibility and accuracy of two radiological methods for tip location—the Sweet Spot Criterion (SSC) and the Carina Criterion (CC)—using IC-ECG as reference. Methods: In this retrospective multicenter study, we reviewed the radiology databases of three hospitals, examining all CXRs performed on patients after insertion of Peripherally Inserted Central Catheters (PICCs), as long as the tip location had been successfully performed during the procedure by IC-ECG. Tip location was verified using SSC and CC, comparing the two methods in terms of feasibility and accuracy. Results: We reviewed the CXR of 1116 PICCs successfully inserted by IC-ECG. CC was not feasible in 0.5% (impossible visualization of the carina) and difficult in 1.5%; in 97.7% of cases, the position of the tip was adequate (1–5 cm below the carina), in 0.6% too high (<1 cm), in 1.2% too low (6–9 cm). On the other hand, because of unclear visualization of radiological landmarks, SSC was not feasible in 0.9% and difficult in 10.5%; though, according to SSC the tip location was always acceptable (in 94.2% the tip was in the middle of the spot, in 2.5% close to the superior border, and in 2.3% close to the inferior border); no tip was visualized outside of the spot. Conclusion: CC and SSC were similar in terms of feasibility (99.5% vs 99.1%) and accuracy (98.1% vs 100%), though CC was subjectively perceived to be easier and more rapid to perform.
Minimally invasive peritoneal access: A new approach of catheter placement for peritoneal dialysis
Authors: Chula Domingos Candiota , Riella Miguel Carlos , Portiolli Franco Ricardo , de Alcântara Márcia Tokunaga , Campos Rodrigo Peixoto , Gordon Gina Moreno , Rokukawa Patrícia Emiko , do Nascimento Marcelo Mazza 
Published: October 2022

Background: Catheter implantation techniques for peritoneal dialysis (PD) have advanced significantly in recent years. We aimed to analyze the survival and associated complications of catheters inserted using a new technique that is guided by ultrasound and fluoroscopy and requires minimal tissue dissection. The procedure was performed by nephrologists in the outpatient basis, we compared these results of the minimally invasive insertion with traditional implantation using trocars. Methods: A total of 152 PD catheters were placed in 152 patients with stage 5 chronic kidney disease; 62.5% of the patients were men, with a mean age of 56.6 ± 18.5 years. The following two methods were used: minimally invasive insertion (MI group, n = 73) and trocar insertion (T group, n = 79). Patients in both the groups were followed prospectively for 26 months from the date of the first implantation. Results: Gender, age, and prevalence of diabetes mellitus were not significantly different between the groups, while the body mass index, presence of obesity, and abdominal scars from previous surgeries were higher in the MI group ( p = 0.021). The incidence of catheter dysfunction was lower in the MI group compared to group T (6.8% vs 20.3%; p = 0.019). Exit site infection was also lower with the new technique (4.1% vs. 18.9%; p = 0.005). Further, the cumulative incidence of peritonitis also reduced with MI ( p = 0.034). Finally, the overall catheter survival at 1 year was 89%, which has been shown as higher in group MI (95% vs 82% in group T; p = 0.025). Conclusion: The MI technique for catheter insertion showed low complication rates and excellent catheter survival as compared to traditional implantation methods; thus, it may be an alternative method for PD catheter placement.
Impact of Body Mass Index on 5-Year Survival Rates in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Authors: Aoyama Takashi , Notsu Akifumi , Ichimaru Koki , Hayashi Kinuko , Tsuji Masanori , Yoshitsugu Kanako , Fukaya Masafumi , Enami Terukazu , Ikeda Takashi 
Published: October 2022

Background: Cancer survival is associated with body mass index (BMI). However, the impact of patients’ baseline characteristics on allogeneic hematopoietic stem cell transplantation (allo-HSCT) outcomes remains unclear. This study aimed to examine the baseline clinical factors associated with 5-year survival rates in patients undergoing allo-HSCT. Material and Methods: This was a retrospective exploratory observational study. Patients (n = 113, 52 women; average age: 55 years) who underwent allo-HSCT at the Division of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, between January 2008 and March 2015, were included in the present study. Results: Patients with low BMI (<18.5 kg/m2) had significantly lower 5-year survival rates than those with normal (18.5-24.9 kg/m2) and high (⩾25.0 kg/m2) BMI. The 5-year survival rate was poorer for patients with sarcopenia (41.5%) than that for those without sarcopenia prior to allo-HSCT ( P = .05). The 5-year survival rate was poorer for patients with geriatric nutritional risk index (GNRI < 98) (34.5%) than that for those without GNRI prior to allo-HSCT ( P < .01). Conclusions: Low BMI before allo-HCST pre-treatment was a predictor of 5-year survival rates in this study. Patients undergoing allo-HSCT may require nutritional interventions during pre-treatment to reduce the risk of sarcopenia and GNRI (<98), which affects their survival rates.
Dental Screening Including Panoramic Radiograph for Gorlin-Goltz Syndrome in Patients With Multiple Basal Cell Carcinomas
Authors: Pitak-Arnnop Poramate , Witohendro Levyn Kay , Tangmanee Chatpong , Bhakdinaronk Anonknart , Subbalekha Keskanya , Auychai Prim , Sirintawat Nattapong , Meningaud Jean-Paul , Neff Andreas 
Published: October 2022

Purpose To answer the following clinical research question: “Among patients with multiple basal cell carcinomas (mBCCs), can panoramic radiograph (PaR) facilitate the diagnosis of Gorlin-Goltz syndrome (GGS)?” Methods This retrospective study enrolled mBCCs subjects who presented to a German tertiary care center between 1 January 2015 and 31 December 2021. The primary predictor was presence of syndromic mBCCs, and the main outcomes were jaw cysts and odontogenic keratocysts (OKCs). Descriptive, bi- and multivariate statistics, diagnostic test evaluation, and number needed to screen (NNS) were computed at α = 95%. Results The sample comprised 527 mBCCs patients (36.1% females; 6.8% GGS; 5.5% OKCs; mean age, 74.5 ± 15.8 years [range, 15-102]). There was a significant association between syndromic mBCCs and jaw cysts ( P < .0001; NNS = 2 [95% CI, CI, 1.1 to 1.4]). In the adjusted logistic model, PaR identified GGS via radiographic diagnosis of jaw cysts in case of 1) age ≤ 35 years, 2) ≥ 5 BCCs, and 3) ≥ 1 high-risk BCCs. Nearly every jaw cyst identified by PaR was OKCs ( P = .01; 95% CI, 3.1 to 3,101.4; NNS = 1.3 [95% CI, .9 to 2]). The post hoc power was 100%. Conclusions Dental screening with the use of PaR for mBCCs patients, especially those aged ≤35 years, or with ≥5 BCCs, or ≥1 high-risk BCCs, may be helpful in detection and identification of GGS through recognition of OKCs.
Negative Ulnar Variance Lessens DRUJ Instability After DRUJ Disruption: A Biomechanical Analysis
Authors: Huddleston Hailey P. , Kurtzman Joey S. , Deegan Liam , Hayes Westley , Austin Kevin , Carter John , Aibinder William R. , Koehler Steven M. 
Published: October 2022

Background: The purpose of this study was to perform a biomechanical investigation on the effect of ulnar variance (UV) on the stability of the distal radioulnar joint (DRUJ) prior to and after DRUJ sectioning. Methods: Ten cadaveric forearm specimens were included in the study and baseline UV was assessed radiographically. Radial motion relative to the ulna was evaluated using Intel real sense cameras and a custom developed program. The forearms were dissected, and a radial osteotomy was performed. Using a custom-made plate, radial stability was assessed with an UV of + 4, 0, and −4 mm by measuring the maximum and minimum radial position relative to the ulna during a simulated Shuck test. The volar radioulnar ligaments and triangular fibrocartilage complex (TFCC) were then sectioned, and testing was repeated at each UV state. Results: Sectioning significantly increased radial translation at neutral ( P = .008), +4 mm UV ( P = .008), and −4 mm UV ( P = .018). There were no significant differences in translation between the 3 UV groups with the DRUJ intact ( P = .124). The ulnar negative (−4 mm) state had significantly lower translation compared to the positive (+4 mm) ( P < .001) and the neutral (0 mm) ( P = .026) UV states. There were no significant differences between the positive and neutral UV groups with the DRUJ sectioned. Conclusions: Fixating the radius in −4 mm of ulnar negativity significantly decreased radial translation after sectioning the volar radioulnar ligament and TFCC. Ulnar variance had no effect on stability with an intact DRUJ. Study Type: Biomechanical Study
Research Participation in Substance Use Disorder Trials: Design and Methods of a Multi-Site Nested Qualitative Study
Authors: Richardson Lindsey , Jaffe Kaitlyn , Socias M. Eugenia , Le Foll Bernard , Lim Ron , Jutras-Aswad Didier 
Published: October 2022

Background Given the health and social harms of problematic substance use, randomized controlled trials (RCTs) are critical in developing and testing pharmacotherapies for substance use disorders. However, substance use RCTs can be challenging to conduct, considering the social and structural barriers to participating in research among people with substance use disorders (PSUD), including stigma, poverty, and criminalization—factors that can shape trial recruitment, enrollment, protocol adherence and study retention. Despite these barriers, adequate representation and participation of PSUD in RCT research is essential to assessing and developing treatments, and thus a deeper understanding of RCT participation dynamics among PSUD is needed to support clinical trial research. Methods We conducted a nested qualitative study within a Canadian, multisite, phase IV, open-label, pragmatic RCT that tested two approved opioid agonist treatments, methadone and buprenorphine/naloxone, among patients with prescription opioid use disorder. A subset of individuals ( n = 60) participating in this RCT were interviewed across four different regions in Canada at the beginning and end of their trial involvement, as well as study clinicians ( n = 16) and staff ( n = 16) operating the trial. Conclusion As a nested study within a real-world addiction medicine trial, this research offers an innovative approach to investigating the experiences, strategies, and challenges associated with RCTs among PSUD. While we acknowledge challenges related to the operations of multisite research and engaging marginalized populations in experimental research, this study has the potential to generate critical insights around the RCT experiences of PSUDs and trial staff to inform the conduct of future RCTs.
Surgical excision and skin grafting combined with intralesional injection of triamcinolone for the treatment of keloids after syndactyly release
Authors: Jiang Yongkang , Zhou Shengbo , Tian Jingshun , Du Xingchao , Sun Wenhai , Wang Bin 
Published: October 2022

The purpose of this study was to investigate the efficacy of surgery combined with triamcinolone acetonide injection in managing the difficult problem of keloid formation after syndactyly release. Twenty-two patients with keloid formation after syndactyly release were retrospectively reviewed. They were divided into a simple surgery group and a surgery plus injection group. Complications, web quality, scar score and satisfaction were assessed and compared. In the surgery plus injection group, three patients (3/13) experienced recurrence and ten webs were good, whereas in the simple surgery group, seven patients (7/9) experienced recurrence and five webs were poor. The mean Vancouver Scar Scale score was significantly lower (4.3 versus 7.8) and the mean Faces Questionnaire satisfaction score was higher (4.2 versus 2.6) in the surgery plus injection group. Combining surgical excision with early and repeated intralesional injection can achieve better results with low recurrence rate and side effects. Level of evidence: IV