bluuebunny/crossref_metadata_2025_split huggingface dataset:
Role of clinical biomarkers in predicting the effectiveness of omalizumab
Authors: Zhang Qing , Li Chunxiao , Wan Jingxuan , Zhang Mengyuan , Nong Ying , Lin Jiangtao 
Published: May 2023

Objective: To explore whether baseline clinical biomarkers and characteristics can be used to predict the responsiveness of omalizumab. Methods: We retrospectively analyzed a cohort of patients with severe asthma who received omalizumab treatment and collected their baseline data and relevant laboratory examination results along with case records of omalizumab treatment responsiveness after 16 weeks. We compared the differences in variables between the group of patients that responded to omalizumab therapy and the non-responder group, and then performed univariate and multivariate logistic regression. Finally, we analyzed the difference in response rate for subgroups by selecting cut-off values for the variables using Fisher’s exact probability method. Results: This retrospective, single-center observational study enrolled 32 patients with severe asthma who were prescribed daily high-dose inhaled corticosteroids and long-acting β2 receptor agonists on long-acting muscarinic receptor antagonists with or without OCS. Data on age, sex, BMI, bronchial thermoplasty, FeNO, serum total IgE, FEV1, blood eosinophils, induced sputum eosinophils, blood basophils, and complications were not significantly different between the responder and non-responder groups. In the univariate and multivariate logistic regression, all the variants were not significant, and we were unable to build a regression model. We used normal high values and the mean or median of variables as cut-off values to create patient subgroups for the variables and found no significant difference in the omalizumab response rate between the subgroups. Conclusion: The responsiveness of omalizumab is not associated with pretreatment clinical biomarkers, and these biomarkers should not be used to predict the responsiveness of omalizumab.
Early transmural healing and its predictors assessed by magnetic resonance enterography in patients with Crohn’s disease receiving ustekinumab
Authors: Zhou Longyuan , Hu Cicong , Zhang Ruonan , Qiu Yun , Wang Yu , Liu Zishan , Chen Baili , He Yao , Zeng Zhirong , Li Xuehua , Mao Ren , Chen Minhu 
Published: May 2023

Background: Transmural healing (TH) is a potential therapeutic goal of Crohn’s disease (CD) and is associated with better clinical outcomes. However, few studies have described early TH and its predictors. Objectives: We aimed to evaluate early TH and its predictors using magnetic resonance enterography (MRE) in patients with CD receiving ustekinumab (UST). Design: This was a retrospective observational study. Methods: Patients with active CD treated with UST and their intestinal segments with bowel wall thickness (BWT) ⩽ 3 mm at baseline were included. Clinical characteristics, laboratory indicators, endoscopic manifestations, and MRE indices were evaluated at baseline and week 26 (W26) of the therapy. The following MRE parameters were assessed: BWT, edema, apparent diffusion coefficient (ADC), Clermont score, Magnetic Resonance Index of Activity score, fat stranding, comb sign, and stricture. TH was defined as BWT ⩽ 3 mm without any signs of inflammation (i.e., ulceration, edema, diffusion-weighted hyperintensity, and increased contrast enhancement) at W26. Results: The study included 37 patients with 106 intestinal segments (including 15 proximal small intestines, 33 terminal ilea, and 58 colons). Clinical features, laboratory indicators, endoscopic results, and MRE parameters at W26 were significantly improved after UST treatment in both patient-based and intestinal segment-based analysis. Seven (18.9%) patients and 26 (24.5%) intestinal segments achieved TH at W26. Baseline BWT [odds ratio (OR) = 0.287, 95% confidence interval (CI), 0.090–0.918, p = 0.035] and ADC (OR = 2.997, 95% CI, 1.009–8.908, p = 0.048) predict TH of patients at W26. Baseline ADC (OR = 2.857, 95% CI, 1.285–6.349, p = 0.010) and presence of stenosis (OR = 0.196, 95% CI, 0.052–0.735, p = 0.016) were associated with TH of segments at W26. Conclusion: Early TH assessed by MRE was observed in nearly one-fifth of patients with CD and intestinal segments after UST treatment for 26 weeks. Baseline MRE indices such as BWT and presence of stenosis might negatively predict TH, while ADC might positively predict early TH.
Free antibodies-to-infliximab are biomarker for predicting the effect of dose intensification in pediatric Crohn’s disease patients with secondary loss of response
Authors: Kim Eun Sil , Kwon Yiyoung , Choe Yon Ho , Kim Mi Jin 
Published: May 2023

Background: Immunogenicity to antitumor necrosis factor alpha agents, such as infliximab (IFX), may lead to therapeutic failure. Objectives: This study evaluated the relationship between free and total antibodies-to-infliximab (ATIs), trough levels (TLs) of IFX, and the response to dose intensification. Design: We performed a prospective, observational study including pediatric patients with Crohn’s disease (CD) receiving IFX maintenance therapy without dose intensification. Methods: We compared clinical and laboratory outcomes according to the presence of free and total ATIs. Factors associated with response to IFX dose intensification were investigated by analyzing IFX TLs and free and total ATIs. Results: Of the 98 patients, 9 patients had detectable free ATIs and 38 patients had total ATIs. Patients with free ATIs had significantly lower TLs (0.7 versus 5.1 µg/mL, p < 0.001) than patients without free ATIs. However, there was no difference in the IFX TLs according to the presence of total ATIs ( p = 0.2523). Analysis of the 38 samples with total ATIs showed that response to dose intensification was significantly lower in patients with free ATIs than those without free ATIs (22.2% versus 65.5%, p < 0.001). In addition, free ATIs were the only factor with poor response to dose intensification [odds ratio (OR): 14.15, 95% confidence interval (CI): 1.31–151.97, p = 0.0140]. According to the receiver operating characteristic analysis, the optimal cutoff level indicating non-response to IFX dose intensification was 30.0 AU/mL for free ATIs concentration (area under curve, 0.792; 95% CI: 0.590–0.942; sensitivity, 60.0%; specificity, 96.7%; p = 0.0241). Conclusion: Free ATIs, but not total ATIs, have a negative impact on the course of CD. Free ATIs are potential reliable biomarker for predicting the effect of dose intensification in patients with loss of response to IFX. Future studies based on serial and proactive therapeutic drug monitoring are required in the future.
Effects of visceral adipose tissue on anti-tumour necrosis factor-α in Crohn’s disease
Authors: Li Kangrong , Gong Pan , Zhang Yongbin , Liu Minji , Zhang Zinan , Yu Xiaoyu , Ye Mingmei , Tian Li 
Published: May 2023

Background: It remains unclear whether visceral adipose tissue (VAT) can predict the response of patients with Crohn’s disease (CD) to anti-tumour necrosis factor-α (anti-TNF-α) therapy. Objectives: This study aimed to investigate whether VAT predicts the efficacy of infliximab (IFX) for different sites of CD and its relationship with serum TNF-α levels and IFX serum trough concentration. Design: This is a multicentre retrospective study. Methods: Patients with CD treated with IFX from January 2014 to January 2021 were included. The perimeter of the visceral adipose area was obtained by a Computed Tomography (CT) scan. Participants were classified according to the lesion site (L1, L2, and L3) and visceral fat area. The participants were divided into colon-uninvolved non-visceral obesity (L1-VATL), colon-uninvolved visceral obesity (L1-VATH), colon-involved non-visceral obesity (L2 + L3-VATL), and colon involved visceral obesity (L2 + L3-VATH) groups. The end points of this study were set as disease remission status at 6 and 12 months. Results: The final cohort included 140 patients. Regarding efficacy at 6 and 12 months, there was a significant difference between L1-VATL (73.8% versus 36.8%, p = 0.006) and L1-VATH (81.0% versus 47.4%, p = 0.008) groups. In the analysis of serum TNF-α levels and IFX serum trough concentrations, there was a significant difference between L1-VATL and L1-VATH (59.5 pg/mL versus 236.0 pg/mL, pTNF-α = 0.006), (10.0 μg/mL versus 0.4 μg/mL, pIFX = 0.000), and L1-VATH and L2 + L3-VATH (78.7 pg/mL versus 118.6 pg/mL, pTNF-α = 0.031), (0.4 μg/mL versus 6.40 μg/mL, pIFX = 0.017). Conclusion: In L1 patients, the VAT level predicted the efficacy of IFX, with high VAT values indicating poor efficacy. The VAT level may be a useful radiological marker to predict the efficacy of IFX in patients with various types of CD.
Concurrent radical cystectomy and nephroureterectomy indications and outcomes: a systematic review and comparative analysis
Authors: Zein Marwan , Nasrallah Ali A. , Abou Heidar Nassib F. , Najdi Jad , Hneiny Layal , El Hajj Albert 
Published: May 2023

Introduction: Urothelial carcinoma can arise from the urinary bladder or from the upper urinary tract. In some instances, urinary bladder cancer (UBC) and upper tract urothelial carcinoma (UTUC) can be concurrently diagnosed, necessitating a combined radical cystectomy (RC) with radical nephroureterectomy (RNU). A systematic review was done on the combined procedure exploring outcomes and indications, in addition to a comparative analysis between the combined procedure and cystectomy alone. Methods: For the systematic review, three databases (Embase, PubMed, and Cochrane) were queried, selecting only studies that included intraoperative and perioperative data. For the comparative analysis, using the NSQIP database, CPT codes for RC and RNU were used to identify two cohorts, one with RC and RNU and one with RC alone. A descriptive analysis was performed on all preoperative variables, and propensity score matching (PSM) was performed. Postoperative events were then compared between the two matched cohorts. Results: For the systematic review, 28 relevant articles were included amounting to 947 patients who underwent the combined procedure. The most common indication was synchronous multifocal disease, the most common approach was open surgery, and the most common diversion technique was using an ileal conduit. Almost 28% of patients required blood transfusion and remained in the hospital for an average of 13 days. The most common postoperative complication was prolonged paralytic ileus. For the comparative analysis, 11,759 patients were included of which 97.5% underwent RC only and 2.5% underwent the combined procedure. After PSM, the cohort that had undergone the combined procedure showed an increased risk of renal injury, increased readmission rates, and increased reoperation rates. Whereas the cohort that had undergone RC only showed an increased risk of deep venous thrombosis (DVT), sepsis, or septic shock. Conclusion: A combined RC and RNU is a treatment option for concurrent UCB and UTUC that should be cautiously utilized as it is associated with high morbidity and mortality. Patient selection, discussion of the risks and benefits of the procedure, and explanation of the available treatment options remain the most important pillars in managing patients with this complex disease.
Accuracy of Continuous Glucose Monitoring in an Insulin-Treated Population Requiring Haemodialysis
Authors: Horne Christopher , Cranston Iain , Amos Mark , Flowers Katey 
Published: May 2023

Background: Continuous glucose monitoring (CGM) is revolutionizing diabetes care by giving both patients and the healthcare professionals unprecedented insights into glucose variability and patterns. It is established in National Institute for Health and Care Excellence (NICE) guidance as a standard of care for type 1 diabetes and diabetes in pregnancy under certain conditions. Diabetes mellitus (DM) is recognized as an important risk factor for chronic kidney disease (CKD). Around a third of patients receiving in-center haemodialysis as renal replacement therapy (RRT) have diabetes, either as a direct cause of renal failure or as an additional co-morbidity. Evidence of poor compliance with the current standard of care (self-monitoring of blood glucose [SMBG]) and overall greater morbidity and mortality, suggests this patient population as an ideal target group for CGM. However, there exists no strong published evidence showing the validity of CGM devices in insulin-treated diabetes patients requiring haemodialysis. Methods: We applied a Freestyle Libre Pro sensor to 69 insulin-treated diabetes haemodialysis (HD) patients on a dialysis day. Interstitial glucose levels were obtained, and time matched within 7 minutes to capillary blood glucose testing and any plasma blood glucose levels sent. Data cleansing techniques were applied to account for rapidly correcting hypoglycaemia and poor SMBG technique. Results: Clarke-error grid analysis showed 97.9% of glucose values in an acceptable range of agreement (97.3% on dialysis days and 99.1% on non-dialysis days). Conclusions: We conclude that the Freestyle Libre sensor is accurate in measuring glucose levels when compared to glucose as measured by capillary SMBG testing and laboratory obtained serum glucose in patients on HD.
CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol
Authors: Goupil Rémi , Nadeau-Fredette Annie-Claire , Prasad Bhanu , Hundemer Gregory L. , Suri Rita S. , Beaubien-Souligny William , Agharazii Mohsen 
Published: May 2023

Background: Emerging data favor central blood pressure (BP) over brachial cuff BP to predict cardiovascular and kidney events, as central BP more closely relates to the true aortic BP. Considering that patients with advanced chronic kidney disease (CKD) are at high cardiovascular risk and can have unreliable brachial cuff BP measurements (due to high arterial stiffness), this population could benefit the most from hypertension management using central BP measurements. Objective: To assess the feasibility and efficacy of targeting central BP as opposed to brachial BP in patients with CKD G4-5. Design: Pragmatic multicentre double-blinded randomized controlled pilot trial. Setting: Seven large academic advanced kidney care clinics across Canada. Patients: A total of 116 adults with CKD G4-5 (estimated glomerular filtration rate [eGFR] < 30 mL/min) and brachial cuff systolic BP between 120 and 160 mm Hg. The key exclusion criteria are 1) ≥ 5 BP drugs, 2) recent acute kidney injury, myocardial infarction, stroke, heart failure or injurious fall, 3) previous kidney replacement therapy. Methods: Double-blind randomization to a central or a brachial cuff systolic BP target (both < 130 mm Hg) as measured by a validated central BP device. The study duration is 12 months with follow-up visits every 2 to 4 months, based on local practice. All other aspects of CKD management are at the discretion of the attending nephrologist. Outcomes: Primary Feasibility: Feasibility of a large-scale trial based on predefined components. Primary Efficacy: Carotid-femoral pulse wave velocity at 12 months. Others: Efficacy (eGFR decline, albuminuria, BP drugs, and quality of life); Events (major adverse cardiovascular events, CKD progression, hospitalization, mortality); Safety (low BP events and acute kidney injury). Limitations: May be challenging to distinguish whether central BP is truly different from brachial BP to the point of significantly influencing treatment decisions. Therapeutic inertia may be a barrier to successfully completing a randomized trial in a population of CKD G4-5. These 2 aspects will be evaluated in the feasibility assessment of the trial. Conclusion: This is the first trial to evaluate the feasibility and efficacy of using central BP to manage hypertension in advanced CKD, paving the way to a future large-scale trial. Trial registration: clinicaltrials.gov (NCT05163158)
“You Can Change the World With a Haircut”: Evaluating the Feasibility of a Barber-led Intervention for Men of Black and Ethnic Minority Heritage to Manage High Blood Pressure
Authors: Thomas Nicola , Ewart Catriona , Lewinson Roberts Debi , Brown Andrew 
Published: May 2023

Background: People of Black, Asian and minority ethnic (BAME) heritage have a higher-than-average incidence of, and mortality from hypertension and stroke. Therefore, it is important to identify new settings for engaging people at risk of high blood pressure (BP). Aim: This feasibility study aimed to evaluate if barbers in a London borough can support and educate men of BAME heritage to manage their BP. Following UK Medical Research Council guidance, the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework was used to guide study objectives and feasibility outcomes. Methods: We collaborated with 8 barbers who were part of an existing BAME barber network. Barbers were trained online (1.5 h) and face-to-face (3 h) to provide BP healthcare advice and take customers BP readings. Qualitative field notes were collected to assess how best to recruit and train barbers, and to understand how to maintain motivation and retention of barbers. BP readings were recorded between June 2021 and March 2022. Results: Both online and face-to-face training were effective, however, greater focus on how to start conversations about BP with clients was needed. We found that motivation, incentivization and regular contact with barbers were important for recruitment, retention, and sustained BP measurement. Obtaining BP readings was challenging due to client concerns about recording their data and the impracticalities of recording results. We captured 236 BP recordings, of which 39 (16.53%) were over 140/90 mmHg; of these, 5 were over 180/100 mmHg. Conclusion: The combined data showed that educating barbers to take BP readings and deliver healthcare advice about BP is a viable intervention for rollout in a large-scale study. It has demonstrated the need to identify strategies to motivate barbers for sustained recruitment and retention, as well as further efforts to build trust among customers for long-term BP surveillance.
Factors Affecting the Surgical Outcomes of Patients Treated With “de-tension” Surgical Strategy for Multilevel Ossification of the Posterior Longitudinal Ligament in the Thoracic Spine: A Minimum 2-year Follow-Up Study of 83 Patients in a Single Center
Authors: Chen Guanghui , Fan Tianqi , Chen Zhongqiang , Li Weishi , Qi Qiang , Guo Zhaoqing , Zhong Woquan , Jiang Yu , Song Chunli , Sun Chuiguo 
Published: May 2023

Study Design Retrospective cohort study Objectives To describe the clinical characteristics and surgical outcomes of patients with multilevel-ossification of the posterior longitudinal ligament (mT-OPLL), and to identify risk factors for unfavorable outcomes. Methods Patients who were diagnosed with mT-OPLL and underwent one-stage thoracic posterior laminectomy combined with selective OPLL resection, spinal cord de-tension, and fusion surgery between August 2012 and October 2020 were recruited. Patients’ demographic-, surgical- and radiological-related parameters were collected and analyzed. Neurological status was evaluated with mJOA score, and recovery rate (RR) was calculated using the Hirabayashi formula. According to RR, patients were divided into a favorable outcome group (FOG, RR ≥50%) and an unfavorable outcome group (UOG, RR <50%). Univariate and multivariate analyses were used to compare the difference between the 2 groups and to identify risk factors for unfavorable outcomes. Results A total of 83 patients were included, with an average age of 50.6 ± 8.3 years. Cerebrospinal fluid leakage (60.2%) and transient neurological deterioration (9.6%) were the most common complications. The average mJOA score improved from preoperative 4.3 ± 2.2 to 9.0 ± 2.4 at the last follow-up, and the mean RR was 74.9 ± 26.3%. Disease duration, preoperative nonambulatory status, and the number of decompressed levels were identified as potential risk factors by Univariate analysis (all P < .05). Multivariate analysis showed that the preoperative disease duration and nonambulatory status were independent risk factors for unfavorable outcomes. Conclusions Long disease duration and nonambulatory status before surgery were independent risk factors for unfavorable outcomes.
The Effect of Education and Telephone Follow-up on the Burden of Family Caregivers of Patients With Cancer
Authors: Abdigaravand Mahin , Goudarzi Fateme , Hasanvand Shirin , Birjandi Mehdi , Galehdar Nasrin , Hojati Zohreh 
Published: May 2023

Introduction Family caregivers of patients with cancer face a care burden due to the responsibilities and problems of providing care to the patients. Applying appropriate strategies to reduce the burden is essential. Objective The study aimed to determine the effect of education and telephone follow-up on family caregivers’ burden on patients with cancer. Methods In this quasi-experimental study, 69 family caregivers of patients with cancer referred to only one chemotherapy center of a hospital in Lorestan province in Iran were recruited by convenience sampling method. They were randomly assigned to intervention ( n  =  33) and control ( n  =  36) groups. For the intervention group, two face-to-face training sessions and six telephone counseling sessions were held related to the care of the patients and self-care. The control group received only routine care. The family caregiver burden was measured by Novak and Gast Caregiver Burden Inventory (1989) completed before, immediately, and 6 weeks after the study. Data were analyzed by SPSS21 using independent t-tests, paired t-tests, and repeated measures. Results Both groups were homogeneous regarding demographic characteristics and the baseline care burden. The caregiver burden decreased significantly in the intervention group, so its score was 77.33  ±  8.49, 58.93  ±  8.03, and 52.78  ±  6.86 before the study, immediately after and 6 weeks later, respectively ( p < .001). In the control group, there were no significant changes. Conclusion Education and telephone counseling reduced the burden on family caregivers. Therefore, this type of support is beneficial for providing holistic care and preserving the health of family caregivers.