Clinical Scores Research Articles

A randomized double-blind pilot study to evaluate the efficacy, safety, and tolerability of intravenous iron versus oral iron for the treatment of restless legs syndrome in patients with iron deficiency anemia.

Restless legs syndrome (RLS) is a neurological disorder that can have a profound effect on sleep and quality of life. Idiopathic RLS is associated with brain iron insufficiency despite normal peripheral iron stores. There is, however, a five- to six-fold increase in prevalence of RLS in patients with iron deficiency anemia (IDA). Several open-label trials have demonstrated symptomatic improvement in RLS following treatment of IDA using oral or intravenous iron supplementation. To date, there have been no randomized double-blind controlled trials of intravenous iron compared with oral iron for the treatment of RLS patients with IDA. In the current study, oral ferrous sulfate and ferumoxytol were compared for efficacy and speed of response for treatment of RLS occurring in patients with IDA. The planned recruitment for this study was 70 patients with RLS and IDA, to be randomly assigned 1:1 to oral or intravenous iron, using double-blind, double-dummy procedures. At Week 6, the primary outcomes of Clinical Global Impression-Improvement score and change from baseline in the International Restless Legs Syndrome Study Group rating scale score were assessed. Due to challenges, performing the clinical trial during the COVID-19 pandemic, final-week data were found missing for 30 patients. As a result, in order to maintain the prespecified statistical analysis, an additional 30 patients were recruited. Both IV and oral iron were associated with a marked improvement in RLS symptoms, with no statistically significant difference between treatment groups. No serious adverse events were observed in either treatment group.

Comparison of the Effects of Govarcin Herbal Capsule and Metoclopramide for Alleviating Gastrointestinal Symptoms in Patients with Functional Dyspepsia: A Randomized Double-blind Clinical Trial

Background: Functional dyspepsia (FD) is felt as a discomfort or pain on the center line or upper abdomen. In this study, we aimed to compare the effects of Govarcin herbal capsule and Metoclopramide for alleviating gastrointestinal symptoms in patients with FD. Methods: Totally, 106 patients enrolled in a double-blind, clinical trial study. The participants had FD and were divided into two groups receiving Govarcin and Metoclopramide by block randomization. The patients were treated for four weeks, taking one Govarcin capsule or Metoclopramide tablet after each meal. The rate of improvement in patients was assessed by mitigation of clinical symptoms, including epigastric pain, fullness, discomfort, nausea, vomiting and heartburn. Also, before and after intervention, we used Nepin questionnaire and ROME III. SPSS statistics 25 software was used for data analyzing. Results: Clinical symptom score changes between Govarcin and Metoclopramide patients’ groups showed that there was no significant difference in any of the clinical symptom scores (except for heartburn, p-value=0.012) between the study groups. Nepean score in Govarcin group before and after treatment were 19.3±4.8 and 8.9±2.8, respectively (p-value<0.001). For Metoclopramide group, these values were 19.8±3.5 and 9.4±2.1 respectively (p-value<0.001). No significant difference was found in terms of Nepean score between the Govarcin and Metoclopramide groups (p-value=0.995). Conclusion: Govarcin herbal capsule can be used to remedy symptoms in patients with FD. It seems that Govarcin is as effective as Metoclopramide in fighting symptoms of FD as no significant difference in efficacy has been demonstrated between them.

Combination of Urinary Neutrophil Gelatinase-associated Lipocalin, Kidney Injury Molecular-1, and Angiotensinogen for the Early Diagnosis and Mortality Prediction of Septic Acute Kidney Injury.

Acute kidney injury (AKI) is one of the most severe complications of sepsis. This study was conducted to analyze the role of urinary neutrophil gelatinase-associated lipocalin (uNGAL), urinary kidney injury molecular-1 (uKIM-1), and urinary angiotensinogen (uAGT) in the early diagnosis and mortality prediction of septic AKI. The prospective study enrolled 80 sepsis patients in the ICU and 100 healthy individuals and divided patients into an AKI group and a non-AKI group. uNGAL, uKIM-1, uAGT, serum creatinine/procalcitonin/C-reaction protein, and other indicators were determined, and clinical prediction scores were recorded. The sensitivity and specificity of uNGAL, uKIM-1, and uAGT in diagnosis and mortality prediction were analyzed by the receiver operator characteristic (ROC) curve and the area under the curve (AUC). uNGAL, uKIM-1, and uAGT levels were higher in sepsis patients than healthy controls, higher in AKI patients than non-AKI patients, and higher in AKI-2 and AKI-3 patients than AKI-1 patients. At 0 h after admission, the combined efficacy of three indicators in septic AKI diagnosis (ROC-AUC: 0.770; sensitivity: 82.5%; specificity: 70.0%) was better than a single indicator. At 24 h, uNGAL, uKIM-1, and uAGT levels were higher in sepsis non-survivals than survivals and higher in septic AKI non-survivals than septic AKI survivals. The combined efficacy of three indicators in the prediction of sepsis/septic AKI mortality (ROC-AUC: 0.828/0.847; sensitivity: 71.4%/100.0%; specificity: 82.7%/66.7%) was better than a single indicator. uNGAL, uKIM-1, and uAGT levels were increased in septic AKI, and their combination helped the early diagnosis and mortality prediction.

Intrinsic network abnormalities in children with autism spectrum disorder: an independent component analysis.

Aberrant intrinsic brain networks are consistently observed in individuals with autism spectrum disorder. However, studies examining the strength of functional connectivity across brain regions have yielded conflicting results. Therefore, this study aimed to investigate the functional connectivity of the resting brain in children with low-functioning autism, including during the early developmental stages. We explored the functional connectivity of 43 children with autism spectrum disorder and 54 children with typical development aged 2 to 12 years using resting-state functional magnetic resonance imaging data. We used independent component analysis to classify the brain regions into six intrinsic networks and analyzed the functional connectivity within each network. Moreover, we analyzed the relationship between functional connectivity and clinical scores. In children with autism, the under-connectivities were observed within several brain networks, including the cognitive control, default mode, visual, and somatomotor networks. In contrast, we found over-connectivities between the subcortical, visual, and somatomotor networks in children with autism compared with children with typical development. Moderate effect sizes were observed in entire networks (Cohen's d = 0.43-0.77). These network alterations were significantly correlated with clinical scores such as the communication sub-score (r = - 0.442, p = 0.045) and the calibrated severity score (r = - 0.435, p = 0.049) of the Autism Diagnostic Observation Schedule. These opposing results observed based on the brain areas suggest that aberrant neurodevelopment proceeds in various ways depending on the functional brain regions in individuals with autism spectrum disorder.

Improving the performance of the Cleveland Clinic Score for predicting acute kidney injury after cardiac surgery: a prospective multicenter cohort study.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is associated with high short- and long-term mortality rates. The prediction of CSA-AKI is crucial for early detection and treatment. Current predictive models may be improved by potentially useful preoperative and intraoperative information. This multicenter prospective cohort study recruited 261 consecutive patients at high risk for developing CSA-AKI, based on a Cleveland Clinical Score (CCS) of ≥4 points from July to December 2017 in 14 hospitals in Spain and the UK. Postoperative AKI occurred in 145 (55.5%) patients. The receiver operating characteristics curve (AUC) of a base model including only the CCS was compared with models including additional preoperative and intraoperative variables such as the estimated glomerular filtration rate (eGFR) instead of plasmatic creatinine, intraoperative urine output, baseline hemoglobin, nadir hemoglobin, and glycosylated hemoglobin (HbA<inf>1c</inf>) instead of diabetes mellitus. The performance of each model for AKI was compared. The CCS alone gave an AUC of 0.67 (95% CI, 0.56-0.78) for postoperative AKI. None of the single variables added to the base model CCS improve discrimination. The AUC for postoperative AKI was improved when baseline hemoglobin, eGFR instead of plasmatic creatinine, HbA<inf>1c</inf>, and nadir hemoglobin were added to the CCS (AUC=0.77; 95% CI, 0.67-0.87; P=0.02). The addition of baseline hemoglobin, eGFR, HbA<inf>1c</inf>, and nadir intraoperative hemoglobin may be useful for improving the discrimination of the clinical predictive risk scores for AKI.

The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

Incremental Value of a Metabolic Risk Score for Heart Failure Mortality: A Population-Based Study.

Heart failure is heterogeneous syndrome with persistently high mortality. Nuclear magnetic resonance spectroscopy enables high-throughput metabolomics, suitable for precision phenotyping. We aimed to use targeted metabolomics to derive a metabolic risk score (MRS) that improved mortality risk stratification in heart failure. Nuclear magnetic resonance was used to measure 21 metabolites (lipoprotein subspecies, branched-chain amino acids, alanine, GlycA (glycoprotein acetylation), ketone bodies, glucose, and citrate) in plasma collected from a heart failure community cohort. The MRS was derived using least absolute shrinkage and selection operator penalized Cox regression and temporal validation. The association between the MRS and mortality and whether risk stratification was improved over the Meta-Analysis Global Group in Chronic Heart Failure clinical risk score and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels were assessed. The study included 1382 patients (median age, 78 years, 52% men, 43% reduced ejection fraction) with a 5-year survival rate of 48% (95% CI, 46%-51%). The MRS included 9 metabolites measured. In the validation data set, a 1 standard deviation increase in the MRS was associated with a large increased rate of death (hazard ratio, 2.2 [95% CI, 1.9-2.5]) that remained after adjustment for Meta-Analysis Global Group in Chronic Heart Failure score and NT-proBNP (hazard ratio, 1.6 [95% CI, 1.3-1.9]). These associations did not differ by ejection fraction. The integrated discrimination and net reclassification indices, and Uno's C statistic, indicated that the addition of the MRS improved discrimination over Meta-Analysis Global Group in Chronic Heart Failure and NT-proBNP. This MRS developed in a heart failure community cohort was associated with a large excess risk of death and improved risk stratification beyond an established risk score and clinical markers.

Total femoral spanning for distal femur "fragility" fractures utilising nail-plate fixation "short-term experience of a district general hospital".

Our primary objective was to investigate the time to radiological union following linked nail-plate fixation of distal femur "fragility" fractures. Secondary objectives were to evaluate all-cause reoperations, 90-day mortality, rate of blood transfusion and the impact on quality of life. In this retrospective study of all adults (≥ 65years) with native or periprosthetic distal femur fragility fractures, underwent a linked nail-plate fixation, data were retrieved on fracture classifications, clinical frailty score, blood transfusion, length of hospital stay, 90-day mortality, time to radiological union, overall complication rates and EuroQoL-5D. In total, 18 out of 23 patients completed sequential follow-up. Radiological union was observed in 14 patients (median 143days; range 42-414). Three patients underwent reoperations. There were no implant failures or a subsequent periprosthetic fractures. Ninety-day mortality was 17.4%. Eighteen patients required blood transfusion. The QoL was significantly lower after index surgery (0.875 vs. 0.684; p < 0.01). Based on our observation, with short-term follow-up, the linked nail-plate yields optimal stability to allow immediate weight bearing, in a cohort with moderate frailty. It is reproducible,with variable radiological union rates. The concept of "total femoral spanning" reduces the risk of subsequent periprosthetic fractures. The additional intervention has increased the rates of allogenic blood transfusion. There is significant impact on overall QoL, with almost 50% being more dependent in self-care.

Trends in Blood Mosaicism and Clinical Phenotype Score in Patients with Beckwith-Wiedemann Syndrome Evaluated for Tongue Reduction Surgery.

Most patients with Beckwith-Wiedemann syndrome (BWS) have macroglossia with some requiring tongue reduction surgery (TRS). This study reports correlations between levels of affected cells (mosaicism) and BWS clinical score in patients evaluated for TRS. We also show correlations of clinical score and mosaicism with obstructive sleep apnea (OSA) severity. Blood mosaicism levels and BWS clinical score were recorded in patients with macroglossia referred to plastic surgery for evaluation. Associations among blood mosaicism, BWS clinical score, TRS, and OSA were assessed with appropriate statistics. Of the 225 patients included, BWS blood testing was available in 128 (56.9%). Mosaicism levels were higher in those who underwent TRS compared to those who did not (85.9 85.9 (56.5-95.9)% vs. 29.7 (2.8-73.1)%, p<0.001). BWS clinical score was also higher in those requiring TRS (9.0 (8.0-11.0) versus 7.0 (6.0-9.0), p<0.001). There was a positive correlation between clinical score and obstructive apnea-hypopnea index (r=0.320, p=0.011). Receiver operating characteristic curve analysis showed a clinical score ≥11 had 100% specificity and 36.4% sensitivity for detecting patients requiring TRS. Blood mosaicism ≥80% had 63.6% sensitivity and 83.6% specificity for predicting surgery. A combined criteria of BWS clinical score ≥11 or mosaicism ≥80% had 72.7% sensitivity and 83.6% specificity for predicting TRS. Blood mosaicism levels and higher BWS clinical scores appear associated with a greater frequency of having surgery in patients with macroglossia referred for surgical evaluation. Elevations in BWS clinical scoring are associated with increased OSA severity while increased blood mosaicism is not.

O142: Current clinical applications and limitations of graft augmentation in rotator cuff repair: a systematic review

Abstract Background Rotator cuff tears (RCTs) are a leading source of chronic and acute shoulder pain globally, with causes spanning from tendon degeneration to traumatic injury. Especially prevalent in the aging population, RCTs have a significant retear rate despite surgical intervention, and recent years have seen an increase in the use of grafts in surgery to address many of the clinical issues previously encountered in tendon-healing. Objectives To compare the effectiveness of various grafts in graft-augmentation surgery for full-thickness rotator cuff tears, assessed with functional and clinical outcomes. Selection criteria Adult patients with MRI-diagnosed full-thickness RCT and subsequently underwent graft-augmentation surgery; followed-up &amp;gt;1year, with assessment for retear and quantitative clinical outcomes. Results 32 primary studies, mean follow-up of 2 years and total of 1052 patients were included. The effectiveness of graft-augmentation was assessed using retear rate, ASES, Constant, UCLA and VAS. Graft-augmentation significantly improves all functional and clinical scores (p&amp;lt;0.05), and decreases retear rate to an average of 18.5% &amp;gt;1year post-surgery (p&amp;lt;0.0001), with no significant difference in effectiveness between the 4 different types of grafts. (p&amp;gt;0.05). No significant difference in outcomes was found in graft-augmentation between different tear sizes. Conclusions Graft augmentation for RCTs shows significant improvements in clinical and functional outcomes, and significantly lowers retear rate compared to conservative treatment or surgery without graft augmentation. The choice of graft has been shown to be of less importance than the clinical decision to use surgical-intervention with graft-augmentation, which applies to full-thickness tears of all sizes; both primary and revision tears.

Spectral exponent assessment and neurofilament light chain: a comprehensive approach to describe recovery patterns in stroke.

Understanding the residual recovery potential in stroke patients is crucial for tailoring effective neurorehabilitation programs. We propose using EEG and plasmatic Neurofilament light chain (NfL) levels as a model to depict longitudinal patterns of stroke recovery. We enrolled 13 patients (4 female, mean age 74.7 ± 8.8) who underwent stroke in the previous month and were hospitalized for 2-months rehabilitation. Patients underwent blood withdrawal, clinical evaluation and high-definition EEG at T1 (first week of rehabilitation) and at T2 (53 ± 10 days after). We assessed the levels of NfL and we analyzed the EEG signal extracting Spectral Exponent (SE) values. We compared our variables between the two timepoint and between cortical and non-cortical strokes. We found a significant difference in the symmetry of SE values between cortical and non-cortical stroke at both T1 (p = 0.005) and T2 (p = 0.01). SE in the affected hemisphere showed significantly steeper values at T1 when compared with T2 (p = 0.001). EEG measures were consistently related to clinical scores, while NfL at T1 was related to the volume of ischemic lesions (r = 0.75; p = 0.003). Additionally, the combined use of NfL and SE indicated varying trends in longitudinal clinical recovery. We present proof of concept of a promising approach for the characterization of different recovery patterns in stroke patients.

Understanding the quality-of-life experiences of older or frail adults following a new dens fracture: Nonsurgical management in a hard collar versus early removal of collar.

In the United Kingdom, fractures of the cervical dens process in older and/or frail patients are usually managed nonsurgically in a hard collar. However, hard collars can lead to complications and this management approach is now being questioned, with growing interest in maximising patients' short-term quality-of-life. It is vital that patients' perspectives are considered; yet, there is a dearth of literature examining the aspect. To help inform wider decision-making about use of collar/no collar management of dens fractures in older/frail people, we explored older/frail people's experience of the two management approaches and how they affected their perceived quality-of-life. We interviewed older and/or frail adults with a recent dens fracture (aged ≥65 years or with a clinical frailty score of ≥5) or their caregiver. Participants were recruited from both arms of a clinical trial comparing management using a hard collar for 12 weeks (SM) with early removal of the collar (ERC) and were interviewed following randomisation and again, 12-16 weeks later. Data were analysed using a framework approach. Both participant groups (SM/ERC) reported substantial, negative quality-of-life (QoL) experiences, with the fall itself and lack of access to care services and information being frequent major contributory factors. Many negative experiences cut across both participant groups, including pain, fatigue, diminished autonomy and reduced involvement in personally meaningful activities. However, we identified some subtle, yet discernible, ways in which using SM/ERC reinforced or alleviated (negative) QoL impacts, with the perceived benefits/burdens to using SM/ERC varying between different individuals. Study findings can be used to support informed decision-making about SM/ERC management of dens fractures in older/frail patients. Public and patient involvement contributors were involved in the study design, development of interview topic guides and interpretation of study findings.

Evaluation of Serum Annexin A1 Values in Patients with Inflammatory Bowel Diseases

Objective: Annexin A1(AnxA1) is an anti-inflammatory mediator. In the current study,we aimed to evaluate whether or not serum Annexin A1 levels of inflammatory boweldiseases (IBDs) patients relate to the clinical and laboratory traits of IBDs.&#x0D; Methods: This case-control study included 67 ulcerative colitis (UC) patients (47 males and 20 females), 53 Crohn’s disease (CD) patients (37 males and 16 females) and 60 healthy controls (36 males and 24 females). The Mayo Clinical scoring system (MCS) was used for UC and the histological activity index (HAI) was determined by Truelove and Richards method. The Crohn's disease activity index (CDAI) was used for CD patients. Montreal classification was used for the localization of IBDs.&#x0D; Results: The mean serum AnxA1 concentrations were not statistically significant in UC, CD and the control groups (26.36±17.30 ng/ml vs 22.98±12.74 vs 24.45±12.18 ng/ml respectively, p=0.404). The MCS, HAI of UC patients negatively correlated with the serum AnxA1 values (rho=-0.616, p

Large-scale bioreactor production of extracellular vesicles from mesenchymal stromal cells for treatment of acute radiation syndrome

BackgroundHematopoietic acute radiation syndrome (H-ARS) occurring after exposure to ionizing radiation damages bone marrow causing cytopenias, increasing susceptibility to infections and death. We and others have shown that cellular therapies like human mesenchymal stromal cells (MSCs), or monocytes/macrophages educated ex-vivo with extracellular vesicles (EVs) from MSCs were effective in a lethal H-ARS mouse model. However, given the complexity of generating cellular therapies and the potential risks of using allogeneic products, development of an “off-the-shelf” cell-free alternative like EVs may have utility in conditions like H-ARS that require rapid deployment of available therapeutics. The purpose of this study was to determine the feasibility of producing MSC-derived EVs at large scale using a bioreactor and assess critical quality control attributes like identity, sterility, and potency in educating monocytes and promoting survival in a lethal H-ARS mouse model.MethodsEVs were isolated by ultracentrifugation from unprimed and lipopolysaccharide (LPS)-primed MSCs grown at large scale using a hollow fiber bioreactor and compared to a small scale system using flasks. The physical identity of EVs included a time course assessment of particle diameter, yield, protein content and surface marker profile by flow-cytometry. Comparison of the RNA cargo in EVs was determined by RNA-seq. Capacity of EVs to generate exosome educated monocytes (EEMos) was determined by qPCR and flow cytometry, and potency was assessed in vivo using a lethal ARS model with NSG mice.ResultsPhysical identity of EVs at both scales were similar but yields by volume were up to 38-fold more using a large-scale bioreactor system. RNA-seq indicated that flask EVs showed upregulated let-7 family and miR-143 micro-RNAs. EEMos educated with LPS-EVs at each scale were similar, showing increased gene expression of IL-6, IDO, FGF-2, IL-7, IL-10, and IL-15 and immunophenotyping consistent with a PD-L1 high, CD16 low, and CD86 low cell surface expression. Treatment with LPS-EVs manufactured at both scales were effective in the ARS model, improving survival and clinical scores through improved hematopoietic recovery. EVs from unprimed MSCs were less effective than LPS-EVs, with flask EVs providing some improved survival while bioreactor EVs provide no survival benefit.ConclusionsLPS-EVs as an effective treatment for H-ARS can be produced using a scale-up development manufacturing process, representing an attractive off-the-shelf, cell-free therapy.

Standing Balance Conditions and Digital Sway Measures for Clinical Trials of Friedreich's Ataxia.

Progressive loss of standing balance is a feature of Friedreich's ataxia (FRDA). This study aimed to identify standing balance conditions and digital postural sway measures that best discriminate between FRDA and healthy controls (HC). We assessed test-retest reliability and correlations between sway measures and clinical scores. Twenty-eight subjects with FRDA and 20 HC completed six standing conditions: feet apart, feet together, and feet tandem, both with eyes opened (EO) and eyes closed. Sway was measured using a wearable sensor on the lumbar spine for 30 seconds. Test completion rate, test-retest reliability with intraclass correlation coefficients, and areas under the receiver operating characteristic curves (AUCs) for each measure were compared to identify distinguishable FRDA sway characteristics from HC. Pearson correlations were used to evaluate the relationships between discriminative measures and clinical scores. Three of the six standing conditions had completion rates over 70%. Of these three conditions, natural stance and feet together with EO showed the greatest completion rates. All six of the sway measures' mean values were significantly different between FRDA and HC. Four of these six measures discriminated between groups with >0.9 AUC in all three conditions. The Friedreich Ataxia Rating Scale Upright Stability and Total scores correlated with sway measures with P-values <0.05 and r-values (0.63-0.86) and (0.65-0.81), respectively. Digital postural sway measures using wearable sensors are discriminative and reliable for assessing standing balance in individuals with FRDA. Natural stance and feet together stance with EO conditions suggest use in clinical trials for FRDA. © 2024 International Parkinson and Movement Disorder Society.

Glucocorticoid-free remission in patients with SLE in the era of biologics: Immune complex disease is likely to benefit from current medications.

In addition to various immunosuppressive agents, belimumab and anifrolumab became available in Japan. We aimed to investigate glucocorticoid-free clinical remission in a single-centre retrospective cohort in October 2023. Our cohort included patients with SLE who needed to start or increase glucocorticoids for disease activity and were followed up for more than 1year. We investigated the rate of achievement of clinical remission off corticosteroids (CR off C), defined as no clinical score on the SLEDAI-2K without glucocorticoids, baseline predictors of CR off C, medications used when CR off C was achieved, and flare rates following CR off C. Out of the 60 patients followed for an average of 5.4 (±2.6) years, 17 (28.3%) achieved CR off C in 3.6 (±1.2) years after enrolment. Use of belimumab and anifrolumab accounted for eight (47.1%) of the achievers. Among the baseline data, male sex, recent enrolment, high glucocorticoid dose, and detection of immune complex (IC) significantly predicted CR off C, while lupus nephritis (LN) and a low C3 level tended to predict it. In the multivariate analysis, IC detection was the only predictor of CR off C. Clinical flares were observed in 5.9% of the achievers during a median 1.2years after achievement of CR off C. In the era of biologics, CR off C was achieved in 28.3% of the patient cohort requiring the start or increase of glucocorticoids for disease activity, with a relatively low rate of flares, suggesting that glucocorticoid-free clinical remission is an achievable target in SLE. IC disease, represented by male sex or nephritis, is likely to benefit from currently available medications.

Borderline personality disorder vs. schizophrenia spectrum disorders in young people recruited within an "Early Intervention in Psychosis" service: clinical and outcome comparisons.

Borderline Personality Disorder (BPD) is under-recognized in First-Episode Psychosis (FEP) and its psychotic manifestations are difficult to differentiate from Schizophrenia Spectrum Disorders (SSD). The aim of this investigation was to compare clinical, sociodemographic, and outcome characteristics between FEP patients with BPD vs. FEP subjects with SSD both at baseline and across a 2-year follow-up period. Participants completed the Health of the Nation Outcome Scale (HoNOS), the Positive And Negative Syndrome Scale (PANSS), and the Global Assessment of Functioning (GAF) scale both at entry and every 12months during the follow-up. A mixed-design ANOVA model was conducted to investigate the temporal stability of clinical scores within and between the two subgroups. Among 356 FEP participants, 49 had a BPD diagnosis. Compared to FEP/SSD (n = 307), FEP/BPD patients showed higher prevalence of employment, current substance use, and past attempted suicide. They had a lower equivalent dose of antipsychotic medication at entry and lower levels of negative symptoms. Finally, they had a higher 2-year drop-out rate and a significant improvement in psychopathological scores limited to the first year of treatment. BPD as categorical entity represents a FEP subgroup with specific clinical challenges. Appropriate treatment guidelines for this FEP subgroup are thus needed.

Cardiovascular Management of Patients Undergoing Hematopoietic Stem Cell Transplantation: From Pretransplantation to Survivorship: A Scientific Statement From the American Heart Association.

Hematopoietic stem cell transplantation can cure various disorders but poses cardiovascular risks, especially for elderly patients and those with cardiovascular diseases. Cardiovascular evaluations are crucial in pretransplantation assessments, but guidelines are lacking. This American Heart Association scientific statement summarizes the data on transplantation-related complications and provides guidance for the cardiovascular management throughout transplantation. Hematopoietic stem cell transplantation consists of 4 phases: pretransplantation workup, conditioning therapy and infusion, immediate posttransplantation period, and long-term survivorship. Complications can occur during each phase, with long-term survivors facing increased risks for late effects such as cardiovascular disease, secondary malignancies, and endocrinopathies. In adults, arrhythmias such as atrial fibrillation and flutter are the most frequent acute cardiovascular complication. Acute heart failure has an incidence ranging from 0.4% to 2.2%. In pediatric patients, left ventricular systolic dysfunction and pericardial effusion are the most common cardiovascular complications. Factors influencing the incidence and risk of complications include pretransplantation therapies, transplantation type (autologous versus allogeneic), conditioning regimen, comorbid conditions, and patient age. The pretransplantation cardiovascular evaluation consists of 4 steps: (1) initial risk stratification, (2) exclusion of high-risk cardiovascular disease, (3) assessment of cardiac reserve, and (4) optimization of cardiovascular reserve. Clinical risk scores could be useful tools for the risk stratification of adult patients. Long-term cardiovascular management of hematopoietic stem cell transplantation survivors includes optimizing risk factors, monitoring, and maintaining a low threshold for evaluating cardiovascular causes of symptoms. Future research should prioritize refining risk stratification and creating evidence-based guidelines and strategies to optimize outcomes in this growing patient population.

Caliper-verified unrestricted kinematically aligned total knee arthroplasty in Asian patients showed efficacious mid- to long-term results regardless of postoperative alignment categories.

There have been insufficient data regarding the long-term results of unrestricted kinematically aligned total knee arthroplasty (unKATKA) in Asian patients. We investigated mid- to long-term clinical and radiological follow-up data of Korean patients after caliper-verified unKATKA of minimum 7.4-10 years includingcategorised data of postoperative tibial component, limb and knee alignment. Additionally, we analysed the preoperative distribution and postoperative restoration of coronal plane alignment of knee (CPAK) phenotypes. This study is a retrospective analysis of 63 patients:96 osteoarthritic underwent consecutive caliper-verified unKATKA between October 2013 and May 2016 by a single surgeon. Implant survivorship was investigated for revision for any reason. Each knee was categorised into an in-range or outlier group by three postoperative alignment parameters: tibial component, knee and limb alignment. Statistical analyses were done for any significant differences in clinical scores and implant survival rates between groups. Finally, all knees were classified into CPAK classification postoperatively and postoperatively. The CPAK restoration rate was calculated. Among 85 knees in the clinically confirmed group, implant survival was 98.8%. There was one case of revision due to periprosthetic fracture. The percentage postoperatively aligned in the varus (valgus) outlier range was 100% (0%) for tibial component, 16.7% (24.8%) for the knee alignmentand 51% (0%) for the limb alignment. All three categories did not affect implant survival or clinical scores. Eighty one out of 96 knees (84.4%) were restored to their CPAK phenotype postoperatively. With the limitation of a case series having a small number of patients and gender deviation, our study suggests that caliper-verified unKATKA could be a good option regardless of geographical variation of constitutional alignment in patients with osteoarthritis (OA). Level IV, therapeutic study.

Is Helicobacter pylori Infection Associated With Ulcerative Colitis Activity?

Objectives: Epidemiological studies have shown an inverse association between &lt;i&gt;Helicobacter pylori&lt;/i&gt; infection and ulcerative colitis (UC). In this study, we investigated the protective effects of H. pylori infection on the severity of UC.Methods: This single-center study included 316 patients with newly diagnosed UC based on findings of colonoscopy and upper endoscopy for H. pylori evaluation between January 1994 and December 2015. Patients’ medical records were retrospectively reviewed, and severity of UC was assessed based on endoscopic findings, clinical symptoms, treatment regimens, and Mayo scores.Results: The prevalence of &lt;i&gt;H. pylori&lt;/i&gt; infection in patients with UC was 74/316 (23.4%). Based on upper endoscopic findings, the percentage of patients with duodenal ulcers was significantly higher in the H. pylori positive group than that in the &lt;i&gt;H. pylori&lt;/i&gt; negative group (27.0% vs. 11.6%, &lt;i&gt;p&lt;/i&gt;=0.022). Disease extent and endoscopic severity showed no significant intergroup difference (&lt;i&gt;p&lt;/i&gt;=0.765 and &lt;i&gt;p&lt;/i&gt;=0.803, respectively). Endoscopic severity was unaffected by the &lt;i&gt;H. pylori&lt;/i&gt; infection status, based on the extent of endoscopically documented disease and endoscopic findings. Furthermore, UC-related symptom severity assessed on the basis of stool frequency, rectal bleeding severity, and rate of admission necessitated by UC aggravation was not associated with &lt;i&gt;H. pylori&lt;/i&gt; infection (&lt;i&gt;p&lt;/i&gt;=0.185, 0.144, and 0.182, respectively). Use of steroids as induction therapy for severe UC did not differ with regard to &lt;i&gt;H. pylori&lt;/i&gt; infection (&lt;i&gt;p&lt;/i&gt;=0.327). No intergroup difference was observed in disease severity of UC classified using the Mayo score (&lt;i&gt;p&lt;/i&gt;=0.323).Conclusions: &lt;i&gt;H. pylori&lt;/i&gt; infection was detected in approximately 25.0% of patients with UC. However, the &lt;i&gt;H. pylori&lt;/i&gt; infection status was not associated with the severity of UC based on endoscopic disease activity, patients’ symptoms, steroid use, or the Mayo clinic score.