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Athletes, both amateur and professional, often resort to the consumption of nutritional supplements without professional supervision and without being aware of the risks they may entail. We conducted an exhaustive literature search to determine the most common substances found as contaminants in dietary supplements. For each substance, we analyzed its mechanism of action, clinical indication, health risk, and putative use as doping agent. In addition, we evaluated the current regulation of these supplements. Contamination of nutritional supplements (accidental or intentional), especially with steroids and stimulants, is a hazardous situation. The prolonged consumption of these products without being aware of their composition can cause serious health risks and, in the case of professional athletes, a possible sanction for doping. [ABSTRACT FROM AUTHOR]

Background: Children with inflammatory bowel disease (IBD) experience extraintestinal side effects including altered body composition, impaired muscle strength, and aerobic capacity. Exercise training may remedy these issues. Purpose: To assess the feasibility, safety, participant satisfaction, and efficacy of a training program for youth with IBD. Methods: Children with IBD completed 16 weeks of training (2 supervised + 1 home sessions per week). Feasibility was assessed by tracking recruitment, adherence, and compliance rates. Safety was assessed by tracking symptoms and adverse events. Posttraining interviews gauged satisfaction. Circulating inflammatory markers, body composition, muscle strength, aerobic fitness, and habitual physical activity were measured at baseline, midtraining (8 wk), and posttraining. Results: Eleven youth were recruited and 10 completed the study. Participants adhered to 28 (1) of 32 prescribed supervised sessions and 8 (4) of 16 prescribed home sessions. There were no adverse events, and overall feedback on training was positive. Posttraining, we observed an increase in lean mass (+2.4 [1.1] kg), bone density (+0.0124 [0.015] g·cm−2), aerobic fitness (+2.8 [5.7] mL·kg LM−1· min−1), and vigorous physical activity levels (+13.09 [8.95] min·h−1) but no change in inflammation or muscle strength. Conclusion: Supervised exercise training is feasible, safe, and effective for youth with IBD and should be encouraged. [ABSTRACT FROM AUTHOR]

Clear definition, identification, and reporting of adverse event (AE) monitoring during training interventions are essential for decision making regarding the safety of training and testing in youths. Purpose: To document the extent to which AEs, resulting from intervention studies targeting muscle strengthening training (MST) in youth, are reported by researchers. Methods: Electronic databases (CINAHL, PubMed, SPORTDiscus, and Web of Science) were searched for English peer-reviewed articles published before April 2018. Inclusion criteria were: (1) average age <16 years, (2) use of MST, (3) statement(s) linked to the presence/absence of AEs, and (4) randomized controlled trials or quasi-experimental designs. Risk of reporting bias for AEs followed recommendations by the Cochrane Collaboration group. Results: One hundred and ninety-one full-text articles were screened. One hundred and thirty met all MST criteria, out of which only 44 (33.8%; n = 1278, age = 12.1 [1.1] y) included a statement as to the presence/absence of adverse events. The 86 other studies (66.2%) included no such statement. Of the reporting 44 studies, 18 (40.1%) indicated one or more adverse events. Of the 93 reported adverse events, 55 (59.1%) were linked to training or testing. Conclusions: Most MST studies in youth do not report presence/absence of adverse events, and when reported, adverse events are not well defined. [ABSTRACT FROM AUTHOR]

Antibody–drug conjugates (ADCs) have demonstrated effectiveness in treating various cancers, particularly exhibiting specificity in targeting human epidermal growth factor receptor 2 (HER2)‐positive breast cancer. Recent advancements in phase 3 clinical trials have broadened current understanding of ADCs, especially trastuzumab deruxtecan, in treating other HER2‐expressing malignancies. This expansion of knowledge has led to the US Food and Drug Administration's approval of trastuzumab deruxtecan for HER2‐positive and HER2‐low breast cancer, HER2‐positive gastric cancer, and HER2‐mutant nonsmall cell lung cancer. Concurrent with the increasing use of ADCs in oncology, there is growing concern among health care professionals regarding the rise in the incidence of interstitial lung disease or pneumonitis (ILD/p), which is associated with anti‐HER2 ADC therapy. Studies on anti‐HER2 ADCs have reported varying ILD/p mortality rates. Consequently, it is crucial to establish guidelines for the diagnosis and management of ILD/p in patients receiving anti‐HER2 ADC therapy. To this end, a panel of Chinese experts was convened to formulate a strategic approach for the identification and management of ILD/p in patients treated with anti‐HER2 ADC therapy. This report presents the expert panel's opinions and recommendations, which are intended to guide the management of ILD/p induced by anti‐HER2 ADC therapy in clinical practice. Antihuman epidermal growth factor receptor 2 antibody–drug conjugate therapies offer significant benefits for treating human epidermal growth factor receptor 2‐positive cancers but carry risks of interstitial lung disease/pneumonitis, which, although generally manageable, requires strict adherence to evaluation and treatment guidelines to mitigate severe outcomes. This consensus from Chinese experts provides strategic recommendations for managing such risks, aiming to enhance real‐world adverse event management and improve the therapeutic safety profile of these agents. [ABSTRACT FROM AUTHOR]

Purpose: Cardiorespiratory fitness (CRF) measured by peak oxygen consumption (...) declines with aging and correlates with mortality and morbidity. Cardiopulmonary exercise testing (CPET) is the criterion method to assess CRF, but its feasibility, validity, and reliability in older adults are unclear. Our objective was to design and implement a dependable, safe, and reliable CPET protocol in older adults. Methods: ... was measured by CPET, performed using treadmill exercise in 875 adults ≥70 yr in the Study of Muscle, Mobility and Aging (SOMMA). The protocol included a symptom-limited peak (maximal) exercise and two submaximal walking speeds. An adjudication process was in place to review tests for validity if they met any prespecified criteria (... <12.0 mL⋅kg-1⋅min-1; maximum heart rate <100 bpm; respiratory exchange ratio <1.05 and a rating of perceived exertion <15). A subset (N = 30) performed a repeat test to assess reproducibility. Results: CPET was safe and well tolerated, with 95.8% of participants able to complete the // phase of the protocol. Only 56 (6.4%) participants had a risk alert and only two adverse events occurred: a fall and atrial fibrillation. Mean ± SD ... was 20.2 ± 4.8 mL⋅kg-1⋅min-1, peak heart rate 142 ± 18 bpm, and peak respiratory exchange ratio 1.14 ± 0.09. Adjudication was indicated in 47 tests; 20 were evaluated as valid and 27 as invalid (18 data collection errors, 9 did not reach ...). Reproducibility of ... was high (intraclass correlation coefficient = 0.97). Conclusions: CPET was feasible, effective, and safe for older adults, including many with multimorbidity or frailty. These data support a broader implementation of CPET to provide insight into the role of CRF and its underlying determinants of aging and age-related conditions. [ABSTRACT FROM AUTHOR]

Introduction: Fragile X syndrome (FXS) is the most common cause of hereditary genetic disorder in a single gene characterised by intellectual disability. Behavioural features such as autism, hyperactivity and anxiety disorder may be present. Biofilm development and pathogenicity of Streptococcus mutans may be altered because FXS renders the dental approach and oral hygiene more complex. Objectives: The purpose of this study was to compare the levels of transcripts for VicRK and CovR of S. mutans isolated from FXS patients with the levels of transcripts for VicRK and CovR of standard strain ATCC, using a quantitative polymerase chain reaction (qPCR). Methods: The caries experience index was assessed by the International Caries Detection and Assessment System (ICDAS), Periodontal Condition Index (PCI) and Invasive Dental Treatment Need Index (INI). Results: The clinical index findings revealed a high rate of caries cavities and bleeding on probing of FXS patients. When VicRK and CovR transcript levels were compared with the reference strain, Fragile X patients were found to have significantly higher values. Conclusion: The present study demonstrated that FXS patients have more adverse clinical conditions, with increased biofilm accumulation and virulence. When combined with behavioural abnormalities, these patients become even more vulnerable to dental caries. [ABSTRACT FROM AUTHOR]

Introduction: Clinical remission is a relatively new concept in asthma but recent research initiatives suggest it could be an ambitious and achievable therapeutic target for patients with asthma. Methods: In this modified Delphi study (comprising two online surveys, completed either side of a virtual scientific workshop), the opinions of a panel of respiratory physicians were evaluated to summarize perspective statements on key therapeutic outcomes and criteria for on-treatment clinical remission in patients with moderate asthma. An agreement threshold was pre-defined as agreement by ≥ 75% of participants. Results: Surveys 1 and 2 were completed by 20 and 18 participants, respectively. Most participants (95%) agreed with the concept of clinical remission in moderate asthma and that this should be a desirable treatment goal (90%). Based on a composite measure of 4–6 desirable therapeutic outcomes, current understanding of clinical remission was considered as 12 months with no exacerbations, no oral corticosteroids, no daytime or night-time asthma symptoms (Asthma Control Test score ≥ 20 or Asthma Control Questionnaire score ≤ 0.75), stable lung function, and no treatment-related adverse events. No agreement was reached on the role of relievers in defining therapeutic outcomes or on the wider use of biomarkers and airway hyperresponsiveness for defining asthma remission in clinical practice. Conclusions: In line with recent consensus statements from the United States and Europe, there was a high level of agreement on the elements of clinical remission among a panel of respiratory physicians from Asia, the Middle East, and South America. Extension of the concept of clinical remission to patients with moderate asthma was considered aligned with the potential of clinical remission as a goal of therapy. [ABSTRACT FROM AUTHOR]

From clinical trials and observational data, oral semaglutide has proven to be the most effective second-line oral therapy for the management of patients with type 2 diabetes. This review aims to describe the perspective of an Italian expert panel that addressed the potential challenges arising during the use of oral semaglutide in the free-living conditions of routine clinical care. A group of Italian experts discussed and generated insights into the use of oral semaglutide in clinical practice. Key topics included the effectiveness of oral semaglutide in clinical practice, the positioning of the agent to optimize the treatment benefits, the possibility to adopt flexibility in the administration schedule, critical issues encountered, the role of patient communication and information in the importance of dose escalation and management of adverse events. Available data on efficacy and effectiveness of oral semaglutide from randomized clinical trials and real-world studies were reported, along with factors that determine tolerability and persistence on treatment. The debate over a fixed versus a flexible dosing schedule was critically addressed, providing anecdotical clues from a small case series and a real-world database. Additionally, a set of recommendations for clinicians to consider when prescribing oral semaglutide and during the process of patient monitoring were provided. [ABSTRACT FROM AUTHOR]

Objectives. To determine facility-level factors associated with COVID-19 outbreaks in US Immigration and Customs Enforcement (ICE) detention centers. Methods. We obtained COVID-19 case counts at 88 ICE detention facilities from May 6, 2020, through June 21, 2021, from the COVID Prison Project. We obtained information about facility population size, facility type (dedicated to immigrants or mixed with other incarcerated populations), and facility operator (public vs private contractor) from third-party sources. We defined the threshold for a COVID-19 outbreak as a cumulative 3-week incidence of 10% or more of the detained population. Results. Sixty-three facilities (72%) had at least 1 outbreak. Facilities with any outbreak were significantly more likely to be privately operated (P <.001), to have larger populations (113 vs 37; P =.002), and to have greater changes in their population size over the study period (‒56% vs −26%; P <.001). Conclusions. Several facility-level factors were associated with the occurrence of COVID-19 outbreaks in ICE facilities. Public Health Implications. Structural and organizational factors that promote respiratory infection spread in ICE facilities must be addressed to protect detainee health. (Am J Public Health. 2024;114(9):909–912. https://doi.org/10.2105/AJPH.2024.307704) [ABSTRACT FROM AUTHOR]

Background: Addressing disparities in blood pressure control must include supporting antihypertensive medication adherence (MA). Developing effective MA interventions requires identifying the most important factors influencing MA. Objective: In this review, the authors aimed to meta-analyze the results of research testing associations between factors potentially influencing antihypertensive MA and assessed antihypertensive MA in historically underrepresented populations. Additional exploratory analyses focused on system-level factors, which have been understudied and may particularly impact disparities inMA. Methods: A health sciences librarian assisted with searching across 10 databases. Inclusion criteria included (1) published in English, (2) sample of adults with hypertension, (3) ≥50% of participants having self-identified as a race/ethnicity underrepresented in the country where the study was conducted, and (4) reporting sufficient data to calculate effect size(s). Results: Fifty-eight studies were eligible for inclusion. Nine factors met criteria for planned analyses. Older age (r = 0.08, P < .01; k = 26 studies) and higher income (r = 0.11, P = .01; k = 15) were significantly correlated with better MA. Having depressive symptoms was significantly correlated with worse MA (r = -0.18, P < .01; k = 11). Effect sizes for sex, education level, marital status, number of medications, comorbidities, and perceived social support were not significant. System-level factors examined included insurance coverage, access to healthcare, perceived barriers, having a primary care provider, perceptions of their healthcare provider, and experiences of discrimination in healthcare. Conclusions: Understanding the impact of factors associated with antihypertensive MA in historically underrepresented adults can support development of targeted, culturally relevant MA interventions. Future research should examine the impact of system-level factors on antihypertensive MA among historically underrepresented populations. [ABSTRACT FROM AUTHOR]

There has been limited evaluation of surgeon-specific factors on outcomes after total shoulder arthroplasty (TSA). The goals of this study were (1) to determine the impact of surgeon procedural volume, career duration, practice type, and fellowship training on TSA outcomes at 2-year follow-up and (2) to evaluate the relative importance of surgeon variables in relation to patient variables in influencing outcomes. The PearlDiver Mariner database was queried to identify all surgeons who performed a minimum of 11 TSA procedures from 2010 to 2018. An Internet search of publicly available data was performed to determine the career duration, practice type, and fellowship training of each surgeon. Multivariate logistic regression models were built to determine the relationship between surgeon-specific variables and 2-year surgical complications and revisions and 90-day readmissions. Variable importance of patient-specific and surgeon-specific factors was determined by the Akaike information criterion increase of these models. A total of 2188 surgeons who performed 93,122 TSA procedures were identified in this database. Higher reverse TSA surgical volume was associated with fewer surgical complications and revisions, although such a relationship was not observed for anatomic TSA. Revision after anatomic TSA was more common among surgeons who were in their first 5 years of practice. There was a higher risk of surgical complication and readmission among academic surgeons, but this did not equate with a higher risk of revision. The impact of these surgeon-specific factors on outcomes was small in relation to patient-level variables, such as age, sex, and number of medical comorbidities. Surgeon procedural volume, career duration, and practice setting influence the surgical complication, revision, and readmission rates after TSA. The impact of surgeon factors was small relative to patient variables, highlighting the importance of patient selection in mitigating adverse outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Current treatment guidelines for patients with epidermal growth factor receptor (EGFR)-mutated metastatic non-small cell lung cancer (mNSCLC) recommend EGFR tyrosine kinase inhibitors (TKIs) as the standard of care for first-line treatment, with third-generation osimertinib the preferred choice. However, most patients develop resistance to targeted therapy, and subsequent systemic chemotherapy is recommended. The aim of this study was to characterize the subsequent line of therapy (LOT) following osimertinib in patients with EGFR-mNSCLC. Methods: Medical and pharmacy claims of adults who initiated a subsequent LOT (index) after initial osimertinib discontinuation between November 2015 and September 2019 were analyzed retrospectively. Results: A total of 135 patients met the inclusion criteria. After metastatic diagnosis, 22.2% and 49.6% of patients were treated with osimertinib in the first and second line, respectively. After osimertinib discontinuation, most patients were treated with a platinum-based chemotherapy regimen (57%), of which 40.3% included immuno-oncology therapy. Reuse or continuation of EGFR TKIs was also common (24%). Overall, the median time to treatment discontinuation for the index LOT was 2.4 months. Proportions of patients with ≥ 1 inpatient or emergency department visit were 31.9% and 35.6%, respectively. Conclusions: The duration of the LOT following osimertinib was short and associated with tolerability issues underscoring a high unmet need for new therapies to address EGFR TKI resistance. [ABSTRACT FROM AUTHOR]

Therapists and the public are becoming increasingly aware that psychotherapy can have side effects. The prevalence varies depending on the patients, treatments, settings, assessment methods and the researched type of side effect. Objective of this study is to assess side effects of routine outpatient psychodynamic and cognitive behaviour therapy. In a cross-sectional study cognitive behaviour therapist (n = 73) and psychodynamic psychotherapists (n = 57) were asked in a semi-structured interview about unwanted events and side effects in reference to their most recent patients (N = 276) using a domain inspection method. Their reports were cross-checked by an expert assessor. Multiple random-intercept models were conducted to investigate the influence of various variables. Therapists reported in 170 patients (61.4%) a total of 468 unwanted events. There was at least one side effect in 33.2% of the cases. Most frequent side effects were "strains in family relations" and "deterioration of symptoms". Illness severity has a significant influence on the amount of side effects reported. The data confirm that side effects of psychotherapy are frequent. The difference between side effects and unwanted events shows the importance of such a distinction. The reporting of side effects for one in three patients may indicate an under recognition of side effects or reporting of only relevant or disturbing side effects. [ABSTRACT FROM AUTHOR]

This single-arm, multicenter, phase 2 trial (NCT04106180) investigated the triple combination of sintilimab (anti-PD1 antibody), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony-stimulating factor (GM-CSF) in metastatic non-small cell lung cancer (NSCLC). With a median follow-up of 32.1 months, 18 (36.7%, 90% CI 25.3%–49.5%) of the 49 evaluable patients had an objective response, meeting the primary endpoint. Secondary endpoints included out-of-field (abscopal) response rate (ASR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). The ASR was 30.6% (95% CI 18.3%–45.4%). The median PFS and OS were 5.9 (95% CI 2.5–9.3) and 18.4 (95% CI 9.7–27.1) months, respectively. Any grade and grade 3 TRAEs occurred in 44 (86.3%) and 6 (11.8%) patients, without grade 4–5 TRAEs. Moreover, in pre-specified biomarker analyses, SBRT-induced increase of follicular helper T cells (Tfh) in unirradiated tumor lesions and patient's blood, as well as of circulating IL-21 levels, was found associated with improved prognosis. Taken together, the triple combination therapy was well tolerated with promising efficacy and Tfh may play a critical role in SBRT-triggered anti-tumor immunity in metastatic NSCLC. Combinations of radiotherapy and immune checkpoint inhibitors have been explored for the treatment of patients with non-small cell lung cancer (NSCLC). Here the authors report the results of a phase 2 trial of sintilimab (anti-PD1) in combination with stereotactic body radiotherapy and GM-CSF in metastatic NSCLC. [ABSTRACT FROM AUTHOR]

In recent years, rapidly changing disease profile patterns, shortage & uneven utilization of healthcare professionals contributed massive burden on the Indian healthcare system, which resulted in varying, fragmented, inconsistent healthcare delivery to the patients and poor patient management. Patients often face and experience many challenges like lack of accessibility, poor patient-healthcare provider relationships, and inadequate quality of care, resulting in unnecessary economic burden in managing their health conditions. Thus Indian healthcare reform is essential in enhancing its capacity to fulfill patients' health needs that can be addressed by focusing on key sustainable strategies and initiatives meant for enhancing coordination of care, expanding services accessibility, redeveloping healthcare infrastructure, implementing workforce innovation and strong governance with the incorporation of core principles such as patient-centeredness, integrated care and collaborative care approaches. The clinical and ambulatory pharmacy practice are fragment of the healthcare delivery which delivers pharmaceutical care and fulfils the needs of patients across healthcare settings. This paper focuses on the present & future perspectives of ambulatory pharmacy practice in India and the factors to be considered for implementing it in patient care. [ABSTRACT FROM AUTHOR]

Introduction: This case report reports an unusual occurrence of gossypiboma, which refers to the accidental retention of surgical materials like sponges in the peritoneal cavity. The term is derived from "gossypium" (cotton) and "boma" (place of concealment). Its incidence varies with surgical type, posing diagnostic challenges due to nonspecific symptoms and equivocal imaging. Despite its rarity, gossypiboma poses significant risks, including intestinal obstruction and abscess formation. Case presentation: A 37-year-old woman with ten previous pregnancies and an emergent caesarean section presented with abdominal pain. Examination and ultrasound suggested an ovarian cyst. During surgery, a 10 × 10 cm gauze-filled mass adherent to the ovary and jejunum was found. Postoperatively, she recovered well with no complications. The patient was treated with intravenous fluids and antibiotics for five days post-surgery and recovered without any complications. She was discharged from the hospital five days after the procedure. Conclusion: To the best of our knowledge, this is the first reported case of gossypiboma in Sudan in 2024, highlighting diagnostic challenges and the need for preventive protocols. Root cause analysis of accidents, enhanced training, application of advanced technologies and a collaborative culture in the operating room can prevent the occurrence of such incidents. This case underscores the importance of meticulous surgical protocols and continuous improvement in safety measures to prevent retained surgical items, ensuring patient safety and optimal outcomes. [ABSTRACT FROM AUTHOR]

Background: Transarterial chemo(embolization) is preferred for treating unresectable hepatocellular carcinoma (uHCC); however, because of emerging immune-targeted therapies, its efficacy is at stake. This systematic review pioneers to evaluate the clinical efficacy and safety of transarterial chemo (embolization) combined with immune-targeted therapy for uHCC patients. Methods: PubMed, Embase, and Cochrane Library were searched for studies comparing immune-targeted therapy with or without transarterial chemo (embolization) until 31 May 2024. The complete response (CR) rate, objective response rate (ORR), and disease control rate (DCR) were considered to be the primary outcomes calculated for the clinical outcomes of transarterial chemo (embolization) combined with immune-targeted therapy, along with progressionfree survival (PFS) and overall survival (OS). The incidence of treatment-related severe adverse events was set as the major measure for the safety outcome. Results: Sixteen studies, encompassing 1,789 patients receiving transarterial chemo(embolization) plus immune-targeted therapy and 1,215 patients receiving immune-targeted therapy alone, were considered eligible. The combination of transarterial chemo(embolization) and immune-targeted therapy demonstrated enhanced outcomes in CR (OR = 2.12, 95% CI = 1.35-3.31), ORR (OR = 2.78, 95% CI = 2.15-3.61), DCR (OR = 2.46, 95% CI = 1.72-3.52), PFS (HR = 0.59, 95% CI = 0.50-0.70), and OS (HR = 0.51, 95% CI = 0.44-0.59), albeit accompanied by a surge in ALT (OR = 2.17, 95% CI = 1.28-3.68) and AST (OR = 2.28, 95% CI = 1.42-3.65). The advantages of additional transarterial chemo(embolization) to immune-targeted therapy were also verified in subgroups of first-line treatment, intervention techniques, with or without extrahepatic metastasis, Child-Pugh grade A or B, and with or without tumor thrombus. Conclusion: The combination of transarterial chemo(embolization) and immune-targeted therapy seems to bolster local control and long-term efficacy in uHCC, albeit at the expense of hepatic complications. [ABSTRACT FROM AUTHOR]

Background: Parameningeal rhabdomyosarcoma (PM-RMS) is a rare and aggressive soft tissue malignancy that primarily occurs in the head and neck region. The standard treatment approach for RMS involves a multimodal therapy regimen, which includes surgery, chemotherapy, and radiotherapy. However, the routine use of radiotherapy and chemotherapy in young patients with RMS in the head and neck region can lead to adverse effects on dental development and thereby, pose a challenge in planning dental intervention. Case presentation: This case report outlines the dental and facial developmental consequences in a 13-year-old child, who received chemo-radiotherapeutic intervention at the age of 7 years for the management of PM-RMS. Following treatment, the child exhibited significant dental complications, including arrested root growth and restricted mouth opening. Conclusions: This case highlights the necessity for interdisciplinary collaboration between oncologists, dentists, and other healthcare professionals to mitigate the adverse effects on dental health and overall quality of life in patients undergoing chemo-radiotherapy for rhabdomyosarcoma. [ABSTRACT FROM AUTHOR]

Background: Sirolimus is increasingly utilized in treating diseases associated with mTOR pathway overactivation. Despite its potential, the lack of evidence regarding its long-term safety across all age groups, particularly in pediatric patients, has limited its further application. This study aims to assess the long-term safety of sirolimus, with a specific focus on its impact on growth patterns in pediatric patients. Methods: This pooled analysis inlcudes two prospective cohort studies spanning 10 years, including 1,738 participants (aged 5 days to 69 years) diagnosed with tuberous sclerosis and/or lymphangioleiomyomatosis. All participants were mTOR inhibitor-naive and received 1 mg/m²/day of sirolimus, with dose adjustments during a two-week titration period to maintain trough blood concentrations between 5 and 10 ng/ml (maximum dose 2 mg). Indicators of physical growth, hematopoietic, liver, renal function, and blood lipid levels were all primary outcomes and were analyzed. The adverse events and related management were also recorded. Results: Sirolimus administration did not lead to deviations from normal growth ranges, but higher doses exhibited a positive association with Z-scores exceeding 2 SD in height, weight, and BMI. Transient elevations in red blood cell and white blood cell counts, along with hyperlipidemia, were primarily observed within the first year of treatment. Other measured parameters remained largely unchanged, displaying only weak correlations with drug use. Stomatitis is the most common adverse event (920/1738, 52.9%). In adult females, menstrual disorders were observed in 48.5% (112/217). Conclusions: Sirolimus's long-term administration is not associated with adverse effects on children's physical growth pattern, nor significant alterations in hematopoietic, liver, renal function, or lipid levels. A potential dose-dependent influence on growth merits further exploration. Trial registration: Pediatric patients: Chinese clinical trial registry, No. ChiCTR-OOB-15,006,535. Adult patients: ClinicalTrials, No. NCT03193892. [ABSTRACT FROM AUTHOR]

Background: Systemic conversion therapy provides patients with initially unresectable hepatocellular carcinoma (HCC) the chance to salvage radical liver resection and superior survival outcomes, but the optimal conversion strategy is unclear. Methods: A systematic literature search was conducted on PubMed, EMBASE, Web of Science, Scopus, and the Cochrane Library between 2007 and 2024 focusing on studies reporting conversion therapy for HCC. The treatment groups were divided into Tyrosine kinase inhibitors (TKI), TKI plus loco-regional therapy (LRT), TKI plus anti-PD-1 therapy (TKI + PD-1), TKI + PD-1 + LRT, immune checkpoint inhibitors (ICI) plus LRT, and Atezolizumab plus bevacizumab (A + T) groups. The conversion to surgery rate (CSR), objective response rate (ORR), grade ≥ 3 treatment-related adverse events (AEs), overall survival (OS) and progression-free survival (PFS) were analyzed. Results: 38 studies and 4,042 patients were included. The pooled CSR were 8% (95% CI, 5-12%) in TKI group, 13% (95% CI, 8-19%) in TKI + LRT group, 28% (95% CI, 19-37%) in TKI + PD-1 group, 33% (95% CI, 25-41%) in TKI + PD-1 + LRT group, 23% (95% CI, 1-46%) in ICI + LRT group, and 5% (95% CI, 3-8%) in A + T group, respectively. The pooled HR for OS (0.45, 95% CI, 0.35–0.60) and PFS (0.49, 95% CI, 0.35–0.70) favored survival benefit of conversion surgery. Subgroup analysis revealed that lenvatinib + PD-1 + LRT conferred higher CSR of 35% (95% CI, 26-44%) and increased ORR of 70% (95% CI, 56-83%). Conclusions: The current study indicates that TKI + PD-1 + LRT, especially lenvatinib + PD-1 + LRT, may be the superior conversion therapy with a manageable safety profile for patients with initially unresectable HCC. The successful conversion therapy favors the superior OS and PFS compared with systemic treatment alone. Trial registration: International prospective register of systematic reviews (PROSPERO) (registration code: CRD 42024495289). [ABSTRACT FROM AUTHOR]

Over the past decades, immune checkpoint inhibitors (ICIs) have shown dramatic efficacy in improving survival rates in multiple malignancies. Recently, gynecological cancer patients also showed to respond favorably to ICI treatment. This study aimed to evaluate the efficacy, safety, and patient-reported outcomes of ICI therapy in gynecological cancers. We conducted a systematic review and meta-analysis by retrieving literature from multiple electronic databases, such as MEDLINE, ScienceDirect, EBSCO, ProQuest, and Google Scholar. The protocol used in this study has been registered in PROSPERO (CRD42022369529). We included a total of 12 trials involving 8 therapies and 8,034 patients. ICI group demonstrated a longer OS (HR: 0.807; 95% CI: 0.719, 0.907; p = 0.000) and greater PFS improvement (HR: 0.809; 95% CI: 0.673, 0.973; p = 0.024) compared to the control group. There was no significant difference in the incidence of treatment-related adverse events [RR: 0.968; 95%CI: 0.936, 1.001; p = 0.061], but a higher incidence of immune-related adverse events (IRAEs) was observed in the ICI group (RR: 3.093; 95%CI: 1.933, 4.798; p = 0.000). Although the mean changes of QOL score from baseline was not significantly different between both groups (SMD: 0.048; 95% CI: -0.106, 0.202; p = 0.542), the time to definitive QOL deterioration was longer in the ICI group (HR: 0.508; 95% CI: 0.461, 0.560; p = 0.000). Despite having a higher incidence of IRAE, ICI was shown to improve survival rates and QOL of patients. Thus, it should be considered as a new standard of care for gynecologic cancers, especially in advanced stages. [ABSTRACT FROM AUTHOR]

This article discusses the national pharmacovigilance systems in Australia for monitoring the safety of seasonal influenza vaccines. The systems involve collaboration between the Therapeutic Goods Administration (TGA), AusVaxSafety, and state and territory health departments. The TGA collects adverse event reports and uses data mining algorithms to identify safety signals. AusVaxSafety conducts active surveillance through surveys sent to vaccine recipients. The article acknowledges the limitations of these systems, such as under-reporting and incomplete reports, and highlights ongoing efforts to improve data capture and reporting. The goal is to provide timely and transparent information to the public and ensure the safety of influenza vaccines. [Extracted from the article]

Background: Patient safety (PS) is a core competency for registered nurses. However, there is a gap between the PS competence of nursing students and their clinical experience in PS. This study explored the effect of PS competence levels on the occurrence of adverse events (AEs) among nursing master's students in China. Methods: A sequential mixed methods design was used, with a purposive sample across seven colleges. A total of 327 graduate nursing students, aged 22 to 38, participated in the survey, and 15 participated in qualitative interviews. The Health Professional Education in Patient Safety Survey (H-PEPSS) assessed the students' competence levels in PS. The respondents also reported any AEs that they had been involved in over the past year. Results: A total of 78 AEs occurred in the past year, with 17.7% of the participants involved 1 to 3 AEs. The most common AEs were medication administration errors (30.77%) and improper use of medical equipment/supplies (28.20%). Students acquired more competencies from the clinical setting than from the classroom setting. Three competencies learned from classroom settings were associated with clinical AEs: low clinical safety skills [OR = 0.61], inappropriate identify, response to and disclosing AE and close calls [OR = 0.454], and low confidence in working in teams with other health professionals [OR = 2.168]. Qualitative data analysis revealed five themes: recognizing AEs, reducing harm by addressing immediate risks to patients and others involved, promoting safe medication and clinical practice, managing members' authority and team dynamics, and dealing with inter-professional conflict. Conclusions: The quantitative and qualitative data align, supporting the enhancement of students' PS competence. [ABSTRACT FROM AUTHOR]

Background: This study aimed to evaluate the effectiveness and safety of recombinant human endostatin (Rh-endostatin) plus programmed cell death 1 (PD-1) inhibitors and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC) in a real-world setting. Methods: This was a retrospective study on patients with EGFR/ALK-negative, advanced or metastatic NSCLC. Patients received Rh-endostatin plus PD-1 inhibitors and chemotherapy every three weeks for 4 to 6 cycles. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Results: A total of 68 patients were included in this retrospective analysis. As of data cutoff (December 13, 2022), the median follow-up of 21.4 months (interquartile range [IQR], 8.3-44.4 months). The median PFS and OS was 22.0 (95% confidence interval [CI]: 16.6-27.4) and 31.0 months (95% CI: 23.4-not evaluable [NE]), respectively. The ORR was 72.06% (95% CI: 59.85-82.27%), and DCR was 95.59% (95% CI: 87.64-99.08%). Patients with stage IIIB/IIIC NSCLC had significantly longer median PFS (23.4 vs. 13.2 months), longer median OS (not reached vs. 18.0 months), and higher ORR (89.2% vs. 51.6%) than those with stage IV NSCLC (all p ≤ 0.001). The ORR was higher in patients with high PD-L1 expression (tumor proportion score [TPS] ≥ 50%) than in those with low PD-L1 expression or positive PD-L1 expression (75% vs. 50%, p = 0.025). All patients experienced treatment-related adverse events (TRAEs), and ≥ grade 3 TRAEs occurred in 16 (23.53%) patients. Conclusions: Rh-endostatin combined with PD-1 inhibitors plus chemotherapy as first-line treatment yielded favorable effectiveness with a manageable profile in patients with advanced or metastatic NSCLC, representing a promising treatment modality. [ABSTRACT FROM AUTHOR]

Background: An essential aspect of human well-being is positive sexual health outcomes. However, the issue of adverse sexual health outcomes continues to be a major public health concern, particularly for women with disabilities in sub-Saharan Africa (SSA). Therefore, this current scoping review mapped studies conducted in the last twenty-nine years on the sexual health of women with disabilities from these five dimensions: sexual activity, contraceptive use, sexual autonomy, sexual violence and risky sexual behaviour, whilst seeking to identify the current state of knowledge and address the study gaps in SSA. Methods: This current scoping review was informed by the methodological framework proposed by Arksey and O'Malley. Exploratory searches were conducted in PubMed, Web of Science, African Journals Online, etc., to identify studies conducted in SSA that focus on sexual activity, contraceptive use, sexual autonomy, sexual violence and risky sexual behaviour among women with disabilities in SSA since the inception of the International Conference on Population and Development in 1994 to 30th of March 2024. This process resulted in the inclusion of seventeen (17) studies. Results: Of the 1362 identified through various databases, 34 studies were included for the full-text retrieval and screening; only 17 studies met the inclusion criteria. The eligible studies were conducted across six countries in SSA and published between 2008 and 2023. Eight studies used quantitative study type, six utilised qualitative approach, and three employed mixed-methods analysis. Two studies were conducted on sexual activity, ten were conducted on contraceptive use, four were conducted on sexual violence, and one study was conducted on risky sexual behaviour, whilst no study on sexual autonomy met the inclusion criteria. Conclusion: This review showed that there were few or scarce studies on sexual activity, contraceptive use, sexual autonomy, sexual violence and risky sexual behaviour among women with disabilities in SSA and even where the studies were substantial (contraceptive use), the majority of the studies were conducted in a country. Future studies should consider examining dimensions of sexual health, such as sexual autonomy, sexual activity and risky sexual behaviour of women with disabilities that were not available or were scarce in the literature. Plain language summary: Sexual health is really important for people's overall well-being, and it includes aspects like how we feel socially, mentally, emotionally, and physically. In sub-Saharan Africa, especially for women with disabilities, sexual health is a big concern. So, this review looked at studies done over the last 29 years about the sexual health of women with disabilities in sub-Saharan Africa. It focused on five areas: sexual activity, contraceptive use, sexual autonomy, sexual violence, and risky sexual behaviour. Databases were searched for relevant studies and found 17 that fit the set criteria. These studies were from six countries in sub-Saharan Africa and were published between 2008 and 2023. Most of the studies were about contraceptive use, with fewer focusing on sexual activity, sexual violence, and risky behaviour. There weren't any eligible studies on sexual autonomy. The review concluded that there's not enough research on these sexual health dimensions among women with disabilities in sub-Saharan Africa, especially on sexual autonomy, and future studies should explore this further. [ABSTRACT FROM AUTHOR]

Background: Immune checkpoint inhibitor (ICI) plus chemotherapy is effective in advanced gastric or gastroesophageal junction (G/GEJ) cancer. This study aims to evaluate the clinical effect of first-line immunotherapy in combination with chemotherapy for advanced G/GEJ cancer. Methods: PubMed, Web of Science, Embase and Cochrane databases were systematically searched from the inception of the databases to December 2021. Randomized trials comparing ICI plus chemotherapy with chemotherapy in first-line treatment for advanced G/GEJ cancer were included. The outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Analyses were performed in Stata 14.0 software. The study protocol was registered with PROSPERO, number CRD42022300907. Results: Five trials were included for analysis, involving 2, 814 patients. ICI plus chemotherapy can significantly improve OS (hazards ratio [HR], 0.86; 95% CI 0.78-0.94; P =.002), PFS (HR, 0.79; 95% CI 0.63-0.99; P ＜.001) and ORR (relative ratio [RR], 1.20; 95% CI 1.11-1.30; P <.001). In safety analyses, there were no significant differences in incidence of all AEs, treatment-related adverse event (TRAE), TRAE of grade 3 or higher, serious TRAE and TRAE leading to death between two arms (P >.05). Conclusions: ICI plus chemotherapy is more effective first-line treatment for advanced G/GEJ cancer in contrast to chemotherapy regrading to improving OS, PFS and ORR, without increasing TRAE risk. This study will redefine the role of ICI in combination with chemotherapy in the first-line setting for G/GEJ cancer, and provide reference for clinical treatment. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of extracorporeal shock waves versus corticosteroids injections on pain, thickness of plantar fascia and foot function in patients with plantar fasciitis. Secondarily, to assess the efficacy of radial and focused extracorporeal shock waves and the most appropriated intensity (high, medium or low). Data sources: PubMed, SCOPUS, CINAHL and PEDro, until April 2024, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Review methods: Randomized controlled trials comparing the efficacy of extracorporeal shock waves versus corticosteroids injections on pain intensity and sensitivity, thickness of plantar fascia and foot function in patients with plantar fasciitis. Methodological quality and risk of bias were assessed using PEDro Scale and Cochrane Risk of Bias Tool. Pooled effect was calculated using the standardized mean difference (SMD) and its 95% confidence interval (95%CI). Results: Sixteen studies involving 1121 patients, showing a mean of 6 points in PEDro scale, were included. At three months, extracorporeal shock waves were better than corticosteroids injections in reducing pain (SMD −0.6; 95%CI −1.1 to −0.11) and thickness of the plantar fascia (SMD −0.4; 95%CI −0.8 to −0.01) and increasing foot function (SMD 0.27; 95%CI 0.12–0.44). At six months, extracorporeal shock waves are more effective in reducing pain (SMD −0.81; 95%CI −1.6 to −0.06) and increasing foot function (SMD 0.67; 95%CI 0.45–0.89). Local pain and slight erythema were the most frequent adverse events. Conclusions: Extracorporeal shock waves are a safe therapy, presenting more efficacy than corticosteroids injections in improving pain, thickness of plantar fascia and foot function at mid-term. [ABSTRACT FROM AUTHOR]

Background: Device‐related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. Methods and Results: This sub‐analysis from the EUROC‐DRT‐registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p =.06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p =.01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p =.40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p =.24). Women were followed‐up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p =.51). Kaplan–Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%‐Confidence interval [95%‐CI]:.68–4.37, p =.25) and no differences in stroke (HR:.83, 95%‐CI:.30–2.32, p =.72) within 2 years after LAAC. Conclusion: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective. [ABSTRACT FROM AUTHOR]

Objectives: Loneliness is common and becoming a public health concern. Although there is the clear evidence of the variable effect of temporal differences in loneliness (transient/situational and persistent/chronic) on health, their effect on dementia risk is unclear. This study aims to assess the effect of transient/situational and persistent/chronic loneliness on dementia risk. Method: Participants aged 55 years and older from the Hunter Community Study were recruited. Loneliness was measured using a single item measure. Dementia was defined as per International Classification of Disease—10 (ICD 10) codes. The Fine‐Gray subdistribution hazard model was performed to calculate dementia risk. Results: Of 1968 total participants with mean age of 66 years, (3%) 57 developed dementia and (7%) 135 died over the mean follow up of 10 years. Both persistent/chronic and transient/situational loneliness significantly increased the risk of all cause dementia in adjusted models (HR 2.74, 95% CI 1.11–6.88, p 0.03 and HR 2.35, 95% CI 1.21–4.55, p 0.01 respectively) with mean time to event of 9.7 years. Feeling lonely below the age of 70 years elevated the risk of dementia in later life (HR 4.01, 95% CI 1.40–11.50, p 0.01). Conclusions: Loneliness (both persistent/chronic and transient/situational) was associated with increased risk of all cause dementia, especially if loneliness was experienced before the age of 70 years. These results suggest that promoting coping strategies for loneliness especially in persons 70 years and younger may play a role in preventing dementia. [ABSTRACT FROM AUTHOR]

The use of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), such as lorlatinib, for the treatment of patients with ALK gene rearrangement (or ALK-positive) non-small cell lung cancer (NSCLC) has been shown to improve the overall survival and quality of life of these patients. However, lorlatinib is not exempt from potential adverse events. Adequate monitoring and management of these adverse events are critical for increasing patient adherence to lorlatinib, thereby maximizing the benefits of treatment and minimizing the risks associated with treatment discontinuation. Considering that the adverse events of lorlatinib can affect different organs and systems, the participation of a multidisciplinary team, including cardiologists, neurologists, internal medicine specialists, and oncology pharmacists, is needed. This article presents specific and pragmatic strategies for identifying and treating the most relevant adverse events associated with lorlatinib in patients with advanced ALK-positive NSCLC based on the clinical experience of a multidisciplinary panel of experts. [ABSTRACT FROM AUTHOR]

This study examined the effectiveness of the ketogenic diet as a therapeutic intervention for cerebral hemorrhage recovery. This randomized controlled trial consisted of 108 patients, recruited for the study, 54 patients were assigned to the intervention group, which followed a ketogenic diet and 54 patients were assigned to the control group, which followed a regular diet. The intervention group followed a ketogenic diet while the control group followed a regular diet. We evaluated the effects of the ketogenic diet on neurological function, metabolic profile, cognitive function, depression levels, physical activity levels, and the occurrence of adverse events over a 6-month period. The results demonstrated significant improvements in the intervention group compared to the control group, with notable reductions in National Institutes of Health Stroke Scale scores and enhancements in Modified Rankin Scale scores at both 3 and 6 months, indicating improved neurological function and faster functional recovery. Ketogenic diet intervention also resulted in significant enhancements in cognitive performance and depression scores, indicating further advantages for mental health, and increased the level of physical activity compared to the control group. Overall, our results demonstrate that the ketogenic diet shows potential as an additional treatment for cerebral hemorrhage recovery. It provides notable advantages in terms of neurological and functional recovery, metabolic health, cognitive performance, and emotional well-being. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the efficacy and safety of using a uterine and infundibulopelvic ligament tourniquet during abdominal myomectomy to reduce intraoperative bleeding in low-resource settings. Methods: PubMed and Cochrane Library database searching up to March 2023. The PICOS standards were as follows: (Population) patients undergoing abdominal myomectomy surgery for uterine fibroids; (Intervention) the use of a uterine and ligament tourniquet during abdominal myomectomy; (Comparators) use of a uterine and infundibulopelvic ligament tourniquet to no intervention or alternative interventions for reducing intraoperative bleeding; and (Outcomes) reduction in intraoperative bleeding, in addition to the relative ease of use of the uterine and infundibulopelvic ligament tourniquet and any reported complications or adverse events of the intervention. Results: Thirteen studies, consisting of seven randomized controlled trials and six observational studies, were included in this review. All studies reported a significant reduction in intraoperative bleeding when using the uterine and infundibulopelvic ligament during abdominal myomectomy, ranging from 30% to 60%. The tourniquet was found to be particularly effective in cases with large or lower segment fibroids, and it was easy to use, even in low-resource settings. Conclusion: The use of a uterine and infundibulopelvic ligament tourniquet during abdominal myomectomy appears to be a safe and effective method of reducing intraoperative bleeding. [ABSTRACT FROM AUTHOR]

In a multicenter clinical trial enrolling patients with degenerative lumbar spinal stenosis and predominately neurogenic claudication pain symptoms, a 6-week course of acupuncture was compared with sham acupuncture with outcomes assessed using a validated disability questionnaire. Visual Abstract. Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis: In a multicenter clinical trial enrolling patients with degenerative lumbar spinal stenosis and predominately neurogenic claudication pain symptoms, a 6-week course of acupuncture was compared with sham acupuncture with outcomes assessed using a validated disability questionnaire. Background: Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient. Objective: To investigate the effect of acupuncture for DLSS. Design: Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729) Setting: 5 hospitals in China. Participants: Patients with DLSS and predominantly neurogenic claudication pain symptoms. Intervention: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment. Measurements: The primary outcome was change from baseline in the modified Roland–Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. Results: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of –1.3 (CI, –2.6 to –0.03; P  = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, –1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient. Limitation: The SA could produce physiologic effects. Conclusion: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment. Primary Funding Source: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ). [ABSTRACT FROM AUTHOR]

Simple Summary: Leukemia history affects some radical prostatectomy (RP) patients. While its prevalence and impact as an adverse risk factor are well-known in cardiac surgery, the number of RP patients with a leukemia history and their rate of adverse in-hospital outcomes are unknown. We identified RP patients with a leukemia history in a large-scale database. Patients with a leukemia history had higher rates of acute kidney injury, more frequent dialysis, and extended hospital stays compared to those without a leukemia history. Introduction: Leukemia history affects some radical prostatectomy (RP) patients. Although its prevalence and effect as an adverse risk factor are well known in cardiac surgery, the number of RP patients with a leukemia history, as well as their rate of adverse in-hospital outcomes, are unknown. Methods: We identified RP patients (National Inpatient Sample 2000–2019), stratified according to the presence or absence of a leukemia history. Descriptive analyses, propensity score matching (PSM, ratio 1:10), and multivariable logistic regression models were used. Results: Of 259,939 RP patients, 416 (0.2%) had a leukemia history. Their proportion increased from 0.1 to 0.2% covering the study span (p < 0.01). Leukemia history patients were older (median age, 64 vs. 62 years, p < 0.001). After PSM for age, insurance status, ethnicity, pelvic lymph node dissection, and Charlson Comorbidity Index, leukemia history RP patients exhibited higher rates of acute kidney injury (<2.6 vs. 0.9%; Odds Ratio [OR] 2.0, p = 0.02), more frequently underwent dialysis (3.6 vs. 1.9%; OR 1.9, p = 0.03), and more frequently had a length of stay exceeding one week (4.8 vs. 2.5%; OR 2.0, p = 0.006). Conclusions: Although leukemia history RP patients are rare, their numbers have increased. Renal complications and extended hospital stays are more frequent in those individuals. [ABSTRACT FROM AUTHOR]

Simple Summary: Mycosis fungoides and Sézary syndrome can impair multiple dimensions of health-related quality of life due to physical symptoms including pruritus, treatment side effects, time and financial burdens associated with high healthcare utilization, and psychological distress. There are several areas of unmet needs around health-related quality of life in this population, and the optimal way to measure health-related quality of life isn't yet clear. Mycosis fungoides (MF) and Sézary syndrome (SS) can impair multiple dimensions of health-related quality of life (HRQoL). Currently, there is no standardized assessment tool for measuring HRQoL in patients with MF/SS. Here, we describe the existing literature on multiple dimensions of HRQoL in MF/SS with a special focus on the gaps in the current knowledge and identify future directions necessary to assess the HRQoL of patients with this disease. [ABSTRACT FROM AUTHOR]

To compare safety and efficacy of centanafadine versus methylphenidate hydrochloride extended release (ER; Concerta) in adults with ADHD. Without head-to-head trials, anchored matching-adjusted indirect comparisons (MAIC) of adverse event rates reported across trials and mean change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score between centanafadine and methylphenidate hydrochloride ER were conducted. Pooled patient-level data from two centanafadine trials (NCT03605680/NCT03605836) and aggregate data from one published methylphenidate hydrochloride ER trial (NCT00937040) were used. Characteristics of individual patients from the centanafadine trials were matched to aggregate baseline characteristics from the methylphenidate hydrochloride ER trial using propensity score weighting. A sensitivity analysis assessed the robustness of the results to the capping of extreme weights (i.e. >99th percentile). Compared with methylphenidate hydrochloride ER, centanafadine was associated with significantly lower risk of dry mouth (risk difference [RD] in percentage points: −11.95), initial insomnia (−11.10), decreased appetite (−8.05), anxiety (−5.39), palpitations (−5.25), and feeling jittery (−4.73) though a significantly smaller reduction in AISRS score (4.16-point). In the sensitivity analysis, the safety results were consistent with the primary analysis but there was no significant difference in efficacy between centanafadine and methylphenidate hydrochloride ER. In this MAIC, centanafadine had better safety and possibly lower efficacy than methylphenidate hydrochloride ER. While safety results were robust across analyses, there was no efficacy difference between centanafadine and methylphenidate hydrochloride ER in the sensitivity analysis. Considering its favorable safety profile, centanafadine may be preferred among patients for whom treatment-related adverse events are a concern. [ABSTRACT FROM AUTHOR]

Objective Ultrasound-guided tibial nerve pulsed radiofrequency (US-guided TN PRF) and fluoroscopy-guided intralesional radiofrequency thermocoagulation (FL-guided intralesional RFT) adjacent to the painful calcaneal spur are two interventions for pain management in painful calcaneal spur and plantar fasciitis. This study aimed to compare the effectiveness of the two procedures. Design A prospective, randomized, single-blind study. Setting Single-center pain clinic. Subjects Forty-nine patients who met the inclusion criteria were randomized into two groups. Methods Group U (25 patients) received US-guided TN PRF at 42°C for 240 s, whereas Group F (24 patients) received FL-guided intralesional RFT at 80°C for 90 s. The most severe numeric rating scale (NRS) score during the first morning steps and the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scores were used to evaluate the effectiveness of the procedures. The study's primary outcome assessed treatment effectiveness via the NRS, whereas the secondary outcomes included changes in the AOFAS score and the incidence of procedure-related mild adverse events. Results NRS and AOFAS scores significantly improved in Groups U and F at 1 and 3 months compared with baseline (P  < .05), and there was no significant difference between the groups. At month 1, 50% or greater pain relief was achieved in 72% of patients in Group U and 75% of patients in Group F. No significant difference was observed in the incidence of mild adverse events between the groups. Conclusions US-guided TN PRF and FL-guided intralesional RFT have shown significant effectiveness in the treatment of painful calcaneal spur and plantar fasciitis. Larger randomized controlled trials are needed. Clinical Trial Number NCT06240507. [ABSTRACT FROM AUTHOR]

Dry needling (DN) uses a monofilament needle to reduce pain and is performed by various healthcare professions. Due to the invasive needle puncture, adverse events (AEs) have been associated with DN. It is unclear, which AEs should be included in a risk statement for Informed Consent (IC). The purpose of this study was to identify which AEs should be included in a risk statement for IC. A three-round e-Delphi study was undertaken using a panel of DN experts. Expert inclusion criteria included: (1) ≥5 years practice performing DN and one of the following secondary criteria: (A) certification in DN; (B) completion of a manual therapy fellowship that included DN training; or (C) ≥1 publication involving the use of DN. Participants rated their level of agreement using a 4-point Likert scale. Consensus was defined as either: 1) ≥80% agreement; or 2) ≥70% and <80% agreement with median ≥3, interquartile range ≤1, and standard deviation ≤1. A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall's Coefficient (w) of agreement for Round 2 was 0.213 and improved to 0.349 after Round 3. Wilcoxon rank tests revealed statistically significant changes for 12 of the 50 AEs. Consensus was attained for 14 AEs for inclusion on IC. The AEs identified can be used for the development of a shorter, more concise IC risk statement. A total of 93.6% of experts agreed on definitions for AE classification. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound-guided pancreatic duct (PD) drainage (EUS-PDD) is being increasingly performed as an alternative method to surgical drainage to achieve PD decompression after failed endoscopic retrograde pancreatography (ERP). However, no directly study has compared EUS-PDD with surgical PD drainage after failed ERP in patients with chronic pancreatitis. Methods: Consecutive patients who underwent EUS-PDD or longitudinal pancreaticojejunostomy after failed ERP were retrospectively identified from our endoscopy and medical information systems. The primary end point was the Izbicki pain score. The secondary end points were pain relief at the end of follow-up, procedure outcomes, adverse events, readmission, and reintervention. Results: A total of 21 patients (11 EUS-PDD, 10 surgical drainages) were analyzed. There were no significant differences in mean Izbicki pain score (EUS-PDD, 13.6 ± 10.1 vs. surgical drainage 10.7 ± 7.9, p = 0.483) or complete/partial pain relief (60%/30% vs. 70%/30%, p = 0.752) at the end of follow-up of the two groups. The rates of overall adverse events (27.3% vs. 30.0%, p = 0.893) and readmission (63.6% vs. 40.0%, p = 0.290) were similar in the two treatment groups, while patients in EUS-PDD group required more reinterventions (45.5% vs. 0%, p = 0.039) compared with patients in the surgery group. Conclusion: EUS-PDD showed comparable pain relief and safety to surgical PD drainage after failed ERP, with a higher rate of reintervention. The selection of EUS-PDD or surgical drainage may be appropriate based on an individualized strategy. [ABSTRACT FROM AUTHOR]

Background: Although myotomy is crucial in peroral endoscopic myotomy (POEM) surgeries, its optimum length remains controversial. Herein, we propose a modified POEM with new method of tailoring myotomy length aim to evaluate the safety, efficacy, and clinical outcomes of this modified POEM compared with standard POEM in type I or II achalasia. Methods: Seventy-five patients with type I or II achalasia who underwent POEM at the First Hospital of Jilin University between January 2018 and December 2022 were retrospectively analyzed. According to the myotomy approach, these patients were divided into the retrograde on-demand myotomy (RDM, n = 34), with myotomy beginning on gastric side and length tailored by determining the degree of lower esophageal sphincter (LES) distention, and standard myotomy (SM, n = 41) groups. The baseline data, myotomy length, operation time, clinical success rate, adverse event rate, and reflux-related adverse events were compared and analyzed. Results: The median myotomy length in the RDM group was significantly shorter than that in the SM group (6 vs. 8 cm, respectively; p < 0.001). Moreover, the median myotomy time in the RDM group was significantly shorter than that in the SM group (10 vs. 16 min, respectively; p < 0.001). POEM was successfully performed in all the patients. At the 2-year follow-up, high clinical success rates were observed in both the RDM and SM groups (92.0% vs. 93.3%, respectively; p = 1.000). The incidence of intraoperative adverse events and postoperative reflux-related adverse events was low and comparable in both groups. Conclusions: RDM POEM is a safe and effective method for patients with type I or II achalasia. Furthermore, it has a shorter myotomy length and operation time than standard POEM technique. [ABSTRACT FROM AUTHOR]

The article focuses on the phenomenon of acute clinical worsening in multiple sclerosis (MS) patients without corresponding magnetic resonance imaging (MRI) changes, termed ACES (acute clinical event with stable MRI). Topics include the prevalence of ACES in a multicenter study; factors associated with these events such as relapse rate and disease progression; and the implications for both clinical practice and research.

Empirical chemotherapy remains the standard of care in patients with unfavourable cancer of unknown primary (CUP). Gene-expression profiling assays have been developed to identify the tissue of origin in patients with CUP; however, their clinical benefit has not yet been demonstrated. We aimed to evaluate the efficacy and safety of site-specific therapy directed by a 90-gene expression assay compared with empirical chemotherapy in patients with CUP. This randomised controlled trial was conducted at Fudan University Shanghai Cancer Center (Shanghai, China). We enrolled patients aged 18–75 years, with previously untreated CUP (histologically confirmed metastatic adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, or poorly differentiated neoplasms) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, who were not amenable to local radical treatment. Patients were randomly assigned (1:1) by the Pocock and Simon minimisation method to receive either site-specific therapy or empirical chemotherapy (taxane [175 mg/m2 by intravenous infusion on day 1] plus platinum [cisplatin 75 mg/m2 or carboplatin area under the curve 5 by intravenous infusion on day 1], or gemcitabine [1000 mg/m2 by intravenous infusion on days 1 and 8] plus platinum [same as above]). The minimisation factors were ECOG performance status and the extent of the disease. Clinicians and patients were not masked to interventions. The tumour origin in the site-specific therapy group was predicted by the 90-gene expression assay and treatments were administered accordingly. The primary endpoint was progression-free survival in the intention-to-treat population. The trial has been completed and the analysis is final. This study is registered with ClinicalTrials.gov (NCT03278600). Between Sept 18, 2017, and March 18, 2021, 182 patients (105 [58%] male, 77 [42%] female) were randomly assigned to receive site-specific therapy (n=91) or empirical chemotherapy (n=91). The five most commonly predicted tissues of origin in the site-specific therapy group were gastro-oesophagus (14 [15%]), lung (12 [13%]), ovary (11 [12%]), cervix (11 [12%]), and breast (nine [10%]). At the data cutoff date (April 30, 2023), median follow-up was 33·3 months (IQR 30·4–51·0) for the site-specific therapy group and 30·9 months (27·6–35·5) for the empirical chemotherapy group. Median progression-free survival was significantly longer with site-specific therapy than with empirical chemotherapy (9·6 months [95% CI 8·4–11·9] vs 6·6 months [5·5–7·9]; unadjusted hazard ratio 0·68 [95% CI 0·49–0·93]; p=0·017). Among the 167 patients who started planned treatment, 46 (56%) of 82 patients in the site-specific therapy group and 52 (61%) of 85 patients in the empirical chemotherapy group had grade 3 or worse treatment-related adverse events; the most frequent of these in the site-specific therapy and empirical chemotherapy groups were decreased neutrophil count (36 [44%] vs 42 [49%]), decreased white blood cell count (17 [21%] vs 26 [31%]), and anaemia (ten [12%] vs nine [11%]). Treatment-related serious adverse events were reported in five (6%) patients in the site-specific therapy group and two (2%) in the empirical chemotherapy group. No treatment-related deaths were observed. This single-centre randomised trial showed that site-specific therapy guided by the 90-gene expression assay could improve progression-free survival compared with empirical chemotherapy among patients with previously untreated CUP. Site-specific prediction by the 90-gene expression assay might provide more disease information and expand the therapeutic armamentarium in these patients. Clinical Research Plan of Shanghai Hospital Development Center, Program for Shanghai Outstanding Academic Leader, and Shanghai Anticancer Association SOAR PROJECT. For the Chinese translation of the abstract see Supplementary Materials section. [ABSTRACT FROM AUTHOR]

Patients with EGFR -mutated non-small-cell lung cancer (NSCLC) and MET amplification as a mechanism of resistance to first-line osimertinib have few treatment options. Here, we report the primary analysis of the phase 2 INSIGHT 2 study evaluating tepotinib, a highly selective MET inhibitor, combined with osimertinib in this population. This open-label, phase 2 study was conducted at 179 academic centres and community clinics in 17 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1 and advanced or metastatic EGFR -mutated NSCLC of any histology, with MET amplification by tissue biopsy fluorescence in-situ hybridisation (FISH; MET gene copy number of ≥5 or MET -to- CEP7 ratio of ≥2) or liquid biopsy next-generation sequencing (MET plasma gene copy number of ≥2·3), following progression on first-line osimertinib. Patients received oral tepotinib 500 mg plus oral osimertinib 80 mg once daily. The primary endpoint was independently assessed objective response in patients with MET amplification by central FISH treated with tepotinib plus osimertinib with at least 9 months of follow-up. Safety was analysed in patients who received at least one study drug dose. This study is registered with ClinicalTrials.gov , NCT03940703 (enrolment complete). Between Feb 13, 2020, and Nov 4, 2022, 128 patients (74 [58%] female, 54 [42%] male) were enrolled and initiated tepotinib plus osimertinib. The primary activity analysis population included 98 patients with MET amplification confirmed by central FISH, previous first-line osimertinib and at least 9 months of follow-up (median 12·7 months [IQR 9·9–20·3]). The confirmed objective response rate was 50·0% (95% CI 39·7–60·3; 49 of 98 patients). The most common treatment-related grade 3 or worse adverse events were peripheral oedema (six [5%] of 128 patients), decreased appetite (five [4%]), prolonged electrocardiogram QT interval (five [4%]), and pneumonitis (four [3%]). Serious treatment-related adverse events were reported in 16 (13%) patients. Deaths of four (3%) patients were assessed as potentially related to either trial drug by the investigator due to pneumonitis (two [2%] patients), decreased platelet count (one [1%]), respiratory failure (one [1%]), and dyspnoea (one [1%]); one death was attributed to both pneumonitis and dyspnoea. Tepotinib plus osimertinib showed promising activity and acceptable safety in patients with EGFR -mutated NSCLC and MET amplification as a mechanism of resistance to first-line osimertinib, suggesting a potential chemotherapy-sparing oral targeted therapy option that should be further investigated. Merck (CrossRef Funder ID: 10.13039/100009945). [ABSTRACT FROM AUTHOR]

Cisplatin (CP) is a chemotherapy drug widely prescribed to treat various neoplasms. Although fundamental for the therapeutic action of the drug, its cytotoxic mechanisms trigger adverse effects in several tissues, such as the kidney, liver, and heart, which limit its clinical use. In this sense, studies point to an essential role of damage to nuclear and mitochondrial DNA associated with oxidative stress, inflammation, and apoptosis in the pathophysiology of tissue injuries. Due to the limitation of effective preventive and therapeutic measures against CP-induced toxicity, new strategies with potential cytoprotective effects have been studied. Therefore, this article is timely in reviewing the characteristics and main molecular mechanisms common to renal, hepatic, and cardiac toxicity previously described, in addition to addressing the main validated strategies for the current management of these adverse events in clinical practice. We also handle the main promising antioxidant substances recently presented in the literature to encourage the development of new research that consolidates their potential preventive and therapeutic effects against CP-induced cytotoxicity. [ABSTRACT FROM AUTHOR]

Prospective data on treatment after immune checkpoint inhibitor (ICI) therapy in hepatocellular carcinoma (HCC) are lacking. We conducted a phase II multicentre study on cabozantinib after ICI treatment in HCC. This is an investigator-initiated, single-arm, clinical trial involving academic centres in Hong Kong and Korea. Key eligibility criteria included diagnosis of HCC, refractoriness to prior ICI-based treatment, and Child-Pugh A liver function. A maximum of two prior lines of therapy were allowed. All patients were commenced on cabozantinib at 60 mg/day. The primary endpoint was progression-free survival (PFS). Forty-seven patients were recruited from Oct 2020 to May 2022; 27 and 20 patients had received one and two prior therapies, respectively. Median follow-up was 11.2 months. The median PFS was 4.1 months (95% CI 3.3-5.3). The median overall survival (OS) was 9.9 months (95% CI 7.3-14.4), and the 1-year OS rate was 45.3%. Partial response and stable disease occurred in 3 (6.4%) and 36 (76.6%) patients, respectively. When used as a second-line treatment (n = 27), cabozantinib was associated with a median PFS and OS of 4.3 (95% CI 3.3-6.7) and 14.3 (95% CI 8.9-NR) months, respectively. The corresponding median PFS and OS were 4.3 (95% CI 3.3-11.0) and 14.3 (95% CI 9.0-NR) months, respectively, for those receiving ICI-based regimens with proven benefits (n = 17). The most common grade 3-4 treatment-related adverse event was thrombocytopenia (6.4%). The median dose of cabozantinib was 40 mg/day. The number of prior therapies was an independent prognosticator (one vs. two; hazard ratio = 0.37; p = 0.03). Cabozantinib demonstrated efficacy in patients who had received prior ICI regimens; survival data for second-line cabozantinib following first-line ICI regimens provide a reference for future clinical trial design. The number of prior lines of treatment may be considered a stratification factor in randomised studies. Prospective data on systemic treatment following prior immune checkpoint inhibitor (ICI) therapy for hepatocellular carcinoma (HCC) are lacking. This phase II clinical trial provides efficacy and safety data on cabozantinib in patients who had received prior ICI-based treatment. Exploratory analyses showed that the performance of cabozantinib differed significantly when used as a second- or third-line treatment. The above data could be used as a reference for clinical practice and the design of future clinical trials on subsequent treatment lines following ICIs. NCT04588051. [Display omitted] • This phase II clinical trial evaluated the use of cabozantinib after prior use of immunotherapy regimens in hepatocellular carcinoma. • The median progression-free and overall survival associated with cabozantinib were 4.1 and 9.9 months, respectively. • When used as second-line therapy, the median and progression-free and overall survival were 4.3 and 14.3 months, respectively. • In multivariable analyses, prior number of treatment lines (one vs. two) was an independent prognosticator for overall survival. [ABSTRACT FROM AUTHOR]

SERENA-1 (NCT03616587) is a phase I, multi-part, open-label study of camizestrant in pre- and post-menopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer. Parts A and B aim to determine the safety and tolerability of camizestrant monotherapy and define doses for clinical evaluation. Women aged ≥18 years with metastatic or recurrent ER+, HER2− breast cancer, refractory (or intolerant) to therapy, were assigned 25 mg up to 450 mg once daily (QD; escalation) or 75, 150, or 300 mg QD (expansion). Safety and tolerability, antitumor efficacy, pharmacokinetics, and impact on mutations in the estrogen receptor gene (ESR1 m) circulating tumor (ct)DNA levels were assessed. By 9 March 2021, 108 patients received camizestrant monotherapy at 25-450 mg doses. Of these, 93 (86.1%) experienced treatment-related adverse events (TRAEs), 82.4% of which were grade 1 or 2. The most common TRAEs were visual effects (56%), (sinus) bradycardia (44%), fatigue (26%), and nausea (15%). There were no TRAEs grade 3 or higher, or treatment-related serious adverse events at doses ≤150 mg. Median t max was achieved ∼2-4 h post-dose at all doses investigated, with an estimated half-life of 20-23 h. Efficacy was observed at all doses investigated, including in patients with prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and/or fulvestrant treatment, with and without baseline ESR1 mutations, and with visceral disease, including liver metastases. Camizestrant is a next-generation oral selective ER antagonist and degrader (SERD) and pure ER antagonist with a tolerable safety profile. The pharmacokinetics profile supports once-daily dosing, with evidence of pharmacodynamic and clinical efficacy in heavily pre-treated patients, regardless of ESR1 m. This study established 75-, 150-, and 300-mg QD doses for phase II testing (SERENA-2, NCT04214288 and SERENA-3, NCT04588298). • SERENA-1 (A/B): safety and efficacy of camizestrant monotherapy (25-450 mg) in women with ER+ HER2- advanced breast cancer. • Efficacy was observed at all doses, regardless of prior treatment with CDK4/6i or fulvestrant, or of ESR1 mutation status. • At all doses investigated, median t max was achieved ∼2-4 h post-dose, with an estimated half-life of 20-23 h. • In total, 86.1% of patients experienced TRAEs, with none beyond grade 2 at ≤150 mg camizestrant. • Camizestrant is a next-generation oral SERD and pure ER antagonist with a tolerable safety profile, suitable for QD dosing. [ABSTRACT FROM AUTHOR]

Introduction: Numerous randomized controlled trials (RCTs) have investigated PD-1/PD-L1 inhibitor-based combination therapies. The debate surrounding the potential additive clinical benefits of combination of two immune-oncology (IO) therapies for cancer patients persists. Methods: Both published and grey sources of randomized clinical trials that compared anti-PD-1/PD-L1-based immunotherapy combinations with monotherapy in patients with advanced or metastatic solid tumors were encompassed. The primary outcome was progression-free survival (PFS), and secondary outcomes included objective response rate (ORR), overall survival (OS) and treatment-related adverse events (TRAEs). Results: Our analysis encompassed 31 studies comprising 10,341 patients, which covered 12 distinct immune-oncology combination regimens. Across all patients, the immunotherapy combinations exhibited the capability to enhance the ORR (OR = 1.23 [95% CI 1.13–1.34]) and extend PFS (HR = 0.91 [95% CI 0.87–0.95]). However, the observed enhancement in OS (HR = 0.96 [95% CI 0.91–1.01]) was of no significance. Greater benefits in terms of PFS (HR = 0.82 [95% CI 0.72 to 0.93]) and OS (HR = 0.85 [95% CI 0.73 to 0.99]) may be particularly pronounced in cases where PD-L1 expression is negative. Notably, despite a heightened risk of any-grade TRAEs (OR = 1.72 [95% CI 1.40–2.11]) and grade greater than or equal to 3 TRAEs (OR = 2.01 [95% CI 1.67–2.43]), toxicity was generally manageable. Conclusions: This study suggests that incorporating an additional immunotherapy agent with PD-1/PD-L1 inhibitors can elevate the response rate and reduce the risk of disease progression, all while maintaining manageable toxicity. However, there remains a challenge in translating these primary clinical benefits into extended overall survival. [ABSTRACT FROM AUTHOR]

Introduction: Atrial fibrillation (AF) and heart failure (HF) commonly coexist, resulting in adverse health and economic consequences such as declining ventricular function, heightened mortality, and reduced quality of life. However, limited information exists on the impact of COVID‐19 on AF patients that hospitalized for HF. Methods: We analyzed the 2020 U.S. National Inpatient Sample to investigate the effects of COVID‐19 on AF patients that primarily hospitalized for HF. Participants aged 18 and above were identified using relevant ICD‐10 CM codes. Adjusted odds ratios for outcomes were calculated through multivariable logistic regression. The primary outcome was inpatient mortality, with secondary outcomes including system‐based complications. Results: We identified 322,090 patients with primary discharge diagnosis of HF with comorbid AF. Among them, 0.73% (2355/322,090) also had a concurrent diagnosis of COVID‐19. In a survey multivariable logistic and linear regression model adjusting for patient and hospital factors, COVID‐19 infection was associated with higher in‐hospital mortality (aOR 3.17; 95% CI 2.25, 4.47, p < 0.001), prolonged length of stay (βLOS 2.82; 95% CI 1.71, 3.93, p < 0.001), acute myocarditis (aOR 6.64; 95% CI 1.45, 30.45, p 0.015), acute kidney injury (AKI) (aOR 1.48; 95% CI 1.21, 1.82, p < 0.001), acute respiratory failure (aOR 1.24; 95% CI 1.01, 1.52, p 0.045), and mechanical ventilation (aOR 2.00; 95% CI 1.28, 3.13, p 0.002). Conclusion: Our study revealed that COVID‐19 is linked to higher in‐hospital mortality and increased adverse outcomes in AF patients hospitalized for HF. [ABSTRACT FROM AUTHOR]

BACKGROUND: Endotracheal suctioning causes discomfort, is associated with adverse effects, and is resource-demanding. An artificial secretion removal method, known as an automated cough, has been developed, which applies rapid, automated deflation, and inflation of the endotracheal tube cuff during the inspiratory phase of mechanical ventilation. This method has been evaluated in the hands of researchers but not when used by attending nurses. The aim of this study was to explore the efficacy of the method over the course of patient management as part of routine care. METHODS: This prospective, longitudinal, interventional study recruited 28 subjects who were intubated and mechanically ventilated. For a maximum of 7 d and on clinical need for endotracheal suctioning, the automatic cough procedure was applied. The subjects were placed in a pressure-regulated ventilation mode with elevated inspiratory pressure, and automated cuff deflation and inflation were performed 3 times, with this repeated if deemed necessary. Success was determined by resolution of the clinical need for suctioning as determined by the attending nurse. Adverse effects were recorded. RESULTS: A total of 84 procedures were performed. In 54% of the subjects, the artificial cough procedure was successful on > 70% of occasions, with 56% of all procedures considered successful. Ninety percent of all the procedures were performed in subjects who were spontaneously breathing and on pressure-support ventilation with peak inspiratory pressures of 20 cm H2O. Rates of adverse events were similar to those seen in the application of endotracheal suctioning. CONCLUSIONS: This study solely evaluated the efficacy of an automated artificial cough procedure, which illustrated the potential for reducing the need for endotracheal suctioning when applied by attending nurses in routine care. [ABSTRACT FROM AUTHOR]

Background: It has long been understood and acknowledged that the Neonatal Intensive Care Unit (NICU) environment and the transport environments are extremely loud, with both long- and short-term sequelae to the neonate, being well over the recommended amount of noise by the American Academy of Pediatrics (AAP). This problem has yet to be properly addressed. The purpose of this manuscript is to define and explain the concept of acoustic neuroprotection. While we cannot change the internal structures of the neonates' auditory system, we could change the acoustics of the environment to be support neuroprotection of these sensitive patients. Evidence acquisition: Walker and Avant's concept analysis steps were followed to create and define the idea of acoustic neuroprotection, as it has not had a definition before. A total of 45 articles from multiple search engines were chosen. A combination of 2 concepts were used: acoustic protection and neurodevelopmental protection/support. The search was expanded past 20 years for lack of research and importance of seminal works. Results: To achieve acoustic neuroprotection, a neonate should not be exposed to sound greater than 45 decibels (dBa) for longer than 10 s, and exposure to sound above 80 dBa should never occur. Appropriate interventions need to include supporting the neurodevelopment of the neonate through therapeutic sound, while decreasing the amount of toxic noise exposure to safe levels. Implications for Practice and research: By further understanding and having a quantifiable goal of acoustic neuroprotection for neonates, neonatal clinicians can work together to create new interventions for how to better protect and support the care of our tiniest patients. [ABSTRACT FROM AUTHOR]