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BackgroundAlthough vaccines are largely effective and safe, there is variability in post-vaccination experience regarding antibody response, side effects, and affective outcomes. Vaccine mindsets, specific beliefs about the vaccine, may be associated with post-vaccination experience. This is important since mindsets are malleable and may help decrease vaccine hesitancy and improve post-vaccination experience.MethodsIn a prospective study, we measured overall positive vaccine mindset and specific mindsets regarding efficacy, body response, and side effects. We tested whether vaccine mindsets before vaccination predicted neutralizing antibody response, side effects, vaccine-related stress, and affective outcomes (general stress, sadness, and happiness). Antibody response was assessed one month and six months after participants completed a SARS-CoV-2 vaccination series. Side effect experience and affective reactions were assessed daily on the vaccination day and the subsequent five days.ResultsThere was no significant association between the aggregate vaccine mindset score and neutralizing antibody response; however, people with a more positive vaccine mindset reported fewer side effects, less same-day vaccine-related anxiety, and improved affective outcomes after vaccination. In secondary analyses, when specific mindsets were explored, the mindset that vaccine side effects are a sign of treatment efficacy predicted higher antibodies, but not side effects experience and vaccine-related anxiety. Vaccine efficacy and body-response mindsets predicted fewer side effects, vaccine-related anxiety, and improved affective outcomes after vaccination.ConclusionThese findings underscore the potential of vaccine mindsets in enhancing the overall post-vaccination experience and, in some cases, increasing antibody response.

Background: Many pregnant women are reluctant to follow the recommendation concerning oral iron prophylaxis due to concerns about gastrointestinal (GI) side effects. Objective: To assess the frequency of GI complaints during low‐dose oral iron prophylaxis and compare three iron formulas in equipotent doses: ferrous fumarate versus ferrous bisglycinate versus ferrous sulphate, in healthy women with an uncomplicated single pregnancy. Methods: Results from two randomized, double‐blind studies are reported: the Gentofte study comprising 404 women allocated into four groups taking 20, 40, 60, and 80 mg of elemental iron as ferrous fumarate/day and the Naestved study comprising 78 women allocated into two groups: 25 mg of elemental iron as ferrous bisglycinate/day and 50 mg of elemental iron as ferrous sulphate/day between meals from 15 to 19 weeks of gestation to delivery. GI complaints (nausea, vomiting, epigastric pain/pyrosis, belching, meteorism, borborygmi, intestinal colic, flatulence, loose stools, constipation, and use of laxatives), as well as black stools, were recorded by interview at the time of inclusion and at regular intervals during gestation. Results: At inclusion, the frequency of total combined GI complaints in all women (n = 482) was 21%. The Gentofte study showed that in the groups taking 20–60 mg iron/day as fumarate, there was no association between the iron dose and the frequency of GI side effects. An iron dose of 80 mg as fumarate was associated with significantly higher frequencies of constipation and the use of laxatives. Comparing the three equipotent doses of iron formulas, which can prevent iron deficiency, ferrous bisglycinate 25 mg iron had the most favourable GI side effect profile, while ferrous fumarate 40 mg iron and ferrous sulphate 50 mg iron had higher but similar GI side effect profiles. The frequency of black stools increased with the iron dose. Ferrous bisglycinate 25 mg iron had a lower frequency of black stools (8%) than ferrous fumarate 40 mg iron (22%) and ferrous sulphate 50 mg iron (31%). Conclusion: Low‐dose iron supplementation appears to have no clinically significant GI side effects, as none of the included women presented with GI complaints of such severity that it necessitated either reduction of iron dose, change to an alternative iron formula, or discontinuation of iron supplement. However, ferrous bisglycinate 25 mg iron/day is associated with significantly fewer GI complaints than ferrous fumarate 40 mg iron/day and ferrous sulphate 50 mg iron/day. Ferrous bisglycinate may be preferred for iron prophylaxis, especially in women experiencing GI side effects when taking other conventional iron formulas. [ABSTRACT FROM AUTHOR]

Background: Despite the availability of evidence-based treatments for anorexia nervosa (AN), remission rates are moderate, and mortality is high. Olanzapine is used as adjunct therapy for AN in case of insufficient response to first-line treatments, even though the evidence is limited. Its effect on eating disorder (ED) psychopathology, its efficacy and tolerability, and its acceptability and adherence rate are unclear. Methods: We assessed the feasibility of a future definitive trial on olanzapine in young people with AN in an open-label, one-armed feasibility study that aimed to include 55 patients with AN or atypical AN aged 12–24 who gained < 2 kg within at least one month of treatment as usual (TAU) during outpatient, inpatient, or day-care treatment. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated the following planning parameters: Recruitment rate (number of patients who agreed to take olanzapine/number eligible), adherence rate (number adhering to treatment/number recruited) and attrition rate (number completing study assessments/number recruited). In addition, two exploratory effect size parameters were estimated: Mean change in body mass index (BMI) and mean change in ED psychopathology. Results: Fifty-two people were pre-screened (June 2022 to May 2023; 10 study sites in England). 13 were ineligible at pre-screening. Of the 39 approached, 4 were found ineligible at screening. Of the remaining 35 eligible, 10 declined and 5 did not take part for other reasons. Thus, 20 participants were recruited and started olanzapine (recruitment rate: 20/35 = 57%). 15 out of 20 (75%) continued olanzapine for ≥ 16 weeks, and 13 participants (65%) remained in the trial until follow-up (either 6 or 12 months). Participants experienced, on average, a decrease over time in their Eating Disorder Examination Questionnaire (EDE-Q) Global scores (0.07 per week, N = 20) and an increase in BMI (0.08 kg/m2 per week, N = 20) during treatment with olanzapine plus TAU. Conclusions: Possible reasons for the recruitment difficulties and low adherence rate include the high clinical workload of ED services during the COVID-19 pandemic and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study. Trial registration: International standard randomised controlled trial register number: ISRCTN80075010. Registration date: 27/04/2022. [ABSTRACT FROM AUTHOR]

Introduction: Cannabis, commonly known for both therapeutic and intoxicating effects, is gaining accessibility on legal markets and traction as a potential alternative therapy for pain mediation, particularly in those suffering from chronic low back pain. However, the effectiveness in this population of legal market forms of cannabis, particularly commonly used edibles, is unknown. Methods: Therefore, this study utilized a naturalistic prospective design where participants with chronic low back pain with intentions to initiate cannabis use for treatment were recruited and self-selected edible cannabis products containing varying amounts of delta- 9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Products were categorized as CBD-dominant, THC-dominant, or combined THC and CBD (THC + CBD). Results: 249 participants [140 female (56.62%), mean (SD) age of 46.30 (16.02), 90% White] were tracked over 2 weeks of ad libitum use and assessed during a naturalistic acute cannabis administration session on changes in pain, mood, and subjective drug effects. During acute administration, a significant correlation between THC dose and short-term pain relief was found, suggesting that higher THC doses were associated with greater pain reduction (p <.05). In addition, THC was associated with higher levels of subjective cannabis drug effects (p <.001), regardless of whether CBD was also in the edible product. Acute CBD dose was primarily associated with short-term tension relief (p <.05); however, there were no associations between CBD dose and acute pain. Over the 2-week ad libitum administration period results suggested pain reductions across participants using all forms of cannabis. However, trends suggested that more frequent use of CBD-dominant edible cannabis may be associated with greater reductions in perceived pain over the 2-week observation period (p =.07). Discussion: These findings support the short-term analgesic effects of THC and anxiolytic effects of CBD and further suggest that orally-administered THC and CBD should continue to be evaluated for the potential to provide both acute and extended relief from chronic low back pain. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT03522324?locStr=Boulder,%20CO&country=United%20States&state=Colorado&city=Boulder&cond=chronic%20low%20back%20pain&intr=Cannabis&rank=1, identifier NCT03522324. [ABSTRACT FROM AUTHOR]

Low-intensity transcranial electrical stimulation (tES), including techniques like transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and oscillatory transcranial direct current stimulation (otDCS), has been widely explored for its neuromodulatory effects on motor, cognitive, and behavioral processes. Despite well-established safety, these techniques can induce varying degrees of discomfort and side effects, potentially impacting their application. This study presents a within-subject sham-controlled experiment directly comparing the subjective experience and side effects of tDCS, tACS, and otDCS. Participants reported their discomfort levels at multiple time points during 20-min stimulation sessions and completed a side-effects questionnaire before and after each session. Results indicated that the overall discomfort levels were low across all conditions, with ≥95% reporting the absence of discomfort or mild procedure-induced discomfort. Nevertheless, tDCS and otDCS were slightly less comfortable compared to sham, especially at the beginning of stimulation, with tACS-induced discomfort levels being overall comparable to sham. The most common side / adverse effects were mild skin sensations, including itching and tingling, particularly with tDCS and otDCS, while tACS occasionally caused phosphenes and blurred vision. These findings provide a systematic comparison of tES-induced discomfort and side effects between different tES techniques, highlighting the high safety of tES, but also the importance of considering within- and between-person variability and time-course effects in tES applications. [ABSTRACT FROM AUTHOR]

Antioxidants have a well-established effect on general health and are essential in preventing oxidative damage to cells by scavenging free radicals. Free radicals are thought to be neutralized by these substances, which include polyphenols, β-carotene, and vitamins C and E, reducing cellular damage. On the other hand, recent data indicates that consuming excessive amounts of antioxidants may have side effects. Apoptosis and cell signaling are two beneficial physiological processes that are affected by excessive supplementation. Other negative effects include paradoxical enhancement of oxidative stress and unbalanced cellular redox potential. Overdosing on particular antioxidants has been associated with increased medication interactions, cancer progression, and fatality risks. Additionally, the complex impacts they may have on fertility might be both useful and adverse, depending on the quantity and duration of usage. This review delves into the dual role of antioxidants and emphasizes the importance of employing antioxidants in moderation. Antioxidant overconsumption may disrupt the oxidative balance necessary for normal sperm and oocyte function, which is one of the potential negative effects of antioxidants on fertility in both males and females that are also investigated. Although modest usage of antioxidants is generally safe and useful, high levels of antioxidants can upset hormonal balance, impair sperm motility, and negatively impact the outcomes of assisted reproductive technologies (ART). The findings emphasize the need to use antioxidant supplements in a balanced way, the importance of further research to optimize their use in fertility treatments, and the importance of supporting reproductive health to avoid adverse effects. [ABSTRACT FROM AUTHOR]

Introduction: There is growing recognition of the potential of cannabis to treat various medical conditions and symptoms, such as chronic pain, spasticity, and epilepsy. However, one of the biggest challenges is the assurance of a standardized cannabis product that contains a consistent amount of its main psychoactive substances delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), and which is compliant with predetermined specifications for these compounds. This is crucial not only to ensure consistent cannabis quality and dosage for patients but also to effectively translate research findings into clinical practice. Methods: This systematic literature review provides an overview of the effects of standardized cannabis products from Bedrocan, a leading Dutch producer of pharmaceutical-quality standardized medicinal cannabis. Results: Cannabis administration to healthy volunteers induces dose-dependent acute effects, such as rapidly rising THC and CBD blood concentrations, the subjective experience of high and anxiety, slower reaction time and impaired attention, learning and working memory. Patient studies suggest that treatment with medicinal cannabis reduces pain intensity across a broad range of chronic pain-related medical conditions. Medicinal cannabis showed a mild safety profile, with minor and transient side effects, such as feeling high, coughing and mental confusion. The strength of acute effects, the experience of side effects and the drop-out rate in patient studies may depend on cannabis dose, cannabis composition (CBD:THC ratio), and cannabis use history of participants. Conclusion: Safety and efficacy of standardized medicinal cannabis products should be further investigated in randomized clinical trials with sufficient sample size, with particular focus on cannabis dose and composition, age and differences between males and females. [ABSTRACT FROM AUTHOR]

Background: Breast cancer patients have an increased risk of cardiometabolic disease and for many patients, adjuvant therapy causes an altered lipid profile, insulin resistance and inflammation. Previous follow-up studies are inconclusive regarding the duration of therapy-induced inflammation. We examined the acute and persistent changes of adjuvant chemotherapy on inflammatory and metabolic health markers in breast cancer patients. Methods: Plasma levels of IL-6, IL-8, IL-10, IFN-γ, TNF-α, high-sensitivity C-reactive protein (hsCRP) and metabolic health parameters were analyzed before, shortly after and every six months up to two years after adjuvant chemotherapy treatment in 51 postmenopausal early breast cancer (EBC) patients, as well as in 41 healthy age- and BMI-matched controls. A target-specific multiplex assay was applied for cytokine measurements. Results: Before initiation of adjuvant therapy, plasma IL-8 levels were higher in EBC patients (31%, p = 0.0001). Also, a larger proportion of the patients had a hsCRP level above 2 mg/L (41%) compared to the controls (17%, Χ2 = 5.15, p = 0.023). Plasma levels of all five cytokines, but not hsCRP, were significantly increased after compared to before adjuvant chemotherapy (15–48% increase; all p ≤ 0.05). Already six months after ending chemotherapy treatment, all plasma cytokine levels were significantly reduced and close to pre-chemotherapy levels. Adjuvant chemotherapy caused a worsened lipid profile (increased triglycerides, lower HDL levels), insulin resistance and increased plasma insulin levels that remained high during the first year after chemotherapy. Conclusion: Postmenopausal women with EBC have temporarily increased plasma levels of pro-inflammatory cytokines after adjuvant chemotherapy. Although transient, the therapy-induced increase in plasma cytokine levels, together with dyslipidemia and insulin resistance, may contribute to cardiometabolic risk in breast cancer patients treated with adjuvant chemotherapy. Trial registration: The clinical trial (registration number NCT03784651) was registered on www.clinicaltrials.gov on 24 December 2018. [ABSTRACT FROM AUTHOR]

Background and Objectives The Agonoscena pistaciae Burckhardt & Lauterer (Hem.: Psyllidae), commonly known as the pistachio psyllid, is a major pest that infests pistachio trees. As the population of this pest increases, this leads to a significant decline in both the quality and the yield of the pistachio harvest. Over the past few years, various types of sulfur have been commonly used to control pests. The common green lacewing, Chrysoperla carnea (Stephens) is a cosmopolitan polyphagous predator, attacking various pests, including eggs and nymphs of the common pistachio psylla. This study aimed to evaluate the effectiveness of three concentrations (1500, 2500, and 4000 ppm) of a commercially available sulfur formulation (WP80%) on C. carnea, which is one of the most important natural enemies in pistachio orchards. Materials and Methods The green lacewing eggs and larvae, collected from pistachio orchards in Yazd, were treated with sulfur using both the dipping method for two days-old eggs and the residual dry-on-glass plate method for larvae. The study was conducted under laboratory conditions at 26 ± 2 •C, 65 ± 5% relative humidity (RH), and a photoperiod of 16:8 h (L: D). Several parameters were measured such as mortality rate, developmental time of the immature stages of the green lacewing, adult longevity, and fecundity. The fertility life table data were analyzed using the TWO-SEX MS Chart 2024 software. A one-way analysis of variance (ANOVA) with a post-hoc Tukey test was conducted to statistically assess the mean percentage of formation across different biological stages and the pre-adult mortality rate data, using SPSS version 27.00. Normality was tested using a nonparametric test, Kolmogorov-Smirnov test. Results The results revealed that the mortality rates of the green lacewing's immature stages in the treatments (4000, 2500, and 1500 ppm) and the control group were 69.2 ± 0.8, 58.9 ± 1.1, 43.7 ± 2.4, and 14.4% ± 1.1, respectively. A significant difference was observed between the control group and the treatments at the 5% significance level. All concentrations resulted in a significant decrease in oviposition period, total fecundity, longevity, and total life span compared with control. Maximum and minimum mean lifespans of C. carnea individuals were observed in the untreated group and a concentration of 4000 ppm of sulfur. Additionally, the net reproduction rate (R•) was 6.1 ± 1.4, 12.7 ± 2.7, 29.2 ± 5.7, and 61.2 ± 7.3 offspring per individual, while the gross reproduction rate (GRR) was 23.6 ± 3.9, 36.4 ± 5.9, 59.03 ± 9.8, and 81.1 ± 8.4 offspring per individual, in the treatments (4000 ppm, 2500 ppm, and 1500 ppm) and the control group, respectively. The mean generation time (T) was 43.9 ± 0.6, 44.2 ± 0.4, 47.23 ± 1.1, and 46.6 ± 0.8 days, and the finite rate of population increase (λ) was 1.05 ± 0.01, 1.07 ± 0.01, 1.097 ± 0.006, and 1.12 ± 0.04 day-1 across the treatments and the control group, respectively. The highest values were observed in the control group, whereas the lowest ones were recorded in the 4000-ppm sulfur treatment. A significant difference was noted between the control group and the treatments at the 5% significance level. Discussion The adaptability of pesticides with biological agents is one of the major concerns of IPM practitioners. Hence, it is essential to have necessary information about the action mode of pesticides on non-target insects. Furthermore, finding efficient biological control agents is considered the first step in developing biological control programs. Therefore, the effects of a commercially available sulfur formulation (WP80%) on C. carnea were discussed to design integrated management programs. The results of this laboratory study demonstrated that sulfur application negatively affects the efficiency of C. carnea, significantly reducing its population. If these findings are confirmed under field conditions, adjustments in the method and timing of sulfur application in integrated pest management (IPM) programs will be necessary to avoid disrupting the sensitive stages of this predator. [ABSTRACT FROM AUTHOR]

Background: COVID-19 was a dreadful disease that turned into a pandemic, which made drug therapy a challenging task. With the advancement of medical science, the treatment of diseases has become much more sophisticated and with the advent of the vaccination system, the prevention of dreadful diseases that affect vast human communities can be effective is possible. Aims and Objectives: This work was initiated to understand the safety of Covishield™ by following the patients for any possible side effects and adverse effects after 1st and 2nd doses of vaccination. Materials and Methods: This retrospective cohort study was conducted in Panimalar Medical College Hospital and Research Institute, Chennai, India, on participants who got vaccinated with Covishield™ and reported the adverse effects that were noticed after 14 days of vaccination. Results: Out of 184 subjects who participated in the study, 161 patients suffered pain at the injection site after the first dose, of which 90% of the participants were relieved and 93 suffered after the second dose, of which 95% of the participants were relieved with little medical intervention in the form of analgesics. Almost 50% of participants suffered fever and fatigue and <30% of the participants suffered headache, chills, and giddiness within 2 days of the first dose. Lump and warmth at the injection site are common with any vaccination and the incidence was <10% of the participants. All the symptoms subsided with intervention with paracetamol. Conclusion: The safety of the vaccine is evident from this study. Through this study, we hope that the administration of the vaccination can be conducted doubtlessly to fight COVID-19 and any symptoms that arise eventually can be monitored and treated. [ABSTRACT FROM AUTHOR]

Introduction: Psychedelic agents have regained the attention of pharmaceutical companies as promising treatments for depressive episodes. 5-Methoxy-N,Ndimethyltryptamine (5-MeO-DMT), an atypical psychedelic, is emerging as a potentially effective, novel rapid-acting antidepressant. In this systematic review, we analyze the safety and tolerability evidence from clinical trials. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, electronic databases (PubMed, SCOPUS, Web of Science, EMBASE, and EBSCO) were searched from inception until 15 May 2024 to identify clinical trials (regardless of phase) reporting on short-term safety and tolerability profile of 5-MeO-DMT using the following keywords in various combinations: 5-methoxy-N, N-dimethyltryptamine, 5-MeO-DMT, safety, adverse, adverse reaction, side effects, tolerability, dropout, healthy volunteer, healthy participant, depression, major depressive disorder. Only studies written in English were considered. Results: Initial search yielded 100 records, out of which 3 met the inclusion criteria. These studies reported on the results from clinical trial phases I and I/II, with a total of 78 participants included; two studies involved healthy volunteers, and one included patients with treatment-resistant depression. Although the data is limited, it confirms a good short-term safety and tolerability profile for 5-MeO-DMT, with no serious adverse events (SAEs) reported. Furthermore, no drop-outs were reported. Conclusion: 5-MeO-DMT administration in human subjects presents favorable short-term safety and tolerability profile. Importantly, no SAEs have been documented, and no adverse events led to participant withdrawal from the studies There is a need for future randomized, double-blind, placebo-controlled trials with larger samples and follow-up to assess potential chronic adverse events. [ABSTRACT FROM AUTHOR]

Rapamycin (sirolimus) is an FDA approved drug with immune modulating properties that is being prescribed off-label in adults as a preventative therapy to maintain healthspan. We recently published one of the first reports on 333 adults with a history of off-label rapamycin use. Along with presenting evidence that rapamycin can be used safely in adults of normal health status, we discovered that about 26% of rapamycin users also reported oral health changes. Given the recent evidence highlighting the potential benefits of rapamycin and its derivatives in enhancing oral health, we conducted a secondary data analysis to profile the oral health of off-label rapamycin users, the true incidence of mouth sores, and present specific case studies of periodontal bone loss quantification using an FDA-approved artificial intelligence platform. Contrary to expected findings and previous literature, dimensions of rapamycin usage (such as length of use, dosage, and interval) were not found to be related to the incidence of mouth ulcers in rapamycin users. Notably, among rapamycin users, the most deleterious forms of ulcers were found to be infrequent and not statistically linked to rapamycin usage, with most rapamycin users having a common transient form of mouth ulcers. Additionally, we describe the general oral health outcomes of off-label rapamycin users and provide recommendations for individuals engaging in off-label rapamycin to be regularly checked by a dentist or an oral health care provider. This report was limited by being a secondary data analysis taken from survey data that focused on a more holistic health model. Future studies will use a focused survey that collects data on more dimensions of oral health outcomes while including questions on oral health for non-rapamycin-using participants. [ABSTRACT FROM AUTHOR]

Background: Transaminase and creatinine elevations have been well described in adults treated with remdesivir for COVID-19. It is hypothesized that a similar safety profile exists in children with COVID-19 treated with remdesivir, but available data are limited, especially in children < 12 months. The primary aim of this study was to determine the prevalence and timing of elevations in transaminases and creatinine in children with COVID-19 who were treated with remdesivir. Methods: This was a retrospective, observational cohort study including all pediatric patients admitted to a single, freestanding children’s hospital who were positive for COVID-19 and received at least 1 dose of remdesivir between 1/1/2020 and 5/31/2022. Available baseline and peak transaminase and creatinine concentrations were evaluated. Multivariable logistic regression analysis was performed to identify risk factors for transaminase elevation. Results: A total of 180 patients met inclusion criteria. Creatinine elevation of any grade was noted in 16% and remained elevated only in those with underlying chronic kidney disease. Transaminase elevation of any grade was noted in 58% of patients and remained elevated in only 1%. Older age and critical respiratory disease were associated with higher risk of significant transaminase elevation, whereas non-Hispanic ethnicity was strongly associated with protection against significant transaminase elevation. Conclusions: In our cohort of hospitalized children with COVID-19 who were treated with remdesivir, most patients experienced only mild transaminitis and normal creatinine concentrations. A limited number of patients experienced laboratory abnormalities which were transient, suggesting a favorable safety profile for remdesivir use in pediatrics. [ABSTRACT FROM AUTHOR]

Over the past few decades, the scientific community has been highly concerned about the obesity epidemic. Artificial sweeteners are compounds that mimic the sweet taste of sugar but have no calories or carbohydrates; hence, they are very popular among patients suffering from diabetes or obesity, aiming to achieve glycemic and/or weight control. There are four different types of sweeteners: artificial, natural, rare sugars, and polyols. Artificial and natural sweeteners are characterized as non-nutritional sweeteners (NNSs) since they do not contain calories. The extended use of sweeteners has been reported to have a favorable impact on body weight and glycemic control in patients with type 2 diabetes (T2DM) and on tooth decay prevention. However, there is concern regarding their side effects. Several studies have associated artificial sweeteners' consumption with the development of insulin resistance, nonalcoholic fatty liver disease (NAFLD), gastrointestinal symptoms, and certain types of cancer. The present review focuses on the description of different types of sweeteners and the benefits and possible deleterious effects of the chronic consumption of NNSs on children's health. Additionally, possible underlying mechanisms of the unfavorable effects of NNSs on human health are described. [ABSTRACT FROM AUTHOR]

Background: Despite advancements in cancer treatment, chemotherapy side effects significantly impact patients both physically and emotionally. While pharmacological treatments can mitigate these side effects, they may trigger additional side effects, exacerbating the overall discomfort experienced by patients; moreover, psychological factors influencing physical symptoms are beyond the reach of pharmacological interventions. Nonpharmacological interventions, however, offer the potential for complementary or alternative solutions. Objectives: This review aims to offer a comprehensive analysis of the literature on the effectiveness of nonpharmacological interventions in managing the physical side effects of chemotherapy. Methods: This review, based on a search of PubMed, PsycINFO, and Web of Science databases, identified 46 relevant studies. It categorizes interventions and evaluates their effectiveness in managing common chemotherapy side effects (fatigue, nausea, pain, diarrhea, and constipation). Results: Guided imagery, tailored exercises, and Qigong show promise in reducing fatigue, while interventions like yoga and cognitive-behavioral approaches address nausea and vomiting. Pain benefits result from guided imagery and educational interventions. Limited evidence exists for diarrhea and constipation interventions, necessitating further research. Conclusions: This review offers provisional conclusions, emphasizing the potential of integrating evidence-based nonpharmacological approaches alongside pharmacological interventions to enhance patient outcomes and reduce chemotherapy-induced side effects, considering factors such as accessibility, safety, customization, and adaptability in clinical settings. [ABSTRACT FROM AUTHOR]

Background: Neurological diseases resulting from nervous system injuries can significantly impact nutritional status and the physical and cognitive capacities necessary for maintaining a sufficient diet. This study focuses on primary nutritional therapies for neurological illnesses. Methods: An integrative literature review was conducted using three databases: PePSIC, Medline, and LILACS. A comprehensive search strategy was employed, incorporating descriptors such as neuropathies, nutritional therapy, efficacy, and side effects. Results: After applying inclusion criteria, 175 relevant items were identified. While traditional medical interventions for neurological conditions typically involve medication, food therapy has shown promise in enhancing clinical outcomes and alleviating symptoms for certain diseases. Specifically, food therapy has been effective in improving the prognosis of adrenoleukodystrophy and mitigating symptoms of Wernicke-Korsakoff syndrome and epilepsy. Conclusion: Patients with neurological illnesses, such as adrenoleukodystrophy, Wernicke-Korsakoff syndrome, and epilepsy, may benefit from dietary interventions to improve prognosis and alleviate symptoms. Therefore, healthcare professionals should consider incorporating food therapy into the treatment plans for these conditions to optimize patient outcomes. [ABSTRACT FROM AUTHOR]

The prevalence of obesity is increasing worldwide, resulting in various health issues such as hypertension, dyslipidemia, diabetes mellitus, heart disease, and a lower life expectancy. Importantly, several psychiatric disorders and the use of psychotropic medications have been linked to obesity, and the possible risk factors need further investigation. This study examined the prevalence of obesity and its associated factors using a self‐administered questionnaire. Participants were recruited from three outpatient clinics and individuals who met one or more of the ICD‐10 F0‐F9, G4 diagnoses were included. In total, 1384 participants completed the questionnaire about their lifestyle. Statistical analysis compared the demographic and clinical characteristics of the individuals who were obese (Body Mass Index: BMI ≥25) and those who were non‐obese (BMI <25). The results revealed that the factors associated with obesity in psychiatric outpatients were being male, prolonged treatment duration, eating out frequently, and use of both second‐ and first‐generation antipsychotics. The study emphasized the importance of closely monitoring BMI in individuals with multiple obesity‐related factors. [ABSTRACT FROM AUTHOR]

As obesity evolves as a global pandemic, the use of drugs to treat it is booming. The latest among these are Glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Along with their use, the incidence of adverse events has become more common. Although severe effects have been mentioned, details and associations are unclear regarding some of them. We performed a systematic review of studies related to GLP-1 RA drugs. Drugs that have been the subject of at least three studies meeting all our criteria were included. Analysis of GLP-1 RA therapies across eight studies, involving 4422 subjects, indicated varying rates of Serious Adverse Events (SAEs). Semaglutide demonstrated an SAE incidence of 8.9%, compared to 6.2% for Liraglutide. These results were not statistically significant. For both drugs, no clear association with pancreatitis or neoplasm was established. Discontinuation rates due to adverse effects were 10.3% for Semaglutide and 8.3% for Liraglutide. Severe adverse effects with GLP-1 RA use are not uncommon, and warrant further close monitoring when patients are started on treatment. Further studies are required to analyze the difference between the adverse effect profiles of each drug and to assess whether or not each of these severe adverse effects is dose dependent. [ABSTRACT FROM AUTHOR]

Aims: This study was conducted to systematically evaluate the biomechanical impact of varying degrees of root and bone resorption resulting from periodontitis and orthodontic tooth movement (OTM) on the mandibular anterior teeth. The objective was to determine whether these distinct resorption patterns exert a specific influence on tooth displacement and strain patterns. Methods: A finite element (FE) model of an idealized anterior mandible from the first premolar in the third to the fourth quadrant was developed without bone or root resorption and a constant periodontal ligament (PDL) thickness of 0.2 mm. Variations included three root resorption levels (0%, 20%, 50%) and three bone resorption types (circular 50%, circular 80%, vestibular 80%). Models ranged from 200,000 to 440,000 elements and 55,000 to 130,000 nodes. Orthodontic forces, namely root torque (5 Nmm), intrusion (0.2 N), and distalization (0.5 N) were applied for subsequent crown displacement and PDL strain analysis. Results: A total of 180 simulations were performed. Simulations showed that displacement was similar across different bone resorption conditions, irrespective of modeled root resorptions. Circumferential bone resorption increased tooth displacement, regardless of root resorption status. Vestibular bone resorption exhibited less increase in tooth displacement. However, when accompanied by root resorption, the combination exacerbated tooth displacement. Strains in the PDL clearly increased with a circumferential bone resorption of 80%. Conclusions: This study highlights the critical role of bone resorption in tooth displacement during OTM, particularly the challenges associated with circumferential resorption. Clinicians must consider both bone and root resorption for personalized medicine treatment of patients with severe periodontitis, in favor of low-force application strategies to optimize outcomes and minimize complications linked to excessive tooth displacement. [ABSTRACT FROM AUTHOR]

Background/Aim: Endocrine therapy is the standard treatment for hormone receptor-positive (HR+) breast cancer (BC). Yet, it is accompanied by treatment-related toxicities, leading to poor treatment adherence, high relapse, and low rates of survival. While pharmacogenomic variants have the potential to guide personalized treatment, their predictive value is inconsistent across published studies. Materials and Methods: To systematically assess the literature's current landscape of pharmacogenomics of endocrine therapy-related adverse drug effects, systematic searches in MEDLINE, Embase, Cochrane CENTRAL, Google Scholar and PharmGKB databases were conducted. Results: We identified 87 articles. Substantial heterogeneity and variability in pharmacogenomic effects were evident across studies, with many using data from the same cohorts and predominantly focusing on the Caucasian population and postmenopausal women. Meta-analyses revealed Factor V Leiden mutation as a predictor of thromboembolic events in tamoxifen-treated women (p<0.0001). Meta-analyses also found that rs7984870 and rs2234693 were associated with musculoskeletal toxicities in postmenopausal women receiving aromatase inhibitors (p<0.0001 and p<0.0001, respectively). Conclusion: Overall, the current body of evidence regarding the potential role of pharmacogenomics in endocrine therapy-related toxicity in BC remains largely inconclusive. Key concerns include the heterogeneity in toxicity definitions, lack of consideration for genotype-treatment interactions, and the failure to account for multiple testing. The review underscores the necessity for larger and well-designed studies, particularly with the inclusion of premenopausal women and non-Caucasian populations. [ABSTRACT FROM AUTHOR]

BACKGROUND: Patients diagnosed with low-risk prostate cancer (PCa) are confronted with a difficult decision regarding whether to undergo definitive treatment or to pursue an active surveillance protocol. This is potentially further complicated by the possibility that patients and physicians may place different value on factors that influence this decision. We conducted a qualitative investigation to better understand patient and physician perceptions of factors influencing treatment decisions for low-risk PCa. METHODS: Semi-structured interviews were conducted among 43 racially and ethnically diverse patients diagnosed with low-risk PCa, who were identified through a population-based cancer registry, and 15 physicians who were selected to represent a variety of practice settings in the Greater San Francisco Bay Area. RESULTS: Patients and physicians both described several key individual (e.g., clinical) and interpersonal (e.g., healthcare communications) factors as important for treatment decision-making. Overall, physicians perceptions largely mirrored patients perceptions. First, we observed differences in treatment preferences by age and stage of life. At older ages, there was a preference for less invasive options. However, at younger ages, we found varying opinions among both patients and physicians. Second, patients and physicians both described concerns about side effects including physical functioning and non-physical considerations. Third, we observed differences in expectations and the level of difficulty for clinical conversations based on information needs and resources between patients and physicians. Finally, we discovered that patients and physicians perceived patients prior knowledge and the support of family/friends as facilitators of clinical conversations. CONCLUSIONS: Our study suggests that the gap between patient and physician perceptions on the influence of clinical and communication factors on treatment decision-making is not large. The consensus we observed points to the importance of developing relevant clinical communication roadmaps as well as high quality and accessible patient education materials.

Background.Vaccines play a critical role in safeguarding public health, particularly for children. It is imperative to proactively address safety concerns to uphold trust in their effectiveness and safety. Skepticism surrounding vaccines can have significant adverse effects on the overall well-being of the entire population, potentially leading to individuals opting out of vital vaccinations, thereby posing risks to public health. Thus, ensuring confidence in vaccine safety remains paramount.Materials and methods.This phase four clinical trial was conducted as a post-marketing study (PMS) on 2 to 7 month old healthy infants (N = 539) to evaluate immunity and safety of Indian pentavalent vaccine containing Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenza type b [DTPW-HEP B-HIB (PRP-T)/PENTAVAC] in four different centers at Tehran province. Blood samples were collected from eligible infants before receiving the vaccine (2 months of age) and 1 month after the third dose (7 months of age) to determine antibodies against all antigens in the pentavalent vaccine using ELISA.Results.The results indicated that the immune responses demonstrated seroprotection and protective antibody levels after three doses of the vaccine for Haemophilus influenza b, diphtheria, tetanus, hepatitis B virus andBordetella pertussiswere 99.1%, 98.7%, 99.8%, 99.4% and 69.6%, respectively. Statistical analysis showed that the P-value for all vaccine components was similar (P 0.001). The five most common side effects reported were mild fever (10%), erythema at the vaccination site (9.1%), inflammation (4.3%), pain at the vaccination site (3.3%), and restlessness (2.6%).Conclusion.This study’s findings demonstrated a significant increase in antibody levels against all five vaccine components. In light of these results, it can be concluded that the Pentavalent vaccine is not only effective in enhancing immunity against multiple diseases but also presents minimal risk of side effects in the study population. These findings contribute to the body of evidence supporting the safety and efficacy of vaccines, underscoring their crucial role in protecting public health.

Abstract Background Breast cancer patients have an increased risk of cardiometabolic disease and for many patients, adjuvant therapy causes an altered lipid profile, insulin resistance and inflammation. Previous follow-up studies are inconclusive regarding the duration of therapy-induced inflammation. We examined the acute and persistent changes of adjuvant chemotherapy on inflammatory and metabolic health markers in breast cancer patients. Methods Plasma levels of IL-6, IL-8, IL-10, IFN-γ, TNF-α, high-sensitivity C-reactive protein (hsCRP) and metabolic health parameters were analyzed before, shortly after and every six months up to two years after adjuvant chemotherapy treatment in 51 postmenopausal early breast cancer (EBC) patients, as well as in 41 healthy age- and BMI-matched controls. A target-specific multiplex assay was applied for cytokine measurements. Results Before initiation of adjuvant therapy, plasma IL-8 levels were higher in EBC patients (31%, p = 0.0001). Also, a larger proportion of the patients had a hsCRP level above 2 mg/L (41%) compared to the controls (17%, Χ2 = 5.15, p = 0.023). Plasma levels of all five cytokines, but not hsCRP, were significantly increased after compared to before adjuvant chemotherapy (15–48% increase; all p ≤ 0.05). Already six months after ending chemotherapy treatment, all plasma cytokine levels were significantly reduced and close to pre-chemotherapy levels. Adjuvant chemotherapy caused a worsened lipid profile (increased triglycerides, lower HDL levels), insulin resistance and increased plasma insulin levels that remained high during the first year after chemotherapy. Conclusion Postmenopausal women with EBC have temporarily increased plasma levels of pro-inflammatory cytokines after adjuvant chemotherapy. Although transient, the therapy-induced increase in plasma cytokine levels, together with dyslipidemia and insulin resistance, may contribute to cardiometabolic risk in breast cancer patients treated with adjuvant chemotherapy. Trial registration The clinical trial (registration number NCT03784651) was registered on www.clinicaltrials.gov on 24 December 2018.

Background:Vaccines are critical to reducing the viral attack by permitting the body to generate a safe immune response that defends it by preventing or limiting infection. Objectives: The study aimed to detect the side effects that caused by immunization with Coronavirus (COVID-19) vaccines. Materials and Methods:286 samples were collected from individuals immunized with Corona vaccines (Pfizer, Sinopharm, and AstraZeneca) of different ages, whether they were previously infected with COVID-19 or not. The side effects and pathological complications of immunization have been clinically determined by specialized doctors. Results:Pfizer vaccine was the most used vaccine, yet its typical side effects of first dose include mild fever (28%) and injection site pain (20%). The second dose side effects of Pfizer vaccine were high fever in 200/246 people (81%). Moreover, 7% of the cases did not experience side effects after both doses. The first dose of Sinopharm vaccine side effects were pain in the area of the injection (30%) and mild fever (19%), and 8% of cases suffered from fever and pain in the head and joints, whereas high fever was one of the most prominent signs when taking the second dose by (51%) whereas 27% of them did not show any side effects when taking the two doses. Only three individuals were immunized with AstraZeneca vaccine and suffered from fever, headache, and joint pain after taking the first dose, whereas two of them were suffering from high temperature, and one was suffering from fatigue and joint pain after taking the second dose. Conclusion:The symptoms of COVID-19 vaccines are as the same as other vaccines, but still needs more studies analyzing their side effects to ensure their safety for immunization.

Abstract The prevalence of obesity is increasing worldwide, resulting in various health issues such as hypertension, dyslipidemia, diabetes mellitus, heart disease, and a lower life expectancy. Importantly, several psychiatric disorders and the use of psychotropic medications have been linked to obesity, and the possible risk factors need further investigation. This study examined the prevalence of obesity and its associated factors using a self‐administered questionnaire. Participants were recruited from three outpatient clinics and individuals who met one or more of the ICD‐10 F0‐F9, G4 diagnoses were included. In total, 1384 participants completed the questionnaire about their lifestyle. Statistical analysis compared the demographic and clinical characteristics of the individuals who were obese (Body Mass Index: BMI ≥25) and those who were non‐obese (BMI

Abstract Background Transaminase and creatinine elevations have been well described in adults treated with remdesivir for COVID-19. It is hypothesized that a similar safety profile exists in children with COVID-19 treated with remdesivir, but available data are limited, especially in children

Objectives: Our aim was to demonstrate the occurrence of post-radiotherapy side effects- even in the case of using intensively modulated therapy (IMRT) in patients with ENT cancer as its are: radiomucositis, dental caries, osteoradionecrosis, the increase in the size of the existing periapical lesions before radiotherapy, dysphagia, dysgeusia. Materials and methods: Our study included 35 cancer patients age between 32-81 years old with ENT cancer- neoplasm of larynx, oropharynx, oral cavity, nasopharynx, hypopharynx, sinuses; under treatment at the Regional Institute of Oncology, Iasi. They were examinated by one dental generalist, two endodontist, one radiologist, one doctor specialized in radiotherapy and an ENT doctor before and after radiotherapy. We used as irradiation dose between 50-70 Gy. Results: All patients suffered from various forms of cancer; the majority (40%) presented a neoplasm of the larynx, 8 patients (22,9%) presented a neoplasm of oropharynx, 6 patients (17,1%) presented a neoplasm of the oral cavity. Other forms of neoplasm found were nasopharynx, hypopharynx and respectively sinus neoplasm (1 case). The vast majority of the patients presented radiomucositis grade 2 (34,3%) and 3 (45,7%). The distribution of the localization of periapical lesions changed before and after radiotherapy. Osteoradionecrosis was initially diagnosed in 3 of the 35 patients (8,6%); after radiotherapy osteoradionecrosis was diagnosed in 6 patients (17,1%). We did not identify a statistically significant relationship between the dose of radiation administered and the degree of radiomucositis. Disscusions: Our retrospective study reported a frequency of 40% cancer of the larynx, 22,9% cancer of the oropharynx and 17,1% neoplasm of the oral cavity, followed by cancer of the nasopharynx, hypopharynx and sinus neoplasm out of a total of 35 patients taken into account. Taking into account the fact that the patients received an irradiation dose between 70 Gy (65,7%)- 66 Gy (22,9%), the degree of radiomucositis was mainly 2 (34,3%) or 3 (45,7%). We observed an increase in the diameter of the periapical lesions after radiotherapy associated with the dose of radiation administered. Areas with osteoradionecrosis revealed the same tendency of increase in their comparative analysis after the applied irradiation doses. Conclusions: The management of the side effects of radiotherapy can be managed favorably for the oncological patient through a close collaboration between the general dentist, ENT and the radiotherapist.

Background. An unfavorable bleeding pattern is a common reason for refusing to continue hormonal contraception. Aim. To evaluate the characteristics of uterine bleeding when using a new combined oral contraceptive (COC) containing estetrol and drospirenone (Esteretta®). Materials and methods. A multicenter observational study included 1402 females aged 18–49 who received Esteretta® for 6 cycles. The frequency, duration, and severity of withdrawal bleeding, as well as the frequency of unpredictable bleeding, were assessed. Results. The rate of regular withdrawal bleeding was 100%. The proportion of women with heavy menstruation/withdrawal bleeding decreased from 29.6 to 10.07% (p0.0001). The duration of regular withdrawal bleeding was significantly reduced (p=0.008). The incidence of unpredictable bleeding during COC use decreased from 4.57 to 3.29% (p=0.05). Satisfactory cycle control was observed in 87.43% of women. 2.5% of participants refused to continue using COCs. Conclusion. Esteretta® provides a high rate of regular withdrawal bleeding and a low rate of unpredictable bleeding. Given the optimal safety profile, this drug may be the first choice for contraception in sexually active women who are not planning a pregnancy.

Background and objective: Hypertension (HTN) has been linked to an elevated risk of prostate cancer (PC) development and poorer prognosis in localized cases, and is a common side effect of hormonal PC treatments. However, its relationship with the prognosis of metastatic PC is still unclear. We assessed the prognostic role of treatment-related HTN in patients with de novo metastatic hormone-sensitive PC (mHSPC) undergoing androgen deprivation therapy (ADT) alone or in combination with docetaxel or androgen receptor pathway inhibitors (ARPIs). Methods: Our retrospective analysis included 100 patients with de novo mHSPC treated with ADT, ADT + docetaxel, or ADT + ARPI between 2014 and 2021. Data on clinical variables, antihypertensive drugs, and blood pressure were collected from treatment initiation to 7 mo from ADT start. HTN development within 7 mo from hormonal treatment initiation was graded according to the Common Toxicity Criteria for Adverse Events version 5.0, and Cox analyses were performed for time to castration resistance (TTCR) and overall survival (OS). Key findings and limitations: In the overall population, grade (G) 2–3 HTN development within 7 mo from hormonal treatment initiation was associated with improved TTCR and OS at both univariate (TTCR: 19.8 vs 7.9 mo, hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.20–0.63, p

Providing treatment side effect information to patients increases the risk of harm due to the nocebo effect. Nocebo education, in which patients learn about nocebo effects, is a novel strategy that can be used across a variety of situations and individuals to decrease unpleasant treatment side effects. It is currently unclear which psychological changes are induced by nocebo education, which is information required to maximize this intervention. Two pre-registered studies investigated the effects of nocebo education on side effect expectations, side effect control beliefs, feelings toward treatments, intentions to avoid or seek side effect information, and perceptions of treatment efficacy. In Study 1 (N = 220), adult participants either watched or did not watch a nocebo education intervention video prior to reading vignettes about receiving a surgical treatment for pain and a medication for pain. Study 2 (N = 252) was similar to Study 1, with the inclusion of a health behavior video control group and participants only reading about a medication treatment for pain. In both experiments, nocebo education reduced global side effect expectations and increased side effect self-efficacy beliefs. Nocebo education also increased intentions to avoid side effect information and decreased intentions to seek more side effect information. Evidence was inconclusive on whether nocebo education changes affective associations with the treatments. The findings demonstrate that nocebo education has a multi-faceted influence with the potential to change patient behavior. The results can be used to improve the management of adverse treatment side effects. [ABSTRACT FROM AUTHOR]

Abstract:Introduction and aim: Pictograms can make taking medication safer. However, little is known about how pictograms on a medication package influence the subjective assessment of a medication. Methods: In this online study, 276 participants were presented with a fictitious package that contained 0 to 5 pictograms of possible side effects. Participants had to assess the probability of side effects occurring as well as the benefits and harms of the medication, both before and after consulting the package insert. Results: The number of pictograms (leveling out at 2 pictograms) influenced the assessment of the probability of side effects occurring. In addition, the assessment of this measure served as an anchor for assessing all subsequent measures (e.g., benefit). Although participants adjusted their measures after package insert consultation - these adjustments were insufficient (as expected from a normative probability account). Discussion and conclusion: Pictograms influence medication assessment, and humans can process only a limited number of pictograms. [ABSTRACT FROM AUTHOR]

As obesity evolves as a global pandemic, the use of drugs to treat it is booming. The latest among these are Glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Along with their use, the incidence of adverse events has become more common. Although severe effects have been mentioned, details and associations are unclear regarding some of them. We performed a systematic review of studies related to GLP-1 RA drugs. Drugs that have been the subject of at least three studies meeting all our criteria were included. Analysis of GLP-1 RA therapies across eight studies, involving 4422 subjects, indicated varying rates of Serious Adverse Events (SAEs). Semaglutide demonstrated an SAE incidence of 8.9%, compared to 6.2% for Liraglutide. These results were not statistically significant. For both drugs, no clear association with pancreatitis or neoplasm was established. Discontinuation rates due to adverse effects were 10.3% for Semaglutide and 8.3% for Liraglutide. Severe adverse effects with GLP-1 RA use are not uncommon, and warrant further close monitoring when patients are started on treatment. Further studies are required to analyze the difference between the adverse effect profiles of each drug and to assess whether or not each of these severe adverse effects is dose dependent.

Abstract Skin inflammation with the potential sequel of moist epitheliolysis and edema constitute the most frequent breast radiotherapy (RT) acute side effects. The aim of this study was to compare the predictive value of tissue-derived radiomics features to the total breast volume (TBV) for the moist cells epitheliolysis as a surrogate for skin inflammation, and edema. Radiomics features were extracted from computed tomography (CT) scans of 252 breast cancer patients from two volumes of interest: TBV and glandular tissue (GT). Machine learning classifiers were trained on radiomics and clinical features, which were evaluated for both side effects. The best radiomics model was a least absolute shrinkage and selection operator (LASSO) classifier, using TBV features, predicting moist cells epitheliolysis, achieving an area under the receiver operating characteristic (AUROC) of 0.74. This was comparable to TBV breast volume (AUROC of 0.75). Combined models of radiomics and clinical features did not improve performance. Exclusion of volume-correlated features slightly reduced the predictive performance (AUROC 0.71). We could demonstrate the general propensity of planning CT-based radiomics models to predict breast RT-dependent side effects. Mammary tissue was more predictive than glandular tissue. The radiomics features performance was influenced by their high correlation to TBV volume.

Introduction: We provide a case report on a patient with scleromyxedema treated with high-dose intravenous immunoglobulins (IVIgs) who reported less fatigue and fewer headaches after transitioning to Yimmugo, a novel IVIg preparation. Scleromyxedema is a rare and chronic cutaneous mucinosis, frequently associated with monoclonal gammopathy and systemic complications, which may be life-threatening. The disease is characterized by papular eruptions and sclerosis of the skin. Treatment of scleromyxedema is challenging because of its unclear pathogenesis. High-dose IVIgs are a promising treatment option to improve cutaneous manifestations. Case Presentation: We present the case of a 57-year-old patient with scleromyxedema and monoclonal gammopathy with end-stage renal failure on hemodialysis (3 times a week). Stabilization of skin symptoms was finally achieved by high-dose IVIg therapy administered at 2 g per kg bodyweight distributed over 2 days every 3 weeks. However, disease stabilization came at the expense of flu-like side effects that significantly affected daily life. After transitioning to Yimmugo®, the patient reported an improved quality of life. Conclusion: Further follow-up is essential to conclusively evaluate effectiveness and tolerability of this novel IVIg preparation.

Abstract Objective This study investigates the prevalent issues of healthcare access and the impact of antiseizure treatments among people with epilepsy (PWE) in rural Limpopo and Mpumalanga, South Africa, where healthcare facilities and affordable treatments are often inadequate. Methods Using a cross‐sectional survey, 162 PWE were selected using multistage sampling across the provinces. Data were collected via a structured questionnaire and analyzed descriptively using SPSS v27. Results Most of the participants experienced seizures intermittently, with 70.6% in Limpopo and 53.3% in Mpumalanga reporting occasional episodes, whereas a significant minority in both regions—20.6% and 40%, respectively—suffered from frequent seizures. A notable portion of PWE also reported recurring side effects from antiseizure drugs, which led to consequential life disruptions, including educational dropout and unemployment. Significance The findings underscore an urgent need for enhanced educational programs and increased awareness to improve the understanding and management of epilepsy in these underserved areas. Optimizing care for PWE requires a multifaceted approach, including evaluating healthcare accessibility, affordability, and societal beliefs influencing treatment adherence. The study advocates for government and policy interventions to mitigate the quality of life deterioration caused by epilepsy and its treatment in rural communities. Plain Language Summary In Limpopo and Mpumalanga, many individuals with epilepsy experience seizures occasionally, while a significant minority have them frequently. Numerous people also suffer recurring side effects from antiseizure medications, impacting their lives severely by causing school dropouts and job losses. This underscores the urgent need for improved education and awareness programs to manage epilepsy in these provinces effectively. The study urges government action and policy reforms to enhance care and support for people with epilepsy in rural areas, aiming to improve their quality of life.

Objective To investigate the application of mycophenolate mofetil (MMF) in oral mucosal pemphigoid and provide a clinical reference. Methods One case of glucocorticoids combined with MMF in the treatment of oral mucosal pemphigoid was reported, and the clinical application of MMF in oral mucosa-related bullous diseases was discussed. Results One patient with a clinical diagnosis of “oral mucosal pemphigoid” was treated with methylprednisolone (36 mg, qd, morning dose) or combined hydroxychloroquine sulfate (0.1 g/time, bid) and thalidomide capsules (50 mg, qd, bedtime) and other drugs. The patient’s disease was slowly controlled but prone to recurrence. The treatment regimen was immediately adjusted, i.e., methylprednisolone (36 mg, qd, morning dose) was combined with MMF (0.5 g/time, bid) for 2 weeks, which resulted in ideal lesion healing control. After 8 weeks of methylprednisolone combined with MMF, the dose of methylprednisolone was gradually reduced to 12 mg, qd, and MMF was reduced to 0.5 g, qd, the patient’s symptoms improved significantly, and no obvious lesions were found in the mouth. The dose was then reduced and maintained according to the principle of pemphigoid treatment. Methylprednisolone (8 mg, qd, morning dose) and MMF (0.5 g, qd) have been used for 6 months of maintenance treatment, and they are still being followed up. As yet, the patient’s condition is stable without obvious lesions and new blisters, and no obvious side effects have been observed. A review of the literature shows that MMF is widely used in the field of dermatology to treat a variety of immune diseases, such as connective tissue diseases and autoimmune blistering diseases. According to the reports of adverse reactions to MMF, digestive system reactions are the most common adverse reactions; therefore, patients with active gastrointestinal diseases should be treated with caution, followed by bone marrow suppression, and it is recommended to monitor liver function and blood routine in patients using MMF. The safety and efficacy of MMF for treating pemphigoid involving the skin have been reported in the literature, but oral mucosal doctors still lack experience for treating mucous membrane pemphigoid. Conclusions As a new immunosuppressant, MMF has high safety and no obvious side effects and can be considered as a combination adjuvant drug for patients with severe clinical disease and refractory oral mucosal pemphigoid.

Abstract Background Spinal muscular atrophy (SMA) is a progressive neurodegenerative disorder that can be treated with intrathecal nusinersen, an antisense oligonucleotide. In addition to efficacy, safety is a determining factor in the success of any therapy. Here, we aim to assess the safety of nusinersen therapy in paediatric patients with SMA. Methods Laboratory data of paediatric patients with SMA who received nusinersen between October 2019 and May 2022 were retrospectively analysed. Results During the observation period, 46 infants and children aged 2.9 months to 13.6 years received a total of 213 nusinersen doses without safety concerns. Inflammatory markers were stable throughout the study. International normalized ratio was increased by 0.09 per injection. Urea levels were increased by 0.108 mmol/L, and cystatin C decreased by 0.029 mg/L per injection. There were no significant changes in platelet count, activated partial thrombin time, creatinine levels or liver enzyme levels during treatment. The cerebrospinal fluid (CSF) leukocyte count remained stable, and total protein increased by 24.038 mg/L per injection. Conclusion Our data showed that nusinersen therapy is generally safe in children with SMA. Laboratory monitoring did not identify any persistent or significantly abnormal findings. CSF protein should be monitored to gain more insights.

Abstract Polypharmacy involves an individual using many medications at the same time and is a frequent healthcare technique used to treat complex medical disorders. Nevertheless, it also presents substantial risks of negative medication responses and interactions. Identifying and addressing adverse effects caused by polypharmacy is crucial to ensure patient safety and improve healthcare results. This paper introduces a new method using Graph Convolutional Networks (GCN) to identify polypharmacy side effects. Our strategy involves developing a medicine interaction graph in which edges signify drug-drug intuitive predicated on pharmacological properties and hubs symbolize drugs. GCN is a well-suited profound learning procedure for graph-based representations of social information. It can be used to anticipate the probability of medicate unfavorable impacts and to memorize important representations of sedate intuitive. Tests were conducted on a huge dataset of patients’ pharmaceutical records commented on with watched medicate unfavorable impacts in arrange to approve our strategy. Execution of the GCN show, which was prepared on a subset of this dataset, was evaluated through a disarray framework. The perplexity network shows the precision with which the show categories occasions. Our discoveries demonstrate empowering advance within the recognizable proof of antagonistic responses related with polypharmaceuticals. For cardiovascular system target drugs, GCN technique achieved an accuracy of 94.12%, precision of 86.56%, F1-Score of 88.56%, AUC of 89.74% and recall of 87.92%. For respiratory system target drugs, GCN technique achieved an accuracy of 93.38%, precision of 85.64%, F1-Score of 89.79%, AUC of 91.85% and recall of 86.35%. And for nervous system target drugs, GCN technique achieved an accuracy of 95.27%, precision of 88.36%, F1-Score of 86.49%, AUC of 88.83% and recall of 84.73%. This research provides a significant contribution to pharmacovigilance by proposing a data-driven method to detect and reduce polypharmacy side effects, thereby increasing patient safety and healthcare decision-making.

Abstract: Introduction and aim: Pictograms can make taking medication safer. However, little is known about how pictograms on a medication package influence the subjective assessment of a medication. Methods: In this online study, 276 participants were presented with a fictitious package that contained 0 to 5 pictograms of possible side effects. Participants had to assess the probability of side effects occurring as well as the benefits and harms of the medication, both before and after consulting the package insert. Results: The number of pictograms (leveling out at 2 pictograms) influenced the assessment of the probability of side effects occurring. In addition, the assessment of this measure served as an anchor for assessing all subsequent measures (e.g., benefit). Although participants adjusted their measures after package insert consultation - these adjustments were insufficient (as expected from a normative probability account). Discussion and conclusion: Pictograms influence medication assessment, and humans can process only a limited number of pictograms.

Abstract Background Many factors contribute to quality of life (QoL) in patients with schizophrenia, yet limited research examined these factors in patients in China. This cross-sectional study explores subjective QoL and its associated factors in patients. Methods The QoL was assessed using the Schizophrenia Quality of Life Scale (SQLS). Clinical symptoms were evaluated using the Brief Psychiatric Rating Scale (BPRS) and seven factors were extracted. Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder Scale (GAD-7) were used to assess depression and anxiety. Cognitive impairment was assessed using the Ascertain Dementia 8 (AD8). The Treatment Emergent Symptom Scale (TESS) and Rating Scale for Extrapyramidal Side Effects (RSESE) were used to evaluate the side effects of medications. Results We recruited 270 patients (male:142,52.6%, mean age:41.9 ± 9.4 years). Positive correlations were observed between SQLS and its subdomains with the total score of BPRS, PHQ-9, GAD-7, AD8, TESS, and RSESE (all P

There has been renewed interest in using mitochondrial uncoupler compounds such as niclosamide and carbonyl cyanide p‐(trifluoromethoxy)phenylhydrazone (FCCP) for the treatment of obesity, hepatosteatosis and diseases where oxidative stress plays a role. However, both FCCP and niclosamide have undesirable effects that are not due to mitochondrial uncoupling, such as inhibition of mitochondrial oxygen consumption by FCCP and induction of DNA damage by niclosamide. Through structure–activity analysis, we identified FCCP analogues that do not inhibit mitochondrial oxygen consumption but still provided good, although less potent, uncoupling activity. We also characterized the functional role of the niclosamide 4′‐nitro group, the phenolic hydroxy group and the anilide amino group in mediating uncoupling activity. Our structural investigations provide important information that will aid further drug development.

Introduction. The study of the effectiveness and safety of allergen-specific immunotherapy remains relevant due to the emergence of a personalized approach in allergology and new dosage forms. Adverse reactions during sublingual allergen-specific immunotherapy are the leading reason of treatment discontinuation. Understanding the mechanisms of side effects and knowing how to overcome them allows us to achieve better tolerability of allergen-specific immunotherapy and maintain patient compliance.The aim of the review is to combine the available literature data on the frequency, nature, and pathogenetic basis of adverse events during sublingual allergen-specific immunotherapy and to consider options for their prevention and treatment.

Background and objectives: COVID-19, caused by SARS-CoV-2, has led to a global pandemic with severe health, economic, and social impacts. Vaccination has emerged as a crucial mitigation strategy. Despite the pivotal role of COVID-19 vaccines in controlling the pandemic, vaccine hesitancy remains a significant concern globally, particularly among young adults. This study aimed to explore the side effects and perceptions of the young adults in Bangladesh following COVID-19 vaccination. Materials and methods: The study, conducted in April 2021 among 325 young Bangladeshi adults who received two doses of Sinopharm (BBIBP-CorV) vaccine against SAR-CoV-2. Participants completed a self-administered online questionnaire covering demographics, health history, post-vaccination adverse events, and perceptions about COVID-19 vaccine. A symptom scoring system, based on the interquartile range (IQR), was used to categorize the severity of the side effects. Data analysis utilized SPSS version 26.0, with appropriate tests for significance. Result: Total 325 participants (male - 64.6%, female - 68.9%) were enrolled. The mean age was 22 ± 1.6 years. Social media (43·1%) was the primary source of information about COVID-19. Vaccine related side effects were experienced by 40.9% and 47.1% participants following 1st and 2nd dose of vaccination respectively. Side effects were more prevalent after the second dose of vaccine, particularly in females (31·3% vs. 8·2%, p

Abstract Pemphigus vulgaris (PV) is a rare autoimmune bullous dermatosis (AIBD) characterized by painful blistering of the skin and mucosa caused by autoantibodies that lead to loss of adhesion in the epidermis. Standard therapy for PV is corticosteroids, either alone or in combination with steroid-sparing immunosuppressants or infusions with rituximab. According to the published European guideline, high-dose intravenous immunoglobulin (IVIg) therapy with a dosage of 2 g per kg body weight distributed over 2–5 days every 4 weeks is a promising treatment option, especially for severe or refractory disease. This report describes a 73-year-old female patient with severe and recurrent disease who achieved stabilization with IVIg treatment. However, the patient experienced side effects such as headaches, nausea, and vomiting, which affected daily life. Hence, she was transitioned to a new IVIg preparation with a new manufacturing process, resulting in fewer side effects and an improved quality of life. Further follow-up is necessary to fully evaluate the effectiveness and tolerability of this new IVIg product.

The relevance of the topic under study is due to the fact that patients receiving large or repeated doses of corticosteroids often suffer from hypersensitivity reactions or side effects from taking this category of drugs. As a result, this poses a serious problem for healthcare authorities, as the scientific understanding of this phenomenon is still at an early stage. The purpose of study is to comprehensively disclose the various types of mechanisms underlying corticosteroid hypersensitivity, as well as to develop recom­mendations for more accurate methods of diagnosis, treatment, and prevention of this reaction. To achieve this goal, this theoretical study used various methods, including analysis, deduction, abstraction and generalization, and the method of synthesis. The results of the study underscore the broad spectrum of applications for corticosteroid drugs in medicine, highlighting their systemic effects and potential for side effects and hypersensitivity reactions across various bodily systems. These adverse reactions encompass hyperglycemia, hypertension, respiratory issues, visual impairments, skin conditions like contact dermatitis, bone tissue complications, and behavioral disorders, notably in children. Administering cortico­steroids in COVID-19 treatment necessitates caution due to the potential for life-threatening immediate hypersensitivity reactions, which may be mistaken for disease progression. The results and conclusions of this study, which were formed using the above methods, may lead to a more accurate diagnosis of hypersensitivity to drugs such as corticosteroids, and may also contribute to the development of effective preventive measures. This study is of practical importance for dermatologists, allergists and immunologists, as well as researchers working in the field of rheumatology, allergology and immunology.

Aim: The clinical symptoms of autoantibody (AAb)-mediated autoimmune diseases (AID) usually correlate with the AAb-titer. Immunoglobulins (Igs) of the IgG type are actively recycled by the neonatal crystallizable fragment receptor (FcRn). The most common Ig type of AAb is IgG. This explorative study evaluates the safety and tolerability of a fully human anti-FcRn monoclonal antibody (mAb) in patients with thyroid autoimmunity (TA). Methods: Adverse events (AEs) and serious AEs (SAEs) were documented and coded according to the standardized Medical Dictionary for Regulatory Activities (MedDRA). AEs were followed up, and seriousness, as defined by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-guideline E6, was documented. All AEs were analyzed for a possible underlying cause, and if not identified, were graded as side effects (SEs). Additionally, safety-relevant serological parameters (liver function and blood cell counts) were evaluated. Furthermore, laboratory parameters influenced by other anti-FcRn agents in clinical studies were considered. Results: Of 31 patients with TA, 19 were administered the anti-FcRn mAb subcutaneously once weekly for 12 weeks, while 12 were on placebo. Compared to placebo, there was no increased occurrence of AE and/or SE in the mAb group. mAb treatment increased total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol. A mAb treatment-induced transient decrease in serum albumin strongly correlated with an increase in total cholesterol (r = –0.893, P = 0.012). Overall compared to placebo, there were no significant changes in blood cell counts, complement factors, or liver enzymes. Serological changes were transient and spontaneously normalized after treatment completion. Two SAEs were deemed no-drug induced (dysthyroid optic neuropathy and a post-COVID infection associated autoimmune encephalomyelitis). Conclusions: The anti-FcRn mAb is a safe and well-tolerated therapy for AAb-mediated AID.

Abstract Background With a wide therapeutic index, efficacy, ease of use, and other neuroprotective and respiratory benefits, caffeine citrate(CC) is currently the drug of choice for preterm neonates (PTNs). Caffeine-induced excessive energy expenditure, diuresis, natriuresis, and other CC-associated potential side-effects (CC-APSEs) result in lower daily-weight gain (WG) in premature neonates. This study aimed to evaluate the risk factors for daily-WG in neonates exposed to different dose regimens of caffeine in ICU. Method This retrospective cohort study included neonates of ≤ 36weeks gestational age (GA) and received CC-therapy. The same participants were followed for data analysis in two postnatal phases: 15–28 and 29–42 days of life (DOL). Based on daily CC-dose, formed group-I (received; standard-doses = 5 mg/kg/day), group-II (received;>5-7 mg/kg/day), and group-III (received;>7 mg/kg/day). Prenatal and postnatal clinical characteristics, CC-regimen, daily-WG, CC-APSEs, and concomitant risk-factors, including daily-caloric intake, Parenteral-Nutrition duration, steroids, diuretics, and ibuprofen exposure, were analyzed separately for group-II and group-III using group-I as standard. Regression analysis was performed to evaluate the risk factors for daily-WG. Results Included 314 PTNs. During 15–28 DOL, the mean-daily-WG(MD-WG) was significantly higher in group-I than group-II [19.9 ± 0.70 g/kg/d vs. 17.7 ± 0.52 p = 0.036] and group-III [19.9 ± 0.70 g/kg/d vs. 16.8 ± 0.73 p 7-10 mg/kg/day (β=-1.36; 95%CI:-1.56,-1.02) were associated with a lower daily-WG. However, during 29-42DOL, this association was present only for > 7-10 mg/kg/day (β=-1.54; 95%CI:-1.66,-1.42). The GA ≤ 27weeks (β=-1.03 95%CI:-1.24, -0.88) was associated with lower daily-WG only during 15-28DOL. During both periods of therapy, higher cumulative-caffeine dose and presence of culture proven sepsis, tachypnea, hyponatremia, and feeding intolerance were significantly associated with lower daily-WG. Conversely, daily kcal intake was found to be linked with an increase in daily-WG in both periods. Conclusion In this study cohort exposure to higher caffeine daily and cumulative doses is associated with lower postnatal daily-WG in PTNs than standard-daily doses, which may be due to its catabolic effects and CC-APSEs.

Benign prostatic hyperplasia affects up to 80% of men in their lifetime. It causes bladder outflow obstruction, leading to lower urinary tract symptoms, which can have a large impact on quality of life. Lifestyle modifications and pharmacotherapy are often offered as first-line treatments for patients. These include alpha blockers, 5-alpha-reductase inhibitors, phosphodiesterase-5 inhibitors, anticholinergics, B3-agonists, and desmopressin. While often well tolerated, these pharmacotherapies do have significant side effects, which both clinicians and patients should understand and discuss in order to make an informed treatment decision among alternatives. The purpose of this review is to provide a current overview of the risks and side effects of commonly used medications in benign prostatic hyperplasia management.

Haiqing Wang,1,&ast; Wentao Bo,1,&ast; Xielin Feng,1 Jinliang Zhang,1 Ge Li,2 Yan Chen3 1Department of Hepatopancreatobiliary Surgery, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital and Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, People’s Republic of China; 2Department of Emergency, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital and Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, People’s Republic of China; 3Department of Pharmacy, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital and Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Yan Chen; Ge Li, Email cyfy1112@163.com; chenyanyaoxuebu@scszlyy.org.cn; 13982129787@qq.comAbstract: Lenvatinib (LVN) is a potentially effective multiple-targeted receptor tyrosine kinase inhibitor approved for treating hepatocellular carcinoma, metastatic renal cell carcinoma and thyroid cancer. Nonetheless, poor pharmacokinetic properties including poor water solubility and rapid metabolic, complex tumor microenvironment, and drug resistance have impeded its satisfactory therapeutic efficacy. This article comprehensively reviews the uses of nanotechnology in LVN to improve antitumor effects. With the characteristic of high modifiability and loading capacity of the nano-drug delivery system, an active targeting approach, controllable drug release, and biomimetic strategies have been devised to deliver LVN to target tumors in sequence, compensating for the lack of passive targeting. The existing applications and advances of LVN in improving therapeutic efficacy include improving longer-term efficiency, achieving higher efficiency, combination therapy, tracking and diagnosing application and reducing toxicity. Therefore, using multiple strategies combined with photothermal, photodynamic, and immunoregulatory therapies potentially overcomes multi-drug resistance, regulates unfavorable tumor microenvironment, and yields higher synergistic antitumor effects. In brief, the nano-LVN delivery system has brought light to the war against cancer while at the same time improving the antitumor effect. More intelligent and multifunctional nanoparticles should be investigated and further converted into clinical applications in the future. Keywords: lenvatinib, nano-drug delivery system, antitumor, side effects, diagnosis