Follow-up Phase Research Articles

Eye movements desensitization and reprocessing with finger movements and Elite mobile health software on guilt feeling of parents of children with autism: A randomized trial.

INTRODUCTION: Caring for an autistic child at home can be challenging for parents, as it can make it difficult to balance their responsibilities. This imbalance can negatively affect the emotional well-being of the caregiver and lead to feelings of guilt. While this is a known issue, there may be gaps in knowledge specific to Iran. In this study, a new method was introduced to address this issue. This study aimed to examine the impact of desensitization with eye movements and reprocessing (EMDR) on reducing parental guilt among autistic children's families. We aim to examine the effectiveness of two different treatment methods. This study involved 90 parents (60 mothers, 30 fathers) of autistic children randomly assigned to either an experimental or control group. The two experimental groups received a 45-min intervention session once a week for 3 weeks, while the control group did not receive any intervention. Data on feelings of guilt was collected using a questionnaire. After 30 days, both groups took a follow-up test. The data were analysed using statistical software. This study found that there were significant differences in guilt feelings among different groups of EMDR therapy and a control group. Specifically, no significant differences were observed in the mean guilt scores between the experimental and control groups at the pre-intervention stage (p > .05). However, the experimental groups exhibited significantly lower mean guilt scores immediately after the intervention and 1 month later than the control group (p < .05). Immediately after the intervention and 1 month later, no significant differences were observed between the two experimental groups (p > .05). The findings of this study demonstrate the efficacy of desensitization treatment using eye movements and reprocessing in reducing feelings of guilt among autistic children's parents. In the follow-up phase, it seems that the two-way stimulation method with finger movements is more effective than Elite software in terms of the continuity of the effect. Healthcare providers are encouraged to learn and use these methods to help prevent and treat psychological issues in autistic children.

A novel Phase II single-arm hybrid design to minimize trial duration and enhance subsequent Phase III trial success rate

Many Phase III trials fail for lack of significant efficacy for the testing agents although their success has been demonstrated in preceding Phase II trials. One of the major reasons for this discordance is the use of different endpoints in Phase II and III trials, respectively. In oncology clinical trials, tumor response (surrogate endpoint) can be determined quickly whereas survival estimation (direct endpoint) requires a long period of follow-up. To better bridge the gap between two endpoints, we propose a novel two-stage single-arm hybrid design for Phase II trials whereby the percent of tumor size change is used as an initial screening to select potentially effective agents within a short time interval followed by a second screening stage where survival is estimated to confirm the efficacy of agents. This design can improve trial efficiency and reduce cost by early stopping the evaluation of an ineffective agent based on the low percent of tumor size change. The second survival endpoint screening will substantially increase the success rate of the follow-up Phase III trial by using the same endpoint. Simulation studies demonstrated that our novel design has improved in terms of trial efficiency, trial length, and the success rate of following Phase III trials.

Topography and Radiological Variables as Ancillary Parameters for Evaluating Tissue Adherence, Hypothalamic-Pituitary Dysfunction, and Recurrence in Craniopharyngioma: An Integrated Multidisciplinary Overview.

Craniopharyngiomas continue to present a challenge in clinical practice due to their heterogeneity and unpredictable adherence to vital neurovascular structures, particularly the hypothalamus. This results in different degrees of hypothalamus-pituitary axis dysfunction and a lack of uniform consensus and treatment guidelines regarding optimal management. MRI and CT are complementary techniques in the preoperative diagnostic phase, enabling the precise definition of craniopharyngioma size, shape, and consistency, as well as guiding classification into histopathological subtypes and topographical categories. Meanwhile, MRI plays a crucial role in the immediate postoperative period and follow-up stages by identifying treatment-related changes and residual tumors. This pictorial essay aims to provide an overview of the role of imaging in identifying variables indicative of the adherence degree to the hypothalamus, hypothalamic-pituitary dysfunction, the extent of surgical excision, and prognosis. For a more comprehensive assessment, we choose to distinguish the following two scenarios: (1) the initial diagnosis phase, where we primarily discuss the role of radiological variables predictive of adhesions to the surrounding neurovascular structures and axis dysfunction which may influence the choice of surgical resection; (2) the early post-treatment follow-up phase, where we discuss the interpretation of treatment-related changes that impact outcomes.

Comparative evaluation of the effectiveness of balneotherapy and balneotherapy in combination with intravenous laser irradiation of blood at the period of spa treatment of patients with psoriasis

Background. Psoriasis is one of the most common, chronic, recurrent dermatoses. To date, a sufficient pool of studies has been accumulated confirming the multifactorial genesis of psoriasis due to genetic and environmental factors. Aim. Сomparative assessment of the effect of different options for spa treatment (ST) balneotherapy and balneotherapy in combination with intravenous laser blood irradiation (ILBI) in patients with psoriasis vulgaris on the level of IL-6 and IL-17, dermatological and psycho-emotional status, assessment of quality of life. Methods. The comparative study involved 108 patients with psoriasis vulgaris, stationary stage (men — 57.4%, women — 42.6%; the average age was 36.2 [24.5; 47.9] years) who underwent spa treatment, which were subsequently divided into 2 groups: 52 patients who received balneotherapy along with the traditional complex of ST were included in the 1 group, 56 patients who received complex treatment were included in the 2 group. The effectiveness of ST was evaluated using the PASI index, the HARS and HDRS scale, the SF-36 questionnaire. The dynamics of IL-6 and IL-10 levels in blood plasma were evaluated. The total duration of the study was 6 months and 14 days: the treatment phase was 14 days and the follow-up phase was 3 and 6 months after the completion of ST. Results. After 14 days of ST in the group in which balneotherapy was performed in combination with IVBI, a statistically significant decrease in the PASI index was more pronounced compared to the group in which balneotherapy was performed (p). Balneotherapy did not have a pronounced effect on psychoemotional status. On the contrary, balneotherapy in combination with ILBI contributed to a statistically significant decrease in the final indicators on the HARS and HDRS scales. The decrease in IL-6 and IL-17 levels was statistically significant in both groups and there were no differences between them. The complex use of balneotherapy and ILBI in comparison with the group of balneotherapy was accompanied by a more pronounced improvement in QOL. The combined use of balneotherapy and ILBI in the follow-up phase showed a long-term positive effect: 6 months after the completion of ST, the number of patients who had clinical remission was statistically significantly higher compared to the group in which balneotherapy was performed (87.4 vs. 44.7%). Conclusion. The advantage of the combined use of balneotherapy and ILBI compared with balneotherapy in patients with psoriasis vulgaris on CL was shown. The complex use of balneotherapy and ILBI of significant indicators of inflammatory biomarkers, improvement of the dermatological and psycho-emotional state, quality of life parameters and good overpopulation. More pronounced effectiveness of the complex use of balneotherapy and ILBI compared to balneotherapy of the quality, diversity of pathophysiological mechanisms of psoriasis and the presence of several targets for pathogenetic therapy.

Bundle care approach to reduce device associated infections in post-living-donor-liver transplantation in a tertiary care hospital, Egypt

BackgroundDevice-associated infections (DAIs) are a significant cause of morbidity following living donor liver transplantation (LDLT). We aimed to assess the impact of bundled care on reducing rates of device-associated infections.MethodsWe performed a before-and-after comparative study at a liver transplantation facility over a three-year period, spanning from January 2016 to December 2018. The study included a total of 57 patients who underwent LDLT. We investigated the implementation of a care bundle, which consists of multiple evidence-based procedures that are consistently performed as a unified unit. We divided our study into three phases and implemented a bundled care approach in the second phase. Rates of pneumonia related to ventilators [VAP], bloodstream infections associated with central line [CLABSI], and urinary tract infections associated with catheters [CAUTI] were assessed throughout the study period. Bacterial identification and antibiotic susceptibility testing were performed using the automated Vitek-2 system. The comparison between different phases was assessed using the chi-square test or the Fisher exact test for qualitative values and the Kruskal-Wallis H test for quantitative values with non-normal distribution.ResultsIn the baseline phase, the VAP rates were 73.5, the CAUTI rates were 47.2, and the CLABSI rates were 7.4 per one thousand device days (PDD). During the bundle care phase, the rates decreased to 33.3, 18.18, and 4.78. In the follow-up phase, the rates further decreased to 35.7%, 16.8%, and 2.7% PDD. The prevalence of Klebsiella pneumonia (37.5%) and Methicillin resistance Staph aureus (37.5%) in VAP were noted. The primary causative agent of CAUTI was Candida albicans, accounting for 33.3% of cases, whereas Coagulase-negative Staph was the predominant organism responsible for CLABSI, with a prevalence of 40%.ConclusionThis study demonstrates the effectiveness of utilizing the care bundle approach to reduce DAI in LDLT, especially in low socioeconomic countries with limited resources. By implementing a comprehensive set of evidence-based interventions, healthcare systems can effectively reduce the burden of DAI, enhance infection prevention strategies and improve patient outcomes in resource-constrained settings.

To Assess the Knowledge and Attitude Regarding Dental Trauma and Its Management among School Teachers

ABSTRACT Background: Dental traumas, particularly tooth avulsion, represent a significant dental emergency among children, frequently occurring in schools. The knowledge and immediate response of schoolteachers are crucial for the prognosis of such emergencies. Materials and Methods: This interventional study assessed the knowledge and attitudes of 248 primary school teachers in Rajasthan, India, regarding dental trauma management. Utilizing a questionnaire-based approach, the study was conducted in three phases: preintervention assessment, an informative 45-minute lecture, and a postintervention follow-up. Statistical significance was set at 5%, and the Chi-square test was employed for analysis. Results: The initial survey revealed a lack of knowledge among teachers regarding dental trauma management, with significant improvement observed in the follow-up phase post intervention. Over 90% of participants showed improved knowledge, with statistical significance (P &lt; 0.0001). Conclusion: The study highlights a notable deficiency in school teachers’ knowledge on dental trauma management initially, which significantly improved following an oral health promotion intervention. This underscores the effectiveness of educational programs in enhancing the management of dental emergencies by schoolteachers.

Effectiveness of an ultrasound basic cancer training program through on-site training and virtual case discussions in rural Tanzania: a proof-of-concept study.

Cancer rates are rising in low- and middle-income countries. While point-of-care ultrasound is now available globally and could serve to mitigate against this rise, its use in diagnosing cancers is inconsistent in lower-resourced healthcare contexts. This proof-of-concept study investigates the feasibility of an ultrasound training concept in a low-resource setting. It evaluates whether this educational concept led to improved knowledge and application of ultrasound diagnostics, cancer screening and staging and patient care. The curriculum was developed through expert exchange and is based on the World Health Organisation's Manual of Diagnostic Ultrasound. It consisted of two didactic components: an on-site training phase across 5 days for a total of 24 hours, and a digital follow-up phase involving the meeting of a bi-weekly tumor board online. The learning objectives of the on-site training were normal imaging and recognition of common pathologies of the abdominal organs, vessels, lymph nodes, female breasts and lungs. The virtual tumour boards met to discuss cases and ultrasound findings, thus aiding continuing professional development after the training sessions had concluded. The face-to-face course component was accompanied by tests given before and after training as well as an evaluation sheet (Likert-scale with 1 = 'completely/very good' and 7 'not at all/very poor'). Of 20 participants from a rural hospital in Tanzania, a total of 16 were included in the analysis (clinical officers n = 6; medical officers n = 10). A significant increase in knowledge (p < 0.01) was measured both in the subjective self-assessment and in the theoretical competence tests. In multivariate linear regression, the status 'medical officers yes' (β = 5.4; p = 0.04) had a significant influence on theory test results at T2. During the 24 virtual tumour board meetings, 28 cases were discussed and a continuous improvement in image acquisition quality was observed. The ultrasound education concept comes with a sustainable increase in clinical competence and improved oncological ultrasound screening locally. There is potential for the transfer of the concept to other locations, which can be explored in the future.

Infant feeding and criticality in children.

Data support the protective effects of human breast milk (HBM) feeding in acute illness but little is known about the impact of HBM feeding on the criticality of infants. To explore the relationship between early HBM feeding and severity of illness and recovery in critically ill children requiring intubation and mechanical ventilation for acute respiratory failure (ARF). Prospective cohort study of mothers of patients aged 1-36 months who participated in the acute and follow-up phases of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial. Participants completed a survey describing HBM dose fed during their infant's first month of life. Of 138 patients, 70 (51%) received exclusive HBM feedings (90%-100% total feeds) and 68 (49%) did not. We found no group differences in severity of illness on paediatric intensive care unit (PICU) admission or severity of paediatric acute respiratory distress syndrome (PARDS) within the first 24-48 h of intubation/mechanical ventilation (Pediatric Risk of Mortality [PRISM] III-12 score median: 5 vs. 5, p = .88; moderate/severe PARDS: 53% vs. 54%, p = .63). While median time to recovery from ARF was reduced by 1 day in patients who received exclusive HBM feedings, the difference between groups was not statistically significant (median 1.5 vs. 2.6 days, hazard ratio 1.40 [95% confidence interval, 0.99-1.97], p = .06). Human breast milk dose was not associated with severity of illness on PICU admission in children requiring mechanical ventilation for ARF. Data support the protective effects of HBM during acute illness and data from this study support a clinically important reduction in time to recovery of ARF. Paediatric nurses should continue to champion HBM feeding to advance improvements in infant health.

From art to insight: The role of a creative arts therapies group workshop on college students' well-being, self-awareness, and loneliness

This study examined the effects of a three-hour Creative Arts Therapies (CATs) group workshop on perceived well-being, self-awareness, and loneliness among college students. Using a within-subjects design, participants completed surveys before and after the workshop and during a follow-up phase. Each workshop, facilitated by two certified art therapists, involved groups of 5 to 13 students. The workshops included 89 students aged 18–51 years, 87 responded after the workshop and 59 during the follow-up. Results indicated a short-term increase in subjective well-being, characterized by heightened positive emotions, life satisfaction, and reduced negative affect. Additionally, the workshop reduced state anxiety and enhanced awareness, fostering both inward self-awareness of feelings and thoughts and outward environmental awareness. A decrease in concerns about social judgments and feelings of loneliness suggested greater self-acceptance and social connection. Predictors of these changes included the perceived therapeutic value of the workshop and group cohesion. Moreover, depressive symptoms were associated with both negative affect and public self-awareness changes. However, follow-up revealed that increases in life satisfaction and loneliness were transient, returning to initial levels, suggesting the need for ongoing interventions and further research on the effects of CATs in group settings.

Effectiveness of Filial Therapy on Preschool Children’s Internalization and Externalization Symptoms with an Insecure Attachment Style During Coronavirus Disease 19 in Tehran District 10

This study aimed to assess the impact of filial therapy on internalization and externalization symptoms among preschool children characterized by an insecure attachment style in Tehran District 10 during the coronavirus disease 19 pandemic. To achieve this goal, a pretest-posttest control group design was employed, supplemented by a follow-up phase. Using the convenience sampling method, 41 students were selected and randomly allocated to either an experimental group or a control group. The results were analyzed by the mixed ANOVA test. The findings revealed a decrease in internalization, externalization, and insecure attachment symptoms among children in the experimental group compared to those in the control group (p < .05).

Design and Validation of a Mentalization Promoting Program for Parents of a Child with Type 1 Diabetes and its Effectiveness on Parents' Reflective Functioning and the Child's Emotional-Behavioral Problems: A Single-Subject Study

Aim: This research was conducted with the aim of designing and validating the Mentalization promoting program for parents of a child with type 1 diabetes and investigating its effectiveness on parents' reflective Functioning and emotional-behavioral problems of the child. Methods: A mixed method was used in this research. In the qualitative part, the mentalization problems of 18 children with T1D and 22 of their parents were extracted through the analysis of interviews with the method of transcendental phenomenology, and three general themes,18 main sub-themes and 50 sub-themes were obtained. Then, based on these themes and within the framework of the concepts of mentalization theory, a program to promote the mentalization of parents with a child with type 1 diabetes was designed. After confirming the content validity based on the CVI, with a semi-experimental method and a single-subject design of the type (A-B) with different subjects, 5 parents of children with diabetes who met the criteria for entering the research, were selected with a purposeful sampling method and participated in the program. The effectiveness of this program was assessed in four phases (baseline, during intervention, after intervention and follow-up) using the Child Behavior Checklist (CBCL) and the Parental Reflective Functioning Questionnaire (PRFQ) and indicators of program goals. Then data was checked based on visual analysis indicators. Results: The final outcome of this phenomenological study is the extraction of three general themes, including the underlying factors of breakdowns in mentalizing, types of common mentalizing problems, and the consequences of breakdowns in mentalizing which became the basis for design the program to promote the mentalization of parents with a child with type 1 diabetes The results showed that the designed program, while having sufficient validity, was effective in increasing the parents reflective Functioning and reducing the emotional-behavioral problems of the child, and this effectiveness continued in the follow-up phase. Conclusion: Considering the validity of this program and its effectiveness, it is suggested that this program be widely implemented to help improve the physical and mental health of children with diabetes and their families, and also for children with other chronic diseases should also be adapted.

Effectiveness of a program to lower unwanted media screens among 2-5-year-old children: a randomized controlled trial.

Limited interventions exist on reducing unwanted screen time (ST) among children from low- and middle-income countries (LMICs), so we developed and assessed the effectiveness of the program to lower unwanted media screen time (PLUMS) among children aged 2-5 years in Chandigarh, Union Territory, North India. An open-label randomized control parallel group trial per CONSORT guidelines was conducted among randomly selected 340 families with children aged 2-5 (±3 months) years in Chandigarh, India. PLUMS was implemented at the family level with a focus on modifying the home media environment and targeted individual-level interventions using parent and child modules for 2 months. A post-intervention (immediately) and a follow-up assessment after 6 months was done. During the follow-up period, the interaction was done passively via WhatsApp groups. The control group received routine healthcare services. Validated and standardized tools, including a digital screen exposure questionnaire with a physical activity component, preschool child behavior checklist, and sleep disturbance scale for children, were used to collect data at baseline, post-intervention, and follow-up periods. The primary outcome was the mean difference in ST (minutes/day) among children in the intervention group versus the control group. Generalized estimating equation (GEE) analysis was performed to adjust for clustering. An equal number of families (n = 170) were randomly assigned to the intervention and control arms. In the post-intervention assessment, 161 and 166 families continued while, at the follow-up assessment, 154 and 147 were in the intervention and control arm, respectively. The mean difference in ST on a typical day [27.7 min, 95% Confidence Interval (CI) 5.1, 50.3] at the post-intervention assessment significantly (p < 0.05) decreased in the intervention (102.6 ± 98.5 min) arm as compared with the control (130.3 ± 112.8 min) arm. A significant reduction in ST (β = -35.81 min, CI -70.6, -1.04) from baseline (β = 123.1 min) to follow-up phase (β = 116 min) was observed in GEE analysis. The duration of physical activity increased both at post-intervention (β = 48.4 min, CI = +6.6, +90.3) and follow-up (β = 73.4 min, CI = 36.2, 110.5) assessments in the intervention arm. The PLUMS intervention significantly reduced the children's mean ST on a typical day and increased the physical activity immediately post-intervention and during the 6-month follow-up period. These results might guide the policymakers to include strategies in the national child health programs in the Southeast Asia Region to reduce unwanted ST.Clinical trial registration: https://clinicaltrials.gov/, identifier CTRI/2017/09/009761.

Neutrophil-Lymphocyte Ratio Values in Schizophrenia: A Comparison between Oral and Long-Acting Antipsychotic Therapies.

Schizophrenia is a mental disorder affecting approximately 0.32% of the global population, according to the World Health Organization. Antipsychotic medications are used to treat this condition by inhibiting D2 dopamine and 5HT2 serotonin receptors. The selection of the appropriate mode of delivery for these drugs is based on factors such as patient adherence, clinical presentation, and patient preferences. However, additional drivers of treatment selection are required in clinical practice. Mounting evidence suggests that neuroinflammation plays a crucial role in the pathogenesis of schizophrenia. NLR, a cost-effective biomarker of inflammation, has increased in several psychiatric conditions and may represent a valid method for studying the inflammatory stage in schizophrenia, relapse, and the first episode of psychosis. The aim of this study is to evaluate whether there are any variations in NLR values between patients given oral antipsychotics and those given long-acting antipsychotics. The study included 50 individuals with schizophrenia, either acute or in the follow-up phase. NLR was obtained by calculating the ratio of absolute neutrophil count (cells/μL) and absolute lymphocyte count (cells/μL). Patients on long-acting antipsychotics exhibited significantly lower mean NLR scores (1.5 ± 0.7) compared to those on oral antipsychotics (2.2 ± 1.3) (p < 0.05). NLR appears promising as a neuroinflammatory biomarker. This study reveals significantly lower NLR values in patients on long-acting antipsychotics, which may signify reduced systemic inflammation and improved adherence.

Assessment of three-dimensional (3-D) left ventricular ejection fraction and speckled tracking echocardiographic strain parameters in non-ischemic left bundle branch block (LBBB) patients and their association with cardiovascular events – A prospective observational study

ObjectiveTo investigate the association between three-dimensional (3-D) left ventricular ejection fraction (LVEF) and various speckle tracking echocardiographic (STE) strain parameters in non-ischemic left bundle branch block (LBBB) patients with major adverse cardiovascular events (MACE) during a one-year follow-up phase. MethodA total of 50 patients with non-ischemic LBBB were assessed using various parameters of 3-D echocardiography. They were compared with their same-age and sex control group and then followed up with repeat 3-D echocardiography for MACE for one year. ResultsComposite outcomes were seen in (n = 11 [22 %], including cardiovascular mortality (n = 2 [4.0 %]) and hospitalization for heart failure (n = 9 [18.0 %]). Mean values of the left ventricle (LV) global longitudinal (GLS), circumferential (GCS), and radial (GRS) strains were −14.4 ± 5.6, −14.3 ± 5.8, and 15.3 ± 5.9 respectively in the study cases. Initial GLS values were significantly impaired among those who had clinical events (−9.2 vs −15.9). Also, significant worsening of GLS (p value < 0.001) was seen in patients with composite outcomes on follow-up. Cut-off values in receiver operating characteristic analyses for composite outcomes were: GLS more than −13.5, GCS more than −12.5, and GRS less than 14.5. Intra-class correlations for both intra-observer and inter-observer variability were found to be good. ConclusionImpaired LV GLS and low 3-D LVEF are significantly associated with the occurrence of MACE in patients with non-ischemic LBBB. This strong association of LV GLS with outcomes can aid in risk stratification, prognostication, and clinical decision-making in non-ischemic LBBB.

Serial angiography and angioscopy of late lumen enlargement after drug-coated balloon for dysfunctional arteriovenous fistula.

The use of a drug-coated balloon (DCB) to treat dysfunctional arteriovenous fistula (AVF) has shown promising results. After percutaneous coronary intervention with DCB, late lumen enlargement (LLE) often develops in the early follow-up phase, but questions regarding the natural history of changes in lesions after DCB angioplasty have not been clearly elucidated. Here, we reported on a patient in whom angiography and angioscopy were performed immediately and 4 months after DCB angioplasty to treat cephalic vein stenosis of the dysfunctional AVF. Immediately after DCB application, angiography showed good dilatation and blood flow and mild vascular dissection that did not affect blood flow. Angioscopy showed that although the balloon had damaged the intima and the paclitaxel particles had adhered to the vessel wall. Four months after DCB treatment, follow-up angiography and angioscopy were performed. Angiography showed LLE in the cephalic vein of the AVF that had been treated by DCB angioplasty. Angioscopy showed that the intima of the vessel had almost completely healed, and the paclitaxel particles had disappeared. LLE might occur when DCB is used for AVF.

Dietary antioxidants and hypertension among menopausal women in Rafsanjan Cohort Study

Studies on the beneficial role of dietary antioxidants in preventing or managing hypertension in postmenopausal women are infrequent. The present cross-sectional study aimed to assess the association between dietary antioxidants and hypertension among menopausal women in Rafsanjan, a city located in the southeast of Iran. This study was based on data from the Rafsanjan Cohort Study (RCS), as part of the Prospective Epidemiological Research Studies in IrAN (PERSIAN). Among 2359 postmenopausal women, finally, 1936 women were included in this study. Participants were grouped as having normal blood pressure (BP), elevated BP, stage 1 hypertension, or stage 2 hypertension as defined by the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) BP guideline. A food frequency questionnaire (FFQ), was utilized to ascertain the levels of various nutrients and dietary antioxidants in the diet. The association between dietary intakes of antioxidants and blood pressure groups was evaluated by crude and adjusted models in the multinominal logistics regression analysis. Normal BP, elevated BP, stage 1 hypertension, and stage 2 hypertension were observed in 35.69%, 3.62%, 10.59%, and 50.10% of postmenopausal women respectively. In the adjusted model, in subjects with higher consumption of β-carotene, the odds ratios of elevated BP in the 3rd quartile was about 2 times (OR: 2.04 (1.06–3.93) higher than 1st quartile. Also, in subjects with medium quality of DAQS, the odds ratios of elevated BP and stage 1 blood pressure were about 2 times (OR: 2.09 (1.05–4.17) and 1.69 times (OR: 1.69 (1.09–2.63) higher than subjects with low quality respectively. Furthermore, we did not find any statistically significant association between increased intake of dietary antioxidants and decreased odds of hypertension. After controlling the effects of confounding variables, increased dietary intake of selenium, carotenoids, vitamin A, vitamin C, and vitamin E did not decrease the odds of hypertension in postmenopausal women. Accordingly, it is suggested that this association be further investigated in the follow-up phase of this prospective study.

The mental health of nursing students during the COVID-19 pandemic: Beneficial effects of mindfulness-based stress reduction

BackgroundFollowing the COVID-19 global emergency, health students were faced with increased workloads, university closures, study interruptions, loss of peer support networks, and the challenges of volunteer work in hospitals. These factors caused health students to experience significant stress and anxiety, highlighting the necessity of psychological interventions for this group. Several studies have reported that a mindfulness-based stress reduction (MBSR) protocol offers valuable coping skills for traumatic events. This study aimed to investigate the impact of Mindfulness-Based Stress Reduction (MBSR) on stress, anxiety, and depression among nursing students at Qom University of Medical Sciences during the COVID-19 pandemic. MethodThis experimental study was conducted on 72 nursing students from the nursing faculty of Qom University of Medical Sciences in 2020. The sampling was conducted using stratified sampling, and the allocation method employed was simple randomization. MBSR intervention based on social networks was implemented for the experimental group. The Stress-Anxiety-Depression Assessment Questionnaire (DASS-21) was completed by both groups before the study commenced, immediately after, and 2 months post-intervention. Data were analyzed in SPSS-16 using t-test, chi-square, and repeated measures analysis. ResultsAnalysis of variance with repeated measures showed that in the experimental group, the effect of time on the average score of stress, anxiety, and depression is significant (p < 0.001). The t-test showed significant differences between the two groups in terms of stress, anxiety, and depression scores immediately after the intervention (p < 0.001) and in the follow-up phase (p < 0.001). ConclusionsMBSR based on social networks is effective and applicable in reducing stress, anxiety, and depression among nursing students during the COVID-19 pandemic. It is suggested that MBSR should be included in the curriculum of nursing students so that they can have the necessary mental preparation to face acute critical conditions such as COVID-19.

Gemcitabine and cisplatin chemotherapy plus penpulimab combined with or without anlotinib as neoadjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: A prospective, phase II clinical trial.

e18038 Background: Patients with locoregionally advanced nasopharyngeal carcinoma (LANPC) still have a risk of disease relapse after receiving the standard treatment of neoadjuvant chemotherapy followed by concurrent chemoradiotherapy (CCRT). Nowadays, PD-1 inhibitors have been widely used in recurrent or metastatic NPC, but the efficacy in LANPC requires further investigation. Besides, the synergistic antitumor effects between immune checkpoint inhibitors and anti-angiogenesis agents have been well established. In this phase II trial, we compared the efficacy and safety of gemcitabine and cisplatin (GP) + penpulimab (PD-1 inhibitor) combined with or without anlotinib (VEGFR-targeted TKI) as neoadjuvant therapy (NAT) for LANPC to establish the optimal regimen. Methods: Patients with LANPC (stage III–IVa, AJCC 8th Staging System, excluding T3–4N0 and T3N1 with only retropharyngeal lymph node +) were enrolled. In the first stage, patients were randomly assigned 1:1 to receive 3 cycles of GP + penpulimab (200 mg, day 1, Q3W) combined with or without anlotinib (10 mg, days 1 to 14, Q3W) for 3 cycles. All patients were followed by CCRT and penpulimab maintenance treatment. The primary endpoint in the first stage was the clinical complete response (CR) rate after NAT based on endoscopy and imaging examinations. A pick-the-winner statistical design was applied and the regimen with a higher CR rate ( &gt; 2.5%) was the winner. In the second stage, patients were continuingly enrolled and treated with the winner regimen; the primary endpoint was 3-year progression-free survival. Results: In the first stage, 60 patients were enrolled between August 2022 and April 2023 (30 patients in each arm). After NAT, 27 patients (45.0%) had CR, with 11 patients (36.7%; 95% CI, 18.4% to 55.0%) in the GP + penpulimab arm and 18 patients (60.0%; 95% CI, 41.4% to 78.6%) in the GP + penpulimab + anlotinib arm (winner regimen). In the second stage, 45 patients were enrolled between June 2023 and October 2023 and treated with GP + penpulimab + anlotinib. Among all 75 patients receiving the winner regimen, the CR rate was 53.3% (95% CI, 41.8% to 64.9%) after NAT. Acute adverse events (AEs) during NAT and CCRT were analyzed. In the first stage, grade 3-4 acute AEs were reported in 22 (73.3%) patients in the GP + penpulimab arm and 26 (86.7%) patients in the GP + penpulimab + anlotinib arm. The most common grades 3-4 acute AEs in the GP + penpulimab arm and GP + penpulimab + anlotinib arm were neutropenia (40% vs 46.7%), leukopenia (40% vs 30%) and mucositis (33.3% vs 36.7%). Among all 75 patients receiving additional anlotinib, the incidence of grade 3-4 acute toxicities was 85.3%. Conclusions: GP + penpulimab + anlotinib regimen showed encouraging efficacy as NAT for LANPC. This finding requires validation in longer follow-up and larger phase III clinical trials. Clinical trial information: NCT05193617 .

ReNeu: A pivotal phase 2b trial of mirdametinib in children and adults with neurofibromatosis type 1 (NF1)-associated symptomatic inoperable plexiform neurofibroma (PN).

3016 Background: PN in patients (pts) with NF1 can cause pain, disfigurement, impaired quality of life (QoL), and can undergo malignant transformation. ReNeu (NCT03962543), a multicenter, open-label, Phase 2b study, evaluated efficacy and safety of the highly selective, oral, investigational MEK1/2 inhibitor mirdametinib in adult (≥18 y) and pediatric (2-17 y) pts with inoperable NF1 PN causing significant morbidities. Methods: Mirdametinib was administered as a capsule or dispersible tablet (2 mg/m2 BID, max 4 mg BID) without regard to food in 3 wk on/1 wk off 28-d cycles. The primary endpoint was confirmed objective response rate (ORR; percentage of pts with MRI-assessed ≥20% reduction of target PN volume by blinded independent central review [BICR] within the 24-cycle treatment phase). The minimum clinically relevant ORR (null) was defined as 23% for adults and 20% for pediatrics. Ptscould continue treatment in an optional long-term follow-up (LTFU) phase. Additional key endpoints were duration of response (DoR), time to response (TTR), change from baseline (BL) in target PN volume, pain severity (Numerical Rating Scale-11 [NRS-11]), pain interference (Pain Interference Index [PII]), health-related (HR) QoL (PedsQL), and safety. Results: All114 pts (58 adult, 56 pediatric) received mirdametinib. As of the 20 Sept 2023 data cutoff (DCO), BICR-confirmed ORR during the treatment phase was 41% (95% CI, 29-55; P&lt;.001 vs null) in adults and 52% (95% CI, 38-65; P&lt;.001 vs null) in pediatric pts. Two adult pts and 1 pediatric pt also had a confirmed response in the ongoing LTFU. Median (min, max) target PN volumetric best response from BL was -41% (-90, 13) and -42% (-91, 48) in adult and pediatric pts, respectively. As of the DCO, median treatment duration was 22 mo for each cohort and median DoR was not reached. Median (range) TTR was 7.8 (4-19) mo in adult pts and 7.9 (4-19) mo in pediatric pts. Adult and pediatric pts had statistically significant improvements from BL to cycle 13 in NRS-11, PII, and key PedsQL measures. Most frequent (≥35% pts) treatment-emergent adverse events (TEAEs) were dermatitis acneiform, diarrhea, nausea, and vomiting in adults and diarrhea, dermatitis acneiform, and vomiting in pediatric pts. 16% and 25% of adult and pediatric pts, respectively, had grade ≥3 treatment-related AEs, and 22% and 9%, respectively, discontinued due to TEAEs. Conclusions: In ReNeu, the largest multicenter NF1 PN trial reported to date, mirdametinib demonstrated a statistically significant ORR by BICR, with deep and durable PN volume reductions, significant improvements in pain severity, pain interference, and HRQoL, and a manageable safety profile in both adults and children. Together with a dispersible tablet formulation, these results underscore mirdametinib’s potential to become an important new treatment option for NF1 PN pts across all ages. Clinical trial information: NCT03962543 .

A phase 2, multicenter study of TILs treatment in advanced tumors with alterations in the SWI/SNF complex: The TILTS study.

TPS2674 Background: Tumors associated with SWI/SNF complex (SWI/SNFc) mutations, mainly SMARCA4 and SMARCB1 loss, are a heterogeneous group of malignancies with rhabdoid features that typically affect young patients (pts). These are aggressive malignancies with poor prognosis for which no standard treatment is available. Despite not having a high tumor mutation burden, tumor infiltrating lymphocytes (TILs) are usually present in high numbers. The biologic reasons for this feature are not clearly understood but might be associated to changes in gene expression due to aberrant chromatin remodeling. However, these TILs indicate that tumor antigens are recognized by lymphocytes unveiling a vulnerability that can be exploited by immunotherapy. The objective of the TILTS study is to develop a personalized adoptive cell therapy using TILs in pts affected by these tumors. Methods: Single arm, multi center, phase 2 study of TILs in pts with advanced tumors associated with SWI/SNFc mutations. Pts are treated at 3 centers in Spain: Catalan Institute of Oncology (ICO), Barcelona, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, and Centro Integral Oncológico Clara Campal (HM CIOCC), Madrid. Primary endpoint is overall response rate (ORR) by RECIST 1.1. Secondary endpoints include toxicity evaluation, duration of response (DOR), progression-free survival (PFS) or overall survival (OS). After informed consent is obtained, tumor resection is performed. Total volume of tumor resected should be at least 1.5 cc to assure TIL isolation. Eligible pts enter the treatment phase. TILs are produced under GMP conditions. During the TILs manufacturing process, pts are allowed to receive standard treatment if clinically indicated. Before TIL infusion, pts receive non-myeloablative preconditioning lymphodepletion with daily intravenous (IV) cyclophosphamide (60 mg/kg; IV x2 doses) and daily fludarabine (25 mg/m2; IV x5 doses). Infusion of autologous TILs is given on Day 0 followed by administration of IL-2 at 600,000 international units (IU)/kg every 8-12 hours for a maximum of 6 doses. After 4 weeks, a new tumor biopsy is optional. First image evaluation is performed after 8 weeks from TIL infusion. Pts without progression enter the follow-up phase. An ancillary translational study will explore mechanisms of immunogenicity, antigen recognition, TILs anti-tumor activity, and changes in the stool microbiome and specific TCR population during treatment. Also, tumor immune microenvironment will be analyzed. Clinical trial information: 2023-504632-17-00 . [Table: see text]