Open Study Research Articles

Toward a framework for the design of fair shared open spaces case study: Effat University, Jeddah

PurposeThis research aims to shed light on the utilization of open spaces at Effat University through a gender lens. By eliminating gender segregation, the study seeks to examine how these spaces are equitably shared between genders, while also delving into the realm of gender sensitive urban design (GSUD). Furthermore, the research strives to gain valuable insights into the experiences of female students in open spaces to propose a framework for the design of fair shared open spaces.Design/methodology/approachTo achieve these objectives, a multi-faceted approach was adopted. First, the research started by reviewing the literature about gender sensitive urban design and inclusive urban design to conclude the indicators examine how open spaces are shared fairly between both genders; second, an online questionnaire was administered to gather comprehensive data. Third, meticulous observations were conducted, involving the study, analysis and mapping of students' activities using maps and photos. Lastly, a walk shop was organized, with a focus group comprising of female participants. The collected data was then analyzed using SPSS descriptive statistics and the Pearson product-moment correlation coefficient, enabling the identification of key patterns and evaluating female students' satisfaction levels.FindingsThe findings unearth a distinctive perspective on the perception and needs of females within a unique subset of open spaces, referred to as “campus open spaces,” in the context of a gender sensitive urban design. This exploration provides valuable insights into the intricacies of gender dynamics within public spaces, contributing to a more inclusive and equitable environment for all individuals at Effat University, framework shows some of significant indicators that effect on other indicators strongly as sense of safety and security and the diversity of activities that increase visiting rates, sense of belonging.Originality/valueThis research presents a framework aimed at improving the concept of equitable and inclusive, open spaces, particularly on campuses within significant communities like KSA. The focus is on creating fair shared places that facilitate interaction and cater to the social and cultural needs of students, with a particular emphasis on supporting female students. By enhancing their sense of belonging and addressing their unique requirements, this framework aims to positively impact their academic performance while fostering an inclusive and engaging campus environment.

Abstract PO3-28-05: Therapeutic Plasmapheresis as a Symptomatic Treatment for Paclitaxel-Associated Peripheral Polyneuropathy

Abstract Relevance: Paclitaxel-associated peripheral polyneuropathy (PIPN) is one of the most common side effects that develop during treatment with drugs of the taxane group. In the treatment of early breast cancer with paclitaxel 80 mg/m2 weekly, 12 injections, PINP develops in 90% of patients of varying severity. The main symptoms are pain and numbness in the arms and legs, which is associated with the accumulation of paclitaxel in the ganglia of the spinal cord, as well as increased expression in the ganglia of the spinal cord of chemokines and cytokines, such as IL-1β, IL-8 and TNF-α, as well as CXCR4, RAGE, CXCL1, CXCL12, CX3CL1 and C3. We hypothesized that the severity of PIPN symptoms can be reduced by lowering the concentration of chemokines and cytokines in the blood by performing plasmapheresis sessions. Research methods: An open prospective study was carried out, the protocol of which was approved by the ethical committee. The study included 30 patients (100% women) aged 30 to 60 years (mean age 45 years) who developed PIPN during paclitaxel therapy 80 mg/m2, weekly, 12 injections. The severity of PIPN symptoms was assessed using a “visual analogue scale” (VAS). The results of the VAS evaluation varied from 6 to 8 points. Patients underwent 5 courses of membrane plasmapheresis with exfusion of 400-500 ml of plasma per session (20 ml per 1 kg of body weight), plasma loss was compensated with saline. Repeated procedures were performed once every two months for 6 months. Results: 30 patients underwent 15 procedures of therapeutic plasmapheresis within 6 months. In 21 patients (70%) there was a pronounced decrease in PIPN symptoms (VAS - 2-3 points), in 3 patients (10%) a moderate decrease in symptoms (VAS -5-6 points), in 6 (20%) no effect of plasmapheresis (VAS - 7-8 points). Approximately 15% of procedures were associated with adverse events, the most common of which were vasovagal reactions; 20% of patients had at least one adverse event. Conclusions: Given the subjective reduction in the severity of PIPN symptoms during courses of therapeutic plasmapheresis in more than 70% of cases, therapeutic plasmapheresis can be used as a symptomatic therapy for PIPN, however, taking into account the subjective assessment of the results by patients, there may be a risk of developing cognitive errors. Therefore, this method of therapy requires more thorough study. Citation Format: Sardor Abdugafforov, Vladimir Vorotnikov, Alexander Soynov, Tornike Mchedlidze, Igor Kopytich, Sofia Kim. Therapeutic Plasmapheresis as a Symptomatic Treatment for Paclitaxel-Associated Peripheral Polyneuropathy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-28-05.

СРАВНЕНИЕ ИНДЕКСА БИОРАЗНООБРАЗИЯ ПАРОДОНТАЛЬНЫХ ПРОСТРАНСТВ У ПАЦИЕНТОВ В ПОСТКОВИДНОМ ПЕРИОДЕ

Relevance. Improving the diagnosis and provision of periodontal care to patients with chronic periodontitis in combination with herpetic and candidal lesions is an urgent goal of many modern studies. The COVID-19 pandemic, and the post-COVID syndrome, have sufficiently changed the view of dentists on the diagnosis and treatment of these comorbid and associative diseases. Purpose: comparison of the Shannon biodiversity index of the studied groups. Materials and methods. We conducted a single-center, randomized, prospective, clinical-microbiological, controlled, open study to determine the comorbidity of herpes and candida infections with chronic generalized periodontitis; 61 patients (aged 18 to 19 years) were examined. Results: In general, I would like to emphasize that the less we record the Shannon biodiversity index, the healthier the space under study, in our case the periodontal area, is. Since less biodiversity is a formed stable microbial community, contributing to the preservation of constancy and protection from opportunistic and pathogenic forms. In conclusion, I would like to note that the pathogenesis of COVID-19 is truly interesting and unique, and there is practically no data on changes in the spectrum of periodontopathogenic and normal microbiota in the pathology under consideration, therefore the use of metagenomic analysis of the oral microbiome against the background of a coronavirus infection will expand the understanding of the course of these comorbid diseases. Therapeutic measures aimed at reducing the viral load in periodontal tissues can help not only reduce the number of possible niches for the life of the virus, but also strengthen periodontal tissues, preventing the development of comorbid and associative forms of diseases.

Guidelines-based therapeutic strategies for controlling hypertension in non-controlled hypertensive patients followed by family physicians in primary health care in Portugal: the GPHT-PT study

Purpose In a prospective open study, with intervention, conducted in Primary Health Care Units by General Practitioners (GPs) in Portugal, the effectiveness of a single pill of candesartan/amlodipine (ARB/amlodipine), as the only anti-hypertension (anti-HTN) medication, in adult patients with uncontrolled HTN (BP > 140/or > 90 mm Hg), either previously being treated with anti-HTN monotherapies (Group I), or combinations with hydrochlorothiazide (HCTZ) (Group II), or not receiving medication at all (Group III), was evaluated across 12-weeks after implementation of the new therapeutic measure. Materials and methods A total of 118 GPs recruited patients with uncontrolled HTN who met inclusion/exclusion criteria. Participants were assigned, according to severity, one of 3 (morning) fixed combination candesartan/amlodipine dosage (8/5 or 16/5 or 16/10 mg/day) and longitudinally evaluated in 3 visits (v0, v6 and v12 weeks). Office blood pressure was measured in each visit, and control of HTN was defined per guidelines (BP< 140/90 mmHg). Results Of the 1234 patients approached, 752 (age 61 ± 10 years, 52% women) participated in the study and were assigned to groups according to previous treatment conditions. The 3 groups exhibited a statistically significant increased control of blood pressure after receiving the fixed combination candesartan/amlodipine dosage. The overall proportion of controlled HTN participants increased from 0,8% at v0 to 82% at v12. The mean arterial blood pressure values decreased from SBP= 159.0 (± 13.0) and DBP= 91.1 (± 9.6) at baseline to SBP= 132,1 (± 11.3) and DBP= 77,5 (± 8.8) at 12 weeks (p < 0.01). Results remained consistent when controlling for age and sex. Conclusion In patients with uncontrolled HTN, therapeutic measures in accordance with guidelines, with a fixed combination candesartan/amlodipine, allowed to overall achieve HTN control at 12 weeks in 82% of previously uncontrolled HTN patients, reinforcing the advantages of these strategies in primary clinical practice.

A Meta-Analysis Investigating the Efficacy and Safety of Allergen-Specific Immunotherapy in the Management of Respiratory Allergies

Background: This meta-analysis aimed to evaluate the effectiveness and adverse effects of specific immunotherapy (SIT) in the management of respiratory allergens, including allergic asthma, rhinitis, and related disorders, based on a review of current literature up to November 8, 2022. Methods: We conducted a search of databases, including PubMed, Embase, Cochrane, and Web of Science, to identify relevant randomized controlled trials (RCTs) assessing respiratory allergy-specific immunotherapy. We employed the Consolidated Standards of Reporting Trials (CONSORT) Statement to select RCTs that adhered to rigorous reporting standards. Specifically, we focused on double-blind placebo-controlled (DBPC) trials and open studies involving both adults and children, considering factors such as dosage, inclusion criteria, allergens, and primary outcome measurements. Results: A total of 25 meta-analyses were included in this study. Among them, 14 evaluated sublingual specific allergen immunotherapy (SLIT), 4 assessed subcutaneous allergen immunotherapy (SCIT), 4 explored both sublingual and subcutaneous immunotherapy, and 3 investigated intralymphatic immunotherapy. The outcomes of these meta-analyses indicated a reduction in medication scores in 20 cases and a decrease in symptom scores in 23 cases. Additionally, six studies reported on changes in IgE levels, seven studies focused on IgG4, four studies examined FEV1 (forced expiratory volume in one second), and eight studies reported on symptom and medication scores. Furthermore, eleven studies reported on differences in adverse reactions. Conclusion: The results of our meta-analysis suggest that specific immunotherapy, while associated with some adverse effects, effectively reduces the symptoms of asthma and rhinitis. Therefore, we recommend its use in the treatment of respiratory allergies.

Safety and Effectiveness of Percutaneous Ultrasound-Guided Galvanic Current in Tunnels of Patients with Hidradenitis Suppurativa: A Pilot Study.

The recurrent nature of hidradenitis suppurativa (HS), even under maintained systemic treatment, makes it necessary to have effective local treatments; however, the response to these therapies is variable (44-81%). The application of galvanic current (GC) has demonstrated its utility in humans in treating lesions structurally similar to those of HS. With this background, the main objective of this study was to evaluate the efficacy and safety of ultrasound-guided percutaneous GC in inflamed and/or draining tunnels of HS. This was an open study (one-way repeated measures design over time). Patients were evaluated at 4 and 12weeks after receiving GC. A combined clinical response at week12 (absence of suppuration/inflammation on examination and clinical interview) was considered the principal variable of efficacy. Adverse effects potentially associated with GC were reported by telephone and at each visit. Twenty-six patients were included, with a male/female ratio of 5:8. The mean age was 35.84 (13.14) years. At 12weeks after the administration of GC, a complete response was achieved in 77% (20/26) of the treated lesions. No serious adverse effects were observed, and the mean procedural pain assessed by the numeric rating scale was 0.03 (0.2). GC has proven to be effective and well tolerated in inflamed and draining tunnels of patients with HS.

Behavioral changes in patients with Prader-Willi syndrome receiving diazoxide choline extended-release tablets compared to the PATH for PWS natural history study

BackgroundPrader-Willi syndrome (PWS) is a rare neurobehavioral-metabolic disease caused by the lack of paternally expressed genes in the chromosome 15q11-q13 region, characterized by hypotonia, neurocognitive problems, behavioral difficulties, endocrinopathies, and hyperphagia resulting in severe obesity if energy intake is not controlled. Diazoxide choline extended-release (DCCR) tablets have previously been evaluated for their effects on hyperphagia and other behavioral complications of people with PWS in a Phase 3 placebo-controlled study of participants with PWS, age 4 and older with hyperphagia (C601) and in an open label extension study, C602.MethodsTo better understand the longer-term impact of DCCR, a cohort from PATH for PWS, a natural history study that enrolled participants with PWS age 5 and older, who met the C601 age, weight and baseline hyperphagia inclusion criteria and had 2 hyperphagia assessments ≥ 6 months apart, were compared to the C601/C602 cohort. Hyperphagia was measured using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT, range 0–36). The primary analysis used observed values with no explicit imputation of missing data. A sensitivity analysis was conducted in which all missing HQ-CT assessments in the C601/C602 cohort were assigned the highest possible value (36), representing the worst-case scenario. Other behavioral changes were assessed using the Prader-Willi Syndrome Profile questionnaire (PWSP).ResultsRelative to the PATH for PWS natural history study cohort, the DCCR-treated C601/C602 cohort showed significant improvements in HQ-CT score at 26 weeks (LSmean [SE] -8.3 [0.75] vs. -2.5 [0.43], p < 0.001) and 52 weeks (LSmean [SE] -9.2 [0.77] vs. -3.4 [0.47], p < 0.001). The comparison between the cohorts remained significant in the worst-case imputation sensitivity analysis. There were also significant improvements in all domains of the PWSP at 26 weeks (all p < 0.001) and 52 weeks (all p ≤ 0.003) for C601/C602 participants compared to the PATH for PWS participants.ConclusionLong-term administration of DCCR to people with PWS resulted in changes in hyperphagia and other behavioral complications of PWS that are distinct from the natural history of the syndrome as exemplified by the cohort from PATH for PWS. The combined effects of administration of DCCR should reduce the burden of the syndrome on the patient, caregivers and their families, and thereby may benefit people with PWS and their families.Trial RegistrationClinical study C601 was originally registered on ClinicalTrials.gov on February 22, 2018 (NCT03440814). Clinical study C602 was originally registered on ClinicalTrials.gov on October 22, 2018 (NCT03714373). PATH for PWS was originally registered on ClinicalTrials.gov on October 24, 2018 (NCT03718416).

Dissipation, processing factors and dietary risk assessment of the bioinsecticide abamectin in herbal plants belonging to Lamiaceae family from open field to herbal tea infusion

Abamectin, the mixture of avermectin B1a and B1b, is widely used as a bioinsecticide and is an alternative to chemical pest control from insects. To our knowledge, its behaviour is not fully recognized, especially in herbs. Thus, the objective of this study was to investigate the environmental fate of abamectin in herbal plants belonging to the Lamiaceae family, its dissipation in open field studies laboratory processing treatments and dietary risk assessment. Three medicinally and culinary important species of herbs: Melissa officinalis L., Mentha × piperita L. and Salvia L. were treated with single and double dose than recommended on the label during their cultivation (BBCH 11–29). Residues were monitored using the QuEChERS method followed by the LC-MS/MS. The dissipation pattern of the sum of avermectin B1a and B1b and their persistence were observed 14 d after spraying. Abamectin decline was very rapid in plants and followed the first-order kinetics model. The half-life (t1/2) was in the range of 0.96–1.08 d (single dose) and 0.93–1.02 d (double dose). The pre-harvest intervals (decrease to the level of 0.01 mg kg−1) were 7.29–7.92 d at single and 7.99–8.64 d at double dose application. Herbal infusion preparation in previously washed and dried mint, lemon balm and sage leaves was the key processing step in the removal of abamectin residues. The reduction of initial deposits after single dose treatment was noted up to 65% (PF = 0.35–0.67) and up to 79% after double dose application (PF = 0.21–0.72) in herbal tea. Acute risk assessment of children and adults for the highest residues in EFSA PRIMo model at single and double dose expressed as hazard quotients (HQ) were <1, indicating no risk to humans via consumption of the herbal products. The data provide a better understanding of abamectin behaviour in herbal plants and can help assure herbs' safety for consumers.

Somatostatin vs. Octreotide for Prevention of Postoperative Pancreatic Fistula The PREFIPS Randomized Clinical Trial A FRENCH 007 - ACHBT Study.

Pharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin versus octreotide as prophylactic treatment. Multicentric randomized controlled open study in patient's candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days versus octreotid 100μg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs. DP) and size of the main pancreatic duct (>4mm) on grade B/C POPF rates at 90 days based on an intention-to-treat analysis. Of 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, with comparable the stratification criteria - type of surgery and main pancreatic duct dilatation. Most patients had PD (n=480; 73.8%), on soft/normal pancreas (n=367; 63.2%) with a non-dilated main pancreatic duct (n=472; 72.5%), most often for pancreatic adenocarcinoma (n=311; 47.8%). Almost all patients had abdominal drainage (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay=16d). A total of 153 patients (23.5%) developed a grade B/C POPF with no difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (Chi-2 test, P=0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis. Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy.

Efficacy and safety of the combined drug (5% benzoyl peroxide + 1% clindamycin) in the treatment of acne: results of an open randomized comparative clinical study

Background. Acne is one of the most common dermatoses, the presence of which significantly reduces the quality of life of patients. For patients with inflammatory, comedonal acne use of fixed combinations is a first-line therapy. Aims: to study the efficacy and safety of the Zerkalin Intensive (ZI) in the treatment of acne in comparison with the Effezel (EF). Methods: an open comparative study included 60 patients with acne: group 1 (n=30) received therapy with ZI, group 2 (n=30) with EF 1 time a day in the evening. The effectiveness of therapy was evaluated 2 weeks, 1, 2 and 3 months. Results: after 1 month of therapy, there was a significant improvement in 9 (30%) patients of the group 1 and in 9 (30%) patients of the group 2 (p=1,000), improvement – in 12 (40%) and 18 (60%) patients (p=0.106). After 2 months of using ZI and EF, complete resolution of rashes was observed in 11 (36.7%) and 6 (20%) (p=0.395), significant improvement in 13 (43.3%) and 11 (36.7%) (p=0.628), improvement in 6 (20%) and 13 (43.3%), respectively. After 3 months complete resolution of rashes was observed in 24 (80%) patients of the group 1 and in 12 (40%) patients of the group 2 (p=0.088), significant improvement in 5 (16.7%) and 11 (36.6%) patients (p=0.236), improvement in 1 (3.3%) and 7 (23.3%) patients, respectively. Against the background of the use of EF, 20 (66.7%) patients showed the appearance of slight dry skin and redness. No side effects were detected when using the ZI. Conclusions. A comparable high efficiency of ZI and EF in acne therapy has been established. Use of ZI made it possible to achieve the onset of a full clinical effect and a significant improvement in the clinical picture in a larger number of patients and in a shorter time.

Clinical evaluation of therapeutic efficacy of a Siddha herbo mineral formulation “Kumaara Veeriya Kaantha Chenduram’’ with “Nellikkai  Legiyam” (internal) in the treatment of Iron Deficiency Anemia

Abstract: Background: Kumaara veeriya kaantha chenduram (KVKC) is a siddha herbomineral formulation indicated for paandunoi in Siddha literature (1).Paandu noi is a disease characterized by changes in the body's natural color andpallor found in the skin, nails and conjunctiva. Objectives: To determine the efficacy of the KVKC, the open labed clinical study was conducted in National Institute of Siddha OPD. Materials and Methods: The 30 patients with Iron deficiency anaemiawere selected and treated with KVKC orally with the dose of 260 milli gram twice in a day with Nellikailegiyam6 gram continuously for 45 days. Laboratory investigations for hemoglobin was done on 1st day and every 15 days once of the study.     Results: Clinical assessment was done, based on the before and after treatment scores which was compared statistically and recorded.Regarding Hemoglobin level, 24(80%) patients showed increase of 1 to 3 grams from base level, 6(20%) patients showed increase of 0.1 to 0.9 grams from base level.Regarding Serum Ferritin, out of 30 patients, 9 (30%) patients showed 0.1-3.5 ng/ml increase from its base level, 21 (70%) patients showed 3.6-7.0 ng/ml increase from its base level.From the Statistical studies, the Mean ± Standard deviation for Haemoglobin before treatment was 9.7 ± 0.93 and after treatment was 11.18 ± 1.08 which was statistically highly significant (p&lt;0.0001).And Serum ferritin before treatment was 9.27 ± 3.31, after treatment was 13.5 ± 3.49 which was statistically significant (p&lt;0.0001).

The long-term impact of vaginal surgical mesh devices on pain clinic and psychological service referrals, anti-inflammatory testing and pelvic scans in UK primary care: A cohort study with the Clinical Practice Research Datalink.

To examine long-term complications in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP), with and without surgical mesh implants. Longitudinal open cohort study from 1 April 2006 (or 1 April 2012) to 30 November 2018. The Clinical Practice Research Datalink (CPRD) Gold database, which is linked to Hospital Episodes Statistics (HES) inpatient data, the HES Diagnostic Imaging Dataset (DID), Office for National Statistics mortality data and Index of Multiple Deprivation socio-economic status data. Women aged ≥18 years with a diagnostic SUI/POP Read code. Rates are estimated using negative binomial regression. Rates of referrals for: psychological and pain services; urinalysis, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) testing; and pelvic ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) scans. A cohort of 220 544 women were eligible for inclusion; 74% (n = 162 687) had SUI, 37% (n = 82 123) had POP and 11% (n = 24 266) had both. Rates of psychological referrals and CT scans were lower in women with SUI mesh surgery, but this was offset by higher rates of CRP testing in women with SUI or POP mesh, MRI scans in women with SUI mesh, and urinalysis testing and referrals to pain clinics for women with POP mesh. Our results suggest a higher burden of morbidity in women with SUI/POP mesh surgery, and that these women may require ongoing follow-up in the primary care setting.

Animal‐pollinated crops and cultivars—A quantitative assessment of pollinator dependence values and evaluation of methodological approaches

Abstract Crop pollinator dependence (PD) values are key when assessing a pollinator's contribution to agriculture, guiding management plans and policies for sustainable crop production. However, the available global compilations of crops PD are outdated and neglect variability between related crops and accessions (variety/cultivar), as well as pollen limitation (PL), that is the production lost due to inadequate pollen receipt. Here, we obtained quantitative PD values for animal‐pollinated crops and their accessions, using data from available pollination experiments worldwide. We also tested pollination methodologies to assess their impact on PD values and to define suitable methodological guidelines for future pollination studies. We provide a list of continuous PD values for 141 crops, including 317 accessions and 37 crops not listed in previous assessments. We found that, globally, 74% of animal‐pollinated crops are highly dependent on pollinators, and more than 40% of their production is associated with animal pollination. Pollen limitation was detected in 51% of the dataset entries, indicating that estimates calculated with open pollination studies underestimate crop pollinator dependence and, therefore, do not represent the true contribution of pollinators to food production. Synthesis and applications: Commonly applied methods for assessing PD values can lead to underestimations. Future studies evaluating pollinator dependence levels of crops and their accessions (i.e. potential pollinator contribution) should consider the possibility of pollen limitation in the study site, incorporating hand pollen supplementation (to open flower), open pollination, and pollinator exclusion treatments, preferably using the whole plant or branch as the unit of assessment. The PD values provided here, from studies that allow the incorporation of the concept of pollen limitation, enable more accurate quantifications of pollinator contribution to crop production. These PD values are an invaluable baseline and a requirement for future accurate evaluations of the value of pollinators for food security, supporting pollinator‐friendly practices in agroecosystems.

Mental health and burnout during medical school: Longitudinal evolution and covariates.

Medical students' rate of depression, suicidal ideation, anxiety, and burnout have been shown to be higher than those of the same-age general population. However, longitudinal studies spanning the whole course of medical school are scarce and present contradictory findings. This study aims to analyze the longitudinal evolution of mental health and burnout from the first to the last year of medical school using a wide range of indicators. Moreover, biopsychosocial covariates that can influence this evolution are explored. In an open cohort study design, 3066 annual questionnaires were filled in by 1595 different students from the first to the sixth year of the Lausanne Medical School (Switzerland). Depression symptoms, suicidal ideation, anxiety symptoms, stress, and burnout were measured along with biopsychosocial covariates. The longitudinal evolution of mental health and burnout and the impact of covariates were modelled with linear mixed models. Comparison to a same-aged general population sample shows that medical students reported significantly more depression symptoms and anxiety symptoms. Medical students' mental health improved during the course of the studies in terms of depression symptoms, suicidal ideation, and stress, although suicidal ideation increased again in the last year and anxiety symptoms remained stable. Conversely, the results regarding burnout globally showed a significant worsening from beginning to end of medical school. The covariates most strongly related to better mental health and less burnout were less emotion-focused coping, more social support, and more satisfaction with health. Both improvement of mental health and worsening of burnout were observed during the course of medical school. This underlines that the beginning and the end of medical school bring specific challenges with the first years' stressors negatively impacting mental health and the last year's difficulties negatively impacting burnout.

Multicomponent Co-Occurring Disorders Treatment and Wraparound Services for Individuals Experiencing Chronic Homelessness.

Individuals experiencing chronic homelessness have high rates of persistent co-occurring mental health and substance use disorders (COD), and they often have difficulty with service engagement and retention, resulting in symptom exacerbation and housing loss. This study pilot tested Maintaining Independence and Sobriety Through Systems Integration, Outreach and Networking (MISSION), a multicomponent wraparound treatment approach to improve COD symptoms and housing stability among individuals experiencing chronic homelessness and persistent COD. This open pilot study enrolled and assessed 109 individuals with a COD experiencing chronic homelessness and offered one year of MISSION. Statistically significant improvements were observed in behavioral health symptoms and functioning, days of illicit drug use, and housing stability. By treatment completion, 85% of participants were referred to social and behavioral supports. This pilot study demonstrates that MISSION helped to successfully engage participants in treatment, reduce substance use and mental health symptoms, and improve housing outcomes.

Patterns and trends of medicinal poisoning substances: a population-based cohort study of injuries in 0–11 year old children from 1998–2018

BackgroundThere have been sharp increases in antidepressant and opioid prescriptions over the last 10 years, as well as increased over-the-counter medicine availability. However, the impact on childhood medicinal poisonings rates, particularly by socioeconomic deprivation is unclear. This study reports population level medicinal poisoning substance patterns in England among children aged 0–11 years, helping inform safety advice and poisoning prevention interventions.MethodsAn open cohort study of 1,489,620 0–11 year olds was conducted from 1998 to 2018, using the Clinical Practice Research Datalink, to examine inpatient hospital admissions for poisoning. Incidence rates and adjusted incidence rate ratios (aIRR) were calculated for poisoning substance groups by age, sex, socio-economic deprivation and year.Results3,685 medicinal poisoning hospital admissions were identified. The most common substances were paracetamol (33.2%), dependence/withdrawal risk drugs (DWRD - antidepressants, opioids, gabapentinoids, benzodiazepines) (13.5%) and other over-the-counter (OTC) analgesics/anti-common cold drugs (13.0%). Over the study period DWRD poisonings decreased 33% (aIRR 0.67, 95%CI 0.50–0.90 comparing 2013/14-2017/18 to 1998/99-2002/03), while paracetamol poisonings increased 43% (aIRR 1.43, 95%CI 1.20–1.70 for the same periods), with no change in incidence rates for other OTC drugs (aIRR 0.82, 95% CI 0.60–1.12) or all medications combined (aIRR 0.97, 95%CI 0.88–1.07). A gradient in poisonings by area-level socioeconomic deprivation was shown for all medications (aIRR 1.32, 95%CI 1.18–1.47 for most deprived compared to least deprived quintile), and DWRDs (aIRR 2.03, 95%CI 1.42–2.88 for 4th most deprived quintile and aIRR 1.88, 95%CI 1.32–2.66 for 5th most deprived quintile, compared to least deprived quintile), but not for paracetamol or other OTC drug poisonings.ConclusionsPoisonings from DWRDs decreased by 33%, while paracetamol poisonings increased by 43% during the study period. There was a gradient by area-level socioeconomic deprivation in prescribed medication poisonings, including drugs with withdrawal/dependence risk, but not OTC medication poisonings. Households in more socioeconomically deprived areas have the potential to benefit most from measures to improve safe storage of medicines and are likely to require targeted interventions providing education and safety equipment. In addition, universal promotion of the safe storage of OTC and prescribed medicines must be provided by prescribers, community pharmacies and other outlets of such medication.

Potential of the domestic biosimile omalizumab in achievement of control in patients with severe asthma: short communication

BACKGROUND: Severe atopic asthma is a medical and social problem due to its prevalence, the tendency to exacerbations, the impact on the quality of life and on the work ability, and high treatment costs. The appearance biosimilar omalizumab among biologicals makes such therapy more accessible to patients. This article presents the results of an open prospective clinical study of the biosimilar omalizumab in patients with the severe atopic asthma.&#x0D; AIM: To evaluate the efficacy and tolerability of the domestically produced biosimilar omalizumab in the real clinical practice.&#x0D; MATERIALS AND METHODS: The study involved 15 adult patients (19–66 years) with a reliable history consistent with moderate to severe atopic asthma who hadn`t have asthma control at the time of inclusion in the study. All patients received the Genolar (omalizumab, Generic JSC, Russia) for 52 weeks at the dose calculated according to the instructions. The efficacy was evaluated taking into account changes in symptom severity, improved asthma control using the Asthma Control Questionnaire (ACQ-5), pulmonary function tests, peak flow measurements, assessment the asthma exacerbations number and the healthcare resources use.&#x0D; RESULTS: According to our study results, all patients demonstrated a decrease in the night and daytime attacks frequency and the shortness of breath severity due to omalizumab, which made it possible to reduce the basic therapy and refuse systemic glucocorticosteroids using in patients who previously received there. After 6 months we obtained an improvement in the asthma symptoms control: ΔACQ-5=-1.87 (p=0.0002) compared to baseline with a trend towards further improvement in indicators and reached ΔACQ-5=-2.18 (p=0.0001) to the 52nd week. We also obtained a statistically significant improvement in pulmonary function (after a year of treatment, the increase in forced expiratory volume in the first second was +19.85% compared to baseline, p=0.0001). No asthma exacerbation was registered during 12 months omalizumab treatment.&#x0D; CONCLUSION: Our study showed that the biosimilar treatment in patients with severe atopic asthma allowed to achieve asthma control, decrease the exacerbations number and reduce the basic therapy volume, including oral-corticosteroid elimination.

Istradefylline/L‐DOPA Parkinson's disease therapy and energy coupling

AbstractBackgroundBoth dopamine and adenosine are physiologically involved in cellular energy metabolism.AimNovel approaches targeting delaying progression strategies for Parkinson's disease (PD) examined the effects of long‐term use of A2AR antagonist/istradefylline (IST) adjunct to L‐DOPA (LD), nutshell IST‐LD, with an expected energy coupling (EC) to attenuate neuronal excitotoxicity.MethodsA single‐center prospective open cohort study was conducted at the Department of Neurology, Okinawa Islands, Japan. The cohort included incident and prevalent PD cases that were non‐randomly assigned to the IST‐LD (n = 90) and LD (n = 157) groups, followed by an open‐label treatment in clinical practice from October 2013 to September 2020. Patients were evaluated using physician‐rated MDS‐UPDRS I/III, and patient‐rated MDS‐NMS using the total score, body weight, and blood biomarkers of EC.ResultsAs the primary clinical outcome, MDS‐UPDRS part III scores showed less worsening in the IST‐LD than in the LD group (1.29 ± 6.0 vs. 5.0 ± 6.5, p &lt; 0.01) and off‐time Hoehn and Yahr stage (0.05 ± 0.49 vs. 0.26 ± 0.54, p &lt; 0.01). As the secondary clinical outcome, the detected mean body weight losses were similar between the two groups; however, the evident linkage of the daily dose of LD and variations in the blood markers of IGF‐I and HKII, which were inferred as LD‐mediated energy demand effects, were partially attenuated by IST.ConclusionIST‐LD plays an essential role in behavioral outputs for patients with PD and might contribute to the interplay of energy‐consuming demands of LD with the attenuation of weight loss and emerging type 2 diabetes mellitus.

The Effects of Pantoprazole on Kidney Outcomes.

Observational studies have found an association between proton pump inhibitor (PPI) use and worsening kidney function. It is unclear whether these associations are causal.We conducted post-hoc analyses to determine the effect of pantoprazole on kidney function using data from the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial, a 17,598 participant randomized trial comparing pantoprazole (8,791) to placebo (8,807). The primary outcome was the rate of change of estimated glomerular filtration rate (eGFR). Rate of eGFR change was based on the two eGFR measures available, the eGFR at randomization and at the open label extension study that enrolled at trial conclusion. Secondary outcomes included incident chronic kidney disease (CKD) (defined by eGFR <60 ml/min/1.73 m2 at open label extension or case report forms) as well as acute kidney injury (AKI), acute nephritis, and nephrotic syndrome. 8,991 of the 17,598 participants randomized to pantoprazole/placebo (51%) had eGFR recorded at baseline and open label extension enrollment and were included in the rate of eGFR change population (mean age 67 [SD 8] years, 22% female, mean baseline eGFR 75 [SD 17.5] ml/min/1.73 m2). The mean duration between randomization and open label extension eGFR was 3.3 years. The placebo rate of eGFR change was -1.41 (SD 4.45) ml/min/1.73 m2 per year. The pantoprazole rate of eGFR change was -1.64 (SD 4.47) ml/min/1.73 m2 per year. In adjusted analyses pantoprazole had a 0.27 ml/min/1.73 m2 per year greater decline in eGFR (95% CI 0.11 to 0.43). The odds ratio for the effect of pantoprazole on incident CKD was 1.11 (95% CI 0.98 to 1.25) and on AKI was 0.89 (95% CI 0.65 to 1.21). There were 5 nephrotic syndrome outcomes recorded and 1 event of acute nephritis. In this post-hoc analysis of the COMPASS trial pantoprazole resulted in a statistically significant greater rate of eGFR decline as compared to placebo. The clinical importance of this is uncertain.

A clinical study of Sidharthakadi Lepa in management of Yuvanpidika (Acne Vulgaris)

Introduction: Acne is a distressing condition that affects the majority of adolescents and harms beauty of the face so person may suffer with inferiority complex, anxiety, isolation etc. Due to wide spectrum of disease, much prevalence in the society and lack of effective medicine, this is the main cause of the global shift toward Ayurveda and Herbal skin care. The present study was conducted to evaluate the effect of Sidharthakadi Lepa in management of Yuvanpidika. Methodology: Single arm open randomized clinical study was conducted on 40 clinically diagnosed patients with Acne Vulgaris for Sidharthakadi Lepa in the Postgraduate Institute of Ayurveda, DSRRAU, Jodhpur. Study evaluates their role in management of Pidika (Prescence of Acne), Kandu (Itching), Vedana (Pain), Daha (Burning sensation) and Srava (Discharge) Results: Result of the study depicts that Lepa has significantly helps in reducing the Acne vulgaris. Conclusion: Out of 40 patients selected for the study, a greater number of young adults &amp; 11 patients were male and 29 were female. It showed the high rate of occurrence and consciousness of this condition in females. Sidharthakadi Lepa is more effective in Vata and Kapha Prakrithi individuals.