Search results for: clinical depression
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 4354

Search results for: clinical depression

4024 Assessment of Barriers to the Clinical Adoption of Cell-Based Therapeutics

Authors: David Pettitt, Benjamin Davies, Georg Holländer, David Brindley

Abstract:

Cellular based therapies, whose origins can be traced from the intertwined concepts of tissue engineering and regenerative medicine, have the potential to transform the current medical landscape and offer an approach to managing what were once considered untreatable diseases. However, despite a large increase in basic science activity in the cell therapy arena alongside a growing portfolio of cell therapy trials, the number of industry products available for widespread clinical use correlates poorly with such a magnitude of activity, with the number of cell-based therapeutics in mainstream use remaining comparatively low. This research serves to quantitatively assess the barriers to the clinical adoption of cell-based therapeutics through identification of unique barriers, specific challenges and opportunities facing the development and adoption of such therapies.

Keywords: cell therapy, clinical adoption, commercialization, translation

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4023 On-Site Coaching on Freshly-Graduated Nurses to Improves Quality of Clinical Handover and to Avoid Clinical Error

Authors: Sau Kam Adeline Chan

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World Health Organization had listed ‘Communication during Patient Care Handovers’ as one of its highest 5 patient safety initiatives. Clinical handover means transfer of accountability and responsibility of clinical information from one health professional to another. The main goal of clinical handover is to convey patient’s current condition and treatment plan accurately. Ineffective communication at point of care is globally regarded as the main cause of the sentinel event. Situation, Background, Assessment and Recommendation (SBAR), a communication tool, is extensively regarded as an effective communication tool in healthcare setting. Nonetheless, just by scenario-based program in nursing school or attending workshops on SBAR would not be enough for freshly graduated nurses to apply it competently in a complex clinical practice. To what extend and in-depth of information should be conveyed during handover process is not easy to learn. As such, on-site coaching is essential to upgrade their expertise on the usage of SBAR and ultimately to avoid any clinical error. On-site coaching for all freshly graduated nurses on the usage of SBAR in clinical handover was commenced in August 2014. During the preceptorship period, freshly graduated nurses were coached by the preceptor. After that, they were gradually assigned to take care of a group of patients independently. Nurse leaders would join in their shift handover process at patient’s bedside. Feedback and support were given to them accordingly. Discrepancies on their clinical handover process were shared with them and documented for further improvement work. Owing to the constraint of manpower in nurse leader, about coaching for 30 times were provided to a nurse in a year. Staff satisfaction survey was conducted to gauge their feelings about the coaching and look into areas for further improvement. Number of clinical error avoided was documented as well. The nurses reported that there was a significant improvement particularly in their confidence and knowledge in clinical handover process. In addition, the sense of empowerment was developed when liaising with senior and experienced nurses. Their proficiency in applying SBAR was enhanced and they become more alert to the critical criteria of an effective clinical handover. Most importantly, accuracy of transferring patient’s condition was improved and repetition of information was avoided. Clinical errors were prevented and quality patient care was ensured. Using SBAR as a communication tool looks simple. The tool only provides a framework to guide the handover process. Nevertheless, without on-site training, loophole on clinical handover still exists, patient’s safety will be affected and clinical error still happens.

Keywords: freshly graduated nurse, competency of clinical handover, quality, clinical error

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4022 Clinical Signs of Neonatal Calves in Experimental Colisepticemia

Authors: Samad Lotfollahzadeh

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Escherichia coli (E.coli) is the most isolated bacteria from blood circulation of septicemic calves. Given the prevalence of septicemia in animals and its economic importance in veterinary practice, better understanding of changes in clinical signs following disease, may contribute to early detection of the disorder. The present study has been carried out to detect changes of clinical signs in induced sepsis in calves with E.coli. Colisepticemia has been induced in 10 twenty-day old healthy Holstein- Frisian calves with intravenous injection of 1.5 X 109 colony forming units (cfu) of O111: H8 strain of E.coli. Clinical signs including rectal temperature, heart rate, respiratory rate, shock, appetite, sucking reflex, feces consistency, general behavior, dehydration and standing ability were recorded in experimental calves during 24 hours after induction of colisepticemia. Blood culture was also carried out from calves four times during the experiment. ANOVA with repeated measure is used to see changes of calves’ clinical signs to experimental colisepticemia, and values of P≤ 0.05 was considered statistically significant. Mean values of rectal temperature and heart rate as well as median values of respiratory rate, appetite, suckling reflex, standing ability and feces consistency of experimental calves increased significantly during the study (P<0.05). In the present study, median value of shock score was not significantly increased in experimental calves (P> 0.05). The results of present study showed that total score of clinical signs in calves with experimental colisepticemia increased significantly, although the score of some clinical signs such as shock did not change significantly.

Keywords: calves, clinical signs scoring, E. coli O111:H8, experimental colisepticemia

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4021 Evaluating the Learning Outcomes of Physical Therapy Clinical Fieldwork Course

Authors: Hui-Yi Wang, Shu-Mei Chen, Mei-Fang Liu

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Background and purpose: Providing clinical experience in medical education is an important discipline method where students can gradually apply their academic knowledge to clinical situations. The purpose of this study was to establish self-assessment questionnaires for students to assess their learning outcomes for two fields of physical therapy, orthopedic physical therapy, and pediatric physical therapy, in a clinical fieldwork course. Methods: The questionnaires were developed based on the core competence dimensions of the course. The content validity of the questionnaires was evaluated and established by expert meetings. Among the third-year undergraduate students who took the clinical fieldwork course, there were 49 students participated in this study. Teachers arranged for the students to study two professional fields, and each professional field conducted a three-week clinical lesson. The students filled out the self-assessment questionnaires before and after each three-week lesson. Results: The self-assessment questionnaires were established by expert meetings that there were six core competency dimensions in each of the two fields, with 20 and 21 item-questions, respectively. After each three-week clinical fieldwork, the self-rating scores in each core competency dimension were higher when compared to those before the course, indicating having better clinical abilities after the lessons. The best self-rating scores were the dimension of attitude and humanistic literacy, and the two lower scores were the dimensions of professional knowledge and skills and problem-solving critical thinking. Conclusions: This study developed questionnaires for clinical fieldwork courses to reflect students' learning outcomes, including the performance of professional knowledge, practice skills, and professional attitudes. The use of self-assessment of learning performance can help students build up their reflective competencies. Teachers can guide students to pay attention to the performance of abilities in each core dimension to enhance the effectiveness of learning through self-reflection and improvement.

Keywords: physical therapy, clinical fieldwork course, learning outcomes assessment, medical education, self-reflection ability

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4020 Comparing the ‘Urgent Community Care Team’ Clinical Referrals in the Community with Suggestions from the Clinical Decision Support Software Dem DX

Authors: R. Tariq, R. Lee

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Background: Additional demands placed on senior clinical teams with ongoing COVID-19 management has accelerated the need to harness the wider healthcare professional resources and upskill them to take on greater clinical responsibility safely. The UK NHS Long Term Plan (2019)¹ emphasises the importance of expanding Advanced Practitioners’ (APs) roles to take on more clinical diagnostic responsibilities to cope with increased demand. In acute settings, APs are often the first point of care for patients and require training to take on initial triage responsibilities efficiently and safely. Critically, their roles include determining which onward services the patients may require, and assessing whether they can be treated at home, avoiding unnecessary admissions to the hospital. Dem Dx is a Clinical Reasoning Platform (CRP) that claims to help frontline healthcare professionals independently assess and triage patients. It guides the clinician from presenting complaints through associated symptoms to a running list of differential diagnoses, media, national and institutional guidelines. The objective of this study was to compare the clinical referral rates and guidelines adherence registered by the HMR Urgent Community Care Team (UCCT)² and Dem Dx recommendations using retrospective cases. Methodology: 192 cases seen by the UCCT were anonymised and reassessed using Dem Dx clinical pathways. We compared the UCCT’s performance with Dem Dx regarding the appropriateness of onward referrals. We also compared the clinical assessment regarding adherence to NICE guidelines recorded on the clinical notes and the presence of suitable guidance in each case. The cases were audited by two medical doctors. Results: Dem Dx demonstrated appropriate referrals in 85% of cases, compared to 47% in the UCCT team (p<0.001). Of particular note, Dem Dx demonstrated an almost 65% (p<0.001) improvement in the efficacy and appropriateness of referrals in a highly experienced clinical team. The effectiveness of Dem Dx is in part attributable to the relevant NICE and local guidelines found within the platform's pathways and was found to be suitable in 86% of cases. Conclusion: This study highlights the potential of clinical decision support, as Dem Dx, to improve the quality of onward clinical referrals delivered by a multidisciplinary team in primary care. It demonstrated that it could support healthcare professionals in making appropriate referrals, especially those that may be overlooked by providing suitable clinical guidelines directly embedded into cases and clear referral pathways. Further evaluation in the clinical setting has been planned to confirm those assumptions in a prospective study.

Keywords: advanced practitioner, clinical reasoning, clinical decision-making, management, multidisciplinary team, referrals, triage

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4019 The Role of Social Influences and Cultural Beliefs on Perceptions of Postpartum Depression among Mexican Origin Mothers in San Diego

Authors: Mireya Mateo Gomez

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The purpose of this study was to examine the perceptions first-generation Mexican origin mothers living in San Diego have on postpartum depression (PPD), with a special focus on social influences and cultural beliefs towards those meanings. This study also aimed to examine possible PPD help-seeking behaviors that first-generation Mexican origin mothers can perform. The Health Belief Model (HBM) and Social Ecological Model (SEM) were the guiding theoretical frameworks for this study. Data for this study were collected from three focus groups, four in-depth interviews, and the distribution of an acculturation survey (ARSMA II). There were a total of 15 participants, in which participant’s mean age was 45, and the mean age migrated to the United States being 22. Most participants identified as being married, born in Southern or Western Mexico, and with a strong Mexican identity in relation to the ARSMA survey. Participants identified four salient PPD perceptions corresponding to the interpersonal level of SEM. These four main perceptions were: 1) PPD affecting the identity of motherhood; 2) PPD being a natural part of a mother’s experience but mitigated by networks; 3) PPD being a U.S. phenomenon due to family and community breakdown; and 4) natural remedies as a preferred PPD treatment. In regard to themes relating to help seeking behaviors, participants identified seven being: 1) seeking help from immediate family members; 2) practicing home remedies; 3) seeking help from a medical professional; 4) obtaining help from a clinic or organization; 5) seeking help from God; 6) participating in PPD support groups; and 7) talking to a friend. It was evident in this study that postpartum depression is not a well discussed topic within the Mexican immigrant population. In relation to the role culture and social influences have on PPD perceptions, most participants shared hearing or learning about PPD from their family members or friends. Participants also stated seeking help from family members if diagnosed with PPD and seeking out home remedies. This study as well provides suggestions to increase the awareness of PPD among the Mexican immigrant community.

Keywords: cultural beliefs, health belief model, Mexican origin mothers, perceptions, postpartum depression social ecological model

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4018 [Keynote Talk]: From Clinical Practice to Academic Setup, 'Quality Circles' for Quality Outputs in Both

Authors: Vandita Mishra

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From the management of patients, reception, record, and assistants in a clinical practice; to the management of ongoing research, clinical cases and department profile in an academic setup, the healthcare provider has to deal with all of it. The victory lies in smooth running of the show in both the above situations with an apt solution of problems encountered and smooth management of crisis faced. Thus this paper amalgamates dental science with health administration by means of introduction of a concept for practice management and problem-solving called 'Quality Circles'. This concept uses various tools for problem solving given by experts from different fields. QC tools can be applied in both clinical and academic settings in dentistry for better productivity and for scientifically approaching the process of continuous improvement in both the categories. When approached through QC, our organization showed better patient outcomes and more patient satisfaction. Introduced in 1962 by Kaoru Ishikawa, this tool has been extensively applied in certain fields outside dentistry and healthcare. By exemplification of some clinical cases and virtual scenarios, the tools of Quality circles will be elaborated and discussed upon.

Keywords: academics, dentistry, healthcare, quality

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4017 Innovative Food Related Modification of the Day-Night Task Demonstrates Impaired Inhibitory Control among Patients with Binge-Purge Eating Disorder

Authors: Sigal Gat-Lazer, Ronny Geva, Dan Ramon, Eitan Gur, Daniel Stein

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Introduction: Eating disorders (ED) are common psychopathologies which involve distorted body image and eating disturbances. Binge-purge eating disorders (B/P ED) are characterized by repetitive events of binge eating followed by purges. Patients with B/P ED behavior may be seen as impulsive especially when relate to food stimulation and affective conditions. The current study included innovative modification of the day-night task targeted to assess inhibitory control among patients with B/P ED. Methods: This prospective study included 50 patients with B/P ED during acute phase of illness (T1) upon their admission to specialized ED department in tertiary center. 34 patients repeated the study towards discharge to ambulatory care (T2). Treatment effect was evaluated by BMI and emotional questionnaires regarding depression and anxiety by the Beck Depression Inventory and State Trait Anxiety Inventory questionnaires. Control group included 36 healthy controls with matched demographic parameters who performed both T1 and T2 assessments. The current modification is based on the emotional day-night task (EDNT) which involves five emotional stimulation added to the sun and moon pictures presented to participants. In the current study, we designed the food-emotional modification day night task (F-EDNT) food stimulations of egg and banana which resemble the sun and moon, respectively, in five emotional states (angry, sad, happy, scrambled and neutral). During this computerized task, participants were instructed to push on “day” bottom in response to moon and banana stimulations and on “night” bottom when sun and egg were presented. Accuracy (A) and reaction time (RT) were evaluated and compared between EDNT and F-EDNT as a reflection of participants’ inhibitory control. Results: Patients with B/P ED had significantly improved BMI, depression and anxiety scores on T2 compared to T1 (all p<0.001). Task performance was similar among patients and controls in the EDNT without significant A or RT differences in both T1 and T2. On F-EDNT during T1, B/P ED patients had significantly reduced accuracy in 4/5 emotional stimulation compared to controls: angry (73±25% vs. 84±15%, respectively), sad (69±25% vs. 80±18%, respectively), happy (73±24% vs. 82±18%, respectively) and scrambled (74±24% vs. 84±13%, respectively, all p<0.05). Additionally, patients’ RT to food stimuli was significantly faster compared to neutral ones, in both cry and neutral emotional stimulations (356±146 vs. 400±141 and 378±124 vs. 412±116 msec, respectively, p<0.05). These significant differences between groups as a function of stimulus type were diminished on T2. Conclusion: Having to process food related content, in particular in emotional context seems to be impaired in patients with B/P ED during the acute phase of their illness and elicits greater impulsivity. Innovative modification using such procedures seem to be sensitive to patients’ illness phase and thus may be implemented during screening and follow up through the clinical management of these patients.

Keywords: binge purge eating disorders, day night task modification, eating disorders, food related stimulations

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4016 A Cross-Sectional Study on Clinical Self-Efficacy of Final Year School of Nursing Students among Universities of Tigray Region, Northern Ethiopia

Authors: Awole Seid, Yosef Zenebe, Hadgu Gerensea, Kebede Haile Misgina

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Background: Clinical competence is one of the ultimate goals of nursing education. Clinical skills are more than successfully performing tasks; it incorporates client assessment, identification of deficits and the ability to critically think to provide solutions. Assessment of clinical competence, particularly identifying gaps that need improvement and determining the educational needs of nursing students have great importance in nursing education. Thus this study aims determining clinical self-efficacy of final year school of nursing students in three universities of Tigray Region. Methods: A cross-sectional study was conducted on 224 final year school of nursing students from department of nursing, psychiatric nursing, and midwifery on three universities of Tigray region. Anonymous self-administered questionnaire was administered to generate data collected on June, 2017. The data were analyzed using SPSS version 20. The result is described using tables and charts as required. Logistic regression was employed to test associations. Result: The mean age of students was 22.94 + 1.44. Generally, 21% of students have been graduated in the department in which they are not interested. The study demonstrated 28.6% had poor and 71.4% had good perceived clinical self-efficacy. Beside this, 43.8% of psychiatric nursing and 32.6% of comprehensive nursing students have poor clinical self-efficacy. Among the four domains, 39.3% and 37.9% have poor clinical self- efficacy with regard to ‘Professional development’ and ‘Management of care’. Place of the institution [AOR=3.480 (1.333 - 9.088), p=0.011], interest during department selection [AOR=2.202 (1.045 - 4.642), p=.038], and theory-practice gap [AOR=0.224 (0.110 - 0.457), p=0.000] were significantly associated with perceived clinical self-efficacy. Conclusion: The magnitude of students with poor clinically self efficacy was high. Place of institution, theory-practice gap, students interest to the discipline were the significant predictors of clinical self-efficacy. Students from youngest universities have good clinical self-efficacy. During department selection, student’s interest should be respected. The universities and other stakeholders should improve the capacity of surrounding affiliate teaching hospitals to set and improve care standards in order to narrow the theory-practice gap. School faculties should provide trainings to hospital staffs and monitor standards of clinical procedures.

Keywords: clinical self-efficacy, nursing students, Tigray, northern Ethiopia

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4015 Influence of Gender, Race, and Psychiatric Disorders on Sun Protective Behavior and Outcomes: A Population-Based Study

Authors: Holly D. Shan, Monique L. Bautista Neughebauer

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Sunscreen usage is emphasized in public health strategy as it reduces the risk of sunburns and skin cancers. This study aims to explore factors that influence sun protective behavior and outcomes. Data was received from the National Health Interview Survey (NHIS) 2020. Adults were asked how often they wore sunscreen when outside on a sunny day. Consistent use (“always”) of sunscreen, the incidence of sunburn within a year, and ever having a diagnosis of skin melanoma were compared by gender, race, and the diagnosis of anxiety, depression, and dementia. Individuals identifying as a mixed race were excluded. Statistical analysis was adjusted for large-scale surveys using STATA VSN 7.0, and a two-sided p<0.05 was considered significant. Of the 37,352 participants (53.18% females, 75.01% white, 10.49% black, 0.76% Indian Americans,5.60% Asian), 13.11% had a diagnosis of anxiety, 14.78% depression, and 0.84% dementia. Females wore sunscreen more often than males (24.72% vs. 10.91%, p<0.001). White individuals wore sunscreen most frequently; black individuals the least (17.37% vs. 6.49%, p<0.001). White individuals had the highest rate of sunburn (25.61%, p<0.001) and a history of skin melanoma (3.38%, p<0.001). Participants with anxiety, depression, and dementia all had statistically significantly decreased sunscreen use and increased frequency of sunburn compared to the general population. Only those with dementia had an increased incidence of skin melanoma (2.85% vs. 1.22%, p=0.009). Dermatologists and public health professionals should consider gender, race, and psychiatric comorbidities when counseling patients on sun protection.

Keywords: sun protective behavior, psychiatric disorder, melanoma, sunburn

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4014 Comparative Evaluation of Pharmacologically Guided Approaches (PGA) to Determine Maximum Recommended Starting Dose (MRSD) of Monoclonal Antibodies for First Clinical Trial

Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

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First-in-human (FIH) studies are a critical step in clinical development of any molecule that has shown therapeutic promise in preclinical evaluations, since preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies for guidance in pharmaceutical industry for the treatment of human diseases. Therefore, comparison between USFDA and nine pharmacologically guided approaches (PGA) (simple allometry, maximum life span potential, brain weight, rule of exponent (ROE), two species methods and one species methods) were made to determine maximum recommended starting dose (MRSD) for first in human clinical trials using four drugs namely Denosumab, Bevacizumab, Anakinra and Omalizumab. In our study, the predicted pharmacokinetic (pk) parameters and the estimated first-in-human dose of antibodies were compared with the observed human values. The study indicated that the clearance and volume of distribution of antibodies can be predicted with reasonable accuracy in human and a good estimate of first human dose can be obtained from the predicted human clearance and volume of distribution. A pictorial method evaluation chart was also developed based on fold errors for simultaneous evaluation of various methods.

Keywords: clinical pharmacology (CPH), clinical research (CRE), clinical trials (CTR), maximum recommended starting dose (MRSD), clearance and volume of distribution

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4013 Resistance of Mycobacterium tuberculosis to Daptomycin

Authors: Ji-Chan Jang

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Tuberculosis is still major health problem because there is an increase of multidrug-resistant and extensively drug-resistant forms of the disease. Therefore, the most urgent clinical need is to discover potent agents and develop novel drug combination capable of reducing the duration of MDR and XDR tuberculosis therapy. Three reference strains H37Rv, CDC1551, W-Beijing GC1237 and six clinical isolates of MDRTB were tested to daptomycin in the range of 0.013 to 256 mg/L. Daptomycin is resistant to all tested M. tuberculosis strains not only laboratory strains but also clinical MDR strains that were isolated at different source. Daptomycin will not be an antibiotic of choice for treating infection of Gram positive atypical slowly growing M. tuberculosis.

Keywords: tuberculosis, daptomycin, resistance, Mycobacterium tuberculosis

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4012 Isotretinoin and Psychiatric Adverse Events: A Review of the Evidence

Authors: Thodoris Tsagkaris, Marios Stavropoulos, Panagiotis Theodosis-Nobelos, Charalampos Triantis

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Isotretinoin is a widely used therapeutic for the treatment of acne vulgaris and various other skin disorders. However, since its approval, many side effects and contraindications have been described, particularly important, such as teratogenicity as well as liver disease and dermal deterioration. In a very important allegation, isotretinoin has been linked with psychiatric symptoms like depression, suicidal ideation, schizophrenia, and hypervitaminosis A syndrome characteristics. These adverse effects have raised significant concerns regarding the safety of isotretinoin. Numerous studies and research have associated isotretinoin with side effects on the mental health of patients and have proposed plausible mechanisms regarding this suspected causative relationship. However, the evidence is still contradicting, and the data disperse, making their validity less valuable. Thus, in the present study, we aim to analyze further the available literature and present a complete analysis of the side effects of isotretinoin, with particular emphasis on the effects it may have on the mental health of patients. The review is based on international articles from broad scientific electronic databases like PubMed and Scopus. This review concludes that although many studies have associated isotretinoin with mental effects like depression, bipolar disorder, schizophrenia, and suicidal ideation, the data are still insufficient and often contradictory. In fact, additional studies with accurate data and larger double-blinded samples, and more analytic systematic reviews are required. It is especially important to monitor the dose and the intervals that isotretinoin has to be administered in order to potentially cause mental health problems, as well as the duration of treatment and the role that the patient's medical and pharmaceutical history may play.

Keywords: acne, depression, isotretinoin, mental health

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4011 Resilience, Mental Health, and Life Satisfaction

Authors: Saba Harati, Nasrin Arian Parsa

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The current research was an attempt to investigate the effect of resilience on mental health and life satisfaction. In one Cross Sectional research, 287 (173 females and 114 males) students of Tehran University were participated their average age was 23.17 years old (SD=4.9). The instruments used for assessing the research variables included: Cutter and Davidson resilience scale (CD-RISC), the short form of the depression-anxiety-stress scale, and life satisfaction scale. The data analysis was done in the form of structural equation model. The results of Simultaneous Hierarchical Multiple Regression Analysis indicated that there was a significant mediating role of the negative emotions (depression, anxiety, and stress), in the relationship between the family resilience (p < 0.001) and satisfaction with life (p < 0.001). Resilience results in life satisfaction by reducing the emotional problems (or increasing the mental health level). The effect of the resilience variable on life satisfaction was indirect.

Keywords: resilience, negative emotion, mental health, life satisfaction

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4010 Estimating Current Suicide Rates Using Google Trends

Authors: Ladislav Kristoufek, Helen Susannah Moat, Tobias Preis

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Data on the number of people who have committed suicide tends to be reported with a substantial time lag of around two years. We examine whether online activity measured by Google searches can help us improve estimates of the number of suicide occurrences in England before official figures are released. Specifically, we analyse how data on the number of Google searches for the terms “depression” and “suicide” relate to the number of suicides between 2004 and 2013. We find that estimates drawing on Google data are significantly better than estimates using previous suicide data alone. We show that a greater number of searches for the term “depression” is related to fewer suicides, whereas a greater number of searches for the term “suicide” is related to more suicides. Data on suicide related search behaviour can be used to improve current estimates of the number of suicide occurrences.

Keywords: nowcasting, search data, Google Trends, official statistics

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4009 Interprofessional School-Based Mental Health Services for Rural Adolescents in South Australia

Authors: Garreth Kestell, Lukah Dykes, Danielle Zerk, Kyla Trewartha, Rhianon Marshall, Elena Rudnik

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Adolescent mental health is an international priority and the impact of innovative service models must be evaluated. Secondary school-based mental health services (SBMHS) involving private general practitioners and psychologists are a model of care being trialed in South Australia. Measures of depression, anxiety, and stress are routinely collected throughout psychotherapy sessions. This research set out to quantify the impact of psychotherapy for rural adolescents in a school setting and explore the importance of session frequency. Methods: Demographics, session date and DASS21 scores from students (n=65) seen in 2016 by three psychologists working at the SBMHS were recorded. Students were aged 13-18 years (M=15.43, SD= 1.24), mostly female (F=51, M=14), attended between 1 and 23 sessions with a median of 6 sessions (MAD 5.93) in one-year. The treating psychologist collected self-administered DASS21 scores. A mixed model analysis was used with age, sex, treating psychologist, months from first session, and session number as fixed effects, with response variables of DASS depression, anxiety, and stress scores. Results: 71.5% were classified as having extreme or severe anxiety and half had extreme or severe depression and/or stress scores. On average males had a greater increase in DASS scores over time but males attending more sessions benefited most from therapy. Discussion: Psychologists are treating rural adolescents in schools for severe anxiety, depression, and stress. This pilot study indicates that a predictive model combining demographics, session frequency, and DASS scores may help identify who is most likely to benefit from individual psychotherapy. Variations in DAS scores of individuals over time indicate the need for the collection of information such as living situation and exposure to alcohol. A larger sample size and additional data are currently being collected to allow for a more robust analysis.

Keywords: adolescent health, psychotherapy, school based mental health services, DAS21

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4008 Reasons to Live - Positive Psychology and Self Determination Theory in the Prevention of Depression and Suicidal Ideation

Authors: Luiz Carlos Dias Lima De Oliveira

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Psychology does not have the task of being confined only to the knowledge of losses, weaknesses or diseases, because it is necessary to give analogous dedication to the investigation of human virtues, efforts and aptitudes. The reasons for living with greater constancy and expressiveness act as a protective condition for risk behaviors, but with less constancy and expressiveness they can be a viable parameter of suicidal ideation or potential suicidal initiatives. In other words, Positive Psychology scientifically studies human strengths and virtues. In the same way, we refer to the basic psychological needs of the human being, according to the Theory of Self-Determination: the need for belonging, competence and autonomy to live the best possible life or the ability to make positive decisions in life. In this sense, following the assumptions of Positive Psychology, we raise the question of what are the reasons for living, seeking a way to draw attention to positive aspects of life.

Keywords: psychology, positive, self-determination, belonging, competence, autonomy, depression, suicide.

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4007 Endodontic Pretreatments, Clinical Opportunities and Challenges

Authors: Ilma Robo, Manola Kelmendi, Saimir Heta, Megi Tafa, Vera Ostreni

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Preservation of a natural tooth, even if endodontically treated, is more indicated than its replacement with an artificial tooth placed in prosthetic ways or with implant treatment. It is known how technology and endodontic treatment procedures have evolved significantly. It is also known that significant developments have been made in both dental prostheses and implant treatments, and again, in both specialties, it is emphasized that both the tooth placed with dental prostheses and the tooth placed with implant treatment cannot replace the natural tooth. The issue is whether long-term periapical tissue healing is achieved after a successful endodontic treatment, and for this, clinical data should be collected. In the cases when the apical closure or "apical filling" with the endodontic filling was carried out correctly clinically, but for various reasons, the healing of the periapical tissues did not occur, but also for those cases when the endodontic treatment did not reach the "apical filling" of the root canal. Teeth Endodontic retreatments have their clinical difficulty, but knowing the reason why endodontic treatment success has not been achieved clinically, the clinical endodontic approach is easier. In this process, it is important for the dentist to recognize the clinical and radiographic signs of persistent apical periodontitis or renewed apical periodontitis. After this initial procedure, dentists must know and evaluate the possibility of clinical endodontic retreatment by reporting, not precisely, but with very approximate values, the percentage of clinical success of endodontic retreatment. Depending on the reason for the performance, endodontic re-treatment may also need more specialized equipment or tools, for which even the professional who undertakes the re-treatment must be equipped with the relevant knowledge of their use and clinical application. Evaluating the clinical success of endodontic re-treatment is actually a more difficult process and requires more clinical responsibility since it must be considered that the initial treatment was performed by the same specialist as the specialist who undertakes the same endodontic re-treatment. Tooth So, the clinical endodontic re-treatment of a tooth should not be seen as a fund of clinical practice only of a good successful endodontist, but as part of routine endodontic treatments, nor should it be seen as a typical case where the tools and the most advanced technological devices in the endodontic field. So, the clinical picture of endodontic re-treatments offers the possibility of finding endodontic malpractice, the possibility of more accurate assessment of dental morphological anomalies, and above all, the cognitive and professional possibilities of the diagnosis of persistent apical periodontitis. This study offers the possibility of evaluating these three directions by presenting in numbers and in percentage the frequency of the reasons why the endodontic success of the root canal treatment is not always achieved.

Keywords: apical periodontitis, clinical susccess, endodontics, E.faecalis

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4006 The Importance of Reflection and Collegial Support for Clinical Instructors When Evaluating Failing Students in a Clinical Nursing Course

Authors: Maria Pratt, Lynn Martin

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Context: In nursing education, clinical instructors are crucial in assessing and evaluating students' performance in clinical courses. However, instructors often struggle when assigning failing grades to students at risk of failing. Research Aim: This qualitative study aims to understand clinical instructors' experiences evaluating students with unsatisfactory performance, including how reflection and collegial support impact this evaluation process. Methodology, Data Collection, and Analysis Procedures: This study employs Gadamer's Hermeneutic Inquiry as the research methodology. A purposive maximum variation sampling technique was used to recruit eight clinical instructors from a collaborative undergraduate nursing program in Southwestern Ontario. Semi-structured, open-ended, and audio-taped interviews were conducted with the participants. The hermeneutic analysis was applied to interpret the interview data to allow for a thorough exploration and interpretation of the instructors' experiences evaluating failing students. Findings: The main findings of this qualitative research indicate that evaluating failing students was emotionally draining for the clinical instructors who experienced multiple challenges, uncertainties, and negative feelings associated with assigning failing grades. However, the analysis revealed that ongoing reflection and collegial support played a crucial role in mitigating the challenges they experienced. Conclusion: This study contributes to the theoretical understanding of nursing education by shedding light on clinical instructors' challenges in evaluating failing students. It emphasizes the emotional toll associated with this process and the role that reflection and collegial support play in alleviating those challenges. The findings underscore the need for ongoing professional development and support for instructors in nursing education. By understanding and addressing clinical instructors' experiences, nursing education programs can better equip them to effectively evaluate struggling students and provide the necessary support for their professional growth.

Keywords: clinical instructor, student evaluation, nursing, reflection, support

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4005 An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Authors: Simone Huber, Bianca Schnalzer, Baptiste Alcalde, Sten Hanke, Lampros Mpaltadoros, Thanos G. Stavropoulos, Spiros Nikolopoulos, Ioannis Kompatsiaris, Lina Pérez- Breva, Vallivana Rodrigo-Casares, Jaime Fons-Martínez, Jeroen de Bruin

Abstract:

Developing new medicine and health solutions and improving patient health currently rely on the successful execution of clinical trials, which generate relevant safety and efficacy data. For their success, recruitment and retention of participants are some of the most challenging aspects of protocol adherence. Main barriers include: i) lack of awareness of clinical trials; ii) long distance from the clinical site; iii) the burden on participants, including the duration and number of clinical visits and iv) high dropout rate. Most of these aspects could be addressed with a new paradigm, namely the Remote Decentralized Clinical Trials (RDCTs). Furthermore, the COVID-19 pandemic has highlighted additional advantages and challenges for RDCTs in practice, allowing participants to join trials from home and not depend on site visits, etc. Nevertheless, RDCTs should follow the process and the quality assurance of conventional clinical trials, which involve several processes. For each part of the trial, the Building Blocks, existing software and technologies were assessed through a systematic search. The technology needed to perform RDCTs is widely available and validated but is yet segmented and developed in silos, as different software solutions address different parts of the trial and at various levels. The current paper is analyzing the availability of technology to perform RDCTs, identifying gaps and providing an overview of Basic Building Blocks and functionalities that need to be covered to support the described processes.

Keywords: architectures and frameworks for health informatics systems, clinical trials, information and communications technology, remote decentralized clinical trials, technology availability

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4004 A Report on the Elearning Programme of the Irish College of General Practitioners Which Can Address Continuing Education Needs of Primary Care Physicians

Authors: Nicholas P. Fenlon, Aisling Lavelle, David Mclean, Margaret O'riordan

Abstract:

Background: The case for continuing professional development has been well made, and was formalized in Ireland in recent years through the enactment of the Medical Practitioner’s Act, which requires registered medical practitioners to complete a minimum of 50 hours CPD each year. The ICGP, who have been providing CPD opportunities to its members for many years, have responded to this need by developing a series of evidence-based, high-quality, multimedia modules across a range of clinical and non-clinical areas. (More traditional education opportunities are still being provided by the college also). Overview of Programme: The first module was released in September 2011, since when the eLearning program has grown steadily, and there are currently almost 20 modules available, with a further 5 in production. Each module contains three to six 10-minute video lessons, which use a combination of graphics, images, text, voice-over and clinical clips. These are supported by supplementary videos of expert pieces-to-camera, Q&As with content experts, clinical scenarios, external links and relevant documentation and other resources. Successful completion of MCQs will result in a Certificate of Completion, which can be printed or stored in Professional Competence portfolio. The Medical Practitioner’s Act requires doctors to gather CPD credits across 8 domains of practice, and various eLearning modules have been developed to address each. For instance, modules with a strong clinical content would include Management of Hypertension, Management of COPD, and Management of Asthma. Other modules focus on health promotion such as Promoting Smoking Cessation, Promoting Physical Activity, and Addressing Childhood Obesity. Modules where communication skills are keys include modules on Suicide Prevention and Management of Depression. Other modules, currently in development include non-clinical topics around risk management, including Confidentiality, Consent etc. Each module is developed by a core group, which includes where possible, a GP with a special interest in the area, and a content expert(s). The college works closely with a medical education consultant and a production company in developing and producing the modules. Modules can be accessed (with password) through the ICGP website and are available free to all ICGP members. Summary of Evaluation: There are over 1700 registered users to date (over 55% of College membership). The program was evaluated using an online survey in 2013 (N = 144/950 – 12%) and results were very positive overall but provided material for the further improvement of the program also. Future Plans: While knowledge can be imparted well through eLearning, skills and attitudes are more difficult to influence through an online environment. The college is now developing a series of linked workshops, which will lead to ICGP Professional Competence Awards. The first pilot workshop is scheduled for February 2015 and is Cardiology-themed. Participants will be required to complete the following 4 modules in advance of attending – Management of Hypertension, Management of Heart Failure, Promoting Smoking Cessation, and Promoting Physical Activity. The workshop will be case-based and interactive, addressing ECG Interpretation in General Practice. Conclusions: The ICGP have responded to members needs for high-quality evidence-based education delivered in a way that suits GPs.

Keywords: CPD opportunities, evidence-based, high quality, multimedia modules across a range of clinical and non-clinical areas, medical practitioner’s act

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4003 Techno-Psych Serv: Technology-Based Psychological Services Extended to Adults Experiencing Symptoms of Mild Anxiety and Depression

Authors: Marissa C. Esperal

Abstract:

This university-based research project attempted to determine the relevance and effectiveness of the technology-based psychological services extended to selected adults experiencing symptoms of mild anxiety and depression. Ninety-seven participants who voluntarily availed the free online psychological services advertised through a Facebook page (Techno-Psych Serv) signed up for the Informed Consent and Psychological Services Contract Agreement form. These clients availed a maximum of 5 online sessions devoted to online assessment, online counseling and brief therapy sessions using the Google Meet App. Participants who, upon evaluation, were found to still be needing extended psychological and other services were referred to other mental health services institutions. Post-evaluations were conducted using Google Forms upon termination. Findings showed that with a mean of 4.87 (n=97), it was noted that the services provided through the online platform were effective. However, it was noted that the majority of those who availed the services were professionals and skilled workers, thus defeating the objective of extending free psychological services to the marginalized group. It was concluded that offering free technology-based psychological services, though proven effective, is found to be less relevant if the intention is to reach out to the less fortunate and marginalized group. It was further concluded that there is still a need for psychoeducation and mental health promotion among the marginalized sectors. It was recommended that if mental health services are extended to the community of marginalized group, providing physical services are still a better option.

Keywords: technology-based psychological services, adults, mild anxiety, depression

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4002 Psychological Impact of the COVID-19 Pandemic on Health Care Workers in Tunisia: Risk and Protective Factor

Authors: Ahmed Sami Hammami, Mohamed Jellazi

Abstract:

Background: The aim of the study is to evaluate the magnitude of different psychological outcomes among Tunisian health care professionals (HCP) during the COVID-19 pandemic and to identify the associated factors. Methods: HCP completed a cross-sectional questionnaire from April 4th to April, 28th 2020. The survey collected demographic information, factors that may interfere with the psychological outcomes, behavior changes and mental health measurements. The latter was assessed through 3 scales; the 7-item questions Insomnia Severity Index, the 2-item Patient Health Questionnaire and the 2-item Generalized Anxiety Disorder. Multivariable logistic regression was conducted to identify factors associated with psychological outcomes. Results: A total of 503 HCP successfully completed the survey; among those, n=493 consented to enroll in the study, 411 [83.4%] were physicians, 323 [64.2%] were women and 271 [55%] had a second-line working position. A significant proportion of HCP had anxiety 35.7%, depression 35.1% and insomnia 23.7%. Females, those with psychiatric history and those using public transport exhibited the highest proportions for overall symptoms compared to other groups e.g., depression among females vs. males: 44,9% vs. 18,2%, P=0.00. Those with a previous medical history and nurses, had more anxiety and insomnia compared to other groups e.g. anxiety among nurses vs. interns/residents vs. attending 45,1% vs 36,1% vs 27,5%; p=0.04. Multivariable logistic regression showed that female gender was a risk factor for all psychological outcomes e.g. female sex increased the odds of anxiety by 2.86; 95% confidence interval [CI], 1, 78-4, 60; P=0.00, whereas having a psychiatric history was a risk factor for both anxiety and insomnia. (e.g. for insomnia OR=2,86; 95% [CI], 1,78-4,60; P=0.00), Having protective equipment was associated with lower risk for depression (OR=0,41; 95% CI, 0,27-0,62; P=0.00) and anxiety. Physical activity was also protective against depression and anxiety (OR=0,41, 95% CI, 0,25-0,67, P=0.00). Conclusion: Psychological symptoms are usually undervalued among HCP, though the COVID-19 pandemic played a major role in exacerbating this burden. Prompt psychological support should be endorsed and simple measures such as physical activity and ensuring the necessary protection are paramount to improve mental health outcomes and the quality of care provided to patients.

Keywords: COVID-19 pandemic, health care professionals, mental health, protective factors, psychological symptoms, risk factors

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4001 The Relationship between Elderly People with Depression and Built Environment Factors

Authors: Hung-Chun Lin, Tzu-Yuan Chao

Abstract:

As the population aging has become an inevitable trend globally, issues of improving the well-being of elderly people in urban areas have been a challenging task for urban planners. Recent studies of ageing trend have also expended to explore the relationship between the built environment and mental condition of elderly people. These studies have proved that even though the built environment may not necessarily play the decisive role in affecting mental health, it can have positive impacts on individual mental health by promoting social linkages and social networks among older adults. There has been a great amount of relevant research examined the impact of the built environment attributes on depression in the elderly; however, most were conducted in the Western countries. Little attention has been paid in Asian cities with contrarily high density and mix-use urban contexts such as Taiwan regarding how the built environment attributes related to depression in elderly people. Hence, more empirical cross-principle studies are needed to explore the possible impacts of Asia urban characteristics on older residents’ mental condition. This paper intends to focus on Tainan city, the fourth biggest metropolis in Taiwan. We first analyze with data from National Health Insurance Research Database to pinpoint the empirical study area where residing most elderly patients, aged over 65, with depressive disorders. Secondly, we explore the relationship between specific attributes of the built environment collected from previous studies and elderly individuals who suffer from depression, under different socio-cultural and networking circumstances. To achieve the results, the research methods adopted in this study include questionnaire and database analysis, and the results will be proceeded by correlation analysis. In addition, through literature review, by generalizing the built environment factors that have been used in Western research to evaluate the relationship between built environment and older individuals with depressive disorders, a set of local evaluative indicators of the built environment for future studies will be proposed as well. In order to move closer to develop age-friendly cities and improve the well-being for the elderly in Taiwan, the findings of this paper can provide empirical results to grab planners’ attention for how built environment makes the elderly feel and to reconsider the relationship between them. Furthermore, with an interdisciplinary topic, the research results are expected to make suggestions for amending the procedures of drawing up an urban plan or a city plan from a different point of view.

Keywords: built environment, depression, elderly, Tainan

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4000 A Script for Presentation to the Management of a Teaching Hospital on MYCIN: A Clinical Decision Support System

Authors: Rashida Suleiman, Asamoah Jnr. Boakye, Suleiman Ahmed Ibn Ahmed

Abstract:

In recent years, there has been an enormous success in discoveries of scientific knowledge in medicine coupled with the advancement of technology. Despite all these successes, diagnoses and treatment of diseases have become complex. MYCIN is a groundbreaking illustration of a clinical decision support system (CDSS), which was developed to assist physicians in the diagnosis and treatment of bacterial infections by providing suggestions for antibiotic regimens. MYCIN was one of the earliest expert systems to demonstrate how CDSSs may assist human decision-making in complicated areas. Relevant databases were searched using google scholar, PubMed and general Google search, which were peculiar to clinical decision support systems. The articles were then screened for a comprehensive overview of the functionality, consultative style and statistical usage of MYCIN, a clinical decision support system. Inferences drawn from the articles showed some usage of MYCIN for problem-based learning among clinicians and students in some countries. Furthermore, the data demonstrated that MYCIN had completed clinical testing at Stanford University Hospital following years of research. The system (MYCIN) was shown to be extremely accurate and effective in diagnosing and treating bacterial infections, and it demonstrated how CDSSs might enhance clinical decision-making in difficult circumstances. Despite the challenges MYCIN presents, the benefits of its usage to clinicians, students and software developers are enormous.

Keywords: clinical decision support system, MYCIN, diagnosis, bacterial infections, support systems

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3999 Survey on Resilience of Chinese Nursing Interns: A Cross-Sectional Study

Authors: Yutong Xu, Wanting Zhang, Jia Wang, Zihan Guo, Weiguang Ma

Abstract:

Background: The resilience education of intern nursing students has significant implications for the development and improvement of the nursing workforce. The clinical internship period is a critical time for enhancing resilience. Aims: To evaluate the resilience level of Chinese nursing interns and identify the factors affecting resilience early in their careers. Methods: The cross-sectional study design was adopted. From March 2022 to May 2023, 512 nursing interns in tertiary care hospitals were surveyed online with the Connor-Davidson Resilience Scale, the Clinical Learning Environment scale for Nurse, and the Career Adapt-Abilities Scale. Structural equation modeling was used to clarify the relationships among these factors. Indirect effects were tested using bootstrapped Confidence Intervals. Results: The nursing interns showed a moderately high level of resilience[M(SD)=70.15(19.90)]. Gender, scholastic attainment, had a scholarship, career adaptability and clinical learning environment were influencing factors of nursing interns’ resilience. Career adaptability and clinical learning environment positively and directly affected their resilience level (β = 0.58, 0.12, respectively, p<0.01). career adaptability also positively affected career adaptability (β = 0.26, p < 0.01), and played a fully mediating role in the relationship between clinical learning environment and resilience. Conclusion: Career adaptability can enhance the influence of clinical learning environment on resilience. The promotion of career adaptability and the clinical teaching environment should be the potential strategies for nursing interns to improve their resilience, especially for those female nursing interns with low academic performance. Implications for Nursing Educators Nursing educators should pay attention to the cultivation of nursing students' resilience; for example, by helping them integrate to the clinical learning environment and improving their career adaptability. Reporting Method: The STROBE criteria were used to report the results of the observations critically. Patient or Public Contribution No patient or public contribution.

Keywords: resilience, clinical learning environment, career adaptability, nursing interns

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3998 Adverse Childhood Experiences and the Sense of Effectiveness and Coping with Emotions among Adolescents Taking Drugs

Authors: Monika Szpringer, Aneta Pawlinska

Abstract:

Adverse childhood experiences are linked to various types of health and adapt problems at different stages of life. They include various types of abuse, neglect, and dysfunctional environment. They have an unfavorable impact on the development of a child and his future functioning in society. Adolescents who were exposed to bad treatment may suffer from health problems during adulthood, like chronic diseases, psychological disorders, drug addiction, and suicide attempts. Objective: The aim of the project is to assess the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs. Material And Methods: The research was carried out in the period from March to December 2018 in Mazowieckie, Świętokrzyskie, Łódzkie, and Lubelskie Voivodship. The group consisted of 600 people aged 16-18 (M=16,58; SD=0, 78), men (63,2%) aged 16-18 (M=16,60;SD= 0,78) and women (35,5%) aged 16-18 (M16,55;SD=0,79). Participants included residents from Youth Educational Centers and Youth Sociotherapy Centers. Each participant filled in Author's Questionnaire, Adverse Childhood Questionnaire, then Courtland Emotional Control Scale-CECS and Generalized Self Efficacy Scale-GSES. Results and conclusions: The most common adverse experiences, according to teenagers, were family abuse, divorce/separation/parent's death, overuse of alcohol or drugs by an inmate, and emotional neglect. Adolescents who suffered from five to twelve adverse experiences had a higher level of depression's control. Adverse childhood experiences have an importance for the level of anger and depression's control among teenagers taking drugs. The greatest importance of the level of anger's control has emotional neglect. A higher level of emotional neglect is linked to a lower ability to control anger. The greatest importance of the level of depression's control has physical abuse and emotional neglect. The higher physical abuse during childhood, and the higher frequency of emotional neglect, the bigger the depression's control. The sense of efficacy in the group of people who suffered from one to four adverse experiences is close to the sense of efficacy that suffered people from five to twelve adverse experiences. The most important factor lowering the sense of one's efficacy was the intensification of sexual abuse. It was confirmed that the intensification and frequency of adverse childhood experiences were higher among women than men. Women also characterized lower anger control and greater depression's control. The authors’ own analyses confirmed the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs.

Keywords: adolescences, adverse childhood experiences, coping with emotions, drugs

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3997 An Open-Label Phase I Clinical Study: Safety, Tolerability and Pharmacodynamics of Mutant Collagenase Injection in Adults for Localized Fat Reduction

Authors: Yong Cang

Abstract:

RJV001 is a subcutaneous injection containing mutated recombinant Collagenase H (ColH), leading to disruption of collagen matrix in adipose tissue and programmed cell death of adipocytes. Here we reported our clinical investigation of the safety, tolerance and pharmacodynamics of localized RJV001 injection into healthy human abdominal fat tissues (NCT04821648, Arizona Research Center). Investigate the safety, tolerance and clinical pharmacodynamics of subcutaneous RJV001 in humans. In the dose-escalating study, 18 subjects completed the study, 100% female, 78% white, with a mean age of 42[±9.9]. All three tested dose (0.05, 0.075 and 0.15 mg/injection), up to 30 injections, were safe and well-tolerated. Bruising and tenderness to palpation, mild to moderate, were the most frequent local skin reactions but nearly all resolved within 30 days. Additionally, physician-monitored ultrasound measurement showed that a reduction in abdominal fat tissue thickness was consistently observed in Cohort C (0.075, 0.15 mg/injection, 30injections), with a mean reduction of 7.37 [± 2.020] mm. Based on this clinical study, RJV001 has been advanced to phase II clinical studies. In the dose-escalating study, subcutaneously administered RJV001 was safe and well-tolerated in healthy adults up to 0.15 mg/injection, 30 injections. Fat reduction and adipocytolysis were observed by ultrasound measurements and histological analysis for exploratory purposes.

Keywords: fat reduction, mutant collagenase, clinical trial, subcutaneous injection

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3996 Efficacy and Safety of Computerized Cognitive Training Combined with SSRIs for Treating Cognitive Impairment Among Patients with Late-Life Depression: A 12-Week, Randomized Controlled Study

Authors: Xiao Wang, Qinge Zhang

Abstract:

Background: This randomized, open-label study examined the therapeutic effects of computerized cognitive training (CCT) combined with selective serotonin reuptake inhibitors (SSRIs) on cognitive impairment among patients with late-life depression (LLD). Method: Study data were collected from May 5, 2021, to April 21, 2023. Outpatients who met diagnostic criteria for major depressive disorder according to the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria (i.e., a total score on the 17-item Hamilton Depression Rating Scale (HAMD-17) ≥ 18 and a total score on the Montreal Cognitive Assessment scale (MOCA) <26) were randomly assigned to receive up to 12 weeks of CCT and SSRIs treatment (n=57) or SSRIs and Control treatment (n=61). The primary outcome was the change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores from baseline to week 12 between the two groups. The secondary outcomes included changes in the HAMD-17 score, Hamilton Anxiety Scale (HAMA) score and Neuropsychiatric Inventory (NPI) score. Mixed model repeated measures (MMRM) analysis was performed on modified intention-to-treat (mITT) and completer populations. Results: The full analysis set (FAS) included 118 patients (CCT and SSRIs group, n=57; SSRIs and Control group, n =61). Over the 12-week study period, the reduction in the ADAS-cog total score was significant (P < 0.001) in both groups, while MMRM analysis revealed a significantly greater reduction in cognitive function (ADAS-cog total scores) from baseline to posttreatment in the CCT and SSRIs group than in the SSRI and Control group [(F (1,115) =13.65, least-squares mean difference [95% CI]: −2.77 [−3.73, −1.81], p<0.001)]. There were significantly greater improvements in depression symptoms (measured by the HAMD-17) in the CCT and SSRIs group than in the control group [MMRM, estimated mean difference (SE) between groups −3.59 [−5.02, −2.15], p < 0.001]. The least-squares mean changes in the HAMA scores and NPI scores between baseline and week 8 were greater in the CCT and SSRIs group than in the control group (all P < 0.05). There was no significant difference between groups on response rates and remission rates by using the last-observation-carried-forward (LOCF) method (all P > 0.05). The most frequent adverse events (AEs) in both groups were dry mouth, somnolence, and constipation. There was no significant difference in the incidence of adverse events between the two groups. Conclusions: CCT combined with SSRIs was efficacious and well tolerated in LLD patients with cognitive impairment.

Keywords: late-life depression, cognitive function, computerized cognitive training, SSRIs

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3995 OnabotulinumtoxinA Injection for Glabellar Frown Lines as an Adjunctive Treatment for Depression

Authors: I. Witbooi, J. De Smidt, A. Oelofse

Abstract:

Negative emotions that are common in depression are coupled with the activation of the corrugator supercilli and procerus muscles in the glabellar region of the face. This research investigated the impact of OnabotulinumtoxinA (BOTOX) in the improvement of emotional states in depressed subjects by relaxing the mentioned muscles. The aim of the study was to investigate the effectiveness of BOTOX treatment for glabellar frown lines as an adjunctive therapy for Major Depressive Disorder (MDD) and to improve the quality of life and self-esteem of the subjects. It is hypothesized that BOTOX treatment for glabellar frown lines reduces depressive symptoms significantly and therefore augment conventional antidepressant medication. Forty-five (45) subjects diagnosed with MDD were assigned to a treatment (n = 15), placebo (n = 15), and control (n = 15) group. The treatment group received BOTOX injection, while the placebo group received saline injection into the Procerus and Corrugator supercilli muscles with follow-up visits every 3 weeks (weeks 3, 6 and 12 respectively). The control group received neither BOTOX nor saline injections and were only interviewed again on the 12th week. To evaluate the effect of BOTOX treatment in the glabellar region on depressive symptoms, the Montgomery-Asberg Depression Rating (MADRS) scale and the Beck Depression Inventory (BDI) were used. The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) and Rosenberg Self-Esteem Scale (RSES) were used in the assessment of self-esteem and quality of life. Participants were followed up for a 12 week period. The expected primary outcome measure is the response to treatment, and it is defined as a ≥ 50% reduction in MADRS score from baseline. Other outcome measures include a clinically significant decrease in BDI scores and the increase in quality of life and self-esteem respectively. Initial results show a clear trend towards such differences. Results showed trends towards expected differences. Patients in the Botox group had a mean MADRS score of 14.0 at 3 weeks compared to 20.3 of the placebo group. This trend was still visible at 6 weeks with the Botox and placebo group scoring an average of 10 vs. 18 respectively. The mean difference in MDRS scores from baseline to 3 weeks were 9.3 and 2.0 for the Botox and placebo group respectively. Similarly, the BDI scores were lower in the Botox group (17.25) compared to the placebo group (19.43). The two self-esteem questionnaires showed expected results at this stage with the RSES 19.1 in the Botox group compared to 18.6 in the placebo group. Similarly, the Botox patients had a higher score for the Q-LES-Q-SF of 49.2 compared to 46.1 for the placebo group. Conclusions: Initial results clearly demonstrated that the use of Botox had positive effects on both scores of depressions and that of self-esteem when compared to a placebo group.

Keywords: adjunctive therapy, depression, glabellar area, OnabotulinumtoxinA

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