Search results for: clinical trials (CTR)

Authors: Lukman Thalib, Luis Furuya-Kanamori, Rachel Walker, Brigid Gillespie, Suhail Doi

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Background and objectives: There are many topical treatments available for Pressure Injury (PI) treatment, yet there is a lack of evidence with regards to the most effective treatment. The objective of this study was to compare the effect of various topical treatments and identify the best treatment choice(s) for PI healing. Methods: Network meta-analysis of published randomized controlled trials that compared the two or more of the following dressing groups: basic, foam, active, hydroactive, and other wound dressings. The outcome complete healing following treatment and the generalised pair-wise modelling framework was used to generate mixed treatment effects against hydroactive wound dressing, currently the standard of treatment for PIs. All treatments were then ranked by their point estimates. Main Results: 40 studies (1,757 participants) comparing 5 dressing groups were included in the analysis. All dressings groups ranked better than basic (i.e. saline gauze or similar inert dressing). The foam (RR 1.18; 95%CI 0.95-1.48) and active wound dressing (RR 1.16; 95%CI 0.92-1.47) ranked better than hydroactive wound dressing in terms of healing of PIs when the latter was used as the reference group. Conclusion & Recommendations: There was considerable uncertainty around the estimates, yet, the use of hydroactive wound dressings appear to perform better than basic dressings. Foam and active wound dressing groups show promise and need further investigation. High-quality research on clinical effectiveness of the topical treatments are warranted to identify if foam and active wound dressings do provide advantages over hydroactive dressings.

Keywords: Net work Meta Analysis, Pressure Injury, Dresssing, Pressure Ulcer

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Authors: Johnson C. Y. Pang, Amy S. N. Fu, Ryan K. L. Lee, Allan C. L. Fu

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Dry needling (DN) is one of the puncturing methods that involves the insertion of needles into the tender spots of the human body without the injection of any substance. DN has long been used to treat the patient with knee pain caused by knee osteoarthritis (KOA) and patellofemoral pain syndrome (PFPS), but the effectiveness is still inconsistent. This study aimed to conduct a systematic review and meta-analysis to assess the intervention methods and effects of DN with and without ultrasound guidance for treating pain and dysfunctions in people with KOA and PFPS. Design: This systematic review adhered to the PRISMA reporting guidelines. The registration number of the study protocol published in the PROSPERO database was CRD42021221419. Six electronic databases were searched manually through CINAHL Complete (1976-2020), Cochrane Library (1996-2020), EMBASE (1947-2020), Medline (1946-2020), PubMed (1966-2020), and Psychinfo (1806-2020) in November 2020. Randomized controlled trials (RCTs) and controlled clinical trials were included to examine the effects of DN on knee pain, including KOA and PFPS. The key concepts included were: DN, acupuncture, ultrasound guidance, KOA, and PFPS. Risk of bias assessment and qualitative analysis were conducted by two independent reviewers using the PEDro score. Results: Fourteen articles met the inclusion criteria, and eight of them were high-quality papers in accordance with the PEDro score. There were variations in the techniques of DN. These included the direction, depth of insertion, number of needles, duration of stay, needle manipulation, and the number of treatment sessions. Meta-analysis was conducted on eight articles. DN group showed positive short-term effects (from immediate after DN to less than 3 months) on pain reduction for both KOA and PFPS with the overall standardized mean difference (SMD) of -1.549 (95% CI=-0.588 to -2.511); with great heterogeneity (P=0.002, I²=96.3%). In subgroup analysis, DN demonstrated significant effects in pain reduction on PFPS (p < 0.001) that could not be found in subjects with KOA (P=0.302). At 3-month post-intervention, DN also induced significant pain reduction in both subjects with KOA and PFPS with an overall SMD of -0.916 (95% CI=-0.133 to -1.699, and great heterogeneity (P=0.022, I²=95.63%). Besides, DN induced significant short-term improvement in function with the overall SMD=6.069; 95% CI=8.595 to 3.544; with great heterogeneity (P<0.001, I²=98.56%) when analyzed was conducted on both KOA and PFPS groups. In subgroup analysis, only PFPS showed a positive result with SMD=6.089, P<0.001; while KOA showed statistically insignificant with P=0.198 in short-term effect. Similarly, at 3-month post-intervention, significant improvement in function after DN was found when the analysis was conducted in both groups with the overall SMD=5.840; 95% CI=9.252 to 2.428; with great heterogeneity (P<0.001, I²=99.1%), but only PFPS showed significant improvement in sub-group analysis (P=0.002, I²=99.1%). Conclusions: The application of DN in KOA and PFPS patients varies among practitioners. DN is effective in reducing pain and dysfunction at short-term and 3-month post-intervention in individuals with PFPS. To our best knowledge, no study has reported the effects of DN with ultrasound guidance on KOA and PFPS. The longer-term effects of DN on KOA and PFPS are waiting for further study.

Keywords: dry needling, knee osteoarthritis, patellofemoral pain syndrome, ultrasound guidance

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Authors: Sayantika Biswas, Dipanshu Sur, Amitoj Athwal, Ratnabali Chakravorty

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Title: Impact of serum estrogen and progesterone levels in the outcome pregnancy rate in frozen embryo transfer cycles. A prospective cohort study Objective: The aim of the current study was to evaluate the effect of serum estradiol (E2) and progesterone (P4) levels at different time points on pregnancy outcomes in frozen embryo transfer (FET) cycles. Materials & Method: A prospective cohort study was performed in patients undergoing frozen embryo transfer. Patients under age 37 years of age with at least one good blastocyst or three good day 3 embryos were included in the study. For endometrial preparation, 14 days of oral estradiol use (2X2 mg for 5 days. 3X2 mg for 4 days, and 4X2 mg for 5 days) was followed by vaginal progesterone twice a day and 50 mg intramuscular progesterone twice a day. Embryo transfer was scheduled 72-76 hrs or 116-120hrs after the initiation of progesterone. Serum E2 and P4 levels were examined at 4 times a) at the start of the menstrual cycle prior to the hormone supplementation. b) on the day of P4 start. c) on the day of ET. d) on the third day after ET. Result: A total 41 women were included in this study (mean age 31.8; SD 2.8). Clinical pregnancy rate was 65.55%. Serum E2 levels on at the start of the menstrual cycle prior to the hormone supplementation and on the day of P4 start were high in patients who achieved pregnancy compared to who did not (P=0.005 and P=0.019 respectively). P4 levels on on the day of ET were also high in patients with clinical pregnancy. On the day of P4 start, a serum E2 threshold of 186.4 pg/ml had a sensitivity of 82%, and P4 had a sensitivity of 71% for the prediction of clinical pregnancy at the threshold value 16.00 ng/ml. Conclusion: In women undergoing FET with hormone replacement, serum E2 level >186.4 pg/ml on the day of the start of progesterone and serum P4 levels >16.00 ng/ml on embryo transfer day are associated with clinical pregnancy.

Keywords: serum estradiol, serum progesterone, clinical pregnancy, frozen embryo transfer

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Authors: Ricardo Munguia-Perez, Nayeli Remigio-Alvarado, M.Miriam Hernandez-Arroyo, Elsa Castañeda-Roldan

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Fungi have emerged as important pathogens causing morbidity and mortality mainly in immunosuppressed, malnourished and elderly patients. It has detected an increase in resistance to azoles primarily to fluconazol. The fungal infections have become a problem of public health for the resistance to antifungal agents, they have developed new antifungals with broad-spectrum. The aim of this study was determine the antifungal susceptibility of yeasts isolated from clinical samples (respiratory secretions, exudates, wounds, blood cultures, urine cultures) obtained from inpatients and outpatients of a tertiary hospital from State of Puebla. The antifungal susceptibility of the yeast from several clinical samples were determined by the CLS M44-A disk diffusion methods. 149 samples of yeast were analyzed. All species were 100% susceptible to nystatin and amphotericin B. Candida albicans showed resistance of 95.5 % to fluconazole, 50.7 % to 5-flurocytosine and 55.2 % intermediate susceptibility to ketoconazole. Candida glabrata 81.3 % was susceptibility to ketoconazole and 75 % to fluconazole, for the case of 5-flurocytosine the 56.3 % was susceptible. Candida krusei 100 % was susceptible to ketoconazole, 50 % to fluconazole and 37.5 % to 5-flurocytosine. The internal medicine have greater diversity of yeast, the samples have susceptibility of 64.7% to ketoconazole, 47.1 % to fluconazole and 27.5 % to 5-flurocytosine. Hospitalized patients are more resistant to fluconazole and nystatin, but in the case of outpatients presents resistance to ketoconazole.

Keywords: antifungal, susceptibility, yeast, clinical samples

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Authors: Corbel Camille, Le Cerf Flora, Corveleyn Xavier

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Introduction: Aging is a physiological phenomenon accompanied by anatomical and cognitive changes leading to anxiety and pain. This could have significant impacts on quality of life, life expectancy, and the progression of cognitive disorders. Virtual Reality Intervention (VRI) is increasingly recognized as a non-pharmacological approach to alleviate pain and anxiety in children and young adults. However, while recent studies have explored the feasibility of applying VRI in the older population, confirmation through studies is still required to establish its benefits in various contexts. Objective: This pilot study, following a clinical trial methodology international recommendation for VRI in healthcare, aims to evaluate the feasibility and effects of using VRI with a 101-year-old woman residing in a nursing home undergoing weekly painful and anxious wound dressing changes. Methods: Following the international recommendations, this study focused on feasibility and preliminary results. A Single Case Experimental Design protocol consists of two distinct phases: control (Phase A) and personalized VRI (Phase B), each lasting for 6 sessions. Data were collected before, during and after the care, using measures of pain (Algoplus and numerical scale), anxiety (Hospital anxiety scale and numerical scale), VRI experience (semi-structured interview) and physiological measures. Results: The results suggest that the utilization of VRI is both feasible and well-tolerated by the participant. VRI contributed to a decrease in pain and anxiety during care sessions, with a more significant impact on pain compared to anxiety, which showed a gradual and slight decrease. Physiological data, particularly those related to stress, also indicate a reduction in physiological activity during VRI. Conclusion: This pilot study confirms the feasibility and benefits of using virtual reality in managing pain and anxiety in an older adult in a nursing home. In light of these results, it is essential that future studies focus on setting up randomized controlled trials (RCTs). These studies should involve a representative number of older adults to ensure generalizable data. This rigorous, controlled methodology will enable us to assess the effectiveness of virtual reality more accurately in various care settings, measure its impact on clinical parameters such as pain and anxiety, and explore the long-term implications of this intervention.

Keywords: anxiety reduction, nursing home, older adult, pain management, virtual reality

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Authors: Suin Seo, Sung-Il Cho

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Background: The use of mobile apps for smoking cessation has grown exponentially in recent years. Yet, there were limited researches which evaluated the quality of smoking cessation apps to our knowledge. In most cases, a clinical practice guideline which is focused on clinical physician was used as an evaluation tool. Objective: The objective of this study was to develop a user-centered measure for quality of mobile smoking cessation apps. Methods: A literature search was conducted to identify articles containing explicit smoking cessation guideline for smoker published until January 2018. WHO’s guide for tobacco users to quit was adopted for evaluation tool which assesses smoker-oriented contents of smoking cessation apps. Compared to the clinical practice guideline, WHO guideline was designed for smokers (non-specialist). On the basis of existing criteria which was developed based on 2008 clinical practice guideline for Treating Tobacco Use and Dependence, evaluation tool was modified and developed by an expert panel. Results: There were five broad categories of criteria that were identified including five objective quality scales: enhancing motivation, assistance with a planning and making quit attempts, preparation for relapse, self-efficacy, connection to smoking. Enhancing motivation and assistance with planning and making quit attempts were similar to contents of clinical practice guideline, but preparation for relapse, self-efficacy and connection to smoking (environment or habit which reminds of smoking) only existed on WHO guideline. WHO guideline had more user-centered elements than clinical guideline. Especially, self-efficacy is the most important determinant of behavior change in accordance with many health behavior change models. With the WHO guideline, it is now possible to analyze the content of the app in the light of a health participant, not a provider. Conclusion: The WHO guideline evaluation tool is a simple, reliable and smoker-centered tool for assessing the quality of mobile smoking cessation apps. It can also be used to provide a checklist for the development of new high-quality smoking cessation apps.

Keywords: smoking cessation, evaluation, mobile application, WHO, guideline

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Authors: Natalia C. E. S. Nascimento, Mercia L. Oliveira, Fernando R. A. Lima, Leonardo T. C. do Nascimento, Marina B. Silveira, Brigida G. A. Schirmer, Andrea V. Ferreira, Carlos Malamut, Juliana B. da Silva

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Tissue hypoxia is a common characteristic of solid tumors leading to decreased sensitivity to radiotherapy and chemotherapy. In the clinical context, tumor hypoxia assessment employing the positron emission tomography (PET) tracer ¹⁸F-fluoromisonidazole ([¹⁸F]FMISO) is helpful for physicians for planning and therapy adjusting. The aim of this work was to implement the synthesis of 18F-FMISO in a TRACERlab® MXFDG module and also to establish the quality control procedure. [¹⁸F]FMISO was synthesized at Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN/Brazil) using an automated synthesizer (TRACERlab® MXFDG, GE) adapted for the production of [¹⁸F]FMISO. The FMISO chemical standard was purchased from ABX. 18O- enriched water was acquired from Center of Molecular Research. Reagent kits containing eluent solution, acetonitrile, ethanol, 2.0 M HCl solution, buffer solution, water for injections and [¹⁸F]FMISO precursor (dissolved in 2 ml acetonitrile) were purchased from ABX. The [¹⁸F]FMISO samples were purified by Solid Phase Extraction method. The quality requirements of [¹⁸F]FMISO are established in the European Pharmacopeia. According to that reference, quality control of [¹⁸F]FMISO should include appearance, pH, radionuclidic identity and purity, radiochemical identity and purity, chemical purity, residual solvents, bacterial endotoxins, and sterility. The duration of the synthesis process was 53 min, with radiochemical yield of (37.00 ± 0.01) % and the specific activity was more than 70 GBq/µmol. The syntheses were reproducible and showed satisfactory results. In relation to the quality control analysis, the samples were clear and colorless at pH 6.0. The spectrum emission, measured by using a High-Purity Germanium Detector (HPGe), presented a single peak at 511 keV and the half-life, determined by the decay method in an activimeter, was (111.0 ± 0.5) min, indicating no presence of radioactive contaminants, besides the desirable radionuclide (¹⁸F). The samples showed concentration of tetrabutylammonium (TBA) < 50μg/mL, assessed by visual comparison to TBA standard applied in the same thin layer chromatographic plate. Radiochemical purity was determined by high performance liquid chromatography (HPLC) and the results were 100%. Regarding the residual solvents tested, ethanol and acetonitrile presented concentration lower than 10% and 0.04%, respectively. Healthy female mice were injected via lateral tail vein with [¹⁸F]FMISO, microPET imaging studies (15 min) were performed after 2 h post injection (p.i), and the biodistribution was analyzed in five-time points (30, 60, 90, 120 and 180 min) after injection. Subsequently, organs/tissues were assayed for radioactivity with a gamma counter. All parameters of quality control test were in agreement to quality criteria confirming that [¹⁸F]FMISO was suitable for use in non-clinical and clinical trials, following the legal requirements for the production of new radiopharmaceuticals in Brazil.

Keywords: automatic radiosynthesis, hypoxic tumors, pharmacopeia, positron emitters, quality requirements

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Authors: Debjyoti Bhakat, Indranil Mondal, Asish K. Mukhopadayay, Nabendu S. Chatterjee

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Enterotoxigenic Escherichia coli is one of the leading causes of diarrhea in infants and travelers in developing countries. Colonization factors play an important role in pathogenesis and are one of the main targets for Enterotoxigenic Escherichia coli (ETEC) vaccine development. However, ETEC vaccines had poorly performed in the past, as the prevalence of colonization factors is region-dependent. There are more than 25 classical colonization factors presently known to be expressed by ETEC, although all are not expressed together. Further, there are other multiple non-classical virulence factors that are also identified. Here the presence and expression of common classical and non-classical virulence factors were studied. Further studies were done on the expression of prevalent colonization factors in different strains. For the prevalence determination, multiplex polymerase chain reaction (PCR) was employed, which was confirmed by simplex PCR. Quantitative RT-PCR was done to study the RNA expression of these virulence factors. Strains negative for colonization factors expression were confirmed by SDS-PAGE. Among the clinical isolates, the most prevalent toxin was est+elt, followed by est and elt, while the pattern was reversed in the control strains. There were 29% and 40% strains negative for any classical colonization factors (CF) or non-classical virulence factors (NCVF) among the clinical and control strains, respectively. Among CF positive ETEC strains, CS6 and CS21 were the prevalent ones in the clinical strains, whereas in control strains, CS6 was the predominant one. For NCVF genes, eatA was the most prevalent among the clinical isolates and etpA for control. CS6 was the most expressed CF, and eatA was the predominantly expressed NCVF for both clinical and controlled ETEC isolates. CS6 expression was more in strains having CS6 alone. Different strains express CS6 at different levels. Not all strains expressed their respective virulence factors. Understanding the prevalent colonization factor, CS6, and its nature of expression will contribute to designing an effective vaccine against ETEC in this region of the globe. The expression pattern of CS6 also will help in examining the relatedness between the ETEC subtypes.

Keywords: classical virulence factors, CS6, diarrhea, enterotoxigenic escherichia coli, expression, non-classical virulence factors

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Authors: Kingston Rajiah, Mari Kannan Maharajan, Si Jen Yeen, Sara Lew

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Parkinson’s disease (PD) is a progressive neurodegenerative disorder with evolving layers of complexity. Both motor and non-motor symptoms of PD may affect patients’ quality of life (QoL). Life expectancy for an individual with Parkinson’s disease depends on the level of care the individual has access to, can have a direct impact on length of life. Therefore, improvement of the QoL is a significant part of therapeutic plans. Patients with PD, especially those who are in advanced stages, are in great need of assistance, mostly from their family members or caregivers in terms of medical, emotional, and social support. The role of a caregiver becomes increasingly important with the progression of PD, the severity of motor impairment and increasing age of the patient. The nature and symptoms associated with PD can place significant stresses on the caregivers’ burden. As the prevalence of PD is estimated to more than double by 2030, it is important to recognize and alleviate the burden experienced by caregivers. This study focused on the impact of the clinical features on the QoL of PD patients, and of their caregivers. This study included PD patients along with their caregivers and was undertaken at the Malaysian Parkinson's Disease Association from June 2016 to November 2016. Clinical features of PD patients were assessed using the Movement Disorder Society revised Unified Parkinson Disease Rating Scale (MDS-UPDRS); the Hoehn and Yahr Staging of Parkinson's Disease were used to assess the severity and Parkinson's disease activities of daily living scale were used to assess the disability of Parkinson’s disease patients. QoL of PD patients was measured using the Parkinson's Disease Questionnaire-39 (PDQ-39). The revised version of the Zarit Burden Interview assessed caregiver burden. At least one of the clinical features affected PD patients’ QoL, and at least one of the QoL domains affected the caregivers’ burden. Clinical features ‘Saliva and Drooling’, and ‘Dyskinesia’ explained 29% of variance in QoL of PD patients. The QoL domains ‘stigma’, along with ‘emotional wellbeing’ explained 48.6% of variance in caregivers’ burden. Clinical features such as saliva, drooling and dyskinesia affected the QoL of PD patients. The PD patients’ QoL domains such as ‘stigma’ and ‘emotional well-being’ influenced their caregivers’ burden.

Keywords: carers, quality of life, clinical features, Malaysia

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Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Juan Carlos Martínez-Castrillo, David A. Pérez-Martínez

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Background: Monitoring motor symptoms in Parkinson's patients is often a complex and time-consuming task for clinicians, as Hauser's diaries are often poorly completed by patients. Recently, new automatic devices (Parkinson's holter: STAT-ON®) have been developed capable of monitoring patients' motor fluctuations. The MoMoPa-EC clinical trial (NCT04176302) investigates which of the two methods produces better clinical results. In this sub-analysis, the concordance between both methods is analyzed. Methods: In the MoMoPa-EC clinical trial, 164 patients with moderate-severe Parkinson's disease and at least two hours a day of Off will be included. At the time of patient recruitment, all of them completed a seven-day motor fluctuation diary at home (Hauser’s diary) while wearing the Parkinson's holter. In this sub-analysis, 71 patients with complete data for the purpose of this comparison were included. The intraclass correlation coefficient was calculated between the patient diary entries and the Parkinson's holter data in terms of time On, Off, and time with dyskinesias. Results: The intra-class correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.74) for daily time in Off (%), 0.48 (95% CI: 0.14-0.68) for daily time in On (%), and 0.37 (95% CI %: -0.04-0.62) for daily time with dyskinesias (%). Conclusions: Both methods have a moderate agreement with each other. We will have to wait for the results of the MoMoPa-EC project to estimate which of them has the greatest clinical benefits. Acknowledgment: This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195], and the European Fund for Regional Development, 'A way to make Europe'.

Keywords: Parkinson, sensor, motor fluctuations, dyskinesia

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Authors: Shideh Mohseni Movahed, Mansoureh Safari

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Intelligent drug delivery systems (IDDS) are innovative technological innovations and clinical way to advance current treatments. These systems differ in technique of therapeutic administration, intricacy, materials and patient compliance to address numerous clinical conditions that require different pharmacological therapies. IDDS capable of releasing an active molecule at the proper site and at a amount that adjusts in response to the progression of the disease or to certain functions/biorhythms of the organism is particularly appealing. In this paper, we describe the most recent advances in the development of intelligent drug delivery systems.

Keywords: drug delivery systems, IDDS, medicine, health

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Authors: Rameshwar Singh Seema

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In today’s world where diabetes has become an epidemic, our aim was to potentiate the effect of probiotics by integrating probiotics with cereals to formulate composite foods using Lactobacillus rhamnosus GG (LGG) and Lactobacillus casei NCDC19 against type 2 diabetes. After optimizing the product by Response Surface Methodology, it was studied for their effect on induction and progression of type 2 diabetes in HFD-fed Wistar rats. After 9 weeks study, best results were shown by the group fed with oat and milk based product fermented with LGG and L. casei NCDC19 which resulted in a significant decrease in blood glucose, HBA1c, improved OGTT, oxidative stress, cholesterol and triglycerides level during progression study of type 2 diabetes. During induction study also, there was significant reduction in blood glucose level, oxidative stress, cholesterol level and triglycerides level but slightly less as compared to progression study. Real time PCR gene expression studies were done for 5 genes (GLUT-4, IRS-2, ppar-γ, TNF-α, IL-6) whose expression is directly related to type 2 diabetes. The relative fold change expression was increased in case of GLUT-4, IRS-2, ppar-γ and decreased in case of TNF-α and IL-6 during both induction and progression study of diabetes but more significantly during progression study. Hence it was concluded that oat and milk based probiotic fermented product showed the synergistic effect of probiotics and oats especially in case of progression of type 2 diabetes. The benefits of these probiotic formulations may be further validated by clinical trials.

Keywords: type 2 diabetes, LGG, L.casei NCDC19, food science

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Authors: Manoj Kumar Reddy Pulim, Lakshmi Muthukrishnan, Geetha Jayapathy, Radhika Raman

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Introduction: In the past two decades, noninvasive positive pressure ventilation (NIPPV) emerged as one of the most important advances in the management of both acute and chronic respiratory failure in children. In the acute setting, it is an alternative to intubation with a goal to preserve normal physiologic functions, decrease airway injury, and prevent respiratory tract infections. There is a need to determine the clinical profile and parameters which point towards the need for NIV in the pediatric emergency setting. Objectives: i) To study the clinical profile of children who required non invasive ventilation and invasive ventilation, ii) To study the clinical parameters common to children who required non invasive ventilation. Methods: All children between one month to 18 years, who were intubated in the pediatric emergency department and those for whom decision to commence Non Invasive Ventilation was made in Emergency Room were included in the study. Children were transferred to the Paediatric Intensive Care Unit and started on Non Invasive Ventilation as per our hospital policy and followed up in the Paediatric Intensive Care Unit. Clinical profile of all children which included age, gender, diagnosis and indication for intubation were documented. Clinical parameters such as respiratory rate, heart rate, saturation, grunting were documented. Parameters obtained were subject to statistical analysis. Observations: Airway disease (Bronchiolitis 25%, Viral induced wheeze 22%) was a common diagnosis in 32 children who required Non Invasive Ventilation. Neuromuscular disorder was the common diagnosis in 27 children (78%) who were Intubated. 17 children commenced on Non Invasive Ventilation who later needed invasive ventilation had Neuromuscular disease. High frequency nasal cannula was used in 32, and mask ventilation in 17 children. Clinical parameters common to the Non Invasive Ventilation group were age < 1 year (17), tachycardia n = 7 (22%), tachypnea n = 23 (72%) and severe respiratory distress n = 9 (28%), grunt n = 7 (22%), SPO2 (80% to 90%) n = 16. Children in the Non Invasive Ventilation + INTUBATION group were > 3 years (9), had tachycardia 7 (41%), tachypnea 9(53%) with a male predominance n = 9. In statistical comparison among 3 groups,'p' value was significant for pH, saturation, and use of Ionotrope. Conclusion: Invasive ventilation can be avoided in the paediatric Emergency Department in children with airway disease, by commencing Non Invasive Ventilation early. Intubation in the pediatric emergency department has a higher association with neuromuscular disorders.

Keywords: clinical parameters, indications, non invasive ventilation, paediatric emergency room

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Authors: Daly M. J, Condron C, Mulhall C, Eppich W, O'Neill J.

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Introduction: In contemporary clinical cardiology, comprehensive and holistic bedside evaluation including accurate cardiac auscultation is in decline despite having positive effects on patients and their outcomes. Methods: Scripted histories and scoring checklists for three clinical scenarios in cardiology were co-created and refined through iterative consensus by a panel of clinical experts; these were then paired with recordings of auscultatory findings from three actual patients with known valvular heart disease. A wearable vest with embedded pressure-sensitive panel speakers was developed to transmit these recordings when examined at the standard auscultation points. RCSI medical students volunteered for a series of three formative long case examinations in cardiology (LC1 – LC3) using this hybrid simulation. Participants were randomised into two groups: Group 1 received individual teaching from an expert trainer between LC1 and LC2; Group 2 received the same intervention between LC2 and LC3. Each participant’s long case examination performance was recorded and blindly scored by two peer participants and two RCSI examiners. Results: Sixty-eight participants were included in the study (age 27.6 ± 0.1 years; 74% female) and randomised into two groups; there were no significant differences in baseline characteristics between groups. Overall, the median total faculty examiner score was 39.8% (35.8 – 44.6%) in LC1 and increased to 63.3% (56.9 – 66.4%) in LC3, with those in Group 1 showing a greater improvement in LC2 total score than that observed in Group 2 (p < .001). Using the novel checklist, intraclass correlation coefficients (ICC) were excellent between examiners in all cases: ICC .994 – .997 (p < .001); correlation between peers and examiners improved in LC2 following peer grading of LC1 performances: ICC .857 – .867 (p < .001). Conclusion: Hybrid simulation and quantitative grading improve learning, standardisation of assessment, and direct comparisons of both performance and acumen in clinical cardiology.

Keywords: cardiology, clinical skills, long case examination, hybrid simulation, checklist

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Authors: Jui-Chien Hsieh

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Background:12-lead electrocardiography(ECG) is one of frequently-used tools to detect atrial fibrillation (AF), which might degenerate into life-threaten stroke, in clinical Practice. Based on this study, the AF detection by the clinically-used 12-lead ECG device has only 0.73~0.77 positive predictive value (ppv). Objective: It is on great demand to develop a new algorithm to improve the precision of AF detection using 12-lead ECG. Due to the progress on artificial intelligence (AI), we develop an ECG deep model that has the ability to recognize AF patterns and reduce false-positive errors. Methods: In this study, (1) 570-sample 12-lead ECG reports whose computer interpretation by the ECG device was AF were collected as the training dataset. The ECG reports were interpreted by 2 senior cardiologists, and confirmed that the precision of AF detection by the ECG device is 0.73.; (2) 88 12-lead ECG reports whose computer interpretation generated by the ECG device was AF were used as test dataset. Cardiologist confirmed that 68 cases of 88 reports were AF, and others were not AF. The precision of AF detection by ECG device is about 0.77; (3) A parallel 4-layer 1 dimensional convolutional neural network (CNN) was developed to identify AF based on limb-lead ECGs and chest-lead ECGs. Results: The results indicated that this model has better performance on AF detection than traditional computer interpretation of the ECG device in 88 test samples with 0.94 ppv, 0.98 sensitivity, 0.80 specificity. Conclusions: As compared to the clinical ECG device, this AI ECG model promotes the precision of AF detection from 0.77 to 0.94, and can generate impacts on clinical applications.

Keywords: 12-lead ECG, atrial fibrillation, deep learning, convolutional neural network

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Authors: Maariyah Irfan

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Intro: Current cardiovascular (CV) care faces challenges such as low budgets and high hospital admission rates. This review aims to evaluate Big Data in CV healthcare management through the use of wearable devices in atrial fibrillation (AF) detection. AF may present intermittently, thus it is difficult for a healthcare professional to capture and diagnose a symptomatic rhythm. Methods: The iRhythm ZioPatch, AliveCor portable electrocardiogram (ECG), and Apple Watch were chosen for review due to their involvement in controlled clinical trials, and their integration with smartphones. The cost-effectiveness and AF detection of these devices were compared against the 12-lead ambulatory ECG (Holter monitor) that the NHS currently employs for the detection of AF. Results: The Zio patch was found to detect more arrhythmic events than the Holter monitor over a 2-week period. When patients presented to the emergency department with palpitations, AliveCor portable ECGs detected 6-fold more symptomatic events compared to the standard care group over 3-months. Based off preliminary results from the Apple Heart Study, only 0.5% of participants received irregular pulse notifications from the Apple Watch. Discussion: The Zio Patch and AliveCor devices have promising potential to be implemented into the standard duty of care offered by the NHS as they compare well to current routine measures. Nonetheless, companies must address the discrepancy between their target population and current consumers as those that could benefit the most from the innovation may be left out due to cost and access.

Keywords: atrial fibrillation, big data, cardiovascular healthcare management, wearable devices

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Authors: Niloufar Yadgari

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GANs are a potent form of deep learning models that have found success in various fields. They are part of the larger group of generative techniques, which aim to produce authentic data using a probabilistic model that learns distributions from actual samples. In clinical settings, GANs have demonstrated improved abilities in capturing spatially intricate, nonlinear, and possibly subtle disease impacts in contrast to conventional generative techniques. This review critically evaluates the current research on how GANs are being used in imaging studies of different neurological conditions like Alzheimer's disease, brain tumors, aging of the brain, and multiple sclerosis. We offer a clear explanation of different GAN techniques for each use case in neuroimaging and delve into the key hurdles, unanswered queries, and potential advancements in utilizing GANs in this field. Our goal is to connect advanced deep learning techniques with neurology studies, showcasing how GANs can assist in clinical decision-making and enhance our comprehension of the structural and functional aspects of brain disorders.

Keywords: GAN, pathology, generative adversarial network, neuro imaging

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Authors: H. Zidoum, A. AlShareedah, S. Al Sawafi, A. Al-Ansari, B. Al Lawati

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Systemic lupus erythematosus (SLE) is an autoimmune disease with genetic and environmental components. SLE is characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares. Despite recent progress in classification tools, the early diagnosis of SLE is still an unmet need for many patients. This study proposes an interpretable disease classification model that combines the high and efficient predictive performance of CatBoost and the model-agnostic interpretation tools of Shapley Additive exPlanations (SHAP). The CatBoost model was trained on a local cohort of 219 Omani patients with SLE as well as other control diseases. Furthermore, the SHAP library was used to generate individual explanations of the model's decisions as well as rank clinical features by contribution. Overall, we achieved an AUC score of 0.945, F1-score of 0.92 and identified four clinical features (alopecia, renal disorders, cutaneous lupus, and hemolytic anemia) along with the patient's age that was shown to have the greatest contribution on the prediction.

Keywords: feature selection, classification, systemic lupus erythematosus, model interpretation, SHAP, Catboost

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Authors: Jungbin Lim, Bohee Kang, Heelim Lee, Sunjin Kim, GeumHee Choi, Jae-Suk Jung, Suk Ji

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Nonsurgical periodontal therapies have, for several decades, been the basis of periodontal treatment concepts. The aim of this paper is to investigate the effectiveness of non-surgical periodontal therapy according to the severity of periodontitis disease. Methods: Retrospective data of patients who visited Department of periodontics in Ajou University Medical Center from 2016 to 2022 were collected. Among the patients, those who took full mouth examination of clinical parameters and non-surgical periodontal therapy were chosen for this study. Selected patients were divided into initial, moderate, and severe periodontitis based on severity and complexity of management (2018 World Workshop EFP/AAP consensus). Recall visits with clinical periodontal examination were scheduled for 1,2,3 months or 1,3,6 months after the treatment. The results were evaluated by recordings of mean probing pocket depth (mean PD), mean clinical attachment levels (mean CAL), bleeding on probing (BOP%), mean gingival index (mean GI), mean regression, mean sulcus bleeding index (mean SBI), mean plaque scores (mean PI). All statistical analyses were performed with R software, version 4.3.0. A level of significance, P<0.05, was considered to be statistically significant. Results: A total of 92 patients were included in this study. 15 patients were diagnosed as initial periodontitis, 14 moderate periodontitis, and 63 severe periodontitis. The all parameters except for mean recession decreased over time in all groups. The amount of mean PD decreased were the greatest in severe periodontitis group followed by moderate and initial, which was found to be statistically significant. The changes of mean PD were 0.15±0.05 mm, 0.37±0.06 mm, and 1.01±0.07 mm (initial, moderate, and severe, respectively, P<0.001). When comparing before and after treatment, the reductions in BOP(%), mean GI, mean SBI, and mean PI were statistically significant. Conclusion: All patients who received non-surgical periodontal therapy showed periodontal healing in terms of improvements in clinical parameters, and it was greater in the severe group.

Keywords: periodontology, clinical periodontology, oral treatment, comprehensive preventive dentistry, non-surgical periodontal therapy

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Authors: James Jin, Weisi Xia, Runzhe Gao, Alain Vandal, Darren Svirkis, Andrew Hill

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Background: Post-haemorrhoidectomy pain is concerned by patients/clinicians. Minimizing the postoperation pain is highly interested clinically. Combinations of topical cream targeting three hypothesised post-haemorrhoidectomy pain mechanisms were developed and their effectiveness were evaluated. Specifically, a multi-centred double-blinded randomized clinical trial (RCT) was conducted in adults undergoing excisional haemorrhoidectomy. The primary analysis was conveyed on the data collected to evaluate the effectiveness of the combinations of topical cream targeting three hypothesized pain mechanisms after the operations. Methods: 192 patients were randomly allocated to 4 arms (each arm has 48 patients), and each arm was provided with pain cream 10% metronidazole (M), M and 2% diltiazem (MD), M with 4% lidocaine (ML), or MDL, respectively. Patients were instructed to apply topical treatments three times a day for 7 days, and record outcomes for 14 days after the operations. The primary outcome was VAS pain on day 4. Covariates and models were selected in the blind review stage. Multiple imputations were applied for the missingness. LMER, GLMER models together with natural splines were applied. Sandwich estimators and Wald statistics were used. P-values < 0.05 were considered as significant. Conclusions: The addition of topical lidocaine or diltiazem to metronidazole does not add any benefit. ML had significantly better pain and recovery scores than combination MDL. Multimodal topical analgesia with ML after haemorrhoidectomy could be considered for further evaluation. Further trials considering only 3 arms (M, ML, MD) might be worth exploring.

Keywords: RCT, primary analysis, multiple imputation, pain scores, haemorrhoidectomy, analgesia, lmer

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Authors: Ran An, Dang Wang

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Background: Mechanical ventilation has been confirmed to increase the incidence of postoperative pulmonary complications (PPCs), and several studies have shown that low tidal volumes combined with positive end-expiratory pressure (PEEP) and recruitment manoeuvres (RM) reduce the incidence of PPCs. However, the optimal lung-protective ventilatory strategy remains unclear. Methods: Multiple databases were searched for randomized controlled trials (RCTs) published prior to October 2023. The association between individual PEEP (iPEEP) or other forms of lung-protective ventilation and the incidence of PPCs was evaluated by Bayesian network meta-analysis. Results: We included 58 studies (11610 patients) in this meta-analysis. The network meta-analysis showed that low ventilation (LVt) combined with iPEEP and RM was associated with significantly lower incidences of PPCs [HVt: OR=0.38 95CrI (0.19, 0.75), LVt: OR=0.33, 95% CrI (0.12, 0.82)], postoperative atelectasis, and pneumonia than was HVt or LVt. In abdominal surgery, LVT combined with iPEEP or medium-to-high PEEP and RM were associated with significantly lower incidences of PPCs, postoperative atelectasis, and pneumonia. LVt combined with iPEEP and RM was ranked the highest, which was based on SUCRA scores. Conclusion: LVt combined with iPEEP and RM decreased the incidences of PPCs, postoperative atelectasis, and pneumonia in noncardiac surgery patients. iPEEP-guided ventilation was the optimal lung protection ventilation strategy. The quality of evidence was moderate.

Keywords: protection ventilation strategies, postoperative pulmonary complications, network meta-analysis, noncardiac surgery

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Authors: Karl Owen L. Suan, Juliet Marie S. Lambayan, Floramay P. Salo-Curato

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Objective: To predict the outcome among patients admitted with community-acquired pneumonia (ages 3 months to 59 months old) admitted in Visayas Community Medical Center using the Respiratory Index of Severity in Children (RISC). Design: A cross-sectional study design was used. Setting: The study was done in Visayas Community Medical Center, which is a private tertiary level in Cebu City from January-June 2013. Patients/Participants: A total of 72 patients were initially enrolled in the study. However, 1 patient transferred to another institution, thus 71 patients were included in this study. Within 24 hours from admission, patients were assigned a RISC score. Statistical Analysis: Cohen’s kappa coefficient was used for inter-rater agreement for categorical data. This study used frequency and percentage distribution for qualitative data. Mean, standard deviation and range were used for quantitative data. To determine the relationship of each RISC score parameter and the total RISC score with the outcome, a Mann Whitney U Test and 2x2 Fischer Exact test for testing associations were used. A p value less of than 0.05 alpha was considered significant. Results: There was a statistical significance between RISC score and clinical outcome. RISC score of greater than 4 was correlated with intubation and/or mortality. Conclusion: The RISC scoring system is a simple combination of clinical parameters and a reliable tool that will help stratify patients aged 3 months to 59 months in predicting clinical outcome.

Keywords: RISC, clinical outcome, community-acquired pneumonia, patients

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Authors: Sonia Alberti

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The Regional Conference to Restructure Psychiatric Care in Latin America, convened by the Pan American Health Organization (PAHO) in 1990, oriented the Brazilian Federal Act in 2001 that stipulated the psychiatric reform which requires deinstitutionalization and community-based treatment. Since then, the 15 years’ experience of different working teams in mental health led an academic working group – supervisors from personal practices, professors and researchers – to discuss certain clinical issues, as well as supervisions, and to organize colloquia in different cities as a methodology. These colloquia count on the participation of different working teams from the cities in which they are held, with team members with different levels of educational degrees and prior experiences, in order to increase dialogue right where it does not always appear to be possible. The principal aim of these colloquia is to gain interlocution between practitioners and academics. Working with the theory of case constructions, this methodology revealed itself helpful in unfolding new solutions. The paper also observes that there is not always harmony between what the psychiatric reform demands and clinical ethics.

Keywords: mental health, supervision, clinical cases, Brazilian experience

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Authors: Boroka Gács, Tibor Szolcsányi, Árpad Csathó

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Background: Individuals frequently show habituation to repeated noxious heat. However, given the defensive function of human pain processing, it is reasonable to assume that individuals imagine that they would become increasingly sensitive to repeated thermal pain stimuli. To the best of the authors' knowledge, no previous studies have, however, been addressed to this assumption. Therefore, in the current study, we investigated how healthy human individuals imagine the intensity of repeated thermal pain stimulations, and compared this with the intensity ratings given after physically induced thermal pain trials. Methods: Healthy participants (N = 20) gave pain intensity ratings in two conditions: imagined and real thermal pain. In the real pain condition thermal pain stimuli of two intensities (minimal and moderate pain) were delivered in four consecutive trials. The duration of the peak temperature was 20s, and stimulation was always delivered to the same location. In each trial, participants rated the pain intensity twice, 5s and 15s after the onset of the peak temperature. In the imagined pain condition, participants were subjected to a reference pain stimulus and then asked to imagine and rate the same sequence of stimulations as in the induced pain condition. Results: Ratings of imagined pain and physically induced pain followed opposite courses over repeated stimulation: Ratings of imagined pain indicated sensitization whereas ratings for physically induced pain indicated habituation. The findings were similar for minimal and moderate pain intensities. Conclusions: The findings suggest that, rather than habituating to pain, healthy individuals imagine that they would become increasingly sensitive to repeated thermal pain stimuli.

Keywords: habituation, imagined pain, pain perception, thermal stimulation

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Authors: Ravi Kiran Pothamsetty, Radha Rani Ghosh, Baby Paul Thaliath

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Radiation therapy has undergone many advancements and evloved from 2D to 3D. Recently, with rapid pace of drug discoveries, cutting edge technology, and clinical trials has made innovative advancements in computer technology and treatment planning and upgraded to intensity modulated radiotherapy (IMRT) which delivers in homogenous dose to tumor and normal tissues. The present study was a hospital-based experience comparing two different conformal radiotherapy techniques for brain tumors. This analytical study design has been conducted at Regional Cancer Centre, India from January 2014 to January 2015. Ten patients have been selected after inclusion and exclusion criteria. All the patients were treated on Artiste Siemens Linac Accelerator. The tolerance level for maximum dose was 6.0 Gyfor lenses and 54.0 Gy for brain stem, optic chiasm and optical nerves as per RTOG criteria. Mean and standard deviation values of PTV98%, PTV 95% and PTV 2% in IMRT were 93.16±2.9, 95.01±3.4 and 103.1±1.1 respectively; for 3DCRT were 91.4±4.7, 94.17±2.6 and 102.7±0.39 respectively. PTV max dose (%) in IMRT and 3D-CRT were 104.7±0.96 and 103.9±1.0 respectively. Maximum dose to the tumor can be delivered with IMRT with acceptable toxicity limits. Variables such as expertise, location of tumor, patient condition, and TPS influence the outcome of the treatment.

Keywords: brain tumors, intensity modulated radiotherapy (IMRT), three dimensional conformal radiotherapy (3D-CRT), radiation therapy oncology group (RTOG)

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Authors: Narottam Puri, Bishnu Panigrahi, Narayan Pendse

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Background: Clinical Outcomes are the globally agreed upon, evidence-based measurable changes in health or quality of life resulting from the patient care. Reporting of outcomes and its continuous monitoring provides an opportunity for both assessing and improving the quality of patient care. In 2012, International Consortium Of HealthCare Outcome Measurement (ICHOM) was founded which has defined global Standard Sets for measuring the outcome of various treatments. Method: Monitoring of Clinical Outcomes was identified as a pillar of Fortis’ core value of Patient Centricity. The project was started as an in-house developed Clinical Outcomes Reporting Portal by the Fortis Medical IT team. Standard sets of Outcome measurement developed by ICHOM were used. A pilot was run at Fortis Escorts Heart Institute from Aug’13 – Dec’13.Starting Jan’14, it was implemented across 11 hospitals of the group. The scope was hospital-wide and major clinical specialties: Cardiac Sciences, Orthopedics & Joint Replacement were covered. The internally developed portal had its limitations of report generation and also capturing of Patient related outcomes was restricted. A year later, the company provisioned for an ICHOM Certified Software product which could provide a platform for data capturing and reporting to ensure compliance with all ICHOM requirements. Post a year of the launch of the software; Fortis Healthcare has become the 1st Healthcare Provider in Asia to publish Clinical Outcomes data for the Coronary Artery Disease Standard Set comprising of Coronary Artery Bypass Graft and Percutaneous Coronary Interventions) in the public domain. (Jan 2016). Results: This project has helped in firmly establishing a culture of monitoring and reporting Clinical Outcomes across Fortis Hospitals. Given the diverse nature of the healthcare delivery model at Fortis Network, which comprises of hospitals of varying size and specialty-mix and practically covering the entire span of the country, standardization of data collection and reporting methodology is a huge achievement in itself. 95% case reporting was achieved with more than 90% data completion at the end of Phase 1 (March 2016). Post implementation the group now has one year of data from its own hospitals. This has helped identify the gaps and plan towards ways to bridge them and also establish internal benchmarks for continual improvement. Besides the value created for the group includes: 1. Entire Fortis community has been sensitized on the importance of Clinical Outcomes monitoring for patient centric care. Initial skepticism and cynicism has been countered by effective stakeholder engagement and automation of processes. 2. Measuring quality is the first step in improving quality. Data analysis has helped compare clinical results with best-in-class hospitals and identify improvement opportunities. 3. Clinical fraternity is extremely pleased to be part of this initiative and has taken ownership of the project. Conclusion: Fortis Healthcare is the pioneer in the monitoring of Clinical Outcomes. Implementation of ICHOM standards has helped Fortis Clinical Excellence Program in improving patient engagement and strengthening its commitment to its core value of Patient Centricity. Validation and certification of the Clinical Outcomes data by an ICHOM Certified Supplier adds confidence to its claim of being leaders in this space.

Keywords: clinical outcomes, healthcare delivery, patient centricity, ICHOM

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Authors: Sajjad Jafari, Reza Akbari

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Background and Aim: Chrysin, a flavonoid compound found in medicinal plants, honey, and propolis, has potential biological activities that make it an important perspective in the treatment of infectious and cancer diseases. The aim of this review study is to evaluate the biological activities of chrysin in the treatment of infectious and cancer diseases. Material and Methods: The present study is a review study that searched reputable scientific databases such as PubMed, Google Scholar, Scopus, and Web of Science from 2000 to 2023 using keywords such as antimicrobial, antifungal, chrysin, anticancer, antioxidants, and infectious diseases. The researchers examined 25 articles to determine the biological activities of chrysin. Results: Chrysin has high inhibitory or lethal activities on gram-positive and gram-negative bacteria, including Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis, and Enterococcus faeces. It also has anti-biofilm effects and antifungal effects on strains such as Aspergillus niger and Candida albicans. Chrysin also has anticancer effects on various cancers, including colorectal cancer, pancreatic cancer, breast cancer, and MCF-7 cancer, which have been confirmed in vitro and in vivo. Conclusion: Chrysin has the potential as an important therapeutic option in the treatment of infectious and cancer diseases. Its high antimicrobial and anticancer activities, combined with its low toxicity in nanoparticle form, make it a promising candidate for further clinical trials. The production of anti-microbial and anti-cancer drugs from natural substances, such as chrysin, is a valuable contribution to the field of medicine.

Keywords: chrysin, antimicrobial, anticancer, infectious diseases

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Authors: Jiayan Gou, Kexin He, Xin Zhang, Fei Wang, Liuni Zou

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Background: Homocysteine is a high-risk factor for cognitive decline, and folic acid supplementation can lower homocysteine levels. However, current clinical research results are inconsistent, and the effects of folic acid on homocysteine levels and cognitive function in older people are inconsistent. Objective: The objective of this study is to systematically evaluate the effects of folic acid alone or in combination with other nutrients on homocysteine levels and cognitive function in older adults. Methods: Systematic searches were conducted in five databases, including PubMed, Embase, the Cochrane Library, Web of Science, and CINAHL, from inception to June 1, 2023. Randomized controlled trials were included investigating the effects of folic acid alone or in combination with other nutrients on cognitive function in older people. Results: 17 articles were included, with six focusing on the effects of folic acid alone and 11 examining folic acid in combination with other nutrients. The study included 3,100 individuals aged 60 to 83.2 years, with a relatively equal gender distribution (approximately 51.82% male). Conclusion: Folic acid alone or combined with other nutrients can effectively lower homocysteine level and improve cognitive function in patients with mild cognitive impairment. But for patients with Alzheimer's disease and dementia, the intervention only can reduce the homocysteine level, but the improvement in cognitive function is not significant. In healthy older people, high baseline homocysteine levels (>11.3 μmol/L) and good ω-3 fatty acid status (>590 μmol/L) can enhance the improvement effect of folic acid on cognitive function. This trial has been registered on PROSPERO as CRD42023433096.

Keywords: B-complex vitamins, cognitive function, folic acid, homocysteine

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Authors: T. S. Sowmya Bhaskaran, Shekhar Seshadri

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This study aims to study the clinical features of with a history of Child Sexual Abuse (CSA). A chart review of 40 children (<16 years) with history of CSA evaluated at the Department of Child and Adolescent Psychiatry of NIMHANS during a two year period was performed. Results:The most common form of abuse was contact penetrative abuse (65%) followed by non-contact penetrative abuse (32.5%). 75% (N=30) had a psychiatric diagnosis at baseline. 50% of these children had one or more psychiatric comorbidities. Anxiety disorder was the most common diagnosis (27.5%) which included PTSD (11%) followed by Depressive disorder (25.2%). Children abused by multiple perpetrators were found to be more likely to have depression, to having a comorbid psychiatric disorder and more prone to exhibit sexualized behaviour. Children who also experienced physical violence at home were more likely to develop psychiatric illness following child sexual abuse. Psychiatric morbidity is high in clinic population of children with history of CSA. It is important to increase the awareness regarding the consequences of CSA in order to increase help seeking.

Keywords: child sexual abuse, India, tertiary care centre, clinical characteristics

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Authors: Pascale Brasseur, Binu Gurung, Nicholas Halfpenny, James Eaton

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Development of minimally invasive treatments in recent years provides a potential alternative to invasive surgical interventions which are of limited value to patients with spinal metastases due to short life expectancy. A systematic review was conducted to explore the efficacy and safety of radiofrequency ablation (RFA), a minimally invasive treatment in patients with spinal metastases. EMBASE, Medline and CENTRAL were searched from database inception to March 2017 for randomised controlled trials (RCTs) and non-randomised studies. Conference proceedings for ASCO and ESMO published in 2015 and 2016 were also searched. Fourteen studies were included: three prospective interventional studies, four prospective case series and seven retrospective case series. No RCTs or studies comparing RFA with another treatment were identified. RFA was followed by cement augmentation in all patients in seven studies and some patients (40-96%) in the remaining seven studies. Efficacy was assessed as pain relief in 13/14 studies with the use of a numerical rating scale (NRS) or a visual analogue scale (VAS) at various time points. Ten of the 13 studies reported a significant decrease in pain outcome, post-RFA compared to baseline. NRS scores improved significantly at 1 week (5.9 to 3.5, p < 0.0001; 8 to 4.3, p < 0.02 and 8 to 3.9, p < 0.0001) and this improvement was maintained at 1 month post-RFA compared to baseline (5.9 to 2.6, p < 0.0001; 8 to 2.9, p < 0.0003; 8 to 2.9, p < 0.0001). Similarly, VAS scores decreased significantly at 1 week (7.5 to 2.7, p=0.00005; 7.51 to 1.73, p < 0.0001; 7.82 to 2.82, p < 0.001) and this pattern was maintained at 1 month post-RFA compared to baseline (7.51 to 2.25, p < 0.0001; 7.82 to 3.3; p < 0.001). A significant pain relief was achieved regardless of whether patients had cement augmentation in two studies assessing the impact of RFA with or without cement augmentation on VAS pain scores. In these two studies, a significant decrease in pain scores was reported for patients receiving RFA alone and RFA+cement at 1 week (4.3 to 1.7. p=0.0004 and 6.6 to 1.7, p=0.003 respectively) and 15-36 months (7.9 to 4, p=0.008 and 7.6 to 3.5, p=0.005 respectively) after therapy. Few minor complications were reported and these included neural damage, radicular pain, vertebroplasty leakage and lower limb pain/numbness. In conclusion, the efficacy and safety of RFA were consistently positive between prospective and retrospective studies with reductions in pain and few procedural complications. However, the lack of control groups in the identified studies indicates the possibility of selection bias inherent in single arm studies. Controlled trials exploring efficacy and safety of RFA in patients with spinal metastases are warranted to provide robust evidence. The identified studies provide an initial foundation for such future trials.

Keywords: pain relief, radiofrequency ablation, spinal metastases, systematic review

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