Search results for: randomized trial

Authors: Shivakumar M, Leslie Edward S Lewis, Shashikala Devadiga, Sonia Khurana

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Introduction: Methylxanthines are used for the treatment of AOP, to facilitate extubation and as a prophylactic agent to prevent apnea. Though the popularity of Caffeine has risen, it is expensive in a resource constrained developing countries like India. Objective: To evaluate the cost-effectiveness of Caffeine compared with Aminophylline treatment for AOP with respect to additional ventilatory resource utilized in different birth weight categorization. Design, Settings and Participants – Single centered, retrospective economic evaluation was done. Participants included preterm newborns with < 34 completed weeks of gestation age that were recruited under an Indian Council of Medical Research funded randomized clinical trial. Per protocol data was included from Neonatal Intensive Care Unit, Kasturba Hospital, Manipal, India between April 2012 and December 2014. Exposure: Preterm neonates were randomly allocated to either Caffeine or Aminophylline as per the trial protocol. Outcomes and Measures – We assessed surfactant requirement, duration of Invasive and Non-Invasive Ventilation, Total Methylxanthine cost and additional cost for respiratory support bared by the payers per day during hospital stay. For the purpose of this study Newborns were stratified as Category A – < 1000g, Category B – 1001 to 1500g and Category C – 1501 to 2500g. Results: Total 146 (Caffeine -72 and Aminophylline – 74) babies with Mean ± SD gestation age of 29.63 ± 1.89 weeks were assessed. 32.19% constitute of Category A, 55.48% were B and 12.33% were C. The difference in median duration of additional NIV and IMV support was statistically insignificant. However 60% of neonates who received Caffeine required additional surfactant therapy (p=0.02). The total median (IQR) cost of Caffeine was significantly high with Rs.10535 (Q3-6317.50, Q1-15992.50) where against Aminophylline cost was Rs.352 (Q3-236, Q1-709) (p < 0.001). The additional costs spent on respiratory support per day in neonates on either Methylxanthines were found to be statistically insignificant in the entire weight based category of our study. Whereas in Category B, the median O2 charges per day were found to have more in Caffeine treated newborns (p=0.05) with border line significance. In category A, providing one day NIV or IMV support significantly increases the unit log cost of Caffeine by 13.6% (CI – 95% ranging from 4 to 24; p=0.005) over log cost of Aminophylline. Conclusion: Cost of Caffeine is expensive than Aminophylline. It was found to be equally efficacious in reducing the number duration of NIV or IMV support. However adjusted with the NIV and IMV days of support, neonates fall in category A and category B who were on Caffeine pays excess amount of respiratory charges per day over aminophylline. In perspective of resource poor settings Aminophylline is cost saving and economically approachable.

Keywords: methylxanthines include caffeine and aminophylline, AOP (apnea of prematurity), IMV (invasive mechanical ventilation), NIV (non invasive ventilation), category a – <1000g, category b – 1001 to 1500g and category c – 1501 to 2500g

Procedia PDF Downloads 407

Authors: Gregory Chown, Benjamin Infantolino, Christopher Wise, Rachel Holmes, Samantha O'Donnell, Katelyn Pfeiffer, Victoria Ward

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Background: There is a lack of understanding of how Kinesio Tape® physiologically works. Furthermore, few studies compare Kinesio Tape® to other forms of taping. The research question is: Does Kinesio Tape® cause a difference in muscle facilitation, inhibition, and pain, between Kinesio Tape® and no tape for collegiate athletes with self-reported shoulder pain? Method: This quantitative non-randomized design used a convenience sampling method. There were eleven participants with self-reported shoulder pain who were athletes on the men’s and women’s lacrosse and tennis teams. Participants attended one 30-45 minute session for data collection. Each participant received all three taping conditions and performed four repetitions of 120 degrees of active shoulder flexion for the three separate trials (no tape, Kinesio Tape® inhibition, and Kinesio Tape® facilitation). Surface electromyography (sEMG) electrodes were placed on the anterior deltoid, supraspinatus, and lower trapezius to measure muscle facilitation and inhibition. Each participant completed the visual analogue scale (VAS) before and after each trial to measure pain. Results: No statistical significance was found for pain scores on the VAS between the taping methods of facilitation, inhibition, and no tape (p = .118). No statistical significance was found for the percentage of change in muscle function for each taping method; Anterior deltoid (p = .993), supraspinatus (p = .997) and lower trapezius (p = .922). Conclusion: Based on the results, Kinesio Tape® appears to not have an effect on muscle function or pain when utilizing the facilitation or inhibition taping method when compared to no tape.

Keywords: Kinesio tape, muscle facilitation, muscle inhibition, pain

Procedia PDF Downloads 159

Authors: M. Sepahvand, M. Khorushy

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Gladiolus, being a cormous plant, it is principally propagated by the natural multiplication of new corms and cormels. In order to obtain callus from segmented corm which was obtained from in vitro culture, callus formation media were MS media supplemented with 4 levels of hormones such as 1.0 mg l-1 NAA + 0.5 mg l-1 BAP, 0.5 mg l-1 NAA + 0.25 mg l-1 BAP, 1.0 mg l-1 2, 4-D + 0.5 mg l-1 BAP, and 0.5 mg l-1 2, 4-D + 0.25 mg l-1 BAP. The results showed that the most weight of callus (2.28 g) was produced in MS callus formation media which were supplemented with 1.0 mg l-1 NAA + 0.5 mg l-1 BAP. This experiment was carried out in randomized completely design with 3 replications and each treatment with six jars. In second experiment for regeneration of callus, a factorial experiment in the form of randomized complete design with 12 treatments and 3 replications and each replication with six jars was carried out. The treatments consisted of callus culture media in 4 levels and regeneration culture media in 3 levels [control (no PGRs), MS with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin + 0.01 mg l-1 NAA, and MS with 0.2 mg l-1 BAP + 0.05 mg l-1 Kin + 0.01 mg l-1 NAA]. The results showed that the best regeneration media were MS media which were supplemented with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin. + 0.01 mg l-1 NAA that had the highest number of shoots (7/83 N), and shoot length (7/3 cm).

Keywords: regeneration, Segmented corm explant, callus, in vitro, gladiolus cv. white prosperity

Procedia PDF Downloads 418

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

Procedia PDF Downloads 38

Authors: Woogul Lee, Johnmarshall Reeve

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Learners’ perceived autonomy predicts learners’ interest, engagement, and learning. To understand these processes, we conducted an fMRI experiment. In this experiment, participants saw the national flag and were asked to rate how much they freely wanted to learn about that particular national flag. The participants then learned the characteristics of the national flag. Results showed that (1) the degree of participants’ perceived autonomy was positively correlated with the degree of insula activity, (2) participants’ early-trial insula activity predicted corresponding late-trial dorsolateral prefrontal cortex activity, and (3) the degree of dorsolateral prefrontal cortex activity was positively correlated with the degree of participants’ learning about the characteristics of the national flag. Results suggest that learners’ perceived autonomy predicts learning through the mediation of insula activity associated with intrinsic satisfaction and 'pure self' processes.

Keywords: insular cortex, autonomy, self-determination, dorsolateral prefrontal cortex

Procedia PDF Downloads 177

Authors: Jiyeon Kang, Yeon Jin Jeong, Hoon Heo

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Purpose: Bullying in nursing workplace has been a serious problem that increases the turnover of nurses. Few studies have examined the effects of communication training on workplace bullying for nurses, and all used a single-group design and a small sample size. Thus, more rigorous research has been needed to evaluate the effects properly. This research was aimed to identify the effects of the mobile type communication training of responses on bullying behaviors among nurses. Methods: A randomized controlled trial was performed. Subjects were 62 critical care nurses working in university hospitals in Busan, South Korea. We developed a mobile phone application to train nurses to deal with bullying situation. This application includes 6 common bullying situations and appropriate empathetic communication (non-violent communication) samples in the form of webtoons. The experimental group used this application for 4 weeks, and we measured interpersonal relationship, workplace bullying, symptom experience, and intention to leave before, post, and 8 weeks after the intervention from both experimental and control groups. The effect of the intervention was analyzed using repeated measures ANOVA. Results: The mobile type communication training developed in this study was effective for decreasing nurses’ intention to leave workplace (F = 5.11, p = .027). However, it had no effect on interpersonal relationship (F = 2.54, p = .116), workplace bullying (F = 2.99, p = .089) or symptom experience (F = 2.81, p = .099). The beneficial effects on intention to leave lasted at least up to 4 weeks after the training. Conclusion: The mobile type communication training can be utilized as an effective personal coping strategy for workplace bullying among nurses. Further studies on the long-term effects of the communication training are necessary.

Keywords: bullying, communication, mobile applications, nurses, training, workplace

Procedia PDF Downloads 305

Authors: Siti Sabariah Buhari, Ruzita Abdul Talib, Poh Bee Koon

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This study aims to develop and evaluate an intervention to improve eating habits, active lifestyle and weight status of overweight and obese children in Negeri Sembilan. The H.E.B.A.T! Program involved children, parents, and school and focused on behaviour and environment modification to achieve its goal. The intervention consists of H.E.B.A.T! Camp, parent’s workshop and school-based activities. A total of 21 children from intervention school and 22 children from control school who had BMI for age Z-score ≥ +1SD participated in the study. Mean age of subjects was 10.8 ± 0.3 years old. Four phases were included in the development of the intervention. Evaluation of intervention was conducted through process, impact and outcome evaluation. Process evaluation found that intervention program was implemented successfully with minimal modification and without having any technical problems. Impact and outcome evaluation was assessed based on dietary intake, average step counts, BMI for age z-score, body fat percentage and waist circumference at pre-intervention (T0), post-intervention 1 (T1) and post-intervention 2 (T2). There was significant reduction in energy (14.8%) and fat (21.9%) intakes (at p < 0.05) at post-intervention 1 (T1) in intervention group. By controlling for sex as covariate, there was significant intervention effect for average step counts, BMI for age z-score and waist circumference (p < 0.05). In conclusion, the intervention made an impact on positive behavioural intentions and improves weight status of the children. It is expected that the HEBAT! Program could be adopted and implemented by the government and private sector as well as policy-makers in formulating childhood obesity intervention.

Keywords: childhood obesity, diet, obesity intervention, physical activity

Procedia PDF Downloads 270

Authors: Mbanzulu Kennedy, Zanga Josue, Wumba Roger

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Malaria and schistosomiasis remain life-threatening public health problems in sub-Saharan Africa. The infection pattern related to age indicates that preschool and school-age children are at the highest risk of malaria and schistosomiasis. Both parasitic infections, separately or combined, may have negative impacts on the haemoglobin concentration levels. The existing data revealed that artemisinin derivatives commonly used to cure malaria present also in antischistosomal activities. The current study investigated the impact of Artesunate-Amodiaquine (AS-AQ) on schistosomiasis when administered to treat malaria in rural area of Lemfu, DRC. A prospective longitudinal study including 171 coinfected children screened for anaemia, Schistosoma mansoni, and Plasmodium falciparum infections. The egg reduction rate and haemoglobin concentration were assessed four weeks after the treatment with AS-AQ, of all coinfected children of this series. One hundred and twenty-five (74.4%) out of 168 coinfected children treated and present during the assessment were found stool negative for S. mansoni eggs. Out of 43 (25.6%) children who remained positives, 37 (22%) showed a partial reduction of eggs amount, and no reduction was noted in 3.6% of coinfected. The mean of haemoglobin concentration and the prevalence of anaemia were, respectively, 10.74±1.5g/dl , 11.2±1.3g/dl, and 64.8%, 51.8%, respectively, before and after treatment, p<0.001. The AS-AQ commonly used against Plasmodium allowed curing S. mansoni in coinfected children and increasing the Hb level. For the future, the randomized and multicentric clinical trials are needed for a better understanding of the effectiveness of AS-AQ against Schistosoma spp. The trial registration number was 3487183.

Keywords: paludisme, schistosomiase, as-aq, enfants lemfu

Procedia PDF Downloads 74

Authors: Kazeem Adesina Dauda, Waheed Babatunde Yahya

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To design a tree that maximizes within-node homogeneity, there is a need for a homogeneity measure that is appropriate for event history data with multiple risks. We consider the use of Deviance and Modified Cox-Snell residuals as a measure of impurity in Classification Regression Tree (CART) and compare our results with the results of Fiona (2008) in which homogeneity measures were based on Martingale Residual. Data structure approach was used to validate the performance of our proposed techniques via simulation and real life data. The results of univariate competing risk revealed that: using Deviance and Cox-Snell residuals as a response in within node homogeneity classification tree perform better than using other residuals irrespective of performance techniques. Bone marrow transplant data and double-blinded randomized clinical trial, conducted in other to compare two treatments for patients with prostate cancer were used to demonstrate the efficiency of our proposed method vis-à-vis the existing ones. Results from empirical studies of the bone marrow transplant data showed that the proposed model with Cox-Snell residual (Deviance=16.6498) performs better than both the Martingale residual (deviance=160.3592) and Deviance residual (Deviance=556.8822) in both event of interest and competing risks. Additionally, results from prostate cancer also reveal the performance of proposed model over the existing one in both causes, interestingly, Cox-Snell residual (MSE=0.01783563) outfit both the Martingale residual (MSE=0.1853148) and Deviance residual (MSE=0.8043366). Moreover, these results validate those obtained from the Monte-Carlo studies.

Keywords: within-node homogeneity, Martingale residual, modified Cox-Snell residual, classification and regression tree

Procedia PDF Downloads 241

Authors: Vahid Mazloum, Mansour Sahebozamani, Amirhossein Barati, Nouzar Nakhaee, Pouya Rabiei

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Non-specific chronic low back pain (NSCLBP) is a common condition with no exact diagnosis and mechanism for its occurrence. Recently, different therapeutic exercises have taken into account to manage NSCLBP. So, the aim of this study has mainly been placed on comparing the effects of Pilates and Mackenzie exercises on quality of life (QOL) lumbar spine position sense (LSPS) in patients with NSCLBP. In this randomized clinical trial, 47 patients with NSCLBP were voluntarily divided into three groups of Pilates (n=16) (with mean age 37.1 ± 9.5 years, height 168.9 ± 7.4 cm, body mass 76.1 ± 5.9 k), McKenzie (n=15) (with mean age 42.7 ± 8.1 years, height 165.7 ± 6.8, body mass 74.1 ± 4.8 kg) and control (n=16) (with mean age 39.3 ± 9.8 years, height 168.1 ± 8.1 cm, body mass 74.2 ± 5.8 kg). Primary outcome included QOL and secondary was LSPS. Both variables were assessed by the WHOQOL-BREF questionnaires and electrogoniameter, respectively. The measurements were performed at baseline, following a 6-week intervention, and after a 4-week follow-up. The ANCOVA test at P < 0.05 was administrated to analyze the collected data using SPSS software. There was a statistically significant difference between experimental groups and the control group to improve QOL. But, no difference was seen regarding the effects of two exercises on LSPS (p < 0.05). Both Pilates and Mackenzie exercises demonstrated improvement in QOL after 6-week intervention and a 4-week follow-up while none of them considerably affected LSPS. Further studies are required to establish a supporting evidence for the effectiveness of two exercises on NSCLBP.

Keywords: pilates, Mackenzie, preconception, low back pain, physical health

Procedia PDF Downloads 158

Authors: M. A. Abdel-Wahed, Nayera Elmorsi Hassan, Safaa Shafik Imam, Ola G. El-Farghali, Khadija M. Alian

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Low-birth-weight is a challenging public health problem. Aim: to clarify role of zinc on enhancing catch-up growth of low-birth-weight and find out a proposed relationship between zinc effect on growth and the main growth hormone mediator, IGF-1. Methods: Study is a double-blind-randomized-placebo-controlled trial conducted on low-birth-weight-neonates delivered at Ain Shams University Maternity Hospital. It comprised 200 Low-birth-weight-neonates selected from those admitted to NICU. Neonates were randomly allocated into one of the following two groups: group I: low-birth-weight; AGA or SGA on oral zinc therapy at dose of 10 mg/day; group II: Low-birth-weight; AGA or SGA on placebo. Anthropometric measurements were taken including birth weight, length; head, waist, chest, mid-upper arm circumferences, triceps and sub-scapular skin-fold thicknesses. Results: At 12-month-old follow-up visit, mean weight, length; head (HC), waist, chest, mid-upper arm circumferences and triceps; also, infant’s proportions had values ≥ 10th percentile for weight, length and HC were significantly higher among infants of group I when compared to those of group II. Oral zinc therapy was associated with 24.88%, 25.98% and 19.6% higher proportion of values ≥ 10th percentile regarding weight, length and HC at 12-month-old visit, respectively [NNT = 4, 4 and 5, respectively]. Median IGF-1 levels measured at 6 months were significantly higher in group I compared to group II (median (range): 90 (19 – 130) ng/ml vs. 74 (21 – 130) ng/ml, respectively, p=0.023). Conclusion: Oral zinc therapy in low-birth-weight neonates was associated with significantly more catch-up growth at 12-months-old and significantly higher serum IGF-1 at 6-month-old.

Keywords: low-birth-weight, zinc, catch-up growth, neonates

Procedia PDF Downloads 380

Authors: Akinwumi Omotayo, Badu-B Apraku, Joseph Olobasola, Petra Abdul Saghir, Yinka Sobowale

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In southwestern Nigeria, climate change has led to loss of at least two months of rainfall. Consequently, only one cycle of maize can now be grown because of the shorter duration of rainy season as against two cycles in the past. The Early and Extra-early maturing varieties of maize were originally developed for the semi-arid and arid zones of West and Central Africa where there are seasonal challenges of water threatening optimum performance of the traditional maize grown, which are commonly late in maturity (115 to 120 days). The early varieties of maize mature in 90 to 95 days; while the Extra-Early maize varieties reach physiological maturity in less than 90 days. It was broadly hypothesized that the extra early varieties of maize could mitigate the effects of climate change in southwestern Nigeria with higher levels of rainfall by reinstating the original two cycles of rain-fed maize crop. Trials were therefore carried out in southwestern Nigeria on the possibility of adapting the extra early maize to mitigate the effects of climate change. The trial was the Mother/Baby design. The mother trial involves the evaluation of extra-early varieties following ideal recommendations and closely supervised centrally at the University research farm and the Agricultural Development Programmes (ADPs). This requires farmers to observe and evaluate the technology and the management regime meant to precede the second stage of evaluation at several satellite farmers field managed by selected farmers. The Baby Trial is expected to provide a realistic assessment of the technology by farmers in their own environment. A stratified selection of thirty farmers for the Baby Trial ensured appropriate representation across the different categories of the farming population by age and gender. Data from the trials indicate that extra early maize can be grown in two cycles rain fed in south west Nigeria and a third and fourth cycle could be obtained with irrigation. However the long duration varieties outyielded the extra early maize in both the mother and baby trials. When harvested green, the extra early maize served as source of food between March and May when there was scarcity of food. This represents a major advantage. The study recommends that further work needs to be done to improve the yield of extra early maize to encourage farmers to adopt.

Keywords: adaptation, climate change, extra early, maize varieties, mitigation

Procedia PDF Downloads 169

Authors: Ratna Farida Soenarto, Anas Alatas, Made Ryan Kharmayani

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Background: Conventional ultrafiltration (CUF) system was shown to be helpful in reducing anti-inflammatory mediators for patients who underwent open heart surgery. Additionally, modified ultrafiltration (MUF) has been shown to reduce anti-inflammatory mediators further while reducing interstitial fluid volume at the same time. However, there has been minimal data concerning the efficacy of combining both ultrafiltration methods. This study aims to compare inflammation marker, vascular resistance, and cardiac index on CUF+MUF patients with CUF only patients undergoing open heart surgery. Method: This is a single blind randomized controlled trial on patients undergoing open heart surgery between June 2021 - October 2021 in CiptoMangunkusumo National Referral Hospital and Jakarta Heart Hospital. Patients wererandomized using block randomization into modified ultrafiltration following conventional ultrafiltration (CUF+MUF) and conventional ultrafiltration (CUF) only. Outcome assessed in this study were 24-hoursinterleukin-6 levels, systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), and cardiac index. Results: A total of 38patients were included (19 CUF+MUF and 19 CUF subjects). There was no difference in postoperative IL-6 level between groups (p > 0.05).No difference in PVR was observed between groups.Higher difference in SVR was observed in CUF+MUF group (-646 vs. -261dyn/s/cm-5, p < 0.05). Higher cardiac index was observed on CUF+MUF group (0.93 vs. 0.48, p < 0.05). Conclusion: Patients undergoing open heart surgery with modified ultrafiltration following conventional ultrafiltration had similar systemic inflammatory response and better cardiac response than those having conventional ultrafiltration.

Keywords: open-heart, CUF, MUF, SVR, PVR, IL-6

Procedia PDF Downloads 124

Authors: Muthukuda Arachchige Dona Shiroma Jeeva Shirajanie Niriella

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The necessity of protection of the rights of victims of crime is a matter of concerns today. In the criminal justice system, child victims who are subjected to sexual abuse/violence are more vulnerable than the other crime victims. When they go to the police to lodge the complaint and until the end of the court proceedings, these victims are re-victimized in the criminal justice system. The rights of the suspects, accused and convicts are recognized and guaranteed by the constitution under fair trial norm, contemporary penal laws where crime is viewed as an offence against the State and existing criminal justice system in many jurisdictions including Sri Lanka. In this backdrop, a reasonable question arises as to whether the existing criminal justice system, especially which follow the adversarial mode of judicial trial protect the fair trial norm in the criminal justice process. Therefore, this paper intends to discuss the rights of the sexually abused child victims in the criminal justice system in order to restore imbalance between the rights of the wrongdoer and victim and suggest legal reforms to strengthen their rights in the criminal justice system which is essential to end secondary victimization. The paper considers Sri Lanka as a sample to discuss this issue. The paper looks at how the child victims are marginalized in the traditional adversarial model of the justice process, whether the contemporary penal laws adequately protect the right of these victims and whether the current laws set out the provisions to provide sufficient assistance and protection to them. The study further deals with the important principles adopted in international human rights law relating to the protection of the rights of the child victims in sexual offences cases. In this research paper, rights of the child victims in the investigation, trial and post-trial stages in the criminal justice process will be assessed. This research contains an extensive scrutiny of relevant international standards and local statutory provisions. Case law, books, journal articles, government publications such as commissions’ reports under this topic are rigorously reviewed as secondary resources. Further, randomly selected 25 child victims of sexual offences from the decided cases in last two years, police officers from 5 police divisions where the highest numbers of sexual offences were reported in last two years and the judicial officers both Magistrates and High Court Judges from the same judicial zones are interviewed. These data will be analyzed in order to find out the reasons for this specific sexual victimization, needs of these victims in various stages of the criminal justice system, relationship between victimization and offending and the difficulties and problems that these victims come across in criminal justice system. The author argues that the child victims are considerably neglected and their rights are not adequately protected in the adversarial model of the criminal justice process.

Keywords: child victims of sexual violence, criminal justice system, international standards, rights of child victims, Sri Lanka

Procedia PDF Downloads 341

Authors: Masoumeh Khailghi Sikaroudi, Mohsen Masoodi, Fazad Shidfar, Meghdad Sedaghat

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Background: The hypertonicity of internal anal sphincter resting pressure is one of the main reasons for chronic anal fissures. The aim of this study is to assess the effect of oral administration of L-arginine on anal fissure symptom improvement by relaxation of the internal anal sphincter. Method: Seventy-six chronic anal fissure patients (age: 18-65 years) took part in this randomized, double-blind, placebo-controlled trial study from February 2019 to October 2020 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were allocated into treatment (L-arginine) or placebo groups. They took a 1000 mg capsule three times a day for one month and were followed up at the end of the first and third months after receiving the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. Result: The analysis of data was shown significant improvement in bleeding, fissure size, and pain within each group; however, this effect was more seen in the arginine group compared to the control group at the end of the study (P-values<0.001). Following that, a significant increase in QoL was seen just in patients who were treated with arginine (P-value=0.006). Also, the comparison of anal pressures to baseline and between groups at the end of the study showed a significant reduction in sphincter pressure in treated patients (P-value<0.001, =0.049; respectively). Conclusion: Oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing anal internal sphincter pressure with fewer side effects. However, a long-term study with more follow-up is recommended.

Keywords: L-arginine, anal fissure, sphincter pressure, clinical symptoms, quality of life

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Authors: Raman Sharma, S. K. Jain

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Aims and Objectives: Fixation of the mesh during laparoscopic total extraperitoneal (TEP) repair of inguinal hernia is thought to be necessary to prevent recurrence. However, mesh fixation may increase surgical complications and postoperative pain. Our objective was to compare the outcomes of nonfixation with fixation of polypropylene mesh by metal tacks during TEP repair of inguinal hernia. Methods: Forty patients aged 18 to72 years with inguinal hernia were included who underwent laparoscopic TEP repair of inguinal hernia with (n=20) or without (n=20) fixation of the mesh. The outcomes were operative duration, postoperative pain score, cost, in-hospital stay, time to return to normal activity, and complications. Results: Patients in whom the mesh was not fixed had shorter mean operating time (p < 0.05). We found no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications (P > 0.05). Moreover, a net cost savings was realized for each hernia repair performed without stapled mesh. Conclusions: TEP repair without mesh fixation resulted in the shorter operating time and lower operative cost with no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications. All this contribute to make TEP repair without mesh fixation a better choice for repair of uncomplicated inguinal hernia, especially in developing nations with scarce resources.

Keywords: postoperative pain score, inguinal hernia, nonfixation of mesh, total extra peritoneal (TEP)

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Authors: Maha Alhussain, Moira A Taylor, Ian A. Macdonald

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Background: It is well established that dietary composition has effects on metabolism and therefore impacts on health; however other aspects of diet, such as meal pattern, could also be important in both obesity management and promoting health. The present study investigated the effect of irregular meal frequency on anthropometric measurements and energy expenditure (EE) in healthy women. Design: 11 healthy weight women (18–40 years) were studied in a randomized crossover trial with two phases of 2 weeks each. In Phase 1, participants consumed either a regular meal pattern (6 meals/day) or an irregular meal pattern (varying from 3 to 9 meals/day). In Phase 2, participants followed the alternative meal pattern to that followed in Phase 1, after a 2-weeks washout period. In the two phases, identical foods were provided to a participant in amounts designed to keep body weight constant. Participants came to the laboratory after an overnight fast at the start and end of each phase. EE was measured in fasting state by indirect calorimetry. Postprandial EE was measured during the 3 h period after consumption of a milkshake, test drink. Results: There were no significant changes in body weight and anthropometric measurements after both meal pattern interventions. There was also no significant difference in mean daily energy intake between the regular and irregular meal pattern (2043 ±31 and 2099 ±33 respectively). EE in the fasting state showed no significant differences cross the experiment visits. There was a significant difference in Postprandial EE (measured for 3 h) by visit (P=0.04). Postprandial EE after the regular meal pattern was significantly higher than at baseline (P=0.002) or than after the irregular meal pattern (P= 0.04). Conclusion: Eating regularly for 14-day period significantly increases Postprandial EE which may contribute to weight loss and obesity management.

Keywords: energy expenditure, energy intake, meal pattern, weight loss

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Authors: V. Endo, A. G. Silva Sobrinho, F. A. Almeida, N. L. L. Lima, G. M. Manzi, L. G. A. Cirne, N. M. B. L. Zeola

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We used 24 Ile de France lambs, weighing between 15 and 32 kg (BW). Treatments were supplemented with concentrate: “in nature” sugarcane (IN), sugarcane hydrolyzed using 0.6% calcium oxide (CaO) under aerobic condition (AER), and sugarcane hydrolyzed using 0.6% CaO under anaerobic condition (ANA), constituting a completely randomized design with eight repetitions per treatment. Lambs were housed in individual stalls and fed into the through, allowing 10% of leftovers. Lambs were slaughtered when body weight reached 32 kg. The following parameters were determined on Longissimus lumborum muscle of hot and cold carcasses: pH and color, 45 minutes and 24 hours after slaughtering. Qualitative analysis of the meat were performed in the loins, water-holding capacity (WHC), cooking loss (CL), and shear force (SF). We used a completely randomized design with three treatments and eight repetitions. Means were compared by Tukey test at 5% significance. A higher value for redness (a*) 45 minutes after slaughter (10.48) was found for lambs fed sugarcane hydrolyzed under anaerobic conditions. The other qualitative characteristics of meat were not affected by treatments (P >0.05). The comparison of meat quality resulting from the treatments shows that it is possible to feed in nature sugarcane to lambs, thus waiving hydrolyses process and the spending with alkalizing agent.

Keywords: oxide, hydrolysis, meat quality, pH

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Authors: Jong Yeop Kim, Sung Young Park, Dae Hee Kim, Han Bum Joe, Ji Young Yoo, Jong Bum Choi, Sook Young Lee

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Emergence agitation (EA) is commonly reported adverse events after sevoflurane anesthesia in pediatric patients. The efficacy of prophylactic remifentanil, one of mu opioid agonist, in preventing EA is controversial. This meta-analysis assessed the effectiveness of remifentanil to decrease the incidence of EA from sevoflurane anesthesia in children. We searched for randomized controlled trials comparing sevoflurane alone anesthesia with sevoflurane and remifentanil anesthesia to prevent EA in the Cochrane Library, Embase, Pubmed, and KoreaMed, and included 6 studies with 361 patients. The number of patients of reporting EA was summarized using risk ratio (RR) with 95% confidence interval (CI), with point estimates and 95CIs derived from a random effects Mantel-Haenszel method. Overall incidence of EA was about 41%. Compared with sevoflurane alone anesthesia, intravenous infusion of remifentanil with sevoflurane significantly reduced the incidence of EA (RR 0.53, 95% CI 0.39-0.73, P < 0.0001), (heterogeneity, I2 = 0, P = 0.42). This meta-analysis suggested that continuous infusion of remifentanil could be effective in decreasing the EA of about 47% after sevoflurane anesthesia. However, considering limitations of the included studies, more randomized controlled studies are required to verify our results.

Keywords: emergence agitation, meta-analysis, remifentanil, pediatrics

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Authors: Mohammad Nassiri, Farhad Ahmadi

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This research was carried out to investigate the effects of copper oxide nanoparticles (nano-CuO) on performance and gut morphology of broiler chickens. A total of 240 one-day-old male chickens (Ross-308) were randomly divided in a completely randomized design, the inclusion of 4 groups of 60 birds with 4 replicates and 15 birds in each. Experimental diets were as follow: T1 control (basal diets, without nano-CuO but contain 9.1 mg Cu/kg from CuO), T2, T3, and T4 basal diet supplementation with 30, 60, and 90 mg nano-CuO/kg, respectively. Feed intake (FI) and gain weight as weekly recorded and on d 21 feed conversion ratio (FCR) were calculated. Furthermore, at the end of the trial (21 d), four birds per treatment (one bird/replicate) randomly selected and after removed blood samples, they slaughtered and then to the analysis of gut morphological. A segment (10 cm) from the middle part of duodenum and jejunum was removed and put in the formalin 10% (pH = 7). The results revealed that nano-CuO had significantly increased body weight (P = 0.029, but feed intake (P = 0.017), and feed conversion ratio (P = 0.031) decreased in the birds that fed 90 mg nano-CuO when compared to control and the other groups. Total antioxidant capacity (P = 0.041), superoxide dismutase (P = 0.036), and glutathione peroxidase (P = 0.048) were more in the birds fed diet inclusion of 60 and 90 mg nano-CuO (T4) than other treatments. The lowest malonaldehyde (MDA) level was observed in T3 (P = 0.23) and T4 (P = 0.028) decreased (P = 0.17). The villi height and villi height to crypt depth (VH/CD ratio) numerically increased (P = 0.09) in the bird fed 90 mg nano-CuO in comparison with other treatments. According to present results, it could be concluded that dietary nano-CuO improved performance parameters and antioxidant status of broiler chickens during starter period. As well, the optimum improvement observed in the birds fed diet inclusion of 90 mg nano-CuO/kg.

Keywords: antioxidant, broilers, copper, performance, nanoparticles

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Authors: Chia-Chen Hsieh, Fei-Hsiu Hsiao

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Objective: To examine the effects of supportive care interventions on depressive symptoms in patients with lung cancer. Methods: The databases of Cochrane Central Register of Controlled Trials (CENTRAL), Ovid EMBASE, PubMed, and Chinese Electronic Periodical Services (CEPS) were searched from their inception until September 2015. We included the studies with randomized controlled trial design that compared standard care with supportive care interventions using psychotherapeutic or exercises approach. The standardized mean differences (SMD) (Cohen’s d) were calculated to estimate the treatment effects. The Cochrane Risk of Bias Tool was used for quality assessment and subgroup analysis was conducted to identify possible sources of heterogeneity. Results: A total of 1472 patients with lung cancer were identified. Compared with standard care, the overall effects of all supportive care interventions significantly reduced depressive symptoms (SMD = -0.74 with 95% CI = -1.07 to -0.41), and the effect was maintained at the 4th, 8th, and 12th weeks of follow-up. Either psychotherapy combined with psychoeducation or exercise alone produced significant improvements in depressive symptoms, while psychoeducation alone did not. The greater improvements in depressive symptoms occurred in lung cancer patients with severe depressive symptoms at baseline, total duration of interventions of less than ten weeks, and intervention provided through face-to-face delivery. Conclusions: Psychotherapy combined with psychoeducation can help patients manage the causes of depressive symptoms, including both symptom distress and psychological trauma due to lung cancer. Exercise can target the impaired respiratory function that is a cause of depressive symptoms in lung cancer patients.

Keywords: supportive care intervention, depressive symptoms, lung cancer, meta-analysis

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Authors: Fatemeh Rasooli, Behzad Simiari, Pooya Payandemehr, Amir Nejati, Maryam Bahreini, Atefeh Abdollahi

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Introduction: Pain is a complex physiological reaction to tissue injury. In the course of painful procedures such as nerve block, ice has been shown to be a feasible and inexpensive material to control pain. It delays nerve conduction, actives other senses and reduces inflammatory and painful responses. This study assessed the effect of ice in reducing pain caused by needling and infiltration during digital block. Patient satisfaction recorded as a secondary outcome. Methods: This study was designed as a non-blinded randomized clinical trial approved by Tehran University of Medical Sciences Ethical Committee. Informed consent was taken from all the participants who were then randomly divided into two groups. Digital block performed by standard approach in selected patients. Tubes of ice were prepared in gloves and were fragmented at a time of application for circling around the finger. Tubes were applied for 6 minutes before digital nerve block in the site of needling in the case group. Patients in the control group underwent digital nerve block with the conventional method without ice administration. Numeric Rating Scale (NRS) used for grading pain. 0 used for no pain and 10 for the worst pain that patient had experienced until now. Scores were analyzed by Wilcoxon Rank Sum test and compared in case and control groups. Results: 100 patients aged 16-50 years were enrolled. Mean NRS scores with and without ice were 1.5 mm (S.D ± 1.44) and 6.8 mm (S.D ± 1.40) for needling pain and for infiltration pain were 2.7mm ( S.D ±1.65) and 8.5mm ( S.D ± 1.47), respectively (p<0.001). Besides, patients’ satisfactions were significantly higher in the ice group (p<0.001). Conclusion: Application of ice for 6 minutes significantly reduced pain of needling and infiltration in digital nerve block; thus, it seems to be a feasible and inexpensive material which acts effectively to decrease pain and stress before the procedure.

Keywords: digital block, ice, needle, pain

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Authors: Dylan Shiting Lu, Samson Okello, Anita Chunyan Wei, Daniel Xiao Li

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Mammotome vacuum-assisted breast biopsy (MVB) introduced in 1995 can be used for the removal of benign breast lesions. Whether or not MVB is a better option compared to conventional open surgery is inconclusive. We aim to compare the clinical and patient-related outcomes between MVB and open surgery to remove benign breast tumors less than 5 cm in women. We searched English and Chinese electronic databases with the keywords of Mammotome, clinical trial (CT), vacuum-assisted breast biopsy for studies comparing MVB and open surgery until May 2021. We performed a systematic review and random-effects meta-analysis to compare incision size, operation time, intraoperative blood loss, healing time, scar length, patient satisfaction, postoperative hematoma rate, wound infection rate, postoperative ecchymosis, and postoperative sunken skin among those who have Mammotome and those who have surgery. Our analysis included nine randomized CTs with 1155 total patients (575 Mammotome, 580 surgery) and mean age 40.32 years (standard deviation 3.69). We found statistically significant favorable outcomes for Mammotome including blood loss (ml) [standardized mean difference SMD -5.03, 95%CI (-7.30, -2.76)], incision size (cm) [SMD -12.22, 95%CI (-17.40, -7.04)], operation time (min) [SMD -6.66, 95%CI (-9.01, -4.31)], scar length (cm) [SMD -7.06, 95%CI (-10.76, -3.36)], healing time (days) [SMD -6.57, 95%CI (-10.18, -2.95)], and patient satisfaction [relative risk RR 0.38, 95%CI (0.13, 1.08)]. In conclusion, Mammotome vacuum-assisted breast biopsy compared to open surgery shows better clinical and patient-related outcomes. Further studies should be done on whether or not MVB is a better option for benign breast tumors excision.

Keywords: clinical and patient outcomes, open surgery, Mammotome vacuum-assisted breast biopsy, meta-analysis

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Authors: Carmen W. H. Chan, Helen Y. L. Chan, Kai Chow Choi, Ka Ming Chow, Cecilia W. M. Kwan, Nancy H. Y. Ng, Jackie Robinson

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Introduction: In Hong Kong, a significant number of deaths occur in acute care wards, which requires nurses in these settings to provide end-of-life care and lead ACP implementation. However, nurses in these settings, in fact, have very low-level involvement in ACP discussions because of limited training in ACP conversations. Objective: This study aims to assess the impact of a multi-media experiential ACP (MEACP) training program, which is guided by the experiential learning model and theory of planned behaviour, on nurses' knowledge and confidence in assisting patients with ACP. Methodology: The study utilizes a cluster randomized controlled trial with a 12-week follow-up. Eligible nurses working in acute care hospital wards are randomly assigned at the ward level, in a 1:1 ratio, to either the control group (no ACP education) or the intervention group (4-week MEACP training program). The training programme includes training through a webpage and mobile application, as well as a face-to-face training workshop with enhanced lectures and role play, which is based on the Theory of Planned Behavior and Kolb's Experiential Learning Model. Questionnaires were distributed to assess nurses' knowledge (a 10-item true/false questionnaire) and level of confidence (five-point Likert scale) in ACP at baseline (T0), four weeks after the baseline assessment (T1), and 12 weeks after T1 (T2). In this interim report, data analysis was mainly descriptive in nature. Result: The interim report focuses on the preliminary results of 165 nurses at T0 (Control: 74, Intervention: 91) over a 5-month period, 69 nurses from the control group who completed the 4-week follow-up and 65 nurses from the intervention group who completed the 4-week MEACP training program at T1. The preliminary attrition rate is 6.8% and 28.6% for the control and intervention groups, respectively, as some nurses did not complete the whole set of online modules. At baseline, the two groups were generally homogeneous in terms of their years of nursing practice, weekly working hours, working title, and level of education, as well as ACP knowledge and confidence levels. The proportion of nurses who answered all ten knowledge questions correctly increased from 13.8% (T0) to 66.2% (T1) for the intervention group and from 13% (T0) to 20.3% (T1) for the control group. The nurses in the intervention group answered an average of 7.57 and 9.43 questions correctly at T0 and T1, respectively. They showed a greater improvement in the knowledge assessment at T1 with respect to T0 when compared with their counterparts in the control group (mean difference of change score, Δ=1.22). They also exhibited a greater gain in level of confidence at T1 compared to their colleagues in the control group (Δ=0.91). T2 data is yet available. Conclusion: The prevalence of nurses engaging in ACP and their level of knowledge about ACP in Hong Kong is low. The MEACP training program can enrich nurses by providing them with more knowledge about ACP and increasing their confidence in conducting ACP.

Keywords: advance directive, advance care planning, confidence, knowledge, multi-media experiential, randomised control trial

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Authors: Romina Beqiri

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In the context of the prosecution of those responsible for the commission of the most hideous crimes and the fight against impunity, a fundamental role is played by witnesses of the crimes who contribute to ascertaining the ‘procedural truth’. This article examines recent decisions and legislation of the Hague-based International Criminal Court in terms of the endangerment of the integrity of the criminal proceedings in consequence of witness tampering. The analysis focuses on the new developments in the courtroom and the academia, in particular, on the first-ever sentence confirming the charges of corruptly influencing witnesses, interpretation of presenting false evidence and giving false testimony when under an obligation to tell the truth. Confronted with recent tampering with witnesses and their credibility at stake in the ongoing cases, the research explores different Court’s decisions and scholars’ legal disputes concerning the deterrence approach to punish the authors of offences against the administration of justice when committed intentionally. Therefore, the analysis concludes that the Court cannot tolerate any witness false testimony and should enhance consistency and severity of sanctions for the sake of fair trial and end impunity.

Keywords: International Criminal Court, administration of justice, credibility of witness, fair trial, false testimony, witness tampering

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Authors: Yasmin Sayed, Hala Hamdy, Hafez Bazaraa, Hanaa Rady, Sherif Elanwary

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Intravenous and inhaled magnesium sulfate (MgSO₄) had been recently used as an adjuvant therapy in cases suffering from the wheezy chest. Objective: We aimed to determine the possible change in the hemodynamic state in cases received intravenous or inhaled MgSO₄ in comparison to cases received standard treatment in critically ill infants and children with the wheezy chest. Methods: A randomized controlled trial comprised 81 patients suffering from wheezy chest divided into 3 groups. In addition to bronchodilators and systemic steroids, MgSO₄ was given by inhalation in group A, intravenously in group B, and group C didn't receive MgSO₄. The hemodynamic state was determined by assessment of blood pressure, heart rate, capillary refill time and the need for shock therapy or inotropic support just before and 24 hours after receiving treatment in 3 groups. Results: There was no significant difference in the hemodynamic state of the studied groups before and after treatment. Means of blood pressure were 102.2/63.2, 105.1/64.8 before and after inhaled MgSO₄; respectively. Means of blood pressure were 105.5/64.2, 104.1/64.9 before and after intravenous MgSO₄; respectively. Means of blood pressure were 107.4/62.8, 104.4/62.1 before and after standard treatment, respectively. There was a statistically insignificant reduction of the means of the heart rate in group A and group B after treatment rather than group C. There was no associated prolongation in capillary refill time and/or the need for inotropic support or shock therapy after treatment in the studied groups. Conclusion: MgSO₄ is a safe adjuvant therapy and not associated with significant alteration in the hemodynamic state in critically ill infants and children with the wheezy chest.

Keywords: critically ill infants and children, inhaled MgSO₄, intravenous MgSO₄, wheezy chest

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Authors: Bruno Biagianti, Angela Tseng, Kathy Wannaviroj, Allison Corlett, Megan DuBois, Kyu Lee, Suma Jacob

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Background: ASD is characterized by pervasive Sensory Processing Abnormalities (SPA) and social cognitive deficits that persist throughout the course of the illness and have been linked to functional abnormalities in specific neural systems that underlie the perception, processing, and representation of sensory information. SPA and social cognitive deficits are associated with difficulties in interpersonal relationships, poor development of social skills, reduced social interactions and lower academic performance. Importantly, they can hamper the effects of established evidence-based psychological treatments—including PEERS (Program for the Education and Enrichment of Relationship Skills), a parent/caregiver-assisted, 16-weeks social skills intervention—which nonetheless requires a functional brain capable of assimilating and retaining information and skills. As a matter of fact, some adolescents benefit from PEERS more than others, calling for strategies to increase treatment response rates. Objective: We will present interim data on CICADAS (Care Improving Cognition for ADolescents on the Autism Spectrum)—a clinician-assisted, closed-loop technology mobile application for adolescents with ASD. Via ten mobile assessments, CICADAS captures data on sensory processing abnormalities and associated cognitive deficits. These data populate a machine learning algorithm that tailors the delivery of ten neuroplasticity-based social cognitive training (NB-SCT) exercises targeting sensory processing abnormalities. Methods: In collaboration with the Autism Spectrum and Neurodevelopmental Disorders Clinic at the University of Minnesota, we conducted a fully remote, three-arm, randomized crossover trial with adolescents with ASD to document the acceptability of CICADAS and evaluate its potential as a stand-alone treatment or as a treatment enhancer of PEERS. Twenty-four adolescents with ASD (ages 11-18) have been initially randomized to 16 weeks of PEERS + CICADAS (Arm A) vs. 16 weeks of PEERS + computer games vs. 16 weeks of CICADAS alone (Arm C). After 16 weeks, the full battery of assessments has been remotely administered. Results: We have evaluated the acceptability of CICADAS by examining adherence rates, engagement patterns, and exit survey data. We found that: 1) CICADAS is able to serve as a treatment enhancer for PEERS, inducing greater improvements in sensory processing, cognition, symptom reduction, social skills and behaviors, as well as the quality of life compared to computer games; 2) the concurrent delivery of PEERS and CICADAS induces greater improvements in study outcomes compared to CICADAS only. Conclusion: While preliminary, our results indicate that the individualized assessment and treatment approach designed in CICADAS seems effective in inducing adaptive long-term learning about social-emotional events. CICADAS-induced enhancement of processing and cognition facilitates the application of PEERS skills in the environment of adolescents with ASD, thus improving their real-world functioning.

Keywords: ASD, social skills, cognitive training, mobile app

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Authors: Eman Merza, Stephen Pearson, Glen Lichtwark, Peter Malliaras

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The Achilles tendon (AT) exhibits volume changes related to fluid flow under acute load which may be linked to changes in stiffness. Fluid flow provides a mechanical signal for cellular activity and may be one mechanism that facilitates tendon adaptation. This study aimed to investigate whether isometric intervention involving a high level of load duration and intensity could maximize the immediate reduction in AT volume and stiffness compared to interventions involving a lower level of load duration and intensity. Sixteen healthy participants (12 males, 4 females; age= 24.4 ± 9.4 years; body mass= 70.9 ± 16.1 kg; height= 1.7 ± 0.1 m) performed three isometric interventions of varying levels of load duration (2 s and 8 s) and intensity (35% and 75% maximal voluntary isometric contraction) over a 3 week period. Freehand 3D ultrasound was used to measure free AT volume (at rest) and length (at 35%, 55%, and 75% of maximum plantarflexion force) pre- and post-interventions. The slope of the force-elongation curve over these force levels represented individual stiffness (N/mm). Large reductions in free AT volume and stiffness resulted in response to long-duration high-intensity loading whilst less reduction was produced with a lower load intensity. In contrast, no change in free AT volume and a small increase in AT stiffness occurred with lower load duration. These findings suggest that the applied load on the AT must be heavy and sustained for a long duration to maximize immediate volume reduction, which might be an acute response that enables optimal long-term tendon adaptation via mechanotransduction pathways.

Keywords: Achilles tendon, volume, stiffness, free tendon, 3d ultrasound

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Authors: Lucile Rapin, Cynthia El Hage, Rihab Gamaoun, Maria-Fernanda Arboleda, Erin Prosk

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Introduction: Sante Cannabis (SC), a Canadian group of clinics dedicated to medical cannabis, based in Montreal and in the province of Quebec, has served more than 8000 patients seeking cannabis-based treatment over the past five years. As randomized clinical trials with natural medical cannabis are scarce, real-world evidence offers the opportunity to fill research gaps between scientific evidence and clinical practice. Data on the use of medical cannabis products from SC patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to report information on the profiles of both patients and prescribed medical cannabis products at SC clinics, and to assess the safety of medical cannabis among Canadian patients. Methods: This is an observational retrospective study of 1342 adult patients who were authorized with medical cannabis products between October 2017 and September 2019. Information regarding demographic characteristics, therapeutic indications for medical cannabis use, patterns in dosing and dosage form of medical cannabis and adverse effects over one-year follow-up (initial and 4 follow-up (FUP) visits) were collected. Results: 59% of SC patients were female, with a mean age of 56.7 (SD= 15.6, range= (19-97)). Cannabis products were authorized mainly for patients with a diagnosis of chronic pain (68.8% of patients), cancer (6.7%), neurological disorders (5.6%), and mood disorders (5.4 %). At initial visit, a large majority (70%) of patients were authorized exclusively medical cannabis products, 27% were authorized a combination of pharmaceutical cannabinoids and medical cannabis and 3% were prescribed only pharmaceutical cannabinoids. This pattern was recurrent over the one-year follow-up. Overall, oil was the preferred formulation (average over visits 72.5%) followed by a combination of oil and dry (average 19%), other routes of administration accounted for less than 4%. Patients were predominantly prescribed products with a balanced THC:CBD ratio (59%-75% across visits). 28% of patients reported at least one adverse effect (AE) at the 3-month follow-up visit and 12% at the six-month FUP visit. 84.8% of total AEs were mild and transient. No serious AE was reported. Overall, the most common side effects reported were dizziness (11.95% of total AEs), drowsiness (11.4%), dry mouth (5.5%), nausea (4.8%), headaches (4.6%), cough (4.4%), anxiety (4.1%) and euphoria (3.5%). Other adverse effects accounted for less than 3% of total AE. Conclusion: Our results confirm that the primary area of clinical use for medical cannabis is in pain management. Patients in this cohort are largely utilizing plant-based cannabis oil products with a balanced ratio of THC:CBD. Reported adverse effects were mild and included dizziness and drowsiness. This real-world data confirms the tolerable safety profile of medical cannabis and suggests medical indications not yet validated in controlled clinical trials. Such data offers an important opportunity for the investigation of the long-term effects of cannabinoid exposure in real-life conditions. Real-world evidence can be used to direct clinical trial research efforts on specific indications and dosing patterns for product development.

Keywords: medical cannabis, safety, real-world data, Canada

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Authors: Modi Alsubaie, Chris Dickens, Barnaby Dunn, Andy Gibson, Obioha Ukoumunned, Alison Evans, Rachael Vicary, Manish Gandhi, Willem Kuyken

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Background: Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to effectively treat acute depression in those with comorbid cardiovascular disorders, to date there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Therefore, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with co-morbid depression and cardiovascular disorders. Methods: A 3-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU, and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, immediately after, and three months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Results: 3400 potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. 242 (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable, and 33 (<1%) were eventually randomised to the three groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disease (one to 25 years). Of 11 participants randomised to adapted MBCT seven completed the full course, levels of home mindfulness practice were high, and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 participants randomised completed all the assessment measures at all three-time points. With regards to the primary outcome (depression), five out of the seven people who completed the adapted MBCT and three out of five under MBSR showed significant clinical change, while in TAU no one showed any clinical change at the three-month follow-up. Conclusions: The adapted MBCT intervention was feasible and acceptable to participants. However, aspects of the trial design were not feasible. In particular, low recruitment rates were achieved, and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high meaning the adapted intervention was unlikely to be well tailored to all participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to more successfully recruit a target sample that optimally matches the adapted intervention.

Keywords: mindfulness-based cognitive therapy (MBCT), depression, cardiovascular disorders, feasibility, acceptability

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