Search results for: randomized controlled trial

Authors: Muhammad Tanziel Aziezi

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In Indonesia, pre-trial (in Indonesia called ‘praperadilan’) is a mechanism that is regulated on Criminal Procedure Code as a form of oversight and check and balance on the process at the stage of inquiry, investigation, and prosecution, so that actions taken by the State (in this case, the police and prosecutor) is carried out in accordance with its authority and not violate human rights. Article 77 of the Criminal Procedure Code has been set that the object may be filed pretrial is just about the lawfulness of the arrest, the lawfulness of the detention, and the legitimacy of stopping investigation and prosecution. However, since the beginning of 2015, there was a further object which is then entered as a pre-trial object, namely the lawfulness of the determination of a criminal suspect. This is because the determination of the suspect is considered as one of the forceful measures that could restrict the rights of a person, so the implementation should have oversight and checks and balances by the courts. This paper will discuss the development of the pre-trial on the lawfulness of the determination of a criminal suspect as a new judicial mechanism as the protection of human rights in Indonesia.

Keywords: criminal procedure law, pre-trial, lawfulness of determination of a criminal suspect, check and balance by the court

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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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Authors: Pitchaporn Purngpiputtrakul, Suttasinee Petsakul, Sunisa Chatmongkolchart

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Nasogastric tube (NGT) insertion in anaesthetized and intubated patients can be challenging even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between the GlideScope visualization and neck flexion with lateral neck pressure techniques. This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery under relaxant general anaesthesia who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of first and second attempts, duration of insertion, and complications were recorded. The total success rate was 79.1% in Group G compared with 76.7% in Group F (P=1) The median time required for NGT insertion was significantly longer in Group G, for both first and second attempts (97 vs 42 seconds P<0.001) and (70 vs 48.5 seconds P=0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications in both techniques. Using GlideScope visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique in degree of success rate of insertion, while neck flexion with lateral neck pressure technique had fewer complications and was less time-consuming.

Keywords: anaesthesia, nasogastric tube, GlideScope, intubation

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Authors: Daniela V. Bavaresco, Tamy Colonetti, Antonio Jose Grande, Francesc Colom, Joao Quevedo, Samira S. Valvassori, Maria Ines da Rosa

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Objective: Performed a systematic review and meta-analysis to evaluated the potential effect of the cyclo-oxygenases (Cox)-2 inhibitor Celecoxib adjunct treatment in Bipolar Disorder (BD), through of randomized controlled trials. Method: A search of the electronic databases was proceeded, on MEDLINE, EMBASE, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), Biomed Central, Web of Science, IBECS, LILACS, PsycINFO (American Psychological Association), Congress Abstracts, and Grey literature (Google Scholar and the British Library) for studies published from January 1990 to February 2018. A search strategy was developed using the terms: 'Bipolar disorder' or 'Bipolar mania' or 'Bipolar depression' or 'Bipolar mixed' or 'Bipolar euthymic' and 'Celecoxib' or 'Cyclooxygenase-2 inhibitors' or 'Cox-2 inhibitors' as text words and Medical Subject Headings (i.e., MeSH and EMTREE) and searched. The therapeutic effects of adjunctive treatment with Celecoxib were analyzed, it was possible to carry out a meta-analysis of three studies included in the systematic review. The meta-analysis was performed including the final results of the Young Mania Rating Scale (YMRS) at the end of randomized controlled trials (RCT). Results: Three primary studies were included in the systematic review, with a total of 121 patients. The meta-analysis had significant effect in the YMRS scores from patients with BD who used Celecoxib adjuvant treatment in comparison to placebo. The weighted mean difference was 5.54 (95%CI=3.26-7.82); p < 0.001; I2 =0%). Conclusion: The systematic review suggests that adjuvant treatment with Celecoxib improves the response of major treatments in patients with BD when compared with adjuvant placebo treatment.

Keywords: bipolar disorder, Cox-2 inhibitors, Celecoxib, systematic review, meta-analysis

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Authors: In Kyong Yi, Yun Jeong Chae, Jihoon Hwang, Sook-Young Lee, Jong-Yeop Kim

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Background: Pentax airway scope (AWS) is a recently developed video laryngoscope for use in both normal and difficult airways, providing a good laryngeal view. The purpose of this randomized noninferior study was to evaluate the efficacy of the Pentax-AWS regarding intubation time, laryngeal view and ease of intubation in pediatric patients with normal airway, compared to Macintosh laryngoscope. Method: A total of 136 pediatric patients aged 1 to 10 with American Society of Anesthesiologists physical status I or II undergoing general anesthesia required orotracheal intubation were randomly allocated into two groups: Macintosh laryngoscope (n =68) and Pentax AWS (n=68). Anesthesia was induced with propofol, rocuronium, and sevoflurane. The primary outcome was intubation time. Cormack-Lehane laryngeal view grade, application of optimal laryngeal external manipulation (OELM), intubation difficulty scale (IDS), intubation failure rate and adverse events were also measured. Result: No significant difference was observed between the two groups regarding intubation time (Macintosh; 23[22-26] sec vs. Pentax; 23.5[22-27.75] sec, p=0.713). As for the laryngeal view grade, the Pentax group showed less number of grade 2a or higher grade cases compared to the Macintosh group (1/2a/2b/3; 52.9%/41.2%/4.4%/1.5% vs. 98.5%/1.5%/0%/0%, p=0.000). No optimal laryngeal external manipulation application was required in the Pentax group (38.2% vs. 0%, p=0.000). Intubation difficulty scale resulted in lower values for Pentax group (0 [0-2] vs. 0 [0-0.55], p=0.001). Failure rate was not different between the two groups (1.5% vs. 4.4%, p=0.619). Adverse event-wise, slightly higher incidence of bleeding (1.5% vs. 5.9%, p=0.172) and teeth injury (0% vs. 5.9%, p=0.042) occurred in the Pentax group. Conclusion: In conclusion, Pentax-AWS provided better laryngeal view, similar intubation time and similar success rate compared with Macintosh laryngoscope in children with normal airway. However, the risk of teeth injury might increase and warrant special attention.

Keywords: Pentax-AWS, pediatric, video laryngoscope, intubation

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Authors: Nalanda Roy

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The project will offer a fresh and critical perspective into the Tokyo Trial judgment led by the Indian Jurist Dr. Radha Binod Pal. The project will focus on the Third World Approach to International Law (TWAIL) methodology to examine the relevance of international law from the post-colonial perspectives. The project will analyze Pal’s dissenting arguments from a new and comparative perspective, apply for work from other disciplines, and create an understanding of the significance of the historic judgment considering its contemporary relevance, and fill in the gaps that exist in the call for global justice.

Keywords: Tokyo trial, third world, judgment, international law

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Authors: Mohamed A. Eid, Sobhy M. Aly, Marwa M. Ibrahim, Nadia L. Radwan

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To investigate the interaction effects of vitamin D supplementation combined with aerobic exercises (AE) and conventional physical therapy program (CPTP) on balance and physical performance in children with Down syndrome (DS).Methods: A randomized controlled trial was conducted for 38 children with DS, with ages ranging from 8 to 12 years. They were divided randomly to two groups. The control group (n=19) received the CPTP, while the study group (n=19) received the CPTP, AE, and vitamin D in the form of an oral daily dose of vitamin D3 400 IU (Cholecalciferol). Evaluation of balance by using the Biodex Stability System and physical performance by using the six-minute walk test (6MWT)was performed before and after 12 weeks of the treatment program. Findings: All groups showed a significant improvement in balance and physical performance after treatment (p < 0.05). The study group showed a significant improvement in balance and physical performancecompared with that of the control group (p < 0.05). Conclusion: Vitamin D supplementation combined with AE and CPTP could improve balance and physical performance in children with DS. Therefore, vitamin D and AEshould be considered as adjunctive to the rehabilitation program of these children.

Keywords: aerobic exercises, balance, down syndrome, physical performance, vitamin D

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Authors: Erinda Male

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Participation of a lawyer in any criminal proceedings on behalf of an accused person or a victim is essential to a fair trial. Legal representation is particularly crucial in proceedings before international tribunals, especially in the International Criminal Court. The paper thus focuses on the importance of the legal representation of victims and defendants before the ICC, as well as on the role of the legal representative in the proceedings before the court and the principle of freedom of choice of legal representatives. Also, the paper presents a short overview of the significance of legal representatives for victims and the necessity to protect their primary role in the ICC system, and ensure that it is coherent and respectful of victims’ rights. Victim participation is an important part of the ICC Statute and it is designed to help ensure that those most affected by the crimes are able to engage with the Court. Proper and quality legal representation ensures meaningful participation of victims at stages of the proceedings before ICC. Finally, the paper acknowledges the role of legal representatives during the pre-trial, trial and post-trial phase, the different modalities in selecting the legal representatives as well as balancing victims’ participation with the right of the accused to a fair trial.

Keywords: fair trial, freedom of choice principle, international criminal court, legal representatives, victims

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Authors: Mohammad Java Esmaeily

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Background: We evaluate the effects of tissue and organ perfusion during and after coronary artery bypass graft surgery with either colloid (Voluven) or crystalloid (Lactated ringers) as a prime solution. Materials and Methods: In this prospective randomized-controlled trial study, 70 patients undergoing on-pump coronary artery bypass graft surgery were randomly assigned to receive either colloid (Voluven) or crystalloid (Lactated ringer's) as a prime solution for initiation of cardiopulmonary bypass machine procedure. Tissue and organ perfusion markers, including lactate, troponin I, liver and renal function tests and electrolytes, were measured sequentially before induction (T1) to the second days after surgery (T5). Results: With the exception of chloride and potassium levels, no significant differences were detected in other measurements, and laboratory results were identical entirely in the two groups. Conclusion: Voluven® (hydroxyethyl starch, HES 130/0.4) has a not significant difference in comparison with crystalloid (Lactated ringer's) as priming solution on the basis of organ and tissue perfusion tests assessment.

Keywords: prime, colloid, crystalloid, lactate, troponin, hydroxyethyl starch

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Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

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Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

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In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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Authors: Che Jusoh, Mohd Rahimi, Toby Mundel

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This study was designed to investigate the physiological and performance effects of a local Malaysian native starch (Metroxylin sago) on cycling in a hot (30°C) and humid (78% RH) environment. Eight male, non-heat acclimated, well-trained club cyclists (VO2max 65 ± 10 ml kg-1 min-1, peak aerobic power 397 ± 71 W) completed one familiarization and three experimental trials in our laboratory simulating cycling in environmental conditions of heat and humidity. Each trial consisted of 45 minutes at a fixed workload (55% VO2max) followed by a 15 minute time-trial (~75% VO2max). Sago in porridge form was consumed 1h before exercise (Pre), in gel form during exercise (Dur) and compared to a control trial (Con), using a random, cross-over design. Plasma glucose concentration did not differ between trials (P = 0.06) with an increase from 4.1 ± 0.6 to 6.1 ± 1.6 mmol-1 (Con), 4.8 ± 1.7 to 5.7 ± 0.4 mmol-1 (Pre) and 4.7 ± 0.8 to 6.9 ± 1.4 mmol-1 (Dur) from start to end of exercise. Plasma lactate increased (P = 0.02) from 1.6 ± 0.3 to 7.6 ± 2.2 mmol-1 (Con), 1.7 ± 0.5 to 7.3 ± 2.9 mmol-1 (Pre) and 1.6 ± 0.2 to 7.3 ± 1.8 mmol-1 (Dur) with no effect of trial (P = 0.74). No differences were found between trials for RER (P = 0.328) with values of 0.93 ± 0.05 (Con), 0.94 ± 0.04 (Pre) and 0.92 ± 0.04 (Dur). There were no differences between trials in rectal (P = 0.64) and skin (P = 0.56) temperatures; values reaching 39.1 ± 0.5°C (Con), 38.9 ± 0.4°C (Pre) and 39.1 ± 0.4°C (Dur) for rectal and 32.7 ± 1.2°C (Con), 32.8 ± 1.4°C (Pre) and 32.8 ± 1.8°C (Dur) for skin temperature, respectively. Heart rate (P = 0.07) also did not differ between trials but reached maximal values by the end of time-trial for all trials. Performance was unaffected by trial (P = 0.98) with the average work completed in 15 minutes being 221 ± 33 kJ (Con), 222 ± 31 kJ (Pre) and 219 ± 32 kJ (Dur), respectively. Therefore, the results of this investigation do not support consumption of sago, either before or during exercise, in altering the thermoregulatory, metabolic or performance responses in a hot and humid environment.

Keywords: hot and humid, physiology, time trial performance, thermoregulatory

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Authors: Mohamed Salaheldien Mohamed Alayat, Ahmed Mohamed Elsoudany, Roaa Abdulghani Sroge, Bayan Muteb Aldhahwani

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Background: Neck pain is a common illness that could affect individual’s daily activities. Class IV laser with longer wavelength can stimulate tissues and penetrate more than the classic low-level laser therapy. Objectives: The aim of the study was to investigate the efficacy of class IV diode laser in the treatment of patients with chronic neck pain (CNP). Methods: Fifty-two patients participated and completed the study. Their mean age (SD) was 50.7 (6.2). Patients were randomized into two groups and treated with laser plus exercise (laser + EX) group and placebo laser plus exercise (PL+EX) group. Treatment was performed by Class IV laser in two phases; scanning and trigger point phases. Scanning to the posterior neck and shoulder girdle region with 4 J/cm2 with a total energy of 300 J applied to 75 cm2 in 4 minutes and 16 seconds. Eight trigger points on the posterior neck area were treated by 4 J/cm2 and the time of application was in 30 seconds. Both groups received exercise two times per week for 4 weeks. Exercises included range of motion, isometric, stretching, isotonic resisted exercises to the cervical extensors, lateral bending and rotators muscles with postural correction exercises. The measured variables were pain level using visual analogue scale (VAS), and neck functional activity using neck disability index (NDI) score. Measurements were taken at baseline and after 4 weeks of treatment. The level of statistical significance was set as p < 0.05. Results: There were significant decreases in post-treatment VAS and NDI in both groups as compared to baseline values. Laser + EX effectively decreased VAS (mean difference -6.5, p = 0.01) and NDI scores after (mean difference -41.3, p = 0.01) 4 weeks of treatment compared to PL + EX. Conclusion: Class IV laser combined with exercise is effective treatment for patients with CNP as compared to PL + EX therapy. The combination of laser + EX effectively increased functional activity and reduced pain after 4 weeks of treatment.

Keywords: chronic neck pain, class IV laser, exercises, neck disability index, visual analogue scale

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Authors: Pramote Thangkratok

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The aims of this experimental study were to investigate the effect of Reverse Trendelenburg Position on the Back Pain after Cardiovascular Angiography and Interventions. In addition, to compare bleeding and hematoma occurrences at the Access site between experimental and control groups. The randomized controlled trial (RCT) was conducted in 70 patients who underwent Cardiovascular Angiography and Interventions via the femoral artery and received post procedural care at the intermediate cardiac care unit, Bangkok Heart Hospital. From December 2015 to February 2016. The control group (35 patients) was to get standard care after the intervention, whereas the experimental group (35 patients) was Reverse Trendelenburg Position 30-45 degrees. The groups were not significantly different in terms of demographic characteristics, Age, Gender, BMI, blood pressure, heart rate. While not significantly different from each other, the intensity of back pain control group had a significantly higher pain score than experimental group. Vascular complications in terms of bleeding and hematoma were not significantly different between the control and experimental groups. The findings show that Reverse Trendelenburg Position after Cardiovascular Angiography and Interventions would reduce or prevent the back pain without increasing the chance of bleeding and hematoma.

Keywords: reverse trendelenburg position, back pain, cardiovascular angiography, cardiovascular interventions

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Authors: Chloe Fauchon

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In Europe, the right to a fair trial is enshrined in the European Convention on Human Rights, signed in 1950, in its famous Article 6, and, in the field of the European Union, in Article 47 of the Charter of Fundamental Rights, binding since 2009. The right to a fair trial is, therefore, a fundamental right protected by all the relevant treaties. The right to a fair trial is an "umbrella right" which encompasses various sub-rights and principles. Although this right applies in all the proceedings, it gets a special relevance in criminal matters and, particularly, regarding the defendant. In criminal proceedings, the parties are not equal: the accusation is represented by a State-organ, with specific prerogatives, and the defense does not benefit from these specific powers and is often inexperienced in criminal law. Equality of arms, and consequently the right to a fair trial, needs some specific mechanisms to be effective in criminal proceedings. For instance, the defendant benefits from some procedural rights, such as the right to a lawyer, the right to be informed of the charges against them, the right to confront witnesses, and so on. These rights aim to give the defendant the tools to dispute the accusation. The role of the defense is, therefore, very important in criminal matters to avoid unjustified convictions. This specificity of criminal matters justifies that the focus will be put on them during this study. Then this paper will also focus on French and Spanish legal orders. Indeed, if the European Court and Convention on Human Rights are the most famous instruments to protect the right to a fair trial, this right is also guaranteed at a constitutional level in European national legal orders in Europe. However, this enshrinement differs from one country to the other: for instance, in Spain, the right to a fair trial is protected explicitly by the 1978 constitutional text, whereas, in France, it is more of a case-law construction. Nevertheless, this difference between both legal orders does not imply huge variations in the substantive aspect of the right to a fair trial. This can be specifically explained by the submission of both States to the European Convention on Human Rights. This work aims to show that, although the French and Spanish legal orders differ in the way they protect the right to a fair trial, this right eventually has the same substantive meaning in both legal orders.

Keywords: right to a fair trial, constitutional law, French law, Spanish law, European Court of Human Rights

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Authors: Yaxian Chen, Yeonhee Park

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Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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Authors: Selina Studer, Maria Kleinstäuber, Cornelia Weise

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Background: Finding words to report what you have been through may be challenging, especially when dealing with stressful or highly emotional experiences. Photovoice (PV) represents a possible way of facilitating experience reporting. In this approach, people take photos about a particular topic (in our study: worries about the future) and talk about the topic based on the photos. So far, the benefits of Photovoice have been quantitatively insufficiently tested. There is a lack of randomized controlled trials investigating PV in comparison to other methods. This study aimed to fill this research gap. Methods: 65 participants took part in the study and were randomly assigned to the PV group, the writing group (WG), or the control group (CG). The PV group received the task to take photos of worries regarding the future for one week and send max. 5 of them to the interviewer before the interview. The WG had to write down the worries about the future and send max. 5 of them to the interviewer before the interview. The control group did not receive a specific assignment. The semi-structured interview consisted of six open-ended questions and was applied to all future worries. The questions included the content of the future worries, the meaning, and how the worry expressed itself emotionally and physically. The interview was recorded and later transcribed. After the interview, online questionnaires were filled out. They covered a range of variables such as access to emotional content, ability to describe feelings, the extent of self-disclosure, and relationship quality. Results: Contrary to our hypotheses, one-way ANOVA revealed no differences between the three conditions concerning all variables (access to emotional content, ability to describe feelings, the extent of self-disclosure, and so on), all p's > 0.14, BF₀₁ = 1.78-7.66. In a subsequent step, the words in the transcribed interviews were analyzed. The LIWC program counted how many emotional words occurred in the text and assigned them to predefined categories. Planned contrasts revealed that the PV reported more negative emotional words compared to the two groups t(62) = 2.62, p = .011, and also compared to the WG only, t(62) = 2.36, p = .022, BF₀₁ = 0.62. Conclusions and implications: The applied self-report instruments did not reveal any differences between the groups. However, the PV group used more negative emotional words than the other two groups. The discrepancy between self-report and observation variables regarding emotionality is noticeable. It is suggested that the highly educated and above-average female sample may not have needed PV to access emotional content. It is possible that the approach would yield clearer results in a clinical sample. This and other approaches are currently being investigated in a follow-up study.

Keywords: photovoice, controlled randomized study, online intervention, emotional awareness, self-disclosure, data triangulation, interviews

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Authors: Michael Wagner, Philipp Steinbauer, Andrea Katharina Lietz, Alexander Hoffelner, Johannes Fessler

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Background: Cardiopulmonary resuscitations are stressful situations in which vital decisions must be made within seconds. Lack of routine due to the infrequency of pediatric emergencies can lead to serious medical and communication errors. Virtual reality can fundamentally change the way simulation training is conducted in the future. It appears to be a useful learning tool for technical and non-technical skills. It is important to investigate the use of VR in providing a strong sense of presence within simulations. Methods: In this randomized study, we will enroll doctors and medical students from the Medical University of Vienna, who will receive learning material regarding the resuscitation of a one-year-old child. The study will be conducted in three phases. In the first phase, 20 physicians and 20 medical students from the Medical University of Vienna will be included. They will perform simulation-based training with a standardized scenario of a critically ill child with a hypovolemic shock. The main goal of this phase is to establish a baseline for the following two phases to generate comparative values regarding cognitive load and stress. In phase 2 and 3, the same participants will perform the same scenario in a VR setting. In both settings, on three set points of progression, one of three predefined events is triggered. For each event, three different stress levels (easy, medium, difficult) will be defined. Stress and cognitive load will be analyzed using the NASA Task Load Index, eye-tracking parameters, and heart rate. Subsequently, these values will be compared between VR training and traditional simulation-based training. Hypothesis: We hypothesize that the VR training and the traditional training groups will not differ in physiological response (cognitive load, heart rate, and heart rate variability). We further assume that virtual reality training can be used as cost-efficient additional training. Objectives: The aim of this study is to measure cognitive load and stress level during a real-life simulation training and compare it with VR training in order to show that VR training evokes the same physiological response and cognitive load as real-life simulation training.

Keywords: virtual reality, cognitive load, simulation, adaptive virtual reality training

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Authors: Judge Paul Smith

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Abstract—This paper addresses the use and admissibility of psychiatric/psychological evidence in Australia Courts. There have been different approaches in the Courts to the acceptance of such expert evidence. It details how such expert evidence is admissible at trial and sentence. The methodology used is an examination of the decided cases and relevant legislative provisions which relate to the admission of such evidence. The major findings are that the evidence can be admissible if it is relevant to issues in a trial or sentence. It concludes that psychiatric/psychological evidence can be very useful and indeed may be essential at sentence or trial.

Keywords: criminal, law, psychological, evidence

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Authors: Samira Rabiei, Faezeh Askari, Reza Rastmanesh

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Objective: To evaluate the effects of nutrition education and adherence to a healthy diet on glycemic and lipidemic control in patients with T2DM. Material and Methods: A randomized controlled trial was conducted on 494 patients with T2DM, aged 14-87 years from both sexes who were selected by convenience sampling from referees to Aliebneabitaleb hospital in Ghom. The participants were divided into two 247 person groups by stratified randomization. Both groups received a diet adjusted based on ideal body weight, and the intervention group was additionally educated about healthy food choices regarding diabetes. Information on medications, psychological factors, diet and physical activity was obtained from questionnaires. Blood samples were collected to measure FBS, 2 hPG, HbA1c, cholesterol, and triglyceride. After 2 months, weight and biochemical parameters were measured again. Independent T-test, Mann-Whitney, Chi-square, and Wilcoxon were used as appropriate. Logistic regression was used to determine the odds ratio of abnormal glycemic and lipidemic control according to the intervention. Results: The mean weight, FBS, 2 hPG, cholesterol and triglyceride after intervention were significantly lower than before that (p < 0.05). Discussion: Nutrition education plus a weigh reducer diet is more effective on glycemic and lipidemic control than a weight reducer diet, alone.

Keywords: type 2 diabetes mellitus, nutrition education, glycemic control, lipid profile

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Authors: Neda Jamalimoghadam, Naval Heydari, Maliheh Abootalebi, Maryam Kasraeian, M. Emamghoreishi , Akbarzadeh Marzieh

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Background: The aim was to investigate the effect of aromatherapy using Citrus aurantium blossom essential oil on premenstrual syndrome in university students. Methods: In this double-blind clinical trial was controlled on 62 students from March 2016 to February 2017. The intervention with 0.5% of C. Aurantium blossom essential oil and control was inhalation of odorless sweet almond oil in the luteal phase of the menstrual cycle. The screening questionnaire (PSST) for PMSwas filled out before and also one and two months after the intervention. Results: Mean score of overall symptoms of PMS between the Bitter orange and control groups In the first (p < 0.003) and second months (p < 0.001) of the intervention was significant. Besides, decreased the mean score of psychological symptoms in the intervention group (p < 0.001), but on physical symptoms and social function were not significant (p > 0.05). Conclusion: The aromatherapy with Citrus aurantium blossom improved the symptoms of premenstrual syndrome.

Keywords: aromatherapy, Citrus Aurantium, premenstrual syndrome, oil, students

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Authors: Stephanie PB Caligiuri, Harold M Aukema, Delfin Rodriguez-Leyva, Amir Ravandi, Randy Guzman, Grant N. Pierce

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Background: Hypertension leads to cardiac and cerebral events and therefore is the leading risk factor attributed to death in the world. Oxylipins may be mediators in these events as they can regulate vascular tone and inflammation. Oxylipins are derived from fatty acids. Dietary flaxseed is rich in the n3 fatty acid, alpha-linolenic acid, and, therefore, may have the ability to change the substrate profile of oxylipins. As a result, this could alter blood pressure. Methods: A randomized, double-blinded, controlled clinical trial, the Flax-PAD trial, was used to assess the impact of dietary flaxseed on blood pressure (BP), and to also assess the relationship of plasma oxylipins to BP in 81 patients with peripheral arterial disease (PAD). Patients with PAD were chosen for the clinical trial as they are at an increased risk for hypertension and cardiac and cerebral events. Thirty grams of ground flaxseed were added to food products to consume on a daily basis for 6 months. The control food products contained wheat germ, wheat bran, and mixed dietary oils instead of flaxseed. Central BP, which is more significantly associated to organ damage, cardiac, and cerebral events versus brachial BP, was measured by pulse wave analysis at baseline and 6 months. A plasma profile of 43 oxylipins was generated using solid phase extraction, HPLC-MS/MS, and stable isotope dilution quantitation. Results: At baseline, the central BP (systolic/diastolic) in the placebo and flaxseed group were, 131/73 ± 2.5/1.4 mmHg and 128/71 ± 2.6/1.4 mmHg, respectively. After 6 months of intervention, the flaxseed group exhibited a decrease in blood pressure of 4.0/1.0 mmHg. The 6 month central BP in the placebo and flaxseed groups were, 132/74 ± 2.9/1.8 mmHg and 124/70 ± 2.6/1.6 mmHg (P<0.05). Correlation and logistic regression analyses between central blood pressure and oxylipins were performed. Significant associations were observed between central blood pressure and 17 oxylipins, primarily produced from arachidonic acid. Every 1 nM increase in 16-hydroxyeicosatetraenoic acid (HETE) increased the odds of having high central systolic BP by 15-fold, of having high central diastolic BP by 6-fold and of having high central mean arterial pressure by 15-fold. In addition, every 1 nM increase in 5,6-dihydroxyeicosatrienoic acid (DHET) and 11,12-DHET increased the odds of having high central mean arterial pressure by 45- and 18-fold, respectively. Flaxseed induced a significant decrease in these as well as 4 other vasoconstrictive oxylipins. Conclusion: Dietary flaxseed significantly lowered blood pressure in patients with PAD and hypertension. Plasma oxylipins were strongly associated with central blood pressure and may have mediated the flaxseed-induced decrease in blood pressure.

Keywords: hypertension, flaxseed, oxylipins, peripheral arterial disease

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Authors: Ebert Brea

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We propose a novel direct search algorithm for identifying at least a local minimum of mixed integer nonlinear unconstrained optimization problems. The Mixed Integer Randomized Pattern Search Algorithm (MIRPSA), so-called by the author, is based on a randomized pattern search, which is modified by the MIRPSA for finding at least a local minimum of our problem. The MIRPSA has two main operations over the randomized pattern search: moving operation and shrinking operation. Each operation is carried out by the algorithm when a set of conditions is held. The convergence properties of the MIRPSA is analyzed using a Markov chain approach, which is represented by an infinite countable set of state space λ, where each state d(q) is defined by a measure of the qth randomized pattern search Hq, for all q in N. According to the algorithm, when a moving operation is carried out on the qth randomized pattern search Hq, the MIRPSA holds its state. Meanwhile, if the MIRPSA carries out a shrinking operation over the qth randomized pattern search Hq, the algorithm will visit the next state, this is, a shrinking operation at the qth state causes a changing of the qth state into (q+1)th state. It is worthwhile pointing out that the MIRPSA never goes back to any visited states because the MIRPSA only visits any qth by shrinking operations. In this article, we describe the MIRPSA for mixed integer nonlinear unconstrained optimization problems for doing a deep study of its convergence properties using Markov chain viewpoint. We herein include a low dimension case for showing more details of the MIRPSA, when the algorithm is used for identifying the minimum of a mixed integer quadratic function. Besides, numerical examples are also shown in order to measure the performance of the MIRPSA.

Keywords: direct search, mixed integer optimization, random search, convergence, Markov chain

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Authors: Dong Wook Lee, Seung Hyun Kim

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Trial blasting is conducted to identify the characteristics of the blasting of the applicable ground before production blasting and to investigate various problems posed by blasting. The methods and pattern of production blasting are determined based on an analysis of the results of trial blasting. The bedrock in Jeju Island, South Korea is formed through the volcanic activities unlike the inland areas, composed of porous basalt. Trial blasting showed that the blast vibration frequency of sedimentary and metamorphic rocks in the inland areas is in a high frequency band of about 80 Hz while the blast vibration frequency of Jeju Island is in a low frequency band of 10~25 Hz. The frequency band is analyzed to be low due to the large cycle of blasting pattern as blast vibration passes through the layered structured ground layer where the rock formation and clickers irregularly repeat. In addition, the blast vibration equation derived from trial blasting was R: 0.885, S.E: 0.216 when applying the square root scaled distance (SRSD) relatively suitable for long distance, estimated at the confidence level of 95%.

Keywords: attenuation index, basaltic ground, blast vibration constant, blast vibration equation, clinker layer

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Authors: Mohamed Eftal Bin Mohamed Ebrahim, Alexander Varey

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Aim: Topical negative pressure has been shown to enhance angiogenesis during wound healing, both for open and closed wounds. Since angiogenesis is a key requirement for successful fat grafting, there may be a role for topical negative pressure as a means of enhancing the take rate during autologous fat grafting to breasts. Here we present a systematic review of the literature on this topic. Methods: Ovid and Embase were utilized, with searches ranging between 1960 – 2019. Terms (“Liposculpting” OR “Fat grafting” OR “Lipofilling” OR “Lipograft” OR “Fat transfer”) AND (“Negative Pressure” OR “Brava” OR “Kiwi”) AND (“Breast”) were merged as keywords. Inclusion criteria were females, autologous fat graft to breast with topical negative pressure prior to the procedure. Studies were excluded if there was no primary endpoint or non-original article. Results: Upon reviewing 219 articles, 2 met inclusion criteria. A total of 565 and 46 breasts in each article were treated respectively using the negative pressure device BRAVA®, with each cohort having different pre-and post-operative pressure settings. Khouri et al. cohort had higher graft survival (79%) compared to Del Vecchio et al. cohort (64%); however, the latter had fewer complications compared to Khouri’s cohort, e.g., fat necrosis, pneumothorax and infection. Conclusion: There is limited evidence regarding the use of topical negative pressure for fat grafting to the breasts. However, in the two studies published, the reported rates of success are high, suggesting there may be a benefit. Consequently, a randomized controlled trial on this area is required.

Keywords: fat grafting, lipograft, negative pressure, breast, breast augmentation, brava

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Authors: Emmanuel A. David, Rebecca O. Soremekun, Roseline I. Aderemi-Williams

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Background: The complexities involved in the management of diabetes mellitus require a multi-dimensional, multi-professional collaborative and continuous care by health care providers and a substantial self-care by the patients in order to achieve desired treatment outcomes. The effect of pharmacists’ care in the management of diabetes in resource-endowed nations is well documented in literature, but randomised-controlled assessment of the impact of pharmacist-led care among patients with diabetes in resource-limited settings like Nigeria and sub-Saharan Africa countries is scarce. Objective: To evaluate the impact of Pharmacist-led care on glycaemic control in patients with uncontrolled type 2 diabetes, using a randomised-controlled study design Methods: This study employed a prospective randomised controlled design, to assess the impact of pharmacist-led care on glycaemic control of 108 poorly controlled type 2 diabetic patients. A total of 200 clinically diagnosed type 2 diabetes patients were purposively selected using fasting blood glucose ≥ 7mmol/L and tested for long term glucose control using Glycated haemoglobin measure. One hundred and eight (108) patients with ≥ 7% Glycated haemoglobin were recruited for the study and assigned unique identification numbers. They were further randomly allocated to intervention and usual care groups using computer generated random numbers, with each group containing 54 subjects. Patients in the intervention group received pharmacist-structured intervention, including education, periodic phone calls, adherence counselling, referral and 6 months follow-up, while patients in usual care group only kept clinic appointments with their physicians. Data collected at baseline and six months included socio-demographic characteristics, fasting blood glucose, Glycated haemoglobin, blood pressure, lipid profile. With an intention to treat analysis, Mann-Whitney U test was used to compared median change from baseline in the primary outcome (Glycated haemoglobin) and secondary outcomes measure, effect size was computed and proportion of patients that reached target laboratory parameter were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each study. Mean age was 51±11.75 and majority were female (68.5%). Intervention patients had significant reduction in Glycated haemoglobin (-0.75%; P<0.001; η2 = 0.144), with greater proportion attaining target laboratory parameter after 6 months of care compared to usual care group (Glycated haemoglobin: 42.6% vs 20.8%; P=0.02). Furthermore, patients who received pharmacist-led care were about 3 times more likely to have better glucose control (AOR 2.718, 95%CI: 1.143-6.461) compared to usual care group. Conclusion: Pharmacist-led care significantly improved glucose control in patients with uncontrolled type 2 diabetes mellitus and should be integrated in the routine management of diabetes patients, especially in resource-limited settings.

Keywords: glycaemic control , pharmacist-led care, randomised-controlled trial , type 2 diabetes mellitus

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Authors: Ahmed M. F. El Shiwi

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Background: Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Myofascial pain syndrome is a condition characterized by muscles shortening with increased tone and associated with trigger points that aggravated with the activity of daily living. Purpose: To examine the effects of magnetic field therapy in patients with lower back myofascial pain syndrome. Methods: Thirty patients were assigned randomly into two groups. Subjects in the experimental group (n=15) with main age of 36.73 (2.52) received traditional physical therapy program (Infrared radiation, ultrasonic, stretching and strengthening exercises for back muscles) as well as magnetic field, and control group (n=15) with main age of 37.27 (2.52) received traditional physical therapy only. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending, and left side bending) were measured before and after four weeks of treatment. Results: The results showed significant improvement in all parameters in the experimental group compared with those in the control group. Interpretation/Conclusion: By the present date, it is possible to conclude that a magnetic field is effective as a method of treatment for lower back myofascial pain syndrome patients with the parameters used in the present study.

Keywords: magnetic field, lower back pain, myofascial pain syndrome, biological systems engineering

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Authors: Hazel Ann Gianelli Cu, Stephanie Co, Radcliff Cobankiat

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Objectives: TRC101/Veverimer is an orally administered, non absorbed, sodium- and counterion-free hydrochloric acid binder for the treatment of metabolic acidosis associated with chronic kidney disease. The main objective of this study is to determine the efficacy of TRC 101/ Veverimer 6g/day in increasing serum bicarbonate levels of chronic kidney disease patients with metabolic acidosis. In this meta analysis, we also aim to look at safety outcomes, adverse effects and if the level of serum bicarbonate reached metabolic alkalosis when given TRC101/Veverimer. Methodology: Pubmed, Cochrane, Google Scholar and Science direct were used to search for randomized controlled trials about TRC101/Veverimer use in Chronic kidney disease patients with metabolic acidosis. Search strategy according to the Prisma checklist was done with evaluation of biases and synthesis of results using the Cochrane Review Manager software 5.4. Results: Two randomized controlled trials involving 371 chronic kidney disease patients were included in this study. Results show there was a significant increase in the serum bicarbonate level when given TRC101/Veverimer compared to the placebo. Both studies had a significant number of participants who completed the studies until the end. P value of <0.00001 was used in both studies with a confidence interval of 95%. Conclusion: TRC101/Veverimer 6g/day was shown to effectively and safely increase serum bicarbonate or achieve normalization in chronic kidney disease patients with metabolic acidosis as compared with a placebo. This was associated with delayed progression of kidney disease with improvement of physical functioning, however longer duration of future studies is ideal in order to assess further the long advantages and consequences of TRC 101/Veverimer.

Keywords: chronic kidney disease, metabolic acidosis, Veverimer, TRC101

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Authors: Johnson C. Y. Pang, Bo Peng, Kara K. L. Reeves, Allan C. L. Fud

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Objective: Dry needling (DN) has long been used as a treatment method for various musculoskeletal pain conditions. However, the evidence level of the studies was low due to the limitations of the methodology. Lack of randomization and inappropriate blinding is potentially the main sources of bias. A method that can differentiate clinical results due to the targeted experimental procedure from its placebo effect is needed to enhance the validity of the trial. Therefore, this study aimed to validate the method as a placebo ultrasound(US)-guided DN for patients with knee osteoarthritis (KOA). Design: This is a randomized controlled trial (RCT). Ninety subjects (25 males and 65 females) aged between 51 and 80 (61.26 ± 5.57) with radiological KOA were recruited and randomly assigned into three groups with a computer program. Group 1 (G1) received real US-guided DN, Group 2 (G2) received placebo US-guided DN, and Group 3 (G3) was the control group. Both G1 and G2 subjects received the same procedure of US-guided DN, except the US monitor was turned off in G2, blinding the G2 subjects to the incorporation of faux US guidance. This arrangement created the placebo effect intended to permit comparison of their results to those who received actual US-guided DN. Outcome measures, including the visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of pain, symptoms, and quality of life (QOL), were analyzed by repeated measures analysis of covariance (ANCOVA) for time effects and group effects. The data regarding the perception of receiving real US-guided DN or placebo US-guided DN were analyzed by the chi-squared test. The missing data were analyzed with the intention-to-treat (ITT) approach if more than 5% of the data were missing. Results: The placebo US-guided DN (G2) subjects had the same perceptions as the use of real US guidance in the advancement of DN (p<0.128). G1 had significantly higher pain reduction (VAS and KOOS-pain) than G2 and G3 at 8 weeks (both p<0.05) only. There was no significant difference between G2 and G3 at 8 weeks (both p>0.05). Conclusion: The method with the US monitor turned off during the application of DN is credible for blinding the participants and allowing researchers to incorporate faux US guidance. The validated placebo US-guided DN technique can aid in investigations of the effects of US-guided DN with short-term effects of pain reduction for patients with KOA. Acknowledgment: This work was supported by the Caritas Institute of Higher Education [grant number IDG200101].

Keywords: ultrasound-guided dry needling, dry needling, knee osteoarthritis, physiotheraphy

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Authors: Maryam Zarra-Nezhad, Ali Moazami-Goodarzi, Joona Muotka, Nina Sajaniemi

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This study examines the extent to which the impact of a universal intervention program, i.e., POMPedaSens, on children’s early social-emotional learning (SEL) is different depending on early childhood education (ECE) teaches stress at work. The POMPedaSens program aims to promote children’s (5–6-year-olds) SEL by supporting ECE teachers’ engagement and emotional availability. The intervention effectiveness has been monitored using an 8-month randomized controlled trial design with an intervention (IG; 26 teachers and 195 children) and a waiting control group (CG; 36 teachers and 198 children) that provided the data before and after the program implementation. The ECE teachers in the IG are trained to implement the intervention program in their early childhood education and care groups. Latent change score analysis suggests that the program increases children’s prosocial behavior in the IG when teachers show a low level of stress. No significant results were found for the IG regarding a change in antisocial behavior. However, when teachers showed a high level of stress, an increase in prosocial behavior and a decrease in antisocial behavior were only found for children in the CG. The results suggest a promising application of the POMPedaSens program for promoting prosocial behavior in early childhood when teachers have low stress. The intervention will likely need a longer time to display the moderating effect of ECE teachers’ well-being on children’s antisocial behavior change.

Keywords: early childhood, social-emotional learning, universal intervention program, professional development, teachers' stress

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