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Historically, natural products have been the principal source of medications for the treatment of human diseases. Traditional medical practitioners employ Detarium microcarpum as a treatment for diabetes, malaria, wounds, inflammation, and even cancer. This study emphasizes the importance of harmonizing D. microcarpum research so that results from various sources may be directly compared to reach a scientific conclusion. We searched Google Scholar, Science Direct, Google.com, Wiley, PubMed, Hindawi, and Springer for research papers on Detarium microcarpum. This analysis excludes untrustworthy online data, thesis papers, and review publications on D. microcarpum. The leaves and stem bark were shown to have high antioxidant, anti-inflammatory, antibacterial, antidiabetic, and anticancer properties. The study also discovered that too much consumption is harmful. Polyphenols and flavonoids were the most commonly reported compounds. However, human safety and efficacy are yet to be fully evaluated, and further well-designed clinical trials are needed to confirm preclinical findings. The leaves and stem bark extracts and isolated compound mechanism of action should be investigated. It is necessary to set a standard dose and ensure its safety. [ABSTRACT FROM AUTHOR]

This paper adopts virtual reality technology to conduct in-depth research and analysis on sports rehabilitation training, designs a corresponding sports rehabilitation training program, and applies it to practice. An AR algorithm based on dynamic target tracking under VSLAM is proposed. The algorithm can effectively reject dynamic targets in static scenes while ensuring that the virtual objects registered based on dynamic template target tracking are still in the world coordinate system of VSLAM. To facilitate patients' hand function rehabilitation training, this paper uses OpenPose for 2D gesture pose recognition, combines camera pose information and depth information provided by VSLAM to map key points of the hand into the world coordinate system, and then completes the interaction by collision detection algorithm. The virtual interaction module is implemented in this paper to meet the demand for multiuser off-site interaction in virtual training. This paper uses the Unity3D software and Photon Server server to create a VR virtual scene and design a user interaction mechanism to realize a system that supports multiple users to train together online, which effectively extends the application scope of the VR training system. The module utilizes Unity3D's VR development capabilities to develop VR virtual basketball gym scenes and single-player offline interaction mechanisms such as virtual user single shooter and shooter; then, Photon Server is used to design and implement a multiuser remote login system and a multiuser interpass mechanism, thus achieving the effect of multiplayer remote online interaction in the same VR space. Finally, the proposed module was validated, and the results proved the effectiveness of the sports rehabilitation training program. [ABSTRACT FROM AUTHOR]

There are about 10 million people with epilepsy (PWE) in China. In addition to therapies approved by the National Medical Products Administration, the use of complementary and alternative medicine (CAM) is prevalent in Chines PWE. These CAM therapies mainly comprise traditional Chinese medicine herbs (TCMHs), acupuncture, and music. A retrospective literature search was performed to summarize the updates of CAM in China in the past ten years, and sixty‐two papers were finally included. In this following review, we listed the animal and clinical studies to summarize the antiepileptic mechanisms and clinical efficacy of CAM in Chines PWE. The main mechanisms of TCMHs and acupuncture included regulation of neurotransmitters and receptors, voltage‐gated ion channels modulation, expression of apoptosis‐related genes, antioxidant response, and anti‐inflammation. Although there were enormous clinical studies on them, the current available clinical trials were small, short‐term, heterogeneous, and had a high risk of bias. With regard to music, a few studies conducted by Chinese scholars suggested that it was beneficial for PWE as an add‐on therapy, which was consistent with the results of foreign studies. Further randomized clinical trials in large populations are required to prove the effectiveness and safety of CAM. [ABSTRACT FROM AUTHOR]

This paper presents findings from the evaluation of an Australian trial of self‐managed home aged care. The self‐management model was codesigned by advocacy organisation COTA Australia, consumers and service providers. The primary aim of the evaluation was to examine whether self‐management improved consumers' perceptions of their choice, control, and wellbeing. The secondary aim was to examine whether provider prior experience with self‐managed packages significantly influenced consumers' perceptions of choice, control and wellbeing, thereby confounded trial effects. A pre‐test post‐test quasi‐experimental design and mixed‐methods design were used to collect data over nine months in 2018–2019. The pre‐trial methods and findings have been published. The post‐trial evaluation replicated the pre‐trial data collection method of an online survey (n = 60) and semi‐structured telephone interviews with consumers (n = 9), family carers (n = 13), and consumers and carers jointly (n = 2), totalling 24 interviews. Semi‐structured telephone interviews were also conducted with CEOs and senior managers from each of the seven providers (n = 14). Three providers had prior experience supporting self‐management. Parametric and non‐parametric tests examined the statistical data. Qualitative data were analysed thematically and framed according to self‐determination principles and ecological systems theory. Both datasets demonstrated that consumers reported greater choice and control at post‐trial than pre‐trial. This finding was not affected by providers' prior experience with self‐management; therefore, it was not a confounding factor. Participants reported improved wellbeing in interviews, however this was not reinforced statistically. Key desirable features of self‐management included greater autonomy and control over spending, recruiting support staff and paying lower administration fees. There was no evidence of increased risks or fraud. The research limitations included a small sample size, convenience sampling with providers recruiting interview participants, no control group and differences in trial implementation. The findings support the expansion of self‐management opportunities and more comprehensive evaluations that use mixed methods. [ABSTRACT FROM AUTHOR]

Aim: To explore the experiences of a nursing team who implemented an international nurse‐led clinical trial in practice and understand the facilitators to their involvement. Background: The role and responsibilities of the clinical nurse are advancing to encompass research activity to help inform evidence‐based practice. However, several personal and organisational challenges can inhibit nurses' capacity to implement and undertake research within clinical practice. Methods: Three focus groups were conducted with members of a nursing team (N = 18). Thematic analysis was employed, and themes were identified and agreed upon by the research team. Results: Five themes were identified: 'Previous experience of and attitudes to participation in clinical research', 'Decision‐making regarding participation in the clinical trial', 'Facilitators of participation in the clinical trial', 'Challenges of research in nursing practice' and 'Future orientation towards research'. Conclusion: Through their experiences of implementing a nurse‐led clinical trial within practice, nurses recognized a number of facilitators and challenges to their participation. The perceived relevance of the clinical trial to the nurses' practice, potential to improve patient care and appreciation of the nurse leader's expertise and understanding of their context were key motivators. Reciprocal trust with the nurse leader who was encouraging, motivating, supportive and accessible resulted in the engagement and commitment of the nursing team. Implications for Nursing Management: This paper offers a perspective that can inform senior nursing management teams when implementing and conducting evidence‐based research amongst nursing teams and in doing so meet the needs of developing research capacity amongst clinical nurses. [ABSTRACT FROM AUTHOR]

Garcinia kola belongs to the Garcinia genus of the Clusiaceae family and Malpighiales order. It contains more than 180 members all over the globe. It is found all over Asia and in tropical African countries. In Africa, traditionally, G kola is used to manage and treat cancer, diabetes, malaria, analgesics, hypertension, and other numerous ailments. This review aimed to comprehensively update relevant information regarding the pharmacological potential of Garcinia kola. Electronic databases such as ScienceDirect, PubMed, Wiley, Google Scholar, Hindawi, and Springer extracted valuable information from original scientific research papers. Inclusion Criteria. Antioxidant, antimicrobial, antidiabetic, antibacterial, medications, antiviral, traditional medicine, ethnopharmacology, toxicity, cytotoxic action, chemical composition, mineral elements, GCMS analysis, and any other related phrases were used as filters to find studies. Exclusion Criteria. Data from questionable online sources, as well as thesis reports and review publications, were excluded from this investigation. The investigation revealed that seeds of G. kola are very efficient as antioxidant, antimicrobial, antidiabetic, antihypertension, antianalgesic, and anti-inflammatory. The study also found that too much consumption of the seeds caused low fertility and toxicity. However, the safety and efficacy of G. kola have not been wholly assessed in humans, and further well-designed clinical trials are needed to corroborate preclinical findings. The mechanism of action of the seed extract should be examined. The standard dose and safety of the seed should be established. [ABSTRACT FROM AUTHOR]

What is known and objective: The purpose of this review paper is to review the efficacy and safety of subcutaneous semaglutide, marketed as Wegovy, a glucagon‐like peptide‐1 receptor agonist for obesity management. Methods: A MEDLINE search (1970 to June 2021) was conducted to identify Phase 3 trials of subcutaneous semaglutide for obesity management. Published Phase 3 trials from The Semaglutide Treatment Effect in People with obesity (STEP) program were reviewed and summarized. Results and discussion: Based on four Phase 3 trials, subcutaneous semaglutide as 2.4 mg once weekly was compared in efficacy and safety among 5000 randomized participants who were overweight or had obesity. A change in body weight from baseline to end of study was the primary outcome in the STEP program. Participants who received semaglutide had a dose‐dependent reduction in body weight from baseline, compared to placebo. Higher percentages of participants had 5%–10% weight reduction from baseline when receiving subcutaneous semaglutide. The patient population was mainly middle‐aged female participants with Class II obesity. Additional studies are needed, especially active‐comparator trials, to determine the efficacy and safety of semaglutide in a diverse patient population. What is new and conclusion: Subcutaneous semaglutide is another available option as adjunct therapy to lifestyle modifications for people who are overweight or have obesity based on body weight and body mass index. It resulted in more weight reduction than placebo with gastrointestinal adverse events being the most common safety concerns. Clinical utilization of subcutaneous semaglutide will be determined, as insurance coverage will be a limitation for this new medication. [ABSTRACT FROM AUTHOR]

Mesenchymal stromal cells (MSCs) are a heterogeneous population of adult stem cells, which are multipotent and possess the ability to differentiate/transdifferentiate into mesodermal and nonmesodermal cell lineages. MSCs display broad immunomodulatory properties since they are capable of secreting growth factors and chemotactic cytokines. Safety, accessibility, and isolation from patients without ethical concern make MSCs valuable sources for cell therapy approaches in autoimmune, inflammatory, and degenerative diseases. Many studies have been conducted on the application of MSCs as a new therapy, but it seems that a low percentage of them is related to clinical trials, especially completed clinical trials. Considering the importance of clinical trials to develop this type of therapy as a new treatment, the current paper is aimed at describing characteristics of MSCs and reviewing relevant clinical studies registered on the NIH database during 2016-2020 to discuss recent advances on MSC-based therapeutic approaches being used in different diseases. [ABSTRACT FROM AUTHOR]

The clinical research faces numerous challenges, from patient enrollment to data privacy concerns and regulatory requirements to spiraling costs. Blockchain technology has the potential to overcome these challenges, thus making clinical trials transparent and enhancing public trust in a fair and open process with all stakeholders because of its distinct features such as data immutability and transparency. This paper proposes a permissioned blockchain platform to ensure clinical data transparency and provides secure clinical trial-related solutions. We explore the core functionalities of blockchain applied to clinical trials and illustrate its general principle concretely. These clinical trial operations are automated using the smart contract, which ensures traceability, prevents a posteriori reconstruction, and securely automates the clinical trial. A web-based user interface is also implemented to visualize the data from the blockchain and ease the interaction with the blockchain network. A proof of concept is implemented on Hyperledger Fabric in the case study of clinical management for multiple clinical trials to demonstrate the designed approach's feasibility. Lastly, the experiment results demonstrate the efficiency and usability of the proposed platform. [ABSTRACT FROM AUTHOR]

Backgrounds. The objective of the present research was to systematically revise the international literature about the genetic biomarkers related to oral cancer (OC) evaluating the recent findings in clinical studies. Methods. A comprehensive review of the current literature was conducted according to the PRISMA guidelines by accessing the NCBI PubMed database. The authors conducted the search of articles in the English language published from 2008 to 2018. The present systematic review included only papers with significant results about correlation between wound healing, genetic alteration, and OC. Prognostic capacity of genetic markers was not evaluated in vivo. Results. The first analysis with filters recorded about 1884 published papers. Beyond reading and consideration of suitability, only 20 and then 8 papers, with case report exclusion, were recorded for the revision. Conclusion. All the researches recorded the proteomic and genetic alterations in OC human biopsy cells. The gene modification level in the different studies, compared with samples of healthy tissues, has always been statistically significant, but it is not possible to associate publications with each other because each job is based on the measurement of different biomarkers and gene targets. Further investigations should be required in order to state scientific evidence about a clear advantage of using these biomarkers for diagnostic purpose. [ABSTRACT FROM AUTHOR]

Background. The Zung Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS) are two norm-referenced scales commonly used to identify the presence of depression and anxiety in clinical research. Unfortunately, several researchers have mistakenly applied index score criteria to raw scores when assigning clinical significance and symptom severity ratings. This study examined the extent of this problem. Method. 102 papers published over the six-year period from 2010 to 2015 were used to establish two convenience samples of 60 usages of each Zung scale. Results. In those papers where cut-off scores were used (i.e., 45/60 for SDS and 40/60 for SAS), up to 51% of SDS and 45% of SAS papers involved the incorrect application of index score criteria to raw scores. Inconsistencies were also noted in the severity ranges and cut-off scores used. Conclusions. A large percentage of publications involving the Zung SDS and SAS scales are using incorrect criteria for the classification of clinically significant symptoms of depression and anxiety. The most common error—applying index score criteria to raw scores—produces a substantial elevation of the cut-off points for significance. Given the continuing usage of these scales, it is important that these inconsistencies be highlighted and resolved. [ABSTRACT FROM AUTHOR]

Objective: To investigate the correlation between the clinical effects of Huangqi (Astragalus membranaceus) on different stages of diabetic nephropathy (DN) and the pharmacological effect of Huangqi on the activity of inducible nitric oxide synthase (iNOS) in macrophages in different states.Methods: The PubMed, China National Knowledge Infrastructure, and Wanfang databases were searched. Clinical data was sourced from papers on treatment of different stages of DN with Huangqi, and pharmacological data was from papers on the effects of Huangqi on the iNOS activity of macrophages in a resting or an activated state.Results: Meta-analysis of Huangqi injections on stages III and III-IV DN and randomized controlled trials on other stages showed that Huangqi had therapeutic effects on different stages of DN and on macrophages in different states: inducing normal macrophages in a resting state to generate nitric oxide (NO), tumor necrosis factor-α, and so forth upon iNOS activation; inhibiting NO generation by normal lipopolysaccharide- (LPS-) activated macrophages; and enhancing NO generation by LPS-induced macrophages from patients with renal failure.Conclusions: Huangqi can regulate iNOS activity of macrophages in different states in vitro. These biphasic or antagonistic effects may explain why Huangqi can be used to treat different stages of DN. [ABSTRACT FROM AUTHOR]

Background and Objectives: Exposure‐based interventions (EBIs) are the first‐line treatment for anxiety disorders and posttraumatic stress disorder. Although common, the association between EBIs and benzodiazepines is controversial. Therefore, we systematically reviewed the literature to evaluate if benzodiazepines could undermine the efficacy of EBIs in treating these disorders. Methods: We conducted a systematic review aiming for randomized clinical trials (RCTs) in ISI Web of Science, Scopus, PubMed/MEDLINE, and PsycINFO databases. We scrutinized the reference list of selected papers and other systematic reviews. Finally, we evaluated the methodological quality and the scientific evidence of the studies. Results: We screened 1,529 studies and included 12 RCTs in this review (all showing some concerns or high risk of bias). Benzodiazepines did not impact the efficacy of EBIs in nine studies at posttreatment, improved efficacy in two, and reduced it in one. In the follow‐up, benzodiazepines (after its discontinuation) did not impact the efficacy in six studies and reduced it in five. The scientific level of evidence achieved was B for both phases. Conclusions: Until now there is no definitive evidence that benzodiazepines could hinder the EBIs' efficacy for treating posttraumatic stress disorder and anxiety disorders. [ABSTRACT FROM AUTHOR]

Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Although their mechanism of action is not clearly explained, it is known that they positively modulate the immune system, which leads to immunity potentiation. A number of studies prove that probiotics strengthen cognitive functions, reduce anxiety, and regulate the lipid metabolism in the human body. Probiotics used in humans are most often of the Lactobacillus and Bifidobacterium species. However, as more research is conducted, new species with beneficial, probiotic properties are being discovered. This paper provides a review of available information about the influence of probiotics on human health. It summarizes the current knowledge on the mechanism of action of probiotics as well as clinical trial results proving their efficacy in allergic, neurodegenerative, and cardiac diseases. This review also discusses the data concerning the safety of probiotics in clinical treatment. [ABSTRACT FROM AUTHOR]

In any longitudinal study, a dropout before the final timepoint can rarely be avoided. The chosen dropout model is commonly one of these types: Missing Completely at Random (MCAR), Missing at Random (MAR), Missing Not at Random (MNAR), and Shared Parameter (SP). In this paper we estimate the parameters of the longitudinal model for simulated data and real data using the Linear Mixed Effect (LME) method. We investigate the consequences of misspecifying the missingness mechanism by deriving the so-called least false values. These are the values the parameter estimates converge to, when the assumptions may be wrong. The knowledge of the least false values allows us to conduct a sensitivity analysis, which is illustrated. This method provides an alternative to a local misspecification sensitivity procedure, which has been developed for likelihood-based analysis. We compare the results obtained by the method proposed with the results found by using the local misspecification method. We apply the local misspecification and least false methods to estimate the bias and sensitivity of parameter estimates for a clinical trial example. [ABSTRACT FROM AUTHOR]

A brief intervention using Zero‐time Exercise (ZTEx), a foot‐in‐the‐door approach, was developed to reduce sedentary behaviour and increase physical activity. ZTEx refers to the integration of simple strength‐ and stamina‐enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. This paper presents the development, feasibility, and preliminary evidence for the effectiveness of this intervention under the Hong Kong Jockey Club FAMILY Project. Needs assessments were conducted with social workers from the Christian Family Services Center(CFSC) and the Social Welfare Department (SWD). This single group prospective ZTEx intervention trial, guided by the Health Action Process Approach, included a 3‐hr core session at baseline and a 1‐hr booster session at 1‐month follow‐up. Fifty‐six participants (social and service‐related workers) from CFSC (n = 28) and SWD (n = 28) received the intervention and completed the self‐administered questionnaires at baseline. Forty‐nine and 43 participants completed the 1‐month and 3‐month self‐administered questionnaires, respectively. Fifteen participants attended the focus group interviews to share their feedback on ZTEx intervention after implementing their community‐based ZTEx activities. Intention‐to‐treat analysis was conducted with missing data replaced by baseline values. Participants reported significant decreases in sitting time by 27 (2, 52) minutes (mean [95% confidence interval]) and 36 (0.2, 71) minutes on a weekday, increases in physical activity while seated by 0.7 (0.2, 1.4) days and 1.1 (0.6, 1.7) days in a week, and improvements in perceived knowledge, outcome expectancies and plan on doing ZTEx at the 1‐month and 3‐month follow‐up, respectively. Balance and muscle strength significantly improved at the 1‐month follow‐up. The effect ranged from small to large (Cohen's d: 0.27–1.05, all p < 0.05). The qualitative feedbacks support the quantitative findings. Our findings show early evidence that ZTEx effectively reduced sedentary behaviour and enhanced physical activity and fitness. Further trials on this simple and low‐cost intervention as the first step to promote higher intensity exercise are warranted. [ABSTRACT FROM AUTHOR]

The last couple of decades have seen brilliant progress in stem cell therapies, including native, genetically modified, and engineered stem cells, for osteonecrosis of the femoral head (ONFH). In vitro studies evaluate the effect of endogenous or exogenous factor or gene regulation on osteogenic phenotype maintenance and/or differentiation towards osteogenic lineage. The preclinical and clinical outcomes accelerate the clinical translation. Bone marrow mesenchymal stem cells and adipose-derived stem cells have demonstrated better effects in the treatment of femoral head necrosis. Various materials have been used widely in the ONFH treatment in both preclinical and clinical trials. In a word, in vivo and multiscale efforts are expected to overcome obstacles in the approaches for treating ONFH and provide clinical relevance and commercial strategies in the future. Therefore, we will discuss the above aspects in this paper and present our opinions. [ABSTRACT FROM AUTHOR]

Background: Comorbid anxiety is common in bipolar disorder (BD) and associated with worse clinical outcomes including increased suicidality. Despite effective psychological treatments for anxiety, research into treating anxiety in BD is underdeveloped. This paper describes a novel psychological intervention to address anxiety in context of bipolar disorder (AIBD).Methods: Adults with BD and clinically significant anxiety symptoms were randomized to AIBD plus treatment as usual (TAU) or TAU alone. AIBD offered 10 sessions of psychological therapy using a formulation-based approach. Feasibility and acceptability were evaluated through recruitment, retention, therapy attendance, alliance, fidelity, and qualitative feedback. Clinical outcomes were assessed at baseline, 16, 48, and 80 weeks: interim assessments of relapse at 32 and 64 weeks.Results: Seventy-two participants were recruited with 88% retention to 16 weeks and 74% to 80 weeks (similar between arms). Therapy participants attended x ¯ 7.7 (SD 2.8) sessions. Therapeutic alliance and therapy fidelity were acceptable. Qualitative interviews indicated that participants valued integrated support for anxiety with BD and coping strategies. Some suggested a longer intervention period. Clinical outcomes were not significantly different between arms up to 80 weeks follow-up.Conclusions: AIBD is feasible and acceptable but lack of impact on clinical outcomes indicates that adaptations are required. These are discussed in relation to qualitative feedback and recent literature published since the trial completed. [ABSTRACT FROM AUTHOR]

This article is a continuation of our previously published annual reviews of transcatheter aortic valve replacement (TAVR). In 2017, TAVR further established a foothold in the management of intermediate risk patients with the publication of SURTAVI trial. Randomized trials also addressed the use of cerebral protection during TAVR and single versus dual antiplatelet therapy after TAVR. Newer generation valve systems continued to be studied for their efficacy and safety. This paper summarizes the major studies published in 2017. [ABSTRACT FROM AUTHOR]

Diabetic retinopathy is caused by the retinal micro vasculature which may be formed as a result of diabetes mellitus. Blindness may appear as a result of unchecked and severe cases of diabetic retinopathy. Manual inspection of fundus images to check morphological changes in microaneurysms, exudates, blood vessels, hemorrhages, and macula is a very time-consuming and tedious work. It can be made easily with the help of computer-aided system and intervariability for the observer. In this paper, several techniques for detecting microaneurysms, hemorrhages, and exudates are discussed for ultimate detection of nonproliferative diabetic retinopathy. Blood vessels detection techniques are also discussed for the diagnosis of proliferative diabetic retinopathy. Furthermore, the paper elaborates a discussion on the experiments accessed by authors for the detection of diabetic retinopathy. This work will be helpful for the researchers and technical persons who want to utilize the ongoing research in this area. [ABSTRACT FROM AUTHOR]

There is an increasing concern that the term adipose tissue-derived stem cell (ASC) is inappropriately used to refer to the adipose stromal vascular fraction (SVF). To evaluate the accuracy and quality of reporting, 116 manuscripts on the application of ASC in humans and animals were examined based on the 2013 published International Federation for Adipose Therapeutics and Science (IFATS)/ International Society for Cellular Therapy (ISCT) joint statement and in reference to current guidelines for clinical trials and preclinical studies. It is disconcerting that 4 among the 47 papers or 8.51% (CI 2.37–20.38) surveyed after publication of IFATS/ISCT statement reported using ASCs but in fact they used unexpanded cells. 28/47 or 59.57% (CI 44.27–73.63) explicitly reported that adherent cells were used, 35/47 or 74.47% (CI 59.65–86.06) identified expression of surface markers, and 25/47 or 53.19% (CI 14.72–30.65) verified the multilineage potential of the cells. While there are a number of papers examined in this survey that were not able to provide adequate information on the characteristics of ASCs used with some erroneously referring to the SVF as stem cells, there are more room for improvement in the quality of reporting in the application of ASCs in humans and animals. [ABSTRACT FROM AUTHOR]

There is an increasing concern that the term adipose tissue-derived stem cell (ASC) is inappropriately used to refer to the adipose stromal vascular fraction (SVF). To evaluate the accuracy and quality of reporting, 116 manuscripts on the application of ASC in humans and animals were examined based on the 2013 published International Federation for Adipose Therapeutics and Science (IFATS)/ International Society for Cellular Therapy (ISCT) joint statement and in reference to current guidelines for clinical trials and preclinical studies. It is disconcerting that 4 among the 47 papers or 8.51% (CI 2.37–20.38) surveyed after publication of IFATS/ISCT statement reported using ASCs but in fact they used unexpanded cells. 28/47 or 59.57% (CI 44.27–73.63) explicitly reported that adherent cells were used, 35/47 or 74.47% (CI 59.65–86.06) identified expression of surface markers, and 25/47 or 53.19% (CI 14.72–30.65) verified the multilineage potential of the cells. While there are a number of papers examined in this survey that were not able to provide adequate information on the characteristics of ASCs used with some erroneously referring to the SVF as stem cells, there are more room for improvement in the quality of reporting in the application of ASCs in humans and animals. [ABSTRACT FROM AUTHOR]

A growing body of evidence suggests yogic practices may benefit adults with type 2 diabetes (DM2). In this systematic review, we evaluate available evidence from prospective controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management. To identify qualifying studies, we searched nine databases and scanned bibliographies of relevant review papers and all identified articles. Controlled trials that did not target adults with diabetes, included only adults with type 1 diabetes, were under two-week duration, or did not include quantitative outcome data were excluded. Study quality was evaluated using the PEDro scale. Thirty-three papers reporting findings from 25 controlled trials (13 nonrandomized, 12 randomized) met our inclusion criteria (N = 2170 participants). Collectively, findings suggest that yogic practices may promote significant improvements in several indices of importance in DM2 management, including glycemic control, lipid levels, and body composition. More limited data suggest that yoga may also lower oxidative stress and blood pressure; enhance pulmonary and autonomic function, mood, sleep, and quality of life; and reduce medication use in adults with DM2. However, given the methodological limitations of existing studies, additional high-quality investigations are required to confirm and further elucidate the potential benefits of yoga programs in populations with DM2. [ABSTRACT FROM AUTHOR]

Risankizumab is a novel anti‐interleukin 23 humanized antibody developed to treat severe psoriasis. In this paper, we analyze the key information about this new drug and the results of phase 3 clinical trials already present in literature in order measure its safety and effectiveness in every day practice. Risankizumab seems to be one of the best performing drugs in the treatment of psoriasis, with a good safety profile and a dosage regimen less frequent than all other biologic agents, although head‐to‐head randomized clinical trials with other anti‐interleukin treatments will be necessary in order to confirm these preliminary results. [ABSTRACT FROM AUTHOR]

Cardiovascular diseases are the main causes of mortality. Sudden cardiac death may also appear in athletes, due to underlying congenital or inherited cardiac abnormalities. The electrocardiogram is used in clinical practice and clinical trials, as a valid, reliable, accessible, inexpensive method. The aim of the present paper was to review electrocardiographic (ECG) signs associated with cardiovascular mortality and the mechanisms underlying those associations, providing a brief description of the main studies in this area, and consider their implication for clinical practice in the general population and athletes. The main ECG parameters associated with cardiovascular mortality in the present paper are the P wave (duration, interatrial block, and deep terminal negativity of the P wave in V1), prolonged QT and Tpeak-Tend intervals, QRS duration and fragmentation, bundle branch block, ST segment depression and elevation, T waves (inverted, T wave axes), spatial angles between QRS and T vectors, premature ventricular contractions, and ECG hypertrophy criteria. [ABSTRACT FROM AUTHOR]

Hydatic disease has always been the most common in countries where large amount of sheep and cattle is raised, but increased travel and immigration have made this condition a serious worldwide public problem. Cyst hydatid may affect all parts of the human body like the heart, the bone marrow, the eye, the brain, the kidney, and the spermatic cord. Humans can become infested by accidentally ingesting the eggs that are passed in the feces from definitive hosts (usually a canid, such as a wolf, fox, or dog). Even in endemic countries, the primitive pleural hydatid cyst is exceptional, and it is very difficult to distinguish from other pleural and parietal cystic masses especially that in majority of cases the immunologic tests are negative. We report two cases of pleural hydatid cyst discovered in two young patients, with a nonspecific clinical presentation. The interest of this paper is to raise the primordial role of imaging in the positive diagnosis of primary pleural hydatid cyst. [ABSTRACT FROM AUTHOR]

Background: Deep brain stimulation is increasingly being used for treatment-resistant depression. Blinded, randomized controlled trials of active versus sham treatment have been limited to small numbers.Method: We performed a systematic review and meta-analysis on the effectiveness of deep brain stimulation (DBS) in depression. Cochrane Central Register of Controlled Trials, PubMed/Medline, Embase and PsycINFO, Chinese Biomedical Literature Service System, and China Knowledge Resource Integrated Database were searched for single- or double placebo-controlled, crossover, and parallel-group trials in which DBS was compared with sham treatment using validated scales.Results: Ten papers from nine studies met inclusion criteria, all but two of which were double-blinded RCTs. The main outcome was a reduction in depressive symptoms. It was possible to combine data for 190 participants. Patients on active, as opposed to sham, treatment had a significantly higher response (OR = 5.50; 95% CI = 2.79, 10.85; p < .0001) and reductions in mean depression score (SMD = -0.42; 95% CI = -0.72, -0.12; p = .006). However, the effect was attenuated on some of the subgroup and sensitivity analyses, and there were no differences for most other outcomes. In addition, 84 participants experienced a total of 131 serious adverse effects, although not all could be directly associated with the device or surgery. Finally, publication bias was possible.Conclusions: DBS may show promise for treatment-resistant depression but remains an experimental treatment until further data are available. [ABSTRACT FROM AUTHOR]

Euphorbia hirta commonly known as Tawa-Tawa is a plant used in folklore medicine in the Philippines for the treatment of dengue. Though, E. hirta has been extensively investigated for numerous bioactivities, limited studies have been conducted on the antidengue activity. Thus, the present study provides a comprehensive review of studies conducted on the antidengue activity of E. hirta. A systematic literature survey was carried out in scientific databases, PubMed®, Scopus, and Google Scholar, for research carried on the antidengue activity of E. hirta. The literature search identified a total of 867 articles: databases PubMed = 6, Scopus SciVerse® = 423, and Google Scholar = 437; one additional article was identified by searching reference lists. Eight full papers were entitled to the review; out of those, two studies focused on ethnobotanical surveys, three on animal experiments, one on human trial, and two on in vitro antiviral activities, and one was computational study. The available evidence conclusively demonstrates the potential of E. hirta against dengue as it holds significant antiviral and platelet increasing activities. However, the number of studies conducted to validate its antidengue activity was found to be inadequate. Hence, well-controlled clinical trials and contemporary pharmacological approaches including activity guided fractionation and elucidation of the mode of action are encouraged to establish the use of E. hirta for dengue. [ABSTRACT FROM AUTHOR]

As a versatile nanofiber manufacturing technique, electrospinning has been widely employed for the fabrication of tissue engineering scaffolds. Since the structure of natural extracellular matrices varies substantially in different tissues, there has been growing awareness of the fact that the hierarchical 3D structure of scaffolds may affect intercellular interactions, material transportation, fluid flow, environmental stimulation, and so forth. Physical blending of the synthetic and natural polymers to form composite materials better mimics the composition and mechanical properties of natural tissues. Scaffolds with element gradient, such as growth factor gradient, have demonstrated good potentials to promote heterogeneous cell growth and differentiation. Compared to 2D scaffolds with limited thicknesses, 3D scaffolds have superior cell differentiation and development rate. The objective of this review paper is to review and discuss the recent trends of electrospinning strategies for cartilage tissue engineering, particularly the biomimetic, gradient, and 3D scaffolds, along with future prospects of potential clinical applications. [ABSTRACT FROM AUTHOR]

Drug addiction can be a devastating and chronic relapsing disorder with social, psychological, and physical consequences, and more effective treatment options are needed. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation technique that has been assessed in a growing number of studies for its therapeutic potential in treating addiction. This review paper offers an overview on the current state of clinical research in treating drug addiction with rTMS. Because of the limited research in this area, all studies (including case reports) that evaluated the therapeutic use of rTMS in nicotine, alcohol, or illicit drug addiction were included in this review. Papers published prior to December 2012 were found through an NCBI PubMed search. A total of eleven studies were identified that met review criteria. There is nascent evidence that rTMS could be effective in reducing cocaine craving and nicotine and alcohol craving and consumption and might represent a potential therapeutic tool for treating addiction. Further studies are needed to identify the optimal parameters of stimulation for the most effective treatment of drug addiction, to improve our comprehension of the treatment neurophysiological effects, and to conduct rigorous, controlled efficacy studies with adequate power. [ABSTRACT FROM AUTHOR]

The life expectancy in the Western world is increasing for a long time, which is the courtesy of a higher life standard, a more thorough hygiene, and, of course, the progress of modern medicine. Nevertheless, one of the illnesses that still proves to be a great challenge regardless of the recent advancements in medicine is cancer. Skin cancer is, according to the World Health Organization, the most common malignancy for the white population. The beginning of the paper offers a brief overview of the latest available information concerning epidemiology, aetiology, diagnostics, and treatment options for skin cancer, whereas the rest of the article deals with modern approaches to skin cancer treatment, highlighting recent development of nanotechnology based treatment approaches. Among these, we focus especially on the newest nanotechnological approaches combined with chemotherapy, a field which specialises in target specificity, drug release control, and real time monitoring with the goal being to diminish unwanted side effects and their severity, achieving a cheaper treatment and a generally more efficient chemotherapy. The field of nanotechnology is a rapidly developing one, judging by already approved clinical studies or by new theranostic agents that combine both the therapeutic and diagnostic modalities. [ABSTRACT FROM AUTHOR]

Target selection is a key feature in cancer immunotherapy, a promising field in cancer research. In this respect, gangliosides, a broad family of structurally related glycolipids, were suggested as potential targets for cancer immunotherapy based on their higher abundance in tumors when compared with the matched normal tissues. GD2 is the first ganglioside proven to be an effective target antigen for cancer immunotherapy with the regulatory approval of dinutuximab, a chimeric anti-GD2 therapeutic antibody. Although the therapeutic efficacy of anti-GD2 monoclonal antibodies is well documented, neuropathic pain may limit its application. O-Acetyl-GD2, the O-acetylated-derivative of GD2, has recently received attention as novel antigen to target GD2-positive cancers. The present paper examines the role of O-acetyl-GD2 in tumor biology as well as the available preclinical data of anti-O-acetyl-GD2 monoclonal antibodies. A discussion on the relevance of O-acetyl-GD2 in chimeric antigen receptor T cell therapy development is also included. [ABSTRACT FROM AUTHOR]

This paper presents two cases of women who had extensive vaginal adenosis from prenatal DES exposure, extending almost halfway down the vaginal canal. Both women were followed for decades with annual exams and Pap smears until after menopause. Clinical examination in both cases initially showed an absent pars vaginalis of the cervix, vaginal adenosis, and shallowness of the fornices. Several decades of annual exams showed these stigmata of DES exposure gradually disappear as the upper vagina progressively contracted. After menopause the upper vagina in both cases transformed into what appeared to be a normal cervix with all adenosis involuted into a normal endocervical canal. A timeline was created to show the morphological changes that were observed over time. This timeline illustrates how severe vaginal stenosis above the level of the squamocolumnar junction developed in middle age and was followed in the postmenopause by fusion of the upper vaginal walls in the midline resulting in the appearance of a normal, but prolapsed, cervix. [ABSTRACT FROM AUTHOR]

Objective. Insomnia is one of the most common sleep disorders. Hypnotics have poor long-term efficacy. Mongolian medical warm acupuncture has significant efficacy in treating insomnia. The paper evaluates the role of Mongolian medical warm acupuncture in treating insomnia by investigating the Mongolian medicine syndromes and conditions, Pittsburgh sleep quality index, and polysomnography indexes. Method. The patients were diagnosed in accordance with International Classification of Sleep Disorders (ICSD-2). The insomnia patients were divided into the acupuncture group (40 cases) and the estazolam group (40 cases). The patients underwent intervention of Mongolian medical warm acupuncture and estazolam. The indicators of the Mongolian medicine syndromes and conditions, Pittsburgh sleep quality index (PSQI), and polysomnography indexes (PSG) have been detected. Result. Based on the comparison of the Mongolian medicine syndrome scores between the warm acupuncture group and the drug treatment group, the result indicated P<0.01. The clinical efficacy result showed that the effective rate (85%) in the warm acupuncture group was higher than that (70%) in the drug group. The total scores of PSQI of both groups were approximated. The sleep quality indexes of both groups decreased significantly (P<0.05). The sleep quality index in the Mongolian medical warm acupuncture group decreased significantly (P<0.01) and was better than that in the estazolam group. The sleep efficiency and daytime functions of the patients in the Mongolian medical warm acupuncture group improved significantly (P<0.01). The sleep time was significantly extended (P<0.01) in the Mongolian medical warm acupuncture group following PSG intervention. The sleep time during NREM in the Mongolian warm acupuncture group increased significantly (P<0.01). The sleep time exhibited a decreasing trend during REM and it decreased significantly in the Mongolian warm acupuncture group (P<0.01). The percentage of sleep time in the total sleep time during NREM3+4 in the Mongolian medical warm acupuncture group increased significantly. Conclusion. Mongolian medical warm acupuncture is efficient and safe in treating insomnia. It is able to better improve the patients’ sleep time and daytime functions. It is better than that in the estazolam group following drug withdrawal in terms of improving the sleep time. It is more effective in helping the insomnia patients than hypnotics. [ABSTRACT FROM AUTHOR]

Mild cognitive impairment, especially executive dysfunction might occur early in the course of Parkinson's disease. Cognitive training is thought to improve cognitive performance. However, transfer of improvements achieved in paper and pencil tests into daily life has been difficult. The aim of the current study was to investigate whether a multimodal cognitive rehabilitation programme including physical exercises might be more successful than cognitive training programmes without motor training. 240 PD-patients were included in the study and randomly allocated to three treatment arms, group A cognitive training, group B cognitive training and transfer training and group C cognitive training, transfer training and psychomotor and endurance training. The primary outcome measure was the ADAS-Cog. The secondary outcome measure was the SCOPA-Cog. Training was conducted for 4 weeks on a rehabilitation unit, followed by 6 months training at home. Caregivers received an education programme. The combination of cognitive training using paper and pencil and the computer, transfer training and physical training seems to have the greatest effect on cognitive function. Thus, patients of group C showed the greatest improvement on the ADAS-Cog and SCOPA-COG and were more likely to continue with the training programme after the study. [ABSTRACT FROM AUTHOR]

Endothelial dysfunction is found in hypertensive patients and may serve as a prognostic marker of future cardiovascular events. Endothelial function can be assessed noninvasively by flow-mediated vasodilation (FMD). The goal of this paper is to summarize comprehensively the clinical trials that investigated the effects of antihypertensive drugs on endothelial function assessed by FMD in hypertensive patients. A PubMed-based search found 38 clinical trial papers published from January 1999 to June 2011. Significant improvement of FMD after antihypertensive treatment was shown in 43 of 71 interventions (among 38 clinical trial papers). Angiotensin II receptor blockers and angiotensin converting enzyme inhibitors appeared to improve FMD more than other drug types. Antihypertensive treatment can improve endothelial dysfunction when assessed by FMD, although there are conflicting data that require further research. [ABSTRACT FROM AUTHOR]

Background. Current methods to diagnose malignant biliary strictures are of low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) is a new approach that can be used to evaluate in vivo histopathology of the GI tract. This paper is of studies evidencing pCLE's application in the diagnosis of indeterminate biliary strictures. Methods. This paper examined peerreviewed studies conducted between January 2000 and November 2011. A PubMed search for relevant articles was performed using the following keywords:"pCLE", "confocal", "endomicroscopy", "probe-based confocal laser endomicroscopy", "and "bile duct". Further individual review was done to assess the screened articles' relevance to the topic. Results. After individual review, 6 studies were included; with a cumulative sample size of 165, with 75 subjects identified as having a malignancy. These studies included tertiary care centers in Germany, France, and USA, including one multicenter trial. 3 studies assessed pCLE's specificity (range 67%-88%) ,sensitivity (range 83%-98), and accuracy (range 81%-86%). Conclusion. Confocal endomicroscopy is a novel and promising modality for the biliary tree. Further studies need to be conducted both to establish its usefulness for the diagnosis of indeterminate biliary strictures and to understand the histological meaning of the imaging patterns that are observed. [ABSTRACT FROM AUTHOR]

Measuring quality in Emergency Medical Services (EMSs) systems is challenging. This paper reviews the current approaches to measuring quality in health care and EMS with a focus on currently used clinical performance indicators in EMS systems (US and international systems). The different types of performance indicators, the advantages and limitations of each type, and the evidence-based prehospital clinical bundles are discussed. This paper aims at introducing emergency physicians and health care providers to quality initiatives in EMS and serves as a reference for tools that EMS medical directors can use to launch new or modify existing quality control programs in their systems. [ABSTRACT FROM AUTHOR]

Thyroid cancer is the most common endocrine tumor. Thyroidectomy, radioactive iodine, and TSH suppression represent the standard treatment for differentiated thyroid cancer. Since chemotherapy has been shown to be unsuccessful in case of advanced thyroid carcinomas, the research for new therapies is fundamental. In this paper, we reviewed the recent literature reports (pubmed, medline, EMBASE database, and abstracts published in meeting proceedings) on new treatments in advanced nonmedullary and medullary thyroid carcinomas. Studies of many tyrosine kinase inhibitors as well as antiangiogenic inhibitors suggest that patients with thyroid cancer could have an advantage with new target therapy. We summarized both the results obtained and the toxic effects associated with these treatments reported in clinical trials. Reported data in this paper are encouraging, but further trials are necessary to obtain a more effective result in thyroid carcinoma treatment. [ABSTRACT FROM AUTHOR]

Drug self-administration procedures have played a critical role in the experimental analysis of psychoactive compounds, such as cocaine, for over 50 years. While there are numerous permutations of this procedure, this paper will specifically focus on choice procedures using concurrent schedules of intravenous drug self-administration. The aims of this paper are to first highlight the evolution of drug choice procedures and then review the subsequent preclinical body of literature utilizing these choice procedures to understand the environmental, pharmacological, and biological determinants of the reinforcing stimulus effects of drugs. A main rationale for this paper is our proposition that choice schedules are underutilized in investigating the reinforcing effects of drugs in assays of drug self-administration. Moreover, we will conclude with potential future directions and unexplored scientific space for the use of drug choice procedures. [ABSTRACT FROM AUTHOR]

In many clinical trials, it is important to balance treatment allocation over covariates. Although a great many papers have been published on balancing over discrete covariates, the procedures for continuous covariates have been less well studied. Traditionally, a continuous covariate usually needs to be transformed to a discrete one by splitting its range into several categories. Such practice may lead to loss of information and is susceptible to misspecification of covariate distribution. The more recent papers seek to define an imbalance measure that preserves the nature of continuous covariates and set the allocation rule in order to minimize that measure. We propose a new design, which defines the imbalance measure by the maximum assignment difference when all possible divisions of the covariate range are considered. This measure depends only on ranks of the covariate values and is therefore free of covariate distribution. In addition, we developed an efficient algorithm to implement the new procedure. By simulation studies we show that the new procedure is able to keep good balance properties in comparison with other popular designs. [ABSTRACT FROM AUTHOR]

Recent preclinical work investigating the role of progenitor cell therapies for central nervous system (CNS) injuries has shown potential neuroprotection in the setting of traumatic brain injury (TBI), spinal cord injury (SCI), and ischemic stroke. Mechanisms currently under investigation include engraftment and transdifferentiation, modulation of the locoregional inflammatory milieu, and modulation of the systemic immunologic/inflammatory response. While the exact mechanism of action remains controversial, the growing amount of preclinical data demonstrating the potential benefit associated with progenitor cell therapy for neurological injury warrants the development of well-controlled clinical trials to investigate therapeutic safety and efficacy. In this paper, we review the currently active or recently completed clinical trials investigating the safety and potential efficacy of bone marrow-derived progenitor cell therapies for the treatment of TBI, SCI, and ischemic stroke. Our review of the literature shows that while the preliminary clinical trials reviewed in this paper offer novel data supporting the potential efficacy of stem/progenitor cell therapies for CNS injury, a great deal of additional work is needed to ensure the safety, efficacy, and mechanisms of progenitor cell therapy prior to widespread clinical trials. [ABSTRACT FROM AUTHOR]

Many Japanese reports of acupuncture and moxibustion for chronic pain are not listed in medical databases such as Medline. Therefore, they are not easily accessible to researchers outside of Japan. To complement existing reviews of acupuncture and moxibustion for chronic pain and to provide more detailed discussion and analysis, we did a literature search using 'Igaku Chuo Zasshi Wed' (Japana Centra Revuo Medicina) and 'Citation Information by National Institute of Information' covering the period 1978-2006. Original articles and case reports of acupuncture and moxibustion treatment of chronic pain were included. Animal studies, surveys, and news articles were excluded. Two independent reviewers extracted data from located articles in a pre-defined structured way, and assessed the likelihood of causality in each case. We located 57 papers written in Japanese (20 full papers, 37 case reports). Conditions examined were headache (12 trials), chronic low back pain (9 trials), rheumatoid arthritis (8 trials), temporomandibular dysfunction (8 trials), katakori (8 trials) and others (12 trials). While 23 were described as clinical control trials (CCTs), 11 employed a quasi-random method. Applying the 5-point Jadad quality assessment scoring system, the mean score was 1.5 - 1.3 (SD). Eleven (52%) of the CCTs were conducted to determine a more effective procedure for acupuncture; these compared a certain type of acupuncture with another type of acupuncture or specific additional points. In particular, the trigger point acupuncture was widely used to treat chronic low back pain in Japan. Many reports of chronic pain treatment by acupuncture and moxibustion are listed in Japanese databases. From the data, we conclude that there is limited evidence that acupuncture is more effective than no treatment, and inconclusive evidence that trigger point acupuncture is more effective than placebo, sham acupuncture or standard care. [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) are considered to be the gold standard in evaluating medical interventions; however, people from ethnic minorities are frequently under-represented in such studies. The present paper addresses a previously neglected debate about the tensions which inform clinical trial participation amongst people from ethnic minorities, in particular, South Asians, the largest ethnic minority group in the UK. In a narrative review of the available literature, based mainly on US studies, the present authors aim to make sense of the issues around under-representation by providing a theoretical reconciliation. In addition, they identify a number of potential barriers to ethnic minority participation in clinical trials. In so doing, the authors recognise that the recent history of eugenic racism, and more general views on clinical trials as a form of experimentation, means that clinical trial participation among people from ethnic minorities becomes more problematic. Lack of participation and the importance of representational sampling are also considered, and the authors argue that health professionals need to be better informed about the issues. The paper concludes by offering a number of strategies for improving ethnic minority accrual rates in clinical trials, together with priorities for future research. [ABSTRACT FROM AUTHOR]

This paper provides an overview of modelling in the economic evaluation of pharmaceuticals, reflecting the increasing use of models in analyses prepared for reimbursement applications to national and local drug formularies. The paper seeks to demystify the most commonly encountered modelling techniques (extrapolation, decision analysis, Markov modelling and Monte Carlo simulation), and to provide guidance in assessing the quality of submitted or published modelled economic evaluations. [ABSTRACT FROM AUTHOR]

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in thewake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard ControlOrganisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of EthicsCommittees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, aswell as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research. [ABSTRACT FROM AUTHOR]

The paper presents current evidence on the properties of human umbilical cord-derived mesenchymal stem cells, including origin, proliferative potential, plasticity, stability of karyotype and phenotype, transcriptome, secretome, and immunomodulatory activity. A review of preclinical studies and clinical trials using this cell type is performed. Prospects for the use of mesenchymal stem cells, derived from the umbilical cord, in cell transplantation are associated with the need for specialized biobanking and transplant standardization criteria. [ABSTRACT FROM AUTHOR]

This paper presents the outcome of a home-based autism intervention program (HBAIP) in 18- to 40-month-old children newly diagnosed and treatment naïve. Intervention was exclusively implemented at home. Outcome was measured at 3 months and 6 months after intervention and compared with a group of newly diagnosed children with autism who were >40 months at intake but had not received any autism specific clinical management. Aim was also to estimate whether natural development would contribute to gain in skills and compare with the effect of intervention. Five selected parameters of behavior representing social interaction and social communication were used to assess outcome. Results showed a statistically significant improvement between preintervention and postintervention in all the measured parameters. The effect size was large when compared to preintervention and gains were indicated by changes in mean scores and p values within a narrow confidence interval. Highest gains were in first 3 months of postintervention which continued up to 6 months. Although the comparison group was more advanced in the measured skills at intake, they were significantly below the level reached by experimental group at 3 months and 6 months after intervention. This study was registered in the Sri Lanka Clinical Trials Registry (SLCTR/2009/011). [ABSTRACT FROM AUTHOR]

The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB). [ABSTRACT FROM AUTHOR]

Percutaneous nephrolithotomy (PCNL), a minimally invasive method for removal of renal calculi, was initially started in the 1950s but gained popularity about two decades later and has now become standard practice for management. There has been an immense improvement in technique and various guidelines have been established for treatment of renal stones. However, it has its own share of complications which can be attributed to surgical technique as well as anesthesia related complications. PubMed and Google search yielded more than 30 articles describing the different complications seen in this procedure, out of which 15 major articles were selected for writing this review. The aim of this review article is to describe the implications of the complications associated with PCNL related to the anesthesiologist. The anesthesiologist is as much responsible for the management of the patient perioperatively as the surgeon. Therefore, it is mandatory to be familiar with the various complications, some of which may be life threatening and he should be able to manage them efficiently. The paper also analyses the advantages and drawbacks of the available options in anesthesia, that is, general and regional, both of which are employed for PCNL. [ABSTRACT FROM AUTHOR]