Search results for: decentralized clinical trials

Authors: Rob van den Dam

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Today’s Internet of Things (IoT) comprises more than a billion intelligent devices, connected via wired/wireless communications. The expected proliferation of hundreds of billions more places us at the threshold of a transformation sweeping across the communications industry. Yet, we found that the IoT architecture and solutions that currently work for billions of devices won’t necessarily scale to tomorrow’s hundreds of billions of devices because of high cost, lack of privacy, not future-proof, lack of functional value and broken business models. As the IoT scales exponentially, decentralized networks have the potential to reduce infrastructure and maintenance costs to manufacturers. Decentralization also promises increased robustness by removing single points of failure that could exist in traditional centralized networks. By shifting the power in the network from the center to the edges, devices gain greater autonomy and can become points of transactions and economic value creation for owners and users. To validate the underlying technology vision, IBM jointly developed with Samsung Electronics the autonomous decentralized peer-to- peer proof-of-concept (PoC). The primary objective of this PoC was to establish a foundation on which to demonstrate several capabilities that are fundamental to building a decentralized IoT. Though many commercial systems in the future will exist as hybrid centralized-decentralized models, the PoC demonstrated a fully distributed proof. The PoC (a) validated the future vision for decentralized systems to extensively augment today’s centralized solutions, (b) demonstrated foundational IoT tasks without the use of centralized control, (c) proved that empowered devices can engage autonomously in marketplace transactions. The PoC opens the door for the communications and electronics industry to further explore the challenges and opportunities of potential hybrid models that can address the complexity and variety of requirements posed by the internet that continues to scale. Contents: (a) The new approach for an IoT that will be secure and scalable, (b) The three foundational technologies that are key for the future IoT, (c) The related business models and user experiences, (d) How such an IoT will create an 'Economy of Things', (e) The role of users, devices, and industries in the IoT future, (f) The winners in the IoT economy.

Keywords: IoT, internet, wired, wireless

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Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

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Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

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Authors: Yasmeen Jamal Alabdallat, Almutazballlah Bassam Qablan, Hamza Al-Salhi, Salameh Alarood, Ibraheem Alkhawaldeh, Obada Abunar, Adam Abdallah

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Obstructive sleep apnea (OSA) is a disorder caused by the repeated collapse of the upper airway during sleep. It is the most common cause of sleep-related breathing disorder, as OSA can cause loud snoring, daytime fatigue, or more severe problems such as high blood pressure, cardiovascular disease, coronary artery disease, insulin-resistant diabetes, and depression. The hypoglossal nerve stimulator (HNS) is an implantable medical device that reduces the occurrence of obstructive sleep apnea by electrically stimulating the hypoglossal nerve in rhythm with the patient's breathing, causing the tongue to move. This stimulation helps keep the patient's airways clear while they sleep. This systematic review and meta-analysis aimed to assess the clinical outcome of hypoglossal nerve stimulation as a treatment of obstructive sleep apnea. A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials was conducted from inception until August 2022. Studies assessing the following clinical outcomes (Apnea-Hypopnea Index (AHI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Oxygen Desaturation Indices (ODI), (Oxygen Saturation (SaO2)) were pooled in the meta-analysis using Review Manager Software. We assessed the quality of studies according to the Cochrane risk-of-bias tool for randomized trials (RoB2), Risk of Bias In Non-randomized Studies - of Interventions (ROBINS-I), and a modified version of NOS for the non-comparative cohort studies.13 Studies (Six Clinical Trials and Seven prospective cohort studies) with a total of 817 patients were included in the meta-analysis. The results of AHI were reported in 11 studies examining OSA 696 patients. We found that there was a significant improvement in the AHI after 12 months of HNS (MD = 18.2 with 95% CI, (16.7 to 19.7; I2 = 0%); P < 0.00001). Further, 12 studies reported the results of ESS after 12 months of intervention with a significant improvement in the range of sleepiness among the examined 757 OSA patients (MD = 5.3 with 95% CI, (4.75 to 5.86; I2 = 65%); P < 0.0001). Moreover, nine studies involving 699 participants reported the results of FOSQ after 12 months of HNS with a significant reported improvement (MD = -3.09 with 95% CI, (-3.41 to 2.77; I2 = 0%); P < 0.00001). In addition, ten studies reported the results of ODI with a significant improvement after 12 months of HNS among the 817 examined patients (MD = 14.8 with 95% CI, (13.25 to 16.32; I2 = 0%); P < 000001). The Hypoglossal Nerve Stimulation showed a significant positive impact on obstructive sleep apnea patients after 12 months of therapy in terms of apnea-hypopnea index, oxygen desaturation indices, manifestations of the behavioral morbidity associated with obstructive sleep apnea, and functional status resulting from sleepiness.

Keywords: apnea, meta-analysis, hypoglossal, stimulation

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Authors: Sneh Laller, Kamini C. Tanwar

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Human beings are social animals. The scenario is changing and people become angry towards petty things and this may lead to committing a crime. Objective: The aim of the present research is: 1. To find out the difference between convicts and under-trials on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 2. To find out the difference between male and female jail inmates on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 3. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in convicts and under-trials; 4. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in male and female jail inmates. Method: The study was conducted on 100 participants (consisting of 50 convicts- 25 males and 25 females, and 50 under-trials- 25 males and 25 females); age range was 20-60 years. The NEO Five-Factor Inventory-3 by McCrae, Costa (2010), Brief Fear of Negative Evaluation scale- II by Leary (1983) and Life Orientation Test-R by Scheier et al. (1994) was used and purposive sampling technique was done for data collection. The t-test was applied to find out the comparison and Pearson correlation was applied to determine the relationship between personality, FNE and life-orientation in both the groups. Results: There is a significant difference in the dimension of personality that is neuroticism and life-orientation in convicts and under-trials and also, in the dimensions of personality such as neuroticism, extraversion, openness to experience and agreeableness, and FNE in male and female jail inmates. In convicts the dimension of personality, agreeableness shows significant positive correlation with life-orientation (r = 0.430**) whereas, in under-trials the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.315*) and another dimension of personality, extraversion shows significant negative correlation with life-orientation (r = -0.409**). In male jail inmates, the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.474**) whereas in female jail inmates, the dimension of personality, openness to experience shows significant negative correlation with FNE (r = -0.356*) and significant positive correlation of neuroticism with life-orientation (r = 0.292*). Conclusion: It was found that under-trials are neurotic and life-oriented than convicts, and female jail inmates are also neurotic and exhibit fear of negative evaluation whereas male jail inmates are extravert and agreeable.

Keywords: convicts, fear of negative evaluation, life-orientation, personality, under-trials

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Authors: S. Ghasemi, K. Khorasani

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In this paper, the problem of fault detection and isolation in the attitude control subsystem of spacecraft formation flying is considered. In order to design the fault detection method, an extended Kalman filter is utilized which is a nonlinear stochastic state estimation method. Three fault detection architectures, namely, centralized, decentralized, and semi-decentralized are designed based on the extended Kalman filters. Moreover, the residual generation and threshold selection techniques are proposed for these architectures.

Keywords: component, formation flight of satellites, extended Kalman filter, fault detection and isolation, actuator fault

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Authors: Hassan Abo Salem, Guo Feng, Xiaolin Huang

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The objective of this study is to determine the effectiveness of mirror therapy on motor recovery and functional abilities after stroke. The following databases were searched from inception to May 2014: Cochrane Stroke, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, and PEDro. Two reviewers independently screened and selected all randomized controlled trials that evaluate the effect of mirror therapy in stroke rehabilitation.12 randomized controlled trials studies met the inclusion criteria; 10 studies utilized the effect of mirror therapy for the upper limb and 2 studies for the lower limb. Mirror therapy had a positive effect on motor recover and function; however, we found no consistent influence on activity of daily living, Spasticity and balance. This meta-analysis suggests that, Mirror therapy has additional effect on motor recovery but has a small positive effect on functional abilities after stroke. Further high-quality studies with greater statistical power are required in order to accurately determine the effectiveness of mirror therapy following stroke.

Keywords: mirror therapy, motor recovery, stroke, balance

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Authors: Chandragiri Nagadeep, M. V. V. S. Durga, Sadu Mahikshith

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Future generation is depended on new ideas and innovations that develops the country economical growth and technology standards so, Startups plays an important role in satisfying above goals. Startups includes support which is given by investing into it by investors but, single digit investors can’t keep supporting one startup and lot of security problems occurs while transferring large funds to startup’s bank account. Targeting security and most supportive funding, TogEther solves these issues by providing a platform where “Crowd Funding” is available in a decentralized way such that funding is done with digital currency called cryptocurrency where transactions are done in a secured way using “Block Chain Technology”. Not only Funding but also Ideas along with their documents can be presented and hosted with help of IPFS (Inter Planetary File System).

Keywords: blockchain, ethereum, web3, reactjs, interplanetary file system, funding

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Authors: Raheel Shakoor Siddiqui, Shahbaz Malik, Manikandar Srinivas Cheruvu, Sanjay Narayana Murthy, Livio DiMascio

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Background: elderly traumatic hip fracture patients frequently present to trauma services globally. Rising low energy falls amongst an osteoporotic aging population is the commonest cause for injury. Hip fractures in this population are a major cause for severe pain, morbidity and mortality. The term hip fracture is interchangeable with neck of femur fracture, fractured neck of femur or proximal femur fracture. Hip fracture pain management protocols and guidelines suggest conventional analgesia, nerve block and opioid based treatment as rescue analgesia. There is a current global opioid crisis with overuse, abuse and dependence. Adverse opioid related complications in vulnerable elderly patients further adds to morbidity and mortality. Systematic reviews in literature have evidenced superiority of multimodal analgesia in osteoarthritic primary joint replacements compared to opioids however, this has not yet been conducted for elderly traumatic hip fracture patients. Aims: The primary aim of this systematic review is to provide standardised evidence following Cochrane and PRISMA guidance in determining advantages of perioperative multimodal analgesia over conventional opioid based treatments in elderly traumatic hip fractures. Methods: 5 databases were searched from January 2000-2023 which identified 8 randomised controlled trials and 446 total participants. These trials met defined PICOS eligibility criteria of patient mean age ≥ 65 years presenting with a unilateral traumatic fractured neck of femur for operative intervention. Analgesic intervention with perioperative multimodal analgesia has been compared to conventional opioid based analgesia. Outcomes of interest include, primarily, the change in postoperative opioid consumption within a 0-30 postoperative period and secondarily, the change in postoperative adverse events and complications. A qualitative synthesis has been performed due to clinical heterogenicity and variance amongst trials. Results: GRADE evidence of moderate quality supports perioperative multimodal analgesia leads to a reduction in postoperative opioid consumption however, low quality evidence supports a reduction of adverse effects and complications. Conclusion: Perioperative multimodal analgesia whether used preoperative, intraoperative and/or postoperative leads to a reduction in postoperative opioid consumption for elderly traumatic hip fracture patients. This review recommends the use of perioperative multimodal analgesia as part of hip fracture pain protocols however, caution and clinical judgement should be used as the risk of adverse effects may not be lower.

Keywords: trauma, orthopaedics, hip, fracture, neck of femur fracture, analgesia, multimodal analgesia, opioid

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Authors: Shashank Tiwari, S. P. Mahapatra

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The aim of this technique is to reduce the steps of process scales up, save time & cost of the industries. This technique will minimise the steps of process scale up. The new steps are, Novel Lab Scale, Novel Lab Scale Trials, Novel Trial Batches, Novel Exhibit Batches, Novel Validation Batches. In these steps, it is not divided to validation batches in three parts but the data of trials batches, Exhibit Batches and Validation batches are use and compile for production and used for validation. It also increases the batch size of the trial, exhibit batches. The new size of trials batches is not less than fifty Thousand, the exhibit batches increase up to two lack and the validation batches up to five lack. After preparing the batches all their data & drugs use for stability & maintain the validation record and compile data for the technology transfer in production department for preparing the marketed size batches.

Keywords: batches, technique, preparation, scale up, validation

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Authors: Fahmi Hassan, Noorizan Abdul Aziz, Yahaya Hassan, Hazlinda Abu Hassan

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Sepsis incidence in critical care settings is a major problem in health care. Extended antibiotic infusion is thought to be superior to traditional dosing especially when treating critically ill patients with sepsis. We compared clinical outcomes of critically ill patients with sepsis receiving 30-minute meropenem infusion and three-hour meropenem infusion. A retrospective case-control study was conducted among septic patients treated with meropenem infusion in ICUs of three hospitals. Patients included in the study received either extended or standard meropenem infusion as per the practice of individual settings. Outcomes and clinical data were retrospectively collected from the electronic databases and patients’ files. A total of 108 patients received extended meropenem infusion while another 117 patients received standard meropenem infusion. Patients receiving the extended meropenem infusion were found to have a significantly lower shorter length of hospital and ICU stay. It was also found that among those receiving extended meropenem infusion, 54.7% (64/117) had a reduction of SAPS II score, while only 44% (48/108) of patients receiving standard meropenem infusion had reduced scores. This study will strengthen the evidence in using extended meropenem infusion as a standard practice in critical care settings. As this is the first study of its kind done in Malaysia, it proves that prolonged meropenem infusion may be beneficial to critically ill patients with sepsis. However, randomized clinical trials with large sample size should be carried out in local settings in order to minimize other confounders that may influence with the result of the study.

Keywords: antibiotics, beta lactams, critical care, extended infusion, meropenem

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Authors: Mai Ashraf Talaat

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Objectives: The aim of this review article is to assess the success of dental implants in breast cancer patients receiving bisphosphonate therapy and to evaluate the risk of developing bisphosphonate-related osteonecrosis of the jaw following dental implant surgery. Materials and Methods: A thorough search was conducted, with no time or language restriction, using: PubMed, PubMed Central, Web of Science, and ResearchGate electronic databases. Medical Subject Headings (MeSH) terms such as “bisphosphonate”, “dental implant”, “bisphosphonate-related osteonecrosis of the jaw (BRONJ)”, “osteonecrosis”, “breast cancer, MRONJ”, and their related entry terms were used. Eligibility criteria included studies and clinical trials that evaluated the impact of bisphosphonates on dental implants. Conclusion: Breast cancer patients undergoing bisphosphonate therapy may receive dental implants. However, the risk of developing BRONJ and implant failure is high. Risk factors such as the type of BP received, the route of administration, and the length of treatment prior to surgery should be considered. More randomized controlled trials with long-term follow-ups are needed to draw more evidence-based conclusions.

Keywords: dental implants, breast cancer, bisphosphonates, osteonecrosis, bisphosphonate-related osteonecrosis of the jaw

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Authors: F. O’Dowd, G. Murphy, M. Roche, E. Shudell, F. Keane, M. O’Kane

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Intoduction: Apremilast (Otezla®) is an oral phosphodiesterase-4 (PDE4) inhibitor indicated for treatment of adult patients with moderate to severe plaque psoriasis who have contraindications to have failed or intolerant of standard systemic therapy and/or phototherapy; and adult patients with active psoriatic arthritis. Apremilast influences intracellular regulation of inflammatory mediators. Two randomized, placebo-controlled trials evaluating apremilast in 1426 patients with moderate to severe plague psoriasis (ESTEEM 1 and 2) demonstrated that the commonest adverse reactions (AE’s) leading to discontinuation were nausea (1.6%), diarrhoea (1.0%), and headaches (0.8%). The overall proportion of subjects discontinuing due to adverse reactions was 6.1%. At week 16 these trials demonstrated significant more apremilast-treated patients (33.1%) achieved the primary end point PASI-75 than placebo (5.3%). We began prescribing apremilast in July 2015. Aim: To evaluate efficacy and tolerability of apremilast in an Irish teaching hospital psoriasis population. Methods: A proforma documenting clinical evaluation parameters, prior treatment experience and AE’s; was completed prospectively on all patients commenced on apremilast since July 2015 – July 2017. Data was collected at week 0,6,12,24,36 and week 52 with 20/71 patients having passed week 52. Efficacy was assessed using Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). AE’s documented included GI effects, infections, changes in weight and mood. Retrospective chart review and telephone review was utilised for missing data. Results: A total of 71 adult subjects (38 male, 33 female; age range 23-57), with moderate to severe psoriasis, were evaluated. Prior treatment: 37/71 (52%) were systemic/biologic/phototherapy naïve; 14/71 (20%) has prior phototherapy alone;20/71 (28%) had previous systemic/biologic exposure; 12/71 (17%) had both psoriasis and psoriatic arthritis. PASI responses: mean baseline PASI was 10.1 and DLQI was 15.Week 6: N=71, n=15 (21%) achieved PASI 75. Week 12: N= 48, n=6 (13%) achieved a PASI 100%; n=16 (34.5%) achieved a PASI 75. Week 24: N=40, n=10 (25%) achieved a PASI 100; n=15 (37.5%) achieved a PASI 75. Week 52: N= 20, n=4 (20%) achieved a PASI 100; n= 16 (80%) achieved a PASI 75. (N= number of pts having passed the time point indicated, n= number of pts (out of N) achieving PASI or DLQI responses at that time). DLQI responses: week 24: N= 40, n=30 (75%) achieved a DLQI score of 0; n=5 (12.5%) achieved a DLQI score of 1; n=1 (2.5%) achieved a DLQI score of 10 (due to lack of efficacy). Adverse Events: The proportion of patients that discontinued treatment due to AE’s was n=7 (9.8%). One patient experienced nausea alleviated by dose reduction; another developed significant dysgeusia for certain foods, both continued therapy. Two patients lost 2-3 kg. Conclusion: Initial Irish patient experience of Apremilast appears comparable to that observed in trials with good efficacy and tolerability.

Keywords: Apremilast, introduction, Ireland, clinical audit

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Authors: Mohammed S. Mohammed, Asmaa M. S. Mohammed

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Background: To achieve the quality of cancer care, the oncologic academic programs should be continuously developed with establishing new ones. We highlighted three disciplines, Clinical nutrition, medical biophysics and radiobiology and Psycho-oncology programs; without a doubt, the Egyptian National Cancer Institute, in ‎the accreditation era, will be establishing them ‎ due to their importance in improving the skills of cancer practitioners. Methods: The first suggested program in Clinical Nutrition that is dealing with the assessment of the patient's well-being before, during and after treatment to avoid the defects in the metabolism resulting from the cancer disease and its treatment by giving the supplements in the patient's diet. The second program is Medical Biophysics and Radiobiology, which there's no denying that it ‎is ‎provided ‎in Cairo University as a good program in the faculty of science but lacks the clinical ‎practice. Hence, it is probably better to establish this program in our institute to ‎improve the ‎practitioner skills and introduce a tailored radiation therapy regimen for every patient according to ‎their characteristic profile.‎ While patients are receiving their treatment, the risk of post-traumatic stress disorder arises, so the importance of the third program, Psycho-Oncology, is clearly obtained. This program is concerned with the psychological, social, behavioral, and ethical aspects of cancer. The area of multi-disciplinary interest has boundaries with the major specialties in oncology: the clinical disciplines (surgery, medicine, pediatrics, and radiotherapy), epidemiology, immunology, endocrinology, biology, pathology, bioethics, palliative care, rehabilitation medicine, clinical trials research and decision making, as well as psychiatry and psychology. Results: It is a prospective academic plan which is compatible with the institutional vision and its strategic plan. Conclusion: In this context, evaluating and understanding the suggested academic programs has become a mandatory part of cancer care. And it is essential to be provided by the NCI.

Keywords: clinical nutrition, psycho-oncology, medical biophysics and radiobiology, medical education

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Authors: Ben Clapperton, Daniel Stahl, Kimberley Goldsmith, Trudie Chalder

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Chronic fatigue syndrome (CFS) is a condition characterised by chronic disabling fatigue and other symptoms that currently can't be explained by any underlying medical condition. Although clinical trials support the effectiveness of cognitive behaviour therapy (CBT), the success rate for individual patients is modest. Patients vary in their response and little is known which factors predict or moderate treatment outcomes. The aim of the project is to develop a prediction model from baseline characteristics of patients, such as demographics, clinical and psychological variables, which may predict likely treatment outcome and provide guidance for clinical decision making and help clinicians to recommend the best treatment. The project is aimed at identifying subgroups of patients with similar baseline characteristics that are predictive of treatment effects using modern cluster analyses and data mining machine learning algorithms. The characteristics of these groups will then be used to inform the types of individuals who benefit from a specific treatment. In addition, results will provide a better understanding of for whom the treatment works. The suitability of different clustering methods to identify subgroups and their response to different treatments of CFS patients is compared.

Keywords: chronic fatigue syndrome, latent class analysis, prediction modelling, self-organizing maps

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Authors: H. Cano, P. Ferrer, N. Garcia, M. Popovic, J. Zapata

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Positive Reinforcement Training is a well-known methodology which has been reported frequently to be used in captive non-human primates. As a matter of fact, it is an invaluable tool for different purposes related with animal welfare, such as primate husbandry and environmental enrichment. It is also essential to perform some cognitive experiments. The main propose of this pilot study was to establish an efficient protocol to train captive olive baboons (Papio anubis). This protocol seems to be vital in the context of a larger research program in which it will be necessary to train a complete population of around 40 baboons. Baboons were studied at the Veterinary Research Farm of the University of Murcia. Temporally isolated animals were trained to perform three basic tasks. Firstly, they were required to take food prices directly from the researchers’ hands. Then a clicker sound or bridge stimulus was added each time the animal acceded to the reinforcement. Finally, they were trained to touch a target, consisted of a whip with a red ball in its end, with their hands or their nose. When the subject completed correctly this task, it was also exposed to the bridge stimulus and awarded with a food price, such as a portion of banana, orange, apple, peach or a raisin. Two protocols were tested during this experiment. In both of them, there were 6 series of 2min training periods each day. However, in the first protocol, the series consisted in 3 trials, whereas in the second one, in each series there were 5 trials. A reliable performance was obtained with only 6 days of training in the case of the 5-trials protocol. However, with the 3-trials one, 26 days of training were needed. As a result, the 5-trials protocol seems to be more effective than the 3-trials one, in order to teach these three basic tasks to olive baboons. In consequence, it will be used to train the rest of the colony.

Keywords: captive primates, olive baboon, positive reinforcement training, Papio anubis, training

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Authors: Jamal Alasiri, Naif Hakeem, Saoud Almaslmani

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Background: Patients with humeral shaft fractures have two different treatment options. Surgical therapy has lesser risks of non-union, mal-union, and re-intervention than non-surgical therapy. These positive clinical outcomes of the surgical approach make it a preferable treatment option despite the risks of radial nerve palsy and additional surgery-related risk. We aimed to evaluate patients’ outcomes and return to work after surgical vs. non-surgical management of shaft humeral fracture. Methods: We used databases, including PubMed, Medline, and Cochrane Register of Controlled Trials, from 2010 to January 2022 to search for potential randomised controlled trials (RCTs) and cohort studies comparing the patients’ related outcome measures and return to work between surgical and non-surgical management of humerus fracture. Results: After carefully evaluating 1352 articles, we included three RCTs (232 patients) and one cohort study (39 patients). The surgical intervention used plate/nail fixation, while the non-surgical intervention used a splint or brace procedure to manage shaft humeral fracture. The pooled DASH effects of all three RCTs at six (M.D: -7.5 [-13.20, -1.89], P: 0.009) I2:44%) and 12 months (M.D: -1.32 [-3.82, 1.17], p:0.29, I2: 0%) were higher in patients treated surgically than in non-surgical procedures. The pooled constant Murley score at six (M.D: 7.945[2.77,13.10], P: 0.003) I2: 0%) and 12 months (M.D: 1.78 [-1.52, 5.09], P: 0.29, I2: 0%) were higher in patients who received non-surgical than surgical therapy. However, pooled analysis for patients returning to work for both groups remained inconclusive. Conclusion: Altogether, we found no significant evidence supporting the clinical benefits of surgical over non-surgical therapy. Thus, the non-surgical approach remains the preferred therapeutic choice for managing shaft humeral fractures due to its lesser side effects.

Keywords: shaft humeral fracture, surgical treatment, Patient-related outcomes, return to work, DASH

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Authors: Achim Kampker, Kai Kreiskoether, Johannes Wagner, Sarah Fluchs

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The growing speed of innovation in related industries requires the automotive industry to adapt and increase release frequencies of new vehicle derivatives which implies a significant reduction of investments per vehicle and ramp-up times. Emerging markets in various parts of the world augment the currently dominating established main automotive markets. Local content requirements such as import tariffs on final products impede the accessibility of these micro markets, which is why in the future market exploitation will not be driven by pure sales activities anymore but rather by setting up local assembly units. The aim of this paper is to provide an overview of the concept of decentralized assembly and to discuss and critically assess some currently researched and crucial approaches in production technology. In order to determine the scope in which complementary mobile assembly can be profitable for manufacturers, a general cost model is set up and each cost driver is assessed with respect to varying levels of decentralization. One main result of the paper is that the presented approaches offer huge cost-saving potentials and are thus critical for future production strategies. Nevertheless, they still need to be further exploited in order for decentralized assembly to be profitable for companies. The optimal level of decentralization must, however, be specifically determined in each case and cannot be defined in general.

Keywords: automotive assembly, e-mobility, production technology, release capability, small series assembly

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Authors: Saeed M. Alshahrani

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This research integrated blockchain technology to reform medical records management in healthcare informatics. It was aimed at resolving the limitations of centralized systems by establishing a secure, decentralized, and user-centric platform. The system was architected with a sophisticated three-tiered structure, integrating advanced cryptographic methodologies, consensus algorithms, and the Fast Healthcare Interoperability Resources (HL7 FHIR) standard to ensure data security, transaction validity, and semantic interoperability. The research has profound implications for healthcare delivery, patient care, legal compliance, operational efficiency, and academic advancements in blockchain technology and healthcare IT sectors. The methodology adapted in this research comprises of Preliminary Feasibility Study, Literature Review, Design and Development, Cryptographic Algorithm Integration, Modeling the data and testing the system. The research employed a permissioned blockchain with a Practical Byzantine Fault Tolerance (PBFT) consensus algorithm and Ethereum-based smart contracts. It integrated advanced cryptographic algorithms, role-based access control, multi-factor authentication, and RESTful APIs to ensure security, regulate access, authenticate user identities, and facilitate seamless data exchange between the blockchain and legacy healthcare systems. The research contributed to the development of a secure, interoperable, and decentralized system for managing medical records, addressing the limitations of the centralized systems that were in place. Future work will delve into optimizing the system further, exploring additional blockchain use cases in healthcare, and expanding the adoption of the system globally, contributing to the evolution of global healthcare practices and policies.

Keywords: healthcare informatics, blockchain, medical records management, decentralized architecture, data security, cryptographic algorithms

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Authors: Fuqiang Wang, Jun Liu, Liyan Cai

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This paper investigates the coordination of the conflicting two-stage low carbon supply chain consisting of upstream and downstream manufacturers. The conflict means that the upstream manufacturer takes action for carbon emissions reduction under carbon trading mechanism while the downstream manufacturer’s production cost rises. It assumes for the Stackelberg game that the upstream manufacturer plays as a leader and the downstream manufacturer does as a follower. Four kinds of the situation of decentralized decision making, centralized decision-making, the production cost sharing contract and the carbon emissions reduction revenue sharing contract under decentralized decision making are considered. The backward induction approach is adopted to solve the game. The results show that the more intense the conflict is, the lower the efficiency of carbon emissions reduction and the higher the retail price is. The optimal investment of the decentralized supply chain under the two contracts is unchanged and still lower than that of the centralized supply chain. Both the production cost sharing contract and the carbon emissions reduction revenue sharing contract cannot coordinate the supply chain, because that the sharing cost or carbon emissions reduction sharing revenue will transfer through the wholesale price mechanism. As a result, it requires more complicated contract forms to coordinate such a supply chain.

Keywords: cap-and-trade mechanism, carbon emissions reduction, conflict, supply chain coordination

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Authors: Laila Akbarali

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In the small scale study, an attempt is made to explore the structure and administrative relationships adopted by Multi Campus Universities [MCU] in UK and Pakistan and how these universities deal with some selected issues with respect to student related functions. For this study, literature on multi-site, divisionalized and other complex organizations related to business and Industry was consulted and an attempt was made to empirically test the normative models in the literature with respect to centralized , deconcentrated and decentralized structures. A questionnaire was used to gather data for this study. Purposive sampling was used. The findings of this study are somewhat different for UK and Pakistan. Contrary to a substantial body of organization theory, the results show that deconcentrated and decentralized universities in the UK are prone to delays in decision making and tend not to sensitive to local needs. In Pakistan on the other hand, deconcentrated and decentralized universities are more sensitive to local needs and there are less delays in decision making. The findings suggest that distance and reporting relationships could perhaps be responsible for the contradiction. The results also suggest that there is better coordination when the subsidiary campus sub-registrar reports to the registrar. The findings also highlight, that in both contexts, leadership at the campus level remains an issue. The results suggest that there may be factors other than structure that allow universities to keep their identity intact. The study highlights that MCU are inclined to use Information Technology and develop broad policies within which they allow their campuses to operate.

Keywords: administrative relationships, Multi-Campus, organization structure, registrar

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Authors: Norimichi Nagano, Yoshio Hirano, Tsutomu Yasukawa

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Mesenchymal stem cells are thought to confer neuroprotection, facilitate tissue regeneration and exert their effects on retinal degenerative diseases, however, adverse events such as proliferative vitreoretinopathy and preretinal membrane disease associated with cell suspension transplantation have also been reported. We have recently developed human (allogeneic) adipose tissue-derived mesenchymal stem cell (adMSC) sheets through our proprietary sheet transformation technique, which could potentially mitigate these adverse events. To clarify the properties of our adMSC sheets named PAL-222, we performed in vitro studies such as viability testing, cytokine secretions by ELISA, immunohistochemical study, and migration assay. The viability of the cells exceeded 70%. Vascular Endothelial Growth Factor (VEGF) and Pigment Epithelium-Derived Factor (PEDF), which are quite important cytokines for the retinal area, were observed. PAL-222 expressed type I collagen, a strength marker, type IV collagen, a marker of the basement membrane, and elastin, an elasticity marker. Finally, the migration assay was performed and showed negative, which means that PAL-222 is stably kept in the topical area and does not come to pieces. Next, to evaluate the efficacy in vivo, we transplanted PAL-222 into the subretinal space of the eye of Royal College of Surgeons rats with congenital retinal degeneration and assessed it for three weeks after transplantation. We confirmed that PAL-222 suppressed the decrease in the thickness of the outer nuclear layer, which means that the photoreceptor protective effect treated with PAL-222 was significantly higher than that in the sham group. (p < 0.01). This finding demonstrates that PAL-222 showed their retinoprotective effect in a model of congenital retinal degeneration. As the study suggested the efficacy of PAL-222 in both in vitro and in vivo studies, we are presently engaged in clinical trials of PAL-222 for myopic chorioretinal atrophy, which is one of the retinal degenerative diseases, for the purpose of regenerative medicine.

Keywords: cell sheet, clinical trial, mesenchymal stem cell, myopic chorioretinal atrophy

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Authors: Mette Kjerholt, Thora Grothe Thomsen, Connie Bøttcher Berthelsen, Bibi Hølge Hazelton

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Academic nursing is a relatively new phenomenon in Denmark. Leadership and management training in nursing does not prepare Danish nurse leaders to become leaders for nurses with academic background, and some leaders may feel estranged with including this kind of nursing staff in clinical settings. Currently there is a debate regarding what academic nurses can contribute with in clinical practice, and some managers express concern regarding whether this will lead to less focus on clinical practice and more focus on theoretical issues that may not seem so relevant in a busy everyday clinical setting. The paper will present the experiences of integrating three advanced nurse practitioners with Ph.D. degrees (ANP) in three different clinical departments at a regional hospital in Denmark with no prior experiences with such profiles among its staff.

Keywords: leadership, advanced nurse practitioners, clinical practice, academic nursing

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Authors: Shi-xia Xu, Zai-wen Zhang, Ru-xue Chen, Shan Zhou, Xiang-feng Tang

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Objective: The clinical influence of HLA-DPB1 mismatches on clinical outcome of HSCT is less clear. This is the first meta-analysis to study the HLA-DPB1 matching statues on clinical outcomes after unrelated donor HSCT. Methods: We searched the CIBMTR, Cochrane Central Register of Controlled Trials (CENTRAL) and related databases (1995.01–2017.06) for all relevant articles. Comparative studies were used to investigate the HLA-DPB1 loci mismatches on clinical outcomes after unrelated donor HSCT, such as the disease-free survival (DFS), overall survival, GVHD, relapse, and transplant-related mortality (TRM). We performed meta-analysis using Review Manager 5.2 software and funnel plot to assess the bias. Results: At first, 1246 articles were retrieved, and 18 studies totaling 26368 patients analyzed. Pooled comparisons of studies found that the HLA-DPB1 mismatched group had a lower rate of DFS than the DPB1-matched group, and lower OS in non-T cell depleted transplantation. The DPB1 mismatched group has a higher incidence of aGVHD and more severe ( ≥ III degree) aGvHD, lower rate of relapse and higher TRM. Moreover, compared with 1-antigen mismatch, 2-antigen mismatched led to a higher risk of TRM and lower relapse rate. Conclusions: This meta-analysis indicated HLA-DPB1 has important influence on survival and transplant-related complications during unrelated donor HSCT and HLA-DPB1 donor selection strategies have been proposed based on a personalized algorithm.

Keywords: human leukocyte antigen, DPB1, transplant, meta-analysis, outcome

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Authors: Medani Prasad Rijal

Abstract:

The study outlines the impacts of decentralized forest policy on natural Sal (shorea robusta) forests in the Terai region of Nepal. The government has implemented community forestry program to manage the forest resources and improve the livelihood of local people collectively. The forest management authorities such as conserve, manage, develop and use of forest resources were shifted to the local communities, however, the ownership right of the forestland retained by the government. Local communities took the decision on harvesting, distribution, and sell of forest products by fixing the prices independently. The local communities were putting the low value of forest products and distributed among the user households on the name of collective decision. The decision of low valuation is devaluating the worth of forest products. Therefore, the study hypothesized that decision-making capacities are equally prominent next to the decentralized policy and program formulation. To accomplish the study, individual to group level discussions and questionnaire survey methods were applied with executive committee members and user households. The study revealed that the local intuition called Community Forest User Group (CFUG) committee normally took the decisions on consensus basis. Considering to the access and affording capacity of user households having poor economic backgrounds, low pricing mechanism of forest products has been practiced, even though the Sal timber is far expensive in the local market. The local communities thought that low pricing mechanism is accessible to all user households from poor to better off households. However, the analysis of forest products distribution opposed the assumption as most of the Sal timber, which is the most valuable forest product of community forest only purchased by the limited households of better economic conditions. Since the Terai region is heterogeneous by socio-economic conditions, better off households always have higher affording capacity and possibility of taking higher timber benefits because of low price mechanism. On the other hand, the minimum price rate of forest products has poor contribution in community fund collection. Consequently, it has poor support to carry out poverty alleviation activities to poor people. The local communities have been fixed Sal timber price rate around three times cheaper than normal market price, which is a strong evidence of forest product devaluation itself. Finally, the study concluded that the capacity building of local executives as the decision-makers of natural Sal forests is equally indispensable next to the policy and program formulation for effective decentralized forest management. Unilateral decentralized forest policy may devaluate the forest products rather than devolve of power to the local communities and empower to them.

Keywords: community forestry program, decentralized forest policy, Nepal, Sal forests, Terai

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Authors: A. Mech

Abstract:

Repetitive transcranial magnetic stimulation has proven to be a valuable treatment option for patients who have failed to respond to multiple courses of antidepressant medication. In fact, the American Psychiatric Association recommends TMS after one failed treatment course of antidepressant medication. Genetic testing has proven valuable for pharmacokinetic variables, which, if understood, could lead to more efficient dosing of psychotropic medications to improve outcomes. Pharmacodynamic testing can identify biomarkers, which, if addressed, can improve patients' outcomes in antidepressant therapy. Monotherapy treatment of major depressive disorder with methylated B vitamin treatment has been shown to be safe and effective in patients with MTHFR polymorphisms without waiting for multiple trials of failed medication treatment for depression. Such treatment has demonstrated remission rates similar to antidepressant clinical trials. Combining pharmacodynamics testing with repetitive TMS treatment with NeuroStar has shown promising potential for enhancing remission rates and durability of treatment. In this study, a retrospective chart review (ongoing) of patients who obtained repetitive TMS treatment enhanced by dietary supplementation guided by Pharmacodynamic testing, displayed a greater remission rate (90%) than patients treated with only NeuroStar TMS (62%).

Keywords: improved remission rate, major depressive disorder, pharmacodynamic testing, rTMS outcomes

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

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

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

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Authors: Khaled M. Alhawiti

Abstract:

This paper investigates the future of medicine and the use of Natural language processing. The importance of having correct clinical information available online is remarkable; improving patient care at affordable costs could be achieved using automated applications to use the online clinical information. The major challenge towards the retrieval of such vital information is to have it appropriately coded. Majority of the online patient reports are not found to be coded and not accessible as its recorded in natural language text. The use of Natural Language processing provides a feasible solution by retrieving and organizing clinical information, available in text and transforming clinical data that is available for use. Systems used in NLP are rather complex to construct, as they entail considerable knowledge, however significant development has been made. Newly formed NLP systems have been tested and have established performance that is promising and considered as practical clinical applications.

Keywords: clinical information, information retrieval, natural language processing, automated applications

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Authors: Paria Baharvand, Mohammad Reza Abbasi, Soha Namazi

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Introduction: Uremic pruritus (UP) is one of the major complaints in hemodialysis patients. The aim of this randomized clinical trial study was the evaluation of the anti-pruritus effect of Melatonin on hemodialysis patients with UP. Methods: This multi-centered double, blinded randomized clinical trial study was conducted on hemodialysis patients with UP that referred to the dialysis department of Imam Khomeini Hospital, Labbafinezhad Hospital and Ghiasi Hospital in Tehran, Iran, in 2018. Forty participants were enrolled and block randomization was performed by using a randomized list and divided into 2 groups of twenty patients. Evaluation of the 12-Item Pruritus Severity Scale (12-PSS), Visual analog scale (VAS), and Calculation of the affected body surface area for pruritus extent (BSA %) was performed every week. The Melatonin group received a 10 mg soft gel capsule, and the placebo group received a soft gel capsule placebo after dinner. For statistical analysis used by SPSS version 21(IRCT20180714040462N1). Results: 38 hemodialysis patients enrolled in this study. The mean age in the placebo group and in the Melatonin group was 55.88 ± 11.70 and 54.52 ± 13.00 years (p> 0.05). Also, 46% of all participants were female. Aspartate transaminase, alanine transaminase and C-reactive protein have significant differences between the two groups (p< 0.05). VAS score reduction in the two groups had a statistically significant (CI 95% = -1.71, P= 0.015(.The results of BSA% showed Melatonin had a significant effect on the decrease of the pruritus extent compared to placebo (CI 95% = -22.82, P= 0.001(. Conclusion: According to the results of this study and the preliminary effects of Melatonin on uremic pruritus, we suggest performing advanced clinical trials studies.

Keywords: Melatonin, Uremic Pruritus, hemodialysis, anti-pruritus

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Authors: John Hang Leung, Shyh-Yau Wang, Hei-Tung Yip, Fion, Ho Tsung-chin, Agnes LF Chan

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Objectives: Platinum-resistant ovarian cancer has a short overall survival of 9–12 months and limited treatment options. The combination of immunotherapy and targeted therapy appears to be a promising treatment option for patients with ovarian cancer, particularly to patients with platinum-resistant recurrent ovarian cancer (PRrOC). However, there are no direct head-to-head clinical trials comparing their efficacy and toxicity. We, therefore, used a network to directly and indirectly compare seven newer immunotherapies or targeted therapies combined with chemotherapy in platinum-resistant relapsed ovarian cancer, including antibody-drug conjugates, PD-1 (Programmed death-1) and PD-L1 (Programmed death-ligand 1), PARP (Poly ADP-ribose polymerase) inhibitors, TKIs (Tyrosine kinase inhibitors), and antiangiogenic agents. Methods: We searched PubMed (Public/Publisher MEDLINE), EMBASE (Excerpta Medica Database), and the Cochrane Library electronic databases for phase II and III trials involving PRrOC patients treated with immunotherapy or targeted therapy plus chemotherapy. The quality of included trials was assessed using the GRADE method. The primary outcomes compared were progression-free survival, the secondary outcomes were overall survival and safety. Results: Seven randomized controlled trials involving a total of 2058 PRrOC patients were included in this analysis. Bevacizumab plus chemotherapy showed statistically significant differences in PFS (Progression-free survival) but not OS (Overall survival) for all interested targets and immunotherapy regimens; however, according to the heatmap analysis, bevacizumab plus chemotherapy had a statistically significant risk of ≥grade 3 SAEs (Severe adverse effects), particularly hematological severe adverse events (neutropenia, anemia, leukopenia, and thrombocytopenia). Conclusions: Bevacizumab plus chemotherapy resulted in better PFS as compared with all interested regimens for the treatment of PRrOC. However, statistical differences in SAEs as bevacizumab plus chemotherapy is associated with a greater risk for hematological SAE.

Keywords: platinum-resistant recurrent ovarian cancer, network meta-analysis, immune checkpoint inhibitors, target therapy, antiangiogenic agents

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Authors: A. Alzahrani, G. Arnold, W. Wang

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Background: Stroke commonly occurs in middle-aged and elderly populations, and the diagnosis of early stroke is still difficult. Patients who have suffered a stroke have different balance and gait patterns from healthy people. Advanced techniques of motion analysis have been routinely used in the clinical assessment of cerebral palsy. However, so far, little research has been done on the direct diagnosis of early stroke patients using motion analysis. Objectives: The aim of this study was to investigate whether patients with stroke have different balance and gait from healthy people and which biomechanical parameters could be used to predict and diagnose potential patients who are at a potential risk to stroke. Methods: Thirteen patients with stroke were recruited as subjects whose gait and balance was analysed. Twenty normal subjects at the matched age participated in this study as a control group. All subjects’ gait and balance were collected using Vicon Nexus® to obtain the gait parameters, kinetic, and kinematic parameters of the hip, knee, and ankle joints in three planes of both limbs. Participants stood on force platforms to perform a single leg balance test. Then, they were asked to walk along a 10 m walkway at their comfortable speed. Participants performed 6 trials of single-leg balance for each side and 10 trials of walking. From the recorded trials, three good ones were analysed using the Vicon Plug-in-Gait model to obtain gait parameters, e.g., walking speed, cadence, stride length, and joint parameters, e.g., joint angle, force, moments, etc. Result: The temporal-spatial variables of Stroke subjects were compared with the healthy subjects; it was found that there was a significant difference (p < 0.05) between the groups. The step length, speed, cadence were lower in stroke subjects as compared to the healthy groups. The stroke patients group showed significantly decreased in gait speed (mean and SD: 0.85 ± 0.33 m/s), cadence ( 96.71 ± 16.14 step/min), and step length (0.509 ± 017 m) in compared to healthy people group whereas the gait speed was 1.2 ± 0.11 m/s, cadence 112 ± 8.33 step/min, and step length 0.648 ± 0.43 m. Moreover, it was observed that patients with stroke have significant differences in the ankle, hip, and knee joints’ kinematics in the sagittal and coronal planes. Also, the result showed that there was a significant difference between groups in the single-leg balance test, e.g., maintaining single-leg stance time in the stroke patients showed shorter duration (5.97 ± 6.36 s) in compared to healthy people group (14.36 ± 10.20 s). Conclusion: Our result showed that there are significantly differences between stroke patients and healthy subjects in the various aspects of gait analysis and balance test, as a consequences of these findings some of the biomechanical parameters such as joints kinematics, gait parameters, and single-leg stance balance test could be used in clinical practice to predict and diagnose potential patients who are at a high risk of further stroke.

Keywords: gait analysis, kinetics, kinematics, single-leg stance, Stroke

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