The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

BACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. METHODS: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). RESULTS: Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. CONCLUSIONS: As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.Peer reviewedFinal Published versio

Cardiovascular magnetic resonance in wet beriberi

The clinical presentation of beriberi can be quite varied. In the extreme form, profound cardiovascular involvement leads to circulatory collapse and death. This case report is of a 72 year-old male who was admitted to the Neurology inpatient ward with progressive bilateral lower extremity weakness and parasthesia. He subsequently developed pulmonary edema and high output cardiac failure requiring intubation and blood pressure support. With the constellation of peripheral neuropathy, encephalopathy, ophthalmoplegia, unexplained heart failure, and lactic acidosis, thiamine deficiency was suspected. He was empirically initiated on thiamine replacement therapy and his thiamine level pre-therapy was found to be 23 nmol/L (Normal: 80-150 nmol/L), consistent with the diagnosis of beriberi. Cardiovascular magnetic resonance (CMR) showed severe left ventricular systolic dysfunction, markedly increased myocardial T2, and minimal late gadolinium enhancement (LGE). After 5 days of daily 100 mg IV thiamine and supportive care, the hypotension resolved and the patient was extubated and was released from the hospital 3 weeks later. Our case shows via CMR profound myocardial edema associated with wet beriberi

Comparative Study of Fingerprint and Centroid Localization Protocol Using COOJA

AbstractSensor networks are in a numerous number of applications. However, implementing wireless sensor networks present new challenges compared with theoretical networks. Cooja is the Contiki network simulator. It allows large and small networks of Contiki motes to be simulated; moreover, motes can be emulated at the hardware level. In this paper, we evaluate the accuracy performance of two very well-known localization protocols, namely: fingerprint and centroid protocols using Tmote sky in Cooja. It is worth mentioning that this the first time this study is conducted in Cooja. The results conform to the theory that fingerprint protocol has a better performance than centroid in terms of accuracy when accuracy is quantified

Evaluation, Antioxidant, Antimitotic and Anticancer Activity of Iron Nanoparticles Prepared by Using Water Extract of Vitis Vinifera L. Leaves

The water extract of Vitis vinifera was used for the rapid synthesis of the iron nanoparticle, which is very simple and eco-friendly in nature. The UV-visible spectroscopy technique was employed to establish the formation of which inhibition onion root growth in a dose-dependent manner. A decrease in the mitotic index may indicate its genotoxic effect on Allium cepa root assay. Nanoparticle was studied for its in vitro anti-inflammatory and antioxidant activity using different models, all the testing, gave significant correlation existed between concentrations of the nanoparticle and percentage inhibition of protein denaturation and scavenging free radicals.  These results clearly indicate that iron nanoparticle is effective against inflammation and free radical-mediated disease

Laparoscopic Hernia Repair in Infancy and Childhood; Evaluation of Two Different Techniques

Background/Purpose: There are many techniques available for laparoscopic hernia repair in infancy and childhood. The objective of this study is to compare two different laparoscopic techniques as regards operative time, recurrence rate, hydrocele formation and post operative cosmetic results. Materials & Methods: A prospective randomized controlled study was carried out in the Pediatric Surgery Unit of Al- Azhar University Hospitals, over three years period. ne-hundred and fifty patients with congenital inguinal hernia were randomized into two equals groups; (n = 75). Group A was subjected to purse-string suture around the internal inguinal ring (IIR) using two needle holders (TNH). Group B was subjected to laparoscopic hernia repair of inguinal hernia by Reverdin Needle (RN). Inclusion criteria included; bilateral inguinal hernia, recurrent hernia, hernia in obese child, incarcerated hernia and hernia on ipsilateral with questionable contralateral side. Exclusion criteria included; unilateral inguinal hernia, and hernia with undescended testicles. The main outcome measurements were; operative time, hospital stay, postoperative hydrocele formation, recurrence rate, and cosmetic results. Results: There were no significant differences as regard age, sex and mode of presentation between both groups. All cases were completed successfully without conversion. There were significant statistical differences in the operative time between the studied groups, while there were no significant statistical differences in the hospital stay, post operative hydrocele formation and recurrence rate. The cosmetic result is excellent in group B. Conclusion: Laparoscopic hernia repair by RN is an effective line of hernia repair in infancy and childhood. It resulted in marked reduction of operative time and excellent cosmetic results with low recurrence. Index Word: Laparoscopic, Reverdin Needle, Purse-string, Intracorporeal sutures

Magnetic Inversion Approach For Modeling Data Acquired Across Faults: Various Environmental Cases Studies

An effective extension to the particle swarm optimizer scheme has been developed to visualize and modelize robustly magnetic data acquired across vertical or dipping faults. This method can be applied to magnetic data sets that support various investigations, including mining, fault hazards assessment, and hydrocarbon exploration. The inversion algorithm is established depending on the second horizontal derivative technique and the particle swarm optimizer algorithm and was utilized for multi-source models. Herein, the inversion method is applied to three synthetic models (a dipping fault model contaminated without and with different Gaussian noises levels, a dipping fault model affected by regional anomaly, and a multi-source model) and three real datasets from India, Australia, and Egypt, respectively. The output models confirm the inversion approach\u27s accuracy, applicability, and efficacy. Also, the results obtained from the suggested approach have been correlated with those from other methods published in the literature

A RESTful API for Supporting Automated BioBrick Model Assembly

Constructing simulatable models for BioBricks by hand is a complex and time-consuming task. The time taken could be reduced by using Computer Aided Design (CAD) tools to aid in designing models, but these tools need to be augmented with domain-specific knowledge. Here we propose a standard for a RESTful (Richardson, 2007) API which facilitates the discovery and publication of models of functional biological units. This API is designed to produce parts models which can be automatically combined into complete, simulatable models of entire systems

Fatal disseminated toxoplasmosis in a zoological collection of meerkats (Suricata suricatta)

Two confirmed cases of fatal disseminated toxoplasmosis occurred in an urban zoological collection of meerkats (Suricata suricatta). Both cases are suspected to be the result of feral cats gaining access to the enclosure. Toxoplasmosis has rarely been documented in meerkats. Subsequent to prophylactic treatment of all the animals and structural changes being implemented within the enclosure, no new cases have been recorded to date. Very little information is available on the disease in viverrids.http://www.jsava.co.zaam2017Veterinary Tropical Disease

Role of anti-inflammatory interleukin 10 in asymptomatic heartworm infection (Dirofilariasis) in dogs

Background: Dirofilaria immitis causes heartworm disease (HWD), a vector-borne zoonotic disease that primarily affects dogs and cats. Occasionally, human beings were reported to be infected as well. The current study aims to discover the asymptomatic dirofilariasis infection in dogs. In addition, to determine the prevalence of heartworm disease and the role of anti-inflammatory interleukin 10 (IL10) in developing the disease. Household dogs were selected from 10 veterinary clinics throughout Basrah, south of Iraq.Methods: The study included 117 dogs older than 12 months, none of them had received heartworm vaccinations, and all of them lived in their owners’ houses for at least 9 months. Animal ethics instructions were followed after the owner’s consent was obtained.  Physical and biochemical examinations were conducted including the examination of circulating antigens of microfilaria. The levels of anti-inflammatory IL10 and pro-inflammatory IL17, IL4, and IFN-γ were measured using ELISA tests. Descriptive statistics were used to evaluate the prevalence and the clinical and immunological results of the study.Results: Canine heartworm disease prevalence was 29.05% (34 out of 117). The physical examination showed normal vital signs for both infected and non-infected dogs. A significant elevation in the total WBC count was noticed in the infected group.  On the other hand, a significant decrease in RBCs count and hemoglobin was found in the infected group. There were neither changes in the platelet count nor the liver enzymes concentration between infected and non-infected groups.  A significant increase in anti-inflammatory interleukin 10 level and a significant decrease in pro-inflammatory IL17, IL4, and IFN-γ were noticed in the infected dogs. Conclusion: It is concluded that dirofilariasis infection is considered to be a serious life-threatening disease for dogs in Iraq. Therefore, a periodic test for heartworm infection every six months is recommended to eradicate heartworm infestations. The infected animals must be treated according to the American Heartworm Association recommendations

Does COVID-19 contribute to development of neurological disease?

Background: Although coronavirus disease 2019 (COVID-19) has been associated primarily with pneumonia, recent data show that the causative agent of COVID-19, the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can infect a large number of vital organs beyond the lungs, such as the heart, kidneys, and the brain. Thus, there is evidence showing possible retrograde transmission of the virus from the olfactory epithelium to regions of the brain stem. Methods: This is a literature review article. The research design method is an evidence-based rapid review. The present discourse aim is first to scrutinize and assess the available literature on COVID-19 repercussion on the central nervous system (CNS). Standard literature and database searches were implemented, gathered relevant material, and extracted information was then assessed. Results: The angiotensin-converting enzyme 2 (ACE2) receptors being the receptor for the virus, the threat to the central nervous system is expected. Neurons and glial cells express ACE2 receptors in the CNS, and recent studies suggest that activated glial cells contribute to neuroinflammation and the devastating effects of SARS-CoV-2 infection on the CNS. The SARS-CoV-2-induced immune-mediated demyelinating disease, cerebrovascular damage, neurodegeneration, and depression are some of the neurological complications discussed here. Conclusion: This review correlates present clinical manifestations of COVID-19 patients with possible neurological consequences in the future, thus preparing healthcare providers for possible future consequences of COVID-19