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

Retinopathy of prematurity in infants with birth weight above 1500 grams

Objective: To identify the rate and prognosis of retinopathy of prematurity (ROP) among newborn infants of birthweight of above 1500 grams, and the possible risk factors associated with the disease.Design: A prospective cohort study.Setting: Neonatal unit at Maternity Hospital, Kuwait city, Kuwait.Methods: All low birth weight infants were examined for the presence of ROP in the period between January 1996 to December 1997. Prospective collection of data on babies who were above 1500 grams was done to find an association between the disease in these babies and some of the maternal and neonatal risk factors.Results: A total of 68 babies of birth weight above 1500 grams were screened for ROP out of which 13 (19.1%) had different stages of the disease. None of the patients had threshold disease requiring surgery. Among the risk factors chosen, oxygen therapy, presence ofhypotension at birth and the non-use of surfactant were the only risk factors to be associated with disease. However, with logistic regression analysis, none of these were independently associated with ROP.Conclusion: ROP may occur in newborn infants of larger birthweight but with good prognosis, and oxygen therapy seems to predispose to the disease

Případová studie pacienta po roztrhání šlachy hlavních svalů pectoralis

Abstracts Title: Case Study of patient After Tear of Tendon of Pectoralis Major Muscle. Goals: The aim of this thesis is to discuss the rehabilitation of patient after fixing the rupture tendon of pectoralis major muscle and to review the anatomy, kinesiology and rehabilitation of this type of injury. Methods: Methods used in this study are all based on the literature given by the Faculty of Physical Education and Sport. Results: After 8 therapy sessions results of therapy were in reduction of pain level, increasing ROM in the shoulder joint and muscle imbalances. Keywords: Pectoralis major, Tendon tear, Tendon rupture, shoulder joint, shoulder pain,Abstrakty Název: Případová studie pacienta Po roztrhání šlachu hlavních svalů pectoralis. Cílem práce: Cílem této práce je diskutovat o rehabilitaci pacienta po fixaci proražené šlachy pektorálního hlavního svalu a přezkoumat anatomii, kineziologii a rehabilitaci tohoto druhu zranění. Metodika: Metody používané v této studii vycházejí z literatury fakulty tělesné výchovy a sportu. Výsledek: Po 8 terapiích byly výsledky léčby snížením bolesti, zvýšením ROM v ramenním kloubu a svalovou nerovnováhou. Klíčová slova: Pectoralis, Tendonová slza, roztrhnutí šlachu, ramenní kloub, bolesti ramen.FyzioterapieFaculty of Physical Education and SportFakulta tělesné výchovy a sport

Sequence analysis of the VSX1 and SOD1 genes in families with Keratoconus and a review of the literature

AbstractObjectiveKeratoconus (KC) is a non-inflammatory disorder of the cornea in which the cornea becomes thin and conical, inducing myopia and irregular astigmatism and resulting in mild to marked impairment of vision. The present study was designed to screen two candidate KC genes to identify pathogenic sequence variants responsible for KC in Saudi families.MethodsPeripheral blood samples from members of five Saudi families with KC from the Northern region were collected. Genomic DNA was isolated, and bidirectional sequencing was performed of all coding exons of VSX1 and SOD1 genes using Sanger sequencing.ResultsAll five of the KC families showed a pattern of autosomal recessive inheritance. Phenotyping of these families was performed by a senior ophthalmologist. Sequence analysis of the VSX1 and SOD1 genes failed to reveal any pathogenic sequence variant that could account for KC in the affected individuals.ConclusionOur failure to detect sequence variants in two of the known KC associated genes triggers an interest in other known KC candidate genes, including miR-184, DOCK9, IL1RN and SLC4A11. Future genotyping with dense SNP arrays followed by exome sequencing in these families will be a useful approach to identify the gene(s) underlying KC in this Saudi cohort, which may be different from those reported elsewhere

Evaluating molecular study of the association of Glutathione S – Transferase GST (T1 , M1) genetic polymorphism in Iraqi Arab Femals with Type 2 Diabetes Mellitus and Coronary Artery Disease

Coronary artery disease (CAD) is a major health concern and leading of death in individuals with type 2 diabetes mellitus (T2DM). Glutathione S – Transferase(GST) are known for their broad range of detoxification and in the metabolism of xenobiotics . The role of functional variants of these genes in the development of various disorder is proven. We investigated the possible role of these variants in the development of CAD in T2DM patients. In this case – control study a total of 60 patients (T2DM = 30 ; T2DM – CAD = 30) and 30 controls were included. Serum lipid profiles were measured and DNA was extracted from the blood samples. Multiplex PCR for GSTT1/M1 (present / null) polymorphism, were performed for genotyping of study participants. Gene frequency and lipid profiles were statistically analyzed for disease association. Regression analysis showed that, there was no significant difference of the frequency of GSTT1 (positive /null) genotype and GSTM1 (positive /null) genotype in the 3 study groups . GSTT1 – positive genotype is associated with a 0.51 fold increased ( OR = 0.51 ; 95%CI = 2- 0.1 ;P = 0.321 ) , while the GSTM1 – positive genotype was associated with a 3 fold increase ( OR = 3.06 ; 95%CI=1- 9.7 ; P = 0.055) .We conclude GSTT1 positive genotype considered to be a protective risk from CAD in T2DM patients . The GSTM1 – positive genotype it was considered to be a risk factor of the CAD in T2DM patients

Methylphenidate improves executive functions in patients with traumatic brain injuries : a feasibility trial via the idiographic approach

Background: Road traffic accidents are known to be the main cause of traumatic brain injury (TBI). TBI is also a leading cause of death and disability. This study, by means of the idiographic approach (single-case experimental designs using multiple-baseline designs), has examined whether methylphenidate (MPH - trade name Ritalin) had a differential effect on cognitive measures among patients with TBI with the sequel of acute and chronic post-concussion syndromes. The effect on gender was also explored. Methods: In comparison with healthy controls, patients with TBI (acute and chronic) and accompanying mild cognitive impairment (MCI) were screened for their integrity of executive functioning. Twenty-four patients exhibiting executive dysfunction (ED) were then instituted with the pharmacological intervention methylphenidate (MPH). The methylphenidate was administered using an uncontrolled, open label design. Results: The administration of methylphenidate impacted ED in the TBI group but had no effect on mood. Attenuation of ED was more apparent in the chronic phases of TBI. The effect on gender was not statistically significant with regard to the observed changes. Conclusions: To our knowledge, this is the first feasibility trial from the Arabian Gulf to report the performance of a TBI population with mild cognitive impairment according to the IQCODE Arabic version. This investigation confirms anecdotal observations of methylphenidate having the potential to attenuate cognitive impairment; particularly those functions that are critically involved in the integrity of executive functioning. The present feasibility trial should be followed by nomothetic studies such as those that adhere to the protocol of the randomized controlled trial. This evidence-based research is the foundation for intervention and future resource allocation by policy- or public health decision-makers

The role of self-esteem and self-efficacy in women empowerment in the Kingdom of Saudi Arabia: A cross-sectional study

The study aimed to explore the role of self-esteem and self-efficacy in women empowerment among academic and administrative staff at Saudi universities. A cross-sectional design was carried out at 15 governmental universities. A  multistage cluster sampling technique was used to select 5587 participants. Multiple linear regression was used to analyze the predictive relation. Data collection included socio-demographic variables, Rosenberg self-esteem scale, general self-efficacy scale, and women empowerment scale. The results indicated that study participants' self-esteem was equally distributed between moderate (49.8%) and high (50.2%). Also, 66.9% of the participants had high self-efficacy, and 86.8% had high total women's empowerment. Regression coefficient showed that self-esteem (B=0.521, b=0.127, t=13.785 and p<0.001) and self-efficacy (B=2.388, b=0.702, t=76.049 and p<0.001) are important predictors of the total women empowerment. However, self-efficacy was observed to be the most dominant predictor (t=76.049). The total model summary shows that 73.4% of the women empowerment level can be predicted through self-esteem and self-efficacy. The study results can be used as a base to build women empowerment programs in the Kingdom of Saudi Arabia (KSA) and help to achieve the 2030 KSA vision regarding women empowerment. Keywords: Self-esteem, self-efficacy, women empowerment, 2030 KSA vision L'étude visait à explorer le rôle de l'estime de soi et de l'efficacité personnelle dans l'autonomisation des femmes parmi le personnelacadémique et administratif des universités saoudiennes. Une conception transversale a été réalisée dans 15 universités gouvernementales. Une technique d'échantillonnage en grappes à plusieurs degrés a été utilisée pour sélectionner 5587 participants.Une régression linéaire multiple a été utilisée pour analyser la relation prédictive. La collecte de données comprenait des variablessociodémographiques, une échelle d'estime de soi de Rosenberg, une échelle d'auto-efficacité générale et une échelle d'autonomisation des femmes. Les résultats ont indiqué que l'estime de soi des participants à l'étude était également répartie entremodérée (49,8%) et élevée (50,2%). En outre, 66,9% des participants avaient une auto-efficacité élevée et 86,8% avaient une forteautonomisation totale des femmes. Le coefficient de régression a montré que l'estime de soi (B = 0,521, b = 0,127, t = 13,785 et p<0,001) et l'auto-efficacité (B = 2,388, b = 0,702, t = 76,049 et p <0,001) sont des prédicteurs importants du l'autonomisation totaledes femmes. Cependant, l'auto-efficacité a été observée comme le prédicteur le plus dominant (t = 76,049). Le résumé total dumodèle montre que 73,4% du niveau d'autonomisation des femmes peut être prédit grâce à l'estime de soi et à l'auto-efficacité. Lesrésultats de l'étude peuvent être utilisés comme base pour élaborer des programmes d'autonomisation des femmes dans le Royaumed'Arabie saoudite (KSA) et aider à réaliser la vision 2030 de la KSA concernant l'autonomisation des femmes. Mots-clés: Estime de soi, efficacité personnelle, autonomisation des femmes, vision 2030 KS

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