The toxicity effects of the individual and combined exposure of methyl tert-butyl ether (MTBE) and tire rubber powder (RP) on Nile tilapia fish (Oreochromis niloticus).

Methyl tert-butyl ether (MTBE) is soluble in water and can contaminate water sources when it spills during transportation or leaks from underground storage tanks. Incomplete combustion releases MTBE as exhaust fumes that can be deposited on urban surfaces. Meanwhile, car tires erosion emits of large amounts of rubber dust (RP), easily transported to water bodies. Therefore, this study has the objective of assessing the toxicity of varying concentrations of MTBE (0, 2.5, 5.0 µL L-1) and RP (0, 5.0, 10.0 mg L-1 RP), both individually and in combination, over a period of 28 days on Nile tilapia (Oreochromis niloticus). MTBE and PR decreased fish growth performance. Blood biochemical analytes indicated that MTBE and RP led to increasing Aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), and creatinine phosphokinase (CPK), alkaline phosphatase and gamma-glutamyl transferase (GGT) activities. Alterations related to glucose, triglycerides, cholesterol, and creatinine, plasma contents, were also observed. Increased antioxidant biomarkers, including superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPx), glutathione reductase (GR), and malondialdehyde (MDA), was observed. Exposure fish to MTBE and PR changed metabolic profile of muscle tissue. Moreover, results showed that MTBE, its metabolites, and PR could accumulate in the muscle tissue of fish. Results suggest that MTBE and RP can impact fish health, both individually and when combined. The presence of MTBE enhances the toxicity of RP, indicating a synergistic effect. Nevertheless, further studies are needed to understand the impact of toxic compounds on aquatic environments and organisms' health.

Economic perspective of evaluating fertility treatment in obese and overweight infertile women.

OBJECTIVES: To evaluate direct cost of in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle and reproductive outcomes among infertile women with different body mass index (BMI). METHODS: A retrospective study of 826 subfertility patients who had IVF or IVF-ICSI in 2017 to 2018 were reviewed. The patients were divided into 4 groups bestowing to BMI to normal weight (18.5-24.9 kg/m2), underweight (<18.5 kg/m2), overweight(25-29.9 kg/m2), and obese(≥30 kg/m2). Data on treatment costs of IVF/ICSI and reproductive outcomes were collected and analyzed. A total of 338 patients (40.9%) were overweight, and 300 (36.3%) patients were obese. A bottom-up methodology was used to measure the resource utilization. The capital inputs needed for individual procedures were defined and calculated by consulting with appropriate clinicians and priced using market prices for 2017-2018. RESULTS: There was no statistical significant difference for live birth rate (LBR) among the BMI groups, with the occurrence of LBR in 23 women with normal BMI (13.1%), in 48 (14.2%) women who were overweight, in 48 (16%) in women who were obese (p=0.7). The median cost for IVF/ICSI treatment cycle did not differ across BMI groups; the cost was 10,380 SAR for women of normal weight, 10,440 SAR for women who are overweight and obese (p=0.6). CONCLUSION: Our results suggest that costs of IVF/IVF-ICSI is not significantly affected in women who are overweight or obese.

Streamlining and cycle time reduction of the startup phase of clinical trials.

OBJECTIVE: The startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Further, it focuses on streamlining and reducing the cycle time of the startup phase of newly sponsored CTs. METHODS: Thirteen sponsored CTs conducted between 2016 and 2017 at the Clinical Research Department of King Fahad Medical City, Riyadh, Saudi Arabia, were considered for this study. Eight trials were analyzed to identify the data specific to startup metrics using the FOCUS-PDCA cycle (Find an improvement area-Organize a team-Clarify current practices-Understand the source of variation/problem-Select a Strategy-Plan-Do-Check-Act). Six measures incorporated in the metrics were (1) date of initial contact with site to the signing of confidentiality agreement, (2) date of receiving questionnaire from sponsor to date of its completion, (4) time taken to review protocol and approve investigational drug service form, and (5) time taken to study protocol and approve pharmacy and pathology and clinical laboratory medicine form and date of receipt of institutional review board (IRB) submission package to final IRB approval. Fishbone analysis was used to understand the potential causes of process variation. Mean (SD) time was calculated for each metric before and after implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs. Data were represented as mean (SD), and the P value was calculated for each metric. The significance level was set at P < 0.05. RESULTS: Of the various potential factors of delay identified through fishbone analysis, the two major ones were lack of a well-defined timeline for approval and review of the study protocol and inconsistent IRB meetings. After introduction of the new intervention protocol, the entire CT life cycle was reduced by 45.6% (mean [SD], 24.8 [8.2] weeks vs. 13.5 [11.6] weeks before and after the intervention, respectively). CONCLUSION: Various factors are responsible for the delay of the startup phase of CTs, and understanding the impact of each element allows for optimization and faster execution of the startup phase of CTs.

Atraumatic Scala Tympani Cochleostomy; Resolution of the Dilemma.

OBJECTIVES: While an accurate placement in cochleostomy is critical to ensure appropriate insertion of the cochlear implant (CI) electrode into the scala tympani (ST), the choice of preferred cochleostomy sites widely varied among experienced surgeons. We present a novel technique for precise yet readily applicable localization of the optimum site for performing ST cochleostomy. MATERIAL AND METHODS: Twenty fresh frozen temporal bones were dissected using the mastoidectomy-posterior tympanotomy approach. Based on the facial nerve and the margins of the round window membrane (RWM), the cochleostomy site was chosen to insert the electrode into the ST while preserving the surrounding intracochlear structures. RESULTS: There is a limited safe area suitable for the ST implantation in the area inferior and anterior to the RWM. There is a higher risk of scala vestibuli (SV) insertion anterior to that area. Posterior to that area, the cochlear aqueduct (CA) and inferior cochlear vein (ICV) are liable for the injury. CONCLUSION: For atraumatic CI, precise and easy localization of the site of cochleostomy play a pivotal role in preserving intracochlear structures. Accurate setting of the vertical and horizontal orientations is mandatory before choosing the site of cochleostomy. The facial nerve and the margins of the RWM offer a very helpful clue for such localization; meanwhile, it is readily identifiable in the surgical field.

Causes and management of urogenital fistulas. A retrospective cohort study from a tertiary referral center in Saudi Arabia.

OBJECTIVES: To reviewe the etiology and management of urogenital fistulas at a tertiary care referral center. METHODS: We retrospectively identified all patients with urogenital fistula referred to the King Fahad Medical City, Riyadh, Saudi Arabia, between January 2005 and July 2016 from electronic records. We collected data on age, parity, etiology and type of fistula, radiologic findings, management, and outcome. Results: Of the 32 patients with urogenital fistula identified, 17 (53.1%) had vesicovaginal fistula. The mean parity was 5.9 (0-15). Obstetric surgery was the most common etiology, accounting for 22 fistulas (68.8%). Twenty of these (90.9%) were complications of cesarean delivery, of which 16 (80%) were repeat cesarean delivery. Forty surgical repair procedures were performed: 20 (50%) via an abdominal approach, 11 (27.5%) via a vaginal approach, 7 (17.5) via a robotic approach, and 2 (5%) using cystoscopic fulguration. The primary surgical repair was successful in 23 patients (74%), the second repair in 5 (16.1%), and the third repair in one (3.1%). One fistula was cured after bladder catheterization, and 2 patients are awaiting their third repair. Conclusion: Unlike the etiology of urogenital fistulas in other countries, most fistulas referred to our unit followed repeat cesarean delivery: none were caused by obstructed labor, and only a few occurred after hysterectomy. Most patients were cured after the primary surgical repair.

Knowledge, attitudes, practices and perceptions of clinicians towards conducting clinical trials in an Academic Tertiary Care Center.

OBJECTIVES: To investigate the knowledge, attitudes practices and perceptions of clinicians concerning the conducting of clinical trials (CTs).  Methods: A cross-sectional study was conducted on clinicians at King Fahad Medical City, Riyadh, Saudi Arabia. Data were collected using a self-administered questionnaire which divided into 5 sections: Section 1 covered respondents' demographics. The other 4 sections explored respondents' knowledge, attitudes, perceptions and practice towards conducting CTs.  Results: A total of 316 clinicians completed the questionnaire. The majority were assistant consultants and consultants 125 (39.5%) and 108 (34.2%), respectively. One hundred sixty-nine (56%) respondents were not aware of the Declaration of Helsinki at all. Two hundred seventy-five (88.4%) respondents expressed interest in conducting CTs and 61.7% and participants showed their willingness to facilitate and assist in CTs conducted by other clinicians. Moreover, 112 (35.9%) respondents participated in CTs previously. Regarding the disadvantages in conducting CTs, participants indicated that the paperwork was complicated and they believed that they might lose patients from their clinical practice once they are recruited in CTs. Lack of research protected time for clinicians 295 (97.7%), and a shortage of clinical research coordinators 293 (97%) were the main problems reported by respondents.  Conclusions: Although the majority of participants had an unsatisfactory level of knowledge and misperceptions about CTs, they showed an interest in and positive attitudes about conducting CTs.

Characterizing sleeping habits and disturbances among Saudi adults.

OBJECTIVES: To characterize sleeping habits, assess sleep disturbance prevalence, and identify associated factors among Saudi adults.  Methods: A total of 1720 adults were approached for this observational cross-sectional study between October 2014 and March 2015. The study took place in Riyadh, the capital of Saudi Arabia. We used a questionnaire to describe sleeping characteristics in relation to existing chronic diseases, smoking status, obesity, daily performance and sociodemographic variables. Results: The response rate was 79.6% (1369 participants), 61.6% have or may have sleeping disturbances of which 18.6% claimed either slowed or stopped breathing during sleep. Women reported a higher prevalence of sleep disturbances (65.2%). Feeling tired was significantly associated with sleep disturbance (49% versus 19.7%) (p greater than 0.001). Approximately 78.4% of those with sleep disturbance significantly believed that their ability to perform daily tasks is affected (p=0.005). Moreover, smoking and obesity were significantly associated with sleep disturbances (p less than 0.01). Participants with asthma, hypertension, chronic heart disease, and diabetes mellitus reported significantly more sleeping disturbance (p=0.016 to p=0.001). Conclusions: Sleep disturbances are associated with obesity, smoking, chronic health conditions, and lower performance among  Saudi adults.

Expression Levels of Some Detoxification Genes in Liver and Testis of Rats Exposed to a Single Dose of Methyl-Tertiary Butyl Ether.

AIM: Methyl-tertiary-butyl ether (MTBE), a well-known gasoline oxygenate compound, is still used in several countries. Several studies investigated the effects of MTBE on the activity of phase II metabolism enzymes. There is no published data on the effect(s) of short-term exposure to MTBE on mRNA levels of antioxidant genes. Therefore, the present study was carried out. METHODS: A total of 15 adults male Wistar rats were randomly divided into five equal experimental groups. They received a single dose of 0, 400, 800 and 1600 mg/Kg MTBE in peanut oil by gavages. The final group received no MTBE and peanut oil. After 24 hr animals were slaughtered then livers and testis were removed to extract the total RNA. Real-time PCR was done to detect the gene expressions of glutathione S-transferase family (Gstt1, Gstm1, and Gstp1). RESULTS: The mRNAs levels of the examined genes neither in liver nor in testis showed a significant difference between the exposed groups and control rats. CONCLUSIONS: The present data revealed that exposure to a single dose of MTBE has no significant effect on the mRNA levels of the Gstt1, Gstm1, and Gstp1 genes.

Prevalence of major congenital anomalies at King Fahad Medical City in Saudi Arabia: a tertiary care centre-based study.

BACKGROUND AND OBJECTIVES: The prevalence of major congenital anomalies in Saudi Arabia is a largely understudied area. Knowing the prevalence of birth defects and their trends is important in identifying potential factors that are either causative or preventative. Early antenatal diagnosis of major congenital anomalies is important for possible termination of pregnancy, fetal or neonatal. We determined the prevalence of major congenital anomalies in our hospital population since implementation of an improved screening system. PATIENTS AND METHODS: This single-centre prospective cross-sectional study was conducted in a tertiary care hospital in Riyadh. A total of 63452 obstetrical ultrasound examinations were performed for 30632 female Saudi obstetric patients from the period of January 2007 to December 2012. RESULTS: A total of 1598 fetuses were diagnosed with major congenital anomalies, including 1064 (66.6 %) fetuses with isolated major anomalies and 534 (33.4%) fetuses with non-isolated major anomalies. The antenatal prevalence of congenital anomalies was 52.1 per 1000 pregnancies. The median maternal age at diagnosis was 29 years. The median gestational age at diagnosis was 30 weeks of gestation. Two hundred and eighty five cases (17.85%) had a previous family history of similar anomalies. The most commonly diagnosed anomalies involved the genitourinary system (652 cases). The birth prevalence of major congenital anomalies was 46.5 per 1000 live births. CONCLUSION: The prevalence of major congenital anomalies in our hospital population appears to be higher than international prevalences, with a high recurrence rate. Environmental, nutritional and social factors may be contributing to this phenomenon.

Reliability of Arabic ICIQ-UI short form in Saudi Arabia.

CONTEXT: The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) provides a brief measure of symptoms and impact of urinary incontinence on quality of life. It is suitable for use in clinical practice and research. An Arabic version of the ICIQ-UI SF was translated and validated in Egypt and Syria. AIMS: The objective was to assess the reliability of the Arabic version of the ICIQ-UI SF in women from Saudi Arabia. SETTINGS AND DESIGN: A study at the Urogynecology Clinic was conducted from November 2010 until August 2011. MATERIALS AND METHODS: Thirty-seven consecutive Saudi women attending urogynecologic clinic were recruited. Questionnaires were distributed for self-completion and then redistributed to the same set of respondents two to four weeks later as part of a test-retest analysis for assessing questionnaire's stability. STATISTICAL ANALYSIS USED: Agreement between two measurements was determined by weighted Kappa. Internal consistency was assessed using Cronbach's alpha coefficient. RESULTS: Participants had a mean (SD) age of 39 (9.9), median parity of 4, and mean BMI (SD) of 30.9 kg/m(2) (4.6). There were no differences in the frequency and amount of urine leaks or the impact of UI on quality of life observed between the two visits. Assessment of internal consistency was excellent with the Cronbach's alpha coefficient of 0.97 (95% CI: 0.88-0.98). Participants agreed that the questionnaire was clear, appropriate, and easy to understand. CONCLUSIONS: The Arabic ICIQ-UI SF is a stable and clear questionnaire that can be used for UI assessment in clinical practice and research among Saudi women.

Randomized trial of oxybutynin extended versus immediate release for women aged 65 and older with overactive bladder: lessons learned from conducting a trial.

OBJECTIVE: This trial was designed to investigate the effectiveness of extended release versus immediate release oxybutynin in reducing symptoms of overactive bladder in a community-dwelling female population over the age of 65. METHODS: This was a prospective randomized 12-week, open-label study. The primary outcome was number of micturitions per 24 hours, 12 weeks after treatment. The a priori sample size estimate was 60 patients per group. RESULTS: Of the 318 women approached, only 72 women (23%) were enrolled over 34 months (33 in the immediate release group, and 39 in the extended release group). The study was stopped prematurely because of recruitment difficulties and an interim analysis revealing the need for a much larger sample than had been estimated to show a significant difference between treatments. After 12 weeks of treatment, there was no difference between the oxybutynin extended release and immediate release groups in the number of micturitions per 24 hours or in other outcomes. CONCLUSION: This study did not demonstrate differences between oxybutynin extended release and immediate release and in reducing symptoms of overactive bladder or quality of life, possibly because the study did not reach the necessary sample size. The difficulty in recruiting subjects for the trial likely resulted from the onerous study requirements (4 study visits required over 12 weeks) and the downtown location of the study centres: these factors would cause particular difficulties for women over age 65 with overactive bladder, for whom travelling may be a problem. Evidence is needed to guide prescribing for older patients, but designing research to obtain adequate sample sizes is difficult. Studies in older subjects should ensure that a much larger budget is allocated for recruitment than would be allocated for studies in younger subjects, that meticulous attention is paid to issues of transport and access, and that support is provided for subjects who agree to take part research.

Tribulus terrestris: preliminary study of its diuretic and contractile effects and comparison with Zea mays.

OBJECTIVES: Tribulus terrestris L. (Zygophyllaceae) which is called Al-Gutub (in Iraqi dialect) or Quti;ba (in classical Arabic medicine), and Zea mays were both used alone or in combination by Iraqi herbalists to propel urinary stones. We studied the aqueous extract of the leaves and fruits of T. terrestris and the hair of Z. mays, to determine their diuretic activity and the contractile effect of T. terrestris. METHODS: The aqueous extract was filtered and the solvent was evaporated to produce a dry crude extract. The dry extract was then dissolved in physiological saline to make the required concentrations. Wistar male rats were used for the diuresis test and strips of isolated Guinea pig ileum were used for the contractility test. RESULTS: The aqueous extract of T. terrestris, in oral dose of 5g/kg elicited a positive diuresis, which was slightly more than that of furosemide. Z. mays aqueous extract did not result in significant diuresis when given alone in oral dose of 5g/kg, while combination of Z. mays and T. terrestris extracts produced the same extent of diuresis as that produced by T. terrestris alone. Na(+), K(+) and Cl(+) concentrations in the urine had also much increased. In addition to its diuretic activity T. terrestris had evoked a contractile activity on Guinea pig ileum. CONCLUSION: T. terrestris has long been used empirically to propel urinary stones. The diuretic and contractile effects of T. terrestris indicate that it has the potential of propelling urinary stones and merits further pharmacological studies.