Prospective Clinical Analysis Research Articles

Hist-P-04 - Topical mechlorethamine in mycosis fungoides: a prospective clinical, histopathological, and molecular analysis of 13 cases

Background: Mycosis fungoides (MF) has long been treated with topical mechlorethamine hydrochloride (MCH), but reports on skin tissue changes over the course of treatment are still lacking.

Microbiotes of the vagina, cervical canal and uterine cavity in chronic endometritis

The objective: to determine the profile of vaginal, cervical and uterine microbiota in chronic endometritis in patients with failed ART attempts in history. Materials and method. A prospective study and clinical laboratory analysis of vaginal microbiocenosis, cervical canal and uterine cavity in women with chronic endometrite in a history on the basis of MC LLC «ISIDA - IVF», in the period from 2020 to 2021 was carried out. The group consisted of 55 women of reproductive age with chronic endometritis and repeated failed ART attempts, and 40 women of reproductive age without fertility impairment who formed the control group. Amount of research – Vaginal Secretion PH, Vaginal Microbial Estimation of Pap Smear Microscopy, Polymerase Chain Reaction Study (PCR), Culture Study of Vaginal Secretions, Study of microflora of the cervical channel and bioptat of endometrium. Results. In women with infertility, against the background of chronic endometritis in history, as a result of bacterial sowing from the uterine cavity, the predominance of mixed bacterial flora, which is represented by various associations of opportunistic and pathogenic micro-organisms, has been detected. Chronic inflammatory endometry is caused by a persistent viral bacterial infection in the uterine cavity, which differs in species composition from the microflora of the lower genital tract. Conclusions. The characteristic feature of the vaginal flora in chronic endometritis is a high level of dissbiotic changes, combined with high values of the notional pathogenic flora. The microbiotopes of the cervical channel and endometrium in the inflammatory processes of endometry are characterized by the predominance of obligatory-anaerobic micro-organisms in the form of associations with viral infection much more than twice as frequently detected in endocervix as compared to endometrium.

The Unknown Prevalence of Postrandomization Bias in 15 Physical Therapy Journals: A Methods Review.

To determine the prevalence of prospective clinical trial registration and postrandomization bias in published musculoskeletal physical therapy randomized clinical trials (RCTs). A methods review. Articles indexed in MEDLINE and published between January 2016 and July 2020 were included. Two independent blinded reviewers identified the RCTs using Covidence. We included RCTs related to musculoskeletal interventions that were published in International Society of Physiotherapy Journal Editors member journals. Data were extracted independently for the variables of interest from the identified RCTs by 2 blinded reviewers. The data were presented descriptively or in frequency tables. One hundred thirty-eight RCTs were identified. One third of RCTs were consistent with their prospectively registered intent (49/138); consistency with prospectively registered intent could not be determined for two thirds (89/138) of the RCTs. Four RCTs (8%)reported inconsistent results with the primary aims and 7 (14%) with the outcomes from the prospective clinical trial registry, despite high methodological quality (Physiotherapy Evidence Database [PEDro] scale score). Differences between prospectively registered and non-prospectively registered RCTs for PEDro scale scores had a medium effect size (r = 0.30). Two of 15 journals followed their clinical trial registration policy 100% of the time; in 1 journal, the published RCTs were consistent with the clinical trial registration. Postrandomization bias in musculoskeletal physical therapy RCTs could not be ruled out, due to the lack of prospective clinical trial registration and detailed data analysis plans. J Orthop Sports Phys Ther 2021;51(11):542-550. Epub 21 Sep 2021. doi:10.2519/jospt.2021.10491.

A prospective clinical and biomechanical analysis of feet following first metatarsophalangeal joint replacement.

There is a lack of research providing a biomechanical outcome following 1st MTPJ replacement for hallux rigidus. Despite this, 1st MTPJ replacement continues to be an alternative surgical option to fusion for this painful debilitating condition. Several studies do consider the patient reported outcomes which are subjective. The objective of this study is to provide an in depth biomechanical analysis to examine the effects of 1st MTPJ replacement for hallux rigidus on gait mechanics. Kinematic data was collected at our CMAS (Clinical Movement Analysis Society) UK accredited gait laboratory during the gait cycle together with pressure plate pressure readings and a validated patient outcome measure before surgery and at 6 and 12 months after surgery. A complete literature review is performed. Kinematic data revealed a significant increase in stride length, cadence and velocity following 1st MTPJ replacement for hallux rigidus. Foot kinematic data revealed significantly reduced tibia-hindfoot abduction and pronation and reduced hindfoot-forefoot supination and adduction. There was no effect on 1st MTPJ weight bearing range of motion. Pressure plate data revealed an increase in peak pressure and pressure time integral towards the 1st metatarsal following surgery. There was a significant improvement in the patient reported outcome measure. This study has demonstrated objectively that following 1st MTPJ replacement, biomechanically, a restoration of the foot posture to allow medialisation of foot pressures towards the medial column and normalisation of gait including an increase in the stride length, cadence and velocity and that clinically, there was an improvement in the MOXFQ.

Adverse events in the treatment of motorcycle-related isolated limb injuries at a regional hospital in Uganda: a prospective clinical analysis.

Although motorcycle accidents are a leading cause of limb injury in Uganda, little is known about injury care quality at regional hospitals. This study measured the incidence of clinical adverse events (CAEs) and identified associated treatment barriers surrounding motorcycle-related isolated limb injuries at a regional hospital. A prospective descriptive study was conducted among patients with motorcycle-related isolated limb injuries at a Ugandan regional hospital between September 2017 and February 2018. Patients were surveyed upon admission and monitored throughout their course of treatment. Weight-bearing status and quality of life measures (EQ-5D) were assessed at four and 12weeks. One hundred twenty-four participants enrolled. Of the total participants, 12% refused definitive treatment. Among 108 treated patients, six experienced CAEs: four wound infections, one amputation, and one death. At 12weeks follow-up, the majority of patients had no difficulty with mobility, pain/discomfort, or self-care, but 51% endorsed challenges completing certain daily chores, and 40% of patients could ambulate without an assistive device with restoration of pre-fracture gait. Both longer hospital stays and poorer 12-week functional recovery were seen among patients sustaining open fracture (p < 0.001). Treatment of isolated limb injuries at a Ugandan Regional Hospital was associated with minimal short-term CAEs. However, patients with more severe injuries may be at risk for delayed post-operative recovery. Future studies measuring long-term functional outcomes should be performed to better understand and optimize injury care in this population.

Enhanced Eye Velocity in Head Impulse Testing-A Possible Indicator of Endolymphatic Hydrops.

Introduction: On video head impulse testing (vHIT) of semicircular canal function, some patients reliably show enhanced eye velocity and so VOR gains >1.0. Modeling and imaging indicate this could be due to endolymphatic hydrops. Oral glycerol reduces membranous labyrinth volume and reduces cochlear symptoms of hydrops, so we tested whether oral glycerol reduced the enhanced vHIT eye velocity.Study Design: Prospective clinical study and retrospective analysis of patient data.Methods: Patients with enhanced eye velocity during horizontal vHIT were enrolled (n = 9, 17 ears) and given orally 86% glycerol, 1.5 mL/kg of body weight, dissolved 1:1 in physiological saline. Horizontal vHIT testing was performed before glycerol intake (time 0), then at intervals of 1, 2, and 3 h after the oral glycerol intake. Control patients with enhanced eye velocity (n = 4, 6 ears) received water and were tested at the same intervals. To provide an objective index of enhanced eye velocity we used a measure of VOR gain which captures the enhanced eye velocity which is so clear on inspecting the eye velocity records. We call this measure the initial VOR gain and it is defined as: (the ratio of peak eye velocity to the value of head velocity at the time of peak eye velocity). The responses of other patients who showed enhanced eye velocity during routine clinical testing were analyzed to try to identify how the enhancement occurred.Results: We found that oral glycerol caused, on average, a significant reduction in the enhanced eye velocity response, whereas water caused no systematic change. The enhanced eye velocity during the head impulses is due in some patients to a compensatory saccade-like response during the increasing head velocity.Conclusion: The significant reduction in enhanced eye velocity during head impulse testing following oral glycerol is consistent with the hypothesis that the enhanced eye velocity in vHIT may be caused by endolymphatic hydrops.

Is there bacterial infection in the intact crowns of teeth with pulp necrosis of sickle cell anaemia patients? A case series study nested in a cohort.

To evaluate the presence of bacteria in permanent teeth with intact crowns (without caries, periodontal disease or dental trauma) in patients with sickle cell anaemia (HbSS genotype) by analysing their clinical, imaging and microbiological parameters. This is a case series study nested in a cohort. In the first follow-up of this cohort study (Journal of Endodontics, 2013, 39, 177), 10 HbSS patients with at least one tooth with an intact crown and clinically diagnosed with pulp necrosis by pulse oximetry adapted for dentistry and a cold pulp sensitivity test (n=27 teeth) were selected. Changes in the pulp chamber, root and periodontal ligament were identified in the tomographic analysis. Bacterial culture, staining for live and dead bacteria, and real-time polymerase chain reaction with 16S rRNA primers were used to identify the presence of bacteria. Culture sample collection was performed immediately after access to the pulp chamber. The microbiome was analysed with a MiSeq sequencer (Illumina, San Diego, CA). The diagnosis of pulp necrosis was confirmed clinically in 82% (22/27) of the teeth. The amount of bacterial load identified was less than 100copiesμL-1 in 23% (5/22) of the teeth with intact crowns and pulp necrosis. Thirteen bacterial species were identified that are commonly found in urinary tract infections, septicaemia and infective endocarditis. Only one of these species, Granulicatella adjacens, has also be found in primary endodontic infections. Prospective clinical, imaging and microbiological analyses suggest that pulp necrosis of teeth with intact crowns in HbSS patients is not associated with the presence of bacteria.

Comparison of Transvaginal and Transumbilical Laparoscopic Single-Site Surgery for Ovarian Cysts

Background:Minimally invasive surgery is currently a preferred treatment for symptomatic ovarian cyst(s), with single-site techniques, such as transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal laparoendoscopic single-site surgery (TV-LESS), gaining increasing popularity. Although both methods have delivered positive outcomes, there is currently limited literature directly comparing TU-LESS and TV-LESS.Objectives:This study had two primary objectives: (1) to evaluate the safety and feasibility of TV-LESS and TU-LESS for the treatment of ovarian cysts and (2) to compare the surgical and postoperative outcomes of the two procedures.Method:This was a prospective observational clinical analysis of 81 patients with a diagnosis of benign ovarian cyst with indication for TV-LESS or TU-LESS. Surgeries were performed at a tertiary hospital between February 1, 2018 and January 31, 2020. Patients were divided into TV-LESS (n = 40) and TU-LESS groups (n = 40), with one excluded due to severe pelvic adhesive disease. Demographics, operation outcomes, and follow-up details were compared.Results:All 80 patients underwent uncomplicated procedures. The two groups were demographically matched (except age), with no difference in operation time, intra-operative blood loss, hemoglobin loss, and hospitalization costs (P > 0.05). However, TV-LESS patients had significantly faster time to ambulation (P < 0.001), faster time to return of bowel function (P < 0.001), less postoperative pain level (P < 0.001), and shorter length of hospital stay (P < 0.001). The cosmetic scores at 1, 4, and 24 weeks after surgery were also higher for the TV-LESS group.Conclusion:Our preliminary experience suggested that TU-LESS and TV-LESS are both feasible and safe for ovarian cystectomy and salpingo-oophorectomy. However, TV-LESS may provide three main advantages including: (1) fewer postoperative complications (i.e. incisional hernia); (2) less postoperative pain; and (3) improved cosmetic satisfaction.

Leprosy in a prison population: A new active search strategy and a prospective clinical analysis.

This study evaluates an active search strategy for leprosy diagnosis based on responses to a Leprosy Suspicion Questionnaire (LSQ), and analyzing the clinical, immunoepidemiological and follow-up aspects for individuals living in a prison population. A cross-sectional study based on a questionnaire posing 14 questions about leprosy symptoms and signs that was distributed to 1,400 prisoners. This was followed by dermatoneurological examination, anti-PGL-I serology and RLEP-PCR. Those without leprosy were placed in the Non-leprosy Group (NLG, n = 1,216) and those diagnosed with clinical symptoms of leprosy were placed in the Leprosy Group (LG, n = 34). In total, 896 LSQ were returned (64%), and 187 (20.9%) of the responses were deemed as positive for signs/symptoms, answering 2.7 questions on average. Clinically, 1,250 (89.3%) of the prisoners were evaluated resulting in the diagnosis of 34 new cases (LG), based on well-accepted clinical signs and symptoms, a new case detection rate of 2.7% within this population, while the NLG were comprised of 1,216 individuals. The confinement time medians were 39 months in the LG while it was 36 months in the NLG (p>0.05). The 31 leprosy cases who responded to the questionnaire (LSQ+) had an average of 1.5 responses. The symptoms "anesthetized skin area" and "pain in nerves" were most commonly mentioned in the LG while "tingling, numbness in the hands/feet", "sensation of pricks and needles", "pain in nerves" and "spots on the skin" responses were found in more than 30% of questionnaires in the NLG. Clinically, 88.2% had dysesthetic macular skin lesions and 97.1% presented some peripheral nerve impairment, 71.9% with some degree of disability. All cases were multibacillary, confirming a late diagnosis. Anti-PGL-I results in the LG were higher than in the NLG (p<0.0001), while the RLEP-PCR was positive in 11.8% of the patients. Our findings within the penitentiary demonstrated a hidden prevalence of leprosy, although the individuals diagnosed were likely infected while living in their former communities and not as a result of exposure in the prison. The LSQ proved to be an important screening tool to help identify leprosy cases in prisons.

Faziale Migräne

*** Lambru G, Elias LA, Yakkaphan P, et al. Migraine presenting as isolated facial pain: A prospective clinical analysis of 58 cases. Cephalalgia 2020; doi: 10.1177/0333102420933277

Migraine presenting as isolated facial pain: A prospective clinical analysis of 58 cases.

Sparse evidence has detailed the clinical phenotype of migraine presenting as isolated facial pain.Objective and methods: This was a prospective audit, part of our multidisciplinary facial pain service evaluation, aiming to phenotype patients with migraine presenting as isolated facial pain who attended our service between 2013 and 2018. Fifty-eight patients were diagnosed with migraine with isolated facial pain (F = 46, 79.3%; mean age: 49.0 years, ± 9.85). Sixty-six percent of patients met the criteria for episodic migraine. The pain was strictly unilateral in 79% and located over the maxillary region in 85% of patients. Associated cranial autonomic signs/symptoms were reported by 45% of our cohort. A percentage of 77% of patients was triptan responders. Migraine presenting as isolated facial pain is a rare but treatable condition with some distinct demographic and clinical characteristics. It is a diagnosis of exclusion that should be evaluated in specialised multidisciplinary facial pain clinics.

The Effects of Granulocyte Colony-Stimulating Factor in Patients with a Large Anterior Wall Acute Myocardial Infarction to Prevent Left Ventricular Remodeling: A 10-Year Follow-Up of the RIGENERA Study.

Background: the RIGENERA trial assessed the efficacy of granulocyte-colony stimulating factor (G-CSF) in the improvement of clinical outcomes in patients with severe acute myocardial infarction. However, there is no evidence available regarding the long-term safety and efficacy of this treatment. Methods: in order to evaluate the long-term effects on the incidence of major adverse events, on the symptom burden, on the quality of life and the mean life expectancy and on the left ventricular (LV) function, we performed a clinical and echocardiographic evaluation together with an assessment using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Seattle Heart Failure Model (SHFM) at 10-years follow-up, in the patients cohorts enrolled in the RIGENERA trial. Results: thirty-two patients were eligible for the prospective clinical and echocardiography analyses. A significant reduction in adverse LV remodeling was observed in G-CSF group compared to controls, 9% vs. 48% (p = 0.030). The New York Heart Association (NYHA) functional class was lower in G-CSF group vs. controls (p = 0.040), with lower burden of symptoms and higher quality of life (p = 0.049). The mean life expectancy was significantly higher in G-CSF group compared to controls (15 ± 4 years vs. 12 ± 4 years, p = 0.046. No difference was found in the incidence of major adverse events. Conclusions: this longest available follow-up on G-CSF treatment in patients with severe acute myocardial infarction (AMI) showed that this treatment was safe and associated with a reduction of adverse LV remodeling and higher quality of life, in comparison with standard-of-care treatment.

Balance training can enhance hip fracture patients' independence in activities of daily living: A meta-analysis of randomized controlled trials.

Background:We conducted this meta-analysis to analyze the effectiveness of balance training in improving postoperative rehabilitation outcomes in hip fracture surgery patients.Methods:The Cochrane Library, Web of Science, Embase, and PubMed electronic databases were searched from their inception to December 2018. We selected prospective clinical control analyses and high-quality randomized controlled trials (RCTs) following the inclusion standards. We used Stata 12.0 to perform the meta-analysis. Where possible, the standard mean difference (SMD) with the 95% confidence interval (CI) was determined using a random effects model.Results:Ten RCTs involving 955 hips (balance training = 487, control = 468) published between 2002 and 2019 were assessed for eligibility of inclusion in the meta-analysis. Balance training was shown to remarkably improve the aspects of quality of life associated with physical health (standard mean difference [SMD], 2.20; 95% CI, 1.63–2.78, P = .000), a fast gait speed (SMD, 1.01; 95% CI, 0.25–1.77, P = .009), and balance (SMD = 0.26, 95% CI: [0.12, 0.41], P = .000). Moreover, the balance training group showed increases in independence in activities of daily living (ADLs), performance task scores, and health-related quality of life (HRQoL) scores compared with the control group (P < .05).Conclusion:According to the present meta-analysis, balance training improves one's independence in activities of daily living, performance tasks, lower limb strength, gait, and total physical function compared with no balance training. More high-quality RCTs with large sample sizes are required for the identification of the best balance training program after hip fracture.

Акушерські та перинатальні наслідки у жінок із загрозою переривання вагітності, які проживають у зоні збройного конфлікту

The objective: was to evaluate the course of pregnancy, childbirth and perinatal outcomes of delivery of women with threatened interruption of pregnancy (TIP), living in the Lugansk region, to improve treatment and preventive measures and prevent obstetric and perinatal complications in such women. Materials and methods. A prospective clinical and statistical analysis of the course of pregnancy and childbirth of 86 pregnant women in first and second trimesters of pregnancy were hospitalized regarding TIP in the hospitals located in the Luhansk region was performed (group I). The control group consisted of 64 pregnant women with non-complicated obstetric anamnesis and physiological course of pregnancy with similar gestational period of pregnancy and place of residence (group II). Results. In women of group I, a history of female genital inflammatory diseases was significantly more frequent, and a complicated course of pregnancy and childbirth was registered. The number of cases of acute respiratory viral infection (ARVI) was in 4, isthmic-cervical insufficiency (ICI) was in 3 times more often than in healthy pregnant women, asymptomatic bacteriuria, recurring TIP, gestational pyelonephritis and ureaplasma infection were found only in pregnant women of group I, the number of cases of anemia there was no significant difference. 13 (15.12%) of women of group I and 3 (4.69%) of group II (p=0.041) had spontaneous preterm birth at 33–37 weeks of gestation; operative delivery was registered in 23 (26.74%) and 8 (12.50%) cases, respectively (p=0.033). It was established that recurrent TIP, ARVI during this pregnancy, ICI, gestational pyelonephritis are statistically significant risk factors for preterm delivery and operative delivery. Premature rupture of the membranes was found in 1.58, weakness of labor – in 2.2, premature detachment of a normally located placenta – in 6, fetal distress – in 1.9 times more often in women of group I, central placenta previa was noted only in group I. Conclusions. The complicated course of the first and second trimesters of pregnancy, in particular, recurrent TIP, ARVI during this pregnancy, ICI, gestational pyelonephritis, had a direct effect on frequency increase of premature termination of pregnancy and operative delivery in patients of the main group compared with women of the control group. The presence of a history of chronic female genital inflammatory diseases, sexually transmitted infections, ARVI during this pregnancy, TIP in the first and second trimesters, allows pregnant women to be at high risk of developing gestational complications in order to conduct timely treatment. Key words: pregnancy, the threat of abortion, childbirth, the condition of newborns.

An Exclusively Skewed Distribution of Pediatric Immune Reconstitution Inflammatory Syndrome Toward the Female Sex Is Associated With Advanced Acquired Immune Deficiency Syndrome.

In human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS) patients with very low CD4 cell counts, there is a temporal relationship between administration of antiretroviral therapy (ART) and an increased inflammatory response state known as the immune reconstitution inflammatory syndrome (IRIS). The predominant clinical presentation of IRIS is an infectious disease that can be life-threatening. IRIS-related infectious events are distributed similarly between adult males and females, albeit a few studies have shown a skewing toward the male sex in pediatric IRIS. Here, we assessed sex-specific differences in the causes and extent of IRIS infectious events in HIV-infected pediatric patients on ART. We carried out a prospective clinical analysis (from 2000 to 2018) of IRIS-related infectious events after ART in a cohort of 82 Brazilian children and adolescents infected with HIV-1 through mother-to-child transmission as well as a comprehensive cross-referencing with public records on IRIS-related infectious causes in pediatric HIV/AIDS. Twelve events fulfilling the criteria of IRIS occurred exclusively in 11 females in our cohort. The median age at IRIS events was 3.6 years. The infectious causes included Mycobacterium bovis, varicella-zoster virus, molluscum contagiosum virus, human papillomavirus, cytomegalovirus, and Mycobacterium tuberculosis. In one female, there was regional bacillus Calmette-Guérin dissemination and cytomegalovirus esophagitis. There was complete health recovery after 10 IRIS events without the use of corticosteroids or ART interruption. One case of IRIS-associated miliary tuberculosis was fatal. The biological female sex was a significant risk factor for IRIS events (odds ratio: 23.67; 95% confidence interval 95%: 1.341–417.7; P = 0.0016 and P < 0.01 by the multivariable analysis). We observed an effect of the advanced HIV/AIDS variable in IRIS females as compared with non-IRIS females (mean CD4+ T cell percentage 13.36 vs. 18.63%; P = 0.0489 and P < 0.05 by the multivariable analysis), underpinning the exclusively skewed distribution toward the female sex of this cohort. Moreover, the IRIS females in our cohort had higher mean CD4+ T cell percentages before (13.36%) and after IRIS (26.56%) than those of the IRIS females (before IRIS, 4.978%; after IRIS, 13.81%) in previous studies conducted worldwide. The exclusively skewed distribution of pediatric IRIS toward the female sex in the cohort was not linked to preferential X-chromosome inactivation rates. We concluded that the exclusively skewed distribution of pediatric IRIS toward females is associated with more advanced AIDS.

Outcome of the modified Lapidus procedure for hallux valgus deformity during the first year following surgery: A prospective clinical and gait analysis study

BackgroundThe modified Lapidus procedure is a surgical option to treat moderate to severe hallux valgus deformity with good radio-clinical outcome. However, comprehensive biomechanical outcome evaluation of this surgery at mid-term follow-up is missing. This study assesses and compares the radio-clinical and gait outcome at 6 and 12 months following modified Lapidus procedure. MethodTen consecutive female patients with moderate to severe hallux valgus who underwent modified Lapidus procedure participated in the study. Comprehensive gait assessment was performed preoperatively, at 6 and 12 months postoperatively. Gait parameters including spatiotemporal, kinematics and plantar pressure were analyzed using pressure insoles and 3-dimensional inertial sensors. Outcome was evaluated using two clinical questionnaires, i.e. the American Orthopaedic Foot and Ankle Score and the Foot and Ankle Ability Measure, and X-rays. FindingsThree spatiotemporal, two kinematics, and seven plantar pressure parameters significantly improved between 6 months and 12 months postoperatively. Significant improvement in radiological and clinical outcome was reported at 6 and 12 months. The Foot and Ankle Ability Measure showed non-significant improvement at 12 months. InterpretationThe outcome of this study is consistent with the previously reported good clinical and radiological results at one year following Lapidus for moderate to severe hallux valgus. Twelve gait parameters demonstrated that outcome improves from 6 months to 12 months postoperative with room for further improvement at long term. The gait outcome in this study confirms the longer rehabilitation period following modified Lapidus procedure. Studies with a larger sample size are required to confirm these findings.

Brief Overview: Assessment of Compound-induced Acute Kidney Injury Using Animal Models, Biomarkers, and In Vitro Platforms.

The inability to unequivocally predict translatable drug-induced kidney injury in nonclinical studies during pharmacological development is evidenced by drug attrition in human clinical trials. Eight urinary proteins have been qualified as renal safety biomarkers for limited context of use in nonclinical drug development studies in rats. Formal qualification of human renal safety biomarkers is pending the submission of data from prospective clinical trials and analyses of biomarker performance to the Food and Drug Administration and European Medicines Agency by the Foundation for the National Institutes of Health and Predictive Safety Testing Consortium's Nephrotoxicity Working Group. In vitro kidney platforms may be leveraged to investigate the potential risk of compound-induced acute kidney injury and/or dysfunction. The early assessment of drug-related kidney safety profiles using biomarker-level changes in animal models and in vitro platforms could significantly reduce renal safety-related drug attrition; yet, there are no well-validated in vitro systems to enable comprehensive investigations of compound-induced nephrotoxicity. Thus, histopathology remains the gold standard for diagnosing nephron-specific damage. Traditional and emerging biomarker panels should be combined with histopathology and/or cytopathology to enable early identification of compound-induced kidney injury.

A prospective clinical, cost and environmental analysis of a clinician-led virtual urology clinic.

A virtual clinic is a form of telemedicine where contact between clinical teams and patients occur without face-to-face consultation. Our study aims to quantify the clinical, financial and environmental benefits of our virtual urology clinic. We collected data prospectively from our weekly follow-up virtual clinic over a continuous four-month period between July and September 2017. In total, we reviewed 409 patients. Following virtual clinic consultation, 68.5% of our patients were discharged from further follow-up. The majority of our patients (male 57.7%, female 55.5%) were of working age. The satisfaction scores were high, at 90.1%, and there were no reported adverse events as a result of using the virtual clinic. Our calculated cost savings were £18,744, with a predicted 12-month cost saving of £56,232. The creation of additional face-to-face clinic capacity has created an estimated 12-month increase in tariff generation for our unit of £72,072. In total, 4623 travel miles were avoided by patients using the virtual clinic, with an estimated avoided carbon footprint of 0.35-1.45 metric tonnes of CO2e, depending on mode of transport. Our predicted 12-month avoided carbon footprint is 1.04-4.04 metric tonnes of CO2e. Our virtual clinic model has demonstrated a trifecta of positive outcomes, namely, clinical, financial and environmental benefits. The environmental importance and benefits of a virtual clinic should be promoted as a social enterprise value when engaging stakeholders in setting up such a urological service. We propose the adoption of our virtual clinic model in those urological units considering this method of telemedicine.

A Novel Suture Button Construct for Acute Ankle Syndesmotic Injuries; A Prospective Clinical and Radiological Analysis.

The importance of the syndesmosis in ankle stability is well recognized. Numerous means of fixation have been described for syndesmotic injuries including the suture button technique. Significant cost limits the use the commercially available options. We, therefore, designed a cheap and readily available alternative construct. We aim to assess the results of using a novel suture-button construct in treatment of syndesmotic ankle injuries. Fifty-two patients (34 males and 18 females) fulfilled our inclusion/exclusion criteria. Five patients were lost to follow-up. The remaining 47 patients were successfully followed up for a minimum of 24 months. The pre and post-surgery American Orthopedic Foot and Ankle Society scores (AOFAS) together with reported complications and post-operative radiological analysis were assessed. In this innovative construct, we utilized polyester braided surgical sutures jointly with double mini two- holed plates, a No.2 polygalactin 910 suture, a 4 mm drill bit, together with a 15 cm long suture needle with slotted end. This technique was supported with the use of the image intensifier. The AOFAS score improved significantly from a mean of 32.4 to 94.2 (P<0.004). Radiologically, the medial clear space (MCS), tibio-fibular clear space (TFCS) (P=0.05) and tibio-fibular overlap (TFO) measurements showed a significant improvement postoperatively (P=0.02). Patients reported good satisfaction rates with a 96% success rate (95% CI: 94.0% to 99.3%). We have observed that this low cost suture button construct is a simple, safe and cost effective treatment option for acute syndesmotic injuries.

The rationale of critical view of safety in laparoscopic cholecystectomyA study done in Al Diwanyia teaching hospital

Laparoscopic cholecystectomy (LC) has become the standard method for the removal of a diseased gallbladder. The technique most commonly employed is the infundibular approach which entails dissecting the gallbladder (GB) from its neck upward, after dissecting the cystic artery and cystic duct using laser or electrocautery. Common bile duct (CBD) injury is one of the most serious complications of LC. misidentification of the bile duct during dissection of the Calot's triangle can lead to such injuries. The critical view of safety (CVS) has been recently discussed in controlled study, it is characterized by dissection of the upper part of the Calot's space, which does not usually contain arterial or biliary anomalies so it is ideal for a safe dissection even in less experienced hands2. This study was amid to introduce a safe method for dissection of the GB away from CBD which forms one boarder in the Calot's triangle. This Prospective clinical analysis of 1000 cases of LC was utilizing the CVS technique over a period from January 2014 to January 2017 was conducted at Al-Diwanyia Teaching Hospital Laparscopic Center.The diagnosis of acute cholecystitis, chronic cholecystitis and cholilithiasis was established with history, physical examination, and ultrasound examination. The patients were categorized for sex, age, operating time and post operative There were 270 (27%) LC for (acute cholecystitis) and 730 (73%) LC for (chronic cholecystitis and cholilithiasis). There were minor significant complications when compared with CBD injuries complications, with short operating time (mean time for operation in our study35.9 minutes). Critical view of safety (CVS) seems to be a safe method of dissection that clearly demonstrating the cystic duct and help to reduce the bile duct injuries.&#x0D;