: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and skin test reagent as a novel adjuvant.: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 μg per peptide). : The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 μg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations ( = 0.02). : This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that which induces interleukin-12 (IL-12) , may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.
BackgroundThe Department of Obstetrics and Gynecology (OB/GYN) at the University of Arkansas for Medical Sciences (UAMS) tested various, new system-restructuring ideas such as varying number of different types of nurses to reduce patient wait times for its outpatient clinic, often with little or no effect on waiting time. Witnessing little progress despite these time-intensive interventions, we sought an alternative way to intervene the clinic without affecting the normal clinic operations.AimThe aim is to identify the optimal (1) time duration between appointments and (2) number of nurses to reduce wait time of patients in the clinic.MethodsWe developed a discrete-event computer simulation model for the OB/GYN clinic. By using the patient tracker (PT) data, appropriate probability distributions of service times of staff were fitted to model different variability in staff service times. These distributions were used to fine-tune the simulation model. We then validated the model by comparing the simulated wait times with the actual wait times calculated from the PT data. The validated model was then used to carry out “what-if” analyses.ResultsThe best scenario yielded 16 min between morning appointments, 19 min between afternoon appointments, and addition of one medical assistant. Besides removing all peak wait times and bottlenecks around noon and late in the afternoon, the best scenario yielded 39.84 % (p<.001), 30.31 % (p<.001), and 15.12 % (p<.001) improvement in patients’ average wait times for providers in the exam rooms, average total wait time at various locations and average total spent time in the clinic, respectively. This is achieved without any compromise in the utilization of the staff and in serving all patients by 5pm.ConclusionsA discrete-event simulation model is developed, validated, and used to carry out “what-if” scenarios to identify the optimal time between appointments and number of nurses. Using the model, we achieved a significant improvement in wait time of patients in the clinic, which the clinic management initially had difficulty achieving through manual interventions. The model provides a tool for the clinic management to test new ideas to improve the performance of other UAMS OB/GYN clinics.
A case of an advanced abdominal pregnancy diagnosed by ultrasound and magnetic resonance imaging (MRI) at 21 weeks' gestation is presented. The complementary roles of ultrasound and MRI in achieving accurate diagnosis and the role of ultrasound in ongoing pregnancy assessment are emphasized.
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