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070) or the IDCs (p = 0.447). When considering all laceration types the EDS was correct for 21 (5.9%) lacerations that were incorrect according to the IDCs. Overall, the EDS was more accurate (p < 0.05) owing to errors in IDC minor laceration diagnoses. Electronic medical record delivery summary data and EMR-derived diagnostic codes similarly characterize OASI. The EDS does not improve OASI reporting, but may be more accurate when considering all perineal lacerations. This assumes that providers have correctly identified and categorized the lacerations that they record in the EMR. Electronic medical record delivery summary data and EMR-derived diagnostic codes similarly characterize OASI. The EDS does not improve OASI reporting, but may be more accurate when considering all perineal lacerations. This assumes that providers have correctly identified and categorized the lacerations that they record in the EMR. To describe the knowledge and perceptions of obstetric fistula (OF) among affected and unaffected women. Twenty-five semi-structured interviews were conducted with women who had received OF repair. Three focus groups were conducted one group of women with urinary incontinence but no OF, one group of women with OF, and one group of women without genitourinary complaints. Interviews and focus groups were conducted using the grounded theory approach. This study took place in two urban hospitals in Rwanda from April to November 2015. Transcripts were coded using MAXDA11 and analyzed using the axial technique and the constant comparative method. Nearly all participants correctly described OF and its symptoms, and 93% of interviewed women attributed OF to complications in vaginal delivery or cesarean section. Several participants described renouncing stigmatizing beliefs after learning about OF from the radio, health workers, or word of mouth. Still, it was found that women with OF were more knowledgeable about OF etiology than women without genitourinary conditions. Compared to prior studies, women's knowledge about OF appears to be more medically based, with media and health workers playing a role in reducing stigmatizing beliefs. These findings support continued investment in OF awareness campaigns, which seem to be increasing knowledge about OF and reducing stigma. Compared to prior studies, women's knowledge about OF appears to be more medically based, with media and health workers playing a role in reducing stigmatizing beliefs. These findings support continued investment in OF awareness campaigns, which seem to be increasing knowledge about OF and reducing stigma. Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that requires multimodal management. https://www.selleckchem.com/products/ins018-055-ism001-055.html The American Urologic Association includes sacral neuromodulation in the treatment algorithm for refractory IC/BPS. We sought to determine the rate of overall symptom improvement of IC/BPS symptoms, using validated measures, after treatment with percutaneous tibial nerve stimulation (PTNS), a form of peripheral neuromodulation. This was a single-arm, dual-center, pilot study examining a standard PTNS protocol in subjects with IC/BPS. Our primary outcome was subject response of "moderately" or "markedly improved" on the Global Response Assessment (GRA) scale after 12-weekly PTNS sessions. Assuming a 60% response rate, 24 subjects were needed to detect a response rate between 40 and 80% with 95% confidence. Secondary objectives included change in urinary frequency on a 24-h bladder diary, bladder pain as measured by VAS and responses to validated questionnaires for pelvic pain and IC/BPS. Of 21 subjects enrolled, 16 initiated and 10 completed the PTNS treatment course. The GRA response rate was 40% at week 6 and 30% at week 12. Seventy percent of the cohort had some degree of improvement. There were no adverse events. While only a minority of subjects with IC/BPS were responders to PTNS per GRA criteria, 70% of the cohort had some degree of improvement. Due to low recruitment and loss to follow-up, we did not achieve our predetermined significance. However, our promising findings add to the limited literature on this subject. While only a minority of subjects with IC/BPS were responders to PTNS per GRA criteria, 70% of the cohort had some degree of improvement. Due to low recruitment and loss to follow-up, we did not achieve our predetermined significance. However, our promising findings add to the limited literature on this subject. Pegfilgrastim-cbqv was developed as a biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor approved for decreasing febrile neutropenia-associated infection in patients receiving myelosuppressive drugs. This multicenter, randomized, single-blind, partial-reference-replicated, three-sequence crossover study assessed pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects. One hundred twenty-two subjects were randomized to one of three treatment sequences; each included one dose of pegfilgrastim-cbqv and two doses of pegfilgrastim separated by ≥ 28days. The primary pharmacokinetic end points were area under the curve (AUC) from 0 to infinity (AUC ) and maximum concentration (C ). The primary pharmacodynamic end points were maximum absolute neutrophil count (ANC ) and ANC AUC from time 0 to the last measurable observation (ANC AUC ). Pharmacokinetic and pharmacodynamic bioequivalences were demonstrated if the 90% CI for the geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim was within 80-125% for the primary end points. Pharmacokinetic bioequivalence criteria were met for C (GMR 105.0; 90% CI 95.5-115.4) and AUC (GMR 97.5; 90% CI 88.6-107.2). Pharmacodynamic bioequivalence criteria were met for ANC (GMR 99.6; 90% CI 96.2-103.2) and ANC AUC (GMR 96.7; 90% CI 92.2-101.4). Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigators found no drug-related serious adverse events. This study established pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv to pegfilgrastim. The treatments displayed similar safety profiles, including immunogenicity, with no unexpected safety findings. ClinicalTrials.gov, NCT02650973, February 2016. ClinicalTrials.gov, NCT02650973, February 2016.
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