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Stem cell therapy (SCT) is used for regeneration of injured tissues. This seems a novel promising strategy for restoring urethral sphincter function in patients with stress urinary incontinence (SUI).
To summarize the clinical trials available to date on SCT for treatment of SUI in women.
PubMed, Cochrane Library, Scopus and Embase.
Prospective interventional case series, randomized prospective interventional study and prospective cohort study assessing women aged 18years and over diagnosed with SUI and treated by SCT were included. The quality of studies was finally assessed using the JBI Critical Appraisal Checklists according to the PRISMA guidelines.
Nineteen studies (n=773 patients) were selected for final analysis. These were conducted worldwide between the years 2005 and 2016. Although different cell types were used, general processing steps were similar. The follow-up period ranged between 6weeks and 6years and included common subjective and objective evaluation tools.
Overall, the studies imply that SCT for treatment of SUI is a safe and effective treatment.
In our opinion, the initial results of SCT for the treatment of SUI seem promising. Standardization and validation of this treatment modality is required before it can be recommended for routine use.
In our opinion, the initial results of SCT for the treatment of SUI seem promising. Standardization and validation of this treatment modality is required before it can be recommended for routine use.The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA) reviewers. Yet, of the 116 pivotal trials supporting Breakthrough-designated drugs approved 2013-2018, 96 (83%) were already underway or completed when the designation was granted, limiting the potential of the designation to influence trial design. We found no difference between these trials and the 20 (17%) that had not yet begun when the designation was granted (which had greater potential to be impacted by the designation) with respect to phase, size, intervention model (single-arm vs. multi-arm), or use of surrogate end points under the Accelerated Approval (AA) pathway. This finding suggests that, in contrast to previous studies, observed trial characteristics were not likely attributable to the designation, and instead other factors such as disease category (e.g., oncology) may be driving both trial design and Breakthrough designation. The 20 trials in our sample that began after designation was granted were, however, over 8 months shorter than trials of nondesignated drugs. This suggests that designations granted early in clinical development may reduce trial time by influencing aspects of clinical programs other than design characteristics, such as timelines for FDA responses. Alternately, certain drugs may be more likely to both receive an early designation and have a shorter trial duration, for example, because of therapeutic category or large effect size.The absolute abundance of bacterial taxa in human host-associated environments plays a critical role in reproductive and gastrointestinal health. However, obtaining the absolute abundance of many bacterial species is typically prohibitively expensive. In contrast, relative abundance data for many species are comparatively cheap and easy to collect (e.g., with universal primers for the 16S rRNA gene). In this paper, we propose a method to jointly model relative abundance data for many taxa and absolute abundance data for a subset of taxa. Our method provides point and interval estimates for the absolute abundance of all taxa. Crucially, our proposal accounts for differences in the efficiency of taxon detection in the relative and absolute abundance data. We show that modeling taxon-specific efficiencies substantially reduces the estimation error for absolute abundance, and controls the coverage of interval estimators. We demonstrate the performance of our proposed method via a simulation study, a study of the effect of HIV acquisition on microbial abundances, and a sensitivity study where we jackknife the taxa with observed absolute abundances.Despite focus on prevention of needlestick injuries, intraoperative injuries involving suture needles have increased in the past two decades. When interruptions occur during surgery, a practitioner's focus is disengaged, creating an "error space;" re-engagement of the practitioner takes exponentially longer as each subsequent interruption occurs during the procedure. Human factors studies focus on the interaction between individuals and the environment in which they work (eg, processes, equipment). Researchers use a human factors approach to understand distractions during surgery. Using this methodology, wound closure is viewed as a standalone process and the effect of distractions and interruptions on suture needle injuries is examined. Competing priorities combined with interruptions present opportunities for altered situational awareness, which can lead to injury. This article redefines wound closure as a vulnerable time with great potential for error-a time during which distractions and interruptions can lead to suture needle injuries and other unexpected outcomes.A cochlear implant (CI) is used in the auditory rehabilitation of adult and pediatric patients with sensorineural hearing loss who do not benefit from conventional hearing aids. Perioperative nursing care of the patient with sensorineural hearing loss undergoing cochlear implantation is not extensively discussed in the literature. RBPJ Inhibitor-1 research buy Preoperative care involves managing the patient and family's expectations for the procedure and determining the most effective communication techniques for each patient. Postoperative care involves monitoring patients closely and identifying the signs and symptoms of a number of possible postoperative complications, as well as knowing how to prevent these complications and respond to them. Thorough patient and family discharge instructions are vital to a successful cochlear implantation result. This article provides perioperative nurses caring for patients receiving a CI with detailed information to help ensure that they provide these patients with the most appropriate and effective care.
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