Cross Sectional Survey of Ob/Gyn Residents' Graduated Experience with Robotic Surgery.

Study Objective: Obstetrics and gynecology (Ob/Gyn) resident experience with robotic gynecologic surgery has been evaluated at time of graduation, but no specific surgical procedures were identified to differentiate the experiences of residents at each level. This study proposes to determine which factors are correlated with more hands-on robotic surgery experience and resident satisfaction.

Design: An Investigational Review Board-approved, 15-question survey was distributed electronically.

Decoupling Protein Concentration and Aggregate Content Using Diffusion and Water NMR.

Protein-based biopharmaceutical drugs, such as monoclonal antibodies, account for the majority of the best-selling drugs globally in recent years. For bioprocesses, key performance indicators are the concentration and aggregate level for the product being produced. In water NMR (NMR), the use of the water transverse relaxation rate [(HO)] has been previously used to determine protein concentration and aggregate level; however, it cannot be used to separate between them without using an additional technique.

Comprehensive Stress Stability Studies Reveal the Prominent Stability of the Liquid-Formulated Biotherapeutic Asymmetric Monovalent Bispecific IgG1 Monoclonal Antibody Format.

The developed asymmetric monovalent bispecific IgG1 or Duet monoclonal antibody (Duet mAb) has two distinct fragment antigen-binding region (Fab) subunits that target two different epitope specificities sequentially or simultaneously. The design features include unique engineered disulfide bridges, knob-into-hole mutations, and kappa and lambda chains to produce Duet mAbs. These make it structurally and functionally complex, so one expects challenging developability linked to instability, degradation of products and pathways, and limited reports available.

Identification and quantification of chain-pairing variants or mispaired species of asymmetric monovalent bispecific IgG1 monoclonal antibody format using reverse-phase polyphenyl chromatography coupled electrospray ionization mass spectrometry.

Developing a knob-into-hole asymmetric bispecific IgG1 monoclonal antibody (mAb) poses manufacturing challenges due to the expression of chain pairing variants, also called mispaired species, in the desired product. The incorrect pairing of light and heavy chains could result in heterogeneous mispaired species of homodimers, heterodimers, light chain swapping, and low molecular weight species (LMWS). Standard chromatography, capillary electrophoretic, or spectroscopic methods poorly resolve these from the main variants.

Enhanced harvest performance predictability through advanced multivariate data analysis of mammalian cell culture particle size distribution.

The industry's pursuit for higher antibody production has led to increased cell density cultures that impact the performance of subsequent product recovery steps. This increase in cell concentration has highlighted the critical role of solids concentration in centrifugation yield, while recent product degradation cases have shed light on the impact of cell lysis on product quality. Current methods for measuring solids concentration and cell lysis are not suited for early-stage high-throughput experimentation, which means that these cell culture outputs are not well characterized in early process development.

Next-generation cell line selection methodology leveraging data lakes, natural language generation and advanced data analytics.

Cell line development is an essential stage in biopharmaceutical development that often lies on the critical path. Failure to fully characterise the lead clone during initial screening can lead to lengthy project delays during scale-up, which can potentially compromise commercial manufacturing success. In this study, we propose a novel cell line development methodology, referenced as , which involves four steps enabling autonomous data-driven selection of the lead clone.

Abortion Stigma and Its Relationship with Grief, Post-traumatic Stress, and Mental Health-Related Quality of Life After Abortion for Fetal Anomalies.

Background: Despite the prevalence of abortion stigma in the United States, few studies have examined the relationship between stigma and psychological well-being postabortion among women who undergo abortion for fetal anomalies.

Materials And Methods: We conducted a cross-sectional study of women who underwent second-trimester abortion for pregnancy complications to assess the association between abortion stigma and psychological outcomes. We asked women to retrospectively report self-judgment and perceived community condemnation at the time of their abortion and evaluated present-day grief, post-traumatic stress, and self-reported mental health.

Data integrity within the biopharmaceutical sector in the era of Industry 4.0.

Data Integrity (DI) in the highly regulated biopharmaceutical sector is of paramount importance to ensure decisions on meeting product specifications are accurate and hence assure patient safety and product quality. The challenge of ensuring DI within this sector is becoming more complex with the growing amount of data generated given increasing adoption of process analytical technology (PAT), advanced automation, high throughput microscale studies, and managing data models created by machine learning (ML) tools. This paper aims to identify DI risks and mitigation strategies in biopharmaceutical manufacturing facilities as the sector moves towards Industry 4.

A decade in review: use of data analytics within the biopharmaceutical sector.

There are large amounts of data generated within the biopharmaceutical sector. Traditionally, data analysis methods labelled as multivariate data analysis have been the standard statistical technique applied to interrogate these complex data sets. However, more recently there has been a surge in the utilisation of a broader set of machine learning algorithms to further exploit these data.

Offering routine trichomonas vaginalis testing to patients presenting for abortion at an urban hospital-based clinic.

Introduction: The Centers for Disease Control and Prevention recommend considering screening asymptomatic women for trichomonas in high-prevalence settings. Whether urban abortion clinics constitute such a setting is unknown.

Material And Methods: We offered trichomonas screening to patients presenting for abortion from October 2018 to February 2019 as a practice improvement and conducted a chart review.

The impact of gravidity, symptomatology and timing of infection on placental malaria.

Background: Placental malaria is associated with increased risk of adverse perinatal outcomes. While primigravidity has been reported as a risk factor for placental malaria, little is known regarding the relationship between gravidity, symptomatology and timing of Plasmodium falciparum infection and the development of placental malaria.

Methods: The aim of this study was to investigate the relationship between the development of placental malaria and gravidity, timing of infection, and presence of symptoms.

Provider Practices and Young Women's Experiences with Provider Self-disclosure during Emergency Contraceptive Visits.

Background: Research on the impact of providers disclosing personal contraceptive experiences with patients is limited. In this study, we examine patient and provider perspectives about provider self-disclosure (PSD) of personal contraceptive experiences and its effects on contraceptive decision making and the provider-patient relationship.

Methods: We conducted 18 one-on-one telephone interviews with clinicians who provide contraceptive services to young women and 17 patients seeking emergency contraception from three Bay Area community-based, youth-friendly clinics regarding their contraceptive counseling practices and experiences, respectively.

Computer-Aided Strategies for Determining the Amino Acid Composition of Medium for Chinese Hamster Ovary Cell-Based Biomanufacturing Platforms.

Chinese hamster ovary (CHO) cells are used for the production of the majority of biopharmaceutical drugs, and thus have remained the standard industry host for the past three decades. The amino acid composition of the medium plays a key role in commercial scale biologics manufacturing, as amino acids constitute the building blocks of both endogenous and heterologous proteins, are involved in metabolic and non-metabolic pathways, and can act as main sources of nitrogen and carbon under certain conditions. As biomanufactured proteins become increasingly complex, the adoption of model-based approaches become ever more popular in complementing the challenging task of medium development.

Multivariate Data Analysis Methodology to Solve Data Challenges Related to Scale-Up Model Validation and Missing Data on a Micro-Bioreactor System.

Multivariate data analysis (MVDA) is a highly valuable and significantly underutilized resource in biomanufacturing. It offers the opportunity to enhance understanding and leverage useful information from complex high-dimensional data sets, recorded throughout all stages of therapeutic drug manufacture. To help standardize the application and promote this resource within the biopharmaceutical industry, this paper outlines a novel MVDA methodology describing the necessary steps for efficient and effective data analysis.

Correction to: Inequality and Innovation: Barriers and Facilitators to 17P Administration to Prevent Preterm Birth among Medicaid Participants.

The original version of this article unfortunately contained a mistake in the order of authors. The co-author "Sarah Benatar" should be the second author and "Brigette Courtot" should be the third author of the article.

Inequality and Innovation: Barriers and Facilitators to 17P Administration to Prevent Preterm Birth among Medicaid Participants.

Objectives Strategies to prevent preterm birth are limited. 17 Alpha-Hydroxyprogesterone Caproate (17P) injections have been shown to be effective, but the intervention is under-used. This mixed methods study investigates barriers and facilitators to 17P administration among Medicaid and CHIP participants enrolled in Strong Start for Mothers and Newborns, a federal preterm birth prevention program.

Facilitators and Barriers to Healthy Pregnancy Spacing among Medicaid Beneficiaries: Findings from the National Strong Start Initiative.

Background: Closely spaced, unintended pregnancies are common among Medicaid beneficiaries and create avoidable risks for women and infants, including preterm birth. The Strong Start for Mothers and Newborns Initiative, a program of the Center for Medicare and Medicaid Innovation, intended to prevent preterm birth through psychosocially based enhanced prenatal care in maternity care homes, group prenatal care, and birth centers. Comprehensive care offers the opportunity for education and family planning to promote healthy pregnancy spacing.

A Quality Improvement Project to Increase Early Detection of Syphilis Infection or Re-infection in HIV-infected Men Who Have Sex With Men.

Our quality improvement project evaluated whether testing for syphilis every 3 to 6 months with routine HIV laboratory monitoring had an effect on early detection of asymptomatic syphilis infection/re-infection in HIV-infected men who have sex with men. Retrospective analysis of syphilis testing and infections in a sample of this population (N = 245) was conducted after establishing a change-of-practice quality improvement initiative in a not-for-profit, community-based, grant-funded clinic. We compared the clinic's annual rates of syphilis before and after intervention implementation.

Gene transfection of HEK cells on supermacroporous polyacrylamide monoliths: a comparison of transient and stable recombinant protein expression in perfusion culture.

Transient and continuous recombinant protein expression by HEK cells was evaluated in a perfused monolithic bioreactor. Highly porous synthetic cryogel scaffolds (10 ml bed volume) were characterised by scanning electron microscopy and tested as cell substrates. Efficient seeding was achieved (94% inoculum retained, with 91-95% viability).

Immobilized metal affinity chromatography of histidine-tagged lentiviral vectors using monolithic adsorbents.

Histidine-tagged lentiviral vectors were separated from crude cell culture supernatant using labscale monolithic adsorbents by immobilized metal affinity chromatography. The capture capacity, concentration factor, purification factor, and elution efficiency of a supermacroporous cryogel monolith were evaluated against the BIA Separations convective interaction media (CIM) disc, which is a commercial macroporous monolith. The morphology of the polymeric cryogel material was characterised by scanning electron microscopy.

Efficacy and safety of two unfractionated heparin dosing strategies with tenecteplase in acute myocardial infarction (results from Assessment of the Safety and Efficacy of a New Thrombolytic Regimens 2 and 3).

We investigated the effect of smaller dose, weight-adjusted heparin with earlier monitoring of activated partial thromboplastin time on the incidence of ischemic and hemorrhagic complications in patients with ST-elevation myocardial infarction treated with full-dose tenecteplase. We compared the outcomes of patients enrolled in the Second Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT-2; n = 8,461) who received heparin stratified by weight (patients weighing >67 kg received a 5,000-U bolus plus infusion at 1,000 U/hour; those weighing < or =67 kg received a 4,000-U bolus plus infusion at 800 U/hour) with patients in ASSENT-3 who received weight-adjusted heparin (60-U/kg bolus, maximum 4,000 U/hour, followed by a 12-U/kg/hour infusion, maximum 1,000 U/hour). Compared with patients in ASSENT-2, those in ASSENT-3 had similar rates of 30-day mortality, recurrent infarction, and intracranial hemorrhage, less major bleeding (2.

Relation between hospital intra-aortic balloon counterpulsation volume and mortality in acute myocardial infarction complicated by cardiogenic shock.

Background: Increasing evidence suggests an inverse relationship between outcome and the total number of invasive cardiac procedures performed at a given hospital. The purpose of the present study was to determine if a similar relationship exists between the number of intra-aortic balloon counterpulsation (IABP) procedures performed at a given hospital per year and the in-hospital mortality rate of patients with acute myocardial infarction complicated by cardiogenic shock.

Methods And Results: We analyzed data of 12 730 patients at 750 hospitals enrolled in the National Registry of Myocardial Infarction 2 from 1994 to 1998.

Central retinal artery occlusion: a complication of the knee-chest position.

A rare complication of the knee-chest position used for lumbar disk surgery is reported. Central retinal artery occlusion resulted in permanent loss of vision secondary to direct ocular pressure. Prevention is the only rational treatment for this unfortunate condition.

Spinal cord compression in Scheuermann's kyphosis: case report.

Compression of the spinal cord secondary to disc disorders in Scheuermann's kyphosis is rare. This review reports an unusual case emphasizing mechanisms of compression of the spinal cord from this disc disorder. Contrasts and comparisons with previously published cases are included.