Predicting Spray Dried Dispersion Particle Size Via Machine Learning Regression Methods.

Spray dried dispersion particle size is a critical quality attribute that impacts bioavailability and manufacturability of the spray drying process and final dosage form. Substantial experimentation has been required to relate formulation and process parameters to particle size with the results limited to a single active pharmaceutical ingredient (API). This is the first study that demonstrates prediction of particle size independent of API for a wide range of formulation and process parameters at pilot and commercial scale.

Extended Human Papillomavirus Genotyping to Predict Progression to High-Grade Cervical Precancer: A Prospective Cohort Study in the Southeastern United States.

Background: High-risk human papillomavirus (hrHPV) testing is utilized in primary cervical cancer screening, generally along with cytology, to triage abnormalities to colposcopy. Most screening-based hrHPV testing involves pooled detection of any hrHPV or of HPV16/18. Cervical neoplasia progression risks based on extended hrHPV genotyping-particularly non-16/18 hrHPV types-are not well characterized.

A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system.

Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture.

Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening.

Background: Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening.

Methods: We recruited women ages 25-65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women.

Racial and Ethnic Differences in Acceptability of Urine and Cervico-Vaginal Sample Self-Collection for HPV-Based Cervical Cancer Screening.

We compared women's acceptability of urine and cervico-vaginal sample self-collection for high-risk (oncogenic) human papillomavirus (hrHPV) testing and assessed whether acceptability varied across racial/ethnic groups. As part of a test accuracy study of urine-based hrHPV testing, we recruited a convenience sample of women 25-65 years of age at two colposcopy clinics in North Carolina between November 2016 and January 2019. After self-collection of urine and cervico-vaginal samples, women completed a questionnaire on the acceptability of the sample collection methods.

Feasibility of spectral pH measurement during the low-pH virus inactivation step of continuous therapeutic antibody production.

Acidic virus inactivation is commonly used during production of biotherapeutic products to provide virus safety in case of undetected virus contamination. Accurate pH measurement is required to ensure the product pH reaches a virus-inactivating level (typically 3.5-3.

Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia.

The objective was to assess the diagnostic test accuracy of high-risk human papillomavirus (hrHPV) testing of self-collected urine and cervicovaginal samples for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). We recruited a convenience sample of women 25 to 65 years of age who were undergoing clinically indicated colposcopy at two medical centers in North Carolina between November 2016 and January 2019. Women with normal cytology results and positive hrHPV results were also recruited.

Impact of slope on dynamics of running and climbing.

By combining biological studies and modeling work, the dynamics of running on horizontal terrain and climbing pure vertical surfaces have been distilled down to simple reduced order models. These models have inspired distinct control and design considerations for robots operating in each terrain. However, while the extremes are understood, the intermediate regions of moderate slopes have yet to be fully explored.

Forecasting and control of lactate bifurcation in Chinese hamster ovary cell culture processes.

Biomanufacturing exhibits inherent variability that can lead to variation in performance attributes and batch failure. To help ensure process consistency and product quality the development of predictive models and integrated control strategies is a promising approach. In this study, a feedback controller was developed to limit excessive lactate production, a widespread metabolic phenomenon that is negatively associated with culture performance and product quality.

Using fetal scalp stimulation with Doppler ultrasonography to enhance intermittent auscultation in low-resource settings: a diagnostic trial from Tanzania.

Background: Hypoxia during labor contributes to 2.2 million intrapartum and early neonatal deaths each year. An additional 0.

Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope.

Goal: In this paper, we propose methods for (1) automatic feature extraction and classification for acetic acid and Lugol's iodine cervigrams and (2) methods for combining features/diagnosis of different contrasts in cervigrams for improved performance.

Methods: We developed algorithms to pre-process pathology-labeled cervigrams and extract simple but powerful color and textural-based features. The features were used to train a support vector machine model to classify cervigrams based on corresponding pathology for visual inspection with acetic acid, visual inspection with Lugol's iodine, and a combination of the two contrasts.

An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis.

Introduction: We have previously developed a portable Pocket Colposcope for cervical cancer screening in resource-limited settings. In this manuscript we report two different strategies (cross-polarization and an integrated reflector) to improve image contrast levels achieved with the Pocket Colposcope and evaluate the merits of each strategy compared to a standard-of-care digital colposcope. The desired outcomes included reduced specular reflection (glare), increased illumination beam pattern uniformity, and reduced electrical power budget.

A system identification approach for developing model predictive controllers of antibody quality attributes in cell culture processes.

As the biopharmaceutical industry evolves to include more diverse protein formats and processes, more robust control of Critical Quality Attributes (CQAs) is needed to maintain processing flexibility without compromising quality. Active control of CQAs has been demonstrated using model predictive control techniques, which allow development of processes which are robust against disturbances associated with raw material variability and other potentially flexible operating conditions. Wide adoption of model predictive control in biopharmaceutical cell culture processes has been hampered, however, in part due to the large amount of data and expertise required to make a predictive model of controlled CQAs, a requirement for model predictive control.

Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening.

Objective: Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

Objective: Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.

Materials And Methods: There were 2 protocols, which included 44 and 18 patients.

The Bakri tamponade balloon as an adjunct treatment for refractory postpartum hemorrhage.

Objective: To evaluate the Bakri tamponade balloon as an adjunct treatment for refractory postpartum hemorrhage (PPH).

Methods: A prospective observational intervention study was conducted between January 1, 2013, and May 31, 2015, at Great Lakes Hospital and Moi Teaching and Referral Hospital in Kenya. Eligible participants were diagnosed with PPH (blood loss >500mL after vaginal or >1000mL after cesarean delivery, and/or hemodynamic changes suggestive of excessive blood loss) unresponsive to standard intervention and were treated using the Bakri balloon.

Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings.

Introduction: Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost.

Global ratings of change do not accurately reflect functional change over time in clinical practice.

Study Design: Retrospective longitudinal cohort study.

Objectives: To determine whether the global rating of change (GROC) is valid for assessing functional change over time in the clinical setting, and whether validity decreases as length of recall increases.

Background: The validity of GROC instruments for representing change over time has been questioned.

Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale.

Study Design: Multicenter, prospective, longitudinal cohort study.

Objectives: To investigate the minimum important difference (MID) of the Patient-Specific Functional Scale (PSFS), 4 region-specific outcome measures, and the numeric pain rating scale (NPRS) across 3 levels of patient-perceived global rating of change in a clinical setting.

Background: The MID varies depending on the external anchor defining patient-perceived "importance.

Life balance and perceived stress: predictors and demographic profile.

This article explored differences in life balance scores between demographic groups and whether life balance predicted perceived stress. This research used secondary analysis of 1,048 subjects from a database for the Life Balance Inventory (LBI). Analysis of variance showed that the profile of people with the highest total life balance scores was: white, 61 years or older, earned a master's degree, had incomes between $81,000 and $100,000, lived in the suburbs, had two children (but the children were not at home), were not working (if working, they were self-employed), owned a home, and lived in the United States.

The Patient-Specific Functional Scale was valid for group-level change comparisons and between-group discrimination.

Objectives: To examine the validity of the Patient-Specific Functional Scale (PSFS) for the assessment of group-level change and between-group discrimination in group-level data.

Study Design And Setting: We collected complete baseline and follow-up PSFS data in 1,181 consecutive patients reporting to physical therapy with a musculoskeletal disorder. Physical function was assessed at the baseline and final physical therapy visits using the PSFS and four region-specific patient-reported outcome (PRO) measures: The Neck Disability Index, Oswestry Disability Index, Upper Extremity Functional Index, and Lower Extremity Functional Scale.

Patient global ratings of change did not adequately reflect change over time: a clinical cohort study.

Background: Global ratings of change (GROCs) are commonly used in research and clinical practice to determine which patients respond to therapy, but their validity as a criterion for change has not been firmly established. One factor related to their validity is the length of the recall period.

Objective: The study objective was to examine the influence of the length of the recall period on the validity of a GROC for determining true change over time in the clinical setting.