Development of a Single Vial Mass Flow Rate Monitor to Assess Pharmaceutical Freeze Drying Heterogeneity.

During pharmaceutical lyophilization processes, inter-vial drying heterogeneity remains a significant obstacle. Due to differences in heat and mass transfer based on vial position within the freeze drier, edge vials freeze differently, are typically warmer and dry faster than center vials. This vial position-dependent heterogeneity within the freeze dryer leads to tradeoffs during process development.

Associations of seasonally available global positioning systems-derived walkability and objectively measured sleep in the Nurses' Health Study 3 Mobile Health Substudy.

Background: Sleep is influenced by the environments that we experience while awake and while asleep. Neighborhood walkability has been linked with chronic disease and lifestyle factors, such as physical activity; however, evidence for the association between walkability and sleep is mixed. Extant studies assign walkability based on residential addresses, which does not account for mobility.

Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial.

Background And Aims: Performing a high-quality colonoscopy is critical for optimizing the adenoma detection rate (ADR). Colonoscopy withdrawal time (a surrogate measure) of ≥6 minutes is recommended; however, a threshold of a high-quality withdrawal and its impact on ADR are not known.

Methods: We examined withdrawal time (excluding polyp resection and bowel cleaning time) of subjects undergoing screening and/or surveillance colonoscopy in a prospective, multicenter, randomized controlled trial.

Safety of same-day discharge after peroral endoscopic myotomy.

There are limited data on the safety of same-day discharge (SDD) after peroral endoscopic myotomy (POEM). The aim of our study is to assess the frequency and relationship to POEM for emergency department (ED) visits and hospitalizations after SDD in these patients. We retrospectively identified consecutive patients between November 2019 and August 2021 who underwent POEM with SDD and at least 6 months follow-up.

Ensemble Models for Tick Vectors: Standard Surveys Compared with Convenience Samples.

Ensembles of Species Distribution Models (SDMs) represent the geographic ranges of pathogen vectors by combining alternative analytical approaches and merging information on vector occurrences with more extensive environmental data. Biased collection data impact SDMs, regardless of the target species, but no studies have compared the differences in the distributions predicted by the ensemble models when different sampling frameworks are used for the same species. We compared Ensemble SDMs for two important Ixodid tick vectors, and in mainland Florida, USA, when inputs were either convenience samples of ticks, or collections obtained using the standard protocols promulgated by the U.

Retrospective, observational, cross-sectional study of detection of recurrent Barrett's esophagus and dysplasia in post-ablation patients with adjunctive use of wide-area transepithelial sample (WATS-3D).

Background: Barrett's esophagus (BE) and dysplasia are often missed by Seattle protocol biopsies (SPB). Wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS-3D) with SPB improves detection in treatment-naïve patients. We aimed to determine to what extent WATS-3D adds to SPB in the detection of non-dysplastic BE (NDBE) and dysplasia in patients undergoing post-endoscopic eradication therapy (EET).

Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy.

Introduction: There are limited data correlating symptoms with reflux episodes during pH studies after peroral endoscopic myotomy.

Methods: Consecutive patients who underwent POEM followed up ≥6 months later by 48-hour ambulatory wireless pH testing off antisecretory therapy were identified. Reflux symptom association was defined as symptom association probability >95%.

Prothrombin G20210A Gene Mutation-Induced Recurrent Deep Vein Thrombosis and Pulmonary Embolism: Case Report and Literature Review.

Inherited thrombophilia is an important cause of venous thrombosis. The Factor V Leiden (FVL) is the most commonly encountered mutation, followed by the prothrombin G20210A gene mutation (PTM). The typical venous thrombotic events (VTEs) associated with PTM mutations are deep vein thrombosis (DVT) and pulmonary embolisms (PE).

High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial.

Background And Aims: Mucosal exposure devices including distal attachments such as the cuff and cap have shown variable results in improving adenoma detection rate (ADR) compared with high-definition white light colonoscopy (HDWLE).

Methods: We performed a prospective, multicenter randomized controlled trial in patients undergoing screening or surveillance colonoscopy comparing HDWLE to 2 different types of distal attachments: cuff (CF) (Endocuff Vision) or cap (CP) (Reveal). The primary outcome was ADR.

Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy.

Background And Aims: Outcomes after peroral endoscopic myotomy (POEM) are assessed clinically by the Eckardt score (ES) or objectively by high-resolution manometry (HRM) and functional lumen imaging probe (FLIP). This study compared HRM and FLIP to evaluate clinical response after POEM.

Methods: This was a single tertiary center retrospective study of consecutive patients who underwent POEM for treatment-naive achalasia and with ≥6 months of follow-up.

A Compact Model for Lyophilizer Equipment Capability Estimation.

This work presents a compact model for the equipment capability limit of a common configuration of pharmaceutical lyophilizers, a product chamber separated from the condenser by a duct and isolation valve, at a wide range of design parameters. The equipment capability limit is one of the most important characteristics determining the lyophilization design space for a particular product, container, and equipment combination. Experimental measurements of equipment capability are time-consuming and expensive, especially at the production scale.

Evaluation of timed barium esophagram after per-oral endoscopic myotomy to predict clinical response.

 The aim of this study was to evaluate whether timed barium esophagram within 24 hours post-per-oral endoscopic myotomy (POEM) (TBE-PP) could predict clinical outcomes.  This was a single-center retrospective study of prospectively collected data on consecutive patients with ≥ 6-month follow-up who underwent POEM followed by TBE-PP. Esophageal contrast retention 2 minutes after TBE-PP was assessed as Grade 1 (< 10 %), 2 (10 %-49 %), 3 (50 %-89 %) or 4 (> 90 %).

A Software Tool for Lyophilization Primary Drying Process Development and Scale-up Including Process Heterogeneity, I: Laboratory-Scale Model Testing.

Freeze-drying is a deceptively complex operation requiring sophisticated design of a robust and efficient process that includes understanding and planning for heterogeneity across the batch and shifts in parameters due to vial or lyophilizer changes. A software tool has been designed to assist in process development and scale-up based on a model that includes consideration of the process heterogeneity. Two drug formulations were used to test the ability of the new tool to develop a freeze-drying cycle and correctly predict product temperatures and drying times.

5q Deletion Myelodysplastic Syndrome in a Young Male Patient.

Myelodysplastic syndromes (MDS) are a diverse group of hematopoietic stem cell malignancies with various phenotypic variability that are categorized by abnormal differentiation of one or multiple cell lines of the bone marrow. A large part of the phenotypic heterogeneity is in part due to the wide set of genetic defects related to MDS. Though clinically, MDS is centered on diagnostic measures that do not incorporate molecular genetic data, an isolated deletion of the long arm of chromosome 5 (del(5q)) is the only subset of MDS to be identified by genetic defects.

Non-Articular Felty Syndrome Refractory to Granulocyte Colony-Stimulating Factor Therapy.

Felty syndrome (FS), an uncommon manifestation seen in patients with rheumatoid arthritis (RA), usually presents as a triad of erosive arthritis, splenomegaly, and neutropenia. It is extremely rare for RA to present as FS or develop after initially presenting as neutropenia and splenomegaly. In this report, we describe a case of a 55-year-old woman who initially presented with fever and vaginal pain.

Reactive Thrombocytosis after Splenectomy in Hereditary Spherocytosis: Case Report and Literature Review.

Unlabelled: Reactive thrombocytosis after splenectomy is a feared cause of thrombosis throughout the arterial and venous system. There are many causes of splenomegaly, ranging from cirrhosis to lymphoma to hereditary spherocytosis. In this report, we will discuss a case of reactive thrombocytosis after splenectomy in a patient with hereditary spherocytosis.

The role of female endoscopists: are women gastroenterologists better at obtaining biopsies for celiac disease than men?

Objectives: Celiac disease (CD) is commonly found in women. Given the sex differences in diagnosed patients, we hypothesized sex differences in physicians obtaining biopsies for CD may exist.

Materials And Methods: We retrospectively reviewed duodenal biopsies for suspected CD excluding pre-existing CD patients.

Validating Species Distribution Models With Standardized Surveys for Ixodid Ticks in Mainland Florida.

Tick-borne pathogens are of growing concern. The U.S.

Seroprevalence of Old World Hantaviruses and Crimean Congo Hemorrhagic Fever Viruses in Human Populations in Northwestern Ukraine.

In Ukraine, a retrospective review of clinical case reports by public health officials suggest that human cases of febrile illnesses associated with hemorrhage may be due to infections of Crimean-Congo hemorrhagic fever virus (CCHFV) and Old World hantaviruses. In a serosurvey of 966 healthy individuals in the Lviv Oblast, Ukraine, bordering Poland, we found that 1.6% showed cross-reactivity to hantaviral antigens by an immunofluorescence assay (IFA) and 1.

Standardized Ixodid Tick Survey in Mainland Florida.

A statewide survey of questing ixodid ticks in mainland Florida was developed consistent with U.S. CDC standards to maximize the amount of epidemiologic and environmental data gathered.

A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial.

Background And Aims: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing.

Methods: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE.

Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial.

Background And Aims: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring-fitted cap (EndoRings; EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy.

A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video).

Background And Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent.