Calibrating Observational Health Record Data Against a Randomized Trial.

Importance: The conditions required for health record data sources to accurately assess treatment effectiveness remain unclear. Emulation of randomized clinical trials (RCTs) with health record data and subsequent calibration of the results can help elucidate this.

Objective: To pilot an emulation of the KEYNOTE-189 RCT using a commercially available electronic health record (EHR) data source.

The Effect of Process Parameters on the Microstructure, Stability, and Sensorial Properties of an Emulsion Cream Formulation.

A classical emulsion formulation based on petrolatum and mineral oil as the internal phase with emulsifier wax as a typical topical emulsion cream was investigated for the effect of process parameters on drug product quality and performance attributes. The Initial Design of Experiment (DoE) suggested that an oil phase above 15%, coupled with less than 10% emulsifying wax, resulted in less stable emulsions. Different processing parameters such as homogenization speed, duration, cooling rate, and final temperature showed minimal influence on properties and failed to improve stability.

A meta-analysis of efficacy and safety data from head-to-head first-line trials of epidermal growth factor receptor inhibitors versus bevacizumab in adult patients with RAS wild-type metastatic colorectal cancer by sidedness.

The first-line treatment choice of EGFRIs plus doublet chemotherapy vs. bevacizumab plus doublet chemotherapy remains a topic of interest for patients with left-sided RAS WT mCRC. We conducted a systematic literature review and meta-analysis of clinical trial data published between 2015 and 2024.

Potential of medicinal plants to ameliorate neovascularization activities in diabetes: A systematic review.

Hyperglycemia in diabetes mediates the release of angiogenic factors, oxidative stress, hypoxia, and inflammation, which in turn stimulate angiogenesis. Excessive angiogenesis can cause diabetic retinopathy, diabetic neuropathy, and diabetic nephropathy. All of these complications are debilitating, which may lead to an increased susceptibility to lower-limb amputations due to ulcerations and infections.

Influence of Manufacturing Process on the Microstructure, Stability, and Sensorial Properties of a Topical Ointment Formulation.

The manufacturing process for ointments typically involves a series of heating, cooling, and mixing steps. Precise control of the level of mixing through homogenization and the cooling rate, as well as temperature at different stages, is important in delivering ointments with the desired quality attributes, stability, and performance. In this work, we investigated the influence of typical plant processing conditions on the microstructure, stability, and sensorial properties of a model ointment system through a Design of Experiments (DoE) approach.

Real-world outcomes in patients with KRAS G12C-mutated advanced non-small cell lung cancer treated with docetaxel in second-line or beyond.

Introduction: The KRAS G12C mutation has recently become a druggable target in non-small cell lung cancer (NSCLC). In this observational study, we present real-world clinicopathological characteristics, treatment patterns, and survival outcomes data in patients with KRAS mutation-positive advanced NSCLC (aNSCLC), including those with KRAS G12C and KRAS non-G12C mutations, who received docetaxel as standard-of-care treatment in the second-line and beyond (2L+).

Methods: US-based electronic health record-derived de-identified databases were used to assess clinicopathological characteristics and outcomes in adult aNSCLC patients with KRAS mutations treated with 2L+ docetaxel between January 1, 2011, and March 31, 2021.

Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data.

Purpose: Evaluation of drug safety during pregnancy is dependent on the number of exposed women during routine clinical practice with data available for analysis. We examined medication fills in pregnant and nonpregnant women within select disease cohorts: general population, migraine, diabetes, and hyperlipidemia to explore the potential use of claims data to assess medication use and safety during pregnancy.

Methods: This cohort study, using IBM MarketScan® Research Databases claims data, included women 10-54 years of age with pregnancy resulting in a liveborn infant between January 2010 and September 2015 and matched nonpregnant women.

The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology.

Legislative and technological advancements over the past decade have given rise to the proliferation of healthcare data generated from routine clinical practice, often referred to as real-world data (RWD). These data have piqued the interest of healthcare stakeholders due to their potential utility in generating evidence to support clinical and regulatory decision making. In the oncology setting, studies leveraging RWD offer distinct advantages that are complementary to randomized controlled trials (RCTs).

A Patient with Myxoid/Round Cell Liposarcoma (MRCL) Involving the Well-known Translocation t(12;22): A Case Report with the Cytogenomic Landscape of this Rearrangement.

Myxoid/Round Cell Liposarcoma (MRCL) is characterized as a soft tissue sarcoma that is associated with unusual patterns of metastasis to extrapulmonary sites, such as bones and other soft tissue sites. Here, we present a case of a 48-year-old male patient, diagnosed with MRCL. The patient presented with a grade 1 myxoid liposarcoma in his left leg.

Real-World Study of Characteristics and Treatment Outcomes Among Patients with KRAS p.G12C-Mutated or Other KRAS Mutated Metastatic Colorectal Cancer.

Background: The KRAS p.G12C mutation has recently become an actionable drug target. To further understand KRAS p.

Comparative clinical evaluation of removable partial denture frameworks fabricated traditionally or with selective laser melting: A randomized controlled trial.

Statement Of Problem: The clinical efficacy of selective laser melting (SLM) for fabricating removable partial dentures (RPDs) is not well established.

Purpose: The purpose of this clinical study was to compare the performance of SLM-fabricated frameworks with that of those fabricated via traditional lost wax casting.

Material And Methods: A double-blind, randomized, crossover design was used to compare cobalt chromium partial denture frameworks (n=29) fabricated by using SLM or traditional methods.

Combining patient reported outcomes and EHR data to understand population level treatment needs: correcting for selection bias in the migraine signature study.

Background: Electronic health records (EHR) data can be used to understand population level quality of care especially when supplemented with patient reported data. However, survey non-response can result in biased population estimates. As a case study, we demonstrate that EHR and survey data can be combined to estimate primary care population prescription treatment status for migraine stratified by migraine disability, without and with adjustment for survey non-response bias.

Risk for ischemic stroke and coronary heart disease associated with migraine and migraine medication among older adults.

Background: Migraine has been associated with cardiovascular disease (CVD) events among middle-aged adults. The objective of this study was to determine the risk for ischemic stroke and coronary heart disease (CHD) events among older adults with versus without migraine.

Methods: This retrospective cohort study was conducted using data from US adults ≥66 years of age with Medicare health insurance between 2008 and 2017.

Management of Cervical Ectopic Pregnancies: A Scoping Review.

Objective: To investigate published cases of cervical ectopic pregnancy between 2000 and 2018 and compare management strategies and treatment success rates based on initial patient characteristics.

Methods: PubMed, EMBASE, and Web of Science were searched to capture peer-reviewed citations published between 2000 and 2018. Cases reporting either β-hCG level, crown-rump length, or gestational sac diameter for each individual patient were included.

An Idic(7)(q11.2) Resulting in Two Copies of 7p and Deletion 7q: A Rare Cytogenetic Event in a Case of Acute Myeloid Leukemia.

A 67-year-old male patient was diagnosed with acute myeloid leukemia (AML) in April 2018. Chromosome analysis showed an abnormal male karyotype with an isodicentric chromosome 7q resulting in deletion 7q and two copies of 7p and a derivative chromosome 18 in 13 of the 20 metaphase cells examined. This karyotype was described as 46,XY,idic(7)(q11.

The migraine signature study: Methods and baseline results.

Objective: To characterize patients who utilize services for migraine in a large integrated health care network, and describe patterns of care and utilization.

Background: Within health care systems, migraine is a common reason for seeking primary and neurology care, but relatively little is documented about who seeks care and the factors that explain variation in utilization.

Methods: We conducted a retrospective cohort study using electronic health record (EHR) data from Sutter Health primary care (PC) patients who had at least one office visit to a PC clinic between 2013 and 2017.

Rates of Vascular Events in Patients With Migraine: A MarketScan Database Retrospective Cohort Study.

Objective: To estimate the baseline rates of vascular events among people with migraine.

Background: Several novel medications that target the calcitonin gene-related peptide (CGRP) pathway are approved to treat people with migraine. Given that the CGRP pathway also plays a role in maintaining cardiovascular homeostasis, determining the baseline rates of vascular events among people with migraine will help inform the safety of these novel medications.

Accuracy of Implant Analogs in 3D Printed Resin Models.

Purpose: To study the effect of implant analog system, print orientation, and analog holder radial offset on 3D linear and absolute angular distortions of implant analogs in 3D printed resin models.

Materials And Methods: A sectional master model simulating a 2-implant, 3-unit fixed prosthesis in a partially edentulous jaw was fabricated. Three implant analog systems for 3D printed resin models-Straumann (ST), Core3DCentres (CD) and Medentika (MD)-were tested.

Development of microemulsion based topical ivermectin formulations: Pre-formulation and formulation studies.

The aim of this work was to develop microemulsions and microemulsion gels which can be used as vehicles for the topical delivery of ivermectin. Tea tree oil and ethyl butanoate were found to be suitable for ivermectin-loaded microemulsion formulations due to the higher solubility of ivermectin in these two oils than other tested oils. The pseudo-ternary phase diagrams were constructed based on these selected oils and combination of different surfactant/co-surfactant at different ratios.

COMPARING INTRAVITREAL AIR AND GAS FOR THE TREATMENT OF VITREOMACULAR TRACTION.

Purpose: To compare the effect of intravitreal injections of air with gas on vitreomacular traction (VMT) release and attempt to analyze predictive factors for success.

Methods: The medical records of patients with symptomatic VMT undergoing intravitreal injections (0.3 mL) of either octafluoropropane (C3F8) or air were retrospectively reviewed.

Socioecological risk factors associated with teen pregnancy or birth for young men: A scoping review.

Introduction: Teen pregnancy prevention typically focuses on young women, overlooking the unique prevention needs of young men. Identifying factors associated with teen pregnancy for young men is essential to developing relevant and effective programming.

Methods: We conducted a scoping review of studies with findings on factors associated with pregnancies/birth specific to young men.