The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID.

Background: Individuals with long COVID lack evidence-based treatments and have difficulty participating in traditional site-based trials. Our digital, decentralized trial investigates the efficacy and safety of nirmatrelvir/ritonavir, targeting viral persistence as a potential cause of long COVID.

Methods: The PAX LC trial (NCT05668091) is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial in 100 community-dwelling, highly symptomatic adult participants with long COVID residing in the 48 contiguous US states to determine the efficacy, safety, and tolerability of 15 days of nirmatrelvir/ritonavir compared with placebo/ritonavir.

IL-33 Induces Murine Intestinal Goblet Cell Differentiation Indirectly via Innate Lymphoid Cell IL-13 Secretion.

Regulation of the intestinal mucus layer by goblet cells is important for preventing inflammation and controlling infection. IL-33, a cytokine upregulated in inflammatory bowel disease and helminth infection, induces intestinal goblet cells, but the mechanism remains unclear. Enteroids are three-dimensional structures of primary small intestinal epithelial cells that contain all differentiated intestinal epithelial cell types.

IL-33 Signaling Protects from Murine Oxazolone Colitis by Supporting Intestinal Epithelial Function.

Background: IL-33, a member of the IL-1 cytokine family that signals through ST2, is upregulated in ulcerative colitis (UC); however, the role of IL-33 in colitis remains unclear. IL-33 augments type 2 immune responses, which have been implicated in UC pathogenesis. We sought to determine the role of IL-33 signaling in oxazolone (OXA) colitis, a type 2 cytokine-mediated murine model of UC.

An over-the-counter simulation study of a single-tablet emergency contraceptive in young females.

Objectives: To evaluate use of a single-tablet (levonorgestrel 1.5 mg) emergency contraceptive administered to young females under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events.

Endometrial stripe thickness and pregnancy outcome in first-trimester pregnancies with bleeding, pain or both.

Objective: To determine the association between endometrial stripe (ES) thickness and pregnancy outcome in women with a symptomatic first-trimester pregnancy and to determine how vaginal bleeding, pelvic pain and 1 human chorionic gonadotropin (hCG) level affect ES thickness.

Study Design: Data on ES thickness, serum hCG, presence of pain, characterization of vaginal bleeding and ultimate clinical outcome were collected for 576 women presenting to the emergency room.

Results: ES was thinner with increased vaginal bleeding and associated with hCG level and pregnancy outcome.

The effect of ambulation on vaginal distribution of miconazole nitrate (1200 mg).

Objective: To evaluate the effect activity has on the vaginal distribution of a 1200 mg miconazole nitrate gelatin encapsulated insert, an antifungal agent commonly used to treat vaginal vulvocandidiasis.

Method: Nine subjects underwent two sessions of serial magnetic resonance imaging after insertion of the insert. One session required that the subjects ambulate between images; the other session required the subjects remain supine between images.

Use of "2-dose" regimen of methotrexate to treat ectopic pregnancy.

Objective: To evaluate the safety and acceptability of a novel dosing regimen of methotrexate to treat ectopic pregnancy.

Design: Prospective study.

Setting: Three academic medical centers.

Application of redefined human chorionic gonadotropin curves for the diagnosis of women at risk for ectopic pregnancy.

Objective: To validate recently characterized curves of hCG rise and fall that are seen in viable and nonviable pregnancies in a population of women who have pregnancies of unknown location.

Design: Historical cohort study.

Setting: University hospital.

Risk factors for ectopic pregnancy in women with symptomatic first-trimester pregnancies.

Objective: To evaluate the association between ectopic pregnancy (EP) and clinical and historical factors among women presenting with pain and/or bleeding in early pregnancy.

Design: Nested case-control study.

Setting: University medical center.

Defining the curve when initial levels of human chorionic gonadotropin in patients with spontaneous abortions are low.

Because lower initial hCG concentrations are associated with slower rates of decline in spontaneous abortions, the aim of this study was to provide a detailed description of the expected rates of hCG decline in patients presenting with very low initial hCG levels and who ultimately were confirmed to have spontaneous abortions. When initial levels lie between 50 and 500 mIU/mL, the slowest expected percentage decline ranges from 12% to 24% in 2 days and from 34% to 68% in 7 days.

Human chorionic gonadotropin profile for women with ectopic pregnancy.

Objective: To analyze serial human chorionic gonadotropin (hCG) levels in women presenting to the emergency department who were ultimately confirmed to have ectopic pregnancies.

Methods: Human chorionic gonadotropin levels were obtained over time until definitive diagnosis. To be included, women had to have at least 2 hCG measurements.

Risk factors for spontaneous abortion in early symptomatic first-trimester pregnancies.

Objective: To evaluate the association of an ultimate diagnosis of miscarriage with various clinical symptoms and historical factors in a cohort of women presenting with pain, bleeding, or both in the first trimester of pregnancy.

Methods: This was a case-control study from a population of women presenting for care with pelvic pain or vaginal bleeding in the first trimester of pregnancy whose diagnoses were not definite upon initial evaluation. Analyses were performed in 2 ways.

Supplementation with DHEA: effect on muscle size, strength, quality of life, and lipids.

Objective: To evaluate the effects of combination estrogen/androgen therapy on muscle mass, strength and endurance, serum hormone and lipid profiles, and quality of life measures in postmenopausal women.

Methods: Prospective, randomized, placebo-controlled pilot study at a tertiary care medical center. Fifty postmenopausal women were randomized to a 12-week course of (1) dehydroepiandrostenedione (DHEA) 50 mg daily, (2) conjugated equine estrogen (CEE) 0.

Decline of serum human chorionic gonadotropin and spontaneous complete abortion: defining the normal curve.

Objective: We sought to estimate a standard curve of serum human chorionic gonadotropin (hCG) decline that characterizes spontaneous abortion.

Methods: Data were extracted from a clinical database of women with symptomatic early pregnancies and nondiagnostic ultrasonography who required follow-up with serial hCG levels. The evaluation was restricted to women who had a pregnancy of unknown location, a decrease in serum levels, and who were ultimately diagnosed with miscarriage (a decrease in serum hCG to < 5 mIU/mL in the absence of surgical intervention or confirmation of products of conception after dilation and curettage).

Symptomatic patients with an early viable intrauterine pregnancy: HCG curves redefined.

Objective: To analyze the change in serial human chorionic gonadotropin (hCG) levels in women symptomatic with pain or bleeding who presented with nondiagnostic ultrasonography but were ultimately confirmed to have a viable intrauterine pregnancy.

Methods: The rise in serial hCG measures were modeled over time, with the start point defined in 2 ways: by last menstrual period and by date of presentation for care. Both semiparametric (spline) curves and linear random-effects models were explored.

Vaginal distribution of miconazole nitrate suspension from administration of a single vaginal insert.

Objective: To perform a phase IV, open-label study of OVULE (Personal Care Products, Skillman, New Jersey) using magnetic resonance imaging (MRI) to describe the release, vaginal distribution and retention of a suspension containing miconazole nitrate in healthy female volunteers.

Study Design: Three parous and 3 nulligravid women were enrolled. Each subject self-inserted the OVULE on the MRI table and remained recumbent after insertion.

Acute and chronic presentation of ectopic pregnancy may be two clinical entities.

Objective: The diagnosis of ectopic pregnancy (EP) is often confirmed at presentation (acute), but often requires serial beta-hCG levels to confirm the diagnosis (chronic). The purpose of this study is to analyze whether these clinical presentations represent a spectrum of disease.

Design: The retrospective cohort study of 452 patients diagnosed with EP at the University of Pennsylvania in the years 1990-1999.

Risk factors and clinical features of recurrent ectopic pregnancy: a case control study.

Objective: To compare signs and symptoms between patients with recurrent and single ectopic pregnancies.

Design: Case-control study.

Setting: University medical center.

Presumed diagnosis of ectopic pregnancy.

Objective: To evaluate the accuracy of the diagnosis of presumed ectopic pregnancy.

Methods: This was a retrospective cohort analysis at a tertiary care medical center. The patient population was composed of 1) clinically stable pregnant women with human chorionic gonadotropin (hCG) above 2000 mIU/mL and no evidence of an intrauterine pregnancy by ultrasound, or 2) women with an abnormal rise or fall of serial hCG below 2000 mIU/mL.