A Randomized Trial to Assess the Effect of Doravirine on the QTc Interval Using a Single Supratherapeutic Dose in Healthy Adult Volunteers.

Introduction: Doravirine is a novel HIV-1 non-nucleoside reverse transcriptase inhibitor exhibiting a robust safety and efficacy profile in combination with other antiretrovirals. While existing data do not suggest that doravirine delays cardiac repolarization, the aim of this trial was to evaluate the effects of a supratherapeutic dose of doravirine on the heart-rate corrected QT (QTc) interval in healthy adults.

Methods: A randomized, three-period, crossover, placebo-controlled trial was conducted in healthy adults, 18-55 years of age.

CIN in pregnancy: antepartum and postpartum cytology and histology.

Objective: To determine the rates of antepartum and postpartum cervical intraepithelial neoplasia (CIN) 2 or worse in pregnant women with abnormal cervical cytology.

Study Design: A prospective, cohort study of 283 pregnant women referred for colposcopy between 1992 and 1999 for the evaluation of abnormal Pap smears. In this analysis, the population was stratified by severity of referral cytology (atypical squamous cells of undetermined significance [ASCUS] or low grade squamous intraepithelial lesion [LSIL] versus high grade squamous intraepithelial lesion [HSIL] and atypical glandular cells of undetermined significance [AGUS]).

A randomized comparison of propofol and methohexital as general anesthetics for vacuum abortion.

The objective of this study was to determine whether propofol and methohexital differ in their efficacy, acceptability, cost and side effects when used as the single anesthetic agent for inducing general anesthesia in first-trimester vacuum abortion. We randomized 400 unpremedicated American Society of Anesthesiologists grade I-II women to receive 1% propofol or 1% methohexital by intravenous bolus infusion during abortion. No ancillary anesthetic or adjunctive drugs were used.

Development and preclinical evaluation of a Bacillus Calmette-Guérin-MUC1-based novel breast cancer vaccine.

Due to the high incidence of breast cancer and associated mortality rate,the development of an effective vaccine may be beneficial for the prevention or adjuvant treatment of this malignancy. We have constructed a novel breast cancer vaccine, Bacillus Calmette-Guérin (BCG)-hIL2MUC1, that consists of BCG and expresses a truncated form of MUC1 and human interleukin (IL)-2. In vitro analysis of the BCG-hIL2MUC1 construct confirmed coexpression of MUC1 and human IL-2.

A randomized trial of the sleeved cytobrush and the endocervical curette.

Objective: To compare endocervical specimens obtained with the endocervical curette to those obtained with the sleeved cytobrush.

Methods: All nonpregnant women undergoing either cervical conization or hysterectomy were eligible for this randomized, split-sample trial. Both endocervical curette and cytobrush sampling were performed on all 62 participants before surgery, with randomization designating the order of the sampling procedures.

Preterm premature rupture of membranes: risks of recurrent complications in the next pregnancy among a population-based sample of gravid women.

Objective: The purpose of this study was to ascertain the predictive value of antecedent preterm premature rupture of membranes for recurrent preterm premature rupture of membranes and preterm delivery rates in the next pregnancy compared with background rates among a population-based sample of women at a single institution.

Study Design: Records of patients with index singleton pregnancies that were complicated by preterm premature rupture of membranes whose next delivery resulted in a delivery at >or=20 weeks at the same institution were reviewed for the incidence and gestational age of recurrent preterm premature rupture of membranes and preterm delivery. All subjects were patients of physicians whose obstetric practices were based at a single institution.

Down syndrome and cell-free fetal DNA in archived maternal serum.

Objective: Increased levels of cell-free fetal DNA (f-DNA) in the maternal circulation are a potential noninvasive marker for fetal Down syndrome. Our objectives were to (1) determine whether f-DNA could be quantified by using archived serum and amniotic fluid, (2) examine whether serum f-DNA levels are elevated in Down syndrome pregnancies in a case-control series matched for gestational age and duration of sample storage, and (3) determine whether f-DNA levels are elevated in the amniotic fluid of Down syndrome fetuses.

Study Design: Eleven serum and six amniotic fluid samples previously collected and stored at -20 degrees C from gravid women carrying a 47,XY,+21 fetus were each paired with five matched control samples of identical specimen type from gravid women carrying a presumed euploid male fetus.

Combination of bacterial vaginosis and leukorrhea as a predictor of cervical chlamydial or gonococcal infection.

Objective: To evaluate whether the combination of bacterial vaginosis and leukorrhea on microscopic evaluation of a saline wet preparation is associated with cervical infection with Chlamydia trachomatis (C. trachomatis) or Neisseria gonorrhea (N. gonorrhea).

Microflora changes with the use of a vaginal microbicide.

Background: The rate of HIV transmission is increasing more in women than in any other group. There is an urgent need for the development of microbicides with activity against this virus that women can use during intercourse. These products must be convenient, effective, and safe, and ideally they will cause minimal disruption in the normal vaginal ecosystem.