Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).

Background: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC.

A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing.

Objective: Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China.

Methods: In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFireâ„¢ HPV detection systems (Atila Biosystems) were sufficient to provide pooled 15-HPV type data within an hour.

Assessing the implementation of a patient navigation intervention for colonoscopy screening.

Background: A recent study demonstrated the effectiveness of the New Hampshire Colorectal Cancer Screening Program's (NHCRCSP) patient navigation (PN) program. The PN intervention was delivered by telephone with navigators following a rigorous, six-topic protocol to support low-income patients to complete colonoscopy screening. We applied the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework to examine implementation processes and consider potential scalability of this intervention.

Cost-effectiveness of a patient navigation intervention to increase colonoscopy screening among low-income adults in New Hampshire.

Background: Colonoscopy is the most widely used colorectal cancer (CRC) screening test in the United States. Through the detection and removal of potentially precancerous polyps, it can prevent CRC. However, CRC screening remains low among adults who are recommended for screening.

A Phase 3, Multicenter, Prospective, Open-Label Study to Evaluate the Safety of a Single Dose of Secnidazole 2 g for the Treatment of Women and Postmenarchal Adolescent Girls with Bacterial Vaginosis.

Background: A novel formulation of secnidazole is under development in the United States for the treatment of bacterial vaginosis (BV). Efficacy and safety of other formulations of secnidazole have been reported. The objective of this study is to evaluate the safety of a single-dose oral granule formulation of secnidazole in a U.

Increasing colonoscopy screening in disparate populations: Results from an evaluation of patient navigation in the New Hampshire Colorectal Cancer Screening Program.

Background: To investigate uniformly successful results from a statewide program of patient navigation (PN) for colonoscopy, this comparison study evaluated the effectiveness of the PN intervention by comparing outcomes for navigated versus non-navigated patients in one of the community health clinics included in the statewide program. Outcomes measured included screening completion, adequacy of bowel preparation, missed appointments and cancellations, communication of test results, and consistency of follow-up recommendations with clinical guidelines.

Methods: The authors compared a subset of 131 patients who were navigated to a screening or surveillance colonoscopy with a similar subset of 75 non-navigated patients at one endoscopy clinic.

Effect of Extended 30 μg Ethinyl Estradiol with Continuous Low-Dose Ethinyl Estradiol and Cyclic 20 μg Ethinyl Estradiol Oral Contraception on Adolescent Bone Density: A Randomized Trial.

Study Objective: To compare changes in lumbar spine bone mineral density after 12 months of a 91-day extended regimen or 28-day combined oral contraceptive with those in a healthy reference group not using hormonal contraceptives.

Design: Phase 2, multicenter, open-label, randomized, controlled study.

Setting: Forty-five academic centers, clinical research centers, and community practices in the United States.

Development and Evaluation of the Lifestyle History Questionnaire (LHQ) for People Entering Treatment for Substance Addictions.

Objective: We developed and investigated the psychometric properties of the Lifestyle History Questionnaire (LHQ), a self-report instrument designed to measure the extent of occupational dysfunction attributable to substance abuse.

Method: The instrument was developed using concepts in the ecological models of occupational therapy and in the work of William L. White, who defined addiction culture in terms of the patterns of life in context.

Induced spin filtering in electron transmission through chiral molecular layers adsorbed on metals with strong spin-orbit coupling.

Recent observations of considerable spin polarization in photoemission from metal surfaces through monolayers of chiral molecules were followed by several efforts to rationalize the results as the effect of spin-orbit interaction that accompanies electronic motion on helical, or more generally strongly curved, potential surfaces. In this paper we (a) argue, using simple models, that motion in curved force-fields with the typical energies used and the characteristic geometry of DNA cannot account for such observations; (b) introduce the concept of induced spin filtering, whereupon selectivity in the transmission of the electron orbital angular momentum can induce spin selectivity in the transmission process provided there is strong spin-orbit coupling in the substrate; and (c) show that the spin polarization in the tunneling current as well as the photoemission current from gold covered by helical adsorbates can be of the observed order of magnitude. Our results can account for most of the published observations that involved gold and silver substrates; however, recent results obtained with an aluminum substrate can be rationalized within the present model only if strong spin-orbit coupling is caused by the built-in electric field at the molecule-metal interface.

Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids.

Aim: To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids.

Materials & Methods: This was a pooled analysis of two pivotal Phase III studies. Fibroids were evaluated by transvaginal ultrasonography.

Tranexamic acid increases hemoglobin and ferritin levels in women with heavy menstrual bleeding.

Background: Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in women. A novel, modified-release oral formulation of tranexamic acid (TA) designed to reduce gastrointestinal side effects was approved recently for treatment of HMB. We assessed improvements in objective laboratory measures of IDA in women with self-reported HMB who received long-term TA therapy.

Leveraging network connectivity for quality assurance of clinical display monitors.

The VA Midwest Health Care Network, VISN 23, is one of 21 veteran integrated health service networks (VISN) under the Department of Veterans Affairs. There are approximately 300,000 imaging studies generated per year and currently more than 14,000 picture archiving and communication system (PACS) users in VISN 23. Biomedical Engineering Services within VISN 23 coordinates the provision of medical technology support.

Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid.

Aims: A multicenter, long-term, open-label study was conducted to assess the safety and health-related quality of life (HRQoL) of an oral tranexamic acid (TA) formulation in women with cyclic heavy menstrual bleeding (HMB).

Materials & Methods: Following a screening menstrual cycle, women with a history of cyclic HMB initiated 27 cycles of treatment with TA 1.3 g administered three-times daily for up to 5 days per menstrual cycle (maximum of 15 doses).

A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding.

Objective: We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding.

Study Design: This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.

Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial.

Objective: To assess the efficacy and safety of an oral formulation of tranexamic acid for the treatment of heavy menstrual bleeding.

Methods: Adult women with heavy menstrual bleeding (mean menstrual blood loss 80 mL or more per cycle) were enrolled in a double-blind, placebo-controlled study. After two pretreatment menstrual cycles, women were randomized to receive tranexamic acid 3.

Improving outpatient diabetes management through a collaboration of six competing, capitated Medicare managed care plans.

This report addresses diabetes care in the managed care setting and improvement in care brought about by collaboration between 6 Medicare managed care plans (MCPs) and a Peer Review Organization (PRO). The objective was to improve the quality of care of outpatient diabetes patients provided by primary care physicians through the mutual collaboration of 6 Medicare managed care plans and a Medicare Peer Review Organization. The design involved pre-post intervention trial based on 2 random samples, a baseline sample drawn in 1995 and a remeasurement sample drawn in 1996.

Outpatient management of diabetes mellitus in five Arizona Medicare managed care plans.

We report findings on the outpatient management of diabetes mellitus in Medicare beneficiaries enrolled in five Arizona Medicare-managed care plans. These findings are the baseline of an ongoing collaboration between the Health Services Advisory Group, Inc., Arizona's Peer Review Organization (PRO), and the five plans whose object is improved care of diabetes patients.

Validity of children's reports of parental alcohol abuse.

Data from interviews with parents and 9-12 year old children from 303 families were used to test the validity of children's reports of parental alcoholism or problem drinking status. Children's responses to several single-item screening questions that had been used previously to identify children of alcoholics, as well as their responses to the Short Michigan Alcoholism Screening Test for each parent, were compared to parents' alcoholism diagnosis and screening test scores. In general, children's responses correctly identified only a small portion of alcoholic parents and, when all screening items were combined into a single screening tool to increase sensitivity, the false positive rate became unreasonable for most applications.

Linking empirically based theory and evaluation: the Family Bereavement Program.

Evaluated the effects of a theoretically derived program to prevent mental health problems in children who had experienced the death of a parent. The program was designed to improve variables in the family environment which were specified as mediators of the effects of parental death on child mental health. The evaluation design involved the random assignment of families to either an intervention or control group.

Small theory and the strategic choices of prevention research.

Our comments on the discussion of mediational screening for prevention research highlight two issues: (a) There are advantages to giving a high priority to theory in a strategic sequence of prevention research studies. (b) Screening to identify a subgroup that is experiencing problems on processes the program is designed to change may be useful in accomplishing specific goals within an overall strategy of prevention research studies.

Theory-based screening for prevention: focusing on mediating processes in children of divorce.

Prevention programs in mental health theoretically can benefit from selecting participants who have a greater likelihood of developing psychological problems because of their exposure to the putative mediators targeted for change in an intervention. Screening on mediators may increase statistical power to detect program effects, enhance the cost-effectiveness of intervention trials, and decrease the possibility of iatrogenic effects. The circumstances that optimize the strategy of screening on the basis of mediating variables are discussed, and data are presented to illustrate the development of a mediational selection strategy to identify families who might best benefit from a preventive intervention for children of divorce.