Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

Objective: A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts.

Methods: A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives.

Pharmacokinetics and pharmacodynamics of a novel depot formulation of abarelix, a gonadotropin-releasing hormone (GnRH) antagonist, in healthy men ages 50 to 75.

This study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel depot formulation of abarelix, a new gonadotropin-releasing hormone (GnRH) antagonist. This was an open-label, sequential two-phase study in healthy male subjects ages 50 to 75. Subjects received a single intramuscular (IM) dose of 15 microg/kg abarelix injectable solution, followed by a 21-day washout period and a subsequent intramuscular dose of 100 mg abarelix depot.

Multicenter, double-blind, placebo-controlled study of the use of filgrastim in patients hospitalized with pneumonia and severe sepsis.

Objective: To determine the safety and efficacy of filgrastim (r-metHuG-CSF) in combination with intravenous antibiotics to reduce the rate of mortality in patients with pneumonia and sepsis.

Design: This study was multicenter, double-blind, and randomized.

Setting: Intensive care units PATIENTS Adult patients with bacterial pneumonia, either acquired or nosocomial, as confirmed by chest radiograph and positive culture or Gram-negative stain, and severe sepsis, defined as sepsis-induced hypotension or organ dysfunction.

A phase 3, multicenter, open label, randomized study of abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer.

Purpose: We compared the endocrinological and biochemical efficacy of abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen.

Materials And Methods: A total of 255 patients were randomized to receive open label 100 mg. abarelix depot or 7.

A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer.

Objectives: To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with abarelix versus leuprolide acetate.

Methods: Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.

Filgrastim in patients with pneumonia and severe sepsis or septic shock.

Study Objectives: Evaluate the safety of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor) administration, combined with standard therapy, in patients with pneumonia and either septic shock or severe sepsis who were receiving mechanical ventilation.

Design: Multicenter, double-blind, randomized, placebo-controlled study.

Setting: ICU, multicenter.

A randomized controlled trial of filgrastim for the treatment of hospitalized patients with multilobar pneumonia.

This study assessed the safety and efficacy of filgrastim (r-metHuG-CSF [recombinant human methionine granulocyte colony-stimulating factor]), when combined with intravenous (IV) antibiotics, in the treatment of hospitalized adult patients with multilobar community-acquired pneumonia (CAP). Four hundred eighty patients were randomized to receive placebo (n=243) or filgrastim 300 microg/day (n=237), in addition to standard therapy. Treatment with study drug was continued for 10 days, until the peak white blood cell (WBC) count reached 75x109/L, until discharge from the hospital, until death, or until IV antibiotics were discontinued.

Randomized, placebo-controlled, double-blind, multicenter trial of efficacy and safety of granulocyte colony-stimulating factor in liver transplant recipients.

Background: Infection and rejection are two common complications after liver transplants. In a preliminary study, administration of granulocyte colony-stimulating factor (G-CSF) to liver transplant recipients was associated with a decrease in sepsis episodes, sepsis-related deaths, and rejection compared with a historical control group of patients. The purpose of this study was to evaluate further the efficacy of G-CSF in liver transplant patients in a randomized, placebo-controlled, double-blind, multicenter trial.

A randomized controlled trial of filgrastim as an adjunct to antibiotics for treatment of hospitalized patients with community-acquired pneumonia. CAP Study Group.

Because of the critical role of neutrophils in host defenses, it was hypothesized that stimulation of neutrophil production and function with Filgrastim would improve the outcome of hospitalized patients with community-acquired pneumonia. To test this hypothesis, a randomized, placebo-controlled, multicenter trial of Filgrastim (300 micrograms/day up to 10 days) as an adjunct to antibiotics was conducted for these patients. Outcome measures included time to resolution of morbidity (TRM, a composite measure of temperature, respiratory rate, blood oxygenation, and chest radiograph), 28-day mortality, length of stay, and adverse events.

Time to resolution of morbidity: an endpoint for assessing the clinical cure of community-acquired pneumonia.

Clinical trials of new therapeutics for community-acquired pneumonia (CAP) have typically used a subjective endpoint of clinical response. However, as this endpoint is not quantitative, it is subject to observer bias and renders the conduct of multicenter trials difficult. For the purposes of conducting a clinical trial of filgrastim, as an adjunct to antibiotics for the treatment of CAP, a set of clinical criteria were developed prospectively to determine the time when a clinical cure was achieved, based on respiratory rate, temperature, oxygenation and roentgenographic findings, which was termed the time to resolution of morbidity (TRM).

Monocyte monolayer assay as a predictor of severity of hemolytic disease of the fetus and newborn.

The monocyte monolayer assay (MMA), an in vitro model of in vivo antibody-mediated red blood cell destruction, was previously reported to predict the severity of hemolytic disease of the fetus and newborn accurately when only Rh antibodies and antigen-positive babies were studied. We studied 33 women whose serum contained antibodies with the potential to cause erythroblastosis fetalis; 7 of the 33 women had antibodies other than Rh. None of the babies of the ten women who had consistently negative test results required intrauterine or neonatal transfusions.

Could the fasting plasma glucose assay be used to screen for gestational diabetes?

The fasting plasma glucose assay was compared with the one-hour post-glucose test as a screening test for identification of gestational diabetes. Of 4,561 consecutive patients screened with a 50-g glucose test, 968 (21.2%) had results > or = 135 mg/dL; 141 (14.

A randomized trial of three methods of obtaining Papanicolaou smears.

The relationship between technique of obtaining Papanicolaou smears, presence of endocervical cells, and rate of cervical neoplasia was studied by comparing an endocervical and ectocervical nylon brush (Bayne brush), Ayre spatula plus endocervical brush, and spatula plus cotton-tipped swab in a randomized, prospective trial involving 11,061 patients. Eligible patients had a cervix and were not pregnant. Clinic records of patients with abnormal cytology were reviewed to determine the pathologic diagnosis.

Presentation of cervical cancer.

To determine how patients with invasive cervical cancer present and whether presentation affects disease-free survival (DFS), a review of 81 patients treated for cervical cancer by the Division of Gynecologic Oncology and Pelvic Surgery at the Southern California Permanente Medical Group between January 1, 1986, and December 31, 1986, was performed. Fifty-six percent of patients presented with abnormal vaginal bleeding, twenty-eight percent presented with abnormal Papanicolaou (Pap) smears, nine percent presented with pain, four percent presented with vaginal discharge, and four percent presented with other symptoms. Follow-up was 24 to 41 months.

How reliable is the fifty-gram, one-hour glucose screening test?

The Second International Workshop-Conference on Gestational Diabetes recommended screening all pregnant women with a 1-hour 50 gm oral glucose screening test, given without regard to time of day or time elapsed from the last meal. This study was designed to evaluate the reproducibility of that test, given under those clinical conditions. Thirty women with gestational diabetes and 80 control volunteers between 24 and 28 weeks' gestation were tested at the same time of day on two successive days.

Do the current standards for glucose tolerance testing in pregnancy represent a valid conversion of O'Sullivan's original criteria?

The venous plasma values for the 100 gm glucose tolerance test endorsed by the Second International Workshop-Conference on Gestational Diabetes represent an arbitrary conversion from O'Sullivan's original values. The latter were calculated from whole blood by means of the Somogyi-Nelson method. The factor used to convert the whole blood values to plasma glucose values was empirically derived in a population in whom pregnancy status was not stated.