bluuebunny/crossref_metadata_2025_split huggingface dataset:
Etravirine Has No Effect on QT and Corrected QT Interval in HIV-Negative Volunteers
Authors: Peeters Monika , Janssen Katrien , Kakuda Thomas N , Schöller-Gyüre Monika , Lachaert Ruth , Hoetelmans Richard MW , Woodfall Brian , Smedt Goedele De 
Published: April 2008

Background: Etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, has shown antiviral efficacy in 2 large Phase 3 trials. In vitro and in vivo studies have shown that etravirine is not associated with proarrhythmic potential. Electrocardiograms (ECGs) from healthy and HIV 1–infected volunteers showed no clinically relevant changes. Objective: To evaluate the effect of 2 etravirine dosing regimens on QT/corrected QT interval (QTc) in HIV-negative volunteers and assess pharmacokinetic and additional safety parameters. Methods: A double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial was conducted in 41 HIV-negative volunteers. Participants received 4 regimens: etravirine 200 mg twice daily, etravirine 400 mg once daily, moxifloxacin 400 mg once daily (positive control), and placebo in separate 8-day sessions, with each followed by a washout period of 14 or more days. On days -1, 1, and 8 of each session, ECGs were recorded at 11 time points over 12 hours. Pharmacokinetic profiles of etravirine regimens were evaluated and safety was assessed. Results: Thirty-seven subjects completed the study. For etravirine, the upper limit of the 90% CIs of mean time-matched differences in QTc determined using Fridericia's formula (QTcF) was below 10 msec at all time points, the threshold for prolonged QT as defined by regulatory guidelines. The maximum mean (90% CI) difference of time-matched changes in QTcF versus placebo on day 1 was +0.1 msec (–2.6 to 2.9), -0.2 msec (-2.6 to 2.1), and +10.1 msec (7.3 to 12.8) for etravirine 200 mg twice daily, etravirine 400 mg once daily, and moxifloxacin, respectively. On day 8, these values were +0.6 msec (-2.1 to 3.3), -1.0 msec (-4.4 to 2.5), and +10.3 msec (6.8 to 13.9), respectively. Etravirine produced no clinically significant changes in other ECG parameters. No significant differences between males and females were observed. Both etravirine regimens had similar pharmacokinetic exposure and safety profiles. Conclusions: Etravirine does not prolong the QTc interval. No clinically relevant ECG changes were observed in HIV-negative volunteers. Short-term dosing of etravirine in HIV-negative volunteers was generally safe and well tolerated.
Switching Statin Therapy Using a Pharmacist‐Managed Therapeutic Conversion Program versus Usual Care Conversion Among Indigent Patients
Authors: Miller Amy E. , Hansen Laura B. , Saseen Joseph J. 
Published: April 2008

Study Objective. To evaluate the effectiveness of switching statin therapy using a therapeutic conversion program versus usual care conversion among patients enrolled in the Colorado Indigent Care Program when atorvastatin was removed from the formulary.Design. Prospective cohort study.Setting. Family medicine center and other ambulatory care clinics of a university‐based health care system.Patients. One hundred seventeen ambulatory care patients with dyslipidemia who were treated with atorvastatin.Intervention. Clinical pharmacists in the family medicine center implemented a therapeutic conversion program (30 patients), switching atorvastatin to a new formulary regimen of simvastatin, rosuvastatin, or ezetimibe‐simvastatin, using an algorithm designed to achieve patient‐specific goals for low‐density lipoprotein cholesterol (LDL). Usual care occurred in the other ambulatory care clinics without clinical pharmacists (87 patients), where medical providers switched atorvastatin to a formulary regimen based on a suggested (but optional) equipotency conversion algorithm.Measurements and Main Results. Primary end points were LDL concentration and LDL goal attainment before and after conversion. Before and after conversion, respectively, mean LDL concentrations were 86.7 and 82.3 mg/dl in the therapeutic conversion group (p=0.44) versus 78.3 and 85.2 mg/dl in the usual care group (p=0.01). Percentages of patients attaining LDL goal were 80% before and 97% after conversion in the therapeutic conversion group (p=0.04) compared with 90% before and 75% after conversion in the usual care group (p=0.01).Conclusion. Use of a prospective, therapeutic statin conversion program was associated with increased control of dyslipidemia, whereas usual care statin conversion was associated with decreased control. These data suggest that proactive involvement of clinical pharmacists in converting lipid‐lowering drugs results in superior patient care outcomes compared with a less aggressive approach.
Effectiveness of a Fenofibrate 145‐mg Nanoparticle Tablet Formulation Compared with the Standard 160‐mg Tablet in Patients with Coronary Heart Disease and Dyslipidemia
Authors: Maciejewski Stephanie , Hilleman Daniel 
Published: April 2008

Study Objective. To compare the effectiveness of a fenofibrate 145‐mg nanoparticle tablet formulation with the standard 160‐mg tablet in patients with dyslipidemia and coronary heart disease.Design. Retrospective medical record review.Setting. Outpatient university‐affiliated cardiology clinic.Patients. One hundred thirty patients with dyslipidemia and coronary heart disease treated for a minimum of 6 months with fenofibrate 160 mg/day (with or without 3‐hydroxy‐3‐methylglutaryl coenzyme A reductase inhibitor [statin] therapy) who were then switched to a minimum of 3 months of treatment with fenofibrate 145 mg/day.Measurements and Main Results. Low‐density lipoprotein cholesterol (LDL), high‐density lipoprotein cholesterol (HDL), and triglyceride levels were compared during treatment with each formulation. In patients not taking statins, statistically significant reductions of 4.6% and 2.3%, respectively, were noted in mean triglyceride and LDL levels after the switch to fenofibrate 145 mg/day. In patients taking statins, statistically significant reductions of 5.1% and 2.8%, respectively, were observed in mean triglyceride and LDL levels. In total, a larger proportion of patients had 10% or greater improvement in LDL (14/130 [11%]) and triglyceride (32/130 [25%]) levels compared with the proportion of patients who had 10% or greater worsening in LDL (3/130 [2%]) and triglyceride (9/130 [7%]) levels, and a net additional 14 patients (11%) achieved National Cholesterol Education Program (NCEP) lipid panel targets after the switch to fenofibrate 145 mg/day. Mean HDL level was not significantly different after the switch to fenofibrate 145 mg/day. Safety parameters of fenofibrate 145‐mg/day therapy were not examined, although fenofibrate 160 mg/day is generally well tolerated.Conclusion. Eleven percent of the patients in our study had improvements in their lipid profiles that resulted in achievement of NCEP lipid panel targets after treatment with the 145‐mg nanoparticle formulation of fenofibrate. This improvement in lipid levels may have been related to increased bioavailability of the 145‐mg formulation. However, the exact mechanism of the improvement in lipid levels is unknown.
Comparison of Scales for Evaluating Premenstrual Symptoms in Women Using Oral Contraceptives
Authors: Coffee Andrea L. , Kuehl Thomas J. , Sulak Patricia J. 
Published: April 2008

Study Objective. To compare two scales used in research to evaluate daily premenstrual mood symptoms during use of a monophasic oral contraceptive. Design. Subanalysis of data from a prospective study. Setting. University‐affiliated medical center.Subjects. One hundred two reproductive‐aged (18–48 yrs) women taking a monophasic oral contraceptive containing ethinyl estradiol and drospirenone in the standard 21‐7 fashion (21 days of hormones followed by 7 days of placebo), and who had self‐identified premenstrual symptoms of headache, mood changes, or pelvic pain.Intervention. Subjects completed a single‐item questionnaire, the Scott & White Daily Diary of Symptoms, and a multiple‐item questionnaire, the Penn State Daily Symptom Report (DSR), to assess their premenstrual symptoms. The Scott & White diary used a visual analog scale of 0–10 to assess pelvic pain, headache, and mood (a composite of anxiety, depression, and irritability). The Penn State DSR contained 17 items: 10 behavioral and seven physical components, each rated on a scale of 0–4, with one item that specifically rated mood swings.Measurements and Main Results. Scores from the two scales were compared by using Spearman correlation coefficients, the Kendall W for concordance, and linear regression of ranked sums for study cycles. The Scott & White mood score significantly correlated with the total of the 17 items on the Penn State DSR, as well as the 10 behavioral items, the seven physical items, and the single mood‐swing item (p<0.0001); specific coefficients of concordance were 0.44, 0.23, 0.10, and 0.28, respectively, and R2 values were 0.39, 0.39, 0.30, and 0.34, respectively. The daily Scott & White mood score was positively correlated with all 17 elements of the Penn State DSR (0.25‐0.57). The greatest correlation was seen with the mood‐swing element. Both instruments demonstrated the same patterns during the 21‐7 oral contraceptive cycle, with symptoms increasing immediately before and peaking during the 7‐day hormone‐free interval.Conclusion. A single‐item daily mood score using a rating scale of 0–10 was concordant with a relatively complex 17‐element symptom index and demonstrated the same pattern of change during cycles of oral contraception. The simple scoring system offers an advantage, especially in clinical studies of long duration.
Intraperitoneal Chemotherapy for Women with Epithelial Ovarian Cancer
Authors: Trimble Edward L. , Thompson Sharon , Christian Michaele C. , Minasian Lori 
Published: April 2008

Abstract

Learning Objectives
After completing this course, the reader will be able to: Assess the rationale behind using i.p. chemotherapy for epithelial ovarian cancer patients and critically evauate the data supporting its use.Interpret the argument that i.p. chemotherapy cannot be accepted as standard of care for first-line systemic treatment of advanced ovarian carcinoma.Determine which epithelial ovarian cancer patients may be appropriate for i.p. chemotherapy.Avoid and/or manage the toxicities observed with i.p. chemotherapy.
CME Access and take the CME test online and receive 1 AMA PRA Category 1 Credit™ at CME.TheOncologist.com
The CME activity for this article consists of material from both “Intraperitoneal Chemotherapy for Women with Epithelial Ovarian Cancer” (Trimble et al.) and “Intraperitoneal Chemotherapy in Patients with Advanced Ovarian Cancer: The Con View” (Vergote et al.).
In 2006, i.p. chemotherapy re-emerged as a controversial topic in debates about the optimal treatment for women with advanced epithelial ovarian cancer. In this paper, we address the rationale behind i.p. chemotherapy, the data supporting its use, the selection of appropriate patients for i.p. chemotherapy, how best to avoid and manage the toxicities observed with i.p. chemotherapy, and directions for future research.
Utility of Radiolabeled Somatostatin Receptor Analogues for Staging/Restaging and Treatment of Somatostatin Receptor–Positive Pediatric Tumors
Authors: Khanna Geetika , Bushnell David , O'Dorisio M. Sue 
Published: April 2008

Abstract
In this paper, we review the pediatric oncologic applications of somatostatin receptor–targeted imaging and therapy. Somatostatin receptors are expressed in high densities by embryonal tumors, such as neuroblastoma and medulloblastoma, and neuroendocrine tumors like carcinoids and islet cell tumors. We first review the distribution of these receptors in normal tissues and tumor cells. We then discuss the technique of somatostatin receptor scintigraphy (SRS) in the pediatric population. Next, the specific clinical applications of SRS with regard to the imaging of neuroblastoma, central nervous system tumors, and gastroenteropancreatic neuroendocrine tumors of childhood are discussed. Finally, we discuss the potential role of somatostatin receptor–targeted radiotherapy for improving the duration and quality of life of children with these tumors.
Trastuzumab plus Paclitaxel or Docetaxel in HER-2–Negative/HER-2 ECD–Positive Anthracycline- and Taxane-Refractory Advanced Breast Cancer
Authors: Ardavanis Alexandros , Kountourakis Panteleimon , Kyriakou Flora , Malliou Savoula , Mantzaris Ioannis , Garoufali Anastasia , Yiotis Ioulia , Scorilas Andreas , Baziotis Nikolaos , Rigatos Gerasimos 
Published: April 2008

Abstract
Trastuzumab is considered effective against human epidermal growth factor receptor (HER)-2–positive breast cancer as assessed by immunohistochemistry (IHC) and fluorescence or chromogenic in situ hybridization (FISH/CISH) on biopsy material. Trastuzumab is now approved in both the adjuvant and metastatic settings for this patient population. Because HER-2 extracellular domain (ECD) levels have been correlated with disease progression in the metastatic setting, we considered trastuzumab salvage therapy plus a taxane in heavily pretreated trastuzumab-naive relapsed breast cancer patients with high serum levels of HER-2 ECD (≥15 ng/ml). All patients had previously failed at least two lines of anthracycline- and taxane-based regimens and were HER-2 negative by IHC and FISH/CISH prior to a centralized reanalysis, and were serum positive for HER-2 ECD (≥15 ng/ml) at baseline. Regular serum accounts of HER-2 ECD were recorded and compared with response and survival outcomes. Twenty-two patients were finally eligible for salvage therapy. Minor responses were observed in five (23%) and stable disease (SD) was observed in 11 patients, leading to a clinical benefit rate of 73% (16 of 22 patients). The median time to progression and overall survival time were 5 (6.5 months in minor responders and SD) and 12 months, respectively; 11 and eight patients remained progression free for &gt;6 and &gt;12 months, respectively. Eleven and seven patients were alive at 12 and 15 months, respectively, after treatment start. Furthermore, in total, 13 (59.1%) patients obtained a biochemical response. In our study, patients with conventionally HER-2–negative disease but with expression of HER-2 ECD above the normal limit (≥15 ng/ml) displayed a rapid response, both biochemically and clinically, to the trastuzumab–taxane combination. This is the first study assessing anti-HER-2–based treatment in HER-2–negative advanced breast cancer according to HER-2 ECD positivity; if our results are confirmed, additional patients with “hidden” HER-2–positive breast cancer might benefit from anti-HER-2 treatment.
HIV Prevalence and Associated Risk Behaviors in New York City’s House Ball Community
Authors: Murrill Christopher S. , Liu Kai-lih , Guilin Vincent , Colón Edgar Rivera , Dean Laura , Buckley Lisa A. , Sanchez Travis , Finlayson Teresa J. , Torian Lucia V. 
Published: April 2008

Objectives. We measured HIV seroprevalence and associated risk factors among persons in New York City’s house ball community. Methods. In 2004 we conducted a venue-based risk-behavior survey and HIV testing in the house ball community. Results. Of the 504 study participants, 67% were male, 14% female, and 18% transgender. Mean age was 24 years (range=15–52 years); 55% were Black, and 40% were Latino. More than 85% of participants had previously been tested for HIV, although only 60% had been tested in the previous 12 months. Of the 84 (17%) persons who tested positive for HIV in our study, 61 (73%) were unaware of their HIV status. A logistic regression analysis on data from 371 participants who had had a male sexual partner in the previous 12 months showed that HIV-infected participants were more likely than were HIV-negative participants to be Black, to be older than 29 years, and not to have been tested for HIV in the previous 12 months. Conclusions. Culturally specific community-level prevention efforts are warranted to reduce risk behaviors and increase the frequency of HIV testing in New York City’s house ball community.
Paternal Race/Ethnicity and Birth Outcomes
Authors: Ma Sai 
Published: April 2008

Objectives. I sought to identify whether there were associations between paternal race/ethnicity and birth outcomes among infants with parents of same- and mixed-races/ethnicities.Methods. Using the National Center for Health Statistics 2001 linked birth and infant death file, I compared birth outcomes of infants of White mothers and fathers of different races/ethnicities by matching and weighting racial/ethnic groups following a propensity scoring approach so other characteristics were distributed identically. I applied the same analysis to infants of Black parents and infants with a Black mother and White father.Results. Variation in risk factors and outcomes was found in infants of White mothers by paternal race/ethnicity. After propensity score weighting, the disparities in outcomes by paternal or parental race/ethnicity could be largely attributed to nonracial parental characteristics. Infants whose paternal race/ethnicity was unreported on their birth certificates had the worst outcomes.Conclusions. The use of maternal race/ethnicity to refer to infant race/ethnicity in research is problematic. The effects of maternal race/ethnicity on birth outcomes are estimated to be much larger than that of paternal race/ethnicity after I controlled for all covariates. Not listing a father on the birth certificate had a strong association with outcomes, which might be a source of bias in existing data and a marker for identifying infants at risk.
Health-Related Quality of Life Among Adults Who Experienced Maltreatment During Childhood
Authors: Corso Phaedra S. , Edwards Valerie J. , Fang Xiangming , Mercy James A. 
Published: April 2008

Objectives. We sought to assess the difference in a preference-based measure of health among adults reporting maltreatment as a child versus those reporting no maltreatment. Methods. Using data from a study of adults who reported adverse childhood experiences and current health status, we matched adults who reported childhood maltreatment (n = 2812) to those who reported no childhood maltreatment (n = 3356). Propensity score methods were used to compare the 2 groups. Health-related quality-of-life data (or “utilities”) were imputed from the Medical Outcomes Study 36-Item Short Form Health Survey using the Short Form–6D preference-based scoring algorithm. Results. The combined strata-level effects of maltreatment on Short Form–6D utility was a reduction of 0.028 per year (95% confidence interval=0.022, 0.034; P<.001). All utility losses for the childhood-maltreatment versus no-childhood-maltreatment groups by age group were significantly different: 18–39 years, 0.042; 40–49 years, 0.038; 50–59 years, 0.023; 60–69 years, 0.016; 70 or more years, 0.025. Conclusions. Persons who experienced childhood maltreatment had significant and sustained losses in health-related quality of life in adulthood relative to persons who did not experience maltreatment. These data are useful for asessing the cost-effectiveness of interventions designed to prevent child maltreatment in terms of cost per quality-adjusted life years saved.
Beyond Abuse and Exposure: Framing the Impact of Prescription-Medication Sharing
Authors: Goldsworthy Richard C. , Schwartz Nancy C. , Mayhorn Christopher B. 
Published: April 2008

Objectives. We sought to document the frequency, circumstances, and consequences of prescription medication–sharing behaviors and to use a medication-sharing impact framework to organize the resulting data regarding medication-loaning and -borrowing practices. Methods. One-on-one interviews were conducted in 2006, and participants indicated (1) prescription medicine taken in the past year, (2) whether they had previously loaned or borrowed prescription medicine, (3) scenarios in which they would consider loaning or borrowing prescription medicine, and (4) the types of prescription medicines they had loaned or borrowed. Results. Of the 700 participants, 22.9% reported having loaned their medications to someone else and 26.9% reported having borrowed someone else’s prescription. An even greater proportion of participants reported situations in which medication sharing was acceptable to them. Conclusions. Sharing prescription medication places individuals at risk for diverse consequences, and further research regarding medication loaning and borrowing behaviors and their associated consequences is merited.
Failure of long-term nerve root stimulation to improve neuropathic pain
Authors: Weigel Ralf , Capelle Hans-Holger , Krauss Joachim K. 
Published: April 2008

Object
Stimulation of dorsal nerve roots or dorsal root ganglia was reported to alleviate neuropathic pain in selected patients during the early postoperative period. A prospective study was initiated to investigate long-term outcome in patients with neuropathic pain of the lower extremities or groin who were treated with selective nerve root stimulation.

Methods
The study included patients with dermatomally distributed neuropathic pain who were > 18 years of age and in whom the pain was refractory to medical treatment. The patients were prospectively evaluated using a visual analog scale (VAS) for pain and ratings for quality of life, activities of daily living, and depression preoperatively, and after defined intervals postoperatively. Implantation of electrodes was performed via foraminotomy or interlaminar fenestration in an awake procedure. An implantable pulse generator (IPG) was implanted in a second operation after successful test stimulation performed over several days.

Results
Three patients were included in the study before it was stopped. The mean maximum pain score preoperatively was 9.3. All patients had successful test stimulation with > 50% pain relief prior to implantation of the IPG (mean maximum VAS Score 3.6). The beneficial effect, however, was lost within the next few months despite adjustment of stimulation settings. With higher amplitudes, side effects such as pain attacks or motor phenomena occurred. They disappeared after stopping stimulation, but neuropathic pain recurred to its full extent. The study was stopped 18 months after the first implantation, when the third and last IPG of this series was explanted. Due to the overall short-term effect of stimulation, no relevant changes in ratings for quality of life, activities of daily living, or depression were detected.

Conclusions
Spinal nerve root stimulation proved to be effective on short-term follow-up in 3 patients with neuropathic pain in a dermatomal distribution. Long-term stimulation, however, was disappointing because of the loss of effectiveness and the occurrence of side effects.