The maintenance of wakefulness test: normative data by age.
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Adult↗
Biomedical subjects
C Shapiro
Publications and source records attributed to C Shapiro.
Behavioral versus behavioral and pharmacological treatment in ADHD children attending a summer treatment program.
As part of the behavioral treatment in the Multimodal Treatment Study of Children with ADHD (MTA9), children participated in an intensive summer treatment program (STP). This study examined the differences between 57 children in the combined treatment (Comb) group, who were medicated, and 60 children in the behavioral treatment (Beh) group, who were unmedicated throughout the STP. Comb children were significantly better than Beh on 5 measures: rule following, good sportsmanship, peer negative nominations, and STP teacher posttreatment ratings of inattention/overactivity. Groups did not differ on any of the other 30 measures, and responded similarly to the STP over time. Comparisons to normative data revealed that Comb children were more likely to fall within the normative range on 6 measures. The differences between these results and the main MTA results, in which Comb was always superior to Beh, are discussed in terms of the relative intensity of combined treatments. The implications for future studies of pharmacological and behavioral treatment for ADHD are discussed.
Attention Deficit Disorder with Hyperactivity↗
Effect of maternal weight gain on infant birth weight.
OBJECTIVE: To ascertain whether increased weight gain during pregnancy resulted in higher birth weight infants. METHODS: A database was constructed from valid data of a sample of 159 healthy women between 19 to 37 years of age. The inclusion criteria were: maternal age of 19-37 years, term gestations (37-42 weeks), a baseline weight obtained at 0-15 weeks gestation, and a final weight obtained within 2 weeks of delivery. Weight gain was calculated by subtracting baseline weight from the final weight. A documented height enabled calculation of BMI. A negative screen for gestational diabetes was required. RESULTS: Women with lower first trimester BMI (< 25) had infants of lower birth weight than women of higher BMI (> 25). Women with lower gain (< 35 lbs) delivered smaller infants than women with higher gain (> 35 lbs). Women of higher BMI and higher gain delivered the largest infants (F = 5.37; p = 0.0015). Underweight women (BMI < 19) gained less weight than women of normal weight (BMI 19-25), who gained the most weight. Obese women (BMI > 29) gained the least weight (F = 6.26; p = 0.0005). CONCLUSION: The results confirmed that excessive maternal weight gain in pregnancy (> 35 lbs), does result in higher birth weight infants.
Adult↗
Multi-institutional study of the angiogenesis inhibitor TNP-470 in metastatic renal carcinoma.
PURPOSE: Renal cell carcinoma is resistant to most chemotherapy, and only a minority of patients respond to immunotherapy. Its highly vascular nature suggests that antiangiogenesis therapy might be useful. We thus performed a phase II study of the fumigillin analog TNP-470 in previously treated patients with metastatic renal cell carcinoma. PATIENTS AND METHODS: Metastatic renal cell carcinoma patients with good organ function were entered onto the study through five separate institutions. There were no exclusion criteria for prior therapy. All patients were treated at a dose of 60 mg/m(2) of TNP-470 infused over 1 hour three times per week. RESULTS: Thirty-three patients were enrolled. Therapy was generally well tolerated, but asthenia, fatigue, vertigo, dizziness, sense of imbalance, and loss of concentration were common and severe enough to lead to therapy discontinuation in five patients. There was only one partial response of short duration (response rate, 3%, 95% confidence interval, 0% to 16%), but six patients (18%) remained on study for 6 or more months without toxicity or disease progression. CONCLUSION: Long-term therapy with TNP-470 has manageable toxicities and is feasible in patients with metastatic renal cell carcinoma but does not lead to any significant objective responses. Further studies in this population using TNP-470 schedules that produce more prolonged drug levels and clinical trial end points other than objective tumor regression may be indicated.
Adult↗
Emerging ethical issues in nephrology nursing--part I.
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Aged↗
Mononeuropathy multiplex due to infiltration of lymphoma in hematologic remission.
We report a case of progressive mononeuropathy multiplex in a patient with lymphoma in hematologic remission. At the time of presentation there was no evidence of meningeal or central nervous system metastasis. At autopsy, extensive infiltration of tumor cells was found in both femoral nerves. We review the literature pertaining to multifocal malignant lymphoid infiltration of peripheral nerves, which can occur during hematologic remission or in the absence of any evidence of systemic lymphoma.
Fatal Outcome↗
Face-to-face confrontation: effects of closed-circuit technology on children's eyewitness testimony and jurors' decisions.
The present study was designed to examine effects of closed-circuit technology on children's testimony and jurors' perceptions of child witnesses. For the study, a series of elaborately staged mock trials was held. First, 5- to 6-year-old and 8- to 9-year-old children individually participated in a play session with an unfamiliar male confederate. Approximately 2 weeks later, children individually testified about the event at downtown city courtroom. Mock juries composed of community recruits viewed the trials, with the child's testimony presented either live in open court or over closed-circuit television. Mock jurors made ratings concerning the child witness and the defendant, and deliberated to reach a verdict. Results indicated that overall, older children were more accurate witnesses than younger children. However, older, not younger children produced more inaccurate information in free recall. Compared to live testimony in open court, use of closed-circuit technology led to decreased suggestibility for younger children. Testifying in open court was also associated with children experiencing greater pretrial anxiety. Closed-circuit technology did not diminish fact finders' abilities to discriminate accurate from inaccurate child testimony, nor did it directly bias jurors against the defendant. However, closed-circuit testimony biased jurors against child witnesses. Moreover, jurors tended to base their impressions of witness credibility on perceived confidence and consistency. Implications for the use of closed-circuit technology when children testify are discussed.
Adult↗
Autonomic correlates of antidepressant treatment using heart-rate variability analysis.
OBJECTIVE: To assess the 24-hour temporal-domain heart-rate variability correlates of treatment with fluoxetine or doxepin for depression. METHOD: A randomized evaluation of fluoxetine and doxepin measured a 50% change in the Hamilton Depression Rating Scale (HDRS) score as a response to therapy and was correlated with measures of standard deviation of the mean of all 5-minute segments of normal electrocardiographic R-R intervals (SDANN), standard deviation of all normal R-R intervals (SDNN), root mean square of successive differences in R-R intervals (r-MSSD), and percentage difference between adjacent normal R-R intervals that are greater than 50 msec (pNN50) from 24-hour electrocardiogram (ECG) tapes. RESULTS: Ten out of 14 patients responded. Response was associated with an increase in SDANN of 17% (P < 0.05). Nonresponse was associated with a 17% decrease in SDANN and a 22% decrease in SDNN (both P < 0.05). No other measures correlated with therapeutic response. No heart-rate variability (HRV) differences between the 2 drug therapies were observed. CONCLUSION: Twenty-four-hour HRV measures may be useful in assessing response to antidepressant therapy.
Analysis of Variance↗
High-dose multimodality therapy with autologous stem-cell support for stage IIIB breast carcinoma.
PURPOSE: Women with locally unresectable and inflammatory breast carcinoma (IBC) have an approximately 30% 5-year disease-free survival (DFS) rate with conventional multimodality therapy. A short but dose-intensive multimodality phase II trial was designed in an attempt to improve outcome in stage IIIB disease. Mastectomy was performed after high-dose therapy to evaluate pathologic response to treatment. METHODS: Women with newly diagnosed disease received four 2-week cycles of doxorubicin 90 mg/m2 with granulocyte colony-stimulating factor (G-CSF), followed by cyclophosphamide 6,000 mg/m2, thiotepa 500 mg/m2, and carboplatin 800 mg/m2 (CTCb) with marrow and peripheral-blood progenitor cell (PBPC) support. Local therapy consisted of mastectomy and radiotherapy. Tamoxifen (5 years) was begun if the patient was estrogen receptor-positive (ER+). RESULTS: Fifty women (46 stage IIIB [91% IBC], four stage IIIA) entered the study and 47 are assessable. Ten had mastectomy before any systemic therapy (seven with pathologic IBC, three with residual tumor after mastectomy). Eighty percent received full-dose doxorubicin with 60% on schedule. Clinical response rates to induction were 15% complete response (CR), 5% very good partial response (VGPR), 59% partial response (PR), and 21% minor response (MR)/stable disease (SD). Mastectomy after CTCb in 37 patients showed a 14% pathologic CR rate, 29% microscopic foci in breast and/or axilla, and 57% gross tumor. Fifteen (32%) patients have relapsed (median, 17 months post-CTCb). The 30-month DFS is estimated at 64%. For those in pathologic CR, with microscopic, or with gross disease remaining after CTCb, the 30-month DFS is estimated at 100%, 70%, and 38%, respectively. Those with zero, one to three, or > or = four positive nodes at axillary dissection had a median DFS of 31, 18, and 13 months, respectively. CONCLUSION: This short but dose-intensive multimodality approach for stage IIIB breast carcinoma is feasible with encouraging results to date.
Adult↗
A normative study of the maintenance of wakefulness test (MWT).
The maintenance of wakefulness test (MWT) is a daytime polysomnographic procedure which quantifies wake tendency by measuring the ability to remain awake during soporific circumstances. We present normative data based on 64 healthy subjects (27 males and 37 females) who adhered to uniform MWT procedural conditions including polysomnographic montage, illuminance level, seating position, room temperature, meal timing, and subject instructions. When allowed a maximum trial duration of 40 min, subjects' mean sleep latency to the first epoch of sustained sleep was 35.2 +/- 7.9 min. The lower normal limit, defined as two standard deviations below the mean, was 19.4 min. Calculation of data on the basis of a maximum trial duration of 20 min and sleep latency to the first appearance of brief sleep (a microsleep episode or one epoch of any stage of sleep) yielded a mean sleep latency of 18.1 +/- 3.6 min and a lower normal limit of 10.9 min. Sleep latency scores were significantly higher than those previously reported in patients with disorders of excessive somnolence. Therefore, the MWT appears to be a useful procedure in differentiating groups with normal daytime wake tendency from those with impaired wake tendency and in identifying individuals with pathologic inability to remain awake under soporific circumstances.
Adult↗
FFT analysis of EEG during stage 2-to-REM transitions in narcoleptic patients and normal sleepers.
The EEG in REM sleep is markedly different from the EEG in non-REM sleep; however, very little research has been conducted analyzing the transition from NREM to REM sleep. The purpose of this study was to describe the changes in EEG power spectra that coincide with significant physiological events throughout the transition from stage 2 to REM sleep. Furthermore, a comparison of the stage 2 to REM transition between narcoleptic patients and normal sleepers was conducted. Five female and five male patients diagnosed with narcolepsy-cataplexy and 10 normal sleepers matched for age and gender participated. Analyses were based on the consecutive appearance of 3 common physiological indicators of REM sleep: First, a decrease in tonic submental EMG activity; second, the appearance of saw tooth waves; and third, the appearance of rapid eye movements. Systematic changes in EEG power density were evident for delta, theta, alpha and sigma frequencies, across the stage 2-REM transition. These changes appeared to be relatively continuous throughout this transition rather than changing dramatically following the onset of any one of the 3 primary physiological indicators of REM sleep. Furthermore, the transition from stage 2 to stage REM appeared to be similar for narcoleptic patients and normal sleepers.
Adult↗
Children's religious knowledge: implications for understanding satanic ritual abuse allegations.
OBJECTIVES: The goals of the present study were to examine the extent of children's religious, especially satanic, knowledge and to understand the influence of children's age, religious training, family, and media exposure on that knowledge. METHODS: Using a structured interview, 48 3- to 16-year-old children were questioned about their knowledge of: (a) religion and religious worship; (b) religion-related symbols and pictures; and (c) movies, music, and television shows with religious and horror themes. RESULTS: Although few children evinced direct knowledge of ritual abuse, many revealed general knowledge of satanism and satanic worship. With age, children's religious knowledge increased and became more sophisticated. Increased exposure to nonsatanic horror media was associated with more nonreligious knowledge that could be considered precursory to satanic knowledge, and increased exposure to satanic media was associated with more knowledge related to satanism. CONCLUSIONS: Our results suggest that children do not generally possess sufficient knowledge of satanic ritual abuse to make up false allegations on their own. However, many children have knowledge of satanism as well as nonreligious knowledge of violence, death, and illegal activities. It is possible that such knowledge could prompt an investigation of satanic ritual abuse or possibly serve as a starting point from which an allegation is erected.
Adolescent↗
Electrocardiographic effects of fluoxetine and doxepin in patients with major depressive disorder.
Cardiovascular adverse effects are amongst the most serious observed with antidepressant drugs and are often due to effects on cardiac conduction and refractoriness. However, such electrophysiologic effects may not be evident when using conventional electrocardiographic measures. Forty patients with major depressive disorder (according to DSM-III-R criteria) were enrolled in a 6-week double-blind parallel group study of fluoxetine (N = 20) or doxepin (N = 20). Cardiac conduction (QRS duration) and repolarization (corrected QT interval, QTc), were measured using signal-averaged electrocardiograms and 12-lead electrocardiogram at baseline and after 2, 4, and 6 weeks of treatment. Patients taking doxepin (mean daily dosage at 6 weeks 169 +/- 42 mg) were similar to those taking fluoxetine (37 +/- 18 mg) for demographic variables and improvement in depression scores but volunteered more side effects (p = 0.011), especially dry mouth (p < 0.001) and dizziness/lightheadedness (p = 0.005). After 6 weeks, doxepin increased heart rate (69 +/- 12 to 81 +/- 13 beats per minute; p = 0.0003) and prolonged QTc (from 417 +/- 36 to 439 +/- 28 msec; p < 0.03); overall QRS duration was not prolonged but was correlated with serum doxepin concentrations (r = 0.78, p < 0.0001). Fluoxetine had no effect on QTc (428 +/- 24 msec at baseline vs. 430 +/- 24 msec at 6 weeks) or QRS duration (97 +/- 12 msec at baseline vs. 94 +/- 12 msec at 6 weeks). The standard 12-lead electrocardiogram showed no significant change in QRS or QTc for either drug. Using a sensitive measure of electrocardiographic effects, doxepin prolongs repolarization and may slow cardiac conduction. Fluoxetine has no measurable electrocardiographic effects, which suggests an increased safety margin for cardiac adverse effects. The ability of the signal-averaged electrocardiogram to resolve small changes in the electrocardiogram is useful in the assessment of drugs with subtle electrophysiologic effects.
Adult↗
Epidemiology of group C rotavirus infection in Western New York women of childbearing age.
Umbilical cord serum samples (380), an average of 10 per month for 3 years (1990 to 1992), were tested by indirect immunofluorescence assay for group C rotavirus immunoglobulin G. Thirty percent were positive, suggesting that approximately one-third of women of childbearing age in western New York have experienced group C rotavirus infection.
Antibodies, Viral↗
Age-related patterns of care: evidence against ageism in the treatment of early-stage breast cancer.
PURPOSE: To assess whether the use of adjuvant systemic therapy in postmenopausal women with early-stage breast cancer is influenced by patient age. METHODS: A retrospective cohort study based on data collected from medical records and from patients and their surgeons was performed among 746 postmenopausal patients diagnosed with early-stage breast cancer at 30 hospitals located throughout Minnesota. The adjusted odds of receiving hormonal therapy, chemotherapy, and both hormonal therapy and chemotherapy as a function of age was determined. RESULTS: Among women with negative lymph nodes, 62% received some form of adjuvant drug therapy. For these women, the likelihood of receiving hormonal therapy or both hormonal therapy and chemotherapy did not vary with patient age and the likelihood of receiving chemotherapy declined with age. Among women with positive lymph nodes, 92% received some form of adjuvant therapy. For these women, the likelihood of receiving hormonal therapy increased with age and the likelihood of receiving chemotherapy declined with age, as did the likelihood of receiving both hormonal therapy and chemotherapy. CONCLUSION: The observed associations between age and the use of adjuvant systemic therapy appear to reflect, in general, available information about treatment efficacy and do not suggest underuse among elderly women with early-stage breast cancer. The use of adjuvant therapy depends on clinical factors that predict the increased risk of metastases or the increased likelihood of response to treatment, rather than other sociodemographic factors. Our results also suggest that younger postmenopausal women with positive lymph nodes compared with older women may be undertreated with respect to tamoxifen because of the substitution of chemotherapy for hormonal therapy.
Age Factors↗
Trials of 9-amino-20(S)-camptothecin in Boston.
9-Amino-20(S)-camptothecin (9-AC) is an analog of camptothecin with limited water solubility which has shown significant preclinical activity in a variety of human solid tumor xenografts. A Phase I trial using a soluble formulation of 9-AC, given as a 72-hour continuous infusion, has been completed. Thirty-one patients with resistant cancers received 5-60 micrograms/M2/h at three week intervals. The Maximum Tolerated Dose (MTD) was 45 micrograms/M2/hour. Neutropenia was the dose limiting toxicity, with few significant non-myelosuppressive toxicities. Minor responses were seen in 3/31 patients. Pharmacokinetic studies of 9-AC lactone (closed ring) showed substantial interpatient variability with a predicted half-life of 36 hours. A phase I/II trial of the same formulation of 9-AC is ongoing in refractory leukemia. Stomatitis and diarrhea are the non-myelosuppressive dose limiting toxicities. Evidence of antineoplastic activity has been seen in 3/15 patients. A Phase II trial in previously untreated metastatic breast cancer is also underway. A Phase I trial of a colloidal dispersion formulation, not yet completed, is better tolerated with a MTD > 45 micrograms/M2/h as a 72-hour continuous infusion. Evidence of antineoplastic activity has also been demonstrated.
Adult↗
An economic analysis of unilateral refusals to license intellectual property.
The intellectual property laws in the United States provide the owners of intellectual property with discretion to license the right to use that property or to make or sell products that embody the intellectual property. However, the antitrust laws constrain the use of property, including intellectual property, by a firm with market power and may place limitations on the licensing of intellectual property. This paper focuses on one aspect of antitrust law, the so-called "essential facilities doctrine," which may impose a duty upon firms controlling an "essential facility" to make that facility available to their rivals. In the intellectual property context, an obligation to make property available is equivalent to a requirement for compulsory licensing. Compulsory licensing may embrace the requirement that the owner of software permit access to the underlying code so that others can develop compatible application programs. Compulsory licensing may undermine incentives for research and development by reducing the value of an innovation to the inventor. This paper shows that compulsory licensing also may reduce economic efficiency in the short run by facilitating the entry of inefficient producers and by promoting licensing arrangements that result in higher prices.
Costs and Cost Analysis↗
Aggressive variants of chromophobe renal cell carcinoma.
BACKGROUND: Chromophobe renal cell carcinoma (RCC) is a distinctive subtype of RCC with a more favorable prognosis than clear cell RCC. We describe the pathologic features of 23 solitary cases and 2 cases with coexistent papillary RCCs, 7 of which developed metastases. METHODS: Cases were retrieved from the pathology files of our institutions. Clinical follow-up was obtained from the medical records. DNA analysis was performed on Feulgen-stained slides using image analysis. RESULTS: Twenty-five cases were identified. All cases had characteristic pathologic features, including diffuse cytoplasmic reactivity for Hale's colloidal iron. DNA ploidy analysis of ten cases revealed a diploid pattern in five, a hyperdiploid pattern in four, and a hypodiploid pattern in one. Follow-up was available for 20 cases, and metastases developed in 7 (from 4 to 120 months after surgery). In 5 of these cases, the tumors were solitary and more than 8 cm in greatest dimension and metastases developed in the liver. In both cases with papillary RCCs in the same kidney, metastases developed in the lung, although which tumor metastasized is unknown. CONCLUSIONS: Despite the overall favorable prognosis for chromophobe RCC, large tumors and those with coexistent papillary RCCs may produce in metastases.
Adenocarcinoma↗