nils-herrmann/clean_scirepeval huggingface dataset:
Effects of raloxifene treatment on the phenotype of blood monocytes.

Raloxifene (RLX), a selective oestrogen receptor modulator, has oestrogen-agonist effects on bone, lipoproteins, and homocysteine and oestrogen-antagonist activity in the breast and uterus, positioning it as a potential drug for long-term prevention of coronary heart disease in postmenopausal women. To further evaluate its influence on cardiovascular risk factors, we studied the effects of 60 mg/day RLX on serum lipid levels, inflammatory (high-sensitivity C-reactive protein, and coagulation (fibrinogen) markers, monocytes, and fibrinolysis in 15 healthy postmenopausal women. Markers were measured at baseline, after 1 month without treatment, and after 3 months of treatment. Fibrinolysis was evaluated using the euglobulin clot lysis time (ECLT) determined with a new semiautomatic optical method. Monocyte phenotype was determined by measurement of the expression of the antigens CD14, HLA-DR, and CD62-L using flow cytometry. After 3 months of RLX treatment, we observed a decrease in total cholesterol (p = 0.002), in low-density lipoprotein cholesterol (p <0.001), and in lipoprotein A (p = 0.01). Fibrinogen (p = 0.002) decreased significantly, and high-sensitivity C-reactive protein had a tendency to decrease, but this did not reach statistical significance (p = 0.06). RLX treatment had no effect on ECLT (p = 0.223) or on white blood cell, lymphocyte, and total monocyte counts (p = 0.313). Monocyte expression of HLA-DR, CD14, and CD62-L was not modified by the treatment. In conclusion, we confirm that RLX has beneficial short-term effects on levels of lipids and inflammatory markers, with no effect on fibrinolysis or monocyte phenotype.
Effects of omalizumab in patients with food allergy.

Omalizumab is a novel therapy approved for treating patients with moderate to severe persistent allergic asthma with a serum IgE ranging from 30 to 700 IU/mL. We examined the efficacy of omalizumab as a treatment for IgE-mediated food allergy. An Institutional Review Board-approved prospective pilot study was performed to assess the efficacy of omalizumab in 22 patients with persistent asthma and concomitant IgE-mediated food allergy. All patients showed skin test positivity to foods and experienced allergic food reactions based on history. Patients were interviewed on unintentional and/or unauthorized exposures to sensitized foods. Thirteen female and nine male patients (range, 4-66 years old; mean, 38 years) were evaluated in a private practice setting. Mean IgE level was 1120.74 IU/mL. Sensitized allergens included fish, shellfish, peanuts, tree nuts, egg, soybean, and wheat. All 22 (100%) patients maintained significant improvement as shown by a decrease/lack of clinical symptoms on reexposure to sensitized foods. Clinical improvement by the sixth dosage of omalizumab (150-300 mg q. 2-4 weeks) was noted by history and physical examination. Eight patients noted a decrease in their food-induced atopic dermatitis, 13 patients noted a decrease in their food-induced asthma symptoms, 3 patients noted a decrease in their food-induced urticaria, 6 patients noted a decrease in their food-induced rhinosinusitis symptoms, and 9 patients showed efficacy for angioedema and/or anaphylaxis. While treating asthma patients with omalizumab, patients subjectively observed a reduction in their concomitant IgE-mediated food allergy symptoms.
Prehospital electrocardiograms (ECGs) do not improve the process of emergency department care in hospitals with higher usage of ECGs in non-ST-segment elevation myocardial infarction patients.

This article will describe the impact of prehospital electrocardiogram (ECG) use on emergency department (ED) processes of care for non-ST-segment elevation myocardial infarction (NSTEMI) patients and assess the characteristics associated with prehospital ECG use.



This is a retrospective, multicenter, observational analysis of NSTEMI patients captured by the National Cardiovascular Data Registry-Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines (NCDR ACTION-GWTG) in 2007. Patient and hospital data were stratified by documentation of a prehospital ECG (pECG). Hospitals were stratified into tertiles of pECG use by higher pECG (>5.6%, n 91), lower pECG (< or = 5.6%, n = 83), or no pECG (n = 100). Statistical evaluation was done via Wilcoxon rank sum and chi(2) tests.



There were 21 251 patients eligible for analysis. A pECG was documented in 1609 (7.6%) patients. Of 274 hospitals, 100 (36.5%) had no pECGs recorded. Median ED length of stay (LOS) was shorter at no pECG hospitals vs lower pECG hospitals (3.97 h vs 4.12 h, P < 0.05), but not higher pECG hospitals vs no pECG hospitals (3.85 h vs 3.97 h, P = not significant [NS]). A pECG was not associated with an improvement in ED performance metrics (use of aspirin, beta-blocker, any heparin) in the higher pECG hospitals vs no pECG hospitals or the lower pECG hospitals vs no pECG hospitals.



Use of prehospital ECG in NSTEMI patients is uncommon. In contrast to its impact on reperfusion times in ST-segment elevation myocardial infarction (STEMI) patients, its use does not appear to be associated with an improvement in ED processes of care at the hospital level.
Phase III study of cyclophosphamide , doxorubicin , and etoposide compared with carboplatin and paclitaxel in patients with extensive disease small-cell lung cancer 5 , 55

The progression-free survival (PFS) of cyclophosphamide/doxorubicin/etoposide (CDE) and carboplatin/paclitaxel (CP) was compared in chemonaive patients with extensive disease small-cell lung cancer (ED-SCLC). A total of 203 patients were randomised to three-weekly CDE (n = 102) or CP (n = 101) for five cycles. Tumour response rates in CDE and CP were 60% and 61%. PFS of CP was 5.2 months, PFS of CDE 4.9 months (p = 0.60). The major difference in toxicity between CDE and CP was grade 4 leukocytopaenia in 64% and 9% of the patients (p < 0.0001), leading to febrile neutropaenia in 30% and 4% of the patients (p < 0.0001), respectively. This was the reason for differences in the total number of hospital admissions (63 for CDE and 40 for CP, p = 0.0025). This study failed to demonstrate any benefit in PFS with CP compared with CDE. CP was associated with significantly less haematological toxicity, leading to 37% less hospital admissions for febrile neutropaenia.
Beverage-consumption patterns and associations with metabolic risk factors among low-income Latinos with uncontrolled type 2 diabetes.

In the United States, Latinos experience disproportionately higher rates of type 2 diabetes and diabetes-related complications than non-Latino whites. Sugar-sweetened beverage (SSB) consumption is strongly associated with increased risk of developing type 2 diabetes. Reducing caloric intake, particularly from energy-dense, low-nutrient foods or beverages, can be an effective and key strategy for metabolic and weight control. However, little is known about the contribution of various types of beverages, including but not limited to SSBs, to total caloric intake among Latinos with type 2 diabetes. Low-income Latinos (87.7% Puerto Rican) participating in a diabetes self-management intervention trial (N=238) provided cross-sectional, descriptive data on beverage-consumption patterns, anthropometric outcomes, and metabolic characteristics. Beverages accounted for one fifth of the total daily caloric intake. SSBs and milk beverages, respectively, contributed 9.6% of calories to overall daily caloric intake. Interventions directed at diabetes risk factors among low-income Latinos with diabetes can benefit from consideration of beverage-consumption behaviors as an important strategy to reduce caloric and sugar intake.
Pediatric infratentorial ependymoma: prognostic significance of anaplastic histology

Pediatric infratentorial ependymomas are difficult to cure. Despite the availability of advanced therapeutic modalities for brain tumors, total surgical resection remains the most important prognostic factor. Recently, histological grade emerged as an independent prognostic factor for intracranial ependymoma. We retrospectively reviewed the treatment outcome of 33 pediatric patients with infratentorial ependymoma. Progression-free survival (PFS) and overall survival (OS) rates were calculated and relevant prognostic factors were analyzed. Fourteen patients (42%) were under the age of 3 at diagnosis. Gross total resection was achieved in 16 patients (49%). Anaplastic histology was found in 13 patients (39%). Adjuvant therapies were delayed until progression in 12 patients (36%). Actuarial PFS rates were 64% in the first year and 29% in the fifth year. Actuarial OS rates were 91% in the first year and 71% in the fifth year. On univariate analysis, brainstem invasion (P = 0.047), anaplastic histology (P = 0.004), higher mitotic count (P = 0.001), and higher Ki-67 index (P = 0.004) were significantly related to a shorter PFS. Gross total resection (P = 0.029) and a greater age at diagnosis (P = 0.033) were significantly related to a longer PFS. On multivariate analysis, anaplastic histology alone was significantly related to a shorter PFS (P = 0.023). Gross total resection (P = 0.039) was significantly related to a longer overall survival (OS) on multivariate analysis. Anaplastic histology and gross total resection were the most important clinical factors affecting PFS and OS, respectively. Anaplastic histology, mitotic count, and Ki-67 index can be used as universal and easily available prognostic parameters in infratentorial ependymomas.
Preoperative localization of hand motor cortex by adaptive spatial filtering of magnetoencephalography data.

OBJECT
The goal of this study was to examine the sensitivity and specificity in preoperative localization of hand motor cortex by imaging regional event-related desynchronization (ERD) of brainwaves in the beta frequency band (15-25 Hz) involved in self-paced movement.



Using magnetoencephalography (MEG), the authors measured ERD that occurred before self-paced unilateral index finger flexion in 66 patients with brain tumors, epilepsy, and arteriovenous malformations.



The authors applied an adaptive spatial filtering algorithm to MEG data and found that peaks of the tomographic distribution of beta-band ERD sources reliably localized hand motor cortex compared with electrical cortical stimulation. They also observed high specificity in estimating contralateral hand motor cortical representations relative to somatosensory cortex. Neither presence nor location of tumor changed the qualitative or quantitative location of motor cortex relative to somatosensory cortex.



An imaging protocol using ERD obtained by adaptive spatial filtering of MEG data can be used for extremely reliable preoperative localization of hand motor cortex.
Predictors of outcome from computer-based treatment for substance use disorders: Results from a randomized clinical trial.

Although empirical evidence for the effectiveness of technology-mediated interventions for substance use disorders is rapidly growing, the role of baseline characteristics of patients in predicting treatment outcomes of a technology-based therapy is largely unknown.



Participants were randomly assigned to either standard methadone maintenance treatment or reduced standard treatment combined with the computer-based therapeutic education system (TES). An array of demographic and behavioral characteristics of participants (N=160) was measured at baseline. Opioid abstinence and treatment retention were measured weekly for a 52-week intervention period. Generalized linear model and Cox-regression were used to estimate the predictive roles of baseline characteristics in predicting treatment outcomes.



We found significant predictors of opioid abstinence and treatment retention within and across conditions. Among 21 baseline characteristics of participants, employment status, anxiety, and ambivalent attitudes toward substance use predicted better opioid abstinence in the reduced-standard-plus-TES condition compared to standard treatment. Participants who had used cocaine/crack in the past 30 days at baseline showed lower dropout rates in standard treatment, whereas those who had not used exhibited lower dropout rates in the reduced-standard-plus-TES condition.



This study is the first randomized controlled trial, evaluating over a 12-month period, how various aspects of participant characteristics impact outcomes for treatments that do or do not include technology-based therapy. Compared to standard alone treatment, including TES as part of the care was preferable for patients who were employed, highly anxious, and ambivalent about substance use and did not produce worse outcomes for any subgroups of participants.
Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.

To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission.



Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm.



Study participants from Malawi, South Africa, Zambia, Zimbabwe, and the USA were instructed to apply study gel up to 1 h before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up.



The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 gel, BufferGel, placebo gel, and no gel arms were 2.70, 4.14, 3.91, and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 gel arm was lower than the placebo gel arm (hazard ratio = 0.7, P = 0.10) and the no gel arm (hazard ratio = 0.67, P = 0.06). HIV incidence rates were similar in the BufferGel and both placebo gel (hazard ratio = 1.10, P = 0.63) and no gel control arms (hazard ratio = 1.05, P = 0.78). HIV incidence was similar in the placebo gel and no gel arms (hazard ratio = 0.97, P = 0.89).



The 0.5% PRO2000 gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the Microbicide Development Programme (MDP) 301 trial have confirmed that 0.5% PRO2000 gel has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were well tolerated.
Interactive Exposure With a Blood Glucose Monitor With a Novel Glucose Color Range Indicator Is Associated With Improved Glucose Range Interpretation and Awareness in Patients With Type 2 Diabetes.

The ability of patients to achieve glycemic control depends in part on their ability to interpret and act on blood glucose (BG) results. This clinical study was conducted to determine if a simple on-meter color range indicator (CRI) could improve the ability of patients to categorize BG values into low, in-range, and high glycemic ranges.



The clinical study was conducted in 59 subjects with type 2 diabetes (T2DM). Subjects classified 50 general, 15 before- and 15 after-meal BG values as low, in-range, or high based on their current knowledge. Subjects then interactively experienced the on-meter CRI, which showed whether alternate BG values were low, in-range, or high. After CRI interaction, subjects repeated the original scoring assessment followed by a survey exploring their awareness of glucose ranges.



Following interaction with the CRI, subjects improved their ability to categorize general, before-meal and after-meal BG results by 23.4% ± 3.0% (SEM), 14.2% ± 2.4%, and 16.1% ± 2.9%, respectively (all P < .001), into low, in-range, and high glycemic ranges. Improvement was not accompanied by an increase in time spent categorizing results. There was no correlation between subject HbA1c, test frequency, or duration of diabetes and ability to correctly classify results. Subjects agreed the CRI feature helped them easily interpret glucose values and improved their awareness of glucose ranges.



A short interactive session with a meter including a CRI feature improved the ability of T2DM subjects to interpret and categorize BG values into recommended ranges.
Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement

As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here.



A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated.



Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point.



Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.
Effect of switch to the highest dose of rosuvastatin versus add-on-statin fenofibrate versus add-on-statin nicotinic acid/laropiprant on oxidative stress markers in patients with mixed dyslipidemia.

Oxidative stress plays an important role in atherosclerosis. Both F2-isoprostane (8-iso-PGF2a) and oxidized low-density lipoprotein (ox-LDL) have emerged as biomarkers of oxidative stress and have been proposed as useful biomarkers that could potentially be used as indicators of cardiovascular disease.



This is a prespecified analysis of a prospective, randomized, open-label, blinded endpoint (PROBE) study ( Patients (N = 100) with mixed dyslipidemia on a standard statin dose (10-40 mg simvastatin or 10-20 mg atorvastatin or 5-10 mg rosuvastatin) who had not achieved lipid targets were randomized to switch to the highest dose of rosuvastatin (40 mg/day) or to add-on-statin extended release nicotinic acid (ER-NA)/laropiprant (LRPT) (1000/20 mg/day for the first 4 weeks followed by 2000/40 mg/day for the next 8 weeks) or to add-on-statin micronized fenofibrate (200 mg/day) for a total of 3 months. Levels of plasma and urine F2-isoprostane and plasma ox-LDL were assessed at baseline and 3 months later.



Plasma F2-isoprostane levels decreased similarly in all groups. On the other hand, both ox-LDL and urine F2-isoprostane levels decreased similarly in the add-on ER-NA/LRPT and rosuvastatin monotherapy group, while a less pronounced decrease was observed in the add-on fenofibrate group.



All treatment interventions reduced the concentration of the assessed oxidative stress markers, but the reduction was more pronounced in the add-on ER-NA/LRPT and rosuvastatin monotherapy groups, compared with add-on fenofibrate. Specifically designed studies should address the abovementioned risk factors modulation in terms of cardiovascular risk.
'Remind-to-move' treatment versus constraint-induced movement therapy for children with hemiplegic cerebral palsy: a randomized controlled trial.

To evaluate 'remind-to-move' (RTM) treatment by comparing it with constraint-induced movement therapy (CIMT) and conventional rehabilitation of the upper extremity in children with hemiplegic cerebral palsy (CP).



Seventy-three children (44 males, 29 females; mean age 11y 8mo, standard deviation [SD] 3y 1mo) - with 20, 38, and 15 in Manual Ability Classification System levels I, II, and III respectively - were recruited from three special schools and randomly selected for an RTM (n=25) or CIMT (n=24) programme (for 75h over 3wks) or for conventional rehabilitation (n=24). The Jebsen-Taylor Hand Function Test, the Bruininks-Oseretsky Test of Motor Proficiency (Subtest 3), the Caregiver Functional Use Survey, and arm movement duration captured by accelerometers were used at the baseline, post-test, and 1-month and 3-month follow-ups.



Both the RTM and CIMT treatments achieved significant gains in manual capacities and spontaneous hand use immediately after the intervention compared with conventional rehabilitation, but there were no significant differences between the two interventions.



The RTM treatment demonstrated similar therapeutic effects with CIMT in manual dexterity and functional hand use, but both interventions were superior to conventional rehabilitation. RTM is recommended as an alternative treatment for the hemiplegic upper extremity in children with CP.
Gammadelta T cells for immune therapy of patients with lymphoid malignancies.

There is increasing evidence that gammadelta T cells have potent innate antitumor activity. We described previously that synthetic aminobisphosphonates are potent gammadelta T cell stimulatory compounds that induce cytokine secretion (ie, interferon gamma [IFN-gamma]) and cell-mediated cytotoxicity against lymphoma and myeloma cell lines in vitro. To evaluate the antitumor activity of gammadelta T cells in vivo, we initiated a pilot study of low-dose interleukin 2 (IL-2) in combination with pamidronate in 19 patients with relapsed/refractory low-grade non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). The objectives of this trial were to determine toxicity, the most effective dose for in vivo activation/proliferation of gammadelta T cells, and antilymphoma efficacy of the combination of pamidronate and IL-2. The first 10 patients (cohort A) who entered the study received 90 mg pamidronate intravenously on day 1 followed by increasing dose levels of continuous 24-hour intravenous (IV) infusions of IL-2 (0.25 to 3 x 106 IU/m2) from day 3 to day 8. Even at the highest IL-2 dose level in vivo, gammadelta T-cell activation/proliferation and response to treatment were disappointing with only 1 patient achieving stable disease. Therefore, the next 9 patients were selected by positive in vitro proliferation of gammadelta T cells in response to pamidronate/IL-2 and received a modified treatment schedule (6-hour bolus IV IL-2 infusions from day 1-6). In this patient group (cohort B), significant in vivo activation/proliferation of gammadelta T cells was observed in 5 patients (55%), and objective responses (PR) were achieved in 3 patients (33%). Only patients with significant in vivo proliferation of gammadelta T cells responded to treatment, indicating that gammadelta T cells might contribute to this antilymphoma effect. Overall, administration of pamidronate and low-dose IL-2 was well tolerated. In conclusion, this clinical trial demonstrates, for the first time, that gammadelta T-cell-mediated immunotherapy is feasible and can induce objective tumor responses.