nils-herrmann/clean_scirepeval huggingface dataset:
Reliability and validity of a Chinese version of the Impact of Pediatric Epilepsy Scale

The Impact of Pediatric Epilepsy Scale (IPES) is an accurate, acceptable, and quick tool that assesses the impact of epilepsy on the child with epilepsy and his or her family. The aim of this study was to investigate its applicability in China. After multistage translation and cultural adaptation, the final Chinese version was administered to 110 parents of children with epilepsy to evaluate its validity, reliability, and sensitivity. All items contributed significantly to the summary measure. With respect to validity, all items were substantially correlated with the criterion questionnaire subscales, and principal component analysis indicated that three factors accounted for 72% of the variance of the scale. The internal consistency coefficients of the first and second tests for the total were 0.916 and 0.930, respectively, and test-retest reliability ranged from 0.891 to 0.992. Additionally, the IPES can detect differences in health-related quality of life (HRQOL) between subjects according to epilepsy severity. In conclusion, this study indicates that the Chinese IPES has good validity, reliability, and sensitivity, and is an epilepsy-specific HRQOL questionnaire that is a brief, accurate, and valid assessment of the influence of epilepsy on the child and family.
Propofol sedation during awake craniotomy for seizures: patient-controlled administration versus neurolept analgesia.

This prospective study evaluated the safety and efficacy of patient-controlled sedation (PCS) using propofol during awake seizure surgery performed under bupivacaine scalp blocks. Thirty-seven patients were randomized to receive either propofol PCS combined with a basal infusion of propofol (n = 20) or neurolept analgesia using an initial bolus dose of fentanyl and droperidol followed by a fentanyl infusion (n = 17). Both groups received supplemental fentanyl and dimenhydrinate for intraoperative pain and nausea, respectively. Comparisons were made between groups for sedation, memory, and cognitive function, patient satisfaction, and incidence of complications. Levels of intraoperative sedation and patient satisfaction were similar between groups. Memory and cognitive function were well preserved in both groups. The incidence of transient episodes of ventilatory rate depression (<8 bpm) was more frequent among the propofol patients (5 vs 0, P = 0.04), particularly after supplemental doses of opioid. Intraoperative seizures were more common among the neurolept patients (7 vs 0, P = 0.002). PCS using propofol represents an effective alternative to neurolept analgesia during awake seizure surgery performed in a monitored care environment.
Phase II study of high-dose aclarubicin in previously treated patients with small-cell lung cancer

Aclarubicin is one of the antitumor anthracyclines (aclacinomycin A) isolated from Streptomyces galilaeus by Oki et al. in 1975 . Preclinical evaluation of aclarubicin has revealed several important differences in the drug's properties relative to the classic anthracyclines doxorubicin and daunombicin. Cellular uptake of aclarubicin occurs more rapidly [11], and in contrast to the classic anthracyclines, aclarubicin does not stimulate topoisomerase II-mediated DNA breaks [6]. Furthermore, only limited, if any crossresistance with aclarubicin has been demonstrated in the two well-defined doxorubicin-resistant phenotypes, P-gp MDR (P-glycoprotein multidrug-resistant) and at-MDR (altered topoisomerase MDR) cells [4, 5]. Aclarubicin given on a single-bolus schedule has not shown clinically relevant activity against solid tumors [1, 2, 7]. In contrast, the drug has demonstrated activity against leukemia. However, these trials have involved the administration of aclarubicin on prolonged schedules over 3 5 consecutive days and at higher cumulative doses [3, 8, 10, 12]. The present report describes a phase II trial of high-dose aclarubicin given on a 3-day treatment schedule to previously treated patients with small-cell lung cancer.
Tissue effects of glutamine in rectal cancer patients treated with preoperative chemoradiotherapy.

The aim was to evaluate the effects of glutamine on tumor regression and histological damage in patients with rectal patients following chemoradiotherapy previous to surgery.



Ten patients with rectal cancer surgically removed after chemoradiotherapy were included, a subgroup of a randomized trial that compared glutamine and placebo in the prevention of acute radiation enteritis. Samples of neoplasm and healthy tissue were evaluated by an expert pathologist searching for signs of tumor regression, muciphages, and signs of radiation-induced damage.



There were no differences in the grade of tumor regression with either glutamine or placebo. All patients who received glutamine presented muciphages, compared with 28.6% of the placebo group (p = 0.038). Histological damage was similar in patients receiving glutamine or placebo, and between those with radiation enteritis or without toxicity.



Glutamine did not exert a protective effect over chemoradiotherapy in rectal cancer or healthy rectal tissue.
A phase 1b study of erlotinib in combination with gemcitabine and nab-paclitaxel in patients with previously untreated advanced pancreatic cancer: an Academic Oncology GI Cancer Consortium study

Addition of either nab-paclitaxel or erlotinib to gemcitabine to treat advanced pancreatic cancer has demonstrated overall survival benefit. This study was conducted to evaluate the tolerability and safety of combining all three drugs and assess preliminary evidence of efficacy. In this open-label, phase 1b study, patients with previously untreated, advanced pancreatic cancer were treated in 28-day cycles with intravenous gemcitabine/nab-paclitaxel on days 1, 8, and 15, and once daily oral erlotinib. A standard “3 + 3” design was used. Dose level 1 (DL1) for gemcitabine (mg/m2)/nab-paclitaxel (mg/m2)/erlotinib (mg) was 1000/125/100, respectively, with de-escalation to DL−1 (1000/100/100), DL−2b (1000/75/100), and DL−3 (1000/75/75). The maximum tolerated dose (MTD) was defined by occurrence of dose-limiting toxicity (DLT) in ≤1 of six patients within the first cycle. Efficacy was assessed with CT scans performed at two-cycle intervals. Nineteen patients were enrolled. DLTs occurred in two patients at DL1, three patients at DL−1, two patients at DL−2b, and one patient at DL−3. The MTD for the combination of gemcitabine/nab-paclitaxel/erlotinib was DL−3 (1000/75/75). In analyses of efficacy among 14 evaluable patients, partial responses were observed in four of six patients at DL1, one of two patients at DL−2b, and two of six patients at DL−3. The addition of erlotinib to gemcitabine and nab-paclitaxel is not tolerable at standard single-agent dosing of all drugs. However, significant clinical activity was noted, even at DL−3. Further study of the combination will need to incorporate reduced dosing.
Link of dietary patterns with metabolic syndrome: analysis of the National Health and Nutrition Examination Survey

Population-based interventions aimed at halting the increasing prevalence of metabolic syndrome (MetS) require thorough understanding of dietary interplays. Objective is to identify the independent dietary nutrients associated with MetS and its components using dietary pattern identification and the single-nutrient approaches in The United States.This is a cross-sectional observation. Participants are selected from the National Health and Nutrition Examination Survey (NHANES) with available dietary intake, biochemical and anthropometrical data from 2001 to 2012. Exposure is diet obtained from 24-h dietary recall. Main outcome measure is MetS and its components.Overall, 23 157 eligible individuals including 6561 with MetS were included in the final analysis. Using principle component analysis, we identified three food patterns that explained 50.8% of the variance of the dietary nutrient consumption. The highest quartile of the factor score representative of saturated/monounsaturated fatty acids or the first dietary pattern was associated with 1.27-fold (95% confidence interval (CI): 1.10–1.46, P=0.001) higher odds of association with MetS when compared with the first quartile. The second pattern representative of vitamins and trace elements had an odds ratio of 0.79 (95% CI: 0.70–0.89, P<0.001) for association with MetS, and the third pattern representative of polyunsaturated fatty acids did not have any association with MetS. The nutrient-by-nutrient approach showed that mild alcohol intake and lower consumption of total saturated fatty acids and sodium were associated with lower risk of MetS.Conclusions:Application of multiple complementary analytic approaches reveals more comprehensive dietary determinants of MetS and its components as potential intervening targets.
Osseofix® system for percutaneous stabilization of osteoporotic and tumorous vertebral compression fractures - clinical and radiological results after 12 months.

Determining whether implantation of an expandable titanium mesh cage (Osseofix® system) is a successful and safe minimally invasive therapy for osteoporotic and tumorous vertebral compression fractures (VCFs).



32 patients (25 women, 7 men, mean age 71) with 46 osteoporotic or tumorous VCFs (T6 to L4) from June 2010 to January 2012 were included. All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). The clinical and radiological results were evaluated preop, postop and 12 months postop based on the visual analog scale (VAS) and the Oswestry Disability Index (ODI), X-ray (Beck Index, Cobb angle) and CT.



There was a significant improvement in pain intensity (VAS) (7.8 to 1.6) as well as a significant reduction in the mean ODI (71.36 % to 30.4 %) after 12 months. The mean kyphotic angle according to Cobb showed significant improvements (12.3° to 10.8°) after 12 months. Postinterventional imaging showed one case of loss of height in a stabilized lumbar vertebral body (2.2 %) in osteoporosis and one case with adjacent fracture (2.2 %) in osteoporosis. We saw no changes in the posterior vertebral wall. Except for one pronounced postoperative hematoma, we saw no surgical complications including no cement leakage.



The clinical mid-term results are good at a low complication rate. The stabilization of symptomatic osteoporotic and tumorous VCFs with the Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.



• The Osseofix® system is well suited for stabilizing osteoporotic and tumorous VCFs.• It is a safe and effective procedure without cement leakage and with a low complication rate.• The procedure is an interesting alternative to established cement augmentation procedures.
Randomized trial of tamoxifen alone or combined with fluoxymesterone as adjuvant therapy in postmenopausal women with resected estrogen receptor positive breast cancer. North Central Cancer Treatment Group Trial 89-30-52

This clinical trial evaluated the addition of fluoxymesterone (Flu) to tamoxifen (Tam) in women with resected early stage breast cancer and attempted to corroborate the findings of superiority for the combination over Tam alone seen in a previous randomized trial in metastatic disease. Postmenopausal women with early stage breast cancer that was known to be estrogen receptor (ER) positive were randomized to treatment with Tam (20 mg per day orally for 5 years) alone or combined with Flu (10 mg orally twice per day for 1 year). The primary endpoint was relapse-free survival (RFS) defined as local-regional or distant recurrence including ductal carcinoma in situ of the ipsilateral, but not contralateral breast, and death from any cause. There were 541 eligible patients entered between 1991 and 1995 and the treatment arms were balanced with respect to patient characteristics. The median follow up of patients still alive was 11.4 years. No significant difference was found between Tam plus Flu and Tam alone in terms of RFS or overall survival. The adjusted hazard ratio (Tam+Flu/Tam) for relapse or death without relapse was estimated to be 0.84 (95% CI: 0.64–1.10) and that for death was 0.89 (95% CI: 0.67–1.18). As expected there was more virilization in women who received Flu. This clinical trial did not demonstrate superiority of Tam plus Flu over Tam alone as adjuvant therapy for postmenopausal women with resected early breast cancer known to be ER positive.
Effect of surgical approach for total hip replacement on hip function using Harris Hip scores and Trendelenburg's test. A retrospective analysis.

A retrospective analysis of osteoarthritis patients undergoing primary hip arthroplasty, to assess which surgical approach produces the best functional results at one-year post-operatively, using common clinical scoring systems and tests. The aim of this study was to compare the anterolateral and the posterior approaches to total hip arthroplasty using Harris Hip scores and Trendelenburg's test by looking at pre-operative results and comparing them to post-operative results.



Data from 3416 consecutive cases were extracted from a multicentre database, maintained by the Tayside Arthroplasty Audit Group (TAAG) situated in Tayside, using only patients who had undergone a primary hip arthroplasty and had a clinical diagnosis of osteoarthritis.



Analysis showed that there was statistically significant difference between the two approaches for Harris Hip score (p = 0.0344), Harris Hip function score (p = 0.0035) and Trendelenburg Test (p =< 0.00001). The posterior approach showed larger improvements in Harris Hip scores. There was an increased incidence of dislocation in the posterior approach group (6.9%) but an increased incidence of Trendelenburg gait in anterolateral approach group (5.7%). It was found that patients who suffered a dislocation had similar functional outcomes for both groups with no statistical difference.



These results suggest that there may be benefit in using a posterior approach to primary total hip arthroplasty but due to limitations of the data within this study further more detailed research is required.
Effect of inhaled sulphur dioxide and carbon particles on heart rate variability and markers of inflammation and coagulation in human subjects.

To measure the inflammatory and autonomic responses of healthy humans and patients with coronary artery disease to controlled concentrations of two specific components of vehicle derived air pollution, carbon particles and sulphur dioxide (SO2).



Placebo controlled, double blind, random order human challenge study examining the effects of carbon particles (50 microg/m3) and SO2 (200 parts per billion (ppb)) on heart rate variability (HRV) and circulating markers of inflammation and coagulation in healthy volunteers and patients with stable angina.



In healthy volunteers, markers of cardiac vagal control did not fall in response to particle exposure but, compared with the response to air, increased transiently immediately after exposure (root mean square of successive RR interval differences (RMSSD) 15 (5) ms with carbon particles and 4 (3) ms) with air, p < 0.05). SO2 exposure resulted in no immediate change but a significant reduction in HRV markers of cardiac vagal control at four hours (RMSSD -2 (3.6) ms with air, -7 (2.7) ms with SO2, p < 0.05). No such changes were seen in patients with stable angina. Neither pollutant caused any change in markers of inflammation or coagulation at zero, four, or 24 hours.



In healthy volunteers, short term exposure to pure carbon particles does not cause adverse effects on HRV or a systemic inflammatory response. The adverse effects of vehicle derived particulates are likely to be caused by more reactive species found on the particle surface. SO2 exposure does, however, reduce cardiac vagal control, a response that would be expected to increase susceptibility to ventricular arrhythmia.
Scalp hypothermia to prevent chemotherapy-induced alopecia is effective and safe: A pilot study of a new digitized scalp-cooling system used in 74 patients

Goals. The aim of this study was to examine the efficacy and safety of a new digitized, controlled, scalp-cooling system to prevent chemotherapy-induced alopecia.  Seventy-four female cancer patients who received 13 varying chemotherapy regimens were included in a nonrandomized pilot study. The Digni 2–3 with Dignicap system consists of a refrigerator unit and a control unit integrated into a mobile cabinet and connected to a tight-fitting cooling cap. This system maintains a constant scalp temperature of +5°C for many hours. In this study, 60 patients were treated for ovarian cancer with either taxane or epirubicin combination chemotherapy. Eight patients with Hodgkin's lymphoma, three with breast cancer, two with endometrial cancer, and one with sarcoma were also included. Photo documentation and patient assessment of hair loss and discomfort were performed.  In anthracycline-treated patients, total prevention of hair loss was observed, whereas hair loss in paclitaxel/docetaxel-treated patients was minimal to none. The combination of anthracycline and taxane resulted in more hair loss, but only three of six patients used a wig. Scalp cooling was generally very well tolerated; only two of 74 patients discontinued use of the cold cap due to discomfort. No scalp metastases occurred over a median follow-up period of 15 months.  The digitized, controlled, scalp-cooling system represents an effective and safe device that should be clinically evaluated in a randomized trial and in studies using other chemotherapy regimens to determine optimal temperatures and durations of cooling for maximal efficacy.
Changes of exhaled nitric oxide during steroid treatment of childhood asthma.

Exhaled nitric oxide (eNO) is elevated in several inflammatory airway diseases and is significantly reduced by anti-inflammatory treatment with inhaled steroids. The aim of this randomized, open clinical trial was to evaluate eNO in relation to conventional lung function parameters at rest and after exercise during sequential changes of inhaled steroids in children with persistent asthma. The study consisted of a 4 week run-in period, a 4 week washout phase and a randomized treatment period during which only one group was treated again with inhaled budesonide. After run-in, eNO was reduced to normal values, and rose again during washout. In the patients randomized to steroid treatment, eNO was again decreased, whereas it remained unchanged in the untreated patients. Forced expiratory volume in one second and forced vital capacity at rest and after exercise improved significantly after run-in, but showed no difference after randomization. However there was a strong correlation of eNO with patient compliance. Exhaled nitric oxide was able to differentiate between children briefly treated with or without steroids, the conventional lung-function variables however could not. In practice exhaled nitric oxide may thus be a valuable parameter to monitor adherence to steroids, but less suitable to describe physiologically relevant impairments of lung function.
Diabetes Antibody Standardization Program: evaluation of assays for insulin autoantibodies

Insulin autoantibodies (IAA) are important in type 1 diabetes risk assessment. However, their determination varies more between laboratories than other diabetes autoantibodies. The Diabetes Antibody Standardization Program (DASP) aims to improve and standardise measurement of autoantibodies associated with type 1 diabetes. We report the results of measurement of IAA from DASP workshops in 2002, 2003 and 2005. Up to 32 laboratories in 14 countries participated in each workshop. Aliquots of coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 blood donor controls were circulated to participating laboratories. Reported results were analysed using receiver operator characteristic (ROC) curves. We compared concordance of antibody levels by ranking, IAA and insulin antibody (IA) indices and units derived from an IA standard curve. In all three workshops IAA assay performance had improved compared with DASP 2000. The median area under the ROC curve was 0.73 in DASP 2002, 0.78 in 2003 and 0.80 in 2005 (p = 0.0012), and median laboratory-assigned sensitivity was 26% in 2002, 36% in 2003 and 45% in 2005 (p < 0.0001). There was, however, marked variation between assays. The range of AUC was 0.36–0.91 and that of laboratory-assigned sensitivity was 22–57%. Concordance of ranking of patient serum samples was related to AUC (p < 0.001). Using an index related to common IAA and IA-positive or -negative control sera improved the concordance between assays (p < 0.0001). The overall performance of IAA assays has improved but there is still wide variation between laboratories. Concordance between assays would be improved by the use of a common reference reagent.
Virtual Reality Exposure Therapy: 150-Degree Screen to Desktop PC

Virtual reality exposure therapy (VRET) developed using immersive or semi-immersive virtual environments present a usability problem for practitioners. To meet practitioner requirements for lower cost and portability VRET programs must often be ported onto desktop environments such as the personal computer (PC). However, success of VRET has been shown to be linked to presence, and the environment's ability to evoke the same reactions and emotions as a real experience. It is generally accepted that high-end virtual environments (VEs) are more immersive than desktop PCs, but level of immersion does not always predict level of presence. This paper reports on the impact on presence of porting a therapeutic VR application for schizophrenia from the initial research environment of a semi-immersive curved screen to PC. Presence in these two environments is measured both introspectively and across a number of causal factors thought to underlie the experience of presence. Results show that the VR exposure program successfully made users feel they were "present" in both platforms. While the desktop PC achieved higher scores on presence across causal factors participants reported they felt more present in the curved screen environment. While comparison of the two groups was statistically significant for the PQ but not for the IPQ, subjective reports of experiences in the environments should be considered in future research as the success of VRET relies heavily on the emotional response of patients to the therapeutic program.