nils-herrmann/clean_scirepeval huggingface dataset:
Zabofloxacin versus moxifloxacin in patients with COPD exacerbation: a multicenter, double-blind, double-dummy, randomized, controlled, Phase III, non-inferiority trial

A new quinolone, zabofloxacin, has now been developed; hence, a non-inferiority trial is needed to compare this new compound with another widely used quinolone to examine its efficacy and safety for the treatment of chronic obstructive pulmonary disease (COPD) exacerbations. This was a prospective, multicenter, double-blind, double-dummy, randomized, controlled, parallel-group, Phase III, non-inferiority clinical trial designed to compare oral zabofloxacin (367 mg once daily for 5 days) with moxifloxacin (400 mg once daily for 7 days) for the treatment of patients with COPD exacerbation. In all, 345 COPD patients with a moderate COPD exacerbation were enrolled in the study via the outpatient clinics at 31 university hospitals. Clinical per protocol analysis revealed that the clinical cure rate for zabofloxacin was 86.7% and that for moxifloxacin was 86.3% (the rate difference, 0.4%; 95% confidence interval, -7.7%-8.6%). Intention-to-treat analysis revealed clinical cure rates of 77.1% and 77.3% (difference, -0.2%; 95% confidence interval, -9.0%-8.8%), respectively. These results confirm that zabofloxacin is not inferior to moxifloxacin. The favorable microbiological response rate for zabofloxacin was 67.4% and that for moxifloxacin was 79.5% (P=0.22). Patients in the zabofloxacin group showed better patient-oriented outcomes, as measured by EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome and the COPD assessment test scores, than patients in the moxifloxacin group. Adverse drug reactions related to zabofloxacin occurred in 9.7% of cases and those related to moxifloxacin occurred in 9.6% of cases (P=0.97). The dropout rate due to adverse events was 0% (0/175) in the zabofloxacin group and 1.8% (3/167) in the moxifloxacin group (P=0.12). Oral zabofloxacin (367 mg once daily for 5 days) was not inferior to oral moxifloxacin (400 mg once daily for 7 days) for the treatment of patients with COPD exacerbation.
Acute toxicity profile in prostate cancer with conventional and hypofractionated treatment

To compare the acute toxicities in radical treatment of prostate cancer between conventional schedule (C-ARM) with 78 Gy/39 fractions and hypofractionation conformal treatment (H-ARM) with 69 Gy/23 fractions.



This prospective double arm study consisted of 217 patients with prostate cancer, 112 in H-ARM and 105 in C-ARM arm. C-ARM received conventional six- field conformal radiotherapy with 78 Gy in 39 fractions while H-ARM received hypofractionation with 69 Gy in 23 fractions. Weekly assessment of acute reactions was done during treatment and with one, and 3 months using RTOG scale. Univariated analysis was performed to evaluate differences between the incidences of acute reaction in the treatment arms. Variables with p value less than 0.1 were included in the multivariated logistic regression.



There was no difference between H-ARM versus C-ARM for severity and incidence in genitourinary (GU) and gastrointestinal (GI) acute toxicity. During the treatment comparing H-ARM with C-ARM no differences was observed for GI toxicity (grade 0-3; H-ARM=45.5%, 34%, 18.7% and 1.8% versus C-ARM=47.6%, 35.2%, 17.2% and 0). For acute GU toxicity no difference was detected between H-ARM (grade 0-3; 22.3%, 54.5%, 18.7% and 4.5%) and C-ARM (grade 0-3; 25.8%, 53.3%, 17.1% and 3.8%).At the 3- months follow-up, persistent Grade> =2 acute GU and GI toxicity were 2.5% and 1.8% in H-ARM versus 5.7% and 3% in C-ARM (p>0.05). In univariated and multivariated analyses, there was not any dosimetric predictor for GI and GU toxicity.



Our data demonstrate that hypofractionated radiotherapy achieving high biological effective dose using conformal radiotherapy is feasible for prostate cancer, being well tolerated with minimal severe acute toxicity.
Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen.



In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy.



The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events.



Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks.
Understanding and beliefs of diabetes in the UK Bangladeshi population.

To examine the understanding and beliefs of people with diabetes from the Bangladeshi community living in the UK.



Structured interviews were carried out with 14 people invited to a peer educational programme. All interviews were on a one-to-one basis and were in Sylheti or in English. Interviews were transcribed and analysed by two independent researchers.



The majority of participants did not know what caused diabetes. Knowledge of the management of diabetes was linked to controlling sugar intake and a number of participants reported eating bitter foods such as bitter gourd to control their diabetes. There was little access to information as many participants did not speak English and did not have a Bengali-speaking doctor. The majority of participants felt that education classes should teach them what the doctor thought was important and that these classes would best be advertised by word of mouth. Therefore, participants were quite passive about their own self management and relied very strongly on the doctor's views and recommendations.



Findings from this study can be used to help health professionals working with Bangladeshi people. There is a need for improved information for Bangladeshi people and much of this information might need to come from health professionals. In addition, there is a need for increased awareness by health professionals of practices used by Bangladeshi people, such as eating bitter gourd (which may enhance the effects of rosiglitazone), and the influence these practices could have on the individual's diabetes management.
Community and Team Member Factors that Influence the Early Phase Functioning of Community Prevention Teams: The PROSPER Project

This research examines the early development of community teams in a specific university–community partnership project called PROSPER (Spoth et al.,  2004). PROSPER supports local community teams in rural areas and small towns to implement evidence-based programs intended to support positive youth development and reduce early substance use. The study evaluated 14 community teams and included longitudinal data from 108 team members. Specifically, it examined how community demographics and team member characteristics, perceptions, and attitudes at initial team formation were related to local team functioning 6 months later, when teams were planning for prevention program implementation. Findings indicate that community demographics (poverty), perceived community readiness, characteristics of local team members (previous collaborative experience) and attitudes toward prevention played a substantial role in predicting the quality of community team functioning 6 months later. Editors’ Strategic Implications: The authors identify barriers to successful long-term implementation of prevention programs and add to a small, but important, longitudinal research knowledge base related to community coalitions.
Tegaserod for the Treatment of Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Multinational Study

Chronic constipation is a common, persistent disorder with limited effective treatment options. This study investigated the efficacy, safety, and tolerability of tegaserod in the treatment of chronic constipation.After a 2-wk baseline period, patients were randomized to double-blind treatment of 12 wk with tegaserod (2 or 6 mg b.i.d.) or placebo. Response during weeks 1–4 (primary variable) was defined as an increase in complete spontaneous bowel movement (CSBM)/wk. Secondary variables included response during weeks 1–12, patient evaluation of individual symptoms, and global assessment of bowel habits and constipation.One thousand two hundred and sixty-four patients were randomized to tegaserod or placebo. Responder rates for the primary efficacy variable were 35.6% for tegaserod 2 mg b.i.d. (p = 0.0059 vs placebo), 40.2% for 6 mg b.i.d. (p < 0.0001 vs placebo) and 26.7% for placebo. The number needed to treat was 7.3 for the 6 mg b.i.d. dose compared with 11.1 for tegaserod 2 mg b.i.d. Tegaserod 6 mg b.i.d. reduced straining, abdominal bloating/distension, and abdominal pain/discomfort during the 12-wk treatment period compared with placebo (p < 0.05 for all symptoms). Significant improvements were also seen in stool form and in global assessment of bowel habits and constipation. The most common adverse events, headache and abdominal pain, were more frequent with placebo than with tegaserod.Tegaserod was efficacious in relieving symptoms of chronic constipation and was well tolerated.
Dose and polymorphic genes xrcc1, xrcc3, gst play a role in the risk of articledeveloping erythema in breast cancer patients following single shot partial breast irradiation after conservative surgery

To evaluate the association between polymorphisms involved in DNA repair and oxidative stress genes and mean dose to whole breast on acute skin reactions (erythema) in breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery. Acute toxicity was assessed using vers.3 criteria. single nucleotides polymorphisms(SNPs) in genes: XRCC1(Arg399Gln/Arg194Trp), XRCC3 (A4541G-5'UTR/Thr241Met), GSTP1(Ile105Val), GSTA1 and RAD51(untranslated region). SNPs were determined in 57 BC patients by the Pyrosequencing analysis. Univariate(ORs and 95% CI) and logistic multivariate analyses (MVA) were performed to correlate polymorphic genes with the risk of developing acute skin reactions to radiotherapy. After SSPBI on the tumour bed following conservative surgery, grade 1 or 2 acute erythema was observed in 19 pts(33%). Univariate analysis indicated a higher significant risk of developing erythema in patients with polymorphic variant wt XRCC1Arg194Trp, mut/het XRCC3Thr241Met, wt/het XRCC3A4541G-5'UTR. Similarly a higher erythema rate was also found in the presence of mut/het of XRCC1Arg194Trp or wt of GSTA1. Whereas, a lower erythema rate was observed in patients with mut/het of XRCC1Arg194Trp or wt of XRCC1Arg399Gln. The mean dose to whole breast(p = 0.002), the presence of either mut/het XRCC1Arg194Trp or wt XRCC3Thr241Met (p = 0.006) and the presence of either mut/het XRCC1Arg194Trp or wt GSTA1(p = 0.031) were confirmed as predictors of radiotherapy-induced erythema by MVA. The Whole breast mean dose together with the presence of some polymorphic genes involved in DNA repair or oxidative stress could explain the erythema observed after SSPBI, but further studies are needed to confirm these results in a larger cohort.
What's smart about the smart grid?

The paper explores the meaning of smart grid, concluding that the term is closely linked with enhanced sensing, actuation and control of power systems. It is suggested that such cyber-physical systems would be more meaningfully described as responsive grids. The paper provides a brief historical perspective of the decision-making that underlies existing, seemingly inflexible, grid structures. It emphasizes the future needs for responsive grids, as a consequence of inevitable growth in renewable generation and newer types of loads such as plug-in electric vehicles. The paper considers the cyber-infrastructure requirements for supporting controllability of highly distributed generation and load resources.
Effects of high-fat overfeeding on mitochondrial function, glucose and fat metabolism, and adipokine levels in low-birth-weight subjects.

Low birth weight (LBW) is associated with an increased risk of insulin resistance and downregulation of oxidative phosphorylation (OXPHOS) genes when exposed to a metabolic challenge of high-fat overfeeding (HFO). To elaborate further on the differential effects of HFO in LBW subjects, we measured in vivo mitochondrial function, insulin secretion, hepatic glucose production, and plasma levels of key regulatory hormones before and after 5 days of HFO in 20 young LBW and 26 normal-birth-weight (NBW) men. The LBW subjects developed peripheral insulin resistance after HFO due to impaired endogenous glucose storage (9.42 ± 4.19 vs. 5.91 ± 4.42 mg·kg FFM(-1)·min(-1), P = 0.01). Resting muscle phosphorcreatine and total ATP in muscle increased significantly after HFO in LBW subjects only, whereas additional measurements of mitochondrial function remained unaffected. Despite similar plasma FFA levels, LBW subjects displayed increased fat oxidation during insulin infusion compared with normal-birth-weight (NBW) subjects after HFO (0.37 ± 0.35 vs. 0.17 ± 0.33 mg·kg FFM(-1)·min(-1), P = 0.02). In contrast to NBW subjects, the plasma leptin levels of LBW subjects did not increase, and the plasma gastric inhibitory polypeptide (GIP) as well as pancreatic polypeptide (PP) levels increased less in LBW compared with NBW subjects during HFO. In conclusion, HFO unmasks dissociation between insulin resistance and mitochondrial dysfunction in LBW subjects, suggesting that insulin resistance may be a cause, rather than an effect, of impaired muscle OXPHOS gene expression and mitochondrial dysfunction. Reduced increments in response to HFO of fasting plasma leptin, PP, and GIP levels may contribute to insulin resistance, lower satiety, and impaired insulin secretion in LBW subjects.
Reversed C sternotomy versus conventional sternotomy in cardiac surgery.

In this study, cardiac surgery with minimally invasive reversed C sternotomy was compared with conventional sternotomy in patients undergoing valve replacement or septal defect repair.



In this prospective randomized study, 35 patients were assigned into one of two groups for elective cardiac surgery under general anesthesia: Group A (reversed C sternotomy group) and Group B (conventional sternotomy group). Intraoperative variables, intubation time, postoperative drainage volume, pulmonary function tests, sleep quality and quality of life, and requirement for blood transfusion were compared.



A significant difference between the two groups was found in blood transfusion requirement, extubation time, and drainage volume. Forced expiratory volume in one second and functional vital capacity were significantly lower in Group B than in Group A at postoperative Month 1. Total sleep component score of Pittsburg Sleep Quality Index in Group B patients was significantly worse at postoperative Month 1. Postoperative assessment of quality of life (physical and mental) also showed a significant difference between the two groups.



These preliminary findings suggest that creating an access point without compromising the integrity of the sternum seems to be an advantageous and appropriate technique for suitable patients undergoing cardiac surgery.
Impact of Diabetes Susceptibility Loci on Progression From Pre-Diabetes to Diabetes in At-Risk Individuals of the Diabetes Prevention Trial–Type 1 (DPT-1)

The unfolding of type 1 diabetes involves a number of steps: defective immunological tolerance, priming of anti-islet autoimmunity, and destruction of insulin-producing beta-cells. A number of genetic loci contribute to susceptibility to type 1 diabetes, but it is unclear which stages of the disease are influenced by the different loci. Here, we analyzed the frequency of type 1 diabetes-risk alleles among individuals from the Diabetes Prevention Trial-Type 1 (DPT-1) clinical trial, which tested a preventive effect of insulin in at-risk relatives of diabetic individuals, all of which presented with autoimmune manifestations but only one-third of which eventually progressed to diabetes.



In this study, 708 individuals randomized into DPT-1 were genotyped for 37 single nucleotide polymorphisms in diabetes susceptibility loci.



Susceptibility alleles at loci expected to influence immunoregulation (PTPN22, CTLA4, and IL2RA) did not differ between progressors and nonprogressors but were elevated in both groups relative to general population frequencies, as was the INS promoter variant. In contrast, HLA DQB1*0302 and DQB1*0301 differed significantly in progressors versus nonprogressors (DQB*0302, 42.6 vs. 34.7%, P = 0.0047; DQB*0301, 8.6 vs. 14.3%, P = 0.0026). Multivariate analysis of the factors contributing to progression demonstrated that initial titers of anti-insulin autoantibodies (IAAs) could account for some (P = 0.0016) but not all of this effect on progression (P = 0.00038 for the independent effect of the number of DQB*0302 alleles). The INS-23 genotype was most strongly associated with anti-IAAs (median IAA levels in TT individuals, 60 nU/ml; AT, 121; and AA, 192; P = 0.000037) and only suggestively to the outcome of oral insulin administration.



With the exception of HLA, most susceptibility loci tested condition the risk of autoimmunity rather than the risk of failed immunoregulation that results in islet destruction. Future clinical trials might consider genotyping INS-23 in addition to HLA alleles as disease/treatment response modifier.
Exhaled 8-isoprostane in childhood asthma

Exhaled breath condensate (EBC) is a non-invasive method to assess airway inflammation and oxidative stress and may be useful in the assessment of childhood asthma.



Exhaled 8-isoprostane, a stable marker of oxidative stress, was measured in EBC, in children (5-17 years) with asthma (13 steroid-naïve and 12 inhaled steroid-treated) and 11 healthy control.



Mean exhaled 8-isoprostane concentration was significantly elevated in steroid-naïve asthmatic children compared to healthy children 9.3 (SEM 1.7) vs. 3.8 (0.6) pg/ml, p < 0.01. Children on inhaled steroids also had significantly higher 8-isoprostane levels than those of normal subjects 6.7 (0.7) vs. 3.8 (0.6) pg/ml, p < 0.01. Steroid-naïve asthmatics had higher exhaled nitric oxide (eNO) than those of controls 28.5 (4.7) vs. 12.6 (1.5) ppb, p < 0.01. eNO in steroid-treated asthmatics was similar to control subjects 27.5(8.8) vs. 12.6(1.5) ppb. Exhaled 8-isoprostane did not correlate with duration of asthma, dose of inhaled steroids or eNO.



We conclude that 8-isoprostane is elevated in asthmatic children, indicating increased oxidative stress, and that this does not appear to be normalized by inhaled steroid therapy. This suggests that 8-isoprostane is a useful non-invasive measurement of oxidative stress in children and that antioxidant therapy may be useful in the future.
Reordering an index to speed query processing without loss of effectiveness

Following Long and Suel, we empirically investigate the importance of document order in search engines which rank documents using a combination of dynamic (query-dependent) and static (query-independent) scores, and use document-at-a-time (DAAT) processing. When inverted file postings are in collection order, assigning document numbers in order of descending static score supports lossless early termination while maintaining good compression.
 Since static scores may not be available until all documents have been gathered and indexed, we build a tool for reordering an existing index and show that it operates in less than 20% of the original indexing time. We note that this additional cost is easily recouped by savings at query processing time. We compare best early-termination points for several different index orders on three enterprise search collections (a whole-of-government index with two very different query sets, and a collection from a UK university). We also present results for the same orders for ClueWeb09-CatB. Our evaluation focuses on finding results likely to be clicked on by users of Web or website search engines --- Nav and Key results in the TREC 2011 Web Track judging scheme.
 The orderings tested are Original, Reverse, Random, and QIE (descending order of static score). For three enterprise search test sets we find that QIE order can achieve close-to-maximal search effectiveness with much lower computational cost than for other orderings. Additionally, reordering has negligible impact on compressed index size for indexes that contain position information. Our results for an artificial query set against the TREC ClueWeb09 Category B collection are much more equivocal and we canvass possible explanations for future investigation.
Assessment of presence and grade of activity in ileal Crohn's disease.

To assess the sensitivity of magnetic resonance enterography (MRE) in the diagnosis of Crohn's disease (CD) activity and correlation between endoscopic and MRE scores in predicting the activity grade.



Twenty-five ileal CD patients with clinical and biochemical evidence of activation underwent ileocolonoscopy and MRE within 7 days of their application. Simplified endoscopic scoring of CD (SES-CD) and MRE scores was done and compared with each other and other parameters of activation (CRP, leukocyte count, platelet count).



The sensitivity of MRE scoring was found to be 92%; however, the statistical correlation with SES-CD was not significant (p=0.83) for the grading of the activity.



MRE scoring is sensitive enough to use in CD activity evaluation; however, it can not be used alone, and it is rather a complementary technique to endoscopy and is especially valuable for patients with extraluminal disease.