nils-herrmann/clean_scirepeval huggingface dataset:
A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study.

This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone.



Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis.



In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization.



There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91%. Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1% to 17.2% (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0% to 16.7% (p < 0.001), respectively.



Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; NCT00998439).
Dexmedetomidine for attenuating haemodynamic response to intubation stimuli in morbidly obese patients anaesthetised using low-opioid technique: comparison with fentanyl-based general anaesthesia.

Anaesthesiologists are facing the problem of an increasing population of morbidly obese patients. In order to minimize the risk of opioid-induced postoperative respiratory failure, the intraoperative administration of opioids should be reduced or replaced with other drugs. The purpose of this study was to compare haemodynamic response elicited by intubation in morbidly obese patients between two variants of anaesthesia induction: fentanylbased or low-opioid using dexmedetomidine.



Forty-two morbidly obese patients scheduled for bariatric surgery were randomly assigned to two groups: low-opioid using dexmedetomidine (DEX) or fentanyl-based (FNT) anaesthesia. Patients were premedicated with 100 μg of fentanyl i.v. In the DEX group, a 10 minute infusion of a loading dose of 200 μg of dexmedetomidine was started. In the FNT group, 2 mg of intravenous midazolam was given. Thereafter, propofol was used in both groups. In the FNT group, patients received a dose of fentanyl up to 5 μg kg⁻¹ of ideal body weight. Following administration of rocuronium, laryngoscopy and tracheal intubation were performed. Haemodynamic parameters, including systolic (SBP), diastolic (DBP) and mean arterial (MAP) blood pressure, as well as heart rate (HR), were recorded before and after intubation. Patients who were not intubated at first attempt were excluded from the study.



Data from 33 patients were analysed. There were no statistically significant differences between the DEX and FNT groups regarding demographic data. Haemodynamic response to intubation was defined as mean change (d) in values of analysed parameters that occurred during intubation. The following differences were observed: dSBP FNT +11.6 mm Hg vs. DEX +0.4 mm Hg (P = 0.15); dDBP FNT +3.7 mm Hg vs. DEX +3.5 mm Hg (P = 0.98); dMAP FNT +8.6 mm Hg vs. DEX +1.4 mm Hg (P = 0.36); dHR FNT +2 beats min-1 vs. DEX -1 beat min⁻¹ (P = 0.30). None of these comparisons yielded significant differences.



The study revealed no advantage of fentanyl over low opioid dexmedetomidine-based induction of general anaesthesia in attenuating cardiovascular response to intubation in morbidly obese patients.
Large Multidatabases: Beyond Federation and Global Schema Integration

Advances in wide area networking is making the goal of achieving a worldwide interoperable database system closer than ever. Because of the large environment , new problems have surfaced that need to be addressed. We distinguish several reasons for a new design approach. Traditional approaches like global integration and federated approaches are better suited to small and medium scale heterogeneous databases. In a large network of interoperable autonomous heterogeneous databases, the architecture should be exible enough to allow negotiation to take place to establish grouping of databases. In such a large environment, it is important that databases be made aware of other participating databases in an incremental fashion. Further, users should be educated about the space of information in an incremental and dynamic fashion. These goals are to be achieved under the major assumptions that participating databases keep their autonomy intact as much as possible and that the overhead in bridging heterogeneity be proportional to the level of sharing. In this paper, we describe a two-level approach that addresses these issues.
Failure of "effective" treatment for heart failure to improve normal customary activity.

To examine the effects of drug treatment on laboratory exercise tests in relation to measures of daily activity in patients with chronic heart failure.



University teaching hospital.



18 patients with mild to moderate chronic heart failure (New York Heart Association functional class II-III) and 10 age matched healthy controls.



Assessments were made before and after 12 weeks of vasodilator drug treatment. Exercise capacity was measured during two different types of treadmill exercise, one using a ramp protocol and the other a fixed work load. Corridor walk tests at three self selected speeds were also undertaken and measures of customary activity assessed from pedometer scores.



Exercise times were significantly increased from baseline (P < 0.01) with both treadmill protocols after 12 weeks of drug treatment, with a positive correlation between the duration of treadmill exercise for both protocols (r = 0.69, P < 0.01). Corridor walk tests of 100 m at a self selected slow speed also improved (P < 0.02) but these did not correlate with the changes in treadmill exercise time. The pedometer scores of the patients with heart failure were greatly reduced compared with those of the controls (258 (45) x 10(2) v 619 (67) x 10(2) steps/week, P < 0.001) and after 12 weeks of treatment were unchanged (261 (42) x 10(2) steps/week).



These data confirm the need to use different exercise protocols when assessing the benefits of drug treatment in patients with chronic heart failure. Treatments that seem effective with conventional laboratory based exercise tests may not improve daily activities. This may reflect a failure of apparently successful treatment and should be considered when interpreting clinical trials.
Efficacy of treatment to relieve mucositis-induced discomfort

To determine the efficacy of a mouthwash in relieving mucositis-induced discomfort in patients receiving chemotherapy, 31 (16 male, 15 female) with a mean age of 45 (range 16–80) were given an in-house three-drug (lidocaine, diphenhydramine and sodium bicarbonate in normal saline) mouthwash when they developed mucositis of any severity. The complications were assessed on the CALGB (Cancer and Leukemia Group B) scale. The response to the mouthwash was reported on a self-assessment scale. Patients' response data were analyzed with reference to: (1) relief throughout the duration of mucositis and (2) relief during the worst stage (for each episode) of mucositis. Five patients with fungal, viral or bacterial oral infection were excluded from study. Overall, 4 patients had grade I, 16 patients had grade II, 10 patients had grade III and 1 patient had grade IV mucositis. The average duration of mucositis was 7.9 days (range 3–23 days), and the mean duration of the worst stage of mucositis was 4.81 days (range 2–13 days). The mean mucositis severity score was 1.9 (range 1–4), and the average self-assessment (response) score was 0.81 (range 0–2). The mean mucositis score during the worst stage of mucositis was 2.25 (range 1–4), and the average self-assessment (response) score during the worst stage of mucositis was 0.91 (range 0–2.7). These results suggests that this three-drug mouthwash provides effective symptomatic relief in patients with chemotherapy-induced mucositis.
Pre-engraftment syndrome after myeloablative dual umbilical cord blood transplantation: risk factors and response to treatment

High fevers and/or rashes prior to neutrophil engraftment are frequently observed after umbilical cord blood (UCB) transplantation, and the condition is referred to as pre-engraftment syndrome (PES). Few studies have evaluated the risk factors for and treatment response to PES. Therefore, we retrospectively characterized PES in 57 consecutive engrafted patients (⩾12 years old) who received myeloablative dual UCB transplantation. All patients received TBI (⩾13.2 Gy)-based myeloablative conditioning. Tacrolimus (n=35) or CYA (n=22) combined with mycophenolate mofetil was used as GVHD prophylaxis. PES was defined as the presence of non-infectious fever (⩾38.5 °C) and/or rash prior to or on the day of neutrophil engraftment. The incidence (95% confidence interval) of PES was 77% (66–88%). The incidence of PES was significantly higher in patients who received CYA as a GVHD prophylaxis than those who received tacrolimus (P<0.001), and this association was confirmed in the multivariate analysis. The occurrence of PES did not impact OS or tumor relapse, although it may have increased non-relapse mortality (P=0.071). The incidence of acute GHVD or treatment-related mortality was not influenced by the choice to use corticosteroids to treat PES. This study suggests that use of CYA for GVHD prophylaxis increases the risk of PES following dual UCB transplantation.
Dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder.

This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.



All of the children were stabilized for > or =2 weeks on a total dose (nearest equivalent) MPH 40 mg/day or immediate-release D-MPH 20 mg/day before screening. After a practice day, they received 6 days of D-MPH-ER 20 mg/day or placebo at home, returning on day 7 for one dose. Subjects were evaluated at predose and postdose hours 0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 and then crossed over to the other treatment arm using the identical protocol. The primary efficacy variable was the change from predose in Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score from 1 to 12 hours. Secondary efficacy variables included SKAMP combined score at 0.5 hours, SKAMP subscale scores, and math test results over 12 hours.



Sixty-eight children were randomized, with 67 completing the study. Onset of action was indicated by a significant difference between D-MPH-ER and placebo at 0.5 hour on the SKAMP combined score (p = .001). For efficacy measures, differences from placebo were significant at all points between 0.5 and 12 hours (p < .001 top = .013).



D-MPH-ER provided sustained improvement in attention, deportment, and academic productivity throughout the 12-hour laboratory day.
Compliance with osteoporosis drug therapy and risk of fracture

Patient compliance with osteoporosis drug therapy is often poor in clinical practice and may be associated with higher risk of fracture. A nested case-control study was undertaken using a US health insurance claims database. The source population included all women aged ≥45 years who began drug therapy for osteoporosis. Cases consisted of those who experienced an osteoporosis-related fracture; they were matched to controls without osteoporosis-related fracture. Compliance with osteoporosis drug treatment was assessed in terms of the number of therapy-days received and medication possession ratio (MPR). Conditional logistic regression was employed to examine the relationship between compliance and fracture risk. A total of 453 women with osteoporosis-related fracture were identified and matched to 2,160 controls. Fracture risk was significantly lower for patients with >180 days of therapy [181–360 days: odds ratio (OR) = 0.70, 95% CI = 0.49–0.99; >360 days: OR = 0.65, 95% CI = 0.43–0.99) versus those with ≤30 days. Risk was also lower for patients with MPR ≥90% (OR = 0.70, 95% CI = 0.52–0.93) versus those with MPR <30%. Fracture risk decreased as compliance increased (ptrend < 0.05). Among women initiating drug therapy for osteoporosis, better compliance is associated with reduced risk of fracture.
Can an electronic glycaemic notebook associated with an insulin calculator improve HbA1c in diabetic patients on a multiple insulin injections regimen? A 26-week observational real-life study.

Automated insulin calculators (AICs) with carbohydrate counting (CHC) have been shown to be effective in improving glycated haemoglobin (HbA1c) levels. By contrast, use of AICs without CHC, with predetermined prandial insulin doses modified according to a correction factor and modulated as a function of glycaemia, has not yet been investigated.



This comparative, retrospective, observational and non-randomized study took place over a 6-month period of routine clinical practice. It evaluated the use of Free-style InsuLinx® and Free-style Neo® Abbott Diabetes Care (AIC) in easy mode (no CHC). All patients performed a basal-prandial insulin dosing schedule, and were not educated as to how to determine carbohydrate intake. Changes in HbA1c and capillary blood glucose levels, insulin therapy, frequency of blood glucose tests and body weight were analyzed 6 months prior to inclusion (T-6), at the time of inclusion (T0) and 6 months later (T+6). From T-6 to T0 (period A), patients used a standard blood glucose meter and adjusted their insulin doses themselves, and from T0 to T+6 (period B), each patient was provided with an AIC on easy mode function.



Of the 230 patients, 221 were retained at the end of the study (126 type 1 diabetes mellitus (T1DM) and 95 type 2 diabetes mellitus (T2DM)). At T-6, average (±standard error of mean) HbA1c level was 8.3 ± 0.1%; T1DM: 8.5 ± 0.1% and T2DM: 8.0 ± 0.1%, respectively. At T0, the average HbA1c level was 8.4 ± 0.1% (p = 0.02); T1DM: 8.5 ± 0.1% (ns) and T2DM: 8.2 ± 0.1% (p = 0.004). At T+6, with AIC in easy mode, average HbA1c level decreased significantly to 7.7 ± 0.1% (p < 0.0001); T1DM: 8.0 ± 0.1% (p < 0.0001) and T2DM: 7.5 ± 0.1% (p < 0.0001). At T+6, in all diabetics, blood glucose monitoring frequency increased by 0.4/day (p < 0.0001). Insulin correction amounted to 14% of changes in predetermined prandial insulin doses.



Routine clinical use of an AIC without CHC improved self-management of blood glucose and on average, decreased HbA1c levels by 0.52% in T1DM and 0.80% in T2DM after 6 months.
Efficacy and tolerability of telmisartan plus amlodipine in added-risk hypertensive patients.

Added-risk hypertensive patients with co-morbidities such as diabetes and metabolic syndrome often require two or more antihypertensives to achieve blood pressure (BP) targets. The aim of this sub-analysis was to determine the efficacy and safety of telmisartan 40 or 80 mg plus amlodipine 5 or 10 mg in patients with hypertension, stratified according to certain criteria such as type 2 diabetes mellitus and metabolic syndrome.



Patients were treated for 8 weeks with telmisartan 20-80 mg plus amlodipine 2.5-10 mg. This post-hoc analysis included patients treated with higher doses, and stratified according to a number of sub-populations (age, race, diabetes, obesity, metabolic syndrome, elevated baseline systolic BP (SBP), renal impairment).



Eight weeks' treatment with telmisartan plus amlodipine combinations provided consistent reductions in mean SBP/diastolic BP (DBP) across the different sub-populations, similar to the overall population. SBP/DBP reductions ranged from -13.5 to -34.7/-12.6 to -26.1 mmHg and BP goal rates (<140/90 mmHg) ranged from 29.8-100% for the four key dose combinations of telmisartan plus amlodipine. For the highest dose combination of telmisartan 80 mg plus amlodipine 10 mg, SBP/DBP reduction ranged from -19.1 to -34.7/-16.4 to -22.8 mmHg and goal attainment rate from 66.7% to 87.0%. Across the sub-populations, high SBP and DBP response rates were seen with combination treatment (83.3-97.7% and 75.0-95.7%, respectively, with telmisartan 80 mg plus amlodipine 10 mg). The combination was safe and well tolerated across all sub-populations and the incidence of peripheral oedema with telmisartan 40-80 mg plus amlodipine 10 mg was generally lower than with A10 monotherapy.



Despite small patient numbers in some sub-populations and the post-hoc nature of the analysis, this does show that the combination of telmisartan plus amlodipine provides an effective, safe and well-tolerated antihypertensive treatment for added-risk hypertensive patients.
A Bandwidth Friendly Search Engine

The Internet plays host to many millions of documents and images and is increasing in size all the time. As a result locating web content is becoming increasingly difficult for users, and search traffic from users and spiders is increasing rapidly. A directory of the contents of the emerging cache hierarchy would be more complete than existing tools and avoid the need for spider traffic. However it is also essential to minimise the user traffic. A promising approach is to encourage users to refine their queries through categories. Automatic categorisation of a cache directory is demonstrated, and an adaptive categorisation scheme is proposed.
Pharmacological analysis of etoposide in elderly patients with lung cancer.

To analyze the pharmacological characteristics of etoposide in elderly patients, we conducted a Phase I trial of a 14-day administration of oral etoposide on 12 chemotherapy-naive patients, ages 75 years or older, with lung cancer. The pharmacological profiles of etoposide in elderly patients were compared with those of younger patients in our previous studies (H. Minami et al.,  1993; H. Minami et al.,  1995; Y. Ando et al.,  1996). The sigmoid Emax model and logistic regression model were used for pharmacodynamic analysis. The maximum tolerated dose for elderly patients was 75 mg/body/day. The apparent oral clearance in elderly patients was 37+/-10 (mean +/- SD) ml/min, which was not different from that in younger patients (44+/-12 ml/min). The area under the concentration-versus-time curve of etoposide over the treatment period (total AUC) that produced a 50% decrease in absolute neutrophil counts was significantly different between elderly and younger patients, 14.3+/-2.5 and 21.6+/-2.7 mg x min/ml, respectively (P = 0.048). The incidence of grade 3 or 4 neutropenia at total AUC of 30 mg x min/ml (corresponding to a plasma concentration of 1.5 microg/ml for 14 days) was 81% in elderly patients but only 48% in younger patients. Although there was no pharmacokinetic difference between elderly and younger patients, equivalent exposure to etoposide resulted in severer myelosuppression in elderly patients. These findings suggest that prolonged etoposide administration with plasma concentration maintained at 1-2 microg/ml may cause severe myelotoxicity in elderly patients.
The Safety and Immunological Effects of rAd5-EBV-LMP2 Vaccine in Nasopharyngeal Carcinoma Patients: A Phase I Clinical Trial and Two-Year Follow-Up.

Epstein-Barr virus (EBV)-encoded latent membrane protein 2 (LMP2) promotes nasopharyngeal carcinoma (NPC) progression. Previously, we reported that the dendritic cells (DCs) transfected with EBV-LMP2 recombinant serotype 5 adenoviruses (rAd5) induced anti-tumor effect by eliciting cytotoxic T lymphocytes (CTLs)-mediated immune response in vitro and the adenoviral vaccine of EBV-LMP2 (rAd5-EBV-LMP2) stimulated antigen-specific cellular immunity in mice. However, the safety and immunological effect of rAd5-EBV-LMP2 vaccine in human still remained unknown. Here we conducted a single-center, non-randomized, open-label, single-arm phase I clinical trial to clarify this unsolved issue. A total of 24 patients with regional advanced NPC were sequentially enrolled into three dose level groups (2×10(9), 2×10(10), 2×10(11) vp). The rAd5-EBV-LMP2 vaccines were intramuscularly injected for four times within 28 d (D0, D7, D14, D28). Blood samples were harvested immediately before every vaccination, one week and one month after the last vaccination (D0, D7, D14, D28, D35, D58). All the vaccine inoculation-related toxicities presented as grade I/II adverse events. The most frequent systemic adverse reactions were fatigue (33.0%, 8/24), myalgia (29.2%, 7/24) and cough (29.2%, 7/24), while the most common regional adverse reaction was tenderness in the inoculation site (54.2%, 13/24). In addition, proportion of CD(3+)CD(4+) cells in peripheral blood was significantly increased in the high dose group (2×10(11) vp). The rAd5-EBV-LMP2 vaccine was generally well-tolerated and the high dose (2×10(11) vp) is recommended to be adopted in phase II studies. The long-term outcome of rAd5-EBV-LMP2 vaccine inoculation is required to be determined in following placebo-controlled trials.
Land Cover and Climate Change May Limit Invasiveness of Rhododendron ponticum in Wales

Invasive plant species represent a serious threat to biodiversity precipitating a sustained global effort to eradicate or at least control the spread of this phenomenon. Current distribution ranges of many invasive species are likely to be modified in the future by land cover and climate change. Thus, invasion management can be made more effective by forecasting the potential spread of invasive species. Rhododendron ponticum (L.) is an aggressive invasive species which appears well suited to western areas of the UK. We made use of MAXENT modeling environment to develop a current distribution model and to assess the likely effects of land cover and climatic conditions (LCCs) on the future distribution of this species in the Snowdonia National park in Wales. Six global circulation models (GCMs) and two representative concentration pathways (RCPs), together with a land cover simulation for 2050 were used to investigate species' response to future environmental conditions. Having considered a range of environmental variables as predictors and carried out the AICc-based model selection, we find that under all LCCs considered in this study, the range of R. ponticum in Wales is likely to contract in the future. Land cover and topographic variables were found to be the most important predictors of the distribution of R. ponticum. This information, together with maps indicating future distribution trends will aid the development of mitigation practices to control R. ponticum.