nils-herrmann/clean_scirepeval huggingface dataset:
Effect of low-dose beclomethasone dipropionate on asthma control and airway inflammation.

The effects of usual or low doses of inhaled corticosteroids on airway mucosal inflammation have not yet been examined. We therefore, compared the effects of inhaled beclomethasone dipropionate (BDP) 336 microg x day(-1) on asthma control outcomes and markers of airway inflammation. Twenty-four adult subjects with mild and moderate asthma were randomized to receive either BDP or placebo for four weeks; then subjects entered a single blind four week placebo run-in period. We found that the BDP group had significantly greater improvements in forced expiratory volume in one second (FEV1), morning peak flow, and rescue salbutamol use than the placebo-treated group. The improvement in FEV1 largely reversed one week after treatment was stopped. The decrease in the median percentage of eosinophils in induced sputum in the BDP group from 3.8% to 3.4% was not significant, but because eosinophils increased from 8.4% to 12.7% in the placebo group, there was a significant difference between treatment groups (p=0.03). There was no significant difference between groups during treatment in the levels of eosinophil cationic protein (ECP), tryptase mucin-like glycoprotein, or fibrinogen in induced sputum. The change in FEV1 in the BDP group did not correlate significantly with the change in eosinophil percentage or ECP levels. We concluded that four weeks of treatment with inhaled beclomethasone dipropionate 336 microg x day(-1) was associated with significant improvements in peak flow, forced expiratory volume in one second, and rescue salbutamol use in asthmatic subjects but was not associated with large reductions in markers of eosinophilic inflammation, bronchovascular permeability, or mucus hypersecretion.
Effect of raloxifene on bone mineral density in premenopausal women at increased risk of breast cancer.

Raloxifene is a promising breast cancer prevention agent in postmenopausal women at increased risk for breast cancer. The effects of raloxifene in premenopausal women are unknown.



We evaluated the effect of raloxifene in premenopausal women at increased risk for breast cancer on bone mineral density (BMD).



This was a phase II clinical trial.



This study was conducted at an academic medical center.



Thirty-seven premenopausal women at increased risk for breast cancer enrolled in the trial. Thirty subjects began treatment and 27 were evaluable.



Raloxifene (60 mg daily) and elemental calcium (500 mg daily) were given for 2 yr. Subjects were followed up off medications for 1 yr.



The primary end point was the intrasubject percent change in BMD at 1 yr measured by dual-energy x-ray absorptiometry.



The mean baseline lumbar spine density was 1.027 g/cm(2). Lumbar spine density decreased 2.3% at 1 yr (P < 0.00001) and 3.5% at 2 yr (P < .00001). Percent change from yr 2 to 3 was +1.4%. The mean baseline total hip bone density was 0.905 g/cm(2). Total hip density decreased 0.3% at 1 yr and 1.0% at 2 yr (P = 0.033). Percent change from yr 2 to 3 was +1.7%.



Raloxifene use is associated with a decrease in BMD in premenopausal women at increased risk for breast cancer. The clinical significance of this decrease is unknown and is attenuated with stopping raloxifene.
A Method for Phase Noise Analysis of RF Circuits

In this paper we present a method for analysis of phase noise in logic circuits. This method allows the design and verification of phase noise critical circuits using a digital toolchain, significantly reducing the design time and effort compared to the traditional approach using analog tools such as SPICE simulation. It is based on a set of pre-characterized standard cells and the generated phase noise is estimated using a lookup table approach. Comparison of the estimation results with back-annotated analog simulations in 28 nm CMOS technology show that the error of the estimation is within 7.2 % of the actual phase noise, and the runtime is reduced by three orders of magnitude.
Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients.

The aim of this analysis was to characterize viral resistance in the Phase III, randomized ODIN trial, which demonstrated non-inferiority of once-daily darunavir/ritonavir (DRV/r) 800/100 mg to DRV/r 600/100 mg twice daily, each combined with an optimized background regimen in treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening.



Virological failure (VF) was defined as never achieving or losing confirmed virological suppression after week 12, with patients being classed as 'never suppressed' (never achieved HIV-1 RNA<50 copies/ml) or 'rebounders' (achieved two consecutive HIV-1 RNA<50 copies/ml but then ≥ 50 copies/ml). Phenotypes and genotypes of plasma HIV-1 viruses, using population-based sequencing and Antivirogram(®), were determined at screening/baseline and on samples from VFs with HIV-1 RNA ≥ 50 copies/ml.



Mean baseline HIV-1 RNA was 4.16 log10 copies/ml and 53.9% of patients were protease inhibitor (PI)-experienced at enrolment. VF rate was similar in both arms. A similar proportion of virologically failing patients in both arms developed PI RAMs (11.7% versus 9.5%, respectively) or nucleoside reverse transcriptase inhibitor RAMs (6.7% versus 7.1%). One patient with VF (once-daily arm) developed four primary PI mutations, three of which were also DRV RAMs. This patient was also the only VF to lose susceptibility to DRV. Loss of susceptibility to other PIs (once daily 3.4%; twice daily 0%) and nucleoside reverse transcriptase inhibitors (once daily 13.6%; twice daily 9.8%) in VF patients was infrequent and comparable between treatment arms.



These analyses showed once-daily DRV/r 800/100 mg was associated with similar rates of VF and emergence of resistance as DRV/r 600/100 mg twice daily in treatment-experienced patients with no DRV RAMs.
Efficacy and safety of dapagliflozin in addition to insulin therapy in Japanese patients with type 2 diabetes: Results of the interim analysis of 16‐week double‐blind treatment period

Dapagliflozin treatment when added to insulin therapy in Japanese patients with type 2 diabetes remains to be evaluated.



This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate efficacy (at 16 weeks) and long-term safety (at 52 weeks) of dapagliflozin in addition to insulin therapy. The interim analysis was carried out at week 16 to assess the efficacy and safety profiles. The patients receiving insulin (n = 182) were randomized to either dapagliflozin 5 mg or a placebo at a 2:1 ratio. The primary efficacy end-point was the change in hemoglobin A1c (HbA1c) from baseline at week 16.



Patients in the dapagliflozin group showed an adjusted decrease in HbA1c of -0.55% from baseline, whereas the placebo showed a marginal increase of 0.05%. The placebo-corrected mean change of HbA1c from baseline to week 16 in dapagliflozin was -0.60% (P < 0.0001). In addition, the placebo-corrected mean change of fasting plasma glucose and bodyweight from baseline to week 16 in the dapagliflozin group was -22.7 mg/dL (P < 0.0001) and -1.21 kg (P < 0.0001), respectively. The placebo-corrected mean daily insulin dose in the dapagliflozin group was numerically decreased (treatment difference: -0.72 IU/day; P = 0.0743). No major episodes or discontinuations as a result of hypoglycemia were reported during the study period.



Dapagliflozin used as add-on treatment to insulin therapy showed significantly greater reduction of HbA1c, fasting plasma glucose and bodyweight without severe hypoglycemia compared with the placebo at week 16. These results show the clinical benefit of prescribing dapagliflozin for Japanese patients with insufficient glycemic control even with insulin therapy.
High serum level of retinol and α-tocopherol affords protection against oral cancer in a multiethnic population.

A comparative cross-sectional study involving oral cancer patients and healthy individuals was designed to investigate associations between retinol, α-tocopherol and β-carotene with the risk of oral cancer.



This study included a total of 240 matched cases and controls where subjects were selected from the Malaysian Oral Cancer Database and Tissue Bank System (MOCDTBS). Retinol, α-tocopherol and β-carotene levels and intake were examined by high-performance liquid chromatography (HPLC) and food frequency questionnaire (FFQ) respectively.



It was found that results from the two methods applied did not correlate, so that further analysis was done using the HPLC method utilising blood serum. Serum levels of retinol and α-tocopherol among cases (0.177±0.081, 1.649±1.670μg/ml) were significantly lower than in controls (0.264±0.137, 3.225±2.054μg/ml) (p<0.005). Although serum level of β-carotene among cases (0.106±0.159 μg/ml) were lower compared to controls (0.134±0.131μg/ml), statistical significance was not observed. Logistic regression analysis showed that high serum level of retinol (OR=0.501, 95% CI=0.254-0.992, p<0.05) and α-tocopherol (OR=0.184, 95% CI=0.091-0.370, p<0.05) was significantly related to lower risk of oral cancer, whereas no relationship was observed between β-carotene and oral cancer risk.



High serum levels of retinol and α-tocopherol confer protection against oral cancer risk.
Prediction of time of death after withdrawal of life-sustaining treatment in potential donors after cardiac death*.

Organ donation after cardiac death increases the number of donor organs. In controlled donation after cardiac death donors, the period between withdrawal of life-sustaining treatment and cardiac arrest is one of the parameters used to assess whether organs are suitable for transplantation. The objective of this study was to identify donation after cardiac death donor characteristics that affect the interval between withdrawal of life-sustaining treatment and cardiac death.



Prospective multicenter study of observational data.



All potential donation after cardiac death donors in The Netherlands between May 2007 and June 2009 were identified.



None.



Of the 242 potential donation after cardiac death donors, 211 entered analysis, 76% of them died within 60 mins, and 83% died within 120 mins after withdrawal of life-sustaining treatment. The median time to death was 20 mins (range 1 min to 3.8 days). Controlled mechanical ventilation, use of norepinephrine, absence of reflexes, neurologic deficit as cause of death, and absence of cardiovascular comorbidity were associated with death within 60 and 120 mins. The use of analgesics, sedatives, or extubation did not significantly influence the moment of death. In the multivariable logistic regression analysis, controlled mechanical ventilation remained a risk factor for death within 60 mins, and norepinephrine administration and absence of cardiovascular comorbidity remained risk factors for death within 120 mins. The clinical judgment of the intensivist predicted death within 60 and 120 mins with a sensitivity of 73% and 89%, respectively, and a specificity of 56% and 25%, respectively.



Despite the identification of risk factors for early death and the additional value of the clinical judgment by the intensivist, it is not possible to reliably identify potential donation after cardiac death donors who will die within 1 or 2 hrs after life-sustaining treatment has been withdrawn. Consequently, a donation procedure should be initiated in every potential donor.
Biomechanical wall properties of human intracranial aneurysms resected following surgical clipping (IRRAs Project).

Individual rupture risk assessment of intracranial aneurysms is a major issue in the clinical management of asymptomatic aneurysms. Aneurysm rupture occurs when wall tension exceeds the strength limit of the wall tissue. At present, aneurysmal wall mechanics are poorly understood and thus, risk assessment involving mechanical properties is inexistent. Aneurysm computational hemodynamics studies make the assumption of rigid walls, an arguable simplification. We therefore aim to assess mechanical properties of ruptured and unruptured intracranial aneurysms in order to provide the foundation for future patient-specific aneurysmal risk assessment. This work also challenges some of the currently held hypotheses in computational flow hemodynamics research.



A specific conservation protocol was applied to aneurysmal tissues following clipping and resection in order to preserve their mechanical properties. Sixteen intracranial aneurysms (11 female, 5 male) underwent mechanical uniaxial stress tests under physiological conditions, temperature, and saline isotonic solution. These represented 11 unruptured and 5 ruptured aneurysms. Stress/strain curves were then obtained for each sample, and a fitting algorithm was applied following a 3-parameter (C(10), C(01), C(11)) Mooney-Rivlin hyperelastic model. Each aneurysm was classified according to its biomechanical properties and (un)rupture status.



Tissue testing demonstrated three main tissue classes: Soft, Rigid, and Intermediate. All unruptured aneurysms presented a more Rigid tissue than ruptured or pre-ruptured aneurysms within each gender subgroup. Wall thickness was not correlated to aneurysmal status (ruptured/unruptured). An Intermediate subgroup of unruptured aneurysms with softer tissue characteristic was identified and correlated with multiple documented risk factors of rupture.



There is a significant modification in biomechanical properties between ruptured aneurysm, presenting a soft tissue and unruptured aneurysms, presenting a rigid material. This finding strongly supports the idea that a biomechanical risk factor based assessment should be utilized in the to improve the therapeutic decision making.
Clinical and pharmacokinetic phase II study of fotemustine in refractory and relapsing multiple myeloma patients.

Patients with relapsing or refractory multiple myeloma have poor prognosis. Few compounds are active in these patients and response duration remains short. We report the results of an open phase II trial evaluating the efficacy and safety of fotemustine monotherapy.



Twenty-one patients with relapsing (17) or refractory (four) multiple myeloma received fotemustine 100 mg/m(2) on an outpatient basis on days 1 and 8 of the induction cycle, followed after a 6-week rest period by fotemustine 100 mg/m(2) every 3 weeks until progression or unacceptable toxicity. Fotemustine pharmacokinetics during the first day of induction was compared between patients with normal or abnormal renal function.



Five of 20 eligible patients had an objective response giving an intention-to-treat response rate of 25% [95% confidence interval (CI) 6% to 44%] and a 35.7% response rate (95% CI 11% to 61%) in the 14 patients having received at least four injections of fotemustine. The median time to objective response was 8.9 months. The median times to progression and survival were 13.8 and 23.1 months, respectively, with a 2-year survival rate of 49%. The main toxicity was myelosuppression with grade 3-4 neutropenia and thrombocytopenia in 66% and 71% of patients, respectively. There was one toxic death by sepsis after induction. The pharmacokinetic parameters in renal-impaired patients were not significantly different from those in patients with normal renal function with a similar incidence of grade 3-4 toxicity in both groups.



Fotemustine as a single agent has definite activity in patients with relapsing or refractory multiple myeloma, with acceptable toxicity and can be administered at conventional doses in patients with mild or moderate renal impairment.
Comparison of contact force-guided procedure with non-contact force-guided procedure during left atrial mapping and pulmonary vein isolation: impact of contact force on recurrence of atrial fibrillation

The aim of this study was to evaluate the impact of contact force (CF) visualization on the incidence of low and high CF during left atrial (LA) mapping and pulmonary vein isolation (PVI). CF was assessed in 70 patients who underwent PVI. Three highly experienced operators performed all procedures. The operators were blinded to CF in group A (35 patients), and CF was displayed in group B (35 patients). In group B, optimal CF was defined as mean CF between 10 and 39g, and operators attempted to acquire points and ablate within this range. A total of 8401 mapping points were analyzed during LA mapping (group A: 4104, group B: 4297). Low CF <10g and high CF ≥40g were noted in a significantly larger number of points in group A (37.7 vs. 12.0 %, P < 0.001; 11.5 vs. 1.5 %, P < 0.001). At the mitral isthmus and ridge areas, CF was significantly lower (7.7 vs. 12.2g, P < 0.001; 5.3 vs. 11.7g, P < 0.001) in group A than in group B. PVI was successfully achieved in all patients. There were significant site-dependent CF differences between the two groups. Optimal CF was achieved in significantly more applications in group B (P < 0.001). There was no significant difference in atrial fibrillation (AF) recurrence rates after a minimum follow-up of 1 year between the two groups in this cohort (P = 0.24). No significant peri-procedural complications occurred in either group. CF visualization can assist in avoiding both low and high CF, which may have the potential to improve lesion formation and patient safety profile. In this study, CF-guided ablation did not affect AF recurrence.
Measuring Symptom Distress and Health-Related Quality of Life in Clinical Trials of Gastroesophageal Reflux Disease Treatment: Further Validation of the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS)

This study reports the reliability and validity of the distress subscale of the GERD Symptom Assessment Scale (GSAS) and the acute SF-36 Health Survey in a clinical trial setting. Patients with moderately severe GERD completed the GSAS and SF-36 at baseline and four weeks following treatment. The age (mean ± sd) of the 187 patients was 45.5 ± 11.1 years and most were female (63%) and Caucasian (78%). All scales met the 0.70 reliability criterion except for the SF-36 bodily pain scale. Mean baseline GSAS scores were significantly (P < 0.001) poorer by 10–17% among patients reporting more severe levels of all symptoms. Mean baseline SF-36 physical component summary scores were significantly (P < 0.02) poorer among patients reporting more severe levels of regurgitation, early satiety, bloating, and nausea. Patients reporting complete and satisfactory heartburn relief reported improvements in GSAS scores that were 13% and 10% greater, respectively, than patients who did not experience these levels of relief (P < 0.001). In conclusion, the GSAS and SF-36 scales were reliable and valid measures in this clinical trial. Differences of 10% in GSAS distress scores correspond to differences in symptom severity at a point in time and to changes in symptom severity over time. The SF-36 was not as useful in detecting differences in symptom severity over time.
Evening use of light-emitting eReaders negatively affects sleep, circadian timing, and next-morning alertness.

In the past 50 y, there has been a decline in average sleep duration and quality, with adverse consequences on general health. A representative survey of 1,508 American adults recently revealed that 90% of Americans used some type of electronics at least a few nights per week within 1 h before bedtime. Mounting evidence from countries around the world shows the negative impact of such technology use on sleep. This negative impact on sleep may be due to the short-wavelength-enriched light emitted by these electronic devices, given that artificial-light exposure has been shown experimentally to produce alerting effects, suppress melatonin, and phase-shift the biological clock. A few reports have shown that these devices suppress melatonin levels, but little is known about the effects on circadian phase or the following sleep episode, exposing a substantial gap in our knowledge of how this increasingly popular technology affects sleep. Here we compare the biological effects of reading an electronic book on a light-emitting device (LE-eBook) with reading a printed book in the hours before bedtime. Participants reading an LE-eBook took longer to fall asleep and had reduced evening sleepiness, reduced melatonin secretion, later timing of their circadian clock, and reduced next-morning alertness than when reading a printed book. These results demonstrate that evening exposure to an LE-eBook phase-delays the circadian clock, acutely suppresses melatonin, and has important implications for understanding the impact of such technologies on sleep, performance, health, and safety.
The role of fibular tape in the prevention of ankle injury in basketball: A pilot study.

Prospective nonrandomized controlled trial.



To determine the effect of fibular repositioning tape (FRT) on incidence and severity of ankle injury.



Pain and functional disability is common following ankle sprain and a major problem in sport. A novel method of taping, FRT, which has been described to prevent ankle sprain, requires less tape than traditional methods and is easier to apply. The objective of this study was to determine the effect of FRT on the incidence and severity of ankle injury in basketball.



One hundred twenty-five male basketball players were assigned at time of play to either the control (209 exposures) or FRT (224 exposures) condition in a manner of convenience. Control participants had the choice on the use and type of prophylaxis, excluding FRT. FRT participants were taped using the method described by Mulligan. Ankle injury data were collected after each exposure. Injury severity was determined by functional limitation, pain levels, and days to return to play.



Four hundred forty-three measured basketball exposures resulted in 11 ankle injuries. All injuries occurred in subjects with a history of previous ankle sprain. Significantly less ankle injuries were sustained by members of the FRT condition (n = 2), compared to members of the control condition (n = 9) (Fisher exact test, P = .03). The odds ratio of sustaining an ankle injury was 0.20 (P = .04; 95% confidence interval [CI]: 0.04, 0.93) when taped with FRT and the number needed to treat was 22 (95% CI, 12-312).



This study provides preliminary data regarding the prophylactic effects of FRT on ankle injury in male basketball players.