nils-herrmann/clean_scirepeval huggingface dataset:
Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study

The mismatch between diffusion weighted imaging (DWI) lesion and perfusion imaging (PI) deficit volumes has been used as a surrogate of ischemic penumbra. This pathophysiology-orientated patient selection criterion for acute stroke treatment may have the potential to replace a fixed time window. Two recent trials - DEFUSE and EPITHET - investigated the mismatch concept in a multicenter prospective approach. Both studies randomized highly selected patients (n = 74/n = 100) and therefore confirmation in a large consecutive cohort is desirable. We here present a single-center approach with a 3T MR tomograph next door to the stroke unit, serving as a bridge from the ER to the stroke unit to screen all TIA and stroke patients. Our primary hypothesis is that the prognostic value of the mismatch concept is depending on the vessel status. Primary endpoint of the study is infarct growth determined by imaging, secondary endpoints are neurological deficit on day 5-7 and functional outcome after 3 months.



1000Plus is a prospective, single centre observational study with 1200 patients to be recruited. All patients admitted to the ER with the clinical diagnosis of an acute cerebrovascular event within 24 hours after symptom onset are screened. Examinations are performed on day 1, 2 and 5-7 with neurological examination including National Institute of Health Stroke Scale (NIHSS) scoring and stroke MRI including T2*, DWI, TOF-MRA, FLAIR and PI. PI is conducted as dynamic susceptibility-enhanced contrast imaging with a fixed dosage of 5 ml 1 M Gadobutrol. For post-processing of PI, mean transit time (MTT) parametric images are determined by deconvolution of the arterial input function (AIF) which is automatically identified. Lesion volumes and mismatch are measured and calculated by using the perfusion mismatch analyzer (PMA) software from ASIST-Japan. Primary endpoint is the change of infarct size between baseline examination and day 5-7 follow up.



The aim of this study is to describe the incidence of mismatch and the predictive value of PI for final lesion size and functional outcome depending on delay of imaging and vascular recanalization. It is crucial to standardize PI for future randomized clinical trials as for individual therapeutic decisions and we expect to contribute to this challenging task.
Parenteral nutrition does not improve postoperative recovery from radical cystectomy: results of a prospective randomised trial.

After radical cystectomy, patients are in a catabolic state because of postoperative stress response, extensive wound healing, and ileus.



To evaluate whether recovery can be improved with total parenteral nutrition (TPN) in patients following extended pelvic lymph node dissection (ePLND), cystectomy, and urinary diversion (UD).



We conducted a prospective, randomised, single-centre study of 157 consecutive cystectomy patients.



Seventy-four patients (group A) received TPN during the first 5 postoperative days, with additional oral intake ad libitum. Eighty-three patients (group B) received oral nutrition alone.



The primary outcome was the occurrence of postoperative complications. Secondary outcomes were time to recovery of bowel function, biochemical nutritional (serum albumin, serum prealbumin, serum total protein) and inflammatory (C-reactive protein) parameters, length of hospital stay, and costs attributed to the TPN. The Pearson χ(2) test was used for dichotomous variables; the Wilcoxon rank sum test was used for continuous variables.



Postoperative complications occurred in 51 patients (69%) in group A and in 41 patients (49%) in group B (p=0.013), a difference resulting from group A having more infectious complications than group B (32% vs 11%; p=0.001). Serum prealbumin and serum total protein were significantly lower in group B on postoperative day 7 but not on postoperative day 12. Time to gastrointestinal recovery and length of hospital stay did not differ between the two groups. The costs for TPN were €614 per patient. A potential limitation is the use of a glucose-based parenteral nutrition without lipids.



Postoperative TPN is associated with a higher incidence of complications, mainly infections, and higher costs following ePLND, cystectomy, and UD versus oral nutrition alone.
Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial

Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.



During an investigator-initiated, randomized, double-blind trial, we evaluated the need for preventive verapamil administration. After vascular access was established, patients received either 5 mg verapamil (n=297) or placebo (n=294). We compared the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain were investigated as secondary end points. The rate of access site conversions was not different in the 2 arms (placebo 1.7% versus verapamil 0.7%, P=0.28, difference 1.0%, 95% CI for the difference -1.1% to 3.3%). Proportion of code breaks was similar in the 2 groups (3.4% versus 1.3%, P=0.11), whereas overall verapamil use was markedly lower in the placebo arm (2.0% versus 100%, P<0.0001). Procedural time (median [IQR] 16.0 minutes [9.0 to 30.0 minutes] versus 17.0 minutes [10.0 to 31.0 minutes], P=0.37), fluoroscopic time (4.4 minutes [2.1 to 9.6 minutes] versus 4.8 minutes [2.4 to 10.7 minutes], P=0.28), contrast volume (72.5 mL [48.0 to 146.0 mL] versus 75.5 mL [47.0 to 156.5 mL], P=0.74), and pain score (P for trend=0.12) were comparable in the 2 groups.



The preventive use of verapamil may be unnecessary for transradial procedures. The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil.
Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease.

An association between the sputum eosinophil count and the response to a 2 week course of prednisolone has previously been reported in patients with chronic obstructive pulmonary disease (COPD). Whether the response to inhaled corticosteroids is related to the presence of eosinophilic inflammation is unclear.



A randomised, double blind, crossover trial of placebo and mometasone furoate (800 microg/day), each given for 6 weeks with a 4 week washout period, was performed in subjects with COPD treated with bronchodilator therapy only. Spirometric tests, symptom scores, chronic respiratory disease questionnaire (CRQ), and induced sputum were performed before and after each treatment phase.



Ninety five patients were recruited of which 60 were randomised. Overall there were no treatment associated changes in forced expiratory volume in 1 second (FEV(1)), total CRQ, or sputum characteristics. After stratification into tertiles by baseline eosinophil count, the net improvement in post-bronchodilator FEV(1) increased with mometasone compared with placebo progressively from the least to the most eosinophilic tertile. The mean change in post-bronchodilator FEV(1) with mometasone compared with placebo in the highest tertile was 0.11 l (95% CI 0.03 to 0.19). This improvement was not associated with a fall in the sputum eosinophil count.



An increased sputum eosinophil count is related to an improvement in post-bronchodilator FEV(1) following treatment with inhaled mometasone in COPD, but the improvement is not associated with a reduction in the sputum eosinophil count.
Inverted papilloma of the sphenoid sinus: risk factors for disease recurrence.

Surgical treatment of inverted papilloma (IP) of the sphenoid sinus is complicated by close proximity to vital structures of the skull base. Identifying the site of tumor attachment and achieving complete removal can be challenging compared to IP at other sites. The objective of this study is to illustrate the clinical presentation, management, and risk factors for tumor recurrence for sphenoid IP.



Retrospective study.



A multi-institutional, retrospective review of endoscopic resections of IP based within the sphenoid sinus was performed from 1996 to 2014. Demographic and tumor data, operative notes, complications, and recurrence rates were collected. Statistical analysis was performed to identify risk factors for tumor recurrence.



Forty-eight patients (31 males, 17 females) were identified. Mean age was 57 years, with a median follow-up of 13.6 months (range 6.8-36). Rate of tumor recurrence was 14.6%, with median time to recurrence of 13.1 months. Patients with dysplasia/carcinoma in situ (CIS) had a 3.6 greater rate of recurrence (RR) compared to patients with no dysplasia, approaching significance (RR = 3.6; P = 0.08). Patients with IP attachment sites overlying the optic nerve or carotid artery had a 4.76 greater rate of recurrence compared to other sites (RR = 4.76; P = 0.073).



Sphenoid sinus IP is associated with a 14.6% rate of recurrence after surgery. Potential risk factors for tumor recurrence identified in this study include attachment sites over the optic nerve and carotid artery or evidence of dysplasia or CIS. Close follow-up in the postoperative period is essential for these patients to monitor for tumor recurrence.
Prevalence of migraine in patients with restless legs syndrome: a case-control study.

To assess and compare the prevalence of migraine in patients with restless legs syndrome (RLS) and matched controls.



Recent studies have suggested an association between migraine and RLS. Our work is the first case-control study on this subject performed in an RLS population.



A case-control study was conducted in 47 RLS patients (27 women and 20 men aged between 18 and 65 years) and 47 age- and sex-matched controls. Validated questionnaires were used to investigate the presence of migraine, anxiety, and depression (Zung Self-Rating Anxiety and Depression scales), sleep quality (Pittsburgh Sleep Quality Index), and RLS severity (International RLS scale).



RLS patients had higher lifetime prevalence of migraine than non-RLS controls (53.2% vs. 25.5%, P = .005; matched-OR 1.3 [P = .019]; adjusted odds ratio (OR) 3.8 [P = .03]). No significant associations were found between RLS and active migraine with aura or inactive migraine (no episodes in the previous year). However, active migraine without aura was significantly more prevalent in patients with RLS than in controls (40.4% vs. 12.8%, P = .001; matched OR 1.5 [P = .001]; adjusted OR 2.7 [P = .04]). Within the RLS group, patients with migraine had poorer sleep quality than those without migraine (Pittsburgh Sleep Quality Index >5:100 vs. 80.9%, P = .038) but did not differ in terms of RLS severity, anxiety and depression, use of dopaminergic agonists, and body mass index.



There appears to be a relationship between RLS and migraine, in particular for active migraine without aura.
Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism.

The clinical benefit of thrombolytic treatment over heparin in patients with pulmonary embolism without hemodynamic compromise remains controversial. In these patients bolus tenecteplase has the potential to provide an effective and safe thrombolysis.



We evaluated the effect of tenecteplase on right ventricle dysfunction (RVD) assessed by echocardiography in hemodynamically stable patients with PE in a multicenter, randomized, double-blind, placebo-controlled study. RVD was defined as right/left ventricle end-diastolic dimension ratio >1 in the apical 4-chamber view. Patients were randomized to receive weight-adjusted single-bolus tenecteplase or placebo. All patients received unfractionated heparin. Reduction of RVD at 24 hours was the primary efficacy end-point and was evaluated by an independent committee unaware of treatment allocation.



Overall, 58 patients were randomized. Echocardiograms were adequate for efficacy analysis in 51 patients, 23 randomized to tenecteplase and 28 to placebo. The reduction of right to left ventricle end-diastolic dimension ratio at 24 hours was 0.31+/-0.08 in patients randomized to tenecteplase as compared to 0.10+/-0.07 in patients randomized to placebo (p=0.04). One patient randomized to tenecteplase suffered a clinical event (recurrent pulmonary embolism) in comparison to three patients randomized to placebo (1 recurrent pulmonary embolism; 1 clinical deterioration and 1 non pulmonary embolism-related death). Two non fatal major bleedings occurred with tenecteplase (1 intracranial) and one with placebo.



In hemodynamically stable patients with PE, treatment with single bolus tenecteplase is feasible at the same dosages used for acute myocardial infarction and is associated with reduction of RVD at 24 hours. Whether this benefit is associated with an improved clinical outcome without excessive bleeding is currently explored in a large clinical trial.
A clinical prediction rule and platelet count predict esophageal varices in children.

The validation of noninvasive tests to diagnose esophageal varices is a priority in children because repeated endoscopic evaluations are too invasive. We measured the ability of a previously developed noninvasive clinical prediction rule (CPR) to predict the presence of esophageal varices in children.



We analyzed data from 108 children, younger than age 18, who received endoscopies at 8 centers, to assess portal hypertension from chronic liver disease or portal vein obstruction. Blood test and abdominal ultrasound scan results were obtained within 4 months of endoscopy. Grading of varices identified by endoscopy was confirmed by independent blinded review. Spleen size, based on data from the ultrasound scan, was expressed as a standard deviation score relative to normal values for age.



Of the children studied, 74 had esophageal varices (69%), including 35 with large varices (32%). The best noninvasive predictors of esophageal varices of any size were as follows: platelet:spleen size z-score ratio (area under the receiver operating characteristic curve [AUROC], 0.84; 95% confidence interval [CI] 0.75-0.93), CPR (AUROC, 0.80; 95% CI, 0.70-0.91), and platelet count (AUROC, 0.79; 95% CI, 0.69-0.90). The positive predictive values for the CPR and platelet count were 0.87 and 0.86, the negative predictive values were 0.64 and 0.63, the positive likelihood ratios were 3.06 and 2.76, and the negative likelihood ratios were 0.64 and 0.63, respectively. Based on positive and negative predictive values, the most accurate noninvasive tests were the CPR and platelet counts.



Noninvasive tests such as CPR and platelet count can assist in triaging children for endoscopy to identify esophageal varices.
Does the Mediterranean diet counteract the adverse effects of abdominal adiposity?

We tested the hypothesis that an intervention with a Mediterranean diet (MeDiet) could mitigate the well-known harmful effects of abdominal obesity on cardiovascular health.



We assessed the relationship between baseline waist-to-height ratio (WHtR) and major cardiovascular events during a median follow-up of 4.8 years in the Prevention with Mediterranean Diet (PREDIMED) randomized primary prevention trial, which tested a MeDiet against a control diet (advice on a low-fat diet). We also examined whether the MeDiet intervention was able to counteract the detrimental cardiovascular effects of an increased WHtR. The trial included 7447 participants (55-80 years old, 57% women) at high cardiovascular risk but free of cardiovascular disease (CVD) at enrollment. An increased risk of CVD events (myocardial infarction, stroke, or cardiovascular death) was apparent for the highest versus the lowest quartile of WHtR (multivariable-adjusted hazard ratio: 1.98) (95% confidence interval: 1.10-3.57; linear trend: p = 0.019) only in the control-diet group, but not in the two groups allocated to intervention with MeDiet (p for interaction = 0.034). This apparent interaction suggesting that the intervention counterbalanced the detrimental cardiovascular effects of adiposity was also significant for body mass index (BMI) (p = 0.01) and waist circumference (p = 0.043).



The MeDiet may counteract the harmful effects of increased adiposity on the risk of CVD.
Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms

A wide search for ischemic preconditioning (IPC) mechanisms of cardioprotection identified the light elicited circadian rhythm protein Period 2 (Per2) to be cardioprotective. Studies on cardiac metabolism found a key role for light elicited Per2 in mediating metabolic dependence on carbohydrate metabolism. To profile Per2 mediated pathways following IPC of the mouse heart, we performed a genome array and identified 352 abundantly expressed and well-characterized Per2 dependent micro RNAs. One prominent result of our in silico analysis for cardiac Per2 dependent micro RNAs revealed a selective role for miR-21 in the regulation of hypoxia and metabolic pathways. Based on this Per2 dependency, we subsequently found a diurnal expression pattern for miR-21 with higher miR-21 expression levels at Zeitgeber time (ZT) 15 compared to ZT3. Gain or loss of function studies for miR-21 using miRNA mimics or miRNA inhibitors and a Seahorse Bioanalyzer uncovered a critical role of miR-21 for cellular glycolysis, glycolytic capacity, and glycolytic reserve. Exposing mice to intense light, a strategy to induce Per2, led to a robust induction of cardiac miR-21 tissue levels and decreased infarct sizes, which was abolished in miR-21-/- mice. Similarly, first translational studies in humans using intense blue light exposure for 5 days in healthy volunteers resulted in increased plasma miR-21 levels which was associated with increased phosphofructokinase activity, the rate-limiting enzyme in glycolysis. Together, we identified miR-21 as cardioprotective downstream target of Per2 and suggest intense light therapy as a potential strategy to enhance miR-21 activity and subsequent carbohydrate metabolism in humans.
A population-based study to evaluate the effectiveness of multidisciplinary heart failure clinics and identify important service components.

Multidisciplinary heart failure (HF) clinics are efficacious in clinical trials. Our objectives were to compare real-world outcomes of patients with HF treated in HF clinics versus usual therapy and identify HF clinic features associated with improved outcomes.



The service components at all HF clinics in Ontario, Canada, were quantified using a validated instrument and categorized as high/medium/low intensity. We used propensity-scores to match HF clinic and control patients discharged alive after a HF readmission in 2006-2007. Outcomes were mortality, and both all-cause and HF readmission. Cox-proportional hazard models were used to evaluate HF clinic-level characteristics associated with improved outcomes. We identified 14 468 patients with HF, of whom 1288 were seen in HF clinics. Within 4 years of follow-up, 52.1% of patients treated at a HF clinic died versus 54.7% of control patients (P=0.02). Patients treated at HF clinics had increased readmissions (87.4% versus 86.6% for all-cause [P=0.009]; 58.7% versus 47.3% for HF related [P<0.001]). There was no difference between high, medium, or low intensity clinics in terms of mortality, all-cause, or HF readmissions. HF clinics with greater frequency of visits (>4 contacts of significant duration for 6 months) were associated with lower mortality (hazard ratio, 0.14; P<0.0001) and hospitalization (hazard ratio, 0.69; P=0.039). More intensive medication management was associated with lower all-cause (hazard ratio, 0.46; P<0.001) and HF readmission (hazard ratio, 0.42; P<0.001).



In this real-world population-based study, we found that multidisciplinary HF clinics are associated with a decrease in mortality, but an increase in readmissions.
Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction

Growing evidence suggests that the left radial approach (LRA) is related to decreased coronary procedure duration and fewer cerebrovascular complications as compared to the right radial approach (RRA) in elective percutaneous coronary intervention (PCI). However, the feasibility of LRA in primary PCI has yet to be studied further. Therefore, the aim of this study was to investigate the efficacy of LRA compared with RRA for primary PCI in ST-elevation myocardial infarction (STEMI) patients.



A total of 200 consecutive patients with STEMI who received primary PCI were randomized to LRA (number [n]=100) or RRA (n=100). The study endpoint was needle-to-balloon time, defined as the time from local anesthesia infiltration to the first balloon inflation. Radiation dose by measuring cumulative air kerma (CAK) and CAK dose area product, as well as fluoroscopy time and contrast volume were also investigated.



There were no significant differences in the baseline characteristics between the two groups. The coronary procedural success rate was similar between both radial approaches (98% for left versus 94% for right; P=0.28). Compared with RRA, LRA had significantly shorter needle-to-balloon time (16.0±4.8 minutes versus 18.0±6.5 minutes, respectively; P=0.02). Additionally, fluoroscopy time (7.4±3.4 minutes versus 8.8±3.5 minutes, respectively; P=0.01) and CAK dose area product (51.9±30.4 Gy cm(2) versus 65.3±49.1 Gy cm(2), respectively; P=0.04) were significantly lower with LRA than with RRA.



Primary PCI can be performed via LRA with earlier blood flow restoration in the infarct-related artery and lower radiation exposure when compared with RRA; therefore, the LRA may become a feasible and attractive alternative to perform primary PCI for STEMI patients.