nils-herrmann/clean_scirepeval huggingface dataset:
Assessment of mastication in healthy children and children with cerebral palsy: a validity and consistency study.

The aim of this study was to develop the Mastication Observation and Evaluation instrument for observing and assessing the chewing ability of children eating solid and lumpy foods. This study describes the process of item definition and item selection and reports the content validity, reproducibility and consistency of the instrument. In the developmental phase, 15 experienced speech therapists assessed item relevance and descriptions over three Delphi rounds. Potential items were selected based on the results from a literature review. At the initial Delphi round, 17 potential items were included. After three Delphi rounds, 14 items that regarded as providing distinctive value in assessment of mastication (consensus >75%) were included in the Mastication Observation and Evaluation instrument. To test item reproducibility and consistency, two experts and five students evaluated video recordings of 20 children (10 children with cerebral palsy aged 29-65 months and 10 healthy children aged 11-42 months) eating bread and a biscuit. Reproducibility was estimated by means of the intraclass correlation coefficient (ICC). With the exception of one item concerning chewing duration, all items showed good to excellent intra-observer agreement (ICC students: 0.73-1.0). With the exception of chewing duration and number of swallows, inter-observer agreement was fair to excellent for all items (ICC experts: 0.68-1.0 and ICC students: 0.42-1.0). Results indicate that this tool is a feasible instrument and could be used in clinical practice after further research is completed on the reliability of the tool.
A basic diagnostic headache diary (BDHD) is well accepted and useful in the diagnosis of headache. a multicentre European and Latin American study.

We tested the usability and usefulness of the basic diagnostic headache diary (BDHD) for the diagnosis of migraine, tension-type headache and medication-overuse headache in European and Latin American countries.



Patients were subdivided into two groups according to a 1:1 randomization list. Those in group 1 were sent the BDHD before their first visit to the headache centre and asked to complete it for at least 1 month. Those in group 2 made their first visit to the headache centre without receiving the BDHD.



A total of 626 patients from nine countries and 16 centres completed the study. The BDHD entries were complete in 97.5% of cases. BDHD information and clinical interview were, when taken together, considered complete for diagnosis in 97.7% of cases in group 1 whereas the information obtained by clinical interview alone in group 2 was considered complete in only 86.8% of cases (p < 0.001). The median number of diagnoses per patient in group 1 was significantly higher than in group 2 (p = 0.04). The BDHD was very well accepted by both patients and doctors.



It is concluded that the BDHD is a useful tool in the diagnostic assessment of the most frequent and disabling forms of primary headache and in headache management.
Matrix Metalloproteinase-9 for the Earliest Stage Acute Coronary Syndrome : Comparison With High-Sensitivity Troponin T

cute coronary syndrome (ACS) is evoked by rupture or erosion of vulnerable atherosclerotic plaques, which contain large lipid cores underneath thin and collagen-poor fibrous caps, followed by thrombus formation. The consequent luminal occlusion or critical narrowing of a coronary artery causes myocardial necrosis or ischemic damage.1 Thus, the identification of biomarkers that can detect plaque rupture or vulnerability might allow earlier diagnosis of ACS, although acute myocardial infarction (AMI) is currently diagnosed using biomarkers of myocardial necrosis or damage, such as creatine kinase-MB (CK-MB)2 and cardiac troponins.3–7 In recent years, highly sensitive assays for cardiac troponins have been developed.8,9 These high-sensitivity troponins, however, may be insufficient for diagnosing the earliest stages of ACS.10 Matrix metalloproteinases (MMPs), which are expressed in atherosclerotic plaques, induce degradation of extracellular matrix proteins, including collagens and elastins, in atherosclerotic fibrous caps.11,12 ACS is evoked by expression and activation of MMPs through disruption of the atherosclerotic fibrous caps and subsequent thrombus formation.12,13 Among MMPs, MMP-9, known as gelatinase B or 92-kDa type IV collagenase, is expressed in atherosclerotic plaques, especially
Patients' perceptions of information and support received from the nurse specialist during HCV treatment.

To identify patients' perceptions of support received from the nurse specialist during Hepatitis C virus (HCV) treatment.



HCV is a worldwide health problem. However, it is a treatable disease and treatment success rates are high. Unfortunately, treatment comes with a multitude of adverse side effects and patients require informational and psychological support from specialist nurses while on treatment. To date, there is little nursing research on support received from this specialist nursing care.



This study used a quantitative descriptive design.



A 59-item questionnaire collected data from 106 patients with a diagnosis of HCV attending a HCV outpatient clinic.



Overall, patients were very satisfied with support received. Advice on contraception was well received. However, many patients did not feel supported with regard to advice on sleep management. There were no statistically significant differences between overall satisfaction and gender, age, genotype and risk factor. However, there were significant correlations found between support received and reported genotype. Those patients presenting with genotype 1, who are mostly infected through blood or blood products, indicated that they require more support in relation to information on side effects of treatment, quality of life and support groups. Specific approaches to support and advice for this cohort may need to be incorporated into current services.



Results of this study reinforce the need for the ongoing use of specialist nurse services and development of this service where no such facilities exist. In addition, the service may need to further recognise and support the information and psychological needs of patients with differing modes of HCV infection.


 TO CLINICAL PRACTICE
Findings provide information to practising nurse specialists about patient's views of information and support received from nurse specialists in HCV treatment centres and identify where deficits exist.
Postal questionnaires identified hospitalizations for self-reported acute myocardial infarction.

We validated the diagnoses of self-reported acute myocardial infarction (AMI) treated in hospital.



The agreement between myocardial infarction reported in a postal questionnaire in 1998 and data from the Augsburg Coronary Event Register were assessed in a representative sample of German men and women (n = 9,176) aged 25 to 74 years at baseline examination.



Of the 9,176 persons, 207 men and women reported an incident AMI treated in hospital during the follow-up period. Of these, 148 persons fulfilled the criteria for verified AMI (positive predictive value 71.5%). Among the 8,969 respondents who reported no AMI, three persons had an AMI (negative predictive value 100%). The sensitivity was 98.0%, and the specificity 99.3%. Much of the false-positive reporting was related to cardiac hospitalizations, predominantly for coronary heart disease (42%).



A postal questionnaire seems to be a useful method to identify hospitalizations for incident nonfatal AMI cases in epidemiologic cohort studies. Because the proportion of false negatives is low, medical record reviews for case ascertainment can be limited to the group of positive responders.
Prospective, randomized, single-blind comparison of effects of 6 months' treatment with atorvastatin versus pravastatin on leptin and angiogenic factors in patients with coronary artery disease

Leptin has been reported to exert an atherosclerotic effect by regulating expression of angiogenic factors that have been implicated in the pathogenesis of coronary artery disease (CAD). The purpose of this study was to investigate whether lipid-lowering therapy (LLT) with statins could affect leptin levels and angiogenic factors in patients with CAD. This study included 76 patients with CAD and 15 subjects without CAD (non-CAD). CAD patients were randomized to 6 months of intensive LLT with atorvastatin or moderate LLT with pravastatin. Plasma leptin, angiopoetin-2 (Ang-2), hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF) levels were measured prior to statin therapy (baseline) and after 6 months. Baseline levels of leptin, Ang-2, HGF and VEGF were higher in the CAD group than in the non-CAD group (all P < 0.05). Treatment with intensive LLT decreased leptin, Ang-2, HGF and VEGF levels, whereas moderate LLT did not change these levels. This study suggests that LLT with atorvastatin decreases leptin levels and angiogenic factors in patients with CAD, possibly contributing to the beneficial effects of LLT with atorvastatin in CAD.
Is oxaliplatin combined with weekly bolus 5-fluorouracil and leucovorin an option for stage II and III colon cancer?

The Multicenter International Study of Oxaliplatin/5-Fluorouracil, Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) study reported that the addition of oxaliplatin to a regimen of bolus and continuous-infusion 5-fluorouracil (5-FU) combined with leucovorin (LV)—the FOLFOX4 regimen—improved 3-year disease-free survival (DFS) in comparison with FULV (5-FU and LV administered alone).
Bacteremia is an independent risk factor for mortality in nosocomial pneumonia: a prospective and observational multicenter study

Since positive blood cultures are uncommon in patients with nosocomial pneumonia (NP), the responsible pathogens are usually isolated from respiratory samples. Studies on bacteremia associated with hospital-acquired pneumonia (HAP) have reported fatality rates of up to 50%. The purpose of the study is to compare risk factors, pathogens and outcomes between bacteremic nosocomial pneumonia (B-NP) and nonbacteremic nosocomial pneumonia (NB-NP) episodes.



This is a prospective, observational and multicenter study (27 intensive care units in nine European countries). Consecutive patients requiring invasive mechanical ventilation for an admission diagnosis of pneumonia or on mechanical ventilation for > 48 hours irrespective of admission diagnosis were recruited.



A total of 2,436 patients were evaluated; 689 intubated patients presented with NP, 224 of them developed HAP and 465 developed ventilation-acquired pneumonia. Blood samples were extracted in 479 (69.5%) patients, 70 (14.6%) being positive. B-NP patients had higher Simplified Acute Physiology Score (SAPS) II score (51.5 ± 19.8 vs. 46.6 ± 17.5, P = 0.03) and were more frequently medical patients (77.1% vs. 60.4%, P = 0.01). Mortality in the intensive care unit was higher in B-NP patients compared with NB-NP patients (57.1% vs. 33%, P < 0.001). B-NP patients had a more prolonged mean intensive care unit length of stay after pneumonia onset than NB-NP patients (28.5 ± 30.6 vs. 20.5 ± 17.1 days, P = 0.03). Logistic regression analysis confirmed that medical patients (odds ratio (OR) = 5.72, 95% confidence interval (CI) = 1.93 to 16.99, P = 0.002), methicillin-resistant Staphylococcus aureus (MRSA) etiology (OR = 3.42, 95% CI = 1.57 to 5.81, P = 0.01), Acinetobacter baumannii etiology (OR = 4.78, 95% CI = 2.46 to 9.29, P < 0.001) and days of mechanical ventilation (OR = 1.02, 95% CI = 1.01 to 1.03, P < 0.001) were independently associated with B-NP episodes. Bacteremia (OR = 2.01, 95% CI = 1.22 to 3.55, P = 0.008), diagnostic category (medical patients (OR = 3.71, 95% CI = 2.01 to 6.95, P = 0.02) and surgical patients (OR = 2.32, 95% CI = 1.10 to 4.97, P = 0.03)) and higher SAPS II score (OR = 1.02, 95% CI = 1.01 to 1.03, P = 0.008) were independent risk factors for mortality.



B-NP episodes are more frequent in patients with medical admission, MRSA and A. baumannii etiology and prolonged mechanical ventilation, and are independently associated with higher mortality rates.
In fl uence of Rho kinase inhibitor fasudil on late endothelial progenitor cells in peripheral blood of COPD patients with pulmonary artery hypertension

To investigate the infl uence of Fasudil, a Rho inhibitor on the number and functions of the late endothelial progenitor cells in peripheral blood of chronic obstructive pulmonary diseases (COPD) patients with pulmonary artery hypertension.  It is not clear yet, whether Rho Kinase Inhibitor Fasudil can reduced pulmonary artery pressure through improving lung endothelial function.  80 COPD patients with pulmonary artery hypertension were selected and divided into two groups: the treatment group and the control group, which had 40 patients, respectively. Changes in the number and function of the late endothelial progenitor cells in peripheral blood of the patients before and after the treatment were compared between the two groups. The changes on the pulmonary artery pressure were also compared.  The number of the late endothelial progenitor cells in peripheral blood of the treatment group increased and the function was enhanced. The pulmonary artery pressure was reduced. The difference before and after the treatment and with the control group was statistically signifi cant (p < 0.05).  The Rho-kinase inhibitor Fasudil increased the number and enhanced the function of the late endothelial progenitor cells in peripheral blood of COPD patients with pulmonary artery hypertension (Tab. 3, Fig. 2, Ref. 17). Text
Valproic acid combined with 13-cis retinoic acid and 1,25-dihydroxyvitamin D3 in the treatment of patients with myelodysplastic syndromes.

Valproic acid (VPA), an inhibitor of histone deacetylases, inhibits the growth of leukemia cells and induces their differentiation in vitro. In the present study, VPA in combination with two differentiating agents, 13-cis retinoic acid and 1,25-dihydroxyvitamin D3, was given to 19 previously untreated patients with MDS or CMML. Eight patients had to discontinue treatment before week 16 due to toxicity. According to international working group criteria, three patients (16%) responded to treatment. No correlation between VPA serum level, histone acetylation or clinical response was observed.
Early bronchodilator action of glycopyrronium versus tiotropium in moderate-to-severe COPD patients: a cross-over blinded randomized study (Symptoms and Pulmonary function in the moRnING)

Morning symptoms associated with COPD have a negative impact on patients' quality of life. Long-acting bronchodilators with rapid onset may relieve patients' symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY) and tiotropium (TIO) during the first few hours after dosing in patients with moderate-to-severe COPD.



Patients were randomized (1:1) to receive either once-daily GLY (50 μg) or TIO (18 μg) and corresponding placebos in a cross-over design for 28 days. The primary objective was to demonstrate the superiority of GLY versus TIO in area under the curve from 0 to 4 hours (AUC0-4h) forced expiratory volume in 1 second (FEV1) after the first dose. The secondary objective was to compare GLY versus TIO using the patient reported outcomes Morning COPD Symptoms Questionnaire 3 hours post-inhalation.



One-hundred and twenty-six patients were randomized (male 70.2%; mean age 65.7 years) and 108 patients completed the study. On Day 1, GLY resulted in significantly higher FEV1 AUC0-4h after the first dose versus TIO (treatment difference [Δ], 0.030 L, 95% confidence interval 0.004-0.056, P=0.025). Improvements in morning COPD symptoms from baseline at Days 1 and 28 were similar between GLY and TIO. Post hoc analysis of the FEV1 AUC0-4h by time point on Day 1 showed significant improvements in patients receiving GLY versus TIO at 5 minutes (Δ=0.029 L, P=0.015), 15 minutes (Δ=0.033 L, P=0.026), and 1 hour (Δ=0.044 L, P=0.014). Safety results were comparable between both treatments.



The SPRING study demonstrates the superiority of GLY versus TIO in terms of superior bronchodilation in the first 4 hours after administration, thus extending the clinical data that support a faster onset of action of GLY versus TIO.
Randomized, controlled trial of entecavir versus placebo in children with hepatitis B envelope antigen-positive chronic hepatitis B.

This ongoing, randomized phase III study assesses the safety and efficacy of entecavir versus placebo in nucleos(t)ide-naïve children (2 to <18 years) with hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis B (CHB). Blinded treatment was administered for a minimum of 48 weeks. After week 48, patients with HBeAg seroconversion continued blinded treatment; those without switched to open-label entecavir. The primary endpoint was HBeAg seroconversion and HBV DNA <50 IU/mL at week 48. A total of 180 patients were randomized (2:1) and treated. Baseline median age was 12 years, with approximately 50% of children ages >12 to <18, and 25% each ages ≥2 to ≤6 and >6 to ≤12. Rates for the primary endpoint at week 48 were significantly higher with entecavir than placebo (24.2% [29 of 120] vs. 3.3% [2 of 60]; P = 0.0008). Furthermore, higher response rates were observed with entecavir compared with placebo for the key week 48 secondary endpoints: HBV DNA <50 IU/mL (49.2% [59 of 120] vs. 3.3% [2 of 60]; P < 0.0001); alanine aminotransferase normalization (67.5% [81 of 120] vs. 23.3% [14 of 60]; P < 0.0001); and HBeAg seroconversion (24.2% [29 of 120] vs. 10.0% [6 of 60]; P = 0.0210). Among entecavir-randomized patients, there was an increase in all efficacy endpoints between weeks 48 and 96, including an increase from 49% to 64% in virological suppression. The cumulative probability of emergent entecavir resistance through years 1 and 2 of entecavir was 0.6% and 2.6%, respectively. Entecavir was well tolerated with no observed differences in adverse events or changes in growth compared with placebo.



In childhood CHB, entecavir demonstrated superior antiviral efficacy to placebo with a favorable safety profile. These results support the use of entecavir as a therapeutic option in children and adolescents with CHB.
Fractionated neem leaf extract is safe and increases CD4+ cell levels in HIV/AIDS patients.

The safety and effect of an acetone-water neem leaf extract (IRAB) on CD4 cells was investigated in 60 HIV/AIDS patients as part of an ongoing study to determine the influence of neem on immunity and viral load in HIV/AIDS. Patients were confirmed as HIV I or II positive, as having CD4 cell count, less than 300 cells/microL, and as antiretrovirally naïve. They were given oral IRAB (1.0 g daily for 12 weeks). Clinical and laboratory tests were carried out at baseline and at 4 weekly intervals. Thus, the patients served as their own controls. Sixty patients completed treatment. Fifty (83.33%) were completely compliant with respect to laboratory tests. Increase in mean CD4 cells, 266 cells/microL (159%), for the 50 patients was significant (P < 0.001) between baseline and week 12. Erythrocyte sedimentation rate (64 mm/hr at baseline) was 16 mm/hr at week 12, whereas total number of incidences of HIV/AIDS-related pathologies decreased from 120 at baseline to 5. Mean bodyweight, hemoglobin concentration, and lymphocyte differential count increased significantly by 12% (P < 0.05), 24% (P < 0.0001), and 20% (P < 0.0001), respectively. There were no adverse effects and no abnormalities in kidney and liver function parameters. The results support the safety of IRAB in HIV/AIDS, and its significant influence on CD4 cells may be useful in the formulation of multidrug combination therapies for HIV/AIDS. However, its antiretroviral activity is being evaluated in our laboratory.
Langzeitergebnisse der Katheterablation von Vorhofflimmern

Die Kenntnis über die Stolpersteine bei der Beurteilung von Langzeitergebnissen nach der Ablationsbehandlung von Vorhofflimmern ermöglicht ein kritisches Hinterfragen der in Studien erzielten Resultate. Dennoch ist die Katheterablation ein sicheres und langfristig zielführendes Verfahren bei der Therapie des symptomatischen Vorhofflimmerns v. a. für Patienten mit paroxysmalem Vorhofflimmern. Bei Patienten mit persistierendem symptomatischem Vorhofflimmern muss die Entscheidung zur Ablationsbehandlung aufgrund der höheren Rezidivraten und häufigeren Notwendigkeit wiederholter Eingriffe mit Bedacht getroffen werden. Knowing the pitfalls when evaluating the long-term results after catheter ablation of atrial fibrillation enables a critical analysis of the outcome presented in numerous studies on this topic. Nevertheless, catheter ablation is a long-term successful and safe therapeutic procedure for symptomatic atrial fibrillation, especially for patients with paroxysmal atrial fibrillation. In patients with persistent symptomatic atrial fibrillation, the decision for ablation has to be made with caution due to a higher recurrence rate and higher likelihood for multiple procedures.
Efficacy and safety of 10-mg azilsartan compared with 8-mg candesartan cilexetil in Japanese patients with hypertension: a randomized crossover non-inferiority trial

We investigated whether 10 mg per day of azilsartan, one-half of the normal dosage, would be non-inferior to 8 mg per day of candesartan cilexetil for controlling blood pressure in Japanese patients with hypertension. In this open-label, randomized, crossover trial, 309 hypertensive Japanese adults treated with 8-mg candesartan cilexetil were randomized into two arms and received either 10-mg azilsartan or 8-mg candesartan cilexetil in a crossover manner. The primary efficacy outcome was systolic blood pressure, and the margin of non-inferiority was set to be 2.5 mm Hg. The participants were 67±11 years old, and 180 (58%) were male. The baseline systolic and diastolic blood pressure levels were 127.1±13.2 and 69.7±11.2 mm Hg, respectively. During the study period, the difference in systolic blood pressure between the treatments with 10-mg azilsartan and 8-mg candesartan cilexetil was −1.7 mm Hg, with the two-sided 95% confidence interval (CI) ranged from −3.2 to −0.2 mm Hg. The upper boundary of the 95% CI was below the margin of 2.5 mm Hg, confirming the non-inferiority of 10-mg azilsartan to 8-mg candesartan cilexetil. The difference also reached significance (P=0.037). The corresponding difference in diastolic blood pressure was −1.4 (95% CI: −2.4 to −0.4) mm Hg (P=0.006). Treatment with 10-mg azilsartan was similar to 8-mg candesartan cilexetil in its association with rare adverse events. In conclusion, 10-mg azilsartan was non-inferior to 8-mg candesartan cilexetil for controlling systolic blood pressure in Japanese hypertensive patients already being treated with 8-mg candesartan cilexetil.