nils-herrmann/clean_scirepeval huggingface dataset:
A clinical trial with an “anti-regurgitation” formula

To determine whether a new “anti-regurgitation formula” containing a bean gum preparation decreases the number of regurgitations and gastro-oesophageal reflux (GOR), we studied 20 infants from 1 week to 4 months of age, referred for evaluation of regurgitation, in a double-blind prospective study. The number of regurgitations decreased significantly in both the treatment group (the formula with thickening product, positional treatment, parental reassurance) and the placebo group (the same formula without thickening product, positional treatment, parental reassurance) (P 0.002 and 0.032, respectively). The results of a 24-h oesophageal pH monitoring, performed before and during treatment, showed a significant decrease in the percentage of time oesophageal pH was <4.0 in the treatment group. It is concluded that conservative treatment of regurgitations in infants, consisting mainly of parental reassurance and postural therapy, is sufficient to obtain clinical remission in most patients. In addition, milk thickening products tend to improve clinical remission and contribute to the normalisation of some pH metric parameters.
Validation of early risk-prediction models for gestational diabetes based on clinical characteristics.

Gestational diabetes (GDM) is generally diagnosed late in pregnancy, precluding early preventive interventions. This study aims to validate, in a large Caucasian population of pregnant women, models based on clinical characteristics proposed in the literature to identify, early in pregnancy, those at high risk of developing GDM in order to facilitate follow up and prevention.



This is a cohort study including 7929 pregnant women recruited prospectively at their first prenatal visit. Clinical information was obtained by a self-administered questionnaire and extraction of data from the medical records. The performance of four proposed clinical risk-prediction models was evaluated for identifying women who developed GDM and those who required insulin therapy.



The four models yielded areas under the receiver operating characteristic curve (AUC) between 0.668 and 0.756 for the identification of women who developed GDM, a performance similar to those obtained in the original studies. The best performing model, based on ethnicity, body-mass index, family history of diabetes and past history of GDM, resulted in sensitivity, specificity and AUC of 73% (66-79), 81% (80-82) and 0.824 (0.793-0.855), respectively, for the identification of GDM cases requiring insulin therapy.



External validation of four risk-prediction models based exclusively on clinical characteristics yielded a performance similar to those observed in the original studies. In our cohort, the strategy seems particularly promising for the early prediction of GDM requiring insulin therapy. Addition of recently proposed biochemical markers to such models has the potential to reach a performance justifying clinical utilization.
Feasibility and Timing of Prehospital Administration of Reteplase in Patients with Acute Myocardial Infarction

In myocardial infarction patients undergoing thrombolysis, treatment delays negatively impact outcomes. This pilot study was conducted to determine the feasibility and timing of field administration of intravenous double bolus reteplase in patients with ST-elevation myocardial infarction.  Sixty three patients with symptoms and EKG changes consistent with acute myocardial infarction of less than six hours duration received the first bolus of reteplase before arriving at the emergency department. A second bolus of reteplase was given in the emergency department. Subsequent resolution of ST-segment elevation was measured. Mean time from symptom onset to paramedic dispatch, and paramedic arrivals to first bolus of reteplase were measured. The mean time from the first bolus of reteplase to heparin bolus in an emergency department was also measured. All patients with evidence of ST-elevation and suspected acute myocardial infarction gave consent for the thrombolytic therapy. There were no refusals of therapy among those candidates eligible for thrombolysis.  The mean times from the first bolus of reteplase to heparin bolus in the emergency department was substantially longer than the in-field times. Resolution of ST-segment elevation was recorded in 52 of the 63 patients and the times of resolution ranged from five minutes after the first bolus dose to 190 minutes after the second bolus of reteplase. Resolution of ST-segment elevation and relief of pain occurred almost simultaneously.  These results demonstrated that in-field administration of thrombolytic therapy is a viable option to reduce the delay from symptom onset to initiation of thrombolysis. They demonstrated that satisfactory resolution of ST-segment elevation can be recorded in the field. The reduction in mortality observed in this study is comparable to previously published studies on inpatients.  This open-label pilot study was conducted to determine the feasibility and timing of field administration of intravenous double-bolus reteplase and to measure subsequent resolution of ST elevation in 63 patients with symptoms and ECG changes consistent with acute myocardial infarction for less than 6 hours. These results demonstrated that in-field administration of thrombolytic therapy is a viable option to reduce the delay from symptom onset to initiation of thrombolytic therapy.
Clinical use of cobicistat as a pharmacoenhancer of human immunodeficiency virus therapy

The pharmacoenhancement of plasma concentrations of protease inhibitors by coadministration of so-called boosters has been an integral part of antiretroviral therapy for human immunodeficiency virus (HIV) for 1.5 decades. Nearly all HIV protease inhibitors are combined with low-dose ritonavir or cobicistat, which are able to effectively inhibit the cytochrome-mediated metabolism of HIV protease inhibitors in the liver and thus enhance the plasma concentration and prolong the dosing interval of the antiretrovirally active combination partners. Therapies created in this way are clinically effective regimens, being convenient for patients and showing a high genetic barrier to viral resistance. In addition to ritonavir, which has been in use since 1996, cobicistat, a new pharmacoenhancer, has been approved and is widely used now. The outstanding property of cobicistat is its cytochrome P450 3A-selective inhibition of hepatic metabolism of antiretroviral drugs, in contrast with ritonavir, which not only inhibits but also induces a number of cytochrome P450 enzymes, UDP-glucuronosyltransferase, P-glycoprotein, and other cellular transporters. This article reviews the current literature, and compares the pharmacokinetics, pharmacodynamics, and safety of both pharmacoenhancers and discusses the clinical utility of cobicistat in up-to-date and future HIV therapy.
Identification of penumbra and infarct in acute ischemic stroke using computed tomography perfusion-derived blood flow and blood volume measurements.

We investigated whether computed tomography (CT) perfusion-derived cerebral blood flow (CBF) and cerebral blood volume (CBV) could be used to differentiate between penumbra and infarcted gray matter in a limited, exploratory sample of acute stroke patients.



Thirty patients underwent a noncontrast CT (NCCT), CT angiography (CTA), and CT perfusion (CTP) scan within 7 hours of stroke onset, NCCT and CTA at 24 hours, and NCCT at 5 to 7 days. Twenty-five patients met the criteria for inclusion and were subsequently divided into 2 groups: those with recanalization at 24 hours (n=16) and those without (n=9). Penumbra was operationally defined as tissue with an admission CBF <25 mL x 100 g(-1) x min(-1) that was not infarcted on the 5- to 7-day NCCT. Logistic regression was applied to differentiate between infarct and penumbra data points.



For recanalized patients, CBF was significantly lower (P<0.05) for infarct (13.3+/-3.75 mL x 100 g(-1) x min(-1)) than penumbra (25.0+/-3.82 mL x 100 g(-1) x min(-1)). CBV in the penumbra (2.15+/-0.43 mL x 100 g(-1)) was significantly higher than contralateral (1.78+/-0.30 mL x 100 g(-1)) and infarcted tissue (1.12+/-0.37 mL x 100 g(-1)). Logistic regression using an interaction term (CBFxCBV) resulted in sensitivity, specificity, and accuracy of 97.0%, 97.2%, and 97.1%, respectively. The interaction term resulted in a significantly better (P<0.05) fit than CBF or CBV alone, suggesting that the CBV threshold for infarction varies with CBF. For patients without recanalization, CBF and CBV for infarcted regions were 15.1+/-5.67 mL x 100 g(-1) x min(-1) and 1.17+/-0.41 mL x 100 g(-1), respectively.



We have shown in a limited sample of patients that CBF and CBV obtained from CTP can be sensitive and specific for infarction and should be investigated further in a prospective trial to assess their utility for differentiating between infarct and penumbra.
Effect of robotic gait training on cardiorespiratory system in incomplete spinal cord injury.

The objectives in this study were to investigate the effect of robot-assisted gait training on cardiorespiratory fitness in subjects with motor incomplete spinal cord injury and document the exercise intensity of robotic walking in comparison with the recommended guidelines. Ten patients followed a 24-session training program with a robotic gait orthosis in addition to physiotherapy sessions completed within 10 to 16 wk. Cardiorespiratory fitness was determined in a graded arm crank exercise test before and after the training program. To assess the intensity of robot-assisted walking, oxygen consumption (VO2) and heart rate (HR) were measured during a training session early in and at the end of the training program, and exercise intensity measures (percentage of VO2 reserve [%VO2R], percentage of HR reserve [%HRR], and metabolic equivalents [METs]) were calculated. Whereas no changes were found in peak VO2, the resting and submaximal HR at a constant work load were significantly lower after training. Most subjects exercised at low intensity (<30%VO2R, <30%HRR, <3.0 METs), and only two subjects exercised at moderate intensity (>3.0 METs). In spite of the low exercise intensity of the training program and no changes in peak VO2, robot-assisted gait training induced some improvement in cardiorespiratory fitness, as suggested by lower resting and submaximal HR values.
Reduced oxidative metabolic response in dysfunctional myocardium with preserved glucose metabolism but with impaired contractile reserve.

The recovery of function in myocardium defined as viable by (18)F-FDG PET may differ from that defined by dobutamine stress echocardiography (DSE). The aim of this study was to investigate the difference in the oxidative metabolic response between myocardial segments with preserved contractile reserve (CR) and those without CR, in segments with and without preserved glucose metabolism (GM), using (11)C-acetate PET.



Twenty patients with previous myocardial infarction (left ventricular ejection fraction, 37.1% +/- 16.5%) underwent dynamic (11)C-acetate PET at rest and during dobutamine (7.5 microg/kg/min) infusion. GM was evaluated using (18)F-FDG PET and CR was evaluated using DSE. Dysfunctional segments were divided into 3 groups: group A (n = 26) with preserved CR and GM, group B (n = 15) without CR but with preserved GM, and group C (n = 41) without CR and without preserved GM.



Resting oxidative metabolism (k mono = monoexponential clearance rate) was preserved in group A and group B (0.052 +/- 0.011/min vs. 0.051 +/- 0.012/min, P = not significant) but was reduced in group C (0.040 +/- 0.015/min) (P < 0.03 vs. group A and group B). The change in k mono, as a measure of the metabolic response to low-dose dobutamine, was significantly higher in group A (0.018 +/- 0.012) than that in group B (0.0075 +/- 0.0096, P < 0.03) and group C (0.0080 +/- 0.012, P < 0.005).



Viable segments based on (18)F-FDG PET have preserved resting oxidative metabolism. However, segments without CR but with preserved GM show a reduction in the oxidative metabolic response to low-dose dobutamine infusion. The decrease in CR may be related to the reduction in the metabolic response to inotropic stimulation despite preservation of tissue viability on (18)F-FDG PET.
Prevalence of fatigue in patients 3 months after stroke and association with early motor activity: a prospective study comparing stroke patients with a matched general population cohort

Fatigue is a common complaint after stroke. Reasons for higher prevalence are still unclear. This study aimed to determine if fatigue prevalence in stroke patients is different to that of age and gender matched general population controls, and to explore whether early motor activity was associated with reduced likelihood of fatigue three months after stroke.



This was a prospective multicenter cohort study of stroke patients admitted to eleven regional Norwegian hospitals, within 14 days after stroke. Stroke patients (n = 257) were age and gender matched to participants in a general population health survey (HUNT3-survey) carried out in a regional county of central Norway. The single-item fatigue questionnaire from the HUNT3-survey was administered to both groups to compare prevalence. The association between early motor activity (time in bed, time sitting out of bed, and time upright) and fatigue at three months after stroke (Fatigue Severity Scale) was tested with logistic regression. Simple models including each activity outcome, with adjustment for stroke severity and pre-stroke function, were tested, as well as a comprehensive model that included additional independent variables of depression, pain, pre-stroke fatigue, age and gender.



Prevalence was higher after stroke compared with the general population: 31.1% versus 10.9%. In the simple regression models, none of the early motor activity categories were associated with fatigue three months after stroke. In the comprehensive model, depression, pain and pre-stroke fatigue were significantly associated with post-stroke fatigue. Time in bed through the daytime during hospital stay approached statistical significance (p = 0.058) with an odds ratio for experiencing fatigue of 1.02 (95% CI 1.00-1.04) for each additional 5.4 minutes in bed.



Stroke patients had higher prevalence of fatigue three months after stroke than the age and gender matched general population sample, which may be partly explained by the stroke population being in poorer health overall. The relationship between early motor activity (and inactivity) and fatigue remains unclear. Further research, which may help drive development of new treatments to target this challenging condition, is needed.
Measurement of the Effect of Physical Exercise on the Concentration of Individuals with ADHD

Attention Deficit Hyperactivity Disorder (ADHD) mainly affects the academic performance of children and adolescents. In addition to bringing physical and mental health benefits, physical activity has been used to prevent and improve ADHD comorbidities; however, its effectiveness has not been quantified. In this study, the effect of physical activity on children's attention was measured using a computer game. Intense physical activity was promoted by a relay race, which requires a 5-min run without a rest interval. The proposed physical stimulus was performed with 28 volunteers: 14 with ADHD (GE-EF) and 14 without ADHD symptoms (GC-EF). After 5 min of rest, these volunteers accessed the computer game to accomplish the tasks in the shortest time possible. The computer game was also accessed by another 28 volunteers: 14 with ADHD (GE) and 14 without these symptoms (GC). The response time to solve the tasks that require attention was recorded. The results of the four groups were analyzed using D'Agostino statistical tests of normality, Kruskal-Wallis analyses of variance and post-hoc Dunn tests. The groups of volunteers with ADHD who performed exercise (GE-EF) showed improved performance for the tasks that require attention with a difference of 30.52% compared with the volunteers with ADHD who did not perform the exercise (GE). The (GE-EF) group showed similar performance (2.5% difference) with the volunteers in the (GC) group who have no ADHD symptoms and did not exercise. This study shows that intense exercise can improve the attention of children with ADHD and may help their school performance.
Outcomes and perception of lung surgery with implementation of a patient video education module: a prospective cohort study.

Although surgeons are constantly making efforts to improve efficiency of care, it is important to also optimize the patients' understanding and satisfaction with their surgical experience. We investigated the effect of a preoperative educational video on patient outcomes and perception of surgery.



An educational video was developed outlining preoperative, operative, and postoperative expectations for patients undergoing pulmonary resection. A prospective study was conducted with 150 patients undergoing surgery with routine preoperative discussion (control group, January 2008 to June 2009) and 150 patients who were provided a supplemental video module (video or study group, September 2009 to October 2010) in addition to routine discussion. Demographics and outcomes data were recorded. Patients completed a pain survey (McGill Questionnaire) and a standardized patient satisfaction survey at discharge and within 1 month of operation.



The groups were similar in sex, age, comorbidities, and forced expiratory volume, 1 second, % predicted. Length of hospital stay (5.19 ± 7.4 days vs 4.31 ± 4.3 days; p = 0.2) and hospital readmission rates (12 of 134 [9%] vs 5 of 103 [4.9%]; p = 0.3) were similar for the 2 groups. At discharge, patients in the study group reported less pain at rest (0.98 ± 0.09) vs controls (1.39 ± 0.11) (p = 0.01) with no difference in pain with lifting or coughing. Patients in the study group reported better overall satisfaction with their operation (2.14 ± 0.07 vs 1.85 ± 0.07; p = 0.02), believed they were better prepared (2.01 ± 0.07 vs 1.70 ± 0.06; p = 0.006), and reported less anxiety about the surgical experience (2.79 ± 0.10 vs 2.24 ± 0.09; p = 0.0001).



Implementation of a pulmonary resection education module improves patient preparedness, relieves anxiety, and improves pain perception. Additional development and dissemination of a comprehensive education program can improve patients' experience with lung surgery and impact outcomes.
Colistin alone or combined with sulbactam or carbapenem against A. baumannii in ventilator-associated pneumonia.

Colistin use has increased over the last ten years because of multidrug-resistant microorganisms. The aim of this study was to compare the clinical and microbiological efficacy of colistin alone or in combination with sulbactam or carbapenem in the treatment of ventilator-associated pneumonia (VAP) due to multidrug-resistant (MDR) and extremely drug-resistant (XDR) A. baumannii.



Cases treated for VAP because of MDR and XDR A. baumannii between January 2011 and January 2013 were included in the study. The primary and secondary outcome for colistin alone, colistin with sulbactam, and colistin with carbapenems were evaluated. The primary outcomes were clinical efficacy and microbiological efficacy; the secondary outcomes were nephrotoxicity, length of hospitalization, and mortality.



A total of 70 VAP patients were evaluated. A total of 17 patients (24.3%) were administered colistin alone, 20 patients (28.6%) were administered colistin and sulbactam, and 33 patients (47.1%) were administered colistin and carbapenem. Clinical and microbiological response rates were higher in the carbapenem combination group (63.6% and 63.6% in both) than in the sulbactam combination group, which registered 55.0% and 60.0%, respectively. However, this did not represent a significant difference statistically (p > 0.05). There was also no significant difference between colistin alone and the combination groups regarding clinical and microbiological efficacy and mortality.



Neither the administration of colistin alone nor colistin combined with either sulbactam or carbapenem had any noticeable advantage in the treatment of VAP in terms of clinical response, microbiological response, nephrotoxicity, length of hospitalization, and mortality.
The polycomb group protein EZH2 is involved in progression of prostate cancer

Prostate cancer is a leading cause of cancer-related death in males and is second only to lung cancer. Although effective surgical and radiation treatments exist for clinically localized prostate cancer, metastatic prostate cancer remains essentially incurable. Here we show, through gene expression profiling, that the polycomb group protein enhancer of zeste homolog 2 (EZH2) is overexpressed in hormone-refractory, metastatic prostate cancer. Small interfering RNA (siRNA) duplexes targeted against EZH2 reduce the amounts of EZH2 protein present in prostate cells and also inhibit cell proliferation in vitro. Ectopic expression of EZH2 in prostate cells induces transcriptional repression of a specific cohort of genes. Gene silencing mediated by EZH2 requires the SET domain and is attenuated by inhibiting histone deacetylase activity. Amounts of both EZH2 messenger RNA and EZH2 protein are increased in metastatic prostate cancer; in addition, clinically localized prostate cancers that express higher concentrations of EZH2 show a poorer prognosis. Thus, dysregulated expression of EZH2 may be involved in the progression of prostate cancer, as well as being a marker that distinguishes indolent prostate cancer from those at risk of lethal progression.
Novel metabolic risk factors for incident heart failure and their relationship with obesity: the MESA (Multi-Ethnic Study of Atherosclerosis) study.

The objectives of this study were to determine the associations of the metabolic syndrome, inflammatory markers, and insulin resistance with incident congestive heart failure (CHF), beyond established risk factors, and to examine whether these risk factors may provide the link between obesity and CHF.



Recently, increasing interest has emerged on the potential role of novel risk factors such as systemic inflammation, insulin resistance, and albuminuria in the pathophysiology of CHF and their relationship with obesity.



The MESA (Multi-Ethnic Study of Atherosclerosis) study is a community-based multicenter cohort study of 6,814 participants (age 45 to 84 years, 3,601 women) of 4 ethnicities: Caucasians, African Americans, Hispanics, and Chinese Americans. Participants were recruited between 2000 and 2002 from 6 U.S. communities. Median follow-up time was 4 years. Participants with history of symptomatic cardiovascular disease were excluded. Cox proportional hazards models were used to analyze the associations of the metabolic syndrome, inflammatory markers, insulin resistance, and albuminuria with incident CHF, independent of established risk factors (age, gender, hypertension, diabetes mellitus, left ventricular hypertrophy, obesity, serum total cholesterol, and smoking), an interim myocardial infarction, and baseline magnetic resonance imaging parameters of left ventricular structure and function.



A total of 79 participants developed CHF during follow-up, and 26 participants (32.9%) had a myocardial infarction prior to CHF and 65% of the cases had CHF with preserved function (left ventricular ejection fraction >or=40%). In multivariable analyses, serum interleukin-6 (hazard ratio [HR] for 1 standard deviation 1.50, 95% confidence interval [CI] 1.10 to 2.03) or C-reactive protein (HR for 1 standard deviation 1.38; 95% CI 1.01 to 1.86) and macroalbuminuria (HR 4.31, 95% CI 1.58 to 11.76) were predictors of CHF, independent of obesity and the other established risk factors. Although obesity was significantly associated with incident CHF, this association was no longer significant after adding inflammatory markers (interleukin-6 or C-reactive protein) to the model.



Inflammatory markers and albuminuria are independent predictors of CHF. The association of obesity and CHF may be related to pathophysiologic pathways associated with inflammation.