nils-herrmann/clean_scirepeval huggingface dataset:
Optimal projection estimation for transcatheter aortic valve implantation based on contrast-aortography: validation of a Prototype Software.

We investigate the accuracy of a new software system (C-THV, Paieon) designed to calculate the optimal projection (OP) view for transcatheter aortic valve implantation (TAVI) based on two aortograms, and its agreement with the operator's choice. An optimal fluoroscopic working view projection with all three aortic cusps depicted in one line, is crucial during TAVI. In our institution selection of the OP is based on multislice computed tomography (MSCT). Seventy-three consecutive patients referred for TAVI were divided into two groups. For the first group (53 patients, retrospective cohort) we compared the OP views estimated by C-THV with the ones estimated by MSCT. For the second group (20 patients, prospective cohort), we compared the OP views estimated by C-THV with the operator's choice during TAVI. For the retrospective cohort, the mean absolute difference (mean ± SD) between C-THV and MSCT was 6.6 ± 4.9 degrees. In 77% of the cases the mean difference between C-THV and MSCT was <10 degrees. For the prospective cohort, the mean absolute difference (mean ± SD) between C-THV and the operator's choice was 5.5 ± 3.4 degrees. A mean difference of <10 degrees was found in 90% of the cases. In this study we found that the C-THV software estimated the OP view for TAVI with good accuracy. The level of agreement between C-THV and either the MSCT or the operator's choice was deemed satisfactory, with the vast majority of observed differences being <10 degrees.
EU-geförderte Therapiestudie WAKE-UP

Patienten, bei denen Schlaganfallsymptome beim Erwachen bemerkt werden, sind in der Regel von der Behandlung mit einer Thrombolyse ausgeschlossen. Aktuelle Arbeiten zeigen, dass mittels MRT bei Sichtbarkeit einer akuten ischämischen Läsion im DWI (diffusionsgewichteten) -Bild und fehlender Sichtbarkeit im FLAIR („fluid attenuated inversion recovery“) -Bild, dem sog. DWI-FLAIR-Mismatch, Patienten identifiziert werden können, bei denen der Symptombeginn mit hoher Wahrscheinlichkeit weniger als 4,5 h zurückliegt. WAKE-UP ist eine Investigator-initiierte, europäische, randomisierte, doppelblinde, placebokontrollierte Studie zur Untersuchung der Effektivität und Sicherheit der MRT-basierten Thrombolyse mit Alteplase bei Patienten mit unbekanntem Zeitpunkt des Symptombeginns, z. B. Bemerken der Symptome beim Erwachen. Achthundert Patienten mit DWI-FLAIR-Mismatch werden zur Behandlung mit Alteplase oder Placebo randomisiert. Der primäre Effektivitätsendpunkt ist ein gutes klinisches Ergebnis definiert als ein Wert von 0 bis 1 auf der Modified Rankin Scale (MRS) nach 90 Tagen. Primäre Sicherheitsendpunkte sind Tod oder Tod und Abhängigkeit definiert als ein Wert von 4 bis 5 auf der MRS nach 90 Tagen. Bei positivem Ergebnis kann WAKE-UP eine effektive und sichere Akutbehandlung einer großen Anzahl von Schlaganfallpatienten verfügbar machen, die bisher von einer spezifischen Akutbehandlung ausgeschlossen sind. Patients waking up with stroke symptoms are generally excluded from intravenous thrombolysis. It was shown that magnetic resonance imaging (MRI) can identify patients within the time window for thrombolysis (≤ 4.5 h from symptom onset) by a mismatch between the acute ischemic lesion visible on diffusion-weighted imaging (DWI) but not visible on fluid-attenuated inversion recovery (FLAIR) imaging. The WAKE-UP trial is an investigator initiated, European, randomized, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based thrombolysis with alteplase (tPA) in stroke patients with unknown time of symptom onset, e.g. due to symptom recognition on awakening. A total of 800 patients showing MRI findings of a DWI-FLAIR-mismatch will be randomized to either tPA or placebo. The primary efficacy endpoint will be favourable outcome defined by a modified Rankin scale score 0–1 at day 90. The primary safety outcome measures will be mortality and death or dependency defined by modified Rankin scale score 4–6 at 90 days. If positive the WAKE-UP trial is expected to change clinical practice and to make effective and safe treatment available for a large group of acute stroke patients currently excluded from specific acute treatment.
Dose-response study of nebulized bitolterol mesylate solution in asthmatic patients.

Bitolterol mesylate, a new beta 2 adrenergic bronchodilator, is a "pro-drug" which is activated by esterases in the lung. In order to determine the optimal bronchodilator dose of bitolterol, six doses, (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg and 3.0 mg), were administered by closed-port, intermittent-flow nebulization (CPIF) to asthmatic patients on different days. For most patients, the onset of bronchodilator activity (FEV1 increase of at least 15 percent above baseline) occurred within 5 minutes and lasted at least 8 hours. Maximum mean increases in FEV1 were 46-50 percent at the 1.0 mg to 3.0 mg doses. Beyond the 1.0 mg dose, there was no significant improvement in bronchodilator effect, but adverse effects, particularly tremor, increased at higher doses. The optimal dose of bitolterol administered by CPIF was determined to be 1.0 mg which is similar to the dose of bitolterol recommended for use by metered-dose inhaler (MDI) which is 0.7 mg to 1.1 mg. If continuous-flow nebulization is used, two-three times more drug may be needed for a comparable effect. Bitolterol appears to be a safe, effective and long-lasting bronchodilator when administered by jet nebulization.
Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study.

To compare the efficacy and safety of glimepiride versus metformin in pediatric subjects with type 2 diabetes inadequately controlled with diet and exercise alone or oral monotherapy.



This 26-week, single-blind, active-controlled, multinational study randomized 285 subjects to receive glimepiride (1-8 mg once daily) or metformin (500-1000 mg twice daily) for 24 weeks. The primary end point was mean change in A1C from baseline to week 24. Safety was assessed by incidence of hypoglycemia and other adverse events.



Significant reductions from baseline A1C were seen in both the glimepiride (-0.54%, P = 0.001) and metformin (-0.71%, P = 0.0002) groups. A total of 42.4% (56 of 132) and 48.1% (63 of 131) of subjects in the glimepiride and metformin groups, respectively, in the intent-to-treat population achieved A1C <7.0% at week 24. No significant differences were observed between groups in reductions in A1C and self-monitored blood glucose levels, changes in serum lipid concentrations, or hypoglycemia incidence. Significant differences were observed in mean changes from baseline in BMI between groups (0.26 kg/m(2) for glimepiride and -0.33 kg/m(2) for metformin; P = 0.003). The adjusted mean body weight increase was 1.97 kg for glimepiride and 0.55 kg for metformin (P = 0.005). A hypoglycemic episode with blood glucose <50 mg/dl (<2.8 mmol/l) was experienced by 4.9 and 4.2% of glimepiride- and metformin-treated subjects, respectively. A single severe hypoglycemic event occurred in each group.



Glimepiride reduced A1C similarly to metformin with greater weight gain, and there was comparable safety over 24 weeks in the treatment of pediatric subjects with type 2 diabetes.
The Effect of Frequent Hemodialysis on Nutrition and Body Composition: Frequent Hemodialysis Network Trial

We investigated the effects of frequency of hemodialysis on nutritional status by analyzing the data in the Frequent Hemodialysis Network Trial. We compared changes in albumin, body weight, and composition among 245 patients randomized to six or three times per week in-center hemodialysis (Daily Trial) and 87 patients randomized to six times per week nocturnal or three times per week conventional hemodialysis, performed largely at home (Nocturnal Trial). In the Daily Trial, there were no significant differences between groups in changes in serum albumin or the equilibrated protein catabolic rate by 12 months. There was a significant relative decrease in predialysis body weight of 1.5 ± 0.2 kg in the six times per week group at 1 month, but this significantly rebounded by 1.3 ± 0.5 kg over the remaining 11 months. Extracellular water (ECW) decreased in the six times per week compared with the three per week hemodialysis group. There were no significant between-group differences in phase angle, intracellular water, or body cell mass (BCM). In the Nocturnal Trial, there were no significant between-group differences in any study parameter. Any gain in 'dry' body weight corresponded to increased adiposity rather than muscle mass but was not statistically significant. Thus, frequent in-center hemodialysis reduced ECW but did not increase serum albumin or BCM while frequent nocturnal hemodialysis yielded no net effect on parameters of nutritional status or body composition.
Phenotypic factors influencing the variation in response of circulating cholesterol level to personalised dietary advice in the Food4Me study.

Individual response to dietary interventions can be highly variable. The phenotypic characteristics of those who will respond positively to personalised dietary advice are largely unknown. The objective of this study was to compare the phenotypic profiles of differential responders to personalised dietary intervention, with a focus on total circulating cholesterol. Subjects from the Food4Me multi-centre study were classified as responders or non-responders to dietary advice on the basis of the change in cholesterol level from baseline to month 6, with lower and upper quartiles defined as responder and non-responder groups, respectively. There were no significant differences between demographic and anthropometric profiles of the groups. Furthermore, with the exception of alcohol, there was no significant difference in reported dietary intake, at baseline. However, there were marked differences in baseline fatty acid profiles. The responder group had significantly higher levels of stearic acid (18 : 0, P=0·034) and lower levels of palmitic acid (16 : 0, P=0·009). Total MUFA (P=0·016) and total PUFA (P=0·008) also differed between the groups. In a step-wise logistic regression model, age, baseline total cholesterol, glucose, five fatty acids and alcohol intakes were selected as factors that successfully discriminated responders from non-responders, with sensitivity of 82 % and specificity of 83 %. The successful delivery of personalised dietary advice may depend on our ability to identify phenotypes that are responsive. The results demonstrate the potential use of metabolic profiles in identifying response to an intervention and could play an important role in the development of precision nutrition.
Usefulness of one-stage coronary artery bypass grafting on the beating heart and abdominal aortic aneurysm repair.

Abdominal aortic aneurysm (AAA) is commonly associated with coronary artery disease (CAD). Simultaneous coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) under cardiac arrest and AAA repair may be considerably invasive. Recently CABG under the beating heart without CPB has been reported as a less invasive method. We report the combined operation of CABG on a beating heart and AAA repair for AAA patients with CAD, and compare it with a separate operation. A retrospective review of the records of consecutive patients who underwent elective combined procedure or single operation for CABG on a beating heart and/or repair of the AAA between May 1999 and October 2001 was carried out. Ten patients underwent combined procedures. A single operation, CABG on a beating heart or repair of AAA, were performed in 27 or 19 patients. There were no significant differences with regard to intraoperative blood loss, transfusion and postoperative intubation time among the three groups. There was no operative mortality for any of the three groups. All cases were discharged without severe complications and with patent coronary bypass grafts. There was a decrease in mean total hospital costs for the combined operation group compared with the CABG group plus AAA repair group (3.34 million versus 5.87 million yen). Combined CABG on a beating heart and AAA repair on a one-step approach appears to be a safe and useful therapeutic strategy for AAA patients with CAD.
Blood flow restriction does not result in prolonged decrements in torque

We sought to determine if blood flow restriction (BFR) by itself or in combination with exercise would result in prolonged decrements in torque when using restriction pressures relative to the participants’ limb size. Sixteen participants were randomized into Experiment A (n = 9) or Experiment B (n = 7). Experiment A participants performed unilateral knee extensions at 30 % of their one repetition maximum (1RM) with moderate blood flow restriction on one leg (BFR + Exercise) and exercised the other leg without BFR (CON + Exercise). Experiment B participants rested for 4 min with BFR applied to one leg and rested for 4 min without any treatment on the other leg (CON). Maximal voluntary isometric torque (MVC) was measured before and immediately after the exercise or 4 min of rest, 1 h post, and 24 h post. Ratings of perceived exertion (RPE) and discomfort were taken before and after each set. MVC was significantly reduced following both exercise conditions with BFR + Exercise having the largest reduction in torque. However, torque quickly recovered by 1 h post exercise and was back to baseline by 24 h. No changes in torque were observed in Experiment B. RPE and discomfort were rated consistently higher for those in the BFR + Exercise and BFR conditions compared to control. In conclusion, BFR + Exercise does not result in prolonged decrements in torque. The acute changes in torque are due to fatigue and quickly recover back to baseline within 24 h of exercise. In addition, BFR in the absence of exercise has no effect on torque at any time point.
Increased Nonstationarity of Neonatal Heart Rate Before the Clinical Diagnosis of Sepsis

The clinical diagnosis of neonatal sepsis is preceded by abnormal heart rate (HR) characteristics of transient decelerations and reduced variability, which intuitively appear to be more nonstationary than normal HR variability. Our goals were to investigate stationarity of HR, and to devise measures useful for early diagnosis of neonatal sepsis. In this context, we define non-stationarity to be present when the observed data differ from surrogate data generated by stationary Gaussian noise with arbitrary linear correlations. We devised statistical methods for determining stationarity of HR data based on the two-sample Kolmogorov–Smirnov (KS) test. We compared distributions of KS distances between small sample epochs from clinical data with those of isospectral surrogates and of surrogates generated using the amplitude-adjusted Fourier transform technique, reasoning that they should differ significantly for nonstationary data. We found significant evidence of non-stationarity for records longer than 1 min. We developed new HR measures based on the empirical cumulative distribution function (ECDF) that are highly significantly associated with sepsis, but are not correlated with HR measures such as moments or sample entropy. We conclude that neonatal HR data cannot be assumed to be stationary, and become even less stationary prior to sepsis.
Cardiovascular and metabolic effects of 48-h glucagon-like peptide-1 infusion in compensated chronic patients with heart failure.

The incretin hormone glucagon-like peptide-1 (GLP-1) and its analogs are currently emerging as antidiabetic medications. GLP-1 improves left ventricular ejection fraction (LVEF) in dogs with heart failure (HF) and in patients with acute myocardial infarction. We studied metabolic and cardiovascular effects of 48-h GLP-1 infusions in patients with congestive HF. In a randomized, double-blind crossover design, 20 patients without diabetes and with HF with ischemic heart disease, EF of 30 +/- 2%, New York Heart Association II and III (n = 14 and 6) received 48-h GLP-1 (0.7 pmol.kg(-1).min(-1)) and placebo infusion. At 0 and 48 h, LVEF, diastolic function, tissue Doppler regional myocardial function, exercise testing, noninvasive cardiac output, and brain natriuretic peptide (BNP) were measured. Blood pressure, heart rate, and metabolic parameters were recorded. Fifteen patients completed the protocol. GLP-1 increased insulin (90 +/- 17 pmol/l vs. 69 +/- 12 pmol/l; P = 0.025) and lowered glucose levels (5.2 +/- 0.1 mmol/l vs. 5.6 +/- 0.1 mmol/l; P < 0.01). Heart rate (67 +/- 2 beats/min vs. 65 +/- 2 beats/min; P = 0.016) and diastolic blood pressure (71 +/- 2 mmHg vs. 68 +/- 2 mmHg; P = 0.008) increased during GLP-1 treatment. Cardiac index (1.5 +/- 0.1 l.min(-1).m(-2) vs. 1.7 +/- 0.2 l.min(-1).m(-2); P = 0.54) and LVEF (30 +/- 2% vs. 30 +/- 2%; P = 0.93), tissue Doppler indexes, body weight, and BNP remained unchanged. Hypoglycemic events related to GLP-1 treatment were observed in eight patients. GLP-1 infusion increased circulating insulin levels and reduced plasma glucose concentration but had no major cardiovascular effects in patients without diabetes but with compensated HF. The impact of minor increases in heart rate and diastolic blood pressure during GLP-1 infusion requires further studies. Hypoglycemia was frequent and calls for caution in patients without diabetes but with HF.
Albuterol multidose dry powder inhaler efficacy and safety versus placebo in children with asthma.

A novel, inhalation-driven, multidose dry powder inhaler (MDPI) that does not require coordination of actuation with inhalation has been developed.



To evaluate the efficacy and safety of albuterol MDPI versus placebo MDPI after chronic dosing in children with asthma.



This phase III, double-blind, parallel-group study included children with asthma (ages, 4-11 years) with forced expiratory volume in 1 second (FEV1) of 50-95% of predicted. After a 14-day run-in period wherein the patients continued their current asthma therapy and received single-blind placebo MDPI, they were randomized to albuterol MDPI 90 μg per inhalation, two inhalations four times daily (total daily dose, 720 μg), or placebo for 3 weeks. Pulmonary function was assessed on days 1 and 22. Efficacy and safety were evaluated by measuring the baseline-adjusted percent-predicted FEV1 (PPFEV1) area under the time curve over 6 hours (AUC0-6) after the dose and adverse events, respectively.



The full analysis set included 184 patients. Patients treated with albuterol MDPI versus patients treated with placebo MDPI had significantly greater baseline-adjusted PPFEV1 AUC0-6 over 3 weeks (least squares mean difference, 25.0%•hour, which favored albuterol; p < 0.001). The benefit of albuterol (mean change in PPFEV1) was evident 5 minutes after dosing and lasted several hours; the maximal effect was noted 1 to 2 hours after dosing. Albuterol MDPI was well tolerated.



In children with persistent asthma, albuterol MDPI improved pulmonary function significantly better than placebo MDPI over 3 weeks of treatment. Clinical efficacy was evident within 5 minutes of dosing and maintained for >2 hours. Four times daily administration was well tolerated.
Effect of Waon therapy on oxidative stress in chronic heart failure.

A previous report by our team showed that Waon therapy, using a far infrared-ray dry sauna at 60°C, improves cardiac and vascular function in patients with chronic heart failure (CHF). The purpose of the present study was to clarify the effect of Waon therapy on oxidative stress in CHF patients and investigate its mechanism by animal experiments.



Forty patients with CHF were divided into control (n=20) and Waon therapy (n=20) groups. All patients received standard optimal medications for CHF. Waon therapy group was treated with Waon therapy daily for 4 weeks. After 4 weeks of Waon therapy, concentrations of hydroperoxide and brain natriuretic peptide (BNP) decreased significantly (hydroperoxide, 422±116 to 327±88U.CARR, P<0.001; BNP, 402±221 to 225±137pg/ml, P<0.001), and the nitric oxide metabolites increased (71.2±35.4 to 92.0±40.5mmol/L, P<0.05). In contrast, none of these variables changed over the 4-week interval in the control group. Furthermore, animal experiments were performed using TO-2 cardiomyopathic hamsters. On immunohistochemistry, cardiac expression of 4-hydroxy-2-nonenal, a marker of oxidative stress, was decreased in the 4-week Waon therapy compared to untreated hamsters. On Western blotting, cardiac expressions of heat shock protein (HSP) 27, manganese superoxide dismutase and HSP32, which reduce oxidative stress, were significantly upregulated in the 4-week Waon therapy compared to untreated hamsters.



Waon therapy decreases oxidative stress in patients and hamsters with heart failure.
High prevalence of cardio-metabolic risk factors among adolescents with intellectual disability.

Adults with intellectual disabilities (IDs) have poor lifestyle-related health compared with the general population. Our aim was to study whether such differences are present already in adolescents.



To compare the prevalence and severity of cardio-metabolic risk factors and cardio-vascular fitness in adolescents with and without IDs.



Intellectual disability (ID) students (n = 66) and non-intellectual disability (non-ID) students from practical (non-ID-p) (n = 34) and theoretical (non-ID-t) (n = 56) programmes were recruited from three upper secondary schools. Anthropometric data, blood pressure, body composition, fasting-insulin, fasting-glucose, fasting-lipids and cardio-vascular fitness were measured.



Participants with and without ID differed significantly in the prevalence of cardio-metabolic risk factors with participants with ID having a higher percentage of total fat mass, wider waist circumferences (WCs), lower levels of fat-free mass (FFM), lower bone mineral density (BMD) and higher insulin and homeostasis model assessment of insulin resistance (HOMA) levels and poorer cardio-vascular fitness. The healthiest levels were found in the non-ID-t group compared to the group with ID and the group with non-ID-p in between.



The prevalence of cardio-metabolic risk factors and poor cardio-vascular fitness was found to be high in this young population with intellectual disabilities. Measures should be taken to improve the health messages directed towards children and adolescents with intellectual disabilities.