nils-herrmann/clean_scirepeval huggingface dataset:
Institutional report-Cardiac general A pilot randomized study of the neutrophil elastase inhibitor , Sivelestat , in patients undergoing cardiac surgery

The primary objective of this study was to determine the feasibility and safety of treatment with Sivelestat in humans to attenuate postcardiopulmonary bypass lung injury. Twenty patients scheduled to undergo on-pump coronary artery bypass surgery were randomized to receive either 0.3 mgykgyh intravenous Sivelestat sodium (Sivelestat group; ns10) or isotonic sodium chloride solution (placebo group, ns10), peri-operatively. Postoperative adverse events were recorded until hospital discharge. The alveolar–arterial oxygen gradient (AaDO ), intrapulmonary shunt (Qs/Qt) and dynamic lung compliance were determined four times peri-operatively as secondary exploratory 2 outcomes. All patients completed study protocol without discontinuation of intervention. The number of total adverse clinical outcomes, including atrial fibrillation and superficial wound infection, was nine in seven patients in the placebo group and four in four patients in the Sivelestat group (Ps0.37). The mean duration of the postoperative hospital stay was shorter in the Sivelestat group (19.0"3.4 vs. 25.6"9.1, Ps0.04). The exploratory analysis of relative changes in lung functions showed trends toward attenuation of lung injury in the Sivelestat group in all three pulmonary parameters, though the inter-group difference could be due to chance (P)0.05). It is feasible to administer Sivelestat as a preventive measure against lung dysfunction after cardiopulmonary bypass.
Treatment of severe decompensated heart failure with high-dose intravenous nitroglycerin: a feasibility and outcome analysis.

We perform a feasibility and outcome assessment of the treatment of severe decompensated heart failure with high-dose nitroglycerin.



This study was designed as a nonrandomized, open-label, single-arm study of high-dose nitroglycerin. Patients with hypertension (systolic blood pressure > or = 160 mm Hg or mean arterial pressure > or = 120 mm Hg) who were refractory to initial therapy were eligible for inclusion. Enrolled patients began receiving a titratable nitroglycerin infusion and were given a bolus of high-dose nitroglycerin (2 mg). Repeated administration of high-dose nitroglycerin was allowed every 3 minutes, up to a total of 10 doses. Predefined effectiveness and safety outcomes were tracked throughout hospital admission. To provide a frame of reference for these outcomes, data were retrospectively compiled for similar patients with severe decompensated heart failure who did not receive high-dose nitroglycerin.



Twenty-nine patients received high-dose nitroglycerin. Endotracheal intubation was required in 13.8% of patients, bilevel positive airway pressure (BiPAP) ventilation in 6.9%, and ICU admission in 37.9%. Symptomatic hypotension developed in 1 patient (3.4%), and biomarker evidence of myocardial infarction was found in 17.2% of patients. The mean dose of high-dose nitroglycerin was 6.5 mg (+/-3.4). For patients who were treated without high-dose nitroglycerin (n=45), endotracheal intubation occurred in 26.7%, BiPAP in 20.0%, and ICU admission in 80.0%. None of these patients developed symptomatic hypotension, and biomarker evidence of myocardial infarction was observed in 28.9% of patients.



In this nonrandomized, open-label trial, high-dose nitroglycerin was associated with endotracheal intubation, BiPAP, and ICU admission less frequently than expected to occur without high-dose nitroglycerin, and adverse events were uncommon. Treatment of hypertensive, severely decompensated heart failure patients with high-dose nitroglycerin seems promising, but a randomized, blinded study is needed to more completely define its clinical utility. According to this trial, such a study seems feasible.
The effect of t'ai chi exercise on autonomic nervous function of patients with coronary artery disease.

The objective of this study was to evaluate the effect of t'ai chi (TC) on heart rate variability (HRV) from baseline to 9 months in patients with coronary artery disease (CAD).



A comparative trial was undertaken comparing the acute and long-term effect of TC on HRV in patients with CAD.



Sixty-one (61) subjects with CAD undergoing percutaneous intervention or coronary bypass grafting for a period of more than 1 month were recruited from the clinics of cardiology and cardiovascular surgery at Chia-Yi Christian Hospital, Taiwan.



The experimental group (n = 22) practiced weekly 90-minute Yang's style TC for 9 months and the control group (n = 39) continued their normal daily physical activity.



HRV was recorded at baseline, 3 months, 6 months, and 9 months in the control group. Resting HRV was recorded before TC exercise and recovery HRV was recorded 30 minutes post TC at the same four time points in the experimental group.



The change in the normalized low-frequency power, normalized high-frequency power, and the low-/high-frequency power ratio between resting and post-TC was significantly different at 9 months when compared with those at baseline, 3, and 6 months. The mean difference in normalized low-frequency power and the low/high-frequency power ratio changed from positive values at baseline, 3, and 6 months to negative values at 9 months. However, there were no significant differences in resting HRV between the patients in TC and control groups in either time domain or frequency domain HRV indices.



The change in heart rate and HRV between resting and post-TC suggested that TC exercise could enhance vagal modulation. The potential beneficial effect of long-term regular TC exercise in patients with CAD merits further investigation.
Self-efficacy and distress in women with AIDS: the SMART/EST women's project.

Though African American and Hispanic women accounted for 14% of the female population in the USA, they represented 66% of the total HIV/AIDS diagnoses among women in 2007. Among men living with HIV, increased coping self-efficacy (SE) following a cognitive behavioral intervention has been related to decreased distress, anxiety, anger, and confusion, but comparable studies had not been carried out with HIV+ women. The purpose of this study was to examine the impact of changes in SE following a cognitive behavioral stress management plus expressive supportive therapy (CBSM+) intervention on depression and anxiety in low-income urban predominantly minority women living with AIDS. Women (n=451) were randomized to a group CBSM+ or individual informational intervention condition and completed baseline, post-intervention and long-term follow-up (12 months) assessments of depression, anxiety and SE. Women who were assigned to the CBSM+ group condition and increased their level of cognitive behavioral SE reported significant decreases in anxiety and depression at post-intervention and long-term follow-up in comparison with controls who did not improve. Results suggest that both cognitive behavioral skills and a concomitant increase in the perceived level of SE in the use of those skills are predictive of distress reduction.
Prevalence of type-specific HPV infection by age and grade of cervical cytology: data from the ARTISTIC trial

Human papillomavirus (HPV) infection causes cervical cancer and premalignant dysplasia. Type-specific HPV prevalence data provide a basis for assessing the impact of HPV vaccination programmes on cervical cytology. We report high-risk HPV (HR-HPV) type-specific prevalence data in relation to cervical cytology for 24 510 women (age range: 20–64; mean age 40.2 years) recruited into the ARTISTIC trial, which is being conducted within the routine NHS Cervical Screening Programme in Greater Manchester. The most common HR-HPV types were HPV16, 18, 31, 51 and 52, which accounted for 60% of all HR-HPV types detected. There was a marked decline in the prevalence of HR-HPV infection with age, but the proportion due to each HPV type did not vary greatly with age. Multiple infections were common below the age of 30 years but less so between age 30 and 64 years. Catch-up vaccination of this sexually active cohort would be expected to reduce the number of women with moderate or worse cytology by 45%, but the number with borderline or mild cytology would fall by only 7%, giving an overall reduction of 12% in the number of women with abnormal cytology and 27% in the number with any HR-HPV infection. In the absence of broader cross-protection, the large majority of low-grade and many high-grade abnormalities may still occur in sexually active vaccinated women.
Autologous blood perfusion for myocardial protection during coronary angioplasty: a feasibility study.

During coronary angioplasty, inflation of the balloon within the coronary artery produces transient arterial occlusion and frequently results in myocardial ischemia. Delivery of oxygenated autologous blood to the myocardium at risk during inflation may help mitigate this ischemia. Accordingly, we investigated the feasibility and safety of infusing blood through the central lumen of a dilatation catheter around the guidewire using both a model in vitro and clinical trials. In the tests in vitro, fresh blood was infused at flow rates up to 120 ml/min. Hemolysis was minimal at flow rates of 60 ml/min or less (less than or equal to 0.92 +/- 0.18%), but increased exponentially at higher rates (13.64 +/- 2.37% at 120 ml/min, p less than .002). A similar pattern was observed for potassium release. Platelet and leukocyte counts did not vary significantly, and beta-thromboglobulin and muramidase remained at control levels. Although mean erythrocyte volume did not change, erythrocyte histograms and light microscopy demonstrated a subpopulation of red cell fragments averaging 25 to 40 fl in size at higher rates. A randomized, crossover clinical trial was next performed by delivery of blood perfusion at 60 ml/min to 15 patients undergoing coronary angioplasty. Levels of plasma hemoglobin, beta-thromboglobulin, lactate dehydrogenase, and potassium remained constant before and after the perfusion and the control inflations. The maximum pain score was significantly lower with the perfusion inflation (4.1 +/- 0.8 vs 6.0 +/- 0.9, p less than .003). Relative to baseline, the maximum ST segment elevation during the perfusion inflation (0.5 +/- 0.3 mm) was nearly one-fourth that during the control inflation (1.9 +/- 0.6 mm, p less than .02). Thus, myocardial protection with oxygenated autologous blood perfusion at rates of 60 ml/min appears to be a safe and effective technique that may permit increased inflation time and extend the range of coronary angioplasty to include individuals at high risk for the procedure.
Efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in hepatitis C patients with advanced fibrosis and cirrhosis.

The objective of this study is to determine the efficacy and safety of peginterferon alfa-2a (40 KD)/ribavirin in patients with advanced fibrosis. Data from 341 genotype 1/4 patients (99 with bridging fibrosis/cirrhosis) treated for 48 weeks and 1547 genotype 2/3 patients (380 with bridging fibrosis/cirrhosis) treated for 16 or 24 weeks enrolled in three randomized international studies were analyzed. Sustained virological response (SVR) rates decreased progressively from 60% in genotype 1/4 patients without advanced fibrosis to 51% in those with bridging fibrosis and 33% in those with cirrhosis (trend test P = 0.0028); and from 76% to 61% and 57%, respectively, in genotype 2/3 patients treated for 24 weeks (trend test P < 0.0001). Irrespective of genotype, patients without advanced fibrosis were more likely to have an earlier response to treatment that was associated with higher SVR rates and lower relapse rates during untreated follow-up. Among patients with or without a diagnosis of advanced fibrosis, rates of SVR and relapse were similar for patients with similar responses in the first 12 weeks.



Compared with patients with less severe disease, SVR rates are significantly lower in patients with advanced fibrosis. However, irrespective of genotype and degree of fibrosis, the time to become hepatitis C virus (HCV) RNA undetectable was the strongest predictor of SVR.
A multicenter risk index for atrial fibrillation after cardiac surgery.

Atrial fibrillation is a common, but potentially preventable, complication following coronary artery bypass graft (CABG) surgery.



To assess the nature and consequences of atrial fibrillation after CABG surgery and to develop a comprehensive risk index that can better identify patients at risk for atrial fibrillation.



Prospective observational study of 4657 patients undergoing CABG surgery between November 1996 and June 2000 at 70 centers located within 17 countries, selected using a systematic sampling technique. From a derivation cohort of 3093 patients, associations between predictor variables and postoperative atrial fibrillation were identified to develop a risk model, which was assessed in a validation cohort of 1564 patients.



New-onset atrial fibrillation after CABG surgery.



A total of 1503 patients (32.3%) developed atrial fibrillation after CABG surgery. Postoperative atrial fibrillation was associated with subsequent greater resource use as well as with cognitive changes, renal dysfunction, and infection. Among patients in the derivation cohort, risk factors associated with atrial fibrillation were advanced age (odds ratio [OR] for 10-year increase, 1.75; 95% confidence interval [CI], 1.59-1.93); history of atrial fibrillation (OR, 2.11; 95% CI, 1.57-2.85) or chronic obstructive pulmonary disease (OR, 1.43; 95% CI, 1.09-1.87); valve surgery (OR, 1.74; 95% CI, 1.31-2.32); and postoperative withdrawal of a beta-blocker (OR, 1.91; 95% CI, 1.52-2.40) or an angiotensin-converting enzyme (ACE) inhibitor (OR 1.69; 95% CI, 1.38-2.08). Conversely, reduced risk was associated with postoperative administration of beta-blockers (OR, 0.32; 95% CI, 0.22-0.46), ACE inhibitors (OR, 0.62; 95% CI, 0.48-0.79), potassium supplementation (OR, 0.53; 95% CI, 0.42-0.68), and nonsteroidal anti-inflammatory drugs (OR, 0.49; 95% CI, 0.40-0.60). The resulting multivariable risk index had adequate discriminative power with an area under the receiver operating characteristic (ROC) curve of 0.77 in the validation sample. Forty-three percent (640/1503) of patients who had atrial fibrillation after CABG surgery experienced more than 1 episode of atrial fibrillation. Predictors of recurrent atrial fibrillation included older age, history of congestive heart failure, left ventricular hypertrophy, aortic atherosclerosis, bicaval venous cannulation, withdrawal of ACE inhibitor or beta-blocker therapy, and use of amiodarone or digoxin (area under the ROC curve of 0.66). Patients with recurrent atrial fibrillation had longer hospital stays and experienced greater infectious, renal, and neurological complications than those with a single episode.



We have developed and validated models predicting the occurrence of atrial fibrillation after CABG surgery based on an analysis of a large multicenter international cohort. Our findings suggest that treatment with beta-blockers, ACE inhibitors, and/or nonsteroidal anti-inflammatory drugs may offer protection. Atrial fibrillation after CABG surgery is associated with important complications.
Pain perception after isometric exercise in women with fibromyalgia.

The purpose of this study was to identify exercise protocols incorporating isometric contractions that provide pain relief in women with fibromyalgia.



A before-after trial.



A physical therapy department in an academic setting.



Fifteen women (mean ± SD, 52±11y) with fibromyalgia.



Subjects completed 4 sessions: 1 familiarization and 3 experimental. The following randomized experimental sessions involved the performance of isometric contractions with the elbow flexor muscles that varied in intensity and duration: (1) 3 maximal voluntary contractions (MVCs), (2) 25% MVC held to task failure, and (3) 25% MVC held for 2 minutes.



Experimental pain (pain threshold and pain rating), Fibromyalgia Impact Questionnaire, and fibromyalgia pain intensity (visual analog scale).



After all 3 isometric contractions, there was considerable variability between subjects in the pain response. Based on the changes in experimental pain, subjects were divided into 3 groups (increase, decrease, no change in pain). Multiple regression analysis revealed that age, baseline experimental pain, and change in fibromyalgia pain intensity were significant predictors of the experimental pain response after the isometric contractions.



We identified subgroups of women with fibromyalgia based on how they perceived pain after isometric contractions. The greatest pain relief for women with fibromyalgia occurred at a younger age and in women with the greatest experimental pain before exercise. Additionally, we established a link between experimental and clinical pain relief after the performance of isometric contractions.
No overt influence of lymphadenectomy on cancer-specific survival in organ-confined versus locally advanced upper urinary tract urothelial carcinoma undergoing radical nephroureterectomy: a retrospective international, multi-institutional study

Lymph node dissection (LND) is not routinely performed during radical nephroureterectomy (RNU) in upper tract urothelial carcinomas (UTUC), and its clinical relevance is unclear. The purpose of the present study was to evaluate the impact of LND on clinical outcomes in a large multicenter series of RNU for UTUC. Detailed data on 785 patients subject to RNU were provided by nine international academic centers. The choice to perform lymphadenectomy was determined by the treating surgeon. All pathology slides were evaluated by dedicated genitourinary pathologists. Univariable and multivariable Cox regression models evaluated the association of nodal status with recurrence-free (RFS) and cancer-specific (CSS) survival. One hundred and ninety patients had LND. Pathological N stage was pN0 in 17%, pNx in 76%, and pN+ in 7%. The median follow-up period of the entire cohort was 34 months (interquartile range [IQR]: 15–65 months). Overall, five-year RFS and CSS estimates were 72.2 and 76%, respectively. In multivariable Cox regression analyses, pN0/pNx substaging was not an independent predictor of either RFS (hazard ratio [HR]: 1.1; P = 0.631) or CSS (HR: 1.3; P = 0.223). Similar results were obtained in a subgroup analysis limited to patients with organ-confined disease (HR: 0.9; P = 0.907 for RFS; HR: 0.4; P = 0.419 for CSS). Conversely, in patients with locally advanced disease, patients with pN0 disease have significantly better cancer-related outcomes (HR: 0.3; P < 0.001 for RFS; HR: 0.3; P < 0.001 for CSS). The present series suggests pNx is more significantly associated with a worse prognosis than pN0, but only in patients with locally advanced UTUC.
Pediatric Tuberculosis in Young Children in India: A Prospective Study

India has one of the highest tuberculosis (TB) burdens globally. However, few studies have focused on TB in young children, a vulnerable population, where lack of early diagnosis results in poor outcomes.



Young children (≤ 5 years) with suspected TB were prospectively enrolled at a tertiary hospital in Pune, India. Detailed clinical evaluation, HIV testing, mycobacterial cultures, and drug susceptibility testing were performed.



223 children with suspected TB were enrolled. The median age was 31 months, 46% were female, 86% had received BCG, 57% were malnourished, and 10% were HIV positive. 12% had TB disease (definite or probable), 35% did not have TB, while TB could not be ruled out in 53%. Extrapulmonary disease was noted in 46%, which was predominantly meningeal. Tuberculin skin test (TST) was positive in 20% of children with TB. Four of 7 (57%) children with culture-confirmed TB harbored drug-resistant (DR) strains of whom 2 (50%) were multi-DR (MDR). In adjusted analyses, HIV infection, positive TST, and exposure to household smoke were found to be significantly associated with children with TB (P ≤ 0.04). Mortality (at 1 year) was 3 of 26 (12%) and 1 of 79 (1%), respectively, in children with TB and those without TB (P < 0.05).



Diagnosis of TB is challenging in young children, with high rates of extra-pulmonary and meningeal disease. While the data on DR-TB are limited by the small sample size, they are however concerning, and additional studies are needed to more accurately define the prevalence of DR strains in this vulnerable population.
Efficacy and safety of entecavir plus carnitine complex (GODEX®) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study

Carnitine and vitamin complex (Godex®) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients.



130 treatment-naïve patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months.



Among the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-γ secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment.



ALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.
Positron emission tomography changes management, improves prognostic stratification and is superior to gallium scintigraphy in patients with low-grade lymphoma: results of a multicentre prospective study

Positron emission tomography (PET) was evaluated in low-grade non-Hodgkin lymphoma (NHL) to determine its impact on staging and management and to compare PET and gallium scans. PET resulted in management plan changes in 74 patients with untreated low-grade NHL stages I to III. Patient outcomes to 12 months were documented. PET identified additional lesions in 50% of patients, led to a change in stage in 32%, and had a significant impact on management in 34%. Inferior progression-free survival was noted in patients with additional lesions detected by PET (p=0.001) and in the 28% of patients upstaged by PET to stage III or IV (p=0.024). In a subset of 16 patients undergoing both PET and gallium scans, PET was found to be superior. PET has a major role in the management of low-grade NHL in addition to its proven role in aggressive lymphoma.