nils-herrmann/clean_scirepeval huggingface dataset:
Effects of Oxytocin on Attention to Emotional Faces in Healthy Volunteers and Highly Socially Anxious Males

Evidence suggests that individuals with social anxiety demonstrate vigilance to social threat, whilst the peptide hormone oxytocin is widely accepted as supporting affiliative behaviour in humans.



This study investigated whether oxytocin can affect attentional bias in social anxiety. In a double-blind, randomized, placebo-controlled, within-group study design, 26 healthy and 16 highly socially anxious (HSA) male volunteers (within the HSA group, 10 were diagnosed with generalized social anxiety disorder) were administered 24 IU of oxytocin or placebo to investigate attentional processing in social anxiety. Attentional bias was assessed using the dot-probe paradigm with angry, fearful, happy and neutral face stimuli.



In the baseline placebo condition, the HSA group showed greater attentional bias for emotional faces than healthy individuals. Oxytocin reduced the difference between HSA and non-socially anxious individuals in attentional bias for emotional faces. Moreover, it appeared to normalize attentional bias in HSA individuals to levels seen in the healthy population in the baseline condition. The biological mechanisms by which oxytocin may be exerting these effects are discussed.



These results, coupled with previous research, could indicate a potential therapeutic use of this hormone in treatment for social anxiety.
Spanish Version of the Patient Dignity Inventory: Translation and Validation in Patients With Advanced Cancer.

The Patient Dignity Inventory (PDI) is an instrument to measure sources of distress related to dignity at the end of life.



To obtain a Spanish version of the PDI and measure psychometric aspects in patients with advanced cancer.



A back-translation method was used to obtain the Spanish version. Inpatients and outpatients with advanced cancer were included. Patients completed the Spanish versions of the PDI (PDI-s), Edmonton Symptom Assessment System (ESAS), Hospital Anxiety and Depression Scale (HADS), and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12) instruments. The psychometric properties evaluated were internal consistency; concurrent validity between PDI-s/ESAS, PDI-s/HADS, and PDI-s/FACIT-Sp-12; discriminant validity, test-retest reliability, and factor analysis. The usefulness of the instrument also was tested.



A Spanish version of the PDI was obtained. One hundred twenty-four patients completed the study. Cronbach's alpha coefficient for the PDI-s was 0.89. The PDI-s significantly correlated with the ESAS (rs = 0.669; P < 0.001), HADS (rs = 0.788; P < 0.001), and FACIT-Sp-12 (rs = -0.442; P = 0.008). The instrument distinguished outpatients from inpatients and between patients with differing Karnofsky Performance Status scores (rs = -0.328; P < 0.001). The test-retest method indicated excellent reproducibility (intraclass correlation coefficient = 0.931). Factor analysis showed three factors accounting for 79.4% of the variance. Factors were labeled psychological and existential distress, physical symptoms and dependency, and social support. Patients had no difficulties in understanding or completing the questionnaire (mean time to complete: 7.2 minutes).



The Spanish version of the PDI showed adequate psychometric properties when tested with advanced cancer patients. This research provides a three-factor alternative in Spanish to the PDI.
Phosphorylated ERalpha, HIF-1alpha, and MAPK signaling as predictors of primary endocrine treatment response and resistance in patients with breast cancer.

We aimed to identify signaling pathways involved in the response and resistance to aromatase inhibitor therapy in patients with breast cancer.



One hundred fourteen women with T2-4 N0-1, estrogen receptor (ER) alpha-positive tumors were randomly assigned to neoadjuvant letrozole or letrozole plus metronomic cyclophosphamide. Twenty-four tumor proteins involved in apoptosis, cell survival, hypoxia, angiogenesis, growth factor, and hormone signaling were assessed by immunohistochemistry in pretreatment samples (eg, caspase 3, phospho- mammalian target of rapamycin, hypoxia-inducible factor 1alpha [HIF-1alpha], vascular endothelial growth factor, mitogen-activated protein kinase [MAPK], phosphorylated epidermal growth factor receptor, phosphorylated ERalpha [pERalpha]). A multivariate generalized linear regression approach was applied using a penalized least-square minimization to perform variable selection and regularization. Ten-fold cross-validation and iterative leave-one-out were employed to validate and test the model, respectively. Tumor size, nodal status, age, tumor grade, histological type, and treatment were included in the analysis.



Ninety-one patients (81%) attained a disease response, 48 achieved a complete clinical response (43%) whereas 22 did not respond (19%). Increased pERalpha and decreased p44/42 MAPK were significant factors for complete response to treatment in all leave-one-out iterations. Increased p44/42 MAPK and HIF-1alpha were significant factors for treatment resistance in all leave-one-out iterations. There was no significant interaction between these variables and treatment.



Activated ERalpha form was an independent factor for sensitivity to chemoendocrine treatment, whereas HIF-1alpha and p44/42 MAPK were independent factors for resistance. Although further confirmatory analyses are needed, these findings have clear potential implications for future strategies in the management of clinical trials with aromatase inhibitors in the breast cancer.
LigAmp for sensitive detection of single-nucleotide differences

We developed the LigAmp assay for sensitive detection and accurate quantification of viruses and cells with single-base mutations. In LigAmp, two oligonucleotides are hybridized adjacently to a DNA template. One oligonucleotide matches the target sequence and contains a probe sequence. If the target sequence is present, the oligonucleotides are ligated together and detected using real-time PCR. LigAmp detected KRAS2 mutant DNA at 0.01% in mixtures of different cell lines. KRAS2 mutations were also detected in pancreatic duct juice from patients with pancreatic cancer. LigAmp detected the K103N HIV-1 drug resistance mutation at 0.01% in plasmid mixtures and at ∼0.1% in DNA amplified from plasma HIV-1. Detection in both systems is linear over a broad dynamic range. Preliminary evidence indicates that reactions can be multiplexed. This assay may find applications in the diagnosis of genetic disorders and the management of patients with cancer and infectious diseases.
Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial

Raised resting heart rate is a marker of cardiovascular risk. We postulated that heart rate is also a risk factor for cardiovascular events in heart failure. In the SHIFT trial, patients with chronic heart failure were treated with the selective heart-rate-lowering agent ivabradine. We aimed to test our hypothesis by investigating the association between heart rate and events in this patient population.



We analysed cardiovascular outcomes in the placebo (n=3264) and ivabradine groups (n=3241) of this randomised trial, divided by quintiles of baseline heart rate in the placebo group. The primary composite endpoint was cardiovascular death or hospital admission for worsening heart failure. In the ivabradine group, heart rate achieved at 28 days was also analysed in relation to subsequent outcomes. Analysis adjusted to change in heart rate was used to study heart-rate reduction as mechanism for risk reduction by ivabradine directly.



In the placebo group, patients with the highest heart rates (>or=87 beats per min [bpm], n=682, 286 events) were at more than two-fold higher risk for the primary composite endpoint than were patients with the lowest heart rates (70 to <72 bpm, n=461, 92 events; hazard ratio [HR] 2.34, 95% CI 1.84-2.98, p<0.0001). Risk of primary composite endpoint events increased by 3% with every beat increase from baseline heart rate and 16% for every 5-bpm increase. In the ivabradine group, there was a direct association between heart rate achieved at 28 days and subsequent cardiac outcomes. Patients with heart rates lower than 60 bpm at 28 days on treatment had fewer primary composite endpoint events during the study (n=1192; event rate 17.4%, 95% CI 15.3-19.6) than did patients with higher heart rates. The effect of ivabradine is accounted for by heart-rate reduction, as shown by the neutralisation of the treatment effect after adjustment for change of heart rate at 28 days (HR 0.95, 0.85-1.06, p=0.352).



Our analysis confirms that high heart rate is a risk factor in heart failure. Selective lowering of heart rates with ivabradine improves cardiovascular outcomes. Heart rate is an important target for treatment of heart failure.
Systemic lupus international collaborating clinics renal activity/response exercise: comparison of agreement in rating renal response.

To assess the degree to which physicians agree with each other and with ratings obtained with 3 existing responder indices, in rating the response to treatment of lupus nephritis.



Lupus nephritis patient medical records from 125 pairs of visits (6 months apart) were used to create renal response scenarios. Seven nephrologists and 22 rheumatologists rated each scenario as demonstrating complete response, partial response, same, or worsening. The plurality (most frequent) rating of renal response by the physicians was compared with the calculated score from the renal component of the British Isles Lupus Assessment Group (BILAG) index (original and updated [2004] version) and of the Responder Index for Lupus Erythematosus (RIFLE). The degree of agreement among the physicians was assessed by calculating intraclass correlation coefficients (ICCs). The degree of agreement between the plurality physician rating and ratings obtained with the established response indices was assessed using the kappa statistic.



The ICC among all physicians was 0.64 (0.62 for nephrologists and 0.67 for rheumatologists). The chance-adjusted measure of agreement (kappa coefficient) between the plurality physician rating and the calculated score obtained using established indexes was 0.50 (95% confidence interval [95% CI] 0.38-0.61) for the RIFLE, 0.14 (95% CI 0.03-0.25) for the original BILAG, and 0.23 (95% CI 0.21-0.44) for the BILAG 2004.



These findings indicate that rheumatologists as a group and nephrologists as a group have equal agreement in their rating of renal response. There was moderate agreement between plurality physician ratings and ratings obtained using the renal component of the RIFLE. Ratings of response using an index based on the original BILAG did not have good agreement with the plurality physician rating.
Combination goserelin and tamoxifen therapy in premenopausal advanced breast cancer: a multicentre study by the ITMO group. Italian Trials in Medical Oncology.

It has been suggested that tamoxifen may improve the efficacy of medical castration with luteinising hormone-releasing hormone analogues, but very few data have so far been published concerning the clinical and endocrinological activity of this therapeutic modality. In this phase II multicentre trial conducted by the Italian Trials in Medical Oncology group (ITMO), 64 premenopausal patients with hormone receptor-positive or unknown breast cancer were treated with monthly s.c. injections of goserelin 3.6 mg, in association with a tamoxifen daily dose of 20 mg, as first-line therapy for their advanced disease. All of the patients were evaluable for efficacy and there was an overall response rate of 41% (95% confidence interval 28-52%), with 7 of the 26 responders achieving complete remission. The median time to response was 4 months (range 2-17), and the median response duration was 13 months (range 6-37 +). Better responses were observed in soft tissues (51%); the response in visceral and bone metastases was respectively 19% and 37%. Serum concentrations of gonadotrophins and oestradiol were significantly decreased by the treatment, oestrogen levels being constantly suppressed to within the range observed in post-menopausal women. No significant change was detected in serum testosterone levels. In our experience, although it was not associated with any increased clinical efficacy, the concurrent use of goserelin and tamoxifen proved to be a feasible approach in the management of premenopausal advanced breast cancer.
Mediators of exercise maintenance after cardiac rehabilitation.

Exercise maintenance after completing phase II cardiac rehabilitation (CR) is challenging for many patients. A telephone-based maintenance intervention improved exercise participation compared with a control group at 12 months post-CR discharge. We examined the 6-month mediators of intervention effects on exercise.



In a randomized controlled trial, 130 patients who had completed CR (mean age: 63.6 [SD = 9.7] years, 20.8% female) were randomized to Maintenance Counseling (n = 64) or Contact Control (n = 66). Putative mediators examined the following: self-efficacy, behavioral processes of change, decisional balance index, social support for exercise, and enjoyment of exercise.



Multiple mediation analyses showed that the intervention significantly increased social support from friends at 6 months but not the other constructs. Decreasing support from friends mediated greater exercise participation in Maintenance Counseling than in Contact Control at 12 months.



Social support from friends functioned as a suppressor mediator for exercise maintenance among cardiac patients.
Sex differences in clinical characteristics and outcomes in elderly patients with heart failure and preserved ejection fraction: the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial.

There are few sex-specific outcome data in heart failure with preserved ejection fraction.



We assessed sex differences in baseline characteristics and outcomes among 4128 patients with heart failure with preserved ejection fraction in the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Women (n=2491) with heart failure with preserved ejection fraction were ≈1 year older (72±7 years versus 71±7 years) and more likely to be obese (46% versus 35%) and have chronic kidney disease (34% versus 26%) and hypertension (91% versus 85%) than men but less likely to have an ischemic cause (19% versus 34%), atrial fibrillation (27% versus 33%), or chronic obstructive pulmonary disease (8% versus 13%) (all P<0.001). During a mean of 49.5 months, there were 881 deaths (447 in women, 434 in men; risk ratio, 0.64; 95% CI, 0.56-0.74) and 5776 hospitalizations (3239 in women, 2537 in men; risk ratio, 0.80; 95% CI, 0.76-0.84). Women had lower risk of all-cause events (deaths and hospitalizations), even after adjusting for baseline characteristics (adjusted hazards ratio, 0.81; 95% CI, 0.73-0.89). However, the sex-related difference in risk of all-cause events was modified in the presence or absence of atrial fibrillation, renal dysfunction, stable angina pectoris, or advanced New York Heart Association class symptoms.



In patients with typical heart failure with preserved ejection fraction, there were prominent sex differences in baseline characteristics and outcomes. Women had better overall prognosis, although the presence of 4 common baseline characteristics seemed to moderate this finding.
Effect of alpha-lipoic acid on the progression of endothelial cell damage and albuminuria in patients with diabetes mellitus: an exploratory study.

Oxidative stress plays a central role in the pathogenesis and progression of late microangiopathic complications (diabetic nephropathy) in diabetes mellitus. Previous studies suggested that treatment of diabetic patients with the antioxidant alpha-lipoic acid reduce oxidative stress and urinary albumin excretion. In this prospective, open and non-randomized study, the effect of alpha-lipoic acid on the progression of endothelial cell damage and the course of diabetic nephropathy, as assessed by measurement of plasma thrombomodulin and urinary albumin concentration (UAC), was evaluated in 84 patients with diabetes mellitus over 18 months. Forty-nine patients (34 with Type 1 diabetes, 15 with Type 2 diabetes) had no antioxidant treatment and served as a control group. Thirty-five patients (20 with Type 1 diabetes, 15 with Type 2 diabetes) were treated with 600 mg alpha-lipoic acid per day. Only patients with an urinary albumin concentration <200 mg/l were included into the study. After 18 months of follow up, the plasma thrombomodulin level increased from 35.9+/-9.5 to 39.7+/-9.9 ng/ml (P<0.05) in the control group. In the alpha-lipoic acid treated group the plasma thrombomodulin level decreased from 37.5+/-16.2 to 30.9+/-14.5 ng/ml (P<0.01). The UAC increased in patients without alpha-lipoic acid treatment from 21.2+/-29.5 to 36.9+/-60.6 ng/l (P<0.05), but was unchanged with alpha-lipoic acid. It is postulated that the significant decrease in plasma thrombomodulin and failure of UAC to increase observed in the alpha-lipoic acid treated group is due to antioxidative effects of alpha-lipoic acid, and if so that oxidative stress plays a central role in the pathogenesis of diabetic nephropathy. Furthermore, progression of the disease might be inhibited by antioxidant drugs. A placebo-controlled study is needed.
Predictive Factors of Plasma HIV Suppression during Pregnancy: A Prospective Cohort Study in Benin

To investigate the factors associated with HIV1 RNA plasma viral load (pVL) below 40 copies/mL at the third trimester of pregnancy, as part of prevention of mother-to-child transmission (PMTCT) in Benin.



Sub study of the PACOME clinical trial of malaria prophylaxis in HIV-infected pregnant women, conducted before and after the implementation of the WHO 2009 revised guidelines for PMTCT.



HIV-infected women were enrolled in the second trimester of pregnancy. Socio-economic characteristics, HIV history, clinical and biological characteristics were recorded. Malaria prevention and PMTCT involving antiretroviral therapy (ART) for mothers and infants were provided. Logistic regression helped identifying factors associated with virologic suppression at the end of pregnancy.



Overall 217 third trimester pVLs were available, and 71% showed undetectability. Virologic suppression was more frequent in women enrolled after the change in PMTCT recommendations, advising to start ART at 14 weeks instead of 28 weeks of pregnancy. In multivariate analysis, Fon ethnic group (the predominant ethnic group in the study area), regular job, first and second pregnancy, higher baseline pVL and impaired adherence to ART were negative factors whereas higher weight, higher antenatal care attendance and longer ART duration were favorable factors to achieve virologic suppression.



This study provides more evidence that ART has to be initiated before the last trimester of pregnancy to achieve an undetectable pVL before delivery. In Benin, new recommendations supporting early initiation were well implemented and, together with a high antenatal care attendance, led to high rate of virologic control.
Patient Navigation and Time to Diagnostic Resolution: Results for a Cluster Randomized Trial Evaluating the Efficacy of Patient Navigation among Patients with Breast Cancer Screening Abnormalities, Tampa, FL

The objective of this study was to evaluate a patient navigation (PN) program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida.



The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect.



1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control). Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months) showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR) was 0.85 (95% Confidence Interval [CI]: 0.64-1.13) suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13). The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months.



PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months.
Short and Medium Time Experience with a Tined, Multilumen Steroid Eluting Defibrillation Lead

Both leads and pulse generators of implantable defibrillators have undergone important improvements during the last years. New leads should be tested against previous models to demonstrate safety and reliability. When introduced in 1995, the Medtronic 6932 pace, sense and defibrillation lead was compared to the alternative larger 6936 lead in a short-term randomized study with a mean follow-up of 2.4±2.0 months. A subgroup of patients were followed for 23.9±9.0 months. Three hundred and thirty-six patients were randomized to receive either the 6932 or the 6936 lead. Defibrillation threshold at implant, tested using a binary search protocol, was similar for the two leads. The pacing threshold was significantly lower for the 6932 lead both at implant and at follow-up, probably due to the steroid eluting tip of the electrode. R-wave amplitudes were similar for the leads, as were the complication rates. During about two years of follow-up, both leads performed well, with a slightly lower pacing threshold for the 6932 lead.