nils-herrmann/clean_scirepeval huggingface dataset:
Effects of eicosapentaenoic acid and fluoxetine on plasma cortisol, serum interleukin-1beta and interleukin-6 concentrations in patients with major depressive disorder

Treatment studies have suggested that omega-3 fatty acids (omega-3 FAs) as monotherapy or adjunctive treatment have therapeutic effects in depression. The authors recently reported a study in which fluoxetine and eicosapentaenoic acid (EPA), which is an omega-3 fatty acid, appeared to be equally effective in controlling depressive symptoms and their combination was superior to either of them alone. Regulation of hypothalamus-pituitary-adrenal (HPA) axis activity and reduction of inflammatory cytokines are among several biological mechanisms which potentially explain the impact of omega-3 FAs on depression. In the present study, plasma cortisol and serum interleukin-1beta (IL-1 beta) and interleukin-6 (Il-6) were measured in patients with a diagnosis of major depressive disorder (MDD) participating in aforementioned trial to determine the effects of 8 weeks of treatment of depression with 1000 mg EPA alone or in combination with 20 mg fluoxetine on HPA axis activity and inflammatory cytokine production and compare the changes in these variables with those of treating with 20 mg fluoxetine alone. Forty-two patients were included in analysis. Two-way repeated measures analysis of variance (ANOVA) showed that plasma cortisol decreased significantly after 8 weeks of intervention without significant difference among the groups. There was no interaction between group and response to treatment over time in the cortisol response based on three-way ANOVA. Serum concentrations of IL-1beta and IL-6 did not change significantly after intervention. In conclusion, EPA alone or in combination with fluoxetine, as well as fluoxetine alone decreased serum cortisol after 8 weeks of treatment in patients with major depression disorder (MDD) without any significant effect of response to treatment. Serum IL-1beta and IL-6 did not change significantly after intervention. These findings suggest that EPA may exert its therapeutic effects through reduction of cortisol.
A human model of intra-abdominal hypertension: even slightly elevated pressures lead to increased acute systemic inflammation and signs of acute kidney injury

phic eff ects on critically ill patients, but its patho physiology is only partially understood . Oliguria and renal dysfunction are among the earliest signs of increasing intra-abdominal pressure (IAP) . A number of diff erent pathophysiological mechanisms may be responsible . One of these may be an increase in pro-infl ammatory cytokines provoked by IAH . In IAPs of greater than 20 mm Hg, an increase in circulating levels of a variety of infl ammatory mediators has been described . We analyzed markers of infl ammation and renal function in a prospective randomized clinical trial. In this trial, 50 living kidney donors were randomly assigned between hand-assisted laparoscopy by a transperitoneal approach and open nephrectomy by a retroperitoneal approach . In this human model of IAH, a carbon dioxide pneumo-peritoneum of 12 mm Hg was induced during the procedure in the laparoscopic group.  open nephrectomy group served as a control group, and IAH was not applied. Markers of systemic infl ammation – C-reactive protein (CRP) and interleukin-6 (IL-6) – were determined in both groups peri-operatively. Th ese results were previously published in a large study on the eff ect of diff erent operative procedures on outcome of kidney donors . As a marker of renal function, neutrophil gelatinaseassociated lipocalin (NGAL) in plasma and urine was determined in both groups at the start of the procedure and just before extraction of the donor kidney. All data are expressed as means with standard deviations. Paired t tests were performed to test for statistical signifi cance at every time point; a P value of less than 0.05 was considered statistically signifi cant. CRP was 1.5 times higher after 24 hours and 1.3 times higher after 48 hours in the laparoscopic group. IL-6 was 1.5 times higher after 12 hours in the laparoscopic group. NGAL in plasma was 1.2 times higher just before extraction of the kidney in the laparoscopic group. NGAL in urine did not change . Although procedure time is shorter [4], laparoscopic nephrectomy leads to increased infl ammation and signs of renal injury. It is tempting to hypothesize that even mild IAH leads to mildly increased systemic infl am mation and increased plasma NGAL as a sign of acute kidney injury in this group. Other factors such as operative technique or infl ammation caused by carbon dioxide gas may contribute. Further studies to dissect the contributions of infl ammation, hemodynamics, and local pressure eff ects on renal injury in IAH are warranted.
Superoxide anion production by monocytes of corticosteroid-treated asthmatic patients.

Reactive oxygen species play an important role in promoting inflammation. Blood monocytes have been described to release higher amounts of superoxide anion in uncontrolled and untreated asthmatics. Corticosteroids are widely used in asthma, but little is known about their molecular mechanism of action. The aim of our study was to analyse the ex vivo effect of corticosteroid treatments on superoxide anion release by blood monocytes. Superoxide anion release was measured by a spectrophotometric method based on the superoxide dismutase (SOD) -inhibitable reduction of ferricytochrome C by blood monocytes from untreated patients and asthmatics treated with i.v., inhaled and oral corticosteroids. Monocytes from uncontrolled and untreated asthmatics, released high amounts of superoxide anions. After short-term treatment with i.v., corticosteroids, this release was found to decrease significantly (1.410 versus 0.340 nM, p<0.05). Cells from asthmatics who had undergone long-term treatment with inhaled or oral steroids presented low amounts of superoxide anion production, with a significant difference as compared to untreated asthmatics (0.375 nM p<0.01 and 0.620 nM p<0.02 respectively). In general, patients with controlled asthma (treated with short-term oral steroids, or with long-term inhaled steroids) released lesser amounts of superoxide anion than uncontrolled and untreated asthmatics. In the case of steroid-dependent asthmatics there was no difference between patients with a controlled or uncontrolled disease.
The role of spirituality and religious coping in the quality of life of patients with advanced cancer receiving palliative radiation therapy.

National palliative care guidelines outline spiritual care as a domain of palliative care, yet patients' religiousness and/or spirituality (R/S) are underappreciated in the palliative oncology setting. Among patients with advanced cancer receiving palliative radiation therapy (RT), this study aims to characterize patient spirituality, religiousness, and religious coping; examine the relationships of these variables to quality of life (QOL); and assess patients' perceptions of spiritual care in the cancer care setting.



This is a multisite, cross-sectional survey of 69 patients with advanced cancer (response rate = 73%) receiving palliative RT. Scripted interviews assessed patient spirituality, religiousness, religious coping, QOL (McGill QOL Questionnaire), and perceptions of the importance of attention to spiritual needs by health providers. Multivariable models assessed the relationships of patient spirituality and R/S coping to patient QOL, controlling for other significant predictors of QOL.



Most participants (84%) indicated reliance on R/S beliefs to cope with cancer. Patient spirituality and religious coping were associated with improved QOL in multivariable analyses (β = 10.57, P < .001 and β = 1.28, P = .01, respectively). Most patients considered attention to spiritual concerns an important part of cancer care by physicians (87%) and nurses (85%).



Limitations include a small sample size, a cross-sectional study design, and a limited proportion of nonwhite participants (15%) from one US region.



Patients receiving palliative RT rely on R/S beliefs to cope with advanced cancer. Furthermore, spirituality and religious coping are contributors to better QOL. These findings highlight the importance of spiritual care in advanced cancer care.
An angiographic analysis of atherosclerosis progression in below-the-knee arteries after femoropopliteal angioplasty in claudicants.

To report an angiographic investigation of midterm atherosclerotic disease progression in below-the-knee (BTK) arteries of claudicants.



Angiograms were performed in 58 consecutive claudicants (35 men; mean age 68.3+/-8.7 years) with endovascular treatment of femoropopliteal arteries in 58 limbs after a mean follow-up of 3.6+/-1.2 years. Angiograms were reviewed in consensus by 2 experienced readers blinded to clinical data. Progression of atherosclerosis in 4 BTK arterial segments (tibioperoneal trunk, anterior and posterior tibial arteries, and peroneal artery) was assessed according to the Bollinger score. The composite per calf Bollinger score represented the average of the 4 BTK arterial segment scores. The association of the Bollinger score with cardiovascular risk factors and gender was scrutinized.



A statistically significant increase in atherosclerotic burden was observed for the mean composite per calf Bollinger score (5.7+/-8.3 increase, 95% CI 3.5 to 7.9, p<0.0001), as well as for each single arterial segment analyzed. In multivariate linear regression analysis, diabetes mellitus was associated with a more pronounced progression of atherosclerotic burden in crural arteries (beta: 5.6, p = 0.035, 95% CI 0.398 to 10.806).



Progression of infrapopliteal atherosclerotic lesions is common in claudicants during midterm follow-up. Presence of diabetes mellitus was confirmed as a major risk factor for more pronounced atherosclerotic BTK disease progression.
Antiviral activity, pharmacokinetics, and safety of BMS-488043, a novel oral small-molecule HIV-1 attachment inhibitor, in HIV-1-infected subjects.

BMS-488043 is a novel and unique oral small-molecule inhibitor of the attachment of human immunodeficiency virus type 1 (HIV-1) to CD4(+) lymphocytes. The antiviral activity, pharmacokinetics, viral susceptibility, and safety of BMS-488043 were evaluated in an 8-day monotherapy trial. Thirty HIV-1-infected study subjects were randomly assigned to sequential, safety-guided dose panels of 800 and 1,800 mg BMS-488043 or a matched placebo in a 4:1 ratio, and the drug was administered every 12 h with a high-fat meal for 7 days and on the morning of day 8. Dose-related, albeit less-than-dose-proportional, increases in plasma BMS-488043 concentrations were observed. Mean plasma HIV-1 RNA decreases from the baseline for the BMS-488043 800- and 1,800-mg dose groups on day 8 were 0.72 and 0.96 log(10) copies/ml, respectively, compared with 0.02 log(10) copies/ml for the placebo group. A lower baseline BMS-488043 50% effective concentration (EC(50)) in the active-treatment groups was predictive of a greater antiviral response. Although absolute drug exposure was not associated with an antiviral response, the trough concentration (C(trough)), adjusted by the baseline EC(50) (C(trough)/EC(50)), was associated with antiviral activity. During dosing, four subjects experienced >10-fold reductions in viral susceptibility to BMS-488043, providing further support of the direct antiviral mechanism of BMS-488043. BMS-488043 was generally safe and well tolerated. These results suggest that further development of this novel class of oral HIV-1 attachment inhibitors is warranted.
Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial

Pulmonary vein isolation (PVI) is conventionally performed using 3D electroanatomical mapping to guide point-to-point ablation. The Pulmonary Vein Ablation Catheter (PVAC)® is a phased multipolar ablation (PMRA) catheter designed for rapid PVI using radiological anatomical information. Comparison of these methods of PVI using continuous beat-to-beat monitoring was undertaken. Fifty patients with drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF) were recruited. Patients all had REVEAL® XT ILR or a DDDRP permanent pacemaker (PPM) inserted prior to PVI. PPM was programmed to monitoring mode (ODO). Patients were randomised 1:1 to undergo PVI with either point-to-point irrigated radiofrequency ablation (Conv) or PMRA technology. Follow-up was performed at 0, 3, 6, 9, and 12 months using Holter downloads to assess arrhythmia burden. Outcomes were examined following a 3-month blanking period. The AF burden pre-ablation, at 3-month and at 12-month post-ablations, was not significantly different (pre-ablation AF burdens (mean ± SE) Conv 16.6 ± 5.0 %, PVAC 17.0 ± 5.6 %, 3 months Conv 4.0 ± 1.6 %, PVAC 4.7 ± 1.5 %, 12 months Conv 4.3 ± 2.3 %, PVAC 3.8 ± 1.5 %). In both groups, there was a significant reduction in AF burden from pre-ablation (at 3 months p = 0.01, p = 0.04, at 12 months p = 0.04, p = 0.03 for Conv and PMRA groups, respectively). Overall success rate for zero AF recurrence at 12 months was 54 %. PMRA PVI is comparable to conventional technology for AF extinction at 1 year. The PMRA is as safe as conventional technology but enables the operator to perform the procedure faster. Device monitored success rates were lower than other studies not utilising such intensive monitoring confirming that sporadic ECG monitoring is not sufficient to detect all AF recurrence.
Effects of dual transcranial direct current stimulation on post-stroke unilateral visuospatial neglect

Based on the interhemispheric inhibition model of unilateral visuospatial neglect (USN) after stroke, the effects of dual-mode transcranial direct current stimulation (tDCS) over the parietal cortices were assessed in a double-blind random-order cross-over experiment. Ten chronic right hemispheric stroke patients (4 men; mean age: 62.6 years) with USN were recruited. All participants underwent three randomly arranged tDCS sessions: (1) dual-mode, anodal tDCS over the right posterior parietal cortex (PPC) and cathodal tDCS over the left PPC; (2) single-mode, anodal tDCS over the right PPC; and (3) sham mode. Each session lasted 20min. Before and immediately after the stimulation, a line bisection test and star cancelation test were carried out. In the line bisection test, significant improvements were observed after both the dual- and the single-mode tDCS (p<0.05), but not after sham stimulation. Statistical analysis showed a significant interaction between time and tDCS mode, where the dual tDCS had a stronger effect than the single or sham stimulation modes (p<0.05). The star cancelation test did not show any significant change. These results suggest that dual tDCS over the bilateral PPC is an effective method for the treatment of USN in stroke patients.
Exploring older peoples' experiences of nocturia: a poorly recognised urinary condition that limits participation.

This study sought to understand the experience of living and coping with nocturia, from the perspective of community-living older men and women.



Individual semi-structured interviews were undertaken with 32 older people with self-reported nocturia of twice nightly or more.



Four key characteristics of nocturia were identified. Nocturia was described as simultaneously debilitating, frustrating, distressing and puzzling. It impacted on sleep patterns and quality, personal relationships and increased the fear of falling among older people when rising to use the toilet at night. Previously unrecognised variability and unpredictability in the condition were highlighted features. Nocturia was not prioritised for health intervention. There were gender differences in initial help-seeking however once prostate disease was eliminated, self-management strategies to cope with the effects of nocturia were the norm.



. This study indicates that nocturia has a widespread and profound influence on older people's quality of life and participation, despite being regarded as a relatively benign condition by both older people and health professionals. Several features of the condition, which have the potential for great impact, are poorly recognised in particular its variability and unpredictability.
MODY 2: mutation identification and molecular ancestry in a Brazilian family.

Maturity Onset Diabetes of the Young (MODY) is a heterogeneous group of genetic diseases characterized by a primary defect in insulin secretion and hyperglycemia, non-ketotic disease, monogenic autosomal dominant mode of inheritance, age at onset less than 25 years, and lack of auto-antibodies. It accounts for 2-5% of all cases of non-type 1 diabetes. MODY subtype 2 is caused by mutations in the glucokinase (GCK) gene. In this study, we sequenced the GCK gene of two volunteers with clinical diagnosis for MODY2 and we were able to identify four mutations including one for a premature stop codon (c.76C>T). Based on these results, we have developed a specific PCR-RFLP assay to detect this mutation and tested 122 related volunteers from the same family. This mutation in the GCK gene was detected in 21 additional subjects who also had the clinical features of this genetic disease. In conclusion, we identified new GCK gene mutations in a Brazilian family of Italian descendance, with one due to a premature stop codon located in the second exon of the gene. We also developed a specific assay that is fast, cheap and reliable to detect this mutation. Finally, we built a molecular ancestry model based on our results for the migration of individuals carrying this genetic mutation from Northern Italy to Brazil.
Enhancing assertive community treatment with cognitive behavioral social skills training for schizophrenia: study protocol for a randomized controlled trial.

Schizophrenia leads to profound disability in everyday functioning (e.g., difficulty finding and maintaining employment, housing, and personal relationships). Medications can effectively reduce positive symptoms (e.g., hallucinations and delusions), but they do not meaningfully improve daily life functioning. Psychosocial evidence-based practices (EBPs) improve functioning, but these EBPs are not available to most people with schizophrenia. The field must close the research and service delivery gap by adapting EBPs for schizophrenia to facilitate widespread implementation in community settings. Our hybrid effectiveness and implementation study represents an initiative to bridge this divide. In this study we will test whether an existing EBP (i.e., Cognitive Behavioral Social Skills Training (CBSST)) modified to work in practice settings (i.e., Assertive Community Treatment (ACT) teams) commonly available to persons with schizophrenia results in better consumer outcomes. We will also identify key factors relevant to developing future CBSST implementation strategies.



For the effectiveness study component, persons with schizophrenia will be recruited from existing publicly funded ACT teams operating in community settings. Participants will be randomized to one of the 2 treatments (ACT alone or ACT + Adapted CBSST) and followed longitudinally for 18 months with assessments every 18 weeks after baseline (5 in total). The primary outcome domain is psychosocial functioning (e.g., everyday living skills and activities related to employment, education, and housing) as measured by self-report, testing, and observation. Additional outcome domains of interest include mediators of change in functioning, symptoms, and quality of services. Primary analyses will be conducted using linear mixed-effects models for continuous data. The implementation study component consists of a structured, mixed qualitative-quantitative methodology (i.e., Concept Mapping) to characterize and assess the implementation experience from multiple stakeholder perspectives in order to inform future implementation initiatives.



Adapting CBSST to fit into the ACT service delivery context found throughout the United States creates an opportunity to substantially increase the number of persons with schizophrenia who could have access to and benefit from EBPs. As part of the implementation learning process training materials and treatment workbooks have been revised to promote easier use of CBSST in the context of brief community-based ACT visits.
Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema.

To compare modified Early Treatment Diabetic Retinopathy Study (mETDRS) focal/grid laser photocoagulation with normal-density (ND-SDM) or high-density (HD-SDM) subthreshold diode-laser micropulse photocoagulation for the treatment diabetic macular edema (DME).



A prospective, randomized, controlled, double-masked clinical trial with patients with previously untreated DME and best corrected visual acuity (BCVA) worse than 20/40 and better than 20/400. Patients were randomized to receive either mETDRS focal/grid photocoagulation (42 patients), ND-SDM (39 patients), or HD-SDM (42 patients). Before treatment and 1, 3, 6, and 12 months after treatment, all patients underwent ophthalmic examinations, BCVA, color fundus photography, fluorescein angiography, and optical coherence tomography (OCT).



At 12 months, the HD-SDM group had the best improvement in BCVA (0.25 logMAR), followed by the mETDRS group (0.08 logMAR), whereas no improvements were seen in the ND-SDM group (0.03 logMAR). All groups showed statistically significant progressive reduction of central macular thickness (CMT) throughout the study (P < 0.001). The HD-SDM group exhibited the greatest CMT reduction (154 μm), which was not significantly different from that of the mETDRS group (126 μm; P = 0.75).



At 1 year, the clinical performance of HD-SDM was superior to that of the mETDRS photocoagulation technique, according to the anatomic and functional measures of improvement used in this investigation. A rationale for this treatment modality as a preferable approach is suggested, and the precise role of subthreshold micropulse laser treatment may become more defined as experience grows, guided by optimized treatment guidelines and more comprehensive trials. (Clinicaltrials.gov number, NCT00552435.).
Impaired postural compensation for respiration in people with recurrent low back pain

This study evaluated the degree to which the disturbance to posture from respiration is compensated for in healthy normals and whether this is different in people with recurrent low back pain (LBP), and to compare the changes when respiratory demand is increased. Angular displacement of the lumbar spine and hips, and motion of the centre of pressure (COP), were recorded with high resolution and respiratory phase was recorded from ribcage motion. With subjects standing in a relaxed posture, recordings were made during quiet breathing, while breathing with increased dead-space to induce hypercapnoea, and while subjects voluntarily increased their respiration to match ribcage expansion that was induced in the hypercapnoea condition. The relationship between respiration and the movement parameters was measured from the coherence between breathing and COP and angular motion at the frequency of respiration, and from averages triggered from the respiratory data. Small angular changes in the lumbopelvic and hip angles were evident at the frequency of respiration in both groups. However, in quiet standing, the LBP subjects had a greater displacement of their COP that was associated with respiration than the control subjects. The LBP group had a trend for less hip motion. There were no changes in the movement parameters when respiratory demand increased involuntarily via hypercapnoea, but when respiration increased voluntarily, the amplitude of motion and the displacement of the COP increased in both groups. The present data suggest that the postural compensation to respiration counteracts at least part of the disturbance to posture caused by respiration and that this compensation may be less effective in people with LBP.