nils-herrmann/clean_scirepeval huggingface dataset:
Stent-assisted coiling of bifurcation aneurysms may improve endovascular treatment: a critical evaluation in an experimental model.

Endovascular treatment of wide-neck bifurcation aneurysms often results in incomplete occlusion or aneurysm recurrence. The goals of this study were to compare results of coil embolization with or without the assistance of self-expandable stents and to examine how stents may influence neointima formation.



Wide-neck bifurcation aneurysms were constructed in 24 animals and, after 4-6 weeks, were randomly allocated to 1 of 5 groups: 1) coil embolization using the assistance of 1 braided stent (n = 5); 2) coil embolization using the assistance of 2 braided stents in a Y configuration (n = 5); 3) coil embolization without stent assistance (n = 6); 4) Y-stenting alone (n = 4); and 5) untreated controls (n = 4). Angiographic results were compared at baseline and at 12 weeks, by using an ordinal scale. Neointima formation at the neck at 12 weeks was compared among groups by using a semiquantitative grading scale. Bench studies were performed to assess stent porosities.



Initial angiographic results were improved with single stent-assisted coiling compared with simple coiling (P = .013). Angiographic results at 12 weeks were improved with any stent assistance (P = .014). Neointimal closure of the aneurysm neck was similar with or without stent assistance (P = .908), with neointima covering coil loops but rarely stent struts. Y-stent placement alone had no therapeutic effect. Bench studies showed that porosities can be decreased with stent compaction, but a relatively stable porous transition zone was a limiting factor.



Stent-assisted coiling may improve results of embolization by allowing more complete initial coiling, but these high-porosity stents did not provide a scaffold for more complete neointimal closure of aneurysms.
Comparison of SSFP and IR GRE techniques for measurement of total myocardial mass-influence of applied contrast dosage and implication for relative infarct size assessment.

To compare total left ventricular mass assessment using steady state free precession (SSFP) and inversion recovery fast gradient echo (IR GRE) imaging and further to assess the influence of contrast dosage on mass by IR GRE and its implications on relative infarct size assessment with both methods.



Forty-three patients with first documented myocardial infarction and single vessel disease underwent measurement of total myocardial mass using SSFP technique and an IR GRE sequence. As part of a Phase 2 multi-center dose ranging study for infarct identification patients received 1 of 4 possible dosages (0.05, 0.1, 0.2 or 0.3 mmol/kg body weight) of the contrast agent gadoversetamide (OptiMARK, Tyco Healthcare Mallinckrodt, St. Louis, MO, USA).



Left ventricular mass assessment using IR GRE resulted in a slightly greater detection of myocardial mass than from the SSFP images (160.1 and 156.4 g, respectively, p < 0.001). The overall good correlation of both methods (R2 = 0.97 for the total study group, p < 0.001) was further improved by using gadoversetamide at doses of 0.2 or 0.3 mmol/kg (R2= 0.99, p < 0.001), mainly as a result of a considerably higher blood-myocardial contrast-to-noise ratio (CNR) in the IR GRE images. Bland-Altman analysis in these subgroups showed very little scatter of the residuals over the mean (3.5 +/- 5.4 g and 1.3 +/- 6.9 g respectively, 95% confidence interval). The observed differences in total mass calculation, while statistically significant, were not correlated with clinically relevant differences in estimation of relative infarct size.



Total LV mass calculations using SSFP and IR GRE techniques are interchangeable when using appropriate contrast media, such as gadoversetamide. Late gadolinium enhancement results in good blood myocardial CNR. Hence, for relative infarct size assessment either method for calculation of total myocardial mass can be used.
New single-nucleotide polymorphisms associated with differences in platelet reactivity and their influence on survival in patients with type 2 diabetes treated with acetylsalicylic acid: an observational study

Genetic polymorphisms may contribute to platelet reactivity in diabetic patients; however, the information on their influence on long-term antiplatelet therapy is lacking. Our aim was to evaluate the role of previously described genetic variants and platelet reactivity on risk of all-cause mortality and cardiovascular events. Blood samples were obtained from 303 Caucasian patients. Genome-wide genotyping was performed using Illumina Human Omni 2.5-Quad microarrays, and individual genotyping of selected SNPs was performed using a custom Sequenom iPLEX assay in conjunction with the Mass ARRAY platform. Platelet reactivity was measured with VerifyNow Aspirin Assay and PFA-100 Assay. Univariate and multivariate Cox regression analyses were performed to determine the impact of genetic variants and platelets reactivity on risk of all-cause mortality and cardiovascular events. Among the 237 patients included in the follow-up, death from any cause occurred in 34 (14.3%) patients and cardiovascular events occurred in 51 (21.5%) patients within a median observation time of 71 months (5.9 years). In univariate analyses, significant association in the presence of minor alleles in TXBA2R (rs1131882) with primary (HR 2.54, 95% CI 1.15–5.60, p = 0.021) and secondary endpoint (HR 2.06, 95% CI 1.06–4.04, p = 0.034) was observed. In addition, multivariate analyses revealed the impact of this polymorphism on primary (HR 2.34, 95% CI 1.09–5.00, p = 0.029) and secondary endpoint (HR 1.89, 95% CI 1.00–3.57, p = 0.048). Results of the study demonstrate for the first time an association between genetic polymorphism within TXBA2R gene encoding platelet’s surface receptor and long-term survival of diabetic patients treated with ASA.
Multicenter hospital study on prescribing patterns for prophylaxis and treatment of complications of cirrhosis

To describe the prescribing patterns for liver disease management.  A multicenter cross-sectional prospective observational study was carried out in 25 Spanish hospitals. Inpatients, admitted to gastrointestinal and liver units with a diagnosis of liver cirrhosis, were included in five centrally assigned index days between February and June 1999. Information was collected about demographic variables and pharmacological treatments used on admission and recommended at discharge.  Five hundred and sixty-eight patients (70% men, mean age 61 years) were studied. Alcoholic cirrhosis of the liver accounted for 44% of the sample, ascites being the most prevalent complication. The most frequent diuretic schedule on admission was the combination of spironolactone and furosemide at a ratio of 1 (100 mg/40 mg). Hospitalization resulted in an increase in the percentage of patients that received the combination at a ratio higher than 1. Diuretics were a major cause of adverse drug events on admission (7.5%). Ulcer-healing drugs showed a notable increase at discharge (35%; range 10–59%) compared with 24% (6–37%) on admission. Utilization rates at discharge were 65% (59–74%) for diuretics, 51% (38–76%) for laxatives, 31% (0–75%) for vitamin K, 24% (4–53%) for β-adrenergic blocking agents, and 13% (0–47%) for nitrates, which were significantly higher than on admission.  These results provide the first quantitative data of drug utilization in liver disease and highlight the wide variability in prescribing practices across centers and the higher than expected use of non-evidence-based treatments, especially vitamin K and antiulcer drugs.
Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response.

Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.



Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14 wks.



169 patients included (48%males, mean age 39 +/- 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1,355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 48% remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41 wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients.



Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.
Preliminary experience with the LionHeart left ventricular assist device in patients with end-stage heart failure.

The Arrow LionHeart LVD 2000 left ventricular assist device is the first fully implantable system designed for destination therapy. We report on 2 years of experience with this device, which we implanted for the first time in October 1999.



Since October 1999, 6 male patients between 55 and 69 years of age (mean 65 +/- 6 years) have received the device at our center; all were in New York Heart Association functional class IV and ineligible for heart transplantation.



All surgical procedures were uneventful, with a timely extubation in 5 of 6 patients. Duration of support was 17 to 670 (mean 245 +/- 138) days, with a cumulative experience of 4.5 years. Three patients recovered to be discharged from hospital under support and are long-term survivors. Three patients died 17, 31, and 112 days after implantation from multiple organ failure without being discharged to their homes. The survival rate is 50% after 18 months. There were no major system-related problems or any device-related infections, which are otherwise commonly found among vertricular assist device patients.



Our preliminary experience demonstrates the reliability and efficacy of the different parts of the system. Nevertheless, further sophistication is needed to reduce the size of its components, which so far still constitutes a limiting factor.
Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study

Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices.



This single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm).



In total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9% of patients (90.9% for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7% of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3% of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0% of all access-site complications). One patient died due to septic shock (non-procedure related).



In daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe.
Abnormalities of erythropoiesis during HIV-1 disease: a longitudinal analysis.

Impaired erythropoiesis is a key abnormality described in untreated HIV-1 disease. Most of the available data on HIV-associated hematopoietic abnormalities were obtained using unfractionated bone marrow-derived mononuclear cells, thus resulting in significant inter (and intra)-individual variability in the number of cultured precursors. Aim of this study was to assess the erythropoietic capability of purified CD34+ progenitors through a longitudinal analysis of burst-forming units-erythroid (BFU-E) growth before and after antiretroviral therapy (ART).



Twelve HIV-infected individuals were studied before and after ART; 31 HIV-uninfected individuals were enrolled as controls. CD34+ progenitors were purified from peripheral blood by immunomagnetic sorting and cultured in methylcellulose-based medium containing stem cell factor, granulocyte-monocyte colony-stimulating factor, interleukin-3, and erythropoietin. Serum levels of iron, transferrin, transferrin saturation index, soluble transferrin receptor, ferritin, and erythropoietin were also evaluated.



Baseline BFU-E levels were increased in untreated HIV-infected individuals when compared with controls but declined significantly after successful ART. In contrast, serum levels of erythropoietin and soluble transferrin receptor increased significantly after ART.



These findings suggest that, in untreated HIV-infected individuals, chronic inflammation and/or immune activation is associated with defective erythropoiesis and accumulation of erythroid precursors. ART-induced suppression of HIV-1 replication is associated with normalization of BFU-E levels.
Cost-effectiveness evaluation of compliance therapy for people with psychosis.

Non-compliance rates with antipsychotic medication can be high, and the personal and societal costs are considerable. A new psychological intervention, compliance therapy seeks to improve compliance and patient outcomes and reduce treatment costs.



A randomised controlled study examined the cost-effectiveness of compliance therapy compared to non-specific counselling over 18 months for 74 people with psychosis admitted as inpatients at the Maudsley Hospital. Bivariate and multivariate analyses were conducted to test for differences and to explore inter-patient cost variations.



Compliance therapy is more effective and is no more expensive. Consequently, compliance therapy is more cost-effective than non-specific counselling at six, 12 and 18 months.



There are compliance, outcome and cost-effectiveness arguments in favour of compliance therapy in preference to non-specific counselling.
Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study

Vaniprevir is a potent macrocyclic hepatitis C virus (HCV) nonstructural protein 3/4A protease inhibitor. This phase III study evaluated the safety and efficacy of vaniprevir in combination with peginterferon alfa-2b and ribavirin (PR) for 24 weeks compared with PR alone for 48 weeks in treatment-naive Japanese patients with HCV genotype 1 infection. Treatment-naive Japanese patients with HCV genotype 1 infection were randomly assigned to receive vaniprevir (300 mg twice daily) plus PR for 12 weeks then PR alone for 12 weeks, vaniprevir (300 mg twice daily) plus PR for 24 weeks, or PR alone for 48 weeks. The primary end point was sustained virologic response 24 weeks after completion of treatment (SVR24). In total, 294 patients were randomly assigned to receive treatment. Most patients had HCV genotype 1b infection (98 %, 288 of 294 patients). SVR24 was achieved in 83.7, 84.5, and 55.1 % of the patients in the vaniprevir 12-week, vaniprevir 24-week, and control arms, respectively. The difference in SVR24 rates between each vaniprevir arm and the control arm was statistically significant (p < 0.001 for both). Relapse was commoner in the control arm (29.5 %) than in the vaniprevir arms (8.6 % and 10.5 % for the 12-week and 24-week arms, respectively). Commonly reported adverse events were generally similar across treatment arms, with the exception of an increase in the incidence of gastrointestinal adverse events such as nausea, diarrhea, and vomiting in patients receiving vaniprevir. These events were considered manageable. Vaniprevir is a valuable addition to the therapeutic options available to Japanese patients with HCV genotype 1 infection who are eligible for interferon-based treatment. NCT01370642.
An Interactive Robot Facilitating Social Skills for Children

In this paper, we propose an interactive robot system to facilitate easy improvement of children's social capability, with robot-assisted interventions effectively offering social skill training for children with autism. This is achieved through therapeutic protocols with therapy, encouragement, and pause modes, which are determined by behavioral responses of children. Furthermore, the robot evaluates the level of children's reactivity in the child-robot interaction by recognition modules for frontal face and touch, and it generates appropriate training tasks through the combination of kinesic acts and displayable contents. From the experiments of the interplay training with autistic and non-autistic children, it is verified that the proposed system has positive effects on social development of children with autism spectrum disorders.
Both Atomoxetine and Stimulants Improve Quality of Life in an ADHD Population Treated in a Community Clinic

To evaluate change in quality of life in a community clinic ADHD population treated with atomoxetine or stimulants. No direct comparisons between atomoxetine and stimulants to improve quality of life in ADHD are available. A prospective, nonrandomized comparison between ADHD patients treated with atomoxetine or stimulants in one clinic. Structured diagnostic assessment tools and a specific quality of life measure were used. 84 patients (atomoxetine n = 39/stimulants n = 45), between the ages of 5 and 18, were treated for approximately 8 months. At end point, there were no significant differences in improvements of quality of life between the two groups. Age, participation in psychotherapy, and parental disability were not correlated with quality of life changes. Patients with lower baseline scores improved most. Both atomoxetine and stimulants led to a modest increase in quality of life in this community clinic ADHD population.
Selective estrogen receptor alpha agonist GTx-758 decreases testosterone with reduced side effects of androgen deprivation therapy in men with advanced prostate cancer.

A need remains for new therapeutic approaches for men with advanced prostate cancer, particularly earlier in the disease course.



To assess the ability of an oral selective estrogen receptor α agonist (GTx-758) to lower testosterone concentrations compared with leuprolide while minimizing estrogen deficiency-related side effects of androgen-deprivation therapy.



Hormone-naive advanced prostate cancer patients were randomized to oral GTx-758 1000 mg/d, 2000 mg/d, or leuprolide depot.



GTx-758 and leuprolide.



The primary end point was the proportion of patients achieving total testosterone ≤ 50 ng/dl by day 60. Secondary end points included serum free testosterone, prostate-specific antigen (PSA), sex hormone-binding globulin, hot flashes, bone turnover markers, and insulin-like growth factor (IGF)-1 levels.



Of 159 randomized patients, leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients than GTx-758 by day 60 (43.4%, 63.6%, and 88.2% of subjects receiving GTx-758 1000 mg [p<0.001], GTx-758 2000 mg [p=0.004], and leuprolide, respectively). GTx-758 reduced free testosterone and PSA earlier and to a greater degree than leuprolide. GTx-758 led to fewer hot flashes, decreases in bone turnover markers, and alterations in IGF-1 compared with leuprolide. A higher incidence of venous thromboembolic events (VTEs) was seen with GTx-758 (4.1%) compared with leuprolide (0.0%).



Although leuprolide reduced total testosterone to ≤ 50 ng/dl in a greater proportion of patients compared with GTx-758, GTx-758 was superior in lowering free testosterone and PSA. GTx-758 reduced estrogen deficiency side effects of hot flashes, bone loss, and insulin resistance but with a higher incidence of VTEs.



This paper reports findings that leuprolide lowered total testosterone more than GTx-758 but that GTx-758 lowered free testosterone and prostate-specific antigen more than leuprolide. GTx-758 also reduced estrogen deficiency side effects, albeit at a higher rate of vascular events.
Sensitization to horse allergens in Italy: a multicentre study in urban atopic subjects without occupational exposure.

Horses play a significant role in people's leisure time in Italy and other countries, but few data are available on IgE-mediated sensitization to horse allergens in patients without occupational exposure. We assessed, in a multicentric survey, the prevalence of horse sensitization in atopic subjects and its clinical characteristics.



Allergists from the whole Italian territory were required to collect the results of skin prick tests from at least 100 consecutive subjects. Those patients with a positive skin test to horse dander underwent a detailed interview concerning clinical history, pet ownership and possible exposure.



Data from 3,235 outpatients were collected and 2,097 had at least 1 skin positivity. Among them, 113 (5.38%) were sensitized to horse dander (9 monosensitized). Thirty patients reported direct horse contact (4 owners and 26 for riding or occasional contact), 23 patients were sometimes in contact with horse owners and 60 subjects denied any direct or indirect exposure. Among 9 horse monosensitized patients, 6 had intermittent and mild rhinitis and 3 persistent moderate/severe rhinitis plus asthma. Three of them were horse owners or riders and the remaining had no contact with the animal.



Our data evidence that the rate of sensitization to horse dander is not negligible and probably underestimated. In susceptible, not occupationally exposed individuals, horse contact, but also indirect or no apparent exposure, may induce sensitization. We recommend inclusion of horse allergen in the routine panel for the diagnosis of respiratory allergy.