nils-herrmann/clean_scirepeval huggingface dataset:
Pegylated Liposomal Doxorubicin as Adjuvant Therapy for Stage I-III Operable Breast Cancer.

Conventional anthracyclines play an essential role for the treatment of breast cancer and have potent cytotoxic activity, but are associated with severe toxicity. In metastatic breast cancer, pegylated liposomal doxorubicin (PLD) is a formulation with efficacy similar to conventional doxorubicin but with reduced toxicity. This multicenter study evaluated the efficacy and safety of PLD-based adjuvant chemotherapy for women with stage I-III operable breast cancer.



One hundred and eighty women with stage I-III breast cancer who received PLD-based adjuvant chemotherapy at six different Institutions in Taiwan from February 2002 to March 2008 were included and followed-up until April 2015. Treatment efficacy was determined by disease-free survival (DFS) rate and safety was evaluated by adverse events.



The 5- and 10-year DFS rates were 76.3 and 72.6%, respectively. Univariate analysis revealed that tumor size >5 cm (p=0.045; hazard ratio=3.31) and stage III (hazard ratio=3.54; p=0.019) were each associated with shorter DFS. Only stage III (hazard ratio=5.60; p=0.018) retained statistical significance with regard to DFS in the multivariate analysis. Grade 3/4 hematological toxicity was neutropenia (n=13; 7.2%). The women receiving PLD had low-grade 3 or 4 nausea/vomiting, mucositis, and alopecia. Grade 3 hand-foot syndrome occurred in three patients (1.7%).



PLD could be considered an effective and safe alternative to conventional anthracyclines in the treatment of stage I-III operable breast cancer.
Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized.

The clinical syndrome of frailty identified through the assessment of weight loss, gait speed, grip strength, physical activity, and physical exhaustion has been used to identify patients with reduced reserves. We hypothesized that frailty is useful in predicting adverse outcomes in optimized elective elderly colorectal surgery patients.



A prospective study was conducted at 2 centers (Singapore and Japan). All patients over 75 years of age undergoing colorectal resection were assessed for the presence of the syndrome of frailty. All these patients had already had their comorbidities optimized for surgery. The outcome measure was postoperative major complications (defined as Clavien-Dindo type II and above complications).



Eighty-three patients were studied from February 2008 to April 2010. The mean age was 81.5 years (range 75-93 years). The mean comorbidity index was 3.37 (range 0-11). Twenty-six (31.3%) patients were an American Society of Anesthesiologists (ASA) score of 3 and above. Chi-square analysis revealed that the odds ratio of postoperative major complications was 4.083 (95% confidence interval, 1.433-11.638) when the patient satisfied the criteria for frailty. Albumin <35, ASA >3, comorbidity index >5, and Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) scores were not predictive of postoperative major complications.



Preliminary findings show that frailty is a potent adjunctive tool of predicting postoperative morbidity. Frailty can be used to identify elderly patients needing further optimization before major surgery.
A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer.

To evaluate the efficacy and toxicity of an oxaliplatin, fluorouracil (5-FU), and folinic acid (FOLFOX-6) combination therapy in patients with advanced or recurrent gastric cancer.



Patients with previously untreated advanced or recurrent gastric cancer received oxaliplatin 100 mg/m(2) and leucovorin 400 mg/m(2) (2-hour intravenous infusion) followed by a 5-FU bolus of 400 mg/m(2) (10-min infusion) and then 5-FU 2,600-3,000 mg/m(2) (46-hour continuous infusion). The chemotherapy was repeated every 14 days.



Fifty-one patients were enrolled in this study. Of these, 46 were assessable for efficacy, and all patients were assessable for toxicity. Three of 51 patients achieved a complete response, and 18 had partial responses, giving an overall response rate of 41.2%. Stable disease was observed in 11 (21.6%) patients and progressive disease in 14 (27.5%). The median time to progression was 5.4 months, and the median overall survival was 12.1 months. NCI-CTC grade 3/4 hematological toxicities were neutropenia and anemia in 9.8 and 7.8% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in 3 (5.9%) patients. Other NCI-CTC grade 3 or 4 toxicities included diarrhea in 3 patients (5.9%) and vomiting in 5 (9.8%). There were no treatment-related deaths.



This oxaliplatin/5-FU/folinic acid regimen shows good efficacy and an acceptable toxicity profile in advanced or recurrent gastric cancer patients; further clinical trials are warranted.
Chest pain in the emergency room: a multicenter validation of the HEART Score.

Decision-making in chest pain patients is hampered by poor diagnostic power of patient's history, electrocardiogram, age, risk factors, and troponin. Each of these findings may be qualified with 0, 1, or 2 points. Together they compose the HEART score. We tested the hypothesis that the HEART score predicts major adverse cardiac events.



Retrospective multicenter analysis in patients presenting at the cardiology emergency room.



Patient inclusion between January 1 and March 31, 2006.



A total of 2161 patients were admitted, of which 910 patients (42%) presented with chest pain. Analysis was performed in 880 cases (96.7%).



The primary endpoint was a composite of acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery and death, within 6 weeks after presentation, together called major adverse cardiac events.



A total of 158 patients (17.95%) reached the primary endpoint. Ninety-two patients had an acute myocardial infarction (10.45%), 82 a percutaneous coronary intervention (9.32%), 36 a coronary artery bypass graft (4.09%), and 13 died (1.48%). Of 303 patients with HEART score 0 to 3, three (0.99%) had an endpoint. In 413 patients with HEART score 4 to 6, 48 cases (11.6%) reached an endpoint. In case of a HEART score of 7 to 10, an endpoint was reached in 107/164 cases (65.2%).



The HEART score helps in making accurate diagnostic and therapeutic decisions without the use of radiation or invasive procedures. The HEART score is an easy, quick, and reliable predictor of outcome in chest pain patients and can be used for triage.
Assessing the visual vertical: how many trials are required?

The visual vertical (VV) consists of repeated adjustments of a luminous rod to the earth vertical. How many trials are required to reach consistency in this measure? This question has never been addressed despite the widespread clinical use of the measurement in stroke rehabilitation.



VV perception was assessed (10 trials) in 117 patients undergoing rehabilitation after a first hemisphere stroke. The intraclass correlation coefficient (ICC) and standard error of measurement (SEM) were calculated for each patient category: with contralesional VV bias (n = 48), ipsilesional VV bias (n = 17) and normal VV (n = 52).



For patients with VV biases, 6 trials were required to reach high inter-trial reliability (contralesional: ICC = 0.9, SEM = 1.36°; ipsilesional: ICC = 0.896, SEM = 0.96°). For patients with normal VV, a minimum of 10 trials was required (ICC =  .728, SEM = 1.13°). A set of 6 trials correctly classified 96 % of patients.



In the literature, 10 is the most frequently used number of trials used to assess VV orientation. Our study shows that 10 trials are required to adequately measure VV orientation in non-selected subacute stroke patients. For complex protocols imposing a decrease in the number of trials in each condition, 6 trials are needed to identify VV biases in most patients.
Circulating suPAR levels are affected by glomerular filtration rate and proteinuria in primary and secondary glomerulonephritis.

Circulating levels of soluble urokinase-like plasminogen activator receptor (suPAR) have been associated with proteinuria and renal function in focal segmental glomerulosclerosis (FSGS). This study aimed to evaluate if circulating suPAR levels are independently associated with proteinuria in patients with non-FSGS glomerulonephritis.



This is a cross-sectional analysis of suPAR levels on 42 patients with primary non-FSGS glomerulonephritis (group GN) and 140 patients with secondary glomerulonephritis within an autoimmune disease (group AID).



suPAR serum levels were significantly higher in AID patients (4,733 ± 3,073 pg/ml) than in healthy controls (1,908 ± 1,685 pg/ml; p < 0.001), whereas GN patients displayed intermediate levels (3,670 ± 2,435 pg/ml; p = 0.021). Multivariate analysis for elevated serum suPAR (>3,000 pg/ml) showed an independent association with estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m(2) [odds ratio (OR) = 4.19, 95% confidence interval (CI): 1.67-10.54, p = 0.002], proteinuria >0.5 g/day (OR = 2.97; 95% CI: 1.32-6.70; p = 0.009) and presence of secondary vs. primary GN (OR = 2.87, 95% CI: 1.25-6.23; p = 0.013). A general linear model confirmed that suPAR levels were significantly affected by proteinuria >0.50 g/day (coefficient +1,477 pg/ml), eGFR (-38 pg/ml per 1 ml/min/1.73 m(2) increase) and presence of secondary vs. primary GN (+1,368 pg/ml).



This study shows that elevated serum suPAR levels are associated with reduced eGFR and presence of proteinuria in both primary and secondary GN, suggesting that circulating suPAR may represent a common biomarker of renal involvement in a wide spectrum of GN.
Gender differences in risk profile and outcome of Middle Eastern patients undergoing percutaneous coronary intervention

To determine the gender differences in cardiovascular risk profile and outcomes among patients undergoing percutaneous coronary intervention (PCI).  In a prospective multicenter study of consecutive Middle Eastern patients managed with PCI from January 2013 to February 2014 in 12 tertiary care centers in Amman and Irbid, Jordan. Clinical and coronary angiographic features, and major cardiovascular events were assessed for both genders from hospital stay to 1 year.  Women comprised 20.6% of 2426 enrolled patients, were older (mean age 62.9 years versus 57.2 years), had higher prevalence of hypertension (81% versus 57%), diabetes (66% versus 44%), dyslipidemia (58% versus 46%), and obesity (44% versus 25%) compared with men, p less than 0.001. The PCI for ST-segment elevation myocardial infarction was indicated for fewer women than men (23% versus 33%; p=0.001). Prevalence of single or multi-vessel coronary artery disease was similar in women and men. More women than men had major bleeding during hospitalization (2.2% versus 0.6%; p=0.003) and at one year (2.5% versus 0.9%; p=0.007). There were no significant differences between women and men in mortality (3.1% versus 1.7%) or stent thrombosis (2.1% versus 1.8%) at 1 year.  Middle Eastern women undergoing PCI had worse baseline risk profile compared with men.Except for major bleeding, no gender differences in the incidence of major adverse cardiovascular events were demonstrated.
Growth in HIV-infected children on long-term antiretroviral therapy.

To describe growth in HIV-infected children on long-term antiretroviral therapy (ART) and to assess social, clinical, immunological and virological factors associated with suboptimal growth.



This observational cohort study included all HIV-infected children at an urban ART site in South Africa who were younger than 5 years at ART initiation and with more than 5 years of follow-up. Growth was assessed using weight-for-age Z-scores (WAZ), height-for-age Z-scores (HAZ) and body mass index (BMI)-for-age Z-scores (BAZ). Children were stratified according to pre-treatment anthropometry and age. Univariate and mixed linear analysis were used to determine associations between independent variables and weight and height outcomes.



The majority of the 159 children presented with advanced clinical disease (90%) and immunosuppression (89%). Before treatment underweight, stunting and wasting were common (WAZ<-2 = 50%, HAZ<-2 = 73%, BAZ<-2 = 19%). Weight and BMI improved during the initial 12 months, while height improved over the entire 5-year period. Height at study exit was significantly worse for children with growth impairment at ART initiation (P < 0.001), and infants (<1 year) demonstrated superior improvement in terms of BMI (P = 0.04). Tuberculosis was an independent risk factor for suboptimal weight (P = 0.01) and height (P = 0.02) improvement. Weight gain was also hindered by lack of electricity (P = 0.04). Immune reconstitution and virological suppression were not associated with being underweight or stunted at study endpoint.



Malnutrition was a major clinical concern for this cohort of HIV-infected children. Early ART initiation, tuberculosis co-infection management and nutritional interventions are crucial to ensure optimal growth in HIV-infected children.
Electroencephalographic abnormalities in borderline personality disorder

Epilepsy and non-localized brain dysfunction have been invoked, among others, as underlying factors in borderline personality disorder. We have recorded 58 electroencephalograms in 20 borderline patients, first after complete drug washout and then under carbamazepine or placebo double-blind treatment. Taking into account only definite abnormal tracings, we found a 40% incidence of abnormal diffuse slow activity. No patient disclosed focal or epileptiform EEG features. Carbamazepine did not appear to modify the electroencephalogram.
Endothelial fibrinolytic reactivity and the risk of deep venous thrombosis after spinal cord injury

Deep vein thrombosis (DVT) is a frequent event in patients with spinal cord injury, even with prophylactic anticoagulant therapy. Lower limb paralysis is a known major risk factor for venous thrombosis, supposedly due to the venostasis in relation with total immobility. The main goal of this study was to evaluate the endothelial response to anoxia to determine whether recovery of fibrinolytic potential occurs in patients subjected to forced bedrest because of a spinal cord injury and whether this recovery is related to the incidence and/or evolution of DVT. We evaluated vascular endothelium reactivity in the lower limbs no longer submitted to the hydrostatic pressure of the erected position in 15 patients with paraplegia or tetraplegia and in 10 normal volunteers after venous occlusion produced by the application of 10 cm Hg pressure to the lower limb for 15 min comparatively to the upper limb used as reference. Among the 15 patients, 10 whose spinal cord injury had occurred 1 to 6 months earlier were still receiving prophylactic anticoagulant therapy, whereas the five other patients were not receiving prophylactic anticoagulants because the injury dated back 6 months or more. After venostasis, tissue plasminogen activator (tPA) increased significantly in both patients and controls in the upper limb (tPA levels twofold and threefold respectively in controls and patients) but showed no significant changes in the lower limb; prolonged immobility did not allow recovery in the lower limbs of a level of fibrinolytic responsiveness identical to that in the upper limbs. The plasminogen activator inhibitor (PAI1) remained unchanged after anoxia, although wide interindividual variations were seen. Natural coagulation inhibitors and circulating blood stigmates of hypercoagulability were measured. None of the patients had abnormally low levels of coagulation inhibitors (ie, antithrombin III, protein C and protein S levels were normal). Seventy-five per cent of patients (prophylactically anticoagulated or not) had very high levels of fibrin degradation products (D. Dimer levels sevenfold to eightfold those of the controls), but all patients had normal levels of thrombin-antithrombin complexes and prothrombin fragments 1+2. The permanence of the thrombotic process characterized by an increase in D. Dimer levels without recovery of fibrinolytic potential suggests a proposal for the patients an indefinite antithrombotic treatment at curative doses.
Comparative Effects of Different Doses of Ribavirin Plus Interferon-α2b for Therapy of Chronic Hepatitis C: Results of a Controlled, Randomized Trial

Compared to either drug alone, therapy with the combination of ribavirin and interferon-α leads to improved rates of response in patients with chronic hepatitis C. Side effects often mandate downward dose adjustment or cessation of therapy, and the optimal dose of ribavirin has not been established. The aim of this study was to learn whether 600 mg ribavirin per day would prove as efficacious as 1000–1200 mg/day when combined with interferon (3 million units thrice weekly) for therapy of patients previously treated with standard interferon who had failed to respond or who had relapsed. We enrolled 69 patients with chronic hepatitis C and compensated liver disease: 45 were men, 65 were Caucasian, 48 were infected with genotype 1 hepatitis C virus. By random assignment, 35 received 600 mg ribavirin/day (group A), whereas the other 34 received 1000 mg (≤75 kg body wt) or 1200 mg/day (>75 kg body wt) (group B). At baseline, the two groups were well matched for demographic and laboratory features. In both groups, mean serum levels of alanine aminotransferase (ALT) and hepatitis C viral (HCV) RNA levels fell promptly and remained significantly lower than baseline throughout 24 weeks of therapy. There was no significant difference in mean levels of ALT or HCV RNA during therapy or at the end of follow-up (24 weeks after cessation of therapy). At the end of 24 weeks of posttherapy follow-up, 12 patients in each group had undetectable HCV RNA in serum, whereas 11 (31%) in group A and 9 (26.5%) in group B had normal serum ALT levels. The lower doses of ribavirin (group A) were tolerated better. %In conclusion, in previous nonresponders or relapsers to interferon done, combination therapy with interferon-α2b (3 MU thrice weekly) + 600 mg ribavirin/day is tolerated better and is as effective as interferon plus higher (standard) doses of ribavirin (1000–1200 mg/day).
European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.

The SOURCE XT Registry ( assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting.



Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath.



The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure.



The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality.



The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting.
[Treatment of lesions with a high risk of stenosis. Comparative study in 300 patients of rapamycin- and Paclitaxel-eluting polymer-based stents, and bare metal stents].

Rapamycin- and taxol-eluting stents have been shown to reduce restenosis, but there are no large-scale studies of their usefulness in lesions with a high risk of restenosis, or of the relative merits of the two devices. This prospective study compared their safety and efficacy in lesions with a high risk of restenosis.



We included consecutive patients with lesions to treat that met at least one of the following criteria: a) in-stent restenosis; b) diffuse (>20 mm) restenosis; c) small vessel (< or =2.5 mm) restenosis; or d) total occlusion. Patients received different devices along three consecutive study periods: bare metal (conventional) stents, sirolimus-eluting (rapamycin) stents and paclitaxel-eluting (taxol) stents.



One hundred patients in each group were included, for a total of 300 patients. In the sirolimus group, after 8.5+/-2 months of follow-up, there were 2 late thromboses (2%) and only 1 patient (1%) required target lesion revascularization. In the paclitaxel group 2 patients (2%) had in-hospital stent thrombosis (1 acute, 1 subacute), and after 9+/-2.5 months of follow-up only 1 patient (1%) needed target lesion revascularization. In the conventional group, after 8+/-2 months of follow-up, there was 1 subacute thrombosis (1%) and 15 patients (15%) had clinical restenosis requiring target lesion revascularization. Event-free survival curves were significantly better with drug-eluting stents (P<.01 vs conventional stents).



Rapamycin- and taxol-eluting stents were safe for lesions with a high risk of restenosis. These stents were associated with a lower rate of target lesion revascularization during follow-up compared to bare metal stents.