nils-herrmann/clean_scirepeval huggingface dataset:
Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial.

Boceprevir (BOC) added to peginterferon alfa-2b (PegIFN) and ribavirin (RBV) significantly increases sustained virologic response (SVR) rates over PegIFN/RBV alone in previously untreated adults with chronic hepatitis C genotype 1. We evaluate the relationship of incident anemia with triple therapy. A total of 1,097 patients received a 4-week lead-in of PegIFN/RBV followed by: (1) placebo plus PegIFN/RBV for 44 weeks (PR48); (2) BOC plus PegIFN/RBV using response-guided therapy (BOC/RGT); and (3) BOC plus PegIFN/RBV for 44 weeks (BOC/PR48). The management of anemia (hemoglobin [Hb]<10 g/dL) included RBV dose reduction and/or erythropoietin (EPO) use. A total of 1,080 patients had ≥1 Hb measurement during treatment. The incidence of anemia was 50% in the BOC arms combined (363/726) and 31% in the PR48 arm (108/354, P<0.001). Among BOC recipients, lower baseline Hb and creatinine clearance were associated with incident anemia. In the BOC-containing arms, anemia was managed by the site investigators as follows: EPO without RBV dose reduction, 38%; RBV dose reduction without EPO, 8%; EPO with RBV dose reduction, 40%; and neither RBV dose reduction nor EPO, 14%. SVR rates were not significantly affected by management strategy (70%-74%), and overall patients with anemia had higher rates of SVR than those who did not develop anemia (58%). Serious and life-threatening adverse events (AEs) and discontinuations due to AEs among BOC-treated patients did not differ by EPO use.



With BOC/PR therapy, SVR rates in patients with incident anemia were higher than nonanemic patients and did not vary significantly according to the investigator-selected approach for anemia management. Prospective studies are needed to confirm this observation.
Prospective evaluation of alcohol consumption and the risk of breast cancer in BRCA1 and BRCA2 mutation carriers

Given the adverse effect of alcohol in the development of breast cancer among women in the general population, we evaluated whether a similar association exists among women with a BRCA1 or BRCA2 mutation. Information regarding baseline daily alcohol consumption was abstracted from a research questionnaire for 3067 BRCA mutation carriers enrolled in a prospective cohort study. Women were followed biennially until the date of the last follow-up questionnaire, date of breast cancer diagnosis, date of prophylactic bilateral mastectomy, or date of death. Cox proportional hazards models were used to estimate relative risks (RRs) and 95 % confidence intervals (CIs) for invasive breast cancer associated with alcohol consumed at or prior to completion of the baseline questionnaire. After a mean of 5.4 years of follow-up, we observed 259 incident cases of primary invasive breast cancer. Compared with non-users, the adjusted RRs were 1.06 (95 % CI 0.78–1.44) for ever use and 1.08 (0.79–1.47) for current alcohol use. For women in the highest versus lowest quintile of cumulative alcohol consumption, the RR was 0.94 (95 % CI 0.63–1.40; P trend = 0.65). Our findings suggest that alcohol consumption is not a risk factor for breast cancer among women with a BRCA1 or BRCA2 mutation.
Can pregabalin prevent paclitaxel-associated neuropathy?—An ACCRU pilot trial

Paclitaxel can cause an acute pain syndrome (P-APS), considered to be an acute form of neuropathy and chronic chemotherapy-induced peripheral neuropathy (CIPN). Anecdotal reports suggested that gabapentin may be helpful in the prevention of these toxicities. The purpose of this pilot study was to obtain data to support or refute the utility of pregabalin for the prevention of P-APS and CIPN. Patients scheduled to receive weekly paclitaxel (80 mg/m2/dose) were randomized 1:1 to receive pregabalin 75 mg or a placebo, twice daily, during the 12 weeks of chemotherapy. Patients completed the European Organization of Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20 questionnaire at baseline, prior to each dose of paclitaxel and monthly for 6 months post-treatment. Patients completed a post-paclitaxel questionnaire for 6 days after each dose of paclitaxel and an acute pain syndrome symptom questionnaire on day 8. The primary end point was to determine the effect of pregabalin on the maximum of the worst acute pain scores for the week following paclitaxel administration for cycle 1. Forty-six patients were randomly assigned to the treatment or placebo arm. There was no suggestion of a difference between the two study arms with regard to P-APS measures. While there was a suggestion that pregabalin decreased numbness, there was no suggestion that it decreased tingling, pain, or the EORTC QLQ-CIPN20 subscale scores. There were no evident toxicity differences between the two study arms. The results of this pilot trial do not support that pregabalin is helpful for preventing P-APS or paclitaxel-associated CIPN.
Evolution of infarct size during the early use of nifedipine in patients with acute myocardial infarction: the Norwegian Nifedipine Multicenter Trial.

In a multicenter double-blind study, 227 patients with suspected acute myocardial infarction (AMI) were randomized within 12 hr from onset of symptoms to treatment with nifedipine (112 patients) or placebo (115 patients). AMI was confirmed in 74 patients on nifedipine and in 83 on placebo. Patients with AMI received nifedipine 5.5 +/- 2.9 hr (mean +/- SD) after onset of symptoms. Infarct size was assessed by the release of creatine kinase isoenzyme MB (CK-MB). Infarct size index (CK-MB geq/m2) was 25 +/- 16 (n = 71) in the nifedipine group and 23 +/- 13 (n = 77) in the placebo group (NS). After the first 10 mg of nifedipine systolic blood pressure fell from 147 +/- 30 to 135 +/- 28 mm Hg (p less than .01) and heart rate rose from 75 +/- 18 to 79 +/- 19 beats/min (p less than .01). No change was observed after the first placebo dose. The treatment was continued for 6 weeks. Over this period there were 10 deaths in each group. Early treatment with nifedipine in patients with AMI does not seem to reduce infarct size as determined by enzyme level.
Phase I study of the anthrapyrazole biantrazole: clinical results and pharmacology

In a phase I study the anthrapyrazole biantrazole (Warner-Lambert Company) was given to 41 patients with tumour refractory to existing therapy. The drug was given i.v. weekly for 3 weeks, with a 3-week interval between courses. At the 1st week a full pharmacokinetic study was performed, and at weeks 2 and 3, blood samples were taken at 1 and 6 h following treatment to check for drug accumulation. Biantrazole pharmacokinetics were linear with respect to the AUC (r=0.924) over the full range of doses studied (4–36 mg/m2) but exhibited large inter-patient variations at each dose level. Elimination was triphasic, comprising two rapid early phases and a long terminal half-life (mean, 14.1±7.8 h). There was no evidence of drug accumulation over the 3-week treatment period. Approximately 12% of the parent drug was excreted unchanged in the urine together with two non-circulating, more water-soluble metabolites. Biantrazole was well tolerated but did cause moderate emesis at doses of >18 mg/m2 and mild alopecia. The dose-limiting side effect was leucopenia, with no other major toxicity being observed. One patient developed biventricular failure that was not clearly related to biantrazole administration. On the present schedule, the recommended dose of biantrazole is 24 mg/m2. No response were seen in this patient population.
The Edinburgh Postnatal Depression Scale: translation and antepartum validation for a Hungarian sample.

the Edinburgh Postnatal Depression Scale (EPDS) is an important screening instrument routinely used during the peripartum period for the identification of depression. The purpose of the study was to assess the validity of the 10-item EPDS in screening for antepartum depression (APD) in Hungary.



validation study carried out between July and December 2010.



Department of Obstetrics and Gynecology, University of Szeged, Hungary.



219 women attending a routine check-up at 12 weeks antepartum.



participants completed the newly translated Hungarian version of the EPDS and underwent a clinical assessment with the Structured Clinical Interview for DSM-IV disorders (SCID-I).



seven (3.2%) of the mothers were diagnosed with major antepartum depression and 15 persons (6.85%) with minor depression on the basis of the SCID. Internal consistency of the EPDS was satisfactory (Cronbach α coefficients ≥0.728). The best cut-off on the Hungarian version of the EPDS for major depression was 8/9, with a sensitivity of 71.4%, and a specificity of 91.5%. The area under the ROC curve was found significant for combined depression as well and at a cut-off of 6/7 indicated a sensitivity of 81.8% and a specificity of 83.2%.



the EPDS showed acceptable validity despite a considerable scatter in the total scores in our sample.



the EPDS is a reliable instrument for the screening of depressive disorders, especially major depressive disorder in early pregnancy among Hungarian women.
Infusion of autologous bone marrow mononuclear cells leads to transient reduction in proteinuria in treatment refractory patients with Idiopathic membranous nephropathy

The current treatment options for idiopathic membranous nephropathy (IMN) carry significant toxicity. In this prospective, observational pilot study, we used single time infusion of bone marrow derived autologous mononuclear cells (MNCs) in adult patients with treatment refractory IMN.



Twelve patients of biopsy proven IMN who had failed a cyclical 6-month regimen of steroid and cyclophosphamide were enrolled in the study. Bone-marrow was harvested from the iliac crest and underwent processing to isolate MNCs. Cells were counted and subjected to viability testing before being infused through a peripheral vein on the same day. After the infusion, subjects were followed up monthly for the next six months. Supportive treatment including angiotensin antagonists and statins was continued throughout the study period.



The proteinuria, serum albumin and creatinine values at entry were 2.97 ± 0.6 gm/1.73 m2/d, 2.27 ± 1.1 gm/l and 0.9 ± 0.8 mg/dl respectively. There was a reduction in proteinuria (p < 0.0001), and increase in serum albumin (p = 0.001) at 1 month, with 64% of the subjects showing >50% reduction in proteinuria. However, the response was ill sustained. At 6 months, only 2 patients had >50% reduction. Serum creatinine remained stable throughout the study period. No infusion related side effects were noted.



Autologous mononuclear cell infusion leads to transitory reduction in proteinuria and improvement in serum albumin in treatment refractory IMN. This effect, however, is transient. Whether this can be overcome by repeated infusion of cultured mesenchymal cells needs to be investigated.
Is Propranolol Safe and Effective for Outpatient Use for Infantile Hemangioma? A Prospective Study of 679 Cases From One Center in China.

The protocol for the treatment of infantile hemangioma with propranolol varies among different clinical centers.



Six hundred seventy-nine patients who were 1 to 12 months old were recruited in this prospective study to receive propranolol treatment. The response to the propranolol therapy was classified as 4 levels. The results were primarily evaluated using color Doppler ultrasound examinations before and after propranolol treatment.



The response was excellent in 176 (25.9%), good in 492 (72.5%), stable in 5 (0.7%), and poor in 6 (0.9%) of the patients. The mean age at the initiation of the therapy was 3.3 months (range, 1 to 10.9 months) and the mean duration of the therapy was 7.1 months (range, 3-17 months). The mean duration of the follow-up time after the discontinuation of the therapy was 5.3 months (range, 3-17 months). Regrowth of the hemangioma was observed in 92 cases (13.5%). Seventy-nine (11.6%) of the parents complained of their child's minor discomfort during the therapy.



Propranolol (2 mg/kg per day) may significantly reduce the size of a hemangioma. As an outpatient therapy, propranolol was found to be safe for Chinese children and to have minor side effects.
Is ankle involvement underestimated in rheumatoid arthritis? Results of a multicenter ultrasound study

The aim of this study is to investigate the prevalence of subclinical ankle involvement by ultrasound in patients with rheumatoid arthritis (RA). The study was conducted on 216 patients with RA and 200 healthy sex- and age-matched controls. Patients with no history or clinical evidence of ankle involvement underwent US examination. For each ankle, tibio-talar (TT) joint, tibialis anterior (TA) tendon, extensor halux (EH) and extensor common (EC) tendons, tibialis posterior (TP) tendon, flexor common (FC) tendon and flexor hallux (FH) tendon, peroneous brevis (PB) and longus (PL) tendons, Achilles tendon (AT) and plantar fascia (PF) were assessed. The following abnormalities were recorded: synovitis, tenosynovitis, bursitis, enthesopathy and rupture. BMI, DAS28, RF ESR and CRP were also obtained. A total of 432 ankles of patients with RA and 400 ankles of healthy controls were assessed. In 188 (87%) patients with RA, US showed ankle abnormalities whereas, in control group, US found abnormalities in 57 (28.5 %) subjects (p = 0.01). The most frequent US abnormality in RA patients was TP tenosynovits (69/216) (31.9 %), followed by PL tenosynovitis (58/216) (26.9 %), TT synovitis (54/216) (25 %), PB tenosynovitis (51/216) (23.6 %), AT enthesopathy (41/216) (19 %) and AT bursitis (22/216) (10.2 %). In 118 RA patients out of 216 (54.6%), a positive PD was found. No statistically significant correlation was found between the US findings and age, disease duration, BMI, DAS28, RF, ESR and CRP. The present study provides evidence of the higher prevalence of subclinical ankle involvement in RA patients than in age- and gender-matched healthy controls identified by US.
Inflammatory cytokines in chronic heart failure: interleukin-8 is associated with adverse outcome. Results from CORONA.

We investigated the ability of prototypical inflammatory cytokines to predict clinical outcomes in a large population of patients with chronic systolic heart failure (HF).



Serum levels of tumour necrosis factor-α (TNF-α), soluble TNF receptors type I and II (sTNF-RI and sTNF-RII), and the chemokines monocyte chemoattractant protein-1 (MCP-1) and interleukin-8 (IL-8) were analysed in 1464 patients with chronic ischaemic systolic HF in the CORONA study, aged ≥ 60 years, in NYHA class II-IV, and related to the primary endpoint (n = 320), as well as any coronary event (n = 255), all-cause mortality (n = 329), cardiovascular (CV) mortality (n = 268), and the composite endpoint hospitalization from worsening heart failure (WHF) or CV mortality (n = 547). TNF-α, sTNF-RI, sTNF-RII, and IL-8, but not MCP-1, were independent predictors of all endpoints except the coronary endpoint in multivariable models including conventional clinical variables. After further adjustment for estimated glomerular filtration rate, the ApoB/ApoA-1 ratio, NT-proBNP, and high-sensitivity C-reactive protein, only IL-8 remained a significant predictor of all endpoints (except the coronary endpoint), while sTNF- RI remained independently associated with CV mortality. Adding IL-8 to the full model led to a significant improvement in net reclassification for all-cause mortality and CV hospitalization, but only a borderline significant improvement for the primary endpoint, CV mortality, and the composite endpoint WHF hospitalization or CV mortality.



Our study supports a relationship between IL-8 and outcomes in patients with chronic HF. However, the clinical usefulness of IL-8 as a biomarker in an unselected HF population is at present unclear.
Digital high frame rate stress echocardiography for detection of coronary artery stenosis by high dose dipyridamole stress testing

Diagnostic accuracy of high dose dipyridamole stress echocardiography (0.84 mg i.v./kg) for detecting coronary artery stenosis was assessed in 94 patients undergoing coronary angiography, and adverse effects were registered in the total study population of 120 patients. Echocardiographic analysis was performed with digital systolic cineloops with high frame-rate (47 frames/sec) for optimal left ventricular wall motion display. Results showed sensitivity of 73% for detection of arterial luminal stenosis ≥ 75% or retrograde collateral flow to an occluded coronary artery. Sensitivity for detection of 1-vessel stenosis was 43% (6 of 14 patients), and for 2- and 3-vessel disease 79% (19 of 24) and 88% (16 of 18), respectively. Specificity was 92% (35 of 38), diagnostic accuracy 81%. The stenosed coronary artery was correctly localized in 85% of positive tests. Dipyridamole-induced increase in wall motion score index differed significantly between patients with 1-, 2-, and 3-vessel disease (0.02 ± 0.17, 0.15 ± 0.17, and 0.27 ± 0.24, respectively), and early positive tests (dipyridamole dose of 0.56 mg/kg) were almost exclusively seen in patients with multivessel disease. Six patients (5%) developed symptomatic bradycardia and hypotension during the test. In conclusion, dipyridamole stress echocardiography is useful for detection and localization of coronary artery stenosis, particularly in patients with multivessel disease.
Evaluating the validity of computerized content analysis programs for identification of emotional expression in cancer narratives.

Psychological interventions provide linguistic data that are particularly useful for testing mechanisms of action and improving intervention methodologies. For this study, emotional expression in an Internet-based intervention for women with breast cancer (n = 63) was analyzed via rater coding and 2 computerized coding methods (Linguistic Inquiry and Word Count [LIWC] and Psychiatric Content Analysis and Diagnosis [). Although the computerized coding methods captured most of the emotion identified by raters (LIWC sensitivity = .88; PCAD sensitivity = .83), both over-identified emotional expression (LIWC positive predictive value = .31; PCAD positive predictive value = .19). Correlational analyses suggested better convergent and discriminant validity for LIWC. The results highlight previously unrecognized deficiencies in commonly used computerized content-analysis programs and suggest potential modifications to both programs that could improve overall accuracy of automated identification of emotional expression. Although the authors recognize these limitations, they conclude that LIWC is superior to PCAD for rapid identification of emotional expression in text.
Phase II study of the antiretroviral activity and safety of the glucocorticoid receptor antagonist mifepristone in HIV-1-infected patients.

Preclinical studies have shown that the anti-glucocorticoid drug mifepristone effectively inhibits HIV replication both in vitro and in vivo. However, the drug did not demonstrate anti-HIV activity in a previous phase I/II study when administered at the daily dose of 75-225 mg. The aim of this study was to assess whether mifepristone may exert antiretroviral activity or influence immunological parameters when administered orally at daily doses of 150 or 300 mg in highly active antiretroviral therapy (HAART)-naïve HIV-infected patients. We performed an open label non-randomized phase II study that included 26 patients who underwent 28 days of once daily oral administration of 150 (12 subjects) or 300 mg (14 subjects) of mifepristone. A total of 3 patients dropped out of the study, respectively 1 in the 150 mg dose group and 2 in the 300 mg dose group. The main hemato-chemical alterations reported were hypokalemia and increase in the blood levels of cortisol, especially in those patients that received mifepristone at the dose of 300 mg/day. Although we observed a trend of reduced viral load along the study in both groups, statistical significance was not achieved for either the primary nor the secondary endpoints. In summary, mifepristone treatment was well-tolerated but it failed to significantly influence viro-immunological parameters in HAART-naïve HIV-infected patients.
SPET brain imaging with 201 diethyldithiocarbamate in acute ischaemic stroke

Thirty-five patients with acute ischaemic stroke were studied within 24 h after hospital admission with thallium 201 diethyldithiocarbamate single photon emission tomography (201TI-DDC SPET) and X-ray computed tomography (CT).201TI-DDC is a non-redistributing agent that allows postponed imaging after early administration and early therapeutic intervention. In 16 patients both investigations were performed within 24 h after stroke onset. The sensitivity of SPET was 94% and of CT 81 % in the first 24 h, when hypodensity and obliteration of sulci were used as CT reading criteria. When only hypodensity was used as a criterion, the sensitivity of CT was 50% in this group. Sensitivity of CT compared with SPET became increasingly better in patients with older infarcts (1–18 days). In two-thirds of patients, the lesion demonstrated on SPET was larger than that on CT, and this was especially so with older infarcts. Crossed cerebellar diaschisis occurred in 69% of patients. The high sensitivity of201TI-DDC SPET in the first 24 h after ischaemic stroke and the favourable properties of this radiopharmaceutical make it a method of interest in the assessment of initial perfusion defects in early experimental stroke therapies.
Higher latitude is significantly associated with an earlier age of disease onset in multiple sclerosis.

Age at onset (AAO) in multiple sclerosis (MS) is an important marker of disease severity and may have prognostic significance. Understanding what factors can influence AAO may shed light on the aetiology of this complex disease, and have applications in the diagnostic process.



The study cohort of 22 162 eligible patients from 21 countries was extracted from the MSBase registry. Only patients with MS aged ≥16 years were included. To reduce heterogeneity, only centres of largely European descent were included for analysis. AAO was defined as the year of the first symptom suggestive of inflammatory central nervous system demyelination. Predictors of AAO were evaluated by linear regression.



Compared with those living in lower latitudes (19.0-39.9°), onset of symptoms was 1.9 years earlier for those at higher latitudes (50.0-56.0°) (p=3.83×10-23). A reciprocal relationship was seen for ambient ultraviolet radiation (UVR), with a significantly increasing AAO for patients with MS per each quartile increment of ambient UVR (p=1.56×10-17). We found that the AAO of female patients was ∼5 months earlier than male patients (p=0.002). AAO of progressive-onset patients with MS were ∼9 years later than relapsing-onset patients (p=1.40×10-265).



An earlier AAO in higher latitude regions was found in this worldwide European-descent cohort and correlated inversely with variation in latitudinal UVR. These results suggest that environmental factors which act at the population level may significantly influence disease severity characteristics in genetically susceptible populations.