nils-herrmann/clean_scirepeval huggingface dataset:
A randomized trial comparing mitoxantrone with doxorubicin in patients with stage IV breast cancer

Mitoxantrone (Novantrone®; dihydroxyanthracenedione) is an anthraquinone previously shown to be active in human breast cancer. It appears to have less toxicity than doxorubicin. Results of this phase II–III randomized cross-over trial to determine the relative efficacy and toxicity of mitoxantrone in comparison to doxorubicin, are presented. Patients with measurable, recurrent breast cancer with limited prior chemotherapy with or without radiotherapy for metastatic disease, and who had not been exposed to prior doxorubicin, were randomized to receive either mitoxantrone or doxorubicin every three weeks with crossover on progression. Response rates, duration of remission, time to treatment failure, and drug toxicity, including cardiac toxicity evaluated with serial radionuclide angiocardiography, were evaluated. Differences in the response rates for the two groups were not statistically significant. Neither time to treatment failure nor duration of response are significantly different (p>0.05). With respect to toxicity, mitoxantrone treated patients consistently exhibited a lower incidence and less severe drug toxicity as compared to their doxorubicin-treated counterparts. Cardiac toxicity was carefully monitored and thus four patients on doxorubicin have had drug related congestive heart failure, as compared to none on mitoxantrone. In summary, mitoxantrone appears to be as active as doxorubicin in patients with stage IV breast cancer previously treated with chemotherapy; however, mitoxantrone causes significantly less nausea, vomiting, stomatitis and alopecia at doses which induce equal or greater myelosuppression than doxorubicin, and appears to be less cardiotoxic.
Prospective study of C-reactive protein, homocysteine, and plasma lipid levels as predictors of sudden cardiac death.

Sudden cardiac death (SCD) is an important cause of mortality even among apparently healthy populations. However, our ability to identify those at risk for SCD in the general population is poor, and more specific markers are needed.



To compare and contrast the relative importance of C-reactive protein (CRP), homocysteine, and lipids as long-term predictors of SCD, we performed a prospective, nested, case-control analysis involving 97 cases of SCD among apparently healthy men enrolled in the Physician's Health Study. Of these plasma markers measured, only baseline CRP levels were significantly associated with the risk of SCD over the ensuing 17 years of follow-up (P for trend=0.001). The increase in risk associated with CRP levels was primarily seen among men in the highest quartile, who were at a 2.78-fold increased risk of SCD (95% CI 1.35 to 5.72) compared with men in the lowest quartile. These results were not significantly altered in analyses that (in addition to the matching variables of age and smoking status) controlled for lipid parameters, homocysteine, and multiple cardiac risk factors (relative risk for highest versus lowest quartile 2.65, 95% CI 0.79 to 8.83; P for trend=0.03). In contrast to the positive relationship observed for CRP, neither homocysteine nor lipid levels were significantly associated with risk of SCD.



These prospective data suggest that CRP levels may be useful in identifying apparently healthy men who are at an increased long-term risk of SCD.
Increased risk of stroke after a herpes zoster attack: a population-based follow-up study.

Varicella zoster virus-induced vasculopathy and postherpes zoster attack stroke syndromes have been reported previously; nevertheless, data regarding the exact prevalence and risk of stroke occurring postherpes zoster attack are still lacking. This study aims to investigate the frequency and risk of stroke after a herpes zoster attack using a nationwide, population-based study of a retrospective cohort design. Method- A total of 7760 patients who had received treatment for herpes zoster between 1997 and 2001 were included and matched with 23 280 randomly selected subjects. A 1-year stroke-free survival rate was then estimated using the Kaplan-Meier method. After adjusting for potential confounders, Cox proportional hazard regressions were carried out to compute the adjusted 1-year survival rate.



Of the sampled patients, 439 patients (1.41%) developed strokes within the 1-year follow-up period, that is, 133 individuals (1.71% of the patients with herpes zoster) from the study cohort and 306 individuals (1.31% of patients in the comparison cohort) from the comparison cohort. The log rank test indicated that patients with herpes zoster had significantly lower 1-year stroke-free survival rates than the control (P<0.001). The adjusted hazard ratios of stroke after herpes zoster and herpes zoster ophthalmicus during the 1-year follow-up period were 1.31 and 4.28, respectively.



The risk for stroke increased after a zoster attack. Although varicella zoster virus vasculopathy is a well-documented complication that may induce a stroke postherpes zoster attack, it does not fully account for the unexpectedly high risk of stroke in these patients.
A Randomized, Controlled Study of Thymosin-α1 Therapy in Patients with Anti-HBe, HBV-DNA-Positive Chronic Hepatitis B

No consistently effective therapy is yet available for the treatment of chronic HBsAg, anti-HBe, HBV-DNA-positive hepatitis. A multicenter trial has shown that the response rates are not significantly different when patients with anti-HBe-positive hepatitis are treated with six-month course of thymosin-α1 or of interferon-α. However, since among these patients, interferon's real efficacy is still debated, with sustained biochemical response achieved in only a few of the treated patients, we conducted this controlled study to investigate the safety and efficacy of thymosin-α1 as compared with no treatment. Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-α1 at a dose of 900 μg/m2 twice a week for six months or no treatment. At entry, both groups of patients were comparable for sex, age, liver histology, ALT, IgM anti-HBc, and HBV-DNA levels. Forty-two patients were followed-up for 20 months (median; range 12–32 months) after completion of therapy: one dropped out, and one developed hepatocellular carcinoma at six months. Thymosin-α1 treatment had no side effects. Six months after the end of the therapy, HBV-DNA was negative and ALT had normalized in 14% of treated cases and in 4.5% of control group, while IgM anti-HBc was negative (<0.200) in 14% of the treated patients and in 4.5% of the controls. Among the treated patients, the median ALT levels stayed significantly lower compared to the pretreatment values during the treatment period and six months of follow-up. During the first year, there were six flares of hepatitis in the control group and five among the treated patients (P = NS), yielding a per year average of 0.3 and 0.23 flares per patient, respectively. Among the treated patients, median IgM anti-HBc levels were low with respect to baseline values 4–10 months after treatment started. None became HBsAg negative. In conclusion, these results indicate that, in anti-HBe, HBV-DNA-positive chronic hepatitis B, thymosin-α1 therapy alone does not increase the response rate, but may contribute to reduce the immune-mediated liver cell necrosis as indirectly assessed by ALT and IgM anti-HBc levels.
Antihypertensive effect of casein hydrolysate in a placebo-controlled study in subjects with high-normal blood pressure and mild hypertension.

We describe a clinical trial to study the efficacy of a casein hydrolysate, prepared using an Aspergillus oryzae protease, containing the major angiotensin-I-converting enzyme inhibitory peptides Val-Pro-Pro (VPP) and Ile-Pro-Pro (IPP) in a single-blind, placebo-controlled study. A total of 131 volunteers with high-normal blood pressure and mild hypertension were randomly divided into four groups (n 32 or 33 in each group). Each volunteer was given two tablets containing four different dosages of VPP and IPP (VPP+IPP: 0, 1.8, 2.5 and 3.6 mg), daily for 6 weeks. A significant decrease in systolic blood pressure was observed at 6 weeks in the active group receiving 1.8 mg (P<0.01) VPP and IPP; in the active groups receiving either 2.5 mg or 3.6 mg, systolic blood pressure was decreased at both 3 weeks (P<0.05 and P<0.05) and 6 weeks (P<0.001 and P<0.0001) compared with systolic blood pressure measured before treatment. Changes in the systolic blood pressure after 6 weeks of treatment in the four groups were --1.7, --6.3, --6.7 and --10.1 mmHg, and these effects were dose dependent. In addition, a significant difference in systolic blood pressure between the placebo group and the VPP and IPP group receiving 3.6 mg was observed (P<0.001) by two-way ANOVA. The antihypertensive effect was greater in mildly hypertensive subjects (n 20 or 21 in each group) than in any of the other subjects. No significant change of diastolic blood pressure was observed for all the test groups, and no differences in diastolic blood pressure in the test sample groups compared with the placebo group were observed during the test period.
The impact of high pressure vs low pressure stent implantation on intimal hyperplasia and follow-up lumen dimensions; results of a randomized trial.

Histology and retrospective clinical studies have indicated that the amount of neointimal hyperplasia is dependent on the arterial injury induced during stent implantation. This study analysed, prospectively, the impact of high vs low pressure stent implantation techniques using a second generation stent on intimal hyperplasia and follow-up lumen dimensions.



Post-intervention and follow-up (mean[+/-SD] 5.5+/-1.3 months) angiographic and intravascular ultrasound studies were performed on 120 Multi-Link HP stents randomized to implantation at either low (8-10 atm) or high (16-20 atm) pressure. Intravascular ultrasound measurements of the external elastic membrane, stent, and lumen cross-sectional area were performed at 1 mm axial increments. Peri-stent plaque+media cross-sectional area (external elastic membrane-stent cross-sectional area, intimal hyperplasia cross-sectional area (stent-lumen cross-sectional area at follow-up), intimal hyperplasia thickness and peri-stent tissue growth cross-sectional area (Deltapersistent plaque+media cross-sectional area) were calculated. Intravascular ultrasound demonstrated a larger minimal lumen cross-sectional area post-intervention in the high pressure group (7.3+/-2.0 vs 6.2+/-1.8 mm(2), P<0.001, high vs low pressure group, respectively). At follow-up, the mean intimal hyperplasia cross-sectional area (1.7+/-0.9 vs 1.5+/-0.8 mm(2), P=0.708), the mean intimal hyperplasia thickness (0.16+/-0.12 vs 0.16+/-0.12 mm, P=0.818) and peri-stent tissue proliferation cross-sectional area were not greater in the high pressure group. Thus, the minimal lumen cross-sectional area at follow-up continued to be greater (5.5+/-2.0 vs 4.7+/-1.7 mm(2), P=0.038) in the high pressure group.



High pressure stent implantation results in greater stent expansion even with the less rigid second generation Multi-Link stent. Larger lumen dimensions persist at follow-up, while intimal hyperplasia is not significantly greater after high pressure implantation compared to the low pressure technique.
Modulation of the cellular metabolism of cytarabine and fludarabine by granulocyte-colony-stimulating factor during therapy of acute myelogenous leukemia.

Previous in vitro investigations demonstrated that human leukemia cells, when incubated with hematopoietic growth factors such as granulocyte-colony-stimulating factor (G-CSF), augment the accumulation of the triphosphate 1-beta-D-arabinofuranosylcytosine (ara-C cytarabine). To test whether G-CSF infusion prior to ara-C infusion would biologically modulate the accumulation of ara-9-beta-D-arabinofuranosylcytosine 5'-triphosphate (ara-CTP) and other ara nucleotides in the leukemia blasts during therapy, protocols were designed to infuse G-CSF prior to fludarabine (9-beta-D-arabinofuranosyl-2-fluoroadenine monophosphate) and ara-C to increase the accumulation of the active triphosphates [9-beta-D-arabinofuranosyl-2-fluoroadenine 5'-triphosphate (F-ara-ATP) and ara-CTP] in acute myelogenous leukemia (AML) blasts during therapy. To complement these in vivo studies, ex vivo accumulation of ara-CTP was also investigated before and after G-CSF infusion. Patients (n = 5) treated on the fludarabine/ara-C/G-CSF regimen received a 30 mg/m2 dose of fludarabine followed by a 2 g/m2 dose of ara-C infused i.v. for 4 h. Beginning at 24 h, and every day, patients received a 6-h infusion of 400 microgram/m2 G-CSF. At 48 h, the fludarabine and ara-C couplet was repeated. Comparison of F-ara-ATP pharmacokinetics in circulating AML cells of patients on the fludarabine/ara- C/G-CSF regimen demonstrated that the area under concentration time curve (AUC) of F-ara-ATP increased significantly (median, 1.4-fold; range, 0.9-1.5; P = 0.045) after G-CSF infusion. This was due to an increased rate of F-ara-ATP accumulation by AML cells. The AUC of ara-CTP, on the other hand, was not affected (median, 1.0-fold; range, 1.0-1.2; P = 0.571) after G-CSF infusion. Because fludarabine potentiates the accumulation of ara-CTP, the effect of G-CSF on ara-CTP metabolism may not be evident in the AML blasts of patients on the fludarabine/ara-C/G-CSF regimen. To determine the effect of G-CSF when ara-C was infused alone, four additional patients were treated on a pilot protocol in which ara-C (2 g/m2) was infused on days 1 and 3 and G-CSF on day 2. The AUC of ara-CTP accumulation in these patients decreased by a median of 48% after G-CSF infusion. Consistent with these in vivo investigations, ex vivo ara-CTP accumulation was decreased in the AML blasts after G-CSF infusion. Based on these data it could be concluded that (a) infusion of G-CSF before fludarabine augmented the rate of F-ara-ATP synthesis in circulating AML blasts during therapy, suggesting that G-CSF may benefit fludarabine therapy by biological modulation; (b) G-CSF did not increase ara-CTP accumulation, rather it may have caused it to decrease; and (c) these data imply that when G-CSF and ara-C are used in combination, administration of fludarabine prior to ara-C may maintain the ara-CTP AUC.
Development and psychometric evaluation of a brief version of the hyperventilation questionnaire: the HVQ-B.

The fear of arousal sensations characterizes some anxiety disorders and is a core feature of an established risk factor for anxiety and related disorders (i.e. anxiety sensitivity; Taylor, 1999). Anxiety sensitivity (AS) refers to a fear of anxiety-related bodily sensations stemming from beliefs that these have catastrophic consequences. Interoceptive exposure (IE; repeated exposure to feared arousal sensations) has been shown to decrease AS. The 33-item Hyperventilation Questionnaire (HVQ; Rapee & Medoro, 1994) measures state levels of cognitive, affective, and somatic responses to IE and arousal induction exercises more generally. The aim of the present set of studies was to develop and evaluate a brief version of the HVQ, the HVQ-B, in order to facilitate its use in research and clinical settings. In Study 1, three existing data sets that used the long version of the HVQ were combined to select the items to be retained for the HVQ-B. In Study 2, the 18-item HVQ-B was administered and its psychometric properties were evaluated. In Study 3, a confirmatory factor analysis (CFA) was performed on the 18 items of the HVQ-B. The HVQ-B demonstrated excellent psychometric properties, and accounted for most of the variance of the questionnaire's longer version. CFA indicated a reasonably good fit of the three-factor measurement model. Finally, the HVQ-B was able to distinguish between responses to arousal induction exercises by high versus low AS participants. The HVQ-B is a useful tool to assess cognitive, affective, and somatic responsivity to arousal sensations in both research and practice.
Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading

Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd; n = 16) or to ALA withdrawal (n = 17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p < 0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p < 0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs.
Contrastive conversational analysis of language production by Alzheimer's and control people

Alzheimer's disease is characterized by memory disorders, although it affects also other cognitive functions (executive functions, attention, gnosia, praxia and language) and the communication ability. Our objective is to study verbal communication of people affected by the Alzheimer's disease at early to moderate stages. One particularity of our approach is that we are working in ecological conversational situations: people are interviewed by persons they know and in non-artificial environment. We propose a contrastive study of verbal productions of five people affected by the Alzheimer's disease and of five control people, both over 80 years old. To obtain quantitative and qualitative results, the oral corpora are transcribed and processed with the NLP methods and tools, and manually. Our results indicate that the Alzheimer's patients present lexical and semantic deficit and that their conversation is reduced comparing to the control people.
Current trend and risk factors for kidney stones in persons with spinal cord injury: a longitudinal study

A multi-center longitudinal study. To estimate the current trend in the incidence of first kidney stone among persons with spinal cord injury (SCI) and to delineate the potential contributing factors.Twenty-one Model SCI Care Systems throughout the United States. A longitudinal cohort of 8314 subjects enrolled in the National SCI Database between 1986 and 1999 was used to estimate and compare the incidence of first kidney stone with a previous report of 5850 SCI patients injured between 1973 and 1982. A Cox regression analysis was performed to identify risk factors for stones, including age, race, gender, severity of injury, and method of urinary drainage. These variables have been routinely collected, on a yearly basis, by the collaborating SCI centers. During the 12 years, 6 months of case ascertainment, 286 incident stone cases were documented. The risk was greatest during the first 3 months after injury (31 cases per 1000 person-years), quickly decreasing and leveling off later (eight cases per 1000 person-years). It was estimated that within 10 years after injury, 7% of persons with SCI would develop their first kidney stone. There was no evidence that the risk has changed over the past 25 years (P=0.96). During the first year post injury only, a significantly increased risk of stones was observed in Caucasians and persons aged 45 years or older. A positive association of the severity of injury and requiring instrumentation for bladder emptying with kidney stones was found after the first year post injury. The type of urinary drainage, including indwelling, intermittent, and condom catheterization, had no significant differential effect on stone formation at either risk period. The highest risk of kidney stones is within the first few months post injury. Little progress has been made in reducing this risk. Although inability to control bladder function is an important risk factor after the first year post injury, for those who need bladder management, the type of urinary drainage does not appear to be an important factor in determining risk.
Efficacy of different therapeutic regimens on hepatic osteodystrophy in chronic viral liver disease.

Metabolic bone disease is common in patients with chronic liver disease. Comparative studies on the efficacies of antiosteoporotic agents in hepatic osteodystrophy have not been conducted yet. The aim of this study was to evaluate the safety and efficacy of different therapeutic regimens on hepatic osteodystrophy.



Eighty-one patients (mean age 48.9 ± 10 years; 50 cases with chronic viral hepatitis and 31 patients with cirrhosis) were enrolled in the study. Treatment groups consisted of 61 patients who had reduced T scores in at least one region, selected randomly and treated for 1 year with vitamin D 400 IU, calcitonin 200 IU, alendronate 10 mg, alendronate 70 mg, or risedronate 5 mg. An untreated group consisting of 20 patients who had no reduction in T scores was followed up during the study period.



No significant adverse effects, including esophageal variceal hemorrhage, were detected. According to the T score at the end of the first year compared with baseline, significant improvements in bone mineral density were observed at all regions with alendronate 70 mg; improvements at the lumbar spine (LS) and distal radius regions with alendronate 10 mg; at the LS and distal radius regions with risedronate; at the LS region with calcitonin; and at the femoral neck region with vitamin D.



All therapeutic regimens seemed to be safe, and oral biphosphonates were the most effective in preventing both cortical and trabecular bone loss in patients with chronic viral liver disease. Larger studies with longer follow-up are warranted in hepatic osteodystrophy of chronic viral liver diseases.
Relation of carbohydrate antigen-125 to left atrial remodeling and its prognostic usefulness in patients with heart failure and preserved left ventricular ejection fraction in women.

Carbohydrate antigen-125 (CA-125) has recently been reported to correlate with the severity of systolic heart failure (HF). However, the association between this marker and HF with preserved ejection fraction (HFpEF) remains elusive. We studied 158 consecutive women with preserved ejection fraction, who were categorized into 3 groups: those with HF (HFpEF group, n = 35), those with ≥1 cardiovascular risk (at-risk group, n = 78), and 45 normal controls (n = 45). All subjects underwent echocardiography with serum N-terminal pro-brain type natriuretic peptide (NT-ProBNP), CA-125 level, and other tumor markers obtained. HFpEF group showed significantly greater baseline levels of CA-125 and NT-ProBNP than both normal and at-risk groups (p <0.05). In addition, the serum CA-125 level correlated with the maximum left atrial volume (r = 0.24, p = 0.002). During a mean follow-up of 828.1 days (interquartile range 38 to 1,504.5), those with CA-125 levels >17.29 U/ml had a greatest incidence of HF hospitalization (hazard ratio 6.2, p <0.01) and remained an independent prognosticator in the multivariate Cox models. CA-125 superimposed on NT-ProBNP successfully expanded the receiver operating characteristic curve further in predicting HF hospitalization (area under curve 0.72 to 0.82, c-statistic 0.0049). In conclusion, serum CA-125 might serve as a novel biomarker for HFpEF and predicting HF hospitalization in women.