nils-herrmann/clean_scirepeval huggingface dataset:
Phase I study to determine the maximal tolerated dose and dose-limiting toxicities of orally administered idarubicin in dogs with lymphoma.

Idarubicin, a PO bioavailable anthracycline antibiotic-class chemotherapeutic, could have substantial convenience advantages over currently available similar class agents in use that require IV delivery.



The primary objective of this study was to determine the maximally tolerated dose (MTD), dose-limiting toxicities (DLTs), and basic pharmacokinetic parameters of oral idarubicin exposure in dogs with lymphoma after a single oral dose. A secondary objective was to document preliminary antitumor efficacy in an expanded treatment cohort using the established MTD.



Client-owned dogs with measurable lymphoma.



Dogs (n = 31) were enrolled in a prospective open label phase I study of oral idarubicin. By means of a 3 + 3 cohort design, dose escalations were made with 3 dogs per dose level, and the MTD was established based on the number of patients experiencing a DLT. Plasma concentrations of idarubicin and idarubicinol were determined by postdose sampling. Assessment of antitumor efficacy focused on evaluation of accessible, measurable lymph nodes and skin lesions by modified RECIST guidelines.



The MTD in dogs > 15 kg body weight was 22 mg/m(2) . Adverse hematologic events (neutropenia and thrombocytopenia) were the predominant DLT and generally correlated with higher plasma concentrations of idarubicin and idarubicinol.



PO administered idarubicin was generally well-tolerated and had preliminary antitumor activity in dogs with lymphoma. Furthermore, the potential clinical advantage of a safe and efficacious oral anthracycline alternative supports further investigations of this agent in repeated-dose, randomized clinical trials.
Computed tomography (CT) of the chest at less than 1 mSv: an ongoing prospective clinical trial of chest CT at submillisievert radiation doses with iterative model image reconstruction and iDose4 technique.

To assess lesion detection and diagnostic confidence of computed tomography (CT) of the chest performed at less than 1 mSv with 2 iterative reconstruction (IR) techniques.



Ten patients gave written informed consent for the acquisitions of images at submillisievert dose (0.9 mSv), in addition to clinical standard-dose (SD) chest CT (2.9 mSv). Submillisievert images were reconstructed with iDose and iterative model reconstruction (IMR). Two radiologists assessed lesion detection, margins, diagnostic confidence, and visibility of small structures. Objective noise and noise spectral density were measured.



Lesion detection was identical for standard-dose filtered back projection (FBP), submSv iDose, and submSv IMR. Lesion margins were better seen for 30% of detected lung lesions with submSv IMR compared to standard-dose FBP and submSv iDose (P < 0.05). Visibility of abdominal structures, and diagnostic confidence with submSv iDose and submSv IMR were similar to standard-dose FBP. There was 21% to 64% noise reduction with submSv IMR and 1% to 15% higher noise with iDose compared to standard-dose FBP (P < 0.0001).



Submillisievert IMR improves delineation of lesion margins compared to standard-dose FBP and submSv iDose.
An assessment of community pharmacists' responses to hypothetical medical emergency situations.

To investigate community pharmacists' proposed actions in hypothetical medical emergency situations in South-East Queensland, Australia.



A survey was posted to 151 Gold Coast and Toowoomba community pharmacies in October 2009. Pharmacists were asked to document their opinions regarding the pharmacist's role in medical emergencies and to respond to statements associated with two hypothetical medical emergency situations: an anaphylaxis and an asthma attack.



Forty-five pharmacists responded to the survey (29.8%). In response to a hypothetical situation involving an asthma attack, 41 pharmacists (91.1%) agreed that they would assist the asthmatic person to administer salbutamol through a spacer, with 28 pharmacists (62.2%) confident in treating an asthma attack in the pharmacy. In comparison, only 21 pharmacists (21/38; 55.3%) agreed to administer an adrenaline auto-injector (Epi-Pen) for a child experiencing an anaphylaxis, with nine respondents (9/38; 23.7%) indicating that they would ask the mother for directions in a situation where they were unsure how to administer it. There were comments questioning whether indemnity insurance covers pharmacists for medicine administration, and 12 pharmacists (12/38; 31.6%) indicated that if they were unsure about insurance cover they would ask the mother to administer the adrenaline.



Pharmacists' responses to administering medications in hypothetical medical emergencies were variable. The cause of this variation is multi-factorial and likely to include familiarity with the medication, its safety profile and uncertainty about the pharmacist's role and responsibilities in these situations. Further clarification, training and guidelines are needed in order to address this.
Hypertension as a Risk Factor for Haemorrhagic Stroke in Females.

To study the effect of hypertension as a risk factor for haemorrhagic stroke in women compared to men.



Confirmed cases of haemorrhagic stroke by Computed Tomography scan were included in this study. The participants underwent detailed clinical examination based on preset questionnaire. Relevant laboratory investigations were done in this group. 100 consecutive cases were studied comparing the baseline characteristics with male patients admitted with haemorrhagic stroke.



Among all the risk factors studied hypertension was the single most important risk factor causing intracerebral bleed. Forty seven point four percentage (47.4%) of females were hypertensive as against 61% in males. Blood pressure recording of females showed lower systolic and diastolic measurement compared to males and the difference was statistically significant with a p value of 0.000. Majority of the female patients were overweight with a significant difference in body mass index compared to males. (p value 0.006).



Hypertension is an important risk factor for intracerebral bleed. Females developed intracerebral bleed at a lower blood pressure measurement compared to males. Females require better control of hypertension than males to prevent intracerebral bleed.
Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain.

In a randomized controlled trial plus a nonrandomized cohort, the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in randomized and nonrandomized patients. In 2001, German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group. Persons who did not consent to randomization were included in a nonrandomized acupuncture group. All patients were allowed to receive routine medical care in addition to study treatment. Back function (Hannover Functional Ability Questionnaire), pain, and quality of life were assessed at baseline and after 3 and 6 months, and cost-effectiveness was analyzed. Of 11,630 patients (mean age=52.9 years (standard deviation, 13.7); 59% female), 1,549 were randomized to the acupuncture group and 1,544 to the control group; 8,537 were included in the nonrandomized acupuncture group. At 3 months, back function improved by 12.1 (standard error (SE), 0.4) to 74.5 (SE, 0.4) points in the acupuncture group and by 2.7 (SE, 0.4) to 65.1 (SE, 0.4) points among controls (difference=9.4 points (95% confidence interval 8.3, 10.5); p<0.001). Nonrandomized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in randomized patients. The incremental cost-effectiveness ratio was euro10,526 (euros) per quality-adjusted life year. Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective.
Predictors of Pulmonary Infarction

In the setting of acute pulmonary embolism (PE), pulmonary infarction is deemed to occur primarily in individuals with compromised cardiac function.The current study was undertaken to establish the prevalence of pulmonary infarction in patients with acute PE, and the relationship between infarction and: age, body height, body mass index (BMI), smoking habits, clot burden, and comorbidities.The authors studied prospectively 335 patients with acute PE diagnosed by computed tomographic angiography (CT) in 18 hospitals throughout central Italy. The diagnosis of pulmonary infarction on CT was based on Hampton and Castleman's criteria (cushion-like or hemispherical consolidation lying along the visceral pleura). Multivariable logistic regression was used to model the relationship between covariates and the probability of pulmonary infarction.The prevalence of pulmonary infarction was 31%. Patients with infarction were significantly younger and with significantly lower prevalence of cardiovascular disease than those without (P < 0.001). The frequency of infarction increased linearly with increasing height, and decreased with increasing BMI. In logistic regression, the covariates significantly associated with the probability of infarction were age, body height, BMI, and current smoking. The risk of infarction grew with age, peaked at approximately age 40, and decreased afterwards. Increasing body height and current smoking were significant amplifiers of the risk of infarction, whereas increasing BMI appeared to confer some protection.Our data indicate that pulmonary infarction occurs in nearly one-third of the patients with acute PE. Those with infarction are often young and otherwise healthy. Increasing body height and active smoking are predisposing risk factors.
Sex differences in clinical characteristics and prognosis in a broad spectrum of patients with heart failure: results of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) program.

We wished to test previous hypotheses that sex-related differences in mortality and morbidity may be due to differences in the cause of heart failure or in left ventricular ejection fraction (LVEF) by comparing fatal and nonfatal outcomes in women and men with heart failure and a broad spectrum of left ventricular ejection fraction.



We compared outcomes in 2400 women and 5199 men randomized in the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) program using multivariable regression analyses. A total of 1188 women (50%) had a low LVEF (< or = 0.40), and 1212 had a preserved LVEF (> 0.40). Among the men, 3388 (65%) had a low LVEF, and 1811 had a preserved LVEF. A total of 1216 women (51%) and 3465 men (67%) had an ischemic cause of their heart failure. All-cause mortality was 21.5% in women and 25.3% in men (adjusted hazard ratio [HR], 0.77; 95% CI, 0.69 to 0.86; P<0.001). Fewer women (30.4%) than men (33.3%) experienced cardiovascular death or heart failure hospitalization (adjusted HR, 0.83; 95% CI, 0.76 to 0.91; P<0.001). The risks of sudden death (HR, 0.70; 95% CI, 0.58 to 0.85) and death due to worsening heart failure (HR, 0.72; 95% CI, 0.58 to 0.89) were reduced to a comparable extent. The adjusted risk of cardiovascular hospitalization was also lower in women (HR, 0.88; 95% CI, 0.82 to 0.95), mainly because of a reduced risk of heart failure hospitalization (HR, 0.87; 95% CI, 0.78 to 0.97). Women had a lower risk of death irrespective of cause of heart failure or LVEF.



Among patients with heart failure, women have lower risks of most fatal and nonfatal outcomes that are not explained, as previously suggested, by LVEF or origin of the heart failure.
A comparison of the bronchodilator action of pseudoephedrine and ephedrine in patients with reversible airway obstruction

A double-blind randomised cross-over study was performed on 12 subjects suffering from reversible airway obstruction (asthma) to determine the relative bronchodilator effects of oral pseudoephedrine 60 mg, pseudoephedrine 180 mg, ephedrine 25 mg and matched placebo. Spirometry was used to measure vital capacity and forced expired volume in 1 s, and whole body plethysmography was used to measure specific airway conductance. Measurements were recorded before each drug was given, and 1 h and 2 h after each drug. Reversibility of the airway obstruction on each day of the study was demonstrated by significant improvements in all parameters of lung function in response to 400 µg of isoprenaline inhaled after the 2-h measurement. No significant bronchodilator effect could be shown following the ingestion of pseudoephedrine 60 mg or 180 mg. Only a week bronchodilator effect was demonstrated after ephedrine 25 mg in that the percentage change in vital capacity at 2 h after ephedrine was greater than that following either dose of pseudoephedrine or the placebo. It is concluded that oral pseudoephedrine in single doses of 60 mg or 180 mg has no significant bronchodilator action in man, and that a single dose of up to 180 mg pseudoephedrine does not cause tachycardia or hypertension.
Education and reported onset of symptoms among individuals with Alzheimer disease.

To examine whether reported age at onset of dementia symptoms among participants with Alzheimer disease (AD) is later for those with fewer years of education and, if so, to see if education is attributed to delayed detection of symptoms.



Case series.



National Alzheimer's Coordinating Center Minimum Data Set (N=21 880 participants) and Washington University Alzheimer's Disease Research Center (N=1449 participants).



Reported age at onset of dementia symptoms is slightly younger in participants with more education. Participants with fewer years of education show greater clinical severity of Alzheimer disease at first assessment.



Symptoms of Alzheimer disease are recognized later among those with less education.
Using an explicit guideline-based criterion and implicit review to assess antipsychotic dosing performance for schizophrenia.

Using structured implicit review as the gold standard, this study assessed the sensitivity and specificity of an explicit antipsychotic dose criterion derived from schizophrenia guidelines.



Two psychiatrists reviewed medical records and made consensus-structured implicit review ratings of the appropriateness of discharge antipsychotic dosages for hospitalized patients who participated in a schizophrenia outcomes study. Structured implicit review ratings were compared with the explicit criterion: whether antipsychotic dose was within the guideline-recommended range of 300-1000 chlorpromazine milligram equivalents (CPZE). In addition, reasons for deviation from guideline dose recommendations were examined.



A total of 66 patients hospitalized for acute schizophrenia at a Veterans Affairs medical center or state hospital in the southeastern US.



The sensitivity and specificity of the explicit dose criterion at hospital discharge were determined in comparison with the gold standard of structured implicit review.



At hospital discharge, 61% of patients (n = 40) were receiving doses within the guideline-recommended range. According to structured implicit review ratings, antipsychotic dose management was appropriate for 80% (n = 53) of patients. When the 300-1000 CPZE dose criterion (dosage within or outside the recommended range) was compared with structured implicit review, it demonstrated 84.6% sensitivity and 71.7% specificity for detecting inappropriate antipsychotic dose.



The explicit antipsychotic dose criterion may provide a useful and efficient screen to identify patients at significant risk for quality of care problems; however, the relatively low specificity suggests that the measure may not be appropriate for quality measurement programs that compare performance among health plans.
Predictive value of low relative lymphocyte count in patients hospitalized for heart failure with reduced ejection fraction: insights from the EVEREST trial.

Low lymphocyte count has been shown to be an independent prognostic marker in heart failure (HF) in the outpatient setting. Limited data exist regarding whether relative lymphocyte count correlates with postdischarge outcomes in patients hospitalized for HF.



We performed a post hoc analysis of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial, which randomized 4133 patients hospitalized for worsening HF with an ejection fraction ≤40% within 48 hours of admission to tolvaptan or placebo for a median follow-up of 9.9 months. The primary end points of all-cause mortality and cardiovascular mortality or HF hospitalization were analyzed in patients with available baseline complete blood counts (n=3717). Lymphocyte percentage was analyzed as a continuous variable. Times to events were compared using log-rank tests and multivariable Cox regression models. Patients with low lymphocyte percentage tended to be older and had higher rates of comorbid disease (diabetes mellitus, atrial fibrillation, and renal insufficiency). Low lymphocyte counts were associated with wide QRS duration, high natriuretic peptides, and low ejection fraction, blood pressure, and serum sodium. These patients were less likely to receive evidence-based HF medications. After adjusting for 22 known clinical risk factors, a 10% decrease in lymphocytes was associated with an increased hazard of all-cause mortality (adjusted hazard ratio 1.31 [95% CI: 1.14-1.150], P<0.001) and cardiovascular mortality or HF hospitalization (adjusted hazard ratio 1.14 [95% CI: 1.04-1.25], P=0.007) in the first 100 days postdischarge. Lymphopenia during hospitalization normalizes in majority of patients in the early postdischarge period.



Low relative lymphocyte count during hospitalization for HF is an independent predictor of poor outcomes in the early postdischarge period, beyond traditional prognostic indicators.
Compliance with a class teaching breast self examination.

As part of the evaluation of a class teaching breast self examination (BSE), a sample of women were interviewed shortly before they were invited to attend the class and again one year later. A comparable sample in a different "control" district were interviewed twice in the same way. The interviewers inquired about the practice of breast self examination (BSE) and about beliefs about breast cancer. The findings enable changes in behaviour and beliefs among those who attended and did not attend the class and among women in the control district during the same year to be compared. Women who attended the class showed a more pronounced improvement in BSE practice compared with non-attenders and with the control group. The improvement was in BSE technique rather than the frequency with which it was carried out.
Evaluate the Sensitivity and Specificity Echocardiography in Trans-Doppler and Tissue Doppler Method in the Estimation of Left Ventricular End-Diastolic Pressure

Non-invasive survey of left ventricular end-diastolic pressure (LVEDP) by transmitral Doppler echocardiography and tissue Doppler imaging carries important information about left ventricular diastolic function in chosen subsets of patients. This study is planned to assess whether mitral annular velocities (lateral annulus) as assessed by tissue Doppler imaging and transmitral Doppler echocardiography are associated with invasive measures of left ventricular end diastolic pressure and also the estimation of sensitivity and specificity of these methods.



One hundred ten consecutive patients admitted to cardiac catheterization underwent simultaneous Doppler interrogation measurements of left ventricular pressure were obtained with fluid-filled pressure. The E/Ea ratio associated well with LVEDP (P<0.005 r=0.4) and the correlation more marked in the patients with reduced contractile function. This correlation was independent of gender.



The E/Ea ration of <8 best discriminated elevated (LVEDP>12) from normal LVEDP with a sensitivity of 73.5% and specificity 57.8%, PPV and NPV were 75.75% and 55% respectively. Our study results also showed that quantitative estimation of LVEDP could be suggested by the equation of LVEDP=1.2 E/Ea+6.67 ± 8 mmHg P<0.005 B=0.4. Male-LVEDP=0.9 E/Ea + 7.78 ± 7.67 mmHg (r=0.4 Pa<0.005) EF ≥ 50 % -+LVEDP=1.48 E/Ea + 9.05 ± 5.23 (r=0.4 P<0.05) EF<50% -+LVEDP=0.76 E/Ea + 8.4 ± 2.3 (r=0.5 P<0.005)
Phase II trial of the histone deacetylase inhibitor romidepsin in patients with recurrent/metastatic head and neck cancer.

Patients with advanced squamous cell carcinoma of the head and neck (SCCHN) have limited treatment options. Inhibition of histone deacetylases (HDACs) represents a novel therapeutic approach warranting additional investigation in solid tumors.



A phase II trial of single agent romidepsin, an HDAC inhibitor, was performed in 14 patients with SCCHN who provided consent for pre- and post-therapy samples of accessible tumor, blood and uninvolved oral mucosa. Romidepsin was administered at 13 mg/m(2) as a 4-h intravenous infusion on days 1, 8 and 15 of 28 day cycles, with response assessment by RECIST every 8 weeks.



Objective responses were not observed, although 2 heavily pretreated patients had brief clinical disease stabilization. Observed toxicities were expected, including frequent severe fatigue. Immunohistochemical analysis of 7 pre- and post-treatment tumor pairs demonstrated induction of p21(Waf1/Cip1) characteristic of HDAC inhibition, as well as decreased Ki67 staining. Exploratory microarray analyses of mucosal and tumor samples detected changes in gene expression following romidepsin treatment that were most commonly associated with regulation of transcription, cell cycle control, signal transduction, and electron transport. Treatment with romidepsin did not alter the extent of DNA methylation of candidate gene loci (including CDH1 and hMLH1) in SCCHN tumors.



Single agent romidepsin has limited activity for the treatment of SCCHN but can effectively achieve tumor-associated HDAC inhibition. Although tolerability of romidepsin in this setting may be limiting, further evaluation of other HDAC inhibitors in combination with active therapies may be justified.
Risk of surgery and anesthesia for ischemic stroke.

The goal of this study was to determine if the combination of surgery and anesthesia is an independent risk factor for the development of incident (first-time) ischemic stroke.



All residents of Rochester, MN, with incident ischemic stroke from 1960 through 1984 (1,455 cases and 1,455 age- and gender-matched controls) were used to identify risk factors associated with ischemic stroke. Cases and controls undergoing surgery involving general anesthesia or central neuroaxis blockade before their stroke/index date of diagnosis were identified. A conditional logistic regression model was used to estimate the odds ratio of surgery and anesthesia for ischemic stroke while adjusting for other known risk factors.



There were 59 cases and 17 controls having surgery within 30 days before their stroke/index date. After adjusting for previously identified risk factors, surgery within 30 days before the stroke/index date (perioperative period) was found to be an independent risk factor for stroke (P<0.001; odds ratio, 3.9; 95% confidence interval, 2.1-7.4). In an analysis that excluded matched pairs where the case and/or control underwent surgery considered "high risk" for stroke (cardiac, neurologic, or vascular procedures), "non-high-risk surgery" was also found to be an independent risk factor for perioperative stroke (P = 0.002; odds ratio, 2.9; 95% confidence interval, 1.5-5.7).



Our results suggest that there is an increased risk of ischemic stroke in the 30 days after surgery and anesthesia. This risk remains elevated even after excluding surgeries (cardiac, neurologic, and vascular surgeries) considered to be high risk for ischemic stroke.