nils-herrmann/clean_scirepeval huggingface dataset:
A scoring system for predicting significant fibrosis in chronic hepatitis B patients with normal or mildly elevated alanine aminotransferase levels.

We aimed to develop a clinically useful scoring system to predict the probability of significant fibrosis (the Scheuer score ≥S2) in patients with chronic hepatitis B infection (CHB) and alanine aminotransferase (ALT) levels 2-fold lower than the upper limit of normal (ULN), in order to facilitate the clinical decision to perform a subsequent liver biopsy.



Consecutive subjects who underwent percutaneous liver biopsy were examined. The predictors evaluated included demographic, clinical, and laboratory variables. A clinical scoring system was developed by rounding the estimated regression coefficients for the independent predictors in multivariate logistic models for the diagnosis of significant fibrosis.



A total of 283 patients with ALT levels 2-fold lower than the ULN were divided into 2 groups to develop (n=190) and validate (n=93) the scoring system. Of the 190 subjects examined, 52 (27.4%) had significant fibrosis. Aspartate transferase levels, platelet counts, and hepatitis B surface antigen levels were independently associated with significant liver fibrosis. A fibrosis clinical scoring system comprising these 3 variables in CHB patients with ALT levels 2-fold lower than the ULN was developed to predict the probability of significant fibrosis in 4 categories (low, intermediate, high, and very high risk).



The proposed fibrosis scoring system predicted the probability of significant fibrosis in CHB patients with ALT levels 2-fold lower than the ULN with sufficient accuracy. It identified individuals with a very high risk for significant fibrosis in whom liver biopsy would most likely yield a diagnostic benefit. It also identified individuals with a low risk of moderate fibrosis in whom a liver biopsy can be delayed or avoided.
Validation of the European Organization for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases.

There is a lack of valid patient-reported outcome (PRO) measures for hepatectomy or palliative treatment of colorectal hepatic metastases. This study examined the validity and reliability of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire liver module (QLQ-LMC21) in patients with liver metastases from colorectal cancer.



Some 356 patients completed the core questionnaire (QLQ-C30), QLQ-LMC21 and a debriefing questionnaire before and 3 months after hepatectomy or palliative treatment. Construct, criterion and clinical validity were evaluated before and after treatment.



Questionnaire compliance was high; less than 1 per cent of data were missing from individual items. Modifications to the hypothesized scale structure produced four scales and nine single items with good reliability, clinical, criterion and construct validity. The QLQ-LMC21 distinguished between patients selected for surgery or palliative treatment in nine of these 13. Significant changes in PROs were observed before and after treatment. The new module discriminated between clinically distinct groups of patients and measured aspects of quality of life not covered in the core questionnaire.



The EORTC QLQ-LMC21 is a valid and reliable questionnaire module to use with the QLQ-C30 in assessing PROs in hepatectomy or palliative treatment for colorectal liver metastases.
Motesanib with or without panitumumab plus FOLFIRI or FOLFOX for the treatment of metastatic colorectal cancer

This study assessed the safety, efficacy, and pharmacokinetics of motesanib, a multitargeted small molecule angiogenesis inhibitor, with and without panitumumab, in combination with FOLFIRI or FOLFOX in patients with metastatic colorectal cancer (mCRC). This open-label, phase 1b, two-part, multicenter study in patients with mCRC and ≤1 prior treatment evaluated escalating doses (50, 75, 100, or 125 mg QD, 75 mg BID) of motesanib with panitumumab and chemotherapy (Part 1) and the target dose of motesanib with chemotherapy (Part 2). At 17 sites in the USA and Australia, 119 patients were enrolled between December 2004 and February 2010. In Part 1 [motesanib plus panitumumab/FOLFIRI (n = 36) or plus panitumumab/FOLFOX (n = 17)], all motesanib doses tested were tolerated and 125 mg QD was deemed the target dose. Following toxicity results for combination therapy in other trials, panitumumab was withdrawn from the study. Part 2 evaluated motesanib 125 mg with chemotherapy [FOLFIRI (n = 37); FOLFOX (n = 29)]. The primary endpoint, objective response rate in patients with measurable disease by RECIST, was 20 % overall and was higher among patients receiving first-line (27 % overall; FOLFOX, 24 %; FOLFIRI, 27 %) compared with second-line therapy (14 % overall; FOLFOX, 0 %; FOLFIRI, 20 %). The most common adverse events were diarrhea, nausea, fatigue, and hypertension. We observed a low rate of cholecystitis [3 of 119 (2.5 %)], a known adverse event of motesanib and other small molecule VEGF inhibitors. Motesanib 125 mg QD in combination with FOLFIRI or FOLFOX chemotherapy was tolerated and demonstrated modest efficacy in first-/second-line mCRC.
Differences in drug prescribing patterns in elderly parkinsonian patients identified at hospital admission.

In the period July 1984 to June 1993 a total of 4541 admissions to a Department of Medicine for the Elderly were investigated. Approximately 9% of the total were diagnosed to have parkinsonism. Full drug histories together with the available demographic and clinical data were investigated in order to identify differences in the prescribing patterns in this group compared to those of non–parkinsonian patients admitted during this time frame. There was a statistically significant lower incidence among the parkinsonian group for the prescribing of all cardiovascular drug groups, anticoagulants, hypoglycaemics, bronchodilators, and corticosteroids compared with non–parkinsonian patients. In contrast, the incidence of hypnotics, laxatives, antidepressants and antipsychotics were significantly higher.
Pharmacoeconomic benefit of antibiotic step-down therapy: converting patients from intravenous ceftriaxone to oral cefpodoxime proxetil.

To evaluate the economic benefit associated with the early conversion of therapy from intravenous ceftiaxone to the comparable oral third-generation cephalosporin, cefpodoxime proxetil.



Open-label, unblind, nonrandomized clinical trial.



A 360-bed Veterans Affairs Medical Center.



Forty patients who began receiving intravenous ceftriaxone for either a community-acquired pneumonia or a complicated urinary tract infection.



twenty patients were selected, based on clinical assessment, to be converted from intravenous ceftriaxone to oral cefpodoxime proxetil. Twenty other comparable patients who would have been appropriate for step-down therapy, did not receive pharmacy intervention and were used as a control group.



Both groups were assessed and compared for length of ceftiaxone therapy, length of oral follow-up therapy (if any), length of hospitalization, results of culture and sensitivity testing, treatment success and readmissions, and cost of respective therapeutic regimens.



In the cefpodoxime study group, the average time receiving intravenous and oral antibiotics was 9.1 days at a total cost of $3040.26 for the 20 patients. In the control group, the average time receiving intravenous and oral antibiotics was 11.9 days at a total cost of $3961.26. A savings of $46.05 per patient was achieved. Patients receiving step-down therapy averaged 1 fewer day of hospitalization.



Pharmacist intervention and cefpodoxime step-down therapy were associated with decreased overall antibiotic costs in our intravenous-to-oral program.
Chronic cough and esomeprazole: a double-blind placebo-controlled parallel study.

Gastro-oesophageal reflux has been implicated in the pathogenesis of chronic cough. Guidelines on management suggest a therapeutic trial of anti-reflux medication. Esomeprazole is a proton pump inhibitor licensed for the long-term treatment of acid reflux in adults and we compared the effects of esomeprazole and placebo on patients with chronic cough.



This was a prospective, single-centre, randomized, double-blind, placebo-controlled, parallel group study conducted over 8weeks. Fifty adult non-smokers with chronic cough and normal spirometry were randomized. Patients completed cough-related quality-of-life and symptom questionnaires and subjective scores of cough frequency and severity at the beginning and end of the study. They also kept a daily diary of symptom scores. Citric acid cough challenge and laryngoscopic examination were performed at baseline and the end of the study. The primary outcome was improvement in cough score.



There were no differences in cough scores in the placebo and treatment arms of the study although some significant improvements were noted when compared to baseline. In the cough diary scores there was a trend towards greater improvement in the treatment arm in patients with dyspepsia.



Esomeprazole did not have a clinically important effect greater than placebo in patients with cough. It suggests a marked placebo effect in the treatment of cough.
An actuarial model of violence risk assessment for persons with mental disorders.

An actuarial model was developed in the MacArthur Violence Risk Assessment Study to predict violence in the community among patients who have recently been discharged from psychiatric facilities. This model, called the multiple iterative classification tree (ICT) model, showed considerable accuracy in predicting violence in the construction sample. The purpose of the study reported here was to determine the validity of the multiple ICT model in distinguishing between patients with high and low risk of violence in the community when applied to a new sample of individuals.



Software incorporating the multiple ICT model was administered with independent samples of acutely hospitalized civil patients. Patients who were classified as having a high or a low risk of violence were followed in the community for 20 weeks after discharge. Violence included any battery with physical injury, use of a weapon, threats made with a weapon in hand, and sexual assault.



Expected rates of violence in the low- and high-risk groups were 1 percent and 64 percent, respectively. Observed rates of violence in the low- and high-risk groups were 9 percent and 35 percent, respectively, when a strict definition of violence was used, and 9 percent and 49 percent, respectively, when a slightly more inclusive definition of violence was used. These findings may reflect the "shrinkage" expected in moving from construction to validation samples.



The multiple ICT model may be helpful to clinicians who are faced with making decisions about discharge planning for acutely hospitalized civil patients.
Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone

Studies of the transplantation of autologous bone marrow cells (BMCs) in patients with chronic ischemic heart disease have assessed effects on viable, peri-infarct tissue. We conducted a single-blinded, randomized, controlled study to investigate whether intramuscular or intracoronary administration of BMCs into nonviable scarred myocardium during CABG improves contractile function of scar segments compared with CABG alone. Elective CABG patients (n = 63), with established myocardial scars diagnosed as akinetic or dyskinetic segments by dobutamine stress echocardiography and confirmed at surgery, were randomly assigned CABG alone (control) or CABG with intramuscular or intracoronary administration of BMCs. The BMCs, which were obtained at the time of surgery, were injected into the mid-depth of the scar in the intramuscular group or via the graft conduit supplying the scar in the intracoronary group. Contractile function was assessed in scar segments by dobutamine stress echocardiography before and 6 months after treatment. The proportion of patients showing improved wall motion in at least one scar segment after BMC treatment was not different to that observed in the control group (P = 0.092). Quantitatively, systolic fractional thickening in scar segments did not improve with BMC administration. Furthermore, BMCs did not improve scar transmurality, infarct volume, left ventricular volume, or ejection fraction. Injection of autologous BMCs directly into the scar or into the artery supplying the scar is safe but does not improve contractility of nonviable scarred myocardium, reduce scar size, or improve left ventricular function more than CABG alone.
Specificity of the antibody response to the pneumococcal polysaccharide and conjugate vaccines in human immunodeficiency virus-infected adults.

Nonspecific antibodies, which are thought to be nonprotective, have been shown to contribute a substantial proportion of the measured concentration in the standardized immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) for pneumococcal polysaccharide capsular antibodies. The presence of such antibodies in human immunodeficiency virus (HIV)-infected persons has not been evaluated. The amount of nonspecific antibodies is proportional to the reduction in IgG antibody concentration that occurs with serum absorption with the heterologous polysaccharide 22F. We measured the amount of nonspecific antibodies before and after vaccination with the pneumococcal conjugate vaccine (PCV; n = 33) or the pneumococcal polysaccharide vaccine (PPV; n = 34) in HIV-infected adults with CD4 counts of >/== 200 cells/mm3. Blood was drawn before and 2 months after vaccination. For prevaccination sera, we found a substantial amount of nonspecific antibodies for serotypes 4, 6B, 9V, and 23F (23 to 47% of measured IgG concentration), but not for serotype 14. There tended to be proportionately less nonspecific antibodies in postvaccine sera than prevaccine sera for PCV, but not for PPV. Subjects with a low HIV viral load (</= 400 copies/ml) had proportionately more nonspecific antibodies than those with higher viral load before and after both vaccines. After 22F absorption, the geometric mean concentrations of antibodies were significantly higher post-PCV than post-PPV for the high viral load group for all five serotypes, but for no serotypes in the low viral load group. These findings confirm that absorption with a heterologous pneumococcal polysaccharide (e.g., 22F) is necessary to remove nonspecific antibodies in a standardized IgG ELISA for pneumococcal capsular antibodies in HIV-infected adults.
Aripiprazole monotherapy in patients with rapid-cycling bipolar I disorder: an analysis from a long-term, double-blind, placebo-controlled study

Rapid-cycling bipolar disorder is difficult to treat and associated with greater morbidity than non-rapid-cycling disease. This post hoc analysis evaluated 28 patients with rapid-cycling bipolar I disorder from a 100-week, double-blind, placebo-controlled study assessing long-term efficacy, safety and tolerability of aripiprazole in patients with bipolar I disorder (most recently manic/mixed).



Following >or= 6 consecutive weeks' stabilisation with open-label aripiprazole, patients were randomised (1 : 1) to aripiprazole or placebo. Patients completing 26 weeks treatment without relapse could continue for a further 74 weeks. Primary end-point was time to relapse for manic, mixed or depressive symptoms, defined as discontinuation due to lack of efficacy. Safety assessments included adverse event (AE) monitoring and changes in weight and lipid, glucose and prolactin levels.



Of the 28 patients (aripiprazole, n = 14; placebo, n = 14) with rapid-cycling bipolar disorder, 12 (aripiprazole, n = 7; placebo, n = 5) completed the initial 26-week treatment period and three (all aripiprazole treated) completed the 100-week, double-blind period. Time to relapse was significantly longer with aripiprazole vs. placebo at week 26 [log-rank p = 0.033; 26-week hazard ratio = 0.21 (95% CI: 0.04, 1.03)] and week 100 [log-rank p = 0.017; 100-week hazard ratio = 0.18 (95% CI: 0.04, 0.88)]. The most commonly reported AEs with aripiprazole during the 100 weeks (>or= 10% incidence and twice placebo) were anxiety (n = 4), sinusitis (n = 4), depression (n = 3) and upper respiratory infection (n = 3). One aripiprazole-treated patient discontinued due to an AE (akathisia). There were no significant between-group differences in mean changes in weight or metabolic parameters.



In this small, post hoc subanalysis, aripiprazole maintained efficacy and was generally well tolerated in the long-term treatment of rapid-cycling bipolar disorder. Further research with prospectively designed and adequately powered trials is warranted.
Impact of diabetes on the risk stratification using stress single-photon emission computed tomography myocardial perfusion imaging in patients with symptoms suggestive of coronary artery disease.

Coronary artery disease can develop prematurely and is the leading cause of death among diabetics, making noninvasive risk stratification desirable.



Patients with symptoms of coronary artery disease who were undergoing stress myocardial perfusion imaging (MPI) from 5 centers were prospectively followed (2.5+/-1.5 years) for the subsequent occurrence of cardiac death, myocardial infarction (MI), and revascularization. Stress MPI results were categorized as normal or abnormal (fixed or ischemic defects and 1, 2, or 3 vessel distribution). Of 4755 patients, 929 (19.5%) were diabetic. Patients with diabetes, despite an increased revascularization rate, had 80 cardiac events (8.6%; 39 deaths and 41 MIs) compared with 172 cardiac events (4.5%; 69 deaths and 103 MIs) in the nondiabetic cohort (P<0.0001). Abnormal stress MPI was an independent predictor of cardiac death and MI in both populations. Diabetics with ischemic defects had an increased number of cardiac events (P<0.001), with the highest MI rates (17.1%) observed with 3-vessel ischemia. Similarly, a multivessel fixed defect was associated with the highest rate of cardiac death (13.6%) among diabetics. The unadjusted cardiac survival rate was lower for diabetic patients (91% versus 97%, P<0.001), but it became comparable once adjusted for the pretest clinical risk and stress MPI results. In multivariable Cox analysis, both ischemic and fixed MPI defects independently predicted cardiac death alone or cardiac death/MI. Diabetic women had the worst outcome for any given extent of myocardial ischemia.



In this large cohort of diabetics undergoing stress MPI, the presence and the extent of abnormal stress MPI independently predicted subsequent cardiac events. Using stress MPI in conjunction with clinical information can provide risk stratification of diabetic patients.
Realising the potential of the family history in risk assessment and primary prevention of coronary heart disease in primary care: ADDFAM study protocol

Coronary heart disease (CHD) is the leading cause of death in the developed world, and its prevention a core activity in current UK general practice. Currently, family history is not systematically integrated into cardiovascular risk assessment in the UK, Europe or the US. Further, primary health care professionals' lack the confidence to interpret family history information and there is a low level of recording of family history information in General Practice (GP) records. Primary prevention of CHD through lifestyle advice has sometimes yielded modest results although, for example, behavioural interventions targeted at "at risk" patients have produced encouraging findings. A family history approach, targeted at those requesting CHD assessment, could motivate lifestyle change. The project will assess the clinical value of incorporating systematic family history information into CHD risk assessment in primary care, from the perspective of the users of this service, the health care practitioners providing this service, and the National Health Service.



The study will include three distinct phases: (1) cross-sectional survey to ascertain baseline information on current recording of family information; (2) through an exploratory matched-pair cluster randomised study, with nested qualitative semi-structured interview and focus group study, to assess the impact of systematic family history recording on participants' and primary care professionals' experience; (3) develop an economic model of the costs and benefits of incorporating family history into CHD risk assessment.



On completion of the project, users and primary care practitioners will be more informed of the value and utility of including family history in CHD risk assessment. Further, this approach will also act as a model of how familial risk information can be integrated within mainstream primary care preventive services for common chronic diseases.
Effect of telehealth on glycaemic control: analysis of patients with type 2 diabetes in the Whole Systems Demonstrator cluster randomised trial

The Whole Systems Demonstrator was a large, pragmatic, cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England. Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely. We examined whether telehealth led to changes in glycosylated haemoglobin (HbA1c) among the subset of patients with type 2 diabetes.



The general practice electronic medical record was used as the source of information on HbA1c. Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period, and adjusted for differences in HbA1c readings recorded before recruitment. Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period.



513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study. Telehealth was associated with lower HbA1c than usual care during the trial period (difference 0.21% or 2.3 mmol/mol, 95% CI, 0.04% to 0.38%, p = 0.013). Among the 457 patients in the secondary analysis, mean HbA1c showed little change for controls following recruitment, but fell for intervention patients from 8.38% to 8.15% (68 to 66 mmol/mol). A higher proportion of intervention patients than controls had HbA1c below the 7.5% (58 mmol/mol) threshold that was targeted by general practices (30.4% vs. 38.0%). This difference, however, did not quite reach statistical significance (adjusted odds ratio 1.63, 95% CI, 0.99 to 2.68, p = 0.053).



Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months. The scale of the improvements is consistent with previous meta-analyses, but was relatively modest and seems unlikely to produce significant patient benefit.