nils-herrmann/clean_scirepeval huggingface dataset:
Good stability but high periprosthetic bone mineral loss and late-occurring periprosthetic fractures with use of uncemented tapered femoral stems in patients with a femoral neck fracture

We previously evaluated a new uncemented femoral stem designed for elderly patients with a femoral neck fracture and found stable implant fixation and good clinical results up to 2 years postoperatively, despite substantial periprosthetic bone mineral loss. We now present the medium-term follow-up results from this study.



In this observational prospective cohort study, we included 50 patients (mean age 81 (70-92) years) with a femoral neck fracture. All patients underwent surgery with a cemented cup and an uncemented stem specifically designed for fracture treatment. Outcome variables were migration of the stem measured with radiostereometry (RSA) and periprosthetic change in bone mineral density (BMD), measured with dual-energy X-ray absorptiometry (DXA). Hip function and health-related quality of life were assessed using the Harris hip score (HHS) and the EuroQol-5D (EQ-5D). DXA and RSA data were collected at regular intervals up to 4 years, and data concerning reoperations and hip-related complications were collected during a mean follow-up time of 5 (0.2-7.5) years.



At 5 years, 19 patients had either passed away or were unavailable for further participation and 31 could be followed up. Of the original 50 patients, 6 patients had suffered a periprosthetic fracture, all of them sustained after the 2-year follow-up. In 19 patients, we obtained complete RSA and DXA data and no component had migrated after the 2-year follow-up. We also found a continuous total periprosthetic bone loss amounting to a median of -19% (-39 to 2). No changes in HHS or EQ-5D were observed during the follow-up period.



In this medium-term follow-up, the stem remained firmly fixed in bone despite considerable periprosthetic bone mineral loss. However, this bone loss might explain the high number of late-occurring periprosthetic fractures. Based on these results, we would not recommend uncemented femoral stems for the treatment of femoral neck fractures in the elderly.
Processed blood volume impacts clinical efficacy in patients with ulcerative colitis undergoing adsorptive depletion of myeloid lineage leucocytes

Hitherto, therapeutic depletion of granulocytes and monocytes by adsorption (GMA) has been associated with significant and insignificant efficacy in patients with ulcerative colitis (UC). Further, the processed blood volume in one GMA session has been fixed at 30 mL/min × 60 min, regardless of patients’ body weight (BW). We were interested to see the efficacy and safety of GMA when administered in relation to patients’ BW. Sixty patients were randomly assigned to the routine GMA (n = 30) and to GMA adjusted to patients’ BW, 60 mL/kg (n = 30). GMA was done with the Adacolumn, up to 10 sessions over 10 weeks. At entry and 1 week post last GMA, patients were clinically and endoscopically evaluated. Remission was defined as clinical activity index (CAI) ≤4, whereas mucosal remission was defined as endoscopic index (EI) ≤3. In the BW group, the processed volume/session was 3,260 ± 581 versus 1,800 mL in the routine group (P < 0.001). In the BW group, 25 of 30 patients (83.3%) achieved remission versus 19 of 30 patients (63.3%) in the routine group. The average CAI in the BW group fell from 9.6 ± 2.6 to 2.3 ± 2.1 versus from 9.1 ± 2.4 to 4.0 ± 2.1 (P < 0.05) in the routine group. Similarly, the EI in the BW group fell from 9.4 ± 1.3 to 2.1 ± 2.1 versus from 9.2 ± 1.8 to 4.5 ± 2.3 (P < 0.01). GMA adjusted to patients’ BW and at a vastly greater processed volume produces significantly higher efficacy as compared with the routine GMA protocol. Further, in this study, up to twofold higher processed volume caused no safety concern.
Effect of early programmes of high and low intensity exercise on physical performance after transmural acute myocardial infarction.

Does a programme of light exercise training after acute myocardial infarction produce the same improvement in treadmill performance as aerobic exercise training? Three hundred and eight men from a consecutive series of 479 men with transmural (Q wave) acute myocardial infarction, admitted to a single coronary care unit, were randomly allocated to eight weeks of group aerobic exercise training or group light exercise. Groups were well matched for all characteristics other than site of infarction, which did not significantly affect results. Mean (SD) physical working capacity (metabolic equivalents) determined by treadmill testing at the start of the study (in the third week after infarction) was 6.8 (2.2) v 6.7 (2.5) METs, at the end (in the eleventh week after infarction) 10.8 (2.3) v 9.9 (2.4) METs, and at 12 month review 10.8 (2.4) v 10.7 (1.9) METs for the exercise training group and the light exercise group respectively. The difference of 0.9 METs at the end of the study was the only significant difference between groups. There were no significant intergroup differences at any stage in resting and maximal heart rate, resting and maximal systolic blood pressure, or rate-pressure product. Apart from a small temporarily greater physical working capacity, the physical benefits of aerobic exercise training were equally well achieved by group light exercise.
The success rate of I-131 ablation in differentiated thyroid cancer: comparison of uptake-related and fixed-dose strategies.

The aim of the study was to compare the success rate of an uptake-related ablation protocol in which the dose depends on an I-131 24-h neck uptake measurement and a fixed-dose ablation protocol in which the dose depends on tumour stage.



All differentiated thyroid carcinoma patients with M0 disease who had undergone (near-) total thyroidectomy followed by I-131 ablation were included. In the uptake-related ablation protocol, 1100 (uptake >10%), 1850 (uptake 5-10%) and 2800 MBq (uptake <5%) were used. In the fixed-dosage ablation strategy, 3700 (T1-3, N0 stage) and 5550 MBq (N1 and/or T4 stage) were applied. We used I-131 uptake on whole-body scintigraphy and thyroglobulin-off values to evaluate the ablation 6-12 months after treatment.



In the uptake-related ablation protocol, 60 out of 139 (43%) patients were successfully treated versus 111 out of 199 for the fixed-dose ablation protocol (56%) (P=0.022). The differences were not statistically significant for patients with T4 (P=0.581) and/or N1 (P=0.08) disease or for patients with T4N1 tumour stage (P=0.937).



The fixed-dose I-131 ablation protocol is more effective in ablation of the thyroid remnant in differentiated thyroid carcinoma patients than an uptake-related ablation protocol. This difference is not observed in patients with a N1 and/or T4 tumour stage.
Research and applications: Comparison and validation of genomic predictors for anticancer drug sensitivity

An enduring challenge in personalized medicine lies in selecting the right drug for each individual patient. While testing of drugs on patients in large trials is the only way to assess their clinical efficacy and toxicity, we dramatically lack resources to test the hundreds of drugs currently under development. Therefore the use of preclinical model systems has been intensively investigated as this approach enables response to hundreds of drugs to be tested in multiple cell lines in parallel.



Two large-scale pharmacogenomic studies recently screened multiple anticancer drugs on over 1000 cell lines. We propose to combine these datasets to build and robustly validate genomic predictors of drug response. We compared five different approaches for building predictors of increasing complexity. We assessed their performance in cross-validation and in two large validation sets, one containing the same cell lines present in the training set and another dataset composed of cell lines that have never been used during the training phase.



Sixteen drugs were found in common between the datasets. We were able to validate multivariate predictors for three out of the 16 tested drugs, namely irinotecan, PD-0325901, and PLX4720. Moreover, we observed that response to 17-AAG, an inhibitor of Hsp90, could be efficiently predicted by the expression level of a single gene, NQO1.



These results suggest that genomic predictors could be robustly validated for specific drugs. If successfully validated in patients' tumor cells, and subsequently in clinical trials, they could act as companion tests for the corresponding drugs and play an important role in personalized medicine.
Dietary counselling and food fortification in stable COPD: a randomised trial.

Malnutrition in chronic obstructive pulmonary disease (COPD) is associated with a poor prognosis, yet evidence to support the role of dietary counselling and food fortification is lacking. A study was undertaken to assess the impact of dietary counselling and food fortification on outcome in outpatients with COPD who are at risk of malnutrition.



A randomised controlled unblinded trial was performed in 59 outpatients with COPD (6 months intervention and 6 months follow-up). The intervention group received dietary counselling and advice on food fortification and the controls received a dietary advice leaflet. Outcome measures were nutritional status, respiratory and skeletal muscle strength, respiratory function, perceived dyspnoea, activities of daily living (ADL) and quality of life.



The intervention group consumed more energy (difference 194 kcal/day; p = 0.02) and protein (difference 11.8 g/day; p<0.001) than controls. The intervention group gained weight during the intervention period and maintained weight during follow-up; the controls lost weight throughout the study. Significant differences were observed between the groups in St George's Respiratory Questionnaire total score (difference 10.1; p = 0.02), Short Form-36 health change score (difference 19.2; p = 0.029) and Medical Research Council dyspnoea score (difference 1.0; p = 0.03); the difference in ADL score approached statistical significance (difference 1.5; p = 0.06). No differences were observed between groups in respiratory function or skeletal and respiratory muscle strength. Improvements in some variables persisted for 6 months beyond the intervention period.



Dietary counselling and food fortification resulted in weight gain and improvements in outcome in nutritionally at-risk outpatients with COPD, both during and beyond the intervention period.
Dimensions and reliability of a questionnaire for the evaluation of subjective experiences of health among patients in mental health services.

Even though the concept of health and its importance has been widely discussed in health care during recent decades, mental health services have been criticised for adopting a biomedical perspective, which does not sufficiently consider the concept of health. The aim of the present study was to investigate the psychometric properties of the Health Questionnaire, a newly developed questionnaire to measure patients' subjective experience of health in mental health services. A cross sectional study was performed using a sample of 139 outpatients in mental health services. A principal component analysis with varimax rotation was used to test the factor structure of the questionnaire. Cronbach's alpha was employed to test internal consistency and Cohen's Kappa assessed test-retest reliability. The final scale, which contained 22 items, derived from three factors (autonomy, social involvement, and comprehensibility) and showed a good reliability in terms of internal consistency. Test-retest reliability was moderate or better for 17 out of 22 items. The Health Questionnaire may enable further empirical studies on subjectively experienced health in mental health services and serve as a measure of outcome and to monitor quality of care.
Psychometric properties of two measures of psychological well-being in adult growth hormone deficiency

Psychometric properties of two measures of psychological well-being were evaluated for adults with growth hormone deficiency (GHD): the General Well-being Index, (GWBI)--British version of the Psychological General Well-being Index, and the 12-item Well-being Questionnaire (W-BQ12).



Reliability, structure and other aspects of validity were investigated in a cross-sectional study of 157 adults with treated or untreated GHD, and sensitivity to change in a randomised placebo-controlled study of three months' growth hormone (GH) withdrawal from 12 of 21 GH-treated adults.



Very high completion rates were evidence that both questionnaires were acceptable to respondents. Factor analyses did not indicate the existence of useful GWBI subscales, but confirmed the validity of calculating a GWBI Total score. However, very high internal consistency reliability (Cronbach's alpha = 0.96, N = 152), probably indicated some item redundancy in the 22-item GWBI. On the other hand, factor analyses confirmed the validity of the three W-BQ12 subscales of Negative Well-being, Energy, and Positive Well-being, each having excellent internal reliability (alphas of 0.86, 0.86 and 0.88, respectively, N from 152 to 154). There was no sign of item redundancy in the highly acceptable Cronbach's alpha of 0.93 (N = 148) for the whole W-BQ12 scale. Whilst neither questionnaire found significant differences between GH-treated and non-GH-treated patients, there were correlations (for GH-treated patients) with duration of GH treatment for GWBI Total (r = -0.36, p = 0.001, N = 85), W-BQ12 Total (r = 0.35, p = 0.001, N = 88) and for all W-BQ12 subscales: thus the longer the duration of GH treatment (ranging from 0.5 to 10 years), the better the well-being. Both questionnaires found that men had significantly better overall well-being than women. The W-BQ12 was more sensitive to change than the GWBI in the GH-Withdrawal study. A significant between-group difference in change in W-BQ12 Energy scores was found [t(18) = 3.25, p = 0.004, 2-tailed]: patients withdrawn from GH had reduced energy at end-point. The GWBI found no significant change.



The W-BQ12 is recommended in preference to the GWBI to measure well-being in adult GHD: it is considerably shorter, has three useful subscales, and has greater sensitivity to change.
Socioeconomic and race/ethnic differences in daily salivary cortisol profiles: The Multi-Ethnic Study of Atherosclerosis

It has often been hypothesized that stress and its biological consequences mediate the relationship between low socioeconomic status (SES) or minority status and poor cardiovascular disease outcomes. The objective of this study was to determine if daily cortisol patterns, a biomarker of the stress response, differ by race/ethnicity and socioeconomic status. Data were collected from 935 Black, White and Hispanic adults age 48-90 years old. Salivary cortisol samples were collected six times per day over 3 days: at awakening, 30min later, at 1000h, noon, 1800h and at bedtime. Blacks and Hispanics had lower levels of wake-up cortisol and less steep early declines, while Blacks had flatter and Hispanics steeper late day declines relative to Whites. Similarly the low socioeconomic status group also had lower levels of wake-up cortisol and less steep decline during the early part of the day. These patterns remained after adjustment for health behaviors and psychosocial factors. This study finds an association between salivary cortisol and race/ethnicity and SES in a multi-ethnic study population. Further work is needed to determine the health consequences of these differences.
MS-20, a chemotherapeutical adjuvant, reduces chemo-associated fatigue and appetite loss in cancer patients.

A small pilot study of the fermented soybean extract MicrSoy-20(MS-20) demonstrated its ability to restore chemotherapy-induced immunosuppression and improve quality of life (QoL). This randomized, cross-over, comparative trial was conducted to confirm the effects of MS-20 on QoL and to understand its underlying mechanism when used in conjunction with chemotherapy. One hundred forty-three patients undergoing cancer chemotherapy were randomly assigned to 2 groups. Group 1 was administered MS-20 for 1 wk followed by 3 wk of concomitant MS-20 plus chemotherapy. Group 2 was administered chemotherapy for 3 wk. QoL was assessed by the EORTC/QLQ-C30 questionnaire and visual analogue scales (VAS). Changes in immunological parameters and antioxidant profiles were also examined. Significant increases were observed in EORTC/QLQ-C30 scores for physical (4.45, P = 0.023) and social (3.99, P = 0.023) functioning in Group 1 patients compared to Group 2 patients. VAS scores for fatigue and appetite loss significantly improved with MS-20 treatment (P < 0.001). Group 1 patients exhibited smaller decreases in peripheral blood mononuclear cells compared to Group 2 patients (P = 0.026). Other immunological parameters, antioxidant, and safety profiles were not significantly different between treatment groups. Addition of MS-20 as an adjuvant to chemotherapy can be effective in improving QoL for cancer patients.
Predictors of symptom resolution in patients with community-acquired pneumonia.

Previous studies have demonstrated that a substantial number of patients with community-acquired pneumonia (CAP) experienced CAP-related symptoms up to 3 months after the completion of antibiotic treatment. We evaluated the frequency of symptoms in a cohort of 535 patients with CAP who presented to a hospital emergency department and completed symptom questionnaires 2 and 6 weeks after the completion of a course of antibiotic therapy. Six weeks after cessation of antibiotic therapy, 64% of patients still reported > or = 1 CAP-related symptoms. Exploratory analyses were performed to identify potential predictors of complete symptom resolution. Logistic regression analysis identified younger age, absence of asthma or chronic obstructive pulmonary disease, and levofloxacin treatment as predictors of complete symptom resolution (all P < .05). Randomized controlled trials should be performed to evaluate the relative efficacy of different antibiotic therapies on the rate of resolution of symptoms.
Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial.

This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced.



Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (> 24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting > 48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 +/- 0.13, 69% were in functional class > or = II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14-0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated.



In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.
Quantitative proteomic analysis for high-throughput screening of differential glycoproteins in hepatocellular carcinoma serum

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related deaths. Novel serum biomarkers are required to increase the sensitivity and specificity of serum screening for early HCC diagnosis. This study employed a quantitative proteomic strategy to analyze the differential expression of serum glycoproteins between HCC and normal control serum samples.



Lectin affinity chromatography (LAC) was used to enrich glycoproteins from the serum samples. Quantitative mass spectrometric analysis combined with stable isotope dimethyl labeling and 2D liquid chromatography (LC) separations were performed to examine the differential levels of the detected proteins between HCC and control serum samples. Western blot was used to analyze the differential expression levels of the three serum proteins.



A total of 2,280 protein groups were identified in the serum samples from HCC patients by using the 2D LC-MS/MS method. Up to 36 proteins were up-regulated in the HCC serum, whereas 19 proteins were down-regulated. Three differential glycoproteins, namely, fibrinogen gamma chain (FGG), FOS-like antigen 2 (FOSL2), and α-1,6-mannosylglycoprotein 6-β-N-acetylglucosaminyltransferase B (MGAT5B) were validated by Western blot. All these three proteins were up-regulated in the HCC serum samples.



A quantitative glycoproteomic method was established and proven useful to determine potential novel biomarkers for HCC.
Affective prosody: What do comprehension errors tell us about hemispheric lateralization of emotions, sex and aging effects, and the role of cognitive appraisal

The Aprosodia Battery was developed to distinguish different patterns of affective-prosodic deficits in patients with left versus right brain damage by using affective utterances with incrementally reduced verbal-articulatory demands. It has also been used to assess affective-prosodic performance in various clinical groups, including patients with schizophrenia, PTSD, multiple sclerosis, alcohol abuse and Alzheimer disease and in healthy adults, as means to explore maturational-aging effects. To date, all studies using the Aprosodia Battery have yielded statistically robust results. This paper describes an extensive, quantitative error analysis using previous results from the Aprosodia Battery in patients with left and right brain damage, age-equivalent controls (old adults), and a group of young adults. This inductive analysis was performed to address three major issues in the literature: (1) sex and (2) maturational-aging effects in comprehending affective prosody and (3) differential hemispheric lateralization of emotions. We found no overall sex effects for comprehension of affective prosody. There were, however, scattered sex effects related to a particular affect, suggesting that these differences were related to cognitive appraisal rather than primary perception. Results in the brain damaged groups did not support the Valence Hypothesis of emotional lateralization but did support the Right Hemisphere Hypothesis of emotional lateralization. When comparing young versus old adults, a robust maturational-aging effect was observed in overall error rates and in the distribution of errors across affects. This effect appears to be mediated, in part, by cognitive appraisal, causing an alteration in the salience of different affective-prosodic stimuli with increasing age. In addition, the maturational-aging effects lend support for the Emotion-Type hypothesis of emotional lateralization and the "classic aging effect" that is due primarily to decline of right hemisphere cognitive functions in senescence. The results of our inductive analysis may help direct future deductive research efforts, exploring the neuropsychology of emotional communication, by taking into account the potentially confounding influence of (1) methodological differences involving construction of test stimuli and assessment procedures, (2) developmental, maturational and aging effects related to cognitive appraisal and (3) whether a stimulus has a primary or social-emotional bias.