nils-herrmann/clean_scirepeval huggingface dataset:
Dyspnoea assessed by visual analogue scale in patients with chronic obstructive lung disease during progressive and high intensity exercise.

A study was carried out to determine whether rating of dyspnoea by means of a visual analogue scale during a progressive exercise test is affected by the subject's awareness of the progressive nature of the protocol.



Nineteen patients with chronic obstructive lung disease (FEV1 mean (SE) 1.06 (0.07) 1) were studied. A preliminary incremental test was carried out with a work rate increasing by 10 watts every minute until the subject could no longer exercise, to determine the maximum work load (Wmax) and to anchor the upper end of the visual analogue scale. This was followed by two exercise tests performed one day apart in randomised sequence, with two different protocols. One was a 12 minute protocol that included two sudden bursts of three minute high intensity exercise, up to the subject's Wmax, each preceded by three minutes of low level exercise. The other test was a conventional three minute incremental test lasting 12 minutes. On both study days the only information given to the subject about the temporal profile of load was that a change would be made every three minutes. The relation between dyspnoea, as assessed by the visual analogue scale, and ventilation, measured during high intensity or progressive exercise, was studied.



The mean (SE) rates of increase of dyspnoea with increasing ventilation (% of line length 1(-1) min) obtained by linear regression analysis were similar for the two tests (2.86 (0.20) for progressive exercise and 2.87 (0.25) for high intensity exercise); it was 2.59 (0.25) for the initial burst of high intensity exercise when the data on this were analysed separately. In six subjects with stable disease studied again two months later the reproducibility of the rating of dyspnoea was reasonably good for both protocols.



The results suggest that in most patients with chronic obstructive lung disease the assessment of exercise induced dyspnoea by means of a visual analogue scale during a progressive exercise test is not affected by the subject's awareness of the progressive increase in work intensity.
Using three-dimensional echocardiography to guide left ventricle lead position in cardiac resynchronization therapy: does it make any difference

Cardiac resynchronization therapy (CRT) is an effective treatment for patients with advanced heart failure. Nearly 30% of candidates are inadequate responders. Proper patient selection, left ventricle (LV) lead placement optimization, and optimization of the programming of the CRT device are important approaches to improve outcome of CRT. We examined the role of three-dimensional (3D) echocardiography in determining the optimal LV lead position as a method of optimizing CRT response. Forty-seven patients with a mean age of 60.2 ± 11.1 years including five (10.6%) females, all having advanced CHF (EF <35%, LBBB >120 mesc, or non-LBBB >150 msec, with NYHA II–III or ambulatory class IV) were enrolled. Detailed history (NYHA class, Minnesota living with heart failure questionnaire), clinical examination, 6-min walk test, and standard 2D echocardiography were done in all cases. 3D echo detailed analysis of the LV 16 segments was done to determine the latest wall to reach the minimal systolic volume. Multisite pacing was done blind to the 3D echo data achieving a stable LV lead position in mid LV segment. This exact fluoroscopic site was determined (in two orthogonal views) and correlated with 3D most delayed area using a resized 16-segment schema. Patients were classified retrospectively into group A with concordance between the delayed LV area and LV lead position and group B with discordance between both. Patients were followed up after 3–6 (5.1 ± 1.8) months. Patients with reduction of 2D LV end-systolic volume of ≥10% at follow-up were termed volumetric responders. Poorly echogenic patients and those with decompensated NYHA class IV, sustained atrial arrhythmias, and rheumatic or congenital heart diseases were excluded. LV lead placement was concordant in 22 (46.8%) cases. After the follow-up period, 31 (65.9%) of the study population were considered volumetric responders with no significant difference among both groups (14 (63.3%) in group A vs 17 (68%) in group B, p > 0.05). CRT insertion resulted in significant improvement of NYHA class in 36 (76.5%) cases, 6-min walk test (447.2 ± 127.0 vs 369.6 ± 87.5 m, p < 0.01), MLHFQ (58.1 ± 19.7 vs 69.6 ± 13.5, p < 0.01), QRS duration (131.2 ± 13.8 vs 149.4 ± 16 msec, p < 0.01), 2D LV EF 33.0 ± 9.5 vs 25.3 ± 6.5, p < 0.001), LVESV (156.0 ± 82.9 vs177.6 ± 92.7 ml, p < 0.05), and 3D LVEF (29.1 ± 9.0 vs 23.6 ± 5.9, p < 0.001) irrespective of the etiology of heart failure. However, there were no significant differences between both groups regarding the same parameters (6-min walk test 470.8 ± 128.7 vs 428.3 ± 126.8 m, MLHFQ 56.8 ± 20.0 vs 58.11 ± 19.0, QRS duration 129.9 ± 12.4 vs 132.1 ± 15.1 msec, 2D LVEF 30.9 ± 8.3 vs 34.58 ± 10.9, LVESV 173.0 ± 110.0 vs 143.0 ± 67.9, 3D LVEF 26 ± 8 vs 31 ± 9, for groups A and B, respectively, p < 0.05). Standard anatomical LV lead placement remains a simple, practical, and effective method in patients undergoing CRT. 3D echocardiography-guided LV lead placement added no clinical benefit compared to standard techniques.
Initial validation of a computerized version of the UCSD Performance-Based Skills Assessment (C-UPSA) for assessing functioning in schizophrenia

This study aimed to validate the Computerized UCSD Performance-Based Skills Assessment (C-UPSA), a newly developed scale for assessing functional capacity in patients with schizophrenia.



The C-UPSA was administered to 21 middle-aged and older adults with schizophrenia and 20 healthy comparison (HC) subjects. Schizophrenia participants also completed the original UPSA and a symptom inventory (during a separate visit), and cognitive functioning was assessed in both groups using a brief neuropsychological screening battery.



The C-UPSA total score was significantly correlated with UPSA total scores, and the magnitude of the correlation was comparable to the test-retest reliability of the original UPSA. The C-UPSA was also significantly correlated with UPSA-Brief scores and neuropsychological status among schizophrenia participants. Furthermore, the schizophrenia group scored significantly lower than the HCs on the C-UPSA. ROC curves were generated to determine the optimal C-UPSA value for discriminating between the two groups, with results indicating an optimal cutoff of 75, which is consistent with the derived cutoff from the original UPSA. The C-UPSA identified persons with schizophrenia with 95% accuracy.



The C-UPSA appears to be highly related to the original UPSA. It has several advantages over the standard version, including increased portability, decreased administration time, and minimized examiner impact on participant performance. Future research would benefit from establishing this test as a clinical and research tool to effectively assess functional capacity.
Dose-response for chiropractic care of chronic low back pain.

There have been no trials of optimal chiropractic care in terms of number of office visits for spinal manipulation and other therapeutic modalities.



To conduct a pilot study to make preliminary identification of the effects of number of chiropractic treatment visits for manipulation with and without physical modalities (PM) on chronic low back pain and disability.



Randomized controlled trial with a balanced 4x2 factorial design. Conducted in the faculty practice of a chiropractic college outpatient clinic.



Seventy-two patients with chronic, nonspecific low back pain of mechanical origin.



Von Korff pain and disability (100-point) scales.



Patients were randomly allocated to visits (1, 2, 3 or 4 visits/week for 3 weeks) and to treatment regimen (spinal manipulation only or spinal manipulation with PM). All patients received high-velocity low-amplitude spinal manipulation. Half received one or two of the following PM at each visit: soft tissue therapy, hot packs, electrotherapy or ultrasound.



Pain intensity: At 4 weeks, there was a substantial linear effect of visits favoring a larger number of visits: 5.7 points per 3 visits (SE=2.3, p=.014). There was no effect of treatment regimen. At 12 weeks, the data suggested the potential for a similar effect of visits on patients receiving both manipulation and PM.  At 4 weeks, a visits effect was noted (p=.018); the slope for group means was approximately 5 points per 3 visits. There were no group differences at 12 weeks.



There was a positive, clinically important effect of the number of chiropractic treatments for chronic low back pain on pain intensity and disability at 4 weeks. Relief was substantial for patients receiving care 3 to 4 times per week for 3 weeks.
Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk.



Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR.



We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant.



In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs.
Tract simplified clinical risk score predicts the need for early endoscopy n non-variceal upper gastrointestinal bleeding

Pre-endoscopic triage of patients who require an early upper endoscopy can improve management of patients with non-variceal upper gastrointestinal bleeding.  To validate a new simplified clinical score (T-score) to assess the need of an early upper endoscopy in non variceal bleeding patients. Secondary outcomes were re-bleeding rate, 30-day bleeding-related mortality.  In this prospective, multicentre study patients with bleeding who underwent upper endoscopy were enrolled. The accuracy for high risk endoscopic stigmata of the T-score was compared with that of the Glasgow Blatchford risk score.  Overall, 602 patients underwent early upper endoscopy, and 472 presented with non-variceal bleeding. High risk endoscopic stigmata were detected in 145 (30.7%) cases. T-score sensitivity and specificity for high risk endoscopic stigmata and bleeding-related mortality was 96% and 30%, and 80% and 71%, respectively. No statistically difference in predicting high risk endoscopic stigmata between T-score and Glasgow Blatchford risk score was observed (ROC curve: 0.72 vs. 0.69, p = 0.11). The two scores were also similar in predicting re-bleeding (ROC curve: 0.64 vs. 0.63, p = 0.4) and 30-day bleeding-related mortality (ROC curve: 0.78 vs. 0.76, p = 0.3).  The T-score appeared to predict high risk endoscopic stigmata, re-bleeding and mortality with similar accuracy to Glasgow Blatchford risk score. Such a score may be helpful for the prediction of high-risk patients who need a very early therapeutic endoscopy.
Measuring goodness of story narratives.

The purpose of this article was to evaluate a new measure of story narrative performance: story completeness. It was hypothesized that by combining organizational (story grammar) and completeness measures, story "goodness" could be quantified.



Discourse samples from 46 typically developing adults were compared with those from 24 adults with acquired brain injuries. Story retellings were elicited and analyzed for episode structure (story grammar). Each story was also evaluated for the presence of 5 key components, yielding the story completeness score. Story goodness was quantified by combining the story grammar and completeness measures using a 2-coordinate grid system. A multivariate analysis of variance was performed as well as correlational analyses between the story grammar and story completeness scores.



There were significant group differences on both story grammar and story completeness. Moderate correlations were noted between the 2 measures, suggesting that the indices were not entirely measuring the same abilities. Plotting the 2 sets of scores into quadrants discriminated the comparison group and the group with brain injury into 4 distinct categories of story "goodness."



The combination of measures provided a more accurate depiction of discourse performance than either measure alone. Results suggest the measure is sensitive, is reliable, and has potential utility for investigating discourse deficits in clinical populations.
Novel paclitaxel formulations for oral application: a phase I pharmacokinetic study in patients with solid tumours

To explore the pharmacokinetics (PKs) of paclitaxel and two major metabolites after three single oral administrations of a novel drinking solution and two capsule formulations in combination with cyclosporin A (CsA) in patients with advanced cancer. Moreover, the tolerability and safety of the formulations was studied. In addition, single nucleotide polymorphisms in the multidrug resistance (MDR1) gene were determined. Ten patients were enrolled and randomized to receive CsA 10 mg/kg followed by oral paclitaxel 180 mg given as (1) drinking solution (formulation 1), (2) capsule formulation 2B, and (3) capsule formulation 2C on day 1, 8, or 15. The median C max of paclitaxel was 0.42 (0.23–0.96), 0.48 (0.08–0.59), and 0.39 (0.11–1.03) μg/ml and the area under the plasma concentration–time curve was 2.83 (1.69–5.12), 2.01 (1.57–3.04), and 2.67 (1.05–3.61) μg h/ml following administration of formulations 1, 2B, and 2C, respectively. The novel formulations were tolerated after single oral dose without causing relevant gastrointestinal or haematological toxicity. The PK and metabolism of paclitaxel were comparable between the oral formulations co-administered with CsA.
Establishment of a Lentiviral Vector Encoding Human HGF and the Infection of Human ADSCs

The delivery of adipose-derived stem cells (ADSCs) for promoting tissue repair has become a potential new therapy, while hepatocyte growth factor (HGF) is an important growth factor with angiogenic, anti-fibrotic, and anti-inflammatory benefits. In this paper, hADSCs were separated, cultured and identified based on the expression of cell surface antigens and multiple differentiation potential. We successfully generated a lentiviral vector encoding human HGF, infected hADSCs with this vector and examined the protein expression pattern. Finally we found that the hHGF lentiviral vector was successfully generated, and the lentiviral vector was able to safely infect hADSCs with high infection efficiency, thereby producing cells that overexpressed hHGF, which may provide a new strategy for the treatment of ischemic heart disease (IHD) and other ischemic diseases.
Description and consequences of prescribing off-label antiretrovirals in the Madrid Cohort of HIV-infected children over a quarter of a century (1988-2012).

Licensing data for paediatric dosing is often sparse and subsequent studies may result in changes to recommended doses. We measured the extent and consequences of off-label antiretroviral (ARV) use in an HIV-infected paediatric cohort.



In this multicentre cohort study involving 318 HIV-infected children and adolescents from the Madrid Cohort, all off-label prescriptions from March 1988 to March 2012 were recorded from the clinical records. The reasons for prescribing ARV off-label, the side effects and the consequences of incorrect dosing of ARVs are discussed.



Among the 318 patients of the cohort, 221 (69%) received off-label ARVs according to EMA licensing at the time of prescription, representing 23% (540) of the 2,353 prescribed ARVs. The main reason for starting an off-label drug was treatment failure. Adverse events led to treatment discontinuation in 12% of the prescriptions. Problems taking the drug led to withdrawal in 5%, more likely when formulation was not suitable for age (P<0.05). Up to 10% were overdosed and 10% underdosed, defined as 25% above or below the current recommended dose, respectively. Treatment failure occurred significantly more frequently among underdosed compared to overdosed patients (50% versus 26%; P<0.05).



Off-label use of ARVs was common in our HIV-1 paediatric patients. Adverse events were common but rarely led to withdrawal. Suitable formulation is important in younger children. Pharmacokinetic studies are needed as frequent incorrect dosing may occur when prescribing off-label and underdosing may lead to treatment failure.
A Neuro-Fuzzy Controller for the estimation of Tidal Volume and Respiration Frequency ventilator settings for COPD patients ventilated in control mode

Patients with chronic obstructive pulmonary disease (COPD) are characterized by increased work of breathing (WOB) and ventilatory muscle dysfunction. Mechanical ventilation is applied to unload the WOB; rest respiratory muscles decrease arterial partial pressure of carbon dioxide (PaCO2) and treat hypoxemia. Since patients' needs are not static, ventilator settings have to be adjusted regularly. The aim of the present study was the development and evaluation of a neuro-fuzzy controller, that utilizes non- invasively acquired parameters for the determination of the appropriate tidal volume (VT) and respiration frequency (RR) ventilator settings for COPD patients. Forty three (43) hours of non-invasively monitored physiology parameters and ventilator settings, from four (4) different COPD patients ventilated in control mode, were collected in two (2) General Hospitals in Greece. Recorded data were randomly allocated into two sets, namely training set (60%) and evaluation set (40%). A neuro- fuzzy controller was developed and trained, by employing the training set. The controller utilizes non-invasively measured parameters, namely oxygen saturation (SpO2), lung compliance (C) and resistance (R), Peak Inspiratory pressure (PIP) and Plateau pressure (Pplateau), for predicting appropriate VT and RR settings. The developed neuro-fuzzy controller was tested against evaluation set. The Mean Square Error of the tidal volume and the respiration rate was 0.222 ml/Kgr and 1.21 breaths per minute (bpm) respectively.
Infliximab treatment in combination with cyclosporin A in patients with severe refractory rheumatoid arthritis.

To investigate whether infliximab can be used in combination with cyclosporin A (CsA) in patients with refractory rheumatoid arthritis (RA) who cannot tolerate methotrexate (MTX).



Eighteen patients with refractory RA receiving low dose CsA (2 mg/kg/day) and prednisone (5 mg/day) were treated with intravenous infliximab. The patients were given infliximab (3 mg/kg weight) at 0, two, six, and every eight weeks thereafter for a total period of 12 months. Clinical improvement was evaluated according to the American College of Rheumatology (ACR) 20% response criteria.



Eighty per cent of patients receiving the combination treatment with CsA and infliximab achieved the 20% ACR criteria for response to treatment, whereas 39% satisfied the 50% response criteria. In addition, a 76% reduction in swollen and tender joint count was found. Finally, a reduction in C reactive protein and erythrocyte sedimentation rate was maintained throughout the study. In general, treatment was well tolerated, with minimal adverse drug reactions. Two patients dropped out; one because of an immediate hypersensitivity reaction and the other because of the development of pulmonary tuberculosis.



Multiple infusions of infliximab and low doses of CsA improve patients with refractory RA. It seems that CsA may be an alternative disease modifying drug to be used in combination with infliximab in patients with refractory RA who cannot tolerate MTX.
Properties of the International Classification for Functioning, Disability and Health in assessing hand outcomes in patients with rheumatoid arthritis.

Variables from a study of patients with rheumatoid arthritis were linked to the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis. The purpose of this analysis was to evaluate the ICF Core Sets for rheumatoid arthritis for assessing the functional outcomes of the rheumatoid hand.



Prospective cohort.



A total of 142 subjects with rheumatoid arthritis.



Patients who elected to have or not have arthroplasty were linked with the ICF Core Sets. Study variables were assigned into one of the Core Set blocks that compose the ICF model. The blocks were then entered into multiple regression models to determine the contribution of each block in explaining the variation in hand outcome at enrollment, as well as the change in hand outcome after one year.



Seventy percent of the reported hand outcome at enrollment was explained by the ICF Core Set blocks. For change in hand outcome at one year, the ICF Core Set blocks measured at enrollment explained 18% of the variance.



The components of the ICF Core Set for rheumatoid arthritis explained much of the variation in hand functioning for patients with rheumatoid arthritis, but were not predictive of the change in hand functioning after one year.