nils-herrmann/clean_scirepeval huggingface dataset:
Effects of nebulized morphine sulfate on the exercise tolerance of the ventilatory limited COPD patient.

We have shown previously that the administration of morphine (0.8 mg/kg) to patients with COPD increases the VO2max by 19.3 percent. A recent study demonstrated that the administration of low-dose nebulized morphine (approximately 2 mg) increased the endurance time of patients with severe lung disease by 1 min (35 percent) with few systemic side effects. This double-blind crossover study evaluated the effects of various doses of nebulized morphine (0, 1, 4, and 10 mg) on the exercise tolerance and the psychologic status of COPD patients. In the present study, eight COPD patients (FEV1 = 0.90 +/- 0.26 L, workload max = 76 +/- 29 W, VO2max = 950 +/- 264 ml, VEmax = 34 +/- 7 L), who were ventilatory limited were tested on four separate days. On each testing day, the patients underwent incremental exercise testing and psychologic testing before and 45 min after receiving the nebulized solution. The mean changes (+/- SD) in the exercise test results after each of the four different regimens were as follows: [table: see text] Although there tended to be larger increases in the workload, VO2max, and VEmax after the largest dose of morphine, none of the changes was statistically significant. Likewise, there were no significant differences in spirometry, resting metabolic measurements, or psychologic test scores after the four different regimens. We conclude that aerosolized morphine in the doses used in this study has no significant beneficial effect on the exercise tolerance of patients with COPD.
Misunderstanding in cancer patients: why shoot the messenger?

We aimed to document the prevalence of misunderstanding in cancer patients and investigate whether patient denial is related to misunderstanding.



Two hundred forty-four adult cancer outpatients receiving treatment completed a survey assessing levels of understanding and denial. Doctors provided the facts against which patient responses were compared. Multiple logistic regression analyses determined the predictors of misunderstanding.



Most patients understood the extent of their disease (71%, 95% CI: 65%-77%) and goal of treatment (60%, 95% CI: 54%-67%). Few correctly estimated the likelihood of treatment achieving cure (18%, 95% CI: 13%-23%), prolongation of life (13%, 95% CI: 8%-17%) and palliation (18%, 95% CI: 10%-27%). Patient denial predicted misunderstanding of the probability that treatment would cure disease when controlling for other patient and disease variables (OR = 2.20, 95% CI: 0.99-4.88, P = 0.05). Patient ratings of the clarity of information received were also predictive of patient understanding.



Patient denial appears to produce misunderstanding, however, doctors' ability to communicate effectively is also implicated. The challenge that oncologists face is how to communicate information in a manner which is both responsive to patients' emotional status and sufficiently informative to allow informed decision-making to take place.
Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)

Observational and epidemiological studies suggest that menopausal hormone therapy (MHT) reduces cardiovascular disease (CVD) risk. However, results from prospective trials showed neutral or adverse effects most likely due to differences in participant demographics, such as age, timing of initiation of treatment, and preexisting cardiovascular disease, which reflected in part the lack of basic science information on mechanisms of action of hormones on the vasculature at the time clinical trials were designed. The Kronos Early Estrogen Replacement Study (KEEPS) is a prospective, randomized, controlled trial designed, using findings from basic science studies, to test the hypothesis that MHT when initiated early in menopause reduces progression of atherosclerosis. KEEPS participants are younger, healthier, and within 3 years of menopause thus matching more closely demographics of women in prior observational and epidemiological studies than women in the Women's Health Initiative hormone trials. KEEPS will provide information relevant to the critical timing hypothesis for MHT use in reducing risk for CVD.
Prognostically relevant breakdown of 123 patients with systemic mastocytosis associated with other myeloid malignancies.

The prognostic heterogeneity of the World Health Organization category of "systemic mastocytosis with associated clonal hematologic nonmast cell lineage disease" (SM-AHNMD) has not been systematically validated by primary data. Among 138 consecutive cases with SM-AHNMD, 123 (89%) had associated myeloid neoplasm: 55 (45%) myeloproliferative neoplasm (SM-MPN), 36 (29%) chronic myelomonocytic leukemia, 28 (23%) myelodysplastic syndrome (SM-MDS), and 4 (3%) acute leukemia. Of the myeloid subgroups, SM-MPN displayed a 2- to 3-fold better life expectancy (P = .003), whereas leukemic transformation was more frequent in SM-MDS (29%; P = .02). The presence of eosinophilia, although prevalent (34%), was prognostically neutral, and the overall results were not affected by exclusion of FIP1L1-PDGFRA-positive cases. We conclude that it is clinically more useful to consider specific entities, such as SM-MPN, systemic mastocytosis with chronic myelomonocytic leukemia, SM-MDS, and systemic mastocytosis with-acute leukemia, rather than their broad reference as SM-AHNMD.
A community-based feasibility study using wheat bran fiber supplementation to lower colon cancer risk.

In this feasibility study, free-living older adults (n = 180; means = 67.5 years old) were randomly assigned to one of three levels of a 3-month standardized compliance enhancement program.



Regarding subject compliance with the 18 g/day wheat bran fiber supplement, the high compliance enhancement group had a superior regimen compliance rate (88%) versus the medium and low groups, (66 and 29%, respectively) (P = 0.01), with similar attrition rates.



No significant gastrointestinal side effects and changes in body weight were reported. For similar efficacy, the comprehensive compliance enhancement group had the greatest cost effectiveness.
Diurnal variation on balance control in patients with symptomatic knee osteoarthritis.

Increasing evidence supports balance control impairment in older adult patients with knee osteoarthritis (OA). However, there is limited data on diurnal variation of balance control in these patients. This study aimed to investigate postural stability in older adult patients with symptomatic knee OA during different periods in a daytime.



Two-hundred and forty-one patients with OA knee (median age=65 ± 12 years; 82 males) were enrolled in this study. Static posturography was performed under four standing conditions: eyes open and eyes closed, without and with foam support. To assess diurnal postural variations, testing sessions were defined as follows: 8-10 am, 10-12 am, 1 pm-3 pm, 3 pm-5 pm. Influence of sex, age, height, weight, and body mass index on postural stability was evaluated. Knee pain was also assessed in these four testing sessions.



Postural control was in particular less efficient in the late morning than in the early afternoon (p<0.05). Diurnal variation of balance control was more noticeable in older, heavier, and male patients (p<0.05). Patients' knee pain was more pronounced in the morning than in the afternoon (p<0.001).



Balance stability of patients with OA knee was different during a daytime. Altered postural performance in the morning could be explained by joint pain. This diurnal variation should be taken into account in the daily management of knee OA.
The diagnostic accuracy of MR imaging in osteoid osteoma

To analyse the MR imaging appearances of a large series of osteoid osteomas, to assess the ability of MR imaging to detect the tumour, and to identify potential reasons for misdiagnosis.  The MR imaging findings of 43 patients with osteoid osteoma were reviewed retrospectively and then compared with other imaging modalities to assess the accuracy of MR localisation and interpretation.  The potential for a missed diagnosis was 35% based solely on the MR investigations. This included six tumours which were not seen and nine which were poorly visualised. The major determinants of the diagnostic accuracy of MR imaging were the MR technique, skeletal location, and preliminary radiographic appearances. There was a wide spectrum of MR signal appearances of the lesion. The tumour was identified in 65% of sequences performed in the axial plane. The nidus was present in only one slice of the optimal sequence in 27 patients. Reactive bone changes were present in 33 and soft tissue changes in 37 patients.  Reliance on MR imaging alone may lead to misdiagnosis. As the osteoid osteoma may be difficult to identify and the MR features easily misinterpreted, optimisation of MR technique is crucial in reducing the risk of missing the diagnosis. Unexplained areas of bone marrow oedema in particular require further imaging (scintigraphy and CT) to exclude an osteoid osteoma.
A phase I study of an oral simulated FOLFOX with high dose capecitabine

A phase I study of high-dose capecitabine given over 2 days, along with oxaliplatin, bolus 5FU and leucovorin (LV), was designed to simulate FOLFOX6 without the need for infusional 5FU.  Schedule A included oxaliplatin 100 mg/m2, 5FU 400 mg/m2, and LV 20 mg/m2 (all given IV on days 1 and 15, 28 day cycle). Capecitabine was administered orally every 8 h × 6 doses, days 1 and 15. Schedule B excluded 5FU and LV, maintaining oxaliplatin and capecitabine. Pharmacokinetics were performed for capecitabine for 6 patients on each schedule.  36 patients were treated. The dose-limiting toxicities seen included nausea, dehydration, fatigue, hypotension and confusion. Minimal palmar-plantar erythrodysesthesia was seen. Myelosuppression was common, but not a dose limiting toxicity. The pharmacokinetic parameters for capecitabine were unaltered.  Using capecitabine to mimic FOLFOX6 is feasible and well tolerated with a toxicity profile that differs from standard 14-day capecitabine dosing, with less palmar-plantar erythrodysesthesia. The phase II dose for capecitabine in combination with oxaliplatin, 5FU, and LV is 1,500 mg/m2/dose or 2,250 mg/m2/dose in the absence of bolus 5FU/LV.
Inhalation of tobramycin in patients with cystic fibrosis: comparison of two methods.

Inhalant tobramycin is established in the treatment of cystic fibrosis patients. Conventional nebulizers require a large amount of the expensive compound, because only a small fraction is deposited in the targeted lung region. In contrast, techniques based on controlled inhalation allow a high and reproducible deposition of the drug in specific lung regions. In our study we compared the efficiency of two techniques based on conventional and controlled inhalation in 16 cystic fibrosis patients aged 13-39 years. Inhalations with the doses of tobramycin of 300 mg and 150 mg were performed twice daily for three days. The efficiency of the drug deposition was measured by the determination of its serum concentration 1 h after the end of the inhalation. The mean FEV1 value in our patients was 61% of predicted, range 36%-116%. There were no differences in tobramycin serum concentrations among the three study days in both methods (controlled inhalation: 0.983 +/-0.381(+/-SD) mg/l, 1.119+/-0.448 mg/l, 1.194+/-0.568 mg/l; conventional inhalation: 1.075+/-0.798 mg/l, 1.294 0.839 mg/l and 1.269+/-0.767 mg/l, on Day 1, Day 2, and Day 3, respectively). Even though the drug amount was double in the conventional technique, there was no significant difference in its overall serum concentration from the three study days (conventional inhalation: 1.210+/-0.783 mg/l, controlled inhalation: 1.092+/-0.461 mg/l). In addition, the coefficient of variation and the required inhalation time were shorter in controlled inhalation than in conventional inhalation (42% vs. 65% and 7-8 min vs. 20 min, respectively). Our data suggest that controlled inhalation can significantly reduce the amount of a drug required for therapy, the inhalation time required for drug deposition, and the variability of pulmonary dosage. It seems probable that controlled inhalation can improve the antibiotic prevention of pulmonary infection.
Costs of cervical cancer screening and treatment using visual inspection with acetic acid (VIA) and cryotherapy in Ghana: the importance of scale

To estimate the incremental costs of visual inspection with acetic acid (VIA) and cryotherapy at cervical cancer screening facilities in Ghana; to explore determinants of costs through modelling; and to estimate national scale-up and annual programme costs.



Resource-use data were collected at four out of six active VIA screening centres, and unit costs were ascertained to estimate the costs per woman of VIA and cryotherapy. Modelling and sensitivity analysis were used to explore the influence of observed differences between screening facilities on estimated costs and to calculate national costs.



Incremental economic costs per woman screened with VIA ranged from 4.93 US$ to 14.75 US$, and costs of cryotherapy were between 47.26 US$ and 84.48 US$ at surveyed facilities. Under base case assumptions, our model estimated the costs of VIA to be 6.12 US$ per woman and those of cryotherapy to be 27.96 US$. Sensitivity analysis showed that the number of women screened per provider and treated per facility was the most important determinants of costs. National annual programme costs were estimated to be between 0.6 and 4.0 million US$ depending on assumed coverage and adopted screening strategy.



  When choosing between different cervical cancer prevention strategies, the feasibility of increasing uptake to achieve economies of scale should be a major concern.
Effects of physical exercise on serum levels of serotonin and its metabolite in fibromyalgia: a randomized pilot study.

To evaluate the effects of aerobic training and stretching on serum levels of serotonin (5HT) and its main metabolite 5-hydroxindolacetic acid (5HIAA). Twenty-two women with FM were randomized into one of two exercise modalities (aerobic walking exercise or stretching exercise) to be accomplished three times a week for 20 weeks. The serum levels of 5HT and 5HIAA were evaluated before and after the exercise program by high performance liquid chromatography (HPLC) with colorimetric detection. Within group analysis (pre-post) showed that serum levels of both 5HT and 5HIAA changed significantly in the aerobic group during the 20-week course of therapy (5HT: P = 0,03; 5HIAA: P = 0,003). In the stretching group, however, no statistically significant change was observed (5HT: P=0,491; 5HIAA: P=0,549). Between group statistical comparisons of laboratory measures disclosed that aerobic training was superior to stretching in that it significantly increased the levels of 5HIAA (F test = 6.61; P = 0.01), but the average difference between groups on the levels of 5HT did not meet significance criteria (F test = 3.42; P = 0.08). Aerobic training increases the 5HIAA and 5HT levels and it could explain why aerobic exercise can improve symptoms in fibromyalgia syndrome patient more than stretching exercise.
Radical retropubic prostatectomy versus brachytherapy for low-risk prostatic cancer: a prospective study

To compare the oncological and functional outcomes reported after radical retropubic prostatectomy (RRP) versus brachytherapy (BT) in the treatment of low-risk prostatic cancer (CaP). Between May 1999 and October 2002, 200 patients (mean age 65.3 ± 8.7) were enrolled and randomized into two groups of 100 patients each to undergo RRP (group 1) or BT (group 2). Prior to and following treatment, all patients were evaluated by physical examination, PSA assay and compilation of IPSS, IIEF-5 and EORTC-QLQ-C30/PR25 questionnaires. Oncological results were reported at 5 years, while functional outcomes were reported at 6 months, and 1 and 5 years mean follow-up. Of the 200 patients studied, 174 completed the 5-year follow-up assessment. With regards to oncological outcomes, similar 5-year biochemical disease-free survival rates were reported for RRP (91.0%) or BT (91.7%). At 6 months and 1 year, both techniques produced a significant decrease in quality of life aspects, while group 2 patients reported a significantly higher and longer lasting rate of urinary irritative disorders and better erective function than group 1. No differences in functional outcomes were encountered after 5 years in either group. RRP and BT are two different options for the treatment of low-risk CaP, which produce different short-term sequelae in terms of urinary disorders and erective functions, but similar biochemical disease-free survival. Further studies with a higher number of patients and a longer follow-up are needed to evaluate their comparative effectiveness on overall disease-specific survival and metastatic disease.
Effect of etanercept, infliximab and methotrexate in the treatment of arthritis.

Rheumatoid arthritis a chronic inflammatory autoimmune disease with inflammation of the joint, leading to damage of bone and surrounding cartilage.



Our study was designed to find the efficacy of etanercept, infliximab and methotrexate in effective therapeutic management against arthritis patients.



A total of 315 patients, including both the sexes in the age group of 45-70 years with active rheumatoid arthritis attending Hospital of Academy of Military Medical Sciences, Beijing, China during the period of December 2012 to November 2013 were included in the study. 100 patients with joint pains, but not with rheumatoid arthritis were taken as a control group. All the patients were treated with infliximab, methotrexate and etanercept.



In our study, patients responded, 75% to infliximab and etanercept combinations than to methotrexate. The combination therapy also showed a radiological decrease in the joint damage. There is significant when combinations of these drugs were used for the therapy (P<0.001).



In our study, use of infliximab and etanercept combinations lowered the joint damage and helped in the improvement of the patient's life.
Short versus conventional term glucocorticoid therapy in acute exacerbation of chronic obstructive pulmonary disease - the "REDUCE" trial.

International guidelines advocate a 10 to 14-day course of systemic glucocorticoid therapy in the management of COPD exacerbations. The optimal duration of therapy is unknown and glucocorticoids have serious adverse effects. The aim of this trial is to demonstrate non-inferiority of a five-day compared to a 14-day course of systemic glucocorticoids with respect to COPD outcome, thereby significantly reducing steroid exposure and side effects in patients with COPD exacerbations.



This is a randomised, placebo-controlled, non-inferiority multicentre trial. Patients with acute COPD exacerbation are randomised to receive 40 mg of prednisone-equivalent daily for 14 days (conventional arm) or glucocorticoid treatment for 5 days, followed by placebo for another 9 days (intervention arm). Follow-up is 180 days. The primary endpoint is time to next exacerbation. Secondary endpoints include cumulative glucocorticoid dose, time to open-label glucocorticoid therapy, glucocorticoid-associated side effects and complications, duration of hospital stay, death, change in FEV1, need for assisted ventilation, clinical outcome assessed by standardised questionnaires, and suppression of the hypothalamic-pituitary-adrenal axis.



Mean age (± SD) of patients who finished the study was 70 ± 11 years. 12% had mild or moderate disease, whereas severe and very severe stages were found in 30 and 58%, respectively. At the time of inclusion, 20% of patients were under treatment with systemic glucocorticoids.



If the strategy of significantly reducing cumulative exposure to glucocorticoids while taking advantage of their beneficial short-term effects proves to be successful, it will warrant a change in common glucocorticoid prescription practice, thereby improving the management of COPD.
Coexistence of sleep and feeding disturbances in young children.

Behavioral insomnia and feeding difficulties are 2 prevalent conditions in healthy young children. Despite similarities in nature, etiology, prevalence, and age distribution, the association between these 2 common disorders in young children has not been examined thus far.



Children aged 6 to 36 months with either behavioral insomnia or feeding disorders were recruited. Children aged 6 to 36 months who attended the well-care clinics were recruited and served as controls. Sleep and feeding were evaluated by using a parental questionnaire.



Six hundred eighty-one children were recruited. Fifty-eight had behavioral insomnia, 76 had feeding disorders, and 547 were controls. The mean age was 17.0 ± 7.6 months. Parents of children with feeding disorders considered their child's sleep problematic significantly more frequently compared with controls (37% vs 16%, P = .0001 [effect size (ES): 0.66]). They reported shorter nocturnal sleep duration and delayed sleep time compared with controls (536 ± 87 vs 578 ± 88 minutes, P = .0001) and 9:13 ± 0.55 PM vs 8:26 ± 1.31 PM, P = .003). Parents of children with behavioral insomnia described their child's feeding as "a problem" more frequently compared with controls (26% vs 9%, P = .001 [ES: 0.69]). They reported being more concerned about their child's growth (2.85 ± 1.1 vs 2.5 ± 1.0, P = .03) and reported higher scores of food refusal compared with controls (3.38 ± 0.54 vs 3.23 ± 0.44, P = .04).



Problematic sleep and feeding behaviors tend to coexist in early childhood. Increased awareness of clinicians to this coexistence may allow early intervention and improve outcome.
Application of GEANT4 radiation transport toolkit to dose calculations in anthropomorphic phantoms.

In this paper, we present a novel implementation of a dose calculation application, based on the GEANT4 Monte Carlo toolkit. Validation studies were performed with an homogeneous water phantom and an Alderson-Rando anthropomorphic phantom both irradiated with high-energy photon beams produced by a clinical linear accelerator. As input, this tool requires computer tomography images for automatic codification of voxel-based geometries and phase-space distributions to characterize the incident radiation field. Simulation results were compared with ionization chamber, thermoluminescent dosimetry data and commercial treatment planning system calculations. In homogeneous water phantom, overall agreement with measurements were within 1-2%. For anthropomorphic simulated setups (thorax and head irradiation) mean differences between GEANT4 and TLD measurements were less than 2%. Significant differences between GEANT4 and a semi-analytical algorithm implemented in the treatment planning system, were found in low-density regions, such as air cavities with strong electronic disequilibrium.