nils-herrmann/clean_scirepeval huggingface dataset:
Protocol: does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction? Nitrites in acute myocardial infarction (NIAMI)

Whilst advances in reperfusion therapies have reduced early mortality from acute myocardial infarction, heart failure remains a common complication, and may develop very early or long after the acute event. Reperfusion itself leads to further tissue damage, a process described as ischaemia-reperfusion-injury (IRI), which contributes up to 50% of the final infarct size. In experimental models nitrite administration potently protects against IRI in several organs, including the heart. In the current study we investigate whether intravenous sodium nitrite administration immediately prior to percutaneous coronary intervention (PCI) in patients with acute ST segment elevation myocardial infarction will reduce myocardial infarct size. This is a phase II, randomised, placebo-controlled, double-blinded and multicentre trial. The aim of this trial is to determine whether a 5 minute systemic injection of sodium nitrite, administered immediately before opening of the infarct related artery, results in significant reduction of IRI in patients with first acute ST elevation myocardial infarction (MI). The primary clinical end point is the difference in infarct size between sodium nitrite and placebo groups measured using cardiovascular magnetic resonance imaging (CMR) performed at 6–8 days following the AMI and corrected for area at risk (AAR) using the endocardial surface area technique. Secondary end points include (i) plasma creatine kinase and Troponin I measured in blood samples taken pre-injection of the study medication and over the following 72 hours; (ii) infarct size at six months; (iii) Infarct size corrected for AAR measured at 6–8 days using T2 weighted triple inversion recovery (T2-W SPAIR or STIR) CMR imaging; (iv) Left ventricular (LV) ejection fraction measured by CMR at 6–8 days and six months following injection of the study medication; and (v) LV end systolic volume index at 6–8 days and six months. This study is funded by a grant from the UK Medical Research Council. This protocol is approved by the Scotland A Research Ethics Committee and has also received clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) (EudraCT number: 2010-023571-26).
Economic evaluation of telephone self-management interventions for blood pressure control.

Half of patients with hypertension have poor blood pressure (BP) control. Recent models for treating hypertension have integrated disease monitoring and telephone-based interventions delivered in patients' homes. This study evaluated the costs of the Hypertension Intervention Nurse Telemedicine Study (HINTS), aimed to improve BP control in veterans.



Eligible veterans were randomized to either usual care or 1 of 3 telephone-based intervention groups using home BP telemonitoring: (1) behavioral management, (2) medication management, or (3) combined. Intervention costs were derived from information collected during the trial. Direct medical costs (inpatient, outpatient, and outpatient pharmacy, including hypertension-specific pharmacy) at 18 months by group were calculated using Veterans Affairs (VA) Decision Support System data. Bootstrapped CIs were computed to compare intervention and medical costs between intervention groups and usual care.



Patients receiving behavior or medication management showed significant gains in BP control at 12 months; there were no differences in BP control at 18 months. In subgroup analysis, patients with poor baseline BP control receiving combined intervention significantly improved BP at 12 and 18 months. In overall and subgroup samples, average intervention costs were similar in the 3 study arms, and at 18 months, there were no statistically significant differences in direct VA medical costs or total VA costs between treatment arms and usual care.



To optimize investment in telephone-based home interventions such as the HINTS, it is important to identify groups of patients who are most likely to benefit from more intensive home BP management.
Impact of pharmaceutical care on knowledge, quality of life and satisfaction of postmenopausal women with osteoporosis

This study describes the analysis of secondary outcomes from a previously published randomised controlled trial, which assessed the effects of pharmaceutical care on medication adherence, persistence and bone turnover markers. The main focus of this manuscript is the effect of the provision of pharmaceutical care on these secondary outcomes, and details on the design of the intervention provided, the osteoporosis care plan and materials used to deliver the intervention.  To evaluate the effects of pharmaceutical care on knowledge, quality of life (QOL) and satisfaction of postmenopausal osteoporotic women prescribed bisphosphonates, and their associating factors.  Randomised controlled trial, performed at an osteoporosis clinic of a tertiary hospital in Malaysia.  Postmenopausal women diagnosed with osteoporosis (T-score ≤−2.5/lowtrauma fracture), just been prescribed weekly alendronate/risedronate were randomly allocated to receive intervention or standard care (controls). Intervention participants received a medication review, education on osteoporosis, risk factors, lifestyle modifications, goals of therapy, side effects and the importance of medication adherence at months 0, 3, 6 and 12.  Knowledge, QOL and satisfaction.  A total of 198 postmenopausal osteoporotic women were recruited: intervention = 100 and control = 98. Intervention participants reported significantly higher knowledge scores at months 3 (72.50 vs. 62.50 %), 6 (75.00 vs. 65.00 %) and 12 (78.75 vs. 68.75 %) compared to control participants. QOL scores were also lower (which indicates better QOL) at months 3 (29.33 vs. 38.41), 6 (27.50 vs. 36.56) and 12 (27.53 vs. 37.56) compared to control participants. Similarly, satisfaction score was higher in intervention participants (93.67 vs. 84.83 %). More educated women, with back pain, who were provided pharmaceutical care had better knowledge levels. Similarly, older, more educated women, with previous falls and back pain tend to have poorer QOL, whilst women who exercised more frequently and were provided pharmaceutical care had better QOL. Satisfaction also increased as QOL increases and when provided pharmaceutical care.  The provision of pharmaceutical care improved knowledge, QOL and satisfaction in Malaysian postmenopausal osteoporotic women, showing that pharmacists have the potential to improve patients’ overall bone health. Policymakers should consider placing a clinical pharmacist in the osteoporosis clinic to provide counselling to improve these outcomes.
Diabetes, race, and functional limitations in older U.S. men and women.

The presence of diabetes is associated with increased odds of difficulties in functional tasks but it remains unclear if the burden is similar by race.



Our study included 122,004 non-Hispanic Black (NHB) and non-Hispanic White (NHW) adults ≥50 years from the U.S. National Health Interview Survey (2001-2012). Diabetes was defined as self-reported diagnosis or medication use. Functional limitations were defined as any self-reported difficulty in performing mobility tasks, general physical activities (GPA), or leisure and social activities (LSA). Logistic regression models were created to investigate the relationship of race with functional limitations accounting for key covariates, among men and women, by diabetes status.



Among older U.S. adults, NHB versus NHW women without diabetes had a higher odds of limitations in mobility (OR=1.39, 1.30-1.49) and LSA (OR=1.13, 1.05-1.23) without diabetes but a similar odds of these limitations with diabetes by race, after adjusting for age, income, education, obesity, arthritis, heart disease, stroke, COPD, and cancer. Interestingly, NHB versus NHW women had significantly lower odds of GPA, irrespective of diabetes status. However, NHB versus NHW men with diabetes had a persistently higher odds for mobility and LSA limitations with diabetes as follows: mobility (OR=1.30, 1.12-1.51) and LSA limitations (OR=1.07, 1.06-1.34). The interaction of race and diabetes was significant among women for mobility limitations (p<0.01), but not men.



The burden of functional limitations differs by race among both men and women with diabetes. Future studies should examine mechanisms underlying these differences to prevent progression to disability in older adults with diabetes.
Acute effects of glucose tablets on craving, withdrawal symptoms, and sustained attention in 12-h abstinent tobacco smokers

Glucose administration may decrease desire to smoke in abstinent smokers. Moreover, glucose administration has been associated with improved performance on measures of attention in healthy humans but evidence remains modest.  The present study aimed to determine whether reported craving and nicotine withdrawal symptoms can be relieved, and sustained attention on the Rapid Visual Information Processing (RVIP) task improved, with the administration of 12 g oral glucose in nicotine-deprived smokers.  Forty-one smokers, abstinent for 12 h, participated in a double-blind, placebo-controlled, randomized study to examine the effect of glucose on desire to smoke, withdrawal symptoms, and attention. Participants completed the RVIP task once and then rated craving and nicotine withdrawal symptoms before chewing four 3 g glucose tablets (experimental group) or four matched placebo tablets (control group). Following tablet consumption participants rated craving and withdrawal symptoms at 5-min intervals for 20 min. Subsequently a second RVIP task was performed, followed by a final rating of craving and withdrawal symptoms.  Any effect of glucose across time was not statistically significant on craving, withdrawal symptoms, or performance on the RVIP task. There were no differences between the groups in measures of 'satisfaction' or 'sickness'.  The present study failed to find a significant effect of 12 g oral glucose on tobacco craving, withdrawal symptoms, or sustained attention in relatively young tobacco smokers after 12 h of tobacco abstinence.
Interferon Alfacon-1 and Ribavirin Versus Interferon α-2b and Ribavirin in the Treatment of Chronic Hepatitis C

Despite advances in the therapy of chronic hepatitis C, a large number of patients do not respond to current therapies. The study objective was to assess whether a combination of interferon (IFN) alfacon-1 and ribavirin improves the response rate compared with a combination of INF α-2b and ribavirin in chronic hepatitis C subjects. The study was designed as an open-label, prospective, randomized, controlled study; 128 subjects with chronic hepatitis C were randomized to INF alfacon-1, 15 μg three times per week, plus ribavirin, 1 g/day, or IFN-α2b, 3 million units three times per week, plus ribavirin, 1 g/day for 48 weeks. The end point of the study was a sustained viral response, defined as undetectable HCV RNA at 24 weeks post 48 weeks of treatment. Overall, 57% of subjects in the INF alfacon-1/ribavirin group achieved a sustained antiviral response, compared with 40% of subjects in the IFN-α2b/ribavirin group (P = 0.052). In the subset of subjects with a high viral load, HCV RNA was successfully eradicated in more individuals who received INF alfacon-1/ribavirin than subjects who received IFN-α2b/ribavirin (57 versus 31%; P = 0.025). Among individuals with genotype 1 and a high viral load, the sustained antiviral response was significantly higher with INF alfacon-1/ribavirin than with IFN-α2b/ribavirin (46 versus 14%; P = 0.019). Adverse events were similar in both treatment groups. In conclusion, this study demonstrated that the combination of INF alfacon-1 and ribavirin provides a significantly better treatment response compared with the combination of IFN-α 2b and ribavirin in chronic HCV subjects infected with genotype 1 and a high viral RNA load.
Sleeve Sensing Technologies and Haptic Feedback Patterns for Posture Sensing and Correction

The world population is aging rapidly. There is an increasing need for health assistance personnel, such as nurses and physiotherapeutic experts, in developed countries. On the other hand, there is a need to improve health care assistance to the population, and especially to elderly people. This will mostly benefit specific user groups, such as elderly, patients recovering from physical injury, or athletes. This paper describes a wearable sleeve being developed under the scope of the Augmented Human Assistance (AHA) project for assisting people. It proposes a new architecture for providing haptic feedback through patterns created by multiple actuators. Different sensing technologies are analyzed and discussed.
Influence of fluoxetine on olanzapine pharmacokinetics

Conventional antidepressant treatment fails for up to 30% of patients with major depression. When there are concomitant psychotic symptoms, response rates are even worse. Thus, subsequent treatment often includes combinations of antidepressants or augmentation with antipsychotic agents. Atypical antipsychotic agents such as olanzapine cause fewer extrapyramidal adverse effects than conventional antipsychotics; for that reason, they are an advantageous augmentation strategy for treatment-resistant and psychotic depression. The purpose of this study was to assess the potential for pharmacokinetic interaction between olanzapine and fluoxetine, a popular antidepressant that is a selective serotonin reuptake inhibitor. The pharmacokinetics of 3 identical single therapeutic doses of olanzapine (5 mg) were determined in 15 healthy nonsmoking volunteers. The first dose of olanzapine was taken alone, the second given after a single oral dose of fluoxetine (60 mg), and the third given after 8 days of treatment with fluoxetine 60 mg, qd. Olanzapine mean C max was slightly higher (by about 18%) and mean CL/F was slightly lower (by about 15%) when olanzapine was coadministered with fluoxetine in single or multiple doses. Olanzapine mean t 1/2 and median t max did not change. Although the pharmacokinetic effects of fluoxetine on olanzapine were statistically significant, the effects were small and are unlikely to modify olanzapines safety profile. The mechanism of influence is consistent with an inhibition of CYP2D6, which is known to control a minor pathway of olanzapine metabolism.
Randomised trial of a computer-generated tailored written education package for patients following stroke.

The ideal method of providing stroke patients with information has not been established.



To evaluate the effectiveness of providing stroke patients with computer-generated tailored written information.



Randomised controlled trial with blinded assessor.



Acute stroke unit.



138 stroke patients.



Patients were randomised to receive either computer-generated tailored written information about stroke or generic written information while in hospital. Three months following discharge, a blinded assessor evaluated the outcomes of knowledge about stroke, self-efficacy (Self-Efficacy to Perform Self-Management Behaviours Scale), anxiety and depression (Hospital Anxiety and Depression (HAD) Scale), perceived health status (COOP charts), satisfaction with content and presentation of the written information received (separate 10-point visual analogue scale for content and presentation), and desire for additional information.



Complete data were obtained for 133 (96.4%) patients. Patients in the intervention group were significantly more satisfied with the content (difference on a 10-point visual analogue scale was 1, 95% confidence interval 0.4 to 1.7, P = 0.003) and presentation (difference on a 10-point visual analogue scale was 1.2, 95% confidence interval 0.6 to 1.9, P < 0.001). Significantly, fewer patients in the intervention group desired additional information about stroke at follow-up than patients in the control group (4.5% versus 32.8%; P < 0.001). Anxiety change scores improved slightly more in favour of the control group (1.4 difference on the HAD subscale, 95% confidence interval 0.2 to 2.8, P = 0.03). No significant differences between the groups were observed for any of the other outcome measures.



Providing stroke patients with computer-generated tailored written information improved satisfaction with the information that was received and was more effective in meeting patients' informational needs than non-tailored information, but had no effect on knowledge about stroke, self-efficacy, depression, or perceived health status.
The reliability and validity of the Malay version of the 18-item audit of Diabetes Dependent Quality of Life (the Malay ADDQOL) questionnaire.

The objective of this study was to examine the reliability and validity of the Malay version of the 18-item Audit of Diabetes Dependent Quality of Life (the Malay ADDQOL). Patients with type 2 diabetes mellitus who fulfilled the inclusion criteria were systematically selected. The Malay ADDQOL linguistically validated from the 18-item English version ADDQOL was self-administered twice at a 1-week interval. Two hundred eighty-eight respondents were included in the study. Analysis involved checking the feasibility, floor and ceiling effects, internal consistency, test-retest reliability and factor analysis. Item means and standard deviations fulfilled the Likert scale assumptions. The Cronbach's alpha was 0.943 (lower bound of the 95% CI of 0.935) and the intraclass correlation coefficient was 0.81 (95% CI from 0.72 to 0.87). Exploratory one factor analysis showed factor loadings above 0.5 for all the 18 items. The Malay ADDQOL has acceptable linguistic validity. It is feasible, has excellent reliability, content, construct validity, and is recommended to be used among Malay-speaking diabetic patients.
Multilevel analysis of the determinants of the global assessment of functioning in an inpatient population

The Global Assessment of Functioning (GAF) is a widely used measure of psychiatric symptoms and functioning, yet numerous concerns persist about its reliability and validity. The objective of this study was to determine the extent to which GAF scores reflect physician-related differences in addition to information about patients.



This is a secondary analysis of clinical data collected between 2005 and 2010 from inpatients at a psychiatric hospital (N = 1,852). Multilevel modeling was used to estimate the influence of physicians on GAF scores at admission and on the change between admission and discharge, controlling for patient clinical presentation.



Controlling for patient-level predictors, 7% of the residual variance in admission GAF scores and 8% of the residual variance in change scores was at the physician level. The physician-level variance was significantly larger than zero in both models.



Although statistically significant, estimates of physician-level variance were not overwhelming, suggesting that the GAF was rated in a consistent manner across physicians in this hospital. While results lend support to the utility of the GAF for drawing comparisons between patients seen by different physicians across a large institution, further study is necessary to determine generalizability and to assess differences across multiple institutions.
The role of high-resolution endoscopy and narrow-band imaging in the evaluation of upper GI neoplasia in familial adenomatous polyposis.

The Spigelman classification stratifies cancer risk in familial adenomatous polyposis (FAP) patients with duodenal adenomatosis. High-resolution endoscopy (HRE) and narrow-band imaging (NBI) may identify lesions at high risk.



To compare HRE and NBI for the detection of duodenal and gastric polyps and to characterize duodenal adenomas harboring advanced histology with HRE and NBI.



Prospective, nonrandomized, comparative study. Retrospective image evaluation study.



Tertiary-care center.



Thirty-seven FAP patients undergoing surveillance upper endoscopies.



HRE endoscopy was followed by NBI. The number of gastric polyps and Spigelman staging were compared. Duodenal polyp images were systematically reviewed in a learning and validation phase.



Number of gastric and duodenal polyps detected by HRE and NBI and prevalence of specific endoscopic features in duodenal adenomas with advanced histology.



NBI did not identify additional gastric polyps but detected more duodenal adenomas in 16 examinations, resulting in upgrades of the Spigelman stage in 2 cases (4.4%). Pictures of 168 duodenal adenomas (44% advanced histology) were assessed. In the learning phase, 3 endoscopic features were associated with advanced histology: white color, enlarged villi, and size ≥1 cm. Only size ≥1 cm was confirmed in the validation phase (odds ratio 3.0; 95% confidence interval, 1.2-7.4).



Nonrandomized study, scant number of high-grade dysplasia adenomas.



Inspection with NBI did not lead to a clinically relevant upgrade in the Spigelman classification and did not improve the detection of gastric polyps in comparison with HRE. The only endoscopic feature that predicted advanced histology of a duodenal adenoma was size ≥1 cm.
Development of the risk appraisal measure: a brief screen to identify risk areas and guide interventions for dementia caregivers.

To develop and validate a brief screening measure for use in research, healthcare, and community settings to systematically assess well-being and identify needed areas of support for caregivers of patients with dementia.



This study used data from Resources for Enhancing Alzheimer's Caregiver Health (REACH II), a multisite randomized clinical trial of a behavioral intervention designed to improve the quality of life of caregivers in multiple domains.



REACH II.



Two hundred twelve Hispanic, 211 black, and 219 white family caregivers providing in-home care to patients with dementia.



Based on conceptual and psychometric analyses, a 16-item measure was developed that assesses six domains linked to caregiver risk and amenable to intervention: depression, burden, self-care and health behaviors, social support, safety, and patient problem behaviors. The reliability and validity of the instrument was evaluated with 642 dementia caregiver dyads from the REACH II program.



The measure was found to have acceptable internal consistency for a multidimensional scale and similar measurement properties for each of the racial and ethnic groups. Concurrent validity was also demonstrated for the measure.



The REACH Risk Appraisal Measure developed in this study shows promise as an assessment tool that can be used in research, clinical, and community settings to guide, prioritize, and target needed areas of support for caregivers of patients with dementia.