nils-herrmann/clean_scirepeval huggingface dataset:
Learning from dying patients during their final days: life reflections gleaned from dignity therapy.

Dignity therapy is a novel therapeutic approach designed to decrease suffering, enhance quality of life and bolster a sense of dignity for patients approaching death. The benefits of dignity therapy were previously documented in a sample of 100 terminally ill patients. One of the products of dignity therapy is a transcript of the edited therapy session(s). In this qualitative study, 50 of the 100 (17 from Winnipeg, Manitoba, Canada, and 33 from Perth, Australia) dignity therapy transcripts were randomly drawn, and independently coded and analysed by three investigators using a grounded theory approach. The transcripts revealed that dignity therapy serves to provide a safe, therapeutic environment for patients to review the most meaningful aspects of their lives in such a manner that their core values become apparent. The most common values expressed by the patients included 'Family', 'Pleasure', 'Caring', 'A Sense of Accomplishment', 'True Friendship', and 'Rich Experience'. Exemplars of each of these values illustrate the pervasive, defining role of values in our lives. The findings are discussed in terms of values theory, the role of dignity therapy, and consideration of values clarification in clinicians' efforts to enhance the dignity of terminally ill patients.
Utility of glycated hemoglobin in diagnosing type 2 diabetes mellitus: a community-based study.

Although glycated hemoglobin (HbA1c) has recently been incorporated as a diagnostic test by the American Diabetes Association, its validity needs to be established in Asian Indians in a community setting.



The objective of the study was to assess the validity of HbA1c as a screening and diagnostic test in individuals with newly detected diabetes mellitus.



Community based randomized cross sectional study in urban Chandigarh, a city in north India, from April 2008 to August 2009.



Subjects included 1972 subjects aged 20 yr or older.



Intervention included an oral glucose tolerance test and glycated hemoglobin in all the subjects.



Utility of HbA1c as a diagnostic method in newly detected diabetes mellitus subjects was evaluated.



Using World Health Organization criteria for diagnosis of diabetes mellitus, 134 (6.7%) had newly detected diabetes mellitus, 192 (9.7%) known diabetes mellitus, 329 (16.6%) prediabetes, and 1317 (69.4%) were normal of 1972 people screened. Using only the ADA criteria, 38% people were underdiagnosed. An HbA1c level of 6.1% had an optimal sensitivity and specificity of 81% for diagnosing diabetes. A HbA1c level of 6.5% (+/-2 SD) and 7% (+/-2.7 SD) had sensitivity and specificity of 65 and 88% and 42 and 92%, respectively, with corresponding positive predictive value and negative predictive value of 75.2 and 96.5% and 90.4 and 94.4%, respectively, for diagnosis of newly detected diabetes mellitus.



A HbA1c cut point of 6.1% has an optimal sensitivity and specificity of 81% and can be used as a screening test, and a cut point of 6.5% has optimal specificity of 88% for diagnosis of diabetes.
The incidence of bradyarrhythmias and clinical bradyarrhythmic events in patients with acute coronary syndromes treated with ticagrelor or clopidogrel in the PLATO (Platelet Inhibition and Patient Outcomes) trial: results of the continuous electrocardiographic assessment substudy.

The aim of this study was to determine whether ticagrelor increased the risk of ventricular pauses compared with clopidogrel and whether these pauses were associated with any clinical bradycardic events in patients presenting with acute coronary syndromes.



Ticagrelor, an oral reversibly binding P2Y(12) inhibitor, provides more potent and consistent inhibition of platelet aggregation than clopidogrel but in a phase II study was associated with increased risk for ventricular pauses. A prospective continuous electrocardiographic (cECG) assessment was therefore performed within the PLATO (Platelet Inhibition and Patient Outcomes) study comparing ticagrelor and clopidogrel in patients hospitalized with acute coronary syndromes.



Patients in the cECG assessment had planned 7-day cECG recording initiated at the time of randomization (week 1), which was within 24 h of symptom onset, and then repeated at 1 month after randomization during the convalescent phase. The principal safety endpoint was the incidence of ventricular pauses lasting at least 3 s. Investigators also reported symptomatic bradycardic adverse events during the entire study duration (median 277 days).



A total of 2,908 patients were included in the cECG assessment, of whom 2,866 (98.5%) had week 1 recordings, 1,991 (68.4%) had 1-month recordings, and 1,949 (67.0%) had both. During the first week after randomization, ventricular pauses ≥3 s occurred more frequently in patients receiving ticagrelor than clopidogrel (84 [5.8%] vs. 51 [3.6%]; relative risk: 1.61; p = 0.006). At 1 month, pauses ≥3 s occurred overall less frequently and were similar between treatments (2.1% vs. 1.7%). Most were ventricular pauses, and the greatest excess associated with ticagrelor were asymptomatic, sinoatrial nodal in origin (66%), and nocturnal. There were no differences between ticagrelor and clopidogrel in the incidence of clinically reported bradycardic adverse events, including syncope, pacemaker placement, and cardiac arrest.



In the PLATO cECG assessment, more patients treated with ticagrelor compared with clopidogrel had ventricular pauses, which were predominantly asymptomatic, sinoatrial nodal in origin, and nocturnal and occurred most frequently in the acute phase of acute coronary syndromes. There were no apparent clinical consequences related to the excess in ventricular pauses in patients assigned to ticagrelor.
Gender difference in the response to valsartan/amlodipine single-pill combination in essential hypertension (China Status II): An observational study

The China STATUS II is a prospective, multicentre, open-label, post-marketing, observational study including Chinese adults (aged ⩾ 18 years) with essential hypertension who were prescribed once-daily valsartan/amlodipine (Val/Aml 80/5 mg) single-pill combination. In order to examine gender differences in treatment response to Val/Aml, we further analysed data from the China STATUS II study.



A total of 11,312 patients (6456 (57%) men and 4856 (43%) women) received the Val/Aml treatment for 8 weeks. After the treatment, we compared the proportion of patients not achieving the target systolic blood pressure (SBP: < 140 mm Hg) or diastolic blood pressure (DBP: < 90 mm Hg) in different age groups (by Fisher exact probability test) and estimated the changes in blood pressure (BP) according to age and gender, using a mixed model.



At enrolment, mean SBP was higher in the female versus the male patients (160.0 ± 12.71 versus 159.3 ± 12.31 mm Hg; p = 0.003), whereas the mean DBP was higher in the male versus the female patients (96.4 ± 10.65 versus 94.5 ± 10.72 mm Hg; p < 0.001). The overall proportion of women not achieving the target BP was less than that of men (57.41% versus 59.59%; p < 0.05) at 4 weeks and (22.22% versus 23.78%; p < 0.05) at 8 weeks after the Val/Aml treatment. Among both men and women, the proportion of patients not achieving the target SBP increased with age; however, the proportion not achieving the target DBP decreased with age. The mixed-model analysis showed that the changes in SBP were closely related to gender, indicating that the SBP-lowering effect after Val/Aml treatment might be better in women. In addition, the changes in DBP were closely related to age.



Gender might be a factor for consideration in the decision-making process of individualised antihypertensive therapy, in the future.
Translation and validation of the parent-adolescent communication scale: technology for DST/HIV prevention.

accomplishment of the transcultural adaptation of the Parent-adolescent Communication Scale, which evaluates the frequency of communication between parents and children concerning the subjects related to sex, condom, DST, HIV and pregnancy.



Methodological research of quantitative approach, accomplished with 313 adolescent pupils of the feminine sex in the 14 to 18 year age group in Fortaleza-CE. The content validity was carried through by means of the initial translation, back translation, pre-final version and final version, being analyzed by a committee of specialists; the reliability was verified by the Cronbach's Alpha and ascertained by testing the hypotheses and test-retest within five weeks. The scale was applied via computer in the online modality in the period November/2010 to January/2011.



The version of the instrument in Portuguese presented an Alpha of 0.86 regarding the validity of the structure, was partially verified since the testing of the hypotheses of the contracted group was not confirmed.



The version of the instrument adapted for Portuguese is considered valid and reliable in the study sample.
The Edinburgh randomised trial of breast cancer screening: results after 10 years of follow-up.

The Edinburgh Randomised Trial of Breast Cancer Screening recruited 44,288 women aged 45-64 years into the initial cohort of the trial during 1978-81, and 10 years of follow-up is now complete. A total of 22,944 women were randomised into the study group and were offered screening for 7 years; the remaining women formed the control group. After 10 years, breast cancer mortality is 14-21% lower in the study group than in the controls depending on the precise definition of the end point. These differences are not statistically significant; for breast cancer as the underlying cause of death the relative risk is 0.82 (95% confidence interval 0.61-1.11). Rates of locally advanced and metastatic cancer were substantially lower in the study group, but screening has failed to achieve marked reductions in rates of small node-positive cancers. Those women who accepted the final invitation to screening have been monitored over the 3 year period prior to their first screen under the UK service screening programme. Interval cases, expressed as a proportion of the control incidence, increased from 12% in the first year to 67% in the third year. The reduction in breast cancer mortality for older women (aged at least 50 years) is the same as that for the total study group for this duration of follow-up. For analyses of breast cancer mortality in younger women updates recruited to the trial from 1982 to 1985 (10,383 women with 6-8 years' follow-up) have been included. The reduction in breast cancer mortality for women aged 45-49 years at entry was 22% (relative risk = 0.78, 95% confidence interval = 0.46-1.31).
The Effect of Patient Navigation on Time to Diagnosis, Anxiety, and Satisfaction in Urban Minority Women with Abnormal Mammograms: A Randomized Controlled Trial

Delay in follow-up after an abnormal mammogram is associated with advanced disease stage, poorer survival, and increased anxiety. Despite the implementation of many patient navigator programs across the country, there are few published, peer-reviewed studies documenting its effectiveness. We tested the effectiveness of a patient navigator in improving timeliness to diagnosis, decreasing anxiety, and increasing satisfaction in urban minority women after an abnormal mammogram. Women with suspicious mammograms were randomly assigned to usual care (N = 50) or usual care plus intervention with a patient navigator (N = 55). There were no demographic differences between the two groups. Women in the intervention group had shorter times to diagnostic resolution (mean 25.0 vs. 42.7 days; p = .001), with 22% of women in the control group without a final diagnosis at 60 days vs. 6% in the intervention group. The intervention group also had lower mean anxiety scores (decrease of 8.0 in intervention vs. increase of 5.8 in control; p < .001), and higher mean satisfaction scores (4.3 vs. 2.9; p < .001). Patient navigation is an effective strategy to improve timely diagnostic resolution, significantly decrease anxiety, and increase patient satisfaction among urban minority women with abnormal mammograms.
Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects

Ketamine, an N-methyl-D-aspartate receptor (NMDAR) channel blocker, has been found to induce rapid and robust antidepressant-like effects in rodent models and in treatment-refractory depressed patients. However, the marked acute psychological side effects of ketamine complicate the interpretation of both preclinical and clinical data. Moreover, the lack of controlled data demonstrating the ability of ketamine to sustain the antidepressant response with repeated administration leaves the potential clinical utility of this class of drugs in question. Using quantitative electroencephalography (qEEG) to objectively align doses of a low-trapping NMDA channel blocker, AZD6765 (lanicemine), to that of ketamine, we demonstrate the potential for NMDA channel blockers to produce antidepressant efficacy without psychotomimetic and dissociative side effects. Furthermore, using placebo-controlled data, we show that the antidepressant response to NMDA channel blockers can be maintained with repeated and intermittent drug administration. Together, these data provide a path for the development of novel glutamatergic-based therapeutics for treatment-refractory mood disorders.
Specificity of genetic and environmental risk factors for symptoms of cannabis, cocaine, alcohol, caffeine, and nicotine dependence.

Although genetic risk factors have been found to contribute to dependence on both licit and illicit psychoactive substances, we know little of how these risk factors interrelate.



To clarify the structure of genetic and environmental risk factors for symptoms of dependence on cannabis, cocaine, alcohol, caffeine, and nicotine in males and females.



Lifetime history by structured clinical interview.



General community.



Four thousand eight hundred sixty-five members of male-male and female-female pairs from the Virginia Adult Twin Study of Psychiatric and Substance Use Disorders.  Lifetime symptoms of abuse of and dependence on cannabis, cocaine, alcohol, caffeine, and nicotine.



Controlling for greater symptom prevalence in males, genetic and environmental parameters could be equated across sexes. Two models explained the data well. The best-fit exploratory model contained 2 genetic factors and 1 individual environmental factor contributing to all substances. The first genetic factor loaded strongly on cocaine and cannabis dependence; the second, on alcohol and nicotine dependence. Nicotine and caffeine had high substance-specific genetic effects. A confirmatory model, which also fit well, contained 1 illicit drug genetic factor--loading only on cannabis and cocaine--and 1 licit drug genetic factor loading on alcohol, caffeine, and nicotine. However, these factors were highly intercorrelated (r = + 0.82). Large substance-specific genetic effects remained for nicotine and caffeine.



The pattern of genetic and environmental risk factors for psychoactive substance dependence was similar in males and females. Genetic risk factors for dependence on common psychoactive substances cannot be explained by a single factor. Rather, 2 genetic factors-one predisposing largely to illicit drug dependence, the other primarily to licit drug dependence-are needed. Furthermore, a large proportion of the genetic influences on nicotine and particularly caffeine dependence appear to be specific to those substances.
Influence of age, renal and liver impairment on the pharmacokinetics of risperidone in man

The pharmacokinetics of the antipsychotic agent risperidone were investigated in healthy young and elderly subjects, cirrhotic patients and patients with moderate and severe renal insufficiency. In a comparative trial, a single oral 1-mg dose was administered to fasting subjects. Plasma and urine concentrations of the parent compound risperidone and the active moiety (i.e. risperidone plus 9-hydroxy-risperidone) were measured by radioimmunoassays. No or only small changes in plasma protein binding were observed in hepatic and renal disease, whereas the protein binding was not influenced by aging. The inter-individual variability in plasma concentrations of the active moiety was much less than the variability in plasma concentrations of risperidone. Three out of six subjects, behaving like poor metabolizers, were on medication (thiethylperazine, amitriptyline, metoprolol) that may inhibit risperidone metabolism by CYP2D6 (debrisoquine 4-hydroxylase). The pharmacokinetics of risperidone in elderly and cirrhotic patients were comparable to those in young subjects, whereas total oral clearance was reduced in renal disease patients. The elimination rate and clearance of 9-hydroxy-risperidone was reduced in elderly and renal disease patients because of a diminished creatinine clearance. The CLoral of the active moiety, which is primarily 9-hydroxy-risperidone, was reduced by about 30% in the elderly and by about 50% in renal disease patients. In addition, the t1/2 of the active moiety was prolonged (19 h in young subjects versus about 25 h in elderly and renal disease patients). Based upon the pharmacokinetics of the active moiety, a dose reduction and a cautious dose titration is advised in the elderly and in patients with renal disease. In cirrhotic patients, the single-dose pharmacokinetics were comparable to those in healthy young subjects.
Rates of non-confounded HIV-associated neurocognitive disorders in men initiating combination antiretroviral therapy during primary infection.

To determine the prevalence of HIV-associated neurocognitive disorders (HAND) in HIV-infected participants who initiated combination antiretroviral therapy (cART) during primary infection.



Cross-sectional observational study.



HIV-infected men without neuropsychiatric confounds who had initiated cART during primary infection were administered a neuropsychological battery as well as questionnaires evaluating depression and quality of life. 
Twenty-six primarily non-Hispanic white (73%), male (100%) participants were enrolled and underwent neurocognitive assessment. Mean age was 44 (28-71) years, with a median of 17 years of education (13-24). Median current and nadir CD4 T-cell counts were 828 (506-1411) and 359 (150-621) cells/μl. All participants had plasma HIV-1 RNA less than 50 copies/ml. Median duration of cART prior to enrolment was 5.7 years (2.2-9.9). Median global deficit score was 0.17 (0.00-0.60). Only one (4%) participant was impaired.



Rates of HAND in this cohort of HIV-infected men without comorbid conditions who initiated early cART are low. Our findings suggest a possible neuroprotective benefit of early cART and an important contribution of comorbidities to observed HAND prevalence.
Effect of raloxifene combined with monofluorophosphate as compared with monofluorophosphate alone in postmenopausal women with low bone mass: a randomized, controlled trial

Raloxifene effectively reduces the incidence of vertebral fractures in patients with postmenopausal osteoporosis. Recent data suggest that low-dose monofluorophosphate (MFP) plus calcium reduces the vertebral fracture rate in postmenopausal women with moderate osteoporosis. The objective of this study was to evaluate the combination of raloxifene and MFP in the treatment of postmenopausal women with osteopenia, osteoporosis and severe osteoporosis. A total of 596 postmenopausal women with osteopenia, osteoporosis and severe osteoporosis (mean femoral neck T-score of –2.87 SD) were randomized to treatment with 60 mg/day raloxifene HCl and 20 mg/day fluoride ions (as MFP) or 20 mg/day fluoride and placebo for 18 months. All patients received calcium (1000 mg/day) and vitamin D (500 IU/day) supplements. Changes in bone mineral density (BMD), as primary endpoint, and the rate of osteoporotic fractures and biochemical markers, as secondary endpoints, were assessed. As compared with MFP, raloxifene plus MFP was associated with significantly greater mean increases in the BMD of the femoral neck (1.37% versus 0.33%; P=0.004), total hip (0.89% versus −0.42%; P<0.001) and lumbar spine (8.80% versus 5.47% P<0.001). In the raloxifene plus MFP group, 16 patients sustained 17 osteoporotic fractures, as compared with 22 patients sustaining 34 incident osteoporotic fractures in the MFP group (P=0.313). One patient in the raloxifene plus MFP group sustained multiple osteoporotic fractures, as compared with eight patients in the MFP group (P=0.020). MFP alone significantly increased the serum bone alkaline phosphatase (bone ALP) and the urinary C-terminal crosslinking telopeptide of type I collagene (U-CTX). The addition of raloxifene in the combination arm blunted the rise in bone ALP, which remained nevertheless significant, and abolished the increase in U-CTX. The combination of raloxifene with MFP was generally well tolerated. This study demonstrates that, in postmenopausal women with osteopenia, osteoporosis and severe osteoporosis, the combination therapy of raloxifene plus MFP favorably influences the BMD and the bone formation and resorption balance, and may reduce the risk of multiple osteoporotic fractures compared to MFP alone.
Reevaluation of moxifloxacin pharmacokinetics and their direct effect on the QT interval.

The objectives of this study were to investigate the population pharmacokinetics of moxifloxacin and their relationship with the observed QT interval as well as the effect of covariates in healthy subjects using nonlinear mixed-effects modeling. A pool of 4 thorough QT studies were used, representing 99 healthy subjects who received moxifloxacin. The data were modeled using Monolix. Moxifloxacin pharmacokinetics were ascribed a 2- compartment open model. The TRANSIT model provided a better description of the delay in absorption than did the LAG model. The most significant covariate was lean body mass (LBM). The population estimates for clearance and central volume of distribution were 10.0 L/h per 60 kg of LBM and 131 L per 60 kg of LBM, respectively. The effect of moxifloxacin on QT was investigated using a direct effect model. The SLOPE model, relating the QT increase as a linear function of concentration, provided a better description of the pharmacodynamic effect than did the Emax model. The unique covariate was gender for both baseline QT and individual heart rate correction factor. The pharmacokinetics of moxifloxacin were satisfactorily described by an open 2-compartmental model with linear elimination. The trigonometric equation with a direct and proportional concentration effect satisfactorily described the effect on QT.