nils-herrmann/clean_scirepeval huggingface dataset:
Effect of Comorbidity on Prostate Cancer–Specific Mortality: A Prospective Observational Study

To determine the effect of comorbidity on prostate cancer (PCa)-specific mortality across treatment types.  These are the results of a population-based observational study in Sweden from 1998 to 2012 of 118,543 men who were diagnosed with PCa with a median follow-up of 8.3 years (interquartile range, 5.2 to 11.5 years) until death from PCa or other causes. Patients were categorized by patient characteristics (marital status, educational level) and tumor characteristics (serum prostate-specific antigen, tumor grade and clinical stage) and by treatment type (radical prostatectomy, radical radiotherapy, androgen deprivation therapy, and watchful waiting). Data were stratified by Charlson comorbidity index (0, 1, 2, or ≥ 3). Mortality from PCa and other causes and after stabilized inverse probability weighting adjustments for clinical patient and tumor characteristics and treatment type was determined. Kaplan-Meier estimates and Cox proportional hazards regression models were used to calculate hazard ratios.  In the complete unadjusted data set, we observed an effect of increased comorbidity on PCa-specific and other-cause mortality. After adjustments for patient and tumor characteristics, the effect of comorbidity on PCa-specific mortality was lost but maintained for other-cause mortality. After additional adjustment for treatment type, we again failed to observe an effect for comorbidity on PCa-specific mortality, although it was maintained for other-cause mortality.  This large observational study suggests that comorbidity affects other cause-mortality but not PCa-specific- mortality after accounting for patient and tumor characteristics and treatment type. Regardless of radical treatment type (radical prostatectomy or radical radiotherapy), increasing comorbidity does not seem to significantly affect the risk of dying from PCa. Consequently, differences in oncologic outcomes that were observed in population-based comparative effectiveness studies of PCa treatments may not be a result of the varying distribution of comorbidity among treatment groups.
Infection control policies and hospital-associated infections among surgical patients: variability and associations in a multicenter pediatric setting.

Hospital-associated infections are an important cause of patient morbidity and death. Little is known about the variability of infection rates and infection control practices among pediatric hospitals.



This cross-sectional study was performed with the Pediatric Health Information System database, which includes demographic and diagnostic data for 35 freestanding, noncompeting, children's hospitals, and with data from a survey of the hospitals, which yielded additional information on infection control policies and practices. Patients undergoing elective surgical procedures were included in this study.



Of the 35 eligible hospitals, 31 (89%) chose to participate in the survey component of this study. A total of 48278 patients met the inclusion criteria for the study; 2.3% of these patients had respiratory infections and 0.8% had gastrointestinal infections. The frequency of patients diagnosed with respiratory or gastrointestinal infections varied considerably among the hospitals and ranged from <1% to 6%. Certain infection control processes also varied among the hospitals during the study period. For instance, of the 31 hospitals, 12 monitored hand hygiene, 19 had administrative support of hand hygiene, and 16 had alcohol hand gel present for the entire study period. The presence of alcohol hand gel for the entire study was strongly and independently associated with lower odds of gastrointestinal infections (adjusted odds ratio: 0.64; 95% confidence interval: 0.49-0.85).



Hospitals should support the use of alcohol hand gel, with the aim of decreasing hospital-associated infection rates.
Memantine enhances recovery from stroke.

Stroke treatment is constrained by limited treatment windows and the clinical inefficacy of agents that showed preclinical promise. Yet animal and clinical data suggest considerable poststroke plasticity, which could allow treatment with recovery-modulating agents. Memantine is a well-tolerated N-methyl-D-aspartate glutamate receptor antagonist in common use for Alzheimer disease.



Memantine, 30 mg/kg per day, or vehicle, was delivered chronically in drinking water beginning >2 hours after photothrombotic stroke.



Although there was no difference in infarct size, behavior, or optical intrinsic signal maps in the first 7 days after stroke, mice treated chronically with memantine showed significant improvements in motor control, measured by cylinder test and grid-walking performance, compared with vehicle-treated animals. Optical intrinsic signal revealed an increased area of forepaw sensory maps at 28 days after stroke. There was decreased reactive astrogliosis and increased vascular density around the infarcted cortex. Peri-infarct Western blots revealed increased brain-derived neurotrophic factor and phosphorylated-tropomyosin-related kinase-B receptor expression.



Our results suggest that memantine improves stroke outcomes in an apparently non-neuroprotective manner involving increased brain-derived neurotrophic factor signaling, reduced reactive astrogliosis, and improved vascularization, associated with improved recovery of sensory and motor cortical function. The clinical availability and tolerability of memantine make it an attractive candidate for clinical translation.
Thought suppression: an experimental investigation of spider phobics.

Researchers have observed that attempts to suppress a thought cause either an immediate increase in the occurrence of the thought (i.e. immediate enhancement effect) or a delayed increase in the occurrence of the thought (i.e. rebound effect). In this study, we examined whether suppression of a personally-relevant, emotional thought item (i.e. a spider to spider phobics) results in an immediate enhancement or a rebound effect. Forty-eight spider phobics were randomly assigned to either a suppression group or a control group. Subjects spent three 5-min periods alone monitoring their thoughts. During the first period, subjects in both groups were instructed to 'think about anything'. During the second period, subjects in the suppression group were instructed 'not to think of a spider', whereas subjects in the control group were instructed to 'think about anything'. During the third period, subjects in both groups were instructed to 'think about anything'. The number of spider-related thoughts was recorded for each period. Results from the second period failed to support an immediate enhancement effect. Evidence for a rebound effect, however, was obtained in the third period. The theoretical and clinical implications of these findings are discussed.
Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. The Diabetes Control and Complications (DCCT) Research Group.

The Diabetes Control and Complications Trial (DCCT) has demonstrated that intensive diabetes treatment delays the onset and slows the progression of retinopathy, nephropathy, and neuropathy in patients with IDDM. A detailed description of the effects of this treatment on diabetic nephropathy is presented here. In the primary prevention cohort, intensive treatment reduced the mean adjusted risk of the cumulative incidence of microalbuminuria (> or = 28 micrograms/min) by 34% (95% CI 2, 56%; P = 0.04). Furthermore, intensive treatment decreased the albumin excretion rate (AER) by 15% after the first year of therapy (6.5 vs. 7.7 micrograms/min, P < 0.001). Thereafter the rates of change for AER within each treatment group were no different from zero, retaining a constant difference in AER between groups in the trial. In the secondary intervention cohort with baseline AER < 28 micrograms/min, intensive therapy reduced the mean adjusted risk of microalbuminuria (> or = 28 micrograms/min) by 43% (95% CI 21, 58%; P < 0.0001); the risk of a more advanced level of microalbuminuria (> or = 70 micrograms/min) by 56% (95% CI 26, 74%; P = 0.002); and the risk of clinical albuminuria (> or = 208 micrograms/min) by 56% (95% CI 18, 76%; P < 0.01). In the secondary intervention cohort, values for AER at year 1 were identical at 9 micrograms/min, but the 6.5% change per year in the conventional group greatly exceeded the rate of change of -0.3% in the intensive group (P < 0.001). Among the 73 secondary cohort subjects with AER levels > or = 28 micrograms/min but < or = 139 micrograms/min at baseline, the reduction of progression to clinical albuminuria with intensive therapy was not statistically significant. The longitudinal treatment effect of conventional versus intensive therapy (11.0% vs. 2.5% per year, respectively, P = 0.087) was similar in magnitude to that among patients with AER < 28 micrograms/min at baseline. For the primary, secondary and combined cohorts, there were no significant differences in the rates of change in creatinine clearance (CCr) between treatment groups during the study. Only seven subjects in the entire study (2 intensive, 5 conventional) developed urinary AER > or = 208 micrograms/min coupled with a CCr < 70 ml/min/1.73 m2. Neither the rate of change of blood pressure nor the appearance of hypertension (BP > 140/90 mm Hg) differed significantly between treatment groups in the primary, secondary or combined cohorts.(ABSTRACT TRUNCATED AT 400
A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients.

Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection.



This multinational, randomized (2:1), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV(1) % predicted relative change was the primary endpoint. Time to exacerbation and patient-reported quality of life were among secondary endpoints.



Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV(1) difference [95% CI -0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.



LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.
Intestinal mucosal dysfunction and infection during remission-induction therapy for acute myeloid leukaemia

Intestinal barrier function was prospectively examined in the course of a clinical trial evaluating the efficacy and safety of lisofylline for reducing cytotoxic therapy-induced intestinal epithelial damage-related infectious morbidity in patients receiving standard remission-induction therapy for acute myeloid leukaemia. The absorption and permeation of oral D-Xylose, lactulose and mannitol were measured weekly from baseline until marrow recovery in adult recipients of idarubicin plus cytarabine for untreated acute myeloid leukaemia. These studies were correlated with non-haematologic chemotherapy-related toxicities reflecting mucosal damage, including nausea, vomiting, stomatitis, diarrhoea, abdominal pain and systemic infection. D-xylose absorption decreased and lactulose:mannitol ratio reflecting intestinal permeability increased from baseline until the second and third week after the beginning of the treatment followed by recovery. These measures correlated with infection rates, nausea, vomiting, diarrhoea and increased blood product utilization. Lisofylline was associated with increased intestinal permeability, nausea, vomiting and infection-related morbidity despite a reduction in the duration of neutropaenia. These surrogates of intestinal barrier function correlated well with clinically important outcomes despite the failure to demonstrate reduced morbidity with lisofylline and represent useful objective outcome measurements for future clinical trials of products for the amelioration of the effects of cytotoxic therapy on the intestinal mucosa.
New educational approach for patients on warfarin improves knowledge and therapy control

Patient education is essential for a safe and efficient oral anticoagulant treatment. We examined if a newly launched booklet with information on anticoagulant treatment with warfarin improved patient knowledge and the time spent in the therapeutic-range (TTR). Standardized questionnaire was administered to 235 consecutive patients on warfarin to assess their baseline knowledge and readministered it 2 months after they received the booklet. A control group of 51 patients was interviewed only after the booklet had been distributed. Patient’s knowledge at the baseline was unsatisfying (mean questionnaire score: 11/16) and a substantial progress was achieved after the educational intervention (mean questionnaire score: 13/16, p = 0.001). TTR is significantly increased after the intervention (63.4 ± 22.3 vs. 74.6 ± 23.8 %; p < 0.01). The mean questionnaire score and TTR after education were not different in the intervention and the control group. Knowledge about oral anticoagulant treatment and TTR is increased after the issue of the booklet in the majority of patients. However, for a small group of patients with unimproved knowledge new forms of education are needed.
Pharmacoepidemiology of psychotropic drugs in patients with severe mental disorders in Italy

To describe the epidemiology of psychotropic drug use in a sample of Italian outpatient psychiatric services.  Drug-utilisation survey conducted within the framework of a broader prospective follow-up study with 67 Italian outpatient psychiatric services.  The data concern 2322 patients recruited over a 3-year period. Three-quarters of the cohort were prescribed antipsychotic drugs, one-half received benzodiazepines and nearly one-third received antidepressants. The trends in drug use from 1994 to 1997 show that for patients with schizophrenia there has been a decrease in the prescription of typical neuroleptics: the use of haloperidol passed from 56% to 42.4% and that of chlorpromazine dropped from 13.5% to 6.1%; during the same period, an increasing use of the atypical compound risperidone was observed. Among patients suffering from unipolar affective psychosis, the prescriptions of tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) have not changed in time, while the proportion of patients receiving neuroleptic drugs has increased from 41% to 45.2%. In addition, the use of antiepileptic drugs and lithium increased, irrespective of diagnosis. Almost 40% of the patients on psychotropic drugs received three or more drugs. Finally, a positive association was found between the number of prescribed compounds and the daily dose administered.  These data indicate that in the absence of a rational approach to drug use, a symptomatic approach is generally adopted, by which common sense, experience, information provided by non-independent agencies and other cultural parameters play an important role in the prescription strategy. Pharmacoepidemiology should more often consider the use of drugs as a dependent variable, to be investigated within the context of other clinical, cultural, social and setting-related parameters; this approach would enable a more comprehensive assessment of prescribing practices and strategies in routine clinical care.
The social and political forces affecting prescribing practices for chronic pain.

Very little attention has been given to chronic nonmalignant pain in the nursing literature. Although there has been increasing debate concerning prescribing practices among physicians for patients with chronic nonmalignant pain, little, if any, understanding exists about advanced practice registered nurses (APRNs) in this context. This study critically examined subjective factors that influence the prescribing practices of APRNs for patients with chronic nonmalignant pain. It was grounded in the critical tradition of Habermas as well as the emancipatory theory of Freire and used a critical methodology. Data were collected through semistructured interviews with participating APRNs. Dialectical analysis and critique were used to interpret the interviews. Critical analysis of the data revealed that prescribing decisions for patients with chronic pain were characterized by a conflict of interests in which the patients' best interests were given a low priority. This conflict, which is socially and politically created and maintained, renders these nurses unlikely to fulfill their ethical responsibility to patients. Teaching basic pain management as an ethical responsibility of practice in graduate education is a first step toward ending the conflict and ensuring that the patients' best interests are addressed.
Therapy of bovine ocular squamous-cell carcinoma with local doses of interleukin-2: 67% complete regressions after 20 months of follow-up

We have tested the therapeutic potency of peritumorally injected low doses of interleukin-2(IL-2). Seventy tumours of the bovine ocular squamous-cell carcinoma (BOSCC), 1–3 cm in diameter, were treated with 5000, 20 000 or 200 000 U IL-2 from Eurocetus (Chiron) to find the optimal dose for treatment. Injections were given peritumorally on Monday to Friday on 2 consecutive weeks. The size of the tumours was measured before treatment and 1, 3, 4, 9 and 20 months after treatment. After 9 months complete regression was observed in 89% of the tumours treated with 5000 U IL-2, 80% treated with 20 000 U and 67% treated with 200 000 U. After 20 months, there was complete regression of 35%, 31% and 67% of the tumours respectively. The 9-and 20-month results of the 200 000-U treatment are significantly better than those of the 5000-U and 20 000-U treatments taken together. This protocol may be useful to treat advanced inoperable tumours (e.g. of the nasopharynx or skin) of human patients.
Comparative analysis of budesonide/formoterol and fluticasone/salmeterol combinations in COPD patients: findings from a real-world analysis in an Italian setting

The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a "real-world" setting. The outcomes included exacerbation rates and health care costs.



An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting β2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40 years and had at least 6 months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System.



After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13 years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74-0.96, P=0.010) for number of hospitalizations, 0.89 (95% CI: 0.87-0.92, P<0.001) for number of oral corticosteroid prescriptions and 0.88 (95% CI: 0.86-0.89, P<0.001) for number of antibiotic prescriptions. The mean annual expenditure for COPD management was €2,436 for patients treated with budesonide/formoterol and €2,784 for patients treated with fluticasone/salmeterol.



Among patients with COPD, treatment with a fixed combination of budesonide/formoterol was associated with fewer exacerbations and a lower, but not significant, cost of illness than the treatment with fluticasone/salmeterol. Real-world analyses are requested to ameliorate interventions to address unmet needs, optimizing treatment pathways to improve COPD-related burden and outcomes.
Prevalence and Time Course of Post-Stroke Pain: A Multicenter Prospective Hospital-Based Study.

Pain prevalence data for patients at various stages after stroke.



Repeated cross-sectional, observational epidemiological study.



Hospital-based multicenter study.



Four hundred forty-three prospectively enrolled stroke survivors.



All patients underwent bedside clinical examination. The different types of post-stroke pain (central post-stroke pain, musculoskeletal pains, shoulder pain, spasticity-related pain, and headache) were diagnosed with widely accepted criteria during the acute, subacute, and chronic stroke stages. Differences among the three stages were analyzed with χ(2)-tests.



The mean overall prevalence of pain was 29.56% (14.06% in the acute, 42.73% in the subacute, and 31.90% in the chronic post-stroke stage). Time course differed significantly according to the various pain types (P < 0.001). The prevalence of musculoskeletal and shoulder pain was higher in the subacute and chronic than in the acute stages after stroke; the prevalence of spasticity-related pain peaked in the chronic stage. Conversely, headache manifested in the acute post-stroke stage. The prevalence of central post-stroke pain was higher in the subacute and chronic than in the acute post-stroke stage. Fewer than 25% of the patients with central post-stroke pain received drug treatment.



Pain after stroke is more frequent in the subacute and chronic phase than in the acute phase, but it is still largely undertreated.