nils-herrmann/clean_scirepeval huggingface dataset:
Patient outcomes after fibrinolytic therapy for acute myocardial infarction at hospitals with and without coronary revascularization capability.

This study evaluated clinical outcomes in patients with acute myocardial infarction (MI) treated with fibrinolytic therapy in hospitals with and without coronary revascularization capability.



Patients with MI may have better outcomes when admitted to certain hospitals with coronary revascularization capability. Development of regional heart care centers for the treatment of MI has been proposed.



We performed a retrospective analysis of 25,515 U.S. patients enrolled in the Global Use of Streptokinase and TPA (alteplase) for Occluded Coronary arteries (GUSTO)-I trial. Outcomes of patients admitted to hospitals with and without coronary revascularization capability were analyzed. We also analyzed patients who remained in hospitals without coronary revascularization capability compared with those transferred to hospitals with revascularization capability.



Baseline characteristics and complications were similar between patients in the two hospital types. Patients in hospitals with coronary revascularization capability more often underwent cardiac catheterization (78.1% vs. 59.2%; p < 0.001), angioplasty (34.6% vs. 22.6%; p < 0.001), or bypass surgery (14.1% vs. 10.4%; p < 0.001) but had a similar adjusted 30-day (odds ratio [OR] 0.91, 95% confidence interval [CI] 82 to 1.02) and one-year (OR 0.98, 95% CI 0.90 to 1.07) mortality. Forty percent of patients admitted to hospitals without revascularization capability were transferred, with 94% of transfer patients undergoing angiography. Almost 80% of transfers occurred >48 h after hospital admission.



Patients receiving fibrinolytic therapy for acute MI admitted to hospitals without coronary revascularization capability appear to have outcomes similar to those of patients admitted to hospitals with such capability when aspirin and beta-adrenergic blocking agents are given appropriately and transfer is available for angiography and angioplasty as needed.
Pain sensitisation and the risk of poor outcome following physiotherapy for patients with moderate to severe knee osteoarthritis: protocol for a prospective cohort study

Pain is the dominant symptom of knee osteoarthritis (OA), and recent evidence suggests factors outside of local joint pathology, such as pain sensitisation, can contribute significantly to the pain experience. It is unknown how pain sensitisation influences outcomes from commonly employed interventions such as physiotherapy. The aims of this study are, first, to provide a comprehensive description of the somatosensory characteristics of people with pain associated with knee OA. Second, we will investigate if indicators of pain sensitisation in patients with knee osteoarthritis are predictive of non-response to physiotherapy.



This is a multicentre prospective cohort study with 140 participants. Eligible patients with moderate to severe symptomatic knee osteoarthritis will be identified at outpatient orthopaedic and rheumatology clinics. A baseline assessment will provide a comprehensive description of the somatosensory characteristics of each participant by means of clinical examination, quantitative sensory testing, and validated questionnaires measuring pain and functional capacity. Participants will then undergo physiotherapy treatment. The primary outcome will be non-response to physiotherapy on completion of the physiotherapy treatment programme as defined by the Osteoarthritis Research Society International treatment responder criteria. A principal component analysis will identify measures related to pain sensitisation to include in the predictive model. Regression analyses will explore the relationship between responder status and pain sensitisation while accounting for confounders.


ETHICS AND DISSEMINATION
This study has been approved by St James' Hospital/AMNCH Research Ethics Committee and by the St Vincent's Healthcare Group Ethics and Medical Research Committee. The results will be presented at international conferences and published in a peer review journal.
Kiwifruit consumption favourably affects plasma lipids in a randomised controlled trial in hypercholesterolaemic men.

The unique composition of green kiwifruit has the potential to benefit CVD risk. The aim of the present study was to investigate the effect of consuming two green kiwifruits daily in conjunction with a healthy diet on plasma lipids and other metabolic markers and to examine response according to APOE genotype in hypercholesterolaemic men. After undergoing a 4-week healthy diet, eighty-five hypercholesterolaemic men (LDL-cholesterol (LDL-C) > 3.0 mmol/l and TAG < 3 mmol/l) completed an 8-week randomised controlled cross-over study of two 4-week intervention sequences of two green kiwifruits per d plus healthy diet (intervention) or healthy diet alone (control). Anthropometric measures, blood pressure (BP) and fasting blood samples (plasma lipids, serum apoA1 and apoB, insulin, glucose, high-sensitivity C-reactive protein (hs-CRP)) were taken at baseline, and at 4 and 8 weeks. After the kiwifruit intervention, plasma HDL-cholesterol (HDL-C) concentrations were significantly higher (mean difference 0.04; 95% CI 0.01, 0.07 mmol/l; P = 0.004) and the total cholesterol (TC):HDL-C ratio was significantly lower (mean difference 20.5; 95% CI 20.24, 20.05 mmol/l; P = 0.002) compared with the control. In carriers of the APOE4 allele, TAG decreased significantly (mean difference -0.18; 95% CI -0.34, -0.02 mol/l; P = 0.03) with kiwifruit compared with control. There were no significant differences between the two interventions for plasma TC, LDL-C, insulin, glucose, hs-CRP and BP. The small but significant increase in HDL-C and decrease in TC:HDL-C ratio and TAG (in APOE4 carriers) suggest that the regular inclusion of green kiwifruit as part of a healthy diet may be beneficial in improving the lipid profiles of men with high cholesterol.
Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study.

Women with breast cancer or those at high risk of developing breast cancer because of familial history of the disease or genetic mutations are frequently indicated for therapeutic or prophylactic mastectomy. Prosthetic reconstruction of the breast with placement of tissue expanders followed by implants offers favorable aesthetic and psychological results while adding only minimal additional surgical intervention. This study describes the confirmatory phase of an earlier feasibility trial that involved seven women who successfully underwent patient-activated controlled expansion for breast reconstruction with 10 AeroForm patient-controlled tissue expanders.



A prospective, open-label, single-arm, single-surgeon confirmatory study in Perth, Australia, evaluated outcomes of two-stage breast reconstruction using the investigational device. Each subject administered a preset 10-cc dose of carbon dioxide gas using a remote dosage controller, three times each day, with a 3-hour lockout between doses until full expansion was achieved.



Thirty-three women with breast cancer, family history, or predisposition because of the BRCA1 or BRCA2 gene mutation underwent pedicled latissimus dorsi flap procedures with placement of 61 carbon dioxide-based tissue expanders. The mean number of days for subjects to achieve desired expansion was 17 ± 5. Operating the dosage controller was described by the surgeon as very easy in 94 percent of the cases and by 97 percent of the subjects. No serious adverse events were reported.



This study confirms that the AeroForm breast tissue expander has demonstrated the ability to provide, relative to saline expanders, a needle-free, patient-controlled, convenient, and time-saving method of tissue expansion.



Therapeutic, IV.
Relapsed childhood acute lymphoblastic leukemia in the Nordic countries: prognostic factors, treatment and outcome.

Relapse is the main reason for treatment failure in childhood acute lymphoblastic leukemia. Despite improvements in the up-front therapy, survival after relapse is still relatively poor, especially for high-risk relapses. The aims of this study were to assess outcomes following acute lymphoblastic leukemia relapse after common initial Nordic Society of Paediatric Haematology and Oncology protocol treatment; to validate currently used risk stratifications, and identify additional prognostic factors for overall survival. Altogether, 516 of 2735 patients (18.9%) relapsed between 1992 and 2011 and were included in the study. There were no statistically significant differences in outcome between the up-front protocols or between the relapse protocols used, but an improvement over time was observed. The 5-year overall survival for patients relapsing in the period 2002-2011 was 57.5±3.4%, but 44.7±3.2% (P<0.001) if relapse occurred in the period 1992-2001. Factors independently predicting mortality after relapse included short duration of first remission, bone marrow involvement, age ten years or over, unfavorable cytogenetics, and Down syndrome. T-cell immunophenotype was not an independent prognostic factor unless in combination with hyperleukocytosis at diagnosis. The outcome for early combined pre-B relapses was unexpectedly poor (5-year overall survival 38.0±10.6%), which supports the notion that these patients need further risk adjustment. Although survival outcomes have improved over time, the development of novel approaches is urgently needed to increase survival in relapsed childhood acute lymphoblastic leukemia.
Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]

Body temperature is a strong predictor of outcome in acute stroke. In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when they had no fever. The purpose of the present trial was to study whether this effect of acetaminophen could be reproduced, and whether ibuprofen would have a similar, or even stronger effect.



Seventy-five patients with acute ischemic stroke confined to the anterior circulation were randomized to treatment with either 1000 mg acetaminophen, 400 mg ibuprofen, or placebo, given 6 times daily during 5 days. Treatment was started within 24 hours from the onset of symptoms. Body temperatures were measured at 2-hour intervals during the first 24 hours, and at 6-hour intervals thereafter.



No difference in body temperature at 24 hours was observed between the three treatment groups. However, treatment with high-dose acetaminophen resulted in a 0.3 degrees C larger reduction in body temperature from baseline than placebo treatment (95% CI: 0.0 to 0.6 degrees C). Acetaminophen had no significant effect on body temperature during the subsequent four days compared to placebo, and ibuprofen had no statistically significant effect on body temperature during the entire study period.



Treatment with a daily dose of 6000 mg acetaminophen results in a small, but potentially worthwhile decrease in body temperature after acute ischemic stroke, even in normothermic and subfebrile patients. Further large randomized clinical trials are needed to study whether early reduction of body temperature leads to improved outcome.
An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12.



In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0-F2 fibrosis, patients with HCV-RNA <25 IU/mL (detectable/undetectable) at Week 2, and undetectable HCV-RNA at Weeks 4 and 8, stopped all treatment at Week 12. All other patients continued PR for a further 12 weeks. Baseline factors significantly associated with SVR12 were identified through logistic regression.



Of 163 patients who participated in the study, 123 (75%) qualified for 12-week treatment; of these, 81 (66%) achieved SVR12. Baseline factors positively associated with SVR12 rates in patients receiving the 12-week regimen were: IL28B CC genotype: (94% SVR12); HCV RNA ≤800,000 IU/mL (82%); F0-F1 fibrosis (74%). Among all 163 patients, 94% experienced ≥1 adverse event (AE), 4% a serious AE, and 2.5% discontinued due to an AE. Reduced impairment in patient-reported outcomes was observed in the 12-week vs >12-week regimen.



Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen.
Impact of ESD protection and power supply decoupling on 10 GHz low noise amplifier

An experimental study has been performed on the effect of 10 GHz LNAs with and without ESD protection. As well, simulations have been done to compare the effect of leaving out power supply decoupling capacitors with comparisons to measurements. For this study, two 10 GHz LNAs, one with and one without ESD protection were designed and implemented in 0.13 μm RFCMOS technology. Measured results of the LNAs showed that both have similar performance. The ESD test results showed that a Human Body Model (HBM) ESD protection threshold higher than 2 kV can be achieved without showing leakage and degradation of the S-parameters and noise figure, demonstrating that degradation of RF parameters can be minimized by choosing the appropriate ESD protection and by taking it into account early in the design process. This study also demonstrated that without on-chip power supply decoupling capacitors, the gain, matching, and noise are severely degraded.
Vertebral and metacarpal morphometry as indicators of nutritional improvement

Because of the importance of nutrition in the development of bone mass, we studied the nutritional state, and bone state by means of metacarpal radiogrammetric measurements and vertebral morphometry in a group of 40 premenopausal women born between 1960 and 1970, mean age 29 ± 5 years, and in another group of 40 postmenopausal women born between 1934 and 1944, mean age 55 ± 4 years. Both groups were considered normal, the main characteristic distinguishing them being that the women born between 1934 and 1944 grew up in a period of widespread malnutrition in Spain and the women born between 1960 and 1970 grew up in a period of normal nutrition. Protein, carbohydrate and fat intake in these two periods differed significantly (p<0.0001 in the three cases by Fischer's exact test). The values of the metacarpal measurements, anterior height of the dorsal vertebrae from T-4 to T-12, and posterior height from L-1 to L-4 between the premenopausal and postmenopausal groups of women were significantly different (p<0.001) (Anova test). These findings show the importance of nutrition in the development of bone mass during childhood.
Treatment-related parameters predicting efficacy of Lym-1 radioimmunotherapy in patients with B-lymphocytic malignancies.

This study was designed to evaluate dosimetric, pharmacokinetic, and other treatment-related parameters as predictors of outcome in patients with advanced B-lymphocytic malignancies. Fifty-seven patients were treated with radiolabeled Lym-1 antibody in early phase trials between 1985 and 1994. Logistic regression and proportional hazards models were used to evaluate treatment parameters for their ability to predict outcome, taking into account patient risk group based on Karnofsky performance status and serum lactic dehydrogenase. The occurrence of a partial or complete response (31 of 57 patients) and development of human antimouse antibody (HAMA) predicted improved survival using a time-dependent proportional hazards model. The final multivariate model for survival with parameters significant at P </= 0.05 included overall response and pretreatment risk group. Although some of the dosimetric and pharmacokinetic parameters were predictive in univariate analyses, only longer half-time of radionuclide in the blood showed any indication of improved prediction beyond that provided by the lactic dehydrogenase/Karnofsky performance status-based risk groups. Splenic volume, splenectomy, and malignant tissue Lym-1 reactivity were not contributory. In this patient group, the effect of radiolabeled Lym-1 treatment as indicated by measurable tumor response was associated with improved survival. Development of HAMA was also associated with improved survival, indicating that concern about HAMA should not preclude exploration of radioimmunotherapy. Although dosimetry has a role in determining safety based on dose to normal organs, when adjusted for baseline clinical features, dosimetric and pharmacokinetic parameters showed limited ability to improve outcome prediction.
Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C.

Autoantibodies were studied in a well-characterized cohort of children with chronic hepatitis C during treatment with pegylated interferon and ribavirin to assess the relation with treatment and development of autoimmune disease.



: A total of 114 children (5-17 years), screened for the presence of high-titer autoantibodies, were randomized to pegylated interferon with or without ribavirin. Anti-nuclear, anti-liver-kidney-microsomal, anti-thyroglobulin, anti-thyroid peroxidase, insulin, anti-glutamic acid decarboxylase (GAD) antibodies were measured after trial completion using frozen sera.



At baseline, 19% had autoantibodies: anti-nuclear antibodies (8%), anti-liver-kidney-microsomal antibodies (4%), and glutamic acid decarboxylase antibodies (4%). At 24 and 72 weeks (24 weeks after treatment completion), 23% and 26% had autoantibodies (P=0.50, 0.48 compared with baseline). One child developed diabetes and 2 hypothyroidism during treatment; none developed autoimmune hepatitis. At 24 weeks, the incidence of flu-like symptoms, gastrointestinal symptoms, and headaches was 42%, 8% and 19% in those with autoantibodies versus 52%, 17%, and 26% in those without (P=0.18, 0.36, and 0.20, respectively). In children with negative hepatitis C virus polymerase chain reaction at 24 weeks, there was no difference in the rate of early virologic response/sustained virologic response, respectively, in those with autoantibodies 76%/69% vs 58%/65% in those without (P=0.48).



Despite screening, we found autoantibodies commonly at baseline, during treatment for chronic hepatitis C and after. The presence of antibodies did not correlate with viral response, adverse effects, or autoimmune hepatitis. Neither screening nor archived samples assayed for thyroid and diabetes-related antibodies identified the 3 subjects who developed overt autoimmune disease, diabetes (1), and hypothyroidism (2).
The temporal stability of electrodermal variables over a one-year period in patients with recent-onset schizophrenia and in normal subjects.

Test-retest stability of electrodermal (EDA) variables indexing both general autonomic arousal (e.g., skin conductance level, number of nonspecific skin conductance responses) and attention to external stimuli (e.g., number of skin conductance orienting responses, electrodermal responder/nonresponder status) was assessed in 71 young, recent-onset schizophrenia patients and 36 demographically matched normal subjects. Significant stability over a 1-year period was found for both patients and normal subjects for most EDA variables and for responder/nonresponder status, with test-retest correlations generally being higher for normal subjects. The lower reliability for patients was not attributable to symptomatic fluctuations during the follow-up period and may reflect poorer arousal regulation among the patients. Among measures of responding to nontask stimuli, a simple count of the number of orienting responses occurring was more stable than was a traditional trials-to-habituation measure.
Racial/Ethnic and Socioeconomic Disparities in Health-Related Quality of Life Among People With Coronary Heart Disease, 2007

Health-related quality of life (HRQOL) refers to a person's or group's perceived physical and mental health over time. Coronary heart disease (CHD) affects HRQOL and likely varies among groups. This study examined disparities in HRQOL among adults with self-reported CHD.



We examined disparities in HRQOL by using the unhealthy days measurements among adults who self-reported CHD in the 2007 Behavioral Risk Factor Surveillance System state-based telephone survey. CHD was based on self-reported medical history of heart attack, angina, or coronary heart disease. We assessed differences in fair/poor health status, 14 or more physically unhealthy days, 14 or more mentally unhealthy days, 14 or more total unhealthy days (total of physically and mentally unhealthy days), and 14 or more activity-limited days. Multivariate logistic regression models included age, race/ethnicity, sex, education, annual household income, household size, and health insurance coverage.



Of the population surveyed, 35,378 (6.1%) self-reported CHD. Compared with non-Hispanic whites, Native Americans were more likely to report fair/poor health status (adjusted odds ratio [AOR], 1.7), 14 or more total unhealthy days (AOR, 1.6), 14 or more physically unhealthy days (AOR, 1.7), and 14 or more activity-limited days (AOR, 1.9). Hispanics were more likely than non-Hispanic whites to report fair/poor health status (AOR, 1.5) and less likely to report 14 or more activity-limited days (AOR, 0.5), and Asians were less likely to report 14 or more activity-limited days (AOR, 0.2). Non-Hispanic blacks did not differ in unhealthy days measurements from non-Hispanic whites. The proportion reporting 14 or more total unhealthy days increased with increasing age, was higher among women than men, and was lower with increasing levels of education and income.



There are sex, racial/ethnic, and socioeconomic disparities in HRQOL among people with CHD. Tailoring interventions to people who have both with CHD and poor HRQOL may assist in the overall management of CHD.
Beyond designing: roles of the designer in complex design projects

Human computer interaction and interaction design have recognised the need for participatory methods of co-design to contribute to designing human-centred interfaces, systems and services. Design thinking has recently developed as a set of strategies for human-centred co-design in product innovation, management and organisational transformation. Both developments place the designer in a new mediator role, requiring new skills than previously evident. This paper presents preliminary findings from a PhD case study of strategy and innovation consultancy Second Road to discuss these emerging roles of design lead, facilitator, teacher and director in action.