nils-herrmann/clean_scirepeval huggingface dataset:
10-year exercise training in chronic heart failure: a randomized controlled trial.

This study investigated the effect of a very long-term exercise training program is not known in chronic heart failure (CHF) patients.



We previously showed that long-term moderate exercise training (ET) improves functional capacity and quality of life in New York Heart Association class II and III CHF patients.



We studied 123 patients with CHF whose condition was stable over the previous 3 months. After randomization, a trained group (T group, n = 63) underwent a supervised ET at 60% of peak oxygen consumption (Vo(2)), 2 times weekly for 10 years, whereas a nontrained group (NT group, n = 60) did not exercise formally. The ET program was supervised and performed mostly at a coronary club with periodic control sessions twice yearly at the hospital's gym.



In the T group, peak Vo(2) was more than 60% of age- and gender-predicted maximum Vo(2) each year during the 10-year study (p < 0.05 vs. the NT group). In NT patients, peak Vo(2) decreased progressively with an average of 52 ± 8% of maximum Vo(2) predicted. Ventilation relative to carbon dioxide output (VE/Vco(2)) slope was significantly lower (35 ± 9) in T patients versus NT patients (42 ± 11, p < 0.01). Quality-of-life score was significantly better in the T group versus the NT group (43 ± 12 vs. 58 ± 14, p < 0.05). During the 10-year study, T patients had a significant lower rate of hospital readmission (hazard ratio: 0.64, p < 0.001) and cardiac mortality (hazard ratio: 0.68, p < 0.001) than controls. Multivariate analysis selected peak Vo(2) and resting heart rate as independent predictors of events.



Moderate supervised ET performed twice weekly for 10 years maintains functional capacity of more than 60% of maximum Vo(2) and confers a sustained improvement in quality of life compared with NT patients. These sustained improvements are associated with reduction in major cardiovascular events, including hospitalizations for CHF and cardiac mortality.
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.

Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking.



In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial.



Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events.



Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).
Radial artery cannulation: A comparison of 15.2- and 4.45-cm catheters

Eighty-nine patients were studied prospectively to compare the incidence of postdecannulation arterial thrombosis and ischemic complications associated with percutaneous insertion of two different radial artery catheters. Patients scheduled for peripheral vascular surgery were randomized to receive a 15.2-cm (6 in, Argon Medical Corp.) or 4.45-cm (1.75 in, Arrow International, Inc.) 20-gauge, Teflon catheter. Extremity blood flow was evaluated prior to cannulation and again after decannulation with the modified Allen's test, pulse-volume plethysmography, and Doppler ultrasound. The incidence of postdecannulation radial artery occlusion for 15.2-cm catheters was significantly less than for 4.45-cm catheters (4 of 45 cases versus 11 of 44 cases,p=0.05). No case of temporary or permanent ischemic injury occurred. Radial artery transfixion (16 of 45 cases versus 5 of 44 cases,p=0.01) and hematoma formation (5 of 45 cases versus 0 of 44 cases,p=0.02) occurred more frequently during insertion of 15.2-cm catheters than 4.45-cm catheters. The number of arterial punctures during catheter insertion and the duration of cannulation were similar for both groups. Of the 8 patients with positive modified Allen's test who underwent radial artery cannulation, one suffered arterial occlusion. Radial artery cannulation with a 15.2-cm catheter was associated with a lower incidence of postdecannulation radial artery thrombosis than cannulation with the 4.45-cm catheter. Radial artery cannulation with longer catheters (>5.0 cm) appears to be a safe practice.
Carbapenem resistance, inappropriate empiric treatment and outcomes among patients hospitalized with Enterobacteriaceae urinary tract infection, pneumonia and sepsis

Drug resistance among gram-negative pathogens is a risk factor for inappropriate empiric treatment (IET), which in turn increases the risk for mortality. We explored the impact of carbapenem-resistant Enterobacteriaceae (CRE) on the risk of IET and of IET on outcomes in patients with Enterobacteriaceae infections.



We conducted a retrospective cohort study in Premier Perspective database (2009-2013) of 175 US hospitals. We included all adult patients with community-onset culture-positive urinary tract infection (UTI), pneumonia, or sepsis as a principal diagnosis, or as a secondary diagnosis in the setting of respiratory failure, treated with antibiotics within 2 days of admission. We employed regression modeling to compute adjusted association of presence of CRE with risk of receiving IET, and of IET on hospital mortality, length of stay (LOS) and costs.



Among 40,137 patients presenting to the hospital with an Enterobacteriaceae UTI, pneumonia or sepsis, 1227 (3.1%) were CRE. In both groups, the majority of the cases were UTI (51.4% CRE and 54.3% non-CRE). Those with CRE were younger (66.6+/-15.3 vs. 69.1+/-15.9 years, p < 0.001), and more likely to be African-American (19.7% vs. 14.0%, p < 0.001) than those with non-CRE. Both chronic (Charlson score 2.0+/-2.0 vs. 1.9+/-2.1, p = 0.009) and acute (by day 2: ICU 56.3% vs. 30.4%, p < 0.001, and mechanical ventilation 35.8% vs. 11.7%, p < 0.001) illness burdens were higher among CRE than non-CRE subjects, respectively. CRE patients were 3× more likely to receive IET than non-CRE (46.5% vs. 11.8%, p < 0.001). In a regression model CRE was a strong predictor of receiving IET (adjusted relative risk ratio 3.95, 95% confidence interval 3.5 to 4.5, p < 0.001). In turn, IET was associated with an adjusted rise in mortality of 12% (95% confidence interval 3% to 23%), and an excess of 5.2 days (95% confidence interval 4.8, 5.6, p < 0.001) LOS and $10,312 (95% confidence interval $9497, $11,126, p < 0.001) in costs.



In this large US database, the prevalence of CRE among patients with Enterobacteriaceae UTI, pneumonia or sepsis was comparable to other national estimates. Infection with CRE was associated with a four-fold increased risk of receiving IET, which in turn increased mortality, LOS and costs.
Randomised Phase II Trial (NCT00637975) Evaluating Activity and Toxicity of Two Different Escalating Strategies for Pregabalin and Oxycodone Combination Therapy for Neuropathic Pain in Cancer Patients

Neuropathic pain is commonly associated with cancer. Current treatments include combination opioid and adjuvant therapies, but no guidelines are available for dose escalation strategies. This phase II study compared the efficacy and tolerability of two dose escalation strategies for oxycodone and pregabalin combination therapy.



Patients (N = 75) with oncological neuropathic pain, previously untreated with pregabalin, were recruited in 5 Italian institutions between 2007 and 2010. Patients were randomised to two different dose escalation strategies (arm A; N = 38) oxycodone at a fixed dose with increasing pregabalin doses; (arm B; N = 37) pregabalin at a fixed dose with increasing oxycodone doses. Patients were evaluated from daily diaries and follow-ups at 3, 7, 10, and 14 days after beginning treatment with a numerical rating scale (NRS), neuropathic pain scale (SDN), and well-being scale (ESAS). The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects. The study had a 90% probability of detecting the best strategy for a true difference of at least 15%.



More patients in arm A (76%) than arm B (64%) achieved ≥1/3 overall pain reduction even after controlling for baseline factors (gender, baseline pain). Group A reported fewer side effects than group B; constipation 52.8% vs. 66.7%; nausea: 27.8% vs. 44.4%; drowsiness: 44.4% vs. 55.6%; confusion: 16.7% vs. 27.8%; itching: 8.3% vs. 19.4%.



Both strategies effectively controlled neuropathic pain, but according to the adopted selection design arm A is preferable to arm B for pain control.
Use of the HEART Pathway with high sensitivity cardiac troponins: A secondary analysis.

The HEART Pathway combines a decision aid and serial contemporary cardiac troponin I (cTnI) measures to achieve >99% sensitivity for major adverse cardiac events (MACE) at 30days and early discharge rates >20%. However, the impact of integrating high-sensitivity troponin (hs-cTn) measures into the HEART Pathway has yet to be determined. In this analysis we compare test characteristics of the HEART Pathway using hs-cTnI, hs-cTnT, or cTnI.



A secondary analysis of participants enrolled in the HEART Pathway RCT was conducted. Each patient was risk stratified by the cTn-HEART Pathway (Siemens TnI-Ultra at 0- and 3-h) and a hs-cTn-HEART Pathway using hs-cTnI (Abbott) or hs-cTnT (Roche) at 3-h. The early discharge rate, sensitivity, specificity, and negative predictive value (NPV) for MACE (death, myocardial infarction, or coronary revascularization) at 30days were calculated.



hs-cTnI measures were available on 133 patients. MACE occurred in 11/133 (8%) of these patients. Test characteristics for the HEART Pathway using serial cTnI vs 3hour hs-cTnI were the same: sensitivity (100%, 95%CI: 72-100%), specificity (49%, 95%CI: 40-58%), NPV (100%, 95%CI: 94-100%), and early discharge rate (45%, 95%CI: 37-54%). The HEART Pathway using hs-cTnT missed one MACE event (myocardial infarction): sensitivity (91%, 95%CI: 59-100%), specificity (48%, 95%CI: 39-57%), NPV (98%, 95%CI: 91-100%), and early discharge rate (45%, 95%CI: 37-54%).



There was no difference in the test characteristics of the HEART Pathway whether using cTnI or hs-cTnI, with both achieving 100% sensitivity and NPV. Use of hs-cTnT with the HEART Pathway was associated with one missed MACE.
Update on PEG-interferon α-2b as adjuvant therapy in melanoma.

Based on the results of European Organization for Research and Treatment of Cancer (EORTC) 18991 trial, the US Food and Drug Administration (FDA) approved PEG-interferon α-2b (PEG-IFN) (Sylatron) as adjuvant therapy for high-risk melanoma. The EORTC 18991 trial was an open-label study of resectable stage III melanoma with 1,256 patients who were randomized to observation-alone or to treatment with PEG-IFN for up to 5 years. The median recurrence-free survival of the treatment groups was significantly longer, while overall survival, a secondary endpoint, was not significantly different between the two groups. This review, after a short summary of interferon α-2b trials, critically analyzes the EORTC18991 trial, as well as the subgroup results and future perspectives for this stage of disease.
A longitudinal assessment of the responsiveness of the ICECAP-A in a randomised controlled trial of a knee pain intervention

The ICECAP-A is a simple measure of capability well-being for use with the adult population. The descriptive system is made up of five key attributes: Stability, Attachment, Autonomy, Achievement and Enjoyment. Studies have begun to assess the psychometric properties of the measure, including the construct and content validity and feasibility for use. This is the first study to use longitudinal data to assess the responsiveness of the measure. This responsiveness study was completed alongside a randomised controlled trial comparing three physiotherapy-led exercise interventions for older adults with knee pain attributable to osteoarthritis. Anchor-based methodologies were used to explore the relationship between change over time in ICECAP-A score (the target measure) and change over time in another measure (the anchor). Analyses were completed using the non-value-weighted and value-weighted ICECAP-A scores. The EQ-5D-3L was used as a comparator measure to contextualise change in the ICECAP-A. Effect sizes, standardised response means and t tests were used to quantify responsiveness. Small changes in the ICECAP-A scores were seen in response to underlying changes in patients’ health-related quality of life, anxiety and depression. Non-weighted scores were slightly more responsive than value-weighted scores. ICECAP-A change was of comparable size to change in the EQ-5D-3L reference measure. This first analysis of the responsiveness using longitudinal data provides some positive evidence for the responsiveness of the ICECAP-A measure. There is a need for further research in those with low health and capability, and experiencing larger underlying changes in quality of life.
Cryptosporidium rubeyi n. sp. (Apicomplexa: Cryptosporidiidae) in multiple Spermophilus ground squirrel species

Previously we reported the unique Cryptosporidium sp. "c" genotype (e.g., Sbey03c, Sbey05c, Sbld05c, Sltl05c) from three species of Spermophilus ground squirrel (Spermophilus beecheyi, Spermophilus beldingi, Spermophilus lateralis) located throughout California, USA. This follow-up work characterizes the morphology and animal infectivity of this novel genotype as the final step in proposing it as a new species of Cryptosporidium. Analysis of sequences of 18S rRNA, actin, and HSP70 genes of additional Cryptosporidium isolates from recently sampled California ground squirrels (S. beecheyi) confirms the presence of the unique Sbey-c genotype in S. beecheyi. Phylogenetic and BLAST analysis indicates that the c-genotype in Spermophilus ground squirrels is distinct from Cryptosporidium species/genotypes from other host species currently available in GenBank. We propose to name this c-genotype found in Spermophilus ground squirrels as Cryptosporidium rubeyi n. sp. The mean size of C. rubeyi n. sp. oocysts is 4.67 (4.4-5.0) μm × 4.34 (4.0-5.0) μm, with a length/width index of 1.08 (n = 220). Oocysts of C. rubeyi n. sp. are not infectious to neonatal BALB/c mice and Holstein calves. GenBank accession numbers for C. rubeyi n. sp. are DQ295012, AY462233, and KM010224 for the 18S rRNA gene, KM010227 for the actin gene, and KM010229 for the HSP70 gene.
Coronary artery surgery study revisited. Limitation of the intent-to-treat principle.

In the two recent 10-year follow-up Coronary Artery Surgery Study (CASS) reportsl-2 in this issue of Circulation, different analyses have been used: intent-to-treat analysis-ignoring a major amount of crossover to surgery-and examining the effect only while on the assigned treatment. The justification is presumed to be that with death and myocardial infarction as end points it is more prudent to adhere to the intent-to-treat principle, assessing the preventive aspect, whereas to evaluate the efficacy of a treatment in relieving symptoms or improving quality of life, the censored analysis examining the actual treatment employed is more relevant. Thus, we have two approaches, neither of which is entirely satisfactory, given the circumstances. With both groups (surgical and medical therapies) receiving medical treatment and a 40% crossover to surgery by medical-therapy patients based on clinical condition and accepted indications for surgery, it is difficult to sort out with confidence the impacts of the two therapies under consideration. The frequency of crossover surgery can be regarded as an outcome if it can be accepted that this indicates a failure of medical therapy. However, no criteria for this were specified in the design of CASS, so it is difficult to judge whether the option for surgery represents a real need or the application of conventional wisdom and hence a self-fulfilling prophesy. The management of patients with coronary disease has changed dramatically during the past several decades. Because absence or abolition of symptoms is no guarantee against coronary attacks and sudden death, the goals are now to prevent attacks and prolong life even when symptoms are absent. Medical therapy has now improved so that it is seldom impossible to relieve angina. The use of p-blockers, calcium antagonists, long-acting nitrates, and aspirin and intervention against coronary risk factors have The opinions expressed in this editorial comment are not necessarily those of the editors or of the American Heart Association. enabled physicians to treat patients for longer periods without resorting to revascularization. Along with these improvements in medical options there have been advances in revascularization procedures , now including coronary angioplasty. Also, improved myocardial preservation techniques have made coronary artery bypass graft (CABG) surgery a reasonable, safe procedure, and the increasing use of internal mammary artery grafts and supplementary platelet-active drugs have extended long-term graft patency. Revascularization for patients whose symptoms cannot be controlled by antianginal therapy or who cannot tolerate the medications required seems justified. Surgery in …
Psychological effects of calisthenic exercises on neuroinflammatory and rheumatic diseases

The aim of this study was to evaluate the effects of calisthenic exercises on psychological status in patients with ankylosing spondylitis (AS) and multiple sclerosis (MS). This study comprised 40 patients diagnosed with AS randomized into two exercise groups (group 1 = hospital-based, group 2 = home-based) and 40 patients diagnosed with MS randomized into two exercise groups (group 1 = hospital-based, group 2 = home-based). The exercise programme was completed by 73 participants (hospital-based = 34, home-based = 39). Mean age was 33.75 ± 5.77 years. After the 8-week exercise programme in the AS group, the home-based exercise group showed significant improvements in erythrocyte sedimentation rates (ESR). The hospital-based exercise group showed significant improvements in terms of the Bath AS Metrology Index (BASMI) and Hospital Anxiety and Depression Scale-Anxiety (HADS-A) scores. After the 8-week exercise programme in the MS group, the home-based and hospital-based exercise groups showed significant improvements in terms of the 10-m walking test, Berg Balance Scale (BBS), HADS-A, and MS international Quality of Life (MusiQoL) scores. There was a significant improvement in the hospital-based and a significant deterioration in the home-based MS patients according to HADS-Depression (HADS-D) score. The positive effects of exercises on neurologic and rheumatic chronic inflammatory processes associated with disability should not be underestimated. Ziel der vorliegenden Studie war die Untersuchung der Wirkungen von gymnastischen Übungen auf die psychische Verfassung von Patienten mit Spondylitis ankylosans (AS) und multipler Sklerose (MS). Die Studie umfasste 40 Patienten mit der Diagnose AS, die randomisiert in 2 Übungsgruppen aufgeteilt wurden (Gruppe 1: stationär, Gruppe 2: ambulant), und 40 Patienten mit der Diagnose MS, die ebenfalls randomisiert in 2 Übungsgruppen aufgeteilt wurden (Gruppe 1: stationär, Gruppe 2: ambulant). Vollständig absolviert wurde das Übungsprogramm von 73 Patienten (stationär: 34, ambulant: 39). Das Durchschnittsalter betrug 33,75 ± 5,77 Jahre. Nach dem 8-wöchigen Übungsprogramm in der AS-Gruppe zeigten sich bei der ambulanten Übungsgruppe signifikante Verbesserungen bei der Blutsenkungsgeschwindigkeit (BSG). Die stationäre Übungsgruppe wies signifikante Verbesserungen in Bezug auf den BASMI-Score (Bath AS Metrology Index) und den HADS-A-Score (Hospital Anxiety and Depression Scale-Anxiety) auf. Nach dem 8-wöchigen Übungsprogramm in der MS-Gruppe zeigten sich sowohl in der ambulanten als auch in der stationären Übungsgruppe signifikante Verbesserungen hinsichtlich des 10-m-Gehtests, des BBS-Ergebnisses (Berg Balance Scale), des HADS-A- sowie des MusiQoL-Scores (MS international Quality of Life). Beim HADS-D-Score (HADS-Depression) bestand eine signifikante Verbesserung bei den stationären und eine signifikante Verschlechterung bei den ambulanten MS-Patienten. Die positiven Wirkungen von gymnastischen Übungen auf neurologische und rheumatische chronisch entzündliche Prozesse mit Behinderung sollten nicht unterschätzt werden.
Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion.

Idraparinux is an inhibitor of activated factor X (FXa) with a long half-life allowing once-weekly dosing. Idrabiotaparinux is a biotinylated version of idraparinux; its activity can be reversed with avidin.



To investigate the tolerability, safety and pharmacodynamics of avidin in healthy subjects and patients with deep vein thrombosis (DVT) receiving idrabiotaparinux.



In a placebo-controlled, randomized, double-blind Phase I study, 41 healthy males received subcutaneous idrabiotaparinux before being randomized to a 30-min intravenous avidin infusion or placebo. Idrabiotaparinux plus avidin were re-administered 10-14 months later in eight subjects. In addition, in a prospective substudy of the Phase III EQUINOX trial, 55 patients who received weekly idrabiotaparinux for 6 months were randomized to receive either 100 mg avidin (n = 33) or placebo (n = 22). The primary activity outcome was anti-FXa activity calculated immediately before and after avidin infusion. Adverse events were recorded to assess safety and tolerability.



Avidin rapidly reversed the anti-FXa activity of idrabiotaparinux, ranging from 66.1 to 90.3% in healthy subjects and from 67 to 97% (mean 78%) in DVT patients. Avidin was well tolerated, with a similar nature and frequency of adverse events to placebo. No venous thromboembolism recurrence occurred in the 3-month post-avidin infusion.



A 30-min intravenous infusion of avidin 100 mg is well tolerated, safe, and offers immediate and specific reversibility both after single and repeated doses of idrabiotaparinux in healthy subjects, and in DVT patients following a 6-month treatment period.