nils-herrmann/clean_scirepeval huggingface dataset:
The Effect of Paracetamol on Core Body Temperature in Acute Traumatic Brain Injury: A Randomised, Controlled Clinical Trial

Strategies to prevent pyrexia in patients with acute neurological injury may reduce secondary neuronal damage. The aim of this study was to determine the safety and efficacy of the routine administration of 6 grams/day of intravenous paracetamol in reducing body temperature following severe traumatic brain injury, compared to placebo.



A multicentre, randomised, blind, placebo-controlled clinical trial in adult patients with traumatic brain injury (TBI). Patients were randomised to receive an intravenous infusion of either 1g of paracetamol or 0.9% sodium chloride (saline) every 4 hours for 72 hours. The primary outcome was the mean difference in core temperature during the study intervention period.



Forty-one patients were included in this study: 21 were allocated to paracetamol and 20 to saline. The median (interquartile range) number of doses of study drug was 18 (17-18) in the paracetamol group and 18 (16-18) in the saline group (P = 0.85). From randomisation until 4 hours after the last dose of study treatment, there were 2798 temperature measurements (median 73 [67-76] per patient). The mean ± standard deviation temperature was 37.4±0.5°C in the paracetamol group and 37.7±0.4°C in the saline group (absolute difference -0.3°C; 95% confidence interval -0.6 to 0.0; P = 0.09). There were no significant differences in the use of physical cooling, or episodes of hypotension or hepatic abnormalities, between the two groups.



The routine administration of 6g/day of intravenous paracetamol did not significantly reduce core body temperature in patients with TBI.
Rates and predictors of uncontrolled bronchial asthma in elderly patients from western Romania

Bronchial asthma (BA) is a chronic inflammatory disorder of the airways, featuring variable and often reversible airflow limitations. An accurate assessment of BA control is difficult in practice, especially in the elderly, requiring the assessment of several clinical and paraclinical parameters that are influenced not only by asthma, but also by comorbidities. The purpose of this study was to evaluate the predictors of uncontrolled BA in a group of elderly patients from western Romania.



We retrospectively evaluated 126 elderly patients (aged $ 65 years), who were consecutively evaluated in the Pulmonology Department of Victor Babes Hospital, Timisoara, Romania, between March 2009 and July 2012. We collected demographic data, performed pulmonary function testing and an asthma control test (ACT), and evaluated the level of BA control based on the 2012 Global Initiative for Asthma guidelines. Statistical processing of the data was done using the Epi Info and STATA programs.



In our study group, 36 (29%) patients were men and 90 (71%) were women; their mean age was 74.42±8.32 years (range: 65-85 years). A total of 14.28% of patients were smokers. About 30.15% of patients had an ACT score <19, 54.76% had an ACT score 20-24, and 15.09% had an ACT of 25. Moreover, 59.52% had normal spirometry results. Infectious exacerbations were found in 58.73% of patients. A history of allergies was demonstrated in 48.41% of patients, 34.12% had occupational exposure, and 82.53% of patients were treated with inhaled corticosteroids. Our results showed that 30.15% of patients had uncontrolled BA. We found six predictive factors for uncontrolled BA: infectious exacerbation, occupational exposure, mixed (obstructive and restrictive) ventilatory dysfunction, persistent airway obstruction on spirometry, duration of disease in months, and current smoking status. Infectious exacerbations, persistent airway obstructions, and occupational exposure were the most powerful predictors.



Elderly patients represent an important group that is at risk for developing uncontrolled BA. Predictors may identify those elderly patients with uncontrolled BA and facilitate early medical interventions.
Depiction of residual emboli following pulmonary embolism with thrombotic scintigraphy.

In the treatment of pulmonary embolism (PE), the presence of residual emboli is known to seriously affect the recurrence and prognosis. We attempted to depict the residual emboli in the subacute stage of PE using indium-111-oxine labeled platelet scintigraphy (In-plt).



In-plt was performed on 22 patients with PE who showed an improvement according to lung perfusion scintigraphy. Their accumulation was assessed along with the blood coagulation ability measured on the same day. In addition, radioisotope venography (RI-veno) was performed simultaneously with In-plt to measure the circulatory findings in the lower limb for comparison. All patients received systemic heparin during the acute stage and received warfarin at the time of testing.



Accumulation of In-pit was observed in 7 patients (32%), and positive signals were found in the lower limbs or pelvic cavity in all cases. Two patients were suspected of having poor lower limb circulation from their RI-veno findings, and these findings were largely consistent with the areas of In-plt accumulation.



Some emboli persist after extensive anti-coagulation therapy. The use of In-pit is effective in determining the therapeutic measures and assessing the prognosis as this method allows us to clearly depict the existence of such emboli.
TALL score for prediction of oncological outcomes after radical nephroureterectomy for high-grade upper tract urothelial carcinoma

We created a prognostic tool for the prediction of oncologic outcomes after radical nephroureterectomy (RNU) for high-grade non-metastatic upper tract urothelial carcinoma (UTUC). UTUC collaboration was utilized to include 586 patients who underwent RNU for non-metastatic high-grade UTUC. Survival outcomes were compared according to a score defined based on the sum of the independent prognostic variables. The study included 382 males with a median age 70 years (range 28–97). Independent prognostic factors included: T (t stage), A (architecture), LVI (lympho-vascular invasion) and L (lymphadenectomy). TALL score (1–7) was the sum of T (≤T1 = 1, T2 = 2, T3 = 3 and T4 = 4), A (papillary = 0 and sessile = 1), LVI (absent = 0 and present = 1) and L (lymphadenectomy = 0 and no lymphadenectomy = 1). Five-year disease-free survival (DFS) and cancer-specific survival (CSS) were stratified into four risk categories according to the TALL score: low (TALL 0–2; 86 % DFS and 90 % CSS), intermediate (TALL = 3; 71 % DFS and 75 % CSS), high (TALL = 4; 57 % DFS and 58 % CSS) and very high risk (TALL ≥ 5; 34 % DFS and 38 % CSS) using Kaplan–Meier survival analyses. TALL score was externally validated in a single-center cohort of 85 UTUC patients. We developed a multivariable prognostic tool for the prediction of oncological outcomes after RNU for high-grade UTUC. The score can be used for patient counseling, selection for adjuvant systemic therapies and design of clinical trials.
High-dose therapy and autologous stem cell transplant for transformed non-Hodgkin lymphoma in the rituximab era.

The impact of rituximab on the outcome of high-dose therapy and autologous stem cell transplant (HD-ASCT) for transformed non-Hodgkin lymphoma (NHL) has not been previously described. We analyzed 18 consecutive patients with indolent NHL who transformed to diffuse large B-cell lymphoma (DLBCL), received rituximab-containing therapy either before or after transformation and underwent subsequent HD-ASCT. With a median follow-up of 40 months, the 2-year progression-free survival (PFS) was 59% and the 2-year overall survival (OS) was 82%. Six patients did not receive rituximab pre-transformation. This group had a significantly better PFS at 2 years post-HD-ASCT compared to 12 patients who were exposed to rituximab pre-transformation (p = 0.03). HD-ASCT remains an effective therapeutic option for transformed NHL in the rituximab era. However, patients exposed to rituximab pre-transformation appear to have inferior HD-ASCT outcomes, and thus may benefit from novel conditioning and maintenance regimens in the setting of HD-ASCT.
Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial.

Suppression of back pain with traditional spinal cord stimulation (SCS) in failed back surgery syndrome patients is often insufficient. The objective of this study was to investigate the efficacy of subcutaneous stimulation (SubQ) as ADD-ON therapy to SCS in treating back pain in failed back surgery syndrome patients.



Patients with a minimal pain score of 50 on a 100 mm visual analog scale for both leg and back pain were eligible. If pain reduction after trial SCS was ≥50% for the leg but <50% for the back, patients received additional SubQ leads and were randomized in a 1:1 ratio in a study arm with subcutaneous leads switched on (SubQ ADD-ON) and an arm with subcutaneous leads switched off (Control). The primary outcome was the percentage of the patients, at three months since implantation, with ≥50% reduction of back pain.



A total of 97 patients were treated with SCS for leg and back pain. Of these, 52 patients were randomized and allocated to the Control group (n = 24) or to the SubQ ADD-ON group (n = 28). The percentage of patients with ≥50% reduction of back pain was significantly higher in the SubQ ADD-ON group (42.9%) compared to the Control group (4.2%). Mean visual analog scale for back pain, at three months, was a statistically significant 28.1 mm lower in the SubQ ADD-ON group compared to the Control group.



Subcutaneous stimulation as an ADD-ON therapy to SCS is effective in treating back pain in failed back surgery syndrome patients where SCS is only effective for pain in the leg.
Sorafenib plus dacarbazine in solid tumors: a phase I study with dynamic contrast-enhanced ultrasonography and genomic analysis of sequential tumor biopsy samples

Improved prognostic accuracy for treatment response and a wider understanding of drug effects in humans are crucial for enhancing the utility of sorafenib and other promising targeted therapies. We developed a strategy of global genomic investigation of sequential tumor biopsy samples at baseline and 21 days post treatment, and applied this approach in a phase I study of sorafenib plus dacarbazine in patients with solid tumors. The objective of this study was also to validate functional parameters of DCE-US as surrogate markers to predict earlier response.  Patients received 21-day cycles of oral sorafenib, 400 mg twice daily and dacarbazine, 1,000 mg/m2 in a 1-h intravenous infusion on day 1. Efficacy was assessed using response evaluation criteria in solid tumors. Sequential biopsy samples (baseline and day 21) were obtained from the same tumor. Changes from baseline in global gene expression (GE) measured by genomic microarrays and in tumor vascularity at baseline, D8, D21, D 42 and every 2 cycles using dynamic contrast-enhanced ultrasonography (DCE-US) were analyzed for patients with and without a clinical response to treatment at 3 months.  Among 23 patients evaluable for treatment efficacy, 17 were eligible for gene expression and DCE-US analyses. One patient achieved a partial response; 14 exhibited stable disease. Ten patients were defined as exhibiting stable disease (SD) and 7, progressive disease (PD) at 3 months. Genomic analyses identified a 237-gene signature that distinguished SD from PD at 3 months. Of note, CDK4 overexpression and PDGFR downregulation were associated with PD. Functional parameters of DCE-US representing the blood volume at baseline, day 8, and day 21 were correlated with disease progression at 3 months.  This novel approach of sequential investigations in a phase I trial was feasible, detecting early changes in gene expression and tumor vascularity evaluated using DCE-US that may be predictive of clinical outcome.
Results from an Audit Feedback Strategy for Chronic Obstructive Pulmonary Disease In-Hospital Care: A Joint Analysis from the AUDIPOC and European COPD Audit Studies

Clinical audits have emerged as a potential tool to summarize the clinical performance of healthcare over a specified period of time. However, the effectiveness of audit and feedback has shown inconsistent results and the impact of audit and feedback on clinical performance has not been evaluated for COPD exacerbations. In the present study, we analyzed the results of two consecutive nationwide clinical audits performed in Spain to evaluate both the in-hospital clinical care provided and the feedback strategy.



The present study is an analysis of two clinical audits performed in Spain that evaluated the clinical care provided to COPD patients who were admitted to the hospital for a COPD exacerbation. The first audit was performed from November-December 2008. The feedback strategy consisted of personalized reports for each participant center, the presentation and discussion of the results at regional, national and international meetings and the creation of health-care quality standards for COPD. The second audit was part of a European study during January and February 2011. The impact of the feedback strategy was evaluated in term of clinical care provided and in-hospital survival.



A total of 94 centers participated in the two audits, recruiting 8,143 admissions (audit 1∶3,493 and audit 2∶4,650). The initially provided clinical care was reasonably acceptable even though there was considerable variability. Several diagnostic and therapeutic procedures improved in the second audit. Although the differences were significant, the degree of improvement was small to moderate. We found no impact on in-hospital mortality.



The present study describes COPD hospital care in Spanish hospitals and evaluates the impact of peer-benchmarked, individually written and group-oral feedback strategy on the clinical outcomes for treating COPD exacerbations. It describes small to moderate improvements in the clinical care provided to COPD patients with no impact on in-hospital mortality.
Comparison of postoperative acute kidney injury between ileal conduit and neobladder urinary diversions after radical cystectomy

Ileal conduit and neobladder urinary diversions are frequently performed after radical cystectomy. However, complications after radical cystectomy may be different according to the type of urinary diversion. Acute kidney injury (AKI) is a common complication after surgery and increases costs, morbidity, and mortality of hospitalized patients. This study was performed to compare the incidence of postoperative AKI between ileal conduit and neobladder urinary diversions after radical cystectomy.All consecutive patients who underwent radical cystectomy in 2004 to 2014 in a single tertiary care center were identified. The patients were divided into the ileal conduit and ileal neobladder groups. Preoperative variables, including demographics, cancer-related data and laboratory values, as well as intraoperative data and postoperative outcomes, including AKI, intensive care unit admission rate, and the duration of hospital stay, were evaluated between the groups. Postoperative AKI was defined according to the Kidney Disease: Improving Global Outcome criteria. Propensity score matching analysis was performed to reduce the influence of possible confounding variables and adjust for intergroup differences.After performing 1:1 propensity score matching, the ileal conduit and ileal neobladder groups each included 101 patients. The overall incidence of AKI after radical cystectomy was 30.7% (62 out of 202) and the incidences did not significantly differ between the groups (27 [26.7%], ileal conduit group vs 35 [34.7%], ileal neobladder group, P = 0.268). Intraoperative data, intensive care unit admission rate, and the duration of hospital stay were not significantly different between the groups.Postoperative AKI did not significantly differ between ileal conduit and neobladder urinary diversions after radical cystectomy. This finding provides additional information useful for appropriate selection of the urinary diversion type in conjunction with radical cystectomy.
Early trends from the Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS).

Launched in January 2011, the prospective payment system (PPS) for the US Medicare End-Stage Renal Disease Program bundled payment for services previously reimbursed independently. Small dialysis organizations may be particularly susceptible to the financial implications of the PPS. The ongoing Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS) was designed to describe trends in care and outcomes over the period of PPS implementation. This report details early results between October 2010 and June 2011.



Prospective observational cohort study of patients from a sample of 51 small dialysis organizations.



1,873 adult hemodialysis and peritoneal dialysis patients.



Secular trends in processes of care, anemia, metabolic bone disease management, and red blood cell transfusions.



Facility-level data are collected quarterly. Patient characteristics were collected at enrollment and scheduled intervals thereafter. Clinical outcomes are collected on an ongoing basis.



Over time, no significant changes were observed in patient to staff ratios. There was a temporal trend toward greater use of peritoneal dialysis (from 2.4% to 3.6%; P = 0.09). Use of cinacalcet, phosphate binders, and oral vitamin D increased; intravenous (IV) vitamin D use decreased (P for trend for all <0.001). Parathyroid hormone levels increased (from 273 to 324 pg/dL; P < 0.001). Erythropoiesis-stimulating agent doses decreased (P < 0.001 for IV epoetin alfa and IV darbepoetin alfa), particularly high doses. Mean hemoglobin levels decreased (P < 0.001), the percentage of patients with hemoglobin levels <10 g/dL increased (from 12.7% to 16.8%), and transfusion rates increased (from 14.3 to 19.6/100 person-years; P = 0.1). Changes in anemia management were more pronounced for African American patients.



Limited data were available for the prebundle period. Secular trends may be subject to the ecologic fallacy and are not causal in nature.



In the period after PPS implementation, IV vitamin D use decreased, use of oral therapies for metabolic bone disease increased, erythropoiesis-stimulating agent use and hemoglobin levels decreased, and transfusion rates increased numerically.
Cyclophilin A in Ruptured Intracranial Aneurysm: A Prognostic Biomarker.

Cyclophilin A (CyPA), an oxidative stress-induced factor, was found to play an important role in the aneurysm formation. Our working hypothesis was that the plasma level of CyPA in ruptured intracranial aneurysm could predict the neurological outcome. From 2011 to 2013, a total of 36 patients with ruptured saccular intracranial aneurysm were recruited in our study. Before coil embolization, we draw blood samples at the orifice of a culprit aneurysm and in the remote peripheral vein for measurements of the CyPA levels. We utilized the modified Rankin scale 30 days after aneurysm rupture as the outcome measure. Generalized linear models were used to estimate the adjusted odds ratios of the poor neurological outcome given the presence of high plasma level of CyPA. The aneurysmal and venous CyPA levels were significantly associated with the initial clinical severity (P = 0.004 and 0.03, respectively) and 30-day outcome (P = 0.01 and 0.02, respectively). The aneurysmal CyPA levels modestly correlated with age and high Fisher grade (ρ = 0.39 and 0.41; P = 0.02 and 0.01, respectively). The aneurysmal CyPA levels strongly correlated with the venous counterpart (ρ = 0.89; P < 0.001). Patients with high levels of aneurysmal CyPA were 15.66 times (95% CI, 1.48-166.24; P = 0.02) more likely to have worse neurological outcome than those with the low levels after adjustment of the age, gender, and the documented confounding factors. High plasma level of CyPA is a significant prognostic biomarker for poor neurological outcome in patients with ruptured intracranial aneurysm.
Energy-Efficient Implementation of ECDH Key Exchange for Wireless Sensor Networks

Wireless Sensor Networks (WSNs) are playing a vital role in an ever-growing number of applications ranging from environmental surveillance over medical monitoring to home automation. Since WSNs are often deployed in unattended or even hostile environments, they can be subject to various malicious attacks, including the manipulation and capture of nodes. The establishment of a shared secret key between two or more individual nodes is one of the most important security services needed to guarantee the proper functioning of a sensor network. Despite some recent advances in this field, the efficient implementation of cryptographic key establishment for WSNs remains a challenge due to the resource constraints of small sensor nodes such as the MICAz mote. In this paper we present a lightweight implementation of the elliptic curve Diffie-Hellman (ECDH) key exchange for ZigBee-compliant sensor nodes equipped with an ATmega128 processor running the TinyOS operating system. Our implementation uses a 192-bit prime field specified by the NIST as underlying algebraic structure and requires only 5.20 · 10 clock cycles to compute a scalar multiplication if the base point is fixed and known a priori. A scalar multiplication using a random base point takes about 12.33 ·10 cycles. Our results show that a full ECDH key exchange between two MICAz motes consumes an energy of 57.33 mJ (including radio communication), which is significantly better than most previously reported ECDH implementations on comparable platforms.
A randomized trial of the effect of community pharmacist intervention on cholesterol risk management: the Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP).

Despite clear evidence for the efficacy of lowering cholesterol levels, there is a deficiency in its real-world application. There is a need to explore alternative strategies to address this important public health problem. This study aimed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events.



A randomized controlled trial conducted in 54 community pharmacies (1998-2000) included patients at high risk for cardiovascular events (with atherosclerotic disease or diabetes mellitus with another risk factor). Patients randomized to pharmacist intervention received education and a brochure on risk factors, point-of-care cholesterol measurement, referral to their physician, and regular follow-up for 16 weeks. Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions. Usual care patients received the same brochure and general advice only, with minimal follow-up. The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication.



The external monitoring committee recommended early study termination owing to benefit. Of the 675 patients enrolled, approximately 40% were women, and the average age was 64 years. The primary end point was reached in 57% of intervention patients vs 31% in usual care (odds ratio, 3.0; 95% confidence interval, 2.2-4.1; P<.001).



A community-based intervention program improved the process of cholesterol management in high-risk patients. This program demonstrates the value of community pharmacists working in collaboration with patients and physicians.