nils-herrmann/clean_scirepeval huggingface dataset:
Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust.

To further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score.



Using pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables.



Although all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores.



Our results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome.
Performance of creatinine and cystatin C-based glomerular filtration rate estimating equations in a European HIV-positive cohort.

To validate glomerular filtration rate (GFR) estimating equations in white HIV-infected patients based on serum creatinine and/or serum cystatin C.



Single-center, cross-sectional evaluation of the predictive performance of GFR estimators.



GFR was measured by iohexol plasma clearance. Serum creatinine (Scr) and serum cystatin C (Scyst) were measured by traceable and standardized methods. We evaluated the performance of the Modification of Diet in Renal Disease (MDRD) and the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equations. We also studied the performance of the cystatin C-based equation (CKD-EPI Scyst) and the combined cystatin and creatinine-based equation (CKD-EPI combined), as recently proposed by the CKD-EPI group.



Two hundred and three participants (18% of women) were included. Mean age was 49 ± 10 years. Mean measured GFR (mGFR) was 95 ± 24 ml/min per 1.73 m². CKD-EPI and CKD-EPI combined significantly outperformed the MDRD equation. The percentage of estimating results within 30% of mGFR was 75, 82 and 81% for the MDRD, CKD-EPI and CKD-EPI combined equation, respectively. Results favoring the CKD-EPI and CKD-EPI combined equation were especially observed for patients with mGFR over 90 ml/min per 1.73 m².



In our European HIV cohort, we confirmed that the creatinine-based CKD-EPI equation should replace the MDRD study equation. However, global performance of this equation remains worse than the performance observed in the general population. This lesser performance is particularly relevant in patients with measured GFR under and around 60 ml/min per 1.73 m². Moreover, the specific interest of Scyst-based equations is not confirmed in this population.
Confidence intervals construction for difference of two means with incomplete correlated data.

Incomplete data often arise in various clinical trials such as crossover trials, equivalence trials, and pre and post-test comparative studies. Various methods have been developed to construct confidence interval (CI) of risk difference or risk ratio for incomplete paired binary data. But, there is little works done on incomplete continuous correlated data. To this end, this manuscript aims to develop several approaches to construct CI of the difference of two means for incomplete continuous correlated data.



Large sample method, hybrid method, simple Bootstrap-resampling method based on the maximum likelihood estimates (B 1) and Ekbohm's unbiased estimator (B 2), and percentile Bootstrap-resampling method based on the maximum likelihood estimates (B 3) and Ekbohm's unbiased estimator (B 4) are presented to construct CI of the difference of two means for incomplete continuous correlated data. Simulation studies are conducted to evaluate the performance of the proposed CIs in terms of empirical coverage probability, expected interval width, and mesial and distal non-coverage probabilities.



Empirical results show that the Bootstrap-resampling-based CIs B 1, B 2, B 4 behave satisfactorily for small to moderate sample sizes in the sense that their coverage probabilities could be well controlled around the pre-specified nominal confidence level and the ratio of their mesial non-coverage probabilities to the non-coverage probabilities could be well controlled in the interval [0.4, 0.6].



If one would like a CI with the shortest interval width, the Bootstrap-resampling-based CIs B 1 is the optimal choice.
Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial.

Corticosteroid therapy induces potentially detrimental hyperglycemia in septic shock. In addition, the benefit of adding fludrocortisone in this setting is unclear.



To test the efficacy of intensive insulin therapy in patients whose septic shock was treated with hydrocortisone and to assess, as a secondary objective, the benefit of fludrocortisone.



A multicenter, 2 x 2 factorial, randomized trial, involving 509 adults with septic shock who presented with multiple organ dysfunction, as defined by a Sequential Organ Failure Assessment score of 8 or more, and who had received hydrocortisone treatment was conducted from January 2006 to January 2009 in 11 intensive care units in France.



Patients were randomly assigned to 1 of 4 groups: continuous intravenous insulin infusion with hydrocortisone alone, continuous intravenous insulin infusion with hydrocortisone plus fludrocortisone, conventional insulin therapy with hydrocortisone alone, or conventional insulin therapy with intravenous hydrocortisone plus fludrocortisone. Hydrocortisone was administered in a 50-mg bolus every 6 hours, and fludrocortisone was administered orally in 50-microg tablets once a day, each for 7 days.



In-hospital mortality.



Of the 255 patients treated with intensive insulin, 117 (45.9%), and 109 of 254 (42.9%) treated with conventional insulin therapy died (relative risk [RR], 1.07; 95% confidence interval [CI], 0.88-1.30; P = .50). Patients treated with intensive insulin experienced significantly more episodes of severe hypoglycemia (<40 mg/dL) than those in the conventional-treatment group, with a difference in mean number of episodes per patient of 0.15 (95% CI, 0.02-0.28; P = .003). At hospital discharge, 105 of 245 patients treated with fludrocortisone (42.9%) died and 121 of 264 (45.8%) in the control group died (RR, 0.94; 95% CI, 0.77-1.14; P = .50).



Compared with conventional insulin therapy, intensive insulin therapy did not improve in-hospital mortality among patients who were treated with hydrocortisone for septic shock. The addition of oral fludrocortisone did not result in a statistically significant improvement in in-hospital mortality.
Allogeneic bone marrow transplantation for acute leukemia in patients over the age of 40 years

Extension of allogeneic transplants to older patients has been limited by a high risk of transplant-related death and graft-versus-host disease. To evaluate the feasibility in older patients, a retrospective analysis of the procedure was performed for first remission acute leukemia in 192 patients aged over 40 years and compared with a group of 1119 recipients aged from 16 to 40 years reported to the EBMT from 1986 to 1992. Patient-, disease-, and treatment-related variables were compared between the two age groups using the χ2 statistical method for categorical variables. Variables differing significantly or recognized as potential prognostic factors were included in a multivariate analysis. Leukemia-free survival and relapse were comparable among the age groups in the two types of leukemias. Incidence of graft-versus-host disease was higher in the older group of ALL patients. Older patients with AML in first remission had a higher treatment-related mortality incidence, with no influence on survival. A pair-matched analysis of AML patients did not show any statistical difference in the probability of LFS, RI, TRM, and survival for the two age cohorts of patients. These results suggest that BMT should be considered for patients over 40 years of age.
Economic Evaluation of Triflusal and Aspirin in the Treatment of Acute Myocardial Infarction

To compare the costs to the Spanish healthcare system of 35 days’ treatment with triflusal (600 mg/day) and aspirin (300 mg/day) in patients with confirmed acute myocardial infarction within 24 hours of onset of symptoms.  A cost minimisation analysis based on the results of the Triflusal in Acute Myocardial Infarction study (TIM) was conducted. The hypothesis was that despite a higher acquisition cost of triflusal, savings would result because of differences in efficacy and safety outcome (non-fatal cerebrovascular event and haemorrhagic events). Diagnostic Related Groups were used as a proxy for determining hospital costs in Spain and the values were obtained from different sources and refer to year 2000 costs. Only direct medical costs were considered for the economic analysis.  Although the acquisition cost of triflusal was more expensive than that of aspirin, the cost of prevented events — non-fatal ischaemic cerebrovascular events and cerebral haemorrhages — entirely compensated for the cost of triflusal. The overall cost of treating patients with triflusal, compared with aspirin, represented a net saving of 28.4% per patient treated.  Our study showed that triflusal is cost saving compared with aspirin in the treatment of the acute phase of myocardial infarction.
Depot-specific regulation of glucose uptake and insulin sensitivity in HIV-lipodystrophy.

Altered fat distribution is associated with insulin resistance in HIV, but little is known about regional glucose metabolism in fat and muscle depots in this patient population. The aim of the present study was to quantify regional fat, muscle, and whole body glucose disposal in HIV-infected men with lipoatrophy. Whole body glucose disposal was determined by hyperinsulinemic clamp technique (80 mU x m(-2) x min(-1)) in 6 HIV-infected men and 5 age/weight-matched healthy volunteers. Regional glucose uptake in muscle and subcutaneous (SAT) and visceral adipose tissue (VAT) was quantified in fasting and insulin-stimulated states using 2-deoxy-[18F]fluoro-D-glucose positron emission tomography. HIV-infected subjects with lipoatrophy had significantly increased glucose uptake into SAT (3.8 +/- 0.4 vs. 2.3 +/- 0.5 micromol x kg tissue(-1) x min(-1), P < 0.05) in the fasted state. Glucose uptake into VAT did not differ between groups. VAT area was inversely related with whole body glucose disposal, insulin sensitivity, and muscle glucose uptake during insulin stimulation. VAT area was highly predictive of whole body glucose disposal (r2 = 0.94, P < 0.0001). This may be mediated by adiponectin, which was significantly associated with VAT area (r = -0.75, P = 0.008), and whole body glucose disposal (r = 0.80, P = 0.003). This is the first study to directly demonstrate increased glucose uptake in subcutaneous fat of lipoatrophic patients, which may partially compensate for loss of SAT. Furthermore, we demonstrate a clear relationship between VAT and glucose metabolism in multiple fat and muscle depots, suggesting the critical importance of this depot in the regulation of glucose and highlighting the significant potential role of adiponectin in this process.
Using a SCIP-PLUS perspective to reduce the risk of SSI

Four risk reduction initiatives were studied, A: Impact of BMI on antimicrobial prophylactic dosing in general, OB and CT surgical patients; B: Development of standardized regimen of CHG preadmission cleansing to improve outcome in surgical patients;  Efficacy of antimicrobial sutures to reduce the risk of suture contamination at wound closure and D: The impact of an innovative antimicrobial surgical glove to reduce the risk of microbial contamination following glove microperforation.
Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results.

To investigate the safety and efficacy of switching to biphasic insulin aspart (BIAsp) 30, 50 or 70 in patients with type 2 diabetes previously treated with biphasic human insulin (BHI) 30/50 (with or without oral glucose-lowering drugs) in routine clinical practice.



This was a 26-week, prospective, observational study conducted in Belgium and Luxembourg. Data were collected at baseline before patients switched and at 12 and 26 weeks after starting BIAsp 30, 50 or 70. Safety endpoints were incidence and rate of hypoglycemia (major, minor, nocturnal), adverse events and body-weight changes. Efficacy assessments included HbA(1c) and 7-point self-measured plasma glucose (PG) profiles. Changes from baseline were analyzed using paired t-tests.



Of 592 patients analyzed, 72% switched to twice-daily BIAsp and 20% to three-times daily BIAsp. Upon switching, 27% of patients received intensified treatment (i.e., more daily doses than with their previous BHI). At all three data-collection points, approximately two-thirds of patients were taking BIAsp 30 and approximately one-third were taking BIAsp 50; very few patients took BIAsp 70. Mean total daily insulin dose increased significantly from baseline (51.2 U) to 26 weeks (54.3 U) and mean time of intake before meals changed from 17 minutes for BHI to ∼3 minutes with BIAsp. Incidence of hypoglycemia did not change during the study (baseline: 30.7%, week 26: 29.2%). HbA(1c) improved significantly from baseline (7.9 %) to weeks 12 and 26 (7.6% and 7.5%, respectively; p < 0.001). Mean PG profiles also showed significant improvements. As this is an observational study, some limitations should be considered such as the absence of a control group and a possible bias of increased medical attention.



Patients with long-standing type 2 diabetes can switch safely from BHI to BIAsp therapy, even if they receive intensified treatment, and they have no problems changing the timing of their insulin injections.
Psychopharmacological treatment of social phobia; a double blind placebo controlled study with fluvoxamine

Previous studies have shown selective and non-selective monoamine oxidase inhibitors (MAOIs) to be effective in the treatment of social phobia. In this study we investigated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in social phobia. Thirty patients with social phobia (DSM-IIIR) were treated with the SSRI fluvoxamine (150 mg daily) using a 12-week double-blind placebo controlled design. A substantial improvement was observed in seven (46%) patients on fluvoxamine and in one (7%) on placebo. Statistically significant effects were seen on measures of social anxiety and general (or anticipatory) anxiety in patients treated with fluvoxamine compared with placebo. The level of phobic avoidance decreased also but the difference at endpoint between fluvoxamine and placebo failed to reach statistical significance. It is concluded that treatment with the SSRI fluvoxamine has beneficial effects in patients suffering from social phobia, suggesting that serotonergic mechanisms might be implicated in social anxiety.
Omega‐3 Fatty Acid Supplementation Provides an Additional Benefit to a Low‐Dust Diet in the Management of Horses with Chronic Lower Airway Inflammatory Disease

Omega-3 polyunsaturated fatty acid (PUFA) may benefit humans and animals with chronic inflammatory diseases.



Omega-3 PUFA supplementation improves clinical signs, lung function, and airway inflammation in horses with recurrent airway obstruction (RAO) and inflammatory airway disease (IAD).



Eight research horses and 35 client-owned horses.



A pilot study examined the dose of PUFA that can alter plasma PUFA composition. Then, a randomized, controlled clinical trial was performed in horses with RAO and IAD. Horses were fed a complete pelleted diet with no hay and randomly assigned to 1 of 3 daily treatments for 2 months: 30 or 60 g of the supplement or 30 g of placebo. Clinical signs, lung function, plasma PUFA composition, and bronchoalveolar lavage fluid (BALF) cytology were evaluated. Data were expressed as median (25-75th percentiles). P < .05 was considered significant.



Polyunsaturated fatty acid supplementation resulted in increased plasma docosahexaenoic acid (DHA) that peaked at 4 weeks. Clinical improvement was noted in all horses involved in the clinical trial, but the group that received PUFA had greater improvement in clinical signs (cough score improved 60%), lung function (respiratory effort decreased 48%), and BALF (neutrophils decreased from 23 to 9%) when compared to placebo (cough score improved 33%, respiratory effort decreased 27%, BALF neutrophils increased from 11 to 17%; P < .05).



Feeding horses with RAO and IAD a PUFA supplement containing 1.5-3 g DHA for 2 months provides an additional benefit to low-dust diet.
Phase II trial of temozolomide plus concurrent whole-brain radiation followed by TNV regimen as adjuvant therapy for patients with newly diagnosed primary CNS lymphoma.

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non-Hodgkin's lymphoma limited to the CNS. Treatment of PCNSL with high-dose methotrexate (HD-MTX)-based chemotherapy and whole-brain radiotherapy (WBRT) is associated with high rates of relapse and severe treatment-related neurotoxicity.



To report our experience of treating newly diagnosed PCNSL with temozolomide, nedaplatin, and vincristine (TNV), as the replacement of HD-MTX, in combination with concurrent chemoradiotherapy.



Newly diagnosed PCNSL patients were given concurrent temozolomide (75 mg/m 2 , orally) daily during WBRT. Then, the TNV regimen was given after four weeks. The TNV regimen consisted of temozolomide (200 mg/m 2 orally: Days 1-5), nedaplatin (80 mg/m 2 intravenous: Day 1), and vincristine (1.4 mg/m 2 intravenous: Day 1). Each cycle was of a duration of four weeks and a maximum of six cycles were applied. The primary end point was response to treatment obtained by magnetic resonance imaging (MRI). Secondary end points were progression-free survival (PFS) and fewer toxic effects.



The study subjects included 14 patients (median age: 53.5, median Karnofsky Performance Scale (KPS): 75). The median number of TNV cycles given was five.  Complete response in 12 (85.7%) patients, partial response in 2 (14.3%) patients, and none with progressive disease. The objective response rate was 100%, and median PFS was 21.4 months. Toxicity was relatively mild, which mainly included nausea in six and fatigue in five, grade 3-4 hematotoxicity in one, and abnormal liver functions in five patients. No neurotoxicity has been observed till date.



The efficacy outcomes in this study are comparable to other reported HD-MTX-based regimens plus WBRT, with an added favorable toxicity profile. Prospective, randomized controlled trials are warranted to confirm such results.
Effect of cinnamon on gastric emptying, arterial stiffness, postprandial lipemia, glycemia, and appetite responses to high-fat breakfast

Cinnamon has been shown to delay gastric emptying of a high-carbohydrate meal and reduce postprandial glycemia in healthy adults. However, it is dietary fat which is implicated in the etiology and is associated with obesity, type 2 diabetes and cardiovascular disease. We aimed to determine the effect of 3 g cinnamon (Cinnamomum zeylanicum) on GE, postprandial lipemic and glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and subsequent food intake following a high-fat meal.



A single-blind randomized crossover study assessed nine healthy, young subjects. GE rate of a high-fat meal supplemented with 3 g cinnamon or placebo was determined using the 13C octanoic acid breath test. Breath, blood samples and subjective appetite ratings were collected in the fasted and during the 360 min postprandial period, followed by an ad libitum buffet meal. Gastric emptying and 1-day fatty acid intake relationships were also examined.



Cinnamon did not change gastric emptying parameters, postprandial triacylglycerol or glucose concentrations, oxidative stress, arterial function or appetite (p < 0.05). Strong relationships were evident (p < 0.05) between GE Thalf and 1-day palmitoleic acid (r = -0.78), eiconsenoic acid (r = -0.84) and total omega-3 intake (r = -0.72). The ingestion of 3 g cinnamon had no effect on GE, arterial stiffness and oxidative stress following a HF meal.



3 g cinnamon did not alter the postprandial response to a high-fat test meal. We find no evidence to support the use of 3 g cinnamon supplementation for the prevention or treatment of metabolic disease. Dietary fatty acid intake requires consideration in future gastrointestinal studies.
Volumetric modulated arc radiotherapy for carcinomas of the oro-pharynx, hypo-pharynx and larynx: a treatment planning comparison with fixed field IMRT.

A planning study was performed to evaluate the performance of volumetric modulated arc radiotherapy on head and neck cancer patients. Conventional fixed field IMRT was used as a benchmark.



CT datasets of 29 patients with squamous cell carcinoma of the oro-pharynx, hypo-pharynx and larynx were included. Plans for fixed beam IMRT, single (RA1) and double (RA2) modulated arcs with the RapidArc technique were optimised. Dose prescription was set to 66 Gy to the primary tumour (at 2.2 Gy/fraction), 60 Gy to intermediate-risk nodes and 54 Gy to low-risk nodal levels. The planning objectives for PTV were minimum dose >95%, and maximum dose <107%. Maximum dose to spinal cord was limited to 46 Gy, maximum to brain stem to 50 Gy. For parotids, mean dose <26 Gy (or median <30 Gy) was assumed as the objective. The MU and delivery time were scored to measure expected treatment efficiency.



Target coverage and homogeneity results improved with RA2 plans compared to both RA1 and IMRT. All the techniques fulfilled the objectives on maximum dose, while small deviations were observed on minimum dose for PTV. The conformity index (CI(95%)) was 1.7+/-0.2 for all the three techniques. RA2 allowed a reduction of D(2%) to spinal cord of approximately 3 Gy compared to IMRT (RA1 D(2%) increased it of approximately 1 Gy). On brain stem, D(2%) was reduced from 12 Gy (RA1 vs. IMRT) to 13.5 Gy (RA2 vs. IMRT). The mean dose to ipsi-lateral parotids was reduced from 40 Gy (IMRT) to 36.2 Gy (RA1) and 34.4 Gy (RA2). The mean dose to the contra-lateral gland ranged from 32.6 Gy (IMRT) to 30.9 Gy (RA1) and 28.2 Gy (RA2).



RapidArc was investigated for head and neck cancer. RA1 and RA2 showed some improvements in organs at risk and healthy tissue sparing, while only RA2 offered improved target coverage with respect to conventional IMRT.