nils-herrmann/clean_scirepeval huggingface dataset:
Measuring breast cancer-specific health-related quality of life in South Asia: psychometric properties of the Sinhala version of the EORTC QLQ-BR23

To evaluate the psychometric properties of the Sinhala version of the breast cancer-specific health-related quality of life (HRQL) module of the European Organization for Research and Treatment of Cancer (QLQ-BR23). Psychometric testing assessed the hypothesized scale structure, internal consistency, construct validity and acceptability of the Sinhala version of the QLQ-BR23 in a consecutive series of 356 newly diagnosed breast cancer patients recruited from tertiary care oncology treatment centres in Sri Lanka. Compliance and self-completion rates were high (98% and 88%, respectively), and missing data low (0.06%). Multitrait scaling confirmed the scale structure of the QLQ-BR23 with excellent item convergence (95%), item discrimination (99%), and scaling success (99%) rates. The Cronbach’s alpha coefficients of the scales for internal consistency reliability ranged from 0.68 to 0.93. Construct validity was confirmed with satisfactory results for interscale correlations and known-groups comparisons. QLQ-BR23 item-scale correlations met or exceeded the convergent validity criterion of 0.40 for all but one item. QLQ-BR23 interscale correlations met this criterion for three comparisons and for five comparisons with conceptually related QLQ-C30 scales. Correlations between QLQ-BR23 scales and QLQ-C30 functional scales were lower as expected. As expected, most dimensions of the QLQ-BR23 were able to discriminate clearly between pretreatment and current treatment patients. Overall psychometric results for the Sinhala version of the QLQ-BR23 confirmed it as a reliable and valid questionnaire for assessing breast cancer-specific HRQL in Sri Lanka.
The Effect of Fingolimod on Conversion of Acute Gadolinium‐Enhancing Lesions to Chronic T1 Hypointensities in Multiple Sclerosis

Brain lesions converting to chronic T1 hypointensities ("chronic black holes" [CBH]), indicate severe tissue destruction (axonal loss and irreversible demyelination) in multiple sclerosis (MS). Two mechanisms by which fingolimod could limit MS lesion evolution include sequestration of lymphocytes in the periphery or direct neuroprotective effects. We investigated the effect of fingolimod on the evolution of acute gadolinium-enhancing (Gd+) brain lesions to CBH in patients with MS.



This was a retrospective nonrandomized comparison of patients with Gd+ brain lesions at the time of starting oral fingolimod [.5 mg/day, n = 26, age (mean ± SD) 39.2 ± 10.6 years, Expanded Disability Status Scale (EDSS) score - median (range): 1.75 (0, 6.5)] to those on no therapy [n = 30, age 41.7 ± 9.3 years; EDSS 1.0 (0, 6)]. Each lesion was classified by whether it converted to a CBH in the year following treatment.



In the fingolimod group, 99 Gd+ baseline lesions (mean ± SD, range: 3.8 ± 5.1; 1, 21 per patient) were identified of which 25 (25%) evolved to CBH (1.0 ± 2.0; 0, 10 per patient). The untreated group had 62 baseline Gd+ lesions (2.1 ± 2.3; 1, 13), 26 (42%) of which evolved to CBH (.9 ± 1.4; 0, 7) (P = .063). Thirteen patients (50%) receiving fingolimod and 17 untreated patients (57%) developed CBH (P = .79).



This pilot study shows a trend of fingolimod on reducing the conversion rate from acute to chronic destructive MS lesions. Such an effect awaits verification in larger randomized prospective studies.
Impact of parathyroidectomy on serum FGF23 and soluble Klotho in hemodialysis patients with severe secondary hyperparathyroidism.

Klotho is a transmembrane protein that functions as a coreceptor for fibroblast growth factor 23 (FGF23). Klotho is cleaved and released into the circulation; however, the main site of production, physiological role, and regulation of soluble Klotho in humans are largely unknown.



The aim of this study was to determine the impact of parathyroidectomy (PTx) on serum FGF23 and soluble Klotho levels in patients with severe secondary hyperparathyroidism.



This was a prospective, single-arm trial conducted at Tokai University School of Medicine.



Thirteen hemodialysis patients with severe secondary hyperparathyroidism who were candidates for PTx participated in the study.



All patients underwent total PTx with forearm autotransplantation.



We evaluated changes in serum FGF23 and soluble Klotho levels for 90 days after PTx. Other biochemical parameters related to mineral and bone metabolism were also assessed.



At baseline, serum FGF23 levels were markedly elevated, whereas serum soluble Klotho levels were modestly decreased. PTx resulted in a marked, progressive decline in serum FGF23 levels together with significant reductions in serum calcium, phosphorus, and intact PTH levels. The serum soluble Klotho levels were reduced 13% from baseline on the day after PTx; however, these levels then increased progressively, reaching 34% above the postoperative values.



Our results suggest that the parathyroid gland is not the major site of soluble Klotho production in patients with end-stage renal disease, and the production of Klotho by other organ(s) is affected by alterations in mineral metabolism or medications taken after PTx.
Effects of Proximal Gut Bypass on Glucose Tolerance and Insulin Sensitivity in Humans

R oux-en-Y gastric bypass (RYGB) surgery produces a significant improvement in glucose metabolism prior to substantial weight loss; this is proposed to result from an enhanced incretin effect secondary to bypass of the duodenum and proximal jejunum. However, the caloric restriction that occurs early after surgery also has beneficial metabolic effects. To dissect the contribution of nutrient bypass of the proximal gut to improved glucose tolerance after RYGB surgery from caloric restriction, we induced a " non-surgical, proximal gut bypass " by directly administering a glucose load to the jejunum via a nasally inserted feeding tube.
Moderate-intensity interval training increases serum brain-derived neurotrophic factor level and decreases inflammation in Parkinson's disease patients.

It has been demonstrated that physical training increases serum brain-derived neurotrophic factor (BDNF) in healthy people. The aim of this study was to establish the effect of physical training on the basal serum level of the BDNF in the Parkinson's disease patients (PD patients) in relation to their health status. Twelve PD patients (mean ± S.E.M: age 70 ± 3 years; body mass 70 ± 2 kg; height 163 ± 3 cm) performed a moderate-intensity interval training (three 1-hour training sessions weekly), lasting 8 weeks. Basal serum BDNF in the PD patients before training amounted to 10,977 ± 756 pg x mL(-1) and after 8 weeks of training it has increased to 14,206 ± 1256 pg x mL(-1) (i.e. by 34%, P=0.03). This was accompanied by an attenuation of total Unified Parkinson's Disease Rating Scale (UPDRS) (P=0.01). The training resulted also in a decrease of basal serum soluble vascular cell adhesion molecule 1 (sVCAM-1) (P=0.001) and serum tumor necrosis factor-α (TNF-α) (P=0.03) levels. We have concluded that the improvement of health status of the Parkinson's disease patients after training could be related to the increase of serum BDNF level caused by the attenuated inflammation in those patients.
Temporal Trends and Factors Associated With Cardiac Rehabilitation Referral Among Patients Hospitalized With Heart Failure: Findings From Get With The Guidelines-Heart Failure Registry.

Current guidelines recommend cardiac rehabilitation (CR) in medically stable outpatients with heart failure (HF); however, temporal trends and factors associated with CR referral among these patients in real-world practice are not entirely known.



The purpose of this study was to assess proportional use, temporal trends, and factors associated with CR referral at discharge among patients admitted with decompensated HF.



Using data from a national Get With the Guidelines-Heart Failure registry, we assessed the temporal trends in CR referral among eligible patients with HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF) at discharge after HF hospitalization between 2005 and 2014. On multivariable analysis, we also assessed patient- and hospital-level characteristics that are associated with CR referral.



Among 105,619 HF patients (48% with HFrEF, 52% with HFpEF), 10.4% (12.2% with HFrEF, 8.8% with HFpEF) received CR referral at discharge. A significant increase in CR referral rates was observed among both HFpEF and HFrEF patients over the study period (ptrend <0.0001 for HFrEF, HFpEF, and overall). Compared with patients discharged without CR referral, patients referred for CR were younger, predominantly men, and more likely to receive evidence-based HF therapies at discharge. On multivariable analysis, younger age, fewer comorbid conditions, and in-hospital procedures such as coronary artery bypass grafting, percutaneous coronary intervention, and cardiac valve surgery were most strongly associated with CR referral.



Only one-tenth of eligible HF patients received CR referral at discharge after hospitalization for HF. The proportional use of CR referral is increasing over time among both HFrEF and HFpEF patients. Further strategies to improve physician and patient awareness in regard to the benefit of CR should be used to increase CR referral among patients with HF.
“High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial” (HIGHLOW trial)

The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial.



The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, β = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients.



The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function.
Stroke Prevention Trial in Sickle Cell Anemia (STOP): extended follow-up and final results.

The Stroke Prevention Trial in Sickle Cell Anemia (STOP) was a randomized trial to evaluate whether chronic transfusion could prevent initial stroke in children with sickle-cell anemia at high risk as determined by transcranial Doppler (TCD). The trial demonstrated a large benefit of transfusion and was halted early. After termination of the trial, patients participated in a post-trial follow-up study. More patients in the transfusion group (70%) elected transfusion for primary stroke prevention compared with those on standard care (45%). Six patients with persistently abnormal TCD results developed stroke. A minority with initially abnormal TCD results remained stroke-free without transfusion. Except for lower baseline and follow-up TCD velocities compared with those with stroke, no predictive features of this apparent lower-risk subgroup could be determined. TCD results at last testing in 108 patients that did not have stroke were: normal (44.4%), conditional (26.9%), abnormal (22.2%), and inadequate (6.5%). Patients on transfusion were more likely to have normal TCD results. Transfusion resulted in iron overload and alloimmunization, but no infection. The study provides new information on acceptance rates and long-term effects of transfusion. Persistent TCD elevation signals ongoing stroke risk. Reduction in TCD results over time without transfusion is observed in some patients and requires further study.
Multicenter prospective nonrandomized controlled clinical trial to prove neurotherapeutic effects of granulocyte colony-stimulating factor for acute spinal cord injury: analyses of follow-up cases after at least 1 year.

An open-labeled multicenter prospective nonrandomized controlled clinical trial.



To confirm the feasibility of using granulocyte colony-stimulating factor (G-CSF) for treatment of acute spinal cord injury (SCI).



We previously reported that G-CSF promotes functional recovery after compression-induced SCI in mice. On the basis of these findings, we conducted a multicenter prospective controlled clinical trial to assess the feasibility of G-CSF therapy for patients with acute SCI.



The trial ran from August 2009 to March 2011, and included 41 patients with SCI treated within 48 hours of onset. Informed consent was obtained from all patients. After providing consent, patients were divided into 2 groups. In the G-CSF group (17 patients), G-CSF (10 μg/kg/d) was intravenously administered for 5 consecutive days, and in the control group (24 patients), patients were similarly treated except for the G-CSF administration. We evaluated motor and sensory functions using the American Spinal Cord Injury Association score and American Spinal Cord Injury Association impairment scale at 1 week, 3 months, 6 months, and 1 year after onset.



Only 2 patients did not experience American Spinal Cord Injury Association impairment scale improvement in the G-CSF group. In contrast, 15 patients in the control group did not experience American Spinal Cord Injury Association impairment scale improvement. In the analysis of increased American Spinal Cord Injury Association motor score, a significant increase in G-CSF group was detected from 1 week after the administration compared with the control group. After that, some spontaneous increase of motor score was detected in control group, but the significant increase in G-CSF group was maintained until 1 year of follow-up.



Despite the limitation that patient selection was not randomized, the present results suggest the possibility that G-CSF administration has beneficial effects on neurological recovery in patients with acute SCI.
Cryptology in Transition

This work is intended to convey to the reader the phase of transition that public cryptology is in at the present time and the evolving state of the art. The transition is multifaceted: In scope of relevancy it has evolved from a government monopoly dealing with military and diplomatic communications to a major concern of business in general, the banking industry in particular, and, more recently, the public at large. Its technology has expanded from paper-andpencil and various mechanical devices to large, high-speed, electronic computers. Its security emphasis has changed from statistical uncertainty to computational complexity. And last, but not least, in concept it has developed from conventional, private-key schemes to public-key cryptosystems providing instant privacy and twoway authentication. This latest transition also reflects the rapidly evolving state of the "art" of cryptology. Since its recent adoption by the
Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial.

Iron deficiency is a common cause of anemia in young persons with chronic kidney disease (CKD). Iron repletion with intravenous (IV) iron formulations has been studied in children; maintenance IV iron regimens have not been reported extensively.



A multicenter randomized trial of IV iron sucrose.



145 children, adolescents, and young adults with CKD receiving erythropoiesis-stimulating agent (ESA) therapy were stratified by dialysis category (hemodialysis, peritoneal dialysis, or non-dialysis dependent) and weight (<50 and ≥50 kg).



Patients were randomly assigned to 1 of 3 dosing arms: 0.5, 1.0, or 2.0 mg/kg (maximum single dose, 100 mg), stratified into hemodialysis versus nonhemodialysis (peritoneal dialysis or non-dialysis-dependent CKD) groups. Patients treated with hemodialysis received study medication once every other week for 6 doses. Patients in the nonhemodialysis group received study medication once every 4 weeks for 3 doses.



We assessed adverse event rates between dosing groups. The main clinical end point was a composite of hemoglobin level ≥10.5-14.0 g/dL, inclusive; transferrin saturation ≥20%-50%, inclusive; and stable ESA dosing (±25% of baseline dose).



Between-group difference for composite clinical end point rate attainment was -3.9% (95% CI, -21.4% to 13.7%) for the 1.0-mg/kg group versus 0.5-mg/kg group, +3.9% (95% CI, -15.1% to 23.0%) for the 2-mg/kg group versus 0.5-mg/kg group, and +7.8% (95% CI, -10.9% to 26.5%) for the 2-mg/kg group versus 1-mg/kg group. No differences were noted between regimens in reported adverse effects, which were all minor.



Absence of a control group receiving no IV iron. Short duration of intervention and observation. A small proportion of patients having achieved the primary clinical outcome.



IV iron sucrose at a dose of 0.5 mg/kg at the intervals prescribed is noninferior to higher doses in maintaining hemoglobin levels >10.5 g/dL in children, adolescents, and young adults receiving ESA therapy.
Hemodialysis catheter survival and complications in children and adolescents

. Venous catheters have become an indispensable form of hemodialysis access. We evaluated catheter performance as temporary and long-term access in children with end-stage renal disease (ESRD). We assessed the survival rates and causes of catheter failure in 78 catheters used for hemodialysis access in 23 pediatric patients (aged 10 months to 22 years) with ESRD over a 5-year period. Median survival was 31 days for 56 uncuffed catheters. One- and 2-month actuarial survival was 69% and 48%, respectively. Reasons for removal were: elective (39%), kinking (36%), trauma (11%), infection (7%), and other (5%). Smaller catheters (7 or 9 French) were more likely to be removed for kinking (P = 0.003). One-year actuarial survival for 22 cuffed catheters was 27%. Cuffed catheters were removed due to: infection (36%), kinking (14%), elective (9%), trauma (9%) and other (9%). Twelve catheters were removed for infection. Infection rates leading to removal were 0.58 and 0.71 per patient-year for uncuffed and cuffed catheters, respectively. Staphylococcus species were cultured most commonly. We conclude that uncuffed catheters function well for short-term hemodialysis access of up to 2 months’ duration and cuffed catheters are successful for long-term access in children and adolescents with ESRD.
High frequency stimulation of the subthalamic nucleus is efficacious in Parkin disease

High frequency stimulation (HFS) of the subthalamic nucleus (STN) is an efficacious symptomatic treatment for Parkinson’s disease. We have analysed the genetic status of a series of consecutive parkinsonian patients implanted for STN HFS and compared the outcome of five carrying mutations in the parkin gene with that of the non-parkin group. All patients obtained sustained control of PD symptoms and achieved functional improvement; in the parkin group the UPDRS motor score improved by 56.4%, the levodopa equivalent daily dosage was reduced by 75.5%. Postoperative medications were reduced more in parkin than in non-parkin patients. We confirm that the current inclusion criteria for STN HFS do not exclude patients carrying mutations in the parkin gene; their clinical outcome is comparable to that of the non-parkin group.
Comparison study of portable bladder scanner versus cone-beam CT scan for measuring bladder volumes in post-prostatectomy patients undergoing radiotherapy.

In post-prostatectomy radiotherapy to the prostatic bed, consistent bladder volume is essential to maintain the position of treatment target volume. We assessed the differences between bladder volume readings from a portable bladder scanner (BS-V) and those obtained from planning CT (CT-V) or cone-beam CT (CBCT-V). Interfraction bladder volume variation was also determined.



BS-V was recorded before and after planning CT or CBCT. The percentage differences between the readings using the two imaging modalities, standard deviations and 95% confidence intervals were determined. Data were analysed for the whole patient cohort and separately for the older BladderScan™ BVI3000 and newer BVI9400 model. Interfraction bladder volume variation was determined from the percentage difference between the CT-V and CBCT-V. Treatment duration, incorporating the time needed for BS and CBCT, was recorded.



Fourteen patients were enrolled, producing 133 data sets for analysis. BS-V was taken using the BVI9400 in four patients (43 data sets). The mean BS-V was 253.2 mL, and the mean CT-V or CBCT-V was 199 cm(3). The mean percentage difference between the two modalities was 19.7% (SD 42.2; 95%CI 12.4 to 26.9). The BVI9400 model produced more consistent readings, with a mean percentage difference of -6.2% (SD 27.8; 95% CI -14.7 to -2.4%). The mean percentage difference between CT-V and CBCT-V was 31.3% (range -48% to 199.4%). Treatment duration from time of first BS reading to CBCT was, on average, 12 min (range 6-27).



The BS produces bladder volume readings of an average 19.7% difference from CT-V or CBCT-V and can potentially be used to screen for large interfraction bladder volume variations in radiotherapy to prostatic bed. The observed interfraction bladder volume variation suggests the need to improve bladder volume consistency. Incorporating the BS into practice is feasible.
Comparative effect of epinephrine and aminophylline in the treatment of asthma

Thirty-seven patients with severe asthma were randomized into three groups and treated double-blindly with either aminophylline, epinephrine, or a combination of these two for one hour and then with both drugs for an additional hour. All patients began with plasma theophylline levels less than 10 µg/ml and all achieved 17 µg/ml. Epinephrine produced 134% improvement in FEV1 in one hour compared to 38% improvement produced by aminophylline. Epinephrine and combination therapy produced the same amount of bronchodilatation in one hour. Patients whose initial PEFR was ≦100 l/min failed to improve with aminophylline alone. After two hours of treatment, there was no difference in FEV1 or PEFR among the three groups. Arrhythmias and vomiting occurred more frequently when aminophylline was used and these adverse responses did not correlate with plasma theophylline levels.