nils-herrmann/clean_scirepeval huggingface dataset:
Boron neutron capture therapy: Preliminary study of BNCT with sodium borocaptate (Na2B1 2H1 1SH) on glioblastoma

To plan the optimal BNCT using BSH for glioblastoma patients, the10B concentration in tumor and blood was investigated in 11newly diagnosed glioblastoma patients. All patients received 20 mg BSH/kgbody weight 2.5–16 hrs prior to tumor removal. The quantitativedistribution of 10B was determined by prompt gamma rayspectrometry and/or α-track autoradiography. 10Bdistribution in tumors was heterogeneous, ± 25% of scatteringat the microscopic level, and the distribution was also heterogeneous at thetissue level. 10B concentration in blood decreased inbi-exponential decay as a function of the time after the end of theadministration. The T/B ratio showed non-exponential increase with largevariation. The maximum T/B ratio would be around 1. The tumor/normal brain(T/N) ratio of 10B concentration was 11.0 ± 3.2. The10B content in normal brain is originated in vascular10B in parenchyma, since the 10B content innormal brain to blood (N/B ratio) being compatible with the blood content inparenchyma. These values allow for BNCT, using thermal neutrons, on braintumors located less than approximately 3.3 cm in depth from the brainsurface of neutron incidence, providing that the dose on the normalendothelium is controlled to less than the tolerance limit. In ourpreliminary study of BNCT, a 31% 3-year survival was achieved overall for 16 glioblastoma patients and a 50% 2-year survival wasachieved on 8 glioblastoma patients in our recent dose escalation studybased on these data.
Transplantation of purified autologous leukapheresis-derived CD34+ and CD133+ stem cells for patients with chronic spinal cord injuries: long-term evaluation of safety and efficacy.

This study is aimed at describing a novel method for treating patients with chronic complete spinal cord injuries (SCIs) by utilizing autologous, purified CD34(+) and CD133(+) stem cells (SCs). The study focuses on the safety and efficacy of transplanting unmanipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period. In this report, 19 patients were included (16 males and 3 females) who presented with a complete SCI (ASIA-A) in the thoracic region. The patients' endogenous cells were mobilized with subcutaneous granulocyte-colony-stimulating factor (G-CSF) for 5 days. We utilized the CliniMACS magnetic separation system to purify leukapheresis-derived CD34(+) and CD133(+) SCs. Purified SCs were directly transplanted into the SCI site. Patients were then monitored and followed for up to 5 years. On average, 76 × 10(6) purified SCs were obtained from each patient, with 95.2% purity and >98% viability. SC transplantation into the cyst cavity or the subarachnoid space was successful and well tolerated in all 19 patients and did not cause any allergic or inflammatory reactions within the CNS in the early or late periods after transplantation. Ten patients (53%) showed no improvement after 42-60 months (ASIA-A), while seven patients (37%) demonstrated segmental sensory improvement (ASIA-B), and the remaining two patients (10%) had motor improvement (ASIA-C). This study presents a safe method for transplanting specific populations of purified autologous SCs that can be used to treat SCIs in a clinical setting. The results may be utilized as a stepping-stone for future investigations in the field of regenerative medicine for treatment of SCIs and other neurological diseases. This manuscript is published as part of the International Association of Neurorestoratology (IANR) special issue of Cell Transplantation.
Vision in a Phase 3 Trial of Natalizumab for Multiple Sclerosis: Relation to Disability and Quality of Life

Low-contrast visual acuity (LCVA), a sensitive measure of visual function in multiple sclerosis (MS), demonstrated treatment effects as a secondary outcome measure in the Phase 3 trial of natalizumab, AFFIRM. In these posttrial analyses, we studied the relation of visual function to quality of life (QOL), magnetic resonance imaging (MRI) measures, and Expanded Disability Status Scale (EDSS) scores.



At baseline and at 52 and 104 weeks in AFFIRM, patients underwent binocular testing of LCVA (1.25% and 2.5% contrast) and high-contrast visual acuity (HCVA). Vision-specific QOL was assessed by the Impact of Visual Impairment Scale (IVIS), whereas the SF-36 Health Survey and Visual Analog Scale were administered as generic QOL measures and the EDSS as a measure of neurologic impairment.



Among QOL measures, IVIS scores showed the most significant correlations with visual dysfunction at all time points in the trial (r= -0.25 to -0.45, P < 0.0001 for LCVA and HCVA). Higher MRI T1- and T2-lesion volumes were also associated with worse vision scores at all time points (P < 0.0001). Clinically meaningful worsening (progression) of LCVA was noted in substantial proportions of patients in AFFIRM and was prevalent even among those without EDSS progression over 2 years (21.9% with LCVA progression at 2.5% contrast; 26.2% at 1.25% contrast). HCVA worsened in only 3.7% of patients without EDSS progression.



Loss of visual function, particularly as measured by LCVA, was common in AFFIRM, occurring in >20% of patients. Both LCVA and HCVA scores reflect vision-specific aspects of QOL, but LCVA provides information about disability progression not entirely captured by the EDSS. Vision represents a key dimension of outcome assessment for MS and adds valuable information on disability and QOL that can be useful to clinicians.
Effects of inhaled furosemide on platelet-activating factor challenge in mild asthma.

Furosemide (Fur) may have an anti-inflammatory effect on airways in patients with asthma although its intrinsic mechanism remains elusive. Platelet-activating factor (PAF) is a potent proinflammatory mediator that induces systemic and respiratory effects in normal control subjects and asthmatics. The aim of this study was to assess whether pretreatment with nebulized Fur (40 mg) was able to modulate PAF-induced systemic and respiratory effects in asthma. Eleven patients were studied (mean+/-sem 22+/-0.8 yrs) with mild asthma (forced expiratory volume in one second, 95+/-4%) in a randomized, double-blind, placebo-controlled, cross-over fashion, one week apart. PAF challenge (18 microg) was carried out 15 min after administration of Fur or placebo. Peripheral blood neutrophils, respiratory system resistance, and arterial blood gases were measured at baseline, and 5, 15 and 45 min after PAF; urinary cysteinyl leukotriene E4 (uLTE4) was also measured, at baseline and 120 min after PAF challenge. Although Fur did not alter PAF-induced systemic and respiratory effects, it did partially inhibit (63%; p<0.04) the increments of uLTE4 levels shown after PAF inhalation. It is concluded that furosemide is not effective in protecting against platelet-activating factor challenge in patients with asthma despite its potential inhibition of leukotriene synthesis. These findings reinforce the view that the pulmonary effects of platelet-activating factor are mediated through different pathways.
Effect of Problem-Solving-Based Diabetes Self-Management Training on Diabetes Control in a Low Income Patient Sample

Lower socioeconomic status is associated with excess disease burden from diabetes. Diabetes self-management support interventions are needed that are effective in engaging lower income patients, addressing competing life priorities and barriers to self-care, and facilitating behavior change. To pilot test feasibility, acceptability, and effect on disease control of a problem-based diabetes self-management training adapted for low literacy and accessibility. Two-arm randomized controlled trial powered to detect a 0.50% change in A1C at follow-up with a 2-sided alpha of 0.05 in a pooled analysis. Fifty-six urban African-American patients with type 2 diabetes and suboptimal blood sugar, blood pressure, or cholesterol control recruited from a diabetes registry within a university-affiliated managed care organization. A group, problem-based diabetes self-management training designed for delivery in an intensive and a condensed program format. Three intensive and three condensed program groups were conducted during the trial. Clinical (A1C, systolic blood pressure [SBP], diastolic blood pressure [DBP], LDL and HDL cholesterol) and behavioral (knowledge, problem solving, self-management behavior) data were measured at baseline, post-intervention, and 3 months post-intervention (corresponding with 6–9 months following baseline). Adoption of both programs was high (>85% attendance rates, 95% retention). At 3 months post-intervention, the between-group difference in A1C change was −0.72% (p = 0.02), in favor of the intensive program. A1C reduction was partially mediated by problem-solving skill at follow-up (ß = −0.13, p = 0.04). Intensive program patients demonstrated within-group improvements in knowledge (p < 0.001), problem-solving (p = 0.01), and self-management behaviors (p = 0.04). Among the subsets of patients with suboptimal blood pressure or lipids at baseline, the intensive program yielded clinically significant individual improvements in SBP, DBP, and LDL cholesterol. Patient satisfaction and usability ratings were high for both programs. A literacy-adapted, intensive, problem-solving-based diabetes self-management training was effective for key clinical and behavioral outcomes in a lower income patient sample.
Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms

Nonsteroidal anti-inflammatory drugs relieve osteoarthritis (OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols, is effective against experimental OA. A pilot study found that D-002 (50 mg/day) for 8 weeks improves OA symptoms. The aim of this study was to investigate the effects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms.



Patients with OA symptoms were double-blindly randomized to D-002 (50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes.



All randomized patients (n = 60) completed the study, and 23 experienced dose titration (two in the D-002 and 21 in the placebo groups). At study completion, D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became enhanced during the trial. The use of rescue medication by the D-002 (6/30) group was lower than that in the placebo (17/30) group. The treatment was well tolerated. Seven patients (two in the D-002 and five in the placebo group) reported adverse events.



These results indicate that D-002 (50 to 100 mg/day) for 6 weeks ameliorated arthritic symptoms and was well tolerated.
Genome-wide association mapping identifies multiple loci for a canine SLE-related disease complex

The unique canine breed structure makes dogs an excellent model for studying genetic diseases. Within a dog breed, linkage disequilibrium is extensive, enabling genome-wide association (GWA) with only around 15,000 SNPs and fewer individuals than in human studies. Incidences of specific diseases are elevated in different breeds, indicating that a few genetic risk factors might have accumulated through drift or selective breeding. In this study, a GWA study with 81 affected dogs (cases) and 57 controls from the Nova Scotia duck tolling retriever breed identified five loci associated with a canine systemic lupus erythematosus (SLE)–related disease complex that includes both antinuclear antibody (ANA)–positive immune-mediated rheumatic disease (IMRD) and steroid-responsive meningitis-arteritis (SRMA). Fine mapping with twice as many dogs validated these loci. Our results indicate that the homogeneity of strong genetic risk factors within dog breeds allows multigenic disorders to be mapped with fewer than 100 cases and 100 controls, making dogs an excellent model in which to identify pathways involved in human complex diseases.
The impact of perceived interpersonal functioning on treatment for adolescent depression: IPT-A versus treatment as usual in school-based health clinics.

Aspects of depressed adolescents' perceived interpersonal functioning were examined as moderators of response to treatment among adolescents treated with interpersonal psychotherapy for depressed adolescents (IPT-A; Mufson, Dorta, Moreau, & Weissman, 2004) or treatment as usual (TAU) in school-based health clinics.



Sixty-three adolescents (12-18 years of age) participated in a clinical trial examining the effectiveness of IPT-A (Mufson, Dorta, Wickramaratne, et al., 2004). The sample was 84.1% female and 15.9% male (mean age = 14.67 years). Adolescents were 74.6% Latino, 14.3% African American, 1.6% Asian American, and 9.5% other. They came primarily from low-income families. Adolescents were randomly assigned to receive IPT-A or TAU delivered by school-based mental health clinicians. Assessments, completed at baseline and at Weeks 4, 8, and 12 (or at early termination), included the Hamilton Rating Scale for Depression (Hamilton, 1967), the Conflict Behavior Questionnaire (Robin & Foster, 1989), and the Social Adjustment Scale-Self-Report (Weissman & Bothwell, 1976).



Multilevel modeling indicated that treatment condition interacted with adolescents' baseline reports of conflict with their mothers and social dysfunction with friends to predict the trajectory of adolescents' depressive symptoms over the course of treatment, controlling for baseline levels of depression. The benefits of IPT-A over TAU were particularly strong for the adolescents who reported high levels of conflict with their mothers and social dysfunction with friends.



Replication with larger samples would suggest that IPT-A may be particularly helpful for depressed adolescents who are reporting high levels of conflict with their mothers or interpersonal difficulties with friends.
Lifestyle change recommendations in major depression: Do they work?

Modifying some lifestyle factors can be useful in depression, at least as an adjuvant treatment. Combining different lifestyle interventions seems to be an adequate strategy to increase their antidepressant efficacy according with preliminary studies, but this issue has not been enough investigated.



The present study is a randomized, double-blinded, multicentre, two arm-parallel clinical trials, with a 12 month follow-up. The sample consisted of 273 Primary Care patients. Four combined hygienic-dietary written recommendations were given to the patients about diet, exercise, light exposure and sleep hygiene.



Both active and control interventions were associated with improvement on BDI (Beck Depression Inventory) scores. However, there were not statistically significant differences (7.0 vs. 7.6; p=0.594).



We were unable to monitor whether patients carry out recommendations. Intervention could be too difficult to accomplish for depressed patients without enough support and supervision.



Just giving written lifestyle recommendations are not enough for depressive patients to benefit from them, so perhaps lifestyle change recommendations work or do not work on Depression depending on how they are presented to patients and on monitoring systems of their implementation.
Evaluation of Enoxaparin Given before and after Operation to Prevent Venous Thromboembolism during Digestive Surgery: Play-the-Winner Designed Study

A total of 316 patients were included in a play-the-winner (PTW) designed study comparing the safety of enoxaprain started preoperatively versus postoperatively as prophylaxis against venous thromboembolism for digestive surgery. In a PTW-designed study the treatment of any next patient depends on the outcome of the previous patient. If successful, the next patient receives the same treatment, if not, the comparative regimen is given. Excessive bleeding according to specified criteria, severe adverse reactions, clinically detected deep venous thrombosis (DVT), or pulmonary embolism (PE) were criteria for classification as “loser.” The PTW design allocates most patients to the superior treatment. The main variable in PTW studies is the number of consecutive patients receiving the same treatment. In this study 163 patients were allocated to postoperatively started and 153 to preoperatively started prophylaxis with enoxaparin. The frequency of “winners” was found to be 82.8% and 78.4% in the post- and preoperatively treated groups, respectively. No significant differences were found between the groups with regard to frequency of “winners” or the number of consecutive patients before change of treatment. The percentile of survival distribution did not detect superiority of any group. Prophylaxis against postoperative venous thromboembolism for digestive surgery using enoxaparin can safely be started preoperatively.
An ILP approach for mapping AUTOSAR runnables on multi-core architectures

AUTOSAR (AUTomotive Open System ARchitecture) standard was developed in order to manage the complexity of automotive E/E (Electrical/Electronic) architectures. It provides a layered modular configurable software architecture in order to facilitate the transfer and the update of applications. Recently, multi-core architectures became supported by AUTOSAR. The design and the implementation of AUTOSAR applications on multi-core architectures have raised new challenges. One of these challenges is related to the static configuration of the OS (Operating System). On a multi-core architecture, an important step of this configuration consists in mapping the runnables (pieces of the applicative code) to the cores. This mapping has to be done efficiently, i.e. satisfy real-time, functional, and safety requirements. For instance, the behavior of the application is affected by several factors like the communication overhead. This paper presents an ILP (Integer Linear Programming) formulation of the mapping process of AUTOSAR runnables on a multi-core architecture, with the aim to minimize inter-core communication and to balance the processor load.
Economic evaluation of a falls prevention exercise program among people With Parkinson's disease.

The aim of this study was to determine the cost-effectiveness of a 6-month minimally supervised exercise program for people with PD.



An economic analysis was conducted alongside a randomized, controlled trial in which 231 people age 40 years and over with PD were randomized into a usual care control group or an exercise group. Cost-effectiveness was estimated using incremental cost per fall prevented (using falls calendars) as the primary analysis and cost per extra person avoiding mobility deterioration (defined as an improvement or no change in the 12-point Short Physical Performance Battery Score between baseline and 6 month). A cost-utility analysis using the Short Form-6D was also performed. Uncertainty was represented using cost-effectiveness scatter plots and acceptability curves. Planned subgroup analyses for the low-disease-severity group were also undertaken.



All results are reported in Australian dollars ($A). The average cost of the intervention was $A1,010 per participant. Incremental cost-effectiveness of the program relative to usual care was $A574 per fall prevented, $A9,570 per extra person avoiding mobility deterioration, and $A338,800 per quality-adjusted life year gained. The intervention had an 80% probability of being cost-effective, relative to the control, at a threshold of $A2,000 per fall prevented. Subgroup analyses for the low-disease-severity group indicate the program to be dominant, that is, less costly and more effective than usual care for all health outcomes.



The exercise intervention appeared cost-effective with regard to fall prevention in the whole sample and cost saving in the low disease severity group, when compared with usual care.
Short versus extended thromboprophylaxis after total knee arthroplasty: a randomized comparison.

The optimal duration of thromboprophylaxis after total knee arthroplasty remains uncertain.



We performed a randomized, open trial to determine whether to stop thromboprophylactic therapy at Day 10±2 ('short thromboprophylaxis') was non-inferior to continue thromboprophylactic therapy up to Day 35±5 ('extended thromboprophylaxis') after total knee arthroplasty. At Day 7±2, subjects were screened by ultrasonography for asymptomatic deep-vein thrombosis and randomized. The primary outcome was a composite of proximal deep-vein thrombosis, any symptomatic deep-vein thrombosis, non-fatal symptomatic pulmonary embolism, major bleeding, heparin-induced thrombocytopenia, or all-cause death up to Day 35±5. The secondary outcome was ultrasonographic (extension or new onset) distal deep-vein thrombosis at Day 35±5.



Twenty-one patients (2.4%) were not randomized, because of asymptomatic proximal deep-vein thrombosis on systematic ultrasonography at Day 7±2. Among the 857 randomized patients, mean (SD) duration of anticoagulant treatment was 11.2 (6.7) and 33.9 (3.7) days in the short and extended thromboprophylaxis groups, respectively. The respective rates of the primary outcome were 4.0% (17/420) and 2.4% (10/422), with an absolute difference of 1.7% (90% confidence interval, -0.3 to 3.7). In 285 patients with asymptomatic distal deep-vein thrombosis at Day 7±2, the respective rates of the primary outcome were 7.8% and 2.8% (p=0.067). The rates of the secondary outcome were 14.8% (62/420) and 4.5% (19/422), respectively (p<0.001).



Short thromboprophylaxis was not non-inferior to extended thromboprophylaxis after total knee arthroplasty. In this setting, the thromboembolic risk persisted longer than seven days, notably in patients with asymptomatic distal deep-vein thrombosis at discharge.
Quantitative cholescintigraphy and bile abnormalities in patients with acalculous biliary pain

Acalculous biliary pain has been related to gallbladder dysfunction that produces a gallbladder emptying defect—a condition which favours the development of lithiasis. It is therefore probable that microlithiasis is present in patients with gallbladder dysfunction. The aims of this study were to measure gallbladder emptying and investigate bile abnormalities in patients with acalculous biliary pain. In 92 consecutive patients, gallbladder emptying was assessed by quantitative cholescintigraphy (abnormal ejection fraction ≤40%). In 64 patients, a microscopic study was performed on duodenal bile, defining abnormality as the presence of cholesterol crystals in any amount and/or calcium bilirubinate granules and/or microspheroliths at a rate of >10 per slide. The ejection fraction was abnormal in 45 patients (49%) (median 25.1%, range 6.8–39.3%) and normal in the remaining 47 cases (median 71.3%, range 41.0–96.1%). Bile was abnormal in 32 of 64 patients (50%), the most frequent finding being calcium bilirubinate granules. In the patients with bile abnormalities, abnormal ejection fraction was more frequent (20 of 32) and the median ejection fraction was lower (30.9%, range 12.0–94.1%) than in the patients with normal bile (16 of 32 with an abnormal ejection fraction; median ejection fraction 50.7%, range 6.8–96.1%). Abnormal bile was frequent (55.5%) in patients with reduced ejection fraction, but was not uncommon in patients with normal ejection fraction (33.3%). Fewer patients showed no alteration (25%). It is concluded that in most patients, acalculous biliary pain coexists with gallbladder dysfunction or abnormal bile, the combination of both alterations being common.