nils-herrmann/clean_scirepeval huggingface dataset:
Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial

Data generated with the body composition monitor (BCM, Fresenius) show, based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood volume-monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid-overloaded hemodialysis patients.



BCM measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel-group, crossover, randomized, controlled clinical trial, we use BCM measurements, routinely introduced in our three maintenance hemodialysis centers shortly prior to the start of the study, to recruit sixty hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final' dry weight is set to normohydration weight -7% of ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a prespecified algorithm. A comparison of intra- and post-dialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters).



Patients are not requested to revert to their initial degree of fluid overload after each study phase. Therefore, the crossover design of the present study merely serves the purpose of secondary endpoint evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management, which decreases the mortality risk of hemodialysis patients.
Predictive factors for the outcome of anterior cervical decompression and fusion

In a prospective study, 103 patients were randomised to anterior cervical decompression and fusion (ACDF) with a cervical carbon-fibre intervertebral fusion cage or the Cloward procedure. Preoperative background variables, active range of neck motion, handgrip strength, radiological evaluation and subjective variables were used in a multiple regression model to find the strongest predictors of postoperative outcome as measured by current pain intensity and the Neck Disability Index (NDI). Male sex, greater kyphosis at the level operated on, non-smoking, a greater neck mobility in right rotation, low disability on NDI, and older age were predictors of pain reduction and explained 30% of current pain intensity at follow-up. Higher educational level, non-smoking, greater kyphosis at the level operated on, a greater flexion mobility, greater right handgrip strength and lower current pain intensity were predictors of improvement, and explained 28% of the postoperative outcome on NDI. The most important predictor for postoperative pain intensity was the magnitude of the preoperative kyphosis. Preoperative pain intensity was the most important predictor for improved NDI. At follow-up about 70% of the patients still had deficit based on current pain intensity and NDI, and 44% had remaining dysfunction based on Odom's criteria. In conclusion, the multivariate analysis shows that male sex, non-smoking, greater segmental kyphosis and a low pain and disability level are preoperative predictors of a good outcome in ACDF. In addition, the study suggests the importance of other predictive variables than those studied for the outcome of ACDF.
Changes in 25-Hydroxyvitamin D3 to oral treatment with vitamin D3 in postmenopausal females with osteoporosis

This study reports on oral treatment with different doses of vitamin D3 ranging from 25 to 200 µg in females with 25-hydroxyvitamin D3 levels < 60 nmol/L screened for participation in an osteoporosis trial. A guidance to safely and efficiently achieve 25-hydroxyvitamin D3 levels > 60 nmol/L is presented. The importance of vitamin D for skeletal health has been implemented in clinical trials in osteoporosis. The threshold of 25-hydroxyvitamin D for inclusion has changed from 30 to 60 nmol/L. This study reports on oral treatment with different doses of vitamin D3 in females with 25-hydroxyvitamin D3 levels < 60 nmol/L. In 131 postmenopausal females screened for participation in an osteoporosis trial, the 25-hydroxyvitamin D3 concentration was < 60 nmol/L. They were treated with 25 (n = 22), 50 (n = 19), 75 (n = 19), 100 (n = 41) or 200 μg (n = 30) of vitamin D3 daily for at least 10 days. In the females treated with 25, 50, 75, 100 and 200 μg of vitamin D3 daily the 25-hydroxyvitamin D3 concentrations increased significantly from 32.4 ± 2.7 (mean ± SEM) to 50.8 ± 2.9, from 46.7 ± 2.8 to 65.8 ± 2.6, from 41.6 ± 2.7 to 67.4 ± 2.9, from 46.7 ± 1.4 to 64.4 ± 2.2 and from 42.1 ± 2.0 to 71.2 ± 2.8 nmol/L, respectively (p < 0.001). S-calcium increased significantly but within the reference range (p < 0.006). Oral vitamin D3 safely increased 25-hydroxyvitamin D3 concentrations in all females above 60 nmol/L. This study demonstrates how to achieve the new recommended 25-hydroxyvitamin D concentrations within the screening period of a clinical trial.
Alveolar Dead Space Fraction Discriminates Mortality in Pediatric Acute Respiratory Distress Syndrome.

Physiologic dead space is associated with mortality in acute respiratory distress syndrome, but its measurement is cumbersome. Alveolar dead space fraction relies on the difference between arterial and end-tidal carbon dioxide (alveolar dead space fraction = (PaCO2 - PetCO2) / PaCO2). We aimed to assess the relationship between alveolar dead space fraction and mortality in a cohort of children meeting criteria for acute respiratory distress syndrome (both the Berlin 2012 and the American-European Consensus Conference 1994 acute lung injury) and pediatric acute respiratory distress syndrome (as defined by the Pediatric Acute Lung Injury Consensus Conference in 2015).



Secondary analysis of a prospective, observational cohort.



Tertiary care, university affiliated PICU.



Invasively ventilated children with pediatric acute respiratory distress syndrome.



None.



Of the 283 children with pediatric acute respiratory distress syndrome, 266 had available PetCO2. Alveolar dead space fraction was lower in survivors (median 0.13; interquartile range, 0.06-0.23) than nonsurvivors (0.31; 0.19-0.42; p < 0.001) at pediatric acute respiratory distress syndrome onset, but not 24 hours after (survivors 0.12 [0.06-0.18], nonsurvivors 0.14 [0.06-0.25], p = 0.430). Alveolar dead space fraction at pediatric acute respiratory distress syndrome onset discriminated mortality with an area under receiver operating characteristic curve of 0.76 (95% CI, 0.66-0.85; p < 0.001), better than either initial oxygenation index or PaO2/FIO2. In multivariate analysis, alveolar dead space fraction at pediatric acute respiratory distress syndrome onset was independently associated with mortality, after adjustment for severity of illness, immunocompromised status, and organ failures.



Alveolar dead space fraction at pediatric acute respiratory distress syndrome onset discriminates mortality and is independently associated with nonsurvival. Alveolar dead space fraction represents a single, useful, readily obtained clinical biomarker reflective of pulmonary and nonpulmonary variables associated with mortality.
Neurotransmitter amino acids in cerebrospinal fluid of patients with Alzheimer's disease

We measured the CSF and plasma levels of glutamate, glutamine, aspartate (only in plasma), asparagine, glutamine, glycine and GABA in 37 patients with Alzheimer's disease and in 32 matched controls. We used an ion-exchange chromatography method. When compared to controls, AD patients had higher CSF glutamate and glycine levels, higher plasma levels of aspartate and glycine, and lower plasma levels of asparagine and GABA. When expressed relative to CSF proteins, CSF levels of glutamate and glycine remained higher, and CSF asparagine levels were lower in AD patients than in controls. The CSF levels of the amino acids measured were not correlated with the clinical features of AD with the exception of plasma GABA levels with duration of the disease. Our results might suggest a possible pathogenetic role of neurotransmitter amino acids in AD.
Preliminary report: genetic variation in the human stromelysin promoter is associated with progression of coronary atherosclerosis.

Stromelysin is a member of the family of metalloproteinases that degrade extracellular matrix. In situ hybridisation and histopathological studies suggest that stromelysin activity may be important in the connective tissue remodelling processes associated with atherogenesis and plaque rupture. Single strand conformation polymorphism analysis identified a common polymorphism in the stromelysin gene promoter located 1171 bp upstream from the start of transcription in which one allele has a run of six adenosines (6A) and another has five adenosines (5A). 72 men with coronary heart disease, were genotyped. They were participants in the St Thomas' Atherosclerosis Regression Study who were randomised to receive usual care (UC), dietary intervention (D), or diet plus cholestyramine (DC), with angiography at baseline and at 39 months. In these patients the frequency of the 5A allele was 0.49 (95% CI from 0.41 to 0.57) and was not significantly different from that in a sample of 354 healthy UK men. In the UC group, patients who were homozygous for the 6A allele showed greater progression of angiographic disease than those with other genotypes: the minimum absolute width of coronary segments decreased by 0.04 (SEM 0.10) mm for 5A5A, 0.20 (0.07) mm for 5A6A, and 0.67 (0.19) mm for 6A6A (P < 0.01). The findings were similar but slightly less significant for the change in mean absolute width of coronary segments (P < 0.05). No significant associations were seen in patients in the D or DC groups. In data pooled from the three treatment groups, the 6A6A genotype was significantly associated with greater progression of coronary atherosclerosis than other genotypes in patients with baseline percentage diameter stenosis less than 20% (P < 0.05), but not in those with baseline percentage diameter stenosis greater than or equal to 20%. These results provide the first evidence of a link between genetic variation in stromelysin and progression of coronary atherosclerosis and support the hypothesis that connective tissue remodeling mediated by metalloproteinases contribute to the pathogenesis of atherosclerosis.
Effect of acute heat exposure on skin blood flow of the paralyzed thigh in persons with spinal cord injury

To investigate whether increased body temperature during heat exposure promotes skin blood flow of the thigh (SBFT) in individuals with spinal cord injury at rest. A prospective study with high lesion and with low lesion.  Hiroshima University, Higashi-Hiroshima, Japan.  Seven male paraplegics (T5-L2) and seven able-bodied subjects volunteered to participate in the experiment. First the subject rested for 1 h at an ambient temperature (Ta) of 25°C and a relative humidity (Rh) of 50%. Thereafter, the subject moved to a climatic chamber heated to Ta of 33°C an Rh of 50–55% and was exposed to this environment for 1 h. SBFT, stroke volume, heart rate, the skin temperature of the medial thigh (Tthigh) and the tympanic membrane temperature (Tty) were assessed during the experiment.  The four subjects with high lesions between Th6 and Th10 (HL) showed no increase in SBFT, while the remaining three subjects with low lesion at Th11 or Th12 (LL) showed increased SBFT in the hot environment. Although Tty increased with exposure time in heat, correlation between Tty and SBFT was not significant in either paraplegic group. However, correlation between SBFT and Tthigh was highly significant in both groups. The increase in Tthigh in LL was due to increased skin blood flow in the thigh, while in HL it was considered attributable to heat transfer from the environment to the skin.  These findings indicate that SBFT during heat exposure was largely dependent on the level of spinal cord injury. SBFT with low lesions increased during heat exposure when the sympathetic cutaneous vasomotor supply of the thigh was preserved. Spinal Cord (2000) 38, 224–228.
Effects of levetiracetam on chronic pain in multiple sclerosis: results of a pilot, randomized, placebo-controlled study.

Central neuropathic pain (CNP) is a prevalent and distressing symptom in patients with multiple sclerosis (MS). The anticonvulsant levetiracetam (LEV) has been shown to be efficacious in some types of CNP, but its efficacy in MS-related CNP has not been confirmed.



To investigate the tolerability and potential effects of LEV against CNP in MS subjects, we performed a single-center, prospective, randomized, single-blind, placebo-controlled study in twenty patients with MS and CNP. Outcomes before and during the 3-month study were assessed using validated measures of pain, depression, disability and quality of life.



The medication was well tolerated and analysis revealed a significant difference between the LEV and placebo arm in all study outcomes related to pain (mean pain intensity score, mean pain difference, percentage of patients with a clinically significant pain reduction). Furthermore, the individual quality of life rating improved in treated patients, showing a significant correlation with pain reduction.



These findings suggest that further studies with larger samples of patients be carried out in order to confirm the efficacy of LEV in MS-related CNP population.
Comparative electroretinograms in argon laser and xenon arc panretinal photocoagulation.

We performed electroretinograms (ERG) on both eyes of 11 diabetic patients before and one month after panretinal photocoagulation for diabetic retinopathy. Each patient had one eye treated with argon laser and the fellow eye treated with the xenon arc photocoagulator. After photocoagulation the ERG was symmetrically reduced unless the retinal area burned with xenon arc was greater than twice the retinal area burned in the fellow eye by the argon laser photocoagulator.
Vision-assisted image editing

V / h a t Is It? When I think of image editing, packages such as Photoshop and Paint Shop Pro come to mind. These packages are used to edit. transform or manipulate, typically with extensive user guidance, one or more images to produce a d e s i r e d result . Tasks such as se lect ion, matting, blending, warping, morphing, etc. are often tedious and t ime consuming.Visionassisted edi t ing can l ighten the burden, whether the goal is a simple cut and paste composition or a major special effect for a movie (see Doug Roble's article in this issue). Thus, this article focuses on computer vision techniques that reduce (often significantly) the time and effort involved in editing images and video. The goal of vision systems is to de tec t edges, regions, shapes, surface features, lighting proper t ies , 3D geometry, etc. Host currently available image editing tools and f i l ters ut i l ize low-level, 2D geometr ic o r image processing operations that manipulate pixels. However, vision techniques extract descriptive object or scene information, thus allowing a user to edit in terms of higher-level features. Fully automatic computer vision remains a major focus in the computer vision community. Comp le te au tomat ion is cer ta in ly preferred for such tasks as robotic navigation, image/v ideo compression, model dr iven object delineation, multiple image correspondence, image-based model ing o r anyt ime autonomous interpretation of images/video is desired. However, general purpose image editing will continue to require human guidante due to the essential role of the user in the creative process and in identifying which image components are of interest. Host vision-assisted image editing techniques fall somewhere between user-assisted vision and vision-based interaction. User-assisted vision describes those techniques where the user interacts in image (or parameter) space to begin and/or guide a vision algorithm so tha t i t produces a desired result , For example, Photoshop's magic wand computes a connected region of similar pixels based on a mouse click in the area co be selected.Visionbased interaction refers to those methods where the computer has done some or all of the "vision" part and the user interacts within the resulUn8 vision-based feature space. One example is the ICE (Interact ive Con tou r Editing) system [4] that computes an image's edge representation and then allows a user to interactively select edge groupings to extract or remove image features. A tool is classified based on where a user can "touch" the data of the underlying vision function the process that computes results from inputs. User-assisted vision manipulates the input (or domain) space of the vision func t ion wh i le v is ion-based in te rac t ion provides access to the result (or range). Some tools al low intervention at several steps in the process, including the ability to adjust partial or intermediate results. Regardless of a tool's classification, there are algorithmic properties that are desirable for image editing tools.These tools should be:
Phase I pharmacological and bioavailability study of oral diflomotecan (BN80915), a novel E-ring-modified camptothecin analogue in adults with solid tumors.

Diflomotecan (BN80915) is an E-ring modified camptothecin analogue that possesses greater lactone stability in plasma compared with other topoisomerase I inhibitors, a potential advantage for antitumor activity. As with other camptothecins, oral administration has pharmacological and clinical advantages. This Phase I study was performed to assess the feasibility of the administration of oral diflomotecan, to determine the maximum-tolerated, dose its bioavailability, and to explore the pharmacokinetics.



An initial i.v. bolus was administered to assess the bioavailability of diflomotecan. Fourteen days later, diflomotecan was administered p.o. once daily for 5 days to adult patients with solid malignant tumors and repeated every 3 weeks. BN80915 and its open lactone form BN80942 were measured.



Twenty-two patients entered the study and received a total of 57 cycles of oral diflomotecan at flat dose levels of 0.10, 0.20, 0.27, and 0.35 mg. The main toxicity was hematological, but some patients experienced alopecia, mild gastrointestinal toxicity, and fatigue. At the 0.35-mg dose level, 2 of 4 patients experienced dose-limiting toxicity comprising grade 3 thrombocytopenia with epistaxis and febrile neutropenia in 1 patient and uncomplicated grade 4 neutropenia lasting for >7 days in another. Toxicity was acceptable at the 0.27-mg dose level at which dose-limiting toxicities were observed in 3 of 12 patients (grade 4 neutropenia > 7 days, complicated by fever in 1 patient but without other signs of infection). After two cycles of diflomotecan, 6 patients had disease stabilization, which was maintained in 2 patients for 9 months and >1 year, respectively. Diflomotecan pharmacokinetics were linear over the dose range studied. Systemic exposure correlated with the fall in WBC counts. The mean oral bioavailability (+/-SD) was 72.24 +/- 59.2% across all dose levels. Urinary excretion of BN80915 was very low.



The recommended oral diflomotecan dose for Phase II studies is 0.27 mg/day x 5 every 3 weeks. This regimen is convenient and generally well tolerated with a favorable pharmacokinetic profile and high but variable bioavailability.
European ancestry as a risk factor for atrial fibrillation in African Americans.

Despite a higher burden of standard atrial fibrillation (AF) risk factors, African Americans have a lower risk of AF than whites. It is unknown whether the higher risk is due to genetic or environmental factors. Because African Americans have varying degrees of European ancestry, we sought to test the hypothesis that European ancestry is an independent risk factor for AF.



We studied whites (n=4543) and African Americans (n=822) in the Cardiovascular Health Study (CHS) and whites (n=10 902) and African Americans (n=3517) in the Atherosclerosis Risk in Communities (ARIC) Study (n=3517). Percent European ancestry in African Americans was estimated with 1747 ancestry informative markers from the Illumina custom ITMAT-Broad-CARe array. Among African Americans without baseline AF, 120 of 804 CHS participants and 181 of 3517 ARIC participants developed incident AF. A meta-analysis from the 2 studies revealed that every 10% increase in European ancestry increased the risk of AF by 13% (hazard ratio, 1.13; 95% confidence interval, 1.03 to 1.23; P=0.007). After adjustment for potential confounders, European ancestry remained a predictor of incident AF in each cohort alone, with a combined estimated hazard ratio for each 10% increase in European ancestry of 1.17 (95% confidence interval, 1.07 to 1.29; P=0.001). A second analysis using 3192 ancestry informative markers from a genome-wide Affymetrix 6.0 array in ARIC African Americans yielded similar results.



European ancestry predicted risk of incident AF. Our study suggests that investigating genetic variants contributing to differential AF risk in individuals of African versus European ancestry will be informative.
Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24

The standard-of-care treatment of patients with hepatitis C virus (HCV)-mixed cryoglobulinemia (MC) vasculitis includes pegylated interferon α (PegIFN)-α plus ribavirin and/or rituximab. About 30-40% of patients are non-responders or relapsers to such combination.



To analyse the safety and efficacy of Peg-IFNα/ribavirin/protease inhibitor combination in HCV-MC vasculitis.



Open-label, prospective, cohort study including 23 patients with HCV-MC vasculitis. Peg-IFNα/ribavirin was associated to telaprevir (375 mg three times daily, for 12 weeks, (n=15)) or boceprevir (800 mg three times daily, for 44 weeks, (n=8)) for 48 weeks.



The median age was 59 (52.5-66) years, with 48.8% women. Thirteen patients (56.5%) were complete clinical responders, and 10 (43.5%) were partial responders at week 24. The virological response (ie, HCV RNA negativation) was of 69.6% at week 24 (p=0.005). The cryoglobulin level decreased from 0.44 to 0.06 g/l (p=0.0006) and the C4 level increased from 0.09 to 0.15 g/l (p=0.045). Grades 3 and 4 adverse events (mainly anaemia, neutropenia and thrombocytopenia) were observed in 10 cases (43.5%). Twenty patients (87%) received erythropoietin, 9 (39.1%) had red cell transfusion, and 2 (8.7%) had granulocyte stimulating agents. Antiviral therapy discontinuation was required in 8 (34.7%) patients for virological non-response (n=5), virological relapse (n=2) and depression (n=1).



Peg-IFNα/ribavirin/protease inhibitor combination seems highly effective in HCV-MC. Such therapeutic regimen should be administered cautiously considering the high rate of side effects.