nils-herrmann/clean_scirepeval huggingface dataset:
First clinical evaluation of a new percutaneous optical fiber glucose sensor for continuous glucose monitoring in diabetes.

This article describes a new fiber-coupled, percutaneous fluorescent continuous glucose monitoring (CGM) system that has shown 14 days of functionality in a human clinical trial.



The new optical CGM system (FiberSense) consists of a transdermal polymer optical fiber containing a biochemical glucose sensor and a small fluorescence photometer optically coupled to the fiber. The glucose-sensitive optical fiber was implanted in abdominal and upper-arm subcutaneous tissue of six diabetes patients and remained there for up to 14 days. The performance of the system was monitored during six visits to the study center during the trial. Blood glucose changes were induced by oral carbohydrate intake and insulin injections, and capillary blood glucose samples were obtained from the finger tip. The data were analyzed using linear regression and the consensus error grid analysis.



The FiberSense worn at the upper arm exhibited excellent results during 14 wearing days, with an overall mean absolute relative difference (MARD) of 8.3% and 94.6% of the data in zone A of the consensus error grid. At the abdominal application site, FiberSense resulted in a MARD of 11.4 %, with 93.8% of the data in zone A.



The FiberSense CGM system provided consistent, reliable measurements of subcutaneous glucose levels in human clinical trial patients with diabetes for up to 14 days.
Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM.

The hemophilus vaccine has been linked to the development of autoimmune type 1 diabetes, insulin dependent diabetes (IDDM) in ecological studies.



We attempted to determine if the Hemophilus influenza B (HiB) vaccine was associated with an increased risk of IDDM by looking for clusters of cases of IDDM using data from a large clinical trial. All children born in Finland between October 1st, 1985 and August 31st, 1987, approximately 116,000 were randomized to receive 4 doses of the HiB vaccine (PPR-D, Connaught) starting at 3 months of life or one dose starting after 24 months of life. A control-cohort included all 128,500 children born in Finland in the 24 months prior to the HiB vaccine study. Non-obese diabetic prone (NOD) mice were immunized with a hemophilus vaccine to determine if immunization increased the risk of IDDM.



The difference in cumulative incidence between those receiving 4 doses and those receiving 0 doses is 54 cases of IDDM/100,000 (P = 0.026) at 7 years, (relative risk = 1.26). Most of the extra cases of IDDM appeared in statistically significant clusters that occurred in periods starting approximately 38 months after immunization and lasting approximately 6-8 months. Immunization with pediatric vaccines increased the risk of insulin diabetes in NOD mice.



Exposure to HiB immunization is associated with an increased risk of IDDM. NOD mice can be used as an animal model of vaccine induced diabetes.
C reactive protein levels are increased in non-allergic but not allergic asthma: a multicentre epidemiological study.

High sensitivity C reactive protein (HsCRP) is an inflammatory marker known to be related to smoking, obesity, and cardiovascular disease. A study was undertaken to determine whether HsCRP is related to respiratory symptoms, asthma, atopy, and bronchial hyperresponsiveness in population samples from three countries.



HsCRP was measured in 1289 subjects from three centres in ECRHS II: Reykjavik, Uppsala and Tartu. The HsCRP values ranged from <0.01 mg/l to 70.0 mg/l and were divided into four equal groups (< or = 0.45, 0.46-0.96, 0.97-2.21, and >2.21 mg/l).



HsCRP increased with increasing body mass index (r = 0.41; p<0.0001) and was higher in smokers than in never smokers (p = 0.02). A significant relationship was found between increased HsCRP levels and respiratory symptoms such as wheeze, attacks of breathlessness after effort, and nocturnal cough (p<0.0001). The crude odds ratio (95% CI) for the probability of non-allergic asthma was 3.57 (1.83 to 6.96) for subjects in the 4th quartile compared with the 1st quartile of HsCRP. This association remained significant after adjusting for study centre, age, sex, body weight, and smoking history (OR 2.19 (95% CI 1.04 to 4.63)). No significant relationship was observed between HsCRP and allergic asthma or bronchial responsiveness.



Raised levels of HsCRP are significantly associated with respiratory symptoms and non-allergic asthma but not with allergic asthma.
Measuring the impact and distress of osteoarthritis from the patients' perspective

To assess the internal construct validity of the Perceived Impact of Problem Profile (PIPP), a patient based outcome measure based on the International Classification of Functioning, Disability and Health (ICF), which assesses impact and distress, in an osteoarthritis (OA) cohort.



A questionnaire comprising the 23-item PIPP, which assesses five domains (mobility, participation, self care, psychological well being and relationships), the Western Ontario McMasters University Osteoarthritis Index (WOMAC), the General Well-Being Index (GWBI), and the Hospital Anxiety and Depression Scale (HADS) was posted to people with clinician diagnosed OA. Assessment of the internal construct validity of the PIPP was undertaken using Rasch analysis performed with RUMM2020 software and concurrent validity through comparator measures.



Two hundred and fifty-nine participants with OA responded. Analysis of the five individual domains of the PIPP indicated that there was good fit to the Rasch model, with high person separation reliability. One item required removal from the Mobility subscale and the Participation subscale. There were strong correlations between the PIPP Mobility scores and the WOMAC disability and pain subscales (rho = .73 and rho = .68), and between the PIPP Psychological well-being and HADS Depression (rho = .71) and GWBI (rho = -.69). High inter-correlations between the impact and distress subscales for each domain (range rho = .85 to .96), suggested redundancy of the latter.



This study demonstrates that the PIPP has good psychometric properties in an OA population. The PIPP, using just the impact subscales, provides a brief, reliable and valid means of assessing the impact of OA from the individual's perspective and operationalizing the bio-psychosocial model by the application of a single multi-domain questionnaire.
A phase II study of the combination of rituximab and granulocyte macrophage colony stimulating factor as treatment of patients with chronic lymphocytic leukemia.

The ideas and opinions expressed in the journal’s Just Accepted articles do not necessarily reflect those of Informa Healthcare (the Publisher), the Editors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the material contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician or other health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Just Accepted articles have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as have articles published in the traditional manner. There may, therefore, be errors in Just Accepted articles that will be corrected in the final print and final online version of the article. Any use of the Just Accepted articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior to publication. Just Accepted by Leukemia & Lymphoma
Beta-Interferon treatment does not always slow the progression of axonal injury in multiple sclerosis

Progression of disability in multiple sclerosis (MS) appears related to axonal damage, which is at least in part associated with white matter lesions. Beta-interferon (BIFN) substantially reduces new inflammatory activity in MS and a recent report suggested that it may reverse a component of axonal injury. To test the generalisability of this conclusion, particularly in a population with relatively active disease, we used magnetic resonance spectroscopy measures to test whether BIFN can reverse or arrest progression of axonal injury in patients with MS. Eleven patients with a history of active (median, 1.5 relapses/year) relapsing-remitting MS were treated with BIFN and responses to treatment were monitored with serial MRI and single voxel magnetic resonance spectroscopic measurements of relative concentrations of brain N-acetylaspartate (NAA), a measure of axonal integrity from a central, predominantly white matter brain region. BIFN treatment was associated with a significant reduction in relapse rate (p = 0.007) and white matter water T2 relaxation time (p = 0.047) over 12 months. Also consistent with a treatment effect, white matter T2-hyperintense lesion loads did not increase. However, the central white matter NAA/creatine ratio (NAA/Cr, which was reduced over 16 % in patients relative to healthy controls at the start of treatment), continued to decrease in the patients over the period of observation (mean 6.2 % decrease, p = 0.02). For individual patients the magnitude of the NAA/Cr decrease was correlated with the frequency of relapses over the two years prior to treatment (r = −0.76, p = 0.006). These data suggest that reduction of new inflammatory activity with BIFN does not invariably halt progression of axonal injury. Nonetheless, there appears to be a relationship between the rate of progression of axonal injury and relapse rate over the previous two years. The consequences of reduced inflammation on pathological progression relevant to disability therefore may be present, but substantially delayed. Alternatively, distinct mechanisms may contribute to the two processes.
Impact of chronic kidney disease on quality of life, lung function, and functional capacity.

To evaluate the impact of the chronic kidney disease (CKD) on quality of life, from the children's and their parents' perspective, respiratory muscle strength, lung function, and functional capacity in children and adolescents.



Cross-sectional study of children with CKD aged 8 to 17 years. Those incapable of taking the tests were excluded. After an interview, quality of life by Pediatric Quality of Life Inventory) (PedsQL(TM)), muscular strength, pulmonary function tests, and the 6-minute walking test (6MWT) were applied. Student's t-test, ANOVA (difference in means), and Pearson's coefficient of correlation were used. The level of significance was set at 5%.



Of the 40 patients, the mean distance walked at the 6MWT was 396 meters, and the mean final score at the quality of life test as perceived by the children and parents was 50.9 and 51, respectively. From the children's perspective, the transplanted patients had a higher quality of life score when compared to those undergoing hemodialysis (p<0.001); those who practiced physical activity had better quality of life when compared to the sedentary children (p<0.001). From the children's and the parents' perspectives, the male gender had a higher quality of life score (p<0.05). There was a positive correlation between the distance walked at the 6MWT and age, height, final PedsQL(TM), forced vital capacity (FVC), and forced expiratory volume in the first second (FEV1), as well as a negative correlation between FEV1/FVC and the distance walked.



A significant reduction in the quality of life and the functional capacity was observed in children with CKD, influenced by the type of treatment, gender, and sedentary life style.
Detection of skin cancer by classification of Raman spectra

Skin lesion classification based on in vitro Raman spectroscopy is approached using a nonlinear neural network classifier. The classification framework is probabilistic and highly automated. The framework includes a feature extraction for Raman spectra and a fully adaptive and robust feedforward neural network classifier. Moreover, classification rules learned by the neural network may be extracted and evaluated for reproducibility, making it possible to explain the class assignment. The classification performance for the present data set, involving 222 cases and five lesion types, was 80.5%/spl plusmn/5.3% correct classification of malignant melanoma, which is similar to that of trained dermatologists based on visual inspection. The skin cancer basal cell carcinoma has a classification rate of 95.8%/spl plusmn/2.7%, which is excellent. The overall classification rate of skin lesions is 94.8%/spl plusmn/3.0%. Spectral regions, which are important for network classification, are demonstrated to reproduce. Small distinctive bands in the spectrum, corresponding to specific lipids and proteins, are shown to hold the discriminating information which the network uses to diagnose skin lesions.
The impact of radiologists’ expertise on screen results decisions in a CT lung cancer screening trial

To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule’s volume. The protocol allowed radiologists to manually adjust screen results in cases of high suspicion of benign or malignant nodule nature. Participants whose baseline CT result was based on a solid or part-solid nodule were included in this study. Adjustments by radiologists at baseline were evaluated. Histology was the reference for diagnosis or to confirm benignity and stability on subsequent CT examinations. A total of 3,318 participants (2,796 male, median age 58.0 years) were included. In 195 participants (5.9 %) the initial baseline screen result was adjusted by the radiologist. Adjustment was downwards from positive or indeterminate to negative in two and 119 participants, respectively, and from positive to indeterminate in 65 participants. None of these nodules turned out to be malignant. In 9/195 participants (4.6 %) the screen result was adjusted upwards from negative to indeterminate or indeterminate to positive; two nodules were malignant. In one in 20 cases of baseline lung cancer screening, nodules were reclassified by the radiologist, leading to a reduction of false-positive screen results. • The NELSON study allowed radiologists to manually adjust the screen result • At baseline, radiologists adjusted the result in about one in 20 cases (95.4 % downwards) • Radiologists’ adjustments led to a 22 % reduction of false-positive screen results • Radiologists’ expertise can improve nodule classification in addition to a nodule protocol
Gating of human theta oscillations by a working memory task.

Electrode grids on the cortical surface of epileptic patients provide a unique opportunity to observe brain activity with high temporal-spatial resolution and high signal-to-noise ratio during a cognitive task. Previous work showed that large-amplitude theta frequency oscillations occurred intermittently during a maze navigation task, but it was unclear whether theta related to the spatial or working memory components of the task. To determine whether theta occurs during a nonspatial task, we made recordings while subjects performed the Sternberg working memory task. Our results show event-related theta and reveal a new phenomenon, the cognitive "gating" of a brain oscillation: at many cortical sites, the amplitude of theta oscillations increased dramatically at the start of the trial, continued through all phases of the trial, including the delay period, and decreased sharply at the end. Gating could be seen in individual trials and varying the duration of the trial systematically varied the period of gating. These results suggest that theta oscillations could have an important role in organizing multi-item working memory.
Phase I combination of sorafenib and erlotinib therapy in solid tumors: safety, pharmacokinetic, and pharmacodynamic evaluation from an expansion cohort.

The aims of this study were to further define the safety of sorafenib and erlotinib, given at their full approved monotherapy doses, and to correlate pharmacokinetic and pharmacodynamic markers with clinical outcome. In addition, a novel pharmacodynamic marker based on the real-time measurement of RAF signal transduction capacity (STC) is described. Sorafenib was administered alone for a 1-week run-in period, and then both drugs were given together continuously. RAF STC was assessed in peripheral blood monocytes prior to erlotinib initiation. Epidermal growth factor receptor (EGFR) expression and K-RAS mutations were measured in archival tumor samples. Changes in pERK and CD31 were determined in fresh tumor biopsies obtained pretreatment, prior to erlotinib dosing, and during the administration of both drugs. In addition, positron emission tomography-computed tomography scans and pharmacokinetic assessments were done. Eleven patients received a total of 57 cycles (median, 5; range, 1-10). Only four patients received full doses of both drugs for the entire study course, with elevation of liver enzymes being the main reason for dose reductions and delays. Among 10 patients evaluable for response, 8 experienced tumor stabilization of >or=4 cycles. Pharmacokinetic analysis revealed no significant interaction of erlotinib with sorafenib. Sorafenib-induced decrease in RAF-STC showed statistically significant correlation with time-to-progression in seven patients. Other pharmacodynamic markers did not correlate with clinical outcome. This drug combination resulted in promising clinical activity in solid tumor patients although significant toxicity warrants close monitoring. RAF-STC deserves further study as a predictive marker for sorafenib.
Bedside adherence to clinical practice guidelines in the intensive care unit: the TECLA study

To assess adherence to clinical practice guidelines for three interventions routinely used in critical care medicine. Multicenter, 1-day cross-sectional observational study in 44 intensive care units in four countries. A total of 419 patients hospitalized in participating ICUs on the day of the survey. Red blood cell transfusion (n = 29) was performed appropriately in 22 patients (76%), while among the 390 patients who received no transfusion 4 (1%) had a valid indication. Setting of tidal volume in acute respiratory distress syndrome, assessed in 45 patients, was deemed appropriate in 37 cases (82%). Prescription of stress ulcer prophylaxis (n = 128) was appropriate in only 24 patients (19%), while among the 268 patients who were not treated 28 (10%) had an indication. The implementation of recommendations varies across different domains of care. While the adherence to current recommendations in routine practice is acceptable as regards tidal volume settings in acute respiratory distress syndrome, it is suboptimal for blood transfusion and prevention of upper gastrointestinal bleeding. Practice surveys are useful to inform strategies currently developed to assess practices of health-care professionals and develop strategies for more effective dissemination of medical knowledge.
Pulmonary function in patients with acute coronary syndrome treated with ticagrelor or clopidogrel (from the Platelet Inhibition and Patient Outcomes [PLATO] pulmonary function substudy).

The Platelet Inhibition and Patient Outcomes (PLATO) trial showed that ticagrelor reduced the risk for cardiovascular events in patients with acute coronary syndromes compared to clopidogrel but was associated with increased incidence of dyspnea. This substudy assessed whether ticagrelor affects pulmonary function in patients with acute coronary syndromes: 199 patients enrolled in the PLATO trial and receiving randomized treatment with ticagrelor 90 mg twice daily (n = 101) or clopidogrel 75 mg/day (n = 98) took part in the pulmonary function substudy. Patients with advanced lung disease, congestive heart failure, or coronary artery bypass graft surgery after the index event were excluded. Pulse oximetry (blood oxygen saturation), spirometry (forced expiratory volume in 1 second, forced vital capacity, and forced expiratory flow between 25% and 75% of forced vital capacity before and 20 minutes after inhalation of a β(2) agonist), lung volumes (total lung capacity, functional residual capacity, residual volume), and diffusion capacity were performed after patients received study medication for 30 to 40 days. Tests were then repeated <10 days before and approximately 30 days after the discontinuation of study medication. After a mean treatment duration of 31 days, there were no differences between the groups for any of the pulmonary function parameters. At the end of treatment (mean 211 days) and after the discontinuation of study medication (mean 32 days after the last dose), there was also no evidence of a change in pulmonary function in either group. For example, forced expiratory volume in 1 second values before β(2) agonist inhalation in the ticagrelor and clopidogrel groups were 2.81 ± 0.73 and 2.70 ± 0.84 L, respectively, at the first visit and did not change significantly at subsequent visits. In conclusion, no effect of ticagrelor on pulmonary function was seen in this cohort of patients with acute coronary syndromes compared to clopidogrel.
Different HLA class II associations in ulcerative colitis patients with and without primary sclerosing cholangitis

Approximately 80% of patients with primary sclerosing cholangitis (PSC) of Northern European origin have inflammatory bowel disease (IBD), the majority ulcerative colitis (UC). An inherent problem in interpreting positive findings in genetic association studies of PSC is thus to distinguish between factors associated with hepatobiliary versus intestinal pathology. We aimed to clarify to what extent human leukocyte antigen (HLA) class II associations in UC patients with and without PSC differ. High-resolution DRB1 and DQB1 typing was performed in 365 Scandinavian PSC patients, an independent cohort of 330 Norwegian UC patients and 368 healthy controls. HLA associations found in PSC were mostly distinct from those seen in UC, and no significant differences were noted between PSC patients with concurrent UC and PSC patients without IBD. This suggests different HLA associated genetic susceptibility to PSC and UC, and supports notions that UC in PSC may represent a distinct UC phenotype.