nils-herrmann/clean_scirepeval huggingface dataset:
Impact of Glycemic Control Strategies on the Progression of Diabetic Peripheral Neuropathy in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Cohort

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial demonstrated similar long-term clinical effectiveness of insulin-sensitizing (IS) versus insulin-providing (IP) treatments for type 2 diabetes on cardiovascular outcomes in a cohort with documented coronary artery disease. We evaluated the effects of randomized glycemic control strategy (IS vs. IP) on the prevalence and incidence of diabetic peripheral neuropathy (DPN).



DPN (defined as Michigan Neuropathy Screening Instrument [MNSI] clinical examination score>2) was assessed at baseline and yearly for 4 years. DPN prevalence and incidence were compared by intention-to-treat modeling by logistic generalized estimating equation models for prevalence and Kaplan-Meier estimates and Cox regression models for incidence rates.



Results are reported for 2,159 BARI 2D participants (70% males) with valid baseline and at least one follow-up MNSI score (mean age 62±9 years, mean HbA1c 7.7±1.6%, diabetes duration 10±9 years). There were no differences in the prevalence of DPN between the IS and the IP groups throughout the 4 years of follow-up. In 1,075 BARI 2D participants with no DPN at baseline, the 4-year cumulative incidence rate of DPN was significantly lower in the IS (66%) than in the IP (72%) strategy group (P=0.02), which remained significant after adjusting for the in-trial HbA1c (P=0.04). In subgroup analyses, IS strategy had a greater benefit in men (hazard ratio 0.75 [99% CI 0.58-0.99], P<0.01).



Among patients with type 2 diabetes followed for up to 4 years during BARI 2D, a glycemic control therapy with IS significantly reduced the incidence of DPN compared with IP therapy and may add further benefit for men.
Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form

To create cross-walk tables to associate scores for the Modified Fatigue Impact Scale (MFIS) with scores for the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) in persons with Multiple Sclerosis (MS). Cross-walk tables were created using equipercentile linking and based on data collected at one time point in a longitudinal study of persons with MS (N = 458). Validation of the tables was conducted using data collected at a subsequent time point (N = 444). Deviations between estimates and actual scores were compared across levels of fatigue. The impact of sample size on the precision of sample mean estimates was evaluated using bootstrapping. Correlations between deviations and fatigue level for the PROMIS Fatigue SF and MFIS were (−0.31) and (−0.30), respectively, indicating moderately greater deviations with lower fatigue scores. Estimated sample means were impacted by sample size. Cross-walk tables allow data from studies using different measures of fatigue to be combined to achieve larger sample sizes and to compare results. These tables are valid for group-level analyses with sample sizes of 150 or greater.
A hybrid optimization algorithm in power filter design

Clonal selection algorithm (CSA) is one of the most widely employed immune-based approaches for handling optimization tasks. Characterized with the similartaxis and dissimilation properties, Mind evolutionary computation (MEC) is a new evolutionary computation method. In this paper, we propose a hybrid optimization algorithm based on the principles of the CSA and MEC to search for the optimal parameters (values of inductor and capacitor) of a passive filter in the diode full-bridge rectifier. Simulation results demonstrate that our algorithm can acquire the optimal LC parameters within the given criteria for power filter design.
Assessment of Still and Moving Images in the Diagnosis of Gastric Lesions Using Magnifying Narrow-Band Imaging in a Prospective Multicenter Trial

Magnifying narrow-band imaging (M-NBI) is more accurate than white-light imaging for diagnosing small gastric cancers. However, it is uncertain whether moving M-NBI images have additional effects in the diagnosis of gastric cancers compared with still images.



A prospective multicenter cohort study.



To identify the additional benefits of moving M-NBI images by comparing the diagnostic accuracy of still images only with that of both still and moving images. Still and moving M-NBI images of 40 gastric lesions were obtained by an expert endoscopist prior to this prospective multicenter cohort study. Thirty-four endoscopists from ten different Japanese institutions participated in the prospective multicenter cohort study. Each study participant was first tested using only still M-NBI images (still image test), then tested 1 month later using both still and moving M-NBI images (moving image test). The main outcome was a difference in the diagnostic accuracy of cancerous versus noncancerous lesions between the still image test and the moving image test.



Thirty-four endoscopists were analysed. There were no significant difference of cancerous versus noncancerous lesions between still and moving image tests in the diagnostic accuracy (59.9% versus 61.5%), sensitivity (53.4% versus 55.9%), and specificity (67.0% versus 67.6%). And there were no significant difference in the diagnostic accuracy between still and moving image tests of demarcation line (65.4% versus 65.5%), microvascular pattern (56.7% versus 56.9%), and microsurface pattern (48.1% versus 50.9%). Diagnostic accuracy showed no significant difference between the still and moving image tests in the subgroups of endoscopic findings of the lesions.



The addition of moving M-NBI images to still M-NBI images does not improve the diagnostic accuracy for gastric lesions. It is reasonable to concentrate on taking sharp still M-NBI images during endoscopic observation and use them for diagnosis.
Small nodules detected on chest radiography: does size predict calcification?

To determine whether the likelihood of lung nodule calcification can be predicted from nodule size as measured on a chest radiograph (CXR).



Retrospective review of CXRs of patients with lung nodules < or =1 cm in size detected on CT scanning. CT images were used to identify calcifications and to provide spatial localization for readers to visualize nodules on a CXR and to measure their size. A subset of these nodules then was reexamined by different readers who did not view the CT scans



Two university hospitals (Albuquerque, NM; Dallas, TX) and a US Air Force/Veterans Administration medical center (Albuquerque, NM).



Two hundred thirty-six nodules in 185 patients



One half of the nodules (118) seen on CT scans could not be located on CXR, of which 8 (7%) were calcified. The prevalence of calcifications in the other 118 nodules visualized on CXRs was much higher (71 of 118 nodules [60%]; p<0.005). Among the nodules visualized on CXRs, those < 7 mm in diameter (44 of 57 nodules [77%]) were more likely to be calcified than those > or = 7 mm in diameter (27 of 61 nodules [44%]; p<0.005). Radiographs of 42 of the smallest nodules visualized on CXRs by the initial readers later were examined prospectively by different readers who did not have access to the CT images. Thirty of 33 of the calcified nodules (91%) but only 3 of 9 of the noncalcified nodules (33%) were detected (p<0.005). These readers also recorded 40 additional small nodules that were not seen on CT scans, which were considered to be false-positives.



Nodules detected on CXRs that measure <7 mm in size are likely to be calcified or to represent a false-positive finding.
Neurological recovery, mortality and length of stay after acute spinal cord injury associated with changes in management

Based on epidemiological data from two populations of patients with acute spinal cord injury (ASCI), three outcome measures were compared to evaluate the effectiveness of management of ASCI patients in a regional, specialized acute spinal cord injury unit (ASCIU). The two populations consisted of a pre-ASCIU group of 351 patients managed from 1947-73 before the establishment of the ASCIU, and an ASCIU group of 201 patients managed in an ASCIU from 1974-81. The three outcome measures were mortality rate, length of stay (LOS) during first hospitalization, and neurological recovery. Linear regression and multiple regression analyses were used to determine whether differences in the outcome measures were attributable to differences in admission variables in addition to the influence of the ASCIU.The results showed that the patients treated in the ASCIU had a significant reduction in the mortality rate of almost 50% (P = 0.022), a significant reduction in the LOS of almost 50% (P < 0.001), and a significant increase in neurological recovery consisting of a doubling of the neurological recovery scale utilized (P < 0.001). Multiple regression analysis showed that the reduction in mortality rate was significantly influenced by differences in the admission variables between the two groups. However, the establishment of the ASCIU was associated with a significant reduction in LOS and a significant improvement in neurological recovery. Thus, these results support the view that management of ASCI patients in a regional, multidisciplinary unit is medically advantageous and can reduce the LOS.
Assessment of asthma control in primary care.

To determine the prevalence of uncontrolled asthma in patients who are visiting their primary care provider for any reason.



This multisite, cross-sectional survey was conducted between January 25 and May 2, 2008. Participants aged > or =18 years were recruited from 35 primary care provider sites. Eligible participants presented to the office for any acute medical, routine, follow-up, or nonmedical reason; had a self-reported physician diagnosis of asthma; used medication to treat asthma in the past year; and had no history of COPD. They completed the Asthma Control Test dagger (ACT) and provided information including demographics, health behaviors, medical history, and asthma medication use. Uncontrolled asthma was defined as ACT score < or =19.



The overall weighted prevalence of uncontrolled asthma in 2238 patients in primary care was 58% (95% confidence interval [CI], 0.56-0.60). Among asthma patients seeking care for a respiratory complaint, 72% (95% CI, 0.68-0.75) had uncontrolled asthma compared to 48% (95% CI, 0.45-0.51) of asthma patients presenting for a non-respiratory reason.



At the population level, over half of patients with asthma under primary care management had uncontrolled asthma at the time of an office visit. Surprisingly, nearly 50% of patients with asthma who presented for office visits not associated with respiratory-related complaints had uncontrolled asthma. The study results may be influenced by a seasonal effect of upper respiratory infections and by the insurance status of the study respondents. However identifying patients with uncontrolled asthma is important and remains a challenge. Therefore, health care providers should consider evaluating asthma control on a regular basis, regardless of reason for visit.
Granulocyte-macrophage colony-stimulating factor induces modest increases in plasma human immunodeficiency virus (HIV) type 1 RNA levels and CD4+ lymphocyte counts in patients with uncontrolled HIV infection.

Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF).



In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 microg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of > or =1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study.



After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P=.036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P=.06) and beyond.



GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.
Long-term follow-up of patients with chronic lymphocytic leukemia treated with fludarabine as a single agent.

The clinical response and survival of 113 patients with at least 3-year follow-up after treatment with fludarabine as a single agent for chronic lymphocytic leukemia has been evaluated. Seventy-eight patients were previously treated and 35 were untreated. The response to therapy and survival were strongly correlated with the degree of previous therapy, the stage of disease, and whether or not the patients were refractory to alkylating agents. Other characteristics associated with survival were the age of the patient and the serum albumin level at the start of therapy. The median time to progression of responders who had not received prior therapy was 33 months and was 21 months for previously treated patients. Survival after progression of disease was also strongly correlated with the degree of prior therapy. No successful salvage regimen after initial fludarabine therapy was shown for patients refractory to alkylating agents, although fludarabine achieved further remissions in patients who had received fludarabine as their initial treatment or were not refractory to alkylating agents. The morbidity of patients in unmaintained remission on discontinuation of fludarabine was low, with less than one episode of infection per patient-year at risk. The morbidity during this time was correlated with clinical response and whether the patients had received prior therapy. Although fludarabine is a very effective cytoreductive regimen, most patients, including those who achieved true complete remissions, will have recurrent disease. Longer follow-up and comparative trials are required before the effect of fludarabine on survival is shown.
Initiating HIV Care: Attitudes and Perceptions of HIV Positive Crack Cocaine Users

There is limited data on the initiation and use of HIV care services by HIV-positive crack cocaine users. We analyzed data from a study of 286 recently infected HIV-positive persons recruited from 4 U.S. cities. Participants completed an Audio Computer Assisted Self Interview (A-CASI) regarding HIV care knowledge, attitudes, beliefs and practices related to the initiation of HIV care. In multiple logistic regression analysis, higher scores on an assessment of knowledge, attitudes and beliefs regarding HIV care, and Hispanic race were positively associated with initiating HIV primary care. Crack cocaine use in the past 30 days and male gender were negatively associated with initiating care. Injection drug use was not associated with initiation of care. Targeted interventions for crack cocaine users, including drug treatment, may be required to provide optimal HIV primary care use in this population.
A pilot study comparing efficacy of a cervical intraepithelial neoplasia Excisor with loop electrosurgical excision procedure.

To determine whether the proportion of incomplete resection of cervical intraepithelial neoplasia (CIN 1-3) may be reduced by CIN Excisor compared with loop excision of the transformation zone (LLETZ).



A prospective trial during a 2-year period at a district general hospital in London, United Kingdom, including 420 women scheduled for treatment due to CIN, after colposcopy guided biopsy results. This study was expected to demonstrate a statistically significant difference (p<0.05) in the proportion of women with clear histopathological resection margins after treatment with CIN Excisor compared with LLETZ. Chi-square or Fisher's exact test were used to compare histopathological resection margins in the CIN Excisor and LLETZ groups.



Overall, there is strong evidence of a difference in the proportion of histopathological specimens with clear resection margins for the CIN Excisor group, compared with the LLETZ group (201/210, 95.7% versus 180/210, 85.7%: p<0.001). Sub-analysis within the two groups, of the proportion of histopathological specimens with clear resection margins in relation to CIN grades, revealed a statistically significant difference in favour of the CIN Excisor group for CIN 1 (99/103, 96.1% versus 82/95, 86.3%: p=0.01), and CIN 2 (73/77, 94.8% versus 68/80, 85%: p=0.04). There is a numerical difference in the proportion of clear resection margins in favour of the CIN Excisor for CIN 3 (29/30, 96.7% versus 30/35, 85.7%), but this difference was not statistically significant (p=0.21). Perioperative complications were similar between the two groups.



CIN Excisor achieved better results than LLETZ for treatment of CIN 1-3 with respect to clear histopathological resection margins. However, further studies including a larger number of women treated for CIN 3 are needed before firm conclusions are drawn.
Inulin and oligofructose do not influence the absorption of cholesterol, or the excretion of cholesterol, Ca, Mg, Zn, Fe, or bile acids but increases energy excretion in ileostomy subjects

To investigate the effects of inulin and oligofructose on cholesterol absorption and excretion of cholesterol, bile acids, energy, nitrogen and minerals in man. Double-blind cross-over study. Metabolic kitchen with policlinic visits, Sahlgrenska Hospital, Göteborg,  Patients with conventional ileostomy because of ulcerative colitis. 17 g of inulin, 17 g of oligofructose and 7 g of sucrose were added to a controlled diet during three experimental periods of three days each. Ileostomy effluents were collected and analysed. Differences between experimental and control diet were investigated with the Wilcoxon’s sign and values test. Inulin and oligofructose were recovered in the ileostomy effluent to 88% (95% CI, 76–100%) and 89% (64–114%) respectively. Dry solid excretion increased by 14.4 g (11.3–17.5) on inulin, and by 14.7 g (13.0–16.4 g) on oligofructose and energy excretion increased 245 kJ (190–307 kJ) on inulin and 230 kJ (217–315 kJ) on oligofructose compared to control diet (P<0.05). Cholesterol absorption, excretion of cholesterol, bile acids, nitrogen, fat, calcium, magnesium, zinc and iron were not affected by inulin and oligofructose. Inulin and oligofructose are not digested in the small intestine. They do not affect mineral excretion and hence hardly mineral absorption. They do not increase fat or nitrogen excretion from the small intestine. Any physiological effect of inulin and oligofructose is probably mediated through other mechanisms than altered excretion from the small intestine. This work was supported by grants from Swedish Council for Agriculture and Forestry, from Gothenburg Medical Society and from ORAFTI Ltd Belgium.
Protocol for the development and validation of a questionnaire to assess concerning behaviours and mental health in individuals with autism spectrum disorders: the Assessment of Concerning Behaviour (ACB) scale

Co-occurring psychiatric conditions and concerning behaviours are prevalent in individuals with autism spectrum disorders (ASD), and are likely to be detrimental to functioning and long-term outcomes. The cognitive rigidity and deficits in emotional literacy and verbal behaviour that commonly occur in ASD can adversely affect clinicians' confidence to identify concerning behaviours and mental health problems. There is a need to develop a measure that is tailored towards individuals with ASD, and differentiates between symptoms of psychopathology and core ASD symptoms. Furthermore, it should be modified to capture internalising symptoms that individuals with ASD may find difficult or be unable to verbalise. This protocol describes the intended development and validation of the Assessment of Concerning Behaviour (ACB) scale. The ACB will aim to be a multidimensional measure of concerning behaviours in ASD incorporating self-report, parent/carer, teacher/employer and clinician report versions that can be used across the lifespan and spectrum of intellectual ability.



This study will be guided by the methods described in the US Food and Drug Administration Guidance for Industry Patient-reported Outcome Measures. A literature review, cognitive interviews and focus groups with individuals who have experience of working or living with ASDs will be used for item generation. A sample of children and adults with ASD will complete the ACB, in addition to other gold standard measures of concerning behaviour in order to establish the initial psychometric properties of the scale.


ETHICS AND DISSEMINATION
This study has received ethical approval from the NHS Research Ethics Committee: London-Camden and King's Cross (ref: 15/LO/0085). Study findings will be disseminated to healthcare professionals and scientists in the field through publication in peer-reviewed journals and conference presentations.
Early phase II study of interferon-alpha and tumor necrosis factor-alpha combination in patients with advanced cancer.

Synergistic enhancement of anti-tumor effects through the combined use of natural human interferon-alpha (nHuIFN-alpha) and natural human tumor necrosis factor-alpha (nHuTNF-alpha) enabled us to decrease the effective dose of each cytokine and consequently to reduce side effects. One hundred and twenty patients with advanced or recurrent solid cancer were entered in the trial from April 1985 to January 1988, of whom 112 patients were evaluable. A mixture of nHuINF-alpha and nHuTNF-alpha was injected intravenously as the maintenance dose 1 x 10(6)U or more/day for over 8 weeks. There was no response in 40 patients injected with the maintenance dose of 1 x 10(6)U/day, but of 72 patients receiving more than 2 x 10(6)U/day (10 micrograms of nHuIFN-alpha and 3 micrograms of nHuTNF-alpha), 4 had complete responses, 10 had partial responses, and 4 had minor responses. The overall response rate was 12.5% (14/112) and the rate was 19.5% in 72 patients with more than 2 x 10(6)U/day. Positive responses were as follows: hepatoma 3/8), renal cell cancer (4/11), breast cancer (4/17), ovarian cancer (1/2), malignant thymoma (1/1) and liposarcoma (1/1). Serious adverse effects like hypotension, oliguria and severe hepatobiliary toxicity were never experienced. The effective and adequate dose of the mixed preparation was considered 2 to 4 x 10(6)U/day/body.