nils-herrmann/clean_scirepeval huggingface dataset:
Is Blood Eosinophil Count a Predictor of Response to Bronchodilators in Chronic Obstructive Pulmonary Disease? Results from Post Hoc Subgroup Analyses

Chronic obstructive pulmonary disease (COPD) patients with blood eosinophil (EOS) count ≥ 2% benefit from exacerbation reductions with inhaled corticosteroids (ICSs). We conducted post hoc analyses to determine if EOS count ≥ 2% is a marker for greater responsiveness to the bronchodilators umeclidinium (UMEC; long-acting muscarinic antagonist), vilanterol (VI; long-acting β2-agonist) or UMEC/VI combination.



Effects of once-daily UMEC/VI 62.5/25, UMEC 62.5 and VI 25 µg versus placebo on trough forced expiratory volume in one second (FEV1), Transition Dyspnoea Index (TDI), St George's Respiratory Questionnaire (SGRQ) scores and adverse event (AE) incidences in four completed, 6-month studies were assessed by EOS subgroup. Trough FEV1 was also evaluated by ICS use and EOS subgroup. Analyses were performed using a repeated measures model.



At baseline, 2437 of 4647 (52%) patients had EOS count ≥ 2%. Overall, ≈ 50% of patients used ICSs. At day 169, no notable variations were observed in trough FEV1 least squares mean differences between EOS subgroups versus placebo for UMEC/VI, UMEC and VI; results according to ICS use were similar. No differences were reported between EOS subgroups in TDI and SGRQ scores on day 168, or for incidences of AEs, serious AEs and AEs leading to withdrawal.



Response to UMEC/VI, UMEC and VI in terms of trough FEV1, dyspnoea and health-related quality of life was similar for COPD patients with baseline EOS counts ≥ 2 or <2%. EOS count did not appear to predict bronchodilator response in either ICS users or non-users.
Differences in Clinical Manifestations according to the Positivity of Interferon-γ Assay in Patients with Intestinal Tuberculosis

Intestinal tuberculosis (ITB) remains prevalent in Asia. An interferon-γ assay (QuantiFERON-TB gold test [QFT]) is considered to be an effective supplementary tool for diagnosing ITB. We retrospectively analyzed the clinical features of ITB patients based on the initial results of QFT. A total of 109 patients with ITB were enrolled, and 82 patients (75.2%) showed positive QFT results. In the QFT-positive group, the mean age (44.1±12.0 years) was significantly higher than that in the QFT-negative group (37.0±14.8, p=0.0096). Abdominal pain (p=0.006) and diarrhea (p=0.030) were more frequent in the QFT-negative group. Further, C-reactive protein (CRP) levels were significantly higher in the QFTnegative group (6.4±9.9 mg/dL) than in the QFT-positive group (1.3±2.3, p<0.001). Multivariate analysis confirmed that younger age (p=0.016), diarrhea (p=0.042), and high levels of CRP (p=0.029) were independent predictors of QFTnegative results in patients with ITB. These results suggest that prior exposure to TB, reflected by QFT positivity, may cause mild inflammation in patients with ITB.
Development and psychometric testing of a short version of the Barriers Questionnaire-Taiwan form for cancer patients.

A comprehensive assessment of patient hesitancy to use analgesics and accurate knowledge related to the promotion of analgesic adherence is necessary for effective pain management. Unfortunately, there has been a lack of a short and concise questionnaire to assess patients' hesitancy to use analgesics in clinical practice.



This paper is a report of the development and psychometric properties of the short version of the Barriers Questionnaire-Taiwan form (S-BQT).



This study employed a descriptive design.



A convenience sample was recruited from oncology clinics at two medical centers in Taiwan.



One hundred and eighty-three (N=183) patients receiving analgesics for cancer pain participated in the study.



Instruments included the Barriers Questionnaire-Taiwan form (BQT), the Taiwanese version of the Morisky Medication Adherence Measure-Taiwan form (MMAM-T). Two self-administered questionnaires were performed at the same time, and the ratio of analgesic usage was computed over a two-week period. Reliability was established by calculating Cronbach's α and test-retest reliability. The validity was estimated by construct validity, criterion-related validity, and known group validity.



To develop the S-BQT, we used reliability analysis to extract nine items from nine subscales. Internal consistency of the S-BQT was indicated by a Cronbach's alphas score of 0.86. Test-retest reliability was assessed as 0.83 over a two-week interval. Factor analysis revealed two factor structures. Criterion-related validity was examined by correlating the S-BQT score, and MMAM-T score, and the ratio of analgesic use. Known group validity was examined by comparing the S-BQT scores of patients with hesitancy to report pain and take analgesics vs. patients demonstrating no such hesitancy in the previous week. Known group validity was also established by comparing the S-BQT scores among patients with low, moderate, and high adherence to the usage of medication.



The S-BQT shows excellent reliability and validity. The use of this instrument can help to improve communication between patients and clinicians regarding the use of analgesics in the management of pain.
Evaluation of skin temperature biofeedback training at two different sites for migraine

All combinations of cooling versus warming and finger versus temporal artery were used in the present study, the aim of which was to identify an optimal biofeedback training site and to assess the specific effects of skin temperature biofeedback upon migraine. After an initial 4-week baseline phase, during which daily records of headache activity and medication were kept, 24 migraine patients were randomly assigned to one of the four experimental conditions. Training sessions for all patients were of 50-min duration and occurred once per week for 8 weeks. The headache charts were completed for another 4 weeks after treatment was terminated and again at 6-month follow-up. The results showed significant reductions in migraine activity and drug usage. However, self-regulation of skin temperature in different directions at different sites did not in fact result in significantly different magnitudes of change in migraine activity across groups. The role of nonspecific factors is discussed and a physiological model is proposed to explain how warming and cooling may produce clinical improvement in migraine.
Cognitive Adaptability as a Moderator of Expressive Writing Effects in an HIV Sample

This study explored the effects of expressive writing on positive and negative outcomes related to perceived psychosocial and health status among persons with HIV. This was the first study to examine the moderating effects of cognitive adaptability—consisting of dispositional optimism coupled with perceived competence—on outcomes of expressive writing. Thirty-seven participants wrote about either traumatic experiences or trivial topics in four 20-min sessions. Dependent measures obtained at baseline were repeated 1 month later. Although no main effects for group were found, baseline levels of cognitive adaptability were differentially associated with changes in a positive outcomes index, and a pain and physical functioning index in those assigned to the two groups. No moderating effects of cognitive adaptability were found for changes in a negative outcomes index. Findings underscore the importance of identification of moderating variables in understanding the impact of expressive writing interventions among individuals with HIV or other conditions.
Effect of addition of inhaled salmeterol to the treatment of moderate-to-severe asthmatics uncontrolled on high-dose inhaled steroids. European Respiratory Study Group.

The aim of this study was to assess the efficacy and safety of inhaled salmeterol 100 micrograms b.d. (SM) versus inhaled salbutamol 400 micrograms q.d.s. (SB), both via the Diskhaler, when added to concurrent treatment, in asthmatic patients who were not controlled on high doses of inhaled steroids (> or = 1,500 micrograms beclomethasone dipropionate (BDP) or equivalent daily). This was a multicentre, parallel group, double-blind study in which 190 patients with a forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR) of 30-75% predicted and 15% reversibility to inhaled bronchodilator were randomized to treatment for 6 weeks. In the SM group, morning PEFR increased from 281 to 315 L-min-1 during treatment and in the SB group from 311 to 315 L.min-1 (p < 0.001). The SM group showed significantly better reduction in diurnal variation, from 39 to 22 L.min-1 during treatment, than the SB group (34 to 37 L.min-1) (p < 0.001). There was a significantly greater improvement in FEV1 in the SM group (from 1.63 to 1.85 L) than in the SB group (from 1.79 to 1.84 L). The SM group had significantly more symptom-free nights than the SB group (p < 0.001), and also more "rescue-free" nights (p = 0.04). The adverse event profile was similar in both groups. This study indicates that in asthmatic patients, not controlled on high-dose inhaled steroids, inhaled salmeterol 100 micrograms b.d. significantly improves lung function and reduces asthma symptoms.
Adaptive response to a low-protein diet in predialysis chronic renal failure patients.

Arandomized, controlled study of 12 patients with mild chronic renal failure was designed to assess the metabolic effects of a low-protein diet supplemented (n = 6) or not (n = 6) with ketoanalogs of amino acids. The protein intake was prescribed so that both groups were isonitrogenous. The dietary survey each month included a 3-d food record and a 24-h urine collection for urea measurement. After a 4- to 6-wk equilibrium period (standard occidental diet, 1.11 g of protein and 32 kcal/kg per d), patients reduced their protein intake to reach 0.71 g of protein/kg per d during the third month. Energy intake was kept constant (31 kcal/kg per d) during the 3-mo period. Compliance to the diet was achieved after 2 mo of training. Leucine turnover measurement was performed before and at the end of the 3-mo low-protein period. There was no clinical change, whereas total body flux decreased by 8% (P < 0.05) and leucine oxidation by 18% (P < 0.05). No difference could be attributed to the ketoanalogs themselves. Thus, under sufficient energy intake, a low-protein diet is nutritionally and metabolically safe during chronic renal failure. The nitrogen-sparing effect of a low-protein diet is still present during mild chronic renal insufficiency.
Therapeutic alliance mediates the association between personality and treatment outcome in patients with major depressive disorder.

Patient personality traits have been shown to influence treatment outcome in those with major depressive disorder (MDD). The trait agreeableness, which reflects an interpersonal orientation, may affect treatment outcome via its role in the formation of therapeutic alliance. No published studies have tested this hypothesis in patients with MDD.



Participants were 209 outpatients with MDD who were treated in a randomized control trial. Mediation analyses were conducted to examine the role of therapeutic alliance in the association between pretreatment personality and the reduction of depression symptom severity during treatment. Separate models were estimated for patient- versus therapist-rated therapeutic alliance.



We found a significant indirect effect of agreeableness on the reduction of depression severity via patient-rated therapeutic alliance. Results were replicated across two well-validated measures of depression symptom severity. Results also partially supported indirect effects for extraversion and openness. Therapist ratings of alliance did not mediate the association between personality and treatment outcomes.



Patients were recruited as part of a randomized control trial, which may limit the generalizability of results to practice-based clinical settings. Due to constraints on statistical power, intervention-specific mediation results were not examined.



These results highlight the importance of personality and the role it plays in treatment process as well as outcome.
Increases in plasma carotenoid concentrations in response to a major dietary change in the women's healthy eating and living study.

Cohort studies suggest that higher circulating carotenoid concentrations through food sources may reduce breast cancer events. Other intervention studies have not achieved the level of change in circulating carotenoids required to properly test this hypothesis.



In a randomized trial of 2,922 breast cancer survivors, we examined blood and self-reported diet at baseline and 1 year. Intensive telephone counseling encouraged a plant-based diet in the intervention group. Diet was measured via 24-hour recalls, and a panel of plasma carotenoid concentrations was assessed at both time points.



The study intervention was associated with a 51% increase in total carotenoid concentration, from 2.272 +/- 1.294 to 3.440 +/- 2.320 micromol/L, achieved mainly by marked increases in targeted carotenoids: alpha-carotene, beta-carotene, and lutein. For each of these targeted carotenoids, the proportion of the intervention sample remaining below the cutpoint for the lowest baseline quartile decreased by one third to one half. After 1 year of study, half of the intervention group was in the highest baseline quartile. No change in distribution was observed in comparison group. Intervention participants achieved this change by both dietary pattern and vegetable juice consumption. Participants who chose to change dietary pattern without consuming significant quantities of vegetable juice achieved 75% of the level of change observed in other intervention participants.



Innovative telephone counseling intervention and dietary targets in the Women's Healthy Eating and Living study were associated with the level of change in circulating carotenoid concentration necessary to test the diet and breast cancer hypothesis suggested by cohort studies.
Comparison of whole-body 18F-FDG PET, 99mTc-MIBI SPET, and post-therapeutic 131I-Na scintigraphy in the detection of metastatic thyroid cancer

The usefulness of fluorine-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) in differentiated thyroid cancer (DTC) has been demonstrated by many investigators, but in only a small number of studies have FDG-PET images been compared with those obtained using other non-iodine tumour-seeking radiopharmaceuticals. In most of the studies, planar imaging was performed for comparison using thallium-201 chloride or technetium-99m 2-methoxyisobutylisonitrile (99mTc-MIBI). Furthermore, FDG-PET studies were not always performed in the hypothyroid state with increased levels of thyroid stimulating hormone (TSH), which are known to increase FDG uptake by DTC. The aim of this study was to compare the ability of FDG-PET to detect metastatic DTC with that of 99mTc-MIBI whole-body single-photon emission tomography (SPET) and post-therapeutic iodine-131 scintigraphy, evaluated under TSH stimulation. Nineteen patients (8 men, 11 women; age range, 38–72 years, mean 60 years; 17 thyroidectomised and 2 inoperable patients following 131I ablation of the remaining thyroid tissue; 16 papillary and 3 follicular carcinomas) with metastatic DTC underwent FDG-PET whole-body scan (WBS) and 99mTc-MIBI SPET WBS at an interval of less than 1 week, followed by 131I therapy. The SPET images were reconstructed using the maximum likelihood expectation maximisation (ML-EM) method. All patients were hypothyroid at the time of each scan. 131I WBS was performed 3–5 days after oral administration of the therapeutic dose. A total of 32 lesions [10 lymph node (LN), 15 lung, 6 bone, 1 muscle] were diagnosed as metastases, as confirmed by histopathology and/or other imaging modalities (X-ray, US, CT, MRI, bone, 201Tl and 131I scans). FDG-PET, 99mTc-MIBI SPET and post-therapeutic 131I scintigraphy respectively revealed a total of 26 (81.3%), 20 (62.5%) and 22 (68.8%) lesions. These techniques respectively demonstrated nine (90.0%), eight (80.0%) and six (60.0%) LN metastases, and eleven (73.3%), seven (46.7%) and ten (66.7%) lung metastases. They each demonstrated five of the six bone metastases (83.3%). FDG-PET and 99mTc-MIBI SPET were positive in 17 (78.3%) and 14 (63.6%) of the 22 131I-positive lesions, respectively, and also in nine (90.0%) and six (60.0%) of the ten 131I-negative lesions, respectively. Three of the five 131I-positive and FDG-PET-negative lesions were miliary type lung metastases with a maximal nodular diameter of less than 10 mm. Comparison of FDG-PET with 99mTc-MIBI SPET revealed concordant results in 24 lesions, and discordant results in eight lesions (seven with positive FDG-PET alone and one with positive 99mTc-MIBI SPET alone).  (a) even using whole-body SPET, FDG PET is superior to 99mTc-MIBI in terms of ability to detect metastases of DTC; (b) the higher sensitivity of FDG-PET compared with the previous studies could partly be due to increased serum TSH.
Simvastatin treatment reduces heat shock protein 60, 65, and 70 antibody titers in dyslipidemic patients: A randomized, double-blind, placebo-controlled, cross-over trial.

This study aimed to evaluate the effects of statin therapy on serum levels of antibodies to several specific heat shock proteins (HSPs) in dyslipidemic patients.



Participants (n=102) were treated with simvastatin (40mg/day), or placebo in a randomized, double-blind, placebo-controlled, cross-over trial. Anti-HSP60, 65, 70, and hs-CRP levels were measured before and after each treatment period. Seventy-seven subjects completed the study.



Treatment with simvastatin was associated with significant reductions in serum anti-HSP60, 65, and 70 titers in the dyslipidemic patients (10%, 14%, and 15% decrease, respectively) (p<0.001). There have been previous reports of reductions in serum CRP with statin treatment, and although median CRP levels were 9% lower on simvastatin treatment, this did not achieve statistical significance.



While it is unclear whether HSP antibodies are directly involved in atherogenesis, our findings suggest that simvastatin inhibits autoimmune responses that may contribute to the development of cardiovascular disease.
Understanding the needs of lung cancer patients during the pre-diagnosis phase

Patients with lung cancer have numerous and varying needs spanning across the cancer trajectory; however, only limited research has focused specifically on the pre-diagnosis phase. A multicentre cross-sectional survey was conducted to explore the experience of lung cancer patients during the pre-diagnosis phase. High levels of anxiety were reported by many participants (45.6 %). Informational (32.1 %), and emotional (24.1 %) needs were reported as most important; the majority (89.0 %) reported these needs were met. Most participants sought information throughout, with many (38.6 %) rating their oncology health care providers to be the best source of information. The majority (70.0 %) reported that they were not directed to any resources to help address their anxiety. During pre-diagnosis, informational and emotional needs appear most important, and for the majority, these were reportedly met. Although many experienced high levels of anxiety, few were directed to resources to address it.
Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial

Further to the patent expiry of Neupogen® (Amgen filgrastim), Hospira has developed a biosimilar filgrastim (Nivestim™) that may offer a clinically effective alternative for multiple hematologic and oncologic indications. Here results are reported from a phase I trial, primarily designed to compare the pharmacodynamic profiles of Hospira filgrastim and Amgen filgrastim. A phase I, single-center, double-blind, randomized trial was undertaken to demonstrate equivalence of the pharmacodynamic characteristics of Hospira filgrastim and Amgen filgrastim. Fifty healthy volunteers were randomized to receive 5 or 10 µg/kg dosing, before further randomization to treatment sequence. All volunteers received five daily subcutaneous doses of Hospira filgrastim or Neupogen, with subsequent crossover to the alternative treatment. Bioequivalence was evaluated by analysis of variance; if the estimated 90% confidence intervals (CIs) for the ratio of ‘test’ to ‘reference’ treatment means were within the conventional equivalence limits of 0.80–1.25, then bioequivalence was concluded. Forty-eight volunteers completed the study. Geometric mean absolute neutrophil count area under the curve from time 0 to the last time point at day 5 (primary endpoint) was comparable in volunteers given Hospira filgrastim or Amgen filgrastim at 5 µg/kg (ratio of means, 0.98; 90% CI, 0.92–1.05) or 10 µg/kg (ratio, 0.97; 90% CI, 0.93–1.01); 90% CIs were within the predefined range necessary to demonstrate bioequivalence. Hospira filgrastim was well tolerated with no additional safety concerns over Amgen filgrastim. Hospira filgrastim is bioequivalent with Amgen filgrastim with regard to its pharmacodynamic characteristics.
Oxaliplatin/capecitabine vs oxaliplatin/infusional 5-FU in advanced colorectal cancer: the MRC COIN trial

COIN compared first-line continuous chemotherapy with the same chemotherapy given intermittently or with cetuximab in advanced colorectal cancer (aCRC).Methods:Choice between oxaliplatin/capecitabine (OxCap) and oxaliplatin/leucovorin (LV)/infusional 5-FU (OxFU) was by physician and patient choice and switching regimen was allowed. We compared OxCap with OxFU and OxCap+cetuximab with OxFU+cetuximab retrospectively in patients and examined efficacy, toxicity profiles and the effect of mild renal impairment.In total, 64% of 2397 patients received OxCap(±cetuximab). Overall survival, progression free survival and overall response rate were similar between OxCap and OxFU but rate of radical surgeries was higher for OxFU. Progression free survival was longer for OxFU+cetuximab compared with OxCap+cetuximab but other efficacy measures were similar. Oxaliplatin/LV/infusional 5-FU (±cetuximab) was associated with more mucositis and infection whereas OxCap(±cetuximab) caused more gastrointestinal toxicities and palmar-plantar erythema. In total, 118 patients switched regimen, mainly due to toxicity; only 16% came off their second regimen due to intolerance. Patients with creatinine clearance (CrCl) 50–80 ml min−1 on OxCap(±cetuximab) or OxFU+cetuximab had more dose modifications than those with better renal function.Overall, OxFU and OxCap are equally effective in treating aCRC. However, the toxicity profiles differ and switching from one regimen to the other for poor tolerance is a reasonable option. Patients with CrCl 50–80 ml min−1 on both regimens require close toxicity monitoring.