nils-herrmann/clean_scirepeval huggingface dataset:
Effect of cyclosporin A on the allergen-induced late asthmatic reaction.

The allergen-induced late asthmatic reaction (LAR) is associated with mucosal inflammation involving several cell types including activated T lymphocytes and eosinophils. In contrast, the early asthmatic reaction (EAR) is considered to results from rapid allergen-induced release of bronchoconstrictor mediators from IgE sensitised mast cells. Cyclosporin A has efficacy in chronic severe corticosteroid-dependent asthma and is believed to act principally by inhibiting cytokine mRNA transcription in T lymphocytes. However, it has effects on other cell types in vitro, including the inhibition of exocytosis/degranulation events in mast cells. It was therefore hypothesised that cyclosporin A would attenuate both the EAR and LAR in subjects with mild asthma.



Twelve sensitised atopic asthmatic subjects with documented dual asthmatic responses were studied in a double blind, placebo controlled, crossover trial. On two separate study visits subjects received two oral doses of either cyclosporin A or matched placebo before inhaled allergen challenges. The forced expiratory volume in one second (FEV1) was measured half hourly for eight hours and blood eosinophil counts were analysed three, six, and 24 hours after the challenge. Treatment effects on blood eosinophil counts as well as the EAR and LAR, respectively defined as the areas under the curve (AUC) of FEV1 changes from baseline between 0-1 and 4-8 hours after challenge, were compared by non-parametric crossover analysis.



Cyclosporin A reduced both the LAR (median AUC -41.9 1.h (interquartile range -82.7 to -12.4) for cyclosporin A and -84.5 1.h (-248.9 to -39.1) for placebo; p = 0.007) and the late increase in blood eosinophils (median 0.2 x 10(9)/1 (0.15 to 0.4) for cyclosporin A and 0.4 x 10(9)/1 (0.25 to 0.55) for placebo; p = 0.024) but had no effect on the EAR. The reduction of the LAR by cyclosporin A correlated significantly with prechallenge blood concentrations of cyclosporin A (r = 0.6, p = 0.028).



These data are consistent with the concept that cyclosporin A has anti-inflammatory actions in asthma resulting from inhibition of mRNA transcription of eosinophil-active cytokines, predominantly in T lymphocytes. Cyclosporin A, possibly in its inhaled form, or other agents which prevent cytokine gene transcription may therefore have potential in ameliorating the inflammatory component of asthma.
Effect of bronchodilators on the cough response to inhaled citric acid in normal and asthmatic subjects.

Coughing was induced in seven normal and eight asthmatic subjects by giving successive inhalations of citric acid aerosols of progressively higher concentration (range 0.5-32%). A baseline cough response was obtained on each of four experimental days, and there was no significant difference between days in this respect. Then the subjects received by inhalation either a bronchodilator (salbutamol 5 mg or ipratropium 1 mg) or placebo, in a paired double blind crossover design. A second citric acid run followed and was used for paired drug-placebo comparisons. In the asthmatic subjects the cough response was diminished by both bronchodilators (p less than 0.05), and the cough threshold was significantly higher after ipratropium but not salbutamol. In normal subjects no significant effects were found. Airways calibre was assessed, by an oscillatory technique that measures the resistance of the respiratory system (Siemens Siregnost FD 5), in four of the seven normal and all eight asthmatic subjects. The mean respiratory resistance was higher in asthmatic than in normal subjects, and fell significantly after both bronchodilators. In normal subjects smaller decreases in respiratory resistance occurred, significant only with salbutamol. The simplest hypothesis which explains the results relates change in cough response to altered neuroreceptor sensitivity associated with rapid changes in bronchial calibre.
[68Ga]DOTATATE PET/MRI and [18F]FDG PET/CT are complementary and superior to diffusion-weighted MR imaging for radioactive-iodine-refractory differentiated thyroid cancer

The purpose of this study was to determine whether [68Ga]DOTATATE PET/MRI with diffusion-weighted imaging (DWI) can replace or complement [18F]FDG PET/CT in patients with radioactive-iodine (RAI)-refractory differentiated thyroid cancer (DTC). The study population comprised 12 patients with elevated thyroglobulin and a negative RAI scan after thyroidectomy and RAI remnant ablation who underwent both [18F]FDG PET/CT and [68Ga]DOTATATE PET/MRI within 8 weeks of each other. The presence of recurrent cancer was evaluated on a per-patient, per-organ and per-lesion basis. Histology, and prior and follow-up examinations served as the standard of reference. Recurrent or metastatic tumour was confirmed in 11 of the 12 patients. [68Ga]DOTATATE PET(/MRI) correctly identified the tumour burden in all 11 patients, whereas in one patient local relapse was missed by [18F]FDG PET/CT. In the lesion-based analysis, overall lesion detection rates were 79/85 (93 %), 69/85 (81 %) and 27/82 (33 %) for [18F]FDG PET/CT, [68Ga]DOTATATE PET/MRI and DWI, respectively. [18F]FDG PET(/CT) was superior to [68Ga]DOTATATE PET(/MRI) in the overall evaluation and in the detection of pulmonary metastases. In the detection of extrapulmonary metastases, [68Ga]DOTATATE PET(/MRI) showed a higher sensitivity than [18F]FDG PET(/CT), at the cost of lower specificity. DWI achieved only poor sensitivity and was significantly inferior to [18F]FDG PET in the lesion-based evaluation in the detection of both extrapulmonary and pulmonary metastases. [18F]FDG PET/CT was more sensitive than [68Ga]DOTATATE PET/MRI in the evaluation of RAI-refractory DTC, mostly because of its excellent ability to detect lung metastases. In the evaluation of extrapulmonary lesions, [68Ga]DOTATATE PET(/MRI) was more sensitive and [18F]FDG PET(/CT) more specific. Furthermore, DWI did not provide additional information and cannot replace [18F]FDG PET for postoperative monitoring of patients with suspected RAI-refractory DTC.
High donor FOXP3-positive regulatory T-cell (Treg) content is associated with a low risk of GVHD following HLA-matched allogeneic SCT.

Regulatory T cells (T(reg)s) that constitutively express FOXP3 are instrumental to the maintenance of tolerance and may suppress graft-versus-host disease (GVHD) in humans. To determine whether regulatory T cells in allogeneic stem cell transplants (SCTs) ameliorate GVHD after transplantation, we quantitated the coexpression of FOXP3 on CD4(+) T cells in 32 donor SCTs infused into HLA-matched siblings and examined GVHD incidence in respective recipients. High CD4(+)FOXP3(+) T-cell count in the donor was associated with a reduced risk of GVHD. We monitored T(reg)s during immune reconstitution in 21 patients with leukemia undergoing a T-cell-depleted allogeneic SCT. Early after SCT, there was a significant expansion in the CD4(+)FOXP3(+) T-cell compartment. A low CD4(+)FOXP3(+) T-cell count early after SCT (day 30) was associated with an increased risk of GVHD, and the ratio of CD4(+)FOXP3(+) T cells to CD4(+)CD25(+)FOXP3(-) T cells was significantly reduced in patients with GVHD, suggesting diminished control of effector T cells. Our findings suggest that graft T(reg) content may predict for risk of GVHD after SCT. Determining the T(reg) levels in the donor and manipulating T(reg)s early after transplantation may provide a new approach to controlling GVHD.
Genetic and environmental influences on schizotypy: a community-based twin study.

This study investigated the factor structure and etiology of four self-report schizotypy questionnaires during young adulthood (age 18-27) in 98 monozygotic and 59 same-sex dizygotic twin pairs from the community. A single phenotypic factor was identified that was primarily associated with Perceptual Aberration,  Ideation, and the Rust Inventory of Schizotypal Cognitions scales, and less so with Social Anhedonia. Univariate etiologic models suggested that in addition to nonshared environmental influences, Perceptual Aberration and Social Anhedonia were significantly influenced by either genes or shared family environment, whereas Magical Ideation and the Rust Inventory were influenced by shared family environment, but not genes. Multivariate twin analyses detected a common schizotypy factor, primarily defined by Perceptual Aberration,  Ideation, and the Rust Inventory scales, that was influenced by genes or shared environment as well as nonshared environment. Contrary to expectations, these results suggest that, at least in community-based samples, these "positive" schizotypy questionnaires are not strongly genetically influenced.
Oxidative stress and endothelium influenced by metformin in type 2 diabetes mellitus

Metformin may influence atherogenesis but the mechanisms are not well understood. A pilot study was undertaken to determine whether metformin administration is associated with changes in oxidative stress and endothelial function. Fifteen type 2 diabetic patients were treated for 3 months with metformin (1,700 mg daily) or with a placebo in a crossover study. Laboratory parameters of oxidative stress, fibrinolysis and endothelial function were evaluated both prior to and following the respective treatments. In addition, laser Doppler was used to determine microcirculation changes in the skin. Increases in serum N-acetyl-β-glucosaminidase activity (p < 0.05) and plasma malondialdehyde concentration were found following 1 month of metformin administration. Three months of treatment was accompanied by significantly increased plasma malondialdehyde (p < 0.001) and ascorbic acid (p < 0.01) concentrations as well as the alpha-tocopherol/(cholesterol + triglyceride) ratio (p < 0.001). The concentration of tissue plasminogen activator (tPA), vascular cell-adhesion molecules (VCAM) and intercellular cell-adhesion molecules (ICAM) were significantly decreased (p < 0.01) compared with placebo. Microcirculation measured by laser Doppler flowmetry was not significantly changed. We conclude that initiation of metformin treatment in type 2 diabetic patients is associated with improved diabetes control as well as with activation of oxidative stress together with antioxidant system. The atherogenic process measured by biochemical indicators is diminished in parallel. Our results show that in short-term metformin administration in type 2 diabetes promotes endothelium effects associated with a complex of metabolic changes.
Favored subjects and psychosocial needs in music therapy in terminally ill cancer patients: a content analysis.

Research has shown positive effects of music therapy on the physical and mental well-being of terminally ill patients. This study aimed to identify favored subjects and psychosocial needs of terminally ill cancer patients during music therapy and associated factors.



Forty-one Patients receiving specialized inpatient palliative care prospectively performed a music therapy intervention consisting of at least two sessions (total number of sessions: 166; per patient average: 4, range, 2-10). Applied music therapy methods and content were not pre-determined. Therapeutic subjects and psychosocial needs addressed in music therapy sessions were identified from prospective semi-structured "field notes" using qualitative content analysis. Patient- and treatment-related characteristics as well as factors related to music and music therapy were assessed by questionnaire or retrieved from medical records.



Seven main categories of subjects were identified: "condition, treatment, further care", "coping with palliative situation", "emotions and feelings", "music and music therapy", "biography", "social environment", and "death, dying, and spiritual topics". Patients addressed an average of 4.7 different subjects (range, 1-7). Some subjects were associated with gender (p = .022) and prior impact of music in patients' life (p = .012). The number of subjects per session was lower when receptive music therapy methods were used (p = .040). Psychosocial needs were categorized into nine main dimensions: "relaxing and finding comfort", "communication and dialogue", "coping and activation of internal resources", "activity and vitality", "finding expression", "sense of self and reflection", "finding emotional response", "defocusing and diversion", and "structure and hold". Patients expressed an average of 4.9 psychosocial needs (range, 1-8). Needs were associated with age, parallel art therapy (p = .010), role of music in patient's life (p = .021), and the applied music therapy method (p = .012).



Seven main categories of therapeutically relevant subjects and nine dimensions of psychosocial needs could be identified when music therapy was delivered to terminally ill cancer patients. Results showed that patients with complex psychosocial situations addressed an average number of five subjects and needs, respectively. Some socio-demographic factors, the role of music in patient's lives and the applied music therapy methods may be related with the kind and number of expressed subjects and needs.
A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee.

To determine if inhibition of inducible nitric oxide synthase (iNOS) with cindunistat hydrochloride maleate slows progression of osteoarthritis (OA)  This 2-year, multinational, double-blind, placebo-controlled trial enrolled patients with symptomatic knee OA (Kellgren and Lawrence Grade (KLG) 2 or 3). Standard OA therapies were permitted throughout. Patients were randomly assigned to cindunistat (50 or 200 mg/day) or placebo. Randomisation was stratified by KLG. Radiographs to assess joint space narrowing (JSN) were acquired using the modified Lyon-schuss protocol at baseline, week 48 and 96.



Of 1457 patients (50 mg/day, n=485; 200 mg/day, n=486; placebo, n=486), 1048 (71.9%) completed the study. Patients were predominantly women; 56% had KLG3. The primary analysis did not demonstrate superiority of cindunistat versus placebo for rate of change in JSN. In KLG2 patients, JSN after 48 weeks was lower with cindunistat 50 mg/day versus placebo (p=0.032). Least-squares mean±SE JSN with cindunistat 50 mg/day ( -0.048±0.028 mm) and 200 mg/day (-0.062±0.028 mm) were 59.9% (95% CI 6.8% to 106.9%) and 48.7% (95% CI -8.4% to 93.9%) of placebo, improvement was not maintained at 96 weeks. No improvement was observed for KLG3 patients at either time-point. Cindunistat did not improve joint pain or function, but was generally well tolerated.



Cindunistat (50 or 200 mg/day) did not slow the rate of JSN versus placebo. After 48-weeks, KLG2 patients showed less JSN; however, the improvement was not sustained at 96-weeks. iNOS inhibition did not slow OA progression in KLG3 patients.
A Phase I Trial of Preoperative Partial Breast Radiotherapy: Patient Selection, Target Delineation, and Dose Delivery

Diffusion of accelerated partial breast irradiation into clinical practice is limited by the need for specialized equipment and training. The accessible external beam technique yields unacceptable complication rates, likely from large postoperative target volumes. We designed a phase 1 trial evaluating preoperative radiation therapy to the intact tumor using widely available technology.



Patients received 15, 18, or 21 Gy in a single fraction to the breast tumor plus margin. Magnetic resonance imaging (MRI) was used in conjunction with standard computed tomography (CT)-based planning to identify contrast enhancing tumor. Skin markers and an intratumor biopsy marker were used for verification during treatment.



MRI imaging was critical for target delineation because not all breast tumors were reliably identified on CT scan. Breast shape differences were consistently seen between CT and MRI but did not impede image registration or tumor identification. Target volumes were markedly smaller than historical postoperative volumes, and normal tissue constraints were easily met. A biopsy marker within the breast proved sufficient for setup localization.



This single fraction linear accelerator-based partial breast irradiation approach can be easily incorporated at most treatment centers. In vivo targeting may improve accuracy and can reduce the dose to normal tissues.
Efficacy of vilazodone on anxiety symptoms in patients with major depressive disorder

Anxiety symptoms are prevalent in patients with major depressive disorder. A post-hoc analysis of two phase III trials was conducted to evaluate the efficacy of vilazodone on depression-related anxiety. Using the 17-item Hamilton Depression Rating Scale (HAMD17) Anxiety/Somatization subscale, patients were classified as anxious or nonanxious. Improvements in depressive symptoms were based on least squares mean changes in HAMD17 and Montgomery-Asberg Depression Rating Scale total scores. Anxiety symptoms in the anxious subgroup were evaluated using Hamilton Anxiety Rating Scale (HAMA) total and subscale (Psychic Anxiety, Somatic Anxiety) scores, HAMD17 Anxiety/Somatization subscale and item (Psychic Anxiety, Somatic Anxiety) scores, and the Montgomery-Asberg Depression Rating Scale Inner Tension item score. Most of the pooled study population [82.0% (708/863)] was classified with anxious depression. After 8 weeks of treatment, least squares mean differences between vilazodone and placebo for changes in HAMA total and HAMD17 Anxiety/Somatization subscale scores were -1.82 (95% confidence interval -2.81 to -0.83; P<0.001) and -0.75 (95% confidence interval -1.17 to -0.32; P<0.001), respectively. Statistically significant improvements with vilazodone were also found on all other anxiety-related measures, except the HAMA Somatic Anxiety subscale. Vilazodone may be effective in treating patients with major depressive disorder who exhibit somatic and/or psychic symptoms of anxiety.
Effects of Chungkookjang supplementation on obesity and atherosclerotic indices in overweight/obese subjects: a 12-week, randomized, double-blind, placebo-controlled clinical trial.

This study was designed to investigate the anti-obesity and anti-atherosclerotic effects of supplementation with Chungkookjang (CKJ), a traditional fermented soybean food, in overweight/obese subjects. The study was a 12-week, randomized, double-blind, placebo-controlled clinical trial followed by a 3-week screening period. Overweight/obese subjects (both groups having a body mass index ≥23 kg/m(2) and waist hip ratio of ≥0.90 for men and ≥0.85 for women) who were not diagnosed with any disease were included in this study. Sixty subjects were randomly divided into a CKJ (n=30, 26 g/day) or placebo (n=30) group. During the 12-week intervention period, subjects were asked to maintain their usual diet and activity and not to take any functional foods or dietary supplements. Anthropometric parameters, abdominal fat distribution by computerized tomography, and blood parameters (lipid profile, atherosclerotic indices) before and after the 12-week intervention period were measured. Fifty-five subjects (29 CKJ group, 26 placebo group) finished the study. After the 12 weeks of supplementation, subjects in the CKJ group showed a significant improvement in apolipoprotein B (P<.05) compared with the placebo group. Visceral fat areas by computerized tomography scans and apolipoprotein B/apolipoprotein A1 showed a tendency to decrease in the CKJ group, but there were no significant differences between the CKJ and placebo groups. These results suggested that CKJ supplementation has potential anti-atherosclerotic effects that might be more pronounced when combined with lifestyle modification.
Bringing forward reperfusion with oxygenated blood perfusion beyond arterial occlusion during endovascular procedures in patients with acute ischemic stroke.

High recanalization rates achieved with endovascular procedures are not always followed by the expected clinical improvement. These time-consuming procedures imply a delayed reperfusion despite the capacity of earlier intravascular microcatheter bypass to the ischemic tissue beyond the clot. We aimed to explore the safety and feasibility of MOB beyond the clot.



We studied patients with stroke undergoing endovascular procedures. The timing of procedural steps was recorded. We then explored the safety and feasibility of repeated femoral artery MOB injections beyond the occlusion every time the clot was crossed in 17 patients. Pre- and postocclusion flow was continuously monitored with TCD.



We studied 60 patients (mean age, 70 ± 11 years; median NIHSS score, 20; IR, 18-21). Of them, 33 (55%) received IV-tPA before the endovascular procedure. The following arteries were occluded: the MCA (63.3%, n = 38) and the ICA (36.6%, n = 22). The TSO to arterial puncture was 193 ± 77 minutes. The occluding clot was successfully crossed with the microcatheter in 46 patients (76.6%; mean TSO, 228 ± 82 minutes). Recanalization was achieved in 44 patients (73.2%; mean TSO, 328 ± 144 minutes). Repeated MOB injections were performed in 17 patients. Patients with/without MOB presented with similar baseline characteristics. The median number of MOB injections was 2 (IR, 2-3), and the median injected blood volume was 40 mL (IR, 27.5-50). The mean time from first MOB to arterial recanalization was 136 ± 86 minutes. During MOB, a nonpulsatile flow appeared in previously nonvisible distal branches on TCD.



In this small series, oxygenated blood delivered through a microcatheter positioned distal to the site of occlusion was feasible and safe. Until final recanalization is achieved, MOB injections may generate intermittent reperfusion for up to 2 hours.
Electronic Synoptic Operative Reporting for Thyroid Surgery using an Electronic Data Management System: Potential for Prospective Multicenter Data Collection

Electronic synoptic operative reports ensure systematic documentation of all critical components and findings during complex surgical procedures. Thyroid surgery lends itself to synoptic reporting, because there are a predefined number of essential intraoperative events and findings that every endocrine surgeon invariably records. An electronic web-based form (e-form) was designed and implemented to record operative data in a synoptic structure for thyroid surgery. The e-form was implemented as a pilot study from January 2008 to October 2009 for use by three attending surgeons. During this period, 514 e-forms were completed with 100% compliance, which recorded data from 384 total thyroidectomies and 130 thyroid lobectomies. All users found the e-form to be easy to use, comprehensive, and took less than 5 min to complete. The main advantages of a web-based e-form for synoptic recording of thyroid surgery are that it is user-friendly and easy to complete, yet comprehensive. Because it is based on a system available across institutions, it can be used as a minimum dataset and could be considered a national and international standard for wider use, especially if endorsed by the American or International Association for Endocrine Surgeons.