nils-herrmann/clean_scirepeval huggingface dataset:
Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study

Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners. A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed. This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.
Differential expression of C-Reactive protein and Serum amyloid A in different cell types in the lung tissue of chronic obstructive pulmonary disease patients

Chronic systemic inflammatory syndrome has been implicated in the pathobiology of extrapulmonary manifestations of chronic obstructive pulmonary disease (COPD). We aimed to investigate which cell types within lung tissue are responsible for expressing major acute-phase reactants in COPD patients and disease-free ("resistant") smokers.



An observational case-control study was performed to investigate three different cell types in surgical lung samples of COPD patients and resistant smokers via expression of the C-reactive protein (CRP) and serum amyloid A (SAA1, SAA2 and SAA4) genes. Epithelial cells, macrophages and fibroblasts from the lung parenchyma were separated by magnetic microbeads (CD326, CD14 and anti-fibroblast), and gene expression was evaluated by RT-PCR.



The sample consisted of 74 subjects, including 40 COPD patients and 34 smokers without disease. All three cell types were capable of synthesizing these biomarkers to some extent. In fibroblasts, gene expression analysis of the studied biomarkers demonstrated increased SAA2 and decreased SAA1 in patients with COPD. In epithelial cells, there was a marked increase in CRP, which was not observed in fibroblasts or macrophages. In macrophages, however, gene expression of these markers was decreased in COPD patients compared to controls.



These results provide novel information regarding the gene expression of CRP and SAA in different cell types in the lung parenchyma. This study revealed differences in the expression of these markers according to cell type and disease status and contributes to the identification of cell types that are responsible for the secretion of these molecules.
Topical Rosiglitazone Treatment Improves Ulcerative Colitis by Restoring Peroxisome Proliferator-Activated Receptor-γ Activity

Impaired epithelial expression of peroxisome proliferator-activated receptor-γ (PPARγ) has been described in animal colitis models and briefly in patients with ulcerative colitis, but the functional significance in humans is not well defined. We examined PPARγ expression and functional activity in human colonic epithelium and explored the potential of topical treatment with rosiglitazone (a PPARγ ligand) in patients with ulcerative colitis.Spontaneous and rosiglitazone-mediated PPARγ and adipophillin expression (a gene transcriptionally activated by PPARγ) were measured by reverse transcriptase PCR in colonic biopsies and isolated epithelial cells from patients with ulcerative colitis and controls. Fourteen patients with active distal ulcerative colitis were randomized to either rosiglitazone (4 mg) or mesalazine (1 g) enema treatment once daily for 14 days.PPARγ expression was fourfold reduced in epithelial cells from inflamed compared with uninflamed mucosa and controls. Adipophillin levels were decreased in parallel. Rosiglitazone induced a concentration-dependent increase in adipophillin levels and restored PPARγ activity in epithelial cells from inflamed mucosa in vitro. Rosiglitazone enema treatment was well tolerated and reduced the Mayo ulcerative colitis score from 8.9 to 4.3 (P<0.01), similar to the effect of mesalazine. Rosiglitazone increased adipophillin levels in the epithelial cells of the patients, indicating PPARγ activation in vivo.Roziglitasone enemas improve impaired PPARγ activity in inflamed colonic epithelium and have beneficial clinical effect in patients with active distal ulcerative colitis. These findings raise interest in further studies of PPARγ ligands that exhibit their anti-inflammatory effect locally in the gut to avoid possible systemic side effects.
Driving simulator performance and psychomotor functions of schizophrenic patients treated with antipsychotics

The objective of the study is to compare schizophrenic inpatients under antipsychotic monotherapy regarding simulated driving behaviour and psychomotor functions related to driving ability. Schizophrenic inpatients (n = 80) were tested before discharge to outpatient treatment. Data were collected with the computerized Act & React Testsystem and the Wiener Testsystem measuring visual perception, reaction time, attention, vigilance and stress-tolerance. Besides, patients underwent various driving simulations on a static driving simulator (FT-SR 200). Before discharge to outpatient treatment, about 25% of schizophrenic patients must be considered as severely impaired with respect to driving skills. Differences between treatment groups could be shown both in psychomotor measures and in driving simulator performance with a better test performance of patients treated with atypical antipsychotics. Controlling for age, psychopathologic symptoms and extrapyramidal signs, differences in psychomotor measures were most pronounced in concentration and vigilance. As mental disorders itself pose an increased risk of accidents, counselling patients with respect to differential effects of antipsychotic treatment is of great relevance. In addition to psychomotor tests computer-simulated driving seems to be a useful tool in assessing traffic safety under pharmacologic treatment.
Acute effects of low dose nicotine gum on platelet function in non-smoking hypertensive and normotensive men

Twenty non-smoking middle-aged men with mild untreated essential hypertension were compared to age-matched controls (n=22) in a double-blind placebo controlled study. Plasma and urinary concentrations of the platelet-specific protein β-thromboglobulin (β-TG), platelet count and mean platelet volume were measured before and after chewing 2 mg nicotine gum. The mean plasma nicotine concentration increased to 4.3 ng/ml in the hypertensive group and to 3.9 ng/ml in the normotensive group after 30 minutes of chewing the nicotine gum. Blood pressure and heart rate increased significantly, but there was no difference between the groups. Venous plasma catecholamine concentrations were unchanged. β-TG concentrations in plasma and urine were similar in the two groups, and plasma β-TG levels did not change after nicotine gum in either group. Urinary high molecular weight β-TG decreased after nicotine compared to placebo. Platelet count and volume increased significantly in the hypertensive group, but not in the normotensive group. The response in platelet count was significantly higher in the hypertensive group. Thus, small amounts of nicotine increase platelet counts more in hypertensive than in normotensive non-smoking men, without inducing the platelet release reaction.
Asthma and Risk of Prostate Cancer: A Population-Based Case-Cohort Study in Taiwan.

Several epidemiologic studies in Western countries have examined the association between asthma and prostate cancer risk, but the results have been inconclusive. We investigated this association in a large, nationwide, population-based case-cohort study. Using the Taiwan National Health Insurance Research Database from 1997 to 2008, we collected data from 12,372 men, including 4124 with asthma and 8248 age-, residence-, and insurance premium-matched control subjects, who were never diagnosed with asthma. Competing risk-adjusted Cox proportional hazards regression was used to calculate the hazard ratios (HRs) and 95% confidence interval (CI) for determining the association between prostate cancer and asthma. During a mean follow-up of 5.05 years (standard deviation, 2.10), there were 74 cases of prostate cancer. The incidence of prostate cancer was 163.0/100,000 person-years (95% CI: 113.0-228.0) in the asthma patients. Asthma was significantly associated with prostate cancer (HR: 2.36; 95% CI: 1.22-4.57; P = 0.011) after adjusting for age, residential area, insurance premium, hypertriglyceridemia, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, duration of hospitalization, and mortality. In the subgroup analysis, independent risk factors for prostate cancer among men with asthma were age (HR: 1.09; 95% CI: 1.05-1.21; P < 0.001) and hypertension (HR: 2.75; 95% CI: 1.24-7.80; P = 0.047). The results of our study suggest that men with asthma have an increased risk of prostate cancer.
The retention indices of 201Tl-SPECT in brain tumors.

The aim of this study was to assess the utility of 201Tl SPECT in the differential diagnosis of intracranial tumors and to determine the relationship between 201Tl uptake and histological types.



Thirty-eight patients (19 males and 19 females) with thirty-eight brain tumors were evaluated with 201Tl-SPECT. The early and delayed 201Tl uptake ratio was calculated, and the retention index (RI) was applied as follows; RI = delayed uptake ratio/early uptake ratio.



The RI of malignant tumors was higher (0.72 +/- 0.18) than that of benign tumors (0.50 +/- 0.16) and the difference was statistically significant (p = 0.00045). The difference between high-grade glioma (0.80 +/- 0.15) and metastatic tumors (0.64 +/- 0.19) was statistically significant (p = 0.039).



201Tl-SPECT may add useful biochemical information and could differentiate malignant brain tumors from benign lesions, but the RI of metastatic tumors varied depending on the organs with the primary lesion and histological types.
Impact of Weight Loss on Plasma Leptin and Adiponectin in Overweight-to-Obese Post Menopausal Breast Cancer Survivors

Women who are obese at the time of breast cancer diagnosis have higher overall mortality than normal weight women and some evidence implicates adiponectin and leptin as contributing to prognostic disadvantage. While intentional weight loss is thought to improve prognosis, its impact on these adipokines is unclear. This study compared the pattern of change in plasma leptin and adiponectin in overweight-to-obese post-menopausal breast cancer survivors during weight loss. Given the controversies about what dietary pattern is most appropriate for breast cancer control and regulation of adipokine metabolism, the effect of a low fat versus a low carbohydrate pattern was evaluated using a non-randomized, controlled study design. Anthropometric data and fasted plasma were obtained monthly during the six-month weight loss intervention. While leptin was associated with fat mass, adiponectin was not, and the lack of correlation between leptin and adiponectin concentrations throughout weight loss implies independent mechanisms of regulation. The temporal pattern of change in leptin but not adiponectin was affected by magnitude of weight loss. Dietary pattern was without effect on either adipokine. Mechanisms not directly related to dietary pattern, weight loss, or fat mass appear to play dominant roles in the regulation of circulating levels of these adipokines.
Valid comparisons and decisions based on clinical registers and population based cohort studies: assessing the accuracy, completeness and epidemiological relevance of a breast cancer query database

Data accuracy and completeness are crucial for ensuring both the correctness and epidemiological relevance of a given data set. In this study we evaluated a clinical register in the administrative district of Marburg-Biedenkopf, Germany, for these criteria. The register contained data gathered from a comprehensive integrated breast-cancer network from three hospitals that treated all included incident cases of malignant breast cancer in two distinct time periods from 1996–97 (N=389) and 2003–04 (N=488). To assess the accuracy of this data, we compared distributions of risk, prognostic, and predictive factors with distributions from established secondary databases to detect any deviations from these “true” population parameters. To evaluate data completeness, we calculated epidemiological standard measures as well as incidence-mortality-ratios (IMRs). In total, 12% (13 of 109) of the variables exhibited inaccuracies: 9% (5 out of 56) in 1996–97 and 15% (8 out of 53) in 2003–04. In contrast to raw, unstandardized incidence rates, (in-) directly age-standardized incidence rates showed no systematic deviations. Our final completeness estimates were IMR=36% (1996–97) and IMR=43% (2003–04). Overall, the register contained accurate, complete, and correct data. Regional differences accounted for detected inaccuracies. Demographic shifts occurred. Age-standardized measures indicate an acceptable degree of completeness. The IMR method of measuring completeness was inappropriate for incidence-based data registers. For the rising number of population-based health-care networks, further methodological advancements are necessary. Correct and epidemiologically relevant data are crucial for clinical and health-policy decision-making.
Cases of Psychiatric Morbidity in Pediatric Patients After Remission of Cushing Syndrome.

Endogenous Cushing syndrome (CS) may have different effects in children than what has been described in adults. Previous studies of children and adolescents with CS have identified cognitive decline despite reversal of brain atrophy after remission of CS. Although the observations of parents of children and adolescents with CS support personality changes, significant psychopathology has not been described in the literature. We report 9 children who underwent successful surgery (transsphenoidal surgery [TSS] or resection of bronchial carcinoid) for treatment of CS and subsequently developed significant affective pathology. Affective symptoms included anger-rage outbursts, suicidal ideation, irritability, anxiety, and depression. One child, who committed suicide 60 months after TSS, had recently discontinued antidepressant medication. She had a history of anxiety during active CS and was treated with an anxiolytic. The 7 patients with onset of symptoms within 7 months of TSS were on glucocorticoid replacement, and 1-year follow-up evaluation showed recovery of hypothalamic-pituitary-adrenal axis and biochemical evidence of remission. The 2 patients who presented with onset of symptoms at 48 months or later underwent endocrine evaluation that showed biochemical evidence of remission and normal anterior pituitary hormone levels. This is the first report of affective symptoms and behavioral dysregulation, including suicidal ideation, in a subgroup of children and adolescents after remission of CS. Health care providers caring for children with CS who have been cured should continue to screen for mental illness, monitor for changes in behavior, and refer as appropriate to mental health professionals.
Recanalization of symptomatic vertebral ostial occlusion in patients with acute or subacute stroke.

Vertebral artery recanalization in symptomatic stenosis/occlusion remains controversial, as no definite evidence exists regarding this topic. There are only a few reports regarding the feasibility and safety of recanalization in the first segment of the vertebral artery with atherosclerotic vertebral ostial occlusion. We report our experience treating first segment occlusion in 8 patients and present a balloon protection technique used to reduce the thromboembolic burden during the stent placement procedure. The outcome at 3 months showed an mRS ≤2 except for a patient with a poor initial status with basilar artery occlusion. Revascularization of a rather long first segment occlusion is technically feasible and can be safely performed by use of embolic protection methods.
Comparison of intraarterial and intravenous thrombolysis for ischemic stroke with hyperdense middle cerebral artery sign.

It is unclear whether intraarterial (IAT) or intravenous (IVT) thrombolysis is more effective for ischemic stroke with hyperdense middle cerebral artery sign (HMCAS) on computed tomography (CT). The aim of this study was to compare IAT and IVT in stroke patients with HMCAS.



Comparison of data from 2 stroke units with similar management of stroke associated with HMCAS, except that 1 unit performed IAT with urokinase and the other IVT with plasminogen activator. Time to treatment was up to 6 hours for IAT and up to 3 hours for IVT. Outcome was measured by mortality and the modified Rankin Scale (mRS), dichotomized at 3 months into favorable (mRS 0 to 2) and unfavorable (mRS 3 to 6).



One hundred twelve patients exhibited a HMCAS, 55 of 268 patients treated with IAT and 57 of 249 patients who underwent IVT. Stroke severity at baseline and patient age were similar in both groups. Mean time to treatment was longer in the IAT group (244+/-63 minutes) than in the IVT group (156+/-21 minutes; P=0.0001). However, favorable outcome was more frequent after IAT (n=29, 53%) than after IVT (n=13, 23%; P=0.001), and mortality was lower after IAT (n=4, 7%) than after IVT (n=13, 23%; P=0.022). After multiple regression analysis IAT was associated with a more favorable outcome than IVT (P=0.003) but similar mortality (P=0.192).



In this observational study intraarterial thrombolysis was more beneficial than IVT in the specific group of stroke patients presenting with HMCAS on CT, even though IAT was started later. Our results indicate that a randomized trial comparing both thrombolytic treatments in patients with middle cerebral artery occlusion is warranted.
Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma

Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients.



Patients with moderate asthma (age ≥ 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of ≥ 12% and ≥ 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for ≥ 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 μg OD, FF or FP 100 μg BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 μg OD and FF 100 μg BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed.



The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 μg OD to be non-inferior (pre-defined limit -110 ml) to FF 100 μg BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p ≤ 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 μg OD, 0.75; 100 μg BD, 0.84; p ≤ 0.02).



FF 200 μg OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.
Patterns of circadian activity rhythms and their relationships with fatigue and anxiety/depression in women treated with breast cancer adjuvant chemotherapy

The purpose of this study was to examine patterns of circadian activity rhythms and their relationship with fatigue, anxiety/depression, and demographic/medical variables in women receiving breast cancer adjuvant therapy treatments (Tx) at three times within a randomized clinical trial (RCT) designed to improve sleep and modify fatigue. A RCT enrolled 219 women with stage I–IIIA breast cancer who were randomized 2 days prior to starting chemotherapy to a behavioral therapy sleep intervention or healthy eating control group. All cases with available data (n = 190) were included in a descriptive, correlational, repeated measures analysis. Activity data were collected continuously by wrist actigraphy for 7 days at three times: the start (Tx 1), continuation (Tx 3), and recovery (30 days after last Tx) of chemotherapy. Circadian activity rhythm parameters were generated using Action4 software (Ambulatory Monitoring, Inc.). Measures collected simultaneously included Piper Fatigue Scale, Hospital Anxiety and Depression Scale, and demographic/medical variables. Circadian activity rhythm parameters at three times in both groups were disrupted compared to healthy adults, but similar to values of cancer patients. Significant changes in mesor, amplitude, peak activity, and 24 h autocorrelation values were found over time in both groups. The intervention group’s amplitude and circadian quotient values were significantly more robust. More robust activity rhythms were associated with lower fatigue, depressive symptoms, body mass index, and higher performance status in both groups. Disrupted patterns of circadian activity rhythms were prevalent and associated with distressing fatigue and depressive symptoms during chemotherapy and at recovery. The intervention resulted in more robust rhythms.
Treatment Interruption after Pregnancy: Effects on Disease Progression and Laboratory Findings

To assess clinical progression and inflammatory markers among women stopping or continuing antiretroviral therapy (ART) after pregnancy.



ART-naïve women with CD4+ lymphocyte counts >350 cells/uL initiating ART during pregnancy had clinical events and laboratory markers compared over one year postpartum between those stopping (n = 59) or continuing (n = 147) ART.



Slopes in CD4 count and HIV RNA did not differ between groups overall and in subsets of ZDV or combination therapy. The hazard ratio (HR) of a new class B event was 2.09 (95% CI 0.79-5.58) among women stopping ART, 1.24 (0.31-4.95) in those stopping ZDV, and 2.93 (0.64-13.36) among those stopping combination therapy. Women stopping ART had increased immune activation. No significant differences were seen in C-reactive protein, lipids, leptin, or interleukin-6.



While changes in CD4 and HIV RNA levels over one year were similar between women stopping or continuing ART postpartum, higher immune activation among women stopping therapy requires further study.