nils-herrmann/clean_scirepeval huggingface dataset:
Semantics of the placebo

With increased interest in the placebo effect and clinical methodology, definitions of the placebo have proliferated. But there is little agreement among lexicographers, historians, clinicians, and researchers about how to define this word. Derivations of the wordplacebo from the Hebrew and Latin and its use in the Bible and literature were reviewed. Historical inaccuracies in classical references to the placebo's origin, history, and development were corrected. An explanation was given for the introduction of the word in 1785, and for the changes in definition that have appeared since that time. Definitions of the placebo and placebo effect, based on historic considerations and heuristic principles, were then proposed.
Bronchodilator effects of exercise hyperpnea and albuterol in mild-to-moderate asthma.

In asthmatic patients, either bronchodilatation or bronchoconstriction may develop during exercise. In 18 patients with mild-to-moderate asthma, we conducted two studies with the aims to 1) quantify the bronchodilator effect of hyperpnea induced by incremental-load maximum exercise compared with effects of inhaled albuterol (study 1, n=10) and 2) determine the time course of changes in airway caliber during prolonged constant-load exercise (study 2, n=8). In both studies, it was also investigated whether the bronchodilator effects of exercise hyperpnea and albuterol are additive. Changes in airway caliber were measured by changes in partial forced expiratory flow. In study 1, incremental-load exercise was associated with a bronchodilatation that was approximately 60% of the maximal bronchodilatation obtainable with 1,500 microg of albuterol. In study 2, constant-load exercise was associated with an initial moderate bronchodilatation and a late airway renarrowing. In both studies, premedication with inhaled albuterol (400 microg) promoted sustained bronchodilatation during exercise, which was additive to that caused by exercise hyperpnea. In conclusion, in mild-to-moderate asthmatic individuals, hyperpnea at peak exercise was associated with a potent yet not complete bronchodilatation. During constant-load exercise, a transient bronchodilatation was followed by airway renarrowing, suggesting prevalence of constrictor over dilator effects of hyperpnea. Finally, the bronchodilator effect of hyperpnea was additive to that of albuterol.
Skin Thickness in Children Treated With Daily or Periodical Inhaled Budesonide for Mild Persistent Asthma. The Helsinki Early Intervention Childhood Asthma Study

In adults, asthma treatment with high doses of inhaled corticosteroids has resulted in dermal thinning. The aim of this study was to investigate the skin thickness in children with asthma during budesonide treatment. In a double-blind study, 113 children, 5–10 y old, with persistent asthma received budesonide 400 μg twice daily for 1 mo and thereafter 200 μg twice daily for 5 mo. Thereafter, 56 children received 100 μg twice daily for 1 y, whereas 57 other children used budesonide periodically for exacerbations. An additional 54 children were treated with disodium cromoglycate (DSCG) for 18 mo. Skin thickness was measured on each forearm before and after treatment for 6, 12, and 18 mo using a 20-MHz high-resolution ultrasonic device. The initial 6-mo budesonide treatment resulted in a greater reduction in mean skin thickness in the forearms compared with DSCG (right: −35.9 versus −5.9 μm; p = 0.004; left: −30.6 versus −7.3 μm; p = 0.03). At month 18, the inter-group differences were no longer significant. Budesonide inhalations in daily doses of 400–800 μg in prepubertal children with newly detected asthma may cause minor dermal thinning. The changes were reversible during low dose or periodic treatment with budesonide.
Phase II study of oral bis (aceto) ammine dichloro (cyclohexamine) platinum (IV) (JM-216, BMS-182751) given daily x 5 in hormone refractory prostate cancer (HRPC)

JM-216 is an orally bioavailable platinum compound with activity against many tumor models. The objective of this study was to determine the safety profile and anti-tumor activity of JM-216 in patients with hormone refractory prostate cancer (HRPC) when given orally daily × 5 days. In this open label phase II study JM-216 was administered orally at the dose of 120 mg/m2/d for 5 days every 4 weeks. Patients continued on the therapy until evidence of disease progression or intolerable toxicity developed. Dose escalation and de-escalation were allowed according to patient's tolerance. Thirty-nine patients were enrolled onto the study and received a total of 155 courses (median 2, range 1–16) of JM-216. Dose delays (77% of courses) and dose reductions (31% of courses) were common and were mainly due to myelosupression. Treatment was discontinued in 5 patients due to treatment related toxicities. One patient developed myelodysplastic syndrome 11 months after the start of treatment. The most frequent grade III or higher adverse events included thrombocytopenia (54%), neutropenia (52%), anemia (24%) nausea (13%), vomiting (16%) and diarrhea (28%). PSA response was assessed in 32 patients, 10 (26%) had partial response, 14 (36%) had stable disease while PSA progression was seen in 8 (21%) patients. Of 20 (54%) patients with measurable disease two patients had a documented partial response. Although JM-216 had moderate activity in HRPC when given on daily basis for 5 days, it is associated with significant treatment related toxicities in this patient population.
Stress Testing of an Artificial Pancreas System With Pizza and Exercise Leads to Improvements in the System's Fuzzy Logic Controller.

Under controlled conditions, the Dose Safety artificial pancreas (AP) system controller, which utilizes "fuzzy logic" (FL) methodology to calculate and deliver appropriate insulin dosages based on changes in blood glucose, successfully managed glycemic excursions. The aim of this study was to show whether stressing the system with pizza (high carbohydrate/high fat) meals and exercise would reveal deficits in the performance of the Dose Safety FL controller (FLC) and lead to improvements in the dosing matrix.



Ten subjects with type 1 diabetes (T1D) were enrolled and participated in 30 studies (17 meal, 13 exercise) using 2 versions of the FLC. After conducting 13 studies with the first version (FLC v2.0), interim results were evaluated and the FLC insulin-dosing matrix was modified to create a new controller version (FLC v2.1) that was validated through regression testing using v2.0 CGM datasets prior to its use in clinical studies. The subsequent 17 studies were performed using FLC v2.1.



Use of FLC v2.1 vs FLC v2.0 in the pizza meal tests showed improvements in mean blood glucose (205 mg/dL vs 232 mg/dL, P = .04). FLC v2.1 versus FLC v2.0 in exercise tests showed improvements in mean blood glucose (146 mg/dL vs 201 mg/dL, P = .004), percentage time spent >180 mg/dL (19.3% vs 46.7%, P = .001), and percentage time spent 70-180 mg/dL (80.0% vs 53.3%, P = .002).



Stress testing the AP system revealed deficits in the FLC performance, which led to adjustments to the dosing matrix followed by improved FLC performance when retested.
A phase-specific psychological therapy for people with problematic cannabis use following a first episode of psychosis: a randomized controlled trial.

Cannabis use is high amongst young people who have recently had their first episode of psychosis, and is associated with worse outcomes. To date, interventions to reduce cannabis consumption have been largely ineffective, and it has been suggested that longer treatment periods are required.



In a pragmatic single-blind randomized controlled trial 110 participants were randomly allocated to one of three conditions: a brief motivational interviewing and cognitive behavioural therapy (MI-CBT) intervention (up to 12 sessions over 4.5 months) with standard care from an early intervention service; a long MI-CBT intervention (up to 24 sessions over 9 months) with standard care; or standard care alone. The primary outcome was change in cannabis use as measured by Timeline Followback.



Neither the extended nor the brief interventions conferred benefit over standard care in terms of reductions in frequency or amount of cannabis use. Also the interventions did not result in improvements in the assessed clinical outcomes, including symptoms, functioning, hospital admissions or relapse.



Integrated MI and CBT for people with cannabis use and recent-onset psychosis does not reduce cannabis use or improve clinical outcomes. These findings are consistent with those in the published literature, and additionally demonstrate that offering a more extended intervention does not confer any advantage. Many participants were not at an action stage for change and for those not ready to reduce or quit cannabis, targeting associated problems rather than the cannabis use per se may be the best current strategy for mental health services to adopt.
Neoadjuvant Radiochemotherapy Increases Matrix Metalloproteinase Activity in Healthy Tissue in Esophageal Cancer Patients

Neoadjuvant radiochemotherapy (RCT) is thought to result in a favorable oncological outcome in esophageal cancer patients. Unfortunately, it also implies that adjacent healthy tissue is preoperatively exposed to the potential damaging influence of RCT. Here, the impact of preoperative RCT on matrix metalloproteinase (MMP) expression in healthy esophageal tissue aligned with the tumor at the time of surgery is examined. 23 patients participating in a clinical trial were randomized to either the control (n = 12) or the neoadjuvant RCT group (n = 11). In the latter group, surgery was performed 5 weeks after the last course of RCT. Full-thickness biopsies were taken from healthy esophageal tissue at the proximal border of the resection specimen and more distally next to the tumor. MMP-2 and MMP-9 activity in the samples was assessed by quantitative gelatin zymography and immunohistochemistry. In the proximal segment, the activities of the MMP-9-dimer (135 kDa) and proMMP-9 (92 kDa) were significantly increased in the RCT group as compared with the control group: 28.5 versus 3.0 (p = 0.025) and 87.7 versus 13.0 (p = 0.015) arbitrary units for 135 kDa and 92 kDa, respectively. In the distal part, RCT resulted in a significant increase of proMMP-2 (72 kDa: 35.8 versus 17.8, p = 0.005) and proMMP-9 (81.2 versus 23.3, p = 0.03). In esophageal cancer patients, neoadjuvant RCT results in increased MMP expression in healthy esophageal tissue as measured at the time of surgery. Since increased levels of MMPs are associated with severe postoperative complications including anastomotic leakage this finding necessitates further clinical research.
Diagnostic criteria for generalized osteoarthritis: a preliminary study in a population with knee osteoarthritis.

nd major role for S. aureus, which was involved in 60% to 100% f cases in earlier studies [1–10]). Atypical organisms may be ound [1,4]. In our study, blood cultures assisted in the diagnois in only one-third of the patients with septic bursitis, whereas ulturing fluid aspirated from the bursa provided the diagnosis n 87% of cases. The similarities in the bacteriological and other esults of studies done over 30 years suggests stability of the feaures and risk factors of prepatellar and olecranon bursitis over ime.
Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial

To test whether offering financial incentives to patients with psychotic disorders is effective in improving adherence to maintenance treatment with antipsychotics.



Cluster randomised controlled trial.



Community mental health teams in secondary psychiatric care in the United Kingdom.



Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder, who were prescribed long acting antipsychotic (depot) injections but had received 75% or less of the prescribed injections. We randomly allocated 73 teams with a total of 141 patients. Primary outcome data were available for 35 intervention teams with 75 patients (96% of randomised) and for 31 control teams with 56 patients (89% of randomised).



Participants in the intervention group were offered £15 (€17; $22) for each depot injection over a 12 month period. Participants in the control condition received treatment as usual.



The primary outcome was the percentage of prescribed depot injections given during the 12 month intervention period.



73 teams with 141 consenting patients were randomised, and outcomes were assessed for 131 patients (93%). Average baseline adherence was 69% in the intervention group and 67% in the control group. During the 12 month trial period adherence was 85% in the intervention group and 71% in the control group. The adjusted effect estimate was 11.5% (95% confidence interval 3.9% to 19.0%, P=0.003). A secondary outcome was an adherence of ≥ 95%, which was achieved in 28% of the intervention group and 5% of the control group (adjusted odds ratio 8.21, 95% confidence interval 2.00 to 33.67, P=0.003). Although differences in clinician rated clinical improvement between the groups failed to reach statistical significance, patients in the intervention group had more favourable subjective quality of life ratings (β=0.71, 95% confidence interval 0.26 to 1.15, P=0.002). The number of admissions to hospital and adverse events were low in both groups and did not show substantial differences.



Offering modest financial incentives to patients with psychotic disorders is an effective method for improving adherence to maintenance treatment with antipsychotics.
The benefits of a simplified method for CPR training of medical professionals: a randomized controlled study.

We developed and tested a training method for basic life support incorporating defibrillator feedback during simulated cardiac arrest (CA) to determine the impact on the quality and retention of CPR skills.



298 subjects were randomized into 3 groups. All groups received a 2h training session followed by a simulated CA test scenario, immediately after training and at 3 months. Controls used a non-feedback defibrillator during training and testing. Group 1 was trained and tested with an audiovisual feedback defibrillator. During training, Group 1 reviewed quantitative CPR data from the defibrillator. Group 2 was trained as per Group 1, but was tested using the non-feedback defibrillator. The primary outcome was difference in compression depth between groups at initial testing. Secondary outcomes included differences in rate, depth at retesting, compression fraction, and self-assessment.



Groups 1 and 2 had significantly deeper compressions than the controls (35.3 ± 7.6 mm, 43.7 ± 5.8 mm, 42.2 ± 6.6 mm for controls, Groups 1 and 2, P=0.001 for Group 1 vs. controls; P=0.001 for Group 2 vs. controls). At three months, CPR depth was maintained in all groups but remained significantly higher in Group 1 (39.1 ± 9.9 mm, 47.0 ± 7.4 mm, 42.2 ± 8.4 mm for controls, Groups 1 and 2, P=0.001 for Group 1 vs. control). No significant differences were noted between groups in compression rate or fraction.



A simplified 2h training method using audiovisual feedback combined with quantitative review of CPR performance improved CPR quality and retention of these skills.
Psychometric properties of a prostate cancer radiation late toxicity questionnaire

To construct a short prostate cancer radiation late toxicity (PCRT) questionnaire with health-related quality-of-life (HRQoL) domains.



The PCRT was developed by item generation, questionnaire construction (n = 7 experts, n = 8 focus group patients), pilot testing (n = 37), item reduction (n = 100), reliability testing (n = 237), and validity testing (n = 274).



Reliability of the three item-reduced subscales demonstrated intraclass correlation coefficients (CC) of 0.811 (GU), 0.842 (GI), and 0.740 (sexual). Discriminant validity demonstrated Pearson CC of 0.449 (GU-GI), 0.200 (sexual-GU), and 0.09 (sexual-GI). Content validity correlations between PCRT-PCQoL were 0.35-0.78, PCRT-FACT-G(c) were 0.19-0.39, and PCRT-SF-36(R) were 0.03-0.34.



We successfully generated a PCRT HRQoL questionnaire including subscales with very good psychometric properties.
How patients choose acupuncturists: a mixed-methods project.

Patients can have difficulties choosing acupuncturists in the United Kingdom because acupuncturists are not all subject to statutory regulation. Research has identified factors that influence patients' choice of general practitioner. However, how patients choose acupuncturists has not been studied. The aim was to investigate how patients choose acupuncturists and to identify which factors might influence this choice.



A mixed-methods design used an exploratory qualitative study followed by a quantitative study. The qualitative study explored patients' experiences of acupuncture. The quantitative vignette study investigated the impact of patient gender and practitioner factors (gender, training location, and qualifications) on choice of acupuncturist.



In the qualitative study, 35 acupuncture patients (recruited through maximum variation sampling from seven clinics and the community) participated in semistructured interviews about their acupuncture experiences. In the quantitative study, 73 participants imagined wanting to consult an acupuncturist for back pain. They rated 8 fictional acupuncturists; ratings were analyzed using analysis of covariance.



Patients wanted qualified, personable acupuncturists and valued recommendations from trusted others. Without such recommendations, potential patients preferred female acupuncturists (F(1,69)=4.504, p<0.05) and those with medical qualifications (F(1,69)=44.832, p<0.01).



The decision to consult a particular acupuncturist is not straightforward. Acupuncturists' trustworthiness and technical competence are important to (potential) patients; practitioner gender also influenced preferences. Patients need to be informed about proposals concerning statutory regulation in CAM and its implications; conventional practitioners might be able to better support their patients wanting to consult acupuncturists.
Influence of ABCB-1 C3435T polymorphisms on plasma nevirapine and efavirenz levels and their effects on virologic and immunological outcomes in HIV/TB co-infected Thai adults under anti-retroviral therapy.

ATP-binding cassette, sub-family B (encoded by ABCB-1 or MDR-1) has an important role in cellular export of antiretroviral agents. A previous study showed that ABCB-1 C3435T polymorphism affects plasma efavirenz and nelfinavir concentrations and rate of CD4+ T cell recovery after starting antiretroviral treatment (ART). The present study examined the influence of ABCB-1 polymorphisms on plasma nevirapine and efavirenz levels when co-administered with rifampicin in 124 HIV/TB patients who received nevirapine- (400 mg/day) (n = 59) and efavirenz- (600 mg/day) (n = 65) based ART. ABCB-1 C3435T polymorphisms were genotyped using real-time PCR. CD4 T cell counts and HIV-1 viral RNA were evaluated in response to ART. The frequencies of CC, CT and TT genotypes of ABCB-1 C3435T polymorphism were 34% (n = 42), 55% (n = 68) and 12% (n = 14), respectively. Contrary to the previous report, no association was found among these genotypes and plasma drug concentrations at weeks 6 and 12 of ART and after rifampicin discontinuation. We also observed no differences in CD4+ T cell recovery rate among different ABCB-1 C3435T genotypes. In nevirapine group, however, all the patients with CT genotype achieved HIV-1 RNA levels of < 50 copies/ml, while 67% of those with TT and 95% with CC genotypes achieved < 50 copies/ml (p = 0.040). These data suggested that ABCB-1 C3435T polymorphisms do not affect plasma nevirapine and efavirenz concentrations in HIV/TB co-infected Thai patients or their immunological outcome, but had an effect on virologic outcome in the nevirapine-treated group.
Prevalence of ADHD in nonpsychotic adult psychiatric care (ADPSYC): A multinational cross-sectional study in Europe

Attention-deficit/hyperactivity disorder (ADHD) often persists into adulthood. This study was designed to estimate the prevalence of ADHD in adult psychiatric outpatients in several European countries.



ADHD diagnosis was made using the Diagnostic Interview for ADHD in Adults, version 2.0 (DIVA), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and 5th Edition (DSM-5).



Of 5662 patients present/approached, 2284 (40.3 %) consented, of whom 1986 patients (87.0 %) completed the study. Based on the DIVA, and applying DSM-IV-TR or DSM-5 criteria, 15.8 % (95 % confidence interval [CI] 14.2 %-17.4 %) or 17.4 % (95 % CI 15.7 %-19.0 %) of patients were diagnosed with ADHD, respectively. The prevalence of ADHD was 15.3 % when counting as non-ADHD those patients who screened positive but did not complete the DIVA (DSM-5).



Estimates from this study indicate that a relevant part of the psychiatric outpatient care population suffers from ADHD.
IL-17 mRNA in sputum of asthmatic patients: linking T cell driven inflammation and granulocytic influx?

The role of Th2 cells (producing interleukin (IL-)4, IL-5 and IL-13) in allergic asthma is well-defined. A distinct proinflammatory T cell lineage has recently been identified, called Th17 cells, producing IL-17A, a cytokine that induces CXCL8 (IL-8) and recruits neutrophils. Neutrophilic infiltration in the airways is prominent in severe asthma exacerbations and may contribute to airway gland hypersecretion, bronchial hyper-reactivity and airway wall remodelling in asthma.



to study the production of IL-17 in asthmatic airways at the mRNA level, and to correlate this with IL-8 mRNA, neutrophilic inflammation and asthma severity.



We obtained airway cells by sputum induction from healthy individuals (n = 15) and from asthmatic patients (n = 39). Neutrophils were counted on cytospins and IL-17A and IL-8 mRNA expression was quantified by real-time RT-PCR (n = 11 controls and 33 asthmatics).



Sputum IL-17A and IL-8 mRNA levels are significantly elevated in asthma patients compared to healthy controls. IL-17 mRNA levels are significantly correlated with CD3gamma mRNA levels in asthmatic patients and mRNA levels of IL-17A and IL-8 correlated with each other and with sputum neutrophil counts. High sputum IL-8 and IL-17A mRNA levels were also found in moderate-to-severe (persistent) asthmatics on inhaled steroid treatment.



The data suggest that Th17 cell infiltration in asthmatic airways links T cell activity with neutrophilic inflammation in asthma.