nils-herrmann/clean_scirepeval huggingface dataset:
Inter-rater reliability of select physical examination procedures in patients with neck pain.

This study evaluated the inter-rater reliability of select examination procedures in patients with neck pain (NP) conducted over a 24- to 48-h period. Twenty-two patients with mechanical NP participated in a standardized examination. One examiner performed standardized examination procedures and a second blinded examiner repeated the procedures 24-48 h later with no treatment administered between examinations. Inter-rater reliability was calculated with the Cohen Kappa and weighted Kappa for ordinal data while continuous level data were calculated using an intraclass correlation coefficient model 2,1 (ICC2,1). Coefficients for categorical variables ranged from poor to moderate agreement (-0.22 to 0.70 Kappa) and coefficients for continuous data ranged from slight to moderate (ICC2,1 0.28-0.74). The standard error of measurement for cervical range of motion ranged from 5.3° to 9.9° while the minimal detectable change ranged from 12.5° to 23.1°. This study is the first to report inter-rater reliability values for select components of the cervical examination in those patients with NP performed 24-48 h after the initial examination. There was considerably less reliability when compared to previous studies, thus clinicians should consider how the passage of time may influence variability in examination findings over a 24- to 48-h period.
Oxygenation With a Single Portable Pulse-Dose Oxygen-Conserving Device and Combined Stationary and Portable Oxygen Delivery Devices in Subjects With COPD.

Portable oxygen devices simplify and facilitate patient therapy. This study was designed to compare S(pO2) and patient satisfaction with a portable oxygen concentrator or a combined system consisting of a fixed device with continuous-flow oxygen dispensation and a portable device with pulse dispensation for ambulation.



This crossover trial assessed 25 subjects with COPD (92% men, mean age of 72.2 ± 7.4 y, mean FEV1 of 34.14 ± 12.51% of predicted) at 4 hospitals in Madrid. All subjects had previously used the combined system, consisting of a fixed oxygenation system and a portable system for ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while walking were determined at baseline. Subjects were maintained on the previous combined system for 1 week and then switched to the portable oxygen concentrator for 1 week. Mean S(pO2) over 24 h was calculated using the software in the oximeter, and compliance was monitored (Visionox).



Low S(pO2) (< 90%) was significantly more frequent during use of the portable concentrator alone than with the combined system (37.1% vs 18.4%, P < .05). The portable system alone was preferred by 43% of subjects, and the combined system was preferred by 36%, whereas 21% were not sure.



Subjects preferred using a single portable oxygenation system both at home and during ambulation. Portable systems alone, however, did not supply the same levels of oxygenation as the combination of fixed and portable systems. Before the widespread adoption of portable systems as a single device, additional studies are needed to determine best-practice protocols for adjustment of daytime and nighttime oxygenation settings.
Continuous Hemodynamic Monitoring in Acute Stroke: An Exploratory Analysis

Non-invasive, continuous hemodynamic monitoring is entering the clinical arena. The primary objective of this study was to test the feasibility of such monitoring in a pilot sample of Emergency Department (ED) stroke patients. Secondary objectives included analysis of hemodynamic variability and correlation of continuous blood pressure measurements with standard measurements.



This study was a secondary analysis of 7 stroke patients from a prospectively collected data set of patients that received 2 hours of hemodynamic monitoring in the ED. Stroke patients were included if hemorrhagic or ischemic stroke was confirmed by neuroimaging, and symptom onset was within 24 hours. They were excluded for the presence of a stroke mimic or transient ischemic attack. Monitoring was performed using the Nexfin device (Edwards Lifesciences, Irvine CA).



The mean age of the cohort was 71 ± 17 years, 43% were male, and the mean National Institute of Health Stroke Scale (NIHSS) was 6.9 ± 5.5. Two patients had hemorrhagic stroke. We obtained 42,456 hemodynamic data points, including beat-to-beat blood pressure measurements with variability of 18 mmHg and cardiac indices ranging from 1.8 to 3.6 l/min/m2. The correlation coefficient between continuous blood pressure measurements with the Nexfin device and standard ED readings was 0.83.



This exploratory investigation revealed that continuous, noninvasive monitoring in the ED is feasible in acute stroke. Further research is currently underway to determine how such monitoring may impact outcomes in stroke or replace the need for invasive monitoring.
A randomized, double-blind, placebo-controlled clinical trial using a low-frequency magnetic field in the treatment of musculoskeletal chronic pain.

Exposure to a specific pulsed electromagnetic field (PEMF) has been shown to produce analgesic (antinociceptive) effects in many organisms. In a randomized, double-blind, sham-controlled clinical trial, patients with either chronic generalized pain from fibromyalgia (FM) or chronic localized musculoskeletal or inflammatory pain were exposed to a PEMF (400 microT) through a portable device fitted to their head during twice-daily 40 min treatments over seven days. The effect of this PEMF on pain reduction was recorded using a visual analogue scale. A differential effect of PEMF over sham treatment was noticed in patients with FM, which approached statistical significance (P=0.06) despite low numbers (n=17); this effect was not evident in those without FM (P=0.93; n=15). PEMF may be a novel, safe and effective therapeutic tool for use in at least certain subsets of patients with chronic, nonmalignant pain. Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted.
99mTc-sestamibi using a direct conversion molecular breast imaging system to assess tumor response to neoadjuvant chemotherapy in women with locally advanced breast cancer.

The objective of this study was to determine the ability of breast imaging with 99mTc-sestamibi and a direct conversion-molecular breast imaging (MBI) system to predict early response to neoadjuvant chemotherapy (NAC).



Patients undergoing NAC for breast cancer were imaged with a direct conversion-MBI system before (baseline), at 3 to 5 weeks after onset, and after completion of NAC. Tumor size and tumor-to-background (T/B) uptake ratio measured from MBI images were compared with extent of residual disease at surgery using the residual cancer burden.



Nineteen patients completed imaging and proceeded to surgical resection after NAC. Mean reduction in T/B ratio from baseline to 3 to 5 weeks for patients classified as RCB-0 (no residual disease), RCB-1 and RCB-2 combined, and RCB-3 (extensive residual disease) was 56% (SD, 0.20), 28% (SD, 0.20), and 4% (SD, 0.15), respectively. The reduction in the RCB-0 group was significantly greater than in RCB-1/2 (P = 0.036) and RCB-3 (P = 0.001) groups. The area under the receiver operator characteristic curve for determining the presence or absence of residual disease was 0.88. Using a threshold of 50% reduction in T/B ratio at 3 to 5 weeks, MBI predicted presence of residual disease at surgery with a diagnostic accuracy of 89.5% (95% confidence interval [CI], 0.64%-0.99%), sensitivity of 92.3% (95% CI, 0.74%-0.99%), and specificity of 83.3% (95% CI, 0.44%-0.99%). The reduction in tumor size at 3 to 5 weeks was not statistically different between RCB groups.



Changes in T/B ratio on MBI images performed at 3 to 5 weeks following initiation of NAC were accurate at predicting the presence or absence of residual disease at NAC completion.
Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned

Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.



Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.



Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.



We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.
Benzhexol and side effects with long-acting fluphenazine therapy.

Sixteen patients who had for some months been on fluphenazine enanthate injections (1-3 ml) every two or three weeks, with daily oral benzhexol (6-40 mg), were divided into two groups comparable in age, diagnostic category, and drug dose.Placebo was substituted under blind controlled conditions for benzhexol in one group, and both groups were regularly assessed by Simpson rating scale for extra-pyramidal signs, and by a 30-question symptom check list. Both assessments were found reliable.Four out of eight patients had severe reactions when off benzhexol, but symptoms such as tremor and daytime sleepiness were unaltered in all patients. The other four did not suffer adversely from withdrawal of benzhexol.Acute withdrawal is therefore unjustified, but occasional revision of dosage of anti-Parkinsonian drugs is advisable. There is no evidence that tolerance develops to any effect of a phenothiazine, but long-continued benzhexol might induce a denervation supersensitivity. It is also possible that Parkinsonian signs are dependent on affective state.
Effects of an Internet-Based Intervention for HIV Prevention: The Youthnet Trials

Youth use the Internet and computers in unprecedented numbers. We have yet to identify interventions that can reach and retain large numbers of diverse youth online and demonstrate HIV prevention efficacy. We tested a single session condom promotion Internet intervention for 18–24 year olds in two RCTs: one sample recruited online and one recruited in clinics. All study elements were carried out on the Internet. Using repeated measures structural equation models we analyzed change in proportion of sex acts protected by condoms (PPA) over time. Among sexually active youth in the Internet sample, persons exposed to the intervention had very slight increases in condom norms, and this was the only factor impacting PPA. We saw no intervention effects in the clinic sample. Internet-based interventions need to be more intensive to see greater effects. We need to do more to reach high risk youth online and keep their attention for multiple sessions.
Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study

The aim of this study was to evaluate short-term safety and tolerability of fingolimod in a real-world population with relapsing multiple sclerosis, focusing on cardiac safety during treatment initiation. Patients received fingolimod 0.5 mg once daily for four months. Patients excluded from the pivotal studies with certain pre-existing cardiac conditions or baseline cardiac findings (PCCs), and those receiving beta blockers (BBs) and/or calcium channel blockers (CCBs), were eligible. Heart rate (HR) and electrical conduction events were monitored using ambulatory electrocardiography for at least 6 h after the first dose. Of 2,417 enrolled patients, 2,282 (94.4 %) completed the study. Fingolimod initiation was associated with a transient, mostly asymptomatic decrease in HR. Bradycardia adverse events occurred in 0.6 % of patients and were more frequent in individuals receiving BBs/CCBs (3.3 %) than in other patient subgroups (0.5–1.4 %); most events were asymptomatic, and all patients recovered without pharmacological intervention. In the 6 h post-dose, the incidences of Mobitz type I second-degree atrioventricular block (AVB) and 2:1 AVB were higher in patients with PCCs (4.1 and 2.0 %, respectively) than in those without (0.9 and 0.3 %, respectively); at pre-dose screening, patients with PCCs had the same incidence of Mobitz type I second-degree AVB (4.1 %) and a slightly lower incidence of 2:1 AVB (0.7 %) than 6 h post-dose. All recorded conduction abnormalities were asymptomatic. This study adds to the evidence showing that cardiac effects during fingolimod initiation remain consistent with those known from previous, controlled studies, even if patients with PCCs are included.
Clevudine demonstrates potent antiviral activity in naïve chronic hepatitis B patients.

Clevudine has demonstrated antiviral potency in the treatment of naïve chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients.



This is a post-marketing surveillance using case report forms which were submitted to the health authorities.



Analysis of individual data showed that hepatitis B virus (HBV) DNA after a 1-year treatment was <141,500 copies/ml in 96% of hepatitis B e antigen (HBeAg)-positive and 100% of HBeAg-negative patients. The proportion of patients with HBV DNA <2,000 copies/ml after a 1-year treatment was 74%: 71% of HBeAg-positive and 93% of HBeAg-negative patients. Most of the patients with HBV DNA below the detection limit with each assay at week 24 showed sustained viral suppression up to week 48. The proportion of patients who showed normal alanine aminotransferase at week 48 was 86% in HBeAg-positive patients and 87% in HBeAg-negative patients. The rates of HBeAg-loss were 21%. Two patients showed viral breakthrough during treatment.



Clevudine monotherapy demonstrates potent antiviral activity as well as biochemical and serological response with a 0.7% rate of viral breakthrough in naïve chronic hepatitis B patients.
Do frequent moderate exacerbations contribute to progression of chronic obstructive pulmonary disease in patients who are ex-smokers?

In addition to smoking, acute exacerbations are considered to be a contributing factor to progression of chronic obstructive pulmonary disease (COPD). However, these findings come from studies including active smokers, while results in ex-smokers are scarce and contradictory. The purpose of this study was to evaluate if frequent acute moderate exacerbations are associated with an accelerated decline in forced expiratory volume in one second (FEV1) and impairment of functional and clinical outcomes in ex-smoking COPD patients.



A cohort of 100 ex-smoking patients recruited for a 2-year follow-up study was evaluated at inclusion and at 6-monthly scheduled visits while in a stable condition. Evaluation included anthropometry, spirometry, inspiratory capacity, peripheral capillary oxygen saturation, severity of dyspnea, a 6-minute walking test, BODE (Body mass index, airflow Obstruction, Dyspnea, Exercise performance) index, and quality of life (St George's Respiratory Questionnaire and Chronic Respiratory Disease Questionnaire). Severity of exacerbation was graded as moderate or severe according to health care utilization. Patients were classified as infrequent exacerbators if they had no or one acute exacerbation/year and frequent exacerbators if they had two or more acute exacerbations/year. Random effects modeling, within hierarchical linear modeling, was used for analysis.



During follow-up, 419 (96% moderate) acute exacerbations were registered. At baseline, frequent exacerbators had more severe disease than infrequent exacerbators according to their FEV1 and BODE index, and also showed greater impairment in inspiratory capacity, forced vital capacity, peripheral capillary oxygen saturation, 6-minute walking test, and quality of life. However, no significant difference in FEV1 decline over time was found between the two groups (54.7±13 mL/year versus 85.4±15.9 mL/year in frequent exacerbators and infrequent exacerbators, respectively). This was also the case for all other measurements.



Our results suggest that frequent moderate exacerbations do not contribute to accelerated clinical and functional decline in COPD patients who are ex-smokers.
Validation of immunocytochemistry as a morphomolecular technique.

Immunocytochemistry (ICC) is a long-established means for clinical laboratories to investigate material for which it is difficult to obtain tissue samples. Unlike immunohistochemistry (IHC), the cells do not retain surrounding tissue environment/architecture. This can be of benefit in that fixation is often immediate and rapid, protecting the cells. Although fixation is frequently observed as the main preanalytic variable of test quality, all cytology preanalytic factors should be identified and controlled. In addition, the validation of ICC should take the same rigorous approach that other molecular pathology techniques follow. A three-step validation protocol is offered here. The end result is a comprehensive, morphomolecular approach to ICC, with an emphasis on therapeutic ICC. Cancer Cytopathol 2016;124:540-5.
Aspirin treatment influences platelet-related inflammatory biomarkers in healthy individuals but not in acute stroke patients.

Platelet-leukocyte aggregation is believed to contribute to acute thrombotic events. While the effect of aspirin on platelet-to-platelet aggregation is well established, the impact of the drug on pro-inflammatory platelet function remains equivocal. Thus we investigated the effect of aspirin on selected platelet-related inflammatory biomarkers in both acute ischaemic stroke patients and healthy volunteers.



Using five-colour flow cytometry the platelet surface expression of CD62P and CD40L and subpopulations of leukocyte-platelet aggregates were assessed in 63 acute stroke patients and 40 healthy volunteers at baseline and after a 10-day period of aspirin intake at a daily dose of 150 mg. Simultaneously the plasma levels of soluble CD62P and CD40L, serum level of TxB(2), and whole blood impedance platelet aggregation under arachidonic acid (AA) stimulation were investigated.



No differences in values of studied platelet-related inflammatory biomarkers in both resting platelets and those activated with TRAP after 10-day treatment with aspirin were confirmed in stroke subjects. In healthy individuals the resting platelet expression of CD62P, plasma level of soluble CD62P and percentage of circulating monocyte-platelet aggregates were lower after the aspirin intake period (P=0.009; P=0.04; P=0.004, respectively). In both studied groups serum level of TxB(2) and platelet aggregation under AA stimulation were lower than before treatment (P<0.001).



Despite effective inhibition of COX-1-dependent platelet aggregation, aspirin does not influence the platelet α-granule-derived inflammatory mediators and monocyte-platelet aggregation in acute stroke subjects, although it does in healthy individuals.
A controlled clinical trial on the effects of motor intervention on balance and cognition in institutionalized elderly patients with dementia.

To analyse the effects of two interventions on the cognition and balance of institutionalized elderly people with mixed dementia.



Fifty-four participants were allocated into three groups. Group 1 was assisted by an interdisciplinary programme comprising physiotherapy, occupational therapy and physical education. A physiotherapist alone carried out the intervention in group 2. Group 3 was considered as control. Assessors were blinded to guarantee the absence of bias. Cognitive functions were analysed with the Mini-Mental State Examination and the Brief Cognitive Screening Battery. Balance was assessed with the Berg Balance Scale and the Timed Get-Up-and-Go Test. Multiple analysis of variance (MANOVA) was used to test possible main effects of the interventions.



The results showed benefits on the balance of subjects in both groups 1 (F=3.9, P<0.05) and 2 (F=3.1, P<0.05), compared with group 3. MANOVA did not indicate benefits on the cognitive functions between groups 1 and 3 (F=1.1, P>0.05) and groups 2 and 3 (F=1.6, P>0.05). However, univariate analysis indicated some benefits of the interdisciplinary intervention on two specific domains measured by the Brief Cognitive Screening Battery (F=26.5, P<0.05;  P<0.05).



Six months of multidisciplinary or physiotherapeutic intervention were able to improve a person's balance. Although global cognition did not improve through treatment, when the intervention was carried out on a multidisciplinary basis we observed an attenuation in the decline of global cognition on two specific cognitive domains. Exercises applied in different contexts may have positive outcomes for people with dementia.