nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.

To demonstrate non-inferior/superior efficacy of flupirtine modified release (MR) compared with tramadol/placebo for the management of moderate to severe chronic low back pain (LBP).



Randomized, double-blind, active-/placebo-controlled double-dummy multicenter study, performed in 31 German study centers. LBP patients (n = 363) with moderate pain intensity were randomized 1:1:1 to receive flupirtine MR 400 mg, tramadol extended release (ER) 200 mg, or matching placebo (each given OD in the evening) over 4 weeks.



Primary endpoint was change from baseline in the LBP intensity index (LBPIX; 11-point NRS) at week 4; last observation carried forward was used to impute missing scores.



Least square (LS) mean ± SD LBPIX changes from baseline at week 4 were clinically significant for all three treatment groups of the intent-to-treat (ITT) and the per-protocol (PP) population (n = 326/276): placebo (n = 110/96): -1.81 ± 1.65/-1.77 ± 1.59; flupirtine MR (n = 109/95): -2.23 ± 1.73/-2.28 ± 1.68; and tramadol ER (n = 107/85): -1.92 ± 1.84/2.03 ± 1.83 (p < 0.001 for each). ITT/PP treatment effects for flupirtine MR were non-inferior when compared with tramadol ER and superior when compared with placebo (p = 0.003/0.033). Significantly more ITT patients treated with flupirtine MR (59.6/37.6 showed a ≥30/50% LBPIX relief in comparison to placebo (46.4/24.6%; p vs. flupirtine MR: 0.049/0.037). Treatment contrasts for tramadol failed to reach significance vs. placebo. Within the safety population (n = 355), flupirtine MR (n = 119) was associated with a significantly lower incidence of treatment emergent AEs (TEAEs; 21.0%) and TEAE-related study discontinuations (3.4%) than tramadol ER (n = 116; 34.5/12.0%; p = 0.039/0.017) and exhibited an overall safety/tolerability profile non-inferior to placebo (n = 120; 15.8/3.3%; p = ns for each). Major limitations of this study were the short treatment duration, the comparison of different drug classes and the lack of a titration phase.



The analgesic efficacy of flupirtine MR 400 mg OD was comparable to that of tramadol ER 200 mg OD and superior to that of placebo.
Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit.



We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. 
Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6.1, 95% CI 3.0-9.2, effect size d=1.9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0.3, 95% CI -2.0 to 2.6) and hallucinations (-1.9, -6.5 to 2.7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment.



Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences.



Research for Patient Benefit Programme, National Institute for Health Research.
Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial.

The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population.



The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair.



The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses.



Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF.



Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Evaluation of trifluperidol in chronic schizophrenia

Trifluperidol, a new butyrophenone compound, was evaluated in chronic schizophrenic women under conditions of a controlled clinical trial. Within this framework significant drug effects associated with the standard drug, chlorpromazine, attested to the sensitivity of the experiment, while trifluperidol, the experimental drug, was shown to be an antipsychotic agent at least equally as effective as the standard. The placebo group tended to deteriorate on all measures. This trend did not differ significantly from a similar trend in a group of subjects receiving neither placebo nor active treatment. The most likely explanation for this deterioration is thought to be an inadequate preliminary dry-out period, although other influences affecting all subjects adversely can not be ruled out. The demonstration of significant drug:placebo differences was dependent in part upon the presence of the negative change in the placebo group. Failure to include a control group in the present study would have precluded the demonstration of statistically significant drug effects.
Bronchodilator effect of terbutaline aerosol is not affected by propellant vapour pressure or dose volume

A randomized, blind cross-over study was carried out in 12 patients with bronchial asthma to determine whether the bronchodilating effect of a metered dose inhaler was influenced by increasing the metering volume from 25 µl to 50 µl, or by increasing the vapour pressure from 374 kPa to 502 kPa. Spirometry, heart rate and tremor were recorded 15 min after terbutaline sulphate 31 µg, 63 µg, 125 µg, 250 µg, 2×250 µg and 5×250 µg. There was no significant difference in any of the variables recorded i.e. in forced expiratory volume in one second, forced vital capacity or in airflows when 50% and 25% of the FVC remained to be exhaled from the total lung capacity. It is concluded that the bronchodilating effect of a β2-agonist from a metered dose inhaler is not substantially affected by changes in metering volume or vapor pressure within the limits studied.
Population-Based External Validation of the Updated 2012 Partin Tables in Contemporary North American Prostate Cancer Patients.

To externally validate the updated 2012 Partin Tables in contemporary North American patients treated with radical prostatectomy (RP) for localized prostate cancer (PCa) at community institutions.



We examined records of 25,254 patients treated with RP and pelvic lymph node dissection (PLND) between 2010 and 2013, within the surveillance, epidemiology, and end results database. The ROC derived AUC assessed discriminant properties of the updated 2012 Partin Tables of organ confined disease (OC), extracapsular extension (ECE), seminal vesical invasion (SVI), and lymph node invasion (LNI). Calibration plots focused on calibration between predicted and observed rates.



Proportions of OC, ECE, SVI, and LNI at RP were 69.8%, 18.4%, 7.4%, and 4.4%, respectively. Accuracy for prediction of OC, ECE, SVI, and LNI was 70.4%, 59.9%, 72.9%, and 77.1%, respectively. In subgroup analyses in patients with nodal yield >10, accuracy for LNI prediction was 76.0%. Subgroup analyses in elderly patients and in African American patients revealed decreased accuracy for prediction of all four endpoints. Last but not least, SVI and LNI calibration plots showed excellent agreement, versus good agreement for OC (maximum underestimation of 10%) and poor agreement for ECE (maximum overestimation of 12%).



Taken together, the updated 2012 Partin Tables can be unequivocally endorsed for prediction of OC, SVI, and LNI in community-based patients with localized PCa. Conversely, ECE predictions failed to reach the minimum accuracy requirements of 70%. Prostate 77:105-113, 2017.
Validity and responsiveness of the Michigan Hand Questionnaire in patients with rheumatoid arthritis: a multicenter, international study.

Millions of patients experience the disabling hand manifestations of rheumatoid arthritis (RA), yet few hand-specific instruments are validated in this population. Our objective was to assess the reliability, validity, and responsiveness of the Michigan Hand Questionnaire (MHQ) in patients with RA.



At enrollment and at 6 months, 128 RA patients with severe subluxation of the metacarpophalangeal joints completed the MHQ, a 37-item questionnaire with 6 domains: function, activities of daily living (ADL), pain, work, aesthetics, and satisfaction. Reliability was measured using Spearman's correlation coefficients between time periods. Internal consistency was measured using Cronbach's alpha. Construct validity was measured by correlating MHQ responses with the Arthritis Impact Measurement Scales 2 (AIMS2). Responsiveness was measured by calculating standardized response means (SRMs) between time periods.



The MHQ demonstrated good test-retest reliability (r = 0.66, P < 0.001). Cronbach's alpha scores were high for ADL (α = 0.90), function (α = 0.87), aesthetics (α = 0.79), and satisfaction (α = 0.89), indicating redundancy. The MHQ correlated well with AIMS2 responses. Function (r = -0.63), ADL (r = -0.77), work (r = -0.64), pain (r = 0.59), and summary score (r = -0.74) were correlated with the physical domain. Affect was correlated with ADL (r = -0.47), work (r = -0.47), pain (r = 0.48), and summary score (r = -0.53). Responsiveness was excellent among arthroplasty patients in function (SRM 1.42), ADL (SRM 0.89), aesthetics (SRM 1.23), satisfaction (SRM 1.76), and summary score (SRM 1.61).



The MHQ is easily administered, reliable, and valid to measure rheumatoid hand function, and can be used to measure outcomes in rheumatic hand disease.
The Natural Language of Interactive Systems

The work reported here stems from our deep belief that improved human engineering can add significantly to the acceptance and use of computer technology.
In particular, this report describes an experiment to test the hypothesis that certain features of natural language provide a useful guide for the human engineering of interactive command languages. The goal was to establish that a syntax employing familiar, descriptive, everyday words and well-formed English phrases contributes to a language that can be easily and effectively used. Users with varying degrees of interactive computing experience used two versions of an interactive text editor; one with an English-based command syntax in the sense described above, the other with a more notational syntax. Performance differences strongly favored the English-based editor.
Prevalence and associated factors of timely initiation of breastfeeding among mothers at Debre Berhan town, Ethiopia: a cross-sectional study

Timely initiation of breastfeeding is defined as putting the newborn to breast within one hour of birth. It serves as the starting point for continuum of care for the newborn health and development. In Ethiopia, there is a considerable variation on timely initiation of breastfeeding among regions. The main aim of this study was to determine prevalence rate and investigate factors associated with timely initiation of breastfeeding practice among mothers in Debre Berhan town, Ethiopia.



A community based cross-sectional study was conducted at Debre Berhan town from April 1 to 30, 2013. A total of 416 mothers who had given birth within the last six months were selected by using simple random sampling technique. Descriptive statistics, bivariable and multivariable logistic regression analysis were employed to identify factors associated with timely initiation of breastfeeding.



The prevalence rate of timely initiation of breastfeeding was 62.6 %. The odds of timely initiation of breastfeeding was high among mothers who have monthly income of greater than 1969 Ethiopian Birr (ETB) (adjusted odds ratio [AOR] 2.77; 95 % Confidence Interval [CI] 1.21, 6.32). Having extended family (AOR 0.5; 95 % CI 0.27, 0.95), not being counseled about timely initiation of breastfeeding during antenatal care (AOR 0.40; 95 % CI 0.18, 0.88), delivered by cesarean section (AOR 0.11; 95 % CI 0.04, 0.33), delivery attended by traditional birth attendants or relatives (AOR 0.22; 95 % CI 0.05, 0.87), and not feeding colostrum (AOR 0.07; 95 % CI 0.02, 0.23) were negatively associated with timely initiation of breastfeeding.



The practice of timely, also known as early, initiation of breastfeeding was suboptimal. Nearly 40 % of the mothers did not start breastfeeding within one hour after delivery. Findings suggest that in order to improve timely initiation of breastfeeding practice, interventions need to target mothers with extended family, poor socioeconomic status and caesarean delivery. Moreover, mothers who discard colostrum and those who do not deliver under the assistance of health care professional need attention and emphasis has to be given for the breastfeeding counseling service given at antenatal service outlets.
Frequency of oestrogen and progesterone receptor positivity by immunohistochemical analysis in 7016 breast carcinomas: correlation with patient age, assay sensitivity, threshold value, and mammographic screening.

A routine immunohistochemical (IHC) assay is now commonly used for determining the oestrogen receptor (ER) and progesterone receptor (PR) status of women with breast cancer. To date, no large studies have been conducted that report the expected frequency of receptor positivity in relation to patient age and sensitivity of the IHC assay. Data on 7016 breast carcinomas from 71 laboratories were analysed to determine the frequency of receptor positivity and investigate possible causes of the observed variation in detection rates.



Members of UK NEQAS-ICC (UK National External Quality Assessment Scheme for Immunocytochemistry) provided data on the receptor status of cases routinely assayed in their departments over a period of two to 26 months between June 1996 and September 1998. Data on 7016 breast carcinomas were stratified according to patient age and receptor status. Frequency of receptor positivity was correlated with IHC assay sensitivity, the threshold value used to determine receptor positivity, and the presence or absence of mammographic screening in the hospitals or clinics served by the laboratories.



The highest proportion of receptor positive cases occurred in patients in the age ranges > 65 years for ER and 41-50 years for PR. There was a significant positive correlation between frequency of receptor positivity and the sensitivity of the IHC assay, for both ER (rs = 0.346; p = 0.019; two tailed) and PR (rs = 0.561; p = 0.003; two tailed). The mean frequency of receptor positivity for laboratories using the same 10% threshold value was 77% for ER (95% confidence interval (CI), 74% to 80%) in laboratories with high sensitivity and 72% (95% CI, 68% to 76%) for those with low assay sensitivity (p = 0.025). For PR, the mean frequency of receptor positivity for laboratories using the same 10% threshold value and having high assay sensitivity was 63% (95% CI, 57% to 69%), and 51% (95% CI, 38% to 65%) for laboratories with assays of low sensitivity (p = 0.022). The mean frequency of ER positivity for laboratories serving hospitals and clinics where mammographic screening does and does not take place was 73.4% and 75.7%, respectively (p = 0.302; two tailed).



Of the parameters investigated, patient age and IHC assay sensitivity were found to be the main variables influencing the frequency of receptor positivity. We recommend the range of receptor values obtained by laboratories achieving high assay sensitivity as a useful guide against which all laboratories can gauge their own results.
Multicenter cohort study on the survival time of cancer patients dying at home or in a hospital: Does place matter?

Although the place of death has a great influence on the quality of death and dying for cancer patients, whether the survival time differs according to the place of death is unclear. The primary aim of this study was to explore potential differences in the survival time of cancer patients dying at home or in a hospital.



This multicenter, prospective cohort study was conducted in Japan from September 2012 through April 2014 and involved 58 specialist palliative care services.



Among the 2426 patients recruited, 2069 patients were analyzed for this study: 1582 receiving hospital-based palliative care and 487 receiving home-based palliative care. A total of 1607 patients actually died in a hospital, and 462 patients died at home. The survival of patients who died at home was significantly longer than the survival of patients who died in a hospital in the days' prognosis group (estimated median survival time, 13 days [95% confidence interval (CI), 10.3-15.7 days] vs 9 days [95% CI, 8.0-10.0 days]; P = .006) and in the weeks' prognosis group (36 days [95% CI, 29.9-42.1 days] vs 29 days [95% CI, 26.5-31.5 days]; P = .007) as defined by Prognosis in Palliative Care Study predictor model A. No significant difference was identified in the months' prognosis group. Cox proportional hazards analysis revealed that the place of death had a significant influence on the survival time in both unadjusted (hazard ratio [HR], 0.86; 95% CI, 0.78-0.96; P < .01) and adjusted models (HR, 0.87; 95% CI, 0.77-0.97; P = .01).



In comparison with cancer patients who died in a hospital, cancer patients who died at home had similar or longer survival. Cancer 2016;122:1453-1460.
A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172).

Human immunodeficiency virus (HIV) vaccine development remains a global priority. We describe the safety and immunogenicity of a multiclade DNA vaccine prime with a replication-defective recombinant adenovirus serotype 5 (rAd5) boost.



The vaccine is a 6-plasmid mixture encoding HIV envelope (env) subtypes A, B, and C and subtype B gag, pol, and nef, and an rAd5 expressing identical genes, with the exception of nef. Three hundred and twenty-four participants were randomized to receive placebo (n=138), a single dose of rAd5 at 10(10) (n = 24) or 10(11) particle units (n = 24), or DNA at 0, 1, and 2 months, followed by rAd5 at either 10(10) (n= 114) or 10(11) particle units (n = 24) boosting at 6 months. Participants were followed up for 24 weeks after the final vaccination.



The vaccine was safe and well tolerated. HIV-specific T cell responses were detected in 63% of vaccinees. Titers of preexisting Ad5 neutralizing antibody did not affect the frequency and magnitude of T cell responses in prime-boost recipients but did affect the response rates in participants that received rAd5 alone (P = .037).



The DNA/rAd5 vaccination regimen was safe and induced HIV type 1 multi-clade T cell responses, which were not significantly affected by titers of preexisting rAd5 neutralizing antibody.