nils-herrmann/clean_scirepeval huggingface dataset:
Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems.



We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires.



This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age.
The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary

Patients report persisting impairment in quality of life (QoL) after treatment for pituitary disease. At present, there is no questionnaire to assess (a) whether patients with pituitary disease are bothered by these consequences, and (b) their needs for support. To develop and validate a disease-specific questionnaire for patients with pituitary disease which incorporates patient perceived bother related to the consequences of the disease, and their needs for support. Items for the Leiden Bother and Needs Questionnaire for patients with pituitary disease (LBNQ-Pituitary) were formulated based on results of a recent focus group study (n = 49 items). 337 patients completed the LBNQ-Pituitary and six validated QoL questionnaires (EuroQoL-5D, SF-36, MFI-20, HADS, AcroQol, CushingQoL). Construct validity was examined by exploratory factor analysis. Reliabilities of the subscales were calculated with Cronbach’s alphas, and concurrent validity was assessed by calculating Spearman’s correlations between the LBNQ-Pituitary and the other measures. Factor analyses produced five subscales (i.e., mood problems, negative illness perceptions, issues in sexual functioning, physical and cognitive complaints, issues in social functioning) containing a total of 26 items. All factors were found to be reliable (Cronbach’s alphas all ≥.765), and the correlations between the dimensions of the LBNQ-Pituitary and other questionnaires (all P ≤ .0001) demonstrated convergent validity. The LBNQ-Pituitary can be used to assess the degree to which patients are bothered by the consequences of the pituitary disease, as well as their needs for support. It could also facilitate an efficient assessment of patients’ needs for support in clinical practice. We postulate that paying attention to needs for support will lead to optimal patient care (e.g., improvement in psychosocial care), and positively affect QoL.
Nutritional content and a phase-I safety clinical trial of a herbal-nutritional supplement (IMUNITI) with putative immune-modulating properties.

The relationship between HIV and AIDS and poor nutrition has been well established. Poor nutrition hastens the progression of HIV infection to AIDS. The rising pandemic of HIV and AIDS and high toxicity associated with anti-retroviral use are major factors that have compelled research to explore traditional herbal medicines as potential alternatives or supplements to anti-retroviral agents. A Phase I clinical trial was conducted on IMUNITI Wellness Pack, a herbal product with putative immune-modulating properties. The product is a combination of 7 herbal preparations, minerals, vitamins, and a specially formulated soya-maize meal porridge and a bottle of water purifier. The aim was to evaluate the safety and tolerability of IMUNITI, with a purpose of developing it for use in HIV-infected patients. The phase I study was conducted at the MRC clinic in Botha's hill and the study lasted 5 weeks from date of participant dosing. The study was a randomised blinded placebo-controlled phase I clinical trial conducted on 48 healthy males. The participants were randomly divided into 4 groups of 12. The 3 groups received different escalating doses of IMUNITI while the forth group received placebo tablets. Participants consumed IMUNITI daily for a period of 5 weeks. Assessments were done at baseline, week 1 and week 5 to determine the safety parameters in all participants. In this study, IMUNITI did not show any safety concerns. In all study participants, there were no significant changes above the upper limit of the reference ranges of the laboratory tests for full blood count, INR, renal and biochemical safety parameters. IMUNITI was well tolerated. Furthermore, the nutritional content analysis of IMUNITI showed that it is a high kilojoule, high protein content product which contains a mixture of sugars, vitamins, traces of calcium, phosphorus and minerals.
Evaluation of the Clinical and Cost Effectiveness of Intermediate Care Clinics for Diabetes (ICCD): A Multicentre Cluster Randomised Controlled Trial

Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics.



This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n=25) or intervention (ICCDs; n=24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention.


PRIMARY OUTCOME
achievement of all three of the NICE targets [(HbA1c ≤ 7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol <154 mg/dl (4 mmol/l)]. PRIMARY OUTCOME was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p=0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain.



Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over time, their role may change as skill levels in primary care increase.
Analysis of exposure–response of CI-945 in patients with epilepsy: application of novel mixed hidden Markov modeling methodology

We propose to describe exposure–response relationship of an antiepileptic agent, using mixed hidden Markov modeling methodology, to reveal additional insights in the mode of the drug action which the novel approach offers. Daily seizure frequency data from six clinical studies including patients who received gabapentin were available for the analysis. In the model, seizure frequencies are governed by underlying unobserved disease activity states. Individual neighbouring states are dependent, like in reality and they exhibit their own dynamics with patients transitioning between low and high disease states, according to a set of transition probabilities. Our methodology enables estimation of unobserved disease dynamics and daily seizure frequencies in all disease states. Additional modes of drug action are achievable: gabapentin may influence both daily seizure frequencies and disease state dynamics. Gabapentin significantly reduced seizure frequencies in both disease activity states; however it did not significatively affect disease dynamics. Mixed hidden Markov modeling is able to mimic dynamics of seizure frequencies very well. It offers novel insights into understanding disease dynamics in epilepsy and gabapentin mode of action.
Effect of Opuntia ficus indica on symptoms of the alcohol hangover.

The severity of the alcohol hangover may be related to inflammation induced by impurities in the alcohol beverage and byproducts of alcohol metabolism. An extract of the Opuntia ficus indica (OFI) plant diminishes the inflammatory response to stressful stimuli.



In this double-blind, placebo-controlled, crossover trial, 64 healthy, young adult volunteers were randomly assigned to receive OFI (1600 IU) and identical placebo, given 5 hours before alcohol consumption. During 4 hours, subjects consumed up to 1.75 g of alcohol per kilogram of body weight. Hangover severity (9 symptoms) and overall well-being were assessed on a scale (0-6), and blood and urine samples were obtained the following morning. Two weeks later, the study protocol was repeated with OFI and placebo reversed.



Fifty-five subjects completed both the OFI and placebo arms of the study. Three of the 9 symptoms-nausea, dry mouth, and anorexia-were significantly reduced by OFI (all P<.05). Overall, the symptom index was reduced by 2.7 points on average (95% confidence interval, -0.2 to 5.5; P =.07), and the risk of a severe hangover (>/=18 points) was reduced by half (odds ratio, 0.38; 95% confidence interval, 0.16-0.88; P =.02). C-reactive protein levels were strongly associated with hangover severity; the mean symptom index was 4.1 (95% confidence interval, 1.2-7.1; P =.007) higher in subjects with morning C-reactive protein levels greater than 1.0 mg/L. In addition, C-reactive protein levels were 40% higher after subjects consumed placebo compared with OFI.



The symptoms of the alcohol hangover are largely due to the activation of inflammation. An extract of the OFI plant has a moderate effect on reducing hangover symptoms, apparently by inhibiting the production of inflammatory mediators.
Differences in immunoreactive trypsin values between type of feeding and ethnicity in neonatal cystic fibrosis screening: a cross-sectional study

We studied the differences in immunoreactive trypsin (IRT) in neonatal screening for cystic fibrosis (CF) associated individually with the age of the newborn, ethnicity and environmental temperature. In this study, we determine the overall influence of environmental temperature at birth, gender, feeding, gestational age, maternal age and ethnic origin on an abnormal IRT result.



Cross-sectional observational study. A sample was selected of newborns from Alicante (Spain) who underwent neonatal CF screening in 2012-2013.  abnormal IRT levels (≥65 ng/ml). Secondary variables: gender, maternal origin, maternal age (years) (<20, 20-40, >40), gestational age (weeks) (<32, 32-37, >37), type of feeding (natural, formula, mixed and special nutrition), >20 days from birth to blood collection, and average temperature during the month of birth (in°C). Using a multivariate logistic regression model the adjusted odds ratios (ORs) were estimated to analyze the association between atypical IRT levels and the study variables. The α error was 5% and confidence intervals (CI) were calculated for the most relevant parameters.



Of a total of 13,310 samples, 199 were abnormal (1.34%). Significant associated factors: feeding method (natural → OR = 1; mixed → OR = 0.53, 95% CI: 0.31-0.89; formula → OR = 0.72, 95% CI: 0.48-1.07; special → OR = 21.88, 95% CI: 6.92-69.14; p < 0.001).



Newborns receiving special nutrition have a 20-fold higher risk for abnormal IRT levels, and screening is advisable once normalized feeding is initiated. It is advisable to consider ethnic variability. Seasonality was not important.
Perceptions of health status in multiple sclerosis patients and their doctors.

To compare neurologist and patient perceptions of multiple sclerosis (MS)-related health status.



MS patients (n=99) were recruited from six sites in Canada. Following a consultation with their neurologist, patients estimated their relapse frequency, rated their general health and quality of life (QoL), reviewed descriptions of eight health domains and selected the three most important, and completed a utility assessment using the standard gamble (SG). Concurrently, neurologists independently used the same instruments to rate their patients' health status. Assessments were compared on the basis of paired mean values of both groups and the degree of exact agreement quantified by intraclass coefficient (ICC) and kappa analyses, which yield values of 1.0 with 100% agreement.



There were significant differences (p<0.001) between patient and neurologist ratings for relapses in the last year (0.86 vs. 0.4, respectively), QoL (61.2 vs. 69.7 (maximum score = 100) and utility (0.864 vs. 0.971); ICC analysis revealed moderate to poor levels of agreement (0.56 for QoL to 0.03 for SG). There was little concordance in identification of important health domain and the only significant associations were in bodily pain and social functioning (kappa statistic = 0.24, p = 0.026 for both). Neurologists identified physical functioning domains as important, while patients placed more emphasis on mental health domains.



Discrepancies between neurologist and patient perceptions of MS were observed. The study identifies a need to educate neurologists on the recognition of MS health domains that are important in the definition of patient QoL.
Completely medial versus hybrid medial approach for laparoscopic complete mesocolic excision in right hemicolon cancer

To explore the feasibilities between operational approaches for laparoscopic complete mesocolic excision (CME) to right hemicolon cancer. This prospective randomized controlled trial included patients admitted to a Shanghai minimally invasive surgical center to receive laparoscopic CME from September 2011 to January 2013 randomized into two groups: hybrid medial approach (HMA) and completely medial approach (CMA). The feasibilities and strategies of the two techniques were studied and compared. Furthermore, the operation time and vessel-related complications were designed to be the primary end points, and other operational findings, including the classification of the surgical plane and postoperative recovery, were designed to be the secondary end points for this study. After screening, 50 cases were allocated to the HMA group and 49 to the CMA group. Within the HMA group, there were 48 cases graded with mesocolic plane and 2 with intramesocolic plane. For the CMA group, there were 42 cases graded with mesocolic plane and seven with intramesocolic plane. The differences between the two were insignificant, as were the number of lymph nodes retrieved. The mean±standard deviation total operation time for the CMA group was 128.3 ± 36.4 min, which was significantly shorter than that for the HMA group, 142.6 ± 34.8 min. For the CMA group, the time involved in central vessel ligations and laparoscopic procedures was 58.5 %, 14.1 and 81.2 ± 23.5 min, respectively, which were shorter than the HMA group. The vessel-related complication rate was significantly higher in the HMA group. Laparoscopic CME via the total medial approach is technically feasible after the precise identification of the surgical planes and spaces for the right hemicolon. The procedure has a shorter operation time and fewer vessel-related complications.
A Cloud-Based Energy Management System for Building Managers

A Local Energy Management System (LEMS) is described to control Electric Vehicle charging and Energy Storage Units within built environments. To this end, the LEMS predicts the most probable half hours for a triad peak, and forecasts the electricity demand of a building facility at those times. Three operational algorithms were designed, enabling the LEMS to (i) flatten the demand profile of the building facility and reduce its peak, (ii) reduce the demand of the building facility during triad peaks in order to reduce the Transmission Network Use of System (TNUoS) charges, and (iii) enable the participation of the building manager in the grid balancing services market through demand side response. The LEMS was deployed on over a cloud-based system and demonstrated on a real building facility in Manchester, UK.
NIHSS-time score easily predicts outcomes in rt-PA patients: The SAMURAI rt-PA registry

We aimed to devise a scale comprising a simple multiplication of initial National Institutes of Health Stroke Scale (NIHSS) score and onset-to-treatment time (OTT) as a scale for predicting outcomes after recombinant tissue plasminogen activator (rt-PA) therapy.



Data from rt-PA patients in 10 stroke centers in Japan were investigated. NIHSS-time score was calculated as initial NIHSS score×OTT.



Subjects comprised 526 patients. Median NIHSS score was 12 (7-18), and median OTT was 2.42 h (2.00-2.75 h). Median NIHSS-time score was 27.7 (16.9-41.7). Good (modified Rankin Scale [mRS] 0-1) and poor (mRS 4-6) outcome rates at 3months for patients with NIHSS-time scores ≤ 10 were 71.1% and 7.8%, compared to 54.7% and 16.5% for scores >10 and ≤ 20, 38.9% and 31.9% for scores >20 and ≤ 30, 25.0% and 44.6% for scores >30 and ≤ 40, and 17.4% and 61.8% for scores >40, respectively. Cut-off NIHSS-time scores to predict good and poor outcomes with 50% probability were defined as 20 and 40, respectively. Multivariate logistic regression analysis revealed NIHSS-time score as an independent predictor of good (odds ratio [OR], 0.587; 95% confidence interval [CI], 0.422-0.818, p=0.002) and poor (OR, 1.756; 95%CI, 1.227-2.514, p=0.002) outcomes after adjusting for age, sex, NIHSS score, OTT, Alberta Stroke Program Early CT Score, internal carotid artery occlusion, and glucose level.



NIHSS-time score predicts clinical outcomes in rt-PA patients.
The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone

The standard of care for metastatic gastric cancer (MGC) is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP), liver resection, and pulmonary resection. Median survival after liver resection for MGC is up to 34 months, with a five year survival rate of 24.5%. Similarly, reported median survival after pulmonary resection of MGC is 21 months with long term survival of greater than 5 years a possibility. Several case reports and small studies have documented evidence of long-term survival in select individuals who undergo CHPP for MGC.



The GYMSSA trial is a prospective randomized trial for patients with MGC. It is designed to compare two therapeutic approaches: gastrectomy with metastasectomy plus systemic chemotherapy (GYMS) versus systemic chemotherapy alone (SA). Systemic therapy will be composed of the FOLFOXIRI regimen. The aim of the study is to evaluate overall survival and potential selection criteria to determine those patients who may benefit from surgery plus systemic therapy. The study will be conducted by the Surgery Branch at the National Cancer Institute (NCI), National Institutes of Health (NIH) in Bethesda, Maryland. Surgeries and followup will be done at the NCI, and chemotherapy will be given by either the local oncologist or the medical oncology branch at NCI.
Pharmacokinetics, bioavailability and opioid effects of liquid versus tablet buprenorphine.

Two tablet formulations of buprenorphine (a buprenorphine mono-product, Subutex, and a buprenorphine/naloxone combination product, Suboxone) are available for use in the treatment of opioid addiction; however, the bulk of the clinical studies supporting its approval by the US Food and Drug Administration (FDA) were conducted with a sublingual liquid preparation. To assist the clinician in interpreting the relevant literature in establishing dosing parameters for prescription of tablet buprenorphine, this study was designed to compare the steady state: (1) pharmacokinetics and bioavailability, and (2) physiological, subjective and objective opiate effects of two 8 mg buprenorphine tablets (16 mg) to those of 1 ml (8 mg/ml) buprenorphine solution based upon early reports suggesting that the bioavailability of the tablet was approximately 50% of that of the liquid.



Randomized, open-label, two-way crossover study.



Inpatient hospitalization for 21 days.



Twenty-four male and females in general good health and meeting DSM-IV criteria for opiate dependence.



Subjects received one of the two buprenorphine formulations in the first 10-day period, and the other for the second 10-day period with no washout.



Pharmacokinetic analyses, opiate effects and adverse events.



Drug steady state was reached by Day 7 of each 10-day period, area under the curve for 16 mg (two 8 mg) tablets was higher than the solution. The only non-kinetic statistically significant difference observed between the formulations was in changes in total opioid agonist score.



The serum concentration achieved by 16 mg of tablet buprenorphine is higher than that of the 8 mg solution, although differences between physiologic, subjective and objective opioid effects were not noted. The relative bioavailability of tablet versus solution is estimated to be 0.71; thus, with respect to dosing parameters for the tablet, clinicians should consider using less than 16 mg to achieve bioequivalence to the 8 mg solution.
User-Driven Design of a Tangible Awareness Landscape

This paper describes the design and evolutionary development of a system for supporting informal interactions between geographically-remote members of a group. Based on simple internet technologies, the system described enables the use of novel, tangible devices for the purpose of discrete event notification. A simple system was initially developed for use in an office environment for providing awareness events via a single notification device. Over a four month period this simple system evolved into a suite of low-cost, low-tech notification devices for public and personal use. The numerous devices utilised by the final system constitute a physical landscape of awareness which have been demonstrated to support group and individual awareness of discrete events in both fixed locations and on the move.