nils-herrmann/clean_scirepeval huggingface dataset:
Accuracy of a new patch pump based on a microelectromechanical system (MEMS) compared to other commercially available insulin pumps: results of the first in vitro and in vivo studies.

The JewelPUMP™ (JP) is a new patch pump based on a microelectromechanical system that operates without any plunger. The study aimed to evaluate the infusion accuracy of the JP in vitro and in vivo. For the in vitro studies, commercially available pumps meeting the ISO standard were compared to the JP: the MiniMed® Paradigm® 712 (MP), Accu-Chek® Combo (AC), OmniPod® (OP), Animas® Vibe™ (AN). Pump accuracy was measured over 24 hours using a continuous microweighing method, at 0.1 and 1 IU/h basal rates. The occlusion alarm threshold was measured after a catheter occlusion. The JP, filled with physiological serum, was then tested in 13 patients with type 1 diabetes simultaneously with their own pump for 2 days. The weight difference was used to calculate the infused insulin volume. The JP showed reduced absolute median error rate in vitro over a 15-minute observation window compared to other pumps (1 IU/h): ±1.02% (JP) vs ±1.60% (AN), ±1.66% (AC), ±2.22% (MP), and ±4.63% (OP), P < .0001. But there was no difference over 24 hours. At 0.5 IU/h, the JP was able to detect an occlusion earlier than other pumps: 21 (19; 25) minutes vs 90 (85; 95), 58 (42; 74), and 143 (132; 218) minutes (AN, AC, MP), P < .05 vs AN and MP. In patients, the 24-hour flow error was not significantly different between the JP and usual pumps (-2.2 ± 5.6% vs -0.37 ± 4.0%, P = .25). The JP was found to be easier to wear than conventional pumps. The JP is more precise over a short time period, more sensitive to catheter occlusion, well accepted by patients, and consequently, of potential interest for a closed-loop insulin delivery system.
A randomized open-label study of gabapentin and lamotrigine in adults with learning disability and resistant epilepsy

The aim of this study was to evaluate the efficacy and safety of gabapentin in patients with learning disabilities and resistant epilepsy, comparing the effects of gabapentin with lamotrigine on efficacy, behaviour and mood. An open-label, randomized, parallel group, multicentre add-on study comparing gabapentin with lamotrigine in 109 patients with drug-resistant localization-related epilepsy and learning disabilities was conducted: 39 patients were randomized to gabapentin and 44 to lamotrigine. The study population had a range of learning disabilities and severe partial epilepsy. The percentage of patients achieving a greater than or equal to 50% reduction in seizure frequency on gabapentin was 50%, (mean reduction in seizures was 51%). Compared to 48.6% of lamotrigine patients, no statistically significant treatment differences could be identified. The safety profile of both drugs was consistent with that seen in previous clinical trials. Carer-rated visual analogue scales detected significant improvements (P< 0.05) for the gabapentin-treated patients in seizure severity, attention, general health and sleeping pattern, while for lamotrigine seizure severity improved significantly. For learning disabled patients with resistant epilepsy, gabapentin and lamotrigine provide safe and effective treatment, with positive benefits on behaviour.
Ovarian cancer prediction in adnexal masses using ultrasound-based logistic regression models: a temporal and external validation study by the IOTA group.

The aims of the study were to temporally and externally validate the diagnostic performance of two logistic regression models containing clinical and ultrasound variables in order to estimate the risk of malignancy in adnexal masses, and to compare the results with the subjective interpretation of ultrasound findings carried out by an experienced ultrasound examiner ('subjective assessment').



Patients with adnexal masses, who were put forward by the 19 centers participating in the study, underwent a standardized transvaginal ultrasound examination by a gynecologist or a radiologist specialized in ultrasonography. The examiner prospectively collected information on clinical and ultrasound variables, and classified each mass as benign or malignant on the basis of subjective evaluation of ultrasound findings. The gold standard was the histology of the mass with local clinicians deciding whether to operate on the basis of ultrasound results and the clinical picture. The models' ability to discriminate between malignant and benign masses was assessed, together with the accuracy of the risk estimates.



Of the 1938 patients included in the study, 1396 had benign, 373 had primary invasive, 111 had borderline malignant and 58 had metastatic tumors. On external validation (997 patients from 12 centers), the area under the receiver-operating characteristics curve (AUC) for a model containing 12 predictors (LR1) was 0.956, for a reduced model with six predictors (LR2) was 0.949 and for subjective assessment was 0.949. Subjective assessment gave a positive likelihood ratio of 11.0 and a negative likelihood ratio of 0.14. The corresponding likelihood ratios for a previously derived probability threshold (0.1) were 6.84 and 0.09 for LR1, and 6.36 and 0.10 for LR2. On temporal validation (941 patients from seven centers), the AUCs were 0.945 (LR1), 0.918 (LR2) and 0.959 (subjective assessment).



Both models provide excellent discrimination between benign and malignant masses. Because the models provide an objective and reasonably accurate risk estimation, they may improve the management of women with suspected ovarian pathology.
Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial.

Additional therapies are needed for prevention of osteoporotic fractures. Abaloparatide is a selective activator of the parathyroid hormone type 1 receptor.



To determine the efficacy and safety of abaloparatide, 80 μg, vs placebo for prevention of new vertebral fracture in postmenopausal women at risk of osteoporotic fracture.



The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) was a phase 3, double-blind, RCT (March 2011-October 2014) at 28 sites in 10 countries. Postmenopausal women with bone mineral density (BMD) T score ≤-2.5 and >-5.0 at the lumbar spine or femoral neck and radiological evidence ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or history of low-trauma nonvertebral fracture within the past 5 years were eligible. Postmenopausal women (>65 y) with fracture criteria and a T score ≤-2.0 and >-5.0 or without fracture criteria and a T score ≤-3.0 and >-5.0 could enroll.



Blinded, daily subcutaneous injections of placebo (n = 821); abaloparatide, 80 μg (n = 824); or open-label teriparatide, 20 μg (n = 818) for 18 months.



Primary end point was percentage of participants with new vertebral fracture in the abaloparatide vs placebo groups. Sample size was set to detect a 4% difference (57% risk reduction) between treatment groups. Secondary end points included change in BMD at total hip, femoral neck, and lumbar spine in abaloparatide-treated vs placebo participants and time to first incident nonvertebral fracture. Hypercalcemia was a prespecified safety end point in abaloparatide-treated vs teriparatide participants.



Among 2463 women (mean age, 69 years [range, 49-86]), 1901 completed the study. New morphometric vertebral fractures occurred less frequently in the active treatment groups vs placebo. The Kaplan-Meier estimated event rate for nonvertebral fracture was lower with abaloparatide vs placebo. BMD increases were greater with abaloparatide than placebo (all P < .001). Incidence of hypercalcemia was lower with abaloparatide (3.4%) vs teriparatide (6.4%) (risk difference [RD], −2.96 [95%CI, −5.12 to −0.87]; P = .006). 
Among postmenopausal women with osteoporosis, the use of subcutaneous abaloparatide, compared with placebo, reduced the risk of new vertebral and nonvertebral fractures over 18 months. Further research is needed to understand the clinical importance of RD, the risks and benefits of abaloparatide treatment, and the efficacy of abaloparatide vs other osteoporosis treatments.
Reliability of body temperature measurements in hospitalised older patients.

To compare different body temperature assessment methods in older people and to assess the role of cognitive and functional characteristics in temperature recordings.



Axillary gallium-in-glass thermometers are commonly used. Their accuracy depends on the proper placement of the device and their permanence in place for eight minutes. With adequate instruction, well-functioning patients can measure their axillary temperature by themselves, while in cognitively and functionally impaired older people, inadequate understanding of instructions and misplacement of the thermometer might determine significant recording errors. Electronic ear and axillary temperature measurements are faster, but their accuracy has not been demonstrated convincingly with older people.



Patients (n = 107; aged 65-104 years) were recruited. Barthel Index and Short Portable Mental Status Questionnaire (SPMSQ) scores were obtained for each patient. Temperature readings were obtained using: the axillary gallium-in-glass thermometer, with (T(nurse)) and without (T(self)) the nurse's assistance; the electronic axillary thermometer (T(el)) and the infrared tympanic thermometer (T(tymp)). The T(nurse) was considered as the reference method.



Mean difference and standard deviation (mean +/- SD) in temperature recordings between the different techniques and T(nurse) differed significantly from zero for T(self) (-0.40 SD 0.42) and T(tymp) (+0.19 SD 0.48). No significant differences in temperature recordings emerged between T(nurse) and T(el). In simple linear regression models, the difference between T(self) and T(nurse) significantly correlated with age, gender, SPMSQ score and Barthel Index. Multiple linear regression analysis showed an underestimation of body temperature in older patients with cognitive impairments.



Unassisted gallium-in-glass axillary temperature assessment is inadequate, in older patients. The differences between T(self) and T(nurse) are significantly influenced by age and mental decline. T(el) provides adequate accuracy. Relevance to clinical practice. In geriatric settings, the electronic axillary thermometer is a safe and accurate alternative to the more traditional gallium-in-glass thermometer, with the advantage of saving time (five seconds in recording vs. eight minutes).
Special track on Autonomic Computing: editorial message

With the widespread use of distributed computing in the enterprise, there have been significant advances in development paradigms for distributed computing applications. Server side component models have considerably simplified development and the complexity has instead shifted to the operational side of these applications. The increase in operational complexity has reached a point where it is no longer feasible for humans to manage the applications required to run an enterprise. This coupled with the lack of skills and skyrocketing costs associated with application management make it imperative to develop techniques to allow applications to manage themselves. The initial steps to provide self-managing applications are now being taken a paradigm known as "autonomic computing" is in its infancy of evolution. It has also been identified as one of the "grand challenges" of computer applications for the next decade. In addition, the exponential growth of handheld devices (e.g. PDAs, laptops, smart phones etc.) pose additional challenges since these devices themselves suffer from a number of limitations such as inadequate processing capability, restricted battery life, limited memory space, frequent line disconnection, and confined host bandwidth. Lack of fixed infrastructure support and the aforementioned limitations augment the complexity of the problems in autonomic computing.
Taurine deficiency in thalassemia major-induced osteoporosis treated with neridronate.

The aetiology of thalassemia major-induced osteoporosis is multifactorial. Up to now, bisphosphonates seem to be a promising therapy. Taurine is found in a high concentration in bone cells enhancing bone tissue formation and inhibiting bone loss. Recently we found a decrease taurine plasma level in children affected by osteogenesis imperfecta during neridronate (amino-bisphosphonate) therapy suggesting a possible interaction between pharmacological effect of this drug and taurine availability. On the basis of these results, we performed plasma and urine amino acid (AA) analysis in thalassemia major-induced osteoporosis before and after 12 months of neridronate treatment. Twelve patients, five males and seven females, aged from 20 to 29 years following a hypertransfusion treatment protocol were enrolled in the study. Patients were treated with neridronate infusion every one month (30 mg in 100ml of saline). Plasma and urine specimens for AA analysis, bone mineral density, bone mineral content and vertebral project area were examined at baseline (T0) and after 12 months of treatment (T12). A significant decrease was observed for plasma level and urinary excretion of taurine (T0 vs. T12=p<0.01) whereas bone mineral content and vertebral projection area showed a statistical significant increase (T0 vs. T12=p<0.05). These results and other experimental researches warrant further studies examining the long-term effect of taurine supplementation in association with neridronate treatment.
Pharmacokinetics of milnacipran in renal impairment

The pharmacokinetics of a single 50 mg dose of milnacipran, a new non tricyclic antidepressant drug, were compared in 8 chronic renal failure subjects (Clcreat between 9 to 84.5 ml.min−1) and in 6 healthy volunteers. Concentrations of unchanged (F2207 racemate and F2695 and F2696, enantiomers) and glucuroconjugated drug (main metabolite) were measured using HPLC and GC-MS. As for drugs mainly eliminated via renal route, the pharmacokinetics of milnacipran were markedly affected by impaired renal function with the elimination half-life of severly impaired subject being approximately three times that of the control group. Milnacipran apparent total clearance and renal clearance were positively correlated with glomerular filtration rate, while non-renal clearance and apparent in plasma, while its total urine excretion remained unchanged. As for the racemate, pharmacokinetics of each enantiomer were modified by renal failure, although, as predictible from its higher renal clearance value, it was more marked for F2696 than for F2695. Considering that modifications were shown to be proportional to the degree of renal impairment and that milnacipran presents low variability, the necessary dose adjustment is therefore easy to predict.
Influence of the physical form of processed rice products on the enzymatic hydrolysis of rice starch in vitro and on the postprandial glucose and insulin responses in patients with type 2 diabetes mellitus.

The manufacturing processes used determined the physicochemical properties of the three kinds of rice food, garaeduk, bagsulgi, and cooked rice. The initial rate of hydrolysis by porcine pancreatic alpha-amylase (PPA) was affected by the food form. The firmer structure of garaeduk was apparently responsible for the difficulty in maceration, resulting in less digestion than with easily digestible food for the same maceration time. The initial rate of hydrolysis of each rice product by PPA increased with increasing maceration time in a Waring Blender for all of the processed rice products. The postprandial glucose and insulin responses to the three processed rice products were also studied in ten patients with type 2 diabetes mellitus (4 men and 6 women aged 56.8 +/- 2.3 yr; duration of diabetes, 3.6 +/- 1.2 yr; body mass index (BMI), 23.7 +/- 2.6 kg/m2; fasting serum glucose, 143.9 +/- 5.1 mg/dl; serum insulin, 20.8 +/- 2.2 microU/ml). Each subject ingested of the three rice foods after a 12-h overnight fast, and the serum glucose and insulin levels were measured over a 0-240 min period. The postprandial serum glucose and insulin levels at 90 min after ingesting bagsulgi and cooked rice were less than those at 60 min, while the levels at 90 min after ingesting garaeduk were higher than those at 60 min. Garaeduk also significantly decreased the incremental responses of glucose and insulin when compared with bagsulgi and cooked rice. The results suggest that garaeduk would be the most unlikely to increase the postprandial serum glucose and insulin levels among the three rice foods. The food form, which eventually differentiated each food by its specific surface area with the same degree of maceration because of the characteristic physical strength, therefore affected the rate of rice starch hydrolysis both in vitro and in vivo.
Developmentally inspired drug prevention: middle school outcomes in a school-based randomized prevention trial.

Prior investigations have linked behavioral competencies in primary school to a reduced risk of later drug involvement. In this randomized prevention trial, we sought to quantify the potential early impact of two developmentally inspired universal preventive interventions on the risk of early-onset alcohol, inhalant, tobacco, and illegal drug use through early adolescence. Participants were recruited as they entered first grade within nine schools of an urban public school system. Approximately, 80% of the sample was followed from first to eighth grades. Two theory-based preventive interventions, (1) a family-school partnership (FSP) intervention and (2) a classroom-centered (CC) intervention, were developed to improve early risk behaviors in primary school. Generalized estimating equations (GEE) multivariate response profile regressions were used to estimate the relative profiles of drug involvement for intervention youths versus controls, i.e. youth in the standard educational setting. Relative to control youths, intervention youths were less likely to use tobacco, with modestly stronger evidence of protection associated with the CC intervention (RR=0.5; P=0.008) as compared to protection associated with the FSP intervention (RR=0.6; P=0.042). Intervention status was not associated with risk of starting alcohol, inhalants, or marijuana use, but assignment to the CC intervention was associated with reduced risk of starting to use other illegal drugs by early adolescence, i.e. heroin, crack, and cocaine powder (RR=0.32, P=0.042). This study adds new evidence on intervention-associated reduced risk of starting illegal drug use. In the context of 'gateway' models, the null evidence on marijuana is intriguing and merits attention in future investigations.
Women and men with unstable angina and/or non-ST-elevation myocardial infarction

In unstable angina and/or non-ST-elevation myocardial infarction (UA/NSTEMI), sex-related differences in outcomes are less well known than in ST-elevation myocardial infarction (STEMI), where women experience worse outcomes than men. Our aim was a prospective comparison between men and women with UA/NSTEMI of baseline characteristics, inhospital complications, mortality, reinfarctions and combined endpoint of mortality and/or reinfarction during hospital stay, at 30 days and at six months.  Initial medical treatment was given to 92 men and 47 women with UA/NSTEMI. Percutaneous coronary interventions (PCI) were performed within the first 48 hours in cases of recurrent chest pain and/or rhythmic and/or hemodynamic instability.  Women were significantly older (66.6 ± 9.6 vs. 59.7 ± 10.6, P = 0.0001), less physically active (76.6% vs. 91.3%, P = 0.035), with significantly more frequent arterial hypertension (78.7% vs. 51%, P = 0.0039) and insulin-treated diabetes (17% vs. 5.4%, P = 0.0341), but with less likely prior MI (21.3% vs. 48.9%, P = 0.003), smoking (10.6% vs. 32.6%, P = 0.009) and dyslipidemia with HDL-cholesterol < 1.0 mmol/L (25.5% vs. 46.4%, P = 0.015) than men. Though medical and invasive treatments were similar in both sexes, women were at significantly increased risk of in-hospital pulmonary edema (OR 4.16, 95% CI 1.51 to 11.45) but not at increased risk of adverse in-hospital, 30-day and six-month outcomes in comparison with men.  Women with UA/NSTEMI, being significantly older and with more comorbidity, were at significantly increased risk of in-hospital heart failure but not at increased risk of in-hospital, 30-day and six-month adverse outcomes when compared with men, despite their similar treatments.
Response to Morrison et al., "Hormonal contraception and the risk of HIV acquisition".

To describe the epidemiology of HIV and its global interface with Progestin injectables ■To outline the research on injectable progestin contraception and the possible increased risk of HIV acquisition ■To outline the content of WHO discussions and recommendations from meetings of experts and of advocates and their consequences Hormonal Contraception and the Risk of HIV Acquisition: An Individual Participant Meta-Analysis 10/6/2013—slide 4 " Love is the answer, but while you are waiting for the answer, sex raises some pretty good questions.
Hyperbaric oxygen in the treatment of acute ischemic stroke. A double-blind pilot study.

The effects of hyperbaric oxygen (HBO) therapy on humans are uncertain. Our study aims first to outline the practical aspects and the safety of HBO treatment and then to evaluate the effect of HBO on long-term disability.



Patients who experienced middle cerebral artery occlusion and were seen within 24 hours of onset were randomized to receive either active (HBO) or sham (air) treatment. The HBO patients were exposed daily to 40 minutes at 1.5 atmospheres absolute for a total of 10 dives. We used the Orgogozo scale to establish a pretreatment functional level. Changes in the Orgogozo scale score at 6 months and 1 year after therapy were used to assess the therapeutic efficacy of HBO. In addition, we used the Rankin scale and our own 10-point scale to assess long term-disability at 6 months and 1 year. Two sample t tests and 95% confidence intervals were used to compare the mean differences between the two treatment groups. Student's two-tailed test was used to compare the differences between pretherapeutic and posttherapeutic scores at 6 months and 1 year in the two treatment groups.



Over the 3 years of study enrollment, 34 patients were randomized, 17 to hyperbaric treatment with air and 17 to hyperbaric treatment with 100% oxygen. There was no significant difference at inclusion between groups regarding age, time from stroke onset to randomization, and Orgogozo scale scores. Neurological deterioration occurred during the first week in 4 patients in the sham group, 3 of whom died; this worsening was clearly related to the ischemic damage. Treatment was also discontinued for 3 patients in the HBO group who experienced myocardial infarction, a worsening related to the ischemic process, and claustrophobia. Therefore, 27 patients (13 in the sham group and 14 in the HBO group) completed a full course of therapy. The mean score of the HBO group was significantly better on the Orgogozo scale at 1 year (P < .02). However, the difference at 1 year between pretherapeutic and posttherapeutic scores was not significantly different in the two groups (P < .16). Moreover, no statistically significant improvement was observed in the HBO group at 6 months and 1 year according to Rankin score (P < .78) and our own 10-point scale (P < .50).



Although the small number of patients in each group precludes any conclusion regarding the potential deleterious effect of HBO, we did not observe the major side effects usually related to HBO. Accordingly, it can be assumed that hyperbaric oxygen might be safe. We hypothesize that HBO might improve outcome after stroke, as we detected an outcome trend favoring HBO therapy. A large randomized trial might be required to address the efficacy of this therapy.