nils-herrmann/clean_scirepeval huggingface dataset:
C-peptide levels in latent autoimmune diabetes in adults treated with linagliptin versus glimepiride: exploratory results from a 2-year double-blind, randomized, controlled study.

Latent autoimmune diabetes in adults (LADA) is a slowly progressing form of immune-mediated diabetes often misdiagnosed as type 2 diabetes because of its typical clinical presentation, i.e., an adult without weight loss or ketoacidosis not initially requiring insulin (1). Prior to insulin dependence, pharmacological options for reducing hyperglycemia comprise the oral glucose-lowering drugs used in type2diabetes; however, nonehas been established as the drug of choice in LADA because of the scarcity of evidence for or against the various agents (2).
Strategies for nevirapine initiation in HIV-infected children taking pediatric fixed-dose combination "baby pills" in Zambia: a randomized controlled trial.

Fixed-dose combination scored dispersible stavudine, lamivudine, and nevirapine minitablets (Triomune Baby and Junior; Cipla Ltd) are simpler and cheaper than liquid formulations and have correct dose ratios for human immunodeficiency virus-infected children. However, they cannot be used for dose escalation (DE) of nevirapine.



Children were randomized to initiate antiretroviral therapy with full-dose (FD) nevirapine (Triomune Baby or Junior in the morning and evening) versus DE (half-dose nevirapine for 14 days [Triomune in the morning and stavudine-lamivudine {Lamivir-S} in the evening], then FD), in accordance with World Health Organization weight-band dosing tables. The primary end point was nevirapine-related clinical or laboratory grade 3 or 4 adverse events (AEs).



In total, 211 children (median [interquartile range {IQR}] age, 5 [ 2-9 ] years; median [IQR] CD4 cell percentage, 13% [8%-18%]) were enrolled and followed up for a median (IQR) of 92 (68-116) weeks. There were 31 grade 3 or 4 AEs that were definitely/probably or uncertainly related to nevirapine in the FD group (18.0 per 100 child-years), compared with 29 in the DE group (16.5 per 100 child-years) (incidence rate ratio, 1.09; 95% confidence interval, 0.63–1.87; P = .74). All were asymptomatic; 11 versus 3 were single grade 3 or 4 elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels, all of which resolved without a change in nevirapine dose or interruption. Thirteen (12%) FD versus 2 (2%) DE children had grade 1 (2 in FD) or grade 2 (11 in FD and 2 in DE) rashes. Three (2 in FD and 1 in DE) substituted efavirenz, 3 (FD) continued FD nevirapine, and 9 (8 in FD and 1 in DE) temporarily interrupted nevirapine, followed by successful DE. Predictors of nevirapine rash were older age (P = .003) and higher CD4 cell count for age (P = .03). Twenty-two children died (12 in FD and 10 in DE), 1 FD and 5 DE children at <4 weeks; none were considered to be drug related by independent review.



Rash was more frequent with FD nevirapine, but 88% had no clinical toxicity; elevated AST or ALT levels were transient and resolved spontaneously, suggesting that routine laboratory monitoring has limited value. Dual pediatric stavudine-lamivudine minitablets are preferred for safe and simple DE; if unavailable, initiating FD Triomune requires timely review for rash, which could be managed by temporary reduction to half-dose Triomune or efavirenz substitution.
Endovascular treatment of ruptured intracranial aneurysms: factors affecting midterm quality anatomic results: analysis in a prospective, multicenter series of patients (CLARITY).

Recanalization is 1 drawback of the EVT of intracranial aneurysms. An analysis of the factors affecting the midterm anatomic results after EVT of ruptured intracranial aneurysms in a large multicenter series (CLARITY) is presented.



Of the 782 patients initially included in the CLARITY trial, 649 would theoretically undergo midterm follow-up examinations. Finally, 517/649 (79.7%) completed a midterm follow-up examination. Midterm anatomic results were independently and anonymously evaluated by 2 experienced neuroradiologists.



In univariate analysis, factors affecting the quality of midterm occlusion were the quality of the postoperative occlusion (P < .001), hypertension (P = .018), aneurysm size (P = .007), neck size (P = .005), and ICA location (P = .049). In multivariate analysis, 3 factors were associated with the quality of postoperative aneurysm occlusion: neck size (P = .003), use of the balloon remodeling technique (P = .031), and the quality of postoperative occlusion (P < .001). In univariate analysis, the evolution of aneurysm occlusion was affected by age (P = .024) and neck size (P = .041). In multivariate analysis, it was associated with the same factors: age (P = .025) and neck size (P = .043).



Among the many factors considered in this analysis, aneurysm neck size was identified as the single most important one in the quality of aneurysm occlusion at midterm follow-up after EVT. The present results suggest developing and evaluating new strategies of treatment and technique, especially for wide-neck aneurysms, with a focus on reinforcement and neoendothelialization at the level of the neck as objectives.
Spatial shifts in visual attention in normal ageing and dementia of the Alzheimer type

Using a spatial-cueing paradigm, we assessed the ability of Alzheimer's disease patients, age-matched controls and younger participants to use cues to guide attention to the location indicated by the cue. In separate experiments, we attempted to isolate cues that attract attention automatically (exogenous cueing) and those that require the wilful movement of attention (endogenous cues). We found significant cueing effects for all three groups of participants for both types of cue. However, the group with Alzheimer's disease showed far greater cueing effects when using an exogenous cue, whilst no difference between group's ability to use the cue was found for the endogenous cue. No differences in cueing were found for either cue type as a function of normal ageing. We further tested whether the differences in cueing found in the group with Alzheimer's disease was due to a generalised slowing of function. After transforming the data to take account of the overall slowing of all responses in this group, we still found significant differences between this group and the control groups. We conclude that patients with Alzheimer's disease have an abnormality in automatic, but not controlled visuospatial attention.
A role for Streptococcus pneumoniae in virus-associated pneumonia

Here we show, in a double-blind, randomized, placebo-controlled trial in 37,107 fully immunized infants in Soweto, South Africa, that a 9-valent pneumococcal conjugate vaccine, PncCV, prevents 31% (95% confidence interval = 15–43%) of pneumonias associated with any of seven respiratory viruses in children in hospital. These data suggest that the pneumococcus has a major role in the development of pneumonia associated with these viruses and that viruses contribute to the pathogenesis of bacterial pneumonia. In the version of this article originally published online, the species name was misspelled Streptococcus pnemoniae in the title of the article. The name should be Streptococcus pneumoniae. This error has been corrected for the HTML and print versions of the article.
Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer—IMIGASTRIC

Gastric cancer represents a great challenge for healthcare providers and requires a multidisciplinary treatment approach in which surgery plays a major role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and recently with the spread of robotic surgery, but a number of issues are currently being debated, including the limitations in performing an effective extended lymph node dissection, the real advantages of robotic systems, the role of laparoscopy for Advanced Gastric Cancer, the reproducibility of a total intracorporeal technique and the oncological results achievable during long-term follow-up.



A multi-institutional international database will be established to evaluate the role of robotic, laparoscopic and open approaches in gastric cancer, comprising of information regarding surgical, clinical and oncological features. A chart review will be conducted to enter data of participants with gastric cancer, previously treated at the participating institutions. The database is the first of its kind, through an international electronic submission system and a HIPPA protected real time data repository from high volume gastric cancer centres.


ETHICS AND DISSEMINATION
This study is conducted in compliance with ethical principles originating from the Helsinki Declaration, within the guidelines of Good Clinical Practice and relevant laws/regulations. A multicentre study with a large number of patients will permit further investigation of the safety and efficacy as well as the long-term outcomes of robotic, laparoscopic and open approaches for the management of gastric cancer.
Atorvastatin decreases serum levels of advanced glycation endproducts (AGEs) in nonalcoholic steatohepatitis (NASH) patients with dyslipidemia: clinical usefulness of AGEs as a biomarker for the attenuation of NASH

Advanced glycation endproducts (AGEs), final reaction products of protein with sugars, are known to contribute to various disorders, including diabetes, aspects of aging, and neurodegenerative diseases. Recently, we reported elevated levels of serum AGEs in patients with nonalcoholic steatohepatitis (NASH); further, we found that AGEs induced the generation of reactive oxygen species followed by the proliferation and activation of hepatic stellate cells, a major contributor to liver fibrosis. In this study, to explore the clinical usefulness of AGEs as a biomarker for the attenuation of NASH, we investigated whether the treatment of NASH with dyslipidemia could decrease serum levels of AGEs. This study included 43 patients with biopsy-proven NASH with dyslipidemia. Serum glyceraldehyde-derived AGE measurements and clinical laboratory tests were performed periodically during an open-label study of atorvastatin (10 mg daily) for 12 months. Standard weight-loss counseling was continued during the treatment period. Oral glucose tolerance tests and liver density assessment by computerized tomography were performed before and after treatment. Follow-up liver biopsy was performed in 22 patients. All 43 patients had dyslipidemia. The body mass indexes and serum glucose levels did not change during the treatment. After the treatment, NASH-related metabolic parameters were significantly improved. Serum glyceraldehyde-derived AGE levels were significantly decreased (10.4 ± 3.8 and 2.5 ± 1.1 IU/mL before and after treatment, respectively). The steatosis grade and nonalcoholic fatty liver disease (NAFLD) activity score were significantly improved. The present data demonstrated that atorvastatin decreased the serum levels of AGEs in NASH patients with dyslipidemia and suggest the usefulness of AGEs as a biomarker for the attenuation of NASH.
Treatment of posttraumatic stress disorder in postwar Kosovo high school students using mind-body skills groups: a pilot study.

This preliminary study examined whether the practice of mind-body techniques decreases symptoms of posttraumatic stress in adolescents. Posttraumatic Stress Reaction Index questionnaires were collected from 139 high school students in Kosovo who participated in a 6-week program that included meditation, biofeedback, drawings, autogenic training, guided imagery, genograms, movement, and breathing techniques. Three separate programs were held approximately 2 months apart. There was no control group. Posttraumatic stress scores significantly decreased after participation in the programs. These scores remained decreased in the 2 groups that participated in the follow-up study when compared to pretest measures. These data indicate that mind-body skills groups were effective in reducing posttraumatic stress symptoms in war-traumatized high school students.
Significant variability in response to inhaled corticosteroids for persistent asthma.

A clinical model is needed to compare inhaled corticosteroids (ICSs) with respect to efficacy.



The purpose of this investigation was to compare the relative beneficial and systemic effects in a dose-response relationship for 2 ICSs.



A 24-week, parallel, open-label, multicenter trial examined the benefit-risk ratio of 2 ICSs in persistent asthma. Benefit was assessed by improvements in FEV(1) and PC(20); risk was assessed by overnight plasma cortisol suppression. Thirty subjects were randomized to either beclomethasone dipropionate (BDP) 168, 672, and 1344 microg/day (n = 15) or fluticasone propionate (FP) 88, 352, and 704 microg/day (n = 15), both administered by means of a metered dose inhaler (MDI) with chlorofluorocarbon propellant via a spacer, in 3 consecutive 6-week intervals; this was followed by 3 weeks of FP dry powder inhaler (DPI) 2000 microg/day.



Maximum FEV(1) response occurred with the low dose for FP-MDI and the medium dose for BDP-MDI and was not further increased by treatment with FP-DPI. Near-maximum methacholine PC(20) improvement occurred with the low dose for FP-MDI and the medium dose for BDP-MDI. Both BDP-MDI and FP-MDI caused dose-dependent cortisol suppression. Responsiveness to ICS treatment was found to vary markedly among subjects. Good (>15%) FEV(1) response, in contrast to poor (<5%) response, was found to be associated with high exhaled nitric oxide (median, 17.6 vs 11.1 ppb), high bronchodilator reversibility (25.2% vs 8.8%), and a low FEV(1)/forced vital capacity ratio (0.63 vs 0.73) before treatment. Excellent (>3 doubling dilutions) improvement in PC(20), in contrast to poor (<1 doubling dilution) improvement, was found to be associated with high sputum eosinophil levels (3.4% vs 0.1%) and older age at onset of asthma (age, 20-29 years vs <10 years).



Near-maximal FEV(1) and PC(20) effects occurred with low-medium dose for both ICSs in the subjects studied. High-dose ICS therapy did not significantly increase the efficacy measures that were evaluated, but it did increase the systemic effect measure, overnight cortisol secretion. Significant intersubject variability in response occurred with both ICSs. It is possible that higher doses of ICSs are necessary to manage more severe patients or to achieve goals of therapy not evaluated in this study, such as prevention of asthma exacerbations.
Randomized Controlled Phase Ib Study of Ghrelin Agonist, RM-131, in Type 2 Diabetic Women With Delayed Gastric Emptying

To investigate the pharmacokinetics (PK), pharmacodynamics, and safety of single-dose RM-131 in type 2 diabetic patients with gastrointestinal cardinal symptoms (GCSI) and previously documented delayed gastric emptying (DGE).



In a randomized crossover study, 10 female patients received RM-131 (100 μg s.c.) or placebo and underwent scintigraphic gastric emptying (GE) and colonic filling at 6 h (CF6) of a solid-liquid meal administered 30 min postdosing. Adverse events, plasma glucose, and hormonal levels were assessed. GCSI daily diary (GCSI-DD) was completed during treatments. PK was assessed in this cohort and healthy volunteers (HVs).



At screening, HbA(1c) was 7.2 ± 0.4% (SEM) and total GCSI-DD score was 1.32 ± 0.21. RM-131 accelerated GE t(1/2) of solids (P = 0.011); mean difference (Δ) in solid GE t(1/2) was 68.3 min (95% CI 20-117) or 66.1%. There were numerical differences in GE lag time, CF6 solids, and GE t(1/2) liquids (all P < 0.14). With a significant (P < 0.014) order effect, further analysis of the first treatment period (n = 5 per group) confirmed significant RM-131 effects on GE t(1/2) (solids, P = 0.016; liquids, P = 0.024; CF6, P = 0.013). PK was similar in DGE patients and HVs. There were increases in 120-min blood glucose (P = 0.07) as well as 30-90-min area under the curve (AUC) levels of growth hormone, cortisol, and prolactin (all P < 0.02) with single-dose RM-131. Only light-headedness was reported more on RM-131.



RM-131 greatly accelerates the GE of solids in patients with type 2 diabetes and documented DGE. PK is similar in diabetic patients and HVs.
Safety and efficacy of the nonsystemic chewable complex carbohydrate dietary supplement PAZ320 on postprandial glycemia when added to oral agents or insulin in patients with type 2 diabetes mellitus.

Our primary objective was to evaluate the effect of the dietary supplement PAZ320 on postprandial glucose excursion. PAZ320 is derived from glucomannan and acts by blocking carbohydrate hydrolyzing enzymes and by binding to ingested polysaccharides. Endpoints included area under the curve during postprandial glucose excursion (gAUC) and adverse reactions.



In an open-label, sequential dose-escalation, prospective study, we examined the efficacy and safety of PAZ320 in 24 subjects with type 2 diabetes treated with oral agents and/or insulin. Subjects consumed 75 g jasmine rice alone or with low-dose (8 g) or high-dose (16 g) PAZ320. A real-time blinded continuous glucose monitor (CGM) was used to assess 3-hour postprandial glycemia.



We found that 45% of subjects responded to high-dose PAZ320 as evidenced by a decrease in gAUC of 40% compared to baseline in a dose-dependent manner. The effect of PAZ320 does not correlate with duration of diabetes and seems to work regardless of concurrent diabetes medications. The responders had higher postmeal glucose elevation at baseline, while the nonresponders showed no effect or paradoxic glucose response to PAZ320. There was no severe hypoglycemia, and the gastrointestinal side effects were mild.



PAZ320 may be useful as an adjunct to decrease postprandial glycemia in type 2 diabetes, although patients should verify its effect on postprandial glucose due to a possible paradoxic response. Its safety profile is reassuring. Further study is required to determine its long-term effects on glycated hemoglobin (HbA1c) and to further define which subpopulation may respond to PAZ320.
Enhancement of Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes

To determine acute effects of intranasal insulin on regional cerebral perfusion and cognition in older adults with type 2 diabetes mellitus (DM).



This was a proof-of-concept, randomized, double-blind, placebo-controlled intervention evaluating the effects of a single 40-IU dose of insulin or saline on vasoreactivity and cognition in 15 DM and 14 control subjects. Measurements included regional perfusion, vasodilatation to hypercapnia with 3-Tesla MRI, and neuropsychological evaluation.



Intranasal insulin administration was well tolerated and did not affect systemic glucose levels. No serious adverse events were reported. Across all subjects, intranasal insulin improved visuospatial memory (P ≤ 0.05). In the DM group, an increase of perfusion after insulin administration was greater in the insular cortex compared with the control group (P = 0.0003). Cognitive performance after insulin administration was related to regional vasoreactivity. Improvements of visuospatial memory after insulin administration in the DM group (R(2)adjusted = 0.44, P = 0.0098) and in the verbal fluency test in the control group (R(2)adjusted = 0.64, P = 0.0087) were correlated with vasodilatation in the middle cerebral artery territory.



Intranasal insulin administration appears safe, does not affect systemic glucose control, and may provide acute improvements of cognitive function in patients with type 2 DM, potentially through vasoreactivity mechanisms. Intranasal insulin-induced changes in cognitive function may be related to vasodilatation in the anterior brain regions, such as insular cortex that regulates attention-related task performance. Larger studies are warranted to identify long-term effects and predictors of positive cognitive response to intranasal insulin therapy.
Efficacy of multi-electrode duty-cycled radiofrequency ablation for pulmonary vein disconnection in patients with paroxysmal and persistent atrial fibrillation.

A novel multi-electrode pulmonary vein ablation catheter (PVAC) combining circular mapping and duty-cycled multi-electrode radiofrequency (RF) energy delivery has been developed to map and isolate the pulmonary veins (PVs). The aim of this study was to assess the efficacy of multi-electrode RF ablation using the PVAC device.



A total of 102 consecutive patients, age 57.9 +/- 9.6 years, with paroxysmal or persistent drug refractory atrial fibrillation (AF) were referred for ablation. All patients had documented AF episodes with an AF duration of 9.3 +/- 7.5 years (range 1.5-25). The mean total procedure time was 139.30 +/- 37.72 (median 135, range 115-172). The mean fluoroscopy time required for PVAC ablation was 17 +/- 12 min (median 16, range 12-33) and the total fluoroscopy time was 32.1 +/- 11.3 min (median 29, range 25-39). The mean multi-electrode RF ablation time required to achieve complete PV isolation was 31 +/- 6.7 min (range 16-51). In eight patients with persistent AF, additional ablations were performed to defragment septal and posterior part of the left atrium. In five patients additional RF ablations using conventional catheters were necessary. After multi-electrode duty-cycled RF ablation, 62 of 102 (60.8%) patients were in sustained sinus rhythm without anti-arrhythmic drugs. The mean follow-up duration was 12.2 +/- 3.9 months (range 6-15).



This novel multi-electrode ablation technique can be used for PV isolation and left atrium ablation with a relatively low medium-term success rate after the first ablation of approximately 61%. Larger studies with longer follow-up are required to evaluate the efficacy and whether multi-electrode RF ablation is associated with a different complication rate compared with standard PV isolation.
Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial.

To compare the effects of mirror therapy (MT) versus control treatment (CT) on movement performance, motor control, sensory recovery, and performance of activities of daily living in people with chronic stroke.



Single-blinded, randomized controlled trial.



Four hospitals.



Outpatients with chronic stroke (N=33) with mild to moderate motor impairment.



The MT group (n=16) received upper extremity training involving repetitive bimanual, symmetrical movement practice, in which the individual moves the affected limb while watching the reflective illusion of the unaffected limb's movements from a mirror. The CT group received task-oriented upper extremity training. The intensity for both groups was 1.5 hours/day, 5 days/week, for 4 weeks.



The Fugl-Meyer Assessment; kinematic variables, including reaction time, normalized movement time, normalized total displacement, joint recruitment, and maximum shoulder-elbow cross-correlation; the Revised Nottingham Sensory Assessment; the Motor Activity Log; and the ABILHAND questionnaire.



The MT group performed better in the overall (P=.01) and distal part (P=.04) Fugl-Meyer Assessment scores and demonstrated shorter reaction time (P=.04), shorter normalized total displacement (P=.04), and greater maximum shoulder-elbow cross-correlation (P=.03). The Revised Nottingham Sensory Assessment temperature scores improved significantly more in the MT group than in the CT group. No significant differences on the Motor Activity Log and the ABILHAND questionnaire were found immediately after MT or at follow-up.



The application of MT after stroke might result in beneficial effects on movement performance, motor control, and temperature sense, but may not translate into daily functions in the population with chronic stroke.