nils-herrmann/clean_scirepeval huggingface dataset:
Preoperative administration of esomeprazole has no influence on frequency of refluxes.

To examine the effect of esomeprazole in a fixed time setting on gastric content volume, gastric acidity, gastric barrier pressure, and reflux propensity.



Randomized, controlled, double-blind trial.



21 healthy, ASA I physical status volunteers.



Esomeprazole was given 12 hours and one hour before investigation. Before the study, a multichannel intraluminal impedance catheter, pH monitoring data logger (PHmetry) catheter, and an intragastric-esophageal manometry catheter were placed nasally after topical anesthesia.



Gastric acidity and gastric content volume were determined by PHmetry after aspiration of gastric contents over a nasogastric tube. Gastroesophageal reflux and intragastric-esophageal barrier pressure were investigated by multichannel intraluminal impedance measurement, PHmetry, and intragastric-esophageal manometry.



The pH of gastric contents was significantly (P < 0.001) higher after esomeprazole (mean [25th-75th percentile], 4.2 [3.9-4.8] vs 2.0 [1.9-2.7]), and gastric content volume was significantly (P < 0.001) lower (5.0 mL [3.0-12.0] vs 15 mL [10.0-25.0]) in comparison to placebo. No significant difference between esomeprazole and placebo was found with respect to number of refluxes per person, duration of reflux, or barrier pressure.



Esomeprazole in a fixed time setting can markedly increase the pH of gastric contents and decrease gastric content volume, but has no influence on the frequency, duration of refluxes, or gastroesophageal barrier pressure.
Randomised clinical trial: prevention of recurrence of peptic ulcers by rabeprazole in patients taking low-dose aspirin.

Few studies have evaluated the effects of rabeprazole on low-dose aspirin (LDA)-induced gastroduodenal injuries.



To conduct a randomised, double-blind, triple-dummy, active-controlled, multicentre trial, named the PLANETARIUM study, to assess the efficacy, dose-response relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients on long-term LDA therapy.



Eligible patients had a history of endoscopically confirmed peptic ulcers and were receiving long-term LDA (81 or 100 mg/day) therapy for cardiovascular or cerebrovascular protection. Subjects were randomly segregated into three groups receiving rabeprazole 10 mg once daily (standard dose in Japan), rabeprazole 5 mg once daily, or teprenone (geranylgeranylacetone; mucosal protective agent commercially available in Japan) 50 mg three times per day as an active control. The primary endpoint was recurrence of peptic ulcers over 24 weeks.



Among 472 randomised subjects, 452 subjects (n = 151, 150, 151, respectively) constituted the full analysis set. The cumulative recurrence rates of peptic ulcers over 24 weeks in the 10- and 5-mg rabeprazole groups were 1.4% and 2.8%, respectively, both of which were significantly lower than that in the teprenone group (21.7%). The cumulative occurrence rate of bleeding ulcers over 24 weeks in the teprenone group was 4.6%, while bleeding ulcers were not observed in the 10- or 5-mg rabeprazole groups. Rabeprazole was well tolerated at both doses.



Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose-response effect in subjects on low-dose aspirin therapy.
Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

Cognitive behaviour therapy (CBT) is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision.



This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis.



This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have very significant benefits in relation to the current policy of improving access to psychological therapies, in addition to addressing more effectively an important and often unmet need of this vulnerable client group. The economic analysis will identify the direct and indirect costs (and/or savings) of the intervention and consider these in relation to the range of observed effects. The qualitative analyses will enhance the interpretation of the quantitative data, and if the study shows positive results, will inform the roll-out of the intervention to the wider community.
The impact of imagery rescripting on memory appraisals and core beliefs in social anxiety disorder.

Negative mental images in social anxiety disorder (SAD) are often rooted in autobiographical memories of formative, distressing life events. In the present study, 25 participants with SAD retrieved an idiosyncratic negative mental image and associated autobiographical memory. Participants were then randomly assigned either to a single-session of imagery rescripting (IR) targeting the retrieved autobiographical memory or to a non-intervention control condition (no-IR). Outcomes were assessed one week later. Compared to control participants, those who received IR experienced substantial reduction in SAD symptoms accompanied by more positive and less negative appraisals of their autobiographical memories. Moreover, IR relative to no-IR participants reported marked shifts in the content, validity, and accuracy of their memory-derived negative core beliefs about self and others, but not about the world. Results support the promise of IR as a stand-alone intervention for SAD and suggest important directions for future research to enhance our understanding of the cognitive mechanisms that underlie its effects.
CYP 2 C 19 But Not PON 1 Genetic Variants Influence Clopidogrel Pharmacokinetics , Pharmacodynamics , and Clinical Efficacy in Post – Myocardial Infarction Patients

Reduced concentrations of clopidogrel active metabolite have been associated with diminished platelet inhibition and higher rates of adverse cardiovascular events. Paraoxonase-1 (PON1) has recently been proposed as a key enzyme for clopidogrel metabolic activation. We tested the effects of PON1 polymorphisms on clopidogrel pharmacokinetics and pharmacodynamics and the occurrence of cardiovascular outcomes in young post–myocardial infarction (MI) patients treated with clopidogrel. We genotyped PON1 (Q192R and L55M) and CYP2C19 variants in 106 patients enrolled in the PK/PD CLOVIS-2 trial. Patients were randomly exposed to a 300-mg or 900-mg clopidogrel loading dose in a crossover study design. Clopidogrel active metabolite isomer H4 (clopi-H4) and platelet function testing were measured serially after loading dose. There was no significant association between PON1 Q192R or L55M and clopi-H4 formation or antiplatelet response to clopidogrel after either loading dose. Using multivariable linear regression analyses, the CYP2C19*2 allele was the only predictor of clopi-H4 generation and platelet response irrespective of the platelet function assay. CYP2C19 loss-of-function but not PON1 variants were significantly associated with increased risk of major cardiovascular events (death, MI, and urgent coronary revascularization) occurring during long-term clopidogrel exposure in 371 young post-MI patients (age 45 years) enrolled in the AFIJI cohort (CYP2C19 loss-of-function allele carrier versus noncarrier: hazard ratio, 2.26; 95% confidence interval, 1.15–4.41, P 0.02; PON1 QQ192 versus QR/RR192: hazard ratio, 1.03; 95% confidence interval, 0.50–2.11, P 0.93; PON1 LL55 versus LM/MM55: hazard ratio, 1.52; 95% confidence interval, 0.75–3.08, P 0.24). Our study does not confirm that PON1 Q192R or L55M can influence clopidogrel pharmacokinetics or pharmacodynamics in post-MI patients.
Glucose metabolism and neurological outcome in congenital hyperinsulinism.

Advances in imaging and surgical techniques allow a complete cure for children with focal-type congenital hyperinsulinism (CHI). In contrast, management of diffuse-type CHI remains a matter of controversy. To prevent hypoglycemic brain damage, extensive surgery has been recommended in the past, resulting in diabetes. On the basis of 2 data sets of patients with congenital hyperinsulinism, the German registry for CHI with 235 patients (ages 1 day to 19 years) and the diabetes treatment register (Diabetes Patienten-Verlaufsdokumentationssystem initiative), a follow-up study was initiated for diabetes mellitus and the intellectual and physical development as well as motor function. In our ongoing study, we investigated 20 patients with CHI (12 male, mean ages 9.9 years). Six of 20 patients had undergone subtotal pancreatectomy. In early infantile development (0-3 years) we observed a trend to motor and speech delay. In early childhood (2.5-7 years) there appeared a trend to an advantage of results of nonverbal tasks compared with verbal tasks. Before 1990 most patients (∼75%) were treated by subtotal pancreatectomy; since 2000, a more conservative approach is obvious (4/68). All patients with diabetes (n = 25) developed the condition after undergoing subtotal pancreatectomy. No spontaneous manifestation of diabetes was noted before adulthood. There was a wide range of age (0-17.7 years) at manifestation indicating a long period during which glucose tolerance is compensated. Compared with >40.000 children with type 1 diabetes mellitus from the Diabetes Patienten-Verlaufsdokumentationssystem registry, we found significant differences with a tendency for being overweight as well as small stature. Mean daily insulin dose and HbA1c was comparable in both groups.
Time to brain imaging in acute stroke is improving: secondary analysis of the INSTINCT trial.

Patients with acute ischemic stroke benefit from rapid evaluation and treatment, and timely brain imaging is a necessary component. We determined the effect of a targeted behavioral intervention on door-to-imaging time (DIT) among patients with ischemic stroke treated with tissue-type plasminogen activator. Second, we examined the variation in DIT accounted for by patient-level and hospital-level factors.



The Increasing Stroke Treatment through Interventional behavioral Change Tactics (INSTINCT) trial was a cluster-randomized, controlled trial involving 24 Michigan hospitals. The intervention aimed to increase tissue-type plasminogen activator utilization. Detailed chart abstractions collected data for 557 patients with ischemic stroke. We used a series of hierarchical linear mixed-effects models to evaluate the effect of the intervention on DIT (difference-in-differences analysis) and used patient-level and hospital-level explanatory variables to decompose variation in DIT.



DIT improved over time, without a difference between intervention and control hospitals (intervention: 23.7-19.3 minutes, control: 28.9-19.2 minutes; P=0.56). Adjusted DIT was faster in patients who arrived by ambulance (7.2 minutes; 95% confidence interval, 4.1-10.2), had severe strokes (1.0 minute per +5-point National Institutes of Health Stroke Scale; 95% confidence interval, 0.1-2.0), and presented in the postintervention period (4.9 minutes; 95% confidence interval, 2.3-7.4). After accounting for these factors, 13.8% of variation in DIT was attributable to hospital. Neither hospital stroke volume nor stroke center status was associated with DIT.



Performance on DIT improved similarly in intervention and control hospitals, suggesting that nonintervention factors explain the improvement. Hospital-level factors explain a modest proportion of variation in DIT, but further research is needed to identify the hospital-level factors responsible.
A Randomized Controlled Trial of Intranasal Ketamine in Major Depressive Disorder

The N-methyl-D-aspartate glutamate receptor antagonist ketamine, delivered via an intravenous route, has shown rapid antidepressant effects in patients with treatment-resistant depression. The current study was designed to test the safety, tolerability, and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial.



In a randomized, double-blind, crossover study, 20 patients with major depression were randomly assigned, and 18 completed 2 treatment days with intranasal ketamine hydrochloride (50 mg) or saline solution. The primary efficacy outcome measure was change in depression severity 24 hours after ketamine or placebo, measured using the Montgomery-Åsberg Depression Rating Scale. Secondary outcomes included persistence of benefit, changes in self-reports of depression, changes in anxiety, and proportion of responders. Potential psychotomimetic, dissociative, hemodynamic, and general adverse effects associated with ketamine were also measured.



Patients showed significant improvement in depressive symptoms at 24 hours after ketamine compared to placebo (t = 4.39, p < .001; estimated mean Montgomery-Åsberg Depression Rating Scale score difference of 7.6 ± 3.7; 95% confidence interval, 3.9-11.3). Response criteria were met by 8 of 18 patients (44%) 24 hours after ketamine administration compared with 1 of 18 (6%) after placebo (p = .033). Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters.



This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine. Treatment was associated with minimal adverse effects. If replicated, these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression.
Latanoprost and respiratory function in asthmatic patients: randomized, double-masked, placebo-controlled crossover evaluation.

To evaluate the effects of single and multiple administrations of the ocular hypotensive drug latanoprost on respiratory function, asthma symptoms, and use of asthma medication in patients with bronchial asthma.



Twenty-four stable patients with asthma (forced expiratory volume in 1 second: 70% to 90% of predicted and a minimum of 10% reversibility after inhalation of albuterol sulfate) with no previous exposure to inhaled corticosteroids participated in this randomized, double-masked crossover trial. Patients received latanoprost, 0.005%, or placebo, 1 drop per day, in each eye during two 6-day treatment periods separated by a 2-week washout period. Acute latanoprost or placebo provocation, methacholine chloride airway reactivity, and 12-stimulator reversibility tests were performed.



Morning and evening peak expiratory flow, spirometric performance throughout treatment periods and during different provocation tests, asthma symptoms, and use of asthma medications were evaluated.



There were no statistically significant differences between treatments in morning and evening peak expiratory flow, scored daytime and nocturnal asthma symptoms, or daily consumption of asthma medication. During placebo provocation, there was a small increase in forced expiratory volume in 1 second that was not seen during latanoprost provocation. This small difference (-0.09 L) was statistically significant but without clinical importance.



Resting and provoked airway function and asthma symptoms were unaffected by latanoprost treatment in patients with asthma with no previous exposure to corticosteroids. Latanoprost can be used in patients with glaucoma and concomitant bronchial asthma.
Comment on the Paper by Esen et al. Entitled "Evaluation of Choroidal Vascular Changes in Patients with Multiple Sclerosis Using Enhanced Depth Imaging Optical Coherence Tomography".

thickness in optic neuritis associated with MS. Similar to Esen et al.  , they found a reduced average-RNFL thickness in MS eyes with optic neuritis. However, they also reported that inferiorand temporal-quadrant RNFL thickness is different between eyes with optic neuritis and control eyes. Moreover, they found a statistically significant difference in the inferior quadrant between eyes without optic neuritis and control eyes  . Esen et al.  only reported the difference between the average-RNFL thicknesses of the groups but they did not compare the quadrants in their study. As Scheel et al.  , we think that RNFL can be used as a marker of MS damage in the optic pathway and white matter and wonder whether there is a significant difference between the control, MS-with-optic-neuritis and MS-without-optic-neuritis groups in their study. We suppose that this comparison will improve our understanding of the application of RNFL measurements in patients with MS.  We read the article by Esen et al.  entitled ‘Evaluation of choroidal vascular changes in patients with multiple sclerosis using enhanced depth imaging optical coherence tomography’ with great interest. The authors evaluated the choroidal thickness changes in patients with multiple sclerosis (MS) using optical coherence tomography. They found that choroidal structural and retinal nerve fiber layer (RNFL) changes can be seen in the course of MS. We congratulate the authors for their study and would like to make a contribution. Scheel et al.  investigated the association of RNFL with white matter damage assessed by diffusion tensor imaging. They reported that there was a significant correlation between RNFL and fractional anisotropy inside the optic radiation, central corpus callosum and remainder of the white matter. They suggested that RNFL can be used as a marker of white matter damage in MS. Chatziralli et al.  evaluated RNFL Received: November 8, 2015  November 26, 2015  2016
Chemomodulation of sequential high-dose cytarabine by fludarabine in relapsed or refractory acute myeloid leukemia: a randomized trial of the AMLCG

Chemomodulation of cytarabine by fludarabine has been attributed with a higher antileukemic efficacy, but randomized trials to address this question are rare. We therefore conducted a multicenter, randomized phase III study to evaluate the antileukemic efficacy of adding fludarabine to sequential high-dose cytarabine+idarubicin (SHAI) re-induction chemotherapy in relapsed or refractory acute myeloid leukemia (AML). Patients (n=326, of which 281 were evaluable) were randomly assigned to SHAI (cytarabine, 1 g/m2 bid, days 1–2 and 8–9 (3 g/m2 for patients ⩽60 years with refractory AML or ⩾2nd relapse); idarubicin 10 mg/m2 daily, days 3–4 and 10–11) or F-SHAI (SHAI with fludarabine, 15 mg/m2, 4 h before cytarabine). Although complete remission (CR) rates (35% SHAI and 44% F-SHAI) and overall survival did not differ between both regimens, fludarabine prolonged time to treatment failure from 2.04 to 3.38 months (median, P<0.05). Twenty-seven percent of patients proceeded to allogeneic stem cell transplantation, with a significantly higher number of patients in CR or incomplete remission in the F-SHAI group (22 vs 10%, P<0.01). In conclusion, fludarabine has a beneficial, although moderate, impact on the antileukemic efficacy of high-dose cytarabine-based salvage therapy for relapsed and refractory AML.
Dynamic memory interval test vs. interprocedural pointer analysis in multimedia applications

Techniques to detect aliasing between access patterns of array elements are quite effective for many numeric applications. However, although multimedia codes usually follow very regular memory access patterns, current commercial compilers remain unsuccessful in disambiguating them due mainly to complex pointer references. The Dynamic Memory Interval Test is a runtime memory disambiguation technique that takes advantage of the specific behavior of multimedia memory access patterns. It evaluates whether or not the full loop is disambiguated by analyzing the region domain of each load or store before each invocation of the loop.This paper provides a detailed evaluation of the approach, compares it against an advanced interprocedural pointer analysis framework, and analyzes the possibility of using both techniques at the same time. Both techniques achieve similar speedups separately (1.25X in average for a 8-issue width architecture). Furthermore, they can be used together to improve performance (reaching an average speed-up of 1.32X). Results also confirm that memory disambiguation is a key optimization to exploit the available parallelism in multimedia codes, especially for wide-issue architectures (1.50X average speed-up when scaling from 4- to 12-issue width in contrast to a low 1.10X for the baseline compiler).
Changes in basal and postmethionine load concentrations of total homocysteine and cystathionine after B vitamin intervention.

Vitamin B-6 is necessary for the metabolism of homocysteine and is often used in combination with folic acid and vitamin B-12 in clinical trials that investigate whether the lowering of plasma total homocysteine (tHcy) can prevent vascular disease.



We compared the effects of vitamin B-6 with the effects of folic acid and vitamin B-12, as used in the Western Norway B-vitamin Intervention Trial (WENBIT), on basal and postmethionine load (PML) tHcy and cystathionine concentrations.



Ninety patients with suspected coronary artery disease were randomly assigned to 1 of 4 groups to receive daily oral treatment with 1) 0.8 mg folic acid, 0.4 mg vitamin B-12, and 40 mg vitamin B-6 (group A); 2) 0.8 mg folic acid and 0.4 mg vitamin B-12 (group B); 3) 40 mg vitamin B-6 (group C); or 4) placebo (group D). For the first 2 wk, groups A and B received additional folic acid (5 mg/d). A methionine-loading test was performed at baseline and after 3 mo.



Treatment with folic acid and vitamin B-12 caused a rapid and significant lowering of basal (31%) and PML tHcy concentrations (22%), with no effect on cystathionine. Vitamin B-6 did not change basal tHcy and had a significant but limited effect on PML tHcy concentrations. However, vitamin B-6 treatment markedly lowered basal and PML cystathionine by 31% and 42%, respectively.



The folic acid and vitamin B-12 combination applied in WENBIT provides rapid, substantial, and long-term tHcy-lowering effects, whereas the effect of vitamin B-6 on tHcy was relatively small and confined to PML tHcy. However, vitamin B-6 treatment caused a marked reduction in plasma cystathionine. Cystathionine could be a useful marker for assessment of the vitamin B-6 effect and should, together with tHcy, be related to clinical outcome in ongoing trials.