nils-herrmann/clean_scirepeval huggingface dataset:
Decompressive craniectomy in diffuse traumatic brain injury.

It is unclear whether decompressive craniectomy improves the functional outcome in patients with severe traumatic brain injury and refractory raised intracranial pressure.



From December 2002 through April 2010, we randomly assigned 155 adults with severe diffuse traumatic brain injury and intracranial hypertension that was refractory to first-tier therapies to undergo either bifrontotemporoparietal decompressive craniectomy or standard care. The original primary outcome was an unfavorable outcome (a composite of death, vegetative state, or severe disability), as evaluated on the Extended Glasgow Outcome Scale 6 months after the injury. The final primary outcome was the score on the Extended Glasgow Outcome Scale at 6 months.



Patients in the craniectomy group, as compared with those in the standard-care group, had less time with intracranial pressures above the treatment threshold (P<0.001), fewer interventions for increased intracranial pressure (P<0.02 for all comparisons), and fewer days in the intensive care unit (ICU) (P<0.001). However, patients undergoing craniectomy had worse scores on the Extended Glasgow Outcome Scale than those receiving standard care (odds ratio for a worse score in the craniectomy group, 1.84; 95% confidence interval [CI], 1.05 to 3.24; P=0.03) and a greater risk of an unfavorable outcome (odds ratio, 2.21; 95% CI, 1.14 to 4.26; P=0.02). Rates of death at 6 months were similar in the craniectomy group (19%) and the standard-care group (18%).



In adults with severe diffuse traumatic brain injury and refractory intracranial hypertension, early bifrontotemporoparietal decompressive craniectomy decreased intracranial pressure and the length of stay in the ICU but was associated with more unfavorable outcomes. (Funded by the National Health and Medical Research Council of Australia and others; DECRA Australian Clinical Trials Registry number, ACTRN012605000009617.).
Internet therapy versus internet self-help versus no treatment for problematic alcohol use: A randomized controlled trial.

Problematic alcohol use is the third leading contributor to the global burden of disease, partly because the majority of problem drinkers are not receiving treatment. Internet-based alcohol interventions attract an otherwise untreated population, but their effectiveness has not yet been established. The current study examined the effectiveness of Internet-based therapy (therapy alcohol online; TAO) and Internet-based self-help (self-help alcohol online; SAO) for problematic alcohol users.



Adult problem drinkers (n = 205; 51% female; mean age = 42 years; mean Alcohol Use Disorders Identification Test score = 20) were randomly assigned to TAO, SAO, or an untreated waiting-list control group (WL). Participants in the TAO arm received 7 individual text-based chat-therapy sessions. The TAO and SAO interventions were based on cognitive-behavioral therapy and motivational interviewing techniques. Assessments were given at baseline and 3 and 6 months after randomization. Primary outcome measures were alcohol consumption and treatment response. Secondary outcome measures included measures of quality-of-life.



Using generalized estimating equation regression models, intention-to-treat analyses demonstrated significant effects for TAO versus WL (p = .002) and for SAO versus WL (p = .03) on alcohol consumption at 3 months postrandomization. Differences between TAO and SAO were not significant at 3 months postrandomization (p = .11) but were significant at 6 months postrandomization (p = .03), with larger effects obtained for TAO. There was a similar pattern of results for treatment response and quality-of-life outcome measures.



Results support the effectiveness of cognitive-behavioral therapy/motivational interviewing Internet-based therapy and Internet-based self-help for problematic alcohol users. At 6 months postrandomization, Internet-based therapy led to better results than Internet-based self-help.
Melatonin does not influence sleep deprivation electroencephalogram recordings in children

The electroencephalogram (EEG) is an essential diagnostic tool in children with epilepsy. The recording of a sleep EEG can increase the yield of EEG recordings in certain epileptic syndromes. The primary aim of this study was to assess the influence of melatonin on EEG recording (quality, EEG characteristics) and to assess its efficacy to induce sleep. Children with epilepsy or non-epileptic neurological patients requiring sleep deprivation EEG studies were enrolled into this prospective study at a tertiary University Hospital study. Sequential recording of sleep deprivation EEGs both with and without prior administration of melatonin was performed. A total of 50 patients (27 with epilepsy, 23 non-epileptic neurological patients) were included in this study (median age 9.5 years; range 1–18 years; male 28). The quality and EEG characteristics (abnormal findings, depth of sleep) were not affected by the use of melatonin. In total, 92 of 100 EEGs were successfully performed without significant differences between the two groups (six failures with melatonin, two failures without melatonin; p = 0.289).  We conclude that melatonin does not alter the quality of sleep EEG studies in children with epilepsy or suspected epilepsy. Melatonin does not increase the rate of successfully performed EEG studies in sleep-deprived children.
Enhanced risk profiling of implanted defibrillator shocks with circulating SCN5A mRNA splicing variants: a pilot trial.

The aim of this study was to determine the association of SCN5A cardiac sodium (Na(+)) channel mRNA splice variants in white blood cells (WBCs) with risk of arrhythmias in heart failure (HF).



HF is associated with upregulation of two cardiac SCN5A mRNA splice variants that encode prematurely truncated, nonfunctional Na(+) channels. Because circulating WBCs demonstrate similar SCN5A splicing patterns, we hypothesized that these WBC-derived splice variants might further stratify patients with HF who are at risk for arrhythmias.



Simultaneously obtained myocardial core samples and WBCs were compared for SCN5A variants C (VC) and D (VD). Circulating variant levels were compared among patients with HF, divided into three groups: HF without an implantable cardioverter-defibrillator (ICD), HF with an ICD without appropriate intervention, and HF with an ICD with appropriate intervention.



Myocardial tissue-derived SCN5A variant expression levels strongly correlated with circulating WBC samples for both VC and VD variants (r = 0.78 and 0.75, respectively). After controlling for covariates, patients with HF who had received an appropriate ICD intervention had higher expression levels of both WBC-derived SCN5A variants compared with patients with HF with ICDs who had not received appropriate ICD intervention (odds ratio, 3.25; 95% CI, 1.64-6.45; p = 0.001). Receiver operating characteristic analysis revealed that circulating SCN5A variant levels were highly associated with the risk for appropriate ICD intervention (area under the curve ≥0.97).



Circulating expression levels of SCN5A variants were strongly associated with myocardial tissue levels. Furthermore, circulating variant levels were correlative with arrhythmic risk as measured by ICD events in an HF population within 1 year. (Sodium Channel Splicing in Heart Failure Trial [SOCS-HEFT]; NCT01185587).
Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study.

Pulmonary vein isolation is the most prevalent approach for catheter ablation of paroxysmal atrial fibrillation. Long-term success of the procedure is diminished by arrhythmia recurrences occurring predominantly because of reconnections in previously isolated pulmonary veins. The aim of the EFFICAS I multicenter study was to demonstrate the correlation between contact force (CF) parameters during initial procedure and the incidence of isolation gaps (gap) at 3-month follow-up.



A radiofrequency ablation catheter with integrated CF sensor (TactiCath, Endosense, Geneva, Switzerland) was used to perform pulmonary vein isolation in 46 patients with paroxysmal atrial fibrillation. During the ablation procedure, the operator was blinded to CF information. At follow-up, an interventional diagnostic procedure was performed to assess gap location as correlated to index procedure ablation parameters. At follow-up, 65% (26/40) of patients showed ≥1 gaps. Ablations with minimum Force-Time Integral (FTI) <400 gs showed increased likelihood for reconnection (P<0.001). Reconnection correlated strongly with minimum CF (P<0.0001) and minimum FTI (P=0.0007) at the site of gap. Gap occurrence showed a strong trend with lower average CF and average FTI. CF and FTI are generally higher on the right side, although the left anterior segment presents a unique challenge to achieve stable position with good CF.



Minimum CF and minimum FTI values are strong predictors of gap formation. Optimal CF parameter recommendations are a target CF of 20 g and a minimum FTI of 400 gs for each new lesion.
The combination of letrozole and trastuzumab as first or second-line biological therapy produces durable responses in a subset of HER2 positive and ER positive advanced breast cancers

Estrogen receptor (ER) and/or progesterone receptor expression occurs in ∼50% HER2 positive (HER2+) breast cancers and cross-talk between the estrogen and HER2 pathways promotes endocrine therapy resistance. The efficacy of the aromatase inhibitor letrozole in combination with trastuzumab was therefore tested in a Phase 2 study. Patients with ER+ and/or PgR+ and HER2+ (IHC 2+ or 3+ or FISH+) advanced breast cancer were treated with trastuzumab plus letrozole until disease progression or unacceptable toxicity. Thirty-three patients were enrolled, of which thirty one were considered evaluable. The majority of patients (82%) had received tamoxifen and 82% had HER2 FISH+ and/or IHC 3+ tumors. Eight patients responded (1 CR and 7 PR) for an overall response rate (ORR) of 26% and a clinical benefit rate (CBR) of 52%. The median time to progression (TTP) was 5.8 months and the median duration of response (DOR) was 20.6+ months. Excluding IHC 2+, FISH− tumors, the OR was 24%, CBR 44%, TTP 5.5 months and DOR 17+ months. The combination was well tolerated with only two toxicity events requiring termination of study medication. Combined trastuzumab and letrozole treatment for patients with HER2+ and ER+ advanced breast cancer produced durable responses consistently lasting at least 1 year in one quarter of the patients. While these data are promising for a subgroup, for half the patients, trastuzumab plus letrozole was inactive. This finding demonstrates ER+ HER2+ advanced disease is heterogeneous and additional agents will be required for optimal management based on targeted therapeutics alone.
Ceramides predict verbal memory performance in coronary artery disease patients undertaking exercise: a prospective cohort pilot study

Coronary artery disease (CAD) is associated with verbal memory decline, although deterioration may be mitigated in individuals undertaking exercise interventions. Ceramide sphingolipids, suggested to play a role in pathological neurodegeneration, have been associated with the development and progression of CAD but their relationship with cognitive response to exercise has not been assessed. In this study, concentrations of very long chain ceramides (C22:0 and C24:0) were assessed as predictors of changes in verbal memory performance over 1 year in subjects with CAD undertaking cardiac rehabilitation (CR).



Verbal memory was measured using the California Verbal Learning Test 2nd Ed. (CVLT-II), from which Z-scores were calculated based on age, gender and education matched norms. Baseline plasma C22:0 and C24:0 ceramide concentrations were measured from fasting blood samples using high performance liquid chromatography coupled electrospray ionization tandem mass spectrometry (LC/MS/MS). Repeated measures general linear models were used to determine the association between baseline plasma ceramides and the change in verbal memory performance over 1 year of CR controlling for age and body mass index (BMI).



In patients with CAD (n = 33, mean age = 62 ± 9 years, 84.8% male, years of education = 17 ± 3 years), higher baseline plasma C22:0 (F1, 29 = 5.30, p = 0.03) and C24:0 (F1, 29 = 4.04, p = 0.05) concentrations significantly predicted less improvement in verbal memory performance over 1 year of CR controlling for age and BMI.



Plasma ceramide concentrations should be further examined as potential predictors of cognitive response to exercise and worse cognitive outcomes in patients with CAD.
Post-operative cognitive functions after general anesthesia with sevoflurane and desflurane in South Asian elderly.

The duration of the recovery of cognition after anesthesia and surgery is multifactorial and is dependent on the type of anesthesia used, the type of surgery, and the patient. The present study compared the speed of recovery in elderly patients undergoing general anesthesia with sevoflurane or desflurane and the incidence and duration of cognitive impairment in them.



The prospective study was conducted at a tertiary care centre in Bangalore from November 2008 to March 2010. Patients aged above 65 years with American Society of Anaesthesiology (ASA) physical status I, II, III undergoing surgeries under general anesthesia lasting from 45 min up to 3 hours were included in the study. The times from discontinuing nitrous oxide to eye opening, tracheal extubation, obeying commands, and the time to orientation to name and place were assessed at 30-60 s intervals. At 1, 3, 6 h after the end of anesthesia, the patient's cognitive functions were assessed by asking them to repeat the Mini Mental Score Examination.


 USED
Student t-test, Chi-square test.



The time to eye opening, time until extubation, time to follow commands and orientation to time, place were significantly better with desflurane compared to sevoflurane (p < .001). Hundred percent of patients in the desflurane group and 97% in the sevoflurane group demonstrated completely normal cognitive function at 6 h postoperatively (p = 0.31).



Desflurane was associated with a faster early recovery than sevoflurane in elderly patients. However, postoperative recovery of cognitive function was similar with both volatile anaesthetics.
Beta cell function after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention

The effects of various weight loss strategies on pancreatic beta cell function remain unclear. We aimed to compare the effect of intensive lifestyle intervention (ILI) and Roux-en-Y gastric bypass surgery (RYGB) on beta cell function.



One year controlled clinical trial (ClinicalTrials.gov identifier NCT00273104).



One hundred and nineteen morbidly obese participants without known diabetes from the MOBIL study (mean (s.d.) age 43.6 (10.8) years, body mass index (BMI) 45.5 (5.6) kg/m², 84 women) were allocated to RYGB (n = 64) or ILI (n = 55). The patients underwent repeated oral glucose tolerance tests (OGTTs) and were categorised as having either normal (NGT) or abnormal glucose tolerance (AGT). Twenty-nine normal-weight subjects with NGT (age 42.6 (8.7) years, BMI 22.6 (1.5) kg/m², 19 women) served as controls. OGTT-based indices of beta cell function were calculated.



One year weight reduction was 30% (8) after RYGB and 9% (10) after ILI (P < 0.001). Disposition index (DI) increased in all treatment groups (all P<0.05), although more in the surgery groups (both P < 0.001). Stimulated proinsulin-to-insulin (PI/I) ratio decreased in both surgery groups (both P < 0.001), but to a greater extent in the surgery group with AGT at baseline (P < 0.001). Post surgery, patients with NGT at baseline had higher DI and lower stimulated PI/I ratio than controls (both P < 0.027).



Gastric bypass surgery improved beta cell function to a significantly greater extent than ILI. Supra-physiological insulin secretion and proinsulin processing may indicate excessive beta cell function after gastric bypass surgery.
Second reduced intensity conditioning allogeneic transplant as a rescue strategy for acute leukaemia patients who relapse after an initial RIC allogeneic transplantation: analysis of risk factors and treatment outcomes

Limited therapeutic options are available after relapse of acute leukaemia following first reduced intensity conditioning haematopoietic stem cell transplantation (RIC1). A retrospective study on European Society for Blood and Marrow Transplantation (EBMT) registry data was performed on 234 adult patients with acute leukaemia who received a second RIC transplantation (RIC2) from 2000 to 2012 as a salvage treatment for relapse following RIC1. At the time of RIC2, 167 patients (71.4%) had relapsed or refractory disease, 49 (20.9%) were in second CR and 18 (7.7%) in third or higher CR. With a median follow-up of 21 (1.5–79) months after RIC2, 51 patients are still alive. At 2 years, the cumulative incidence of non-relapse mortality (NRM), relapse incidence (RI), leukaemia-free survival (LFS) and overall survival (OS) were 22.4% (95% confidence interval (CI): 17–28.4), 63.9% (56.7–70.1), 14.6% (8.8–18.5) and 20.5% (14.9–26.1), respectively. In patients with acute myelogenous, biphenotypic and undifferentiated leukaemia (representing 89.8% of all patients), duration of remission following RIC1 >225 days, presence of CR at RIC2, patient’s Karnofsky performance status >80 at RIC2 and non-myeloablative conditioning were found to be the strongest predictors of patients’ favourable outcome.
Prefrontal cortex modulation using transcranial DC stimulation reduces alcohol craving: a double-blind, sham-controlled study.

Functional neuroimaging studies have shown that specific brain areas are associated with alcohol craving including the dorsolateral prefrontal cortex (DLPFC). We tested whether modulation of DLPFC using transcranial direct current stimulation (tDCS) could alter alcohol craving in patients with alcohol dependence while being exposed to alcohol cues.



We performed a randomized sham-controlled study in which 13 subjects received sham and active bilateral tDCS delivered to DLPFC (anodal left/cathodal right and anodal right/cathodal left). For sham stimulation, the electrodes were placed at the same positions as in active stimulation; however, the stimulator was turned off after 30s of stimulation. Subjects were presented videos depicting alcohol consumption to increase alcohol craving.



Our results showed that both anodal left/cathodal right and anodal right/cathodal left significantly decreased alcohol craving compared to sham stimulation (p<0.0001). In addition, we found that following treatment, craving could not be further increased by alcohol cues.



Our findings showed that tDCS treatment to DLPFC can reduce alcohol craving. These findings extend the results of previous studies using noninvasive brain stimulation to reduce craving in humans. Given the relatively rapid suppressive effect of tDCS and the highly fluctuating nature of alcohol craving, this technique may prove to be a valuable treatment strategy within the clinical setting.
Monitoring time interval for pQCT-derived bone outcomes in postmenopausal women

Evidence of measurement precision, annual changes and monitoring time interval is essential when designing and interpreting longitudinal studies. Despite the precise measures, small annual changes in bone properties led to monitoring time intervals (MTIs) of 2–6 years in peripheral quantitative computed tomography (pQCT)-derived radial and tibial bone area, density, and estimated strength in postmenopausal women. The purpose of the study was to determine the precision error, annual change, and MTI in bone density, area, and strength parameters in postmenopausal women. Postmenopausal women (n = 114) from the Saskatoon cohort of the Canadian Multicentre Osteoporosis Study had annual pQCT scans of the distal and shaft sites of the radius and tibia for 2 years. Median annualized rates of percent change and the MTI were calculated for bone density, area, and strength parameters. Root mean squared coefficients of variation (CV%) were calculated from duplicate scans in a random subgroup of 35 postmenopausal women. CV% ranged from 1.4 to 6.1 % at the radius and 0.7 to 2.1 % at the tibia. MTIs for the distal radius were 3 years for total bone density (ToD) and 4 years for total bone cross sectional area (ToA), trabecular area, and bone strength index. At the diaphyseal radius, MTI was 3 years for ToA, 5 years for cortical density, and 6 years for polar stress strain index (SSIp). Similarly, MTI for total and trabecular density was 3 years at the distal tibia. At the diaphyseal tibia, MTI for ToA was 3 years and SSIp 4 years. MTI for longitudinal studies in older postmenopausal women should be at least 2–6 years at the radius and tibia, with specific monitoring of the total and trabecular area, total density, and bone strength at the radius and total and trabecular density, total area, and bone strength at the tibia.
Selective hepatic arterial infusion of In-111-DTPA-Phe1-octreotide in neuroendocrine liver metastases

The aim of this study is to evaluate the effectiveness of 111In-DTPA-Phe1-octreotide infusions after selective catheterization of the hepatic artery in inoperable metastasised liver, sst2 receptor-positive neuroendocrine tumours due to the effect of 111In Auger electron emission, minimising in parallel the toxicity of non-target tissue. The average dose per session administered monthly to each patient (17 cases in total) was 6.3 ± 2.3 GBq. Repetitions did not exceed 12-fold, except in one case (15 sessions). Response assessment was classified according to the Response Evaluating Criteria in Solid Tumours. CT/MRI scans were performed as baseline before, during and after the end of treatment, and monthly ultrasound images for follow-up measurements. Toxicity (World Health Organization criteria) was measured using blood and urine tests of renal, hepatic and bone marrow function. Complete response was achieved in one (5.9%) patient and partial in eight (47.0%), and disease stabilization in 3 (17.7%) patients; five (29.4%) did not respond. A 32-month median survival time was estimated in 12 (70.5%). Nine of these 12 surviving had a mean target diameter shrinkage from 144 ± 81 to 60 ± 59 mm. Grade 1 erythro-, leuko- and thrombo-cytopenia occurred in three (17.6%) cases. In unresectable metastatic liver lesions positive for somatostatin receptors repeated, transhepatic high doses of 111In-DTPA-Phe1-octreotide show an effective therapeutic outcome. Given the locoregional modality character of the administration technique plus the extremely short range of 111In Auger and internal conversion electrons emission, no nephro-, liver- or myelo-toxicity has so far been observed.