nils-herrmann/clean_scirepeval huggingface dataset:
Laparoscopic approach for solitary insulinoma: a multicentre study

Surgical resection of insulinomas is the preferred treatment in order to avoid symptoms of hypoglycaemia. During the past years, advances in laparoscopic techniques have allowed surgeons to approach the pancreas and treat these lesions laparoscopically. We analysed the feasibility, safety, and outcome of patients undergoing laparoscopic resection of insulinomas in a large, retrospective, multicentre study. Thirty-six patients with pancreatic insulinomas were enrolled in this study. All patients were suspected of having solitary insulinomas after preoperative localisation tests and underwent a laparoscopic approach. Patients, operating characteristics and outcome were analysed. Mean patient age was 48 years (range 20–77 years). Insulinomas were localised in the head (n=7), isthmus (n=2), body (n=14) or tail (n=13) of the pancreas before laparoscopic approach. Mean size of the lesions was 15.5 mm (range 4–25 mm). The surgical procedure was enucleation in 19 cases (52%), spleen-preserving distal pancreatectomy in 12 cases (33%), spleno-pancreatectomy in three cases (8%), one duodenopancreatectomy and one central pancreatectomy. Conversion rate was 30%. The reason for conversion in seven patients (63%) was the inability to localise the tumour during the laparoscopic procedure. In six of these cases laparoscopic ultrasonography was not performed. Mean operating time was 156 min (range 50–420 min). Postoperative course was uneventful in 23 patients (64%). Eleven patients (30%) developed specific complications of pancreatic surgery: intra-abdominal abscess (n=6) or pancreatico-cutaneous fistula (n=5). Mean duration of fistulae was 55 days (range 5–130 days) and all the fistulae were dry at follow-up. After a mean follow-up period of 26 months (range 2–87 months), 33 patients (91%) are free of symptoms, and three patients have been lost to follow-up. The laparoscopic approach is safe to treat preoperatively localised insulinoma, with a morbidity rate comparable to that for the open approach. When the tumour is not found during laparoscopy, laparoscopic ultrasonography seems to be the most efficient tool to localise it and probably to prevent conversion.
Hypnotherapy in the treatment of chronic combat-related PTSD patients suffering from insomnia: a randomized, zolpidem-controlled clinical trial.

This study evaluated the benefits of add-on hypnotherapy in patients with chronic PTSD. Thirty-two PTSD patients treated by SSRI antidepressants and supportive psychotherapy were randomized to 2 groups: 15 patients in the first group received Zolpidem 10 mg nightly for 14 nights, and 17 patients in the hypnotherapy group were treated by symptom-oriented hypnotherapy, twice-a-week 1.5-hour sessions for 2 weeks. All patients completed the Stanford Hypnotic Susceptibility Scale, Form C, Beck Depression Inventory, Impact of Event Scale, and Visual Subjective Sleep Quality Questionnaire before and after treatment. There was a significant main effect of the hypnotherapy treatment with PTSD symptoms as measured by the Posttraumatic Disorder Scale. This effect was preserved at follow-up 1 month later. Additional benefits for the hypnotherapy group were decreases in intrusion and avoidance reactions and improvement in all sleep variables assessed.
Which crime features are important for criminal network members?

Most of the criminals choose each other to commit crime together. They choose each other based on their similarity or need for particular skills and expertise. Research shows that some features of crime and criminals are important for their decisions to commit crime together. Co-offending history of criminals and similarity of hometown and kinship between criminals are important. Choice of crime location, time and similarity of crime committing methods between criminals are other important factors. To see which crime features are important for committing crime together, two data sets which contain thousands of crimes and hundreds of criminals records, are tested for which features are the most important for criminal network members to work together.
Efficacy and tolerability of aliskiren 300  mg/hydrochlorothiazide 25  mg (± amlodipine 5  mg) in hypertensive patients not controlled by candesartan 32  mg plus HCT 25  mg.

The majority of patients with essential hypertension of moderate severity (WHO grade 2) require combination therapy. We aimed to investigate whether the single-pill combination of aliskiren 300  mg and hydrochlorothiazide (HCT) 25  mg (ALIS 300/HCT 25) improves the BP reduction in hypertensive patients not adequately controlled by the free combination of candesartan 32  mg and HCT 25  mg (CAN 32 + HCT 25).



In an open-label, single-arm study, patients with mean sitting diastolic blood pressure (DBP) between 100-109  mmHg at baseline received 4-week treatment with CAN 32 + HCT 25 (Phase 1), followed - in patients whose BP was not controlled - by 4-week treatment with ALIS 300/HCT 25 (Phase 2). The DBP change between weeks 4 and 8 was the primary endpoint. The ClinicalTrials.gov Identifier is NCT00867490.



In the 186 patients treated, CAN 32 + HCT 25 reduced systolic BP (SBP)/DBP by 18.9/12.2 mmHg. Those 123 patients with uncontrolled hypertension switched to ALIS 300/HCT 25 experienced a further SBP/DBP reduction of 2.8/3.1  mmHg between week 4 and week 8 (p = 0.0064 and p < 0.0001), and 33.3% achieved DBP normalisation. In 61 patients not controlled after week 8 (SBP ≥ 140  mmHg or DBP  ≥  90  mmHg), who participated in an optional study extension, amlodipine 5  mg was added. Triple therapy over 4 weeks decreased SBP/DBP by further 9.2/5.9  mmHg (p < 0.0001 each). Adverse events with suspected drug relationship were noted in 4.3% (Phase 1), 3.3% (Phase 2), and 1.6% (extension) of the patients. Limitations of the study include the open-label, non-randomised approach and short treatment duration across the individual phases.



In this open-label, single-arm switch study reflecting clinical practice, patients with moderate hypertension not controlled by the free combination of CAN 32 + HCT 25 achieved a clinically and statistically significant reduction of blood pressure from the single pill combination of ALIS 300/HCT 25, and the optional addition of amlodipine.
Acupressure for smoking cessation – a pilot study

Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT) or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study.



An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO < or = 9 ppm), the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale.



From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of the dressing. Reporting of NRT consumption was poor, with much missing data, but reporting of ratings of withdrawal symptom scores was nearly complete. However, these showed no significant changes or differences between groups for any week.



Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested.
Differences in verbal memory retrieval in breast cancer chemotherapy patients compared to healthy controls: a prospective fMRI study

Cognitive complaints by breast cancer survivors receiving chemotherapy have led to an increasing interest in elucidating the possible causes of such impairment. Although a number of neuroimaging studies have been conducted, only a handful of them have taken into account cognitive status pre-chemotherapy. The current study included pre-chemotherapy and post-chemotherapy assessment. In addition, various factors such as depression, anxiety, fatigue and days since surgery were considered during analyses. Breast cancer patients performed an fMRI verbal recall task before and an average of 1 month after chemotherapy. Well matched controls also performed the task with a similar timeline. Pre-chemotherapy analyses revealed that patients activated the anterior cingulate less than controls during memory retrieval when anxiety and fatigue scores were added as covariates during group comparisons. In addition, there were also changes in brain activation from pre- to post-chemotherapy in patients but not in controls. Post-chemotherapy, patients had less activation in the bilateral insula, the left inferior orbitofrontal cortex and the left middle temporal gyrus. Finally, patients also showed significantly less activation when compared to controls. Brain regions included: the right middle and superior temporal gyrus, the right medial frontal gyrus, the right inferior orbitofrontal cortex, the left insula and left superior temporal pole. Importantly, depression, anxiety, and particularly fatigue accounted for some of brain activation differences. Our results suggest that chemotherapy in part plays a role in brain activation differences and it also highlights the importance of rigorously controlling for confounding variables. Only by controlling such factors can we understand the role that chemotherapy may play on cognition.
Lung deposition and systemic availability of fluticasone Diskus and budesonide Turbuhaler in children.

Pharmacokinetic studies can be used to measure lung dose of inhaled drugs. The aim of this study was to compare the lung deposition of budesonide (BUD) inhaled from Turbuhaler (AstraZeneca, Lund, Sweden) and fluticasone propionate (FP) inhaled from Diskus (GlaxoSmithKline, London, UK) and to assess if the study design used for pharmacokinetic studies can be simplified. Plasma levels of BUD and FP were measured for 21 hours on five separate days in 15 patients aged 8 to 14 years: (1) Intravenous infusion of 200 microg BUD, (2) intravenous infusion of 200 microg fluticasone dipropionate, (3) inhalation of 800 microg BUD via Turbuhaler, (4) inhalation of 750 microg FP via Diskus, and (5) inhalation of BUD and FP on the same day. Charcoal was ingested to eliminate drug uptake from the gastrointestinal tract. The mean lung deposition of drug after Turbuhaler and Diskus inhalation was 30.8 and 8.0% when BUD and fluticasone were administered on separate days and 29.5% (BUD) and 7.6% (fluticasone) when the two drugs were inhaled on the same day. Lung deposition is four times higher in children after inhalation from Turbuhaler than after inhalation from Diskus. Pharmacokinetic studies with BUD and FP can be simplified because the two treatments can be administered on the same day.
High prevalence of cooled tip use as compared with 8-mm tip in a multicenter Italian registry on atrial fibrillation ablation: focus on procedural safety.

Whether cooling catheters should be preferred for atrial fibrillation (AF) ablation is not yet clear.



From April 2005 to October 2006, 991 (74% men) consecutive patients who underwent AF ablation were prospectively enrolled in 10 Italian centers. For the present subanalysis, patients were ranked in the two study groups on the basis of the catheter system chosen: 8-mm tip was used in 86 patients (9% conventional group) and open-irrigated tip in 905 patients (91% cooled group).



The registry clinical data of both groups showed marked heterogeneity due to the fact that the higher number of patients of the cooled group had longer AF history (4.9+/-4.1 versus 1.2+/-1.8 years; P=0.0001), permanent/persistent AF (41.2 versus 27.9%; P=0.01), and larger left atrium (LA) size (44.1+/-6.2 versus 33.4+/-10.5 mm; P<or=0.00001). Moreover, they underwent a longer procedure (207.2+/-70.8 versus 85.2+/-58 min; P=0.00001), with longer fluoroscopy time (36.5+/-20.1 versus 15.6+/-12 min; P<or=0.0000), and LA roof ablation lines were more frequently added (29.6 versus 3.5%; P<0.0001). Data were confirmed in the multivariate analysis, in which a longer procedure [odds ratio (OR) 1.018; 95% CI 1.009-1.027; P=0.0001], added linear lesions (OR 16.847; 95% CI 4.288-66.190; P=0.0001), and a longer AF history (OR 1.311; 95% CI 1.063-1.616; P=0.01) continued to characterize the cooled group. Even though the lack of homogeneity of the groups could not render any reliable comparison about safety, we report that the rate of cumulative complications (4.7 versus 3.8%; P=NS), cerebral thromboembolism (0 versus 0.4%; P=NS), pulmonary vein (PV) stenosis (0 versus 0.5%; P=NS), pericardial effusions or tamponade (1.2 versus 1.5%; P=NS), and groin complications (4.7 versus 2.0%, P=NS) was low and similar in both the groups.



In the present subanalysis, both the systems showed a similar safety procedural profile, though the lack of homogeneity observed in the two study groups could render any straight conclusion as mere speculation. The longer availability and the consequent higher use of open-irrigated catheters technology for LA ablation in Europe could explain the large preference given to the latter system in the present registry.
Comparison between a new once-daily, bronchodilating drug, bambuterol, and terbutaline sustained-release, twice daily.

Bambuterol is a prodrug, from which terbutaline is slowly generated. The objectives of the study were to evaluate whether bambuterol, given once daily, can control symptoms in asthmatic patients and to compare the bronchodilating effect and the side effects with those of terbutaline sustained-release (SR) tablets given twice daily. Twenty-five out-patients with bronchial asthma were treated during two consecutive 14-day periods with either 30 mg bambuterol tablets once every evening or 2 x 5 mg terbutaline SR tablets morning and evening. The study had a double-blind, cross-over and randomized design. The mean evening peak expiratory flow rate (PEFR) (i.e. 24 h after intake of bambuterol and 12 h after intake of terbutaline SR) was significantly (p less than 0.001) higher during bambuterol than during terbutaline treatment (432 vs 415 l/min). The need for beta-adrenoceptor agonist aerosol in the daytime was significantly (p less than 0.05) lower during treatment with bambuterol once daily (0.70 puffs) than with terbutaline SR b.i.d. (1.04 puffs). The type and intensity of the side effects were the same during both treatments.
Mediators and moderators of a psychosocial intervention for children affected by political violence.

The authors examined moderators and mediators of a school-based psychosocial intervention for children affected by political violence, according to an ecological resilience theoretical framework.



The authors examined data from a cluster randomized trial, involving children aged 8-13 in Central Sulawesi, Indonesia (treatment condition n = 182, waitlist control condition n = 221). Mediators (hope, coping, peer/emotional/play social support) and moderators (gender, age, family connectedness, household size, other forms of social support, exposure to political violence, and displacement) of treatment outcome on posttraumatic stress symptoms and function impairment were examined in parallel process latent growth curve models.



Compared with the waitlist group, those receiving treatment showed maintained hope, increased positive coping, maintained peer social support, and increased play social support. Of these putative mediators, only play social support was found to mediate treatment effects, such that increases in play social support were associated with smaller reductions in posttraumatic stress disorder (PTSD) symptoms. Furthermore, the authors identified a number of moderators: Girls showed larger treatment benefits on PTSD symptoms; girls, children in smaller households, and children receiving social support from adults outside the household showed larger treatment benefits on function impairment.



Findings provide limited evidence for an ecological resilience theoretical framework. On the basis of these findings, the authors recommend a stronger separation between universal prevention (e.g., resilience promotion through play) and selective/indicated prevention (e.g., interventions aimed at decreasing posttraumatic stress symptoms). Play-based interventions should be careful to exclude children with psychological distress. In addition, treatment effects may be augmented by selecting girls and socially vulnerable children.
Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer.

The purpose of this study was to compare docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as front-line treatment in women with advanced breast cancer (ABC).



Previously untreated patients with ABC were randomly assigned to receive docetaxel 75 mg/m(2) plus epirubicin 75 mg/m(2) (DE) on day 1 or docetaxel 75 mg/m(2) on day 1 plus capecitabine 950 mg/m(2) orally twice daily on days 1-14 (DC) in 21-day cycles. Previous anthracycline-based (neo)-adjuvant chemotherapy was allowed if completed >1 year before enrollment. The primary objective of the study was to compare time to disease progression (TTP).



One hundred and thirty-six women were treated on each arm and median TTP was 10.6 versus 11.0 months (P = 0.7), for DE and DC, respectively. According to RECIST criteria we observed 15 (11%) versus 11 (8%) complete responses and 55 (40%) versus 61 (45%) partial responses (P = 0.8), with DE and DC, respectively. Severe toxicity included grade 3-4 neutropenia (57% versus 46%; P = 0.07), febrile neutropenia (11% versus 8%; P = 0.4), hand-foot syndrome (0% versus 4%; P = 0.02), grade 2-3 anemia (20% versus 7%; P = 0.001) and asthenia (12% versus 6%; P = 0.09) with DE and DC, respectively.



The DE and DC regimens have similar efficacy but different toxicity. Either regimen can be used as front-line treatment of ABC.
Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance

Metabolomic screening of fasting plasma from nondiabetic subjects identified α-hydroxybutyrate (α-HB) and linoleoyl-glycerophosphocholine (L-GPC) as joint markers of insulin resistance (IR) and glucose intolerance. To test the predictivity of α-HB and L-GPC for incident dysglycemia, α-HB and L-GPC measurements were obtained in two observational cohorts, comprising 1,261 nondiabetic participants from the Relationship between Insulin Sensitivity and Cardiovascular Disease (RISC) study and 2,580 from the Botnia Prospective Study, with 3-year and 9.5-year follow-up data, respectively. In both cohorts, α-HB was a positive correlate and L-GPC a negative correlate of insulin sensitivity, with α-HB reciprocally related to indices of β-cell function derived from the oral glucose tolerance test (OGTT). In follow-up, α-HB was a positive predictor (adjusted odds ratios 1.25 [95% CI 1.00-1.60] and 1.26 [1.07-1.48], respectively, for each standard deviation of predictor), and L-GPC was a negative predictor (0.64 [0.48-0.85] and 0.67 [0.54-0.84]) of dysglycemia (RISC) or type 2 diabetes (Botnia), independent of familial diabetes, sex, age, BMI, and fasting glucose. Corresponding areas under the receiver operating characteristic curve were 0.791 (RISC) and 0.783 (Botnia), similar in accuracy when substituting α-HB and L-GPC with 2-h OGTT glucose concentrations. When their activity was examined, α-HB inhibited and L-GPC stimulated glucose-induced insulin release in INS-1e cells. α-HB and L-GPC are independent predictors of worsening glucose tolerance, physiologically consistent with a joint signature of IR and β-cell dysfunction.
Raloxifene pharmacokinetics in males with normal and impaired renal function.

To compare raloxifene pharmacokinetics between renally impaired and healthy subjects.



Raloxifene 120 mg was administered to 10 males with renal impairment (creatinine 2-4 mg dl(-1)) and to 10 healthy males. Data were analysed by two noncompartmental and one compartmental nonlinear regression methods.



The medians (95% confidence interval) of the area under the curves (AUC) were 35.1 (25.8, 74) and 20.5 (16.8, 28.0) h ng ml(-1) per mg kg(-1), P < 0.01, and of the clearances (CL/F) were 28.5 (13.5, 38.8) and 48.8 (35.8, 59.4) l h(-1) kg(-1), P < 0.01, in renally impaired and healthy subjects, respectively. 95% Confidence intervals on the differences for AUC and CL/F were 6.5-44.1 and -35.1 to -7.9, respectively.



Exposure to raloxifene was twice as high in males with renal impairment compared with healthy subjects.
Motivational intervention to enhance post-detoxification 12-Step group affiliation: a randomized controlled trial

To compare a motivational intervention (MI) focused on increasing involvement in 12-Step groups (TSGs; e.g. Alcoholics Anonymous) versus brief advice (BA) to attend TSGs.



Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge.



One hundred and forty substance use disorder (SUD) patients undergoing in-patient detoxification (detox) in Norway.



The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale (AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured.



At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval (CI) = 0.04 to 1.78; P = 0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI = -6.5 to -0.6; P = 0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI = -7.5 to -0.4; P = 0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results.



A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox.