nils-herrmann/clean_scirepeval huggingface dataset:
Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood.

To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.



Randomised controlled trial.



Well child clinics, Melbourne, 
156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.



Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.



Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.



At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change -3.7, 95% confidence interval -4.7 to -2.7, v -2.5, -1.7 to -3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (-6.0, -7.5 to -4.0, v -3.7, -4.9 to -2.6, P=0.01) and at four months (-6.5, -7.9 to 5.1 v -4.2, -5.9 to -2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.



Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.
In Barrett's esophagus patients and Barrett's cell lines, ursodeoxycholic acid increases antioxidant expression and prevents DNA damage by bile acids.

Hydrophobic bile acids like deoxycholic acid (DCA), which cause oxidative DNA damage and activate NF-κB in Barrett's metaplasia, might contribute to carcinogenesis in Barrett's esophagus. We have explored mechanisms whereby ursodeoxycholic acid (UDCA, a hydrophilic bile acid) protects against DCA-induced injury in vivo in patients and in vitro using nonneoplastic, telomerase-immortalized Barrett's cell lines. We took biopsies of Barrett's esophagus from 21 patients before and after esophageal perfusion with DCA (250 μM) at baseline and after 8 wk of oral UDCA treatment. DNA damage was assessed by phospho-H2AX expression, neutral CometAssay, and phospho-H2AX nuclear foci formation. Quantitative PCR was performed for antioxidants including catalase and GPX1. Nrf2, catalase, and GPX1 were knocked down with siRNAs. Reporter assays were performed using a plasmid construct containing antioxidant responsive element. In patients, baseline esophageal perfusion with DCA significantly increased phospho-H2AX and phospho-p65 in Barrett's metaplasia. Oral UDCA increased GPX1 and catalase levels in Barrett's metaplasia and prevented DCA perfusion from inducing DNA damage and NF-κB activation. In cells, DCA-induced DNA damage and NF-κB activation was prevented by 24-h pretreatment with UDCA, but not by mixing UDCA with DCA. UDCA activated Nrf2 signaling to increase GPX1 and catalase expression, and protective effects of UDCA pretreatment were blocked by siRNA knockdown of these antioxidants. UDCA increases expression of antioxidants that prevent toxic bile acids from causing DNA damage and NF-κB activation in Barrett's metaplasia. Elucidation of this molecular pathway for UDCA protection provides rationale for clinical trials on UDCA for chemoprevention in Barrett's esophagus.
Fibroblast growth factor 23 in acute myocardial infarction complicated by cardiogenic shock: a biomarker substudy of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial

Cardiogenic shock (CS) is the leading cause of death in patients hospitalized with acute myocardial infarction (AMI). Biomarkers might help in risk stratification and understanding of pathophysiology. Preliminary data suggests that patients with CS face a profound increase in the osteocyte-derived hormone fibroblast growth factor 23 (FGF-23), which acts as a negative regulator of serum phosphate levels. The present study aimed to assess the predictive role of FGF-23 for clinical outcome in a large cohort of CS patients with and without renal dysfunction.



In the randomized Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial, 600 patients with CS complicating AMI were assigned to therapy with or without IABP. Our predefined biomarker substudy included 182 patients. Blood sampling was performed in a standardized procedure at three different time points (day 1 (day of admission), day 2 and day 3). Differences in outcome of patients with FGF-23 levelsmedian were compared by log-rank testing. Stepwise logistic regression modeling was performed to identify predictors of death at 30 days and Cox regression analysis for time to death during the first year.



At all three time points, nonsurvivors had significantly higher FGF-23 levels compared to survivors (P<0.001 for all). Patients with FGF-23 levels above the median (395 RU/mL [interquartile range 102;2,395]) were characterized by an increased 30-day mortality and 1-year mortality. In multivariable analysis FGF-23 levels remained independent predictors for 30-day (odds ratio per 10log 1.80, 95% confidence interval (CI) 1.11 to 2.92; P=0.02) and 1-year mortality (hazard ratio 1.50, 95% CI 1.11 to 2.04, P=0.009). After stratifying the patients according to their baseline serum creatinine levels, the negative prognostic association of increased FGF-23 was only significant in those with serum creatinine greater than median.



In CS, high levels of FGF-23 are independently related to a poor clinical outcome. However, this prognostic association appears only to apply in patients with impaired renal function.
The HOT (Healthy Outcome for Teens) project. Using a web-based medium to influence attitude, subjective norm, perceived behavioral control and intention for obesity and type 2 diabetes prevention

We hypothesized that Theory of Planned Behavior (TPB) constructs (behavioral belief, attitude, subjective norm, perceived behavioral control, knowledge and behavioral intention) regarding preventive behaviors for obesity and type 2 diabetes will change favorably after completing the web-based intervention, HOT (Healthy Outcome for Teens) project, grounded in the TPB; and that passive online learning (POL) group will improve more than the active online learning (AOL) group. The secondary hypothesis was to determine to what extent constructs of the TPB predict intentions. 216 adolescents were recruited, 127 randomly allocated to the treatment group (AOL) and 89 to the control group (POL). The subjects completed a TPB questionnaire pre and post intervention. Both POL and AOL groups showed significant improvements from pretest to posttest survey. However, the results indicated no significant difference between POL and AOL for all constructs except behavioral belief. Correlational analysis indicated that all TPB constructs were significantly correlated with intentions for pretest and posttest for both groups. Attitude and behavioral control showed strongest correlations. Regression analysis indicated that TPB constructs were predictive of intentions and the predictive power improved post intervention. Behavioral control consistently predicted intentions for all categories and was the strongest predictor for pretest scores. For posttest scores, knowledge and attitude were the strongest predictors for POL and AOL groups respectively. Thus, HOT project improved knowledge and the TPB constructs scores for targeted behaviors, healthy eating and physical activity, for prevention of obesity and type 2 diabetes.
Development of fast dissolving oral film containing dexamethasone as an antiemetic medication: clinical usefulness.

We developed a fast dissolving oral film containing 4 mg dexamethasone and examined the clinical effect of the film as the antiemetic by a randomized controlled crossover study in breast cancer patients receiving a combination chemotherapy with anthracycline and cyclophosphamide, a highly emetogenic chemotherapy. The film was prepared as reported previously using microcrystalline cellulose, polyethylene glycol, hypromellose, polysorbate 80 and 5% low substituted hydroxypropylcellulose as base materials. The uniformity of the film was shown by the relative standard deviation of 2.7% and acceptance value of 5.9% by the Japanese Pharmacopoeia. Patients were administered with 8 mg dexamethasone as oral film or tablet on days 2-4 after chemotherapy in addition to the standard antiemetic medication. The rates of complete protection from vomiting during acute and delayed phases were not different between film-treated group and tablet-treated group. The time course of the complete protection from nausea or vomiting during 0-120 h was also similar between the two groups. Patient's impressions on the oral acceptability in respect of the taste and ease in taking were significantly better for film than for tablet. Therefore, the present fast dissolving oral film containing dexamethasone seems to be potentially useful as an antiemetic agent in patients receiving highly emetogenic chemotherapy.
A randomized, double-blind, placebo-controlled study of single dose rituximab as induction in renal transplantation: a 3-year follow-up.

-year-old white man underwent LT in January 2009 because of HCV-related cirrhosis. HIV infection was diagnosed in 2004, with a nadir CD4 cell count of 0.347 10/L (347/KL) (stage A2). ART was started in 2005 with a cumulative exposure of 2 months to PIs. The patient was a smoker and is overweight. IS therapy was based on rapamycin and methylprednisolone (cumulative dose of 1880 mg). The same pretransplant ART regimen containing lamivudine, raltegravir, and unboosted atazanavir was resumed on the 10th pod. Two months after transplantation, rapamycin was switched to cyclosporine because of painful peripheral edemas. In April 2009, he reported an intense left coxalgia. MRI revealed bilateral ON in the femoral heads , which was then confirmed by positron emission tomography. For inefficacy of conservative treatment, in July 2009, total hip arthroplasty on the left side was performed. To date, indication for contralateral hip replacement has not yet been placed.
Changes in time to insulin initiation in type 2 diabetes patients: a retrospective database analysis in Germany and UK (2005-2010).

To study whether the time to insulin therapy in type 2 diabetic patients in primary care in Germany and UK has increased (2005-2010).



Longitudinal data from general practices in Germany and UK (Disease Analyser) from 1995 to 2010 were analyzed. Patients who started their insulin treatment from 2005 to 2010 were analyzed regarding the time from the first diabetes diagnosis in the practices (index date) and the first insulin prescription, including 6368 patients (age: 68 (SD: 12) years) in Germany and 1998 patients (age: 64 (12) yrs) in UK.



Median (interquartile range) time to insulin therapy in the practices increased from 943 (214-1994) days in 2005 to 1549 (957-2533) days in 2010 (p < 0.001). In UK, time to onset of insulin treatment increased from 1700 (649-2521) days in 2005 to 2061 (1309-2686) days in 2010 (p < 0.001). The last HbA1c values before insulin initiation were high and slightly increased during the study period (Germany: 2005: 8.2%, 2010: 8.4%; UK: 2005: 9.5%, 2010: 9.8%; both p < 0.001).



This real world data shows that the time to insulin therapy has increased in type 2 diabetes patients from 2005 to 2010 (Germany, UK). The average HbA1c values before insulin therapy also slightly increased during this period.
The global diversion of pharmaceutical drugs. India: the third largest illicit opium producer?

This paper explores India's role in the world illicit opiate market, particularly its role as a producer. India, a major illicit opiate consumer, is also the sole licensed exporter of raw opium: this unique status may be enabling substantial diversion to the illicit market.



Participant observation and interviews were carried out at eight different sites. Information was also drawn from all standard secondary sources and the analysis of about 180 drug-related criminal proceedings reviewed by Indian High Courts and the Supreme Court from 1985 to 2001.



Diversion from licit opium production takes place on such a large scale that India may be the third largest illicit opium producer after Afghanistan and Burma. With the possible exceptions of 2005 and 2006, 200-300 tons of India's opium may be diverted yearly. After estimating India's opiate consumption on the basis of UN-reported prevalence estimates, we find that diversion from licit production might have satisfied a quarter to more than a third of India's illicit opiate demand to 2004.



India is not only among the world's largest consumer of illicit opiates but also one of the largest illicit opium producers. In contrast to all other illicit producers, India owes the latter distinction not to blatantly illicit cultivation but to diversion from licit cultivation. India's experience suggests the difficulty of preventing substantial leakage, even in a relatively well-governed nation.
Leukocytapheresis in Ulcerative Colitis: Results of a Multicenter Double-Blind Prospective Case-Control Study with Sham Apheresis as Placebo Treatment

Leukocytapheresis (LCAP) is a method of therapeutic apheresis that removes peripheral leukocytes. Previous studies showed that in patients with ulcerative colitis (UC), LCAP was more effective than high-dose steroid therapy, and it had few adverse effects. We investigated LCAP in a multicenter study using active and sham devices in a double-blind study in order to elucidate the placebo effect of extracorporeal treatment including anticoagulant medication.Twenty-five patients with active UC of severe or moderately severe grade were enrolled and assigned to the active group or the sham group. Six patients were excluded from the study and 19 (10 in the active group and nine in the sham group) were evaluated. LCAP (treatment using an active device or a sham device) was performed once a week for 5 wk, followed by two additional sessions during the next 4 wk at 2-wk intervals. Steroids and other medications were continued at the same dosage for 4 wk, which included a 2-wk pre-observation period and the first 2 wk after the start of the LCAP treatment. New medications or increase in the dosage of previous medication were prohibited until evaluation was conducted.The clinical activity index (CAI) value of UC, indicated that the active group showed a significantly greater improvement (80%, 8/10) than the sham group (33%, 3/9; p < 0.05). Adverse effects were observed in five patients (one in the active group and four in the sham group). None of these effects was severe and none of the sessions was terminated as a consequence of the adverse effects.The results confirmed that LCAP is a safe and effective therapeutic option for patients with active UC.
Impact of interventricular lead distance and the decrease in septal-to-lateral delay on response to cardiac resynchronization therapy.

To investigate the influence of interlead distance and lead positioning on success of cardiac resynchronization therapy (CRT) in patients with advanced chronic heart failure and electrical dyssynchrony. Despite application of established selection criteria, 20-40% of the patients do not respond to CRT.



We examined consecutive patients in whom CRT was implanted. Response to CRT was defined as a decrease in the left ventricular end-systolic volume >or=10% after 6 months. A comparison was made between patients who were responders to CRT and those who were non-responders. A univariate and stepwise multivariate logistic regression was performed with regard to predictors for response. Between January 2004 and January 2008, 174 patients who were treated with CRT were classified as responders [n = 95 (55%)] or non-responders [n = 79 (45%)]. Responders had a significantly larger horizontal interlead distance on the lateral thoracic X-ray [odds ratio (OR) 2.8 (1.2-6.6), P = 0.01], a septal-to-lateral delay >60 ms [OR 4.9 (2.0-11.4), P < 0.0001], non-ischaemic cardiomyopathy [OR 3.0 (1.3-6.9), P = 0.009], a left ventricular end-diastolic diameter <67 mm [OR 4.2 (1.8-9.9), P = 0.001], angiotensin-converting enzyme inhibitor use [OR 8.1 (1.7-38.2), P = 0.008], and no tricuspid valve insufficiency [OR 6.9 (1.3-35.5), P = 0.02]. Post-implantation responders had a significantly greater decrease in the intraventricular delay (septal-to-lateral delay 62 +/- 62 vs. 26 +/- 65 ms, P = 0.001), but not in the interventricular mechanical delay.



Larger interlead distance on the lateral thoracic X-ray, associated with positioning of the left ventricular lead in the posterior position, is associated with response after 6 months of follow-up. Furthermore, diminishing the septal-to-lateral delay is predictive for response.
International data on supportive therapies at 1 year in acute coronary syndrome patients undergoing PCI: results from the APTOR study.

Supportive therapies of exercise and diet-modifying secondary prevention programmes are associated with reduced morbidity and mortality in acute coronary syndrome (ACS) patients. We sought to evaluate the frequency and correlates of referral to these supportive therapies, and their impact on concordance with prescribed secondary prevention medications at 1 year among ACS patients undergoing percutaneous coronary intervention (PCI) in three European countries.



Data on referral for exercise and diet supportive therapies were collected at discharge through to 1 year in the Antiplatelet Therapy Observational Registry (APTOR) prospective observational study conducted in France, Spain and the UK in 1335 patients.



40% of patients received referral for exercise or diet, while three out of five patients received neither, with large variation between countries. Predictors of recommendation for either diet or exercise when excluding country were enrolment in a non-teaching centre (odds ratio [OR] 1.62, 95% CI [confidence interval] 1.33-1.97, p < 0.0001) and use of only a bare metal stent during PCI (OR 1.59, 95% CI 1.30-1.92, p = 0.0002), while weight and BMI had no bearing. Patients recommended either diet or exercise programmes had significantly more secondary prevention medication rates for each of the five predefined evidence-based BASIC (beta-blockers, aspirin, statins, ACE-inhibitors/ARBs and clopidogrel) medication therapies at 1 year.



Following an ACS treated with PCI, by 1 year the majority of European patients were not recommended supportive therapies of exercise and dietary secondary prevention programmes, which have previously been associated with reduced morbidity and mortality and are recommended in the guidelines. Those recommended such therapies had considerably improved concordance with evidence-based therapies such as aspirin, clopidogrel and statins prescribed at 1 year. These data show a need for greater adherence to the European guidelines to ensure ACS patients are recommended such therapies.
Acute effects of hyperglycaemia with and without exercise on endothelial function in healthy young men

Post-prandial hyperglycaemia impairs endothelial function as evaluated by brachial artery flow-mediated dilation (FMD). Exercise is an intervention to protect against cardiovascular disease and to improve FMD. In this study, we examined whether the effect of acute hyperglycaemia on endothelial function in healthy young men is restored by aerobic exercise. Using a counterbalanced, randomized crossover design, we measured the brachial artery FMD at baseline and 1, 2, 3 and 4 h after 75 g glucose ingestion in 11 healthy young men, with and without a single bout of aerobic exercise. Brachial artery FMD declined from 11.4 ± 3.8% at baseline to 7.3 ± 3.4% 1 h after oral glucose ingestion, and returned to baseline after 4 h. When the oral glucose ingestion was followed immediately by 45 min of treadmill exercise at an intensity of 60% maximal oxygen uptake, FMD demonstrated no significant decrease (11.8 ± 2.5, 11.3 ± 2.8, 12.2 ± 2.7, 13.5 ± 3.5, and 12.6 ± 2.4% at baseline and 4 h after ingestion, respectively). The results indicate that the aerobic exercise restores the impaired FMD induced by oral glucose ingestion.
Distinct effects of fixed combinations of valsartan with either amlodipine or hydrochlorothiazide on lipoprotein subfraction profile in patients with hypertension

The effect of antihypertensive drugs on lipoprotein subfraction profile is still under investigation. In this study the effects of fixed combination of valsartan with either amlodipine (V–A) or hydrochlorothiazide (V–H) on low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) subfraction profile of patients with stage 2 or 3 hypertension were assessed. A total of 60 drug-naive patients were randomized to either V–A (160/5 mg, n=30) or V–H (160/12.5 mg, n=30). At baseline as well as 16 weeks post-treatment analysis of the LDL and HDL subfraction profile was conducted by using LDL Lipoprint System. Both V–A and V–H effectively reduced blood pressure (BP) to similar levels. An increase in the cholesterol concentration of small-dense LDL subfractions (by 18.2%, P<0.05) was observed in the V–H group, whereas this parameter remained unchanged in the V–A group. Therefore, mean LDL particle size was decreased in the V–H group (from 267±5 to 266±5Å, P<0.05). HDL-Cholesterol (HDL-C) levels were reduced by 4.7% (P<0.05) in the V–H group, mirrored by a reduction in the cholesterol mass of small and intermediate HDL particles. In conclusion, despite similar reductions in BP, V–H combination may adversely affect serum lipids as well as LDL and HDL subfraction profile as compared with V–A.
A risk-prediction model for in-hospital mortality after heart transplantation in US children.

We sought to develop and validate a quantitative risk-prediction model for predicting the risk of posttransplant in-hospital mortality in pediatric heart transplantation (HT). Children <18 years of age who underwent primary HT in the United States during 1999-2008 (n = 2707) were identified using Organ Procurement and Transplant Network data. A risk-prediction model was developed using two-thirds of the cohort (random sample), internally validated in the remaining one-third, and independently validated in a cohort of 338 children transplanted during 2009-2010. The best predictive model had four categorical variables: hemodynamic support (ECMO, ventilator support, VAD support vs. medical therapy), cardiac diagnosis (repaired congenital heart disease [CHD], unrepaired CHD vs. cardiomyopathy), renal dysfunction (severe, mild-moderate vs. normal) and total bilirubin (≥ 2.0, 0.6 to <2.0 vs. <0.6 mg/dL). The C-statistic (0.78) and the Hosmer-Lemeshow goodness-of-fit (p = 0.89) in the model-development cohort were replicated in the internal validation and independent validation cohorts (C-statistic 0.75, 0.81 and the Hosmer-Lemeshow goodness-of-fit p = 0.49, 0.53, respectively) suggesting acceptable prediction for posttransplant in-hospital mortality. We conclude that this risk-prediction model using four factors at the time of transplant has good prediction characteristics for posttransplant in-hospital mortality in children and may be useful to guide decision-making around patient listing for transplant and timing of mechanical support.