nils-herrmann/clean_scirepeval huggingface dataset:
Development and Validation of Risk Models to Select Ever-Smokers for CT Lung Cancer Screening.

The US Preventive Services Task Force (USPSTF) recommends computed tomography (CT) lung cancer screening for ever-smokers aged 55 to 80 years who have smoked at least 30 pack-years with no more than 15 years since quitting. However, selecting ever-smokers for screening using individualized lung cancer risk calculations may be more effective and efficient than current USPSTF recommendations.



Comparison of modeled outcomes from risk-based CT lung-screening strategies vs USPSTF recommendations.



Empirical risk models for lung cancer incidence and death in the absence of CT screening using data on ever-smokers from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO; 1993-2009) control group. Covariates included age; education; sex; race; smoking intensity, duration, and quit-years; body mass index; family history of lung cancer; and self-reported emphysema. Model validation in the chest radiography groups of the PLCO and the National Lung Screening Trial (NLST; 2002-2009), with additional validation of the death model in the National Health Interview Survey (NHIS; 1997-2001), a representative sample of the United States. Models were applied to US ever-smokers aged 50 to 80 years (NHIS 2010-2012) to estimate outcomes of risk-based selection for CT lung screening, assuming screening for all ever-smokers, yield the percent changes in lung cancer detection and death observed in the NLST.



Annual CT lung screening for 3 years beginning at age 50 years.



For model validity: calibration (number of model-predicted cases divided by number of observed cases [estimated/observed]) and discrimination (area under curve [AUC]). For modeled screening outcomes: estimated number of screen-avertable lung cancer deaths and estimated screening effectiveness (number needed to screen [NNS] to prevent 1 lung cancer death).



Lung cancer incidence and death risk models were well calibrated in PLCO and NLST. The lung cancer death model calibrated and discriminated well for US ever-smokers aged 50 to 80 years (NHIS 1997-2001: estimated/observed = 0.94 [95%CI, 0.84-1.05]; AUC, 0.78 [95%CI, 0.76-0.80]). Under USPSTF recommendations, the models estimated 9.0 million US ever-smokers would qualify for lung cancer screening and 46,488 (95% CI, 43,924-49,053) lung cancer deaths were estimated as screen-avertable over 5 years (estimated NNS, 194 [95% CI, 187-201]). In contrast, risk-based selection screening of the same number of ever-smokers (9.0 million) at highest 5-year lung cancer risk (≥1.9%) was estimated to avert 20% more deaths (55,717 [95% CI, 53,033-58,400]) and was estimated to reduce the estimated NNS by 17% (NNS, 162 [95% CI, 157-166]).



Among a cohort of US ever-smokers aged 50 to 80 years, application of a risk-based model for CT screening for lung cancer compared with a model based on USPSTF recommendations was estimated to be associated with a greater number of lung cancer deaths prevented over 5 years, along with a lower NNS to prevent 1 lung cancer death.
A single preoperative dose of diclofenac reduces the intensity of acute postcraniotomy headache and decreases analgesic requirements over five postoperative days in adults: A single center, randomized, blinded trial

Postcraniotomy headache causes considerable pain and can be difficult to treat. We therefore tested the hypothesis that a single 100-mg preoperative dose of diclofenac reduces the intensity of postcraniotomy headache, and reduces analgesic requirements.



200 patients having elective craniotomies were randomly assigned to diclofenac (n = 100) or control (n = 100). Pain severity was assessed by an independent observer using a 10-cm-long visual analog scale the evening of surgery, and on the 1st and 5th postoperative days. Analgesics given during the first five postoperative days were converted to intramuscular morphine equivalents. Results were compared using Mann-Whitney-tests; P < 0.05 was considered statistically significant.



Baseline and surgical characteristics were comparable in the diclofenac and control groups. Visual analog pain scores were slightly, but significantly lower with diclofenac at all times (means and 95% confidence intervals): the evening of surgery, 2.47 (1.8-3.1) vs. 4. 37 (5.0-3.7), (P < 0.001); first postoperative day, 3.98 (3.4-4.6) vs. 5.6 (4.9-6.2) cm (P < 0.001) and 5th postoperative day: 2.8 (2.2-3.4) vs. 4.0 ± (3.3-4.7) cm (P = 0.013). Diclofenac reduced systemic analgesic requirements over the initial five postoperative days (mean and 95% CI): 3.3 (2.6-3.9) vs. 4.3 (3.5-5.1) mg morphine equivalents (P < 0.05).



Preoperative diclofenac administration reduces postcraniotomy headache and postoperative analgesic requirements - a benefit that persisted throughout five postoperative days.
Pathogenetic relevance of the pregnancy hormone relaxin to inborn hip instability

The etiology of inborn hip dysplasia is unknown. In general, a multifactorial genesis is assumed. The influence of hormones on the development of the fetal hip joint and its stability is discussed as well as mechanical influences. This study was carried out with the intention to examine the correlation between the concentration of the pregnancy hormone relaxin and the stability of the hip joint in newborns. Both hips of 90 newborn children were examined clinically and sonographically. In 25 hips (13.9%), pathological sonograms according to the classification of Graf were found. The relaxin concentration was measured in cord blood using a heterologous radioimmunoassay. Statistical evaluation revealed an insignificant decrease of relaxin concentration with increasing sonographic hip instability. The results indicate that hip instability frequently occurs with decreasing relaxin concentration. These facts contradict the earlier assumption that hip instability coincides with increased relaxin concentrations in newborns. We assume that there is a worse preparation of the pelvis and the birth canal during pregnancy due to the lower relaxin concentration and thus that there could be a higher pressure on the fetus in the perinatal phase. A decreased relaxin concentration seems to have no direct effect on the hip joint tissue, but indirectly there is consequent rigidity of the tissue in mother and child,
Phase I and pharmacokinetics study of crotoxin (cytotoxic PLA(2), NSC-624244) in patients with advanced cancer.

A Phase I clinical trial was performed on patients with solid tumors refractory to conventional therapy. Crotoxin was administered i.m. for 30 consecutive days at doses ranging from 0.03 to 0.22 mg/m(2). Patients entered the study after providing a written informed consent. Although 26 patients were entered only 23 were evaluated. Reversible, nonlimiting neuromuscular toxicity evidenced as diplopia because of pareses of the external ocular muscles was present in 13 patients. It started at doses of 0.18 mg/m(2) and lasted from 2 to 6 h. These episodes did not require dose adjustment and disappeared in 1-3 weeks of treatment. Three patients experienced palpebral ptosis, nystagmus (grade 2), and anxiety (grade 2-3) at the dose-limiting toxicity of 0.22 mg/m(2). Also at dose-limiting toxicity, 1 patient showed nystagmus (grade 2) and anxiety (grade 3) without evidence of palpebral ptosis. Transient increases (grades 1-3) in the levels of creatinine kinase, aspartate aminotransferase, and alanine transaminase attributed to crotoxin myotoxicity were observed but returned to normal by the last week of treatment. At 0.21 mg/m(2) there was a case of grade-3 anaphylactic reaction on day 31, which required treatment. Hypersensitivity was regarded as an adverse drug-related reaction, and the patient was removed from the protocol. Two patients at different doses (0.12 mg/m(2) and 0.22 mg/m(2)) had sialorrhea. Four patients had asymptomatic transient increase in blood pressure (up to 20 mm Hg) 12 h after the first injection, which lasted 24 h. No treatment was required and toxicity did not reappear. Six patients experienced slight eosinophilia during the first 2 weeks. The maximum tolerated dose was set at 0.21 mg/m(2). Objective measurable partial responses (>50% reduction of tumor mass) were noted in 2 patients treated at 0.21 mg/m(2) and 1 at 0.12 mg/m(2). One patient (at 0.21 mg/m(2)) presented a complete response on day 110. Crotoxin pharmacokinetics showed rapid absorption from the injection site to blood (t(1/2 A) = 5.2 +/- 0.6 min). Plasma concentration reached a peak (C(max) = 0.79 +/- 0.1 ng/ml) at tau(max) = 19 +/- 3 min. The half-life of the distribution (alpha) phase is 22 +/- 2 min. Starting at 1.5 h after injection, the decrease in plasma concentration becomes slower, reaching 14 +/- 3 pg/ml 24 h after injection. The profile is dominated by the elimination (beta) phase with a half-life of 5.2 +/- 0.6 h. Consequently, 24 h after the injection ( approximately 5 half-life) 97% of the product was eliminated. The area under plasma concentration versus time curve was 0.19 +/- 0.05 microg/min/ml. Assuming availability (F) approximately 1, the clearance is C(L) = 26.3 +/- 7 ml/min, and the apparent volume of distribution is V(d) = 12 +/- 3 liter/kg. The recommended dose for a Phase II study is 0.18 mg/m(2).
Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year.

This study examined outcomes beyond 1 year in eculizumab-treated (EC) positive crossmatch kidney transplants (+XMKTx) compared to a historical control group. +XMKTx received desensitization with either plasma exchange (PE) alone (N = 48) or PE and EC (N = 30). EC, given for at least 1 month, was continued in the setting of persistently high DSA (B flow cytometric crossmatch [BFXM] >200) including: 4 weeks (n = 14); 9 weeks (n = 6), 6 months (n = 2), and 12 months (n = 8). All patients had at least 2 years follow-up. The incidence of acute clinical ABMR was lower in the EC group than controls (6.7% vs. 43.8% p < 0.01). Death-censored allograft survival was similar between groups. Chronic ABMR was the main cause of graft loss. On 1-year protocol biopsies, no differences were noted between EC and controls including: cg score >0, 26.7% versus 31.9% (p = 0.62), ptc score ≥ 2, 60.0% versus 60.0% (p = 1.00), or C4d + , 33.8% versus 13.5% (p = 0.08). A persistently high BFXM in EC-treated patients was associated with cg score >0 at 1 year, while EC appeared to protect against cg if the BFXM remained low. We conclude that despite decreasing acute clinical ABMR rates, EC treatment does not prevent chronic ABMR in recipients with persistently high BFXM after +XMKTx.
What is the magnitude of blood pressure response to a programme of moderate intensity exercise? Randomised controlled trial among sedentary adults with unmedicated hypertension.

Current guidelines for the management of hypertension recommend regular, moderate intensity aerobic exercise such as brisk walking as a means of blood pressure reduction. However, there is a lack of consistent evidence regarding the magnitude of blood pressure response to such a prescription. In particular, no well designed studies have investigated the efficacy of a programme of exercise meeting current guidelines.



To investigate the effect of a six-week programme of moderate intensity exercise on daytime ambulatory blood pressure (10.00 am to 10.00 pm) among unmedicated, sedentary adults aged 25 years to 63 years with office blood pressure of 150 mmHg to 180 mmHg systolic and/or 91 mmHg to 110 mmHg diastolic.



Randomised controlled trial of participants carrying out 30 minutes of moderate intensity exercise (brisk walking or equivalent) five days per week for six weeks compared with controls who maintained existing levels of physical activity.



Compliance with the exercise programme was high. The reduction in mean daytime ambulatory blood pressure between baseline and six-week follow-up was greater in the intervention group than in the control group for both systolic and diastolic blood pressure. However, this net hypotensive effect was not statistically significant (systolic = -3.4 mmHg, 95% CI = -7.4 to 0.6; diastolic = -2.8 mmHg, 95% CI = -5.8 to 0.2). Adjusting for baseline differences in mean ambulatory blood pressure in an analysis of covariance led to a reduction in the estimated magnitude of the effect (systolic = -1.9 mmHg, 95% CI = -5.4 to 1.7, P = 0.31; diastolic = -2.2 mmHg, 95% CI = -4.9 to 0.5, P = 0.11).



Despite high compliance with the exercise programme, the magnitude of the hypotensive effect of moderate intensity exercise was not as great as that found in studies of higher intensity exercise among hypertensives. Expectations of general practitioners and patients that a programme of moderate intensity exercise will lead to a clinically important reduction in the individual's blood pressure are unlikely to be realised.
Immediate and 12-Month Outcomes of Ischemic Versus Nonischemic Functional Mitral Regurgitation in Patients Treated With MitraClip (from the 2011 to 2012 Pilot Sentinel Registry of Percutaneous Edge-To-Edge Mitral Valve Repair of the European Society of Cardiology).

In literature, there are limited data comparing ischemic mitral regurgitation (I-MR) versus nonischemic MR regarding outcomes after percutaneous "edge-to-edge" repair. We aimed to describe the early and 12-month results after MitraClip device implantation regarding the 2 etiologies. From January 2011 to December 2012, the Transcatheter Valve Treatment Sentinel Pilot Registry included 452 patients with MR who underwent MitraClip procedure in 25 centers across Europe. The prevalent etiology was I-MR (235 patients, 52.0%). I-MR group had a significantly higher proportion of men (74.9 vs 59.9%, p <0.001) and surgical risk (logistic EuroSCORE 24.8 ± 18.2 vs 18.8 ± 16.3, p <0.001). Acute procedural success was high (96%) and similar between groups (p = 0.48). Patients with I-MR required a higher, albeit not significant, number of clips to reduce MR (p = 0.08). Inhospital mortality was low (2.0%) without significant differences between etiologies. The estimated 1-year mortality and rehospitalization rates were 15.0% and 25.8%, respectively, without significant differences between groups. Paired echocardiographic data showed a persistent improvement of MR at 1 year in both etiologies. Despite a significant overall reverse atrial remodeling after clip, there were no significant changes in left ventricular volumes. In conclusion, this large independent cohort showed that percutaneous "edge-to-edge" therapy was associated with early- and long-term improvement of MR severity and functional condition both in patients with I-MR and nonischemic MR. There were no significant differences between the 2 etiologies regarding survival and freedom from rehospitalization due to heart failure at the 1-year follow-up.
Primary intervention for posthemorrhagic hydrocephalus in very low birthweight infants by ventriculostomy

The objective of our study was to determine the efficacy of ventriculostomy as the primary treatment for posthemorrhagic hydrocephalus in premature infants. Within a period of 4 years, 20 very low birthweight (VLBW) infants (birthweight median 1135 g, range 650–1470 g) were treated for progressive posthemorrhagic hydrocephalus (PHHC) by right parietal ventriculostomy (Salmon Rickham) at a mean age of 21 days. Serial tapping of the subcutaneous reservoir was performed for temporary drainage until conversion to a permanent ventriculoperitoneal (VP) shunt or spontaneous resolution of hydrocephalus. A total of 1402 punctures (median 71 / infant, range 13–168) was performed. The results showed that only 1/20 patients developed a cerebrospinal fluid (CSF) infection, accounting for a 5% patient-related and 0.07% procedure-related infection rate. Major complications such as skin defects, subdural hygroma, or CSF leaks occurred in three patients (15%). A permanent shunt was needed in 17 patients (85%).We concluded that, as an effective alternative to serial or lumbar puncture, there should be early implantation of ventriculostomy reservoirs for serial taps to control intracranial pressure in PHHC of VLBW infants until a permanent shunt can be placed because of the low incidence of infections and technical complications.
Lung ultrasound characteristics of community-acquired pneumonia in hospitalized children.

The diagnosis of community-acquired pneumonia (CAP) is based mainly on the patient's medical history and physical examination. However, in severe cases a further evaluation including chest X-ray (CXR) may be necessary. At present, lung ultrasound (LUS) is not included in the diagnostic work-up of pneumonia.



To describe the ultrasonographic appearance of CAP at presentation and during the follow-up.



A total of 102 patients with clinical signs and symptoms suggesting pneumonia, who underwent a clinically driven CXR, were evaluated by LUS on the same day. LUS signs of pneumonia included subpleural lung consolidation, B-lines, pleural line abnormalities, and pleural effusion. The diagnostic gold standard was the ex-post diagnosis of pneumonia made by two independent experienced pediatricians on the basis of clinical presentation, CXR and clinical course following British Thoracic Guidelines recommendations.



A final diagnosis of pneumonia was confirmed in 89/102 patients. LUS was positive for the diagnosis of pneumonia in 88/89 patients, whereas CXR was positive in 81/89. Only one patient with normal LUS examination had an abnormal CXR, whereas 8 patients with normal CXR had an abnormal LUS. LUS was able to detect pleural effusion resulting from complicated pneumonia in 16 cases, whereas CXR detected pleural effusion in 3 cases.



LUS is a simple and reliable imaging tool, not inferior to CXR in identifying pleuro-pulmonary alterations in children with suspected pneumonia. During the course of the disease, LUS allows a radiation-free follow-up of these abnormalities.
Hemodynamic outcomes of transcatheter aortic valve replacement and medical management in severe, inoperable aortic stenosis: a longitudinal echocardiographic study of cohort B of the PARTNER trial.

Inoperable aortic stenosis may be treated with either transcatheter aortic valve replacement (TAVR) or medical management (MM) with or without balloon aortic valvuloplasty (BAV). The aim of this study was to compare the long-term echocardiographic findings among TAVR, MM, and BAV in patients with severe, inoperable aortic stenosis.



A total of 358 inoperable patients in the Placement of Aortic Transcatheter Valves trial were randomized to MM or TAVR. Echocardiograms obtained at baseline, 30 days, and 1, 2, and 3 years were analyzed by a central core laboratory.



At baseline, TAVR and MM were similar, with more frequent Society of Thoracic Surgeons score > 10 (51.7% vs 65.0%, P = .03) and larger end-systolic volumes (54.5 ± 29.3 vs 69.1 ± 48.0 mL, P = .03) in MM. By 30 days after TAVR, mean aortic valve gradient had decreased (from 43.8 ± 14.7 to 10.0 ± 4.3 mm Hg, P < .001), ejection fraction had increased (from 53.2 ± 12.4% to 56.7 ± 10.0%, P < .001), and left ventricular (LV) mass index had decreased (from 144.7 ± 36.1 to 140.0 ± 37.9 gm/m(2), P < .05). After 1 year, aortic valve gradients and area were unchanged, while LV mass index had decreased by another 16 gm/m(2) (to 124 gm/m(2)). By 30 days after BAV, mean aortic valve gradient had decreased from 43.4 ± 15.0 to 31.9 ± 11.1 mm Hg, while ejection fraction and LV mass index were unchanged; gradient reverted to baseline at 1 year. No changes in gradients or mass were seen in MM patients.



TAVR results in immediate and sustained relief in pressure overload and improved LV systolic function, with continued regression of hypertrophy over 3 years. Poor clinical results with BAV are explained by the modest and transient reductions in pressure overload with BAV, which were not accompanied by improved LV function or remodeling. TAVR is the preferred treatment in eligible inoperable patients (ClinicalTrials.gov identifier NCT00530894).
Impact of Project P.A.T.H.S. on adolescent developmental outcomes in Hong Kong: findings based on seven waves of data.

The present study examined the longitudinal impact of Project P.A.T.H.S. (Positive Adolescent Training through Holistic Social Programmes) on adolescent developmental outcomes in Hong Kong. Using a longitudinal randomized group design, seven waves of data were collected from 24 experimental schools (n=4049 at wave 1) in which students participated in the Tier 1 Program of Project P.A.T.H.S. and 24 control schools (n=3797 at wave 1). Results based on individual growth curve modeling generally showed that, relative to the control participants, participants in the experimental group had: (a) a higher level of positive development; (b) a lower level of substance abuse; and (c) a lower level of delinquent behavior. Participants who regarded the program to be beneficial also showed higher levels of positive development and lower levels of problem behavior than did the control school students. The present findings suggest that Project P.A.T.H.S. is effective in promoting positive development and preventing adolescent problem behavior in Chinese adolescents in Hong Kong.
Factors Affecting the Completion of Adjuvant Chemotherapy in Early-Stage Breast Cancer

Despite the survival benefit associated with adjuvant chemotherapy in early-stage breast cancer, many do not complete treatment. This study identified factors associated with noncompletion of adjuvant chemotherapy among a select population of women with early-stage breast cancer. The study sample was obtained from a multicenter study designed to evaluate patient-assistance program usage among early-stage breast cancer patients requiring adjuvant therapy. In this study, 333 patients with stages I and II breast cancer undergoing surgery from October 2006 to September 2009 completed 6-month follow-up surveys assessing their experiences with care, health status, social support, self-efficacy, and treatment beliefs. In- and outpatient medical records were abstracted to assess treatment completion. Of the 333 patients, 198 initiated adjuvant chemotherapy and formed our study cohort. The study compared patients who did and did not complete adjuvant chemotherapy. The median patient age was 53 years (range 28–86 years). According to self-identification, 41 % of the patients were non-Hispanic white and 21 % were black. A total of 13 patients (7 %) did not complete adjuvant chemotherapy. In the bivariate analysis, the patients not completing chemotherapy were more likely to be black and unmarried women with low emotional social support and a poor body image after treatment. In the multivariate analysis, black race [odds ratio (OR) 5.62; 95 % confidence interval (CI) 1.63–20.36] and poor body image (OR 9.75; 95 % CI 2.12–95.95) were independently associated with noncompletion of chemotherapy. Overall chemotherapy noncompletion rates were low among women exposed to patient-assistance programs. However, poor body image and black race were independent predictors of uncompleted chemotherapy. The true impact of race in this group may result from social factors that occur more often among black women, including poor social support.