nils-herrmann/clean_scirepeval huggingface dataset:
Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials

Malignant infarction of the middle cerebral artery (MCA) is associated with an 80% mortality rate. Non-randomised studies have suggested that decompressive surgery reduces this mortality without increasing the number of severely disabled survivors. To obtain sufficient data as soon as possible to reliably estimate the effects of decompressive surgery, results from three European randomised controlled trials (DECIMAL, DESTINY, HAMLET) were pooled. The trials were ongoing when the pooled analysis was planned.



Individual data for patients aged between 18 years and 60 years, with space-occupying MCA infarction, included in one of the three trials, and treated within 48 h after stroke onset were pooled for analysis. The protocol was designed prospectively when the trials were still recruiting patients and outcomes were defined without knowledge of the results of the individual trials. The primary outcome measure was the score on the modified Rankin scale (mRS) at 1 year dichotomised between favourable (0-4) and unfavourable (5 and death) outcome. Secondary outcome measures included case fatality rate at 1 year and a dichotomisation of the mRS between 0-3 and 4 to death. Data analysis was done by an independent data monitoring committee.



93 patients were included in the pooled analysis. More patients in the decompressive-surgery group than in the control group had an mRS<or=4 (75%vs 24%; pooled absolute risk reduction 51% [95% CI 34-69]), an mRS<or=3 (43%vs 21%; 23% [5-41]), and survived (78%vs 29%; 50% [33-67]), indicating numbers needed to treat of two for survival with mRS<or=4, four for survival with mRS<or=3, and two for survival irrespective of functional outcome. The effect of surgery was highly consistent across the three trials.



In patients with malignant MCA infarction, decompressive surgery undertaken within 48 h of stroke onset reduces mortality and increases the number of patients with a favourable functional outcome. The decision to perform decompressive surgery should, however, be made on an individual basis in every patient.
Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial.

Resistant hypertension (RH) is a growing health burden in this country affecting as many as 1 in 5 adults being treated for hypertension. Resistant hypertension is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure (BP) in this high-risk population are a national priority.



TRIUMPH is a single-site, prospective, randomized clinical trial to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie Dietary Approaches to Stop Hypertension eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (n = 150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic BP; secondary end points include ambulatory BP and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, BP, and CVD risk factors also will be measured at 1-year follow-up.



The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on BP and CVD biomarkers in patients with RH after 4 months of treatment and will determine whether lifestyle changes can be maintained for a year.
Venous thromboembolism among patients with advanced lung cancer randomized to prinomastat or placebo, plus chemotherapy.

Two clinical trials have suggested that the combination of vascular endothelial growth factor inhibitor with chemotherapy is associated with venous thromboembolism (VTE). This retrospective cohort study investigates whether a similar association exists when matrix metalloproteinase inhibitor (prinomastat) is combined with chemotherapy. Patients (n=1,023) with stage IIIB, IV, or recurrent non-small cell lung cancer (NSCLC) were followed during 2 randomized, double-blind trials of prinomastat versus placebo orally bid, plus gemcitabine/cisplatin (GC) or paclitaxel/carboplatin (PC). VTE included deep venous thrombosis (DVT) or pulmonary embolism (PE) confirmed by imaging or autopsy. Risks identified in univariate analysis (incidence densities compared by t test) were confirmed in multivariate analysis (proportional hazards model). During 7,500.3 patient-months, 58 VTE (31 PE, 27 isolated DVT) were confirmed in 54 patients. On univariate analysis, VTE was associated with central venous catheter placed within 3 months, 15 mg prinomastat plus GC, and to a lesser extent, 15 mg prinomastat plus PC, baseline performance status, and histologic type. VTE incidence was not increased by 15 mg prinomastat alone (post-discontinuation of chemotherapy), by chemotherapy plus placebo, or by 5 or 10 mg prinomastat plus chemotherapy. On multivariate analysis,VTE hazards (95% confidence interval) were 5.69 (2.61, 12.40) with recently placed central catheter, 2.78 (1.42, 5.43) with 15 mg prinomastat plus GC, and 2.06 (0.98, 4.31) with 15 mg prinomastat plus PC; performance status and histology were nonsignificant. We can conclude that combined treatment with 15 mg prinomastat plus chemotherapy approximately doubles the hazard of VTE among patients with advanced NSCLC.
Assessment of the dimensions, construct validity, and utility for rheumatoid arthritis screening of the COPCORD instrument

This study aims to evaluate the structural validity of the Community-Oriented Program for the Control of Rheumatic Diseases (COPCORD) core instrument as a screening tool for rheumatoid arthritis (RA) by means of assessing the existence of domains in the questionnaire. The Mexican version of the COPCORD instrument was applied to individuals over18 years of age in five regions of the country through a probabilistic/convenience household survey. Clinical confirmation of RA diagnosis was used. The variables analyzed included self-reported comorbidities and manifestations of the disease, as well as sociodemographic characteristics. The statistical approach was based on polychoric exploratory factor analysis and confirmatory factor analysis by means of probit structural equation models. A total of 19,213 subjects were included in the analysis. The average age for the total sample was 42.89 years old; 40.64 % of the subjects were older than 45 years of age and 20.42 % older than 55. More than 80 % of the variation was related to three underlying factors: recent pain, historical pain, and disability. The findings verified the usefulness of the COPCORD instrument as a screening tool for RA. The results also allowed to characterize how the variation in terms of manifestations of the disease could be accounted for diagnosing the disease in the Mexican context and examined the capabilities of the instrument to measure correctly the main characteristics of patients suffering from RA.
Transbronchial needle aspirates: how many passes per target site?

Transbronchial needle aspiration is a bronchoscopic sampling method for a variety of bronchial and pulmonary lesions. The present study investigated whether and how serial needle passes contribute to the yield of transbronchial needle aspiration at specific target sites. A total of 1,562 needle passes, performed at 374 target sites in 245 patients with neoplastic disease (82%), non-neoplastic disease (15%) or undiagnosed lesions (3%), were prospectively recorded and rated for anatomical location, size, bronchoscopic appearance and underlying disease. Positive aspirates were obtained in 75% of patients and at 68% of target sites. A diagnosis was established with the first, second, third and fourth needle pass at 64, 87, 95 and 98% of targets, respectively. The absolute yield varied strongly with target site features, but the stepwise increment to the maximum yield provided by serial passes was similar across target sites. In conclusion, three transbronchial needle passes per site are appropriate when only a tissue diagnosis is sought and when alternative sites or sampling modalities are available. At least four or five passes should be carried out at lymph node stations critical for the staging of lung cancer.
Direct antimicrobial susceptibility testing method for analysis of sputum collected from patients with cystic fibrosis.

Chronic Pseudomonas aeruginosa colonisation and subsequent exacerbations in patients with cystic fibrosis (CF) require antimicrobial treatment. But since multiple morphotypes and other Gram-negative bacteria with different antibiotic susceptibilities are often isolated inside the same sputum sample, bacteriological analysis is difficult.



To simplify this analysis, we explored a direct sputum antimicrobial susceptibility testing (DSST) method by applying E test directly on plates inoculated with the sputum. A total of 316 samples collected from CF patients were analysed and compared with standard procedures (SP) for the identification and antimicrobial susceptibility testing of all Gram-negative bacterial species.



DSST was as efficient as SP to detect P. aeruginosa including the mucoid morphotype in monomicrobial specimen, but was less sensible to detect all Gram-negative bacteria present in the same sample. It allowed the direct reading of the MIC inhibiting all Gram-negative bacteria. Agreements between these global MICs with the cumulative antibiotics susceptibility of all Gram-negative bacteria measured by SP were excellent for tobramycin and imipenem (>96%) and satisfactory for ticarcillin, ceftazidime, aztreonam and ciprofloxacin (90.4% to 94.3%). In conclusion, the DSST method is an efficient and easy antibiotic susceptibility testing method.
30 years of media coverage on high drug prices in the US – a never-ending story or a time for change?

US drug prices are among the highest worldwide as US policy makers have historically been reluctant to embrace price regulations, instead relying on market forces to set prices. However, the introduction of a number of breakthrough, highly effective and high-cost specialty medicines over the past years has stoked the fire of the long-running drug price debate in the USA. The prices of those specialty medicines – more than $100,000 per treatment course – have resulted in widespread outcry among patients, providers, insurers, and members of the Congress and the Senate. We aimed at analyzing whether the recent debate on drug prices reflects a sign of change in the drug pricing debate in US print media.
Psychosocial interventions for adults with visible differences: a systematic review

Background. Some individuals with visible differences have been found to experience psychosocial adjustment problems that can lead to social anxiety and isolation. Various models of psychosocial intervention have been used to reduce social anxiety and appearance related distress in this population. The objective of this review was to update a previous systematic review assessing the efficacy of psychosocial intervention programs for adults with visible differences. The original review (Bessell & Moss, 2007) identified 12 papers for inclusion.  A search protocol identified studies from 13 electronic journal databases.



Studies were selected in accordance with pre-set inclusion criteria and relevant data were extracted.  This update identified an additional four papers that met the inclusion criteria. Two papers provided very limited evidence for the efficacy of a combined cognitive-behavioural and social skills training approach. None of the papers provided sufficient evidence for the optimal duration, intensity or setting of psychosocial interventions for this population.  The review concluded that a greater number of Randomised Controlled Trials and experimental studies were required to increase the methodological validity of intervention studies.
Does pretreatment with lansoprazole influence Helicobacter pylori eradication rate and quality of life?

It is controversial whether pretreatment with a proton pump inhibitor (PPI) before Helicobacter pylori eradication treatment decreases the eradication rate. To determine the effects of pretreatment with lansoprazole alone, followed by an H. pylori eradication regimen (lansoprazole 30 mg, amoxicillin 750 mg and clarithromycin 200 mg twice daily for 1 week), on the eradication rate and quality of life (QoL) of the patient.



Patients with H. pylori-positive peptic ulcer were randomly assigned to two groups. The patients received either lansoprazole (30 mg) once daily for 6-8 weeks before H. pylori eradication (group A), or eradication treatment and then lansoprazole (30 mg) for 6-8 weeks (group B). To assess the QoL of the patients, the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire was evaluated.



A total of 116 patients were enrolled. The cure rates were 78.9% in group A and 78.0% in group B. In both groups, GSRS analysis showed a significant improvement of the overall GSRS score at the assessment of eradication efficacy, compared to baseline; there was no difference between the groups.



With this H. pylori eradication regimen, there was no difference in the cure rates and QoL associated with PPI pretreatment.
Use and interpretation of on/off diaries in Parkinson's disease.

To explore the use and interpretation of self reported on/off diary data for assessment of daily motor fluctuations in Parkinson's disease.



26 consecutive non-demented patients with fluctuating Parkinson's disease received standardised training on how to fill out the four category CAPSIT-PD on/off diary, followed by four hours of clinical observation and four weeks of daytime on/off diaries every 30 minutes at home.



Overall patient-clinician agreement in diary entries was good (kappa = 0.62; weighted kappa = 0.84). Agreement for individual diary categories was good for "off" and "on with dyskinesias" (kappa = > or =0.72), but moderate for "partial off" and "on" (kappa = 0.49). The overall validity of patient kept diaries was supported by expected symptom severity variability across diary categories, as assessed in the clinic. One day's home diary data failed to predict outcomes from the full four weeks for all diary categories, and data from three days failed to yield good prediction (predefined as R(2) = > or =approximately 0.7) for the time spent in "off" and "partial off". Data from one week yielded good prediction (R(2) = > or =0.74) in all instances except "partial off", which could not be well predicted even when two weeks' home diary data were considered (R(2) = 0.52).



The data provide support for the overall accuracy and validity of the four category CAPSIT-PD on/off diary, but suggest that a three category diary format may improve accuracy and validity. Interpretation of diary data beyond the assessed time frame should be made with caution unless diaries have been kept for sufficiently long periods.
A randomized intervention since infancy to reduce intake of saturated fat: calorie (energy) and nutrient intakes up to the age of 10 years in the Special Turku Coronary Risk Factor Intervention Project.

To evaluate the longitudinal impact of dietary counseling on children's nutrient intake.



A prospective, randomized, clinical trial.



Children were recruited to the study between December 1, 1989, and May 30, 1992. At the age of 7 months, children were randomized to the intervention group (n = 540) or the control group (n = 522) and were followed up until the age of 10 years.  Families in the intervention group have, since randomization, received regularly individualized counseling about how to modify the quality and quantity of fat in the child's diet, the goal being an unsaturated-saturated fat ratio of 2:1.



Nutrient intakes between the ages of 4 and 10 years based on annual 4-day food records.



The fat intake of the intervention children was constantly around 30% of the calorie (energy) intake, while that of the control children was 2 to 3 calorie percentage units higher (P<.001). The intervention children received 2 to 3 calorie percentage units less saturated fats and 0.5 to 1.0 calorie percentage unit more polyunsaturated fats than the control children (P<.001 for both). However, neither group reached the 2:1 goal set for the unsaturated-saturated fatty acid ratio. The vitamin and mineral intakes of the intervention and control children closely resembled each other despite the marked differences in fat intake.



Individualized, biannually given, fat intake-focused dietary counseling that began at the child's age of 8 months continued to influence favorably the diet of 4- to 10-year-old intervention children without disadvantageous dietary effects, but the 2:1 goal for unsaturated-saturated fat ratio was not reached.
Improving colorectal cancer screening in family medicine: an Oklahoma Physicians Resource/Research Network (OKPRN) study.

The purpose of this study was to describe colorectal cancer screening (CRCS) practices across a variety of primary care clinics and identify the methods used by primary care physicians (PCPs) with higher rates of CRCS ("exemplars").



Physician questionnaires, structured interviews, medical record abstractions, and practice observations were conducted for 48 PCPs in 25 practices within a regional practice-based research network followed by secondary in-depth interviews to further investigate the practices of PCPs in the top quartile of CRCS rates ("exemplars").



We abstracted 3596 medical records (mean of 75 records per PCP). Overall, exemplars had higher CRCS rates (median, 57.2% vs. 27.6%; P < .001). Patients of exemplars had higher screening rates for fecal occult blood testing (FOBT) and colonoscopy but not for flexible sigmoidoscopy or double-contrast barium enemas. Exemplars adopted few of the system-based innovations proposed by researchers to improve CRCS. Colonoscopy was promoted as the preferred CRCS method. FOBT was recommended for patients who could not afford or did not want colonoscopy. Flexible sigmoidoscopy or barium enemas were rarely recommended. Exemplars used brief CRCS promotion scripts that informally paralleled theory-driven counseling techniques.



Experienced PCPs use brief CRCS promotion scripts including counseling techniques that improve CRCS performance. Future research should be directed toward whether these techniques can be used to create an intervention aimed at PCPs to improve CRCS.
A comparison study between gross tumor volumes defined by preoperative magnetic resonance imaging, postoperative specimens, and tumor bed for radiotherapy after breast-conserving surgery

The identification and contouring of target volume is important for breast-conserving therapy. The aim of the study was to compare preoperative magnetic resonance imaging (MRI), postoperative pathology, excised specimens' (ES) size, and tumor bed (TB) delineation as methods for determining the gross tumor volume (GTV) for radiotherapy after breast-conserving surgery (BCS).



Thirty-three patients with breast cancer who underwent preoperative MRI and radiotherapy after BCS were enrolled. The GTVs determined by MRI, pathology, and the ES were defined as GTVMRI, GTVPAT, and GTVES, respectively. GTVMRI+1 was defined as a 1.0-cm margin around the GTVMRI. The radiation oncologist delineated GTV of the TB (GTVTB) using planning computed tomography according to ≥5 surgical clips placed in the lumpectomy cavity (LC).



The median GTVMRI, GTVMRI+1, GTVPAT, GTVES, and GTVTB were 0.97 cm (range, 0.01-6.88), 12.58 cm (range, 3.90-34.13), 0.97 cm (range, 0.01-6.36), 15.46 cm (range, 1.15-70.69), and 19.24 cm (range, 4.72-54.33), respectively. There were no significant differences between GTVMRI and GTVPAT, GTVMRI+1 and GTVES, GTVES and GTVTB (P = 0.188, 0.070, and 0.264, respectively). GTVMRI is positively related with GTVPAT. However, neither GTVES nor GTVTB correlated with GTVMRI (P = 0.071 and 0.378, respectively). Furthermore, neither GTVES nor GTVTB correlated with GTVMRI+1 (P = 0.068 and 0.375, respectively).



When ≥5 surgical clips were placed in the LC for BCS, the volume of TB was consistent with the volume of ES. Neither the volume of TB nor the volume of ES correlated significantly with the volume of tumor defined by preoperative MRI.
The association between mammographic density measures and aspirin or other NSAID use

There is evidence that aspirin use reduces the risk of breast cancer. Increased mammographic density is known to be associated with increased breast cancer risk. Little is known about the association between mammographic density and aspirin or other non-steroidal anti-inflammatory drug (NSAID) use, but it is possible that the association between aspirin use and breast cancer risk might be due to the effect of aspirin on mammographic density. Multiple linear regression was used to investigate the association between measures of mammographic density and the use, frequency, and duration of aspirin and other NSAIDs such as paracetamol (acetaminophen), arthritis medication, and other over-the-counter or doctor-prescribed pain medications in 3286 women from the Australian Mammographic Density Twins and Sisters Study and the Genes Behind Endometriosis Study. We found no association between either dense area or percent dense area with any of the NSAIDs examined (all P > 0.06). If aspirin is reducing the breast cancer risk in women, it is likely doing so via a different pathway other than mammographic density measures that predict breast cancer risk.
Small bowel capsule endoscopy in the management of established Crohn's disease: clinical impact, safety, and correlation with inflammatory biomarkers.

Multiple studies have established the superior diagnostic accuracy of video capsule endoscopy (VCE) for the diagnosis of small bowel (SB) Crohn's disease (CD). However, data on the clinical impact of VCE in patients with established CD are scarce. The aim of this study was to examine the impact and safety of VCE on the clinical management of patients with established CD.



A retrospective, multicenter, cross-sectional study. The study cohort included consecutive patients with established SB CD who underwent VCE in 4 tertiary referral centers (1 Canada, 1 Sweden, and 2 United Kingdom) from January 2008 to October 2013. Patients were excluded if VCE was performed as a part of the initial diagnostic workup. The presence of SB mucosal inflammation was quantified using the Lewis score. Inflammatory biomarkers (C-reactive protein and fecal calprotectin) were measured and correlated with the Lewis score.



The study included 187 patients. No SB inflammation was observed in 28.4%, mild-to-moderate inflammation in 26.6%, and moderate-to-severe inflammation in 45% of the patients (median Lewis score, 662; range, 0-6400). A change in management was recommended in 52.3% of the patients based on VCE findings. Elevated C-reactive protein, fecal calprotectin, or the combination of both were poorly correlated with significant SB inflammation. SB capsule retention occurred in 4 patients (2.1%).



VCE in patients with established CD is safe, and the results often have a significant clinical impact. VCE should not be limited to CD patients with positive inflammatory markers because their predictive value for significant SB inflammation is poor.