nils-herrmann/clean_scirepeval huggingface dataset:
Usefulness of D-Dimer Testing in Predicting Recurrence in Elderly Patients with Unprovoked Venous Thromboembolism.

Whether post-anticoagulation D-dimer levels are useful in predicting recurrence in elderly patients with unprovoked venous thromboembolism is unknown.



We followed up 157 patients aged ≥65 years with acute symptomatic, unprovoked venous thromboembolism in a prospective, multicenter cohort study. All patients completed 3-12 months of anticoagulation and then underwent quantitative D-dimer testing (enzyme-linked immunosorbent assay) 12 months after the index venous thromboembolism. The outcome was recurrent symptomatic venous thromboembolism after D-dimer measurement. We examined associations between log-transformed and dichotomized D-dimer values and the time to venous thromboembolism recurrence using competing risk regression, adjusting for age, sex, and overt pulmonary embolism.



There was no statistically significant association between quantitative or dichotomized D-dimer levels and venous thromboembolism recurrence. The area under the receiver operating characteristic curve for predicting recurrent venous thromboembolism was moderate (0.66; 95% confidence interval [CI], 0.51-0.82). The negative likelihood ratios were 0.34 (95% CI, 0.05-2.38) at the usual and 0.34 (95% CI, 0.09-1.29) at the age-adjusted cutoff values. Among patients with normal D-dimer results, venous thromboembolism recurrence rates were 6.8 (95% CI, 2.2-21.2) per 100 patient-years using the usual and 7.1 (95% CI, 3.2-15.8) per 100 patient-years using the age-adjusted cutoff values.



D-dimer testing alone may not be useful in identifying elderly patients with unprovoked venous thromboembolism who are at low risk of recurrent venous thromboembolism and in whom anticoagulants may be safely stopped.
Hyperbaric oxygen in the treatment of delayed radiation injuries of the extremities.

Hyperbaric oxygen (HBO2) is used as an adjunct in the treatment of radiation injury at many sites, including the mandible, larynx, chest wall, bladder, and rectum. In these disorders, HBO2 is effective in stimulating neovascularization and reducing fibrosis. No previous publications report the application of HBO2 to radiation injuries of the extremities. From 1979 until 1997, 17 patients were treated at the Southwest Texas Methodist and Nix Hospitals for nonhealing necrotic wounds of the extremities within previously irradiated fields. All but one wound involved a lower extremity. Most of the patients had been irradiated for soft tissue sarcomas or skin cancers. The rest were irradiated for a variety of malignancies. HBO2 was delivered in a multiplace chamber at 2.4 atm abs daily for 90 min of 100% oxygen at pressure. This report is a retrospective, uncontrolled review of these patients. Eleven patients (65%) healed completely whereas five (29%) failed to heal and one (6%) was lost to follow-up. Three (60%) of those who failed were found to have local or distant recurrence of their tumor early in their course of hyperbaric treatment and were discontinued from therapy at that time. When last seen in the clinic, the wound of the patient who was lost to follow-up was improved but not completely healed. Four of those who failed (including the two with local tumor recurrence) required amputation. If we exclude those with active cancer and the patient lost to follow-up, the success rate was 11 of 13 or 85%. HBO2 was applied successfully with complete wound healing and the avoidance of amputation in a majority of these patients. The consequences of failure in patients suffering from radiation necrosis of the extremities (some complicated by the presence of tumor) are significant, with 80% of the five failures requiring amputation. In radiation injuries of the extremities as in delayed radiation injury at other sites, HBO2 is a useful adjunct and should be part of the overall management.
Perioperative morbidity of laparoscopic cryoablation of small renal masses with ultrathin probes: a European multicentre experience.

Low morbidity has been advocated for cryoablation of small renal masses.



To assess negative perioperative outcomes of laparoscopic renal cryoablation (LRC) with ultrathin cryoprobes and patient, tumour, and operative risk factors for their development.



Prospective collection of data on LRC in five centres.



LRC.



Preoperative morbidity was assessed clinically and the American Society of Anaesthesiologists (ASA) score was assigned prospectively. Charlson Comorbidity Index (CCI) and Charlson-Age Comorbidity Index (CACI) scores were retrospectively assigned. Negative outcomes were prospectively recorded and defined as any undesired event during the perioperative period, including complications, with the latter classed according to the Clavien system. Patient, tumour, and operative variables were tested in univariate analysis as risk factors for occurrence of negative outcomes. Significant variables (p<0.05) were entered in a step-forward multivariate logistic regression model to identify independent risk factors for one or more perioperative negative outcomes. The confidence interval was settled at 95%.



There were 148 procedures in 144 patients. Median age and tumour size were 70.5 yr (range: 32-87) and 2.6 cm (range: 1.0-5.6), respectively. A laparoscopic approach was used in 145 cases (98%). Median ASA, CCI, and CACI scores were 2 (range: 1-3), 2 (range: 0-7), and 4 (range: 0-11), respectively. Comorbidities were present in 79% of patients. Thirty negative outcomes and 28 complications occurred in 25 (17%) and 23 (15.5%) cases, respectively. Only 20% of all complications were Clavien grade > or = 3. Multivariate analysis showed that tumour size in centimetres, the presence of cardiac conditions, and female gender were independent predictors of negative perioperative outcomes occurrence. Receiver operator characteristic curve confirmed the tumour size cut-off of 3.4 cm as an adequate predictor of negative outcomes.



Perioperative negative outcomes and complications occur in 17% and 15.5%, respectively, of cases treated by LRC with multiple ultrathin needles. Most of the complications are Clavien grade 1 or 2. The presence of cardiac conditions, female gender, and tumour size are independent prognostic factors for the occurrence of a perioperative negative outcome.
Spironolactone improves lung diffusion in chronic heart failure.

To evaluate whether anti-aldosteronic treatment influences lung diffusion (DLCO) in chronic heart failure (HF) patients. Spironolactone improves clinical conditions and prognosis in chronic HF and reduces connective tissue matrix turnover; DLCO abnormalities in chronic HF are related to increase in fibrosis and connective tissue derangement.



Thirty stable chronic HF patients, with reduced DLCO (<80% of predicted), were randomly assigned to active treatment (25 mg spironolactone daily) or placebo in addition to conventional anti-failure treatment. They were evaluated by quality of life questionnaire, laboratory investigations, cardiopulmonary exercise test, and pulmonary function test, which included DLCO and membrane diffusing capacity (DM). The evaluation was done before treatment and 6 months after. Quality of life score and standard pulmonary function tests were not significantly affected by spironolactone, while active treatment increased DLCO due to an increase of DM (DLCO: 18.3+/-3.9 vs. 19.9+/-5.5 mL/min/mmHg; DM: 28.1+/-7.7 vs. 33.3+/-8.6 mL/min/mmHg) and peak oxygen consumption (peak VO2 16.8+/-1.9 vs.18.6+/-2.2 mL/min/kg). Increments of DLCO and peak VO2 were linearly related (R=0.849, P<0.001).



These data show a positive effect of spironolactone on gas diffusion and exercise capacity suggesting a novel mechanism by which anti-aldosteronic drugs improve HF clinical condition and prognosis.
The impact of center experience on results of reduced intensity: allogeneic hematopoietic SCT for AML. An analysis from the Acute Leukemia Working Party of the EBMT

Allogeneic hematopoietic SCT with reduced-intensity conditioning (RIC-HSCT) is increasingly adopted for the treatment of older adults with AML. Our goal was to verify for the first time, if center experience influences outcome of RIC-HSCT. Results of 1413 transplantations from HLA-matched related or unrelated donors for adult patients with AML in first CR were analyzed according to the level of center activity. Transplants were performed in 203 European centers between 2001 and 2007. The 2-year probability of leukemia-free survival (LFS) after RIC-HSCT performed in centers with the lowest activity (⩽15 procedures/7 years) was 43±3% compared with 55±2% in the remainder (P<0.001). The incidence of non-relapse mortality (NRM) was 24±3% and 15±1% (P=0.004), whilst relapse rate was 33±3% and 31±1% (P=0.33), respectively. In a multivariate model, adjusted for other prognostic factors, low RIC-HSCT activity was associated with decreased chance of LFS (hazard ratio (HR)=0.64; P<0.001) and increased risk of NRM (HR=1.47, P=0.04) and relapse (HR=1.41, P=0.01). Center experience is a very important predictor of outcome and should be considered in future analyses evaluating the results of RIC-HSCT. The reasons why centers with low RIC-HSCT activity have worse outcomes should be further investigated.
Improvement of nebulised antibiotic delivery in cystic fibrosis.

To investigate deposition patterns and to assess the delivery rate of two nebuliser systems in children with cystic fibrosis (CF).



Thirty three children with CF on regular treatment with nebulised antibiotics had radioisotope scans performed using technetium-99m labelled aerosol antibiotic generated by a Ventstream nebuliser (median mass diameter (MMD), 3.3 microm; delivery rate, 0. 075 ml/min) under conditions similar to their routine home practice. The inhomogeneity of the images was scored on a 1-10 rating scale (a low score indicating even distribution of the antibiotic), and stomach deposition was measured as a percentage of overall deposition. Twenty patients had a repeat scan using an Optimist nebuliser (MMD, 1.8 microm; delivery rate, 0.02 ml/min).



The mean inhomogeneity scores were 5.4 in the Ventstream group and 3. 5 in the Optimist group. Mean stomach deposition was 17.3% in the 33 patients using the Ventstream nebuliser. There was an inverse relation between height and stomach deposition (r = 0.69). In the 20 patients who had both nebulisers, the mean percentages of stomach deposition for the Ventstream and Optimist nebulisers were 11.8% and 1.6%, respectively. The Ventstream nebuliser delivered antibiotic at an average 2.8 times faster rate than the Optimist nebuliser.



A smaller particle size results in a more homogenous distribution of the antibiotic in the lungs with decreased stomach deposition. This should not be seen as a recommendation to use the Optimist nebuliser because more antibiotic was delivered to most parts of the lung with the Ventstream because of its increased delivery rate.
Evaluation of two commercial omalizumab/free IgE immunoassays: implications of use during therapy.

The anti-IgE monoclonal antibody, omalizumab, is approved in the US as add-on therapy for patients ≥12 years of age with moderate-to-severe persistent allergic asthma. Omalizumab is administered according to the US Food and Drug Administration approved dosing table included in the prescribing information. The dosing table was developed using Genentech's free IgE assay and is designed to achieve free serum IgE levels of <50 ng/mL, known to be associated with clinical benefit. Lack of clinical benefit in a subset of patients on omalizumab has prompted demand for commercial free IgE assays to guide omalizumab dosing. To date, two commercial free IgE assays marketed by ViraCor-IBT (no longer offered) and BioTeZ have been available to physicians.



This study compares the results generated from the two commercial free IgE assays with the free IgE levels generated by the Genentech assay.



Two serum sample sets were prepared using 20 samples from patients with a wide range of IgE and omalizumab from an omalizumab clinical trial and 36 samples from omalizumab-naïve patients. Different amounts of omalizumab were added to the 36 omalizumab naïve samples based on measured total IgE levels to ensure that a good range of IgE and omalizumab was represented in the study samples. Samples were randomized for blinded analysis of free IgE levels using the Genentech, ViraCor-IBT and BioTeZ free serum IgE assays. Analysis of samples in the ViraCor-IBT assay were conducted by ViraCor-IBT and the analysis of samples using the Genentech and BioTeZ assay methods were conducted by a third party contract research organization.



The ViraCor-IBT and BioTeZ free IgE assays demonstrated significantly higher free IgE levels than the Genentech free IgE assay. Twenty-nine of 56 samples tested <50 ng/mL in the Genentech assay; of these, 12/29 (41%) and 20/29 (69%) tested >50 ng/mL in the BioTeZ and ViraCor-IBT assays, respectively. In the BioTeZ free IgE evaluations, 11/20 samples that were re-tested had inter-assay differences ranging from 40-190%.



Free ligand (such as IgE) measurements are challenging and dependent on the method and reagents used. The Viracor-IBT and BioTeZ methods tend to over-estimate free serum IgE levels compared with the Genentech free IgE assay. Using these assays to monitor therapy and adjust omalizumab doses post treatment is considered off-label use and could lead to a potential risk for unnecessary treatment and/or risk to patient safety.
Compliance to hypertension guidelines in clinical practice: a multicentre pilot study in Italy

The aim of this study was to investigate the diagnostic approach to recently diagnosed hypertensive patients by primary care physicians in Italy and to find out whether general practitioners manage these patients according to 1999 WHO/ISH guideline recommendations. In total, 228 consecutive patients (117 men and 111 women, mean age 51±12 years) with recently diagnosed hypertension (<2 years) referred for the first time to six outpatient hypertension centres throughout Italy were included in the study. The primary care physicians' approach was evaluated during the specialist visit by a specific questionnaire containing detailed questions about diagnostic work-up and treatment made at the time of the first diagnosis of hypertension. At the study visit, 71% of the patients were on treatment with antihypertensive drugs and 18.7% of them had blood pressure (BP) values lower than 140/90 mmHg. A complete clinical and laboratory evaluation according to the minimum work-up suggested by the guidelines had been carried out in only 10% of the patients. A full physical examination had been performed in 60% of the patients, electrocardiogram in 54%, serum total cholesterol in 53%, glucose in 49%, creatinine in 49%, urine analysis in 46%, potassium in 42%, and fundus oculi in 19%. Additional investigations such as ambulatory BP monitoring, echocardiogram, carotid ultrasonogram, and microalbuminuria had been carried out in a minority of patients (21, 18, 9, and 3%, respectively). The impact on hypertension guidelines on patients' management in everyday primary care practice appears marginal. Thus, our findings indicate that the majority of general practitioners manage hypertensive patients according to a simple BP-based approach rather than a more integrated approach based on global risk stratification.
Gender differences in the management and outcome of patients with acute coronary artery disease.

s: To compare the clinical management and health outcomes of men and women after admission with acute coronary syndromes, after adjusting for disease severity, sociodemographic, and cardiac risk factors.



Prospective national survey of acute cardiac admissions followed up by mailed patient questionnaire two to three years after initial admission.



Random sample of 94 district general hospitals in the UK.



1064 patients under 70 years old recruited between April 1995 and November 1996.



Of the 1064 patients recruited, 126 (11.8%) died before follow up. Of the 938 survivors, 719 (76.7%) completed a follow up questionnaire. There were no gender differences in the use of cardiac investigations during the index admission or follow up period. However, male patients with hypertension were more likely to undergo rehabilitation compared with female hypertensive patients (OR 2.01, 95% CI 0.85 to 4.72). Men were also more likely to undergo coronary artery bypass grafting (CABG) than women (OR 1.90, 95%CI 1.21 to 3.00), but there was no gender difference in the use of revascularisation overall (p=0.14). An indirect indication that the gender differences in CABG were not attributable to bias was provided by the lack of gender differences in health outcomes, which implies that patients received the care they needed.



Despite the extensive international literature referring to a gender bias in favour of men with coronary heart disease, this national survey found no gender differences in the use of investigations or in revascularisation overall. However, the criteria used for selecting percutaneous transluminal coronary angioplasty compared with CABG requires further investigation as does the use of rehabilitation. It is unclear whether the clinical decisions to provide these procedures are made solely on the basis of clinical need.
Transport decreases the quality of cardiopulmonary resuscitation during simulated maternal cardiac arrest.

The purpose of this study was to compare cardiopulmonary resuscitation (CPR) for simulated maternal cardiac arrest rendered during transport to the operating room with that rendered while stationary in the labor room. We hypothesized that the quality of CPR would deteriorate during transport.



Twenty-six teams composed of 2 providers (obstetricians, nurses, or anesthesiologists) were randomized to perform CPR on the Laerdal Resusci Anne SkillReporter™ mannequin during transport or while stationary. The primary outcome measure was the percentage of correctly delivered compressions, defined as compression rate ≥100 beats per minute, correct sternal hand placement, compression depth ≥1.5 inches (3.8 cm), and proper release. Secondary outcomes included interruptions in compressions, position of providers relative to the mannequin during the transport phase, and ventilation tidal volume.



The median (interquartile range) percentage of correctly rendered compressions during phase II was 32% (10%-63%) in the transport group and 93% (58%-100%) in the stationary group (P = 0.002, 95% confidence interval of mean difference = 22%-58%). The median (interquartile range) compression rates were 124 (110-140) beats per minute in the transport group and 123 (115-132) beats per minute in the stationary group (P = 0.531). Interruptions in CPR were observed in 92% of transport and 7% of stationary drills (P < 0.001, 95% confidence interval of difference = 61%-92%). During transport, 18 providers kneeled next to the mannequin, 2 straddled the mannequin, and 4 ran alongside the gurney. Median (interquartile range) tidal volume was 270 (166-430) mL in the transport group and 390 (232-513) mL in the stationary group (P = 0.03).



Our data confirm our hypothesis and demonstrate that transport negatively affects the overall quality of resuscitation on a mannequin during simulated maternal arrest. These findings, together with previously published data on transport-related delays when moving from the labor room to the operating room further strengthen recommendations that perimortem cesarean delivery should be performed at the site of maternal cardiac arrest.
Effect of 12-week administration of 20-mg long-acting methylphenidate on Glu/Cr, NAA/Cr, Cho/Cr, and mI/Cr ratios in the prefrontal cortices of school-age children in Indonesia: a study using 1H magnetic resonance spectroscopy (MRS).

Recent studies on the neurobiology of attention-deficit/hyperactivity disorder (ADHD) have suggested that there is dysregulation of dopamine-mediated neurotransmission, particularly in the prefrontal cortex and basal ganglia, and that treatment with methylphenidate reverses this dysregulation. Using methodology similar to previous studies involving putative markers of brain functioning, we used 1H magnetic resonance spectroscopy to study the effect of 12-week treatment with daily 20-mg long-acting methylphenidate on the glutamate/creatine, N-acetyl-aspartate/creatine, choline/creatine, and myoinositol/creatine ratios in the prefrontal cortices of medication-naive children with ADHD.



This was a prospective study, using a pretest and posttest design, on a single group of 21 children (mean age, 8.52 years; 17 males and 4 females) with a diagnosis of ADHD. A low time echo (TE) magnetic resonance spectroscopic scans sampled voxels of interest (1.5 × 1.5 × 2.0) from both the right and left prefrontal cortices.



After treatment, the N-acetyl-aspartate/creatine ratio increased 18.8% in the right prefrontal cortex (P = 0.001) and 10% in the left prefrontal cortex (P = 0.007); the glutamate/creatine ratio decreased 15% in the right prefrontal cortex (P = 0.005) and 14.1% in the left prefrontal cortex (P = 0.005); the choline/creatine ratio decreased 12.4% in the right prefrontal cortex (P = 0.037) and 16% in the left prefrontal cortex (P = 0.006); and the myoinositol/creatine ratio decreased 14.7% in the left prefrontal cortex (P = 0.011) and 7.7% in the right prefrontal cortex (P = 0.129).



Notwithstanding the limitations of this pilot study, we found, after stimulant treatment, significant neurochemical changes (thought to reflect functional improvement and improved neuroplasticity) in the prefrontal cortices of children with ADHD.
[Interest of a sterilised anti-burning gel in radiation dermatitis: results of a comparative study].

Trial objectives were to assess effectiveness and tolerance of sterilized Avène thermal spring water anti burning gel (ATSW gel) in prevention of radiation dermatitis in adults irradiated (6 weeks) for breast (n=61) or head and neck (n=8) cancer. Patients included in this open labelled, 2 parallel groups, multicentric study, were randomly assigned to apply five times daily for ten weeks either the Avène spring water gel (n=35) or trolamine cream (n=34). The median of emergence of the first objective radiation dermatitis signs was 31 days in the ATSW gel group and 29 days in the control group (p=0,924). The median incidence for pruritus in patients of the ETA gel group was 46 days versus 27 days (p=0,028) and 44 days versus 24 days for pain (p=0,426). Global efficacy was <<very good>> in 46,7 % of patients of the ETA gel group versus 17,2 % (p=0,029) and tolerance was <<very good>> in 65,5 % of the ETA gel group versus 40,7 % (p=0,107). No radionecrosis was observed. In conclusion, the efficacy of the Avène spring water gel was similar to the control product in prophylaxis of radiation dermatitis. Tolerance was better and the pruritus was significantly more delayed in patients who applied the Avène spring water gel than in controls.