nils-herrmann/clean_scirepeval huggingface dataset:
Prediction of relapse by day 100 BCR-ABL quantification after allogeneic stem cell transplantation for chronic myeloid leukemia

Chronic myeloid leukemia (CML) relapse after allogeneic stem cell transplantation (SCT) is a relatively frequent situation, which is correlated to disease status, time from diagnosis to transplant and T-cell depletion. We evaluated the potential for early minimal residual disease (MRD) BCR-ABL quantification to predict relapse of CML patients receiving allogeneic SCT. Minimal residual disease was analyzed by real-time quantitative reverse transcriptase-polymerase chain reaction (RQ-PCR) at day 100 (d100) in 38 patients with >1 year follow-up after conventional non-T-cell-depleted SCT. Normal ABL control values from 1724 follow-up blood samples were used to define an RQ-PCR amplifiability index and the limits of reliable use of BCR-ABL ratios. We then compared the 14 patients with a high-level d100 BCR-ABL/ABL ratio (⩾10−4) to that of the 24 patients with a negative/low-level ratio (<10−4). Despite being comparable for all classical parameters, the incidence of relapse was significantly higher in the high MRD group (11/14 (79%)) compared to that of the low/negative MRD group (7/24 (29%)) (P=0.009), with d100 MRD values representing an independent risk factor of relapse and disease-free survival, but not of overall survival, in multivariate analysis. These data should facilitate risk-adapted post-transplant immunosuppression and/or tyrosine kinase inhibitor therapy based on an early evaluation of MRD.
Daily Physical Education in the School Curriculum in Prepubertal Girls during 1 Year is Followed by an Increase in Bone Mineral Accrual and Bone Width—Data from the Prospective Controlled Malmö Pediatric Osteoporosis Prevention Study

The aim of this study was to evaluate a general school-based 1-year exercise intervention program in a population-based cohort of girls at Tanner stage I. Fifty-three girls aged 7–9 years were included. The school curriculum-based exercise intervention program included 40 minutes/school day. Fifty healthy age-matched girls assigned to the general school curriculum of 60 minutes physical activity/week served as controls. Bone mineral content (BMC, g) and areal bone mineral density (aBMD, g/cm2) were measured with dual X-ray absorptiometry (DXA) of the total body (TB), lumbar spine (L2–L4 vertebrae), third lumbar vertebra (L3), femoral neck (FN), and leg. Volumetric bone mineral density (g/cm3) and bone width were calculated at L3 and FN. Total lean body mass and total fat mass were estimated from the TB scan. No differences at baseline were found in age, anthropometrics, or bone parameters when the groups were compared. The annual gain in BMC was 4.7 percentage points higher in the lumbar spine and 9.5 percentage points higher in L3 in cases than in controls (both P < 0.001). The annual gain in aBMD was 2.8 percentage points higher in the lumbar spine and 3.1 percentage points higher in L3 in cases than in controls (both P < 0.001). The annual gain in bone width was 2.9 percentage points higher in L3 in cases than in controls (P < 0.001). A general school-based exercise program in girls aged 7–9 years enhances the accrual of BMC and aBMD and increases bone width.
Long-term follow up of patients proceeding to transplant using plerixafor mobilized stem cells and incidence of secondary myelodysplastic syndrome/AML

We report the long-term follow up of 49 patients (pts) enrolled on plerixafor compassionate use protocol. Thirty-seven pts (76%) had failed one previous mobilization attempt, while 12 (24%) had failed two or more previous attempts. Using the combination of plerixafor and granulocyte colony-stimulating factor, we collected⩾2.5 × 106 CD34+cells/kg in 33 pts (67%). Forty-three of the 49 pts proceeded to an auto-SCT (ASCT). The median days to WBC and platelet engraftment were 11 (range, 9–13 days) and 16 (range, 11–77 days) days post ASCT, respectively. The median WBC count, Hb and platelet counts 1 year after ASCT were 4.7 × 109/L, 12.2 g/dL and 109 × 109/L, respectively. With median follow up of 42 months (range <1–54 months), 21 pts had evidence of disease progression. Five pts developed myelodysplastic syndrome (MDS)/AML at median of 29 months post ASCT. The cumulative incidence of MDS/AML at 42 months was 17% (95% confidence interval, 6 to 32%). Development of secondary MDS/AML in pts proceeding to ASCT after plerixafor mobilization needs to be studied further in a larger cohort.
Effect of mechanical chest percussion on intracranial pressure: a pilot study.

Treatment of brain injury is often focused on minimizing intracranial pressure, which, when elevated, can lead to secondary brain injury. Chest percussion is a common practice used to treat and prevent pneumonia. Conflicting and limited anecdotal evidence indicates that physical stimulation increases intracranial pressure and should be avoided in patients at risk of intracranial hypertension.



To explore the safety of performing chest percussion for patients at high risk for intracranial hypertension.



A total of 28 patients with at least 1 documented episode of intracranial hypertension who were having intracranial pressure monitored were studied in a prospective randomized control trial. Patients were randomly assigned to either the control group (no chest percussion) or the intervention group (10 minutes of chest percussion at noon). Intracranial pressure was recorded once a minute before, during, and after the intervention.



Mean intracranial pressures for the control group before, during, and after the study period (14.4, 15.0, and 15.9 mm Hg, respectively) did not differ significantly from pressures in the intervention group (13.6, 13.7, and 14.2 mm Hg, respectively).



Mechanical chest percussion may be a safe intervention for nurses to use on neurologically injured patients who are at risk for intracranial hypertension.
C-reactive protein and prediction of 1-year mortality in prevalent hemodialysis patients.

Measurement of C-reactive protein (CRP) levels remains uncommon in North America, although it is now routine in many countries. Using Dialysis Outcomes and Practice Patterns Study data, our primary aim was to evaluate the value of CRP for predicting mortality when measured along with other common inflammatory biomarkers.



We studied 5061 prevalent hemodialysis patients from 2005 to 2008 in 140 facilities routinely measuring CRP in 10 countries. The association of CRP with mortality was evaluated using Cox regression. Prediction of 1-year mortality was assessed in logistic regression models with differing adjustment variables.



Median baseline CRP was lower in Japan (1.0 mg/L) than other countries (6.0 mg/L). CRP was positively, monotonically associated with mortality. No threshold below which mortality rate leveled off was identified. In prediction models, CRP performance was comparable with albumin and exceeded ferritin and white blood cell (WBC) count based on measures of model discrimination (c-statistics, net reclassification improvement [NRI]) and global model fit (generalized R(2)). The primary analysis included age, gender, diabetes, catheter use, and the four inflammatory markers (omitting one at a time). Specifying NRI ≥5% as appropriate reclassification of predicted mortality risk, NRI for CRP was 12.8% compared with 10.3% for albumin, 0.8% for ferritin, and <0.1% for WBC.



These findings demonstrate the value of measuring CRP in addition to standard inflammatory biomarkers to improve mortality prediction in hemodialysis patients. Future studies are indicated to identify interventions that lower CRP and to identify whether they improve clinical outcomes.
Intracytoplasmic sperm injection (ICSI) using cryopreserved sperm from men with malignant neoplasm yields high pregnancy rates.

To investigate the efficacy of IVF-intracytoplasmic sperm injection (ICSI) in patients who cryobanked semen before cancer treatment.



Retrospective consecutive study.



University-based IVF unit.



One hundred eighteen couples undergoing IVF-ICSI using pretreatment frozen sperm.



Treatment follow-up.



Semen parameters and clinical pregnancy rates.



One hundred eighteen couples underwent 169 IVF cycles using pretreatment cryopreserved sperm; the average sperm count was 66.5 x 10(6)/mL, and the average motility was 45.6%. Post-thaw sperm average density was 40.9 x 10(6)/mL with 14.2% motility. The clinical pregnancy rate was 56.8% per retrieval; 96 pregnancies were achieved, resulting in 126 children born and 11 spontaneous abortions. Patients with prostate cancer had the worst semen parameters before sperm banking and the lowest clinical pregnancy rates.


CONCLUSION(S)
IVF-ICSI is the recommended treatment for most couples with cryopreserved sperm for male cancer. High pregnancy and delivery rates after IVF-ICSI using cryopreserved sperm from patients with cancer should encourage all reproductive-age males to cryobank semen immediately after diagnosis; physicians should discuss this and advise freezing multiple samples before treatment.
Phase II trial of carbetimer in metastatic melanoma

A phase II study of the synthetic polyelectrolyte Carbetimer 6500 mg/m2 IV daily for five days every 21-day cycle was conducted in patients with metastatic melanoma. No responses were seen in 18 evaluable patients. Two patients had stable disease for five months. Toxicity was generally manageable and included mild hyperphosphatemia, mild proteinuria, fatigue, pain at the injection site, and nausea. Carbetimer is inactive in metastatic melanoma at this dose and schedule.
Patient Anxiety and Depression Moderate the Effects of Increased Self-management Knowledge on Physical Activity: A Secondary Analysis of a Randomised Controlled Trial on Health-Mentoring in COPD.

Anxiety and depression are common comorbidities in people with chronic obstructive pulmonary disease (COPD). While these comorbidities could potentially lead to a higher motivation to learn about self-management, they could also inhibit patients from translating this knowledge into appropriate self-management behaviours. This paper explores the moderating effects of anxiety and depression on a health-mentoring intervention, focusing on mechanisms of change (mediation).



182 COPD patients participated in an RCT, with anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), self-management knowledge by the Partners in Health Scale, and spontaneous physical activity using accelerometers, all measured at baseline, 6 and 12 months. The moderated mediation model tested the intervention's effect on physical activity, mediated via changes in self-management knowledge, at different levels of anxiety and depression.



Knowledge mediated the effect of the intervention on changes in physical activity only for participants reporting low levels of anxiety or depression. Both acted as moderators: Increased knowledge led to more physical activity among participants reporting low anxiety or depression and to less activity among highly anxious or depressed participants.



Although health-mentoring interventions can be an effective tool to increase knowledge and physical activity among COPD patients, it is essential to take anxiety and depression into account, as increased knowledge may have detrimental effects in highly anxious or depressed participants. This suggests that patients with elevated anxiety or depression may need to be treated appropriately before engaging in chronic disease self-management interventions.
Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial.

Despite promising results with targeted drugs, chemoimmunotherapy with fludarabine, cyclophosphamide (FC), and rituximab (R) remains the standard therapy for fit patients with untreated chronic lymphocytic leukemia (CLL). Herein, we present the long-term follow-up of the randomized CLL8 trial reporting safety and efficacy of FC and FCR treatment of 817 treatment-naïve patients with CLL. The primary end point was progression-free survival (PFS). With a median follow-up of 5.9 years, median PFS were 56.8 and 32.9 months for the FCR and FC group (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.50-0.69, P < .001). Median overall survival (OS) was not reached for the FCR group and was 86.0 months for the FC group (HR, 0.68; 95% CI, 0.54-0.89, P = .001). In patients with mutated IGHV (IGHV MUT), FCR improved PFS and OS compared with FC (PFS: HR, 0.47; 95% CI, 0.33-0.68, P < .001; OS: HR, 0.62; 95% CI, 0.34-1.11, P = .1). This improvement remained applicable for all cytogenetic subgroups other than del(17p). Long-term safety analyses showed that FCR had a higher rate of prolonged neutropenia during the first year after treatment (16.6% vs 8.8%; P = .007). Secondary malignancies including Richter's transformation occurred in 13.1% in the FCR group and in 17.4% in the FC group (P = .1). First-line chemoimmunotherapy with FCR induces long-term remissions and highly relevant improvement in OS in specific genetic subgroups of fit patients with CLL, in particular those with IGHV MUT.
Associations between aspirin use and aging macula disorder: the European Eye Study.

To study associations between aspirin use and early and late aging macula disorder (AMD).



Population-based cross-sectional European Eye Study in 7 centers from northern to southern Europe.



In total, 4691 participants 65 years of age and older, collected by random sampling.



Aspirin intake and possible confounders for AMD were ascertained by a structured questionnaire. Ophthalmic and basic systemic measurements were performed in a standardized way. The study classified AMD according to the modified International Classification System on digitized fundus images at 1 grading center. Nonfasting blood samples were analyzed in a single laboratory. Associations were analyzed by logistic regression.



Odds ratios (ORs) for AMD in aspirin users.



Early AMD was present in 36.4% of the participants and late AMD was present in 3.3% of participants. Monthly aspirin use was reported by 1931 (41.2%), at least once weekly by 7%, and daily use by 17.3%. For daily aspirin users, the ORs, adjusted for potential confounders, showed a steady increase with increasing severity of AMD grades. These were: grade 1, 1.26 (95% confidence interval [CI], 1.08-1.46; P<0.001); grade 2, 1.42 (95% CI, 1.18-1.70), and wet late AMD, 2.22 (95% CI, 1.61-3.05).



Frequent aspirin use was associated with early AMD and wet late AMD, and the ORs rose with increasing frequency of consumption. This interesting observation warrants further evaluation of the associations between aspirin use and AMD.



The author(s) have no proprietary or commercial interest in any materials discussed in this article.
An open-label study to evaluate dose and cycle dependence of the pharmacokinetics of pegylated liposomal doxorubicin

There are no definitive data in humans on the dose dependence and/or cycle dependence of the pharmacokinetics (PK) of pegylated liposomal doxorubicin (PLD). This study examined the PK of PLD across a twofold dose variation and along 3 cycles. Fifteen patients received PLD in successive doses of 60, 30, and 45 mg/m2 (Arm A) and 30, 60, and 45 mg/m2 (Arm B), every 4 weeks. Twelve patients, six on each arm, completed all three cycles and were fully evaluable. Plasma levels of doxorubicin were analyzed by HPLC and fluorimetry. PK analysis was done by non-compartmental method. Repeated measures ANOVA and paired tests were used for statistical analysis. There was no significant difference in the PK parameters examined when the dose was increased from 30 to 60 mg/m2. However, when we analyzed the effect of cycle number on the PK, we found a gradual and significant inhibition of clearance (P < 0.0001) from the 1st through the 3rd cycle of PLD, with a geometric mean increase of 43% in dose-normalized AUC (P = 0.0003). Dose-normalized Cmax and T½ mean values increased by 17 and 18%, respectively between the 1st and 3rd cycles, but only the increase in T½ was statistically significant (P = 0.0017). While the PK of PLD is not dose-dependent within the dose range of 30–60 mg/m2, there is evidence of a cycle-dependent effect that results in inhibition of clearance when patients receive successive cycles of PLD. These results suggest the need for dose adjustments of PLD upon retreatment to minimize the risk of toxicity.
Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial.

The aim of this study was to determine long-term results of renal artery denervation for treatment of treatment-resistant hypertension in the SYMPLICITY HTN-2 study.



SYMPLICITY HTN-2 randomized 106 subjects with treatment-resistant hypertension to renal denervation or medical therapy alone. At 6 months, 37 control subjects crossed over to renal denervation. Office blood pressure measurements, antihypertensive medication use, and safety events were followed every 6 months through 3 years.



Follow-up was available at 36 months in 40 of 52 subjects in the initial renal denervation group and at 30 months in 30 of 37 subjects who crossed over and received renal denervation at 6 months. Baseline blood pressure was 184 ± 19/99 ± 16 mmHg in all treated subjects. At 30-month post-procedure, systolic blood pressure decreased 34 mmHg (95% CI: -40, -27, P < 0.01) and diastolic blood pressure decreased 13 mmHg (95% CI: -16, -10, P < 0.01). The systolic and diastolic blood pressure reduction at 36 months for the initial renal denervation group was -33 mmHg (95% CI: -40, -25, P < 0.01) and -14 mmHg (95% CI: -17, -10, P < 0.01), respectively. Procedural complications included one haematoma, and one renal artery dissection before energy delivery that was treated successfully. Later complications included two cases of acute renal failure, which fully resolved, 15 hypertensive events requiring hospitalization, and three deaths.



Renal denervation resulted in sustained lowering of blood pressure at 3 years in a selected population of subjects with severe, treatment-resistant hypertension without serious safety concerns.
Acute administration of bronchodilators on exercise tolerance in treated COPD patients.

Exercise intolerance is a major feature in patients with Chronic Obstructive Pulmonary Disease (COPD). Bronchodilators increase endurance time (ET) and reduce dynamic hyperinflation (DH). We evaluated whether a single-dose of salbutamol/ipratropium + flunisolide (BD+ICS), added on top of the regular treatment, may improve ET in COPD patients. In a single-blind randomized crossover pilot trial, nebulised BD+ICS or placebo (PL) was administered 30 min before a constant load cardiopulmonary test, in 22 moderate-to-severe COPD patients (FEV₁: 53.9% pred). ET was the primary outcome measured. BD+ICS did not improve ET or VO₂ peak with respect to PL. BD+ICS increased pre-test FEV₁ and pre-test Inspiratory Capacity but did not modify DH. In a retrospective analysis, patients were divided in Improvers (N=11) and Non-Improvers (N=11) according to the difference in ET between BD+ICS and PL (> 25 s). Improvers had a worst BODE index, a higher static hyperinflation and poorer Vd/Vt ratio at peak of exercise with respect to Non-Improvers. Improvers only had a significant increase from BD+ICS on pre-test FEV₁ and IC. In conclusion, although a single-dose BD+ICS did not improve ET in COPD patients under regular treatment, a subgroup of more severe patients may have some benefit from that.
Serum Autotaxin/ENPP2 Correlates with Insulin Resistance in Older Humans with Obesity

Autotaxin (ATX) is an adipocyte-derived lysophospholipase D that generates the lipid signaling molecule lysophosphatidic acid (LPA). The ATX/LPA pathway in adipose tissue has recently been implicated in obesity and insulin resistance in animal models, but the role of circulating ATX in humans remains unclear. The aim of the present study was to determine the relationship between serum ATX and insulin resistance.



Older (60-75 years), nondiabetic human participants with overweight or obesity (BMI 25-37 kg m(-2) ) were characterized for metabolic phenotype including measures of energy, glucose, and lipid homeostasis. The relationship between serum ATX and metabolic parameters was then determined using correlative and predictive statistics.



Serum ATX was higher in females than in males. After controlling for sex, serum ATX correlated with multiple measures of adiposity and glucose homeostasis/insulin action. Serum ATX and BMI also independently predicted glucose infusion rate during a hyperinsulinemic euglycemic clamp and homeostatic model assessment of insulin resistance after controlling for sex and medication use.



Serum ATX correlates with and predicts measures of glucose homeostasis and insulin sensitivity in older humans, suggesting that it may be a potential pathogenic factor and/or diagnostic/therapeutic target for insulin resistance in this population.
Evaluation of effect of self-examination and physical examination on breast cancer.

Breast cancer is the number one cancer of women in the world. More than 90% of breast cancers can be cured with early diagnosis followed by effective multimodality treatment. The efficacy of screening by breast self-examination (BSE) and breast physical examination (BPx) is best evaluated using randomized screening trials.



A total of 12,660 women aged 35-64 years, 6330 in the intervention group and 6330 in the control group, were randomly selected from four areas of Yazd city, I.R. of Iran. The number of detected cancers along with kind of cancer, staging of cancer, the route of detected cancer and the number of deaths during the first 5 years of the study were collected and analyzed.



No significance difference between the two groups was seen in respect to socio-demographic and socio-economic variables (P > 0.05). Subjects in the intervention group had a response rate of 83.5% for attending the health center and 80.2% for visiting the assigned surgeon. A total of 31 and 13 new cases of breast cancer were identified in the intervention and control groups, respectively, of which 48.5% of cases in the intervention group were <50 yr of age. A significant difference between the cumulative incidence of breast cancer in the two groups with a ratio of 2.4 was observed.



BSE & BPx have a significant effect in detecting breast cancers at early stages (<3) suggesting they are effective screening tests with high availability and low costs that can be applied at the community level.