nils-herrmann/clean_scirepeval huggingface dataset:
Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC-line.

(i) To determine which aspects of living with a peripherally inserted central catheter (PICC) line cause Modified de Gramont (MdG) patients most difficulty. (ii) To explore MdG patients' views of the PICC-line experience. (iii) To determine if patients view PICC-lines as a benefit or a burden when receiving ambulatory MdG chemotherapy.



A two-stage, descriptive study.



Phase 1 comprised semi-structured interviews. Phase 2 surveyed the MdG population. Phase 1 interview data informed the Phase 2 questionnaire. The setting was a West of Scotland Cancer Care Centre and the sample was: Phase 1, a convenience sample of 10 MdG patients; Phase 2, 62 consecutive patients.



A response rate of 93.9% for Phase 2. The majority of PICC-line patients held favourable views towards having a PICC-line and adapted well with minimal disruption to daily life. Concerns were evident regarding coping at home with a PICC-line, chemotherapy spillage, dealing with complex information and the responsibility of patients/carers regarding PICC-line management. Patients preferred ambulatory chemotherapy to in-patient treatment.



PICC-lines should be considered for more chemotherapy patients but service development is necessary to ensure individual needs are addressed.


 TO CLINICAL PRACTICE
Contributes to the PICC-line literature by providing a national patient perspective on a range of daily living activities (DLAs). PICC-line patients prefer out-patient ambulatory chemotherapy rather than in-patient treatment. The longer a patient has a PICC-line, the more able they are to manage activities such as dressing. Concerns remain over chemotherapy spillage, partner/carer responsibility for PICC-line maintenance and the proper balance between required information and what the patient wants to know.
Intentional Weight Loss and Longevity in Overweight Patients with Type 2 Diabetes: A Population-Based Cohort Study

This study examined the influence of weight loss on long-term morbidity and mortality in overweight (BMI≥25 kg/m2) patients with type 2 diabetes, and tested the hypothesis that therapeutic intentional weight loss supervised by a medical doctor prolongs life and reduces the risk for cardiovascular disease in these patients.



This is a 19 year cohort study of patients in the intervention arm of the randomized clinical trial Diabetes Care in General Practice. Weight and prospective intentions for weight loss were monitored every third month for six years in 761 consecutive patients (≥40 years) newly diagnosed with diabetes in general practices throughout Denmark in 1989-92. Multivariable Cox regression was used to estimate the association between weight change during the monitoring period (year 0 to 6) and the outcomes during the succeeding 13 years (year 6 to 19) in 444 patients who were overweight at diagnosis and alive at the end of the monitoring period (year 6). The analysis was adjusted for age, sex, education, BMI at diagnosis, change in smoking, change in physical activity, change in medication, and the Charlson comorbidity 6-year score. Outcomes were from national registers.



Overall, weight loss regardless of intention was an independent risk factor for increased all-cause mortality (P<0.01). The adjusted hazard ratio for all-cause mortality, cardiovascular mortality, and cardiovascular morbidity attributable to an intentional weight loss of 1 kg/year was 1.20 (95%CI 0.97-1.50, P = 0.10), 1.26 (0.93-1.72, P = 0.14), and 1.06 (0.79-1.42, P = 0.71), respectively. Limiting the analysis to include only those patients who survived the first 2 years after the monitoring period did not substantially change these estimates. A non-linear spline estimate indicated a V-like association between weight change and all-cause mortality, suggesting the best prognosis for those who maintained their weight.



In this population-based cohort of overweight patients with type 2 diabetes, successful therapeutic intentional weight loss, supervised by a doctor over six years, was not associated with reduced all-cause mortality or cardiovascular morbidity/mortality during the succeeding 13 years.
Effects of theophylline on tolerance to the bronchoprotective actions of salmeterol in asthmatics in vivo.

Long-term treatment with salmeterol produces tolerance for its protective effects against bronchoconstrictor stimuli in patients with asthma. There is human in vitro evidence that theophylline may prevent beta2-adrenoceptor downregulation. Therefore, we investigated the effect of theophylline on the tolerance to the protective effect of salmeterol against histamine challenge in asthma in vivo. In a parallel 6-wk study, 25 asthmatics were treated with theophylline (mean serum level +/- SEM: 9.9 +/- 1.1 mg/L, Days 1 to 40) or placebo, combined with inhaled salmeterol (50 microgram twice daily, Days 8 to 36). Histamine challenges were carried out by tidal breathing method at entry, and at Days 4, 8, 22, 36, and 40. The response was measured by PC20. There was no significant change in PC20 after 4 d monotherapy with theophylline or placebo (mean difference +/- SEM: 0.54 +/- 0.39 and -0.02 +/- 0.41 doubling dose [DD], respectively; p > 0.15). One hour after the first dose, salmeterol afforded significant protection against histamine, as shown by an increase in PC20 in both the theophylline and placebo group (by 3.49 +/- 0.28 and 3.36 +/- 0.32 DD, respectively; p < 0. 001). However, after 2 and 4 wk salmeterol treatment, the improvements in PC20 by salmeterol were significantly reduced to 1. 80 +/- 0.35 and 1.69 +/- 0.36 DD, respectively, in the theophylline group (p < 0.001), and to 1.55 +/- 0.47 and 1.52 +/- 0.56 DD, respectively, in the placebo group (p < 0.002). These changes were not significantly different between the groups (p > 0.80). After cessation of salmeterol treatment, PC20 was not significantly different from the values at entry in either group (p > 0.90). We conclude that regular theophylline treatment neither prevents, nor worsens, the development of tolerance to the bronchoprotective effect of salmeterol in asthmatics in vivo.
The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles.

To study the efficacy, safety, and incidence of BtxA antibody formation with repeated treatments with BtxA in post-stroke upper limb muscle spasticity.



The study was a prospective open label trial. Patients with established post-stroke upper limb spasticity received 1000 units of BtxA (Dysport) into five muscles of the affected arm on study entry. Treatment was repeated every 12, 16, or 20 weeks as clinically indicated. Each patient received a total of three treatment cycles. Efficacy of treatment was assessed using the Modified Ashworth Scale. Patients were assessed on study entry and on week 4 and 12 of each treatment cycle for all safety and efficacy parameters. Blood samples for BtxA antibody assay were taken at baseline and on completion of the trial.



Fifty one patients were recruited and 41 of them completed the study. Improvement from the cycle one baseline was observed in all the outcome measures. Mild to moderately severe treatment related adverse events were reported in 24% of cases. There were no serious adverse events. No BtxA antibodies were detected.



BtxA at a dose of 1000 units Dysport was efficacious in the symptomatic treatment of post-stroke upper limb spasticity. The study suggests that this effect can be maintained with repeated injections for up to at least three treatment cycles, with duration of effect per cycle of between 12 and 20 weeks. BtxA was safe in the dose used in this study and did not induce the formation of detectable levels of neutralising BtxA antibodies.
A pilot study of screening, brief intervention, and referral for treatment (SBIRT) in non-treatment seeking smokers with HIV.

PLHIV have higher rates of smoking and lower motivation to quit smoking; thus to impact smoking rates, cessation interventions need to be acceptable to a wider range of PLHIV smokers as well as feasible to implement in a busy clinical setting. The purpose of this study was to evaluate the acceptability, feasibility, and effects of a Screening, Brief Intervention, and Referral for Treatment (SBIRT) model in an HIV/AIDS clinic among a sample of PLHIV.



PLHIV smokers (N=40) were randomized at baseline, irrespective of their self-reported discrete smoking cessation motivation status, to receive either 8-weeks of combination nicotine replacement therapy (NRT) in conjunction with brief counseling (SBIRT framework) (n=23) or usual care (n=17). Smoking outcome measures included cigarettes smoked per day, nicotine dependence, smoking urge, and smoking withdrawal symptoms.



The SBIRT intervention appeared to be acceptable and feasible, and produced medium to large reductions in cigarettes smoked per day, physical nicotine dependence, smoking urge, and smoking withdrawal symptoms, even for smokers not ready to quit within 6months.



Findings provide preliminary support for the integration of an SBIRT model in an HIV/AIDS clinic setting to screen and provide active treatment to all smokers, regardless of readiness to quit smoking. Given the high prevalence and incredible health burden of continued smoking in this population, identifying brief and effective interventions that are easily translated into clinical practice represents an enormous challenge that if met, will yield significant improvements to overall patient outcomes.
[Screening of prostate cancer with PSA and transperineal six sextant biopsy].

OBJECT
The objectives of this study are to examine how many cancer patients we can detect among the outpatients whose PSA values are above 4.0 ng/ml, and to compare the usefulness of transperineal six sextant biopsy (ss-biopsy) with that of transrectal one.



All the male outpatients (above 50 years old) were inspected Tandem-R PSA levels and digital rectal examination (DRE). Among them, 129 patients showed more than 4.0 ng/ml of PSA values and/or positive finding of DRE, and underwent subsequent transperineal ss-biopsy.



Cancers were detected in 52 patients (40.3%) without major complications. Among 64 gray zone (PSA 4.1-10.0 ng/ml) patients, 17 (26.6%) were found to be cancer by ss-biopsy, meanwhile only 2 cancer patients (8.9%) were detected from 23 gray zone ones by traditional directed biopsy. Application of PSA density could not be found practicable to eliminate unnecessary biopsies in the gray zone group.



Prostate cancer could be found nearly a fourth in the gray zone group of the outpatients. To enhance the detection rate, obtaining at least 6 core samples are recommended from either perineal or rectal root.
Does access to a colorectal cancer screening website and/or a nurse-managed telephone help line provided to patients by their family physician increase fecal occult blood test uptake?: results from a pragmatic cluster randomized controlled trial

Evaluation of the effectiveness of a patient decision aid (nurse-managed telephone support line and/or colorectal cancer screening website), distributed to patients by their family physician, in improving fecal occult blood test (FOBT) colorectal cancer screening rates. A pragmatic, two arm, cluster randomized controlled trial in Winnipeg, Manitoba, Canada (39 medical clinic clusters; 79 fee-for-service family physicians; 2,395 average risk patients). All physicians followed their standard clinical screening practice. Intervention group physicians provided a fridge magnet to patients that facilitated patient decision aid access. Primary endpoint was FOBT screening rate within four months. Multi-level logistic regression to determine effect of cluster, physician, and patient level factors on patient FOBT completion rate. ICC determined. Family physicians were randomized to control (n = 39) and intervention (n = 40) groups. Compared to controls (56.9%; n = 663/1165), patients receiving the intervention had a higher FOBT completion rate (66.6%; n = 805/1209; OR of 1.47; 95% confidence interval 1.06 to 2.03; p < 0.02). Patient aid utilization was low (1.1%; 13/1,221) and neither internet nor telephone access affected screening rates for the intervention group. FOBT screening rates differed among clinics and physicians (p < 0.0001). Patients whose physician promoted the FOBT were more likely to complete it (65%; n = 1140/1755) compared to those whose physician did not (51.1%; n = 242/470; p < 0.0001; OR of 1.54 and 95% CI of 1.23 to 1.92). Patients reporting they had done an FOBT in the past were more likely to complete the test (70.6%; n = 1141/1616; p < 0.0001; 95% CI 2.51 to 3.73) than those who had not (43%; n = 303/705). Patients 50–59 years old had lower screening rates compared to those over 60 (p < 0.0001). 75% of patients completing the test did so in 34 days. Despite minimal use of the patient aid, intervention group patients were more likely to complete the FOBT. Powerful strategies to increase colorectal cancer screening rates include a recommendation to do the test from the family physician and focusing efforts on patients age 50–59 years to ensure they complete their first FOBT.
The leucotriene receptor antagonist montelukast and the risk of Churg-Strauss syndrome: a case-crossover study.

There has been some concern that leucotriene receptor antagonists might precipitate the onset of Churg-Strauss syndrome (CSS). A study was undertaken to investigate the relationship between the leucotriene receptor antagonist montelukast and the onset of CSS.



Medication histories of 78 patients with CSS from France and Germany were retraced by questioning the patients, treating physicians and dispensing pharmacists, and from medical records. Using a case-crossover research design, exposures to montelukast and other asthma medications during the 3-month "index" period immediately preceding the onset of CSS were compared with those of four previous 3-month "control" periods. Odds ratios (ORs) were computed by conditional logistic regression.



The ORs for CSS onset were 4.5 (95% CI 1.5 to 13.9) for montelukast, 3.0 (95% CI 0.8 to 10.5) for inhaled long-acting beta(2) agonists, 1.7 (95% CI 0.5 to 5.4) for inhaled corticosteroids and 4.0 (95% CI 1.3 to 12.5) for oral corticosteroids. Montelukast exposure during control periods increased temporally over three consecutive calendar periods of CSS onset from 1999 to 2003 (p(trend) <0.0001).



Montelukast use was associated with a 4.5-fold higher risk of CSS onset within 3 months. However, the positive estimates obtained for other long-term asthma control medications suggest that this link might be confounded by a general escalation of asthma therapy before CSS onset. The association between montelukast and CSS observed in this study is probably also explained by the increasing use of this medication over time.
Towards high accuracy classification of MER signals for target localization in Parkinson's disease

In recent years Microelectrode recording (MER) analysis has proved to be a powerful localization tool of basal ganglia for Parkinson disease's treatment, especially the Subthalamic Nucleus (STN). In this paper, a signal-dependent method is presented for identification of the STN and other brain zones in Parkinsonian patients. The proposed method, refereed as optimal wavelet feature extraction method (OWFE), is constructed by lifting schemes (LS), which are a flexible and fast implementation of the wavelet transform (WT). The operators in the LS are optimized by means of Genetic Algorithms and Lagrange multipliers considering information contained in MER signals. Then a basic Bayesian classifier (LDC) is used to identify STN and other types of basal ganglia nuclei. The proposed method introduced several advantages from similar works reported in literature. First, the method is signal-dependent and non a priori information is required to decompose the MER signal. Second, the classification accuracy is mostly depended on the feature selection stage because it is not enhanced by elaborated classifiers such as support vector machines or hidden Markov models. Finally, the generalization property of the OWFE has been validated with two databases and different types of classifiers such as k-NN classifier and quadratic Bayesian classifier (QDC). Results have shown that proposed method is able to identify the STN with average accuracy superior than 97%.
The outcome and the frequency of pathological complete response after neoadjuvant radiotherapy in curative resections for advanced rectal cancer: a population-based study.

Pathological complete response (ypCR) after neoadjuvant treatment for rectal cancer is associated with favourable survival and a low rate of local recurrence. The aim of the study was to assess the incidence of ypCR among patients with advanced rectal cancer treated with neoadjuvant chemoradiotherapy and curative resection and to explore factors associated with survival.



From 2000 to 2009, 1384 patients enrolled in the national population- based colorectal cancer registry of Norway with advanced T3 and T4 rectal cancer with N0-2, M0 received neoadjuvant long-course (chemo)radiation. The duration of follow-up was a median of 5 years.



ypCR was achieved in 147 (10.6%) patients. The estimated 5-year overall survival rate was 87% (confidence interval ± 5.4) among ypCR and 67% among non-ypCR (confidence interval ± 2.7) (P < 0.0001). Distant metastasis developed in 12 (8%) of 147 and 328 (26.5%) of 1237 patients respectively (P < 0.001). In a Cox proportional hazards ratio model the effect of ypCR on survival was adjusted for age [hazard ratio (HR) 1.056, P = 0.0001], metachronous metastasis (HR 4.7, P = 0.0001), local recurrence (HR 4.3, P = 0.0001) and surgical procedure (HR 1.48, P = 0.0001). The independent effect of ypCR (HR 0.65, P = 0.041) on survival almost disappeared compared with the univariate analysis.



The rate of ypCR in advanced rectal cancer was about 10%. This phenomenon seems to occur in tumours with a low risk of metastasizing. The contribution of neoadjuvant therapy to ypCR on survival was small or absent.
Missing forms and dropout in the TME quality of life substudy

Missing forms may pose problems in health related quality of life (QOL) studies, because the absence of a QOL measure may be related to the patient’s health and hence to the patient’s QOL itself. Studying patterns of missingness, dropout, and the possible impact of missing data on QOL measures is an important step in reporting outcomes of QOL studies. We study patterns of dropout and evaluate the impact of missing forms in the TME QOL substudy.  Patients with rectal cancer, randomized to receive either radiotherapy plus total mesorectal excision (TME) or TME only were included in the TME trial. QOL was evaluated in 1302 Dutch patients, before treatment, and 3, 6, 12, 18 and 24 months after surgery. Here only the visual analogue score (VAS) was studied.  At baseline, differences between VAS scores were found with respect to whether the QOL forms were dated before or after radiotherapy and surgery. Differences were small between different statistical methods accounting for dropout; only a cross-sectional analysis gave biased results.  The results of the sensitivity analysis indicated that a linear mixed model analysis is a reliable and attractive approach for this study.
Sequential analysis of bone marrow and peripheral blood after stem cell transplant for myeloma shows disparate tumor involvement

Treatment with combination chemotherapy has not resulted in long-term remissions in multiple myeloma (MM) despite advances in drug discovery and protocol improvement over the last 25 years. Increasingly, peripheral blood (PB) stem cell transplants (PBSCT) are being used along with chemotherapy and total body irradiation as treatment for multiple myeloma. Although the majority of tumor cells are found within the bone marrow (BM), tumor cells circulate in the PB in patients with MM. Therefore, one potential problem with PBSCT is contamination of the stem cell harvests with tumor cells. Although substantial reduction in BM tumor load is achieved after chemotherapy and autologous transplantation, most patients still relapse. In an attempt to identify and quantitate the residual tumor within sequential BM and PB samples of patients with MM following autologous PB stem cell transplants we have used a tumor-specific detection assay, allele-specific oligonucleotide-PCR (ASO-PCR). We found that while the BM tumor burden may fluctuate in some patients by as much as 4-logs after transplant, the PB tumor remains quite stable, and does not reflect the tumor burden in the BM. Moreover, analysis of PB involvement over time was not predictive of marrow involvement or of potential relapse. These results suggest that the PB is frequently involved in MM and further indicate that it represents a compartment that is only minimally altered by intensive therapy.
Safety, tolerability, pharmacokinetics, and efficacy of an interleukin-2 agonist among HIV-infected patients receiving highly active antiretroviral therapy.

We sought to determine the safety, maximum tolerated dose, optimal dose, and preliminary dose efficacy of intermittent subcutaneously (s.c.) administered BAY 50-4798 among patients with HIV infection receiving highly active antiretroviral therapy (HAART) compared with patients receiving HAART alone. A phase I/II randomized, double-blind, dose-escalation study was conducted of the safety, tolerability, pharmacokinetics, and efficacy of s.c. BAY 50-4798 administered to HIV-infected patients already receiving stable HAART. There were no unexpected safety findings in a population of HIV-infected patients receiving HAART plus SC BAY 50-4798 as adjunctive therapy. BAY 50-4798 exhibited nearly dose-proportional pharmacokinetics, and accumulation was minimal during multiple-dose treatment. Limited efficacy data indicated that treatment with BAY 50-4798 caused at least a transient increase in CD4(+) T cell counts in some recipients, particularly at the early time points. In general, this effect appeared to increase with increasing dose. Bay 50-4798 was generally well tolerated across the dose range tested, but a lack of potent, sustained immunologic activity suggests that further optimization of dose and schedule will be necessary.
Does attention bias modification improve attentional control? A double-blind randomized experiment with individuals with social anxiety disorder.

People with anxiety disorders often exhibit an attentional bias for threat. Attention bias modification (ABM) procedure may reduce this bias, thereby diminishing anxiety symptoms. In ABM, participants respond to probes that reliably follow non-threatening stimuli (e.g., neutral faces) such that their attention is directed away from concurrently presented threatening stimuli (e.g., disgust faces). Early studies showed that ABM reduced anxiety more than control procedures lacking any contingency between valenced stimuli and probes. However, recent work suggests that no-contingency training and training toward threat cues can be as effective as ABM in reducing anxiety, implying that any training may increase executive control over attention, thereby helping people inhibit their anxious thoughts. Extending this work, we randomly assigned participants with DSM-IV diagnosed social anxiety disorder to either training toward non-threat (ABM), training toward threat, or no-contingency condition, and we used the attention network task (ANT) to assess all three components of attention. After two training sessions, subjects in all three conditions exhibited indistinguishably significant declines from baseline to post-training in self-report and behavioral measures of anxiety on an impromptu speech task. Moreover, all groups exhibited similarly significant improvements on the alerting and executive (but not orienting) components of attention. Implications for ABM research are discussed.