nils-herrmann/clean_scirepeval huggingface dataset:
Current treatment practices of venous thromboembolism in children admitted to pediatric intensive care units.

To describe current treatment practices of VTE in patients admitted to a pediatric intensive care unit (PICU) and compare these practices to published guidelines.



While the incidence of VTE is increasing, current treatment practices of VTE in patients admitted to PICUs are not known.



This multicenter, prospective, observational study enrolled patients with confirmed VTE admitted to 11 PICUs over a rolling 6-month study period. Treatment data were collected and analyzed.



Sixty-six VTEs occurred in 6653 patients. Empiric treatment for VTE was initiated in 30% prior to VTE confirmation, and children with cyanotic heart disease were 15.7 times more like to receive empiric therapy. Overall, 78% received systemic anticoagulation, 8% treated with only catheter-based interventions, and 13% of VTE were not treated. Seven patients (11%) underwent systemic fibrinolysis; more commonly in neonates (23%) vs children (5%). Surgical and interventional procedures were performed on 4 patients. The American College of Chest Physicians recommendations were incompletely followed. Only 28% of the 32 cases treated with low molecular weight heparin titrated dosing to a goal anti-FXa level 0.5-1. Five of the 15 cases treated with unfractionated heparin titrated dosing to aPTT 60-90, and one case did not use goal-directed therapy.



Confirmed VTEs in patients admitted to PICUs are most frequently treated with systemic anticoagulation; however, more intensive treatments such as systemic thrombolysis and surgical or interventional procedures are not uncommon in this critically ill population. Current practices deviate from the published antithrombotic guidelines developed for the general pediatric population.
Voluntary counselling and testing plus information distribution to reduce HIV-related risk behaviours among Hong Kong male cross-border truck drivers: a randomised controlled study.

1. A randomised controlled trial was conducted to compare the efficacy of voluntary counselling and testing (VCT) plus information distribution versus information distribution alone in 300 Chinese male cross-border truck drivers. 2. Two months after the intervention, participants of the VCT intervention group were more likely to be consistent condom users when having sex with female sex workers and non-regular sex partners, were more knowledgeable about HIV, and were less likely to have contracted a sexually transmitted disease in the past 2 months, compared to the controls. 3. Almost all participants of the intervention group were satisfied with the VCT service, and almost 90% agreed that it would increase their chance of using condoms in the future.
Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer.

To report clinical outcomes in patients treated with image guided proton therapy (PT) for localized prostate cancer.



The medical records of 1327 men were reviewed. Each man was enrolled on an outcomes tracking study. Dual enrollment on a prospective clinical trial was allowed. Each patient was treated for localized prostate cancer with PT at our institution between 2006 and 2010. Ninety-eight percent of patients received 78 Gy (radiobiological equivalent [RBE]) or higher; 18% received androgen deprivation therapy (ADT). The 5-year freedom from biochemical progression (FFBP), distant metastasis-free survival, and cause-specific survival rates are reported for each risk group. Data on patient-reported quality of life and high-grade toxicities were prospectively collected and reported. A multivariate analysis was performed to identify clinical predictors of biochemical failure and urologic toxicity.



The median follow-up time was 5.5 years. The 5-year FFBP rates were 99%, 94%, and 74% in low-risk, intermediate-risk, and high-risk patients, respectively. The actuarial 5-year rates of late grade 3+ Common Terminology Criteria for Adverse Events, version 4.0, gastrointestinal (GI) and genitourinary (GU) toxicity were 0.6% and 2.9%, respectively. Multivariate analysis showed a significant correlation between grade 3+ GU toxicity and pretreatment prostate reductive procedures (P<.0001), prostate volume (P=.0085), pretreatment α-blockers (P=.0067), diabetes (P=.0195), and dose-volume histogram parameters (P=.0208). The median International Prostate Symptom Scores pretreatment scores and scores at 5 years after treatment were 7 and 7, respectively. The mean Expanded Prostate Cancer Index Composite (EPIC) scores significantly declined for sexual summary for patients not receiving ADT (from 67 to 53) between baseline and 5 years.



Image guided PT provided excellent biochemical control rates for patients with localized prostate cancer. The actuarial rates of high-grade toxicity were low after PT. From pretreatment to 5 years of follow-up, a significant decline was found only in mean EPIC sexual summary scores. Prospective clinical studies are needed to determine the comparative effectiveness of PT and other radiation treatment strategies.
Modulation of event-related desynchronization during motor imagery with transcranial direct current stimulation (tDCS) in patients with chronic hemiparetic stroke

Electroencephalogram-based brain–computer interface (BCI) has been developed as a new neurorehabilitative tool for patients with severe hemiparesis. However, its application has been limited because of difficulty detecting stable brain signals from the affected hemisphere. It has been reported that transcranial direct current stimulation (tDCS) can modulate event-related desynchronization (ERD) in healthy persons. The objective of this study was to test the hypothesis that anodal tDCS could modulate ERD in patients with severe hemiparetic stroke. The participants were six patients with chronic hemiparetic stroke (mean age, 56.8 ± 9.5 years; mean time from the onset, 70.0 ± 19.6 months; Fugl-Meyer Assessment upper extremity motor score, 30.8 ± 16.5). We applied anodal tDCS (10 min, 1 mA) and sham stimulation over the affected primary motor cortex in a random order. ERD of the mu rhythm (mu ERD) with motor imagery of extension of the affected finger was assessed before and after anodal tDCS and sham stimulation. Mu ERD of the affected hemisphere increased significantly after anodal tDCS, whereas it did not change after sham stimulation. Our results show that anodal tDCS can increase mu ERD in patients with hemiparetic stroke, indicating that anodal tDCS could be used as a conditioning tool for BCI in stroke patients.
Use of varenicline for 4 weeks before quitting smoking: decrease in ad lib smoking and increase in smoking cessation rates.

The use of varenicline tartrate alleviates postquit withdrawal discomfort, but it also seems to reduce the "reward" associated with smoking. The current treatment schedule, which commences 1 week before quitting, relies primarily on the first mechanism. We set out to determine whether increasing the prequit medication period renders cigarettes less satisfying and facilitates quitting.



One hundred one smokers attending a stop-smoking clinic in London, United Kingdom, were randomly allocated to receive varenicline for 4 weeks before the target quit date (TQD) or to receive placebo for 3 weeks before the TQD, followed by varenicline for 1 week before the TQD. In both groups, standard varenicline treatment was given for 3 months after the TQD. Measures included smoking satisfaction and smoke intake before quitting, urges to smoke and withdrawal discomfort after quitting, and sustained abstinence from the TQD to 3 months.



Varenicline preloading reduced prequit enjoyment of smoking (P = .004) and smoke intake (P < .001), with 36.7% of participants reducing their cotinine concentrations by more than 50% (reducers). Varenicline preloading did not affect postquit withdrawal symptoms, but it increased 12-week abstinence rates (47.2% in the varenicline arm vs 20.8% in the placebo arm, P = .005). The effect was particularly strong among the reducers in the varenicline arm (66.7% in reducers vs 22.6% in nonreducers, P = .002). Varenicline preloading was well tolerated.



Although several issues remain to be clarified, varenicline preloading can generate a substantial reduction in ad lib smoking and enhance 12-week quit rates. Current treatment schedules may lead to suboptimal treatment results. Trials with longer follow-up periods are needed to corroborate these findings.
Phase I pharmacokinetic study of DUP-937, a new anthrapyrazole

DUP-937 is a new anthrapyrazole intercalator that inhibits DNA synthesis. A phase I trial was conducted in which DUP-937 was given in an intravenous bolus weekly for 3 weeks. Cycles were repeated every 5 weeks. Twenty men and 13 women with median ECOG performance status of 1 completed 74 cycles. The starting dose was 0.55 mg/m2/week and doses were escalated to 16 mg/m2/week. Non-hematological toxicity was generally mild or moderate and consisted mainly of gastro-intestinal effects, fatigue, alopecia and local-reactions. Grade 3 neutropenia was first documented at 7.36 mg/m2 and became more common at higher dose levels. Three of four patients had ≥ grade 3 neutropenia at the 16 mg/m2 dose level. Thrombocytopenia was minimal. The dose-limiting toxicity was neutropenia and the maximum tolerated dose was 16 mg/m2 weekly for 3 weeks. Mean area under the curve (AUC) values increased with dose. Linear pharmacokinetics were observed as total body clearance (CLtb), half-life (t1/2) and volume of distribution (Vss) did not change with increasing doses. One partial remission in a patient with prostate carcinoma was documented.
Data-Driven Personalized Feedback to Patients with Type 1 Diabetes: A Randomized Trial

A mobile phone-based application can be useful for patients with type 1 diabetes in managing their disease. This results in large datasets accumulated on the patient's devices, which can be used for individualized feedback. The effect of such feedback is investigated in this article.



We developed an application that included a data-driven feedback module known as Diastat for patients on self-measured blood glucose regimens. Using a stepped-wedge design, both groups initially received an application without Diastat. Group 1 activated Diastat after 4 weeks, whereas Group 2 activated Diastat 12 weeks after startup (T1). End points were glycated hemoglobin (HbA1c) level and number of out-of-range (OOR) measurements (i.e., outside the range 72-270 mg/dL).



Thirty patients were recruited to the study, and 15 were assigned to each group after the initial meeting. There were no significant differences between groups at T1 in HbA1c or OOR events. Overall, all patients had a decrease of 0.6 percentage points in mean HbA1c (P < 0.001) and 14.5 in median OOR events over 2 weeks (P < 0.001).



The study does not provide evidence that data-driven feedback improves glycemic control. The decrease in HbA1c was sizeable and significant, even though the study was not powered to detect this. The overall improvement in glycemic control suggests that, in general, mobile phone-based interventions can be useful in diabetes self-management.
Psychometric properties of the HRQOLISP-40: a novel, shortened multiculturally valid holistic stroke measure.

A recent review showed that no existing instrument measured the entire spectrum of health-related quality of life (HRQOL) in stroke patients. However, the HRQOL in stroke patients (HRQOLISP) questionnaire is valid and exceptionally comprehensive. Founded on a holistic model of human life, it comprises both physical and spiritual spheres. However, its 102-item length may discourage routine use. Therefore, the aim was to determine the psychometric attributes of a shortened version based on a multicultural transnational study.



HRQOLISP was administered to 100 stroke patients in Ibadan, 103 in Berlin, and control groups of 100 apparently healthy adults in Ibadan and 50 in Berlin. Analyzing data from both cities, items were reduced to 40. Construct validity of the resulting HRQOLISP-40 was assessed by comparison with the National Institutes of Health Stroke Scale (NIHSS), Stroke Levity Scale (SLS), modified Rankin Scale (mRS), and Short Form 36 (SF-36) Health Survey.



In multicultural settings, the HRQOLISP-40 showed good internal consistency (α = .76, .86) and test-retest reliability. It retained its discriminant validity between stroke and healthy participants and demonstrated good "known-groups" validity in its relationship to the SLS, NIHSS, and mRS in the physical sphere. The physical sphere showed good convergent validity with corresponding facets of the SF-36.



Despite item reduction, the HRQOLISP-40 demonstrated excellent psychometric properties and is valid for routine use and clinical trials in stroke. The relative preservation of the spiritual sphere demonstrated the concept of disability disparity. Its ability to simultaneously assess the physical and spiritual spheres may be beneficial in studies aimed at potentiating internal adaptation in stroke patients.
Randomized controlled trial of pulsating cupping (pneumatic pulsation therapy) for chronic neck pain.

Pneumatic pulsation therapy may combine the effects of cupping therapy and massage. This study investigated the effect of pneumatic pulsation therapy on chronic neck pain compared to standard medical care.



50 patients (79.15% female; 46.17 ± 12.21 years) with chronic nonspecific neck pain were randomized to treatment group (TG; n = 25) or control group (CG; n = 25). The TG received 5 pneumatic pulsation treatments over a period of 2 weeks utilizing a mechanical device. Treatment was applied as a combination of moving and stationary pulsating cupping. Main outcome measure was pain intensity in pain diaries (numerical rating scale). Secondary outcome measures included functional disability (NDI), quality of life (SF-36), and pain at motion. Sensory thresholds, including pressure pain threshold, were measured at pain-related sites.



After the intervention, significant group differences occurred regarding pain intensity (baseline: 4.12 ± 1.45 in TG and 4.20 ± 1.57 in CG; post-intervention: 2.72 ± 1.62 in TG and 4.44 ± 1.96 in CG; analysis of covariance: p = 0.001), NDI (baseline: 25.92 ± 8.23 and 29.83; post-intervention: 20.44 ± 10.17 and 28.83; p = 0.025), and physical quality of life (baseline: 43.85 ± 7.65 and 41.66 ± 7.09; post-intervention: 47.60 ± 7.93 and 40.49 ± 8.03; p = 0.002). Further significant group differences were found for pain at motion (p = 0.004) and pressure pain threshold (p = 0.002). No serious adverse events were reported.



Pneumatic pulsation therapy appears to be a safe and effective method to relieve pain and to improve function and quality of life in patients with chronic neck pain.
Implant Breast Reconstruction and Radiation: A Multicenter Analysis of Long-Term Health-Related Quality of Life and Satisfaction

Indications for radiotherapy in breast cancer treatment are expanding. Long-term satisfaction and health-related quality of life (HR-QOL), important outcomes after alloplastic breast reconstruction and radiation, have not been measured in irradiated patients by using a condition-specific, validated patient-reported outcomes instrument. The aim was to evaluate patient satisfaction and HR-QOL in patients with implant breast reconstruction and radiotherapy. A multicenter cross-sectional survey of patients who underwent implant-based breast reconstruction from three centers in the United States and Canada, with and without radiation, was performed. Satisfaction with breasts, satisfaction with outcome, psychosocial well-being, sexual well-being, and physical well-being outcomes were evaluated using the BREAST-Q© (Reconstruction Module). Multivariable analysis was performed to evaluate the effect of radiotherapy on patient satisfaction with breasts with adjustment by patient and treatment characteristics. The response rate was 71 %, with 633 completed questionnaires returned. Mean follow-up was 3.3 years for irradiated patients (n = 219) and 3.7 years for nonirradiated patients (n = 414). Patients with radiation had significantly lower satisfaction with breasts (58.3 vs. 64.0; p < 0.01), satisfaction with outcome (66.8 vs. 71.4; p < 0.01), psychosocial well-being (66.7 vs. 70.9; p < 0.01), sexual well-being (47.0 vs. 52.3; p < 0.01), and physical well-being (71.8 vs. 75.1; p < 0.01) compared with nonirradiated patients. Multivariable analysis confirmed the negative effect of radiotherapy on satisfaction with breasts (β = −2.6; p = 0.03) when adjusted for patient and treatment factors. Radiotherapy has a negative effect on HR-QOL and satisfaction with breasts in patients with implant reconstruction compared with nonirradiated patients. The information provided here can inform decision-making and help set appropriate expectations for patients undergoing implant breast reconstruction and radiation.
Internal Occipital Crest Misalignment with Internal Occipital Protuberance: A Case Report of Posterior Cranial Fossa Anatomic Variations

During gross anatomy head and neck laboratory session, one dissection group observed an abnormal anatomic variation in the posterior cranial fossa of a 94-year-old male cadaver. The internal occipital crest was not aligned with internal occipital protuberance and groove for superior sagittal sinus. It seemed that the internal occipital protuberance was shifted significantly to the right side. As a result the skull was overly stretched in order to connect with the internal occipital ridge. These internal skull variations of occipital bone landmarks can influence the location of adjacent dural venous sinuses and possibly influence cerebrospinal fluid flow. Similar anatomical anomalies have been attributed to presence of hydrocephalus and abnormalities in cisterna magna.
Intraoperative volume restriction in esophageal cancer surgery: an exploratory randomized clinical trial

To investigate whether the fluid volume administered during esophageal cancer surgery affects pulmonary gas exchange and tissue perfusion.



An exploratory single-center randomized clinical trial was performed. Patients with esophageal cancer who underwent Lewis-Tanner procedure between June 2011 and August 2012 at the Department of Thoracic surgery "Jordanovac", Zagreb were analyzed. Patients were randomized (1:1) to receive a restrictive volume of intraoperative fluid (≤8 mL/kg/h) or a liberal volume (>8 mL/kg/h). Changes in oxygen partial pressure (Pao2), inspired oxygen fraction (FiO2), creatinine, and lactate were measured during and after surgery.



Overall 16 patients were randomized and they all were analyzed (restrictive group n=8, liberal group n=8). The baseline value Pao2/FiO2 ratio (restrictive) was 345.01±35.31 and the value six hours after extubation was 315.51±32.91; the baseline Pao2/FiO2 ratio (liberal) was 330.11±34.71 and the value six hours after extubation was 307.11±30.31. The baseline creatinine value (restrictive) was 91.91±12.67 and the value six hours after extubation was 100.88±18.33; the baseline creatinine value (liberal) was 90.88±14.99 and the value six hours after extubation was 93.51±16.37. The baseline lactate value (restrictive) was 3.93±1.33 and the value six hours after extubation was 2.69±0.91. The baseline lactate value (liberal) was 3.26±1.25 and the value six hours after extubation was 2.40±1.08. The two groups showed no significant differences in Pao2/FiO2 ratio (P=0.410), creatinine (P=0.410), or lactate (P=0.574).



Restriction of intraoperative applied volume does not significantly affect pulmonary exchange function or tissue perfusion in patients undergoing surgical treatment for esophageal cancer.
The Prevention of Osteoporosis Using Sequential Low-Dose Hormone Replacement Therapy with Estradiol-17β and Dydrogesterone

Low-dose hormone replacement therapy (HRT) in postmenopausal women may produce fewer side-effects but its efficacy in the prevention of bone loss and osteoporosis is not established. To address this we compared the effect of 1 mg estradiol-17β with a 2 mg dose, in combination with cyclical dydrogesterone, in the prevention of postmenopausal bone loss. We conducted a multicenter double-masked prospective randomized, placebo-controlled study in 595 apparently healthy postmenopausal women randomized to either placebo, or continuous oral estradiol-17β 1 mg or 2 mg with sequential dydrogesterone for 2 years. The primary endpoint was the percentage change from baseline in bone mineral density (BMD) in the lumbar spine (LS) and femoral neck (FN) of actively treated groups compared with placebo. Women taking either 1 mg or 2 mg estradiol-17β showed a significant increase in BMD of the LS (mean ± SD, 5.2 ± 3.8% and 6.7 ± 4.0% respectively, both p <0.001) whilst BMD in the placebo group decreased (–1.9 ± 4.0%). Increases were also observed in FN BMD in both treated groups (2.7 ± 4.2% and 2.5 ± 5.2% respectively, both p <0.001) in contrast to the placebo group (–1.8 ± 4.8%). The oldest women showed the greatest treatment response. One milligram estradiol-17β in combination with dydrogesterone is effective in conserving LS and proximal femur bone mass, both of which are clinically important sites of osteoporotic fracture, and is as effective as 2 mg in preventing FN bone. The lower dose of estradiol-17β is a particularly suitable treatment for osteoporosis management in older women since it should minimize side-effects and improve the acceptability of HRT.
Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women.

Previous studies have indicated that serotonin-3-receptor antagonists might have a sex-specific effect in patients with irritable bowel syndrome with diarrhea (IBS-D). Alosetron has been approved for the treatment of only women, and ramosetron has been approved for the treatment for only men. We performed a randomized, placebo-controlled, phase 3 study to determine whether ramosetron reduces symptoms of IBS-D in women.



We performed a prospective study of 576 female outpatients with IBS-D (according to the Rome III criteria), from February 2013 through February 2014, at 70 academic Gastroenterology Departments in Japan. After a 1-week baseline period, subjects received either 2.5 μg ramosetron (n = 292) or placebo (n = 284) once daily for 12 weeks. Primary end points were the monthly rates of response for relief from overall IBS symptoms and increased stool consistency at the last evaluation point. Quality of life (QOL) also was quantified.



A significantly higher proportion of patients given ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8-56.6) than patients given placebo (32.0%; 95% CI, 26.7-37.8)--a difference of 18.6% (95% CI, 10.7-26.5; P < .001). The relative risk was 1.58 (95% CI, 1.29-1.94) and the number needed to treat was 6 (95% CI, 4-10). A significantly higher proportion of patients in the ramosetron group reported increased stool consistency (40.8%; 95% CI, 35.1%-46.6%) than in the placebo group (24.3%; 95% CI, 19.4%-29.7%)--a difference of 16.5% (95% CI, 8.9%-24.0%; P < .001). Patients receiving ramosetron had significant reductions in abdominal pain and discomfort (P = .001) and greater improvement in QOL (P = .002) compared with placebo. Ramosetron induced constipation in 11.0% of patients.



In a randomized, placebo-controlled study of 576 women with IBS-D, 2.5 μg ramosetron per day reduced symptoms and increased stool consistency and QOL.