nils-herrmann/clean_scirepeval huggingface dataset:
Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study

In cystic fibrosis (CF), the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa. Pathogens subsequently descend to the lower airways, with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease. Unlike conventional aerosols, vibrating aerosols applied with the PARI Sinus™ nebulizer deposit drugs into the paranasal sinuses. This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage.



To evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage; and on patient quality of life, measured with the Sino-Nasal Outcome Test (SNOT-20), and otologic and renal safety and tolerability.



Patients were randomized to inhalation of tobramycin (80 mg/2 mL) or placebo (2 mL isotonic saline) once daily (4 minutes/nostril) with the PARI Sinus™ nebulizer over 28 days, with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days. Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline.



Nine patients participated, six initially receiving tobramycin and three placebo. Sinonasal inhalation was well tolerated, with serum tobramycin <0.5 mg/L and stable creatinine. P. aeruginosa quantity decreased in four of six (67%) patients given tobramycin, compared with zero of three given placebo (non-significant). SNOT-20 scores were significantly lower in the tobramycin than in the placebo group (P=0.033).



Sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF.
Topiramate augmentation in patients with resistant major depressive disorder: A double-blind placebo-controlled clinical trial

Despite evolution of new antidepressant treatment, clinicians still encounter challenges in the treatment of depressed patients. Looking for new medications that can potentiate the effects of current antidepressants seems to be necessary. Our objective is to survey the efficacy of topiramate augmentation in resistant major depressive disorder (MDD).



This augmentation trial was designed as an 8-week randomized, placebo-controlled, double-blind study. Fifty three patients with DSM-IV diagnosis of MDD who had failed to respond to at least 8 weeks of treatment with an adequate dose of one of the SSRIs (fluoxetine, citalopram or serteraline) were included in the study. Patients were randomized to receive a flexible dose of topiramate (100-200 mg/day) or placebo beside their current antidepressant medication for a period of eight weeks. Outcome measures were Hamilton Depression Scale (HAM-D) and Clinical Global Impression (CGI).



42 patients completed the study and there were 6 and 5 dropouts in topiramate and placebo groups, respectively. The topiramate group demonstrated significant improvement over the study period based on mean HAM-D score at week 8 compared to baseline (P = .000, Z = 3.699). Those receiving topiramate demonstrated to have a mean decrease of 32.0% in HAM-D score, compared to only 5.5% for those receiving placebo. Depressed mood, suicidality, insomnia (early, middle and late), agitation and anxiety symptoms were significantly improved in the topiramate group.



Our double-blind placebo-controlled study demonstrated that topiramate augmentation potentiate the efficacy of selective serotonin reuptake inhibitors (SSRIs) in treatment of resistant major depressive disorder. Of note is that our study is preliminary and larger double-blind studies are needed to confirm the results.
Online windowed subsequence matching over probabilistic sequences

Windowed subsequence matching over deterministic strings has been studied in previous work in the contexts of knowledge discovery, data mining, and molecular biology. However, we observe that in these applications, as well as in data stream monitoring, complex event processing, and time series data processing in which streams can be mapped to strings, the strings are often noisy and probabilistic. We study this problem in the online setting where efficiency is paramount. We first formulate the query semantics, and propose an exact algorithm. Then we propose a randomized approximation algorithm that is faster and, in the mean time, provably accurate. Moreover, we devise a filtering algorithm to further enhance the efficiency with an optimization technique that is adaptive to sequence stream contents. Finally, we propose algorithms for patterns with negations. In order to verify the algorithms, we conduct a systematic empirical study using three real datasets and some synthetic datasets.
Effects of structural intervention on increasing condom availability and reducing risky sexual behaviours in gay bathhouse attendees.

The study purpose was to evaluate the effectiveness of a structural intervention in reducing unprotected sexual behaviours, increasing condom accessibility and their relationship to the prevalence of HIV infection and sexually transmitted infections (STIs) in gay bathhouse attendees. A quasi-experimental study with a non-equivalent control group for comparison was conducted at nine gay bathhouses in Taiwan from 2004 to 2006. A structural intervention designed to increase condom distribution and accessibility inside the bathhouses was implemented at one bathhouse in each city. Bathhouse attendees were invited to complete a questionnaire and to be screened for HIV infection and STIs. Of 632 study participants, 270 were surveyed six months after the intervention was conducted. At the time of follow-up after controlling for baseline data, patrons attending bathhouses for which intervention was performed were more likely to report accessing condoms inside bathhouses than those attending control bathhouses (92.6% versus 81.3%, P = 0.016), and condoms were more likely to be available at the reception desk of the bathhouse entrance (87.5% in intervention bathhouses versus 69.4% in control, P = 0.047). In a multivariate analysis adjusted for age, access to condoms inside bathhouses (adjusted odds ratio (AOR): 4.35; 95% confidence interval (CI): 1.48-12.78) and attendance at bathhouses with intervention (AOR: 2.07; 95% CI: 1.07-3.97) were independently associated with consistent condom use during anal intercourse. There were no significant differences in the prevalences of HIV infection and STIs at the six-month follow-up. Bathhouses with structural intervention were associated with consistent condom use during anal intercourse among bathhouse patrons. Our findings highlight the importance of extension of condom distribution inside the bathhouses to increase condom use among bathhouse patrons.
Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy.

Radiation-induced brachial plexopathy (RIBP) is an untreatable complication of curative radiotherapy for early breast cancer, characterized by chronic neuropathic pain and limb paralysis. Hyperbaric oxygen (HBO2) therapy is known to promote healing of tissue rendered ischaemic by radiotherapy, but is untested in RIBP.



Thirty four eligible research volunteers suffering from RIBP were randomized to HBO2 or control group. The HBO2 group breathed 100% oxygen for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The control group accompanied the HBO2 group and breathed a gas mixture equivalent to breathing 100% oxygen at surface pressure. All volunteers and investigators, except the operators of the hyperbaric chamber and the trial statistician, were blind to treatment assignments. The warm sensory threshold, which measures the function of small sensory fibres, was selected as the primary endpoint.



Pre-treatment neurophysiological tests were grossly abnormal in the affected hand compared to the unaffected hand in both HBO2 and control groups, as expected, but no statistically significant differences were noted in either group at any time up to 12 months post-treatment. However, normalization of the warm sensory threshold in two of the HBO2 group was reliably recorded. Two cases with marked chronic arm lymphoedema reported major and persistent improvements in arm volume for at least 12 months after treatment with HBO2.  There is no reliable evidence to support the hypothesis that HBO2 therapy slows or reverses RIBP in a substantial proportion of affected individuals, although improvements in warm sensory threshold offer some suggestion of therapeutic effect. Improvement in long-standing arm lymphoedema was not anticipated, and justifies further investigation.
Survivorship and relative risk of revision in computer-navigated versus conventional total knee replacement at 8-year follow-up

The long-term effects of computer-assisted surgery in total knee replacement (CAS) compared to conventionally operated knee replacement (CON) are still not clear. We compared survivorship and relative risk of revision in CAS and CON based on data from the Norwegian Arthroplasty Register.  We assessed primary total knee replacements without patellar resurfacing reported to the Norwegian Arthroplasty Register from 2005 through 2014. The 5 most used implants and the 3 most common navigation systems were included. The groups (CAS, n = 3,665; CON, n = 20,019) were compared using a Cox regression analysis adjusted for age, sex, ASA category, prosthesis brand, fixation method, previous surgery, and diagnosis with the risk of revision for any reason as endpoint. Secondary outcomes were reasons for revision and effects of prosthesis brand, fixation method, age (± 65 years), and hospital volume.  Prosthesis survival and risk of revision were similar for CAS and CON. CAS had significantly fewer revisions due to malalignment. Otherwise, no statistically significant difference was found between the groups in analyses of secondary outcomes. Mean operating time was 13 minutes longer in CAS.  At 8 years of follow-up, CAS and CON had similar rates of overall revision, but CAS had fewer revisions due to malalignment. According to our findings, the benefits of CAS at medium-term follow-up are limited. Further research may identify subgroups that benefit from CAS, and it should also emphasize patient-reported outcomes.
Improvement in Asthma Control and Inflammation in Children Undergoing Adenotonsillectomy

Observational studies suggest that asthma control improves after adenotonsillectomy, but longitudinal studies that correlate the effect of the procedure on the levels of biomarkers associated with airway inflammation are limited.We conducted a longitudinal, observational study on pediatric patients, both with and without asthma, undergoing adenotonsillectomy. Asthma control test (ACT) scores and chitinase activity in the circulation were measured at time of surgery and at 6-mo follow-up.Sixty-six children with asthma and 64 control subjects were enrolled. Mean ACT scores improved by three points (P < 0.001) after 6 mo. 85% of children with poorly controlled asthma demonstrated an increase in ACT score of at least three points or a decrease in emergency department/urgent care visits, oral corticosteroid courses, or rescue short acting bronchodilator usage. Chitinase activity decreased significantly in asthmatics who improved (P < 0.01). Higher chitinase activity levels at baseline were associated with improved asthma control following surgery (P < 0.01).Conclusion:In children with high preoperative circulating chitinase activity levels, asthma control and healthcare utilization were significantly improved after adenotonsillecotmy. Chitinase activity decreased after surgery in children with improved control. This suggests that adenotonsillectomy modulates chitinase activity, affecting airway inflammation and improving airway disease.
A randomised phase II study of carmustine alone or in combination with tomour necrosis factor in patients with advanced melanoma

Laboratory data suggest a synergistic interaction between carmustine (BCNU) and tumour necrosis factor (TNF) in melanoma. We therefore studied the activity of 200 mg/m2 BCNU given alone or in combination with 88 μg/m2 recombinant human TNF-alpha (rhTNFα) as a daily i. v. infusion for 5 days at 48-day intervals to patients with metastatic melanoma. In this randomised phase II trial, the rate of response to BCNU alone was 20% [95% confidence interval (CI), 2%–38%], and this was not improved by the addition of TNF (response rate, 10.5%; 95% CI, 1.3%–33%). Toxicity was higher in the combination arm, and there was no difference in survival.
Hormonal contraceptives and the length of their use are not independent risk factors for high-risk HPV infections or high-grade CIN.

To evaluate the role of hormonal contraceptives as a risk factor of high-risk human papillomavirus (HR-HPV), cervical intraepithelial lesions (CIN) and cervical cancer in our multi-center population-based LAMS (Latin American Screening) study.



A cohort study with >12,000 women from Brazil and Argentina using logistic regression to analyze the covariates of hormonal contraception (HOC - oral, injections, patches, implants, vaginal ring and progesterone intrauterine system) use followed by multivariate modeling for predictors of HR-HPV and CIN2+.



HR-HPV infection was a consistent risk factor of high-grade CIN in all three groups of women. The length of HOC use was not significantly related to high-grade squamous intraepithelial lesions (HSIL)+ Pap (p = 0.069), LSIL+ Pap (p = 0.781) or ASCUS+ (p = 0.231). The same was true with the length of HOC use and histology CIN3+ (p = 0.115) and CIN2+ (p = 0.515). Frequently, HOC users have previously shown more HPV-related lesions, as well as lower HPV prevalence if they were current smokers. But HOC use and time of usage were not independent risk factors of either HR-HPV infection or high-grade CIN using multiple logistic regressions.



No evidence was found for an association between the use of HOC with an increased risk for HR-HPV infection or high-grade CIN in this cohort.
Bromocriptine lessens the incidence of mortality in L-Dopa-treated parkinsonian patients: Prado-study discontinued

L-Dopa supplemented by a peripheral decarboxylase inhibitor is considered the most potent therapeutic regimen prolonging active life in Parkinsonian patients. The long-term benefit of therapy is limited by adverse effects, such as dyskinesia and on-off phenomena, which can be mitigated by the concomitant administration of dopamine agonists, such as bromocriptine. In order to quantify the beneficial impact of early combination therapy, a controlled clinical trial (PRADO:PRA vi-del1 +DOpa) in patients with early Parkinson's disease was carried out, whereby L-Dopa monotherapy (in a fixed combination with benserazide (DoBe) was being compared with the same combination plus bromocriptine (DoBeBro). Patients were recruited and treated by 101 practising neurologists in the Federal Republic of Germany and in Hungary. 'Twenty seven clinical university centers cross-checked the patients at regular intervals. The trial started with 3 months of DoBe monotherapy (median dose of 375 mg L-Dopa for both randomized groups) followed by gradual substitution of DoBe by bromocriptine over 3 months in one of the groups (250 mg L-Dopa/10 mg bromocriptine). The target medication was maintained from study months 6 to 54. Parkinsonian symptoms were classified according to the Webster rating scale, the Hoehn and Yahr scale and the Zung Self-Rating Depression Scale. Adverse events and life status were checked at regular intervals. Special emphasis was given to motor performance tests. 587 patients (302 in the DoBe group and 285 in the DoBeBro group) were available for intention-to-treat analysis. Both groups were homogeneous at baseline in all observed parameters. DoBe and DoBeBro proved equi-effective in terms of antiparkinsonian activity after the substitution phase (P II) had been completed. In September 1991, after a median observation period on target medication of 38.4 months in the DoBe group and 40.1 months in the DoBeBro group, 18 versus 8 deaths had been registered. The Logrank test as well as analysis using the Cox model, both adjusted for age and sex, showedP-values of 0.018 and 0.021, respectively. The mortality risk associated with L-Dopa therapy was reduced by more than 50 % by its combination with bromocriptine. The study was terminated due to this difference in mortality. The causes of death were classified by the treating physicians and consultants. At the time of study termination 152 patients in the DoBe group and 121 in the DoBeBro group had already discontinued study medication. Of those further 26 patients had died by the date of the final evaluation, 15 on DoBe and 11 on DoBeBro. The results imply that combination therapy with bromocriptine should be preferred over L-Dopa monotherapy from the very beginning.
Palliative radiotherapy for patients with tracheobronchial and esophageal compression due to intrathoracic malignant tumors.

To evaluate palliative outcomes of patients with extrinsic malignant tracheobronchial or esophageal stenosis treated with radiation. Mediastinal or hilar lymphadenopathy surrounding the tracheobronchi or esophagus may cause compression, presenting as dyspnea and dysphagia respectively. Treatment is important for symptom relief and maintaining patients' quality of life.



Dyspnea and dysphagia were assessed using the Hugh-Jones score and a modified dysphagia scale, respectively. A total of 13 patients (median age, 60 years) with dyspnea received palliative radiotherapy. The primary organs were lung (n = 6), colorectum (n = 5), hypopharynx (n = 1) and uterine cervix (n = 1). Three patients received concurrent chemotherapy. The median time-adjusted biological effective dose (BED) was 33.0 Gy(10) . Ten patients (median age, 61) with dysphagia received palliative radiotherapy. The primary organs were lung (n = 7), esophagus (n = 2) and hypopharynx (n = 1). Three patients received concurrent chemotherapy. The median time-adjusted BED was 32.1 Gy(10) .



Palliation of dyspnea and dysphagia occurred in seven (54%) and five (50%) patients, respectively. Patients treated with doses over 35 Gy(10) had greater score improvements than those treated with less than 35 Gy(10) in both groups. Patients who received concurrent chemoradiotherapy had greater score improvements than those treated with radiotherapy alone. Dyspnea patients with pretreatment scores of 2 (n = 5) had greater score improvements than those with scores of 3 or more (n = 8).



External beam radiotherapy should be considered for patients with tracheobronchial or esophageal stenosis before their symptoms worsen. The prescription dose should be over 35 Gy(10) .
Gd-BOPTA for assessment of myocardial viability on MRI: changes of T1 value and their impact on delayed enhancement

Gadobenate (Gd-BOPTA), injected at a dose of 0.1 mmol/kg body weight, was compared with gadopentetate (Gd-DTPA), injected at a dose of 0.2 mmol/kg body weight, for delineation of myocardial infarction interindividually in two groups of 26 patients each. Delayed enhancement images were assessed subjectively for image quality, and measured for regional T1 values before, 3 min after and 25 min after the injection of each contrast agent. In the 26 patients who received Gd-BOPTA, T1 values of remote myocardium were 1,070 ± 125 ms, 358 ± 78 ms and 562 ± 108 ms before, 3 min after and 25 min after injection, respectively. Infarcted myocardium values were 1,097 ± 148 ms, 246 ± 68 ms and 373 ± 84 ms and left ventricular blood pool 1,238 ± 95 ms, 194 ± 47 ms and 373 ± 72 ms. In the 26 patients who received Gd-DTPA, T1 values were 1,087 ± 96 ms, 325 ± 60 ms and 555 ± 108 ms for remote myocardium; 1,134 ± 109, 210 ± 43 ms and 304 ± 57 ms for infarcted myocardium; and 1,258 ± 104 ms, 166 ± 27 ms and 351 ± 73 ms for left ventricular blood pool. Delayed enhancement image quality showing myocardial infarction was rated good (54%) and excellent (46%) after Gd-BOPTA, and good (58%) and excellent (42%) after Gd-DTPA (no significant differences). A single dose of Gd-BOPTA compared with a double dose of Gd-DTPA causes similar changes of T1 values in infarcted and remote myocardium and provides fairly similar contrast between infarcted and remote myocardium (0.64 ± 14 versus 0.71 ± 11) and slightly higher contrast between left ventricular blood and infarcted myocardium (0.22 ± 17 versus 0.14 ± 6; p < 0.05). Administration of 0.1 mmol/kg body weight Gd-BOPTA can provide similar late enhancement images compared with the standard 0.2 mmol/kg body weight dose of Gd-DTPA due to the higher T1 relaxivity associated with the former.
Body Mass Index and Breast Cancer Defined by Biological Receptor Status in Pre-Menopausal and Post-Menopausal Women: A Multicenter Study in China

Few studies have investigated the association between body mass index (BMI) and breast cancer with consideration to estrogen/progesterone/human epidermal growth factor type 2 receptor status (ER/PR/HER2) in the breast tissue among Chinese pre- and post-menopausal women.



Four thousand two hundred and eleven breast cancer patients were selected randomly from seven geographic regions of China from 1999 to 2008. Demographic data, risk factors, pathologic features, and biological receptor status of cases were collected from the medical charts. Chi-square test, fisher exact test, rank-correlation analysis, and multivariate logistic regression model were adopted to explore whether BMI differed according to biological receptor status in pre- and post-menopausal women.



Three thousand two hundred and eighty one eligible cases with BMI data were included. No statistically significant differences in demographic characteristics were found between the cases with BMI data and those without. In the rank-correlation analysis, the rates of PR+ and HER2+ were positively correlated with increasing BMI among post-menopausal women (rs BMI, PR+=0.867, P=0.001; rs BMI, HER2+ =0.636, P=0.048), but the ER+ rates did not vary by increasing BMI. Controlling for confounding factors, multivariate logistic regression models with BMI<24 kg/m(2) as the reference group were performed and found that BMI ≥ 24 kg/m(2) was only positively correlated with PR+ status among post-menopausal breast cancer cases (adjusted OR=1.420, 95% CI: 1.116-1.808, Wald=8.116, P=0.004).



Post-menopausal women with high BMI (≥ 24 kg/m(2)) have a higher proportion of PR+ breast cancer. In addition to effects mediated via the estrogen metabolism pathway, high BMI might increase the risk of breast cancer by other routes, which should be examined further in future etiological mechanism studies.