nils-herrmann/clean_scirepeval huggingface dataset:
Carcinoma Ex Pleomorphic Adenoma of the Palate Composed of Invasive Micropapillary Salivary Duct Carcinoma and Adenoid Cystic Carcinoma Components

Carcinoma ex pleomorphic adenoma (CXPA) is an unusual epithelial malignancy that develops from a primary or recurrent pleomorphic adenoma (PA), the most common tumor of salivary glands, and constitutes about 11.5% of all carcinomas that affect these glands. Intraoral minor salivary glands and seromucous glands of the oropharynx are uncommon locations of CXPA. On histopathological examination, the tumor comprises a wide morphological spectrum with a variable proportion between the benign and malignant components with the latter often predominating and overlapping the PA, which may cause misdiagnosis. Here, we report a case of palatal minor salivary gland CXPA composed of invasive micropapillary salivary duct carcinoma and adenoid cystic carcinoma components with multiple nodal metastases in a 74-year-old woman. Neoplastic cells showed heterogeneous immunohistochemical profile with both luminal and myoepithelial differentiation. The invasive micropapillary salivary duct carcinoma component demonstrated overexpression of the oncoprotein human epidermal growth factor receptor-2. This feature should be considered and evaluated as a possible target for adjuvant therapy in case of metastatic disease.
Walking in fully immersive virtual environments: an evaluation of potential adverse effects in older adults and individuals with Parkinson’s disease

Virtual reality (VR) has recently been explored as a tool for neurorehabilitation to enable individuals with Parkinson’s disease (PD) to practice challenging skills in a safe environment. Current technological advances have enabled the use of affordable, fully immersive head-mounted displays (HMDs) for potential therapeutic applications. However, while previous studies have used HMDs in individuals with PD, these were only used for short bouts of walking. Clinical applications of VR for gait training would likely involve an extended exposure to the virtual environment, which has the potential to cause individuals with PD to experience simulator-related adverse effects due to their age or pathology. Thus, our objective was to evaluate the safety of using an HMD for longer bouts of walking in fully immersive VR for older adults and individuals with PD. Thirty-three participants (11 healthy young, 11 healthy older adults, and 11 individuals with PD) were recruited for this study. Participants walked for 20 min while viewing a virtual city scene through an HMD (Oculus Rift DK2). Safety was evaluated using the mini-BESTest, measures of center of pressure (CoP) excursion, and questionnaires addressing symptoms of simulator sickness (SSQ) and measures of stress and arousal. Most participants successfully completed all trials without any discomfort. There were no significant changes for any of our groups in symptoms of simulator sickness or measures of static and dynamic balance after exposure to the virtual environment. Surprisingly, measures of stress decreased in all groups while the PD group also increased the level of arousal after exposure. Older adults and individuals with PD were able to successfully use immersive VR during walking without adverse effects. This provides systematic evidence supporting the safety of immersive VR for gait training in these populations.
Irinotecan plus raltitrexed as first-line treatment in advanced colorectal cancer: a phase II study

To evaluate the efficacy and toxicity of irinotecan (CPT-11) in combination with raltitrexed as first-line treatment of advanced colorectal cancer (CRC). A total of 91 previously untreated patients with advanced CRC and measurable disease were enrolled in this phase II study. The median age was 62 years (range 31–77); male/female 54/37; ECOG performance status was 0 in 50 patients (55%), one in 39 (43%) and two in two (2%). Treatment consisted of CPT-11 350 mg m−2 in a 30-min intravenous infusion on day 1, followed after 30 min by a 15-min infusion of raltitrexed 3 mg m−2. Measurements of efficacy included the following: response rate, time to disease progression and overall survival. Of the 83 evaluable patients valuable to objective response, there were five complete responses (6%) and 23 partial responses (28%), for an overall response rate of 34% (95% CI: 25.9–46.5%). In all, 36 patients (43%) had stable disease, whereas 19 (23%) had a progression. The median time to progression was 11.1 months and the median overall survival was 15.6 months. A total of 487 cycles of chemotherapy were delivered with a median of five per patient. Grade 3–4 WHO toxicities were as follows: diarrhoea in 13 patients (15%), nausea/vomiting in four (4%), transaminase increase in six (7%), stomatitis in two (2%), febrile neutropenia in three (3%), anaemia in five (6%) and asthenia in three (3%). The combination CPT-11–raltitrexed is an effective, well-tolerated and convenient regimen as front-line treatment of advanced CRC.
Do level and variability of systolic blood pressure predict arterial properties or vice versa?

No longitudinal study addressed whether systolic blood pressure level (SBPL) or within-visit variability (SBPV) predict arterial properties or vice versa. In families randomly recruited from a Flemish population, we determined SBPL and SBPV from five consecutive blood pressure readings. The indexes of SBPV were variability independent of the mean, the difference between maximum and minimum SBPL, and average real variability. We measured carotid intima-media thickness and distensibility by ultrasound and carotid–femoral pulse wave velocity by tonometry (SphygmoCor, version 8.2). Effect sizes were computed for 1-s.d. increments in the predictors, while accounting for covariables and family clusters. Among 1087 participants (50.4% women; mean age, 41.8 years), followed up for 2.55 years (median), higher SBPL predicted (P⩽0.019) higher carotid intima-media thickness (+15 μm), lower carotid distensibility (−1.53 10−3 kPa−1) and faster carotid–femoral pulse wave velocity (+0.285 m s−1) at follow-up, whereas none of the SBPV indexes predicted the arterial traits at follow-up (P⩾0.11). In a subset of 713 participants, followed up for another 3.14 years, lower carotid distensibility predicted (P<0.01) higher SBPL (+2.57 mm Hg), variability independent of the mean (+0.531 units), difference between maximum and minimum SBPL (+1.75 mm Hg) and average real variability (+0.654 mm Hg). Higher carotid–femoral pulse wave velocity predicted a 1.11 mm Hg increase SBPL (P=0.031). In conclusion, temporality and effect size suggest that SBPL but not within-visit SBPV cause arterial stiffness and carotid intima-media thickness. Carotid stiffness, independent of SBPL, predicts within-visit SBPV, possibly because baroreflexes originating from a stiff carotid artery wall are impaired. Finally, stiffness of the aorta contributes to the age-related SBPL possibly, because faster returning reflected waves augments SBPL.
Phase II evaluation of bisantrene in refractory multiple myeloma

Brian G.M. Durie 1 (for the Myeloma Committee of the Southwest Oncology Group study), John Crowley 2, Charles A. Coltman Jr. 3, Robert A. Chapman 4, Stanley P. Balcerzk 5, John D. Bonnet 6, David A. Lipschitz 7, Ronald L. Stephens 8 and Bruce D. Cheson 9 1University of Arizona Cancer Center; 2Southwest Oncology Group Statistical Center-Seattle; 3University of Texas Health Science Center-San Antonio; 4Henry Ford Hospital; 5Ohio State University Health Center; 6Scott & White Clinic; 7University of Arkansas for Medical Science; 8University of Kansas Medical Center; 9University of Utah Medical Center
Effect of MMX® mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials

MMX(®) mesalamine is a once daily oral 5-aminosalicylic acid formulation, effective in induction and maintenance of ulcerative colitis remission. Patients on long-term mesalamine maintenance may occasionally require concomitant antibiotic treatment for unrelated infections.



To evaluate the potential for pharmacokinetic interactions between MMX mesalamine and amoxicillin, ciprofloxacin extended release (XR), metronidazole, or sulfamethoxazole in four open-label, randomized, placebo-controlled, two-period crossover studies.



In all four studies, healthy adults received placebo once daily or MMX mesalamine 4.8 g once daily on days 1-4 in one of two treatment sequences. In studies 1 and 2, subjects also received a single dose of amoxicillin 500 mg (N=62) or ciprofloxacin XR 500 mg (N=30) on day 4. In studies 3 and 4, subjects received metronidazole 750 mg twice daily on days 1-3 and once on day 4 (N=30); or sulfamethoxazole 800 mg/trimethoprim 160 mg twice daily on days 1-3 and once on day 4 (N=44).



MMX mesalamine had no significant effects on systemic exposure to amoxicillin, ciprofloxacin, or metronidazole; the 90% confidence intervals (CIs) around the geometric mean ratios (antibiotic + MMX mesalamine: antibiotic + placebo) for maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) fell within the predefined equivalence range (0.80-1.25). Sulfamethoxazole exposure increased by a statistically significant amount when coadministered with MMX mesalamine; however, increased exposure (by 12% in Cmax at steady state; by 15% in AUC at steady state) was not considered clinically significant, as the 90% CIs for each point estimate fell entirely within the predefined equivalence range. Adverse events in all studies were generally mild.



MMX mesalamine may be coadministered with amoxicillin, ciprofloxacin, metronidazole, or sulfamethoxazole, without affecting pharmacokinetics or safety of these antibiotics.
Juvenile drug court: enhancing outcomes by integrating evidence-based treatments.

Evaluated the effectiveness of juvenile drug court for 161 juvenile offenders meeting diagnostic criteria for substance abuse or dependence and determined whether the integration of evidence-based practices enhanced the outcomes of juvenile drug court. Over a 1-year period, a four-condition randomized design evaluated outcomes for family court with usual community services, drug court with usual community services, drug court with multisystemic therapy, and drug court with multisystemic therapy enhanced with contingency management for adolescent substance use, criminal behavior, symptomatology, and days in out-of-home placement. In general, findings supported the view that drug court was more effective than family court services in decreasing rates of adolescent substance use and criminal behavior. Possibly due to the greatly increased surveillance of youths in drug court, however, these relative reductions in antisocial behavior did not translate to corresponding decreases in rearrest or incarceration. In addition, findings supported the view that the use of evidence-based treatments within the drug court context improved youth substance-related outcomes. Clinical and policy implications of these findings are discussed.
Effect of intensive outpatient physical training on gait performance and cardiovascular health in people with hemiparesis after stroke.

Stroke can result in severe motor deficits, and many people who have survived a stroke have poor cardiovascular fitness, with potentially disabling effects on daily life.



The objective of this study was to evaluate the impact of intensive physical training on gait performance and cardiovascular health parameters in people with stroke in the chronic stage.



This was a single-group, pretest-posttest experimental study.



Fourteen people with hemiparesis after cerebrovascular injury (mean age=58.4 years, mean time since injury=25 months) participated in a 12-week training intervention, 5 times per week for 1.5 hours per session. The intervention consisted of high-intensity, body-weight-supported treadmill training; progressive resistance strength training; and aerobic exercise. The main outcome measures were gait performance (Six-Minute Walk Test, 10-Meter Walk Test, and aerobic capacity) and parameters of cardiovascular health (systolic and diastolic blood pressures, body mass index, and resting heart rate).



Significant improvements in all main outcome parameters were observed in response to the intervention. Gait speed during the Six-Minute Walk Test increased 62%, and systolic and diastolic blood pressures decreased 10% and 11%, respectively. Weekly testing of walking speed showed that most of the increase in the walking speed occurred in the first 8 weeks of training. Correlation analyses showed that improvements were unrelated to age, chronicity, or level of functioning.



High-intensity physical training for people with stroke in the chronic stage increased walking speed regardless of chronicity, age, or level of functioning. Further studies should investigate the intervention duration needed to reach the full potential of gait recovery.
Breast milk pharmacokinetics of efavirenz and breastfed infants' exposure in genetically defined subgroups of mother-infant pairs: an observational study.

The antiretroviral drug efavirenz is widely used during breastfeeding. Evaluating its safety requires an understanding of its breast milk pharmacokinetics, level of breastfed infants' exposure, and potential influence of polymorphisms in drug disposition genes.



For this observational study, we investigated plasma and breast milk pharmacokinetics of efavirenz and breastfed infants' exposure in human immunodeficiency virus positive nursing mothers and their breastfed infants. We also evaluated potential variability due to genetic polymorphisms in CYP2B6, NR1I3, CYP2A6, ABCB1, ABCB5, and ABCG2.



CYP2B6 516G>T was independently associated with efavirenz concentrations in maternal plasma, breast milk, and infant plasma (n = 134). When stratified based on CYP2B6 516G>T (n = 29 ; 11 GG, 10 GT and 8 TT), efavirenz pharmacokinetic parameters in plasma and breast milk differed significantly between patient groups. The median time-averaged milk-to-plasma concentration ratio was 1.10 (range: 0.57-1.71). The estimated maximum infant efavirenz dose from breast milk was 809 µg/kg/day (215-2760) and pediatric dose weight-adjusted exposure index was 4.05% (1.08-13.8). Infant plasma concentrations did not change significantly during the dosing interval, 157 ng/mL (28.6-1360) in pooled analysis and 315 ng/mL (108-1360) in CYP2B6 516TT group. Infant plasma concentrations were highest up to 8 days of age at 1590 ng/mL (190-4631) and decreased by about 90% in the age stratum day 9 to 3 months. No efavirenz related toxicity was reported.



Most breastfed infants are exposed to <10% of the weight-adjusted therapeutic pediatric dose, the safety threshold for exposure to maternal drugs from breast milk.
Dual-5α-Reductase Inhibition Promotes Hepatic Lipid Accumulation in Man

5α-Reductase 1 and 2 (SRD5A1, SRD5A2) inactivate cortisol to 5α-dihydrocortisol in addition to their role in the generation of DHT. Dutasteride (dual SRD5A1 and SRD5A2 inhibitor) and finasteride (selective SRD5A2 inhibitor) are commonly prescribed, but their potential metabolic effects have only recently been identified.



Our objective was to provide a detailed assessment of the metabolic effects of SRD5A inhibition and in particular the impact on hepatic lipid metabolism.



We conducted a randomized study in 12 healthy male volunteers with detailed metabolic phenotyping performed before and after a 3-week treatment with finasteride (5 mg od) or dutasteride (0.5 mg od). Hepatic magnetic resonance spectroscopy (MRS) and two-step hyperinsulinemic euglycemic clamps incorporating stable isotopes with concomitant adipose tissue microdialysis were used to evaluate carbohydrate and lipid flux. Analysis of the serum metabolome was performed using ultra-HPLC-mass spectrometry.



The study was performed in the Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital, Birmingham, United Kingdom.



Incorporation of hepatic lipid was measured with MRS.



Dutasteride, not finasteride, increased hepatic insulin resistance. Intrahepatic lipid increased on MRS after dutasteride treatment and was associated with increased rates of de novo lipogenesis. Adipose tissue lipid mobilization was decreased by dutasteride. Analysis of the serum metabolome demonstrated that in the fasted state, dutasteride had a significant effect on lipid metabolism.



Dual-SRD5A inhibition with dutasteride is associated with increased intrahepatic lipid accumulation.
Persons with multiple disabilities use orientation technology to find room entrances during indoor traveling.

These two studies assessed adapted orientation technology for promoting correct direction and room identification during indoor traveling by persons with multiple (e.g., sensory, motor and intellectual/adaptive) disabilities. In Study I, two adults were included who had severe visual impairment or total blindness and deafness and used a wheelchair for traveling. In Study II, two adults participated who had visual impairment or total blindness but were ambulatory. All participants were to travel to different rooms located along a hallway to carry out small activities. The orientation technology ensured that the participants received (a) a verbal instruction to go to their right or left and/or a vibratory cue to the right or left side of their body as soon as they exited a room to orient their travel within the hallway and (b) a similar verbal instruction and/or vibratory cue to turn and enter when they reached the next target room entrance. Results of both studies showed that the participants on wheelchairs and those able to ambulate were successful in using the technology, orient their travel, and find the appropriate room entrances. The findings are discussed in relation to the importance of independent indoor traveling and the impact of the new technology.
Use of chemotherapy at end of life in oncology patients.

Appropriately timed cessation of chemotherapy is integral to patient's quality of life. We evaluate the use of and associated factors with chemotherapy at the end of life.



A review of deceased oncology patients treated with palliative intent from April 2005 over 2 years at two cancer centres was carried out. Chi-square tests of patient demographics, cancer and chemotherapy variables were carried out to determine associations with commencing chemotherapy and continuation within 2 and 4 weeks of death. Multivariate analyses were carried out with significant factors to determine their independent effect.



Seven hundred and forty-seven patients died during this period; median age 67 years (range 20-96); female 44%. Three hundred and ninety-eight (53%) received chemotherapy: 18% and 8% within 4 and 2 weeks of death, respectively. Younger age (P < 0.01), cancer type (P < 0.01) and chemosensitivity of the tumour (P < 0.01) were predictors for commencing chemotherapy in multivariate analysis. Treating doctor predicted for chemotherapy in the 4 weeks before death (<0.05), but none of the variables predicted for chemotherapy in the last 2 weeks of life.



Younger age, tumour type and chemosensitivity are important predictors of patients receiving palliative chemotherapy. Individual clinician was the only predictor for continuing chemotherapy in the last 4 weeks of life.
Association of restrictive ventilatory dysfunction with the development of prediabetes and type 2 diabetes in Koreans

This study was performed to investigate whether ventilatory dysfunction is a predictor for the development of prediabetes and type 2 diabetes in Koreans. We analyzed the clinical and laboratory data of 16,195 Korean adults (age 20–79 years) who underwent routine medical checkups with a mean 4.7-years (range 3.0–5.9 years) interval. Spirometry results were categorized into three patterns: normal, obstructive ventilatory dysfunction [OVD; forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <0.70], and restrictive ventilatory dysfunction (RVD; FVC < 80 % predicted, FEV1/FVC ≥ 0.70). Compared with subjects with normal ventilatory function, subjects with RVD had a higher incidence of type 2 diabetes (3.7 vs. 6.3 %; P < 0.001), whereas subjects with OVD did not (3.7 vs. 4.8 %; P = 0.119). On multivariate logistic regression analysis, the odds ratio (OR) of RVD for type 2 diabetes was significantly increased after adjusting for age, sex, and lifestyle factors (1.40; 95 % CI 1.10–1.78). However, further adjustment for body mass index (BMI), waist circumference, and baseline glucose level attenuated the OR to become insignificant (1.12; 95 % CI 0.86–1.47). Among the 9,461 participants who had normal fasting glucose and HbA1c levels at baseline, the OR for progression to prediabetes or diabetes in the RVD group was significantly increased (1.30; 95 % CI 1.12–1.51). The increased OR remained significant after adjusting for BMI, waist circumference, and baseline glucose level (1.26; 95 % CI 1.07–1.47). Our results indicate that restrictive, but not obstructive ventilatory dysfunction, is independently associated with development of prediabetes and precedes the development of type 2 diabetes.
Cultural accommodation of group substance abuse treatment for Latino adolescents: Results of an RCT.

Comparative studies examining the difference between empirically supported substance abuse treatments versus their culturally accommodated counterparts with participants from a single ethnic minority group are frequently called for in the literature but infrequently conducted in practice. This randomized clinical trial was conducted to compare the efficacy of an empirically supported standard version of a group-based cognitive-behavioral treatment (S-CBT) to a culturally accommodated version (A-CBT) with a sample of Latino adolescents primarily recruited from the juvenile justice system. Development of the culturally accommodated treatment and testing was guided by the Cultural Accommodation Model for Substance Abuse Treatment (CAM-SAT). Seventy Latino adolescents (mean age = 15.2; 90% male) were randomly assigned to 1 of 2 group-based treatment conditions (S-CBT = 36; A-CBT = 34) with assessments conducted at pretreatment, posttreatment, and 3-month follow-up. Longitudinal Poisson mixed models for count data were used to conduct the major analyses. The primary outcome variable in the analytic models was the number of days any substance was used (including alcohol, except tobacco) in the past 90 days. In addition, the variables ethnic identity, familism, and acculturation were included as cultural moderators in the analysis. Although both conditions produced significant decreases in substance use, the results did not support a time by treatment condition interaction; however, outcomes were moderated by ethnic identity and familism. The findings are discussed with implications for research and practice within the context of providing culturally relevant treatment for Latino adolescents with substance use disorders.