nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and tolerability of fesoterodine in women with overactive bladder

We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB). This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12. By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate. Fesoterodine is efficacious and well tolerated in women with OAB.
Nonmedical prescription opioid and sedative use among adolescents in the emergency department.

Nonmedical prescription opiate use (NPOU) and nonmedical prescription sedative use (NPSU) are serious public health concerns. The objectives of this study were to determine the prevalence and emergency department (ED) visit characteristics and other correlates associated with past-year NPOU and NPSU among adolescents and young adults using the ED.



Participants aged 14 to 20 presenting to the ED at the University of Michigan Medical Center between September 2010 and September 2011 were systematically recruited. A computerized self-report screening survey with validated items measuring past-year NPOU, NPSU, substance use, and violence was delivered to participants, and a retrospective chart review was performed.



Of the 2135 participants (86.0% response rate), 222 (10.4%) reported either NPOU or NPSU. Among the 185 (8.7%) participants that reported NPOU, 14.6% had a current home prescription for an opioid and among the 115 (5.4%) with NPSU, 12.3% had a current home prescription for a sedative. After controlling for demographics (age, gender, race, public assistance), correlates of NPOU or NPSU included other substance use, and drinking and driving or riding with a drinking driver. Additional correlates of NPOU included receiving an intravenous opioid in the ED and for NPSU, dating violence, presenting to the ED for a noninjury complaint, and previous ED visit in the past year.



Nearly 1 in 10 young people who use the ED for care report NPOU or NPSU, and only 12.3% and 14.6% report having current home prescriptions for sedatives and opioids. The ED represents a key location for screening and intervention efforts.
Surgical versus nonsurgical treatment of selected patients with discogenic low back pain: a small-sized randomized trial.

Seiji Ohtori, MD, PhD, Takana Koshi, MD, PhD, Masaomi Yamashita, MD, Kazuyo Yamauchi, MD, Gen Inoue, MD, PhD, Munetaka Suzuki, MD, Sumihisa Orita, MD, Yawara Eguchi, MD, PhD, Nobuyasu Ochiai, MD, PhD, Shunji Kishida, MD, PhD, Masashi Takaso, MD, PhD, Kazuki Kuniyoshi, MD, PhD, Yasuchika Aoki, MD, PhD, Tetsuhiro Ishikawa, MD, Gen Arai, MD, Masayuki Miyagi, MD, Hiroto Kamoda, MD, Miyako Suzuki, MD, Junichi Nakamura, MD, PhD, Tomoaki Toyone, MD, PhD, and Kazuhisa Takahashi, MD, PhD
The combined evaluation of interim contrast-enhanced computerized tomography (CT) and FDG-PET/CT predicts the clinical outcomes and may impact on the therapeutic plans in patients with aggressive non-Hodgkin’s lymphoma

We investigated the concomitant interim response of patients with aggressive non-Hodgkin’s lymphoma (NHL) using multi-detector row computerized tomography (CT) and 18F-fluoro-2-deoxy-d-glucose-positron emission tomography (PET)/CT for prediction of clinical outcomes. One hundred six newly diagnosed patients with aggressive NHL were enrolled. Both the CT and PET/CT were serially performed at the time of diagnosis and after three to four cycles of chemotherapy (interim). The patients were categorized into four different responsive groups according to the interim PET/CT and CT: (1) complete metabolic response (CMR)–complete response unconfirmed (CRu), (2) CMR–partial response (PR), (3) partial metabolic response (PMR)–Cru, and (4) PMR–PR. Fifty-five patients with CMR–CRu, 20 patients with CMR–PR, seven patients with PMR–Cru, and 23 patients with PMR–PR were distributed. In addition, one patient experienced a disease progression. There was a significant difference in relapse rates between PET/CT-positive (67.3%) and PET/CT-negative patients (17.3%; P < 0.01). Also, there was a significant difference between patients with PMR–PR (32.0% and 26.1%) and CMR–CRu (89.3% and 80.0%) for 3-year overall survival (OS) and event-free survival (EFS), respectively. A multivariate analysis revealed that high international prognostic index (≥3) at diagnosis, T-cell phenotype, and PMR–PR in interim PET/CT and CT were independent prognostic significances for OS. Moreover, bulky disease (>10 cm), T-cell phenotype, and PMR–PR showed significant associations for EFS. PMR–PR in interim response was the predictive prognostic determinant for both OS and EFS, with a hazard ratio of 3.93 (1.61–9.60) and 3.60 (1.62–7.98), respectively. The combined evaluation of interim PET/CT and CT was found to be a significant predictor of disease progression, OS, and EFS.
A case control and family based association study of the neuregulin1 gene and schizophrenia.

D ata from twin, family, and adoption studies provide strong evidence that genetic factors play a major aetiological role in schizophrenia. By a series of linkage studies, chromosome 8p has been implicated as a region harbouring a schizophrenia susceptibility gene. Recently, Stefansson and colleagues reported that neuregulin 1 (NRG1), located in 8p21-12, may be involved in the aetiology of schizophrenia. 5 In their linkage and association studies, a 290 kb core at risk haplotype at the 59 end of NRG1 was found to be strongly associated with schizophrenia in Icelandic and Scottish populations. This haplotype contains the first exon of NRG1, which encodes a part of glial growth factor 2 (GGF2). Deficiency of glial growth factors has been presumed to be implicated in the pathogenesis of schizophrenia. Futhermore, NRG1 mutant mice have fewer functional N-methyl D-aspartate(NMDA) receptors than wild type mice, and display stereotypic behavioural abnormalities similar to those of normal mice treated with the psychogenic drug phenylcyclidine. This core at risk haplotype was defined by five single nucleotide polymorphisms (SNP8NRG221132, SNP8NRG221533, SNP8NRG241930, SNP8NRG243177, SNP8NRG433E1006) and two microsatellites (478B14-848, 420M91395). The frequency of this haplotype in schizophrenic individuals was higher than in controls; in Icelandic samples the frequency was 15.4 (7.5%; p = 0.000087). The first replication using Scottish samples revealed a similar result at 10.2 (5.9%; p = 0.00031). Another replication performed by Williams et al with British or Irish samples used one SNP and the two microsatellites of the core at risk haplotype. However, the association was much weaker at 9.5 (7.5%; p = 0.04). Yang et al reported other markers located in the middle of NRG1 and associated with schizophrenia, in a Chinese population. Another independent analysis using 13 microsatellites found two groups of haplotypes, which were significantly associated with schizophrenia, in a Chinese population. All these studies suggest that NRG1 may be a susceptibility gene for schizophrenia. However, there are differences in the findings and more replications are needed. Here we present results from the haplotype analysis using both case control and TDT. In our studies, only three of the five SNPs (SNP8NRG221533, SNP8NRG241930, SNP8NRG243177) and the two microsatellites reported by Stefansson et al were genotyped. The marker SNP8NRG221132 was abandoned because of low heterozygosity. We genotyped more than 200 individuals at this locus, but no allele A was found. In all, 1724 Han people Chinese participated in our research, including 369 subjects with schizophrenia, 299 controls in the case control study, and 352 family trios in the TDT study.
The VASOGRADE: A Simple Grading Scale for Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage.

Patients are classically at risk of delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. We validated a grading scale-the VASOGRADE-for prediction of DCI.



We used data of 3 phase II randomized clinical trials and a single hospital series to assess the relationship between the VASOGRADE and DCI. The VASOGRADE derived from previously published risk charts and consists of 3 categories: VASOGRADE-Green (modified Fisher scale 1 or 2 and World Federation of Neurosurgical Societies scale [WFNS] 1 or 2); VASOGRADE-Yellow (modified Fisher 3 or 4 and WFNS 1-3); and VASOGRADE-Red (WFNS 4 or 5, irrespective of modified Fisher grade). The relation between the VASOGRADE and DCI was assessed by logistic regression models. The predictive accuracy of the VASOGRADE was assessed by receiver operating characteristics curve and calibration plots.



In a cohort of 746 patients, the VASOGRADE significantly predicted DCI (P<0.001). The VASOGRADE-Yellow had a tendency for increased risk for DCI (odds ratio [OR], 1.31; 95% CI, 0.77-2.23) when compared with VASOGRADE-Green; those with VASOGRADE-Red had a 3-fold higher risk of DCI (OR, 3.19; 95% CI, 2.07-4.50). Studies were not a significant confounding factor between the VASOGRADE and DCI. The VASOGRADE had an adequate discrimination for prediction of DCI (area under the receiver operating characteristics curve=0.63) and good calibration.



The VASOGRADE results validated previously published risk charts in a large and diverse sample of subarachnoid hemorrhage patients, which allows DCI risk stratification on presentation after subarachnoid hemorrhage. It could help to select patients at high risk of DCI, as well as standardize treatment protocols and research studies.
Association study of Parkin gene polymorphisms with idiopathic Parkinson disease.

Previously, we detected linkage of idiopathic Parkinson disease (PD) to the region on chromosome 6 that contains the Parkin gene (D6S305; logarithm of odds score, 5.47) in families with at least one individual with age at onset younger than 40 years (families with early-onset disease). Further study demonstrated the presence of Parkin mutations in this data set. However, previous case-control studies have reported conflicting results regarding the role of more common Parkin polymorphisms as susceptibility alleles for idiopathic PD.



To investigate the association of 7 previously studied Parkin single-nucleotide polymorphisms (SNPs) throughout the promoter and most of the open reading frame with PD in a large cohort of patients with primarily late-onset PD.



One promoter, 3 intronic, and 3 exonic Parkin SNPs were genotyped in 1580 individuals belonging to 397 families, and their association with PD was evaluated using family-based association tests.



No significant association (P>.05) between PD and any Parkin SNP allele or genotype was detected. Haplotype analysis and stratification by age at onset or family history also failed to produce significant results.



These results suggest that these common variants of Parkin are not associated with PD in white patients, although Parkin mutations are known to cause early- and late-onset PD.
Time of hospital presentation after stroke. A multicenter study in north-east Italy

Given the current orientation towards the early treatment of stroke, this multicenter study was carried out in Northeast Italy in order to examine the times between stroke onset and hospital admission, and the possible factors leading to a lengthening of such times. An analysis was made of 348 patients, 79.8% of whom had experienced an ischemic cerebral infarct. Arrival times were not significantly modified by the distance from hospital, age, family cohabitation, socio-cultural level, population density or the geographical location of the Center. Sixty percent of the ischemic stroke cases arrived at the Emergency Department within three hours, and 80% within six hours; the hemorrhagic cases arrived earlier, 100% of them by the tenth hour. The duration of stay in the Emergency Department did not vary in relation to the severity or type of stroke. Greater severity, a reduced level of awareness and daytime onset led to a moderately significant reduction in presentation times. In conclusion, the majority of patients arrived sufficiently quickly to be treated within the “therapeutic window”; nevertheless, an information campaign may be useful in accelerating the hospital presentation of the albeit limited number of cases who arrive late. In considerazione degli attuali orientamenti verso una terapia precoce dell'ictus, è stato compiuto uno studio multicentrico nelle regioni del nord-est italiano per esaminare i tempi intercorrenti tra l'insorgenza dell'ictus ed il ricovero in ospedale ed i possibili fattori determinanti un allungamento di tali tempi. Sono stati analizzati 348 casi, 79,8% dei quali con infarto cerebrale ischemico. La distanza dall'ospedale, l'età, la convivenza con famigliari, il livello socioculturale e le caratteristiche di densità di popolazione o di ubicazione geografica del Centro non hanno modificato in misura significativa i tempi di arrivo. Il 60% degli ictus ischemici si è presentato in Pronto Soccorso entro 3 ore e l'80% entro 6 ore; gli emorragici sono giunti più precocemente raggiungendo il 100% alla decima ora. I tempi di permanenza in Pronto Soccorso non sono variati in rapporto alla diversa gravità o al diverso tipo di ictus. La maggior gravità, il ridotto livello di vigilanza e l'esordio diurno hanno determinato tempi di presentazione ridotti in misura moderatamente significativa. In conclusione, la maggioranza dei pazienti giunge all'osservazione in tempi sufficientemente brevi per poter usufruire di un trattamento entro la “finestra terapeutica”. Tuttavia, potrebbe essere utile una campagna informativa allo scopo di accelerare l'accesso della pur ridotta percentuale di casi che si presentano tardivamente.
Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma.

Pixantrone is an aza-anthracenedione with enhanced, preclinical antitumor activity and reduced cardiotoxicity compared with doxorubicin.



We compared the efficacy and toxic effect of CPOP-R (substituting pixantrone for doxorubicin) against CHOP-R in untreated, diffuse large B-cell lymphoma (DLBCL) patients. The primary objective was to demonstrate non-inferiority of CPOP-R by complete response/complete response unconfirmed (CR/CRu) rate.



The CR/CRu rate for CPOP-R was 75% versus 84% for CHOP-R. Three-year overall survival was lower for CPOP-R (69% versus 85%) (P = 0.029). Median progression-free survival (PFS) was not reached for CPOP-R and was 40 months for CHOP-R [HR 95% confidence interval (CI) = 1.02 (0.60, 1.76), P = 0.934]. Fewer CPOP-R patients developed congestive heart failure (CHF) (0% versus 6%, P = 0.120), ≥ 20% declines in ejection fraction (2% versus 17%, P = 0.004), or elevations in troponin-T (P = 0.003).



CPOP-R is an active regimen with modestly lower response rates than CHOP-R but similar PFS and event-free survival. This study demonstrates a substantially lower cardiotoxicity of pixantrone compared with doxorubicin when used as first-line therapy in DLBCL.
Effect of knowledge of serum enzyme concentrations on doctors' interpretation of electrocardiographic manifestations in suspected myocardial infarction.

3 Berry FA Jr, Yarborough S, Yarborough N, Russell CM, Carpenter MA, Hendley JO. Transient bacteremia during dental manipulation in children. Pediatrics 1973;51:476-9. 4 Shanson DC, Thomas F, Wilson D. Effect of volume of blood cultured on detection of Streptococcus viridans bacteraemia.  Antibiotic prophylaxis for open-heart surgery.  389-91.
Effects of patient-centered communication on anxiety, negative affect, and trust in the physician in delivering a cancer diagnosis: A randomized, experimental study.

When bad news about a cancer diagnosis is being delivered, patient-centered communication (PCC) has been considered important for patients' adjustment and well-being. However, few studies have explored how interpersonal skills might help cancer patients cope with anxiety and distress during bad-news encounters.



A prospective, experimental design was used to investigate the impact of the physician communication style during a bad-news encounter. Ninety-eight cancer patients and 92 unaffected subjects of both sexes were randomly assigned to view a video of a clinician delivering a first cancer diagnosis with either an enhanced patient-centered communication (E-PCC) style or a low patient-centered communication (L-PCC) style. Participants rated state anxiety and negative affect before and immediately after the video exposure, whereas trust in the physician was rated after the video exposure only. Main and interaction effects were analyzed with generalized linear models.



Viewing the disclosure of a cancer diagnosis resulted in a substantial increase in state anxiety and negative affect among all participants. This emotional response was moderated by the physician's communication style: Participants viewing an oncologist displaying an E-PCC style were significantly less anxious than those watching an oncologist displaying an L-PCC style. They also reported significantly higher trust in the physician.



Under a threatening, anxiety-provoking disclosure of bad news, a short sequence of empathic PCC influences subjects' psychological state, insofar that they report feeling less anxious and more trustful of the oncologist. Video exposure appears to be a valuable method for investigating the impact of a physician's communication style during critical encounters. Cancer 2017;123:3167-75.
Prognostic value of normal exercise and adenosine (99m)Tc-tetrofosmin SPECT imaging: results from the multicenter registry of 4,728 patients.

Event rates associated with a normal or low-risk myocardial perfusion SPECT imaging study have been shown by numerous investigators to be associated with <1%/y of follow-up. Thus, the aim of this study was to evaluate the prognostic value of a normal (99m)Tc-tetrofosmin study in a geographically diverse registry of patients undergoing stress myocardial perfusion SPECT. A total of 4,728 consecutively tested patients who underwent stress (99m)Tc-tetrofosmin SPECT at 5 U.S. hospitals were included in this series.



Patients were monitored for the occurrence of major cardiac events and hospitalizations. Uniform methods of data collection and standardized epidemiologic methods for follow-up were used at all centers. We used a risk-adjusted, Cox proportional hazards model to assess time to cardiac death.



Of the 4,728 patients, one third underwent adenosine stress SPECT and two thirds underwent treadmill exercise. The observed annualized survival rate for those patients with a normal (99m)Tc-tetrofosmin study was 0.6%. Similarly, excellent survival rates were noted for the male and female subsets of this population as well as for patients who could exercise and for those undergoing pharmacologic stress testing. Compared with prior published outcomes studies on stress (201)Tl or (99m)Tc-sestamibi SPECT, the overall survival rates were similar and ranged from 99.3% to 99.7%.



Results from this large multicenter registry provide further supportive evidence that the excellent prognosis associated with a normal SPECT scan is independent of the radiopharmaceutical used.
Genetic association of the transcription of neuroplasticity-related genes and variation in stress-coping style

Stress coping has been defined as the cognitive and behavioral efforts made to conquer, endure, or decrease external and internal demands and the conflicts between them. It has two main elements: the control or modification of the person-environment relationship causing the stress (i.e., problem-focused coping) and/or regulation of stressful feelings (i.e., emotion-focused coping). Research suggests that the expressions of brain-derived neurotrophic factor (BDNF) and neurotrophic tyrosine kinase receptor type 2 (NTRK2) play important roles in brain adaptation to investigate stress. To clarify the genetic basis of stress coping, we investigated the association of stress-coping strategies and social adaptation with single-nucleotide polymorphisms (SNPs) involved in neural plasticity, anxiety, and depression.



In 252 healthy controls (94 women; 158 men), we measured and estimated the stress-coping style using the Lazarus-type stress-coping inventory, ego aptitude scale (EAS), and social adaptation self-evaluation scale (SASS). We investigated one SNP of BDNF (rs6265, Val/Met) and five SNPs of NTRK2 (rs11140800, rs1187286, rs1867283, rs1147198, and rs10868235).



We observed significant associations between BDNF and emotion-focused strategies, seeking social support, self-control, and distancing. We also found significant associations between NTRK2 and cognitive strategies, problem-solving, confrontive- coping, seeking social support, distancing and positive reappraisal. Significant associations were also found between BDNF and critical attitudes and between NTRK2 and all seven ego-related factors on the EAS. In the SASS, the minor allele rs1867283 of NTRK2 had a significantly higher score than the heterozygote.



These findings may provide insights into the partial effects of genetic mutations in BDNF and NTRK2 on stress tolerance and personality.
Mild prevalent and incident vertebral fractures are risk factors for new fractures

This prospective four-year study indicates that post-menopausal osteoporotic women with mild prevalent and incident vertebral fractures have an increased risk of incident fractures. Mild vertebral fractures are under diagnosed as there is disagreement about their clinical significance. Our aim was to assess the risk of subsequent fractures induced by both prevalent and incident mild vertebral fractures in osteoporotic post-menopausal women. Three thousand three hundred and fifty-eight patients, aged 74 ± 6 years, with post-menopausal osteoporosis included in the placebo groups of two clinical trials of strontium ranelate were followed for 4 years. A Cox regression model adjusted on age, body mass index and bone mineral density was used to calculate the relative risk (RR) of fracture in subjects with only mild fractures as compared to patients without fracture, and to patients with at least one grade ≥ 2 fracture. These calculations were made for prevalent and then incident fractures. The RR of vertebral fracture in 4 years was 1.8 (1.3–2.4) p < 0.001, and 2.7 (2.3–3.3) p < 0.001 for patients having only mild vertebral fractures and at least one grade ≥ 2 fracture at baseline respectively. The RR of vertebral fracture in the 3rd and 4th years of follow-up was 1.7 (1.1–2.6) p = 0.01, and 1.9 (1.3–2.6) p < 0.001 for patients having during the first 2 years incident mild fractures only, and for patients having at least one grade ≥ 2 incident fracture respectively. The RR of non-vertebral fracture in 4 years was 1.3 (0.9–1.9) p = 0.15 and 1.7 (1.4–2.1) p < 0.001 for patients having only mild or at least one grade ≥ 2 vertebral fracture at baseline respectively. For patients aged more than 70 years, these RR were 1.45 (0.99–2.11) (p = 0.06), and 1.72 (1.36–2.18) p < 0.001 respectively. The RR of non-vertebral fracture in the 3rd and 4th years was 1.68 (1.36–2.09) p < 0.001 for patients having at least one grade ≥ 2 incident fracture during the 2 first years of follow-up. Mild vertebral fractures are a risk factor for subsequent vertebral and non-vertebral fracture in postmenopausal women with osteoporosis; 1 out of 4 patients with an incident mild vertebral fracture in 2 years will fracture again within the 2 next years.