nils-herrmann/clean_scirepeval huggingface dataset:
A metabolic imaging severity rating scale for the assessment of cognitive impairment.

This study was designed to validate a simple scoring system for evaluating fluorodeoxyglucose (FDG) positron emission tomographic (PET) scans that can be used routinely in patients undergoing the clinical assessment of cognitive impairment.



The FDG-PET scans of 106 patients with cognitive impairment (65 with Alzheimer disease, 16 with frontal lobe dementia, and 25 atypical cases) were acquired using the PENN-PET scanner 40 minutes after the intravenous administration of 8 mCi FDG. Metabolic activity in various anatomic structures of the brain was scored using the following qualitative scale: 4 = normal; 3 = mildly decreased; 2 = moderately decreased; 1 = severely decreased; and 0 = no activity. Regions of interest were also placed over these regions to obtain a quantitative value. Two distinct scores were obtained. Values for visual and sensorimotor cortices, thalami, basal ganglia, and cerebellum comprised score I. Score II consisted of the values for the frontal, temporal, and parietal cortices. The qualitative metabolic imaging severity rating scale (MISRS) was compared with a quantitative MISRS (obtained from the region-of-interest analysis of the same structures). The MISRS was then compared with the results from the Mini-Mental Status Examination (MMSE) and the Dementia Severity Rating Score (DSRS).



In all patients, the qualitative MISRS scores correlated significantly with the quantitative MISRS (r = 0.73, P < 0.0001). In all patients with cognitive impairment, the qualitative and quantitative MISRS scores correlated significantly with the DSRS and the MMSE (P < 0.001). In patients with Alzheimer disease, the qualitative and quantitative MISRS significantly correlated with the DSRS and MMSE.



A simple and practical rating scale can be used to assess the severity of cognitive impairment in patients with different types of dementing illnesses.
Phase I study to the immunotherapy of metastatic malignant melanoma by a cancer vaccine consisting of autologous cancer cells transfected with the human IL-2 gene

February 1995 Freiburg: 7 February 1995 Registration of protocol with state authority AMB: 7 November 1994  30 October 1994 Registration of product with federal authority (Paul-Ehrlich-Institut) 30 December 1994 Therapeutic gene Human interleukin-2 Regulatory element(s) CMV promoter Vector constructed by Institute of Molecular Pathology, Vienna, Austria Vector produced by Bender & Co., Vienna, Austria Transfer method Receptor-mediated, adenovirus enhanced gene transfer (transferinfection) in vitro Packaging cells N/A Target cells Autologous human malignant melanoma cells Indication Metastatic malignant melanoma (stage IV) First patient enrolled 15 December 1994 (Vienna) Patient number 12 evaluable patients Expected accrual rate 3 patients per month
A 72-week randomized study of the safety and efficacy of a stavudine to zidovudine switch at 24 weeks compared to zidovudine or tenofovir disoproxil fumarate when given with lamivudine and nevirapine.

Due to superior long-term toxicity profiles, zidovudine (AZT) and tenofovir disoproxil fumarate (TDF) are preferred over stavudine (d4T) for first-line antiretroviral regimens. However, short-term d4T use could be beneficial in avoiding AZT-induced anaemia.



We randomized (1:1:1) 150 treatment-naive Thai HIV-infected adults with CD4(+) T-cell count <350 cells/mm(3) to arm 1 (24-week GPO-VIR S30(®) [d4T plus lamivudine (3TC) plus nevirapine (NVP)] followed by 48-week GPO-VIR Z250(®) [AZT plus 3TC plus NVP]), arm 2 (72-week GPO-VIR Z250(®)) or arm 3 (72-week TDF plus emtricitabine [FTC] plus NVP). Haemoglobin (Hb), dual energy x-ray absorptiometry, neuropathic signs, estimated glomerular filtration rate (eGFR), CD4(+) T-cell count, plasma HIV RNA and adherence were assessed.



In an intention-to-treat analysis, mean Hb decreased from baseline to week 24 in arm 2 compared with arm 1 (-0.19 versus 0.68 g/dl; P=0.001) and arm 3 (0.48 g/dl; P=0.010). Neuropathic signs were more common in arm 2 compared with arm 3 (20.4 versus 4.2%; P=0.028) at week 24. There were no differences in changes in peripheral fat and eGFR from baseline to weeks 24 and 72 among arms. CD4(+) T-cell count increased more in arm 1 than arms 2 and 3 from baseline to week 24 (168 versus 117 and 118 cells/mm(3); P=0.01 and 0.02, respectively) but the increase from baseline to week 72 was similar among arms.



A 24-week d4T lead-in therapy caused less anaemia and greater initial CD4(+) T-cell count increase than initiating treatment with AZT. This strategy could be considered in patients with baseline anaemia or low CD4(+) T-cell count. If confirmed in a larger study, this may guide global recommendations on antiretroviral initiation where AZT is more commonly used than TDF.
Feasibility and acceptability of using bronchial hyperresponsiveness to manage asthma in primary care: a pilot study.

To determine if indirect testing for bronchial hyperresponsiveness (BHR) to monitor inhaled corticosteroid (ICS) treatment in asthma is feasible and acceptable in primary care.



Fourteen adult patients with asthma aged 22-70 years (4M:10F, forced expiratory volume in 1 s >70% predicted) taking ICS performed a test for BHR using mannitol on three visits 6 weeks apart. ICS dose adjustments were made based on the presence of BHR. The Asthma Quality of Life Questionnaire (AQLQ) and the Asthma Control Questionnaire were used at each visit. A semi structured interview at study exit assessed subject acceptability.



BHR did not return in those with no BHR at study entry (n=9) with decreasing ICS dose. Improvements in BHR with increasing ICS dose (n=5) were observed with clinically significant improvements in AQLQ (mean score increase >0.5, p=0.02). Feasibility and acceptability of BHR testing was demonstrated.



It is feasible and acceptable to perform BHR testing using mannitol to help identify patients with asthma who would benefit from ICS dose increases and those with no BHR who could have a dose reduction.
Understanding experience using dialogical methods: the case of serendipity

McCarthy and Wright's (2004) approach to understanding user experience provides a rich conceptual framework. In this paper, we report how this framework was used to guide the development of an approach to researching the richness of a particular experience - serendipity. Three themes were identified; life as lived and felt, the whole person, and dialogical sense making. These were used to help understand the key qualities of the strategy, tools and techniques that were required in the empirical study of the experience of serendipity. The paper explains this process and illustrates the depth of understanding that our choice of tools afforded. After describing the case study we offer some guidance on how to choose appropriate tools and methods for researching other types of experience.
Xanthine oxidase inhibition for hyperuricemic heart failure patients: design and rationale of the EXACT-HF study.

Michael M. Givertz, Douglas L. Mann, Kerry L. Lee, Jenny C. Ibarra, Eric J. Velazquez, Adrian Rationale of the EXACT-HF Study Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients: Design and Print ISSN: 1941-3289.  Dallas, TX Circulation: Heart Failure doi: 10.1161/CIRCHEARTFAILURE.113.000394 2013;6:862-868 Circ Heart Fail. http://circheartfailure.ahajournals.org/content/6/4/862 World Wide Web at: The online version of this article, along with updated information and services, is located on the
A randomized trial comparing two low-intensity psychological interventions for distressed patients with cancer and their caregivers.

To compare the effectiveness of two low-intensity approaches for distressed patients with cancer and caregivers who had called cancer helplines seeking support. Baseline distress was hypothesized as a moderator of intervention effect.



Randomized trial.



Community-based cancer helplines in Queensland and New South Wales, Australia.


SAMPLE
354 patients with cancer and 336 caregivers.



Participants were randomized to either a single session of nurse-led self-management intervention or a five-session psychologist cognitive behavioral intervention delivered by telephone. Assessments were undertaken at baseline (preintervention) and at 3, 6, and 12 months.



Psychological and cancer-specific distress and post-traumatic growth.



No significant moderation by baseline cancer-specific distress was noted. For low-education patients, only the psychologist intervention was associated with a significant drop in distress. For all other participants, distress decreased over time in both arms with small to large effect sizes (Cohen's ds = 0.05-0.82). Post-traumatic growth increased over time for all participants (Cohen's ds = 0.6-0.64).



Many distressed patients with cancer and their caregivers may benefit significantly from a single session of a nurse psychoeducation intervention that can be delivered remotely by telephone and supported by self-management materials. Research is needed to develop an algorithm that moves beyond the use of distress as the only indicator for referral to specialist psychological services. Survivors and caregivers with low education and low literacy may require more in-depth and targeted support.



Brief nurse psychoeducation and stress management for cancer survivors and caregivers should be considered as part of a tiered approach to psychosocial care.
Modified step aerobics training and neuromuscular function in osteoporotic patients: a randomized controlled pilot study

Training programs directed to improve neuromuscular and musculoskeletal function of the legs are scarce with respect to older osteoporotic patients. We hypothesized that a modified step aerobics training program might be suitable for this purpose and performed a randomized controlled pilot study to assess the feasibility of conducting a large study. Here we report on the training-related effects on neuromuscular function of the plantar flexors. Twenty-seven patients with an age of at least 65 years were enrolled and randomized into control and intervention group. The latter received supervised modified step aerobics training (twice weekly, 1 h per session) over a period of 6 months. At baseline, and after 3 and 6 months neuromuscular function of the plantar flexors, i.e., isometric maximum voluntary torque, rate of torque development and twitch torque parameters were determined in detail in all patients of both groups. Twenty-seven patients (median age 75 years; range 66–84 years) were randomized (control group n = 14; intervention group n = 13). After 3 and 6 months of training, maximum voluntary contraction strength in the intervention group was significantly higher by 7.7 Nm (9.1%; 95% CI 3.3–12.2 Nm, P < 0.01) and 12.4 Nm (14.8%; 95% CI 6.4–18.5 Nm, P < 0.01) compared to controls. These changes were most probably due to neural and muscular adaptations. It is worthwhile to investigate efficacy of this training program in a large randomized trial. However, a detailed neuromuscular assessment appears feasible only in a subset of participants.
Validation of the modified telephone interview for cognitive status in amnestic mild cognitive impairment and intact elders.

Although the modified Telephone Interview for Cognitive Status (mTICS) is frequently used as a screening measure of cognition in dementia and aging studies, it has not been validated in individuals with milder cognitive impairments. The current study compared 2 groups [amnestic Mild Cognitive Impairment (n=61) and cognitively intact elders (n=62)] on the mTICS and used regression models to predict baseline scores on standardized memory tests using baseline mTICS scores. Baseline mTICS scores were also used to predict 1-year follow-up scores on memory tests in a subsample (n=91). Large group differences (P<0.01) were found between the amnestic individuals and their healthy peers on the mTICS total score, 2-factor scores, and 3 of 14 individual items. Baseline mTICS scores predicted between 22% and 43% of baseline memory composite scores and 21% and 28% of 1-year memory composite scores. Overall, these results provide additional validation of the mTICS as a valuable screening instrument for cognition in individuals with milder cognitive impairments.
Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects.

Tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) properties of single ascending doses (SADs) and multiple ascending doses (MADs) of PF-06260414, a novel selective androgen receptor modulator, were assessed after oral administration in healthy subjects.



Range of SAD and MAD levels tested were 1 to 400 mg and 3 to 100 mg BID, respectively (n = 8 per cohort). In addition, a 60-mg once-daily (n = 8) cohort and a Japanese cohort receiving 30 mg BID (n = 7) also received PF-06260414. Plasma was collected to study PK properties and hypothalamic-pituitary-gonadal (HPG) axis hormones. Tolerability was evaluated from adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.



PF-06260414 was well tolerated with no serious AEs. The most frequently reported AEs were increase in alanine aminotransferase and headache, which were reported by 7 and 3 subjects, respectively. PF-06260414 had fast absorption (median Tmax, approximately 1-2 hours), a mean t½ of approximately 6.9 to 12.8 hours, time-independent PK properties and dose proportionality. Cmax and AUCτ geometric means in Japanese subjects were 98.6% and 79.5% higher than in Western subjects, respectively, but had similar HPG axis modulation. Changes in HPG axis hormones monitored in SADs were similar to placebo. Maximum placebo-corrected modulations were observed for total testosterone and sex hormone-binding globulin in the MAD 100-mg BID regimen.



This study was the first to compare a number of different factors of PF-06260414, including tolerability, PK and PD properties, and ethnic differences between Japanese and Western healthy subjects. PF-06260414 had favorable PK properties and found that sex hormone-binding globulin, total testosterone, and HDL were most sensitive to modulation.
A Genome-Wide Association Study Suggests Novel Loci Associated with a Schizophrenia-Related Brain-Based Phenotype

Patients with schizophrenia and their siblings typically show subtle changes of brain structures, such as a reduction of hippocampal volume. Hippocampal volume is heritable, may explain a variety of cognitive symptoms of schizophrenia and is thus considered an intermediate phenotype for this mental illness. The aim of our analyses was to identify single-nucleotide polymorphisms (SNP) related to hippocampal volume without making prior assumptions about possible candidate genes. In this study, we combined genetics, imaging and neuropsychological data obtained from the Mind Clinical Imaging Consortium study of schizophrenia (n = 328). A total of 743,591 SNPs were tested for association with hippocampal volume in a genome-wide association study. Gene expression profiles of human hippocampal tissue were investigated for gene regions of significantly associated SNPs. None of the genetic markers reached genome-wide significance. However, six highly correlated SNPs (rs4808611, rs35686037, rs12982178, rs1042178, rs10406920, rs8170) on chromosome 19p13.11, located within or in close proximity to the genes NR2F6, USHBP1, and BABAM1, as well as four SNPs in three other genomic regions (chromosome 1, 2 and 10) had p-values between 6.75×10(-6) and 8.3×10(-7). Using existing data of a very recently published GWAS of hippocampal volume and additional data of a multicentre study in a large cohort of adolescents of European ancestry, we found supporting evidence for our results. Furthermore, allelic differences in rs4808611 and rs8170 were highly associated with differential mRNA expression in the cis-acting region. Associations with memory functioning indicate a possible functional importance of the identified risk variants. Our findings provide new insights into the genetic architecture of a brain structure closely linked to schizophrenia. In silico replication, mRNA expression and cognitive data provide additional support for the relevance of our findings. Identification of causal variants and their functional effects may unveil yet unknown players in the neurodevelopment and the pathogenesis of neuropsychiatric disorders.
Correlation between external and internal respiratory motion: a validation study

In motion-compensated image-guided radiotherapy, accurate tracking of the target region is required. This tracking process includes building a correlation model between external surrogate motion and the motion of the target region. A novel correlation method is presented and compared with the commonly used polynomial model. The CyberKnife system (Accuray, Inc., Sunnyvale/CA) uses a polynomial correlation model to relate externally measured surrogate data (optical fibres on the patient’s chest emitting red light) to infrequently acquired internal measurements (X-ray data). A new correlation algorithm based on $${\varepsilon}$$ -Support Vector Regression (SVR) was developed. Validation and comparison testing were done with human volunteers using live 3D ultrasound and externally measured infrared light-emitting diodes (IR LEDs). Seven data sets (5:03–6:27 min long) were recorded from six volunteers. Polynomial correlation algorithms were compared to the SVR-based algorithm demonstrating an average increase in root mean square (RMS) accuracy of 21.3% (0.4 mm). For three signals, the increase was more than 29% and for one signal as much as 45.6% (corresponding to more than 1.5 mm RMS). Further analysis showed the improvement to be statistically significant. The new SVR-based correlation method outperforms traditional polynomial correlation methods for motion tracking. This method is suitable for clinical implementation and may improve the overall accuracy of targeted radiotherapy.
Relationship between duration of hospital-acquired acute kidney injury and mortality: a prospective observational study

New definitions of acute kidney injury (AKI) have recently emerged. Some studies have suggested that duration of AKI is an additional predictive parameter for mortality. Here, we evaluated whether AKI duration was predictive of long-term mortality in patients with hospital-acquired acute kidney injury (HAAKI).



We prospectively enrolled patients who developed HAAKI at an urban university hospital, from September 2007 to August 2008 and followed them until December 2011. Patients were divided into two groups by duration of the AKI (1 to 5 days vs. ≥ 6 days), and long-term mortality was compared.



HAAKI developed in 1.2% of patients during the enrollment period. The median follow-up period was 240 days (interquartile range, 53 to 1,428). In 42.3% of patients (n = 52), the AKI lasted 1 to 5 days, while it lasted ≥ 6 days in 57.7% (n = 71). Survival analysis showed that a longer duration of AKI increased the risk of death. Long-term survival was significantly different in the two groups.



The duration of AKI influenced mortality rates in hospitalized patients. Thus, AKI duration is a parameter affecting mortality in HAAKI.
A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity.

The Crohn's Disease Activity Index (CDAI) is a measure of disease activity based on symptoms, signs and a laboratory test. The US Food and Drug Administration has indicated that patient reported outcomes (PROs) should be the primary outcome in randomised controlled trials for Crohn's disease (CD).



As no validated PRO exists for CD, to investigate whether CDAI diary card items could be modified for this purpose.



Data from a trial of rifaximin-extended intestinal release were used to identify cut-points for stool frequency, pain and general well-being using receiver operating characteristic curves with CDAI <150 as criterion. The operating properties of 2- and 3-item PRO were evaluated using data from a trial of methotrexate in CD. Regression analysis determined PRO2 and PRO3 scores that correspond to CDAI-defined thresholds of 150, 220 and 450 and changes of 50, 70 and 100 points.



Optimum cut-points for CDAI remission were mean daily stool frequency ≤1.5, abdominal pain ≤1, and general well-being score of ≤1 (areas under the ROC curve 0.79, 0.91 and 0.89, respectively). The effect estimates were similar using 2- and 3-item PROs or CDAI. PRO2 and PRO3 values corresponding to CDAI scores of 150, 220 and 450 points were 8, 14, 34 and 13, 22, 53. The corresponding values for CDAI changes of 50, 70 and 100, were 2, 5, 8 and 5, 9, 14. Responsiveness to change was similar for both PROs.



Patient reported outcomes derived from CDAI diary items may be appropriate for use in clinical trials for CD.
Association of door-to-balloon time and mortality in patients admitted to hospital with ST elevation myocardial infarction: national cohort study

To evaluate the association between door-to-balloon time and mortality in hospital in patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction to assess the incremental mortality benefit of reductions in door-to-balloon times of less than 90 minutes.



Prospective cohort study of patients enrolled in the American College of Cardiology National Cardiovascular Data Registry, 2005-6.



Acute care hospitals.



43 801 patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention.



Mortality in hospital.



Median door-to-balloon time was 83 minutes (interquartile range 6-109, 57.9% treated within 90 minutes). Overall mortality in hospital was 4.6%. Multivariable logistic regression models with fractional polynomial models indicated that longer door-to-balloon times were associated with a higher adjusted risk of mortality in hospital in a continuous non-linear fashion (30 minutes=3.0%, 60 minutes=3.5%, 90 minutes=4.3%, 120 minutes=5.6%, 150 minutes=7.0%, 180 minutes=8.4%, P<0.001). A reduction in door-to-balloon time from 90 minutes to 60 minutes was associated with 0.8% lower mortality, and a reduction from 60 minutes to 30 minutes with a 0.5% lower mortality.



Any delay in primary percutaneous coronary intervention after a patient arrives at hospital is associated with higher mortality in hospital in those admitted with ST elevation myocardial infarction. Time to treatment should be as short as possible, even in centres currently providing primary percutaneous coronary intervention within 90 minutes.
The Caregiver Quality of Life Cystic Fibrosis (CQOLCF) Scale: Modification and validation of an instrument to measure quality of life in cystic fibrosis family caregivers

Modify the Caregiver Quality of Life Index – Cancer (CQOLC) scale (Weitzner, Jacobsen et al. ) as the Caregiver Quality of Life Cystic Fibrosis (CQOLCF) scale, validate it with cystic fibrosis (CF) family caregivers, and assess caregiver quality of life QOL with patient disease severity.  Following modifications, 100 family caregivers were administered the CQOLCF. Construct validity was assessed by the Medical Outcomes Study Short Form (SF-36) and the Beck Depression Inventory (BDI). Pulmonary function scores and hospitalizations assessed relationship between caregiver QOL and patient disease severity.  Split-half reliability was 0.862 and internal consistency (Cronbach's α) was 0.909. As expected, there were relatively high correlations with the mental health (0.634) and emotional distress (−0.687); and low correlations with physical health (0.049). ANCOVA examined differences in the CQOLCF totals based on disease severity, controlling for age. Significant mean differences existed (days hospitalized F = 3.010, sig. = 0.022).  The CQOLCF appears to be a valid, reliable, and internally consistent disease-specific scale with CF family caregivers. Future research recommendations include administering the CQOLCF to an increased study sample to explore item factor analysis.