nils-herrmann/clean_scirepeval huggingface dataset:
Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI

Modic changes (MCs) have been suggested to be a diagnostic subgroup of low back pain (LBP). However, the clinical implications of MCs remain unclear. For this reason, the aims of this study were to investigate how MCs developed over a 14-month period and if changes in the size and/or the pathological type of MCs were associated with changes in clinical symptoms in a cohort of patients with persistent LBP and MCs. Information on LBP intensity and detailed information from MRI on the presence, type and size of MCs was collected at baseline and follow-up. Changes in type (Type I, II, III and mixed types) and size of MCs were quantified at both time points according to a standardised evaluation protocol. The associations between change in type, change in size and change in LBP intensity were calculated using odds ratios (ORs). Approximately 40 % of the MCs followed the expected developmental path from Type I (here Type I or I/II) to Type II (here Type II or II/III) or Type I to Type I/II. In general, the bigger the size of the MC at baseline, the more likely it was that it remained unchanged in size after 14 months. Patients who had MC Type I at both baseline and 14-month follow-up were less likely to experience an improvement in their LBP intensity as compared to patients who did not have Type I changes at both time points (OR 7.2, CI 1.3–37). There was no association between change in size of MCs Type I and change in LBP intensity. The presence of MCs Type I at both baseline and follow-up is associated with a poor outcome in patients with persistent LBP and MCs.
Modelling multivariate biomechanical measurements of the spine during a rowing exercise.

To investigate the ability of statistical techniques to detect systematic changes in rowing technique during a rowing session and to discriminate between rowers of different abilities with and without back pain.



Statistical techniques were applied to kinematic datasets of elite level rowers, in order to construct an empirical model of the rowing stroke.



The size and complexity of datasets generated by biomechanical kinematics evaluations has led to opportunities for analysing pathology whilst introducing substantial challenges for statistical analysis.



Spinal motion and load output of 18 International and National standard competitive rowers were monitored during ergometer rowing sessions. International rower data were used to construct an empirical model of this activity. Linear stroke models were derived using principal components and a generalized cross-validation procedure. Performance characteristics of the identified models were calculated for all rowing groups. The stroke model was applied to distinguishing pattern variations within and between rowers. A multivariate logistic regression analysis was carried out to examine the relationship between stroke model parameters on the incidence of low back pain.



90% of the variability in the data was explained by the first three principal component variables. Stroke models with three basis functions were selected for each variable. The models performed well on the National rowers, providing validation of the models. A 2-variable model showed a significant difference between the rowing stroke characteristics of rowers with and without low back pain (P<0.01).



A parsimonious collection of empirical models effectively describes motion and load characteristics of ergometer rowing. Patterns in rowing technique are found to be strongly associated with the incidence lower back pain.



Empirical statistical models can be used to track changes in rowing technique, and discriminate between different rowing groups. This may impact rowing training, and rehabilitation.
Prognosis Related to Metastatic Burden Measured by ¹⁸F-Fluorocholine PET/CT in Castration-Resistant Prostate Cancer.

This study investigated the prognostic significance of metabolically active tumor volume (MATV) measurements applied to (18)F-fluorocholine PET/CT in castration-resistant prostate cancer (CRPC).



(18)F-fluorocholine PET/CT imaging was performed on 30 patients with CRPC. Metastatic disease was quantified on the basis of maximum standardized uptake value (SUV(max)), MATV, and total lesion activity (TLA = MATV × mean standardized uptake value). Tumor burden indices derived from whole-body summation of PET tumor volume measurements (i.e., net MATV and net TLA) were evaluated as variables in Cox regression and Kaplan-Meier survival analyses.



Net MATV ranged from 0.12 cm(3) to 1,543.9 cm(3) (median, 52.6 cm(3)). Net TLA ranged from 0.40 to 6,688.7 g (median, 225.1 g). Prostate-specific antigen level at the time of PET correlated significantly with net MATV (Pearson r = 0.65, P = 0.0001) and net TLA (r = 0.60, P = 0.0005) but not highest lesional SUV(max) of each scan. Survivors were followed for a median 23 mo (range, 6-38 mo). On Cox regression analyses, overall survival had a significant association with net MATV (P = 0.0068), net TLA (P = 0.0072), and highest lesion SUV(max) (P = 0.0173) and a borderline association with prostate-specific antigen level (P = 0.0458). Only net MATV and net TLA remained significant in univariate-adjusted survival analyses. Kaplan-Meier analysis demonstrated significant differences in survival between groups stratified by median net MATV (log-rank P = 0.0371), net TLA (log-rank P = 0.0371), and highest lesion SUV(max) (log-rank P = 0.0223).



Metastatic prostate cancer detected by (18)F-fluorocholine PET/CT can be quantified on the basis of volumetric measurements of tumor metabolic activity. The prognostic value of (18)F-fluorocholine PET/CT may stem from this capacity to assess whole-body tumor burden. With further clinical validation, (18)F-fluorocholine PET-based indices of global disease activity and mortality risk could prove useful in patient-individualized treatment of CRPC.
Clinical Correlates and Prognostic Value of Proenkephalin in Acute and Chronic Heart Failure.

Proenkephalin (pro-ENK) has emerged as a novel biomarker associated with both renal function and cardiac function. However, its clinical and prognostic value have not been well evaluated in symptomatic patients with heart failure.



The association between pro-ENK and markers of renal function was evaluated in 95 patients with chronic heart failure who underwent renal hemodynamic measurements, including renal blood flow (RBF) and glomerular filtration rate (GFR) with the use of 131I-Hippuran and 125I-iothalamate clearances, respectively. The association between pro-ENK and clinical outcome in acute heart failure was assessed in another 1589 patients. Pro-ENK was strongly correlated with both RBF (P < .001) and GFR (P < .001), but not with renal tubular markers. In the acute heart failure cohort, pro-ENK was a predictor of death through 180 days, heart failure rehospitalization through 60 days, and death or cardiovascular or renal rehospitalization through day 60 in univariable analyses, but its predictive value was lost in a multivariable model when other renal markers were entered in the model.



In patients with chronic and acute heart failure, pro-ENK is strongly associated with glomerular function, but not with tubular damage. Pro-ENK provides limited prognostic information in patients with acute heart failure on top of established renal markers.
Pharmacokinetics of abacavir and its anabolite carbovir triphosphate without and with darunavir/ritonavir or raltegravir in HIV-infected subjects.

Here, we aimed to investigate the pharmacokinetics of abacavir and carbovir triphosphate (CBV-TP) with darunavir/ritonavir 900/100 mg once daily or raltegravir 400 mg twice daily.



HIV-infected subjects on abacavir (600 mg once daily) underwent steady-state pharmacokinetic assessments without and with darunavir/ritonavir or raltegravir. Within-subject changes in plasma and intracellular pharmacokinetic parameters were evaluated by geometric mean ratios (GMRs) and 90% CIs.



A total of 19 patients completed the study. With darunavir/ritonavir (versus abacavir alone), abacavir GMRs (90% CI) were 0.73 (0.66, 0.80), 0.62 (0.50, 0.77) and 0.78 (0.69, 0.87) for area under the curve (AUC), trough concentration (C(trough)) and maximum concentration (C(max)), respectively. With raltegravir, they were 1.03 (0.97, 1.10), 0.83 (0.62, 1.11) and 1.06 (0.95, 1.18), respectively. Intracellular CBV-TP GMRs (90% CI) were 0.88 (0.72, 1.07), 0.68 (0.48, 0.95) and 0.98 (0.79, 1.23) for AUC, C(trough) and C(max), respectively, with darunavir/ritonavir, and 0.96 (0.76, 1.20), 0.57 (0.33, 1.00) and 1.07 (0.85, 1.35), respectively, with raltegravir.



There was a 27% decrease in abacavir plasma exposure with darunavir/ritonavir and no changes with raltegravir. CBV-TP C(trough) was significantly decreased with darunavir/ritonavir (32%) and showed a high inter-individual variability with raltegravir.
Impact of different values of prosthesis-patient mismatch on outcome in male patients with aortic valve replacement.

Mortality and left ventricular mass (LVM) recovery/regression after aortic valve replacement in patients with prosthesis-patient mismatch (PPM) is controversial. This study evaluated the impact of different values of indexed effective orifice area (EOAi) in male patients on mortality and indexed LVM (ILVM) recovery/regression.



The study recruited 376 male patients with and without PPM after aortic valve replacement with different EOAi cut-off values.



At EOAi 0.85 cm/m or less, 295 patients had PPM (78.5%). ILVM recovery occurred in 60.5% of no-PPM patients versus 46.1% of patients with PPM (P = 0.003), and ILVM regression was 35 versus 25% (P < 0.001). Time for ILVM regression was shorter in no-PPM group. At EOAi 0.75 cm/m or less, 201 patients had PPM (53.4%). ILVM recovery occurred in 55.4% of no-PPM patients versus 45.2% of patients with PPM (P = 0.06), regression was 32 versus 29% (P = 0.09). Time for ILVM regression was similar between groups. Regardless the cut-off value for PPM definition, mortality was similar.



LVM recovery/regression, but not mortality, was different at different EOAi. The cut-off value at EOAi 0.75 cm/m or less guaranteed a more balanced patient distribution between groups and the best compromise between specificity and sensitivity.
Association of hypomagnesemia with inferior survival in a phase III, randomized study of cetuximab plus best supportive care versus best supportive care alone: NCIC CTG/AGITG CO.17.

Cetuximab-induced hypomagnesemia has been associated with improved clinical outcomes in advanced colorectal cancer (CRC). We explored this relationship from a randomized clinical trial of cetuximab plus best supportive care (BSC) versus BSC alone in patients with pretreated advanced CRC.



Day 28 hypomagnesemia grade (0 versus ≥1) and percent reduction (<20% versus ≥20%) of Mg from baseline was correlated with outcome.



The median percentage Mg reduction at day 28 was 10% (-42.4% to 63.0%) for cetuximab (N = 260) versus 0% (-21.1% to 25%) for BSC (N = 251) [P < 0.0001]. Grade ≥1 hypomagnesemia and ≥20% reduction from baseline at day 28 were associated with worse overall survival (OS) [hazard ratio, HR 1.61 (95% CI 1.12-2.33), P = 0.01 and 2.08 (95% CI 1.32-3.29), P = 0.002, respectively] in multivariate analysis including grade of rash (0-1 versus 2+). Dyspnea (grade ≥3) was more common in patients with ≥20% versus < 20% Mg reduction (68% versus 45%; P = 0.02) and grade 3/4 anorexia were higher in patients with grade ≥1 hypomagnesemia (81% versus 63%; P = 0.02).



In contrast to prior reports, cetuximab-induced hypomagnesemia was associated with poor OS, even after adjustment for grade of rash.
[Spanish Implantable Cardioverter-Defibrillator Registry. Third Official Report of the Spanish Society of Cardiology Working Group on Implantable Cardioverter-Defibrillators (2006)].

To report the 2006 findings of the Spanish Implantable Cardioverter-Defibrillator (ICD) Registry, established by the Working Group on Implantable Cardioverter-Defibrillators, Electrophysiology and Arrhythmia Section, Spanish Society of Cardiology.



Each ICD team voluntarily reported data to the Spanish Society of Cardiology by completing a single-page questionnaire. Prospective data were collected on 91.8% of implantations.



In total, 2679 implantations were reported to the registry (86.6% of the estimated total). The reported implantation rate was 60 per million inhabitants, and the estimated rate was 69 per million. The proportion of first implantations was 80%. The majority of ICDs were implanted in males (mean age 61.5  years) with severe or moderate-to-severe left ventricular dysfunction who were in functional class II or I. Ischemic heart disease was the most frequent etiology, followed by dilated cardiomyopathy. This is the first year that half of first device implantations were carried out for primary prevention, with substantial increases among patients with ischemic heart disease and dilated cardiomyopathy. The number of ICDs incorporating cardiac resynchronization therapy has continued to grow, and now comprises 28.6% of all devices implanted. As in the previous year, around 70% of ICD implantations were performed in an electrophysiology laboratory by a cardiac electrophysiologist. The incidence of complications during device implantation was very low.



The 2006 Spanish Implantable Cardioverter-Defibrillator Registry contains data on more than 86% of all ICD implantations performed in Spain. Half of first device implantations were carried out for the purposes of primary prevention.
Selective intrabronchial instillation of surfactant in a patient with pneumonia: a preliminary report.

The efficacy of treatment with exogenous surfactant has been reported in children with respiratory failure due to severe pneumonia. Its effect in adults with similar features has not been established. We therefore administered 240 mg of surfactant to a 71 year old man, who had developed right lower lobe pneumonia and hypoxaemia following abdominal aortic surgery. After this treatment, the patient's oxygenation, evaluated by arterial oxygen tension/fraction of inspired oxygen (PaO2/FIO2) ratio during artificial ventilation, gradually improved, and ventilator settings could be reduced whilst maintaining PaO2 at the appropriate level. Although the precise mechanism by which surfactant improves respiratory failure due to pneumonia is unclear, administration of the drug may have overcome a quantitative deficiency of endogenous surfactant attributable to the antagonistic effect of pulmonary exudates and reduced production following damage to type II pneumocytes. The present case provides an indirect suggestion of a possible causal relationship between the improvement of oxygenation and administration of surfactant in adult respiratory failure caused by pneumonia.
Somatostatin analog therapy for severe polycystic liver disease: results after 2 years.

We showed in a randomized double-blinded placebo-controlled clinical trial that octreotide long-acting repeatable depot.® (OctLAR(®)) for 12 months reduces kidney and liver growth in autosomal dominant polycystic kidney patients with severe polycystic liver disease (PLD) and liver growth in patients with severe isolated PLD. We have now completed an open-label extension for one additional year to assess safety and clinical benefits of continued use of OctLAR for 2 years (O → O) and examined drug effect in the placebo group who crossed over to OctLAR in Year 2 (P → O).



The primary end point was change in total liver volume (TLV) measured by magnetic resonance imaging (MRI); secondary end points were changes in total kidney volume (TKV) measured by MRI, glomerular filtration rate (GFR), quality of life (QOL), safety, vital signs and laboratory parameters.



Forty-one of 42 patients received OctLAR (n = 28) or placebo (n = 14) in Year 1 and received OctLAR in Year 2 (maximum dose 40 mg). Patients originally randomized to placebo (P → O) showed substantial reduction in TLV after treatment with OctLAR in Year 2 (Δ% -7.66 ± 9.69%, P = 0.011). The initial reduction of TLV in the OctLAR group (O → O) was maintained for 2 years (Δ% -5.96 ± 8.90%), although did not change significantly during Year 2 (Δ% -0.77 ± 6.82%). OctLAR inhibited renal enlargement during Year 1 (Δ% +0.42 ± 7.61%) in the (O → O) group and during Year 2 (Δ% -0.41 ± 9.45%) in the (P → O) group, but not throughout Year 2 (Δ% +6.49 ± 7.08%) in the (O → O) group. Using pooled analyses of all individuals who received OctLAR for 12 months, i.e. in Year 1 for O → O patients and Year 2 for P → O patients, average reduction in TLV was -6.08 ± 7.58% (P = 0.001) compared to net growth of 0.9 ± 8.35% in the original placebo group. OctLAR-treated individuals continued to experience improvements in QOL in Year 2, although overall physical and mental improvements were not significant during Year 2 compared to Year 1. Changes in GFR were similar in both groups.



Over 2 years, OctLAR significantly reduced the rate of increase in TLV and possibly the rate of increase in TKV.
A technique for removal of the visuoperceptual component from tracking performance and its application to Parkinson's disease

Although it is well established that subjects with Parkinson's disease perform poorly on complex sensory-motor tasks, the extent to which this is due to visuoperceptual deficits is unclear. The authors measured the performance of 16 patients with Parkinson's disease, both on and off drugs, and 16 age and sex matched control subjects on preview and nonpreview tracking tasks and a nonmotor test of dynamic visuoperception. Order effects were controlled for by a randomized cross-over design. Performance on the perceptual task was measured in terms of perceptual resolution and was found impaired in the Parkinsonian group. The contribution of visuoperceptual function to tracking performance was removed using the concept of a visuoperceptual buffer-zone. The mean tracking error remained impaired on all tracking tasks and demonstrated that limitations in visuoperceptual function play only a minor role in the tracking errors in both Parkinsonian and control subjects. It is clear that the technique for determining the visuoperceptual component of performance on complex sensory-motor tasks has considerable scope for application in studies of a variety of brain disorders.
Experience in the Use of Valdoxan in the Treatment of Post-Stroke Depression

Valdoxan at a dose of 25 mg per day for three months was used in 40 patients aged 55–85 years with post-stroke depression. Patients’ status was assessed clinically and in terms of a series of scales (Hamilton, MMSE, Tinnetti, etc.). High antidepressant efficacy and good tolerance were demonstrated. On the background of stabilization of the emotional background, patients showed improvements in motor and cognitive functions.
Triple therapy: Phaco-vitrectomy with ILM peeling, retinal endophotocoagulation, and intraoperative use of Bevacizumab for diffuse diabetic macular edema

The aim of this study was to evaluate the visual acuity and structural outcomes of combined phacovitrectomy with ILM peeling, retinal endophotocoagulation and use of bevacizumab in patients with diffuse diabetic macular edema (DDME).



In this prospective, nonrandomized, interventional study we included 29 eyes of 26 patients with DDME. The best-corrected visual acuity (BCVA) and central retinal thickness and volume (CRT and CRV) were recorded at 4, 8, 12, and 16 months after surgery.



The mean preoperative BCVA was 0.74±0.36 logMAR (0.3-1.5) and improved finally to 0.4±0.24 logMAR (-0.1-1.0) p=0.000006. The mean preoperative CRT in the 1mm zone was 516±184 microm (256-950) and decreased postoperatively at the last control to 237±75 microm (117-489) p=0.000003. The mean preoperative CRV in the 1mm zone was 0.39±0.14 microL (0.19-0.74) and decreased postoperatively at the last control to 0.17±0.06 microL (0.09-0.36) p=0.000003. The mean preoperative CRT in the 6 mm zone was 407±105 microm (279-640) and decreased postoperatively at the last control to 282±40 µm (212-380) p=0.000004. The mean preoperative CRV in the 6 mm zone was 11.4±2.9 microL (7.85-17.93) and decreased postoperatively at the last control to 7.92±1.0 microL (5.62-10.97) p=0.000003. The 23 (79.3%) eyes showed improvement in BCVA ≥0.2 logMAR, 5 (17.2%) eyes improvement or stabilization of BCVA and 1(3.5%) eye deterioration. Preoperative BCVA was a positive factor for prognosis of BCVA at 12th month follow-up (b=0.42; p=0.006), while the negative factors were: previous panretinal photocoagulation (b=-0.24; p=0.04), presence of vitreomacular traction (b=-0.29; p=0.02) and preoperative CRT in the 1000 microm zone (b=-0.24; p=0.07). A greater visual acuity improvement occurred in eyes with worse baseline visual acuity (b=-1.01; p=0.00001). The presentation of vitreomacular traction (b=-0.38; p=0.02), previous panretinal photocoagulation (b=-0.31, p=0.04) and greater preoperative CRT in the 1000 µm zone (b=-0.31; p=0.07) were negative factors for visual improvement.



This combined treatment resulted in improvement or stabilization of BCVA and decrease of CRT and CRV. Larger comparative studies are necessary to establish the real impact of this therapeutic approach.
Delayed sodium 18F-fluoride PET/CT imaging does not improve quantification of vascular calcification metabolism: results from the CAMONA study.

This study aimed to determine if delayed sodium (18)F-fluoride (Na(18)F) PET/CT imaging improves quantification of vascular calcification metabolism. Blood-pool activity can disturb the arterial Na(18)F signal. With time, blood-pool activity declines. Therefore, delayed imaging can potentially improve quantification of vascular calcification metabolism.



Twenty healthy volunteers and 18 patients with chest pain were prospectively assessed by triple time-point PET/CT imaging at approximately 45, 90, and 180 minutes after Na(18)F administration. For each time point, global uptake of Na(18)F was determined in the coronary arteries and thoracic aorta by calculating the blood-pool-corrected maximum standardized uptake value (cSUV(MAX)). A target-to-background ratio (TBR) was calculated to determine the contrast resolution at 45, 90, and 180 minutes. Furthermore, we assessed whether the acquisition time-point affected the relation between cSUV(MAX) and the estimated 10-year risk for fatal cardiovascular disease (SCORE %). Coronary cSUV(MAX) (P = .533) and aortic cSUV(MAX) (P = .654) remained similar with time, whereas the coronary TBR (P < .0001) and aortic TBR (P < .0001) significantly increased with time. Even though the contrast resolution improved with time, positive correlations between SCORE % and coronary cSUV(MAX) (P < .020) and aortic cSUV(MAX) (P < .005) were observed at all investigated time points.



Delayed Na(18)F PET/CT imaging does not improve quantification of vascular calcification metabolism. Although contrast resolution improves with time, arterial Na(18)F avidity is invariant to the time between Na(18)F administration and PET/CT acquisition. Therefore, the optimal PET/CT acquisition time-point to quantify vascular calcification metabolism is achieved as early as 45 minutes after Na(18)F administration.