nils-herrmann/clean_scirepeval huggingface dataset:
Ibandronate Increases Sclerostin Levels and Bone Strength in Male Patients with Idiopathic Osteoporosis

The pathomechanism of male idiopathic osteoporosis (MIO) differs from postmenopausal osteoporosis with regard to alterations in osteoblast activity. We evaluated intravenous ibandronate (IBN) in 25 MIO patients with fragility fractures in a prospective, monocentric, single-arm, and open-label study for 24 months. The impact and changes of sclerostin (Scl), Dickkopf-1 (DKK-1), CTX, and PINP were examined. Additionally, volumetric cortical, trabecular and areal bone mineral density (BMD), trabecular bone score (TBS), and finite element analyses (FEA) were evaluated. Compared to baseline, median Scl levels were increased after 1 month (Δ 121 %, p < 0.0001) and remained elevated for 12 months. DKK-1 decreased (p < 0.001) to a lesser extent until month 9 with values comparable to baseline at study endpoint. Early changes (baseline–month 1) of Scl negatively correlated with early changes of DKK-1 (−0.72), CTX (−0.82), and PINP (−0.55; p < 0.005 for all). The overall changes over the 24 months study period of Scl negatively correlated with decreased CTX (−0.32) and DKK-1 levels (−0.57, p < 0.0001 for both); CTX and PINP changes positively correlated at each time point (p < 0.001). Volumetric hip BMD increased by 12 and 18 %, respectively (p < 0.0001 for both). Cross-sectional moment of inertia and section modulus for total hip significantly improved (p < 0.05 for all). Areal BMD at total hip, spine, and TBS increased. FEA displayed an increase in bone strength both in the hip (17 %) and vertebrae (13 %, all p < 0.0001) at anatomical sites susceptible for fragility fracture. IBN increases Scl and improves cortical and trabecular bone strength with early and ongoing vigorous suppression of bone resorption.
Adding procalcitonin to the MASCC risk-index score could improve risk stratification of patients with febrile neutropenia

Infectious complication could be life-threatening in patients with chemotherapy-induced febrile neutropenia (FN). The Multinational Association of Supportive Care in Cancer (MASCC) risk-index score is used to predict the complications of these patients, and it has been focused on identifying low-risk patients who may be candidates for outpatient management. In this study, we evaluated procalcitonin (PCT) and the MASCC score in predicting bacteremia and septic shock in patients with FN. From November 2010 to October 2011, 355 patients with FN were prospectively enrolled. Clinical and laboratory findings, including procalcitonin, and the MASCC score were analyzed and correlated with the infectious complications of FN. Of the 355 patients, 35 (9.9 %) had bacteremia, and 25 (7.0 %) developed septic shock. PCT ≥0.5 ng/mL (OR 3.96, 95 % CI 1.51–10.40), platelet count <100 × 103/mm3 (OR 2.50, 95 % CI 1.10–5.66), and MASCC score <21 (OR 2.45, 95 % CI 1.03–5.85) were independently predictive of bacteremia, and PCT ≥1.5 ng/mL (OR 29.78, 95 % CI 9.10–97.39) and MASCC score <21 (OR 9.46, 95 % CI 3.23–27.72) were independent factors of septic shock. In 306 patients with low-risk FN classified by the MASCC score, 52 had PCT ≥0.5 ng/mL and 31 had PCT ≥1.5 ng/mL. Of the 52 patients with PCT ≥0.5 ng/mL, 12 (23.1 %) had bacteremia, and of the 31 patients with PCT ≥1.5 ng/mL, 7 (22.6 %) developed septic shock. Implicating PCT as a routine use in clinical practice along with the MASCC score could improve risk stratification of patients with FN.
Retinopathy and risk of congestive heart failure.

Congestive heart failure (CHF) affects a substantial proportion of adults including those without preexisting coronary heart disease. The pathogenesis of CHF is uncertain, but microvascular disease has been hypothesized as a possible factor.



To determine the relationship of retinopathy, a marker of systemic microvascular disease, to risk of CHF.



Population-based, prospective 7-year cohort study in 4 US communities using the Atherosclerosis Risk in Communities Study database. Participants (n = 11,612, aged 49 to 73 years) had retinal photographs taken between 1993 and 1995. The photographs were graded according to a standardized protocol for the presence of retinopathy (eg, microaneurysms, retinal hemorrhages, soft exudates), arteriovenous nicking, focal arteriolar narrowing, and generalized arteriolar narrowing.



Association between retinopathy and incident CHF, identified from hospitalization and death records.



The 7-year cumulative incidence of CHF was 5.4% (492 events). Participants with retinopathy had a higher incidence of CHF compared with those without retinopathy (15.1% vs 4.8%, P<.001). After controlling for age, sex, race, preexisting coronary heart disease, mean arterial blood pressure, diabetes, glucose level, cholesterol level, smoking, body mass index, and study site, the presence of retinopathy was associated with a 2-fold higher risk of CHF (relative risk, 1.96; 95% confidence interval, 1.51-2.54). Among participants without preexisting coronary heart disease, diabetes, or hypertension, retinopathy was associated with a 3-fold higher risk of CHF (relative risk, 2.98; 95% confidence interval, 1.50-5.92).



Retinopathy is an independent predictor of CHF, even in persons without preexisting coronary heart disease, diabetes, or hypertension. This suggests that microvascular disease may play an important role in the development of heart failure in the general population. Some asymptomatic persons with retinopathy on an ophthalmologic examination may benefit from further assessment of CHF risk.
Clinical evaluation of positioning verification using digital tomosynthesis and bony anatomy and soft tissues for prostate image-guided radiotherapy.

To evaluate on-board digital tomosynthesis (DTS) for patient positioning vs. two-dimensional (2D) radiography and three-dimensional cone beam (CBCT).



A total of 92 image sessions from 9 prostate cancer patients were analyzed. An on-board image set was registered to a corresponding reference image set. Four pairs of image sets were used: digitally reconstructed radiographs vs. on-board orthogonal paired radiographs for the 2D method, coronal-reference DTS vs. on-board coronal DTS for the coronal-DTS method, sagittal-reference DTS vs. on-board sagittal DTS for the sagittal-DTS method, and planning CT vs. CBCT for the CBCT method. The registration results were compared.



The systematic errors in all methods were <1 mm/1 degrees . When registering the bony anatomy, the mean vector difference was 0.21 +/- 0.11 cm between 2D and CBCT, 0.11 +/- 0.08 cm between CBCT and coronal DTS, and 0.14 +/- 0.07 cm between CBCT and sagittal DTS. The correlation between CBCT to DTS was stronger (coefficient = 0.92-0.95) than the correlation between 2D and CBCT or DTS (coefficient = 0.81-0.83). When registering the soft tissue, the mean vector difference was 0.18 +/- 0.11 cm between CBCT and coronal DTS and 0.29 +/- 0.17 cm between CBCT and sagittal DTS. The correlation coefficient of CBCT to sagittal DTS and to coronal DTS was 0.84 and 0.92, respectively.



DTS could provide equivalent results to CBCT when the bony anatomy is used as landmarks for prostate image-guided radiotherapy. For soft tissue-based positioning verification, coronal DTS produced equivalent results to CBCT, but sagittal DTS alone was insufficient. DTS could allow for comparable soft tissue-based target localization with faster scanning time and a lower imaging dose compared with CBCT.
[Nonselected use of direct coronary stenting. The DISCO 2 trial].

Direct coronary stenting yields immediate long-term clinical results similar to those obtained with balloon predilation, with the advantage of lower costs and procedural times. Until now, direct stenting has been attempted only for selected lesions, so that the potential scope of its use in everyday practice remains unknown. The DISCO 2 trial was designed to identify the number and type of lesions that could be safely treated by direct stenting. Patients and method. 1,269 lesions (886 patients) were treated consecutively in 7 different hospitals. Direct stenting was attempted in all cases, except for total chronic occlusions, severe tortuosity or calcification of the vessel, lesions in the sinus ostium, or bifurcated lesions and vessel diameter < 2.4 mm. If the procedure failed, the stent was recovered and the lesion dilated with a balloon before a second attempt at stenting.



Direct stenting was attempted in 585 lesions (54.9% of all electively implanted stents and 46.1% of all angioplasties). This was successful in 553 (94.6%) and failed in 32 (5.4%). In 30 of these latter patients a stent was implanted after predilation. Predictors of failure were tortuosity, location in the nonproximal right coronary artery, age > 65 years and type B2 or C lesion. After 6 months of follow-up the total incidence of major adverse cardiovascular events in patients treated with direct stenting was 6.2%, with a target lesion revascularization rate of 4.45%.



In a mostly nonselected sample of coronary lesions, direct stenting was as safe as stenting with predilation. More than half of all elective stenting procedures can be attempted safely without balloon predilation. Greater need for predilation was associated with tortuosity, nonproximal right coronary artery location, older age and lesion complexity (B2, C). The 6-month clinical outcome was excellent, with a low rate of repeat revascularization.
A trabecular metal tibial component in total knee replacement in patients younger than 60 years: a two-year radiostereophotogrammetric analysis.

We compared the performance of uncemented trabecular metal tibial components in total knee replacement with that of cemented tibial components in patients younger than 60 years over two years using radiostereophotogrammetric analysis (RSA). A total of 22 consecutive patients (mean age 53 years, 33 to 59, 26 knees) received an uncemented NexGen trabecular metal cruciate-retaining monobloc tibial component and 19 (mean 53 years, 44 to 59, 21 knees) a cemented NexGen Option cruciate-retaining modular tibial component. All the trabecular metal components migrated during the initial three months and then stabilised. The exception was external rotation, which did not stabilise until 12 months. Unlike conventional metal-backed implants which displayed a tilting migration comprising subsidence and lift-off from the tibial tray, most of the trabecular metal components showed subsidence only, probably due to the elasticity of the implant. This pattern of subsidence is regarded as being beneficial for uncemented fixation.
Effectiveness of coping strategies intervention on caregiver burden among caregivers of elderly patients with dementia.

Coping strategies are a potential way to improve interventions designed to manage the caregiver burden of dementia. The purpose of this study was to develop an intervention targeted towards improving coping strategies and to examine its effectiveness on reducing caregiver burden.



A controlled study design was used. Fifty-seven caregivers of dementia patients were enrolled. Coping strategies were assessed with the Revised Ways of Coping Checklist (WCCL-R) and caregiver burden was assessed with the Chinese version of the Caregiver Burden Inventory. The participants were randomly divided into two groups. The intervention group was offered a series of five interventions in which problem-solving skills, knowledge of dementia, social resources, and emotional support were taught every 2 weeks, and the control group was telephoned every 2 weeks for the usual clinical management. Two weeks after the end of the intervention, we again administered the WCCL-R and the Caregiver Burden Inventory. Two-way repeated-measure anova was used to evaluate the changes in coping strategies and caregiver burden.



Forty-six participants completed the study. No statistically significant differences were noted in the demographic data between the two groups. On the problem-focused coping subscale on the WCCL-R, the intervention group's mean score increased by 3.8 points, and the control group's decreased by 5.1 points (F = 7.988, P = 0.007). On the seeking social support coping subscale on the WCCL-R, the intervention group's mean score increased by 3.8 points, and the control group's decreased by 3.1 points (F = 4.462, P = 0.04). On the Caregiver Burden Inventory, the intervention group's mean score decreased by 7.2 points, and the control group's increased by 2.2 points (F = 6.155, P = 0.017).



Psychosocial intervention can help caregivers to adopt more problem-focused and social support coping strategies, which are beneficial in terms of reducing the caregiver burden.
Psychosocial care for adolescent and young adult hematopoietic cell transplant patients.

Psychological issues following hematopoietic cell transplantation (HCT) are unfortunately common. Literature specific to the transplant experience for the needs of adolescents and young adults (AYA) is lacking. The purpose of this article is to (1) describe the allogeneic transplant experience for AYA transplant patients during the first year following transplantation including demographic and treatment characteristics, (2) present AYA data obtained during and following a six-part posttransplant discharge study, (3) illustrate typical AYA experiences using case studies, and (4) propose AYA intervention strategies within Erickson's stages of psychosocial development. A quality of life model provided the research conceptual framework, and the content analysis framework for the qualitative research. Themes that emerged within each domain were the following: sexuality/fertility, fatigue, depression/poor coping/habits,adherence issues, use of technology, dependency issues, changes in roles/relationships, issues with school/education, financial issues, family problems/issues, miscellaneous, religion/spirituality, fear of future, uncertainty, life, death, more life appreciation. These data guide us for providing targeted interventions for the needs of this AYA population. This paper has presented literature and developmental theory, qualitative and qualitative data from an intervention study, and clinical cases in order to propose a developmental treatment model for AYA transplant patients. A coordinated and multidisciplinary approach is needed for the HCT patient who is an AYA.
Incidence of oncological pathologies 2002-2010 in the southwestern Piedmont area, province of Vercelli, neighbouring municipalities of former nuclear sites.

The Vercelli Province counts two former nuclear installations: a radioactive waste disposal area in Saluggia and a former nuclear power plant in Trino. This study takes also into account four other neighbouring municipalities, counting 20,000 total inhabitants. We studied the incidence of neoplastic pathologies in the 2002-2010 period. The data sources were Hospital Discharge Form (SDO), histological reports from the Registry of Hospital Charts (RHC) and Italy's National Statistics Institute (ISTAT) reports, and the Cancer Register of Turin. The research highlights the excesses for all type of cancers (SIR=1,11; IC 1,04-1,18), including the ones of nervous system (SIR=2,23 IC 1,47-2,98), leukaemia (SIR=1,94 IC 1,35-2,52), and bones (SIR=12,0 IC 9,22-14,7), according to different aggregation levels by age, sex and housing area. Considering such results, previous studies, and the environmental and occupational risk factors in the area, we believe that further epidemiological and environmental studies should be conducted in this area.
Does integration of HIV and SRH services achieve economies of scale and scope in practice? A cost function analysis of the Integra Initiative

Policy-makers have long argued about the potential efficiency gains and cost savings from integrating HIV and sexual reproductive health (SRH) services, particularly in resource-constrained settings with generalised HIV epidemics. However, until now, little empirical evidence exists on whether the hypothesised efficiency gains associated with such integration can be achieved in practice.



We estimated a quadratic cost function using data obtained from 40 health facilities, over a 2-year-period, in Kenya and Swaziland. The quadratic specification enables us to determine the existence of economies of scale and scope.



The empirical results reveal that at the current output levels, only HIV counselling and testing services are characterised by service-specific economies of scale. However, no overall economies of scale exist as all outputs are increased. The results also indicate cost complementarities between cervical cancer screening and HIV care; post-natal care and HIV care and family planning and sexually transmitted infection treatment combinations only.



The results from this analysis reveal that contrary to expectation, efficiency gains from the integration of HIV and SRH services, if any, are likely to be modest. Efficiency gains are likely to be most achievable in settings that are currently delivering HIV and SRH services at a low scale with high levels of fixed costs. The presence of cost complementarities for only three service combinations implies that careful consideration of setting-specific clinical practices and the extent to which they can be combined should be made when deciding which services to integrate.
Intraoperative parathyroid hormone assay in patients with primary hyperparathyroidism and double adenoma.

To determine the utility of parathyroid hormone (PTH) monitoring for double adenomas (DAs).



Retrospective chart review.



Tertiary referral center.



The study included 47 patients with primary hyperparathyroidism who had DAs identified during first-time parathyroid exploration.



Intraoperative PTH levels were measured in every case, and the intraoperative PTH assay and its influence on surgical outcome were examined.



A total of 47 of 552 consecutive patients (8.5%) with primary hyperparathyroidism were found to have DAs; 457 patients (82.7%) had single adenomas; and 48 patients (8.6%) had disease in more than 2 glands. The mean (SD) age of the patients with DAs was 58 (14) years, and 26 patients (55%) were female. The mean (SD) preoperative intact PTH level was 129 (57) pg/mL (to convert to nanograms per liter, multiply by 1), and the preoperative serum calcium level was 11.0 (0.6) mg/dL (to convert to millimoles per liter, multiply by 0.25). In all patients, the intraoperative PTH levels decreased by 79.7% (11.4%) from baseline after removal of both abnormal parathyroid glands. When the location could be confirmed, the second adenoma was ipsilateral in 17 patients (36%) and contralateral in 27 patients (64%). The mean (SD) postoperative intact PTH level was 46 (26) pg/mL at 6 months, and the cure rate was 98%.



Intraoperative PTH monitoring and maintenance of normocalcemia after surgery confirm previous reports that DAs do exist and are not simply missed cases of 4-gland hyperplasia. Intraoperative PTH monitoring accurately predicted the success of parathyroidectomy in 98% of patients with DAs.
Loss of dopamine transporter binding in Parkinson's disease follows a single exponential rather than linear decline.

Imaging of L-dopa uptake or dopamine transporter binding can monitor the progression of Parkinson's disease. Most follow-up studies have provided data best fitted by a linear decline of their outcome measure. However, in these studies, patients were repeatedly scanned during their first years after a diagnosis had been established.



We followed 6 patients with early Parkinson's disease for 7.5 y using 123I-labeled N-(3-iodopropene-2-yl)-2beta-carbomethoxy-3beta-(4-chlorophenyl) tropane and SPECT.



Loss of dopamine transporter binding was best fitted using a single exponential approximation. A 63% loss (tau [time constant tau]) was calculated as 5.18 +/- 7.62 y in the putamen and 10.62 +/- 31.4 y in the caudate nucleus when a 3-parameter fit was used.



These data approximate, for what is to our knowledge the first time, the decline of dopamine transporter binding as expected in biologic systems and may allow for models that correct for exponential decline to be developed and for disease-modifying effects in patients with advanced disease to be determined.
How to use marginal structural models in randomized trials to estimate the natural direct and indirect effects of therapies mediated by causal intermediates.

Although intention-to-treat analysis is a standard approach, additional supplemental analyses are often required to evaluate the biological relationship among interventions, intermediates, and outcomes. Therefore, we need to evaluate whether the effect of an intervention on a particular outcome is mediated by a hypothesized intermediate variable.



To evaluate the size of the direct effect in the total effect, we applied the marginal structural model to estimate the average natural direct and indirect effects in a large-scale randomized controlled trial (RCT).  The average natural direct effect is defined as the difference in the probability of a counterfactual outcome between the experimental and control arms, with the intermediate set to what it would have been, had the intervention been a control treatment. We considered two marginal structural models to estimate the average natural direct and indirect effects introduced by VanderWeele (Epidemiology 2009) and applied them in a large-scale RCT - the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J trial) - that compared angiotensin receptor blockers and calcium-channel blockers in high-risk hypertensive patients.



There were no strong blood pressure-independent or dependent effects; however, a systolic blood pressure reduction of about 1.9  mmHg suppressed all events. Compared to the blood pressure-independent effects of calcium channel blockers, those of angiotensin receptor blockers contributed positively to cardiovascular and cardiac events, but negatively to cerebrovascular events.



There is a particular condition for estimating the average natural direct effect. It is impossible to check whether this condition is satisfied with the available data.



We estimated the average natural direct and indirect effects through the achieved systolic blood pressure in the CASE-J trial. This first application of estimating the average natural effects in an RCT can be useful for obtaining an in-depth understanding of the results and further development of similar interventions.