nils-herrmann/clean_scirepeval huggingface dataset:
Prophylactic Use of Alfacalcidol in Corticosteroid-Induced Osteoporosis

One hundred and forty-five patients suffering from diseases requiring long-term treatment with high doses of corticosteroids (30 mg/day or greater of prednisolone) were recruited to the study. Patients had to be steroid naive on entry to the study (not more than 15 days of treatment with a corticosteroid within the previous 24 months). Patients were randomized to receive either 1 mg/day alfacalcidol or placebo capsules for 12 months. Bone mineral density (BMD) of the lumbar spine was assessed by dual-photon absorptiometry on entry and after 3, 6 and 12 months’ treatment. Safety was monitored by the recording of all adverse events reported by patients and the regular screening of blood samples for hematology and serum biochemistry. Of the 145 patients, 74 were randomized to alfacalcidol and 71 to placebo. The treatment groups were well matched at baseline with no significant differences in demographic, clinical or biochemical parameters. The mean equivalent dose of prednisolone at baseline was 46.6 mg/day and 46.3 mg/day for the alfacalcidol and placebo group respectively. From the 145 patients randomized to treatment, 71 (38 who received alfacalcidol and 33 who received placebo) provided BMD data both at baseline and at 3, 6 and 12 months. The percentage change in BMD after 6 months’ treatment was –2.11% in the alfacalcidol group and –4.00% in the placebo group (p= 0.39). After 12 months the percentage change in BMD was +0.39% (CI: –4.28 to 4.81) in the alfacalcidol group and –5.67% (CI: –8.13 to –3.21) in the placebo group, this difference (6.06%, CI: 0.88 to 11.24) being statistically significant (p= 0.02). An intention to treat analysis also showed a significant difference between the two treatment groups in alfacalcidol’s favor (3.81%, p= 0.01; CI: 0.92 to 6.70). There was no significant difference between the two treatment groups in the corticosteroid dose at any time point during the study. Serum calcium was measured throughout and there were no significant differences between the two treatment groups at any visit. This study suggests that alfacalcidol can prevent corticosteroid-induced bone loss from the lumbar spine. Long-term use of alfacalcidol was not associated with any significant adverse effects in this diverse group of patients.
PET imaging of hypoxia using [18F]HX4: a phase I trial

Noninvasive PET imaging of tumour hypoxia could help in the selection of those patients who could benefit from chemotherapy or radiation with specific antihypoxic treatments such as bioreductive drugs or hypoxic radiosensitizers. In this phase I trial, we aimed to determine the toxicity of [18F]HX4, a member of the 2-nitroimidazole family, at different dose levels. The secondary aim was to analyse image quality related to the HX4 dose and the timing of imaging. Patients with a histologically proven solid cancer without curative treatment options were eligible for this study. A study design with two dose steps was used in which a single dose of a maximum of 222 MBq (step 1) or 444 MBq (step 2) [18F]HX4 was injected. Toxicity was scored on day 0 and on days 3 and 7 after injection, according to the CTCAE 3.0 scoring system. PET/CT images of the largest tumour site were acquired 30, 60 and 120 min after injection. Six patients with stage IV carcinoma were included, four with non-small-cell lung carcinoma, one with thymus carcinoma, and one with colon carcinoma. No toxicity was observed in any of the patients at either dose level. The median tumour to muscle ratio 120 min after injection was 1.40 (range 0.63–1.98). The findings of this study showed that [18F]HX4 PET imaging for the detection of hypoxia is not associated with any toxicity. Imaging was successful; however, future trials are needed to determine the optimal image parameters.
Motivational Interviewing in Permanent Supportive Housing: The Role of Organizational Culture

This study evaluated motivational interviewing (MI) in a permanent supportive housing agency. The agency’s contradictory social service and business missions resulted in an incompatible organizational culture theorized to diminish MI’s effectiveness. A combination of observational, interview, and archival data collected over 3 years were used to examine MI implementation within an incompatible supportive housing agency. Two major themes arose: how MI is used to categorize and change clients in permanent supportive housing and how worker–worker relationships affect MI implementation. The results suggest that within incompatible organizational environments, key elements of effective MI implementation are greatly weakened.
Insoluble carob fiber rich in polyphenols lowers total and LDL cholesterol in hypercholesterolemic sujects.

Recently, polyphenols have been found to affect blood lipids in animals in a similar manner as soluble dietary fibre. The aim was to assess whether an insoluble dietary fiber very rich in polyphenols has a beneficial effect on serum lipids in humans. In a double-blind randomized placebo-controlled clinical study with parallel arms, 88 volunteers with hypercholesterolemia were randomly assigned to consume daily either, fiber with insoluble 84% polyphenols 4 g twice a day (n = 43) or placebo (n = 45). Serum total, LDL and HDL cholesterol and triglycerides were assessed at baseline and after 4 weeks. The insoluble polyphenols consumption reduced the total cholesterol by 17.8 +/- 6.1% (p < 0.05), LDL cholesterol by 22.5 +/- 8.9% (p < 0.001), LDL: HDL cholesterol ratio by 26.2 +/- 14.3% (p < 0.001) and triglycerides by 16.3 +/- 23.4% (p < 0.05) at the end of the study compared with baseline. No significant differences were found during the study time in the placebo group for the lipid profile. The consumption of fiber very rich in insoluble polyphenols shows beneficial effects on human blood lipid profile and may be effective in prevention and treatment of hyperlipemia.
Impact of a Telephone Counseling Intervention on Transitions in Stage of Change and Adherence to Interval Mammography Screening (United States)

Interventions to improve adherence to regular mammography screening have had conflicting results. Many studies have depended on women’s self-report rather than clinical evidence of a mammography encounter. We tested the impact of two interventions on a population-based sample of NH women who were not receiving routine mammography to determine if adherence to screening could be improved. The interventions included a mailing of women’s health information and a telephone counseling intervention based on the Transtheoretical Model. Participant eligibility and outcome measures were based on clinical events obtained from a population-based mammography registry. Two hundred and fifty eight women completed all aspects of the intervention study. The women were randomly assigned to one of two study groups: 51% received the mail intervention and 49% received the telephone intervention. Among women who received the telephone counseling intervention, 67% percent reported being in either an action or maintenance stage at Call 1, which increased to 84% at Call 2 (p<0.001). Seventy-six percent of women identified barriers to screening mammography at Call 1, which decreased to 44% at Call 2 (p<0.01). The most frequently identified barrier was confusion over the guidelines for screening mammography. At the first assessment time interval, greater than 60% of women were up-to-date for screening mammography in the group that received telephone counseling versus 48% in the group that received health information by mail (p = 0.04). However, women’s status as up-to-date fell for both groups between the first and second assessment time intervals. Tailored telephone counseling based on the Transtheoretical Model can improve adherence to screening mammography, though the duration of this effect is in question.
Does seasonal level of serum 25-OH vitamin D correlate with the activity of Crohn's disease?

Vitamin D has immune modulating effects and normal to high levels might be correlated with less severe Crohn's disease (CD). We aimed to review seasonal vitamin D levels in CD patients in correlation with disease activity.



CD patients were identified from an inflammatory bowel disease (IBD) database and given two questionnaires enquiring about vitamin D supplementation, sun exposure, sunblock application and symptoms to complete the CDAI. Participants were examined and serum 25-OH vitamin D [25(OH)D] levels and haematocrit were determined in winter (06/2011-09/2011) and summer (12/2011-03/2012). Patients taking vitamin D supplements or with extensive small bowel resection were excluded.



32 patients (19 women, mean age 39 plus or minus 16 years, range 18-73 years), from Dunedin, New Zealand (45 degrees 52' S, 170 degrees 30' E) consented to participate in the study. Of these, three took vitamin D supplements and were excluded. In winter 76% of the participants had serum 25(OH)D levels classified as deficient (<50 nmol/L) and all of them had insufficient 25(OH)D levels (<75 nmol/L). In summer, serum 25(OH)D levels were deficient only in 10% but insufficient in 55% of the participants. Mean serum 25(OH)D level was 35.9 nmol/L (norm 50-150nmol/L) in winter (range 5-67, SD 17.5) and 69.6 nmol/L in summer (range 13-119, SD 19.0) (p<0.0005). There was no significant difference in the seasonal levels of serum 25(OH)D between male and female participants (p=0.601). Mean CDAI score was 103.9 in winter (range -10-262, SD 76.9) and 90.2 in summer (range -13-331, SD 84.0) (p=0.365). A mixed-effects regression analysis showed no statistically significant correlation between seasonal levels of serum 25(OH)D and CDAI (p=0.612) among our study participants.



Suboptimal levels of serum 25(OH)D were found in the majority of our study participants particularly in winter and they would benefit from supplementation. Our study showed no statistically significant correlation between seasonal serum 25(OH)D levels and CD activity. Given the limitations of the study, the role of 25(OH)D as a predictor of disease activity could not be clearly concluded.
[Profile of the informal carer associated with the clinical management of the Alzheimer's disease patient refractory to symptomatic treatment of the disease].

Many factors influence the satisfaction and quality of life of informal caregivers of non-responder patients with Alzheimer disease (AD). Among these include, the course of the disease, cognitive impairment and behavioural disturbances of the patient, the level of family support and caregiver inherent factors such as, time commitment, psychological status and awareness of the disease. The aim of this work is to determine the profile of informal caregivers of non-responder AD patients and to evaluate the different factors that affect their quality of life, burden and overall satisfaction with treatment.



We carried out a prospective and multicentre study in Spain that included a total of 249 AD patients unresponsive to anticholinesterase treatment, and their informal caregivers. We evaluated caregivers' quality of life with the SF-36 questionnaire and their associated burden with the Zarit scale, both validated for Spain. The severity and progression of the disease was quantified according to Clinical Dementia Rating (CDR) and Mini-Mental State Examination (MMSE).



Caregiver burden showed a significant increase with the time elapsed since the start of the study, while treatment satisfaction increased slightly with this factor. Caregiver burden is highly correlated with CDR scale on patient symptoms, both in the initial visit (p<.0001) and final visit (p=.0001). Caregiver satisfaction with treatment was mainly affected by the degree of change in cognitive deterioration experienced by the patient between the two visits (p=.021).



Overall satisfaction with the treatment stated by the caregiver does not correlate with compliance to treatment, but it does so with the changes in patient's cognitive impairment, a factor that also influences caregiver's burden.
Effect of aripiprazole on cognition in the treatment of patients with schizophrenia.

The aim of this study was to assess the cognitive effects of aripiprazole in inpatients with schizophrenia.



This was an investigator-initiated, open label eight-week trial evaluating 56 inpatients with the DSM-IV diagnosis of schizophrenia. Efficacy was assessed weekly using the Positive and Negative Syndrome Scale (PANSS) and tolerability was assessed each week using the Udvalg for Klinske Undersogelser side effect rating scale (UKU). Cognitive function was assessed at baseline, week 4 and week 8.



Aripiprazole showed significant improvement in PANSS total score and all subscores between baseline and endpoint visit. The substance was very well tolerated. Patients improved significantly in verbal memory, reaction time and reaction quality/attention from baseline to week eight. Furthermore, mean z-values of individual cognitive domains summarized in a global cognitive index improved significantly from baseline to week eight.



Our results suggest that aripiprazole provides a valuable treatment option for patients with schizophrenia.
Plasma pyridoxal-5-phosphate and future risk of myocardial infarction in the European Prospective Investigation into Cancer and Nutrition Potsdam cohort.

Retrospective studies indicate that low concentrations of plasma pyridoxal-5-phosphate (PLP) are associated with cardiovascular events; however, few prospective studies of this issue have been conducted.



We therefore investigated whether PLP concentrations are independently associated with myocardial infarction (MI) in the European Investigation into Cancer and Nutrition (EPIC) Potsdam Study.



After exclusion of prevalent MI or stroke, incident cases of MI were identified among 26 761 participants (aged 35-65 y at baseline). The current analysis is based on a nested case-cohort study consisting of a control group of 810 subjects without MI or stroke at baseline and a case group of 148 subjects who had an MI during a mean follow-up period of 6.0 +/- 1.5 y. Cox proportional hazard models were used to evaluate the association between plasma PLP and risk of MI.



In the age- and sex-adjusted analysis, subjects in the highest quintile of PLP had a significantly reduced risk of MI (hazard ratio: 0.50; 95% CI: 0.29, 0.83). Adjustment for either low-grade inflammation or smoking diminished this association. When both low-grade inflammation and smoking were adjusted for, the association was abolished. In addition, adjustment for established risk factors also abolished the association between PLP and risk of MI.



These findings from a prospective German cohort study suggest that PLP is not independently associated with risk of MI.
18F-Fluoride PET/CT is highly effective for excluding bone metastases even in patients with equivocal bone scintigraphy

Bone scintigraphy (BS) has been used extensively for many years for the diagnosis of bone metastases despite its low specificity and significant rate of equivocal lesions. 18F-Fluoride PET/CT has been proven to have a high sensitivity and specificity in the detection of malignant bone lesions, but its effectiveness in patients with inconclusive lesions on BS is not well documented. This study evaluated the ability of 18F-fluoride PET/CT to exclude bone metastases in patients with various malignant primary tumours and nonspecific findings on BS. We prospectively studied 42 patients (34–88 years of age, 26 women) with different types of tumour. All patients had BS performed for staging or restaging purposes but with inconclusive findings. All patients underwent 18F-fluoride PET/CT. All abnormalities identified on BS images were visually compared with their appearance on the PET/CT images. All the 96 inconclusive lesions found on BS images of the 42 patients were identified on PET/CT images. 18F-Fluoride PET/CT correctly excluded bone metastases in 23 patients (68 lesions). Of 19 patients (28 lesions) classified by PET/CT as having metastases, 3 (5 lesions) were finally classified as free of bone metastases on follow-up. The sensitivity, specificity, and positive and negative predictive values of 18F-fluoride PET/CT were, respectively, 100 %, 88 %, 84 % and 100 % for the identification of patients with metastases (patient analysis) and 100 %, 82 % and 100 % for the identification of metastatic lesions (lesion analysis). The factors that make BS inconclusive do not affect 18F-fluoride PET/CT which shows a high sensitivity and negative predictive value for excluding bone metastases even in patients with inconclusive conventional BS.
Beyond Volume: Hospital-Based Healthcare Technology for Better Outcomes in Cerebrovascular Surgical Patients Diagnosed With Ischemic Stroke

We examined whether the level of hospital-based healthcare technology was related to the 30-day postoperative mortality rates, after adjusting for hospital volume, of ischemic stroke patients who underwent a cerebrovascular surgical procedure. Using the National Health Insurance Service-Cohort Sample Database, we reviewed records from 2002 to 2013 for data on patients with ischemic stroke who underwent cerebrovascular surgical procedures. Statistical analysis was performed using Cox proportional hazard models to test our hypothesis. A total of 798 subjects were included in our study. After adjusting for hospital volume of cerebrovascular surgical procedures as well as all for other potential confounders, the hazard ratio (HR) of 30-day mortality in low healthcare technology hospitals as compared to high healthcare technology hospitals was 2.583 (P < 0.001). We also found that, although the HR of 30-day mortality in low healthcare technology hospitals with high volume as compared to high healthcare technology hospitals with high volume was the highest (10.014, P < 0.0001), cerebrovascular surgical procedure patients treated in low healthcare technology hospitals had the highest 30-day mortality rate, irrespective of hospital volume. Although results of our study provide scientific evidence for a hospital volume/30-day mortality rate relationship in ischemic stroke patients who underwent cerebrovascular surgical procedures, our results also suggest that the level of hospital-based healthcare technology is associated with mortality rates independent of hospital volume. Given these results, further research into what components of hospital-based healthcare technology significantly impact mortality is warranted.
Classification of non-Hodgkin lymphoma in South-eastern Europe: review of 632 cases from the international non-Hodgkin lymphoma classification project.

The distribution of non-Hodgkin lymphoma (NHL) subtypes varies around the world, but a systematic study of South-eastern Europe (SEEU) has never been done. Therefore, we evaluated the relative frequencies of NHL subtypes in three SEEU countries--Croatia, Romania and Macedonia. Five expert haematopathologists reviewed 632 consecutive cases of newly diagnosed NHL from the three SEEU countries using the World Health Organization classification. The results were compared to 399 cases from North America (NA) and 580 cases from Western Europe (WEU). The proportions of B- and T-cell NHL and the sex distribution in SEEU were similar to WEU and NA. However, the median ages of patients with low- and high-grade B-NHL in SEEU (60 and 59 years, respectively) were significantly lower than in NA (64 and 68 years, respectively; P < 0·05). SEEU had a significantly lower proportion of low-grade B-NHL (46·6%) and higher proportion of high-grade B-NHL (44·5%) compared to both WEU (54·5% and 36·4%, respectively) and NA (56·1% and 34·3%, respectively). There were no significant differences in the relative frequencies of T-NHL subtypes. This study provides new insights into differences in the relative frequencies of NHL subtypes in different geographic regions. Epidemiological studies are needed to better characterize and explain these differences.
Analysis of a polymorphism in the tuberous sclerosis (TSC2) gene does not predispose to schizophrenia

The tuberous sclerosis complex (TSC) is an autosomal dominant disorder characterized by the development of malformations in various organs including the brain. A polymorphism in the TSC2 gene has been found to be increased in gangliogliomas, a lesion which is associated with disturbed neuro-glial cell migration pattern. Since these pathomorphological changes are compatible with disturbed neuronal migration in schizophrenic brains, we investigated this polymorphism in 130 families with a schizophrenic index patient. A 222-bp fragment of genomic DNA containing the TSC2 variant was analyzed by SSCP. The analysis revealed that there is no association with schizophrenia.
Association of walking with survival and RRT among patients with CKD stages 3-5.

Patients with CKD can benefit from an increase in physical activity. Walking is one of the most common exercises in patients with CKD; however, the association of walking with outcomes in patients with CKD is not clear. This study investigated the association of walking with overall mortality and RRT in patients with CKD stages 3-5.



All patients with CKD stages 3-5 in the CKD program of China Medical University Hospital from June 2003 to May 2013 were enrolled. The risks of overall mortality and RRT were analyzed using competing-risks regressions.



A total of 6363 patients (average age, 70 years) during a median of 1.3 (range=0.6-2.5) years of follow-up were analyzed. There were 1341 (21.1%) patients who reported walking as their most common form of exercise. The incidence density rate of overall mortality was 2.7 per 100 person-years for walking patients and 5.4 for nonwalking ones. The incidence density rate of RRT was 22 per 100 person-years for walking patients and 32.9 for nonwalking ones. Walking, independent of patients' age, renal function, and comorbidity, was linked to lower overall mortality and lower RRT risk in the multivariate competing-risks regression. The adjusted subdistribution hazard ratio (SHR) of walking was 0.67 (95% confidence interval [95% CI], 0.53 to 0.84; P<0.001) for overall mortality and 0.79 (95% CI, 0.73 to 0.85; P<0.001) for the risk of RRT. The SHRs of overall mortality were 0.83, 0.72, 0.42, and 0.41 for patients walking 1-2, 3-4, 5-6, and ≥7 times per week, and the SHRs of RRT were 0.81, 0.73, 0.57, and 0.56, respectively.



Walking is the most popular form of exercise in patients with CKD and is associated with lower risks of overall mortality and RRT. The benefit of walking is independent of patients' age, renal function, and comorbidity.
Clinical trial: B vitamins improve health in patients with coeliac disease living on a gluten-free diet.

Patients with coeliac disease living on a gluten-free diet show vitamin deficiency and reduced subjective health status.



To study the biochemical and clinical effects of B vitamin supplementation in adults with longstanding coeliac disease.



In a double blind placebo controlled multicentre trial, 65 coeliac patients (61% women) aged 45-64 years on a strict gluten-free diet for several years were randomized to a daily dose of 0.8 mg folic acid,0.5 mg cyanocobalamin and 3 mg pyridoxine or placebo for 6 months. The outcome measures were psychological general well-being (PGWB) and the plasma total homocysteine (tHcy) level, marker of B vitamin status.



Fifty-seven patients (88%) completed the trial. The tHcy level was baseline median 11.7 micromol/L (7.4-23.0), significantly higher than in matched population controls [10.2 micromol/L (6.7-22.6) (P < 0.01)]. Following vitamin supplementation, tHcy dropped a median of 34% (P < 0.001), accompanied by significant improvement in well-being (P < 0.01), notably Anxiety (P < 0.05) and Depressed Mood (P < 0.05) for patients with poor well-being.



Adults with longstanding coeliac disease taking extra B vitamins for 6 months showed normalized tHcy and significant improvement in general well-being, suggesting that B vitamins should be considered in people advised to follow a gluten-free diet.