nils-herrmann/clean_scirepeval huggingface dataset:
Ipriflavone in the treatment of postmenopausal osteoporosis: a randomized controlled trial.

Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting.



To investigate the effect of oral ipriflavone on prevention of postmenopausal bone loss and to assess the safety profile of long-term treatment with ipriflavone in postmenopausal osteoporotic women.



Prospective, randomized, double-blind, placebo-controlled, 4-year study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998.



Four hundred seventy-four postmenopausal white women, aged 45 to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm(2).



Patients were randomly assigned to receive ipriflavone, 200 mg 3 times per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium.



Efficacy measures included spine, hip, and forearm BMD and biochemical markers of bone resorption (urinary hydroxyproline corrected for creatinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for creatinine), assessed every 6 months. Laboratory safety measures and adverse events were recorded every 3 months.



Based on intent-to-treat analysis, after 36 months of treatment, the annual percentage change from baseline in BMD of the lumbar spine for ipriflavone vs placebo (0.1% [95% confidence interval (CI), -7.9% to 8.1%] vs 0.8% [95% CI, -9.1% to 10.7%]; P =.14), or in any of the other sites measured, did not differ significantly between groups. The response in biochemical markers was also similar between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P =.96); urinary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs 268 mg/mol (95% CI, 254-282 mg/mol); P =.81. The number of women with new vertebral fracture was identical or nearly so in the 2 groups at all time points. Lymphocyte concentrations decreased significantly (500/microL (0.5 x 10(9)/L]) in women treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group developed subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treatment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 (81%) of 29 by 2 years.



Our data indicate that ipriflavone does not prevent bone loss or affect biochemical markers of bone metabolism. Additionally, ipriflavone induces lymphocytopenia in a significant number of women.
The Development of a Peritoneal Surface Malignancy Program: a Tale of Three Hospitals

An increasing amount of evidence supports the use of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) for the treatment of select patients with carcinomatosis. The care of such patients is optimal at centers where physicians with expertise in the recognition, treatment, and follow-up of carcinomatosis collaborate to manage issues particular to patients undergoing HIPEC. New Peritoneal Surface Malignancy Programs should be introduced to meet the growing interest in this field; however, there are few guidelines available on how to propose, develop, and safely implement them across different hospital models. A new Peritoneal Surface Malignancy Program was initiated at a large academic medical center affiliated with three hospital systems serving distinct patient populations: a private hospital, a public hospital, and a Veterans Affairs hospital. Ten groups were identified as playing key roles in program implementation. Program approval was successfully obtained at all three hospitals. The initial two-year experience included a total of 20 cases across the three sites. Six of these cases were aborted due to high tumor volume, most of which (4/6) were at the public hospital. No 30-day mortalities occurred. Hospitals vary significantly in their approval process and timeline for new Peritoneal Surface Malignancy Program development. Patient populations differ in their awareness of HIPEC as a therapeutic modality. Public hospitals may serve patient populations with more advanced disease presentations. Careful coordination by the surgical oncologist with ten key groups allows for the safe introduction of a complex procedure within varied hospital models.
Caffeine modifies blood glucose availability during prolonged low-intensity exercise in individuals with type-2 diabetes 

The study investigated the effect of supplementation with maltodextrin (CHO) alone or associated to caffeine during exercise in T2DM subjects.



Pilot study, using eight subjects with T2DM, aged 55±10 years, received CHO (1 g/kg) or caffeine (1.5 mg/kg) alone or associated before exercise protocol. The exercise was executed at 40% heart rate (HR) reserve for 40 min, with 10-min recovery. Blood pressure (BP) and perceived exertion scale (Borg) were checked every 2 min. Blood glucose (BG) was checked every 10 min. For statistical analysis, ANOVA test was used and the value was considered statistically significant at p <0.05.



The results showed that BP and HR did not change significantly among all treatments. Caffeine promoted a significant reduction in BG of 75 mg/dL (65%, p <0.05) during 40 min of exercise protocol compared to all groups.



Supplementation with 1.5 mg/kg of caffeine reduces BG concentration during prolonged exercise in T2DM patients.
Efficacy and safety of Shenyankangfu tablets for primary glomerulonephritis: study protocol for a randomized controlled trial

Chronic kidney disease is a common disease. Most chronic kidney diseases evolve from primary glomerulonephritis. Proteinuria is an independent risk factor for the progression of chronic kidney disease. The general consensus is that therapy administered to decrease proteinuria should include steroids and/or immunosuppressants, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. However, the side effects of, and adverse reactions to, these agents reduce the benefits to patients. In addition, the cost of these drugs is relatively high. Therefore, identification of inexpensive and effective drugs to decrease proteinuria is urgently needed. Shenyankangfu tablets have been a widely applied Chinese patent medicine for many years to decrease proteinuria. However, there is a lack of research-derived data regarding the clinical use. Therefore, we designed the present randomized controlled clinical trial to compare the efficacy and safety of Shenyankangfu tablets versus losartan potassium for control of proteinuria in patients with primary glomerulonephritis.



This study will be a multicenter, prospective, double-blind, double-dummy, randomized controlled clinical trial. We will enroll 720 patients diagnosed with primary glomerulonephritis. The eligible patients will be randomly divided into the following groups at a 1:1:1:1:1 ratio: Shenyankangfu tablets group, losartan potassium 50 mg group, losartan potassium 100 mg group, Shenyankangfu tablets + losartan potassium 50 mg group, and Shenyankangfu tablets + losartan potassium 100 mg group. All groups will be followed up for 48 weeks; follow-up visits will be performed, at weeks 0, 4, 8, 12, 24, 36, and 48. The primary efficacy outcome will be the post-treatment change in the 24-hour proteinuria level, and the secondary efficacy outcomes will be the post-treatment changes in the serum creatinine level, estimated glomerular filtration rate, traditional Chinese medicine syndrome score, and serum albumin level.



The results of this trial will provide solid data for use in evidence-based medicine with respect to the efficacy and safety of Shenyankangfu tablets for control of proteinuria in patients with primary glomerulonephritis compared to those of losartan potassium. Moreover, we infer that therapy comprising Shenyankangfu tablets + losartan potassium can decrease proteinuria to a larger extent than Shenyankangfu tablets or losartan potassium can alone.
Social Rhythm and Mental Health: A Cross-Cultural Comparison

Social rhythm refers to the regularity with which one engages in social activities throughout the week, and has established links with bipolar disorder, as well as some links with depression and anxiety. The aim of the present study is to examine social rhythm and its relationship to various aspects of health, including physical health, negative mental health, and positive mental health.



Questionnaire data were obtained from a large-scale multi-national sample of 8095 representative participants from the U.S., Russia, and Germany.



Results indicated that social rhythm irregularity is related to increased reporting of health problems, depression, anxiety, and stress. In contrast, greater regularity is related to better overall health state, life satisfaction, and positive mental health. The effects are generally small in size, but hold even when controlling for gender, marital status, education, income, country, and social support. Further, social rhythm means differ across Russia, the U.S., and Germany. Relationships with mental health are present in all three countries, but differ in magnitude.



Social rhythm irregularity is related to mental health in Russia, the U.S., and Germany.
Cognitive-behavioral therapy in depressed primary care patients with co-occurring problematic alcohol use: effect of telephone-administered vs. face-to-face treatment-a secondary analysis.

This secondary analysis of a larger study compared adherence to telephone-administered cognitive-behavioral therapy (T-CBT) vs. face-to-face CBT and depression outcomes in depressed primary care patients with co-occurring problematic alcohol use. To our knowledge, T-CBT has never been directly compared to face-to-face CBT in such a sample of primary care patients. Participants were randomized in a 1:1 ratio to face-to-face CBT or T-CBT for depression. Participants receiving T-CBT (n = 50) and face-to-face CBT (n = 53) were compared at baseline, end of treatment (week 18), and three-month and six-month follow-ups. Face-to-face CBT and T-CBT groups did not significantly differ in age, sex, ethnicity, marital status, educational level, severity of depression, antidepressant use, and total score on the Alcohol Use Disorders Identification Test. Face-to-face CBT and T-CBT groups were similar on all treatment adherence outcomes and depression outcomes at all time points. T-CBT and face-to-face CBT had similar treatment adherence and efficacy for the treatment of depression in depressed primary care patients with co-occurring problematic alcohol use. When targeting patients who might have difficulties in accessing care, primary care clinicians may consider both types of CBT delivery when treating depression in patients with co-occurring problematic alcohol use.
Safety of sublingual-swallow immunotherapy in children aged 3 to 7 years.

The minimum age to start specific immunotherapy with inhalant allergens in children has not been clearly established, and position papers discourage its use in children younger than 5 years.



To assess the safety of high-dose sublingual-swallow immunotherapy (SLIT) in a group of children younger than 5 years.



Sixty-five children (51 boys and 14 girls; age range, 38-80 months; mean +/- SD age, 60 +/- 10 years; median age, 60 months) were included in this observational study. They were treated with SLIT with a build-up phase of 11 days, culminating in a top dose of 300 IR (index of reactivity) and a maintenance phase of 300 IR 3 times a week. The allergens used were house dust mites in 42 patients, grass pollen in 11 patients, olive pollen in 5 patients, Parietaria pollen in 4 patients, and cypress pollen in 3 patients. All adverse reactions and changes in the treatment schedule were compared in 2 subgroups: children 38 to 60 months old and children 61. to 80 months old.



The average cumulative dose of SLIT was 36,900 IR. Adverse reactions were observed in 11 children, none of them severe enough to require discontinuation of immunotherapy. Six reactions occurred in the 60 months or younger age group and 7 in the older than 60 months age group, with no differences between these 2 groups.



High-dose immunotherapy in children younger than 5 years does not cause more adverse reactions than in children aged 5 to 7 years. There is no reason to forbear studies on safety and efficacy of these preparations in young children.
Plasma adiponectin levels and sonographic phenotypes of subclinical carotid artery atherosclerosis: data from the SAPHIR Study.

Adipose tissue produces and secretes a number of bioactive molecules, conceptualized as adipocytokines. Adiponectin has been identified as one of the adipocytokines, and hypoadiponectinemia was demonstrated in patients with obesity, diabetes mellitus, and coronary artery disease. Whether decreased adiponectin levels are cause or consequence is an important issue in the discussion on the association between adiponectin and atherosclerosis. In the present study, we investigated the association of plasma adiponectin levels with sonographic phenotypes of subclinical atherosclerosis, which may represent different stages of disease as well as common and distinct determinants.



A total of 1515 middle-aged healthy white subjects (940 males and 575 females) were included. Common carotid artery intima-media thickness (CIMT) and presence of atherosclerotic plaques were assessed by B-mode ultrasound.



After adjustment for established risk factors, per 1 microg/mL decrease in adiponectin CIMT increased on the average by 3.48 microm in males (95% CI, 1.23 to 5.73 microm) and by 2.39 microm in females (95% CI, 0.50 to 4.27 microm). After dichotomizing adiponectin levels at the median and adjustment for established risk factors, the mean difference of CIMT between subjects with low and high adiponectin levels was 20.42 microm in men (95% CI, 6.80 to 34.04; P=0.003) and 20.75 microm in women (95% CI, 1.08 to 40.42; P=0.039). No significant relationship was found between adiponectin levels and presence of atherosclerotic plaques.



Our results demonstrate an independent negative association of adiponectin levels and CIMT, whereas no relationship with presence of atherosclerotic plaques was found, thus suggesting hypoadiponectinemia as a risk factor in the development of early atherosclerosis.
Validation of a multiplex chip-based assay for the detection of autoantibodies against citrullinated peptides

Autoantibodies directed against citrullinated proteins/peptides (ACPAs) are highly specific and predictive for the development of rheumatoid arthritis (RA). Different subgroups of RA patients, which have different prognoses and may require different treatments, are characterized by different autoantibody profiles. The objective of this study was to develop a microarray for the detection of multiple RA-associated autoantibodies, initially focusing on responses against citrullinated epitopes on candidate autoantigens in RA.



The microarray is based on Phadia's ImmunoCAP ISAC system, with which reactivity to more than 100 antigens can be analyzed simultaneously, by using minute serum volumes (< 10 μl). Twelve citrullinated peptides, and the corresponding native arginine-containing control peptides, were immobilized in an arrayed fashion onto a chemically modified glass slide, allowing a three-dimensional layer with high binding capacity. The assay was optimized concerning serum dilution and glass surface, whereas each individual antigen was optimized concerning coupling chemistry, antigen concentration, and selection of spotting buffer. The performance of each peptide in the ImmunoCAP ISAC system was compared with the performance in enzyme-linked immunosorbent assays (ELISAs). Serum from 927 RA patients and 461 healthy controls from a matched case-control study were applied onto reaction sites on glass slides, followed by fluorescent-labeled anti-human immunoglobulin G (IgG) antibody. Fluorescence intensities were detected with a laser scanner, and the results analyzed by using image-analysis software.



Strong correlations between the ImmunoCAP ISAC system and ELISA results were found for individual citrullinated peptides (Spearman ρ typically between 0.75 and 0.90). Reactivity of RA sera with the peptides was seen mainly in the anticyclic citrullinated peptide 2 (CCP2)-positive subset, but some additional reactivity with single citrullinated peptides was seen in the anti-CCP2-negative subset. Adjusting for reactivity against arginine-containing control peptides did not uniformly change the diagnostic performance for antibodies against the individual citrullinated peptides.



The multiplexed array, for detection of autoantibodies against multiple citrullinated epitopes on candidate RA autoantigens, will be of benefit in studies of RA pathogenesis, diagnosis, and potentially as a guide to individualized treatment.
Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial

To determine whether environmental control using nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of patients with persistent atopic asthma.



Randomised, double-blind, placebo-controlled, parallel-group trial.  Nineteen European asthma clinics.



312 patients aged 7-70 with inadequately controlled persistent atopic asthma.



Proportion of patients with an increase of ≥0.5 points in asthma quality of life score after 1 year of treatment.



TLA devices were successfully installed in the bedrooms of 282 (90%) patients included in the primary efficacy analysis. There was a difference in treatment response rate between active (143 of 189, 76%) and placebo (56 of 92, 61%) groups, difference 14.8% (95% CI 3.1 to 26.5, p=0.02).3 In patients aged ≥12, on whom the study was powered, the difference in response rate was similar-active 106 of 143 (74%), placebo 42 of 70 (60%), difference 14.1% (0.6 to 27.7, p=0.059). There was a difference between groups in fractional exhaled nitric oxide change of -7.1 ppb (-13.6 to -0.7, p=0.03). Active treatment was associated with less increase in cat-specific IgE than placebo. There was no difference in adverse event rates between treatment groups.



Inhalant exposure reduction with TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. TLA may be a treatment option for patients with inadequately controlled persistent atopic asthma.
Rehabilitation needs and participation restriction in patients with cognitive disorder in the chronic phase of traumatic brain injury

The purpose of this study was to clarify psychosocial factors/problems, social participation, quality of life (QOL), and rehabilitation needs in chronic-phase traumatic brain injury (TBI) patients with cognitive disorder discharged from the level-1 trauma center (L1-TC), and to inspect the effects of rehabilitation intervention to these subjects.A mixed-method research (cross-sectional and qualitative study) was conducted at an outpatient rehabilitation department.Inclusion criteria of subjects were transfer to the L1-TC due to TBI; acute-stage rehabilitation treatment received in the L1-TC from November 2006 to October 2011; age of ≥18 and <70 years at the time of injury; a score of 0-3 on the Modified Rankin Scale at discharge and that of 4-5 due to physical or severe aggressive behavioral comorbid disorders. Study details were sent, via mail, to 84 suitable candidates, of whom 36 replied. Thirty-one subjects (median age: 33.4 years; male: 17; and average time since injury: 48.1 months), who had consented to study participation, were participated. Cognitive function, social participation, QOL, psychosocial factors/problems, rehabilitation needs, and chronic-phase rehabilitation outcomes were evaluated using the Wechsler Adult Intelligence Scale, Third Edition, the Wechsler Memory Scale-Revised, the Zung Self-Rating Depression Scale, the Sydney Psychosocial Reintegration Scale, Version 2, and the Short Form 36, Version 2, qualitative analysis of semistructured interviews, etc.Participants were classified into achieved-social-participation (n = 11; employed: 8), difficult-social-participation (n = 12; unemployed: 8), and no-cognitive-dysfunction groups (n = 8; no social participation restriction). Relative to the achieved-social-participation group, the difficult-social-participation group showed greater injury and cognitive dysfunction and lower Sydney Psychosocial Reintegration Scale and Short Form 36 role/social component summary scores (64.9/49.1 vs 44.3/30.4, respectively, P < 0.05). Linear regression analysis showed that the social participation status was greatly affected by the later cognitive disorders and psychosocial factors/problems not by the severity of TBI. No changes were observed in these scores following chronic-phase rehabilitation intervention.Chronic-phase TBI with cognitive disorder led to rehabilitation needs, and improvement of subjects' psychosocial problems and QOL was difficult.
Assessment of linear regression techniques for modeling multisensor data for non-invasive continuous glucose monitoring

New scenarios in diabetes treatment have been opened in the last ten years by continuous glucose monitoring (CGM) sensors. In particular, Non-Invasive CGM sensors are particularly appealing, even though they are still at an early stage of development. Solianis Monitoring AG (Zürich, Switzerland) has proposed an approach based on a multisensor concept, embedding primarily dielectric spectroscopy and optical sensors. This concept requires a mathematical model able to reconstruct the glucose concentration from the 150 channels measured with the device. Assuming a multivariate linear regression model (valid and usable for different individuals), the aim of this paper is the assessment of some techniques usable for determining such a model, namely Ordinary Least Squares (OLS), Partial Least Squares (PLS) and Least Absolute Shrinkage and Selection Operator (LASSO). Once the model is identified on a training set, the accuracy of prospective glucose profiles estimated from ”unseen” multisensor data is assessed. Preliminary results obtained from 18 in-clinic study days show that sufficiently accurate reconstruction of glucose levels can be achieved if suitable model identification techniques, such as LASSO, are considered.
Randomized crossover comparison of proportional assist ventilation and patient-triggered ventilation in extremely low birth weight infants with evolving chronic lung disease.

Refinement of ventilatory techniques remains a challenge given the persistence of chronic lung disease of preterm infants.



To test the hypothesis that proportional assist ventilation (PAV) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO(2)) and arterial hemoglobin oxygen saturation in ventilator-dependent extremely low birth weight infants in comparison with standard patient-triggered ventilation (PTV).



Randomized crossover design.



Two level-3 university perinatal centers.



22 infants (mean (SD): birth weight, 705 g (215); gestational age, 25.6 weeks (2.0); age at study, 22.9 days (15.6)).



One 4-hour period of PAV was applied on each of 2 consecutive days and compared with epochs of standard PTV.



Mean airway pressure was 5.64 (SD, 0.81) cm H(2)O during PAV and 6.59 (SD, 1.26) cm H(2)O during PTV (p < 0.0001), the mean peak inspiratory pressure was 10.3 (SD, 2.48) cm H(2)O and 15.1 (SD, 3.64) cm H(2)O (p < 0.001), respectively. The FiO(2) (0.34 (0.13) vs. 0.34 (0.14)) and pulse oximetry readings were not significantly different. The incidence of arterial oxygen desaturations was not different (3.48 (3.2) vs. 3.34 (3.0) episodes/h) but desaturations lasted longer during PAV (2.60 (2.8) vs. 1.85 (2.2) min of desaturation/h, p = 0.049). PaCO(2) measured transcutaneously in a subgroup of 12 infants was similar. One infant met prespecified PAV failure criteria. No adverse events occurred during the 164 cumulative hours of PAV application.



PAV safely maintains gas exchange at lower mean airway pressures compared with PTV without adverse effects in this population. Backup conventional ventilation breaths must be provided to prevent apnea-related desaturations.