nils-herrmann/clean_scirepeval huggingface dataset:
Therapeutic effects of magnetic and copper bracelets in osteoarthritis: a randomised placebo-controlled crossover trial.

To test the effectiveness of a typical magnetic wrist strap for reducing pain and stiffness, and for improving physical functioning amongst patients with osteoarthritis.



A randomised double-blind placebo-controlled crossover trial. Each participant wore four devices over a 16-week period.



Forty five patients with osteoarthritis were recruited from general practices in rural and urban areas of Yorkshire.



Experimental device: a commercially available magnetic wrist strap. Control devices: a weak magnetic wrist strap, a demagnetised wrist strap, and a copper bracelet.



The WOMAC Osteoarthritis Index, the McGill Pain Questionnaire-Pain Rating Index (PRI), a pain visual analogue scale (VAS), and medication use.



No difference was observed between devices in terms of their effects on pain as measured by the primary outcome measure (WOMAC A), the PRI and the VAS. Similar results were obtained for stiffness (WOMAC B), physical function (WOMAC C), and medication use. Further analyses of the PRI subscales revealed a statistically significant difference between devices (P=0.025), which favoured the experimental device. Participants reported lower sensory pain after wearing the standard magnetic wrist strap, than when wearing control devices. However, no adjustment was made for multiple testing.



Our results indicate that magnetic and copper bracelets are generally ineffective for managing pain, stiffness and physical function in osteoarthritis. Reported therapeutic benefits are most likely attributable to non-specific placebo effects. However such devices have no major adverse effects and may provide hope.
Relation between therapeutic response and side effects induced by methylphenidate as observed by parents and teachers of children with ADHD

The desired (therapeutic) and undesired (side) effects of methylphenidate might have underlying correlations. The aim of this study was to explore the strength and the possible sources of these correlations.



One hundred and fifty-seven children with ADHD (6-12 years) were administered placebo and methylphenidate (0.5 mg/kg in a divided b.i.d. dose), each for a one-week period, in a double-blind, crossover trial. Therapeutic response was assessed using the Conners' Global Index for parents (CGI-Parents) and teachers (CGI-Teachers), while side effects were assessed using the Barkley Side Effects Rating Scale (SERS).



The side effect profile as assessed by the SERS was similar to that of previous studies with insomnia, decreased appetite, and headaches showing significant treatment effects (p < 0.005). These "somatic/physical" side effects did not correlate with CGI-Parents or CGI-Teachers. However, the side effects of "irritability", "proneness to crying", and "anxiousness" showed significant relationships with CGI-Parents. These "mood/anxiety" side effects showed no significant correlations with the CGI-Teachers.



The greater "mood/anxiety" side effects on methylphenidate and placebo, the less the parents observe improvement of their children while treated with methylphenidate. This suggests that the correlations between "mood/anxiety" side effects and poor response to treatment may be driven by observer effects rather than biological commonalities between therapeutic and side effects of methylphenidate.
Interactions between single nucleotide polymorphism of SERPINA1 gene and smoking in association with COPD: a case–control study

SERPINA1 gene has been implicated in the pathogenesis of chronic obstructive pulmonary disease (COPD), while smoking is a known risk factor for COPD. Little is known on the effect of SERPINA1 gene and its interaction with smoking in the Chinese population. In this study, the effect of SERPINA1 gene polymorphisms on COPD risk and its interaction with smoking status has been investigated.



A total of 120 COPD patients and 481 healthy controls were recruited at The Armed Police Corps Hospital. Data on demographic variables, smoking status, history of occupational dust exposure, and allergies were collected. Genotyping for single nucleotide polymorphism's (SNP) rs1243160, rs2854254, and rs8004738 was performed in all participants.



SNP rs8004738 genotype was associated with a significantly higher risk for COPD (odds ratio (OR) =1.835, 95% confidence interval (CI): 1.002-3.360), whereas SNPs rs1243160 and rs2854254 did not exhibit such an association. Smoking habit also significantly increased the risk for COPD (OR =2.306, 95% CI: 1.537-3.459). On stepwise logistic regression analysis, advanced age, smoking, and SNP rs8004738 variant were associated with increased risk for COPD, while female gender and higher educational status decreased the risk. On additive interaction analysis, a significant interactive effect of SNP rs8004738 and smoking was observed in this population (relative excess risk due to interaction =0.478; attributable proportion due to interaction (AP) =0.123; S=1.197).



SNP rs8004738 of SERPINA1 gene significantly interacted with smoking status and was associated with a higher risk for COPD in the Chinese population.
The relationship between anthropometric parameters and bone mineral density in an Iranian referral population.

Osteoporosis is a common health concern in both developed and developing countries. In this study the association between anthropometric measures and osteoporosis was investigated in 3630 males and females visiting BMD clinic of Shariati Hospital, Tehran, Iran, a teaching hospital and referral center for osteoporosis affiliated to the Tehran University of Medical Sciences. Anthropometric measurements obtained and also Bone Mineral Density (BMD) measurement was done using a Lunar DPXMD densitometer. Data were analyzed using SPSS with Chi-square and ANOVA with post-hoc tests. Results showed that the weight, BMI and age had the strongest correlation with the BMD values in the studied people. While age is negatively correlated with BMD in all the studied people, a positive association was noted between weight, height and BMI and BMD parameters (P<0.01). It was concluded that certain anthropometric parameters (BMI and weight) can considerably affect one's risk of developing osteoporosis. Further research on the effect of these variables on the association of weight and BMD is needed.
Early antiretroviral therapy and mortality among HIV-infected infants.

In countries with a high seroprevalence of human immunodeficiency virus type 1 (HIV-1), HIV infection contributes significantly to infant mortality. We investigated antiretroviral-treatment strategies in the Children with HIV Early Antiretroviral Therapy (CHER) trial.



HIV-infected infants 6 to 12 weeks of age with a CD4 lymphocyte percentage (the CD4 percentage) of 25% or more were randomly assigned to receive antiretroviral therapy (lopinavir-ritonavir, zidovudine, and lamivudine) when the CD4 percentage decreased to less than 20% (or 25% if the child was younger than 1 year) or clinical criteria were met (the deferred antiretroviral-therapy group) or to immediate initiation of limited antiretroviral therapy until 1 year of age or 2 years of age (the early antiretroviral-therapy groups). We report the early outcomes for infants who received deferred antiretroviral therapy as compared with early antiretroviral therapy.



At a median age of 7.4 weeks (interquartile range, 6.6 to 8.9) and a CD4 percentage of 35.2% (interquartile range, 29.1 to 41.2), 125 infants were randomly assigned to receive deferred therapy, and 252 infants were randomly assigned to receive early therapy. After a median follow-up of 40 weeks (interquartile range, 24 to 58), antiretroviral therapy was initiated in 66% of infants in the deferred-therapy group. Twenty infants in the deferred-therapy group (16%) died versus 10 infants in the early-therapy groups (4%) (hazard ratio for death, 0.24; 95% confidence interval [CI], 0.11 to 0.51; P<0.001). In 32 infants in the deferred-therapy group (26%) versus 16 infants in the early-therapy groups (6%), disease progressed to Centers for Disease Control and Prevention stage C or severe stage B (hazard ratio for disease progression, 0.25; 95% CI, 0.15 to 0.41; P<0.001). Stavudine was substituted for zidovudine in four infants in the early-therapy groups because of neutropenia in three infants and anemia in one infant; no drugs were permanently discontinued. After a review by the data and safety monitoring board, the deferred-therapy group was modified, and infants in this group were all reassessed for initiation of antiretroviral therapy.



Early HIV diagnosis and early antiretroviral therapy reduced early infant mortality by 76% and HIV progression by 75%.
Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial

To study whether Abacor®, a product based on isolated soy protein with high and standardised levels of isoflavones and cotyledon soy fibres, was more effective in lowering total and LDL cholesterol than placebo. Randomised, placebo-controlled, double-blind, parallel group, single centre study. Primary care in Joensuu, North Karelia, Finland. Subjects were screened from the patient database of the health centre; 30 were randomised to the Abacor® group and 30 subjects to placebo. Eight subjects were withdrawn, six from the active group, two from the placebo group. The preparations were given as two daily liquid supplements in addition to the subjects' regular diets for 6 weeks. Abacor® showed a statistically significant lipid-lowering effect as compared to placebo, although an unexpected reduction was seen in the placebo group. The estimated difference between active treatment and placebo was 0.25 mmol/l (95% CI 0.01, 0.50; P=0.049) for total cholesterol, corresponding to reductions of 8.3 and 5.1%, respectively. The difference in reduction of LDL-cholesterol was 0.27 mmol/l (95% CI 0.06, 0.49; P=0.014) and corresponded to a reduction of 13.2% in the active treatment group, and 8.0% in the placebo group. Abacor® showed a rapid onset of effect, as compared with placebo. During a wash-out period of 4 weeks after treatment, the subjects returned to pre-treatment cholesterol levels. Added to a regular diet, Abacor® significantly reduced LDL-cholesterol and total cholesterol. These beneficial effects occurred within 6 weeks of treatment. Commercial organisation.
Insulin sensitivity and lipid profile in prolactinoma patients before and after normalization of prolactin by dopamine agonist therapy

Hyperprolactinemia has been associated with impaired metabolism, including insulin resistance. However, the metabolic effects of elevated prolactin (PRL) levels are not completely clarified. The aim of this study was to obtain more insights of metabolic consequences in hyperprolactinemia patients. Fourteen consecutive patients, eight women and six men, aged 39.7 (±13.7) years with prolactinomas (median PRL 72  μg/L in men) were included. Anthropometric data and metabolic values were studied before and after 2 and 6 months on DA agonists (Bromocriptine [5.7 (±3.9) mg/day, n = 13] or Cabergoline [0.5 mg/week, n = 1]). Euglycemic hyperinsulinemic clamps were studied in six patients before and after 6 months of treatment. PRL normalized in all patients. Anthropometric data changed only in males with a significant decrease of median body weight (95.6 [80.7–110.1] to 83.4 [77.8–99.1] kg, P = 0.046), waist circumference and fat percentage after 6 months. LDL cholesterol was positively correlated to PRL at diagnosis (r = 0.62, P = 0.025) and decreased within 2 months (3.4 [±0.9] to 2.9 [±0.6] mmol/L, P = 0.003). Insulin, IGFBP-1 and total adiponectin levels did not change. Insulin sensitivity tended to improve after 6 months; M-value from 5.7 (±1.8) to 7.8 (±2.6) mg/kg/min, P = 0.083 and per cent improvement in M-value was correlated to per cent reduction in PRL levels (r = −0.85, P = 0.034). In conclusion, beneficial metabolic changes were seen in prolactinoma patients after treatment with DA agonists, underscoring the importance of an active treatment approach and to consider the metabolic profile in the clinical management of hyperprolactinemia patients.
T-cell vaccination against anti-CD4 autoimmunity in HIV-1 subtypes B and C-infected patients--an extended open trial.

This study is an extended clinical trial of the one initiated and reported in the Journal of Clinical Virology 2004;31S:S48-54. Thirteen HIV-1 patients (eight subtype B and five subtype C) that manifested T-cell autoimmunity to recombinant human CD4 (rCD4) were treated with T-cell vaccine composed of glutaraldehyde-treated autologous anti-CD4 reactive T-cells and compared to historical seven non-vaccinated HIV-1-infected subjects. This study proved to be feasible and safe. Follow-up study revealed that 7/8 subtype B and 2/4 subtype C patients (one has just received the first TCV injection) responded with a persistent increase in their blood CD4 T-cell levels and four subtype B patients manifested decreased anti-CD4 autoimmunity. Despite highly active antiretroviral therapy (HAART), the persistence of CD4 T-cell lymphopenia may be associated with anti-CD4 autoimmunity. T-cell vaccination (TCV) may decrease such autoimmunity and elevate CD4 T-cell numbers.
No difference between strontium ranelate (SR) and calcium/vitamin D on bone turnover markers in women with established osteoporosis previously treated with teriparatide: a randomized controlled trial.

To evaluate the effect of strontium ranelate (SR) on bone turnover markers in women with established osteoporosis previously treated with teriparatide (TPTD--recombinant human PTH 1-34).  Twenty-two postmenopausal Caucasian women (aged 65.7 +/- 1.7 years) with established osteoporosis previously treated with TPTD 20 microg daily for 18 months were randomly assigned to receive either SR (SR group, n = 11) or calcium and vitamin D (control group, n = 11).



Blood samples for serum N-terminal propeptide of type 1 collagen (P1NP), C-terminal telopeptide of type 1 collagen (CTx) and total alkaline phosphatase (ALP) were obtained from all women before (pre-TPTD) and after (post-TPTD) TPTD administration, as well as 6 months after SR or calcium/vitamin D administration (post-SR/Ca).



Serum P1NP, CTx and total ALP increased significantly after TPTD treatment and decreased at the end of the study in both SR and control groups, with no difference between them.



SR following TPTD administration acts predominantly as an antiresorptive agent with no evidence of additional osteoanabolic action. In this setting, SR is not more effective than Ca/vitamin D as far as bone turnover markers are concerned.
Platelet 5-HT uptake sites, labelled with [3H] paroxetine, in controls and depressed patients before and after treatment with fluoxetine or lofepramine

Platelet [3H] paroxetine binding was measured in 73 depressed patients and in 64 healthy volunteers. No differences were found in Bmax or Kd either overall, or when the 61 depressed subjects who had never received psychotropic drugs were analysed separately. Within the depressed group, no differences in Bmax or Kd were found between subgroups divided on the basis of endogenicity, suicidal thoughts or severity of depression. None of the subgroups differed significantly from controls. Forty of the depressed subjects were retested after 6 weeks' treatment with fluoxetine (n=22) or lofepramine (n=18). Treatment was not associated with any change in Bmax but a similar and significant increase in Kd was noted following treatment with either antidepressant. Neither pre- nor post-treatment platelet binding parameters appeared to relate to clinical response to treatment.
Long-term interactive group education for type 1 diabetic patients

The aim of this study was to assess the feasibility and efficacy of an Interactive Educational and Support Group programme (IESG) for patients with type 1 diabetes. A sample of 96 type 1 diabetic outpatients was studied measuring the effects of participation in IEGS on metabolic control and diabetes-related quality of life (QoL). Those refusing to participate (n=48) and a sample of 37 patients who were not invited to IESG (control) where studied for comparison. After one year, participants showed a significant (p<0.05) improvement of HbA1c from 7.7±1.6 to 7.2±1.5%, whereas no variation of HbA1c was observed in non-participants and controls. No significant variation of QoL was observed in any of the three groups. At two-years follow-up, HbA1c of the patients attending IESG was not significantly different from that at one-year follow-up, and it was significantly lower than that observed at enrolment. QoL showed a significant improvement at 2 years with respect to baseline and oneyear follow-up. In conclusion, this programme appears to be effective in the improvement of medium term metabolic control and QoL.
Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial

The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken.



Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week.Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities.The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life.



The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people.
Volume-outcome relationships in pancreatoduodenectomy for cancer.

Volume-outcome relationships in pancreatic surgery are well established, but an optimal volume remains to be determined. Studies analyzing outcomes in volume categories exceeding 20 procedures annually are lacking.



A consecutive 3420 patients underwent PD for primary pancreatic or periampullary carcinoma (2005-2013) and were registered in the Netherlands Cancer Registry. Relationships between hospital volume (< 5, 5-19, 20-39 and ≥ 40 PDs/year) and mortality and survival were explored.



There was a non-significant decrease in 90-day mortality from 8.1 to 6.7% during the study period (p = 0.23). Ninety-day mortality was 9.7% in centers performing < 5 PDs/year (n = 185 patients), 8.9% for 5-19 PDs/year (n = 1432), 7.3% for 20-39 PDs/year (n = 240) and 4.3% for ≥ 40 PDs/year (n = 562, p = 0.004). Within volume categories, 90-day mortality did not change over time. After adjustment for confounding factors, significantly lower mortality was found in the ≥ 40 category compared to 20-39 PDs/year (OR = 1.72 (1.08-2.74)). Overall survival adjusted for confounding factors was better in the ≥ 40 category compared to categories under 20 PDs/year: HR (≥ 40 vs 5-19/year) = 1.24 (1.09-1.42). In the ≥ 40 category significantly more patients received adjuvant chemotherapy and had > 10 lymph nodes retrieved compared to lower volume categories.



Volume-outcome relationships in pancreatic surgery persist in centers performing ≥ 40 PDs annually, regarding both mortality and survival. The volume plateau for pancreatic surgery has yet to be determined.
Dynamosaicing: Mosaicing of Dynamic Scenes

This paper explores the manipulation of time in video editing, which allows us to control the chronological time of events. These time manipulations include slowing down (or postponing) some dynamic events while speeding up (or advancing) others. When a video camera scans a scene, aligning all the events to a single time interval will result in a panoramic movie. Time manipulations are obtained by first constructing an aligned space-time volume from the input video, and then sweeping a continuous 2D slice (time front) through that volume, generating a new sequence of images. For dynamic scenes, aligning the input video frames poses an important challenge. We propose to align dynamic scenes using a new notion of "dynamics constancy," which is more appropriate for this task than the traditional assumption of "brightness constancy." Another challenge is to avoid visual seams inside moving objects and other visual artifacts resulting from sweeping the space-time volumes with time fronts of arbitrary geometry. To avoid such artifacts, we formulate the problem of finding optimal time front geometry as one of finding a minimal cut in a 4D graph, and solve it using max-flow methods.
Effects of Velusetrag (TD-5108) on gastrointestinal transit and bowel function in health and pharmacokinetics in health and constipation.

Velusetrag (TD-5108) is a potent, selective high intrinsic activity serotonin 5-HT(4) receptor agonist. We assessed effects of Velusetrag on gastrointestinal transit and compared its pharmacokinetics in healthy volunteers (HV) and chronic constipation (CC) patients. Sixty HV were randomly assigned, double-blind to placebo, 5, 15, 30 or 50 mg Velusetrag (single and 6-day dosing). Primary endpoints were colonic transit (geometric centre at 24 h, GC24) and ascending colon emptying (ACE) T(1/2) after first dose. Secondary endpoints included gastric emptying (GE) T(1/2) and colonic filling at 6 h (CF6). Single dose Velusetrag significantly accelerated GC24, ACE T(1/2), and CF6; 30 and 50 mg Velusetrag accelerated all three endpoints. With multiple doses, Velusetrag 30 mg accelerated GC24, and overall accelerated GE T(1/2) at 15-50 mg. Pharmacokinetics studies showed dose proportionality in health, and no significant differences between health and chronic constipation with a 15 mg oral dose of Velusetrag. Stimulation of bowel function after15 mg Velusetrag was similar in CC and controls. There were no serious adverse events; notable adverse events were the predictable gastrointestinal effects such as diarrhoea or altered bowel movements. Velusetrag significantly accelerated intestinal and colonic transit after single dosing and accelerated gastric emptying after multiple dosing. Further studies of its potential as a gastrointestinal and colonic prokinetic are warranted.