nils-herrmann/clean_scirepeval huggingface dataset:
Consumption of Lactobacillus acidophilus and Bifidobacterium longum do not alter urinary equol excretion and plasma reproductive hormones in premenopausal women

To confirm the results of an earlier study showing premenopausal equol excretors to have hormone profiles associated with reduced breast cancer risk, and to investigate whether equol excretion status and plasma hormone concentrations can be influenced by consumption of probiotics. A randomized, single-blinded, placebo-controlled, parallel-arm trial.Subjects: In all, 34 of the initially enrolled 37 subjects completed all requirements. All subjects were followed for two full menstrual cycles and the first seven days of a third cycle. During menstrual cycle 1, plasma concentrations of estradiol (E2), estrone (E1), estrone-sulfate (E1-S), testosterone (T), androstenedione (A), dehydroepiandrosterone-sulfate (DHEA-S), and sex-hormone-binding globulin (SHBG) were measured on cycle day 2, 3, or 4, and urinary equol measured on day 7 after a 4-day soy challenge. Subjects then received either probiotic capsules (containing Lactobacillus acidophilus and Bifidobacterium longum) or placebo capsules through day 7 of menstrual cycle 3, at which time both the plasma hormone concentrations and the post-soy challenge urinary equol measurements were repeated. During menstrual cycle 1, equol excretors and non-excretors were not significantly different with respect to subject characteristics, diet, or hormone concentrations. Significant inverse correlations were found between E2 and body mass index (BMI) (P=0.02), SHBG and BMI (P=0.01), DHEA-S and dietary fiber (P=0.04), and A and protein:carbohydrate ratio (P=0.02). Probiotic consumption failed to significantly alter equol excretor status or hormone concentrations during menstrual cycle 3, although there were trends towards decreased concentrations of T (P=0.14) and SHBG (P=0.10) in the probiotic group. We were unable to verify a previously reported finding of premenopausal equol excretors having plasma hormone concentrations different from those of nonexcretors. Furthermore, a 2-month intervention with probiotic capsules did not significantly alter equol excretion or plasma hormone concentrations.
Quality of care for acute asthma in emergency departments in Japan: a multicenter observational study.

Little is known about the quality of acute asthma care in emergency departments (EDs) outside of North America.



We evaluated concordance of acute asthma management in Japanese EDs with recommendations in the 2007 National Institutes of Health asthma guidelines and investigated whether guideline concordance was associated with risk of hospital admission.



We conducted a multicenter chart review study in 23 EDs across Japan. We identified ED patients aged 18 to 54 years with acute asthma between 2009 and 2011. Concordance with evidence-based guideline recommendations was evaluated by using item-by-item quality measures and composite concordance scores both at patient and ED levels. These scores ranged from 0 to 100.



Among 1380 patients, the median age was 35 years and 11% were hospitalized. Overall guideline concordance score was suboptimal both at the patient level (mean ± SD, 72 ± 14) and ED level (mean ± SD, 72 ± 6). Specifically, asthma care at the patient level was suboptimal in several areas: inhaled anticholinergics in ED (2%), systemic corticosteroid in ED (56%) and at discharge (36%), and peak flow assessment (9%). A multivariable model that adjusted for severity at presentation and several ED characteristics showed that higher guideline concordance was associated with significantly lower risk of hospital admission (odds ratio, 0.70 per 10-unit increase in composite score; 95% CI, 0.62-0.79 per 10-unit increase in composite score).



The management of acute asthma in Japanese EDs is suboptimal. Greater concordance with guideline-recommended management might reduce unnecessary hospitalizations. Knowledge translation initiatives are warranted to increase adherence with best practice in acute asthma management.
Serum interleukin 6 and interleukin 12 levels in children with chronic hepatitis HBV treated with interferon alpha.

The course of HBV infection and the outcome of interferon alpha (IFNalpha) therapy of patients with chronic hepatitis B, is determined by the antiviral immune response of the host. The aim of the study was to investigate 1) the correlation between IL-6 and IL-12 serum levels and biochemical and histopathological changes in children with chronic hepatitis B, 2) predictive value of pre-treatment serum levels of these cytokines in patients treated with interferon alpha and 3) changes in serum levels of these cytokines after interferon alpha treatment.



Serum levels of IL-6, IL-12 (heterodimer p70) and IL-12 (heterodimer p70 & p40 subunit) were determined by specific ELISA in 39 children with chronic hepatitis B on the first and the last day of IFNalpha therapy.



Serum levels of IL-6, IL-12 (p70) and IL-12 (p70&p40) were respectively within the following ranges of values: 0-1.7 pg/mL, 3.0-85.1pg/mL, 93.7-442.7 pg/mL and they showed no correlation with biochemical and histopathological changes. The pre-treatment cytokines levels in patients who responded and those who did not respond to IFNa therapy did not differ statistically. There was no statistical difference between the end and pre-treatment cytokines levels in both groups.



Serum levels of IL-6 and IL-12 do not reflect the inflammatory activity of hepatitis and have no predictive value of positive response to the IFNalpha therapy in children with chronic hepatitis B. Serum IL-6 and IL-12 levels at the end of INFalpha treatment do not inform of their role in immunological changes which take place while inhibition of HBV replication or virus clearance.
The effect of an aloe polymannose multinutrient complex on cognitive and immune functioning in Alzheimer's disease.

Alzheimer's disease (AD) is a leading killer of Americans, imparts a significant toll on the quality of life of the patient and primary caregiver, and results in inordinate costs in an already overburdened medical system. Prior studies on cholinesterase inhibitors among AD patients have shown minimal amelioration of disease symptoms and/or restoration of lost cognitive functioning. The effect of improved nutrition, particularly with dietary supplements, on cognitive functioning may offer an alternative strategy compared to standard treatment. The present pilot study investigated the effect of an aloe polymannose multinutrient complex (APMC) formula on cognitive and immune functioning over 12 months among adults diagnosed with AD. Subjects participated in an open-label trial and consumed 4 teaspoons per day of the APMC. The ADAS-cog, MMSE, ADCS-ADL, and SIB were administered at baseline and 3, 6, 9, and 12 months follow-up. Cytokines and lymphocyte and monocyte subsets were assessed at baseline and 12 months. The mean ADAS-cog cognition score significantly improved at 9 and 12 months from baseline, and 46% of our sample showed clinically-significant improvement (≥4-point change) from baseline to 12 months. Participants showed significant decreases in tumor necrosis factor-α, vascular endothelial growth factor, and interleukins-2 and-4. CD90+, CD95+CD3+, CD95+CD34+, CD95+CD90+, CD14+CD34+, CD14+CD90+, and CD14+CD95+ decreased significantly, whereas CD14+ significantly increased. Participants tolerated the APMC supplement with few, temporary adverse reactions. Our results showed improvements in both clinical and physiological outcomes for a disease that otherwise has no standard ameliorative remedy.
The effect of dietary glutamate on fibromyalgia and irritable bowel symptoms.

To examine the effects of a challenge with monosodium glutamate (MSG) as compared to placebo on the symptoms of fibromyalgia (FM), in participants who initially experienced >30% remission of symptoms on an excitotoxin elimination diet.



Fifty-seven FM patients who also had irritable bowel syndrome (IBS) were placed on a 4-week diet that excluded dietary additive excitotoxins including MSG and aspartame. Thirty-seven people completed the diet and 84% of those reported that >30% of their symptoms resolved, thus making them eligible to proceed to challenges. Subjects who improved on the diet were then randomised to a 2-week double-blind placebo-controlled crossover challenge with MSG or placebo for 3 consecutive days each week. The primary outcome measure was total symptom score. Secondary outcome measures included visual analogue pain scales (VAS for FM and IBS), an IBS Quality of Life Questionnaire (IBS QOL) and the Fibromyalgia Impact Questionnaire-Revised (FIQR). Repeated measures ANOVA was used to analyse crossover challenge results.



The MSG challenge, as compared to placebo, resulted in a significant return of symptoms (total symptom score, p<0.02); a worsening of fibromyalgia severity as determined by the FIQR (p<0.03); decreased quality of life in regards to IBS symptoms (IBS QOL, p<0.05); and a non-significant trend toward worsening FM pain based on visual analogue scale (VAS, p<0.07).



These findings suggest that dietary glutamate may be contributing to FM symptoms in some patients. Future research on the role of dietary excitotoxins in FM is warranted.
Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial.

Randomized clinical trial.



To compare the short-term effects of upper cervical and upper thoracic high-velocity low-amplitude (HVLA) thrust manipulation to nonthrust mobilization in patients with neck pain.



Although upper cervical and upper thoracic HVLA thrust manipulation and nonthrust mobilization are common interventions for the management of neck pain, no studies have directly compared the effects of both upper cervical and upper thoracic HVLA thrust manipulation to nonthrust mobilization in patients with neck pain.



Patients completed the Neck Disability Index, the numeric pain rating scale, the flexion-rotation test for measurement of C1-2 passive rotation range of motion, and the craniocervical flexion test for measurement of deep cervical flexor motor performance. Following the baseline evaluation, patients were randomized to receive either HVLA thrust manipulation or nonthrust mobilization to the upper cervical (C1-2) and upper thoracic (T1-2) spines. Patients were reexamined 48-hours after the initial examination and again completed the outcome measures. The effects of treatment on disability, pain, C1-2 passive rotation range of motion, and motor performance of the deep cervical flexors were examined with a 2-by-2 mixed-model analysis of variance (ANOVA).



One hundred seven patients satisfied the eligibility criteria, agreed to participate, and were randomized into the HVLA thrust manipulation (n = 56) and nonthrust mobilization (n = 51) groups. The 2-by-2 ANOVA demonstrated that patients with mechanical neck pain who received the combination of upper cervical and upper thoracic HVLA thrust manipulation experienced significantly (P<.001) greater reductions in disability (50.5%) and pain (58.5%) than those of the nonthrust mobilization group (12.8% and 12.6%, respectively) following treatment. In addition, the HVLA thrust manipulation group had significantly (P<.001) greater improvement in both passive C1-2 rotation range of motion and motor performance of the deep cervical flexor muscles as compared to the group that received nonthrust mobilization. The number needed to treat to avoid an unsuccessful outcome was 1.8 and 2.3 at 48-hour follow-up, using the global rating of change and Neck Disability Index cut scores, respectively.



The combination of upper cervical and upper thoracic HVLA thrust manipulation is appreciably more effective in the short term than nonthrust mobilization in patients with mechanical neck pain.
Recruitment of American Indians in epidemiologic research: the Strong Heart Study.

This paper describes the methods used to recruit American Indian (AI) populations for the Strong Heart Study (SHS), a community-based study of cardiovascular disease (CVD) and its risk factors in AI men and women. Recruitment strategies included personal contact by recruiters and drivers/recruiters in remote areas, SHS staff participation in community activities, and mass media. A total of 4,549 participants aged 45-74 years were recruited from 13 American Indian tribes and communities. Overall participation rates were 72&percnt, 55&percnt, and 62&percnt, respectively, for the three study centers (Arizona, the Dakotas, and Oklahoma). Participant feedback and educational material related to risk factor reduction and promoting a healthy lifestyle were emphasized. Participants were likely to be female, young, and nonsmokers. Barriers to recruitment included lack of telephones in a large proportion of households, conflicting beliefs about health/health care/research, fears, taboos, and occasional rumors about study examination procedures. Participants were referred for follow-up of health problems detected by the study. The strong commitment of the participating communities helped to insure the success of the SHS, which can be considered a model for recruitment in future American Indian population-based studies. Success was facilitated by the use of a variety of recruitment techniques.
Non-overlapping Distributed Tracking using Particle Filter

Tracking people or objects across multiple cameras is a challenging research area in visual computing especially when these cameras have non-overlapping field-of-views. The important task is to associate a target of interest with its previous appearances across time and space within the camera network. In this paper, we propose a unified tracking framework using particle filter to efficiently switch between track prediction (to deal with non-overlapping region tracking) and visual tracking. The particle filter tracking system uses a map to provide the possible trajectory information of the target as it moves within the non-overlapping regions. We implemented and tested this tracking approach in an in-house multiple cameras system. Promising results were obtained which suggested the feasibility of such an approach
Initial safety report on the tolerability of modified FOLFOX6 as adjuvant therapy in patients with curatively resected stage II or III colon cancer (JFMC41-1001-C2: JOIN trial)

Adjuvant FOLFOX is a widely accepted standard therapy for resected colon cancer. The incidence of grade 3–4 peripheral sensory neuropathy (PSN) was 12.4 and 5.7 % in the MOSAIC and Eastern MASCOT trials, while that of grade 3–4 allergic reactions (AR) was 2.9 and 3.1 %, respectively. The JFMC41-1001-C2 trial (JOIN trial) investigated the tolerability of modified FOLFOX6 (mFOLFOX6) in Japanese colon cancer patients. Twelve cycles of mFOLFOX6 were given to patients with the same eligibility criteria as in the MOSAIC study: stage II or III curatively resected colon cancer, performance status of 0–1, aged 20 years or older, starting mFOLFOX6 within 7 weeks of surgery, and adequate organ function. The primary endpoints were the incidence of PSN persisting for ≥8 days that interfered with daily activities and the incidence of grade 3–4 AR. The target sample size was 800. From November 2010 to March 2012, 882 patients were enrolled at 198 institutions. Safety was analyzed in 828 patients with finalized data out of 848 patients receiving mFOLFOX6. The incidence of PSN persisting ≥8 days was 3.3 % [95 % confidence interval (CI) 2.2–4.7], while that of grade 3–4 AR was 1.7 % (95 % CI 0.9–2.8). The treatment completion rate was 67.0 %. The median total dosage of oxaliplatin was 811.1 mg/m2. The overall incidence of grade 3–4 PSN was 5.8 %. Interstitial pneumonitis occurred in one patient. There were no treatment-related deaths. Adjuvant mFOLFOX6 is tolerable for Japanese patients with colon cancer.
Granulocyte-macrophage colony-stimulating factor (GM-CSF): what role in bone marrow transplantation?

Infection during the period of bone marrow aplasia remains one of the major risks associated with high-dose chemotherapy and transplantation. Over the past several years, a number of investigators in Europe and North America have evaluated the use of GM-CSF in the setting of autologous bone marrow transplantation. These studies have almost all shown a hastening of myeloid engraftment. This, for the most part, has led to fewer serious infections and a decreased hospital stay for the GM-CSF treated patients. An overall survival advantage has not been noted. There has also not been any consistent multi-lineage effect. Future trials with combinations of sequentially used cytokines may lead to more rapid recovery of red blood cells and platelets in addition to granulocytes. Infektionen in der Phase der Knochenmarkaplasie nach Hochdosis-Chemotherapie und Knochenmarktransplantation stellen nach wie vor eine große Gefahr dar. Der Einsatz von GM-CSF bei autologer Knochenmarktransplantation wurde in den vergangenen Jahren von mehreren Forschungsgruppen in Europa und Nordamerika erprobt. In fast allen Studien wurde eine Beschleunigung des Knochenmark-Engraftment beobachtet. Bei den meisten mit GM-CSF behandelten Patienten war dies mit einer Reduktion schwerer Infektionen und Verkürzung des Krankenhausaufenthaltes verbunden. Doch war insgesamt keine Lebensverlängerung nachzuweisen. Eine Beeinflussung multipler Zellinien konnte nicht konstant festgestellt werden. Eine raschere Erholung der Erythrozyten und Thrombozyten und nicht nur der Granulozyten wird mit der sequentiellen Anwendung kombinierter Zytokine erwartet, die in zukünftigen Studien geprüft werden sollen.
Treatment of Intractable Non-Rapid Cycling Bipolar Affective Disorder with High-Dose Thyroxine: An Open Clinical Trial

Six patients with very severe forms of non-rapid cycling bipolar affective illness whose symptoms had previously been refractory to all current antidepressant and/or prophylactic medications were treated with supraphysiological doses of thyroxine (250 to 500 µg/day) as an adjuvant to their previous medications. The mean follow-up period was 27.8 ± 12.8 months (range 12 to 46). The mean number of relapses during the follow-up period of each patient declined from 5.3 ± 3.1 to 0.8 ± 0.8 and the mean duration of hospitalization from 10.0 ± 5.6 to 0.8 ± 2.2 months as compared to the same length of time for each patient before the start of treatment with high-dose thyroxine (T4). Three of the patients had no further relapses at all. Thus, for these patients, who had previously been severely ill and therapy-resistant, high-dose T4 administration proved to have excellent effects on the course of the illness. However, in five of these patients the effect of the T4 was strong enough only when it was administered in combination with a prophylactic and antidepressant and/or neuroleptic drug, of which in some cases high doses were also needed. The side effects were negligible. Mechanisms that may possibly underlie the beneficial effects of high-dose T4 in bipolar affective disorder are discussed.
Phase 1 study to identify tumour hypoxia in patients with head and neck cancer using technetium-99m BRU 59-21

The aim of this study was to assess the safety and biodistribution of technetium-99m BRU 59-21, a novel radioactively labelled 2-nitro-imidazole hypoxic marker, in head and neck cancer patients and to correlate uptake with pimonidazole staining. 99mTc-BRU 59-21 was administered intravenously (mean dose 824 MBq, range 780–857 MBq) to ten head and neck cancer patients scheduled for primary surgery, and whole-body images and SPET scans were then obtained. Uptake of radioactivity in the regions of interest was determined and tumour to normal tissue ratios were calculated after correlative evaluation with MRI/CT. Twelve to 16 h before surgery (up to 2 weeks after the scan), patients received pimonidazole intravenously. Tumour sections were stained immunohistochemically for pimonidazole binding. No serious adverse events were reported. In five patients there were ten adverse events, which were mild in intensity and resolved completely without intervention. Uptake of 99mTc-BRU 59-21 was observed in eight of the ten primary tumours. Tumour to normal tissue ratios on the SPET scans for primary tumour and lymph nodes increased from 1.8 (range 0.9–2.7) to 2.1 (range 0.8–3.7) between 30 min and 3 h post injection. Tumour to normal tissue ratios in the primary tumour were significantly correlated with pimonidazole staining for SPET scans performed 30 min and 3 h post injection (P=0.016 and P=0.037, respectively). When primary tumour and involved lymph nodes were considered in conjunction, correlation between the tumour to normal tissue ratio and pimonidazole staining was observed for early (P<0.001) but not for late SPET scans (P=0.076). However, late scans showed better tumour delineation than early scans. Administration of 99mTc-BRU 59-21 in head and neck cancer patients appears to be safe and feasible. Uptake and retention in tumour tissue was observed, suggestive of tumour hypoxia, and this was supported by correlations with staining for the hypoxic marker pimonidazole.
Inflammatory phenotypes underlying uncontrolled childhood asthma despite inhaled corticosteroid treatment: rationale and design of the PACMAN2 study

The diagnosis of childhood asthma covers a broad spectrum of pathological mechanisms that can lead to similarly presenting clinical symptoms, but may nonetheless require different treatment approaches. Distinct underlying inflammatory patterns are thought to influence responsiveness to standard asthma medication.



The purpose of the PACMAN2 study is to identify inflammatory phenotypes that can discriminate uncontrolled childhood asthma from controlled childhood asthma by measures in peripheral blood and exhaled air. PACMAN2 is a nested, case-control follow-up study to the ongoing pharmacy-based "Pharmacogenetics of Asthma medication in Children: Medication with Anti-inflammatory effects" (PACMAN) study. The original PACMAN cohort consists of children aged 4-12 years with reported use of asthma medication. The PACMAN2 study will be conducted within the larger PACMAN cohort, and will focus on detailed phenotyping of a subset of the PACMAN children. The selected participants will be invited to a follow-up visit in a clinical setting at least six months after their baseline visit based on their adherence to usage of inhaled corticosteroids, their asthma symptoms in the past year, and their age (≥ 8 years). During the follow-up visit, current and long-term asthma symptoms, medication use, environmental factors, medication adherence and levels of exhaled nitric oxide will be reassessed. The following measures will also be examined: pulmonary function, exhaled volatile organic compounds, as well as inflammatory markers in peripheral blood and blood plasma. Comparative analysis and cluster-analyses will be used to identify markers that differentiate children with uncontrolled asthma despite their use of inhaled corticosteroids (ICS) (cases) from children whose asthma is controlled by the use of ICS (controls).



Asthmatic children with distinct inflammatory phenotypes may respond differently to anti-inflammatory therapy. Therefore, by identifying inflammatory phenotypes in children with the PACMAN2 study, we may greatly impact future personalised treatment strategies, uncover new leads for therapeutic targets and improve the design of future clinical studies in the assessment of the efficacy of novel therapeutics.