nils-herrmann/clean_scirepeval huggingface dataset:
Papaya preparation (Caricol®) in digestive disorders.

Papaya (Carica papaya L.) is used as a natural remedy in abnormal digestion in tropical and industrialized countries. Besides this wide distribution little evidence has been produced with reference to its physiological effect in humans and the proof of efficacy. Former clinical observations had revealed positive effects for patients with constipation, heartburn, and symptoms of irritable bowel syndrome (IBS) after eating papaya preparations. In line with these former positive clinical observations, we studied the clinical effects of the papaya preparation Caricol® in a double blind placebo controlled study design.



In this study the participants were volunteers, with chronic (prevailing) indigestions and dysfunctions in the gastrointestinal tract. During the trial the intake of the substance of intent and placebo was 20 ml daily for 40 days. The endpoints were the frequency of 22 symptoms recorded before and after the documented intake recorded by questionnaire.



The symptoms "Constipation", "Bloating", and "Heartburn" were defined as primary and frequency of "painful (straining) bowel movements" as secondary endpoint. The participation ended after the intake period within two days ("early returnees"). Wash out effects were observed in "late returnees", who returned with a delay of 8.6 (±5.95 days). In the verum group early returnees revealed statistically significant improvements of the symptoms "constipation" and "bloating". The analysis of "heartburn" felt short of significant improvement because of the small number of included cases with this criteria (N=13, p=0.114). None of the significant benefits were observed after the washout phase.



We conclude from these results, that the papaya preparation (Caricol®) contributes to the maintenance of digestive tract physiology. It ameliorates various functional disturbances, like symptoms of IBS. The mechanism of this digestive tract physiology support is discussed.
The perception of breast cancers-a spatial frequency analysis of what differentiates missed from reported cancers

The primary detector of breast cancer is the human eye. Radiologists read mammograms by mapping exogenous and endogenous factors, which are based on the image and observer, respectively, into observer-based decisions. These decisions rely on an internal schema that contains a representation of possible malignant and benign findings. Thus, to understand the hits and misses made by the radiologists, it is important to model the interactions between the measurable image-based elements contained in the mammogram and the decisions made. The image-based elements can be of two types, i.e., areas that attracted the visual attention of the radiologist, but did not yield a report, and areas where the radiologist indicated the presence of an abnormal finding. In this way, overt and covert decisions are made when reading a mammogram. In order to model this decision-making process, we use a system that is based upon the processing done by the human visual system, which decomposes the areas under scrutiny in elements of different sizes and orientations. In our system, this decomposition is done using wavelet packets (WPs). Nonlinear features are then extracted from the WP coefficients, and an artificial neural network is trained to recognize the patterns of decisions made by each radiologist. Afterwards, the system is used to predict how the radiologist will respond to visually selected areas in new mammogram cases.
Omega-3 fatty acid monotherapy for pediatric bipolar disorder: A prospective open-label trial

To test the effectiveness and safety of omega-3 fatty acids (Omegabrite(R) brand) in the treatment of pediatric bipolar disorder (BPD).



Subjects (N=20) were outpatients of both sexes, 6 to 17 years of age, with a DSM-IV diagnosis of BPD and Young Mania Rating Scale (YMRS) score of >15 treated over an 8-week period in open-label trial with omega-3 fatty acids 1290 mg-4300 mg combined EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid).



Subjects experienced a statistically significant but modest 8.9+/-2.9 point reduction in the YMRS scores (baseline YMRS=28.9+/-10.1; endpoint YMRS=19.1+/-2.6, p<0.001). Adverse events were few and mild. Red blood cell membrane levels of EPA and DHA increased in treated subjects.



As only 35% of these subjects had a response by the usual accepted criteria of >50% decrease on the YMRS, omega-3 fatty acids treatment was associated with a very modest improvement in manic symptoms in children with BPD.
Prognostic value of the New York Heart Association classification in end-stage renal disease.

The New York Heart Association (NYHA) classification is a strong predictor of mortality and an established instrument for risk stratification in patients with heart disease but data on the validity of this classification in end-stage renal disease (ESRD) are sparse.



In this study, we tested the predictive value of the NYHA in patients with ESRD and compared it with that of two established indexes of disease severity, i.e. the Khan index and the renal disease severity score (RDSS). The study cohort was composed of 1322 incident patients in a dialysis registry (772 male and 550 female, age 61+/-16 years).



During the follow-up period (41+/-27 months) 551 patients died. A multivariate COX model including the NYHA classification explained 39% of the variation in mortality, a figure almost identical to that of a model based on the RDSS (37%) and superior (P<0.001) to that provided by the Khan index-based model (32%). The area under the receiver operating characteristic curve of NYHA classification, as related to all-cause mortality, was 0.74 (95% CI: 0.71-0.77, P<0.001). Again, RDSS had a predictive value for mortality (0.74, 95% CI: 0.72-0.77) identical to that of NYHA and higher than that of the Khan index (0.70, 95% CI: 0.67-0.72).



The NYHA is a powerful predictor of mortality in ESRD and provides prognostic information equal or superior to that given by other established indexes of disease severity. Given the pervasive nature of cardiovascular disease in ESRD, this classification may be recommended for risk stratification in this population.
Vitamin D-related gene polymorphisms do not influence the outcome and serum vitamin D level in pegylated interferon/ribavirin therapy combined with protease inhibitor for patients with genotype 1b chronic hepatitis C.

Although several vitamin D-related gene polymorphisms were reported to affect the outcome of pegylated interferon/ribavirin (PR) therapy in chronic hepatitis C patients, there are no reports on the impact of the vitamin D-related gene polymorphisms in PR therapy combined with protease inhibitor (PI). Vitamin D-related gene polymorphisms were determined in 177 genotype 1b-infected chronic hepatitis C patients who received 12 weeks of PR therapy with telaprevir, a first-generation PI, followed by 12 weeks of PR therapy. The sustained virologic response (SVR) rate was 83.1% (147 of 177 patients). The frequencies of vitamin D-related gene polymorphisms were: 83 non-TT and 94 TT genotypes for GC, 97 non-AA and 80 AA genotypes for DHCR7, 151 non-AA and 26 AA genotypes for CYP2R1, 162 non-GG and 15 GG genotypes for CYP27B1, and 105 non-GG and 72 GG genotypes for VDR gene. Multivariate analysis extracted IL28B TT genotype (P = 2.05 × 10(-6)) and serum 25(OH) D3 level (P = 0.024) as independent factors contributing to the achieving of SVR. The SVR rate in IL28B TT genotype patients with serum 25(OH) D3 level of < 25 ng/ml was significantly low compared to other patients. None of the vitamin D-related gene polymorphisms affected the treatment outcome and serum 25(OH) D3 level. In conclusions, the IL28B polymorphism and serum 25(OH) D3 level contributed significantly and independently to SVR in PR combined with PI for genotype 1b-infected chronic hepatitis C patients. However, none of vitamin D-related gene polymorphisms had an impact on the treatment outcome and serum 25(OH) D3 level.
A randomized controlled trial of chair interventions on back and hip pain among sewing machine operators: the los angeles garment study.

Determine whether an adjustable chair with a curved or a flat seat pan improved monthly back and hip pain scores in sewing machine operators.



This 4-month intervention study randomized 293 sewing machine operators with back and hip pain. The participants in the control group received a placebo intervention, and participants in the intervention groups received the placebo intervention and one of the two intervention chairs.



Compared with the control group, mean pain improvement for the flat chair intervention was 0.43 points (95% CI = 0.34, 0.51) per month, and mean pain improvement for the curved chair intervention was 0.25 points (95% CI = 0.16, 0.34) per month.



A height-adjustable task chair with a swivel function can reduce back and hip pain in sewing machine operators. The findings may be relevant to workers who perform visual- and hand-intensive manufacturing jobs.
Utilization and cost impact of integrating substance abuse treatment and primary care.

To examine the impact of integrating medical and substance abuse treatment on health care utilization and cost.



Randomized clinical trial assigning patients to one of two treatment modalities: an Integrated Care model where primary health care is provided along with substance abuse treatment within the unit and an Independent Care model where medical care is provided in the HMO's primary care clinics independently from substance abuse treatment.



Adult patients entering treatment at the outpatient Chemical Dependency Recovery Program in Kaiser Sacramento.



Medical utilization and cost for 12 months pretreatment and 12 months after treatment entry.



For the full, randomized cohort, there were no statistically significant differences between the two treatment groups over time. However, among the subset of patients with substance abuse related medical conditions (SAMC), Integrated Care patients had significant decreases in hospitalization rates (P = 0.04), inpatient days (P = 0.05) and ER use (P = 0.02). Total medical costs per member-month declined from 431.12 US dollars to 200.03 US dollars (P = 0.02). Among SAMC Independent Care patients, there was a downward trend in inpatient days (P = 0.08) and ER costs (P = 0.05) but no statistically significant decrease in total medical cost.



(Non)findings for the full sample suggest that integrating substance abuse treatment with primary care, may not be necessary or appropriate for all patients. However, it may be beneficial to refer patients with substance abuse related medical conditions to a provider also trained in addiction medicine. There appear to be large cost impacts of providing integrated care for such patients.
A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia.

The effectiveness and safety of yokukansan (TJ-54), a traditional Japanese medicine (kampo) for the treatment of the behavioural and psychological symptoms of dementia (BPSD), were evaluated in 106 patients diagnosed as having Alzheimer's disease (AD) (including mixed-type dementia) or dementia with Lewy bodies. Patients were randomly assigned to group A (TJ-54 treatment in period I and no treatment in period II; each period lasting 4 wk) or group B (no treatment in period I and TJ-54 treatment in period II). BPSD and cognitive functions were evaluated using the Neuropsychiatric Inventory (NPI) and the Mini-Mental State Examination (MMSE), respectively. Activities of daily living (ADL) were evaluated using Instrumental Activities of Daily Living (IADL) in outpatients and the Barthel Index in in-patients. For the safety evaluation, adverse events were investigated. Significant improvements in mean total NPI score associated with TJ-54 treatment were observed in both periods (Wilcoxon test, p=0.040 in period I and p=0.048 in period II). The mean NPI scores significantly improved during TJ-54 treatment in groups A and B (p=0.002 and p=0.007, respectively) but not during periods of no treatment. Among the NPI subscales, significant improvements were observed in delusions, hallucinations, agitation/aggression, depression, anxiety, and irritability/lability. The effects of TJ-54 persisted for 1 month without any psychological withdrawal symptoms in group A. TJ-54 did not show any effect on either cognitive function or ADL. No serious adverse reactions were observed. The present study suggests that TJ-54 is an effective and well-tolerated treatment for patients with BPSD.
Predicting successful 24-hr quit attempt in a smoking cessation intervention.

The factors that influence the initial phase of quitting smoking have been understudied. Although maintenance of change is the ultimate test of the efficacy of treatment, maintenance is a nonissue for those who fail to manage even brief periods of abstinence. We examined factors associated with smokers' ability to achieve a targeted 24-hr quit during a smoking cessation program. As a comparison, we also examine whether predictors of an initial quit are different from factors that predict smoking abstinence at 52-week follow-up.



Using baseline data from a randomized clinical trial to examine the efficacy of selegiline for cigarette smoking cessation (n = 280), we conducted univariate analyses (analysis of variance or chi-square) to determine statistically significant predictors of a successful quit attempt (SQA) versus unsuccessful quit attempt. Multiple logistic regression was performed with significant predictors from the univariate analyses to determine main effects and interactions in a multivariate model. The same factors and analyses were used to examine predictors of 52-week point prevalence abstinence.



Lower nicotine dependence (modified Fagerström Tolerance Questionnaire [mFTQ]), higher Behavioral Inhibition System score, and lower baseline heart rate were predictive of SQA in both the univariate and the multivariate models. Gender was the only predictor of 52-week smoking abstinence.



Predictors of initial induction of change were not predictors of abstinence at the 1-year follow-up, suggesting that different factors mediate the different subprocesses of behavior change. Knowledge of these pretreatment factors that moderate a SQA could help clinicians target smokers who need more intensive therapy during the initial induction of cessation.
Dietary folate, alcohol and B vitamins in relation to LINE-1 hypomethylation in colon cancer.

Although critical for methylation reactions, how dietary folate and B vitamins affect global DNA methylation level in colorectal cancers is currently unknown. Long interspersed nucleotide element-1 (LINE-1) is an emerging indicator of genome-wide DNA methylation level that has previously been linked to colon cancer survival.



We examined the association between dietary intake of folate, alcohol and B vitamins and LINE-1 hypomethylation in 609 incident colon cancers, utilising the database of two independent prospective cohort studies.



Participants with > or = 400 microg folate intake per day were significantly less likely to develop LINE-1 hypomethylated colon cancers than those reporting <200 microg of folate intake per day (RR=0.57, 95% CI=0.36 to 0.91 for <55% LINE-1 methylated colon tumours; RR=0.74, 95% CI=0.51 to 1.06 for 55-64% LINE-1 methylated colon tumours; and RR=1.08, 95% CI=0.66 to 1.75 for > or = 65% LINE-1 methylated tumours; P(interaction)=0.01). By contrast, high alcohol consumption conferred a higher risk of LINE-1 hypomethylated cancers (> or = 15 g alcohol per day versus none, RR=1.67, 95% CI=1.04 to 2.67 for <55% LINE1 methylated tumours; and RR=1.55, 95% CI=1.10 to 2.18 for 55-64% LINE-1 methylated tumours) but had no association with > or = 65% LINE-1 methylated tumours (RR=1.06, 95% CI=0.69 to 1.62). High intakes of vitamin B(6), B(12) or methionine were not significantly associated with colon cancers, regardless of LINE-1 methylation level.



The influence of dietary folate intake and alcohol consumption on colon cancer risk differs significantly according to tumoral LINE-1 methylation level.
Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial

The project proposes three innovative intervention techniques (treadmill training, mobility training with virtual reality and transcranial direct current stimulation that can be safely administered to children with cerebral palsy. The combination of transcranial stimulation and physical therapy resources will provide the training of a specific task with multiple rhythmic repetitions of the phases of the gait cycle, providing rich sensory stimuli with a modified excitability threshold of the primary motor cortex to enhance local synaptic efficacy and potentiate motor learning.



A prospective, double-blind, randomized, controlled, analytical, clinical trial will be carried out.Eligible participants will be children with cerebral palsy classified on levels I, II and III of the Gross Motor Function Classification System between four and ten years of age. The participants will be randomly allocated to four groups: 1) gait training on a treadmill with placebo transcranial stimulation; 2) gait training on a treadmill with active transcranial stimulation; 3) mobility training with virtual reality and placebo transcranial stimulation; 4) mobility training with virtual reality and active transcranial stimulation. Transcranial direct current stimulation will be applied with the anodal electrode positioned in the region of the dominant hemisphere over C3, corresponding to the primary motor cortex, and the cathode positioned in the supraorbital region contralateral to the anode. A 1 mA current will be applied for 20 minutes. Treadmill training and mobility training with virtual reality will be performed in 30-minute sessions five times a week for two weeks (total of 10 sessions). Evaluations will be performed on four occasions: one week prior to the intervention; one week following the intervention; one month after the end of the intervention;and 3 months after the end of the intervention. The evaluations will involve three-dimensional gait analysis, analysis of cortex excitability (motor threshold and motor evoked potential), Six-Minute Walk Test, Timed Up-and-Go Test, Pediatric Evaluation Disability Inventory, Gross Motor Function Measure, Berg Balance Scale, stabilometry, maximum respiratory pressure and an effort test.



This paper offers a detailed description of a prospective, double-blind, randomized, controlled, analytical, clinical trial aimed at demonstrating the effect combining transcranial stimulation with treadmill and mobility training on functionality and primary cortex excitability in children with Cerebral Palsy classified on Gross Motor Function Classification System levels I, II and III. The results will be published and will contribute to evidence regarding the use of treadmill training on this population.
A pre-seasonal birch/hazel sublingual immunotherapy can improve the outcome of grass pollen injective treatment in bisensitized individuals. A case-referent, two-year controlled study.

The study tests the hypothesis of a reduction of priming due to tree allergy in patients sensitised to both birch/hazel and grass pollen undergoing an associated preseasonal Sublingual/Injective immunotherapy.



36 out of 49 bisensitized candidates were pair-matched into 18 case-referent couples. During two years all patients were administered preseasonal grass-SIT and one patient in each couple received also birch/hazel-SLIT. Diary cards were fulfilled for three consecutive grass pollen seasons. Specific Nasal Provocation Test (NPT) for grass and aspecific bronchial challenge were done; sera were analyzed for specific IgE and IgG.



During the peak of the grass pollen season both groups showed a significant improvement in total symptom-score. Conjunctivitis and cough improved significantly more in patients with associated therapies. While antihistamine score decreased significantly in both groups, antiasthmatics did only in the SLIT-SIT group. The follow-up documented a significant increase in grass- and birch-specific IgG and a decrease in grass-specific IgE. Grass-NPT threshold was clearly higher in SLIT-SIT-group (p = 0.01) and only in this group PD20 methacholine improved significantly (p < 0.05).



Combined birch/hazel-SLIT and grass-SIT are safe and improve clinical outcomes of SIT alone in young bisensitized patients. Priming reduction is supported by specific NPT and bronchial hyperresponsiveness.
Phase I trial of weekly topotecan and gemcitabine in patients with solid tumors.

This phase I trial was designed to determine the maximal tolerated dose (MTD) of the combination of topotecan and gemcitabine given in a weekly schedule.



In this single-arm, open label, dose-escalation study, we administered topotecan (0.75-1.5 mg/m) and gemcitabine (1000 mg/m) on days 1, 8, and 15 every 4 weeks to 25 patients with advanced solid tumors.



The topotecan MTD, when combined with gemcitabine, was 1.25 mg/m/wk. Dose-limiting toxicities consisted of febrile granulocytopenia in 2 patients at the highest dose level. At the MTD, no episodes of granulocytopenia were observed, whereas 2/9 patients exhibited grade 3 thrombocytopenia. Other common grades 3-4 adverse events across all cohorts included non-neutropenic infections, fatigue, skin reactions, vomiting, and fever. One partial response and 2 stable diseases were observed in patients with nasopharyngeal carcinoma. Disease stabilization was also observed in patients with squamous cell carcinoma of the head and neck (3), nonsmall cell lung cancer (1), and thymoma (1).



Topotecan and gemcitabine combined in a weekly schedule exhibit a favorable toxicity profile. Efficacy results support the further evaluation of this regimen in patients with head and neck cancer (particularly nasopharyngeal carcinoma).