nils-herrmann/clean_scirepeval huggingface dataset:
Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up.

To compare the effectiveness of manipulative therapy, physiotherapy, treatment by the general practitioner, and placebo therapy in patients with persistent non-specific back and neck complaints.



Randomised clinical trial.



Primary health care in the Netherlands.



256 patients with non-specific back and neck complaints of at least six weeks' duration who had not received physiotherapy or manipulative therapy in the past two years.



At the discretion of the manipulative therapists, physiotherapists, and general practitioners. Physiotherapy consisted of exercises, massage, and physical therapy (heat, electrotherapy, ultrasound, shortwave diathermy). Manipulative therapy consisted of manipulation and mobilisation of the spine. Treatment by general practitioners consisted of drugs (for example, analgesics), advice about posture, home exercises, and (bed)rest. Placebo treatment consisted of detuned shortwave diathermy (10 minutes) and detuned ultrasound (10 minutes).



Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients.



Many patients in the general practitioner and placebo groups received other treatment during follow up. Improvement in the main complaint was larger with manipulative therapy (4.5) than with physiotherapy (3.8) after 12 months' follow up (difference 0.9; 95% confidence interval 0.1 to 1.7). Manipulative therapy also gave larger improvements in physical functioning (difference 0.6; -0.1 to 1.3). The global perceived effect after six and 12 months' follow up was similar for both treatments.



Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment. Furthermore, manipulative therapy is slightly better than physiotherapy after 12 months.
The effect of royal jelly on oral mucositis in patients undergoing radiotherapy and chemotherapy.

This study was conducted to evaluate the effect of royal jelly on oral mucositis in patients undergoing radiotherapy and chemotherapy. The study population consisted of 103 patients undergoing radiotherapy and chemotherapy. Oral mucositis was graded according to the World Health Organization criteria, and patients were divided into 2 groups. All patients received mouthwash therapy with benzydamine hydrochloride and nystatin rinses. In addition, patients in the experimental group received royal jelly. The mean resolution time of oral mucositis in the royal jelly group was significantly shorter than that of the control group. As a result, the study results demonstrate that royal jelly administrated by a certain procedure improved the signs and symptoms of oral mucositis and markedly shortened its healing time.
Transcranial direct current stimulation for treatment of freezing of gait: a cross-over study.

Progression of Parkinson's disease (PD) is frequently characterized by the occurrence of freezing of gait (FOG) representing a disabling motor complication. We aim to investigate safety and efficacy of transcranial direct current stimulation of the primary motor cortex of PD patients with FOG.



In this cross-over, double-blind, sham-controlled study, 10 PD patients with FOG persisting in "on" state underwent anodal and sham direct current stimulation for 5 consecutive days. Clinical assessment over a 1-month period was performed.



A significant improvement of gait, as assessed by the Stand Walk Sit test, with reduction in number and duration of FOG episodes, along with a significant reduction in the Unified Parkinson's Disease Rating Scale score, were observed after anodal stimulation. Beneficial effects were more evident after the entire 5-day stimulation session, and persisted until the end of the observation period.



Anodal transcranial direct current stimulation of the motor cortex is safe and has therapeutic potential in PD patients with FOG.
Effects of nutritional supplementation combined with low-intensity exercise in malnourished patients with COPD.

The first aim of this study was to investigate the effects of nutritional supplementation combined with low-intensity exercise on body components, exercise tolerance, and health-related quality of life (HRQOL) in malnourished patients with COPD. The second aim of this study was to examine the degree of systemic inflammation and the actual changes in levels of systemic CRP, TNFα, IL-6 and IL-8 actual changes after a combination of nutritional supplementation and low-intensity exercise in these patients.



A prospective randomized trial.



Thirty-two moderate to severe, clinically stable malnourished COPD patients.



Patients were randomly divided into a nutritional supplementation with low-intensity exercise group and a control group. Lung function, maximum inspiratory and expiratory muscle force, the Chronic Respiratory Disease Questionnaire (CRQ), the 6-min walking distance (6MWD), and the Borg scale were measured at baseline and were re-assessed at 3 months after intervention. The degree of systemic inflammation and the changes in levels of systemic CRP, TNFα, IL-6 and IL-8 were assessed before and after a combination nutritional supplementation with low-intensity exercise.



Body weight and FFM increased significantly after 12 weeks of nutritional supplementation therapy in patients with COPD. The dietary intake energy increased and the REE:REEpred ratio decreased significantly in the nutrition with low-intensity exercise group. PI(max), Quadriceps muscle force and the 6-min walking distance (6MWD) increased significantly from baseline through week 12. Health status, as assessed by CRQ, improved in the domains of dyspnea and total sores significantly in the nutrition with low-intensity exercise group after intervention. In this group, hsCRP, IL-6, IL-8, and TNFα, decreased significantly after intervention compared with the control group.



The combination of nutritional supplementation with low-intensity exercise training was successful in increasing weight and energy intake as well as exercise capacity and health-related QOL in our patients. Moreover, REE and major inflammatory cytokines decreased significantly after nutritional supplementation with low-intensity exercise training. The present study results suggest a potential role for the combination of nutritional supplementation and low-intensity exercise in the management of malnourished patients with COPD.
Dietary intakes and food sources of phenolic acids in the European Prospective Investigation into Cancer and Nutrition (EPIC) study.

Phenolic acids are secondary plant metabolites that may have protective effects against oxidative stress, inflammation and cancer in experimental studies. To date, limited data exist on the quantitative intake of phenolic acids. We estimated the intake of phenolic acids and their food sources and associated lifestyle factors in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Phenolic acid intakes were estimated for 36,037 subjects aged 35-74 years and recruited between 1992 and 2000 in ten European countries using a standardised 24 h recall software (EPIC-Soft), and their food sources were identified. Dietary data were linked to the Phenol-Explorer database, which contains data on forty-five aglycones of phenolic acids in 452 foods. The total phenolic acid intake was highest in Aarhus, Denmark (1265·5 and 980·7 mg/d in men and women, respectively), while the intake was lowest in Greece (213·2 and 158·6 mg/d in men and women, respectively). The hydroxycinnamic acid subclass was the main contributor to the total phenolic acid intake, accounting for 84·6-95·3% of intake depending on the region. Hydroxybenzoic acids accounted for 4·6-14·4%, hydroxyphenylacetic acids 0·1-0·8% and hydroxyphenylpropanoic acids ≤ 0·1% for all regions. An increasing south-north gradient of consumption was also found. Coffee was the main food source of phenolic acids and accounted for 55·3-80·7% of the total phenolic acid intake, followed by fruits, vegetables and nuts. A high heterogeneity in phenolic acid intake was observed across the European countries in the EPIC cohort, which will allow further exploration of the associations with the risk of diseases.
Respiratory and Urinary Tract Infections, Arthritis, and Asthma Associated with HTLV-I and HTLV-II Infection

Human T-lymphotropic virus types I and II (HTLV-I and -II) cause myelopathy; HTLV-I, but not HTLV-II, causes adult T-cell leukemia. Whether HTLV-II is associated with other diseases is unknown. Using survival analysis, we studied medical history data from a prospective cohort of HTLV-I- and HTLV-II-infected and -uninfected blood donors, all HIV seronegative. A total of 152 HTLV-I, 387 HTLV-II, and 799 uninfected donors were enrolled and followed for a median of 4.4, 4.3, and 4.4 years, respectively. HTLV-II participants had significantly increased incidences of acute bronchitis (incidence ratio [IR] = 1.68), bladder or kidney infection (IR = 1.55), arthritis (IR = 2.66), and asthma (IR = 3.28), and a borderline increase in pneumonia (IR = 1.82, 95% confidence interval [CI] 0.98 to 3.38). HTLV-I participants had significantly increased incidences of bladder or kidney infection (IR = 1.82), and arthritis (IR = 2.84). We conclude that HTLV-II infection may inhibit immunologic responses to respiratory infections and that both HTLV-I and -II may induce inflammatory or autoimmune reactions.
Registering prostate external beam radiotherapy with a boost from high-dose-rate brachytherapy: a comparative evaluation of deformable registration algorithms

Registering CTs for patients receiving external beam radiotherapy (EBRT) with a boost dose from high-dose-rate brachytherapy (HDR) can be challenging due to considerable image discrepancies (e.g. rectal fillings, HDR needles, HDR artefacts and HDR rectal packing materials). This study is the first to comparatively evaluate image processing and registration methods used to register the rectums in EBRT and HDR CTs of prostate cancer patients. The focus is on the rectum due to planned future analysis of rectal dose-volume response.



For 64 patients, the EBRT CT was retrospectively registered to the HDR CT with rigid registration and non-rigid registration methods in VelocityAI. Image processing was undertaken on the HDR CT and the rigidly-registered EBRT CT to reduce the impact of discriminating features on alternative non-rigid registration methods applied in the software suite for Deformable Image Registration and Adaptive Radiotherapy Research (DIRART) using the Horn-Schunck optical flow and Demons algorithms. The propagated EBRT-rectum structures were compared with the HDR structure using the Dice similarity coefficient (DSC), Hausdorff distance (HD) and average surface distance (ASD). The image similarity was compared using mutual information (MI) and root mean squared error (MSE). The displacement vector field was assessed via the Jacobian determinant (JAC). The post-registration alignments of rectums for 21 patients were visually assessed.



The greatest improvement in the median DSC relative to the rigid registration result was 35 % for the Horn-Schunck algorithm with image processing. This algorithm also provided the best ASD results. The VelocityAI algorithms provided superior HD, MI, MSE and JAC results. The visual assessment indicated that the rigid plus deformable multi-pass method within VelocityAI resulted in the best rectum alignment.



The DSC, ASD and HD improved significantly relative to the rigid registration result if image processing was applied prior to DIRART non-rigid registrations, whereas VelocityAI without image processing provided significant improvements. Reliance on a single rectum structure-correspondence metric would have been misleading as the metrics were inconsistent with one another and visual assessments. It was important to calculate metrics for a restricted region covering the organ of interest. Overall, VelocityAI generated the best registrations for the rectum according to the visual assessment, HD, MI, MSE and JAC results.
Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma.

Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.



We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.



BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.



One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.



These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
Association of interleukin 1B gene polymorphism and gastric cancers in high and low prevalence regions in China.

Our aim was to study the relationship between interleukin 1B (IL-1B) polymorphism, Helicobacter pylori infection, and gastric cancer in high prevalent (Shanxi) and low prevalent (Guangdong) regions in China.



Genomic DNA was extracted from peripheral blood of 192 healthy volunteers, 84 gastric cancer patients from Guangdong and 169 healthy volunteers, and 86 gastric cancer patients from Shanxi. Polymorphisms in IL-1B that encodes IL-1beta and IL-1RN that encodes IL-1 receptor antagonist were analysed by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). These polymorphic sites include promoter regions of IL-1B at positions +3954, -511 (C-T transition), and -31 (T-C transition), and IL-1RN variable tandem repeats.



In the low prevalence region, the frequencies of the IL-1B +3954 T/T and IL-1RN *2/*2 genotypes were similar. IL-1B -511T/T genotype frequency was significantly higher among patients with gastric cancer (25.0%) than control subjects (12.5%) (chi2=6.7, p=0.01). In the high prevalence region, the frequencies of the IL-1B +3954T/T and -511T/T genotypes and the IL-1RN *2/*2 genotype in the cancer and control groups were similar. IL-1B -31C/C genotype frequency was significantly higher among patients with gastric cancer (90.0%) than controls (78.0%) (chi2=5.0, p=0.025). Compared with the low prevalence region, control subjects from the high prevalence region had a higher frequency of the IL-1B -511T/T genotype (23.0% v 12.5%; chi2=7.0, p<0.008). While H pylori infection alone had only a modest effect on the risk of gastric cancer development (odds ratio (OR) 5.0 (95% confidence interval (CI) 1.5-16.3)), combined with the IL-1B -511T/T genotype the risk was markedly elevated (OR 17.1, 95% CI 3.8-76.4).



IL-1B -511T/T genotypes are associated with gastric cancer in China. The effect of IL-1B polymorphism is less obvious in areas of high prevalence for gastric cancer.
Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial.

In locally advanced pancreatic cancer, the role of chemoradiotherapy is controversial and the efficacy of erlotinib is unknown.



To assess whether chemoradiotherapy improves overall survival of patients with locally advanced pancreatic cancer controlled after 4 months of gemcitabine-based induction chemotherapy and to assess the effect of erlotinib on survival.



In LAP07, an international, open-label, phase 3 randomized trial, 449 patients were enrolled between 2008 and 2011. Follow-up ended in February 2013.



In the first randomization, 223 patients received 1000 mg/m2 weekly of gemcitabine alone and 219 patients received 1000 mg/m2 of gemcitabine plus 100 mg/d of erlotinib. In the second randomization involving patients with progression-free disease after 4 months, 136 patients received 2 months of the same chemotherapy and 133 underwent chemoradiotherapy (54 Gy plus capecitabine).



The primary outcome was overall survival from the date of the first randomization. Secondary outcomes were the effect of erlotinib and quality assurance of radiotherapy on overall survival, progression-free survival of gemcitabine-erlotinib and erlotinib maintenance with gemcitabine alone at the second randomization, and toxic effects.



A total of 442 of the 449 patients (232 men; median age, 63.3 years) enrolled underwent the first randomization. Of these, 269 underwent the second randomization. Interim analysis was performed when 221 patients died (109 in the chemoradiotherapy group and 112 in the chemotherapy group), reaching the early stopping boundaries for futility. With a median follow-up of 36.7 months, the median overall survival from the date of the first randomization was not significantly different between chemotherapy at 16.5 months (95% CI, 14.5-18.5 months) and chemoradiotherapy at 15.2 months (95% CI, 13.9-17.3 months; hazard ratio [HR], 1.03; 95% CI, 0.79-1.34; P = .83). Median overall survival from the date of the first randomization for the 223 patients receiving gemcitabine was 13.6 months (95% CI, 12.3-15.3 months) and was 11.9 months (95% CI, 10.4-13.5 months) for the 219 patients receiving gemcitabine plus erlotinib (HR, 1.19; 95% CI, 0.97-1.45; P = .09; 188 deaths vs 191 deaths). Chemoradiotherapy was associated with decreased local progression (32% vs 46%, P = .03) and no increase in grade 3 to 4 toxicity, except for nausea.



In this open-label, randomized trial involving patients with locally advanced pancreatic cancer with disease controlled after 4 months of induction chemotherapy, there was no significant difference in overall survival with chemoradiotherapy compared with chemotherapy alone and there was no significant difference in overall survival with gemcitabine compared with gemcitabine plus erlotinib used as maintenance therapy.
A Quantitative Investigation of Pulse and Tongue Features in Post-Stroke Depressive Patients and Healthy Volunteers: An Observational Pilot Study.

Depression is among the most common neuropsychiatric complications after stroke, having a negative impact on one's quality of life. A number of therapeutic modalities have been used for post-stroke depression (PSD) including traditional Chinese medicine (TCM). However, a lack of objectivity in TCM hampers further improvement in diagnosis and research, since TCM diagnosis is mainly based on subjective judgment of clinicians. In this study, a modern TCM diagnostic device was used to conduct an objective study of pulse and tongue features in PSD patients and healthy individuals.



A total of 67 volunteers participated. Pulse and tongue information of each participant was acquired and analyzed by the TCM Four Diagnosis Auxiliary Apparatus. Quantitative data were gathered and compared between the PSD group and the healthy group.



Higher rates of weak, slow, slippery, and string pulse were observed in the PSD group (p < 0.01), whereas normal pulse (p < 0.01) was detected in the healthy group. In the tongue analysis, higher rates of purple tongue (p < 0.01) with yellow fur (p < 0.01) and pale-pink tongue (p = 0.023) with white fur (p < 0.01) were observed in the PSD and the healthy groups, respectively. Abnormal tongue features (old, soft, thin, enlarged, thorny, and cracked) were detected (p < 0.05) in the PSD group.



Objective and quantitative data of PSD patients and healthy individuals may help providing valuable clinical information for PSD research and establish quantitative TCM diagnostic standards for pulse and tongue diagnosis in clinical practice and research.
Temporal variability of gait in Parkinson disease: effects of a rehabilitation programme based on rhythmic sound cues.

It has been suggested that sequential movements in patients with Parkinson's disease (PD) might be improved by the effects of external rhythmic cues. We studied spatiotemporal gait parameters and temporal gait variability in patients with PD and control subjects under different walking conditions in order to investigate whether rhythmic auditory cues could improve temporal variability. A total of 30 subjects were recruited, comprising 15 patients with idiopathic PD and 15 control subjects with no history of neurological disorder. As an indicator for temporal stability, we used the coefficient of variability (CV=standard deviation/mean X 100) of recorded intervals between two consecutive steps (gait variability). After control values were obtained, subjects underwent a Physical Rehabilitation Programme (PRP) consisting of a variety of motor tasks performed in combination with rhythmic sounds with different cadences. Sessions lasted 1h/day, five times a week for a period of four consecutive weeks. At the end of the PRP subjects were evaluated again. Following completion of the programme the patients' coefficients of variability improved significantly for the preferred gait (gait: t=2.950, p=0.011) but were not significantly different from those obtained in control subjects (gait: t=3.873, p=0.391). These results are consistent with and extend prior studies of rhythmic auditory facilitation in PD and suggest a valuable method of improving gait timing in these patients.