nils-herrmann/clean_scirepeval huggingface dataset:
Daily exercises and education for preventing low back pain in children: cluster randomized controlled trial.

Children report low back pain (LBP) as young as 8 years. Preventing LBP in children may prevent or delay adult incidence.



The purpose of this study was to determine whether education and daily exercise affect LBP episodes in children compared with education alone.



This was a prospective, multicenter cluster randomized controlled trial.



The study was conducted at 7 New Zealand primary schools.



Children (n=708), aged 8 to 11 years, from 7 schools stratified by sample size (36, 114, 151, 168, 113, 45, 83) were randomized and allocated to 2 masked groups: intervention (4 schools, n=469) or control (3 schools, n=239).



Participants in the intervention group were taught 4 spinal movements for daily practice. Both groups participated in education that emphasized "back awareness."



Low back pain history at baseline was assessed. Children reported episodes of LBP during the previous week on trial days 7, 21, 49, 105, 161, and 270. Analysis was at the individual participant level, with adjustment for school clusters.



There were no significant differences between groups in the odds of reporting no LBP in the previous week during the study period (odds ratio [OR]=0.72; 95% confidence interval [95% CI]=0.46, 1.14; P=.16). The intervention group reported significantly fewer episodes of LBP (OR=0.54; 95% CI=0.39, 0.74; P<.001) and significantly fewer lifetime first episodes of LBP (n=86 [34%]) compared with the control group (n=58 [47%]) (OR=0.60; 95% CI=0.39, 0.91; P=.02). The odds of an episode of LBP were greater in participants with a history of LBP (OR=4.21; 95% CI=3.07, 5.78; P<.001). Low back pain episodes decreased across the trial period for both groups (OR=0.89; 95% CI=0.84, 0.95; P<.001). Adherence to exercise was poor.



Replication in other settings is needed.



Regular exercise and education appear to reduce LBP episodes in children aged 8 to 11 years compared with education alone.
Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study

Severe graft-versus-host disease (GVHD) is a life-threatening complication after allogeneic transplantation with haemopoietic stem cells. Mesenchymal stem cells modulate immune responses in vitro and in vivo. We aimed to assess whether mesenchymal stem cells could ameliorate GVHD after haemopoietic-stem-cell transplantation.



Patients with steroid-resistant, severe, acute GVHD were treated with mesenchymal stem cells, derived with the European Group for Blood and Marrow Transplantation ex-vivo expansion procedure, in a multicentre, phase II experimental study. We recorded response, transplantation-related deaths, and other adverse events for up to 60 months' follow-up from infusion of the cells.



Between October, 2001, and January, 2007, 55 patients were treated. The median dose of bone-marrow derived mesenchymal stem cells was 1.4x10(6) (min-max range 0.4-9x10(6)) cells per kg bodyweight. 27 patients received one dose, 22 received two doses, and six three to five doses of cells obtained from HLA-identical sibling donors (n=5), haploidentical donors (n=18), and third-party HLA-mismatched donors (n=69). 30 patients had a complete response and nine showed improvement. No patients had side-effects during or immediately after infusions of mesenchymal stem cells. Response rate was not related to donor HLA-match. Three patients had recurrent malignant disease and one developed de-novo acute myeloid leukaemia of recipient origin. Complete responders had lower transplantation-related mortality 1 year after infusion than did patients with partial or no response (11 [37%] of 30 vs 18 [72%] of 25; p=0.002) and higher overall survival 2 years after haemopoietic-stem-cell transplantation (16 [53%] of 30 vs four [16%] of 25; p=0.018).



Infusion of mesenchymal stem cells expanded in vitro, irrespective of the donor, might be an effective therapy for patients with steroid-resistant, acute GVHD.
Intentional avoidance of the esophagus using intensity modulated radiation therapy to reduce dysphagia after palliative thoracic radiation

Palliative thoracic radiotherapy is an effective technique to alleviate symptoms of disease burden in advanced-stage lung cancer patients. Previous randomized controlled studies demonstrated a survival benefit in patients with good performance status at radiation doses of 35Gy10 or greater but with an increased incidence of esophagitis. The objective of this planning study was to assess the potential impact of esophageal-sparing IMRT (ES-IMRT) compared to the current standard of care using parallel-opposed pair beams (POP).



In this study, 15 patients with lung cancer treated to a dose of 30Gy in 10 fractions between August 2015 and January 2016 were identified. Radiation treatment plans were optimized using ES-IMRT by limiting the max esophagus point dose to 24Gy. Using published Lyman-Kutcher-Burman normal tissue complication probabilities (LKB-NTCP) models, both plans were evaluated for the likelihood of esophagitis (≥ grade 2) and pneumonitis (≥ grade 2).



Using ES-IMRT, the median esophageal and lung mean doses reduced from 16 and 8Gy to 7 and 7Gy, respectively. Using the LKB models, the theoretical probability of symptomatic esophagitis and pneumonitis reduced from 13 to 2%, and from 5 to 3%, respectively. The median normalize total dose (NTD mean) accounting for fraction size for the GTV and PTV of the clinically approved POP plans compared to the ES-IMRT plans were similar.



Advanced radiotherapy techniques such as ES-IMRT may have clinical utility in reducing treatment-related toxicity in advanced lung cancer patients. Our data suggests that the rate of esophagitis can be reduced without compromising local control.
Survey of Pseudomonas aeruginosa genotypes in colonised cystic fibrosis patients.

The current authors aimed to examine whether cystic fibrosis (CF) patients in Belgium shared Pseudomonas aeruginosa genotypes and to compare the genotypes of isolates from the same patients during two consecutive years. A Belgian databank of the P. aeruginosa genotypes of all colonised CF patients was created. Sputum samples from a total of 276 P. aeruginosa colonised patients during 2003, and from a subgroup of 95 patients in 2004, were analysed. Patients were asked about any social contact between each other by questionnaire. All P. aeruginosa isolates exhibiting different colonial morphology on McConkey agar were first genotyped using arbitrarily primed PCR, whereafter single representatives of each randomly amplified polymorphic DNA-type were further genotyped by fluorescent amplified fragment length polymorphism analysis. In the 213 patients from whom P. aeruginosa could be cultured (resulting in 910 isolates), a total of 163 genotypes were found. The majority (75%) of patients harboured only one genotype. In most of the limited number of clusters, previous contacts between patients could be suspected. In 80% of the patients studied during both years, P. aeruginosa genotype remained unchanged. In conclusion, most colonised cystic fibrosis patients harbour only one Pseudomonas aeruginosa genotype, despite showing different colonial morphotypes. The number of clusters is limited, and most patients seem to retain the same genotypic strain during both years.
Effect of out-of-hospital pediatric endotracheal intubation on survival and neurological outcome: a controlled clinical trial.

Endotracheal intubation (ETI) is widely used for airway management of children in the out-of-hospital setting, despite a lack of controlled trials demonstrating a positive effect on survival or neurological outcome.



To compare the survival and neurological outcomes of pediatric patients treated with bag-valve-mask ventilation (BVM) with those of patients treated with BVM followed by ETI.



Controlled clinical trial, in which patients were assigned to interventions by calendar day from March 15, 1994, through January 1, 1997.



Two large, urban, rapid-transport emergency medical services (EMS) systems.



A total of 830 consecutive patients aged 12 years or younger or estimated to weigh less than 40 kg who required airway management; 820 were available for follow-up.



Patients were assigned to receive either BVM (odd days; n = 410) or BVM followed by ETI (even days; n = 420).



Survival to hospital discharge and neurological status at discharge from an acute care hospital compared by treatment group.



There was no significant difference in survival between the BVM group (123/404 [30%]) and the ETI group (110/416 [26%]) (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.61-1.11) or in the rate of achieving a good neurological outcome (BVM, 92/404 [23%] vs ETI, 85/416 [20%]) (OR, 0.87; 95% CI, 0.62-1.22).



These results indicate that the addition of out-of-hospital ETI to a paramedic scope of practice that already includes BVM did not improve survival or neurological outcome of pediatric patients treated in an urban EMS system.
Facets of spirituality as predictors of adjustment to cancer: relative contributions of having faith and finding meaning.

Spirituality is a multidimensional construct, and little is known about how its distinct dimensions jointly affect well-being. In longitudinal studies (Study 1, n = 418 breast cancer patients; Study 2, n = 165 cancer survivors), the authors examined 2 components of spiritual well-being (i.e., meaning/peace and faith) and their interaction, as well as change scores on those variables, as predictors of psychological adjustment. In Study 1, higher baseline meaning/peace, as well as an increase in meaning/peace over 6 months, predicted a decline in depressive symptoms and an increase in vitality across 12 months in breast cancer patients. Baseline faith predicted an increase in perceived cancer-related growth. Study 2 revealed that an increase in meaning/peace was related to improved mental health and lower cancer-related distress. An increase in faith was related to increased cancer-related growth. Both studies revealed significant interactions between meaning/peace and faith in predicting adjustment. Findings suggest that the ability to find meaning and peace in life is the more influential contributor to favorable adjustment during cancer survivorship, although faith appears to be uniquely related to perceived cancer-related growth.
Phase II study of trastuzumab in combination with S-1 plus cisplatin in HER2-positive gastric cancer (HERBIS-1)

CXC chemokine receptor 4 (CXCR4) and its ligand stromal cell-derived factor-1α (SDF-1α, also known as CXCL12) have important roles in promoting tumour growth and metastasis. Therefore, targeting CXCR4 could be a promising strategy for treatment of human cancer.To achieve this goal, we developed a highly purified recombination polypeptide (GST-NT21MP), which is a synthetic 21-mer peptide antagonist of CXCR4 (NT21MP) derived from the viral macrophage inflammatory protein II by fermentation technology, affinity chromatography and fast protein liquid chromatography. In this study, we used multiple methods such as MTT assay, FACS, invasion assay, RT–PCR and western blot to explore the efficacy and mechanism by which GST-NT21MP inhibits cell growth, migration and invasion of breast cancer in vitro and in vivo.We found that blockade of CXCR4 pathway by GST-NT21MP decreased SDF-1-induced cell growth, adhesion and migration capacities in breast cancer cells. Moreover, GST-NT21MP significantly retarded pulmonary metastasis in vivo. Furthermore, GST-NT21MP-mediated antitumour activity was found to be associated with reduced phosphorylated Src, Akt, FAK and ERK1/2 as well as decreased Bcl-2.Conclusions:Our results suggest that GST-NT21MP could be a potential anticancer agent for the treatment of breast cancer.
Transcranial Direct Current Stimulation to Enhance Dual-Task Gait Training in Parkinson’s Disease: A Pilot RCT

To investigate the feasibility and safety of a combined anodal transcranial direct current stimulation (tDCS) and dual task gait training intervention in people with Parkinson's Disease (PD) and to provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present.



A pilot, randomized, double-blind, sham-controlled parallel group trial with 12 week follow-up.



A university physiotherapy department.



Sixteen participants diagnosed with PD received nine dual task gait training sessions over 3 weeks. Participants were randomized to receive either active or sham tDCS applied for the first 20 minutes of each session.



The primary outcome was gait speed while undertaking concurrent cognitive tasks (word lists, counting, conversation). Secondary measures included step length, cadence, Timed Up and Go, bradykinesia and motor speed.



Gait speed, step length and cadence improved in both groups, under all dual task conditions. This effect was maintained at follow-up. There was no difference between the active and sham tDCS groups. Time taken to perform the TUGwords also improved, with no difference between groups. The active tDCS group did however increase their correct cognitive response rate during the TUGwords and TUGcount. Bradykinesia improved after training in both groups.



Three weeks of dual task gait training resulted in improved gait under dual task conditions, and bradykinesia, immediately following training and at 12 weeks follow-up. The only parameter enhanced by tDCS was the number of correct responses while performing the dual task TUG. tDCS applied to M1 may not be an effective adjunct to dual task gait training in PD.
First assessment of needle-based confocal laser endomicroscopy during EUS-FNA procedures of the pancreas (with videos).

Challenges in EUS-guided FNA (EUS-FNA) include sampling error, nondiagnostic cytology, and limited on-site cytological evaluation. A prototype needle-based confocal laser endomicroscopy (nCLE) probe is a submillimeter probe that provides real-time imaging at the microscopic level through the FNA needle.



To evaluate the feasibility of nCLE during EUS-FNA of pancreatic lesions.



Feasibility study.



Multicenter, tertiary care.



Eighteen patients presenting for EUS-FNA.



Patients were injected with 2.5 mL of 10% fluorescein. The lesion was interrogated with the nCLE probe positioned at the tip of a 19-gauge FNA needle.



Device integrity, technical ease, safety, and image acquisition.



Cases included 16 cysts and 2 masses. There were no device malfunctions. Technical challenges were encountered in 6 of 18 attempts to image and reflected challenges with a postloading technique, the longer ferule tip, and a transduodenal approach. Technical feasibility to perform imaging with nCLE during a pancreatic EUS-FNA procedure was achieved in 17 of 18 cases. Ten cases had good to very good image quality. Two serious adverse events occurred; both were pancreatitis requiring hospitalization.



Limited sample size, small number of patients with confirmed pathological diagnosis, lack of coregistered pathology and images.



nCLE in the pancreas is technically feasible via a 19-gauge needle under endosonographic guidance. Future studies will address identification of structures, diagnostic accuracy, and complication profiles. The rate of pancreatitis needs to be further clarified and mitigated.
Possibilities for serial femtosecond crystallography sample delivery at future light sourcesa)

Serial femtosecond crystallography (SFX) uses X-ray pulses from free-electron laser (FEL) sources that can outrun radiation damage and thereby overcome long-standing limits in the structure determination of macromolecular crystals. Intense X-ray FEL pulses of sufficiently short duration allow the collection of damage-free data at room temperature and give the opportunity to study irreversible time-resolved events. SFX may open the way to determine the structure of biological molecules that fail to crystallize readily into large well-diffracting crystals. Taking advantage of FELs with high pulse repetition rates could lead to short measurement times of just minutes. Automated delivery of sample suspensions for SFX experiments could potentially give rise to a much higher rate of obtaining complete measurements than at today's third generation synchrotron radiation facilities, as no crystal alignment or complex robotic motions are required. This capability will also open up extensive time-resolved structural studies. New challenges arise from the resulting high rate of data collection, and in providing reliable sample delivery. Various developments for fully automated high-throughput SFX experiments are being considered for evaluation, including new implementations for a reliable yet flexible sample environment setup. Here, we review the different methods developed so far that best achieve sample delivery for X-ray FEL experiments and present some considerations towards the goal of high-throughput structure determination with X-ray FELs.
Reasons for refusing kidney transplantation among chronic dialysis patients.

The aim of the prospective clinical study was to evaluate the reasons for refusing kidney transplantation among chronic dialysis patients. A total of 164 adult chronic dialysis patients participated in the study. They were asked to complete a detailed questionnaire on specific issues regarding transplantation. The mean age was 60.9 ± 16.0 (20-89) years, 61.6% were male, 11.6% had had a previous transplant. The majority, that is, 72.0%, of the patients believed that transplantation improved the quality of life, and 55.5% believed that transplantation prolonged life. Nevertheless, 45.0% of the patients wanted to be transplanted, 35.0% refused transplantation, and 20.0% were undecided. Patients refusing transplantation were significantly older compared to the patients wanting to be transplanted (67 ± 16 vs. 57 ± 16 years; P < 0.001). The main reasons for refusing transplantation (57 patients) were the side-effects of immunosuppressive therapy (31.6%), unpredictability of transplant outcome (29.8%), and unfavorable outcomes in fellow patients (28.1%). The side-effects of immunosuppressive therapy that patients were most concerned about included mobility problems (29.8%), new-onset diabetes (26.3%), increased risk of severe infections (26.3%), problems with vision (22.8%), and increased risk of cancer (21.1%). Many patients did not want to accept organs from expanded criteria donors (ECD) (44.6% of the patients wanting and 64.9% of those refusing transplantation). The majority believed that patients should be informed if an organ from an ECD donor is being offered (64.9% of patients wanting and 63.2% of those refusing transplantation). The main reasons for refusing kidney transplantation were the side-effects of immunosuppressive therapy, unpredictability of transplant outcome, and unfavorable outcomes in fellow patients.
Investigation of mitigating effect of colon-specific prodrugs of boswellic acid on 2,4,6-trinitrobenzene sulfonic acid-induced colitis in Wistar rats: Design, kinetics and biological evaluation

To develop a colon-targeting bioreversible delivery system for β-boswellic acid (BBA) and explore utility of its prodrugs in 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis in rats.



Synthesis of 4 co-drugs of BBA with essential amino acids was achieved by CDI coupling, followed by their spectral characterization. In vitro kinetics were studied by HPLC in aqueous buffers, homogenates of gastrointestinal tract and fecal matter. In vivo kinetic studies were performed in Wistar rat plasma, urine and feces. The prodrugs were screened in TNBS-induced colitis modeled Wistar rats. Statistical significance was assumed at P < 0.05, P < 0.01, P < 0.001 when compared with disease controls using one-way and two-way ANOVAs.



Prodrugs were stable in 0.05 mol/L HCl buffer (pH 1.2) and stomach homogenates. Negligible hydrolysis was observed in phosphate buffer and intestinal homogenates. Substantial release (55%-72% and 68%-86%) of BBA was achieved in rat fecal matter and homogenates of colon. In vivo studies of BBA with L-tryptophan (BT) authenticated colon-specific release of BBA. But, surprisingly substantial concentration of BBA was seen to reach the systemic circulation due to probable absorption through colonic mucosa. Site-specifically enhanced bioavailability of BBA could be achieved in colon, which resulted in demonstration of significant mitigating effect on TNBS-induced colitis in rats without inducing any adverse effects on stomach, liver and pancreas. Prodrug of BT was found to be 1.7% (P < 0.001) superior than sulfasalazine in reducing the inflammation to colon among all prodrugs tested.



The outcome of this study strongly suggests that these prodrugs might have dual applicability to inflammatory bowel disease and chronotherapy of rheumatoid arthritis.
Adjuvant low dose radiation in childhood non-Hodgkin's lymphoma (report from the United Kingdom Childrens' Cancer Study Group--UKCCSG).

From July 1977 to July 1983, 120 children with non-Hodgkin's Lymphoma entered a randomised trial of combination chemotherapy and radiotherapy. The primary site was abdominal in 42 patients, mediastinal in 27 and in other sites in 51. Failure-free survival (FFS) at 4 years was 74% for the 41 patients with localised disease (Stages I and II) and 51% for the 79 with generalised disease (Stages III and IV). Patients with mediastinal primaries continued to relapse after the completion of 2 years' treatment, but FFS at 4 years for the 93 patients with non-mediastinal primaries was 65% for all stages combined. In the latter group, there was no benefit to patients randomised at the end of induction chemotherapy to receive adjuvant radiation 15 Grays in 10 fractions in 2 weeks to sites of previous bulky disease when compared to those not receiving such radiation (P = 0.6).
Endogenous intrahepatic IFNs and association with IFN-free HCV treatment outcome.

Hepatitis C virus (HCV) infects approximately 170 million people worldwide and may lead to cirrhosis and hepatocellular carcinoma in chronically infected individuals. Treatment is rapidly evolving from IFN-α-based therapies to IFN-α-free regimens that consist of directly acting antiviral agents (DAAs), which demonstrate improved efficacy and tolerability in clinical trials. Virologic relapse after DAA therapy is a common cause of treatment failure; however, it is not clear why relapse occurs or whether certain individuals are more prone to recurrent viremia.  We conducted a clinical trial using the DAA sofosbuvir plus ribavirin (SOF/RBV) and performed detailed mRNA expression analysis in liver and peripheral blood from patients who achieved either a sustained virologic response (SVR) or relapsed.  On-treatment viral clearance was accompanied by rapid downregulation of IFN-stimulated genes (ISGs) in liver and blood, regardless of treatment outcome. Analysis of paired pretreatment and end of treatment (EOT) liver biopsies from SVR patients showed that viral clearance was accompanied by decreased expression of type II and III IFNs, but unexpectedly increased expression of the type I IFN IFNA2. mRNA expression of ISGs was higher in EOT liver biopsies of patients who achieved SVR than in patients who later relapsed.  These results suggest that restoration of type I intrahepatic IFN signaling by EOT may facilitate HCV eradication and prevention of relapse upon withdrawal of SOF/RBV.