nils-herrmann/clean_scirepeval huggingface dataset:
Botulinum toxin A injection for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury: multi-institutional experience in Japan.

To examine the efficacy and safety of onabotulinumtoxinA (Botox) injection into the bladder wall for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury in Japanese patients.



We enrolled Japanese spinal cord injury patients with cystometrically confirmed neurogenic detrusor overactivity who experienced urinary incontinence at least once a week either because they were refractory to anticholinergics or had to discontinue treatment because of adverse events. Patients received 200 units of onabotulinumtoxinA injected into the bladder wall after a 2-week washout of anticholinergics, and urodynamic variables were assessed before and 1 month after injection. Catheterization and urinary incontinence data, as well as International Consultation on Incontinence Questionnaire-Short Form scores, were assessed before injection and every month thereafter until the cessation of treatment effects.



The study enrolled 19 patients (13 men, six women, age range 22-67 years). One month after injection, the mean number of urinary incontinence episodes decreased from 4.3 to 1.5 times/day (P = 0.004), and the maximum cystometric capacity increased from 100 mL to 296 mL (P = 0.0004). The rate of effective cases whose daily urinary incontinence frequency was decreased to less than 50% was 74%. The duration of efficacy without anticholinergic medication ranged from 3 to 12 months (median 8.5 months). Clinically significant adverse events were not observed.



The present findings show the efficacy and tolerability of onabotulinumtoxinA injection for the treatment of neurogenic detrusor overactivity in Japanese spinal cord injury patients.
Differential effect of B-vitamin therapy by antiplatelet use on risk of recurrent vascular events after stroke.

Although several randomized controlled trials failed to show a benefit of B vitamin therapy on composite outcomes of cardiovascular death, myocardial infarction, and stroke among individuals with elevated homocysteine, recent post hoc analyses have suggested that several factors may interact with the effects of vitamin treatment. One post hoc analysis revealed an interaction between B vitamin therapy and antiplatelet use; however, those results have not been replicated in other studies or populations.



We conducted a post hoc analysis of the Vitamin Intervention for Stroke Prevention (VISP) trial, a randomized controlled trial evaluating treatment with high- versus low-dose B vitamin therapy for secondary prevention of vascular events among stroke survivors with elevated homocysteine. Cox regression models were used to assess primary (recurrent stroke) and secondary (stroke, myocardial infarction, or vascular death) outcomes among individuals on high- versus low-dose vitamin therapy, categorized by antiplatelet use, after adjusting for covariates.



Among 3680 participants, 52% took antiplatelet medications. When compared with low-dose therapy, high-dose vitamin therapy was associated with higher stroke risk among individuals on antiplatelets (hazard ratio, 1.43; 95% confidence interval, 1.02-2.01), but trended toward lower risk among those not on antiplatelets (hazard ratio, 0.86; 95% confidence interval, 0.62-1.19).



High-dose B vitamin therapy may be associated with a higher risk of recurrent stroke among stroke survivors taking antiplatelets, but does not have a significant effect on recurrent stroke risk in those who are not on antiplatelets. Future randomized controlled trials may consider evaluating the effect of homocysteine lowering among stroke survivors with elevated homocysteine who are not on antiplatelet therapy.
Prediction of outcome in cancer patients with febrile neutropenia: a prospective validation of the Multinational Association for Supportive Care in Cancer risk index in a Chinese population and comparison with the Talcott model and artificial neural network

We aimed to validate the Multinational Association for Supportive Care in Cancer (MASCC) risk index, and compare it with the Talcott model and artificial neural network (ANN) in predicting the outcome of febrile neutropenia in a Chinese population. We prospectively enrolled adult cancer patients who developed febrile neutropenia after chemotherapy and risk classified them according to MASCC score and Talcott model. ANN models were constructed and temporally validated in prospectively collected cohorts. From October 2005 to February 2008, 227 consecutive patients were enrolled. Serious medical complications occurred in 22% of patients and 4% died. The positive predictive value of low risk prediction was 86% (95% CI = 81–90%) for MASCC score ≥ 21, 84% (79–89%) for Talcott model, and 85% (78–93%) for the best ANN model. The sensitivity, specificity, negative predictive value, and misclassification rate were 81%, 60%, 52%, and 24%, respectively, for MASCC score ≥ 21; and 50%, 72%, 33%, and 44%, respectively, for Talcott model; and 84%, 60%, 58%, and 22%, respectively, for ANN model. The area under the receiver-operating characteristic curve was 0.808 (95% CI = 0.717–0.899) for MASCC, 0.573 (0.455–0.691) for Talcott, and 0.737 (0.633–0.841) for ANN model. In the low risk group identified by MASCC score ≥ 21 (70% of all patients), 12.5% developed complications and 1.9% died, compared with 43.3%, and 9.0%, respectively, in the high risk group (p < 0.0001). The MASCC risk index is prospectively validated in a Chinese population. It demonstrates a better overall performance than the Talcott model and is equivalent to ANN model.
Assessment of genotoxic and molecular mechanisms of cancer risk in smoking and smokeless tobacco users.

Inexpensive forms of tobacco are widely used in developing countries such as India. We have evaluated genotoxicity endpoints (chromosome aberrations, micronucleus frequency, comet assay) and polymorphisms of the XRCC1 and p53 genes among smokers and smokeless tobacco (SLT) users in rural Tamilnadu, South India. Cytogenetic, DNA damage and SNP analyses were performed on peripheral blood samples; micronucleus frequency was measured in peripheral blood and buccal mucosa exfoliated cells. Both categories of tobacco users had elevated levels of genotoxic damage. SNP analysis of tobacco users revealed that 17% carry the XRCC1 gln399gln genotype and 19% carry the p53 pro72pro genotype. Both genotypes are associated with increased risk of cancer.
Quality versus quantity of life in the treatment of patients with advanced small-cell lung cancer? A randomized phase III comparison of weekly carboplatin and teniposide versus cisplatin, adriamycin, etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine. Swiss Group fo

Based on a promising pilot study with weekly carboplatin and teniposide (CBDCA/VM) the Swiss Group for Clinical Cancer Research (SAKK) performed a randomised phase III trial in patients with extensive-disease small-cell lung cancer aimed at the development of an effective palliative treatment with low subjective toxicity.



From September 1989 to September 1991 patients were randomised to a weekly regimen of CBDCA/VM or to our 'standard chemotherapy' of cisplatin, adriamycin and etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine (PAV-CyMOC).



The trial was closed before the planned accrual of 140 evaluable patients due to a significant survival difference shown by an interim analysis. Of the 61 patients 59 were eligible and included in the final analysis. The results achieved with the PAV-CyMOC regimen were significantly better than those observed in patients treated with weekly CBDCA/VM (remission rate of 65% vs. 29%; p = 0.006). The median survival of patients treated with the PAV-CyMOC combination was significantly longer than that of patients receiving weekly CBDCA/VM (260 days vs. 147 days; p = 0.0035). The 1-year survival rate was 30% in the PAV-CyMOC arm compared to 4% in the CBDCA/VM-treated patients. As expected, side effects including myelosuppression, alopecia and mucositis were significantly more pronounced in patients treated with the PAV-CyMOC regimen. No significant difference was found in patient-rated tumor symptoms and general quality-of-life categories.



Contrary to our initial expectation that we would achieve similar therapeutic results with less subjective toxicity, in this randomised prospective trial the results achieved by weekly carboplatin and teniposide were significantly inferior in terms of remission rate and survival to those of our 'standard regimen' of cisplatin, adriamycin and etoposide alternating with cyclophosphamide, methotrexate, vincristine and lomustine. The weekly regimen was less toxic than the standard chemotherapy. Whether patients are willing to accept a significant trade-off between quantity and quality of life remains to be evaluated.
Free fatty acid suppositories are as effective as docusate sodium and sorbitol enemas in treating constipation in children.

A well-documented, clinically proven per rectum treatment for childhood constipation is needed. This phase two clinical trial evaluated the efficacy of suppositories containing free fatty acids (FFA) compared with Klyx docusate sodium and sorbitol enemas.



A randomised, controlled, single-blind study was undertaken on 77 children aged between one and 17 who presented to an emergency department in Iceland and were diagnosed with constipation. In stage one, 23 patients were randomised to receive lower dose FFA suppositories or Klyx (n = 33). In stage two, 21 different patients were randomised to receive higher dose suppositories and compared with the same Klyx control subjects.



The suppositories were effective at bowel emptying in 39% of the group who received the lower FFA doses and 81% of the group receiving higher doses, compared with 88% in the Klyx control group. Symptom relief was obtained in 30% of the group receiving the lower doses and 71% of the group receiving the higher doses, compared with 73% in the control group.



The higher dose FFA suppositories were as effective as the Klyx enemas with regard to bowel emptying and symptom relief and might provide an important and less invasive alternative for childhood constipation.
Non-steroidal anti-inflammatory drug-associated nephrotoxicity in Bartter syndrome

We have followed four patients with Bartter syndrome for a mean of 25.4 years (range 21.5–28.8 years) after diagnosis. All patients received non-steroidal anti-inflammatory drugs (NSAID). In all patients, various degrees of renal dysfunction were noted to be temporally associated with NSAID therapy. In two patients, renal dysfunction resolved after discontinuing NSAID therapy, while maintaining other chronic medications such as potassium-sparing diuretics. Renal dysfunction persisted after NSAID withdrawal in two patients. We report these cases as a warning that NSAID should be considered an important cause of either reversible or irreversible renal dysfunction in Bartter syndrome.
Use of a goal setting intervention to increase adherence to low back pain rehabilitation: a randomized controlled trial.

To examine the effects of a goal setting intervention on self-efficacy, treatment efficacy, adherence and treatment outcome in patients undergoing low back pain rehabilitation.



A mixed-model 2 (time) × 3 (group) randomized controlled trial.



A residential rehabilitation centre for military personnel.



UK military personnel volunteers (N = 48); mean age was 32.9 (SD 7.9) with a diagnosis of non-specific low back pain.



Subjects were randomly assigned to either a goal setting experimental group (Exp, n = 16), therapist-led exercise therapy group (C1, n = 16) or non-therapist-led exercise therapy group (C2, n = 16). Treatment duration for all groups was three weeks.



Self-efficacy, treatment efficacy and treatment outcome were recorded before and after the treatment period. Adherence was rated during regularly scheduled treatment sessions using the Sports Injury Rehabilitation Adherence Scale (SIRAS). The Biering-Sørensen test was used as the primary measure of treatment outcome.



ANCOVA results showed that adherence scores were significantly higher in the experimental group (13.70 ± 1.58) compared with C2 (11.74 ± 1.35), (P < 0.025). There was no significant difference for adherence between the experimental group and C1 (P = 0.13). Self-efficacy was significantly higher in the experimental group compared to both C1 and C2 (P < 0.05), whereas no significant difference was found for treatment efficacy. Treatment outcome did not differ significantly between the experimental and two control groups.



The findings provide partial support for the use of goal setting to enhance adherence in clinical rehabilitation.
Short- and long-term prognosis among veterans with neurological disorders and subsequent lower-extremity amputation.

Although comorbid neurological conditions are not uncommon for individuals undergoing lower-extremity (LE) amputation, short- and long-term prognosis is unclear.



This cohort study on the survival of United States veterans with LE amputations examined the association between different preexisting neurological conditions and short- and long-term (in-hospital and within 1-year of surgical amputation) mortality. Chi(2) and t test statistics compared baseline characteristics for patients with and without neurological disorders. Multiple logistic regression and Cox proportional hazard models were used to examine short- and long-term survival and identify predictors limited to the subset of those with neurological conditions adjusting for age, amputation level and etiology, and co-morbidities.



Of 4,720 patients, 43.3% had neurological disorders documented. Most prevalent were stroke or hemiparesis (18.3%) and peripheral nervous system (PNS) disorders (20.3%). Among patients with neurological conditions, those with a PNS disorder or spinal cord injury (or paralysis) were significantly less likely to die in hospital and within 1 year (p < 0.05) when compared to the other types of neurological condition groups including stroke (or hemiparesis), cerebral degenerative diseases, movement disorders and autonomic disorders.



The high prevalence of preexisting neurological disorders among LE amputees and the varying effect of different conditions on risk of mortality highlights the need to further characterize the diverseness of this understudied subpopulation. While preexisting spinal cord injury and PNS disorders appear to carry a decreased risk among amputees, those with central nervous system disorders have comparatively greater mortalities.
Acute effects of the use of estrogens in association with progestogens on postprandial triglyceridemia and vascular reactivity.

To assess whether hormone replacement therapy with estrogens in association with progestogens in postmenopausal hypertensive women alters postprandial triglyceridemia and vascular reactivity.



A double-blind, placebo-controlled, crossover study was carried out with 15 postmenopausal women (age range: 50 to 70 years, mean = 61.6 +/- 6 years) randomly assigned to 2 weeks of placebo or oral ingestion of 0.625 mg of equine conjugated estrogens and 2.5 mg of medroxyprogesterone, fed a high-fat diet (897 calories; 50.1% fat). Vascular reactivity (VR - % of vessel diameter variation in the fasting period and 2 hours after meals) was measured by using the automated ultrasound method. Lipid profile and glycemia during the fasting period and 2 hours after a high-fat meal were measured.



With placebo, vascular reactivity (VR) decreased from 3.20 +/- 17% during the fasting period to -2.1 +/- 30% 2 hours after the meal (P = 0.041). With the hormone replacement therapy, vascular reactivity decreased from 6.14 +/- 27% during the fasting period to - 0.05 +/- 18% 2 hours after the meal (P = NS). Postprandial triglyceridemia increased as follows: 35 +/- 25% with placebo; and 12 +/- 10% with hormone replacement therapy (P < 0.05).



In postmenopausal hypertensive women, 2 weeks of hormone replacement with an association of estrogens and progestogens decreased hypertriglyceridemia after a high-fat meal, an effect that may reduce the endothelial dysfunction occurring in the postprandial period.
Physical impairment index: reliability, validity, and responsiveness in patients with acute low back pain.

Cohort study of patients with acute low back pain undergoing physical therapy.



Examine the reliability and validity of the Physical Impairment Index in a group of patients with acute low back pain and determine the responsiveness and minimum detectable change of the index and its component tests.



The Physical Impairment Index was originally described as a reliable and valid means of assessing physical impairment in patients with low back pain. The psychometric properties of the index have not been reported in patients with acute low back pain, nor has its responsiveness been examined.



Seventy-eight patients with acute (<3 weeks duration) low back pain participating in a clinical trial were assessed at baseline and after 4 weeks. Interrater reliability of the index was examined in a subgroup of 20 patients. Validity was examined through correlations with concurrent measures of pain, disability, and psychosocial variables. Changes in the index over 4 weeks were used to assess responsiveness and minimum detectable change.



Interrater reliability of the index was high (intraclass correlation coefficient = 0.89), and its validity was generally supported by the pattern of correlations. The index was more responsive to change than any of its component tests but was less responsive than the Oswestry disability score. The minimum detectable change on the index was approximately 1 point.



The Physical Impairment Index appears to be a reliable and valid measure of physical impairment for patients with acute low back pain and may be useful as an adjunct outcome measure for studies involving these patients. Further research on patients with chronic pain is needed before it can be advocated for outcomes research with this population.
Intensity of Proliferative Processes and Degree of Oxidative Stress in the Mucosa of the Ileum in Crohn’s Disease

The intensity of proliferative processes (estimated from Ki-67 expression) and degree oxidative stress (chemiluminescence assay) in biopsy specimens from the terminal portion of the ileal mucosa were studied in patients with Crohn’s disease. Crohn’s disease is characterized by hyper-regenerative processes in the ileal mucosa. The labeling index (Ki-67 expression) in biopsy specimens from the intact ileal mucosa in patients with the irritable bowel syndrome (reference group) was 10.64 ± 0.62%. The corresponding values in patients receiving monotherapy with mesalazine (group 1) and combination therapy with mesalazine and dalargin (group 2) were 24.05 ± 1.17 and 22.90 ± 0.92%, respectively. Analysis of free radical oxidation showed that this state is accompanied oxidative stress. Spontaneous and H2O2-induced luminol-dependent chemiluminescence in biopsy specimens from the ileal mucosa was 1.8-2.3-fold higher compared to the reference group. After therapy, the labeling index in groups 1 and 2 decreased to 18.60 ± 1.18 and 14.38 ± 0.81%, respectively. Histologically, normalization of the disease symptoms was more pronounced after combination therapy. The decrease in free radical oxidation in this group of patients was more pronounced than after mesalazine monotherapy. Our results suggest that oxidative stress plays a role in the hyper-regenerative reaction.
Non-invasive prenatal diagnosis for cystic fibrosis: detection of paternal mutations, exploration of patient preferences and cost analysis

We aim to develop non-invasive prenatal diagnosis (NIPD) for cystic fibrosis (CF) and determine costs and implications for implementation.



A next-generation sequencing assay was developed to detect ten common CF mutations for exclusion of the paternal mutation in maternal plasma. Using uptake data from a study exploring views on NIPD for CF, total test-related costs were estimated for the current care pathway and compared with those incorporating NIPD.



The assay reliably predicted mutation status in all control and maternal plasma samples. Of carrier or affected adults with CF (n = 142) surveyed, only 43.5% reported willingness to have invasive testing for CF with 94.4% saying they would have NIPD. Using these potential uptake data, the incremental costs of NIPD over invasive testing per 100 pregnancies at risk of CF are £9025 for paternal mutation exclusion, and £26,510 for direct diagnosis.



We have developed NIPD for risk stratification in around a third of CF families. There are economic implications due to potential increased test demand to inform postnatal management rather than to inform decisions around termination of an affected pregnancy.
Low frequency of MLL-partial tandem duplications in paediatric acute myeloid leukaemia using MLPA as a novel DNA screenings technique.

Mixed-lineage leukaemia (MLL)-partial tandem duplications (PTDs) are found in 3-5% of adult acute myeloid leukaemia (AML), and are associated with poor prognosis. In adult AML, MLL-PTD is only detected in patients with trisomy 11 or internal tandem duplications of FLT3 (FLT3-ITD). To date, studies in paediatric AML are scarce, and reported large differences in the frequency of MLL-PTD, frequently utilising mRNA RT-PCR only to detect MLL-PTDs. We studied the frequency of MLL-PTD in a large cohort of paediatric AML (n=276) and the results from two different methods, i.e. mRNA RT-PCR, and multiplex ligation-dependent probe amplification (MLPA), a method designed to detect copy number differences of specific DNA sequences. In some patients with an MLL-rearrangement, MLL-PTD transcripts were detected, but were not confirmed by DNA-MLPA, indicating that DNA-MLPA can more accurately detect MLL-PTD compared to mRNA RT-PCR. In paediatric AML, MLL-PTD was detected in 7/276 patients (2.5%). One case had a trisomy 11, while the others had normal cytogenetics. Furthermore 4 of the 7 patients revealed a FLT3-ITD, which was significantly higher compared with the other AML cases (p=0.016). In conclusion, using DNA-MLPA as a novel screenings technique in combination with mRNA RT-PCR a low frequency of MLL-PTD in paediatric AML was found. Larger prospective studies are needed to further define the prognostic relevance of MLL-PTD in paediatric AML.
Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis

The present study adopted a randomized controlled trial design and examined the effect of a physical activity behavioral intervention on cognitive and walking performance among persons with MS who have mild or moderate disability status. A total of 82 MS patients were randomly allocated into intervention or wait-list control conditions. The intervention condition received a theory-based program for increasing physical activity behavior that was delivered via the Internet, and one-on-one video chat sessions with a behavior-change coach. Participants completed self-report measures of physical activity and disability status, and underwent the oral Symbol Digit Modalities Test (SDMT) and 6-minute walk (6MW) test before and after the 6-month period. Analysis using mixed-model ANOVA indicated a significant time × condition × disability group interaction on SDMT scores (p = 0.02, partial-η 2 = 0.08), such that persons with mild disability in the intervention condition demonstrated a clinically meaningful improvement in SDMT scores (~6 point change). There was a further significant time × condition interaction on 6MW distance (p = 0.02, partial-η 2 = 0.07), such that those in the intervention condition demonstrated an increase in 6MW distance relative to those in the control group. The current study supports physical activity as a promising tool for managing cognitive impairment and impaired walking performance in persons with MS, and suggests that physical activity might have specific effects on cognition and non-specific effects on walking performance in this population.