nils-herrmann/clean_scirepeval huggingface dataset:
Vigabatrin and psychosis.

We report a series of 14 cases of psychosis occurring in patients with severe intractable epilepsy, following the prescription of vigabatrin, a new antiepileptic drug. Nine patients had no previous history of psychosis. In eight patients the psychosis occurred following a change in the habitual pattern of seizure activity; in four it developed after a period of seizure freedom followed by a cluster of seizures, and in the other four patients an alternating psychosis was observed. In five patients there was no clear relationship to seizure pattern. Another patient developed psychosis after taking an overdose of between eight and 12 g of vigabatrin. A further three patients, who developed psychosis following vigabatrin withdrawal, were not included in this series. The mean dose at onset of the psychosis (excluding the patient who took an overdose) was 2580 mg, and the period from initiation of therapy to the onset of psychosis varied from five days to 32 weeks (and occurred 24 hours after the overdose of vigabatrin). In all cases the psychosis resolved, but necessitated the withdrawal of vigabatrin, except in the single patient who took the overdose. The mechanism of this behaviour change is unclear, but in some instances may reflect vigabatrin's powerful anti-epileptic action. This is clearly not the case for all patients. Vigabatrin should be started with caution in patients with severe epilepsy, particularly in the presence of a previous history of psychosis, and such patients should be carefully monitored.
Rasch analysis of the pediatric outcomes data collection instrument in 720 patients with cerebral palsy.

The pediatric outcomes data collection instrument (PODCI) was originally developed to carry out a functional assessment of children and adolescents (including patients with cerebral palsy), focusing on musculoskeletal health. Validated questionnaires are important for assessing the functional outcome of cerebral palsy, and are meant to have unidimensionality, proper item gap, no ceiling and floor effects, and no item redundancy. The advances in health measurements have led to the application of Rasch analysis to assess questionnaires. This study evaluated PODCI in patients with cerebral palsy using Rasch analyses.



The study included a total of 720 patients with gross motor function classification system level I to III, 192 with unilateral involvement and 528 with bilateral involvement. Rasch analysis was performed to obtain information on (1) the information weight fit statistic to assess the unidimensionality and redundancy of the items in each domain; (2) average item calibration to detect the item separation; and (3) item map to evaluate the ceiling and floor effects.



The PODCI worked best in the sports/physical function domain. In information weight fit statistics, there were 4 items violating unidimensionality, which included "putting on his/her coat" in transfer/basic mobility and "getting together and do things with friends" in sports/physical function. There were 4 items with item redundancy. Inadequate item separation was observed in the transfer/basic mobility domain. A ceiling effect was found in all domains, except for the sports/physical function.



The sports/physical function domain in PODCI generally satisfies the requirements of Rasch item response theory and is an appropriate measure of the function in cerebral palsy. Although some individual items do not fit well, the PODCI can be improved by eliminating the redundant items and by adding more difficult tasks to fill in the gaps.
Does 48 hours' bed rest influence the outcome of acute low back pain?

Bed rest is a traditional treatment for back pain, yet only in recent years has the therapeutic benefit of this been questioned.



The aim of this pilot study was to ascertain whether or not 48 hours' bed rest had an effect on the outcome of acute low back pain.



The study was conducted as a randomized controlled trial to compare a prescription of 48 hours' strict bed rest with controls; the control subjects were encouraged to remain mobile and to have no daytime rest. Nine general practitioners from practices in the West Midlands recruited patients in the age range 16-60 years who presented with low back pain of less than seven days' duration, with or without pain radiation. The outcome measures assessed were: change in straight leg raise and lumbar flexion after seven days, Oswestry and Roland-Morris disability scores after seven days and 28 days, and time taken from work.



Forty two patients were recruited: 20 were allocated to bed rest and 22 as controls. Compared with the bed rest group the control group had statistically better Roland-Morris scores at day seven (P < 0.05) but not at day 28. At day seven, there were no statistically significant differences between groups in straight leg raise or lumbar flexion measurements although the control group had a better mean lumbar flexion than the bed rest group. The improvement in disability scores at day seven compared with day one was similar for the two groups but more of the control group had fully recovered (defined as scores of one or zero on the Roland-Morris disability scale and five or less on the Oswestry disability scale) by day seven. Remaining mobile did not appear to cause any adverse effects. The number of days lost from work in both groups was equal. A large number of self-remedies and physical therapies were recorded by subjects from both groups.



The results of this pilot study did not indicate whether bed rest or remaining mobile was superior for the treatment of acute low back pain; however, the study sample was small. Subjects in the control group possibly fared better as they appeared to have better lumbar flexion at day seven. It appears that 48 hours' bed rest cannot be recommended for the treatment of acute low back pain on the basis of this small study. Large-scale definitive trials are required to detect clinically significant differences.
Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma.

Major depressive disorder is associated with considerable morbidity, disability, and risk for suicide. Treatments for depression most commonly include antidepressants, psychotherapy, or the combination. Little is known about predictors of treatment response for depression. In this study, 681 patients with chronic forms of major depression were treated with an antidepressant (nefazodone), Cognitive Behavioral Analysis System of Psychotherapy (CBASP), or the combination. Overall, the effects of the antidepressant alone and psychotherapy alone were equal and significantly less effective than combination treatment. Among those with a history of early childhood trauma (loss of parents at an early age, physical or sexual abuse, or neglect), psychotherapy alone was superior to antidepressant monotherapy. Moreover, the combination of psychotherapy and pharmacotherapy was only marginally superior to psychotherapy alone among the childhood abuse cohort. Our results suggest that psychotherapy may be an essential element in the treatment of patients with chronic forms of major depression and a history of childhood trauma.
High-dose chemotherapy in patients with breast cancer: evaluation of infusing peripheral blood stem cells containing occult tumor cells

The purpose of this study was to evaluate the frequency of detecting occult tumor cells in peripheral blood stem cell (PBSC) harvests and to determine the impact of infusing such cells on relapses after high-dose chemotherapy (HDC). Peripheral blood stem cell harvests from 223 patients with breast cancer were examined by an immunocytochemistry (ICC) method for detection of occult tumor cells, and infused after HDC without consideration of test results. Two hundred and four patients, 114 with stage II–III and 90 with stage IV disease who received only PBSC, that were tested by ICC were evaluated for time to relapse. Five hundred and eighty-one of 619 PBSC harvests (94%) from 223 patients were tested. Fifty-three of 581 harvests (9%), 8% from stage II–III and 10% from stage IV patients, were positive by ICC (P = 0.68). Forty-one of 223 patients (18%), 17/122 (14%) with stage II–III and 24/101 (24%) with stage IV disease, had positive harvests (P = 0.06). Eleven percent of patients who had 1–2 harvests tested were positive as compared to 32% of patients who had ⩾3 PBSC harvests tested (P < 0.001). nineteen patients who were infused with a mixture of icc negative and untested pbsc harvests were excluded from analyses of relapse. the probabilities of relapse at 18 months for the 97 patients with stage ii–iii disease infused with icc-negative and the 17 with icc-positive pbsc were 0.19 and 0.13, respectively (P = 0.48). The probabilities of relapse at 18 months for patients achieving a CR or a CR in non-bone sites and improvement in bone lesions were 0.55 for the ICC-negative group (n = 30) and 0.45 for the ICC-positive group (n = 11) (P = 0.60). It was concluded that occult tumor cells were detected by ICC in PBSC harvests from a relatively small fraction of women with breast cancer, but were not associated with a significant increase in the probability of early relapse or progression when infused after HDC.
Carboplatin/gemcitabine alternating with carboplatin/pegylated liposomal doxorubicin and carboplatin/cyclophosphamide in platinum-refractory/resistant paclitaxel - pretreated ovarian carcinoma.

In this phase II study the efficacy and toxicity of an alternating chemotherapy regimen was examined in platinum-resistant relapsed epithelial ovarian cancer (EOC) patients.



Forty-five patients with platinum-refractory/resistant relapsed EOC, previously treated with carboplatin+paclitaxel+/-epirubicin were included. The regimen was consisted of gemcitabine 800 mg/m(2) (days 1+8) and carboplatin AUC 5, alternating with pegylated liposomal doxorubicin 30 mg/m(2) and carboplatin AUC 5, alternating with carboplatin AUC 5 and cyclophosphamide 600 mg/m(2), every 3 weeks for a total of 9 cycles.



Among 38 patients with measurable disease, 39.4% (95% CI: 23.2-55.7) responded (five complete response and 10 partial response), while 30 out of 40 (75%) patients assessable by CA125 criteria had a serological response. Responses were more frequent in patients with platinum-free interval (PFI) 3-6 months than in those with PFI 0-3 months, but this was not statistically-significant. After a median follow-up of 19.5 months (range, 1.0-37+ months) the median progression-free survival was 7.1 months (95% CI: 3.4-10.8) and the median survival (OS) was 18.8 months (95% CI: 15.6-22.0). For patients with PFI 0-3 months PFS was 4.3 (95% CI: 0.8-7.8) months, while for those with PFI 3-6 months PFS was 8.9 (95% CI: 5.3-12.4) months (p=0.062). The regimen was well-tolerated and the main grade 3-4 toxicity was myelosuppression, palmar-plantar erythrodysesthesia, allergy and fatigue.



This alternating regimen, including carboplatin, gemcitabine, liposomal doxorubicin and cyclophosphamide, is an active and well-tolerated treatment in platinum relapsed/refractory EOC patients.
Early fasting glucose measurements can predict later glycaemic response to once weekly dulaglutide.

To assess whether early measures of fasting blood glucose predict later glycaemic response with once-weekly dulaglutide in patients with Type 2 diabetes mellitus.



Post hoc analyses were conducted separately for two phase 3 studies (AWARD-5 and AWARD-1) in patients assigned to once-weekly dulaglutide. Week 2 fasting blood glucose was used as a predictor variable, and glycaemic treatment response was defined by HbA1c response based on a composite efficacy endpoint. The association between fasting blood glucose and the glycaemic response was analysed using chi-square tests.



There was a strong association between fasting blood glucose < 7.9 mmol/l at week 2 and achieving the HbA1c composite efficacy endpoint at week 26 (P < 0.01). Higher fasting blood glucose at week 2, however, did not predict absence of glycaemic response and requires further assessment.



Fasting blood glucose measured at 2 weeks may be an early and useful predictor of glycaemic response to once-weekly dulaglutide treatment.
The effects of a Cognitive Stimulation Therapy [CST] programme for people with dementia on family caregivers’ health

There is growing evidence that Cognitive Simulation Therapy (CST) benefits cognition and quality of life of people with dementia, but little is known about the indirect effects of this intervention on family caregivers. This study sought to investigate the effect of CST on family caregivers general health status of people with dementia living in the community attending the CST intervention.



Eighty-five family caregivers of people with dementia took part in the study. All the people with dementia received the standard twice weekly seven weeks of the CST intervention plus either 24 weeks of a maintenance CST (MCST) intervention or 24 weeks of treatment as usual. Family caregivers were assessed before and after their relatives the CST programme, and after 3 and 6 months of the MCST programme. A pre and post CST groups comparison was undertaken to evaluate the open trial first phase and an ANCOVA model used to analyse the maintenance phase with its controlled comparison.



We found no evidence for a benefit on the family caregiver outcome measures of the intervention before and after CST groups by using a t-test analysis or any significant differences between intervention and control groups for any of the variables considered at any time point (3 and 6 month follow up).



CST seems to have a relatively specific benefit fpr people with dementia that may not carry over to family carers. Future studies need to further explore and compare the effects that CST might bring to family caregivers of people with dementia attending the intervention.
Changing everyday memory behaviour in amnestic mild cognitive impairment: a randomised controlled trial.

One of the defining differences between mild cognitive impairment (MCI) and dementia is the degree of independence in everyday activities. Effecting memory-related behavioural change in MCI could help maintain daily function and prolong the time before onset of dependency. However, it is well known that changing previously well-established behaviours is difficult to achieve. We conducted a randomised controlled trial to evaluate the effectiveness of a multidisciplinary group-based intervention programme in changing everyday memory behaviour in individuals with amnestic MCI. The intervention provided evidenced-based memory training and lifestyle education to optimise memory behaviour. Fifty-four participants were randomly assigned to treatment or waitlist-control conditions. Consistent with our primary goal, treatment participants showed an increase in memory-strategy knowledge and use from pre-test to immediate post-test, and these gains were maintained at three-month post-test relative to waitlist controls. There were no group differences in memory beliefs or on laboratory tests of objective memory performance. The increase in memory-strategy knowledge and use was associated with the degree of participation in the programme. Individuals with MCI, therefore, can acquire and maintain knowledge about memory strategies and, importantly, can change their everyday memory behaviour by putting this knowledge into practice. This incorporation of practical memory strategies into daily routines could potentially provide the means for maintaining functional independence by individuals with MCI, an issue to be addressed in future research.
Step characteristics during obstacle avoidance in hemiplegic stroke

Whereas several animal studies have indicated the important role of the motor cortex in the control of voluntary gait modifications, little is known about the effects of cortical lesions on gait adaptability in humans. Obstacle avoidance tasks provide an adequate paradigm to study the adaptability of the stepping pattern under controlled, experimental conditions. In the present study, an exploratory assessment was made of the failure rate, the preferred stepping strategies (step lengthening vs step shortening), and the spatiotemporal stride characteristics (percentage increases in stride length, duration, and velocity of the crossing and postcrossing strides) during obstacle avoidance in 11 hemiplegic stroke patients and seven healthy controls. Patients were less successful in avoiding obstacles than controls (14% failure rate vs 0.5% in controls), independent of whether the affected or the unaffected leg led the obstacle avoidance. The number of failed trials increased systematically when the available response time became shorter. During successful trials, lengthening of the step was generally preferred over shortening. This bias towards step lengthening was more pronounced in stroke patients (step lengthening in 91% of the trials vs 75% in controls), irrespective of the side of obstacle presentation. For both groups, overall strategy preference did not adhere to a principle of minimal foot displacement, since step lengthening was used even if it would be more spatially efficient to shorten the step. No statistically significant group differences were found for the increases in length, duration, and velocity of the crossing and postcrossing strides. However, for a subgroup of more slowly walking patients, large percentage increases were found in crossing stride length, duration, and velocity. Similar results were obtained for the postcrossing stride, indicating that, for this subgroup of patients, restoration of the normal walking cadence was more difficult. Overall, no systematic differences were found between the affected and the unaffected leg in stroke patients with respect to failure rates, stepping strategies, or spatiotemporal measures of obstacle avoidance. The present findings suggest that the ability to adequately modify the stepping pattern in response to imposed spatiotemporal constraints is impaired in persons with stroke, especially when modifications have to be performed under time pressure. In addition, the stepping strategies employed by subjects with stroke are different from those found in controls, possibly to reduce the complexity of the avoidance maneuver and to enhance safety. Finally, unilateral cortical damage results in an impaired ability to avoid obstacles on both sides of the body, suggesting that the reduced ability of stroke patients to negotiate obstacles may be related to problems of a more general coordinative nature.
Detection of human papillomavirus and adenovirus in benign and malignant lesions of the larynx.

To investigate the role of human papillomavirus (HPV) and adenovirus (AdV) infections in the oncogenesis of squamous cell carcinomas of the larynx and of laryngeal dysplasia.



Cross-sectional study with planned data collection.



Department of Otorhinolaryngology G. Ferreri and Department of Experimental Medicine and Pathology-Section of Virology, Sapienza University of Rome.



Biopsy samples were taken from 68 patients with benign and malignant lesions of the larynx. All tissue samples were analyzed by means of polymerase chain reaction with two groups of primers for HPV and with a pair of primers for AdV.



All cases of carcinomas and dysplasia as well as all control cases were negative for both viruses. Four of the five cases of laryngeal papillomas were positive for only HPV, confirming the role of these viral types in the origin of papillomas.



The absence of viral genomes in laryngeal carcinomas as in the other cases studied suggests the existence of other factors that play a more important role than viral infection in the carcinogenesis of these lesions.
Facilitating a benign attentional bias reduces negative thought intrusions.

The causal role of biased attention in worry was investigated in an experiment in which high worriers were assigned either to a condition requiring attention to nonthreatening words and text while ignoring worry-related material or to a mixed-attention control condition. The former procedure led to fewer negative thought intrusions in a worry test (as rated by both participants and an assessor) than did the control condition. These findings suggest that attentional bias plays a causal role in worry and that its modification can reduce excessive worry.
Effect of insulin feedback on closed-loop glucose control: a crossover study.

Closed-loop (CL) insulin delivery systems utilizing proportional-integral-derivative (PID) controllers have demonstrated susceptibility to late postprandial hypoglycemia because of delays between insulin delivery and blood glucose (BG) response. An insulin feedback (IFB) modification to the PID algorithm has been introduced to mitigate this risk. We examined the effect of IFB on CL BG control.



Using the Medtronic ePID CL system, four subjects were studied for 24 h on PID control and 24 h during a separate admission with the IFB modification (PID + IFB). Target glucose was 120 mg/dl; meals were served at 8:00 AM, 1:00 PM, and 6:00 PM and were identical for both admissions. No premeal manual boluses were given. Reference BG excursions, defined as incremental glucose rise from premeal to peak, and postprandial BG area under the curve (AUC; 0-5 h) were compared. Results are reported as mean ± standard deviation.



The PID + IFB control resulted in higher mean BG levels compared with PID alone (153 ± 54 versus 133 ± 56 mg/dl; p < .0001). Postmeal BG excursions (114 ± 28 versus 114 ± 47 mg/dl) and AUCs (285 ± 102 versus 255 ± 129 mg/dl/h) were similar under both conditions. Total insulin delivery averaged 57 ± 20 U with PID versus 45 ± 13 U with PID + IFB (p = .18). Notably, eight hypoglycemic events (BG < 60 mg/dl) occurred during PID control versus none during PID + IFB.



Addition of IFB to the PID controller markedly reduced the occurrence of hypoglycemia without increasing meal-related glucose excursions. Higher average BG levels may be attributable to differences in the determination of system gain (Kp) in this study. The prevention of postprandial hypoglycemia suggests that the PID + IFB algorithm may allow for lower target glucose selection and improved overall glycemic control.
An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and Non-African Americans in the SYMPLICITY HTN-3 trial.

SYMPLICITY HTN-3, the first trial of renal denervation (RDN) versus sham, enrolled 26% African Americans, a prospectively stratified cohort. Although the 6-month systolic blood pressure (SBP) reduction in African Americans (AAs) was similar in the RDN group (-15.5 ± 25.4 mm Hg, n = 85 vs. -17.8 ± 29.2, n = 49, P = .641), the sham SBP response was 9.2 mm Hg greater (P = .057) in AAs than non-AAs. In multivariate analyses, sham SBP response was predicted by an interaction between AA and a complex antihypertensive regimen (at least one antihypertensive medication prescribed ≥3 times daily), while in the RDN group, SBP response was predicted by an interaction between AA race and baseline BP ≥ 180 mm Hg. AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment arms that affect the observed pattern of SBP responses.