nils-herrmann/clean_scirepeval huggingface dataset:
Randomized trial of deep brain stimulation for Parkinson disease: thirty-six-month outcomes.

Our objective was to compare long-term outcomes of deep brain stimulation (DBS) of the globus pallidus interna (GPi) and subthalamic nucleus (STN) for patients with Parkinson disease (PD) in a multicenter randomized controlled trial.



Patients randomly assigned to GPi (n = 89) or STN DBS (n = 70) were followed for 36 months. The primary outcome was motor function on stimulation/off medication using the Unified Parkinson's Disease Rating Scale motor subscale. Secondary outcomes included quality of life and neurocognitive function.



Motor function improved between baseline and 36 months for GPi (41.1 to 27.1; 95% confidence interval [CI] -16.4 to -10.8; p < 0.001) and STN (42.5 to 29.7; 95% CI -15.8 to -9.4; p < 0.001); improvements were similar between targets and stable over time (p = 0.59). Health-related quality of life improved at 6 months on all subscales (all p values significant), but improvement diminished over time. Mattis Dementia Rating Scale scores declined faster for STN than GPi patients (p = 0.01); other neurocognitive measures showed gradual decline overall.



The beneficial effect of DBS on motor function was stable and comparable by target over 36 months. Slight declines in quality of life following initial gains and gradual decline in neurocognitive function likely reflect underlying disease progression and highlight the importance of nonmotor symptoms in determining quality of life.



This study provides Class III evidence that improvement of motor symptoms of PD by DBS remains stable over 3 years and does not differ by surgical target. Neurology® 2012;79:55-65.
Ambulatory care of children treated with anticonvulsants - pitfalls after discharge from hospital.

Anticonvulsants require special consideration particularly at the interface from hospital to ambulatory care.



Observational study for 6 months with prospectively enrolled consecutive patients in a neuropediatric ward of a university hospital (age 0-<18 years) with long-term therapy of at least one anticonvulsant. Assessment of outpatient prescriptions after discharge. Parent interviews for emergency treatment for acute seizures and safety precautions.



We identified changes of the brand in 19/82 (23%) patients caused by hospital's discharge letters (4/82; 5%) or in ambulatory care (15/82; 18%). In 37/76 (49%) of patients who were deemed to require rescue medication, no recommendation for such a medication was included in the discharge letters. 17/76 (22%) of the respective parents stated that they had no immediate access to rescue medication. Safety precautions were applicable in 44 epilepsy patients. We identified knowledge deficits in 27/44 (61%) of parents.



Switching of brands after discharge was frequent. In the discharge letters, rescue medications were insufficiently recommended. Additionally, parents frequently displayed knowledge deficits in risk management.
Immune thrombocytopenia in patients with chronic lymphocytic leukemia treated with cladribine-based regiments or chlorambucil--follow-up of PALG-CLL randomized trials.

The relationship between treatments of chronic lymphocytic leukemia (CLL) with cladribine (2-CdA) or chlorambucil and immune thrombocytopenia (IT) has not been yet determined.



The records of 777 patients in two randomized Polish Adult Leukemia Group (PALG)-CLL programs treated with these agents were retrospectively analyzed.



Immune thrombocytopenia occurred in 55 of 777 (7.1%) patients. No significant differences in IT prevalence were seen between patients on chlorambucil or 2-CdA-based regiments (P = 0.33). IT developed at a median time of 0.499 yr (0.06-4.8) from the start of CLL therapy. This time was significantly longer in patients treated with chlorambucil (2.03 yr, 95% CI: 0.06-4.22) in relation to patients treated with 2-CdA-based regiments (0.52 yr, 95%CI: 0.34-0.69, P = 0.049). Overall survival (OS) of patients with IT and those without IT were similar (2.65 yr vs. 3.2 yr P = 0.23) but the severity of bleeding was more pronounced in the 2-CdA group. The responses to IT therapy were 35%, 54% and 75% for steroids, chemotherapy and splenectomy, respectively.



In this study, an unexpectedly high percentage of IT incidence was demonstrated in patients with CLL requiring chemotherapy. Although no marked differences were seen in IT frequency in patients treated with 2-CdA-based regiments compared to chlorambucil regimen, the clinical course of hemorrhagic diathesis was more severe in 2-CdA group. Also, the time elapsed from study screening to IT diagnosis was significantly shorter in the 2-CdA group than in the chlorambucil group suggesting a causative relationship. The appearance of IT did not influence the median time of OS.
The effects of drinking goal on treatment outcome for alcoholism.

It is well known to clinicians and researchers in the field of alcoholism that patients vary with respect to drinking goal. The objective in this study was to elucidate the contribution of drinking goal to treatment outcome in the context of specific behavioral and pharmacological interventions.



Participants were 1,226 alcohol-dependent individuals enrolled in a large, multisite trial of combined behavioral intervention, acamprosate, and naltrexone. Drinking goal was coded as follows: (a) controlled drinking, (b) conditional abstinence, and (c) complete abstinence.



Analysis revealed a main effect of drinking goal on percent days abstinent (p < .0001), days to relapse to heavy drinking (p < .0001), and global clinical outcome (p < .001). These results were such that a goal of complete abstinence was associated with the best outcomes, followed by conditional abstinence; controlled drinking was associated with the poorest outcomes. Conversely, a main effect of drinking goal was observed on drinks per drinking day (p < .01), such that controlled drinking was associated with fewer drinks per drinking day whereas complete abstinence was associated with the highest number of drinks per drinking day. Combined behavioral intervention performed better than medical management alone for participants whose drinking goal was not complete abstinence.



These results suggest that drinking goal represents a highly predictive clinical variable and should be an integral part of the clinical assessment of patients with alcohol dependence. Assessment of patients' drinking goals may also help match patients to interventions best suited to address their goals and clinical needs.
Feasibility of minocycline and doxycycline use as potential vasculostatic therapy for brain vascular malformations: pilot study of adverse events and tolerance.

Tetracyclines may be useful in preventing pathological vascular remodeling, thus decreasing the risk of spontaneous hemorrhage from brain vascular malformations.



Arteriovenous malformation (AVM) and intracranial aneurysm patients undergoing noninvasive management were treated with minocycline or doxycycline (200 mg/day) up to 2 years in a prospective open-label safety pilot trial. The primary outcome was to compare dose-limiting intolerance, defined as treatment-related dose reduction or withdrawal between the agents.



Twenty-six patients with AVMs (n = 12) or aneurysms (n = 14) were recruited. Adverse event rates were similar to other reported trials of these agents; 4 of 13 (31%) minocycline and 3 of 13 (23%) doxycycline patients had dose-limiting intolerance (hazard ratio = 3.1, 95% CI = 0.52-18.11, log rank p = 0.70).



It is feasible to propose a long-term trial to assess the potential benefit of tetracycline therapy to decrease hemorrhagic risk in brain vascular malformations.
Biweekly pegylated liposomal doxorubicin as second-line treatment in patients with relapsed ovarian cancer after failure of platinum and paclitaxel: results from a multi-center phase II study of the NOGGO.

Pegylated liposomal doxorubicin (PLD) is one of the most effective cytotoxic agents in recurrent ovarian cancer. Palmar-plantar erythrodysesthesia (PPE) is a typical and commonly noted adverse event and often represents the dose-limiting toxicity. The purpose of this multicenter study was to determine the efficacy of this regimen as second-line therapy for patients with recurrent ovarian cancer.



Patients with recurrent epithelial ovarian cancer after surgery and initial treatment with carboplatin and paclitaxel were enrolled. Eligible patients were required to have an ECOG performance status of < or =2, and sufficient organ function. PLD was administered at a dose of 20 mg/m2 every two weeks.



Twenty patients were recruited into this trial. Overall, 155 cycles of chemotherapy with a median of six courses (range 4-24) were administered. The median patient age was 64 years (range, 41-77 years). The hematological and non-hematological toxicity profile was favorable. No grade IV toxicity was observed. PPE grade III toxicity was noted in only one patient. Median overall survival was 19.2 months (range 1.8 to 39 months; 95% confidence interval (CI) 14.2-29.7 months) Progression-free survival was 3.3 months (range 1.38 to 36.4 months; 95% CI 1.84-13.4 months).



Biweekly PLD is an effective second-line treatment for patients with relapsed ovarian cancer. Toxicity incidence with this treatment schedule does not appear to be associated with the number of previous chemotherapies. Our data supports the need for a randomized study comparing biweekly with conventional monthly administration of 40 mg/m2 or 50 mg/m2 PLD to determine the best therapeutic index for PLD.
A controlled study of eight months of physical training and reduction of blood pressure in children: the Odense schoolchild study.

To examine the effect of physical training on physical fitness and blood pressure in children aged 9-11 years.



Prospective randomised controlled intervention study of a sample of children drawn from a population survey of coronary risk factors in children.



Odense, Denmark.



69 children with mean blood pressure greater than or equal to 95th centile (hypertensive group) and 68 with mean blood pressure less than 95th centile (normotensive group), randomly selected from a population of 1369 children.



67 children were randomised to receive three extra lessons a week of an ordinary school physical education programme for eight months.



Physical fitness assessed by calculation of maximum oxygen uptake and blood pressure recorded by one unblinded observer.



After three months neither blood pressure nor physical fitness had changed significantly. After adjustment for values in weight, height, heart rate, and the variable in question before training physical fitness rose significantly at the end of eight months' training, by 3.7 mlO2/kg/min (95% confidence interval 2.2 to 5.3) in the normotensive training subgroup and by 2.1 mlO2/kg/min (0.1 to 4.2) in the hypertensive training subgroup compared with that in the controls. Systolic and diastolic blood pressures in the training subgroups fell significantly by 6.5 mm Hg (3.2 to 9.9) and 4.1 mm Hg (1.7 to 6.6) respectively in the normotensive group and by 4.9 mm Hg (0.7 to 9.2) and 3.8 mm Hg (0.9 to 6.6) respectively in the hypertensive group.



Physical training lowers blood pressure and improves physical fitness in children and might have implications for an important non-pharmacological approach to primary prevention of essential hypertension.
Does Guanfacine Extended Release Impact Functional Impairment in Children with Attention-Deficit/Hyperactivity Disorder? Results from a Randomized Controlled Trial

In clinical trials of medications to treat attention-deficit/hyperactivity disorder (ADHD) in children, effects on functional impairment have been less well-studied than changes in ADHD symptoms.



Data regarding functional impairment were analyzed from a multicenter, double-blind, placebo-controlled study of guanfacine extended release (GXR) in children with ADHD, using the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). The correspondence of changes in WFIRS-P scores with symptomatic and global response to GXR treatment was also examined, with treatment response defined by scores on both the ADHD Rating Scale IV (ADHD-RS-IV) and the Clinical Global Impressions-Improvement Scale (CGI-I).



In this 8-week, double-blind, placebo-controlled, dose optimization study at 47 sites across the USA and Canada, children aged 6-12 years with a diagnosis of ADHD [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, and an ADHD-RS-IV score ≥28 and CGI-Severity of Illness Scale score ≥4 at baseline], were randomized 1:1:1 into three groups: GXR AM [GXR (1-4 mg/day) in the morning, placebo in the evening], GXR PM [placebo in the morning, GXR (1-4 mg/day) in the evening], or twice-daily placebo. Parents rated their children on the WFIRS-P at screening, baseline, the end of dose optimization, and at the final on-treatment assessment.



The efficacy population was composed of 333 subjects (GXR AM: n = 107; GXR PM: n = 114; placebo: n = 112). At the final on-treatment assessment, there were significant improvements from baseline in the placebo-adjusted difference in least-squares (LS) mean (95 % confidence interval) WFIRS-P Total scores for both GXR treatment groups combined [GXR all-active: -0.16 (-0.25, -0.07), effect size (ES) = 0.448, P <0.001] and separately [GXR AM: -0.15 (-0.26, -0.05), ES = 0.417, P = 0.004; GXR PM: -0.18 (-0.28, -0.07), ES = 0.478, P = 0.001]. Significant improvements in WFIRS-P domain scores for Family, Learning and School (including Academic Performance and Behavior in School), Social, and Risky Behavior were found for both GXR cohorts compared with placebo. However, the Life Skills and Self-Concept domain scores of the WFIRS-P did not improve with GXR treatment. Post hoc stratification by responder status revealed that significant (P <0.001) improvements in WFIRS-P Total and all domain scores were associated with symptomatic treatment response in the GXR all-active group.



GXR treatment in children with ADHD was associated with reductions in WFIRS-P functional impairment scores compared with placebo, regardless of time of GXR administration. Changes in WFIRS-P scores were congruent with clinical response, as determined by both ADHD symptom reduction and CGI-I scores. GOV IDENTIFIER
NCT00997984.
A multi-disciplinary education process related to the discharging of children from hospital when the child has been diagnosed with type 1 diabetes - a qualitative study

Worldwide, insulin-dependent type 1 diabetes is one of the most frequently diagnosed long-term endocrine disorders found in children and the incidences of this diseased is still increasing. In Sweden the routines are, according to national guidelines, when the child is diagnosed with type 1 diabetes, the child and its family remains at the hospital for about two weeks. There is limited knowledge about how a diabetes team handles a child and its family from admission to discharge, therefore the purpose of this study was to seek a deeper understanding of how the diabetes team's parent/child education process works, from admission to discharge, among families with a child newly diagnosed with type 1 diabetes.



Qualitative data collection was used. Four focus-group interviews, with a sample of three diabetes teams from different paediatric hospitals in the south western part of Sweden, were conducted and the data recorded on tape and then analysed using qualitative content analysis.



The results indicate that achieving a status of self-care on the part of the patient is the goal of the diabetes education programme. Part of the programme is aimed at guiding the child and its parents towards self-help through the means of providing them with knowledge of the disease and its treatment to enable the whole family to understand the need for cooperation in the process. To do this requires an understanding, by the diabetes team, of the individualities of the family in order to gain an overall picture.



The results of this study show that the diabetes education programme is specifically designed for each family using the internationally recommended clinical practice guidelines with its specific aims and objectives. Achieving the families' willingness to assist in the self-care of the child care is the goal of the parent education process. To achieve this, the paediatric diabetes specialist nurse and the diabetes specialist paediatrician immediately and deliberately start the process of educating the family using a programme designed to give them the necessary knowledge and skills they will need to manage their child's type 1 diabetes at home.
Gait improvement in patients with cerebral palsy by visual and auditory feedback

Visual and auditory feedback cues have been shown to improve gait and balance in patients with movement disorders, such as Parkinson's disease and multiple sclerosis. Subsequently, closed-loop virtual reality was used to enhance the gait improvement effect of such cues.  To study the effects of gait training with visual and auditory feedback cues on the walking abilities of patients with gait disorders due to cerebral palsy.  Visual and auditory feedback cues were generated by a wearable accelerometry-driven device. Ten randomly selected patients with gait disorders due to cerebral palsy trained with visual feedback cues while ten such patients trained with auditory feedback cues. Baseline performance (walking speed and stride length along a 10m straight track) was measured before device use. Following 20min training with the device, performance without the device was measured again and compared to the baseline performance.  For patients training with visual feedback, the average improvement in walking speed was 21.70%+/−36.06% and in stride length 8.72%±9.47%. For patients training with auditory feedback, average improvement in walking speed was 25.43%±28.65% and in stride length 13.58%±13.10%.  Visual and auditory feedback cues can improve gait parameters in patients with gait disorders due to cerebral palsy.
Reduction of blood pressure with calcium and potassium supplementation in children with salt sensitivity: a 2-year double-blinded placebo-controlled trial

An investigation of the reductive effect of blood pressure and increment of urinary sodium excretion with calcium and potassium supplementation in children with sodium sensitivity is conducted. In total of 261 school children who had completed a 2-year double-blinded, placebo-controlled trial with calcium and potassium supplementation salt sensitivity, with a salt volume expansion and contraction protocol, was determined. The results showed that in children with salt sensitivity, the increase in blood pressure in the supplementary group was lower by 4.3/4.8 mmHg than that in the placebo group (P<0.05), while no significant change was found between the supplementary group and placebo group in children with nonsalt sensitivity. With calcium and potassium supplementation, the night urinary sodium excretion in children with salt sensitivity was significantly increased (P<0.01), and it is negatively correlated with the increase in blood pressure. It was suggested that a moderate increase of calcium and potassium intake in children with salt sensitivity, through interaction with sodium, can promote urinary sodium excretion and may play contribute to the prevention of hypertension.
The effects of postural drainage and positive expiratory pressure physiotherapy on tracheobronchial clearance in cystic fibrosis.

We studied the effects of two chest physiotherapy regimens on whole lung and regional tracheobronchial clearance (TBC) in ten patients with cystic fibrosis. The regimens were given on two separate days and consisted of 20 min of (1) postural drainage and the forced expiration technique (PD + FET), and (2) positive expiratory pressure (PEP-mask) and FET (PEP + FET). A third day served as control. The study days were randomized. Each day, the clearance of lung radioactivity was measured for 3 h by gamma camera. The number of spontaneous coughs was recorded and the sputum expectorated was sampled. We found that both PD + FET and PEP + FET improved whole lung TBC at 30 minutes and 1 h four or fivefold (p less than 0.01) compared with control, whereas at 2 h and 3 h only the improvement following PEP + FET (approximately 1.4 times) was significant (p less than 0.05). There was no significant difference in whole lung or regional TBC between the PD + FET and PEP + FET treatments. The correlations between TBC and the radioactivity content in sputum expectorated (rs2 = 0.76) and between TBC and numbers of coughs (rs2 = 0.65) were better than between TBC and the weight of sputum expectorated (Rs = 0.39). We conclude that PD or PEP when combined with FET have similar effects on short-term whole lung and regional TBC in patients with cystic fibrosis. Evaluation of TBC during chest physiotherapy when only based on the weight of sputum expectorated seems inadequate.
An MRI-based Assessment of Standard and Extralevator Abdominoperineal Excision Specimens: Time for a Patient Tailored Approach?

The extralevator abdominoperineal excision (ELAPE) has been proposed as oncologically superior to standard abdominoperineal excision (SAPE). However, little is known regarding comparative margins achieved in ELAPE and SAPE. The purpose of this study was to compare patterns of tissue removal between these two groups that can aid patient selection. Twenty APE specimens, comprising 10 SAPEs and 10 ELAPEs, were selected randomly from a single UK centre. Transverse slices of pathological specimens were matched to corresponding axial MRI images obtained from conventional pelvic MRI imaging. Measurements from the muscularis propria to the resection margin [muscularis to margin (MTM) distance] were recorded by height (from anal verge) and quadrant for each surgical group. MTM distances achieved on histopathological assessment were also compared to MRI assessed distances necessary to achieve a clear CRM. ELAPE specimens had a greater mean MTM distance than for SAPE (7.75 vs. 5.61 mm, p = 0.02). ELAPE had significantly greater MTM distances in lateral and posterior quadrants (p < 0.05) than SAPE at 30–49 mm. There was no significant difference in mean anterior distances (1.57 vs. 1.16 mm, p = 0.507) with the smallest difference at a height of 60–69 mm. Two (2 %) of pathological MTM distances within ELAPE group failed to achieve the minimum MRI assessed distance compared with 30 (23 %) in the SAPE group, which had higher CRM positivity. ELAPE appears to confer oncological benefit over SAPE but with notable exceptions, including tumours located above and below the puborectalis sling and anteriorly at the level of prostate where exenteration may be more appropriate.
Dyskinesia and motor state detection in Parkinson's Disease patients with a single movement sensor

Parkinson's Disease (PD) is a neurodegenerative disease that alters the patients' motor performance. Patients suffer many motor symptoms: bradykinesia, dyskinesia and freezing of gait, among others. Furthermore, patients alternate between periods in which they are able to move smoothly for some hours (ON state), and periods with motor complications (OFF state). An accurate report of PD motor states and symptoms will enable doctors to personalize medication intake and, therefore, improve response to treatment. Additionally, real-time reporting could allow an automatic management of PD by means of an automatic control of drug-administration pump doses. Such a system must be able to provide accurate information without disturbing the patients' daily life activities. This paper presents the results of the MoMoPa study classifying motor states and dyskinesia from 20 PD patients by using a belt-worn single tri-axial accelerometer. The algorithms obtained will be validated in a further study with 15 PD patients and will be enhanced in the REMPARK project.