nils-herrmann/clean_scirepeval huggingface dataset:
Sensitivity to changes during antidepressant treatment: a comparison of unidimensional subscales of the Inventory of Depressive Symptomatology (IDS-C) and the Hamilton Depression Rating Scale (HAMD) in patients with mild major, minor or subsyndromal depression

In the efficacy evaluation of antidepressant treatments, the total score of the Hamilton Depression Rating Scale (HAMD) is still regarded as the ‘gold standard’. We previously had shown that the Inventory of Depressive Symptomatology (IDS) was more sensitive to detect depressive symptom changes than the HAMD17 (Helmreich et al. 2011). Furthermore, studies suggest that the unidimensional subscales of the HAMD, which capture the core depressive symptoms, outperform the full HAMD regarding the detection of antidepressant treatment effects. The aim of the present study was to compare several unidimensional subscales of the HAMD and the IDS regarding their sensitivity to changes in depression symptoms in a sample of patients with mild major, minor or subsyndromal depression (MIND). Biweekly IDS-C28 and HAMD17 data from 287 patients of a 10-week randomised, placebo-controlled trial comparing the effectiveness of sertraline and cognitive–behavioural group therapy in patients with MIND were converted to subscale scores and analysed during the antidepressant treatment course. We investigated sensitivity to depressive change for all scales from assessment-to-assessment, in relation to depression severity level and placebo–verum differences. The subscales performed similarly during the treatment course, with slight advantages for some subscales in detecting treatment effects depending on the treatment modality and on the items included. Most changes in depressive symptomatology were detected by the IDS short scale, but regarding the effect sizes, it performed worse than most subscales. Unidimensional subscales are a time- and cost-saving option in judging drug therapy outcomes, especially in antidepressant treatment efficacy studies. However, subscales do not cover all facets of depression (e.g. atypical symptoms, sleep disturbances), which might be important for comprehensively understanding the nature of the disease depression. Therefore, the cost-to-benefit ratio must be carefully assessed in the decision for using unidimensional subscales.
Phase I trial of fluorouracil modulation by N-phosphonacetyl-L-aspartate and 6-methylmercaptopurine ribonucleoside

Inhibition of pyrimidine and purine synthesis has been demonstrated to potentiate 5-fluorouracil (5-FU) activity in preclinical models. Low-dose phosphonacetyl-l-aspartate (PALA) potentiates the incorporation of 5-FU into RNA, without detectably increasing its toxicity. 6-Methylmercaptopurine riboside (MMPR) results in inhibition of purine biosynthesis with elevation of phosphoribosyl pyrophosphate (PRPP), which in turn is believed to increase the phosphorylation and intracellular retention of 5-FU. We conducted a phase I clinical trial to determine the maximum tolerated dose of 5-FU in combination with low-dose PALA and a biochemically-optimized dose of MMPR. The regimen consisted of PALA 250 mg/m2 given on day 1, followed 24 h later by MMPR 150 mg/m2, and escalating doses of 5-FU from 1625 to 2600 mg/m2 by 24 h continuous infusion. This regimen was repeated weekly. A group of 29 patients with a diagnosis of malignant solid tumor were entered; their median performance status was 1. The dose-limiting toxicity was mucositis, while other gastrointestinal toxicity was minimal. Two patients also experienced ischemic chest pain during the 5-FU infusion. The maximum tolerated dose of 5-FU in this combination was 2600 mg/m2. Several responses were observed including a complete remission in a previously treated breast cancer patient and two partial responses in breast and colon cancer. MMPR pharmacokinetics were obtained from urine analyses in 21 patients on this trial; there was no correlation between the pharmacokinetics of MMPR and the toxicity observed. This regimen was well tolerated and phase II trials are warranted using PALA 250 mg/m2, MMPR 150 mg/m2, and 5-FU 2300 mg/m2 by continuous infusion over 24 h.
Late cognitive and radiographic changes related to radiotherapy: initial prospective findings.

Assumptions about the damaging effects of radiotherapy (XRT) are based on studies in which total dose, dose fraction, treatment volume, degree of malignancy, chemotherapy, tumor recurrence, and neurologic comorbidity interact with XRT effects. This is a prospective, long-term study of XRT effects in adults, in which total dose and dose fraction were constrained and data related to tumor recurrence and neurologic comorbidity (e.g., hypertension) were excluded.



The effects of XRT on the cognitive and radiographic outcomes of 26 patients with low-grade, supratentorial, brain tumors yearly from baseline (6 weeks after surgery and immediately before XRT) and yearly to 6 years were examined. Radiographic findings were examined regionally.



Selective cognitive declines (in visual memory) emerged only at 5 years, whereas ratings of clinical MRI (T2 images) showed mild accumulation of hyperintensities with post-treatment onset from 6 months to 3 years, with no further progression. White matter atrophy and total hyperintensities demonstrated this effect, with subcortical and deep white matter, corpus callosum, cerebellar structures, and pons accounting for these changes over time. About half of the patients demonstrated cognitive decline and treatment-related hyperintensities.



There was no evidence of a general cognitive decline or progression of white matter changes after 3 years. Results argue for limited damage from XRT at this frequently used dose and volume in the absence of other clinical risk factors.
Effects of Mendelsohn maneuver on measures of swallowing duration post stroke.

The purpose of this pilot study was to determine whether intensive use of the Mendelsohn maneuver in patients post stroke could alter swallow physiology when used as a rehabilitative exercise.



Eighteen outpatients between 6 weeks and 22 months post stroke were enrolled in this prospective study using a crossover design to compare 2 weeks of treatment with 2 weeks of no treatment. Each participant received an initial videofluoroscopic swallow study (VFSS) and an additional VFSS at the end of each week for 1 month for a total of 5 studies. During treatment weeks, participants received 2 treatment sessions per day performing Mendelsohn maneuvers with surface electromyography for biofeedback. Measures of swallowing duration, penetration/aspiration, residue, and dysphagia severity were analyzed from VFSS to compare treatment and no-treatment weeks.



Significant changes occurred for measures of the duration of superior and anterior hyoid movement after 2 weeks of treatment. Improvements were observed for duration of opening of the upper esophageal sphincter (UES), but results were not statistically significant. Measures of penetration/aspiration, residue, and dysphagia severity improved throughout the study, but no differences were observed between treatment and no-treatment weeks.



Intensive use of the Mendselsohn maneuver in isolation altered duration of hyoid movement and UES opening in this exploratory study. Results can guide future research toward improved selection criteria and exploration of outcomes. Larger numbers of participants and variations in treatment duration and intensity will be necessary to determine the true clinical value of this treatment.
A biofeedback cycling training to improve locomotion: a case series study based on gait pattern classification of 153 chronic stroke patients

The restoration of walking ability is the main goal of post-stroke lower limb rehabilitation and different studies suggest that pedaling may have a positive effect on locomotion. The aim of this study was to explore the feasibility of a biofeedback pedaling treatment and its effects on cycling and walking ability in chronic stroke patients. A case series study was designed and participants were recruited based on a gait pattern classification of a population of 153 chronic stroke patients. In order to optimize participants selection, a k-means cluster analysis was performed to subgroup homogenous gait patterns in terms of gait speed and symmetry. The training consisted of a 2-week treatment of 6 sessions. A visual biofeedback helped the subjects in maintaining a symmetrical contribution of the two legs during pedaling. Participants were assessed before, after training and at follow-up visits (one week after treatment). Outcome measures were the unbalance during a pedaling test, and the temporal, spatial, and symmetry parameters during gait analysis. Three clusters, mainly differing in terms of gait speed, were identified and participants, representative of each cluster, were selected. An intra-subject statistical analysis (ANOVA) showed that all patients significantly decreased the pedaling unbalance after treatment and maintained significant improvements with respect to baseline at follow-up. The 2-week treatment induced some modifications in the gait pattern of two patients: one, the most impaired, significantly improved mean velocity and increased gait symmetry; the other one reduced significantly the over-compensation of the healthy limb. No benefits were produced in the gait of the last subject who maintained her slow but almost symmetrical pattern. Thus, this study might suggest that the treatment can be beneficial for patients having a very asymmetrical and inefficient gait and for those that overuse the healthy leg. The results demonstrated that the treatment is feasible and it might be effective in translating progresses from pedaling to locomotion. If these results are confirmed on a larger and controlled scale, the intervention, thanks to its safety and low price, could have a significant impact as a home- rehabilitation treatment for chronic stroke patients.
Long-term outcome of laparoscopic nissen fundoplication compared with laparoscopic thal fundoplication in children: a prospective, randomized study.

Laparoscopic fundoplication is increasingly performed in pediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. To date there has been no prospective randomized study to determine the optimal laparoscopic technique in children. The aim of the study was to compare the long-term outcomes and control of symptoms after laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.



Between July 1998 and April 2007, 175 patients were recruited to this prospective, randomized study. Patients were assessed before the operation and after defined intervals starting at 3 months after surgery. The "absolute" outcome measure for fundoplication failure was recurrence of symptoms that merited a redofundoplication or insertion of a transgastric jejunostomy. "Relative" outcome measures were recurrence of symptoms necessitating reintroduction of antireflux medication (ie, "intention to treat") and postoperative complications (eg, postoperative dysphagia). The median follow-up time was 30 months (range, 1-109). This study has been registered with clinicaltrials.gov (NCT01027975).



Long-term results were available in 167 patients of which 85 underwent a Nissen and 82 a Thal fundoplication. Four patients in the Nissen group (4.7%) and 12 in the Thal group (14.6%) required a redofundoplication. One child in each group developed recurrence of symptoms and had a transgastric jejunostomy performed. The "absolute" failure rate was significant lower in the Nissen group (n = 5; 5.9%) compared with the Thal group (n = 13; 15.9%) (P = 0.038). The vast majority of these patients (17 of 18) had underlying neurological disorders. The "relative" failure rate (ie, "intention to treat") was similar in both groups. Nearly one-quarter of patients developed postoperative dysphagia similarly distributed between both groups. However, severe dysphagia requiring endoscopy +/- dilatation was significantly higher in the Nissen group (n = 10, 11.8%) compared with the Thal group (n = 2; 2.4%) (P = 0.020). One of 31 deaths (0.6%) in this series occurred after surgery, but was not directly related to the fundoplication technique.



In the long-term a laparoscopic Nissen fundoplication had a significantly lower recurrence rate than a Thal fundoplication, particularly in patients with underlying neurological disorders. There was no significant difference between the 2 types of fundoplication in normal children. There was no significant difference between the need for restarting antireflux medication between both groups because of recurrence of moderate symptoms. The incidence of postoperative dysphagia was similar in the 2 groups, however, significantly more patients in the Nissen group required intervention for severe dysphagia. Overall the perioperative death rate was low even in high-risk patients.
Pegylated liposomal doxorubicin, 5-fluorouracil and cisplatin versus mitomycin-C, 5-fluorouracil and cisplatin for advanced gastric cancer: a randomized phase II trial

Clinical data suggested that a regimen incorporating doxorubicin to 5-fluorouracil (5-FU) and cisplatin may be more effective but probably quite toxic for advanced gastric cancer patients. With the aim to maintain efficacy while reducing toxicity, we compared the activity and safety of a combination of 5-FU, cisplatin and pegylated liposomal doxorubicin with a combination of 5-FU, cisplatin and mitomycin-C. Seventy-eight patients were randomised to receive 5-FU (400 mg/m2 bolus, 600 mg/m2 22 h continuous infusion day 1 and 2) and cisplatin (50 mg/m2 day 1) every 2 weeks, combined either with pegylated liposomal doxorubicin (20 mg/m2 day 1 every two weeks) (arm A) or mitomycin-C (7 mg/m2 every 6 weeks) (arm B). The overall response rate was 64.1% in arm A and 38.5% in arm B (P = 0.041). The median time to tumour progression and overall survival were 7.93 and 5.14 months (P = 0.04) and 12.1 and 8.3 months (P = 0.02) in arm A and B, respectively. Fourteen patients in arm A and 18 patients in arm B experienced a grade 3/4 toxic effect. A combination of pegylated liposomal doxorubicin, cisplatin and 5-FU can be safely administered in gastric cancer patients with a promising efficacy profile.
A dose-dense schedule of docetaxel followed by doxorubicin and cyclophosphamide as neoadjuvant treatment for breast cancer: results from a phase II study.

The objective was to evaluate a dose-dense schedule of docetaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant treatment for patients with locally advanced breast cancer.



Ninety-nine patients were included and received 100 mg/m(2) of docetaxel every two weeks for four cycles followed by 60 mg/m(2) of doxorubicin and 600 mg/m(2) of cyclophosphamide every two weeks for four cycles. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) was administered systematically to all patients.



Efficacy and toxicity analyses were carried out on an intention-to-treat basis. After treatment, complete pathological response in the breast and lymph nodes was confirmed in 15 patients (15%, 95% confidence interval [CI]: 8.4-22.9). Clinical response rate was 74% (95% CI: 65-82), of which 19% were complete responses. Breast-conserving surgery could be performed in 41% of patients. The dose-dense schedule was generally well tolerated. The most important grade 3/4 toxicities per patient were cutaneous toxicity (12.1%) and hepatic dysfunction (9.1%) during docetaxel administration, and neutropenia (28.1%) and leucopenia (8.3%) with AC.



A dose-dense schedule of docetaxel followed by AC as neoadjuvant treatment is an effective and safe treatment for locally advanced breast cancer. Primary prophylaxis with G-CSF, and possibly the change in the sequence of drug administration, appears to play a major role in avoiding the excessive toxicity of dose-dense schedules.
Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children.

Asthma exacerbations are a common cause of critical illness in children.



To determine factors associated with exacerbations in children with persistent asthma.



Regression modeling was used to identify historical, phenotypic, treatment, and time-dependent factors associated with the occurrence of exacerbations, defined by need for oral corticosteroids or emergency or hospital care in the 48-week Pediatric Asthma Controller Trial study. Children age 6 to 14 years with mild-to-moderate persistent asthma were randomized to receive either fluticasone propionate 100 microg twice daily (FP monotherapy), combination fluticasone 100 microg AM and salmeterol twice daily, or montelukast 5 mg once daily.



Of the 285 participants randomized, 48% had 231 exacerbations. Using a multivariate analysis, which included numerous demographic, pulmonary, and inflammatory parameters, only a history of an asthma exacerbation requiring a systemic corticosteroid in the past year (odds ratio [OR], 2.10; P < .001) was associated with a subsequent exacerbation during the trial. During the trial, treatment with montelukast versus FP monotherapy (OR, 2.00; P = .005), season (spring, fall, or winter vs summer; P < or = .001), and average seasonal 5% reduction in AM peak expiratory flow (OR, 1.21; P = .01) were each associated with exacerbations. Changes in worsening of symptoms, beta-agonist use, and low peak expiratory flow track together before an exacerbation, but have poor positive predictive value of exacerbation.



Children with mild-to-moderate persistent asthma with previous exacerbations are more likely to have a repeat exacerbation despite controller treatment. Inhaled corticosteroids are superior to montelukast at modifying the exacerbation risk. Available physiologic measures and biomarkers and diary card tracking are not reliable predictors of asthma exacerbations.
Inter-rater reliability of the Berg Balance Scale, 30 s chair stand test and 6 m walking test, and construct validity of the Berg Balance Scale in nursing home residents with mild-to-moderate dementia

When testing physical function, patients must be alert and have the capacity to understand and respond to instructions. Patients with dementia may have difficulties fulfilling these requirements and, therefore, the reliability of the measures may be compromised. We aimed to assess the inter-rater reliability between pairs of observers independently rating the participant in the Berg Balance Scale (BBS), 30 s chair stand test (CST) and 6 m walking test. We also wanted to investigate the internal consistency of the BBS.



Cross-sectional study.



We included 33 nursing home patients with a mild-to-moderate degree of dementia and tested them once with two evaluators present. One evaluator gave instructions and both evaluators scored the patients' performance. Weighted κ, intraclass correlation coefficient (ICC) model 2.1 with 95% CIs and minimal detectable change (MDC) were used to measure inter-rater reliability. Cronbach's α was calculated to evaluate the internal consistency of the BBS sum score.



The mean values of the BBS scored by the two evaluators were 38±13.7 and 38.0±13.8, respectively. Weighted κ scores for the BBS items varied from 0.83 to 1.0. ICC for the BBS's sum score was 0.99, and the MDC was 2.7% and 7%, respectively. The Cronbach's α of the BBS's sum score was 0.9. The ICC of the CST and 6 m walking test was 1 and 0.97, respectively. The MDC on the 6 m walking test was 0.08% and 15.2%, respectively.



The results reveal an excellent relative inter-rater reliability of the BBS, CST and 6 m walking test as well as high internal consistency for the BBS in a population of nursing home residents with mild-to-moderate dementia. The absolute reliability was 2.7 on the BBS and 0.08 on the 6 m walking test.
Preliminary application of multiple parameters spectral CT in the diagnosis of ovarian cancer

The aim of the study was to evaluate the effectiveness of spectral CT in the diagnosis of ovarian cancer. We retrospectively analyzed the data of 22 patients with spectral CT enhanced scan. The patients were divided into 2 groups: ovarian cancer group (n = 11) and benign tumor group (n = 11), according to the pathologic results. CT values at 40 keV, iodine concentration (IC), water concentration (WC) and spectral curve slope (λHU) of arterial phase and venous phase in the tumors of 2 groups were measured with gemstone spectral imaging (GSI) post-processing software. The independent samples t test was used to compare these multiple parameters above between 2 groups. For the parameters which showed statistically different, the ROC curves were further generated to calculate their diagnostic effectiveness respectively. According to the results, CT values at 40 keV, IC and λHU measured in arterial and venous phases were higher in ovarian cancer group than those in benign tumor group. There were significant differences between these 2 groups (P < 0.05). While WC had no significant difference in these 2 groups (P > 0.05). CT values at 40 keV, IC and λHU had high effectiveness to the diagnosis of ovarian cancer according to ROC curves. The optimal parameter among them was IC in arterial phase with AUC of 0.90. Using 10.92 (100 ug/cm3) as a threshold value, the sensitivity and specificity for diagnosis were 88.9% and 94.7%. Thus, we concluded that spectral CT with multiple parameters was valuable in the diagnosis of ovarian cancer.
Translating knowledge for action against stroke – using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke)

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers.



Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle.



Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems.