nils-herrmann/clean_scirepeval huggingface dataset:
Response to “ Neutropenic Events in Community Practices Reduced by First and Subsequent Cycle Pegfilgrastim Use ”

We read with interest the study by Ozer et al. . However, several issues deserve further discussion or documentation, as follows. 1. Was it appropriate medical care for these patients to receive pegfilgrastim? The expected rate of febrile neutropenia (FN) was 8.2% based on registry data. The available guidelines at the time suggested a cutoff risk of about 40%, but these patients had good performance status and few comorbidities. No other data were presented to justify pegfilgrastim use. 2. Were patients informed of the benefits, risks, and alternatives when receiving pegfilgrastim, when the expected risk of FN was only 8.2%? G-CSFs are not harmless drugs. Bone pain is seen in up to one third of patients who receive G-CSF [2] and the odds ratio for bone pain is 2.9 from a meta-analysis . There is also concern that these drugs may increase the risk for subsequent hematologic malignancies . 3. Who paid for the pegfilgrastim, because it was used outside the national guidelines? The cost of this drug is substantial. If 2,202 patients received pegfilgrastim, for a median of 4.6 cycles, at a cost of $3,139 per injection (http://www.drugstore.com), the total cost of drug alone would be $31,795,559. Was the cost borne by the sponsor or by the patients and their insurers? Practicing oncologists should not conclude that the use of pegfilgrastim is indicated when the risk for FN is only 8% in patients with a good performance status and few comorbidities. This question can only be answered by a randomized clinical trial.
N-acetylcysteine has neuroprotective effects against oxaliplatin-based adjuvant chemotherapy in colon cancer patients: preliminary data

Although adding oxaliplatin to fluorouracil and leucovorin in adjuvant chemotherapy for colon cancer may improve disease-free survival, grade 3–4 sensory neuropathy also increases. To determine whether oral N-acetylcysteine is neuroprotective against oxaliplatin-induced neuropathy, we did a pilot study. Fourteen stage III colon cancer patients with 4 or more regional lymph nodes metastasis (N2 disease) receiving adjuvant biweekly oxaliplatin (85 mg/m2) plus weekly fluorouracil boluses and low-dose leucovorin were randomized to oral N-acetylcysteine (1,200 mg) (arm A) or placebo (arm B). Clinical neurological and electrophysiological evaluations were performed at baseline and after 4, 8, and 12 treatment cycles. Treatment-related toxicity was evaluated based on National Cancer Institute (NCI) Criteria. After four cycles of chemotherapy, seven of nine patients in arm B and two of five in arm A experienced grade 1 sensory neuropathy. After eight cycles, five experienced sensory neuropathy (grade 2–4 toxicity) in arm B; none in arm A (p<0.05). After 12 cycles, grade 2–4 sensory neuropathy was observed in eight patients in arm B, one in arm A (p<0.05). There were no significant electrophysiological changes in arm A after 4, 8, or 12 cycles of chemotherapy. We concluded that oral N-acetylcysteine reduces the incidence of oxaliplatin-induced neuropathy in colon cancer patients receiving oxaliplatin-based adjuvant chemotherapy.
Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: a randomized pilot trial.

To evaluate the feasibility and preliminary effectiveness of therapeutic exercise before total hip replacement in frail elderly.



A single-blind, randomized clinical pilot trial.



Outpatient physiotherapy department.



Frail elderly with hip osteoarthritis awaiting total hip replacement.



A short (3-6 weeks) tailor-made, therapeutic exercise programme was compared with usual care.



Feasibility was assessed through patient satisfaction, adherence, occurrence of adverse events and the number of eligible non-volunteers. Preliminary preoperative effectiveness was assessed with performance and self-reported measures of pain, functioning, physical activity and quality of life. Postoperatively we measured functional recovery and length of hospital stay.



Sixty-two eligible patients were approached of whom 21 (mean age 76 years) agreed to participate. Exercisers (n = 10), rated the intervention as very good 8.9 (8-10) (10-point rating scale). No serious adverse events occurred. Forty-one (66%) eligible patients did not participate, mainly because of logistic considerations, resulting in selection bias. The intervention group (trainings sessions participated 91%) showed relevant preoperative improvements on the chair-rise time (delta -2.9 seconds; 95% confidence interval (CI) -6.2 to 0.4) and timed-up-and-go (delta -4.4 seconds; 95% CI -9.3 to 0.5). Postoperatively, no significant differences were seen.



A short, tailor-made, exercise programme is well tolerated and appreciated in elderly patients awaiting total hip replacement. However, a larger randomized clinical trial in the same setting is not warranted, because of the high number of eligible non-volunteers.
Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B.

Treatment of 171 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long-term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty-five patients given ADV 10 mg in year 1 elected to continue in a long-term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log(10) copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 x upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log(10) copies/mL and -50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow-up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV.



Treatment with ADV beyond 48 weeks was well tolerated and produced long-term virological, biochemical, serological, and histological improvement.
Relevance of the Core 70 and IL-28B polymorphism and response-guided therapy of peginterferon alfa-2a ± ribavirin for chronic hepatitis C of Genotype 1b: a multicenter randomized trial, ReGIT-J study

We conducted a multicenter randomized clinical trial to determine the optimal treatment strategy against chronic hepatitis C virus (HCV) with genotype 1b and a high viral load (G1b/high). The study subjects included 153 patients with G1b/high. Patients were initially treated with PEG-IFNα-2a alone and then randomly assigned to receive different treatment regimens. Ribavirin (RBV) was administered to all patients with HCV RNA at week 4. Patients negative for HCV RNA at week 4 were randomly assigned to receive PEG-IFNα-2a (group A) or PEG-IFNα-2a/RBV (group B). Patients who showed HCV RNA at week 4 but were negative at week 12 were randomly assigned to receive weekly PEG-IFNα-2a (group C) or biweekly therapy (group D). Patients who showed HCV RNA at week 12 but were negative at week 24 were randomly assigned to receive PEG-IFNα-2a/RBV (group E) or PEG-IFNα-2a/RBV/fluvastatin (group F). Overall, the rate of sustained virological response (SVR) was 46 % (70/153). The total SVR rate in the group (A, D, and F) of response-guided therapy was significantly higher than that in the group (B, C, and E) of conventional therapy [70 % (38/54) versus 52 % (32/61), p = 0.049]. Although IL28-B polymorphism and Core 70 mutation were significantly associated with efficacy, patients with rapid virological response (RVR) and complete early virological response (cEVR) achieved high SVR rates regardless of their status of IL-28B polymorphism and Core 70 mutation. In addition to knowing the IL-28B polymorphism and Core 70 mutation status, understanding the likelihood of virological response during treatment is critical in determining the appropriate treatment strategy.
Role of 1 and 3 Hz repetitive transcranial magnetic stimulation on motor function recovery after acute ischaemic stroke.

The purpose of this study was to compare the long-term effect of five daily sessions of 1 vs. 3 Hz repetitive transcranial magnetic stimulation (rTMS) on motor recovery in acute stroke.



A total of 36 patients with acute ischaemic stroke participated in the study. The patients were randomly assigned into one of three groups; the first and second groups received real rTMS; 1 and 3 Hz and third group received sham stimulation, daily for 5 days. Motor disability was assessed before and after the last session, and then after first, second and third month. Cortical excitability was assessed before and after the second and fifth session. The outcome measure was clinical disability at 3 months post-rTMS.



No significant differences were found in basal rating scales between the three groups. At the 3-month time point, both of the real rTMS groups had improved significantly more in different rating scales than the sham group; in addition, the 1 Hz group performed better than the 3 Hz group. Measures of cortical excitability immediately after the last session showed that the 1 Hz group had reduced excitability of the non-stroke hemisphere and increased excitability of the stroke hemisphere, whereas the 3 Hz group only showed increased excitability of the stroke hemisphere.



These results confirm that five daily sessions of rTMS over motor cortex using either 1 Hz over the unaffected hemisphere or 3 Hz over the affected hemisphere can enhance recovery. At 3 months, the improvement was more pronounced in 1 Hz group.
Separate dimensions of anxiety differentially predict alcohol use among male juvenile offenders.

Although research has documented robust prospective relationships between externalizing symptomatology and subsequent adolescent alcohol use, the extent to which internalizing symptoms such as anxiety may increase risk for alcohol consumption remains controversial. Recent evidence suggests that one possible reason for mixed findings is that separate dimensions of anxiety differentially confer risk for alcohol use. The present study tested two dimensions of anxiety, worry and physiological anxiety symptoms, as predictors of alcohol use and misuse in a longitudinal sample of juvenile offenders.



Participants were 818 male juvenile offenders drawn from a larger multi-site, longitudinal study. Zero-inflated Poisson regression models estimated the influence of anxiety symptoms on typical drinking quantity, frequency of binge drinking, and alcohol dependence symptoms.



Results indicate that physiological anxiety and worry symptoms showed differential relations with alcohol use risk. Physiological anxiety was positively associated with increased risk for typical alcohol involvement, frequency of binge drinking, and alcohol dependence symptoms, whereas worry was negatively associated with all alcohol use outcomes.



Current findings underscore the importance of considering anxiety as a multidimensional construct when examining the prospective relation between anxiety and adolescent alcohol use risk.
Quantitative comparison of grasp and release abilities with and without functional neuromuscular stimulation in adolescents with tetraplegia

In this study, a functional neuromuscular stimulation (FNS) hand system designed by Case Western Reserve University (CWRU) was implemented in 5 adolescents with C5 tetraplegia and hand function with FNS was evaluated and compared to tenodesis abilities using a grasp and release test designed specifically for this purpose. The test involved the unilateral acquisition, movement and release of 6 objects of various sizes and weights. During a single test session, five 30-second trials were performed with each object with and without the FNS system where the number of completions and failures were recorded for each trial. At least 4 and as many as 8 test sessions were conducted with each subject over periods of 1.5 to 3 years. For each subject, test performance with FNS was compared statistically to tenodesis performance and session-to-session consistency was analyzed. Of 30 comparisons (5 subjects and 6 test objects), FNS was more effective in 23 cases (77%), tenodesis was better in 5 instances (17%) and in 2 cases (6%) there was no difference. Subjects were able to manipulate the 3 heaviest test objects only with FNS and in 60% of all cases involving the 3 lighter test objects there were significantly more trials in which there were more completions or fewer failures with FNS. Performance with FNS and tenodesis was generally inconsistent across sessions; possible reasons for these variations are discussed. Overall, the results of this study support those of the only previous investigation that used the grasp and release test to evaluate hand function with FNS in C5 and C6 tetraplegia.
A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C.

Hepatitis C is the most common indication for liver transplantation (LT) in the United States. Recurrence of hepatitis C virus (HCV) infection post-LT remains a problem for which there is no completely satisfactory treatment. The aim of the present study is to evaluate mycophenolate mofetil (MMF), which has both immunosuppressive and antiviral properties, to determine whether it is associated with a difference in the rate of HCV recurrence and also examine its impact on patient and graft survival. Between August 1995 and May 1998, a total of 106 patients who were HCV positive before LT were randomized to tacrolimus (TAC) and prednisone versus TAC, prednisone, and MMF therapy. The rate of recurrence of HCV, patient and graft survival, incidences of rejection, and histological findings were examined. Fifty six patients were randomized to TAC and steroid therapy (double [D] drug; group D), and 50 patients were randomized to TAC, steroid, and MMF therapy (triple [T] drug; group T). Liver biopsies were performed when liver function was abnormal; protocol liver biopsies were not performed. Mean follow-up was 4.3 +/- 0.8 years. Actuarial patient survivals at 4 years were 72.6% in group D and 73.8% in group T (P = not significant). Actuarial graft survivals at 4 years were 65.6% in group D and 65.4% in group T. One patient in group D and 2 patients in group T underwent a second LT for recurrent HCV. One patient in each group died of recurrent HCV without re-LT. Twenty-six patients in group D (46.4%) and 23 patients in group T (46.0%) showed signs of recurrent HCV. Mean hepatitis activity index (HAI) scores were 7.4 +/- 2.7 in group D and 7.0 +/- 3.4 in group T, and mean fibrosis scores were 2.9 +/- 1.7 in group D and 2.6 +/- 1.1 in group T. The rate of rejection was 0.57/patient in each group for the entire follow-up period. None of these values reached statistical significance. Rates of HCV recurrence, graft loss or death from recurrent HCV, and 4-year actuarial patient and graft survival were not different between the groups. In liver transplant recipients with HCV, MMF has no impact on patient survival, graft survival, rejection, or rate of HCV recurrence based on biochemical changes and histological findings. In addition, there was no difference in HAI or fibrosis score between the two groups. Either MMF has no anti-HCV effect or its immunosuppressive properties overwhelm its antiviral effect in the clinical setting.
Synaptic genes are extensively downregulated across multiple brain regions in normal human aging and Alzheimer's disease

Synapses are essential for transmitting, processing, and storing information, all of which decline in aging and Alzheimer's disease (AD). Because synapse loss only partially accounts for the cognitive declines seen in aging and AD, we hypothesized that existing synapses might undergo molecular changes that reduce their functional capacity. Microarrays were used to evaluate expression profiles of 340 synaptic genes in aging (20-99 years) and AD across 4 brain regions from 81 cases. The analysis revealed an unexpectedly large number of significant expression changes in synapse-related genes in aging, with many undergoing progressive downregulation across aging and AD. Functional classification of the genes showing altered expression revealed that multiple aspects of synaptic function are affected, notably synaptic vesicle trafficking and release, neurotransmitter receptors and receptor trafficking, postsynaptic density scaffolding, cell adhesion regulating synaptic stability, and neuromodulatory systems. The widespread declines in synaptic gene expression in normal aging suggests that function of existing synapses might be impaired, and that a common set of synaptic genes are vulnerable to change in aging and AD.
The AUSCAN subscales, AIMS-2 hand/finger subscale, and FIOHA were not unidimensional scales.

Evaluate the internal construct validity of the Australian/Canadian (AUSCAN) index for hand osteoarthritis (HOA) and identify the physical function instrument with best performance.



AUSCAN, AIMS-2 (Arthritis Impact Measurement Scale 2), and Functional Index of HOA (FIHOA) were self-completed by 209 HOA patients (mean [standard deviation] age 61.6 [5.7] years) at baseline and 128 at follow-up. Rasch analysis was performed.



AUSCAN pain, physical function, and stiffness subscales comprised three constructs. AUSCAN scale performance was improved after removal of "Pain at rest" from the pain scale and division of physical function into two scales of high precision and grip strength tasks. AIMS-2 hand/finger subscale and FIHOA were improved after removal of one and two items, respectively and collapse of two AIMS-2 response categories. AUSCAN physical function scale showed better targeting to the sample and higher person reliability compared with FIHOA and especially AIMS-2 because of less "severe" items concerning grip strength tasks as opposed to precision tasks.



The AUSCAN subscales, AIMS-2 hand/finger scale, and FIHOA were not unidimensional. However, deletion of misfitting items improved scale performance. The revised AUSCAN physical function and FIHOA scales are preferable for measurement of grip strength and precision tasks, respectively.
Randomized Double-Blind Placebo-Controlled Trial on the Potential Modes of Action of SheaFlex 70 TM in Osteoarthritis

Phillip A. Cheras*, Stephen P. Myers, Peta-Anne Paul-Brent, Kerry H. Outerbridge and Gary V. L. Nielsen NatMed-Research, School of Health and Human Sciences, Southern Cross University, Lismore, New South Wales, Australia The Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia Division of Orthopaedics, Greenslopes Private Hospital, Brisbane, Queensland, Australia Orthopaedic Surgery, Mater Health Services, Brisbane, Queensland,
Posterolateral versus posterior interbody fusion in isthmic spondylolisthesis.

Spondylolisthesis is a heterogeneous disorder characterized by subluxation of a vertebral body over another in the sagittal plane. Its most common form is isthmic spondylolisthesis (IS). This study aims to compare clinical outcomes of posterolateral fusion (PLF) with posterior lumbar interbody fusion (PLIF) with posterior instrumentation in the treatment of IS. We performed a randomized prospective study in which 80 patients out of a total of 85 patients with IS were randomly allocated to one of two groups: PLF with posterior instrumentation (group I) or PLIF with posterior instrumentation (group II). Posterior decompression was performed in the patients. The Oswestry low back pain disability (OLBP) scale and Visual Analogue Scale (VAS) were used to evaluate the quality of life (QoL) and pain, respectively. Fisher's exact test was used to evaluate fusion rate and the Mann-Whitney U test was used to compare categorical data. Fusion in group II was significantly better than in group I (p=0.012). Improvement in low back pain was statistically more significant in group I (p=0.001). The incidence of neurogenic claudication was significantly lower in group I than in group II (p=0.004). In group I, there was no significant correlation between slip Meyerding grade and disc space height, radicular pain, and low back pain. There was no significant difference in post-operative complications at 1-year follow-up. Our data showed that PLF with posterior instrumentation provides better clinical outcomes and more improvement in low back pain compared to PLIF with posterior instrumentation despite the low fusion rate.
[Comparison of the mycobacteria growth indicator tube with solid culture for the detection of tuberculosis complex mycobacteria from blood].

The aim of this study was to compare the mycobacteria growth indicator tube and solid culture for recovery of complex tuberculosis mycobacteria from blood.



One hundred and twenty-five specimens from 67 Djiboutian patients with a positive serologic diagnosis of HIV and fever were collected in an Isolator tube. After centrifugation and washing with phosphate-buffer, smears were prepared from the pellet for auramin staining. The remaining sediment was suspended in 1 ml of buffer. One half was inoculated into two MGIT (incubation at 30 and 37 degrees C into Bactec 960) and the other onto two Loewenstein-Jensen and two Coletsos medium (incubation at 30 and 37 degrees C).



Eight cultures were contaminated: three on solid medium and MGIT simultaneously, five in MGIT only (three coagulase negative staphylococci, five enterobacteria). Fourteen strains of M. tuberculosis (six patients) and three M. canettii (two patients) (12 on solid media and MGIT, five in MGIT only) were recovered. The mean time to detection was 32.8 days for solid medium and 20.4 days for MGIT. Of a total of 25 patients with culture-proven tuberculosis, two patients had a positive blood culture only, six had blood and other specimens positive culture, 17 had a non blood specimens positive culture only.



MGIT processed into Bactec 960 is a viable tool for the detection of complexe tuberculosis mycobacteria from blood and the high-frequency of these mycobacteremia in HIV infected patients from country where the prevalence of tuberculosis is high is confirmed. However, the cost/benefit ratio of this bacteriologic diagnosis had to be evaluated in developping country.
Antenatal Risk Factors Associated with the Development of Lenticulostriate Vasculopathy (LSV) in Neonates

To determine the antenatal risk factors associated with neonatal lenticulostriate vasculopathy (LSV).STUDY Women in preterm labor were randomized to magnesium sulfate (MgSO4), other tocolytic, or saline control. The surviving babies underwent head ultrasounds (HUS) (weeks of life 1, 2, and 4) and periodic developmental examinations (months 4, 8, 12, and 18).RESULTS:Of 140 infants, 17.1% (24) had neonatal intraventricular hemorrhage (IVH), and 10.0% (14) had LSV (half of the latter (7 of 14) had both IVH and LSV). In a regression model in which other risk factors were controlled for, the association between antenatal exposures to tocolytic MgSO4 ≥50 g and LSV were significant (adjusted odds ratio (OR), 8.3; 95% confidence interval (CI), 1.5 to 45.0; Based on our data and their analyses, we infer that antenatal exposure to high-dosage, tocolytic MgSO4 may be associated with LSV.