nils-herrmann/clean_scirepeval huggingface dataset:
Pandemic (H1N1) 2009 vaccine in paediatric oncology patients: one dose or two doses?

Although the clinical course of pandemic (2009) H1N1 infection in paediatric oncology patients is, in general, not severe, it frequently results in delay in anti-cancer therapy, which may affect the long-term outcome of these patients (Caselli et al, 2010; Cheng et al, 2010). Moreover, Launes et al (2010) showed that children who received intensive chemotherapy could develop severe disease. Children always have an important role in transmission of influenza infection, annual vaccination remains the most effective way to offer protection in paediatric oncology patients and haematopoietic stem cell transplant recipients (Tramontana et al, 2010). Lu et al (2010) evaluated the immune response of a novel vaccine for H1N1 in healthy Chinese children. Three weeks after the first dose, 50% of children aged 3–9 years had acquired protective antibodies. After second dose of vaccine, protective antibody level was detected in 90% of subjects. Seroconversion rate was about 80% in this age group after two doses of vaccine (Lu et al, 2010). Data on the immunogenicity of this vaccine in paediatric oncology population is not available. Our group evaluated the immune response to pandemic (H1N1) 2009 vaccine in 12 oncology patients who were either on maintenance chemotherapy or had completed intensive chemotherapy within the last 12 months (median age 5Æ2 years, range 2Æ9–9Æ4 years). Written consents were obtained from parents and/or patients before enrolment to study. Ethical approval was obtained from the local institutional ethics committee. Two doses of inactivated pandemic (H1N1) 2009 vaccines (Panenza , Sanofi Pasteur, France) were administered intramuscularly 4 weeks apart. This is a non-adjuvant vaccine formulated to contain 15 lg haemagglutinin (HA) of influenza A/California/07/2009 (H1N1)-like virus. We evaluated the H1N1 antibody titres at baseline (TP0); 4 weeks after the first dose (TP1), and 4 weeks after second dose (TP2). The antibody titres were determined by a microneutralization assay using standard methods (Greenberg et al, 2009). The immunogenicity profiles included the seroprotection rate (the proportion of subjects with antibody levels of 1:40 or more), seroconversion rate (the proportion of subjects with a pre-vaccination antibody titre <1:40 and a post-vaccination titre ‡1:40 or a pre-vaccination titre ‡1:40 and an increase in the titre by a factor of four or more) were assessed. The clinical characteristics and results are shown in Table I. Before vaccination, 75Æ0% of subjects had a neutralizing antibody titre <1:40. At 4 weeks after first dose of vaccine, the seroprotection rate was 58Æ3% (7 out of 12 participants) of
Immediate effects of thoracic spinal mobilisation on erector spinae muscle activity and pain in patients with thoracic spine pain: a preliminary randomised controlled trial.

To investigate the activity of the thoracic erector spinae muscles and perceived pain intensity immediately after central postero-anterior (PA) mobilisation of the thoracic spine.



Randomised, placebo-controlled, experimental design.



Thirty-four participants with non-specific thoracic pain were randomised to the experimental group [grade III central PA mobilisation performed for 3minutes at the level of the seventh thoracic vertebra (T7)] or the placebo group (less than grade I central PA mobilisation performed for 3minutes at T7).



Before and immediately after PA mobilisation, surface electromyography (EMG) was recorded from the thoracic erector spinae muscles as the participants performed 10° spine extension from a prone position for 10seconds. Each participant rated their pain intensity as an investigator performed grade III central PA over the most symptomatic thoracic segment, and the pressure pain threshold (PPT) was evaluated bilaterally over the erector spinae muscles.



The EMG amplitude of thoracic erector spinae activity was reduced significantly after the intervention in the experimental group (P<0.05), but not in the placebo group. The difference between the groups was significant {pre-post change: placebo -14 [standard deviation (SD) 50]mV, experimental 28 (SD 48)mV; mean difference -42mV; 95% confidence interval of the difference -76 to 7; P<0.05} albeit small (Grissom=0.44). However, both groups showed a significant reduction in pain immediately after the intervention, and both groups showed a similar pre-post change in PPT.



These preliminary findings indicate that grade III central mobilisation over the most symptomatic thoracic segment reduces thoracic erector spinae activity during extension of the trunk in people with non-specific thoracic spine pain.
Can we stop bone loss and prevent hip fractures in the elderly?

The two main determinants of hip fractures are falls and bone loss leading to an intrinsic femoral fragility. Substantial femoral bone loss continues throughout old age, with a continuous and exponential increase in the risk of hip fracture; thus any reduction or arrest of this loss will induce an important reduction in the incidence of hip fracture. Preventive measures may be achieved during childhood by increasing peak bone mass with calcium and exercise, by using long-term estrogen replacement therapy after menopause, but also by using vitamin D and calcium supplements for late prevention in the elderly. Vitamin D insufficiency and a deficit in calcium intake are very common in the elderly living either in institutions or at home and the cumulative response to these deficits is a negative calcium balance which stimulates parathyroid hormone secretion. This senile secondary hyperparathyroidism is one of the determinants of femoral bone loss and can be reversed by calcium and vitamin D supplements. We have shown in a 3-year controlled prospective study that the daily use of supplements (1.2 g calcium and 800 IU vitamin D3) given in a large population of 3270 elderly ambulatory women living in nursing homes reduced the number of hip fractures by 23% (intention-to-treat analysis). In parallel, serum parathyroid hormone concentrations were reduced by 28% and low baseline serum 25-hydroxy vitamin D concentration returned to normal values. After 18 months of treatment the bone density of the total proximal femoral region had increased by 2.7% in the vitamin D3-calcium group and decreased by 4.6% in the placebo group (p<0.001). This prevention is safe and can be recommended for people living in institutions. It could also be useful in other elderly subjects at particular risk due to a low calcium intake, an absence of solar exposure, a low femoral bone density, a high serum parathyroid hormone concentration, a low serum 25-hydroxyvitamin D concentration and a previous history of falls. Prospective studies are needed for further evaluation of these risk factors.
Risks of third-party data

R ecent reports of personal information theft are coming in torrents. Criminals are known to have downloaded the personal credit information of over 145,000 individuals from ChoicePoint's network. Hackers took over one of the LexisNexis databases, gaining access to personal files of 32,000 people. Bank of America Corp. lost computer data tapes that contained personal information on 1.2 million federal employees, including members of the U.S. Senate. A hacker downloaded the names, Social Security numbers, voice mail, SMS messages, and digital photos of 400 T-Mobile customers, and probably had access to all of T-Mobile's 16.3 million U.S. customers. In a separate incident, Paris Hilton's phone book and SMS messages were hacked and distributed on the Internet. The risks of third-party data—personal data being held by others—are twofold: the privacy risk and impersonation leading to fraud (popularly called identity theft). Identity theft is the fastest-growing crime in the U.S. A criminal collects enough personal data on someone to impersonate him to banks, credit card companies, and other financial institutions, then racks up debt in the person's name, collects the cash, and disappears. The victim often must spend years clearing his name. Total losses in 2003: $53 billion. People have been told to be careful: not to give out personal financial information, to shred their trash, to be cautious when doing business online. But criminal tactics have evolved, and many of these precautions are useless. Why steal identities one at a time, when they can be stolen by the tens of thousands? The problem is that security of much of our data is no longer under our control.  A dozen years ago, if someone wanted to look through your mail, he had to break into your house. Now he can just break into your ISP. Ten years ago, your voice mail was on an answering machine in your house; now it's on a computer owned by a telephone company. Your financial accounts are on Web sites protected only by passwords; your credit history is stored—and sold—by companies you don't even know exist. Lists of books you buy, and the books you browse, are stored in the computers of online booksellers. Your affinity card allows your supermarket to know what foods you like. Others now control data that was once under your direct control. We have no choice but to trust these companies with our security and privacy, even though …
Effect of supplementation with B vitamins and antioxidants on levels of asymmetric dimethylarginine (ADMA) and C-reactive protein (CRP): a double-blind, randomised, factorial design, placebo-controlled trial.

Cardiovascular risk factors such as elevated levels of asymmetric dimethylarginine (ADMA)/C-reactive protein (CRP) and homocysteine are potentially related to essential micronutrients such as certain B vitamins and antioxidant vitamins. The aim of the present study was to investigate whether supplementation with moderate doses of B vitamins and/or antioxidants could alter either ADMA and/or CRP concentrations in middle-aged, apparently healthy men with mildly elevated homocysteine levels.



A randomised, double-blind, factorial design, intervention study was carried out on 132 men with mildly elevated homocysteine levels, allocated to four groups (a) B vitamins alone--1 mg folic acid, 7.2 mg pyridoxine, 0.02 mg cyanocobalamin daily, (b) antioxidants alone--150 mg ascorbic acid, 67 mg vitamin E, 9 mg β-carotene daily, (c) B vitamins with antioxidant vitamins, or (d) placebo. A total of 101 men completed the study to 8 weeks.



When the percentage of baseline ADMA and CRP was examined at 8 weeks, no statistically significant differences were observed between the four groups (p = 0.21 and p = 0.90, respectively). Similar non-significant results were observed when analysis was stratified based on baseline CRP levels (<1.0 mg/L, p = 0.10; ≥1.0 mg/L, p = 0.64) and smoking status (all p ≥ 0.05).



Supplementation with moderate doses of B vitamins and/or antioxidants did not alter either ADMA or CRP concentrations in these middle-aged, apparently healthy men with mildly elevated homocysteine levels.
Efficacy and safety of zolpidem extended release in elderly primary insomnia patients.

To evaluate the clinical efficacy and safety of zolpidem extended release for the treatment of primary insomnia in elderly patients.



A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted. A total of 205 (117 women, 88 men; mean age 70.2 +/- 4.5 years) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-defined primary insomnia patients were randomized to 3 weeks of nightly treatment with either zolpidem extended release 6.25 mg or placebo; 198 patients completed the study.



Relative to placebo, zolpidem extended release 6.25 mg significantly decreased wake time after sleep onset during the first six hours of the night, as measured by polysomnogram (PSG). PSG latency to persistent sleep was reduced and PSG total sleep time was increased, both at nights 1/2 and 15/16. Patient self-report measures were significantly better with zolpidem extended-release 6.25 mg than with placebo throughout treatment. Some PSG measures indicated a worsening of sleep for a single night after abrupt discontinuation of zolpidem extended release. No next-morning residual effects were observed. The overall incidence and nature of adverse events was comparable between the two groups.



Zolpidem extended release 6.25 mg improved both sleep maintenance and sleep induction in elderly primary insomnia patients during three weeks of administration.
Long-term success rates after an anterior neurectomy in patients with an abdominal cutaneous nerve entrapment syndrome.

Surgery occasionally is proposed in patients with chronic abdominal wall pain caused by an anterior cutaneous nerve entrapment syndrome (ACNES) who are refractory to injection therapy. An anterior neurectomy may seem successful, but follow-up is usually short and populations are small. The primary aim of this study was to determine the long-term success rate of surgery in a large ACNES population.



In this retrospective observational study, patients with ACNES ≥18 years who underwent a primary anterior neurectomy between January 2004 and February 2012 in one single center were studied. Pain scores were obtained before surgery, after surgery, and at the moment of questioning using a pain intensity numeric rating scale (PI-NRS 0-10) and a 6-point verbal category rating scale. Success was defined as a ≥50% PI-NRS reduction or ≥2 point verbal rating scale reduction.



Data of 181 neurectomies in 154 individuals were available for analysis (female, n = 127, 82.5%; age 47 ± 17 years, range, 20-83). Pain before operation was severe (mean PI-NRS 8.08, SD 1.43). Short-term (1-3 months postoperative) success was 70% (127/181 procedures). Three subjects showed spontaneous remission of complaints after ≥3 months. After a mean 32 months (range, 3-93) follow-up, a success rate of 61% (109/180) on the long-term was found.



A 70% short-term success rate and a 61% long-term success rate after a primary anterior neurectomy in patients with chronic abdominal pain due to ACNES were attained. Surgery is the method of choice in ACNES patients who are refractory to a conservative regimen.
A five-gene molecular grade index and HOXB13:IL17BR are complementary prognostic factors in early stage breast cancer.

Histologic tumor grade is a well-established prognostic factor for breast cancer, and tumor grade-associated genes are the common denominator of many prognostic gene signatures. The objectives of this study are as follows: (a) to develop a simple gene expression index for tumor grade (molecular grade index or MGI), and (b) to determine whether MGI and our previously described HOXB13:IL17BR index together provide improved prognostic information.



From our previously published list of genes whose expression correlates with both tumor grade and tumor stage progression, we selected five cell cycle-related genes to build MGI and evaluated MGI in two publicly available microarray data sets totaling 410 patients. Using two additional cohorts (n = 323), we developed a real-time reverse transcription PCR assay for MGI, validated its prognostic utility, and examined its interaction with HOXB13:IL17BR.



MGI performed consistently as a strong prognostic factor and was comparable with a more complex 97-gene genomic grade index in multiple data sets. In patients treated with endocrine therapy, MGI and HOXB13:IL17BR modified each other's prognostic performance. High MGI was associated with significantly worse outcome only in combination with high HOXB13:IL17BR, and likewise, high HOXB13:IL17BR was significantly associated with poor outcome only in combination with high MGI.



We developed and validated a five-gene reverse transcription PCR assay for MGI suitable for analyzing routine formalin-fixed paraffin-embedded clinical samples. The combination of MGI and HOXB13:IL17BR outperforms either alone and identifies a subgroup ( approximately 30%) of early stage estrogen receptor-positive breast cancer patients with very poor outcome despite endocrine therapy.
The inter-rater reliability of a standardised classification system for pregnancy-related lumbopelvic pain.

Pregnancy-related lumbopelvic pain has varying clinical presentations and effects among subgroups. Different lumbopelvic pain subgroups require different specific management approaches which require the differentiation between lumbar and pelvic girdle pain (PGP). Thirty-one consecutive pregnant women with non-specific lumbopelvic pain were evaluated by two examiners and classified into lumbar pain, PGP, or combined pelvic girdle and lumbar pain. A standard history about different positions/activities of daily life such as bending, sitting, standing, walking, and lying, was followed by a standardised mechanical assessment of the lumbar spine (Mechanical Diagnosis and Therapy), including tests of repeated end-range movements to standing and lying, pelvic pain provocation tests (distraction test, posterior pelvic pain provocation test, Gaenslen's test, compression test, and sacral thrust) a hip-rotation range-of-motion test, the active straight-leg-raising test, and a neurological examination. Agreement for the three syndromes (lumbar pain, PGP, or combined pelvic girdle and lumbar pain) was 87% (27/31), with a kappa coefficient of 0.79 (95% CI 0.60-0.98). It was possible to perform the classification procedure throughout pregnancy. There was substantial agreement between the two examiners for the classification of non-specific lumbopelvic pain into lumbar pain and PGP in pregnant women.
Osteopenia and fractures in cystinotic children post renal transplantation

Many of the end-organ effects of cystinosis are known to be risk factors for osteopenia; these include deposition of cystine crystals in bone, hypothyroidism, diabetes mellitus, primary hypogonadism, urinary phosphate wasting, and chronic renal failure. While transplantation may correct the latter, it exposes the child to other risk factors for diminished bone mass, notably the use of high-dose glucocorticoids. Our objective was to determine if these multiple risk factors translate into an increased occurrence of osteopenia, as measured by dual-energy X-ray absorptiometry (DEXA), and/or fractures in this population. We examined the charts, X-rays, and bone mineral density (BMD) of all cystinotic patients post renal transplant for whom this information was available. Lumbar spine BMD was measured by DEXA scan (Hologic 4500). Z-scores were corrected for growth parameters using previously published reference data. Fracture history and pertinent serum markers of bone metabolism were also analyzed. Of the 63 renal transplants performed at our institution, 11 children were transplanted due to cystinosis. Nine of these patients, 5 male and 4 female, had had BMD evaluations, with an average age of 14.3 years (range 5–17 years) at the time of initial BMD post transplant. The mean interval between transplant and BMD evaluation was 39 months (range 3–90 months). Surprisingly, 7 of 9 patients had normal uncorrected BMD values (z-scores −1.92 to +0.02) and 7 of 9 patients had normal corrected values (z-scores –1.20 to +1.93). Three patients suffered from a total of eight fractures. Of the 3 fracture patients, 2 had normal BMD. All patients maintained good graft function and had normal calcium/phosphate mineral status. Of note, 3 of 5 male patients had evidence of primary testicular failure at earlier ages than often described, and this may be an unrecognized risk factor for bone disease in this population. Despite the numerous risk factors for developing osteopenia, these results suggest that the majority of cystinotic patients post renal transplant do not experience reduced bone mineral content as measured by DEXA. However, the significant fracture history among these patients demonstrates that DEXA cannot be used to assess fracture risk in patients with nephropathic cystinosis.
Osteopenia in young hypogonadal women with systemic lupus erythematosus receiving chronic steroid therapy: a randomized controlled trial comparing calcitriol and hormonal replacement therapy.

To evaluate the efficacy of calcitriol and hormonal replacement therapy (HRT) in the treatment of steroid-induced osteoporosis in hypogonadal women.



We studied 28 young patients (aged 37 +/- 6 yr) with systemic lupus erythematosus (SLE) on chronic steroid therapy for 130 +/- 22 months and requiring more than 10 mg/day prednisone. They were amenorrhoeic for more than 2 yr with proven ovarian failure. All had osteopenia with a T score at L2-4 of less than -1. They were randomized to receive HRT (conjugated oestrogen 0.625 mg daily from day 1 to day 21 plus medroxyprogesterone acetate 5 mg daily days 10-21) or calcitriol 0.5 microg daily. All received calcium carbonate 1 g/day.



There were no differences in the baseline demographic, bone mineral density (BMD) and biochemical data between the two groups. Lumbar spine BMD increased by 2.0 +/- 0.4% after 2 yr with HRT (P<0.05), but reduced by 1.74 +/- 0.4% (P<0.05) with calcitriol treatment. No change was seen at the distal one-third radius with HRT treatment but significant bone loss (2.3 +/- 1.4%, P<0.02) was observed with calcitriol therapy. BMD at the hip did not change in both groups. Comparing both treatment groups, significant differences in the BMD at the spine (P<0.03) and radius (P<0.05) were seen at the end of 2 yr. The changes in urinary n-telopeptide excretion but not serum osteocalcin at 6 months and 12 months were inversely correlated with the changes in lumbar spine BMD at 24 months. HRT did not cause an adverse effect on SLE disease activity.



HRT but not calcitriol could prevent bone loss in young hypogonadal women on chronic steroid therapy.
Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study.

The C-Pulse System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV.  We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study.  Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support.  The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time.