Miracle-dz/UniFAR-FTUs huggingface dataset:
Personal Sound Amplification Products vs a Conventional Hearing Aid for Speech Understanding in Noise

Personal Sound Amplification Products vs a Conventional Hearing Aid for Speech Understanding in Noise Presently, hearing aids can only be purchased in the United States through a licensed professional, with a mean cost of $4700 for 2 hearing aids (uncovered by Medicare). 1-3 According to nationally representative estimates based on 2605 adults from 1999 through 2006, less than 20% of adults with hearing loss report hearing aid use.4 Personal sound amplification products (PSAPs) are less-expensive, over-the-counter devices not specifically labeled for hearing loss treatment, but some are technologically comparable with hearing aids and may be appropriate for mild to moderate hearing loss.1 We compared a sample of these devices with a conventional hearing aid among individuals with mild to moderate hearing loss.
Gestational diabetes: Potential of prebiotics intervention

Abstract Gestational Diabetes Mellitus (GDM) is defined as glucose intolerance with first recognition during pregnancy. With the new IADPSG diagnostic criteria the prevalence of GDM increases significantly worldwide. The potential risks of GDM for mother and child both in the short and long term urge more treatments to be explored. Resistant starches as a prebiotics has been shown possessing multiple health benefits including improving glucose tolerance and insulin sensitivity. Altered gut fermentation and microbiota and sequential enhancement in blood gut peptides (i.e. GLP-1) are suggested mechanisms involved. The goal of this paper is to provide a brief overview on GDM and the role of RS in the treatment of GDM.
Regulatory T-cell responses to low-dose interleukin-2 in HCV-induced vasculitis.

BACKGROUND Patients with vasculitis induced by the hepatitis C virus (HCV) have reduced levels of regulatory T cells (Tregs). Resolution of HCV infection correlates with cure of vasculitis and the recovery of Treg levels. We reasoned that interleukin-2, a cytokine that promotes Treg survival and function, could be beneficial for patients with vasculitis that is resistant to HCV therapy. METHODS We investigated the safety and immunologic effects of the administration of low-dose interleukin-2 in a prospective open-label, phase 1-phase 2a study. Ten patients with HCV-induced vasculitis that was refractory to conventional antiviral therapy, rituximab therapy, or both and who were not receiving glucocorticoid or immunosuppressant therapy, received one course of interleukin-2 (1.5 million IU per day) for 5 days, followed by three 5-day courses of 3 million IU per day at weeks 3, 6, and 9. Both the safety of the treatment and its effectiveness were evaluated, the latter by monitoring the Treg response and the clinical signs of HCV vasculitis. RESULTS No adverse events reached a level higher than grade 1. The treatment did not induce effector T-cell activation, vasculitis flare, or increased HCV viremia. We observed a reduction in cryoglobulinemia in 9 of 10 patients and improvement of vasculitis in 8 of 10. Administration of low-dose interleukin-2 was followed by an increase in the percentage of CD4+, CD25(high), forkhead box P3 (FOXP3+) Tregs [E(max) (maximum value)÷baseline value×100=420%] with potent suppressive activity in all subjects and by a concomitantly decreased proportion of marginal-zone B cells. Transcriptome studies of peripheral-blood mononuclear cells revealed that interleukin-2 induced a global attenuation of the signatures for inflammation and oxidative stress mediators. CONCLUSIONS The trial showed that low-dose interleukin-2 was not associated with adverse effects and led to Treg recovery and concomitant clinical improvement in patients with HCV-induced vasculitis, an autoimmune condition. (Funded by the French Agency for Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT00574652.).
Changes in forced expiratory volume in 1 second over time in COPD.

BACKGROUND A key feature of chronic obstructive pulmonary disease (COPD) is an accelerated rate of decline in forced expiratory volume in 1 second (FEV(1)), but data on the variability and determinants of this change in patients who have established disease are scarce. METHODS We analyzed the changes in FEV(1) after administration of a bronchodilator over a 3-year period in 2163 patients. A random-coefficient model was used to evaluate possible predictors of both FEV(1) levels and their changes over time. RESULTS The mean (±SE) rate of change in FEV(1) was a decline of 33±2 ml per year, with significant variation among the patients studied. The between-patient standard deviation for the rate of decline was 59 ml per year. Over the 3-year study period, 38% of patients had an estimated decline in FEV(1) of more than 40 ml per year, 31% had a decline of 21 to 40 ml per year, 23% had a change in FEV(1) that ranged from a decrease of 20 ml per year to an increase of 20 ml per year, and 8% had an increase of more than 20 ml per year. The mean rate of decline in FEV(1) was 21±4 ml per year greater in current smokers than in current nonsmokers, 13±4 ml per year greater in patients with emphysema than in those without emphysema, and 17±4 ml per year greater in patients with bronchodilator reversibility than in those without reversibility. CONCLUSIONS The rate of change in FEV(1) among patients with COPD is highly variable, with increased rates of decline among current smokers, patients with bronchodilator reversibility, and patients with emphysema.
Effect of estrogen on pseudomonas mucoidy and exacerbations in cystic fibrosis.

BACKGROUND Women with cystic fibrosis are at increased risk for mucoid conversion of Pseudomonas aeruginosa, which contributes to a sexual dichotomy in disease severity. METHODS We evaluated the effects of estradiol and its metabolite estriol on P. aeruginosa in vitro and in vivo and determined the effect of estradiol on disease exacerbations in women with cystic fibrosis. RESULTS Estradiol and estriol induced alginate production in P. aeruginosa strain 01 and in clinical isolates obtained from patients with and those without cystic fibrosis. After prolonged exposure to estradiol, P. aeruginosa adopted early mucoid morphology, whereas short-term exposure inhibited bacterial catalase activity and increased levels of hydrogen peroxide, which is potentially damaging to DNA. Consequently, a frameshift mutation was identified in mucA, a key regulator of alginate biosynthesis in P. aeruginosa. In vivo levels of estradiol correlated with infective exacerbations in women with cystic fibrosis, with the majority occurring during the follicular phase (P<0.05). A review of the Cystic Fibrosis Registry of Ireland revealed that the use of oral contraceptives was associated with a decreased need for antibiotics. Predominantly nonmucoid P. aeruginosa was isolated from sputum during exacerbations in the luteal phase (low estradiol). Increased proportions of mucoid bacteria were isolated during exacerbations occurring in the follicular phase (high estradiol), with a variable P. aeruginosa phenotype evident in vivo during the course of the menstrual cycle corresponding to fluctuating estradiol levels. CONCLUSIONS Estradiol and estriol induced mucoid conversion of P. aeruginosa in women with cystic fibrosis through a mutation of mucA in vitro and were associated with selectivity for mucoid isolation, increased exacerbations, and mucoid conversion in vivo. (Funded by the Molecular Medicine Ireland Clinician-Scientist Fellowship Programme.).
Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer.

BACKGROUND Patients receiving chemotherapy for cancer are at increased risk for venous thromboembolism. Limited data support the clinical benefit of antithrombotic prophylaxis. METHODS In this double-blind, multicenter trial, we evaluated the efficacy and safety of the ultra-low-molecular-weight heparin semuloparin for prevention of venous thromboembolism in patients receiving chemotherapy for cancer. Patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy were randomly assigned to receive subcutaneous semuloparin, 20 mg once daily, or placebo until there was a change of chemotherapy regimen. The primary efficacy outcome was the composite of any symptomatic deep-vein thrombosis, any nonfatal pulmonary embolism, and death related to venous thromboembolism. Clinically relevant bleeding (major and nonmajor) was the main safety outcome. RESULTS The median treatment duration was 3.5 months. Venous thromboembolism occurred in 20 of 1608 patients (1.2%) receiving semuloparin, as compared with 55 of 1604 (3.4%) receiving placebo (hazard ratio, 0.36; 95% confidence interval [CI], 0.21 to 0.60; P<0.001), with consistent efficacy among subgroups defined according to the origin and stage of cancer and the baseline risk of venous thromboembolism. The incidence of clinically relevant bleeding was 2.8% and 2.0% in the semuloparin and placebo groups, respectively (hazard ratio, 1.40; 95% CI, 0.89 to 2.21). Major bleeding occurred in 19 of 1589 patients (1.2%) receiving semuloparin and 18 of 1583 (1.1%) receiving placebo (hazard ratio, 1.05; 95% CI, 0.55 to 1.99). Incidences of all other adverse events were similar in the two study groups. CONCLUSIONS Semuloparin reduces the incidence of thromboembolic events in patients receiving chemotherapy for cancer, with no apparent increase in major bleeding. (Funded by Sanofi; ClinicalTrials.gov number, NCT00694382.).
Outcomes after induction failure in childhood acute lymphoblastic leukemia.

BACKGROUND Failure of remission-induction therapy is a rare but highly adverse event in children and adolescents with acute lymphoblastic leukemia (ALL). METHODS We identified induction failure, defined by the persistence of leukemic blasts in blood, bone marrow, or any extramedullary site after 4 to 6 weeks of remission-induction therapy, in 1041 of 44,017 patients (2.4%) 0 to 18 years of age with newly diagnosed ALL who were treated by a total of 14 cooperative study groups between 1985 and 2000. We analyzed the relationships among disease characteristics, treatments administered, and outcomes in these patients. RESULTS Patients with induction failure frequently presented with high-risk features, including older age, high leukocyte count, leukemia with a T-cell phenotype, the Philadelphia chromosome, and 11q23 rearrangement. With a median follow-up period of 8.3 years (range, 1.5 to 22.1), the 10-year survival rate (±SE) was estimated at only 32±1%. An age of 10 years or older, T-cell leukemia, the presence of an 11q23 rearrangement, and 25% or more blasts in the bone marrow at the end of induction therapy were associated with a particularly poor outcome. High hyperdiploidy (a modal chromosome number >50) and an age of 1 to 5 years were associated with a favorable outcome in patients with precursor B-cell leukemia. Allogeneic stem-cell transplantation from matched, related donors was associated with improved outcomes in T-cell leukemia. Children younger than 6 years of age with precursor B-cell leukemia and no adverse genetic features had a 10-year survival rate of 72±5% when treated with chemotherapy only. CONCLUSIONS Pediatric ALL with induction failure is highly heterogeneous. Patients who have T-cell leukemia appear to have a better outcome with allogeneic stem-cell transplantation than with chemotherapy, whereas patients who have precursor B-cell leukemia without other adverse features appear to have a better outcome with chemotherapy. (Funded by Deutsche Krebshilfe and others.).
Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome.

BACKGROUND Dysregulated hedgehog signaling is the pivotal molecular abnormality underlying basal-cell carcinomas. Vismodegib is a new orally administered hedgehog-pathway inhibitor that produces objective responses in locally advanced and metastatic basal-cell carcinomas. METHODS We tested the anti-basal-cell carcinoma efficacy of vismodegib in a randomized, double-blind, placebo-controlled trial in patients with the basal-cell nevus syndrome at three clinical centers from September 2009 through January 2011. The primary end point was reduction in the incidence of new basal-cell carcinomas that were eligible for surgical resection (surgically eligible) with vismodegib versus placebo after 3 months; secondary end points included reduction in the size of existing basal-cell carcinomas. RESULTS In 41 patients followed for a mean of 8 months (range, 1 to 15) after enrollment, the per-patient rate of new surgically eligible basal-cell carcinomas was lower with vismodegib than with placebo (2 vs. 29 cases per group per year, P<0.001), as was the size (percent change from baseline in the sum of the longest diameter) of existing clinically significant basal-cell carcinomas (-65% vs. -11%, P=0.003). In some patients, all basal-cell carcinomas clinically regressed. No tumors progressed during treatment with vismodegib. Patients receiving vismodegib routinely had grade 1 or 2 adverse events of loss of taste, muscle cramps, hair loss, and weight loss. Overall, 54% of patients (14 of 26) receiving vismodegib discontinued drug treatment owing to adverse events. At 1 month, vismodegib use had reduced the hedgehog target-gene expression by basal-cell carcinoma by 90% (P<0.001) and diminished tumor-cell proliferation, but apoptosis was not affected. No residual basal-cell carcinoma was detectable in 83% of biopsy samples taken from sites of clinically regressed basal-cell carcinomas. CONCLUSIONS Vismodegib reduces the basal-cell carcinoma tumor burden and blocks growth of new basal-cell carcinomas in patients with the basal-cell nevus syndrome. The adverse events associated with treatment led to discontinuation in over half of treated patients. (Funded by Genentech and others; ClinicalTrials.gov number, NCT00957229.).
UTILIZATION OF MATERNITY CARE IN NIGERIA

This paper discusses the differentials of maternity care in Nigeria. The objective is to provide information that could form basis for the design, implementation and monitoring of strategies for improved maternity care and hence, of maternal health, in line with the fifth Millennium Development Goal. To achieve this objective, secondary data derived from the 1990, 1999 and 2003 Nigeria Demographic and Health Surveys (NDHS) were analysed using simple descriptive statistics and cross-tabulations. The results of the analyses show that, though the status of maternity care, as measured by Care with a Health Professional (CHP), Delivery with a Health Professional (DHP) and Delivery Within a Health Facility (DHF), in Nigeria is generally low, it is worse in the rural than urban areas. It appears lowest among women under 20 years and lowest in the Northwest region of Nigeria. The level of maternity care also appears to have increased as mother’s education and wealth quintile increased and decreased as birth order increased. Therefore, improved mother’s education and economic status have been recommended among others, as a means of improving the status of maternity care in Nigeria.
Topical 0.5% ivermectin lotion for treatment of head lice.

BACKGROUND The emergence of resistance to treatment complicates the public health problem of head-louse infestations and drives the need for continuing development of new treatments. There are limited data on the activity of ivermectin as a topical lousicide. METHODS In two multisite, randomized, double-blind studies, we compared a single application of 0.5% ivermectin lotion with vehicle control for the elimination of infestations without nit combing in patients 6 months of age or older. A tube of topical ivermectin or vehicle control was dispensed on day 1, to be applied to dry hair, left for 10 minutes, then rinsed with water. The primary end point was the percentage of index patients (youngest household member with ≥3 live lice) in the intention-to-treat population who were louse-free 1 day after treatment (day 2) and remained so through days 8 and 15. RESULTS A total of 765 patients completed the studies. In the intention-to-treat population, significantly more patients receiving ivermectin than patients receiving vehicle control were louse-free on day 2 (94.9% vs. 31.3%), day 8 (85.2% vs. 20.8%), and day 15 (73.8% vs. 17.6%) (P<0.001 for each comparison). The frequency and severity of adverse events were similar in the two groups. CONCLUSIONS A single, 10-minute, at-home application of ivermectin was more effective than vehicle control in eliminating head-louse infestations at 1, 7, and 14 days after treatment. (Funded by Topaz Pharmaceuticals [now Sanofi Pasteur]; ClinicalTrials.gov numbers, NCT01066585 and NCT01068158.).
Bariatric surgery versus intensive medical therapy in obese patients with diabetes.

BACKGROUND Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery. METHODS In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. RESULTS Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. CONCLUSIONS In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
Safety and activity of anti-PD-L1 antibody in patients with advanced cancer.

BACKGROUND Programmed death 1 (PD-1) protein, a T-cell coinhibitory receptor, and one of its ligands, PD-L1, play a pivotal role in the ability of tumor cells to evade the host's immune system. Blockade of interactions between PD-1 and PD-L1 enhances immune function in vitro and mediates antitumor activity in preclinical models. METHODS In this multicenter phase 1 trial, we administered intravenous anti-PD-L1 antibody (at escalating doses ranging from 0.3 to 10 mg per kilogram of body weight) to patients with selected advanced cancers. Anti-PD-L1 antibody was administered every 14 days in 6-week cycles for up to 16 cycles or until the patient had a complete response or confirmed disease progression. RESULTS As of February 24, 2012, a total of 207 patients--75 with non-small-cell lung cancer, 55 with melanoma, 18 with colorectal cancer, 17 with renal-cell cancer, 17 with ovarian cancer, 14 with pancreatic cancer, 7 with gastric cancer, and 4 with breast cancer--had received anti-PD-L1 antibody. The median duration of therapy was 12 weeks (range, 2 to 111). Grade 3 or 4 toxic effects that investigators considered to be related to treatment occurred in 9% of patients. Among patients with a response that could be evaluated, an objective response (a complete or partial response) was observed in 9 of 52 patients with melanoma, 2 of 17 with renal-cell cancer, 5 of 49 with non-small-cell lung cancer, and 1 of 17 with ovarian cancer. Responses lasted for 1 year or more in 8 of 16 patients with at least 1 year of follow-up. CONCLUSIONS Antibody-mediated blockade of PD-L1 induced durable tumor regression (objective response rate of 6 to 17%) and prolonged stabilization of disease (rates of 12 to 41% at 24 weeks) in patients with advanced cancers, including non-small-cell lung cancer, melanoma, and renal-cell cancer. (Funded by Bristol-Myers Squibb and others; ClinicalTrials.gov number, NCT00729664.).
Interventions in labour and birth and satisfaction with care: The Canadian Maternity Experiences Survey Findings

Objective: To examine whether interventions in labour and birth contributed to ratings of satisfaction with these experiences, in women giving birth vaginally or attempting a vaginal birth prior to giving birth by caesarean section. Background: Ratings of satisfaction with women’s overall experience of labour and birth have long been encouraged, yet remain challenging to assess or to interpret. Methods: Data from the Canadian Maternity Experiences Survey (MES) – a nationally representative sample of women who had a singleton live birth in 2005–2006 – were analysed. Associations between the number of and type of labour and birth interventions, and women’s satisfaction with the overall labour and birth experience and six aspects of caregiver interactions, were assessed. Results: Among women having vaginal births, fewer interventions during labour was significantly associated with higher overall satisfaction with the labour and birth experience (ranging from 75% of women having no interventions to 46.4% having eight or more interventions rating their experiences as ‘very postive’). The same pattern was observed for satisfaction with women’s perceptions of caregiver’s respect, concern for dignity, compassion shown to them, the information given to them, their involvement in decision making, and caregiver’s competence. Among women having unplanned caesarean sections following attempted vaginal birth, the number of interventions was not associated with satisfaction ratings; however, satisfaction ratings were consistently lower than among women giving birth vaginally. Conclusion: These findings provide support for demedicalising vaginal labour and birth as well as for optimising the potential for a vaginal birth rather than caesarean section.
Study of the anti‐JCV antibody levels in a Spanish multiple sclerosis cohort

One of the risk factor to develop progressive multifocal leukoencephalopathy (PML) among natalizumab‐treated patients is the presence and high levels of anti‐JCV antibodies. Our purpose was to test the association of different clinical and demographic variables with the presence and levels of anti‐JCV antibodies in a Spanish cohort of patients with multiple sclerosis (MS) during natalizumab treatment.
Correlation of platelet‐to‐lymphocyte ratio and neutrophil‐to‐lymphocyte ratio with thrombolysis in myocardial infarction frame count in ST‐segment elevation myocardial infarction

Impaired coronary artery reflow after primary percutaneous coronary intervention (PPCI) in patients with ST‐segment elevation myocardial infarction has been associated with postintervention adverse effects. Thus, finding an easily achievable index would be of great value to predict no‐reflow phenomenon. In this regard, platelet‐to‐lymphocyte ratio (PLR) and neutrophil‐to‐lymphocyte ratio (NLR) have been introduced. In this study, we aimed to investigate correlation of PLR and NLR with thrombolysis in myocardial infarction (TIMI) frame count.