Researchers are developing biomedical devices with embedded closed-loop algorithms for providing advanced adaptive therapies. As these devices become more capable and algorithms become more complex, ...tasked with integrating and interpreting multi-channel, multi-modal electrophysiological signals, there is a need for flexible bench-top testing and prototyping. We present a methodology for leveraging off-the-shelf audio equipment to construct a biosignal waveform generator capable of streaming pre-recorded biosignals from a host computer. By re-playing known, well-characterized, but physiologically relevant real-world biosignals into a device under test, researchers can evaluate their systems without the need for expensive
experiments.
An open-source design based on the proposed methodology is described and validated, the NeuroDAC. NeuroDAC allows for 8 independent channels of biosignal playback using a simple, custom designed attenuation and buffering circuit. Applications can communicate with the device over a USB interface using standard audio drivers. On-board analog amplitude adjustment is used to maximize the dynamic range for a given signal and can be independently tuned for each channel.
Low noise component selection yields a no-signal noise floor of just 5.35 ± 0.063. NeuroDAC's frequency response is characterized with a high pass -3 dB rolloff at 0.57 Hz, and is capable of accurately reproducing a wide assortment of biosignals ranging from EMG, EEG, and ECG to extracellularly recorded neural activity. We also present an application example using the device to test embedded algorithms on a closed-loop neural modulation device, the Medtronic RC+S.
By making the design of NeuroDAC open-source we aim to present an accessible tool for rapidly prototyping new biomedical devices and algorithms than can be easily modified based on individual testing needs.ClinicalTrials.gov Identifiers: NCT04281134, NCT03437928, NCT03582891.
Immigrants comprise 13 % of the US population. Immigrant families often come to the US for a better life and to improve their economic opportunities; however, immigrants experience higher levels of ...poverty than their native-born counterparts. Despite their financial concerns, less than half of eligible immigrant families in the US receive government assistance. Framed within ecocultural theory, qualitative methods, including in-depth interviews with 40 low-income immigrant mothers from Latin America and Africa, were conducted to examine the economic experiences of immigrant families, including the process of building economic security. The findings indicate that mothers’ development of economic security was shaped by their ecocultural context including the intersection of: accessibility of government programs, family situations, and unique needs of their families.
Background:
In Phase 3 double-blind trials (MS-F203 and MS-F204), dalfampridine extended release tablets 10 mg twice daily (dalfampridine-ER; prolonged-release fampridine in Europe; fampridine ...modified or sustained release elsewhere) improved walking speed relative to placebo in patients with multiple sclerosis (MS).
Objectives:
Evaluation of long-term safety and efficacy of dalfampridine-ER in open-label extensions (MS-F203EXT, MS-F204EXT).
Methods:
Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months. Subjects were categorized as dalfampridine-ER responders or non-responders, based on their treatment response in the double-blind parent trials that assessed T25FW.
Results:
We had 269 patients enter MS-F203EXT and 154 patients complete it; for a maximum exposure of 5 years. We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years. No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase. Improvements in walking speed were lost after dalfampridine-ER was discontinued in the parent trial, but returned by the 2-week assessment after re-initiation of the drug. Throughout the extensions, mean improvement in walking speed declined, but remained improved, among the double-blind responders as compared with non-responders.
Conclusions:
The dalfamipridine-ER safety profile was consistent with the parent trials. Although walking speed decreased over time, dalfampridine-ER responders continued to show improved walking speed, which was sustained compared with non-responders.
Purpose
Primary debulking surgery (PDS) has historically been the standard treatment for advanced ovarian cancer. Recent data appear to support a paradigm shift toward neoadjuvant chemotherapy with ...interval debulking surgery (NACT-IDS). We hypothesized that stage IV ovarian cancer patients would likely benefit from NACT-IDS by achieving similar outcomes with less morbidity.
Methods
Patients with stage IV epithelial ovarian cancer who underwent primary treatment between January 1, 1995 and December 31, 2007, were identified. Data were retrospectively extracted. Each patient record was evaluated to subclassify stage IV disease according to the sites of tumor dissemination at the time of diagnosis. The Kaplan–Meier method was used to compare overall survival (OS) data.
Results
A total of 242 newly diagnosed stage IV epithelial ovarian cancer patients were included in the final analysis; 176 women (73%) underwent PDS, 45 (18%) NACT-IDS, and 21 (9%) chemotherapy only. The frequency of achieving complete resection to no residual disease was significantly higher in patients with NACT-IDS versus PDS (27% vs. 7.5%;
P
< 0.001). When compared to women treated with NACT-IDS, women with PDS had longer admissions (12 vs. 8 days;
P
= 0.01), more frequent intensive care unit admissions (12% vs. 0%;
P
= 0.01), and a trend toward a higher rate of postoperative complications (27% vs. 15%;
P
= 0.08). The patients who received only chemotherapy had a median OS of 23 months, compared to 33 months in the NACT-IDS group and 29 months in the PDS group (
P
= 0.1).
Conclusions
NACT-IDS for stage IV ovarian cancer resulted in higher rates of complete resection to no residual disease, less morbidity, and equivalent OS compared to PDS.
The auditory sensitivity of 67 patients with chronic end-stage renal failure was assessed. In order to determine the incidence of hearing loss and to describe the impairment and possible contributing ...factors, one group of 39 patients was assessed prior to treatment by hemodialysis. Twelve of these subjects were then followed for 1 year as they are treated by hemodialysis. The remaining 27 patients, not treated by hemodialysis, were also retested in one year. A second group of 28 patients who ad been receiving hemodialysis over periods of 1 1/2, 3, and 6 years was also evaluated. A high incidence of high-frequency impairment was obtained which could not be attributed to age, noise exposure, ototoxicity, or hereditary. An association between this high-frequency impairment and both the renal disease and its treatment was suggested. Clinically significant sensorineural hearing loss did not appear associated with non-genetic kidney disease.
Ovarian cancer accounts for more deaths than all other gynecological cancers combined. To identify common low-penetrance ovarian cancer susceptibility genes, we conducted a genome-wide association ...study of 507,094 SNPs in 1,768 individuals with ovarian cancer (cases) and 2,354 controls, with follow up of 21,955 SNPs in 4,162 cases and 4,810 controls, leading to the identification of a confirmed susceptibility locus at 9p22 (in BNC2). Here, we report on nine additional candidate loci (defined as having P ≤ 10−4) identified after stratifying cases by histology, which we genotyped in an additional 4,353 cases and 6,021 controls. We confirmed two new susceptibility loci with P ≤ 5 × 10−8 (8q24, P = 8.0 × 10−15 and 2q31, P = 3.8 × 10−14) and identified two additional loci that approached genome-wide significance (3q25, P = 7.1 × 10−8 and 17q21, P = 1.4 × 10−7). The associations of these loci with serous ovarian cancer were generally stronger than with other cancer subtypes. Analysis of HOXD1, MYC, TIPARP and SKAP1 at these loci and of BNC2 at 9p22 supports a functional role for these genes in ovarian cancer development.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Patients with end-stage renal disease often have derangements in calcium and phosphorus homeostasis and resultant secondary hyperparathyroidism (sHPT), which may contribute to the high prevalence of ...arterial stiffness and hypertension. We conducted a secondary analysis of the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial, in which patients receiving hemodialysis with sHPT were randomly assigned to receive cinacalcet or placebo. We sought to examine whether the effect of cinacalcet on death and major cardiovascular events was modified by baseline pulse pressure as a marker of arterial stiffness, and whether cinacalcet yielded any effects on blood pressure. As reported previously, an unadjusted intention-to-treat analysis failed to conclude that randomization to cinacalcet reduces the risk of the primary composite end point (all-cause mortality or non-fatal myocardial infarction, heart failure, hospitalization for unstable angina or peripheral vascular event). However, after prespecified adjustment for baseline characteristics, patients randomized to cinacalcet experienced a nominally significant 13% lower adjusted risk (95% confidence limit 4-20%) of the primary composite end point. The effect of cinacalcet was not modified by baseline pulse pressure (Pinteraction=0.44). In adjusted models, at 20 weeks cinacalcet resulted in a 2.2 mm Hg larger average decrease in systolic blood pressure (P=0.002) and a 1.3 mm Hg larger average decrease in diastolic blood pressure (P=0.002) compared with placebo. In summary, in the EVOLVE trial, the effect of cinacalcet on death and major cardiovascular events was independent of baseline pulse pressure.
Abstract Objective The purpose of this study is to analyze and compare the demographics, treatment, recurrence, and survival rates in patients with uterine clear cell carcinoma (UCCC) and ovarian ...clear cell carcinoma (OCCC). Methods A retrospective review of the Cancer Registry database was performed. All patients with UCCC and OCCC who underwent surgical staging at the two participating institutions, between January, 1995 and December, 2007, were identified. Categorical variables were evaluated by Chi square test. Survival estimates were plotted utilizing the Kaplan–Meier method. Results Analysis of 41 women with UCCC and 121 with OCCC was performed. In patients with OCCC, 48.4% had localized disease, 18.9% had regional spread, 31.1% had distant metastasis, and in 1.6% spread is unknown; compared to UCCC, 41.5% had localized disease, 12.2% regional spread, and 46.3% distant metastasis (p = 0.2). The median progression free survival was 31.4 months in women with UCCC, compared to 145 months in patients with OCCC (p = 0.04). UCCC women had a median overall survival of 39.5 months, compared to 155.8 months in patients with OCCC (p = 0.002). In the multivariate Cox regression model, age > 55 years old, tumor extension, optimal cytoreduction, and platinum-based chemotherapy were identified as independent predictors of overall survival. UCCC vs. OCCC was not associated with decreased overall survival in multivariate analysis. Conclusion OCCC and UCCC have the same rate of localized disease, regional spread and distant metastasis. After controlling for age, tumor extension, optimal cytoreduction, and platinum based chemotherapy, UCCC was not associated with decreased overall survival compared to OCCC.
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