Notes

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Chronic hypoxic and hypercapnic respiratory failure and obstructive sleep apnoea (OSA) are chronic diseases associated with decreased quality of life and increased mortality. The rationale behind the set up the retrospective nationwide DISCOVERY cohort was to study several questions including disease course and risk factors for incident disease, impaired quality of life, hospitalisation risk and mortality in patients with chronic respiratory failure with long-term oxygen therapy (LTOT), long-term mechanical ventilation (LTMV) and obstructive sleep apnoea (OSA) on treatment with continuous positive airway pressure (CPAP).

Data from the national quality registry for respiratory insufficiency and sleep apnoea (Swedevox) and a population-based control group from Statistics Sweden were merged with governmental registries, the Swedish Cancer Registry, the Swedish Cause of Death Registry, the Swedish Drug registry, the Swedish National Patient Registry and the Swedish Dental Health Registry and with national quas to fill this clinically relevant gap of knowledge.
In patients with chronic respiratory failure and sleep apnoea important questions regarding comorbidity burden, hospitalisation rate, mortality and treatment outcomes are still unexplored to a large extent. The DISCOVERY cohort will provide unique opportunities by its size and comprehensiveness to fill this clinically relevant gap of knowledge.
The clinical significance of subsegmental pulmonary embolism (SSPE) is currently unclear. Although growing evidence from observational studies suggests that withholding anticoagulant treatment may be a safe option in selected patients with isolated SSPE, most patients with this condition receive anticoagulant treatment, which is associated with a 90-day risk of recurrent venous thromboembolism (VTE) of 0.8% and major bleeding of up to 5%. Given the ongoing controversy concerning the risk-benefit ratio of anticoagulation for isolated SSPE and the lack of evidence from randomised-controlled studies, the aim of this clinical trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.

SAFE-SSPE (Surveillance vs. BIX 02189 mw Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism, a multicentre randomised placebo-controlled non-inferiority trial) is an international, multicentre, placebo-controlled, double-blind, parallel-group non-inferiority trial conducted in Switzerland, the Netherlands and Canada. Low-risk patients with isolated SSPE are randomised to receive clinical surveillance with either placebo (no anticoagulation) or anticoagulant treatment with rivaroxaban. All patients undergo bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis before enrolment. Patients are followed for 90 days. The primary outcome is symptomatic recurrent VTE (efficacy). The secondary outcomes include clinically significant bleeding and all-cause mortality (safety). The ancillary outcomes are health-related quality of life, functional status and medical resource utilisation.

The local ethics committees in Switzerland have approved this protocol. Submission to the Ethical Committees in the Netherlands and Canada is underway. The results of this trial will be published in a peer-reviewed journal.

NCT04263038.
NCT04263038.
Few studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.

The study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical da002762; Pre-results.
To examine the association between reimbursement rates and the length of stay (LOS).

A retrospective cohort study.

The study was conducted in Shenzhen, China by using health administrative database from 1 January 2015 to 31 December 2017.

6583 patients with acute myocardial infarction (AMI), 12 395 patients with pneumonia and 10 485 patients who received percutaneous coronary intervention (PCI) surgery.

The reimbursement rate was defined as one minus the ratio of out-of-pocket to the total expenditure, multiplied by 100%. The outcome of interest was the LOS. Multilevel negative binomial regression models were constructed to control for patient-level and hospital-level characteristics, and the marginal effect was reported when non-linear terms were available.

Each additional unit of the reimbursement rate was associated with an average of an additional increase of 0.019 (95% CI, 0.015 to 0.023), 0.011 (95% CI, 0.009 to 0.014) and 0.013 (95% CI, 0.010 to 0.016) in the LOS for inpatients with AMI, pnntries including China.
People suffering from leg muscle weakness caused by neuromuscular disorders (NMDs) are often provided with leg orthoses to reduce walking problems such as increased walking effort, diminished walking speed, reduced balance and falls. However, evidence for the effectiveness of leg orthoses to improve walking in this patient group is limited and there is an absence of standardised practice in orthotic prescription. In 2012 a Dutch multidisciplinary guideline was developed aimed to standardise the orthotic treatment process in NMD. Although application of the guideline in expert centres (specialised orthotic care) seems beneficial regarding clinical effectiveness, larger studies are necessary to confirm results and investigate cost-effectiveness. Therefore, this study aims to examine the effectiveness and cost-effectiveness of specialised orthotic care compared with usual orthotic care in adults with slowly progressive NMD.

A prospective randomised open-label blinded end-point study will be performed, in whid journals and media aimed at a broad audience including patients.
The study is registered in the Dutch trial register (NL 7511) and the protocol has been approved by the Medical Ethics Committee of the Academic Medical Center in Amsterdam. Results will be presented at national and international scientific conferences and disseminated through peer-reviewed journals and media aimed at a broad audience including patients.
Brazil's Bolsa Familia Program (BFP) is the world's largest conditional cash transfer scheme. We shall use a large cohort of applicants for different social programmes to evaluate the effect of BFP receipt on premature all-cause and cardiovascular mortality.

We will identify BFP recipients and non-recipients among new applicants from 2004 to 2015 in the 100 Million Brazilian Cohort, a database of 114 million individuals containing sociodemographic and mortality information of applicants to any Brazilian social programme. For individuals applying from 2011, when we have better recorded income data, we shall compare premature (age 30-69) cardiovascular and all-cause mortality among BFP recipients and non-recipients using regression discontinuity design (RDD) with household monthly per capita income as the forcing variable. Effects will be estimated using survival models accounting for individuals follow-up. To test the sensitivity of our findings, we will estimate models with different bandwidths, include pated in the social media and to policy-makers.
The study was approved by the ethics committees of Oswaldo Cruz Foundation and the University of Glasgow College of Medicine and Veterinary Life Sciences. The deidentified dataset will be provided to researchers, and data analysis will be performed in a safe computational environment without internet access. Study findings will be published in high quality peer-reviewed research articles. The published results will be disseminated in the social media and to policy-makers.
Quality-adjusted life year (QALY) has been recommended by the government as preferred outcome measure for Health Technology Assessment (HTA) in India. As country-specific health-related quality of life tariff values are essential for accurate measurement of QALYs, the government of India has commissioned the present study. The aim of this paper is to describe the methods for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study. Additionally, this study aspires to establish if the design of 10-time trade-off (TTO) blocks is enough to generate valid value sets.

A cross-sectional survey using the EuroQol Group's Valuation Technology (EQ-VT) will be undertaken in a sample of 2700 respondents selected from six different states of India using a multistage stratified random sampling technique. The participants will be interviewed using computer-assisted personal interviewing technique. The TTO valuation will be done using 10 composite TTO (c-TTO) tasks and 7 discrete choice expAgency.
In the 'Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism' (SELECT-D) trial, rivaroxaban showed relatively low venous thromboembolism (VTE) recurrence but higher bleeding compared with dalteparin in patients with cancer. We aim to calculate the cost-effectiveness and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent VTE.

We built a Markov model to calculate the cost-effectiveness from a societal perspective over a 5-year time horizon for the Dutch healthcare setting.

A hypothetical cohort of 1000 cancer patients with VTE entered the model with baseline characteristics based on the SELECT-D trial.

Six months of treatment with rivaroxaban (15 mg two times per day for first 3 weeks followed by 20 mg once daily) was compared with 6 months of treatment with dalteparin (200 IU/kg daily during month 1 followed by 150 IU/kg daily).

The primary outcome of the cost-effectiveness analy0 million per year, primarily driven by the difference in drug costs.
Treatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. The use of rivaroxaban instead of dalteparin can save over €10 million per year, primarily driven by the difference in drug costs.
Laparoscopy has partially replaced open surgery due to the lower infection rate for the patient and hence better and shorter recovery. However, the surgeon's physical load is higher due to longer duration static and awkward body postures, increasing the risk for developing work-related musculoskeletal disorders. Interventions of an organisational nature are work breaks, being either passive or active. The primary objectives of this study are to determine whether passive and active work breaks lead to less discomfort than no work breaks and whether active work breaks lead to less discomfort than passive work breaks.

A controlled, randomised cross-over trial will be performed in the laboratory, of which its protocol is described here according to the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) 2013 Statement. Recruitment of 21 laparoscopic surgeons started in April 2019 and the study is ongoing. The participating surgeons will perform three 1.5 hour experimental conditions, one without work breaks, one with 2.
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