Clinical Approvals Research

02:01 EDT 21st April 2018 | BioPortfolio

The effect of leech extracts on endothelial cell coagulation-related factors and endothelial dysfuction-related molecules.

This study was focused on screening leech extracts to identify those with little or no anti-coagulation effect or with significant anti-endothelial dysfunction activity.

Sex differences in opioid use and medical issues during buprenorphine/naloxone treatment.

There are sex differences in buprenorphine/naloxone clinical trials for opioid use. While women have fewer opioid-positive urine samples, relative to men, a significant decrease in opioid-positive samples was found during treatment for men, but not women. In order to inform sex-based approaches to improve treatment outcomes, research is needed to determine if opioid use, and predictors of opioid u...

The boundaries of auditory perception for within-word syllable segregation in untrained and trained adult listeners.

Syllable segregation is among the core diagnostic features of both childhood apraxia of speech and acquired apraxia of speech; however, little is known about the limen of perception of syllable segregation. The purpose of this research was therefore to explore adult listeners' auditory perception of within-word syllable segregation in trained and untrained adult listeners. Two experimental design ...

Extended-release drug formulations for the treatment of epilepsy.

Extended-release (ER) preparations are either available or have been tested for several antiepileptic drugs (AEDs). Indeed, they may be helpful in improving efficacy, tolerability, adherence, compared to the corresponding immediate release (IR) preparations available. The use of ER preparations has been advocated in women of childbearing age and is - depending on the drug - especially helpful in p...

Oral anticoagulant use in cardiovascular disorders: a perspective on present and potential indications for rivaroxaban.

Four nonvitamin K antagonist oral anticoagulants (NOACs) have been approved for use in various cardiovascular indications. The direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors apixaban, edoxaban, and rivaroxaban are now increasingly used in clinical practice. For some of these agents, available data from real-world studies support the efficacy and safety data in phase III c...

Atherosclerosis of the carotid bulb is associated with the severity of orthostatic hypotension in non-diabetic adult patients: a cross-sectional study.

The carotid bulb has a high density of baroreceptors that play an important role in maintaining blood pressure. We hypothesized that atherosclerosis of the carotid bulb would reflect the severity of orthostatic hypotension more accurately than would atherosclerosis of other carotid artery segments.

Effects of empathic and positive communication in healthcare consultations: a systematic review and meta-analysis.

Background Practitioners who enhance how they express empathy and create positive expectations of benefit could improve patient outcomes. However, the evidence in this area has not been recently synthesised. Objective To estimate the effects of empathy and expectations interventions for any clinical condition. Design Systematic review and meta-analysis of randomised trials. Data sources Six databa...

Incidence and Clinical Characteristics of Ocular Involvement in Mucous Membrane Pemphigoid.

To describe the risk of developing ocular mucous membrane pemphigoid (MMP) or a new extraocular site of MMP, and to identify risk factors for new involvement.

Diagnosis-to-Treatment Interval Is an Important Clinical Factor in Newly Diagnosed Diffuse Large B-Cell Lymphoma and Has Implication for Bias in Clinical Trials.

Purpose Selection bias in clinical trials has consequences for scientific validity and applicability of study results to the general population. There is concern that patients with clinically aggressive disease may not have enrolled in recent diffuse large B-cell lymphoma (DLBCL) trials due to the consent process and the inability to delay therapy for eligibility evaluation. We have examined the d...

National Survey of Operating Room Nurses' Aseptic Techniques and Interventions for Patient Preparation to Reduce Surgical Site Infections.

Surgical site infection (SSI), the third most common type of nosocomial infection in Sweden, is a patient injury that should be prevented. Methods of reducing SSIs include, for instance, disinfecting the skin, maintaining body temperature, and ensuring an aseptic environment. Guidelines for most of these interventions exist, but there is a lack of studies describing to what extent the preventive i...

An Analysis of VR Technology Used in Immersive Simulations with a Serious Game Perspective.

Using virtual environments (VEs) is a safer and cost-effective alternative to executing dangerous tasks, such as training firefighters and industrial operators. Immersive virtual reality (VR) combined with game aspects have the potential to improve the user experience in the VE by increasing realism, engagement, and motivation. This article investigates the impact of VR technology on 46 immersive ...

The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results.

The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) was established to fulfill recommendations identified by an international conference convened to review the available infrastructure and challenges in achieving harmonization of results among different measurement procedures. The specific objectives of the ICHCLR are to: prioritize measurands by medical importan...

Algorithm on age partitioning for estimation of reference intervals using clinical laboratory database exemplified with plasma creatinine.

We describe an algorithm to determine age-partitioned reference intervals (RIs) exemplified for creatinine using data collection from the clinical laboratory database.

An evidence- and risk-based approach to a harmonized laboratory alert list in Australia and New Zealand.

Individual laboratories are required to compose an alert list for identifying critical and significant risk results. The high-risk result working party of the Royal College of Pathologists of Australasia (RCPA) and the Australasian Association of Clinical Biochemists (AACB) has developed a risk-based approach for a harmonized alert list for laboratories throughout Australia and New Zealand. The si...

Indirect methods for reference interval determination - review and recommendations.

Reference intervals are a vital part of the information supplied by clinical laboratories to support interpretation of numerical pathology results such as are produced in clinical chemistry and hematology laboratories. The traditional method for establishing reference intervals, known as the direct approach, is based on collecting samples from members of a preselected reference population, making ...

Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility.

Acute kidney injury (AKI) can occur rarely in patients exposed to iodinated contrast and result in contrast-induced AKI (CI-AKI). A key risk factor is the presence of preexisting chronic kidney disease (CKD); therefore, it is important to assess patient risk and obtain kidney function measurement prior to administration. Point-of-care (PoC) testing provides an alternative strategy but there remain...

Preanalytical errors before and after implementation of an automatic blood tube labeling system in two outpatient phlebotomy centers.

Garlic (Allium sativum) increases SIRT1 and SIRT2 gene expressions in the kidney and liver tissues of STZ- and STZ+niacinamide-induced diabetic rats.

Diabetic nephropathy and liver damage are important complications of diabetes mellitus (DM). Various factors, such as sirtuins (silent information regulators or SIRTs) are associated with these complications. Sirtuins are a family of NAD+-dependent proteins, and seven types of these can be found in mammalians. In this study, we evaluated the effects of aqueous garlic extract (G) on the expressions...

Role of atrial natriuretic peptide in controlling diabetic nephropathy in rats.

Diabetes is a downregulator of atrial natriuretic peptide (ANP), resulting in reduced nitric oxide level and low expression of endothelial nitric oxide synthase by which nitric oxide level get reduced. In the present study, we examined the role of ANP in reduced nitric oxide level, which may be responsible in controlling diabetic nephropathy in rats.

Anti-ulcerogenic effect of the methanol extract of Chasmanthera dependens (Hochst) stem on male Wistar rats.

Oxidative stress and free radical-mediated processes have been implicated in the pathogenesis of indomethacin-induced gastric ulcer. This study investigated the ability of the methanol extract of Chasmanthera dependens to protect the gastric mucosal from oxidative damage induced by oral administration of indomethacin in rats.

Prominent Hypointense Vessel Sign on Susceptibility-Weighted Imaging Is Associated with Clinical Outcome in Acute Ischaemic Stroke.

Prominent hypointense vessel sign (PHVS) is visualized on susceptibility weighted-imaging (SWI) in acute ischaemic stroke (AIS). We aim to test if PHVS is associated with stroke outcome.

Predictive Factors of Portal Hypertensive Enteropathy Exacerbation in Patients with Liver Cirrhosis: A Capsule Endoscopy Study.

The clinical course and exacerbation of portal hypertensive enteropathy (PHE) are yet to be fully clarified. This study aimed to identify factors related to PHE exacerbation in patients with liver cirrhosis (LC).

Clinical Significance of Reddish Depressed Lesions Observed in the Gastric Mucosa after Helicobacter pylori Eradication.

Reddish depressed lesions (RDLs) frequently observed in patients following Helicobacter pylori eradication are indistinguishable from gastric cancer. We examined the clinical and histological feature of RDLs and its relevant endoscopic diagnosis including magnifying narrow-band imaging (M-NBI).

Extended Sessions of Polymyxin-B Immobilized Fiber Column Hemoperfusion Ameliorate Renal Outcome and Mortality in Septic Shock with Acute Kidney Injury.

Polymyxin-B (PMX) treatment has been reported to decrease mortality in patients with septic shock and acute kidney injury (AKI). In this study, we aimed to evaluate whether extended sessions of PMX (Ext-PMX) immobilized fiber column hemoperfusion ameliorate clinical outcomes in patients complicated with septic shock and AKI without surgical control.

Long-term Outcome of Adenosine A2A Receptor Antagonist on Lower Urinary Tract Symptoms in Male Parkinson Disease Patients.

In addition to motor symptoms, bladder dysfunction is a major clinical issue in patients with Parkinson disease (PD). Istradefylline is adenosine A2A receptor antagonist approved for PD patients with wearing-off symptoms. The aim of this study was to determine the long-term effects of istradefylline on lower urinary tract symptoms (LUTSs) in PD patients.

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