Experts document about an adequate utilization of SYSADOAs in controversial clinical situations.

Background And Objective: SYSADOAs (Symptomatic Slow-Acting Drugs for Osteoarthritis) are natural compounds that have been shown to be useful and safe in the treatment of osteoarthritis (OA). However, their use in certain clinical situations still lacks scientific evidence and clear recommendations. The objective of this work was to learn the opinion of a group of experts regarding the appropriate use of SYSADOA in the treatment of OA in controversial clinical situations.

Pilot study of the usability and functionality of a smart ph meter and a mobile medical application for urine ph monitoring.

Objectives: Portable pH meters are robust and reliable tools for measuring urinary pH bypatients at home. This study evaluated the usability of a prototype smart Lit-Control® pH Meter and an associated mobile medical app, with the aim of identifying possible design and functionality issues along with usability problems among non-expert voluntary users.

Matherials And Methods: Twenty-one individuals of both genders, between 26 and 61 years old, tested the dyad pH meter/app for 14 days (three readings per day).

A patients' view of OA: the Global Osteoarthritis Patient Perception Survey (GOAPPS), a pilot study.

Background: Globally, osteoarthritis (OA) is the third condition associated with disability. There is still poor treatment in OA but science holds the key to finding better treatments and a cure. It is essential to learn what's important to patients from them to implement the most effective OA management.

Experts Document About an Adequate Utilization of SYSADOAs in Controversial Clinical Situations.

Background And Objective: SYSADOAs (symptomatic slow-acting drugs for osteoarthritis) are natural compounds that have been shown to be useful and safe in the treatment of osteoarthritis (OA). However, their use in certain clinical situations still lacks scientific evidence and clear recommendations. The objective of this work was to learn the opinion of a group of experts regarding the appropriate use of SYSADOA in the treatment of OA in controversial clinical situations.

Global management of patients with knee osteoarthritis begins with quality of life assessment: a systematic review.

Background: Knee osteoarthritis (KOA) is a prevalent form of chronic joint disease associated with functional restrictions and pain. Activity limitations negatively impact social connectedness and psychological well-being, reducing the quality of life (QoL) of patients. The purpose of this review is to summarize the existing information on QoL in KOA patients and share the reported individual factors, which may influence it.

Patients' beliefs regarding informed consent for low-risk pragmatic trials.

Background: The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.

Who is willing to participate in low-risk pragmatic clinical trials without consent?

Purpose: General notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification.

Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

Aims: Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs.

Memory Retrieval Re-Activates Erk1/2 Signaling in the Same Set of CA1 Neurons Recruited During Conditioning.

The hippocampus enables a range of behaviors through its intrinsic circuits and concerted actions with other brain regions. One such important function is the retrieval of episodic memories. How hippocampal cells support retrieval of contextual fear memory remains largely unclear.

Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit.

Alzheimer's disease (AD) is among the most significant health care burdens. Disappointing results from clinical trials in late-stage AD persons combined with hopeful results from trials in persons with early-stage suggest that research in the preclinical stage of AD is necessary to define an optimal therapeutic success window. We review the justification for conducting trials in the preclinical stage and highlight novel ethical challenges that arise and are related to determining appropriate risk-benefit ratios and disclosing individuals' biomarker status.

Coagulation Factor Concentrates Fail to Restore Alterations in Fibrin Formation Caused by Rivaroxaban or Dabigatran in Studies With Flowing Blood From Treated Healthy Volunteers.

We evaluated the hemostatic alterations in blood from healthy individuals treated for 5 days with direct oral anticoagulants (DOACs) rivaroxaban (20 mg/d) or dabigatran (150 mg/12 h) in a single-blind clinical trial with crossover assignment (NCT01478282). We assessed the potential of prothrombin complex concentrates, activated prothrombin complex concentrates, or recombinant activated factor VII, when added ex vivo, to reverse the alterations caused by these DOACs. Blood was drawn at maximum plasma concentration after the last dose of each DOAC, and modifications in coagulation biomarkers were evaluated using a series of tests performed under steady conditions including routine coagulation, thrombin generation, and thromboelastometry assays.

Dosing of rivaroxaban by indication: getting the right dose for the patient.

Introduction: Vitamin K antagonists were the only oral anticoagulants available for several decades, but they require frequent coagulation monitoring and dose adjustment. The direct oral anticoagulants rivaroxaban , dabigatran, apixaban, and, most recently, edoxaban have been approved for the management of specific thromboembolic indications.

Areas Covered: This review will provide a brief overview of the cell-based coagulation model, the main determinants of arterial and venous thrombosis, and the pharmacological rationale and clinical evidence for the different dosing regimens of rivaroxaban.

Reversal of rivaroxaban-induced alterations on hemostasis by different coagulation factor concentrates – in vitro studies with steady and circulating human blood.

Background: Despite the good safety of rivaroxaban, there is limited information on strategies for urgent reversal of its antihemostatic effects.

Methods And Results: Alterations of hemostasis induced by rivaroxaban (230 ng/ml) were assessed by using several tests applied to steady and circulating human blood. Effects on thrombin generation (TG) and thromboelastometry (TEM) parameters were measured.

Safety and efficacy of uric acid in patients with acute stroke (URICO-ICTUS): a randomised, double-blind phase 2b/3 trial.

Introduction: Uric acid is an antioxidant with neuroprotective effects in experimental models of stroke. We assessed whether uric acid therapy would improve functional outcomes at 90 days in patients with acute ischaemic stroke.

Methods: URICO-ICTUS was a randomised, double-blind, placebo-controlled, phase 2b/3 trial that recruited patients with acute ischaemic stroke admitted to ten Spanish stroke centres.

Should obesity be a limiting factor for clozapine treatment?

Objective: Clozapine is the first choice in drug-resistant schizophrenia but also causes important weight changes. This might discourage clinicians concerned about the risk of developing health problems. To assess this issue we measured change in body mass index (cBMI) induced by clozapine at 18 and 56 weeks.

A common variant of the ABO gene protects against hypertension in a Spanish population.

The objective of this study was to establish whether genetic polymorphisms that could be related to angiotensin-converting enzyme (ACE) levels are associated with hypertension. A total of 10 haplotype-tagging single-nucleotide polymorphisms in ACE, the ACE I/D polymorphism, and 2 polymorphisms in the ABO (rs495828 and rs8176746) were investigated for association with hypertension in 269 hypertensive patients and 254 healthy controls. All analyses were adjusted for age and body mass index, and corrected for multiple testing.

Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.

Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.

Drug exposure and pregnancy outcome in Mozambique.

Background: The intake of medicines during pregnancy can have negative or toxic effects on the fetus, possibly leading to adverse pregnancy outcomes.

Objective: The aim of this study was to describe the level of drug exposure during pregnancy in a rural area of Mozambique and its relation to pregnancy outcome.

Methods: A total of 3105 pregnant women were interviewed in a cohort study.

Clinical trials during pregnancy: what has been done.

Objective: We describe clinical trials conducted in pregnant women.

Methods: We searched PubMed database for articles related to clinical trials between 01/01/2000 and 31/12/2009 involving pregnant women by using the preferred terms "pregnancy", "human", and "clinical trials".

Results: Of 1,264 retrieved publications, 762 (60%) were excluded, leaving 502 for analysis: 53% were preventive studies in maternal or fetal conditions; 47% were therapeutic trials, mostly focused on acute obstetric diseases; 66% were assigned a pharmacological intervention.

Pharmacogenetic predictors of angiotensin-converting enzyme inhibitor-induced cough: the role of ACE, ABO, and BDKRB2 genes.

Background And Objective: Dry cough is the most common reason for stopping angiotensin-converting enzyme inhibitors (ACEi) therapy. The role of ACE in the metabolism of bradykinin has been proposed as a pathogenic mechanism. This study included a complete analysis of the variability of the genes involved in bradykinin metabolism (ACE and XPNPEP2) and bradykinin receptors (BDKRB2).

[Canakinumab, a monoclonal antibody against IL-1β, with potential utility in different inflammatory processes].

Canakinumab is a fully human monoclonal antibody targeted at IL-1β which has shown to be effective in the control the symptoms of patients affected by CAPS and other autoinflammatory diseases. Its effect is rapid and sustained. In clinical trials conducted up until now, the most common adverse effects reported with the use of this drug have been different types of infections, migraines and vertigo.