What's New | Decker

Because of the complex nature of clinical trial design, significant resources and infrastructure are invested in drug development. Many drugs fail to progress beyond the phase I/II stage, and many phase III trials take years to accrue and publish results, leading to a delay in Food and Drug Administration (FDA) approval for diseases that desperately need better therapeutic options. The relatively recent FDA Safety and Innovation Act has allowed for the creation of priority and expedited review for drugs and biologics in serious conditions and where there is an unmet medical need. The designation of fast-track or breakthrough therapy may be granted when there is preclinical or clinical evidence to suggest that the intervention may result in a substantial improvement over currently available therapies.
Prior to embarking on a clinical trial, data entry, editing (“cleaning”), and analysis should be anticipated. Planning for data management begins with developing rules for coding the variables for computer entry. The appropriate hardware and software programs should be selected and standardized across study sites.
A type I error (false positive) occurs if an investigator rejects a null hypothesis that is true in the population. A type II error (false negative) occurs if the investigator fails to reject a null hypothesis that is false in the population. Neither of these errors can be avoided entirely.

Use of ECG monitoring to assess the neonate’s heart rate
Use food grade plastic bag placed to level of neck to aid in keeping infant warm
Initiating resuscitation with oxygen levels of 21-30% is recommended while high oxygen levels of 65-100% are not recommended
Two thumb encircling hands technique is recommended over lower 1/3 of sternum compressing at 1/3 of the A-P diameter
Routine intubation and suctioning is no longer recommended for all cases of meconium

Emphasizes bayesian approach to testing and treatment for infectious and noninfectious diarrheal illnesses
Identifies and directs readers to reliable online resources that are kept current by trusted entities (e.g., CDC.gov)
Encourages the use of smartphone and Web-based tools for calculations rather than providing formulae that lead to mistakes
Describes a modern approach to diarrhea in patients with acute exacerbations of chronic conditions, such as HIV, inflammatory bowel disease, and others who may be immunocompromised
Provides modern information on symptomatic treatment of diarrhea (including probiotics and traditional modalities), with special attention to contraindications
Special focus on diarrhea caused by medications and overdoses
Includes a section on natural and human-made disasters, zoonotic infections, and travel medicine that reflects modern practices
Provides guidance on reconciling government guidelines and patient safety when in conflict

Preconception care can take place at every clinical encounter.
Initial care may simply consist of inquiring about a patient’s plans for pregnancy.
Knowing this can help guide the patient to fulfill her personal reproductive plans.
Identification of medical, nutritional, and psychosocial conditions that may increase pregnancy complications will allow time for referral to maximize healthy outcomes.

Preconception care can take place at every clinical encounter.
Initial care may simply consist of inquiring about a patient’s plans for pregnancy.
Knowing this can help guide the patient to fulfill her personal reproductive plans.
Identification of medical, nutritional, and psychosocial conditions that may increase pregnancy complications will allow time for referral to maximize healthy outcomes.

Preconception care can take place at every clinical encounter.
Initial care may simply consist of inquiring about a patient’s plans for pregnancy.
Knowing this can help guide the patient to fulfill her personal reproductive plans.
Identification of medical, nutritional, and psychosocial conditions that may increase pregnancy complications will allow time for referral to maximize healthy outcomes.

Oxidized low-density lipoprotein induces long-term proinflammatory cytokine production and foam cell formation via epigenetic reprogramming of monocytes... Current guidelines for high-density lipoprotein cholesterol in therapy and future directions... 2014 evidence-based guideline for the management of high blood pressure in adults report from the panel members appointed to the Eighth Joint National Committee (JNC 8).
Current efforts demonstrate that RAAS promotes arterial wall thickening. In particular, angiotensin II influences multiple signaling pathways to promote the chronic inflammatory response needed for plaque progression.
The earliest studies in individuals with familial hypercholesterolemia, marked by elevated serum LDL, showed increased atheroma susceptibility. In contrast, HDL has shown an association with decreased CVD risk. HDL can freely diffuse into the subendothelial space and mediate reverse transport of cholesterol to the liver. Recent in vivo studies have also indicated that HDL increases NO vasodilator bioavailability and promotes intrinsic antioxidant mechanisms, thereby limiting LDL oxidation.

In an attempt to characterize and define the vasculitides, criteria for the diagnosis of GCA were developed. In 1990, a classification system was developed by the American College of Rheumatology.
Most patients demonstrate a marked improvement with medical management alone. However, there are patients who develop vascular complications, such as subclavian steal syndrome, chronic ischemia, aneurysmal degeneration, or aortic dissection. Caution should be advised when considering such patients with GCA for surgical intervention, especially in the acute inflammatory phase of disease.
Although many patients respond to medical therapy, there is a subset of patients who develop complications from the arteritis necessitating surgical intervention, usually for either occlusive or aneurysmal disease. The literature suggests that less than 20% of patients with TA will ultimately require surgery.

Fundamentals