Volume 1 Issue 1
Clinical Trials Recruitment Challenges
Borges JLC*, Silva MS
Recruitment is a challenging phase of clinical trials due to its relevance to research success. Failure in reaching recruitment goals might implicate in trials early termination, loss of statistical power and financial wastes. For the well-trained research centers there are several key points that might be addressed as recruitment challenges: first, finding new trials in the site therapeutic area and getting proper approval at local Institutional Review Board; secondly, having a self-sustainable research institution that can hire and train high qualified staff, and lastly, getting and retaining the potential patient the consent in participating.
Effects of Short-Term Resistance Training on Functional Performance, Cognition, Static Postural Control and Gait in Older Adults: A Pilot Study
Srikant Vallabhajosula*, PhD, Stephen P. Bailey, PT, PhD
Previous studies have examined the efficacy of long-term resistance training for improving health status of older adults. However, long-term programs often encounter adherence issues. Short-term resistance training programs have more clinical utility but their effectiveness to improve cognition, functional performance, postural control and gait in older adults is unknown. Our purpose was to determine the impact of a short-term resistance training program for older adults on cognition, function, postural control and gait. Nine older adults (mean age, 73.4 years) completed four weeks of resistance training consisting of a 30-45 min.
Rapidly Progressing Left Atrial Primary Undifferentiated Pleomorphic Sarcoma
Jun An, Kang An, Abdelsalam M Elhenawy*
Primary cardiac cancers are very rare. Approximately, a quarter of those tumors are malignant and cardiac sarcomas account for 75% being the most common subtype of primary cardiac malignancies. A 61-year-old man was admitted to our hospital for progressive exertional cough, and dyspnea. Transthoracic echocardiography showed a large intra-cardiac mass originated from the roof of left atrium with a wide base. However, the histological diagnosis was a cardiac undifferentiated pleomorphic sarcoma. We present a case of primary undifferentiated pleomorphic sarcoma of the left atrium exhibiting very early recurrence after the first resections.
Ambulatory Arterial Stiffness Index (AASI) and Antihypertensive Drug Effects: A Study with Spironolactone
Bendersky M*, Vassallo A
Patients with essential hypertension have shown increased arterial stiffness. ABPM allows us to obtain AASI (Ambulatory Arterial Stiffness Index) through a mathematical formula (1-slope DBP/SBP) This index has many physiologic components (one of them is arterial stiffness), correlates well with Pulse Wave Velocity (PWV),and shows good prognostic value in normal and hypertensive populations: with increased AASI values, worse CV prognosis.
Hyaluronic Acid and Silver Sulfadiazine Combination: Evaluation in a Second Degree Burns Rat Model
Yannis Guillemin, PhD, Marina Trouillas, PhD, Coralie Ségalen, PhD, Maia M. Alexaline, PhD, Muriel Nivet, Jean-Jacques Lataillade, MD PhD and Jean Noël Gouze, PhD*
Thermal burn is one of the most common injury worldwide. Severity is based on burn depth assessment that will then determine the appropriate treatment. Classification as first, second and third degree burn is closely depending on the severity of epidermis and dermis damage. The major complication for second and third degree burn remains wound infections which are a significant source of morbidity and mortality.
Improving and Preventing Lapse in Institutional Review Board Continuing Review Approval
Min-Fu Tsan*, M.D., Ph.D., and Linda W. Tsan, M.D
Continuing review of on-going research is one way by which institutional review boards (IRBs) ensure the protection of human subjects participating in clinical trials. However, little is known about the prevalence of lapse in IRB continuing reviews, factors that may contribute to it, and measures to prevent its occurrence. Analysis of the United States Department of Veterans Affairs (VA) research facility’s IRB continuing review performance metric data revealed that lapse in IRB continuing reviews was the most commonly identified noncompliance, with lapse rates of 6-7% over a 4-year period from 2010 through 2013. However, investigators from less than 3% of lapsed protocols continued research activities during the lapse.
Offshoring Clinical Trials
Julian J. Javier, MD, FACC, Joseph V. Pergolizzi, Jr., MD, and Jo Ann LeQuang, BA*
As more and more American companies offshore large randomized clinical trials—a cornerstone of evidence-based medicine— considerable debate has occurred over this practice. Hosting clinical studies in certain foreign countries can be more costeffective and allow for easier, more rapid enrollment than studies in the U.S. However, concerns about potential exploitation of vulnerable populations as well as the integrity of data and processes have come to light. Many of these concerns apply to clinical trials in general, regardless of where they take place.