Philip Ames, Anat Galor
Dry eye has gained recognition as a public health problem given its high prevalence, morbidity and cost implications. Although dry eye is common and affects patients' quality of life, only one medication, cyclosporine 0.05% emulsion, has been approved by the US FDA for its treatment. In this review, we summarize the basic science and clinical data regarding the use of cyclosporine in the treatment of dry eye. Randomized controlled trials showed that cyclosporine emulsion outperformed vehicles in the majority of trials, consistently decreasing corneal staining and increasing Schirmer scores...
2015: Clinical Investigation
Frederick A Curro, Dennis A Robbins, Frederick Naftolin, Ashley C Grill, Don Vena, Louis Terracio
A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap...
2015: Clinical Investigation
Stephen L George, Marc Buyse
Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality...
2015: Clinical Investigation
Elinor R Schoenfeld, Leslie Hyman, Leslie Long Simpson, Bryan Michalowicz, Michael Reddy, Marie Gelato, Wei Hou, Steven P Engebretson, Catherine Hytner, Pat Lenton
BACKGROUND: Diabetes and its complications are a major United States public health concern. METHODS: The Diabetes and Periodontal Therapy Trial (DPTT) evaluated whether non-surgical treatment of periodontal disease influenced diabetes management among persons with Type 2 diabetes and periodontitis. The aim of this study was to evaluate DPTT's many recruitment strategies in terms of enrollment success. RESULTS/CONCLUSION: Targeted recruitment strategies were more effective in identifying individuals who met periodontal and diabetes eligibility criteria...
December 1, 2014: Clinical Investigation
Mani Pavuluri
"In reality, it is the interpretation of symptomatology that leads to accurate diagnosis, rather than the short-term training and inter-rater reliability attained by conducting semi-structured research diagnostic interviews."
November 2014: Clinical Investigation
Kouji Izumi, Lei Li, Chawnshang Chang
Both benign prostatic hyperplasia (BPH) and prostate cancer (PCa) are frequent diseases in middle-aged to elderly men worldwide. While both diseases are linked to abnormal growth of the prostate, the epidemiological and pathological features of these two prostate diseases are different. BPH nodules typically arise from the transitional zone, and, in contrast, PCa arises from the peripheral zone. Androgen deprivation therapy alone may not be sufficient to cure these two prostatic diseases due to its undesirable side effects...
October 1, 2014: Clinical Investigation
Sabrina Paganoni, Merit Cudkowicz, James D Berry
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3-5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of 'traditional' outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials...
2014: Clinical Investigation
Dai Chu Luu, Joseph Chao
No abstract text is available yet for this article.
2014: Clinical Investigation
Loretta A Williams, Emre Yucel, Jorge E Cortes, Charles S Cleeland
With the rapid development of new therapies for patients with hematological malignancies, there is an increasing need for patient report of symptom status during all phases of drug testing. The patient's perspective on new treatments reflects treatment tolerability as well as symptom benefit, and may assist patients and clinicians in choosing treatments. Inclusion of patient-reported outcomes, more common in solid-tumor than hematological trials, provides early information about symptoms to guide decisions about appropriate dosing and supportive care needs...
December 1, 2013: Clinical Investigation
Byron P Vaughn, Alan C Moss
The approved treatment options for patients with ulcerative colitis (UC) are currently limited to mesalamine or immunosuppressants. Patients who do not respond to mesalamine-based therapy can be treated with immunomodulators or anti-TNF antibody therapy. Failure or adverse reactions to these medications leaves the patient with little choice other than colectomy. However, novel insights into the pathogenic drivers of UC have led to new developments in drugs that promise clinical efficacy via modulation of targeted pathways...
November 2013: Clinical Investigation
Meenakshi Devidas, James R Anderson
Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy. Although outcomes for children with ALL have improved dramatically over the last 50 years, ALL remains the leading cause of childhood cancer death. In addition, high-risk patient subsets can be identified with significantly inferior survival. In the current era of therapies directed at specific molecular targets, the use of conventional randomized Phase III trials to show benefit from a new treatment regimen may not be feasible when these biologically defined subsets are small...
September 2013: Clinical Investigation
Michael W Konstan, Frank J Accurso, Samya Z Nasr, Richard C Ahrens, Gavin R Graff
BACKGROUND: Pancreatic enzyme replacement therapy (PERT) is used to treat exocrine pancreatic insufficiency in cystic fibrosis. RESULTS/METHODS: Efficacy and safety of a unique enteric-coated (EC) bicarbonate-buffered PERT product (PERTZYE®/PANCRECARB®; Digestive Care, Inc., Bethlehem, PA, USA) was studied in a randomized, double-blind, placebo-controlled cross-over design. Subjects were stabilized on EC-bicarbonate-buffered PERT and a high-fat diet. During two treatment periods, subjects were randomized to EC-bicarbonate-buffered PERT or placebo, followed by a 72-h stool collection employing an ingested stool dye marker...
August 1, 2013: Clinical Investigation
Michael W Konstan, Drucy Borowitz, Nicole Mayer-Hamblett, Carlos Milla, Leslie Hendeles, Susan Murray, Richard A Kronmal, Susan Casey, Lynn M Rose, Wayne J Morgan, Bonnie W Ramsey
In 2006, the US FDA issued a 'Guidance for Industry' regarding submission of New Drug Applications for pancreatic enzyme replacement therapy (PERT) products. Five oral delayed-release PERT products have been approved by the FDA, and several others are under development and/ or evaluation for New Drug Application submission. We present in this paper recommendations of the Cystic Fibrosis Foundation's Cystic Fibrosis (CF) Therapeutics Development Network and Data Safety Monitoring Board regarding study design considerations for evaluating PERT products in patients with CF...
August 2013: Clinical Investigation
Kathryn T Hall, Ted J Kaptchuk
No abstract text is available yet for this article.
April 1, 2013: Clinical Investigation
John H Powers, Thomas R Fleming
No abstract text is available yet for this article.
March 1, 2013: Clinical Investigation
Melanie R Nicol, Jessica L Adams, Angela Dm Kashuba
The global HIV epidemic cannot be controlled by current treatment or prevention strategies. Pre-exposure prophylaxis (PrEP) using antiretrovirals is a promising approach to curbing the spread of HIV transmission. Recently, four clinical trials demonstrated favorable results when antiretroviral PrEP was administered topically or orally. However, two additional trials were unable to demonstrate a benefit, indicating that further study is required to define the populations and conditions under which PrEP will be effective...
March 2013: Clinical Investigation
John Paul Flores, M Wasif Saif
The oral taxanes are analogues of existing taxanes with a possible broad range of antitumor activity. They also have the potential advantages of ease of administration, better efficacy and lesser toxicity than currently available taxanes. These drugs have been used in several Phase I clinical trials, the methodology and results of which will be reviewed here.
2013: Clinical Investigation
Sarah S Lewis, Deverick J Anderson
Clostridium difficile is a major cause of infection worldwide and is associated with increasing morbidity and mortality in vulnerable patient populations. Metronidazole and oral vancomycin are the currently recommended therapies for the treatment of C. difficile infection (CDI) but are associated with unacceptably high rates of disease recurrence. Novel therapies for the treatment of CDI and prevention of recurrent CDI are urgently needed. Important developments in the treatment of CDI are currently underway and include: novel antibacterial agents with narrower antimicrobial spectra of activity, manipulation of the gut microbiota and enhancement of the host antibody immune response...
2013: Clinical Investigation
Kory J Lavine, Douglas L Mann
The incidence and economic burden of heart failure continue to rise worldwide, despite implementation of a number of effective heart failure therapies. Although there have been a number phase I-II studies of potential novel heart failure therapies over the past decade, none of these new compounds have been successful in phase III clinical trials. While there are likely a number of reasons for this failure, one of the problems that has become increasingly apparent is the inability of phase II trials to correctly identify novel therapies that will be successful in phase III clinical trials...
January 1, 2013: Clinical Investigation
John C Morris, Paul S Aisen, Randall J Bateman, Tammie L S Benzinger, Nigel J Cairns, Anne M Fagan, Bernardino Ghetti, Alison M Goate, David M Holtzman, William E Klunk, Eric McDade, Daniel S Marcus, Ralph N Martins, Colin L Masters, Richard Mayeux, Angela Oliver, Kimberly Quaid, John M Ringman, Martin N Rossor, Stephen Salloway, Peter R Schofield, Natalie J Selsor, Reisa A Sperling, Michael W Weiner, Chengjie Xiong, Krista L Moulder, Virginia D Buckles
The Dominantly Inherited Alzheimer Network (DIAN) is a collaborative effort of international Alzheimer disease (AD) centers that are conducting a multifaceted prospective biomarker study in individuals at-risk for autosomal dominant AD (ADAD). DIAN collects comprehensive information and tissue in accordance with standard protocols from asymptomatic and symptomatic ADAD mutation carriers and their non-carrier family members to determine the pathochronology of clinical, cognitive, neuroimaging, and fluid biomarkers of AD...
October 1, 2012: Clinical Investigation
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