Given the increase in novel agents and difficulty with planning and completing many phase III studies, various phase II trial design options should be considered to more effectively guide phase III trial plans. The need for novel phase II trial designs has increased, given the number of novel molecular targeted therapies now available for testing, an abundance of cytostatic agents, and limited ...

BACKGROUND For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trial's findings (that is, non-primary results) are often reported in subsequent publications. METHODS We carried out a cross-sectional review of the characteristics and type of infor...

ANAL CANAL CARCINOMA IS AN uncommon malignancy in the United States. Among 1 437 180 new cancer diagnoses projected for the year 2008, approximately 5070 will be new cases of anal canal carcinoma. Anal canal carcinoma has a unique clinical biology that can be distinguished from all other gastrointestinal cancers. It is mostly a local-regional cancer, with a metastatic potential in only 15% of p...

Intervention: Randomly assigned conventional retraction or retraction with the wound-protection system. Patients were blinded to the study arm in which they were enrolled. All patients were given standardized preoperative antibiotics. Demographics including age, sex, body mass index, history of diabetes, and tobacco use were recorded. The severity of appendicitis as determined by the attending ...

Objectives: To determine if a modified version of the cross body stretch that incorporates scapular stabilization immediately following a bout of pitching will increase passive shoulder range of motion more than the standard cross body stretch in male collegiate baseball players. Background: Overhead athletes, mainly baseball players, often exhibit pathologic gross internal rotation deficit (pG...

Background: Concept-based Indexing is purported to provide more granular data representation for clinical records"'2 This implies that a detailed clinical terminology should be able to provide improved access to clinical records. To date there is no data to show that a clinical reference terminology is superior to a precoordinated terminology in its ability to provide access to the clinical rec...

The high prevalence and diversity of longer-term problems experienced by patients with stroke and their carers has long been recognized, but they remain poorly addressed by existing services. Postdischarge contact with therapy services is associated with improved outcomes. However, these interventions are generally time limited and have little effect on psychosocial outcome. National guidelines...

BACKGROUND: Snoring is extremely common in the general population and may indicate OSA. However, snoring is not objectively measured during polysomnography, and no standard treatment is available for primary snoring or when snoring is associated with mild forms of OSA. Th is study determined the eff ects of oropharyngeal exercises on snoring in minimally symptomatic patients with a primary comp...

Correction Contact me if this article is corrected. http://jama.ama-assn.org/cgi/content/full/jama;294/23/2973 Correction is appended to this PDF and also available at Citations Contact me when this article is cited. This article has been cited 73 times. Topic collections Contact me when new articles are published in these topic areas. Surgery; Surgical Physiology; Surgical Infections; Randomiz...

Background—Previous studies suggested that transplantation of autologous bone marrow–derived mononuclear cells (BMNCs) improves heart function in chronic chagasic cardiomyopathy. We report the results of the first randomized trial of BMNC therapy in chronic chagasic cardiomyopathy. Methods and Results—Patients 18 to 75 years of age with chronic chagasic cardiomyopathy, New York Heart Associatio...