Although traditional phase II cancer trials are usually single arm, with tumor response as endpoint, and phase III trials are randomized and incorporate interim analyses with progression-free survival or other failure time as endpoint, this paper proposes a new approach that seamlessly expands a randomized phase II study of response rate into a randomized phase III study of time to failure. Thi...

The randomized carotid stent versus carotid surgery trial reported by Brooks et al. (1) in this issue of the Journal is a notable accomplishment in several respects. By reporting results in 104 patients, it becomes the largest randomized carotid artery stent versus carotid endarterectomy trial published to date (to my knowledge). It is also an excellent example of team building with a surgeon, ...

BACKGROUND Increasingly, researchers are recognizing that there are many situations where the use of a cluster randomized trial may be more appropriate than an individually randomized trial. Similarly, the need for appropriate standards of reporting of cluster trials is more widely acknowledged. METHODS In this paper, we describe the results of a survey to inform the appropriate reporting of ...

Objective: Inflammation along with oxidative stress has an important role in the pathophysiology of unstable angina which leads to acute myocardial infarction, arrhythmias and eventually heart failure. Curcumin has anti-inflammatory and anti-oxidant effects and thereby, it may reduce cardiovascular complications. This randomized controlled trial aimed to investigate the effects of curcumin on t...

BACKGROUND Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. OBJECTIVES The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the ration...

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and C...

BACKGROUND It is widely thought that widespread antibiotic use selects for community antibiotic resistance, though this has been difficult to prove in the setting of a community-randomized clinical trial. In this study, we used a randomized clinical trial design to assess whether macrolide resistance was higher in communities treated with mass azithromycin for trachoma, compared to untreated co...

OBJECTIVE To present the rationale, design, and methodology of the Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) study. DESIGN Randomized clinical trial. SETTING Two academic medical centers. PATIENT(S) Premenopausal women with symptomatic uterine fibroids. INTERVENTION(S) Participants are randomized to two U.S. Food and Drug Administration-approved minimally inva...

The Effects of a Multidisciplinary Supportive Program on Caregiver Burden among the Family Caregivers Patients with Advanced Chronic Obstructive Pulmonary Disease: A Randomized Controlled Field Trial

Onset of action and duration efficacy inferior alveolar nerve block versus single lingual subperi-osteal injection 4% articaine in mandibular second molars: A randomized clinical trial