Abstract：
:Phase IIA clinical trials are commonly conducted as pilot studies to evaluate efficacy and safety in selected populations of patients with the disease or condition to be treated or prevented. The efficacy objective is to find preliminarily evidence of the effectiveness or ineffectiveness of study treatments. Go/no-go decisions will be made during or at the end of these trials. Interim analyses (multiple stages) are usually built-in to terminate futile treatments. The designs presented in this paper match the efficacy objective with go/no-go decisions. This is achieved by setting up the threshold as the minimal effective response rate. Asymmetric type I error spending at this threshold is also possible. When two-stage designs are used, the stage I sample size is flexible and can cover all practical scenarios.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Zhong Bdoi
10.1016/j.cct.2012.07.006subject
Has Abstractpub_date
2012-11-01 00:00:00pages
1272-9issue
6eissn
1551-7144issn
1559-2030pii
S1551-7144(12)00177-2journal_volume
33pub_type
杂志文章abstract：BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.01.005
更新日期：2015-03-01 00:00:00
abstract：BACKGROUND:Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. METHODS: EXPOSURE:Randomization to cin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.04.001
更新日期：2016-05-01 00:00:00
abstract：:Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-depende...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.10.010
更新日期：2013-01-01 00:00:00
abstract：:Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2010.06.002
更新日期：2010-09-01 00:00:00
abstract：:Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are un...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.006
更新日期：2018-04-01 00:00:00
abstract：:Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular car...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.12.001
更新日期：2014-01-01 00:00:00
abstract：:Thirty percent of all military personnel smoke cigarettes. Because of the negative health consequences and their impact on physical fitness, overall health, and military readiness, the Department of Defense has identified the reduction of tobacco use as a priority of US military forces. This study aims to evaluate the...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.04.009
更新日期：2012-09-01 00:00:00
abstract：UNLABELLED:Latinos bear a disproportionate burden of the dual pandemic of obesity and diabetes. However, successful interventions addressing this disparity through primary care are lacking. To address this gap, the 5-year Vida Sana (Healthy Life) study tests a culturally adapted and technology-enhanced group-based Diab...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.03.003
更新日期：2016-05-01 00:00:00
abstract：BACKGROUND:This paper reports the protocol of a randomised, double-blind, placebo-controlled study to test the efficacy, safety, and tolerability of lubiprostone (LUB) vs. placebo on suppressing gut permeability in non-alcoholic fatty liver disease (NAFLD) patients with constipation. NAFLD, including non-alcoholic stea...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.04.002
更新日期：2018-06-01 00:00:00
abstract：:Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106126
更新日期：2020-11-01 00:00:00
abstract：BACKGROUND:Current guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic ut...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.05.003
更新日期：2019-07-01 00:00:00
abstract：BACKGROUND:Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2005.08.002
更新日期：2006-02-01 00:00:00
abstract：BACKGROUND:Hypertension disproportionately affects African Americans compared to whites, and it is the single most common explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes. Motivatio...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2006.04.002
更新日期：2007-02-01 00:00:00
abstract：INTRODUCTION:Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exer...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.06.020
更新日期：2015-07-01 00:00:00
abstract：OBJECTIVE:Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two appro...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105873
更新日期：2020-03-01 00:00:00
abstract：UNLABELLED:Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified a...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.004
更新日期：2016-07-01 00:00:00
abstract：BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.03.014
更新日期：2012-07-01 00:00:00
abstract：:Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evide...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.09.004
更新日期：2017-11-01 00:00:00
abstract：BACKGROUND:The Fontan circulation is a palliative procedure performed in patients with complex congenital heart disease (CHD), making transpulmonary blood flow dependent on the systemic venous pressure. In a Fontan circulation a low pulmonary vascular resistance (PVR) is crucial, as is epitomized by the observation tha...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2011.04.001
更新日期：2011-07-01 00:00:00
abstract：:It is of vital importance to the success of a randomized clinical trial to maintain the balance of baseline characteristics (covariates) that could potentially confound the outcomes of the trial. Various randomization methods have been proposed to increase the likelihood of having balanced covariates at the end of a t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.03.004
更新日期：2011-07-01 00:00:00
abstract：:The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106218
更新日期：2020-11-14 00:00:00
abstract：:While investigators designing clinical trials face the important issue of endpoint selection, an equally troublesome concern can be the a priori selection of the endpoint analysis. In this latter circumstance, there may be only one endpoint of interest in the clinical trial, but several competing endpoint analyses are...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.05.010
更新日期：2007-01-01 00:00:00
abstract：INTRODUCTION:Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison o...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2012.05.007
更新日期：2012-09-01 00:00:00
abstract：AIMS:To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial. METHODS:Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105834
更新日期：2019-10-01 00:00:00
abstract：BACKGROUND:Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research suggests that MBRP can effectively reduce withdrawal/craving in people with substance use disorder (SUD). An important part of MBRP is to practice mindfulness medi...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.04.006
更新日期：2018-07-01 00:00:00
abstract：BACKGROUND:Intake of sugar-sweetened beverages is associated with overweight in observational studies. A possible explanation is that liquid sugars do not satiate and that their intake is not compensated by reduced caloric intake from other foods. However, evidence from intervention studies for this hypothesis is incon...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2011.10.007
更新日期：2012-01-01 00:00:00
abstract：:Lumbar spinal stenosis is a common degenerative disorder of the spine in elderly patients that can be effectively treated with decompression surgery in some patients. Radiological findings in the diagnostic work-up of the patients do not always correlate well with clinical symptoms, and guidance about when to proceed ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.01.015
更新日期：2011-05-01 00:00:00
abstract：BACKGROUND:Basic research suggests that rapid increases in circulating inflammatory and hemostatic blood markers may trigger or indicate impending plaque rupture and coronary thrombosis, resulting in acute ischemic heart disease (IHD) events. However, these associations are not established in humans. METHODS AND RESUL...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2014.03.009
更新日期：2014-05-01 00:00:00
abstract：OBJECTIVE:Pregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, includin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.09.009
更新日期：2018-10-01 00:00:00
abstract：BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towa...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2013.06.003
更新日期：2013-09-01 00:00:00
