Abstract：
:The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed for the HIV Vaccine Trials Network (HVTN) motivated by characteristics unique to the vaccine setting. The program consists of 3 prototypical stages (Phase I, Ib, II) that provide a unified yet flexible approach to the safety and immunogenicity evaluation of diverse vaccine regimens. The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Moodie Z,Rossini AJ,Hudgens MG,Gilbert PB,Self SG,Russell NDdoi
10.1016/j.cct.2005.11.008keywords:
subject
Has Abstractpub_date
2006-04-01 00:00:00pages
147-60issue
2eissn
1551-7144issn
1559-2030pii
S1551-7144(05)00190-4journal_volume
27pub_type
杂志文章abstract：:Evaluation of time to event outcomes usually is examined by the Kaplan-Meier method and Cox proportional hazards models. We developed a modified statistical model based on histologic grade and other variables to describe the time-dependent outcome for autologous stem cell transplant (autotransplant) performed for non-...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.07.005
更新日期：2008-03-01 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：OBJECTIVE:To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. METHODS:Thirty patients (ASAI-II) who had no neuromuscular disease and underwent selective surgery under general anesthesia were randomly div...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.01.002
更新日期：2012-05-01 00:00:00
abstract：BACKGROUND:Early pregnancy through the first year of life represents an important period for family health promotion and obesity prevention. Overall, preventive interventions in pregnancy and infancy have insufficiently engaged fathers. We describe the rationale and design of First Heroes, an intervention to improve pe...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106253
更新日期：2020-12-17 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：INTRODUCTION:When the Centers for Medicare and Medicaid Services announced coverage for low dose CT lung cancer screening, they also mandated that imaging centers offer smoking cessation services. We designed the Optimizing Lung Screening (OaSiS) trial to evaluate strategies to implement the Public Health Service Guide...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.105963
更新日期：2020-04-01 00:00:00
abstract：OBJECTIVE:Characteristics that may influence participation in DNA banks are not well defined. The purpose of this study was to examine characteristics associated with participation in a DNA bank among veterans diagnosed with Amyotrophic Lateral Sclerosis (ALS). METHODS:Veterans who screened eligible for the National R...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.01.009
更新日期：2007-09-01 00:00:00
abstract：BACKGROUND:In 2007, we commenced the Healthy Beginnings Trial (HBT) Phase 1 study, which is the first randomised controlled trial (RCT) to test the effectiveness of an early childhood obesity intervention in children aged up to 2 years. The results were promising with significant improvements in infant feeding practice...
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.2011.11.008
更新日期：2012-03-01 00:00:00
abstract：BACKGROUND:Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. OBJECTIVES:To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC2...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.05.003
更新日期：2017-08-01 00:00:00
abstract：BACKGROUND:Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, an...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.03.007
更新日期：2017-06-01 00:00:00
abstract：BACKGROUND:Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.08.009
更新日期：2016-09-01 00:00:00
abstract：BACKGROUND:Management of asthma involves adherence to medication regimens. Assessing adherence is difficult for health care providers and researchers. Self-reported medication use is subjective, so objective methods of data collection for medication use are frequently used in asthma research. The aim of this project is...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.05.002
更新日期：2008-01-01 00:00:00
abstract：BACKGROUND:Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventio...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.02.011
更新日期：2012-07-01 00:00:00
abstract：BACKGROUND:Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2019.04.005
更新日期：2019-06-01 00:00:00
abstract：:The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in acti...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,meta分析
doi：10.1016/j.cct.2004.12.009
更新日期：2005-04-01 00:00:00
abstract：:Behavioral weight loss programs help people achieve clinically meaningful weight losses (8-10% of starting body weight). Despite data showing that only half of participants achieve this goal, a "one size fits all" approach is normative. This weight loss intervention science gap calls for adaptive interventions that pr...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.01.011
更新日期：2016-03-01 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：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:Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2013.02.011
更新日期：2013-05-01 00:00:00
abstract：BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists loc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106169
更新日期：2020-11-01 00:00:00
abstract：:Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.08.004
更新日期：2007-05-01 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：:Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.04.003
更新日期：2017-06-01 00:00:00
abstract：:Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.06.005
更新日期：2016-07-01 00:00:00
abstract：INTRODUCTION:Youth in disadvantaged urban areas are frequently exposed to chronic stress and trauma, including housing instability, neighborhood violence, and other poverty-related adversities. These exposures increase risk for emotional, behavioral, and academic problems and ultimately, school dropout. Schools are a p...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105895
更新日期：2020-03-01 00:00:00
abstract：:We report here on the use of interactive telephone technology for collecting longitudinal data in a large randomized non-blinded parallel trial. Data were primarily collected via an automated interactive telephone system which enabled data to be downloaded by researchers periodically via a secure website. Alternative ...
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.2011.10.012
更新日期：2012-03-01 00:00:00
abstract：:Identifying effective strategies for treating obesity is a clinical challenge and a public health priority. The present study is an innovative test of the relative effectiveness of lottery-based financial incentives and environmental strategies on weight loss and maintenance. The Healthy Weigh study is evaluating the ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.10.013
更新日期：2019-01-01 00:00:00
abstract：BACKGROUND:Anxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs. METHODS:Presen...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.05.002
更新日期：2012-09-01 00:00:00
abstract：PURPOSE:Black breast cancer survivors have high rates of obesity and low physical activity levels. Little is known about the acceptability and feasibility of interventions in this population. OBJECTIVE:A two-arm RCT was launched to assess the efficacy of a culturally targeted 12-week multimodal lifestyle intervention ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.12.005
更新日期：2016-01-01 00:00:00
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 ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2012.07.006
更新日期：2012-11-01 00:00:00
