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Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and hav...
Despite the use of evidence-based preventive measures, delirium affects about 40% of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers. There i...
Today’s children are more overweight than previous generations and physical inactivity is a contributing factor. Modelling and promoting positive behaviour in the early years is imperative for the development ...
Recruiting stroke patients into acute treatment trials is challenging because of the urgency of clinical diagnosis, treatment, and trial inclusion. Automated alerts that identify emergency patients promptly ma...
An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based comb...
The Grip on Challenging Behavior care program for managing challenging behavior was implemented in the dementia special care units of 17 Dutch nursing homes. A process evaluation of the implementation of the c...
The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi (a specific and compound sensation during the acupuncture), which is necessary t...
Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no...
In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insur...
The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that ma...
Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (C...
The Erratum to this article has been published in Trials 2016 17:357
Tinnitus occurs in a large part of the general population with prevalences ranging from 10% to 15% in an adult population. One subtype is cervicogenic somatic tinnitus, arising from cervical spine dysfunctions...
The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quit...
The results of preclinical studies suggest that baclofen may be useful in the treatment of stroke patients with persistent hiccups. This study was aimed to assess the possible efficacy of baclofen for the trea...
Depression is a debilitating mental health problem that tends to run a chronic, recurrent course. Even when effectively treated, relapse and recurrence rates remain high. Accordingly, interventions need to foc...
We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effec...
Approximately 85% of vaginal deliveries are accompanied by perineal trauma. The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared...
Aphasia is a common and severely disabling complication in stroke patients. It usually brings about lower rates of functional recovery, longer rehabilitation length of stay (LOS), and significantly poorer LOS ...
Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventi...
About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and...
Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot’ studies to investigate interventions already proven efficacious, offered free of charge t...
Evidence suggests that research protocols often lack important information on study design, which hinders external review. The study protocol should provide an adequate explanation for why the proposed study m...
The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. L...
People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high n...
Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following...
Depression is a leading cause of disability worldwide and, although efficacious treatments are available, their efficacy is suboptimal and recurrence of symptoms is common. Effective preventive strategies coul...
Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can sa...
Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate ...
The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database is an international repository of studies relevant to the development of core outcome sets. By the end of 2013, it included a uniqu...
UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps t...
Intensive care units (ICU) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria (ARGNB) because of high rates of antibiotic usage, rapid patient turnover, immunological susceptibilit...
The optimal crystalloid solution to use perioperatively in patients undergoing open radical cystectomy remains unclear. Many of the fluids used for intravenous hydration contain supraphysiologic concentrations...
The Erratum to this article has been published in Trials 2016 17:95
Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can incre...
At the design stage of a clinical trial, several assumptions have to be made. These usually include guesses about parameters that are not of direct interest but must be accounted for in the analysis of the tre...
Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We desi...
Chronic gastritis (CG), a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure. Chronic non-atrophic gastritis (CNG) is the most common type of CG. Even if treated...
By the age of sixteen, one in five children will sustain a mild traumatic brain injury also known as concussion. Our research found that one in seven school children with mild traumatic brain injury suffer pos...
One of the most dreaded complications of septic shock is acute kidney injury. It occurs in around 50% of patients, with a mortality rate of about 60% at 3 months. There is no consensus on the optimal time to i...
Cerebral palsy (CP) is the most common motor disability in childhood (2 to 3 per 1000 live births), and is frequently accompanied by cognitive impairments and behavioural problems. Children with CP are at incr...
Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from sy...
The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of...
Smoking rates, and associated negative health outcomes, are disproportionately high among people with mental illness compared to the general population. Smoke-free policies within mental health hospitals can p...
Many of the approximately 15 million people with a migration background living in Germany (19% of the population) are inadequately reached by existing healthcare provision. In the literature, the necessity for...
External pilot or feasibility studies can be used to estimate key unknown parameters to inform the design of the definitive randomised controlled trial (RCT). However, there is little consensus on how large pi...
The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designe...
Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to ...
Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently ...
Patients are at risk of drug-related problems (DRPs) at transition points during hospitalization. The community pharmacist (CP) is often the first healthcare professional patients visit after discharge. CPs la...
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention inte...
Preterm birth is the most important single determinant of adverse outcome in the United Kingdom; one in every 70 babies (1.4%) is born before 32 weeks (very preterm), yet these births account for over half of ...
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