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Non-inferiority and equivalence trials aim to determine whether a new treatment is good enough (non-inferior) or as good as (equivalent to) another treatment. To inform the decision about non-inferiority or eq...
Foot complications occur in conjunction with poorly controlled diabetes. Plantar forefoot ulceration contributes to partial amputation in unstable diabetics, and the risk increases with concomitant neuropathy....
In emergency medicine, pain is a frequent reason for consultation. However, there is a great variation in its management which is often insufficient. The use intravenous morphine alone or multimodal analgesia ...
Current dietary strategies to manage cancer cachexia and the relevant outcomes did not provide a comprehensive solution. This study will evaluate the effect of a Mediterranean diet on inflammatory markers, nut...
SARS-CoV-2 infection is associated with a significant risk of hospitalisation, death, and prolonged impact on quality of life. Evaluation of new treatment options and optimising therapeutic management of peopl...
Unhealthy behaviors of coronary heart disease (CHD) patients are closely related to the occurrence of major heart events, which increases the readmission rate and brings a heavy economic burden to families and...
Currently, the standard therapy for autoimmune hepatitis (AIH) consists of a combination of prednisolone and azathioprine. However, 15% of patients are intolerant to azathioprine which necessitates cessation o...
Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a ...
Extremely low gestational age neonates (ELGANs, i.e., neonates born before 28 weeks of gestation) are at high risk of developing retinopathy of prematurity (ROP), with potential long-life visual impairment. Du...
Osteoarthritis (OA) is a common and highly disabling disease that imposes a heavy burden on individuals and society. Although physical therapy is recommended as an important method to relieve OA symptoms, pati...
Postoperative fever is one of the common complications in neurosurgery, and intracranial aseptic inflammation and infection are important risk factors. Continuous drainage of cerebrospinal fluid (CSF) via lumb...
Recent developments in eHealth and mobile health (mHealth), as well as the introduction of information and communication technology innovations in clinical practice, such as telemedicine, telemonitoring, and r...
Substance abuse is the actual psychosocial harm, especially in young people confronted with content marketing in nowadays media environment, a risk factor for experiencing substance abuse. Based on the literat...
Insomnia is the most common sleep disorder. Repetitive transcranial magnetic stimulation (rTMS) is safe and effective for insomnia disorder (ID). Convergent evidence show that the medial prefrontal cortex (mPF...
Children referred for attention-deficit/hyperactivity disorder (ADHD) often present with a broader pattern of conduct problems including oppositionality and defiance. This combination can be extremely stressfu...
Varicocele is a high incidence and is considered to be the most common and correctable cause of male infertility. Oxidative stress (OS) plays a central role in the pathogenesis of varicocele-related male infer...
Compared with optimal blood pressure (BP), the prehypertension increases the risk of incident hypertension, cardiovascular (CV) events, and death. Moderate intensity of regular physical activity can reduce BP....
Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critica...
The original article was published in Trials 2014 15:160
Food insecurity, or the lack of consistent access to nutritionally adequate and safe foods, effects up to 50% of people living with HIV (PWH) in the United States (US). PWH who are food insecure have lower ant...
The German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therape...
Post-craniotomy pain is a common occurrence which is associated with poor outcomes. Pre-emptive scalp infiltration with dexamethasone and ropivacaine has been proven effective in previous studies but with limi...
Gastrointestinal endoscopy has been associated with difficult experiences and can leave patients with an unpleasant impression. Propofol and midazolam are the most commonly used intravenous anesthetics for sed...
Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared ...
Spontaneous breathing trials are performed in critically ill intubated patients in order to assess readiness to be weaned from mechanical ventilation. In patients with difficult weaning (i.e. not extubated aft...
Patients with a history of cardiac disease are prone to develop cardiovascular adverse events such as hypotension, hypertension, and tachycardia during anesthesia induction. Therefore, hemodynamic stability is...
Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversia...
Coronary artery bypass grafting can be conducted using the radial artery as a bypass graft. However, it remains unclear which harvesting method is superior, i.e. endoscopic or open radial artery, and which sit...
The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to st...
Coronary artery disease (CAD) remains a severe socio-economic burden in the Western world. Coronary obstruction and subsequent myocardial ischemia result in the progressive replacement of contractile myocardiu...
The Study protocol to this article has been published in Trials 2020 21:447
Multiple-period parallel group randomized trials (GRTs) analyzed with linear mixed models can represent time in mean models as continuous or categorical. If time is continuous, random effects are traditionally...
More than half of the world’s population lives in Asia. With current life expectancies in Asian countries, the burden of cardiovascular disease is increasing exponentially. Overcrowding in the emergency depart...
The Correction to this article has been published in Trials 2023 24:335
The effect of telemedicine solutions in diabetes remains inconclusive. However, telemedicine studies have shown a positive trend in regards to glycemic control. The telemedicine interventions that facilitate a...
Valvular heart disease remains common in both developed and developing countries, and it requires timely surgical treatment when necessary. However, the stability of hemodynamics during anesthesia induction in...
Behavior change interventions have been the focus of recent studies, and the COVID-19 pandemic highlighted the importance of online interventions. However, no previous studies have investigated behavior change...
Lumbar disc herniation is one of the leading causes of chronic low back pain. Surgery remains the therapy of choice when conservative approaches fail. Full-endoscopic approaches represent a promising alternati...
Our randomized controlled clinical trial will explore the potential of bazedoxifene plus conjugated estrogen to modulate breast tissue-based risk biomarkers as a surrogate for breast cancer risk reduction. Thi...
The aim of this protocol is to describe the study protocol changes made and subsequently implemented to the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT) for ...
Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp. The recommended care is the removal of the coronal pulp (pulpotomy) for emergency treatment in multi-rooted teeth. However, ...
Given the large genetic heterogeneity in amyotrophic lateral sclerosis (ALS), it seems likely that genetic subgroups may benefit differently from treatment. An exploratory meta-analysis identified that patient...
Arthroscopic rotator cuff repair (ARCR) often causes unbearable postoperative pain, even more severe than before surgery. Opioids are the drugs of choice for temporary postoperative analgesia. However, this co...
People living with diabetes must manage a range of factors for optimal control of glycaemia and to minimise the risk of diabetes-related complications. Diabetes practitioners are expected to follow guidelines ...
While inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler nonadherence is a notoriously common problem and a significant cause of asthma-related morbidity....
For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can i...
Interparental violence has persistent adverse effects on victimized parents and children. Young children, including infants and toddlers, are at particular risk to develop long-lasting negative outcomes, and y...
More than 2.5 million people are admitted for surgery in Australia each year, and between 40 to 80% will experience moderate to high preoperative anxiety. Elevated levels of preoperative anxiety can increase t...
The efficacy of psychoeducation as an add-on treatment to pharmacotherapy is well documented in treating symptoms and in relapse prevention for persons with bipolar disorder in western countries. Yet, no studi...
To investigate various patient-level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigated a non-interventional prosp...
At the time of diagnosis, 15–20% of gastric carcinomas are in stage T4 or T4b. Furthermore, 5–20% of patients undergoing potentially curative surgery suffer from synchronous or metachronous peritoneal metastas...
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