Clinical efficacy evaluation of a traditional Miao technique of crossbow needle therapy in the treatment of knee osteoarthritis: a multi-center randomized controlled trial
Knee osteoarthritis (KOA) seriously reduces quality of life and is a major threat to the health of the middle-aged and elderly. This study aimed to assess the efficacy of Miao crossbow needle therapy vs. acupu...Trials 2020 21:560Clinical efficacy of ceramic versus resin-based composite endocrowns in Chinese adults: study protocol for a randomized controlled trial
Endocrown restoration is widely used to restore endodontically treated teeth. However, the clinical effects of different computer-aided design/computer-aided manufacturing (CAD/CAM) materials for endocrown res...Trials 2020 21:559Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
Hypertension is a major pathogenic factor of cardiovascular diseases. Insufficient blood pressure control rate and sub-optimal medication adherence remain challenges for effective management of hypertension. T...Trials 2020 21:558Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength
Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes. However, studies, so far, have employed supervised resistance exercise in a laboratory or g...Trials 2020 21:557Correction to: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:556The original article was published in Trials 2020 21:468Correction to: Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:555The original article was published in Trials 2020 21:481Correction to: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:554The original article was published in Trials 2020 21:491The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France
Suicide constitutes a cause of death which could be prevented by e-health programs accessible to the general population. Effective promotion has the potential to maximize the uptake of such programs. However, ...Trials 2020 21:553Defining key design elements of registry-based randomised controlled trials: a scoping review
Traditional randomised controlled trials remain the gold standard for improving clinical care but they do have their limitations, including their associated high costs, high failure rate and limited external v...Trials 2020 21:552Timing of antiretroviral therapy for HIV-infected patients with moderate to severe Pneumocystis pneumonia: study protocol for a multi-centre prospective randomised controlled trial
Pneumocystis pneumonia (PCP) is a common acquired immune deficiency syndrome (AIDS)-related opportunistic infection. Recent reports estimate that more than 400,000 patients with human immunodeficiency virus (HIV)...Trials 2020 21:551Efficacy and safety of Dingkun pill for female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer: study protocol for a multicenter, double-blind, randomized, placebo-controlled trial
Approximately 15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilizati...Trials 2020 21:550Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial
There is little information about Coronavirus Disease 2019 (COVID-19) management for critically ill patients. Most of these patients develop acute respiratory distress syndrome (ARDS) due to excessive inflamma...Trials 2020 21:549Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) may trigger severe pneumonia in coronavirus disease of 2019 (COVID-19) patients through release of damage-associated molecular patterns (DAMPs) and ...Trials 2020 21:548Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial
Postinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. However, the optimal treatme...Trials 2020 21:547The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial
The direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendo...Trials 2020 21:546Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial
Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including self-m...Trials 2020 21:545AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial
Phase I - To determine the optimal dose of each candidate (or combination of candidates) entered into the platform.Trials 2020 21:544Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials
Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public ...Trials 2020 21:543The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial
Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with in...Trials 2020 21:542The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study
There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising th...Trials 2020 21:541Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determ...Trials 2020 21:540Stakeholder perspectives on adaptive clinical trials: a scoping review
Adaptive clinical trials (ACTs) represent an emerging approach to trial design where accumulating data are used to make decisions about future conduct. Adaptations can include comparisons of multiple dose tier...Trials 2020 21:539Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial
Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibr...Trials 2020 21:538The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. ...Trials 2020 21:528Using targeting to recruit men and women of color into a behavioral weight loss trial
The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment ...Trials 2020 21:537Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:536The original article was published in Trials 2020 21:499Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project
Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavie...Trials 2020 21:535Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial
Vaccines may cause non-specific effects (NSEs) on morbidity and mortality through immune-mediated mechanisms that are not explained by the prevention of the targeted disease. Much of the evidence for NSEs come...Trials 2020 21:534Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial
There has been growing evidence on the favourable outcomes of fast-track-recovery (FTR) surgery; to expedite recovery, minimise complications, and reduce the length of hospital stay for surgical patients. Howe...Trials 2020 21:533IMPROVEjob – Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises – a study protocol of a cluster-randomised controlled trial
Perceived high chronic stress is twice as prevalent among German general practitioners (GPs) and non-physician medical staff compared to the general population. The reasons are multi-factorial and include pati...Trials 2020 21:532Study protocol for daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial
Colonic diverticular disease has been increasing in prevalence due to the rapidly aging global population, but standard treatment has not changed dramatically in recent years. Daiobotanpito (DBT; Da Huang Mu Dan ...Trials 2020 21:531Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
There are few sources of published data on intra-cluster correlation coefficients (ICCs) amongst patients with type 2 diabetes (T2D) and/or hypertension in primary care, particularly in low- and middle-income ...Trials 2020 21:530Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial
Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has b...Trials 2020 21:527Correction to: Effectiveness of a multi-level intervention to reduce men’s perpetration of intimate partner violence: a cluster randomised controlled trial
An amendment to this paper has been published and can be accessed via the original article.Trials 2020 21:526The original article was published in Trials 2020 21:359Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial
Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting ...Trials 2020 21:525Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs
Scaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030...Trials 2020 21:524Corneal cross-linking versus standard care in children with keratoconus – a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan
The KERALINK trial tests the hypothesis that corneal cross-linking (CXL) treatment reduces the progression of keratoconus in comparison to standard care in patients aged 10–16 years. This article describes the...Trials 2020 21:523Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women – the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials
Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother–infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent st...Trials 2020 21:522Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial
Independent of pain intensity, pain-specific distress is highly predictive of pain treatment needs, including the need for prescription opioids. Given the inherently distressing nature of chronic pain, there i...Trials 2020 21:521Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II)
To assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.Trials 2020 21:520Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial
Individuals affected by heart failure (HF) may present fatigue, dyspnea, respiratory muscle weakness, and sympathetic activity hyperstimulation of the myocardium, among other symptoms. Conducting cardiac rehab...Trials 2020 21:519A feasibility study of a WhatsApp-delivered Transtheoretical Model-based intervention to promote healthy eating habits for firefighters in Hong Kong: a cluster randomized controlled trial
Firefighters’ health is often affected by a high prevalence of obesity and cardiovascular diseases, which are common risk factors for sudden cardiac death. The aim of this study is to investigate the feasibili...Trials 2020 21:518
miércoles, 24 de junio de 2020
Trials | Articles
Trials | Articles
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