Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)
ConclusionsWhile the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial.Trial registrationISRCTNISRCTN49875385. Registered on 26 March 2014. (Source: Trials)
Source: Trials - September 23, 2020 Category: Research Source Type: clinical trials

Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial
This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM.MethodsThe study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB ™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these ...
Source: Trials - September 23, 2020 Category: Research Source Type: clinical trials

Correction to: Using qualitative research to explore intervention mechanisms: findings from the trial of the learning together whole-school health intervention
An amendment to this paper has been published and can be accessed via the original article. (Source: Trials)
Source: Trials - September 23, 2020 Category: Research Source Type: clinical trials

A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial
Almost half of people living with HIV (PLWH) in the USA are over 50  years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physica... (Source: Trials)
Source: Trials - September 22, 2020 Category: General Medicine Authors: Gladys E. Iba ñez, Kristopher Fennie, Linda Larkey, Nan Hu, Angel B. Algarin, Chelsea Valdivia and Helen Lavretsky Tags: Study protocol Source Type: research

Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers
Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as p... (Source: Trials)
Source: Trials - September 22, 2020 Category: General Medicine Authors: Signe Sloth Madsen, Kirsten M øller, Karsten Skovgaard Olsen, Mark Bitsch Vestergaard, Ulrich Lindberg, Henrik Bo Wiberg Larsson, Johan Mårtensson, Mads U. Werner, Sofia Alexandra Gaspar Santos and Mohammad Sohail Asghar Tags: Study protocol Source Type: research

A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial
DiscussionWe will assess feasibility and acceptability through questionnaires and adherence to TCQ. We will assess preliminary associations with symptoms such as depression, anxiety, social support, chronic HIV-related fatigue, and clinical outcomes. These will be described through proportions, means, and changes over time through graphing techniques. Outcomes will be assessed at baseline, at post-intervention, and at 3  months follow-up. These preliminary analyses also will provide information necessary to estimate effect size and power needed for a larger clinical trial.Trial registrationClinicalTrials.govNCT0384052...
Source: Trials - September 22, 2020 Category: Research Source Type: clinical trials

Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers
DiscussionTo the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019.Trial registrationApproved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018).www.clinicaltrials.gov, ID:NCT04125121. Retrospectively registered on 10 October 2019. (Source: Trials)
Source: Trials - September 22, 2020 Category: Research Source Type: clinical trials

The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial
Every year, many infants are infected with the respiratory syncytial virus (RSV) or other agents and need hospitalisation due to bronchiolitis. The disease causes much suffering and high costs. Thus, it is imp... (Source: Trials)
Source: Trials - September 21, 2020 Category: General Medicine Authors: Sonja Andersson-Marforio, Annika Lundkvist Josenby, Eva Ekvall Hansson and Christine Hansen Tags: Study protocol Source Type: research

The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial
This study is a clinical two-centre individually randomised controlled trial (RCT) with three parallel groups. The participants will be randomly assigned to an individualised physiotherapy intervention, a non-individualised intervention, or a control group. All three groups will receive the standard care at the ward, and the two intervention groups will receive additional treatment, including different movements of the body. The primary outcome measure is a clinical index based on determinants for hospitalisation. Baseline assessments will be compared with the assessments after 24  h. The secondary outcome measures ...
Source: Trials - September 21, 2020 Category: Research Source Type: clinical trials

Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY)
Fatigue is a well-known common clinical feature of numerous chronic diseases including various forms of cancer, neurological disorders such as multiple sclerosis, and psychiatric disorders. A significant propo... (Source: Trials)
Source: Trials - September 17, 2020 Category: General Medicine Authors: St éphane Raffard, Nicolas Rainteau, Sophie Bayard, Yasmine Laraki, Joanna Norton and Delphine Capdevielle Tags: Study protocol Source Type: research

Patient and healthcare professional experiences of the Salford Lung Studies: qualitative insights for future effectiveness trials
Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved u... (Source: Trials)
Source: Trials - September 17, 2020 Category: General Medicine Authors: Kim Gemzoe, Rebecca Crawford, Ann Caress, Sheila McCorkindale, Rebecca Conroy, Susan Collier, Lynda Doward, Renu M. Vekaria, Sally Worsley, David A. Leather and Elaine Irving Tags: Research Source Type: research

Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
Objectives: The Bacille Calmette-Gu érin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and morta... (Source: Trials)
Source: Trials - September 17, 2020 Category: General Medicine Authors: Anne Marie Rosendahl Madsen, Frederik Schaltz-Buchholzer, Thomas Benfield, Morten Bjerregaard-Andersen, Lars Skov Dalgaard, Christine Dam, Sisse Bolm Ditlev, Gulia Faizi, Isik Somuncu Johansen, Poul-Erik Kofoed, Gitte Schultz Kristensen, Ellen Christine L Tags: Letter Source Type: research

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study
Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation tech... (Source: Trials)
Source: Trials - September 17, 2020 Category: General Medicine Authors: Esther T. Sportel, Martijn J. Oude Wolcherink, Job van der Palen, Anke Lenferink, Boony J. Thio, Kris L. L. Movig and Marjolein G. J. Brusse-Keizer Tags: Study protocol Source Type: research

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial
Safety data is required to be collected in all clinical trials and can be separated into two types of data, adverse events and serious adverse events. Often, these types of safety data are collected as two dis... (Source: Trials)
Source: Trials - September 17, 2020 Category: General Medicine Authors: Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp and Matthew R. Sydes Tags: Methodology Source Type: research

Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial
DiscussionThe results of this study will show if patient-led, fibromyalgia-orientated exercise is more effective than a general exercise programme on fibromyalgia-related outcomes, including quality of life, and on adherence to continued exercise.Trial registrationClinicalTrials.govNCT03895086. Registration no. 2018-A02881-54. Registered on 29 March 2019 (Source: Trials)
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial
ConclusionsThere was low agreement in mapping serious adverse events to already reported adverse events, with nearly 40% of serious adverse events included in the mapping exercise not mapped to an already reported adverse event. Any analyses of safety data that use only adverse event datasets or do not clearly account for serious adverse event data will likely be missing important safety information. Reporting standards should make clear which datasets were used for analyses. (Source: Trials)
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study
DiscussionImmediate smart feedback may improve therapy adherence and inhalation technique, and thus asthma control  in children and prevent unnecessary switches to targeted biologics. Performing this study in children is desired, since they are known to react differently to feedback and medication than adults.Trial registrationDutch Trial RegisterNL7705. Registered on 29 April 2019 (Source: Trials)
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY)
This study will also test to what extent the treatment can be implemented in everyday practice.Trial registrationClinicalTrials.govNCT04332601. Registered on 10 April 2020. (Source: Trials)
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
AbstractObjectives: The Bacille Calmette-Gu érin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID- 19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with S...
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Patient and healthcare professional experiences of the Salford Lung Studies: qualitative insights for future effectiveness trials
ConclusionsPatients and HCPs had positive experiences of the SLS. The study design, closely aligned with routine care, was considered important to their high likelihood of participating in future trials. The experiences of patients and HCPs in the SLS provide valuable insights that will help inform future best practice in the design and conduct of future real-world effectiveness RCTs in primary care. The detailed first-hand experiences of HCPs will be of significant value to others considering engaging in clinical research and participating in effectiveness RCTs. (Source: Trials)
Source: Trials - September 17, 2020 Category: Research Source Type: clinical trials

Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial
In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6... (Source: Trials)
Source: Trials - September 16, 2020 Category: General Medicine Authors: Antonio F. Caballero Bermejo, Bel én Ruiz-Antorán, Ana Fernández Cruz, Elena Diago Sempere, Alejandro Callejas Díaz, Elena Múñez Rubio, Cristina Avendaño-Solá, Antonio Ramos Martínez and Aránzazu Sancho López Tags: Letter Source Type: research

Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial
Osteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. Th... (Source: Trials)
Source: Trials - September 16, 2020 Category: General Medicine Authors: Zhaohua Zhu, Qinghong Yu, Xiaomei Leng, Weiyu Han, Zhanguo Li, Cibo Huang, Jieruo Gu, Yi Zhao, Kang Wang, Tianwang Li, Yifang Mei, Jianhua Xu, Zhiyi Zhang, David Hunter, Flavia Cicuttini, Xiaofeng Zeng & hellip; Tags: Study protocol Source Type: research

Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current... (Source: Trials)
Source: Trials - September 16, 2020 Category: General Medicine Authors: Kim Donoghue, Abigail Rose, Simon Coulton, Rachel Coleman, Joanna Milward, Thomas Philips, Colin Drummond and Hilary Little Tags: Research Source Type: research

Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial
This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context.Trial designA phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio).ParticipantsThey will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen. Patients must present elevation of inflammatory parameters (IL-6> 40 pg/mL ...
Source: Trials - September 16, 2020 Category: Research Source Type: clinical trials

Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial
This study aims to examine the effect of methotrexate (MTX) on knee effusion-synovitis and pain in symptomatic patients with mid- to late-stage KOA.Methods/designThis protocol describes a multicentre randomised placebo-controlled clinical trial aiming to recruit 200 participants with mid- to late-stage symptomatic KOA and with effusion-synovitis grade of ≥ 2. Participants will be randomly allocated to the MTX group (start from 5 mg per week for the first 2 weeks and increase to 10 mg per week for the second 2 weeks and 15 mg per week for the remaining period if tolerated) or the pla...
Source: Trials - September 16, 2020 Category: Research Source Type: clinical trials

Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
ConclusionLarger trials would be needed to draw conclusions about the efficacy of mifepristone.Trial registrationISRCTN registryISRCTN54001953. Registered on 29 September 2011. (Source: Trials)
Source: Trials - September 16, 2020 Category: Research Source Type: clinical trials

Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial
We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients ... (Source: Trials)
Source: Trials - September 15, 2020 Category: General Medicine Authors: Omid Safa, Mehdi Hassani-Azad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour and Mohammad Fathalipour Tags: Letter Source Type: research

The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion —study protocol for a randomized controlled trial
Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgica... (Source: Trials)
Source: Trials - September 15, 2020 Category: General Medicine Authors: Heidi Tegner, Bente Appel Esbensen, Marius Henriksen, Rachid Bech-Azeddine, Mari Lundberg, Louise Nielsen and Nanna Rolving Tags: Study protocol Source Type: research

Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial
Cancer survivors experience compromised quality of life due to impaired cognitive function as a result of cancer diagnosis and treatment. Although exercise has proven to be effective in improving cognitive fun... (Source: Trials)
Source: Trials - September 15, 2020 Category: General Medicine Authors: Neha P. Gothe, Emily E. Erlenbach, Samuel L. Streeter and Linda Lehovec Tags: Study protocol Source Type: research

Long-term physical activity on prescription intervention for patients with insufficient physical activity level —a randomized controlled trial
Physical activity (PA) can be used to prevent and treat diseases. In Sweden, licensed healthcare professionals use PA on prescription (PAP) to support patients to increase their PA level. The aim of this rando... (Source: Trials)
Source: Trials - September 15, 2020 Category: General Medicine Authors: Stefan Lundqvist, Mats B örjesson, Åsa Cider, Lars Hagberg, Camilla Bylin Ottehall, Johan Sjöström and Maria E. H. Larsson Tags: Research Source Type: research

Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial
DiscussionThe STAY Fit Trial will test the effectiveness of yoga, aerobic exercise, and stretching and toning exercises in improving cognitive function and fitness among adult cancer survivors. The results of this pilot study will enable us to understand the most effective physical activity modality to improve cognitive function in this population and potentially combat cancer-related cognitive impairment.Trial registrationClinicalTrials.govNCT03650322. Registered on 28 August 2018. (Source: Trials)
Source: Trials - September 15, 2020 Category: Research Source Type: clinical trials

Long-term physical activity on prescription intervention for patients with insufficient physical activity level —a randomized controlled trial
ConclusionDuring long-term PAP interventions, the PA level, metabolic health, and HRQOL increased in patients at metabolic risk without significant differences between groups. The results indicate to be independent of any changes in pharmacological treatment. We demonstrated that the PAP treatment was feasible in ordinary primary care. Both the patients and the healthcare system benefitted from the improvement in metabolic risk factors. Future studies should elucidate effective long-term PAP-treatment strategies.Trial registrationClinicalTrials.govNCT03012516. Registered on 30 December 2016 —retrospectively registered. (Source: Trials)
Source: Trials - September 15, 2020 Category: Research Source Type: clinical trials

The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion —study protocol for a randomized controlled trial
DiscussionWe hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life.Trial registrationwww.clinicaltrials.govNCT04103970, Registered on 24 September 2019 (Source: Trials)
Source: Trials - September 15, 2020 Category: Research Source Type: clinical trials

Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial
This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.ParticipantsBoth male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria.Inclusion criteria:1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test).2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization.3. Hospitalized ≤48 hours.4. Signing informed consent and will...
Source: Trials - September 15, 2020 Category: Research Source Type: clinical trials

A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive p... (Source: Trials)
Source: Trials - September 14, 2020 Category: General Medicine Authors: Farhan Raza Khan, Syed Murtaza Raza Kazmi, Najeeha Talat Iqbal, Junaid Iqbal, Syed Tariq Ali and Syed Akbar Abbas Tags: Letter Source Type: research

An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial
Despite the enormous investment governments allocate to fight obesity, its worldwide prevalence is still on the rise. Moreover, the majority of the programs implemented are still targeting adults struggling wi... (Source: Trials)
Source: Trials - September 14, 2020 Category: General Medicine Authors: Paula Magalh ães, Cátia Silva, Beatriz Pereira, Gabriela Figueiredo, Ana Guimarães, Armanda Pereira and Pedro Rosário Tags: Study protocol Source Type: research

A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial
To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. (Source: Trials)
Source: Trials - September 14, 2020 Category: General Medicine Authors: Nicole C. Gavin, Tricia M. Kleidon, Emily Larsen, Catherine O ’Brien, Amanda Ullman, Sarah Northfield, Gabor Mihala, Naomi Runnegar, Nicole Marsh and Claire M. Rickard Tags: Research Source Type: research

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial
Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients ’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture ... (Source: Trials)
Source: Trials - September 14, 2020 Category: General Medicine Authors: Hongyu Yue, Shuang Zhou, Huangan Wu, Xuan Yin, Shanshan Li, Tingting Liang, Yan Li, Zhihong Fang, Xufeng Zhang, Linglin Wang, Min Han, Xiaolei Chen, Ming Zhang, Wei Zhang, Zhangjin Zhang and Shifen Xu Tags: Study protocol Source Type: research

Meaningful Activities and Recovery (MA & R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement —study protocol for a randomized controlled trial
Engagement in activities meaningful to the individual may support the process of recovery in those with mental illness. Persons with psychiatric disabilities may reduce their engagement in meaningful activitie... (Source: Trials)
Source: Trials - September 14, 2020 Category: General Medicine Authors: Siv Therese Bogevik Bj ørkedal, Ulrika Bejerholm, Lene Falgaard Eplov and Tom Møller Tags: Study protocol Source Type: research

An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial
DiscussionThe program may play an important role in preventing risky and unhealthy eating behaviors by focusing on the development of self-regulation skills and strategies among elementary school children.Trial registrationClinicalTrials.govNCT04099498. Registered on 23 September 2019. (Source: Trials)
Source: Trials - September 14, 2020 Category: Research Source Type: clinical trials

A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial
ConclusionsThis study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service.Trial registrationAustralia and New Zealand Clinical Trials RegistryACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15 –21, 2017). (Source: Trials)
Source: Trials - September 14, 2020 Category: Research Source Type: clinical trials

Meaningful Activities and Recovery (MA & amp;R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement —study protocol for a randomized controlled trial
This study adds new knowledge to a field with limited evidence, i.e. the clinical effectiveness of rehabilitation interventions among people with psychiatric disabilities, directly targeting activity engagement. The pragmatic design, regarding in- and exclusion criteria and settings, may allow assessment of the intervention ’s effect under real-life conditions. The randomization, adequate power and fidelity monitoring allow testing of the intervention’s efficacy. The multicentre study design increases the potential for implementation in various mental health settings if the findings are positive. As the nature ...
Source: Trials - September 14, 2020 Category: Research Source Type: clinical trials

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial
DiscussionThis large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors.Trial registrationChiCTR ChiCTR1900026395. Registered on 8 October 2019,http://www.chictr.org.cn/showproj.aspx?proj=44068 (Source: Trials)
Source: Trials - September 14, 2020 Category: Research Source Type: clinical trials

A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
This study protocol was registered atwww.clinicaltrials.gov on 10 April 2020NCT04341688.Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file2).Fig. 1Flow diagram of study-participants ’ timeline (Source: Trials)
Source: Trials - September 14, 2020 Category: Research Source Type: clinical trials

Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)
Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and o... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Kathrin Wode, Johanna H ök Nordberg, Gunver S. Kienle, Nils O. Elander, Britt-Marie Bernhardson, Berit Sunde, Lena Sharp, Roger Henriksson and Per Fransson Tags: Study protocol Source Type: research

It is unprecedented: trial management during the COVID-19 pandemic and beyond
The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporari... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Eleanor J. Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield and Alison McDonald Tags: Commentary Source Type: research

Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high resea... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Elizabeth M. Burnette, Wave-Ananda Baskerville, Erica N. Grodin and Lara A. Ray Tags: Study protocol Source Type: research

High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I –II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China
The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant a... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Heshen Tian, Yumin Zhou, Longhui Tang, Fan Wu, Zhishan Deng, Bijia Lin, Peiyu Huang, Shaodan Wei, Dongxing Zhao, Jingping Zheng, Nanshan Zhong and Pixin Ran Tags: Study protocol Source Type: research

Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial
This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Stefan Roehrig, Ali Ait Hssain, Nabil Al Hamid Shallik, Ingi Mohamed A. Elsaid, Salma Faisal Mustafa, Osama A. M. Smain, Ashraf Abdulla Molokhia and Marcus D. Lance Tags: Letter Source Type: research

VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures
Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing techn... (Source: Trials)
Source: Trials - September 11, 2020 Category: General Medicine Authors: Wesley Verla, Marjan Waterloos, Mieke Waterschoot, Benjamin Van Parys, Anne-Fran çoise Spinoit and Nicolaas Lumen Tags: Study protocol Source Type: research