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

It is unprecedented: trial management during the COVID-19 pandemic and beyond
This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers ’ Network (UKTMN), a national network of trial management professionals managing non-commercial trials.In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collecti...
Source: Trials - September 11, 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)
The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.MethodsThe trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20  mg three times per week for 9 months. Stratification is performed for site and palliative chem...
Source: Trials - September 11, 2020 Category: Research Source Type: clinical trials

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
DiscussionCurrently, there are no randomized controlled trials with high-doseN-acetylcysteine (600  mg twice daily) for patients with mild-to-moderate COPD (GOLD I–II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-doseN-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management.Trial registrationChinese Clinical Trial RegistryChiCTR-IIR-17012604. Registered on 07 September 2017. (Source: Trials)
Source: Trials - September 11, 2020 Category: Research Source Type: clinical trials

Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50  mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, perc ent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in...
Source: Trials - September 11, 2020 Category: Research Source Type: clinical trials

VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures
DiscussionThis trial will provide level Ib evidence about the differences in both surgical and functional outcome between vsAR and tAR, which may importantly scape the future of bulbar urethral reconstruction. Depending on the trial results, this phase II trial may generate a larger phase III trial with more statistical power and a lower alpha value.Trial registrationThis trial is registered at clinicaltrials.gov (NCT03572348) and in the Belgian Clinical Trial Registry (B670201837335). The trial was registered prospectively. Registered on 28 June 2018. (Source: Trials)
Source: Trials - September 11, 2020 Category: Research Source Type: clinical trials

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 (ARDS) associated with COVID-19.We define ARDS according to the “Berlin” definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.Trial designThis is a prospective, randomized (1:1 ratio), parallel group feasibility study in adult patients with proven COVID-19 associated ARDS.ParticipantsAll adult patients admitted to ...
Source: Trials - September 11, 2020 Category: Research Source Type: clinical trials

Correction to: Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
An amendment to this paper has been published and can be accessed via the original article. (Source: Trials)
Source: Trials - September 10, 2020 Category: General Medicine Authors: Yi Lin Lee, Yvonne Mei Fong Lim, Kian Boon Law and Sheamini Sivasampu Tags: Correction Source Type: research

Developing consensus on core outcome domains and measurement instruments for assessing effectiveness in perioperative pain management after sternotomy, breast cancer surgery, total knee arthroplasty, and surgery related to endometriosis
Evidence synthesis of clinical trials requires consistent outcome assessment. For pain management after surgery, inconsistency of effectiveness assessment is still observed. A subproject of IMI-PainCare (Innov... (Source: Trials)
Source: Trials - September 10, 2020 Category: General Medicine Authors: Ulrike Kaiser, Hiltrud Liedgens, Winfried Meissner, Claudia Weinmann, Peter Zahn and Esther Pogatzki-Zahn Tags: Study protocol Source Type: research

Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention
This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the ‘Learning Together’ whole-school intervention delivered ... (Source: Trials)
Source: Trials - September 10, 2020 Category: General Medicine Authors: Emily Warren, G. J. Meledez-Torres, Russell Viner and Chris Bonell Tags: Research Source Type: research