Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial
Increasing rates of antibiotic resistance in Gram-negative organisms due to the presence of extended-spectrum beta-lactamases (ESBL), hyperproduction of AmpC enzymes, carbapenemases and other mechanisms of res... (Source: Trials)
Source: Trials - December 7, 2021 Category: General Medicine Authors: Hugh Wright, Patrick N. A. Harris, Mark D. Chatfield, David Lye, Andrew Henderson, Tiffany Harris-Brown, Anna Donaldson and David L. Paterson Tags: Study protocol Source Type: research

Beta blocker use in traumatic brain injury based on the high-sensitive troponin status (BBTBBT): methodology and protocol implementation of a double-blind randomized controlled clinical trial
Beta-adrenergic receptor blockers (BB) play an important role in the protection of organs that are susceptible for secondary injury due to stress-induced adrenergic surge. However, the use of BB in traumatic b... (Source: Trials)
Source: Trials - December 7, 2021 Category: General Medicine Authors: Ayman El-Menyar, Mohammad Asim, Ahmed Abdel-Aziz Bahey, Talat Chughtai, Abdulnasser Alyafai, Husham Abdelrahman, Sandro Rizoli, Ruben Peralta and Hassan Al-Thani Tags: Study protocol Source Type: research

Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial
This study will use a multicentre, open-label non-inferiority trial design comparing cefiderocol and standard of care antibiotics. Eligible participants will be adult inpatients who are diagnosed with a bloodstream infection with a Gram-negative organism on the basis of a positive blood culture result where the acquisition meets the definition for healthcare-associated or hospital-acquired. It will compare cefiderocol with the current standard of care (SOC) antibiotic regimen according to the patient ’s treating clinician. Eligible participants will be randomised 1:1 to cefiderocol or SOC and receive 5–14&thins...
Source: Trials - December 7, 2021 Category: Research Source Type: clinical trials

Beta blocker use in traumatic brain injury based on the high-sensitive troponin status (BBTBBT): methodology and protocol implementation of a double-blind randomized controlled clinical trial
This study will be of great clinical interest to improve survival and functional outcomes of TBI patients.Trial registrationClinicalTrials.gov NCT04508244. Registered on 7 August 2020. Recruitment started on 29 December 2020 and is ongoing. (Source: Trials)
Source: Trials - December 7, 2021 Category: Research Source Type: clinical trials

Evaluating the efficacy, impact, and feasibility of community-based house screening as a complementary malaria control intervention in southern Africa: a study protocol for a household randomized trial
This study aims to add to the evidence base for this intervention in low transmission settings by assessing the efficacy, impact, and feasibility of house screening in areas where LLINs are conventionally used for malaria control.MethodsA two-armed, household randomized clinical trial will be conducted in Mozambique, Zambia, and Zimbabwe to evaluate whether combined the use of house screens and LLINs affords better protection against clinical malaria in children between 6 months and 13 years compared to the sole use of LLINs. Eight hundred households will be enrolled in each study area, where 400 households will be randoml...
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

The COPE-Trial —Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants
AbstractBackgroundOne of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessment and will generally remain uncertain with regard to the individual. This can result in differences in prognostic framing and thus affect the recipients ’ perception. In neonatology, data on the effects of prognostic framing are scarce. In particular, it is unclear whether parents prefer a more optimistic or a more pessimistic prognostic framing.ObjectiveTo explore parents ’ preferences...
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

Combined effects of vitamin D supplementation and endurance exercise training on insulin resistance in newly diagnosed type 2 diabetes mellitus patients with vitamin D deficiency: study protocol for a randomized controlled trial
The objectives of this study is to investigate the synergistic effect of vitamin D supplementation combined with exercise training intervention on IR in T2DM patients.Methods and analysisWe propose a 3-month randomized controlled trial among 60 T2DM patients aged 40 –65, newly diagnosed with T2DM ≤ 1 year, and with stable HbA1c level (≤ 8.0%) in the past 3 months. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generate d random number sequence. At baseline, partici...
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial
This study presents a single-blinded protocol for a non-inferiority randomized controlled trial. One hundred participants diagnosed with knee OA (grades II and III Kellgren and Lawrence system), aged 40  years or more, and BMI
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial
We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4).MethodsA multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

Immediate effect of manual therapy techniques on the limitation of ankle dorsiflexion: a randomized, controlled, blind clinical trial protocol
DiscussionIt is already known that DF RoM limitation can lead to compensatory and potentially damaging lower limb movements and that joint mobilizations are effective to treatment. However, there is no consensus whether the application of these techniques would also improve aspects of dynamic postural balance and performance in individuals practicing physical activity, and whether the sum of two joint mobilization techniques could enhance this effect.Trial registrationBrazilian Registry of Clinical Trials (ReBEC)RBR-93xv9t. Registered on 09 April 2020. (Source: Trials)
Source: Trials - December 6, 2021 Category: Research Source Type: clinical trials

The COPE-Trial —Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants
One of the numerous challenges preterm birth poses for parents and physicians is prognostic disclosure. Prognoses are based on scientific evidence and medical experience. They are subject to individual assessm... (Source: Trials)
Source: Trials - December 6, 2021 Category: General Medicine Authors: Fiona A. Forth, Florian Hammerle, Jochem K önig, Michael S. Urschitz, Philipp Neuweiler, Eva Mildenberger and André Kidszun Tags: Study protocol Source Type: research

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial
Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion tr... (Source: Trials)
Source: Trials - December 6, 2021 Category: General Medicine Authors: Lili Song, Chen Chen, Xiaoying Chen, Yijia Guo, Feifeng Liu, Yapeng Lin, Laurent Billot, Qiang Li, Hueiming Liu, Lei Si, Menglu Ouyang, Hisatomi Arima, Philip M. Bath, Gary A. Ford, Thompson Robinson, Else Charlotte Sandset & hellip; Tags: Study protocol Source Type: research

Immediate effect of manual therapy techniques on the limitation of ankle dorsiflexion: a randomized, controlled, blind clinical trial protocol
The range of motion (RoM) of dorsiflexion (DF) plays an important role in human mobility, such as absorption of body weight during gait deceleration, jump landings, balance, and eccentric movements. This limit... (Source: Trials)
Source: Trials - December 6, 2021 Category: General Medicine Authors: Matheus de Castro Silva, Rodrigo de Marche Baldon, Carolina Lins, Gustavo Martins de Andrade, Gustavo Barros Braga de Castro and Lilian Ramiro Felicio Tags: Study protocol Source Type: research

Effects of a periodized circuit training protocol delivered by telerehabilitation compared to face-to-face method for knee osteoarthritis: a protocol for a non-inferiority randomized controlled trial
Regular exercise is an effective method for reducing pain and disability in patients with knee osteoarthritis (OA), as well as improving body composition. Thus, a combination of both resistance and aerobic tra... (Source: Trials)
Source: Trials - December 6, 2021 Category: General Medicine Authors: J éssica Bianca Aily, Aline Castilho de Almeida, Marcos de Noronha and Stela Marcia Mattiello Tags: Study protocol Source Type: research

Combined effects of vitamin D supplementation and endurance exercise training on insulin resistance in newly diagnosed type 2 diabetes mellitus patients with vitamin D deficiency: study protocol for a randomized controlled trial
Although approximately 50% of Chinese with type 2 diabetes mellitus (T2DM) patients have vitamin D deficiency, studies regarding vitamin D supplementation on insulin resistance (IR) have mainly focused on non-... (Source: Trials)
Source: Trials - December 6, 2021 Category: General Medicine Authors: Mi Xiang, Xiaomin Sun, Junxiang Wei and Zhen-Bo Cao Tags: Study protocol Source Type: research

Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial
There are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1  year. The treatment of osteoporotic fractures is a major challenge as bone quality is poor, and healing is expec... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Ronald Man Yeung Wong, Simon Kwoon Ho Chow, Ning Tang, Yik Lok Chung, James Griffith, Wing Hong Liu, Raymond Wai Kit Ng, Chi Yin Tso and Wing Hoi Cheung Tags: Study protocol Source Type: research

Promoting inclusion in clinical trials —a rapid review of the literature and recommendations for action
Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Danielle H. Bodicoat, Ash C. Routen, Andrew Willis, Winifred Ekezie, Clare Gillies, Claire Lawson, Thomas Yates, Francesco Zaccardi, Melanie J. Davies and Kamlesh Khunti Tags: Methodology Source Type: research

How can behavioural science help us design better trials?
(Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
ConclusionsThis qualitative analysis highlights ways in which insights developed together with patients and healthcare workers might inform approaches towards improved recruitment into trials, with the overall objective of delivering evidence for better treatments. (Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals.Trial registrationChiCTR1900028451. Registered on 22 December 2019,https://www.chictr.org.cn/index.aspx. (Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Performance feedback on the quality of care in hospitals performing thrombectomy for ischemic stroke (PERFEQTOS): protocol of a stepped wedge cluster randomized trial
This study will provide evidence on the effectiveness of performance feedback to healthcare providers. The results will be actively disseminated through peer-reviewed journals, conference presentations, and various stakeholder engagement activities.Trial registrationNetherlands Trial RegisterNL9090. Registered on December 3, 2020 (Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol
The objective of this paper was to provide the details of the study protocol for randomized, controlled trial (RCT) in African Americans (AAs) with gout th at will test the effectiveness of a culturally appropriate gout storytelling intervention.MethodsThe SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) study will be a 12-month, multicenter, open-label RCT that will assess the effect of a culturally appropriate gout storytelling in at least 300 AA veterans with gout. Participants will be randomized to gout-storytelling intervention vs. a stress reduction video in a 1:1 ratio. The primary outcome is urate-lowe...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Safety and efficacy of C1-inhibitor in traumatic brain injury (CIAO@TBI): study protocol for a randomized, placebo-controlled, multi-center trial
AbstractBackgroundTraumatic brain injury (TBI) is a major cause of death and disability across all ages. After the primary impact, the pathophysiologic process of secondary brain injury consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system could therefore be a therapeutic target in TBI.ObjectiveTo study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI. By temporarily blocking the complement system, we hypothe...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial
DiscussionThe current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria.Trial registrationPan African Clinical Trials RegisterPACTR20200480127...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

What do parents think of using informational videos to support recruitment for parenting trials? A qualitative study
ConclusionsInformational videos are acceptable to parents; however, co-production or participant/patient involvement in the development of such videos is recommended. Informational videos may not increase recruitment but have the potential for improving retention. Key design recommendations are to ensure a ‘professional’ look to the video, to supplement videos with paper-based information, to keep the length to
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial
DiscussionResults and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus.Trial registrationClinicalTrials.govNCT04663828. Registered on 11 December 2020. (Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Study protocol for a randomized clinical trial to evaluate the effect of the use of Xylitol gum in the prevention of caries lesions in children living in Ladakh —the Caries Prevention Xylitol in Children (CaPreXCh) trial
DiscussionThis trial will be the first trial conducted in India assessing the efficacy of a school-based caries preventive programme through the use of chewing gum containing only Xylitol as a sweetener. The findings could help strengthen the evidence for the efficacy of Xylitol use in community-based caries prevention programmes in children.Trial registrationClinicaltrials.govNCT04420780. Registered on June 9, 2020 (Source: Trials)
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Promoting inclusion in clinical trials —a rapid review of the literature and recommendations for action
ConclusionsMany of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population ’s particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal developmen...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial
The objective of this study is to investigate the effect of LMHFV on accelerating trochanteric hip fract ure healing and functional recovery.MethodsThis is a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effect of LMHFV in accelerating trochanteric hip fracture healing. All fractures undergo cephalomedullary nail fixation. The primary outcome of this study is time to fracture healing by X-ray. Computed tomography (CT) and dual-energy X-ray absorptiometry (DXA) will also be performed. Blood circulation at the fracture site will be assessed by dynamic perfusion magnetic resonance (MR). Clinica...
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy —PREVED study: study protocol for a randomized controlled trial
DiscussionPREVED is a ground-breaking intervention research project dedicated to perinatal environmental health education that aims to identify pollutant sources in daily life and to offer accessible and realistic alternative solutions, by promoting the sharing of know-how and experience in a positive and non-alarmist approach.Trial registrationClinicalTrials.gov:NCT03233984 (current status: ongoing). Retrospectively registered on 31 July 2017 (https://clinicaltrials.gov/ct2/show/NCT03233984) because when the first participant was enrolled in this non-drug intervention,ClinicalTrials.gov was centered in therapeutic trials....
Source: Trials - December 4, 2021 Category: Research Source Type: clinical trials

A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial
The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a ... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: A. Abayomi, A. Osibogun, O. Ezechi, K. Wright, B. Ola, O. Ojo, Y. Kuyinu, E. Zamba, H. Abdur-Razzaq, O. A. Erinoso and S. E. Anya Tags: Study protocol Source Type: research

Study protocol for a randomized clinical trial to evaluate the effect of the use of Xylitol gum in the prevention of caries lesions in children living in Ladakh —the Caries Prevention Xylitol in Children (CaPreXCh) trial
Xylitol use is reported to be able to reduce dental plaque amount and cariogenic bacteria and, as a consequence, the caries increment. Only few data on the oral health of Ladakh ’s population are available. The... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Maria Grazia Cagetti, Fabio Cocco, Ezio Calzavara, Davide Augello, Phunchok Zangpoo and Guglielmo Campus Tags: Study protocol Source Type: research

What do parents think of using informational videos to support recruitment for parenting trials? A qualitative study
Lower than expected recruitment and retention rates are common challenges in parenting trials —particularly for community-based trials targeting parents of young children that rely on face-to-face recruitment b... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Maiken Pontoppidan, Sarah Blower, Julie Nygaard Solvang and Tracey Bywater Tags: Research Source Type: research

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial
Tinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, p... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Stefan Schoisswohl, Berthold Langguth, Martin Schecklmann, Alberto Bernal-Robledano, Benjamin Boecking, Christopher R. Cederroth, Dimitra Chalanouli, Rilana Cima, Sam Denys, Juliane Dettling-Papargyris, Alba Escalera-Balsera, Juan Manuel Espinosa-Sanchez, Tags: Study protocol Source Type: research

Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy —PREVED study: study protocol for a randomized controlled trial
The suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These intervention... (Source: Trials)
Source: Trials - December 4, 2021 Category: General Medicine Authors: Houria E. L. Ouazzani, Steeve Rouillon, Nicolas Venisse, Lynda Sifer-Rivi ère, Antoine Dupuis, Guillaume Cambien, Sarah Ayraud-Thevenot, Anne-Sophie Gourgues, Pascale Pierre-Eugène, Fabrice Pierre, Sylvie Rabouan, Virginie Migeot and Marion Albouy-Llaty Tags: Study protocol Source Type: research

INFERR-Iron infusion in haemodialysis study: INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis —a protocol for a prospective open-label blinded endpoint randomised controlled trial
The effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is largely dependent on adequate body iron stores. The iron stores are deter... (Source: Trials)
Source: Trials - December 2, 2021 Category: General Medicine Authors: Sandawana William Majoni, Jane Nelson, Darren Germaine, Libby Hoppo, Stephanie Long, Shilpa Divakaran, Brandon Turner, Jessica Graham, Sajiv Cherian, Basant Pawar, Geetha Rathnayake, Bianca Heron, Louise Maple-Brown, Robert Batey, Peter Morris, Jane Davie Tags: Study protocol Source Type: research

TANGO: effect of tango Argentino on cancer-associated fatigue in breast cancer patients —study protocol for a randomized controlled trial
DiscussionArgentine tango, as a music-based movement therapy, can influence different skills and may improve several outcomes. The therapeutic use of Argentine tango in the care of breast cancer patients has not yet been reported. It is anticipated that participants receiving the tango module will have improved CRF, sleep, and quality of life scores compared to a waitlist control.Trial registrationGerman Clinical Trials Registry (DRKS)DRKS00021601. Retrospectively registered on 21 August 2020 (Source: Trials)
Source: Trials - December 2, 2021 Category: Research Source Type: clinical trials

INFERR-Iron infusion in haemodialysis study: INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis —a protocol for a prospective open-label blinded endpoint randomised controlled trial
AbstractBackgroundThe effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is largely dependent on adequate body iron stores. The iron stores are determined by the levels of serum ferritin concentration and transferrin saturation. These two surrogate markers of iron stores are used to guide iron replacement therapy. Most Aboriginal and/or Torres Islander Australians of the Northern Territory (herein respectfully referred to as First Nations Australians) with end-stage kidney disease have ferritin levels higher than current guideline recommendations...
Source: Trials - December 2, 2021 Category: Research Source Type: clinical trials

A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol
DiscussionThis is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. IfFit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms.Trial registrationNetherlands Trial RegisterNL8947. Registered on 14 October 2020. (Source: Trials)
Source: Trials - December 2, 2021 Category: Research Source Type: clinical trials

Clinical and cost-effectiveness of a New psychosocial intervention to support Independence in Dementia (NIDUS-family) for family carers and people living with dementia in their own homes: a randomised controlled trial
DiscussionIncreasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home.Trial registrationInternational Standard Randomised Controlled Trials NumberISRCTN11425138. Registered on 7 October 2019 (Source: Trials)
Source: Trials - December 2, 2021 Category: Research Source Type: clinical trials

Clinical and cost-effectiveness of a New psychosocial intervention to support Independence in Dementia (NIDUS-family) for family carers and people living with dementia in their own homes: a randomised controlled trial
Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia ’s lif... (Source: Trials)
Source: Trials - December 2, 2021 Category: General Medicine Authors: Alexandra Burton, Penny Rapaport, Marina Palomo, Kathryn Lord, Jessica Budgett, Julie Barber, Rachael Hunter, Laurie Butler, Jessica Vickerstaff, Kenneth Rockwood, Margaret Ogden, Debs Smith, Iain Lang, Gill Livingston, Briony Dow, Helen Kales & hellip; Tags: Study protocol Source Type: research

TANGO: effect of tango Argentino on cancer-associated fatigue in breast cancer patients —study protocol for a randomized controlled trial
The majority of breast cancer patients suffer from persistent impairments after completion of their primary oncological therapy. Cancer-related fatigue (CRF) in particular is a multidimensional syndrome having... (Source: Trials)
Source: Trials - December 2, 2021 Category: General Medicine Authors: Shiao Li Oei, Thomas Rieser, Sarah Becker, Jessica Gro ß, Harald Matthes, Friedemann Schad and Anja Thronicke Tags: Study protocol Source Type: research

A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol
Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most p... (Source: Trials)
Source: Trials - December 2, 2021 Category: General Medicine Authors: T. A. Kuut, F. M üller, A. Aldenkamp, E. Assmann-Schuilwerve, A. Braamse, S. E. Geerlings, K. B. Gibney, R. A. A. Kanaan, P. Nieuwkerk, T. C. Olde Hartman, D. Pauëlsen, M. Prins, K. Slieker, M. Van Vugt, C. P. Bleeker-Rovers, S. P. Keijmel & hellip; Tags: Study protocol Source Type: research

Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial
DiscussionThe present randomized, controlled clinical trial would indicate the additive effects of the combination of OK lens and 0.01% atropine, and the extent of these effects, in retarding myopia progression and axial elongation in children.Trial registrationChinese Clinical Trial Registry (ChiCTR),ChiCTR1800018419. Registered on 17 September 2018.http://www.chictr.org.cn/showproj.aspx?proj=29216 (Source: Trials)
Source: Trials - December 1, 2021 Category: Research Source Type: clinical trials

Efficacy of combined orthokeratology and 0.01% atropine for myopia control: the study protocol for a randomized, controlled, double-blind, and multicenter trial
The prevalence of myopia is increasing worldwide and is presently recognized as a major public health issue. Researchers and clinicians have been devoted in exploring appropriate clinical interventions to slow... (Source: Trials)
Source: Trials - December 1, 2021 Category: General Medicine Authors: Ying Yuan, Chengcheng Zhu, Mingming Liu, Yali Zhou, Xiao Yang, Bingru Zheng, Zhouyue Li, Xinjie Mao and Bilian Ke Tags: Study protocol Source Type: research

Prevention of leg cramps by using compression stockings or magnesium supplements in the 50 –84 age group: study protocol for a randomised controlled trial
The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements.MethodsThe study will be set in Finland, and 50 –84-year-old volunteers will be recruited through Google Ads, the Finnish health library website and Finnish primary health care centres. The participants must have a minimum of two episodes of leg cramps per week for the past 4 weeks to be included in the study. The participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium...
Source: Trials - November 29, 2021 Category: Research Source Type: clinical trials

Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial
DiscussionThis trial will provide evidence to guide practice regarding optimum duration of antibiotics for culture-proven neonatal bacterial sepsis. If a 7-day regime is proved to be non-inferior to a 14-day regime, it is likely to reduce hospital stay, costs, adverse effects of drugs, and nosocomial infections.Trial registrationClinical Trials Registry IndiaCTRI/2017/09/009743. Registered on 13 September 2017. (Source: Trials)
Source: Trials - November 29, 2021 Category: Research Source Type: clinical trials

Correction to: Evaluation of a school-based intervention to promote mental health of refugee youth in Sweden (The RefugeesWellSchool Trial): study protocol for a cluster randomized controlled trial
(Source: Trials)
Source: Trials - November 29, 2021 Category: Research Source Type: clinical trials

Correction to: Clinical trial recruiters ’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK
(Source: Trials)
Source: Trials - November 29, 2021 Category: Research Source Type: clinical trials

Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial
Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparin... (Source: Trials)
Source: Trials - November 29, 2021 Category: General Medicine Authors: Sourabh Dutta, Sushma Nangia, Mamta Jajoo, Geeta Gathwala, Saudamini Nesargi, Mangalabharathi Sundaram, Praveen Kumar, Arvind Saili, Dipti Kumar, Poonam Dalal, P. N. Suman Rao, Ramya Shanmugam, Pallab Ray, Valinderjeet Singh Randhawa, Karnika Saigal, Madh Tags: Study protocol Source Type: research