Effects of different doses of methylprednisolone on clinical outcomes in patients with severe community-acquired pneumonia: a study protocol for a randomized controlled trial
DiscussionThe results of our study may find the optimal dose of glucocorticoid in the adjuvant treatment of SCAP and provide evidence-based proof for clinicians to treat patients with SCAP. Since coronavirus disease 2019 (COVID-19) also belongs to community-acquired pneumonia, perhaps the results of our study will help to determine the appropriate dose of methylprednisolone in COVID-19 treatment.Trial registrationChinese Clinical Trial RegistryChiCTR2100045056. Registered on 4 April 2021. (Source: Trials)
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up
The objective is to evaluate the effectiveness of an individual-based multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy focused on kinesiophobia with specific exercises in the treatment of patients with chronic neck pain, employed in different workin g activities.MethodsA randomized, parallel-group superiority-controlled trial will be conducted with 1-year follow-up. One hundred seventy patients engaged in several working activities (blue collar and white collar workers) will be randomly allocated to either the experimental (receiving a multidisciplinary rehabilitation program combining ...
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory
ConclusionIn a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives. (Source: Trials)
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial
DiscussionThe current study aims at providing insights into the efficacy of short-term treatment applications including psychoeducation and self-guided VRET. If successful, this approach might be a feasible and promising way to ease the burden of PD, AG, and PDA on the public health system and contribute to a faster access to treatment.Trial registrationISRCTNISRCTN10661970. Prospectively registered on 17 January 2022. (Source: Trials)
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial
This study aims to identify the impact of a set of sustainable, multimodal interventions in residential aged care targeting three common infection types.MethodsThis protocol details a 20-month stepped-wedge cluster-randomised trial conducted across 18 RACFs (as 18 clusters). A multimodal multi-disciplinary set of interventions, the ‘AMS ENGAGEMENT bundle’, will be tailored to meet the identified needs of participating RACFs. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team in each facility. Prior to ...
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

Preoperative Education for Less Outpatient Pain after Surgery (PELOPS trial) in orthopedic patients —study protocol for a randomized controlled trial
DiscussionThe developed intervention, based on an improved pain scale, offers the advantages of being non-surgery-specific, is easily administered in a short amount of time, and can be delivered individually or in-group, by physicians or nurses.Trial registrationClinicalTrials.govNCT03754699. Registered on November 27, 2018. (Source: Trials)
Source: Trials - May 21, 2022 Category: Research Source Type: clinical trials

Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial
In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Co... (Source: Trials)
Source: Trials - May 19, 2022 Category: General Medicine Authors: Caleb J. Figge, Jeremy C. Kane, Stephanie Skavenski, Emily Haroz, Mwamba Mwenge, Saphira Mulemba, Luke R. Aldridge, Michael J. Vinikoor, Anjali Sharma, Sachi Inoue, Ravi Paul, Francis Simenda, Kristina Metz, Carolyn Bolton, Christopher Kemp, Samuel Bosomp Tags: Study protocol Source Type: research

Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress
Tinnitus is the result of aberrant neuronal activity. As a novel treatment form, neuromodulation is used to modify neuronal activity of brain areas involved in tinnitus generation. Among the different forms of... (Source: Trials)
Source: Trials - May 19, 2022 Category: General Medicine Authors: Mariana Lopes Martins, Tobias Kleinjung, Martin Meyer, Vithushika Raveenthiran, Zino Wellauer, Nicole Peter and Patrick Neff Tags: Study protocol Source Type: research

The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis
Kidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend life with kidney failure. People receiving haemodialysis commonly experi... (Source: Trials)
Source: Trials - May 19, 2022 Category: General Medicine Authors: Lavern Greenham, Paul N. Bennett, Kathryn Dansie, Andrea K. Viecelli, Shilpanjali Jesudason, Rebecca Mister, Brendan Smyth, Portia Westall, Samuel Herzog, Chris Brown, William Handke, Suetonia C. Palmer, Fergus J. Caskey, Cecile Couchoud, John Simes, Step Tags: Study protocol Source Type: research

Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)
Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. How... (Source: Trials)
Source: Trials - May 19, 2022 Category: General Medicine Authors: Akhil Santhosh, Akash Kumar, Raja Pramanik, Ajay Gogia, Chandra Prakash Prasad, Ishaan Gupta, Nishkarsh Gupta, Winson Y. Cheung, Ravindra Mohan Pandey, Atul Sharma and Atul Batra Tags: Study protocol Source Type: research

Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
Patients with wake-up ischemic stroke are frequently excluded from thrombolytic treatment due to unknown symptom onset time and limited availability of advanced imaging modalities. The Tenecteplase in Wake-up ... (Source: Trials)
Source: Trials - May 19, 2022 Category: General Medicine Authors: Agnethe Eltoft, Tom Wilsgaard, Melinda B. Roaldsen, Mary-Helen S øyland, Erik Lundström, Jesper Petersson, Bent Indredavik, Jukka Putaala, Hanne Christensen, Janika Kõrv, Dalius Jatužis, Stefan T. Engelter, Gian Marco De Marchis, David J. Werring, Tho Tags: Update Source Type: research

Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)
In this study, we aim to compare topical 1% diclofenac gel with placebo in the prevention of capecitabine-induced HFS.MethodsThis is a randomized, placebo-controlled, double-blind, parallel-group superiority trial: the Diclofenac Topical in Reducing Capecitabine induced HFS (D-TORCH) study. A total of 264 patients with breast and gastrointestinal malignancies will be randomly allocated (stratified by sex and type of therapy [monotherapy or combination regimen with capecitabine]) to receive either 1% topical diclofenac or placebo that will be applied over the palmar and dorsal surface of the hands twice daily whilst taking ...
Source: Trials - May 19, 2022 Category: Research Source Type: clinical trials

Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
DiscussionPublication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly outlines the pre-specified analyses.Trial registrationClinicalTrials.govNCT03181360. EudraCT Number2014-000096-80. WHO ICRTP registry numberISRCTN10601890. (Source: Trials)
Source: Trials - May 19, 2022 Category: Research Source Type: clinical trials

The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis
DiscussionSWIFT is the first registry-based trial in the Australian haemodialysis population to investigate whether regular symptom monitoring with feedback to participants and clinicians improves QOL. SWIFT is embedded in the ANZDATA Registry facilitating pragmatic recruitment from public and private dialysis clinics, throughout Australia. SWIFT will inform future collection, storage and reporting of patient-reported outcome measures (PROMs) within a clinical quality registry. As the first trial to rigorously estimate the efficacy and cost-effectiveness of routine PROMs collection and reporting in haemodialysis units, SWI...
Source: Trials - May 19, 2022 Category: Research Source Type: clinical trials

Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress
DiscussionTo the best of our knowledge, this is the first study which uses HD-tRNS combined with AS for tinnitus treatment. The crossover design permits the comparison between HD-tRNS active vs. sham and with vs. without AS. Thus, it will be possible to evaluate the efficacy of the combined approach to HD-tRNS alone. In addition, the use of different objective and subjective evaluations for tinnitus enable more reliable and valid results.Trial registrationSwiss Ethics Committee (BASEC-Nr. 2020-02027); Swiss Federal Complementary Database (kofam.ch:SNCTP000004051); and ClinicalTrials.gov (clinicaltrials.gov:NCT04551404). (Source: Trials)
Source: Trials - May 19, 2022 Category: Research Source Type: clinical trials