Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial
DiscussionThe BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients ’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.Trial registrationISRCTN71618461. Registered on 9 September 2019. (Source: Trials)
Source: Trials - August 3, 2021 Category: Research Source Type: clinical trials

A systematic review of endpoint definitions in late phase pulmonary tuberculosis therapeutic trials
ConclusionsIn a review of 31 clinical trials, we found that outcome definitions were heterogeneous, highlighting the need to establish clearer specification and a move towards universal standardization of outcomes across pulmonary TB trials. The ICH E9 (R1) addendum provides guidelines for undertaking and achieving this goal.PROSPERO registrationPROSPEROCRD42020197993. Registration 11 August 2020. (Source: Trials)
Source: Trials - August 3, 2021 Category: Research Source Type: clinical trials

Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial
DiscussionWe aim to compare clinical remission in persons with DFO treated with antibacterial therapy based on either percutaneous bone biopsy culture results or ulcer bed biopsy culture results.Trial registrationNetherlands Trial RegisterNL 7582. Registered on 05 March 2019 (Source: Trials)
Source: Trials - August 3, 2021 Category: Research Source Type: clinical trials

Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial
AbstractObjectivesThe current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection.Trial designRandomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory studyParticipantsWe will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran.Participants ’ inclusion criteria are as follo...
Source: Trials - August 3, 2021 Category: Research Source Type: clinical trials

Financial Incentives for Preventing Postpartum return to Smoking (FIPPS): study protocol for a three-arm randomised controlled trial
AbstractBackgroundFinancial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant ’s birth. There is no evidence for interventions that are effective at preventing postpartum smoking relapse. Financial incentives provided after the birth may help women to sustain cessation. This randomised controlled trial will assess the effectiveness and cost-effectiveness of financial incent ives to help women who are abstinent from smoking at end-of-pregnancy to avoid return to smoking up to 12 mon...
Source: Trials - August 2, 2021 Category: Research Source Type: clinical trials

Rapid deployment of a community engagement study and educational trial via social media: implementation of the UC-COVID study
ConclusionsWe demonstrate that rapid recruitment into a longitudinal intervention trial via social media is feasible, efficient, and acceptable. Recruitment in conjunction with community partners representing target populations, and with outreach across multiple platforms, is recommended to optimize sample size and diversity. Trial implementation, engagement tracking, and retention are feasible with off-the-shelf tools using preexisting platforms.Trial registrationClinicalTrials.govNCT04373135. Registered on May 4, 2020 (Source: Trials)
Source: Trials - August 2, 2021 Category: Research Source Type: clinical trials

Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL)
Enamel white spot lesions (WSLs), characterized by an opaque, matt, and chalky white appearance of enamel, are a sign of incipient caries. WSLs are common in orthodontic practice and can affect both the oral h... (Source: Trials)
Source: Trials - July 31, 2021 Category: General Medicine Authors: Danchen Qin, Yunlei Wang, Colin Levey, Peter Ngan, Hong He and Fang Hua Tags: Study protocol Source Type: research

An Investigation of Levetiracetam in Alzheimer ’s Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study
Although Alzheimer ’s disease affects around 800,000 people in the UK and costs almost £23 billion per year, currently licenced treatments only offer modest benefit at best. Seizures, which are more common in p... (Source: Trials)
Source: Trials - July 31, 2021 Category: General Medicine Authors: Arjune Sen, Mary Akinola, Xin You Tai, Mkael Symmonds, Gabriel Davis Jones, Sergio Mura, Joanne Galloway, Angela Hallam, Jane Y. C. Chan, Ivan Koychev, Chris Butler, John Geddes, Rohan Van Der Putt, Sian Thompson, Sanjay G. Manohar, Eleni Frangou & hellip Tags: Study protocol Source Type: research

Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial
Preterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust associ... (Source: Trials)
Source: Trials - July 31, 2021 Category: General Medicine Authors: Wolfgang Mitterer, Christoph Binder, Anya Blassnig-Ezeh, Lorenz Auer-Hackenberg, Angelika Berger, Burkhard Simma, Martin Wald, Martin Lee and Ursula Kiechl-Kohlendorfer Tags: Study protocol Source Type: research

‘Relearning how to think’: A brief online intervention to modify biased interpretations in emotional disorders—study protocol for a randomised controlled trial
Cognitive biases play an important role in the development and maintenance of emotional disorders, such as depression and anxiety. Novel procedures, known as Cognitive Bias Modification (CBM), aim to reduce th... (Source: Trials)
Source: Trials - July 31, 2021 Category: General Medicine Authors: In és Nieto and Carmelo Vazquez Tags: Study protocol Source Type: research

REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial
Survival after out-of-hospital cardiac arrest (OHCA) is poor and dependent on high-quality cardiopulmonary resuscitation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) may be advantageous i... (Source: Trials)
Source: Trials - July 31, 2021 Category: General Medicine Authors: Jostein R ødseth Brede, Arne Kristian Skulberg, Marius Rehn, Kjetil Thorsen, Pål Klepstad, Ida Tylleskär, Bjørn Farbu, Jostein Dale, Trond Nordseth, Rune Wiseth and Andreas Jørstad Krüger Tags: Study protocol Source Type: research

Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial
DiscussionGiven the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants ’ nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing.Trial registrationClinicalTrials.govNCT04413994. Registered on 4 June 2020. (Source: Trials)
Source: Trials - July 31, 2021 Category: Research Source Type: clinical trials

‘Relearning how to think’: A brief online intervention to modify biased interpretations in emotional disorders—study protocol for a randomised controlled trial
This study develops a brief clinically based online intervention programme to modify biased interpretations in depression and anxiety (CBM-IClin), overcoming some methodological issues that have been addressed in previous literature.MethodsVolunteer participants will be recruited via social media and posters at the university. They will be randomly assigned to an experimental group or a waiting list control group. Both groups will complete two assessment sessions (before and after the intervention) consisting of questionnaires measuring cognitive and emotional variables as well as experimental tasks measuring cognitive bia...
Source: Trials - July 31, 2021 Category: Research Source Type: clinical trials

Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL)
DiscussionThe COS-OWSL will be developed to facilitate the synthesis of evidence regarding the prevention and treatment of orthodontically induced WSLs and to promote the consistent use of relevant patient-important outcomes among future studies in this field.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET) initiative (the COS-WSL project)1399 (Source: Trials)
Source: Trials - July 31, 2021 Category: Research Source Type: clinical trials

An Investigation of Levetiracetam in Alzheimer ’s Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study
DiscussionThis is the first study to evaluate if an anti-seizure medication can offer meaningful benefit to patients with Alzheimer ’s disease. If this study demonstrates at least stabilisation of memory function and/or good tolerability, the next step will be to rapidly progress to a larger study to establish whether levetiracetam may be a useful and cost-effective treatment for patients with Alzheimer’s disease.Trial registrationClinicalTrials.govNCT03489044. Registered on April 5, 2018. (Source: Trials)
Source: Trials - July 31, 2021 Category: Research Source Type: clinical trials

REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial
DiscussionResults from this study will assess the efficacy and safety of REBOA as an adjunctive treatment for non-traumatic OHCA. This novel use of REBOA may contribute to improve treatment for this patient cohort.Trial registrationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Norway (reference 152504) and is registered atClinicalTrials.gov (reference NCT04596514) and as Universal Trial Number WHO: U1111-1253-0322. (Source: Trials)
Source: Trials - July 31, 2021 Category: Research Source Type: clinical trials

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial
Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict... (Source: Trials)
Source: Trials - July 30, 2021 Category: General Medicine Authors: Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray and Tonya M. Palermo Tags: Study protocol Source Type: research

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial
DiscussionDemonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery.Trial registrationNCT04637802 ClinicalTrials.gov. Registered on November 20, 2020 (Source: Trials)
Source: Trials - July 30, 2021 Category: Research Source Type: clinical trials

COVEPIC (Cognitive and spOrt Virtual EPIC training) investigating the effects of home-based physical exercise and cognitive training on cognitive and physical functions in community-dwelling older adults: study protocol of a randomized single-blinded clinical trial
In the context of the COVID-19 pandemic, lockdown and social distancing measures are applied to prevent the spread of the virus. It is well known that confinement and social isolation can have a negative impac... (Source: Trials)
Source: Trials - July 29, 2021 Category: General Medicine Authors: Emma Gabrielle Dupuy, Florent Besnier, Christine Gagnon, Thomas Vincent, Catherine-Alexandra Gr égoire, Caroll-Ann Blanchette, Kathia Saillant, Nadia Bouabdallaoui, Josep Iglesies-Grau, Marie Payer, Marie-France Marin, Sylvie Belleville, Martin Juneau, P Tags: Study protocol Source Type: research

COVEPIC (Cognitive and spOrt Virtual EPIC training) investigating the effects of home-based physical exercise and cognitive training on cognitive and physical functions in community-dwelling older adults: study protocol of a randomized single-blinded clinical trial
DiscussionThis trial will document the remote monitoring of home-based physical exercise alone and home-based physical combined with cognitive training to enhance cognitive and physical health of older adults during the COVID-19 pandemic period. Remote interventions represent a promising strategy to help maintain or enhance health and cognition in seniors, and potentially an opportunity to reach older adults in remote areas, where access to such interventions is limited.Trial registrationClinical trial IdentifierNCT04635462. COVEPIC was retrospectively registered on November 19, 2020. (Source: Trials)
Source: Trials - July 29, 2021 Category: Research Source Type: clinical trials

Resiliency Engagement and Care in Health (REaCH): a telephone befriending intervention for upskilled rural youth in the context of COVID-19 pandemic —study protocol for a multi-centre cluster randomised controlled trial
The lockdown associated with the COVID-19 pandemic is likely to impact people ’s mental health, especially those from economically disadvantaged and vulnerable sections of society. Mental health can be affected... (Source: Trials)
Source: Trials - July 28, 2021 Category: General Medicine Authors: Saju Madavanakadu Devassy, Komal Preet Allagh, Anuja Maria Benny, Lorane Scaria, Natania Cheguvera and I. P. Sunirose Tags: Study protocol Source Type: research

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)
Use of a person ’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a ... (Source: Trials)
Source: Trials - July 28, 2021 Category: General Medicine Authors: Lucy Cureton, Ioana R. Marian, Vicki S. Barber, Adwoa Parker, David J. Torgerson and Sally Hopewell Tags: Methodology Source Type: research

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)
Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, wh... (Source: Trials)
Source: Trials - July 28, 2021 Category: General Medicine Authors: Sophie Juul, Sebastian Simonsen, Stig Poulsen, Susanne Lunn, Per S ørensen, Anthony Bateman and Janus Christian Jakobsen Tags: Update Source Type: research

Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial
New Zealand Greenshell ™ mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA). However, this effect has not been in... (Source: Trials)
Source: Trials - July 28, 2021 Category: General Medicine Authors: Maryam Abshirini, Jane Coad, Frances M. Wolber, Pamela von Hurst, Matthew R. Miller, Hong Sabrina Tian and Marlena C. Kruger Tags: Study protocol Source Type: research

Patient and public involvement in numerical aspects of trials (PoINT): exploring patient and public partners experiences and identifying stakeholder priorities
Patient and public involvement is increasingly common in trials, but its quality remains variable in a lot of settings. Many key decisions in trials involve numbers, but patients are rarely involved in those d... (Source: Trials)
Source: Trials - July 28, 2021 Category: General Medicine Authors: Beatriz Goulao, Hanne Bruhn, Marion Campbell, Craig Ramsay and Katie Gillies Tags: Research Source Type: research

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)
ConclusionOverall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.Trial registrationGRASP TrialISRCTN16539266; SWAT Repository ID 35 (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

The efficacy of Tuina with herbal ointment for patients with post-stroke depression: study protocol for a randomized controlled trial
This study may evaluate clinical application value and safety of Tuina with herbal ointment in PSD patients, which can provide basis for clinical research and mechanism exploration of PSD.Trial registrationChinese Clinical Trial RegistryChiCTR2000033887. Registered on 15 June 2020.DisseminationThe results will be published in peer-reviewed journals and disseminated through the study ’s website and conferences. (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial
DiscussionScreening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings.Trial registrationClinicalTrials.govNCT03937050, registered on 3 May 2019. Clinical Trials Registry IndiaCTRI/2020/02/023605, registered on 26 February 2020. (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO) —efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up
DiscussionA better understanding of the efficiency and effects of opioid tapering could possibly facilitate attempts to taper opioid treatments, which might prove beneficial for both the individual and society.Trial registrationClinicalTrials.govNCT03485430. Retrospectively registered on 26 March 2018, first release date. “Tapering of Long-term Opioid Therapy in Chronic Pain Population. RCT with 12 Months Follow up (TOPIO).” First patient in trial 22 March 2018. (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Resiliency Engagement and Care in Health (REaCH): a telephone befriending intervention for upskilled rural youth in the context of COVID-19 pandemic —study protocol for a multi-centre cluster randomised controlled trial
This study aims to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilise social support from family, friends and significant others by using the telephonic befriending intervention.MethodsIn this article, we report the design and protocol of a multi-centre cluster randomised controlled trial. In total, 1440 participants aged 18 –35 years who have recently completed their course out of the DDU-GKY initiative will be recruited in the study from 12 project-implementing agencies (PIAs) across six geographical zones of India. Participants from 6 of these agencies will be assigned to...
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a  randomized double-blind placebo-controlled trial
This study aims to determine the effect of GSM powder on biomarkers of cartilage metabolism, bone resorption, and inflammation in New Zealand healthy overweight/obese postmenopausal women who are at early stage or at high risk of OA.MethodFifty overweight or obese (BMI 25 –35 kg/m2) postmenopausal women (aged 55 –75 years) will be recruited by advertisement. Participants will be randomized based on a double-blind randomization schedule and stratified randomization based on BMI and age distribution. The participant will be assigned with a 1:1 allocation ratio to receive 3 g/d whole meat GSM ...
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Patient and public involvement in numerical aspects of trials (PoINT): exploring patient and public partners experiences and identifying stakeholder priorities
ConclusionsOur work shows the importance of involving patient and public partners in numerical aspects of trials by assessing their experiences and motivations for the first time and discussing and prioritising which numerical aspects of trials are the most important for patients and the public to contribute to. Our research provides a platform for future efforts to improve patient and public involvement in trials and a prioritised set of future research foci. (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)
DiscussionWe have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.Trial registrationClinicalTrials.govNCT03677037. Registered on 19 September 2018 (Source: Trials)
Source: Trials - July 28, 2021 Category: Research Source Type: clinical trials

Microbial Interventions to Control and Reduce Blood Pressure in Australia (MICRoBIA): rationale and design of a double-blinded randomised cross-over placebo controlled trial
Hypertension is a prevalent chronic disease worldwide that remains poorly controlled. Recent studies support the concept that the gut microbiota is involved in the development of hypertension and that dietary ... (Source: Trials)
Source: Trials - July 27, 2021 Category: General Medicine Authors: Dakota Rhys-Jones, Rachel E. Climie, Paul A. Gill, Hamdi A. Jama, Geoffrey A. Head, Peter R. Gibson, David M. Kaye, Jane G. Muir and Francine Z. Marques Tags: Study protocol Source Type: research

Microbial Interventions to Control and Reduce Blood Pressure in Australia (MICRoBIA): rationale and design of a double-blinded randomised cross-over placebo controlled trial
DiscussionThe findings of this study will provide the first evidence for the use of a combination of pre- and postbiotics to lower BP in humans. The results are expected at the end of 2021.Trial registrationAustralia and New Zealand Clinical Trial RegistryACTRN12619000916145. Registered on 1 July 2019. (Source: Trials)
Source: Trials - July 27, 2021 Category: Research Source Type: clinical trials

The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D... (Source: Trials)
Source: Trials - July 26, 2021 Category: General Medicine Authors: Xiaohui Guo, Meiling Xuan, Huan Zheng, Shumin Qin, Haomeng Wu, Shaogang Huang and Zehuai Wen Tags: Study protocol Source Type: research

Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial
Tactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the... (Source: Trials)
Source: Trials - July 26, 2021 Category: General Medicine Authors: Alessia Di Polito, Arianna Del Vecchio, Milena Tana, Patrizia Papacci, Anna Laura Vento, Benedetta Campagnola, Sefora Celona, Laura Cricenti, Ilaria Bastoni, Chiara Tirone, Alessandra Lio, Claudia Aurilia, Anthea Bottoni, Angela Paladini, Francesco Cota, Tags: Study protocol Source Type: research

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders
Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and ap... (Source: Trials)
Source: Trials - July 26, 2021 Category: General Medicine Authors: Primus Che Chi, Esther Awuor Owino, Irene Jao, Fredrick Olewe, Bernhards Ogutu, Philip Bejon, Melissa Kapulu, Dorcas Kamuya and Vicki Marsh Tags: Research Source Type: research

AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter
There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repu... (Source: Trials)
Source: Trials - July 26, 2021 Category: General Medicine Authors: Gareth O. Griffiths, Richard FitzGerald, Thomas Jaki, Andrea Corkhill, Helen Reynolds, Sean Ewings, Susannah Condie, Emma Tilt, Lucy Johnson, Mike Radford, Catherine Simpson, Geoffrey Saunders, Sara Yeats, Pavel Mozgunov, Olana Tansley-Hancock, Karen Mart Tags: Update Source Type: research

Study protocol for a randomized controlled trial to improve the quality of life of housewives with musculoskeletal disorders: a health promotion intervention based on a participatory ergonomic approach —the Housewives Ergonomic Intervention (HEI) trial
DiscussionThe study will provide a practical approach to reducing stress, reducing musculoskeletal disorders, enhancing the ability to work, and improving the quality of life of women with musculoskeletal disorders associated with housework. If the designed interventions in the present study are effective, they will have the great practical potential for generalization to all housewives.Trial registrationClinicalTrials.govIRCT20200602047640N. Registered on 07 September 2020 with the IRCTID. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

Impact of a “vegetables first” approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial
DiscussionThis randomised, controlled trial will be the first to our knowledge to investigate a “vegetables first” approach to complementary feeding on infants’ liking and intake of vegetables in New Zealand. Comparison against standard practice (fruit and vegetables as first foods) should complement other trials underway, such as the Baby’s First Bites and Nordic OTIS trial. Results m ay contribute to the evidence supporting complementary feeding guidelines in New Zealand and worldwide.Trial registrationAustralian New Zealand Clinical Trial RegistryACTRN12619000737134. Registered on 16 May 2019. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects
ConclusionApproximately half of the overall treatment effect in RCTs seems attributable to contextual effects rather than to the specific effect of treatments. As the study did not include all important contextual factors (e.g., patient-provider interaction), the true proportion of contextual effects could differ from the study ’s results. However, contextual effects should be considered when assessing treatment effects in clinical practice.Trial registrationPROSPEROCRD42019130257. Registered on April 19, 2019. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa —study protocol
DiscussionThis will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW.Trial registrationClinicalTrials.govNCT03977181. Registered ...
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial
DiscussionThis trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment.Trial registrationThe trial was registered with the Chinese Clinical Trial Registry,ChiCTR1900026837. Registered on 24 October 2019. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial
AbstractBackgroundTactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the last years, most preterm newborns with respiratory failure are preferentially managed with non-invasive respiratory support and by stimulating spontaneous respiratory activity from the delivery room and in neonatal intensive care unit (NICU), in order to avoid the risks of intubation and prolonged mechanical ventilation.MethodsPreterm infants with gestational age
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)
ConclusionDetailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation.Trial registrationISRCTNISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018.Process evaluation protocol version 4.0, 1 November 2020. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders
ConclusionDeveloping ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights. (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter
DiscussionFew approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment.Trial registrationEudraCT Number:2020-001860-27 14 March 2020ClinicalTrials.gov Identifier:NCT04746183 19 February 2021ISRCTN reference: 27106947 (Source: Trials)
Source: Trials - July 26, 2021 Category: Research Source Type: clinical trials

Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial
Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe... (Source: Trials)
Source: Trials - July 24, 2021 Category: General Medicine Authors: Antonio Ojeda, Andrea Calvo, Tomas Cu ñat, Ricard Mellado Artigas, Oscar Comino-Trinidad, Jorge Aliaga, Marilyn Arias, Maribel Ahuir, Carlos Ferrando and Christian Dürsteler Tags: Study protocol Source Type: research

Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial
This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors ’ institutional review boardComit é Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov (NCT04394169). (Source: Trials)
Source: Trials - July 24, 2021 Category: Research Source Type: clinical trials