Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency
AbstractThe LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for people with progressive multiple sclerosis (MS) and severe disability. The intervention has been evaluated in a single-arm feasibility study with embedded process evaluation. The feasibility study was due to open to recruitment during the COVID-19 2020 –2021 pandemic, 1 month into the first UK-wide lockdown. We worked rapidly to implement adaptions to the trial procedures and intervention delivery th...
Source: Trials - April 16, 2021 Category: Research Source Type: clinical trials

Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial
The association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, gen... (Source: Trials)
Source: Trials - April 15, 2021 Category: General Medicine Authors: Belen Retamal-Valdes, Wim Teughels, Laryssa Macedo Oliveira, Rebeca Nascimento da Silva, Aretuza Fritoli, Patricia Gomes, Geisla Mary Silva Soares, Natalie Tempor ão, Camila Pinheiro Furquim, Poliana Mendes Duarte, Helio Doyle, Marcelo Faveri, Luciene Cr Tags: Study protocol Source Type: research

A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study)
Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvuls... (Source: Trials)
Source: Trials - April 15, 2021 Category: General Medicine Authors: Virginie Moulier, Mohamed Wassim Krir, Marine Dalmont, Olivier Guillin and Maud Roth ärmel Tags: Study protocol Source Type: research

Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial
Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmoly... (Source: Trials)
Source: Trials - April 15, 2021 Category: General Medicine Authors: Roland Roelz, Fabian Schubach, Volker A. Coenen, Carolin Jenkner, Christian Scheiwe, J ürgen Grauvogel, Wolf-Dirk Niesen, Horst Urbach, Christian Taschner, Jochen Seufert, Jürgen Kätzler, Jürgen Beck and Peter C. Reinacher Tags: Study protocol Source Type: research

Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial
AbstractBackgroundThe association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, generalized. More recently, probiotics have also been suggested as a promising adjunctive treatment for periodontal diseases due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this randomized clinical trial (RCT) is to evaluate the clinical, microbiological, and immunological effects of probiotics as adjuncts to SRP alone or with MTZ+AMX in the treatment of periodontitis....
Source: Trials - April 15, 2021 Category: Research Source Type: clinical trials

A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study)
DiscussionThe aims of this research are to optimize protocols of combined ECT with clozapine in patients with URS and to offer specific recommendations for these patients ’ care.Trial registrationClinicalTrials.govNCT03542903. Registered on May 31, 2018. Id RCB: 2017-A02657-46 (Source: Trials)
Source: Trials - April 15, 2021 Category: Research Source Type: clinical trials

Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial
DiscussionNew approaches for the prevention and therapy of secondary brain injury in patients with aSAH are urgently needed. We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer ’s solution.Trial registrationDeutsches Register Klinischer Studien (German Clinical Trials Register),DRKS00015645. Registered on 8 May 2019 (Source: Trials)
Source: Trials - April 15, 2021 Category: Research Source Type: clinical trials

Conducting clinical trials during the COVID-19 pandemic —a collaborative trial network response
AbstractThe unprecedented demand placed on healthcare systems from the COVID-19 pandemic has forced a reassessment of clinical trial conduct and feasibility. Consequently, the Australasian Kidney Trials Network (AKTN), an established collaborative research group known for conducting investigator-initiated global clinical trials, had to efficiently respond and adapt to the changing landscape during COVID-19. Key priorities included ensuring patient and staff safety, trial integrity and network sustainability for the kidney care community. New resources have been developed to enable a structured review and contingency plan o...
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic
AbstractThe COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations ...
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Conducting clinical trials during the COVID-19 pandemic —a collaborative trial network response
The unprecedented demand placed on healthcare systems from the COVID-19 pandemic has forced a reassessment of clinical trial conduct and feasibility. Consequently, the Australasian Kidney Trials Network (AKTN)... (Source: Trials)
Source: Trials - April 14, 2021 Category: General Medicine Authors: Laura Robison, Yeoungjee Cho, Andrea K. Viecelli, David W. Johnson, Carmel M. Hawley, Andrea Valks, Peta-Anne Paul-Brent, Ruth Stastny, Julie Varghese, Charani Kiriwandeniya, Elaine M. Pascoe, Liza A. Vergara, Magid A. Fahim, Neil Boudville, Rathika Krish Tags: Commentary Source Type: research

Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic
The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring... (Source: Trials)
Source: Trials - April 14, 2021 Category: General Medicine Authors: Sharon B. Love, Emma Armstrong, Carrie Bayliss, Melanie Boulter, Lisa Fox, Joanne Grumett, Patricia Rafferty, Barbara Temesi, Krista Wills and Andrea Corkhill Tags: Research Source Type: research

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve transparent reporting of randomised clinical trials. It comprises a participant flow diagram with the reporting of essential n... (Source: Trials)
Source: Trials - April 14, 2021 Category: General Medicine Authors: Thea N ørgaard Rønsbo, Jens Laigaard, Casper Pedersen, Ole Mathiesen and Anders Peder Højer Karlsen Tags: Review Source Type: research

Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
Dyslipidemia and local inflammation at sites of lipid deposition on blood vessel walls have been demonstrated to be risk factors for patients with acute aortic dissection (AAD). Statins have anti-inflammatory ... (Source: Trials)
Source: Trials - April 14, 2021 Category: General Medicine Authors: Yequn Chen, Nianling Xiong, Xin Wang, Shiwan Wu, Liangli Hong, Xiru Huang, Chang Chen, Weiping Li, Bin Wang, Shu Ye and Xuerui Tan Tags: Study protocol Source Type: research

Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED): a protocol for an open-label non-inferiority diagnostic randomised controlled trial
Children frequently present to the emergency department (ED) with forearm injuries and often have x-rays to determine if there is a fracture. Bedside ultrasound, also known as point-of-care ultrasound (POCUS),... (Source: Trials)
Source: Trials - April 14, 2021 Category: General Medicine Authors: Peter J. Snelling, Gerben Keijzers, Joshua Byrnes, David Bade, Shane George, Mark Moore, Philip Jones, Michelle Davison, Rob Roan and Robert S. Ware Tags: Study protocol Source Type: research

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review
ConclusionsAdherence to participant flow diagrams for RCTs has increased significantly over time. Still, there is room for improvement of adequate reporting of flow diagrams, to increase transparency of trials details. (Source: Trials)
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial
This study is designed to verify the efficacy of atorvastatin on reducing in-hospital mortality of patients with AAD. The aim is to provide a new means of improving survival as a complement to conventional drug therapy.Trial registrationChinese Clinical Trials RegistryChiCTR1900023515. Registered on 1 June 2019. (Source: Trials)
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED): a protocol for an open-label non-inferiority diagnostic randomised controlled trial
DiscussionIf POCUS is non-inferior to x-ray in terms of patient ’s medium-term physical function, it may have an effect on overall health care resource use, including the number of x-ray performed and earlier ED discharge. Although prospective studies have confirmed the accuracy of POCUS, this will be the first RCT to assess non-inferiority of functional outco mes of POCUS to diagnose non-angulated paediatric distal forearm injuries, compared to x-ray. POCUS may be of particular importance in settings where access to x-ray imaging can be limited either during or after-hours, as it can aid the triaging and management ...
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Impact of a shared decision-making mHealth tool on caregivers ’ team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial
DiscussionThis clinical trial will assess the impact of a collaborative mHealth tool on increasing situational awareness and effective team communication during in-hospital pediatric resuscitation. As research in this area is scarce, the results generated by this study may become of paramount importance in improving the care of children receiving in-hospital CPR, in the era of increasing communication technology.Trial registrationClinicalTrials.govNCT04464603. Registered on 9 July 2020. (Source: Trials)
Source: Trials - April 13, 2021 Category: Research Source Type: clinical trials

Improving cognition in severe mental illness by combining cognitive remediation and transcranial direct current stimulation: study protocol for a pragmatic randomized controlled pilot trial (HEADDSET)
The objective of this pilot trial is to investigate the effects of cognitive remediation (CR) on cognitive and daily functioning in people dependent on residential settings. In addition, transcranial direct current stimulation (tDCS) is used to promote neural plasticity. It is expected that the addition of tDCS can enhance learning and will result in longer-lasting improvements in cognitive and daily functioning.MethodsThis is a pragmatic, triple-blinded, randomized, sham-controlled, pilot trial following a non-concurrent multiple baseline design with the participants serving as their own control. We will compare (1) CR to...
Source: Trials - April 13, 2021 Category: Research Source Type: clinical trials

A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe primary objective is to evaluate the efficacy of an inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine (Sinovac, China) in voluntary participants after 14 days of the second dose against RT-PCR confirmed symptomatic COVID-19 cases. The secondary objectives include evaluating the efficacy after at least one dose of the vaccine against RT-PCR confirmed symptomatic COVID-19 cases; the efficacy of two doses of the vaccine on the rates of hospitalization and death; the safety of the vaccine including adverse reactions up to one year after the 2nd dose of vaccination; and the immunogenicity of ...
Source: Trials - April 13, 2021 Category: Research Source Type: clinical trials

Improving cognition in severe mental illness by combining cognitive remediation and transcranial direct current stimulation: study protocol for a pragmatic randomized controlled pilot trial (HEADDSET)
A fundamental challenge for many people with severe mental illness (SMI) is how to deal with cognitive impairments. Cognitive impairments are common in this population and limit daily functioning. Moreover, ne... (Source: Trials)
Source: Trials - April 13, 2021 Category: General Medicine Authors: Anika Poppe, Leonie Bais, Dani ëlle van Duin, Branislava Ćurčić-Blake, Gerdina Hendrika Maria Pijnenborg and Lisette van der Meer Tags: Study protocol Source Type: research

A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial
The primary objective is to evaluate the efficacy of an inactivated and aluminium hydroxide adsorbed SARS-CoV-2 vaccine (Sinovac, China) in voluntary participants after 14 days of the second dose against RT-PC... (Source: Trials)
Source: Trials - April 13, 2021 Category: General Medicine Authors: Murat Akova and Serhat Unal Tags: Letter Source Type: research

Impact of a shared decision-making mHealth tool on caregivers ’ team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial
Effective team communication, coordination, and situational awareness (SA) by team members are critical components to deliver optimal cardiopulmonary resuscitation (CPR). Complexity of care during CPR, involve... (Source: Trials)
Source: Trials - April 13, 2021 Category: General Medicine Authors: Fr édéric Ehrler, Cyril Sahyoun, Sergio Manzano, Oliver Sanchez, Alain Gervaix, Christian Lovis, Delphine S. Courvoisier, Laurence Lacroix and Johan N. Siebert Tags: Study protocol Source Type: research

The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement
This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention.MethodThe study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts.The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are youn...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial
DiscussionThis pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity.Trial registrationISRCTNISRCTN13567538. Registered on 18 March 2019 (Source: Trials)
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial
ConclusionWhen a workplace assessment and management could not be as part of any intervention, adding a smartphone app to GPR for NP may be an appropriate tool to administer a home and work exercise program resulting in elevating pain and disability, as well as improving FHP and endurance.Trial registrationCurrent Controlled Trials using the UMIN-RCT websiteUMIN000039720. Retrospectively registered on January 9, 2020. (Source: Trials)
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia.Secondary objectives, at 14 and 28 days, are to:Determine the efficacy of RUX or FOS to reduce mortalityDetermine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMODetermine the efficacy of RUX or FOS to reduce the need for non-invasive ventilationDetermine the efficacy of RUX or FOS to reduce the proportion of parti...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19.Trial designThis is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group.ParticipantsAll severe COVID-19 patients with at least one of the following five conditions: (respiration rate> 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH)> 245 U / l, Progressive lymphopenia, and admitted to the intensive care...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Prophylactic use of dural tenting sutures in elective craniotomies in adults —is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial
This study is designed as a randomised, multicentre, double-blinded, controlled interventional trial with 1:1 allocation. About one half of the participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures. Both groups will be followed clinically and radiologically. The primary outcome is reoperation due to extradural haematoma. Secondary outcomes aim to evaluate the impact of dural tenting sutures on mortality, readmission risk, postoperative headaches, size of extradural collection, cerebrospinal fluid leak risk a...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-19, in comparison with the group treated with standard of care, at discharge endpoint.The secondary objectives of the presented study are to evaluate different outcomes of the rehabilitation program in comparison to standard of care regarding: functional performance at 4-week and 12-week post- discharge mark; health-related quality of life, the impact on the health services (namely days of hospitaliza...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors... (Source: Trials)
Source: Trials - April 12, 2021 Category: General Medicine Authors: Arash Rahimi, Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Mohsen Arabi and Mitra KazemiJahromi Tags: Letter Source Type: research

Prophylactic use of dural tenting sutures in elective craniotomies in adults —is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial
In the early days of neurosurgery, extradural haemorrhages (EDHs) contributed to a high mortality rate after craniotomies. Almost a century ago, Walter Dandy reported dural tenting sutures as an effective way ... (Source: Trials)
Source: Trials - April 12, 2021 Category: General Medicine Authors: Przemys ław Kunert, Łukasz Przepiórka, Jan Fortuniak, Karol Wiśniewski, Ernest Jan Bobeff, Patrycja Larysz, Rafał Kruk, Bartłomiej Kulesza, Dariusz Szczepanek, Piotr Ładziński, Jarosław Żyłkowski, Sławomir Kujawski, Kamila Łabędzka, Dariusz Tags: Study protocol Source Type: research

Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial
The primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-1... (Source: Trials)
Source: Trials - April 12, 2021 Category: General Medicine Authors: Ana Cristina Carvalho, Jorge Moreira, Pedro Cubelo, Pedro Cantista, Catarina Aguiar Branco and Bruno Guimar ães Tags: Letter Source Type: research

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial
Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might b... (Source: Trials)
Source: Trials - April 12, 2021 Category: General Medicine Authors: Garry A. Tew, Laura Bissell, Belen Corbacho, Caroline Fairhurst, Jenny Howsam, Jess Hugill-Jones, Camila Maturana, Shirley-Anne S. Paul, Tim Rapley, Jenny Roche, Fi Rose, David J. Torgerson, Lesley Ward, Laura Wiley, David Yates and Catherine Hewitt Tags: Study protocol Source Type: research

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial
The primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progre... (Source: Trials)
Source: Trials - April 12, 2021 Category: General Medicine Authors: Nikhil Vergis, Rachel Phillips, Victoria Cornelius, Alexia Katsarou, Taryn Youngstein, Lucy Cook, Michelle Willicombe, Clio Pilay, Tina Shturova, Melanie Almonte, Asad Charania, Richard Turner, Onn Min Kon, Graham Cooke, Mark Thursz, Svetlana Cherlin & he Tags: Letter Source Type: research

Supporting Parents & amp; Kids Through Lockdown Experiences (SPARKLE) : A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families ’ mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children’s behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE fa milies with a smartphone application delivering information and parenting support,Parent Positive, can reverse the negative effects of the pa...
Source: Trials - April 10, 2021 Category: Research Source Type: clinical trials

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families ’ mental health since early lockdown (Co-SPACE) ... (Source: Trials)
Source: Trials - April 10, 2021 Category: General Medicine Authors: Katarzyna Kostyrka-Allchorne, Cathy Creswell, Sarah Byford, Crispin Day, Kimberley Goldsmith, Marta Koch, Walter Muruet Gutierrez, Melanie Palmer, Jasmine Raw, Olly Robertson, James Shearer, Adrienne Shum, Petr Slovak, Polly Waite and Edmund J. S. Sonuga- Tags: Letter Source Type: research

Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial
The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of... (Source: Trials)
Source: Trials - April 9, 2021 Category: General Medicine Authors: Patricia J. Garcia, Hansel Mundaca, Cesar Ugarte-Gil, Patricia Leon, German Malaga, Carlos Chaccour and Cesar P. Carcamo Tags: Letter Source Type: research

Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. (Source: Trials)
Source: Trials - April 9, 2021 Category: General Medicine Authors: Jeremy Horwood, Melanie Chalder, Ben Ainsworth, James Denison-Day, Frank de Vocht, Martha M. C. Elwenspoek, Pippa Craggs, Rachel Denholm, Jonathan Sterne, Cathy Rice, Sascha Miller, Beth Stuart, Paul Little, Michael Moore, Merlin Willcox, John Macleod & h Tags: Letter Source Type: research

Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study
Patients with mild to moderate depressive symptoms can have limited access to regular treatment; to ensure appropriate care, low-threshold treatment is needed. Effective online interventions could increase the... (Source: Trials)
Source: Trials - April 9, 2021 Category: General Medicine Authors: Rico Kr ämer and Stephan Köhler Tags: Study protocol Source Type: research

Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial
Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to... (Source: Trials)
Source: Trials - April 9, 2021 Category: General Medicine Authors: Xin Xue, Xue-Ming Jin, Kai-Liang Luo, Xin-Hao Liu, Li Zhang and Jun Hu Tags: Study protocol Source Type: research

Comparison of single-injection ultrasound-guided thoracic paravertebral block with transversus abdominis plane block in peritoneal dialysis catheter implantation: a randomized controlled trial
Previous study indicated that transversus abdominis plane (TAP) block could be the principal anesthetic technique for peritoneal dialysis catheter (PDC) implantations. However, a TAP block could not provide an op... (Source: Trials)
Source: Trials - April 9, 2021 Category: General Medicine Authors: Xiao-juan Jiang, Zi Li, Qi Li, Hai-yan Zhang, Xiao-hong Tang and Tao Zhu Tags: Research Source Type: research

Comparison of single-injection ultrasound-guided thoracic paravertebral block with transversus abdominis plane block in peritoneal dialysis catheter implantation: a randomized controlled trial
AbstractBackgroundPrevious study indicated that transversus abdominis plane (TAP) block could be the principal anesthetic technique forperitoneal dialysis catheter (PDC) implantations. However, a TAP block could not provide an optimal anesthetic effect on catheter exit site during PDC implantation. We hypothesized that single-injection ultrasound-guided thoracic paravertebral block (US-TPVB) could be the principal anesthetic technique with better pain relief at catheter exit site during PDC implantation, compared to a TAP block. And anesthesia quality of a single-injection US-TPVB was compared with that of a TAP block and ...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesTo examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK.Trial designA two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care.ParticipantsSetting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices.Intervention and comparatorIntervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patient...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial
This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard.MethodsA single-blind, superiority, randomized controlled trial will be employed with evaluations at 3 and 6  months. Seventy-two PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine reh...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study
ConclusionThis randomized and controlled, blinded study will make use of a “dismantled” approach to adequately compare the accompanied and unaccompanied versions of the intervention. Positive and meaningful results are expected that could influence the acceptance and implementation of online interventions.Trial registrationGerman Clinical Trials Register DRKS00017191. Registered on 14 June 2019 (Source: Trials)
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial
AbstractObjectivesThe primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation.The secondary objectives are:To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiationTo assess the efficacy of ivermectin on the improvement of symptomsTo assess the proportion of seroconversions at day 21To assess the saf...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

The COVID-19 pandemic and new clinical trial activations
The COVID-19 pandemic has caused severe disruptions in care for many patients. A key question is whether the landscape of clinical research has also changed. (Source: Trials)
Source: Trials - April 8, 2021 Category: General Medicine Authors: Joseph M. Unger and Hong Xiao Tags: Research Source Type: research

FASTER and SCOTT & EVA trainings for adults with high-functioning autism spectrum disorder (ASD): study protocol for a randomized controlled trial
Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition with a prevalence rate above 1%, characterized by deficits in social communication and interaction; restrictive, repetitive patterns of ... (Source: Trials)
Source: Trials - April 8, 2021 Category: General Medicine Authors: Ludger Tebartz van Elst, Thomas Fangmeier, Ulrich Max Schaller, Oliver Hennig, Meinhard Kieser, Katja Koelkebeck, Charlotte Kuepper, Veit Roessner, Dirk Wildgruber and Isabel Dziobek Tags: Study protocol Source Type: research

The COVID-19 pandemic and new clinical trial activations
We examined 62,252 trial activations. During the initial COVID-19 outbreak (February 2020 through May 2020), model-estimated monthly trial activations for US-based studies were only 57% of the expected estimate had the pandemic not occurred (relative risk  = 0.57, 95% CI 0.52 to 0.61,p 
Source: Trials - April 8, 2021 Category: Research Source Type: clinical trials