Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA))
Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent ris... (Source: Trials)
Source: Trials - February 23, 2021 Category: General Medicine Authors: Lisa Irvine, Jennifer Kirsty Burton, Myzoon Ali, Terence J. Quinn and Claire Goodman Tags: Study protocol Source Type: research

Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia
Congenital diaphragmatic hernia (CDH) is, depending of the severity, a birth defect associated with significant mortality and morbidity. Prenatal screening by ultrasound may detect this condition and comprehen... (Source: Trials)
Source: Trials - February 23, 2021 Category: General Medicine Authors: Simen Vergote, Felix De Bie, Jan Bosteels, Holly Hedrick, James Duffy, Beverley Power, Alexandra Benachi, Paolo De Coppi, Caraciolo Fernandes, Kevin Lally, Irwin Reiss and Jan Deprest Tags: Study protocol Source Type: research

Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial
Atypical antipsychotic medications, which are effective for the treatment of schizophrenia and bipolar disorder, are associated with features of metabolic syndrome, such as weight gain, hyperglycemia, dyslipid... (Source: Trials)
Source: Trials - February 23, 2021 Category: General Medicine Authors: Chenchen Liu, Dongyu Kang, Jingmei Xiao, Yuyan Huang, Xingjie Peng, Weiyan Wang, Peng Xie, Ye Yang, Jingping Zhao and Renrong Wu Tags: Study protocol Source Type: research

Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA))
DiscussionAnalysis of pooled IPD has the potential to inform and direct future practice, research and policy at low cost, enhancing the value of existing data and reducing research waste. We aim to create a permanent archive for care home trial data and welcome the contribution of emerging trial datasets. (Source: Trials)
Source: Trials - February 23, 2021 Category: Research Source Type: clinical trials

Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial
DiscussionTo date, this is the first randomized, placebo-controlled, double-blinded trial investigating the efficacy of dietary fiber and probiotics alone and in combination to reduce metabolic side effects induced by atypical antipsychotic medications. If effective, it is possible to conclude that dietary fiber and probiotics can reduce atypical antipsychotic-induced metabolic side effects.Trial registration numberClinicalTrials.govNCT03379597. Registered on 19 November 2017. (Source: Trials)
Source: Trials - February 23, 2021 Category: Research Source Type: clinical trials

Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia
DiscussionWe have started a procedure to develop a COS for studies on perinatal interventions for congenital diaphragmatic hernia, with the purpose of improving the quality of research, guide clinical practice and improve patient care and eventual use in future clinical trials, systematic reviews and clinical practice guidelines.Trial registrationWe prospectively registered this study in the International Prospective Register of Systematic Reviews (PROSPERO) (registration number:CRD42019124399) and The Core Outcome Measures in Effectiveness Trials (COMET) Initiative (registration number:1296). (Source: Trials)
Source: Trials - February 23, 2021 Category: Research Source Type: clinical trials

The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial
Despite the implementation of the preschool oral healthcare programme (POHP) for 5 –6-year-old children over the past 3 decades in Malaysia, dental plaque and caries levels in this age group remain high. Among ... (Source: Trials)
Source: Trials - February 22, 2021 Category: General Medicine Authors: Zamros Yuzadi Mohd Yusof, Nurul Hayati Anwar, Nor Azlida Mohd Nor, Mariani Md Nor and Siti Ezaleila Mustafa Tags: Study protocol Source Type: research

The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial
This study is a pragmatic, cluster-randomised, parallel-group, matched pair, controlled trial with blinded outcome assessment. Randomisation is performed using a computer-generated table with a 1:1 allocation comparing the SIMSP and the POHP involving 28 preschools in the Kampar district, Perak, Malaysia. The intervention consists of preschool visits by a group of dental therapists, in-class oral health lessons and daily toothbrushing conducted by class teacher, child home toothbrushing supervised by parents, and infographic oral health messages to parents. The control consists of the existing POHP that involves preschool ...
Source: Trials - February 22, 2021 Category: Research Source Type: clinical trials

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: protocol of an international, randomised, double-blind, placebo-controlled trial (OPTIC)
International guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). IVIg treatment usual... (Source: Trials)
Source: Trials - February 19, 2021 Category: General Medicine Authors: S. R. M. Bus, L. Zambreanu, A. Abbas, Y. A. Rajabally, R. D. M. Hadden, R. J. de Haan, C. A. J. M. de Borgie, M. P. Lunn, I. N. van Schaik and F. Eftimov Tags: Study protocol Source Type: research

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: protocol of an international, randomised, double-blind, placebo-controlled trial (OPTIC)
DiscussionIn case of superiority of the combined treatment, patients will experience the advantages of two proven efficacious treatments, namely rapid improvement due to IVIg and long-term remission due to corticosteroids. Long-term remission would reduce the need for maintenance IVIg treatment and may decrease health care costs. Additionally, we expect that the combined treatment leads to a higher proportion of patients with improvement as some patients who do not respond to IVIg will respond to corticosteroids. Risks of short and long-term additional adverse events of the combined treatment need to be assessed.Trial regi...
Source: Trials - February 19, 2021 Category: Research Source Type: clinical trials

COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is... (Source: Trials)
Source: Trials - February 18, 2021 Category: General Medicine Authors: Rebecca Li, Megan von Isenburg, Marcia Levenstein, Stan Neumann, Julie Wood and Ida Sim Tags: Research Source Type: research

Sympathetic Nervous System and Exercise Affects Cognition in Youth (SNEACY): study protocol for a randomized crossover trial
There is an increasing prevalence of physical inactivity during childhood, which is associated with a variety of health problems. However, the mechanisms by which acute exercise benefits cognition in childhood... (Source: Trials)
Source: Trials - February 18, 2021 Category: General Medicine Authors: Lauren B. Raine, Katherine McDonald, Tatsuya T. Shigeta, Shu-Shih Hsieh, Jennifer Hunt, Nathan A. Chiarlitti, Michelle Lim, Kristen Gebhardt, Nina Collins, Michael De Lisio, Sean P. Mullen, Arthur F. Kramer and Charles Hillman Tags: Study protocol Source Type: research

Sympathetic Nervous System and Exercise Affects Cognition in Youth (SNEACY): study protocol for a randomized crossover trial
DiscussionThe results from this study could influence educational and public health recommendations to enhance cognition and learning in pre-adolescent children.Trial registrationClinicalTrials.govNCT03592238. Registered on 19 July 2018 (Source: Trials)
Source: Trials - February 18, 2021 Category: Research Source Type: clinical trials

COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
ConclusionsAt a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited. (Source: Trials)
Source: Trials - February 18, 2021 Category: Research Source Type: clinical trials

Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial
Spinal surgery can be associated with significant postoperative pain. Erector spinae plane (ESP) block is a new regional anaesthesia technique, which promises effective postoperative analgesia compared with sy... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: Dylan T. Finnerty and Donal J. Buggy Tags: Study protocol Source Type: research

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial
Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women ar... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: Ralph J. DiClemente, Jennifer L. Brown, Ariadna Capasso, Natalia Revzina, Jessica M. Sales, Ekaterina Boeva, Lyudmila V. Gutova, Nadia B. Khalezova, Nikolay Belyakov and Vadim Rassokhin Tags: Study protocol Source Type: research

Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial
Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the g... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: Edward C. Deehan, Eloisa Colin-Ramirez, Lucila Triador, Karen L. Madsen, Carla M. Prado, Catherine J. Field, Geoff D. C. Ball, Qiming Tan, Camila Orsso, Irina Dinu, Mohammadreza Pakseresht, Daniela Rubin, Arya M. Sharma, Hein Tun, Jens Walter, Christopher Tags: Study protocol Source Type: research

The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial
First-line pharmacotherapy for neuropathic pain entails the use of systemic antidepressants and anticonvulsants. These drugs are not optimally effective and poorly tolerated, especially for older patients with... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: Oli Abate Fulas, Andr é Laferrière, D. Mark A. Ware, Yoram Shir and Terence J. Coderre Tags: Study protocol Source Type: research

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial
Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is design... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: Yun Gao, Chun Wang, Dawei Chen, Hui Huang, Lihong Chen, Guanjian Liu, Shuang Lin, Min Liu, Xiaorong Wen, Jae-Hoon Cho, Yong Chen, Yingzhu Li and Xingwu Ran Tags: Study protocol Source Type: research

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15  years, and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain ... (Source: Trials)
Source: Trials - February 17, 2021 Category: General Medicine Authors: J. Weindelmayer, V. Mengardo, A. Veltri, G. L. Baiocchi, S. Giacopuzzi, G. Verlato and G. de Manzoni Tags: Study protocol Source Type: research

Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial
DiscussionTo the best of our knowledge, this will be the first randomised control trial to examine the efficacy and safety of the ESP block in terms of patient-centred outcomes in the setting of major spinal surgery. The QoR-15 is a validated means of assessing the quality of recovery after surgery and gives a more holistic assessment of the recovery experience from the patient ’s point of view.Trial registrationThis trial is pre-registered on ClinicalTrials.gov reference numberNCT04370951. Registered on 30 April 2020. All items from the World Health Organisation Trial Registration Data Set have been included. (Source: Trials)
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial
DiscussionThis clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients.Trial registrationChinese Clinical Trial RegistryChiCTR1900025538. Registered on 31 August 2019. (Source: Trials)
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial
DiscussionADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial registrationProspectively registered (last updated on 29 October 2020) at ClinicalTrials.gov with the identifierNCT04227951. (Source: Trials)
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial
This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention.Trial registrationClinicalTrials.govNCT04578652. Registered on 8 October 2020. (Source: Trials)
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial
DiscussionThe proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. We propose to recruit 200 participants.The intervention, if efficacious, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated into clinical care in Russia to reduce women ’s alcohol consumption and enhance HIV/HCV prognosis.Trial registrationClinicalTrials.govNCT03362476. Registered on 5 December 2017 (Source: Trials)
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial
This study could generate the first evidence for the efficacy and safety of the formulation in alleviating pain in patients with neuropathic pain. Furthermore, this trial will provide objective grounds for the investigation of other agents that enhance tissue oxygenation in the topical treatment of peripheral neuropathic pain.Trial registrationThis trial has been registered with ClinicalTrials.gov owned by NIH ’s US National Library of Medicine.ClinicalTrials.govNCT03342950. Registered on November 1, 2017 (trial was prospectively registered).Protocol version and identifiersThis is protocol version 5, dated June 2018....
Source: Trials - February 17, 2021 Category: Research Source Type: clinical trials

Correction to: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system —lessons learned and recommendations
An amendment to this paper has been published and can be accessed via the original article. (Source: Trials)
Source: Trials - February 16, 2021 Category: General Medicine Tags: Correction Source Type: research

Correction to: The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children
An amendment to this paper has been published and can be accessed via the original article. (Source: Trials)
Source: Trials - February 16, 2021 Category: General Medicine Authors: Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. R Tags: Correction Source Type: research

Correction to: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system —lessons learned and recommendations
An amendment to this paper has been published and can be accessed via the original article. (Source: Trials)
Source: Trials - February 16, 2021 Category: Research Source Type: clinical trials

How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods
Fixed orthodontic appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. Fifty to 70% of patients treated with braces encounter these problems. Their care in the USA... (Source: Trials)
Source: Trials - February 15, 2021 Category: General Medicine Authors: Alis ée Le Fouler, Sylvie Jeanne, Olivier Sorel and Damien Brézulier Tags: Study protocol Source Type: research

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial
High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-... (Source: Trials)
Source: Trials - February 15, 2021 Category: General Medicine Authors: Yu Wang, Guang-Xia Shi, Zhong-Xue Tian, Jun-Hong Liu, You-Sheng Qi, Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang and Cun-Zhi Liu Tags: Study protocol Source Type: research

MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion —study protocol for a randomized clinical trial
Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there i... (Source: Trials)
Source: Trials - February 15, 2021 Category: General Medicine Authors: Kilian M. Treurniet, Natalie E. LeCouffe, Manon Kappelhof, Bart J. Emmer, Adriaan C. G. M. van Es, Jelis Boiten, Geert J. Lycklama, Koos Keizer, Lonneke S. F. Yo, Hester F. Lingsma, Wim H. van Zwam, Inger de Ridder, Robert J. van Oostenbrugge, Aad van der Tags: Study protocol Source Type: research

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial
The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other p... (Source: Trials)
Source: Trials - February 15, 2021 Category: General Medicine Authors: Fiona A. Quirke, Patricia Healy, Elaine N í Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy and Declan Devane Tags: Study protocol Source Type: research

MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion —study protocol for a randomized clinical trial
AbstractBackgroundEndovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there is clinical equipoise concerning the added benefit of intravenous alteplase administration (IVT) prior to EVT. The aim of this study is to assess the efficacy and safety of omitting IVT before EVT in patients with AIS caused by an anterior circulation LVO.MethodsMR CLEAN-NO IV is a multicenter randomized open-label clinical trial with blinded outcome assessment (PROBE design). Patients ≥ 18&...
Source: Trials - February 15, 2021 Category: Research Source Type: clinical trials

Ethical care requires pragmatic care research to guide medical practice under uncertainty
ConclusionPragmatic trials can regulate medical practice by providing (i) a transparent demarcation between unvalidated and validated care; (ii) norms of medical conduct when using tests and interventions of yet unknown benefits in practice; and eventually (iii) a verdict regarding optimal care. (Source: Trials)
Source: Trials - February 15, 2021 Category: Research Source Type: clinical trials

How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods
This study is a prospective randomized controlled trial of superiority. It evaluates the effectiveness of three hygiene education techniques. A total of 90 patients from the University Hospital Center of Rennes will be randomized into 3 parallel groups with a 1:1:1 ratio. Each will benefit from a different educational method: oral and/or practical. The main outcome will be the average plaque index for each group after 6  months of treatment. Additional outcomes will be the average gingival index for each group and the plaque and gingival indices over 6 months.DiscussionThe effectiveness of preventive procedur...
Source: Trials - February 15, 2021 Category: Research Source Type: clinical trials

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial
DiscussionThis trial will explore the feasibility and provide potential evidence for the effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.Trial registrationChinese Clinical Trial Registry,ChiCTR 1900024982. Registered on August 6, 2019. (Source: Trials)
Source: Trials - February 15, 2021 Category: Research Source Type: clinical trials

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial
DiscussionThis trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods.Trial registrationNCT04471103. Registered on 14 July 2020. (Source: Trials)
Source: Trials - February 15, 2021 Category: Research Source Type: clinical trials

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2) —study protocol for a randomised controlled trial
Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose cortico... (Source: Trials)
Source: Trials - February 14, 2021 Category: General Medicine Authors: Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen and Sascha K öpke Tags: Study protocol Source Type: research

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2) —study protocol for a randomised controlled trial
This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.MethodsThe pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruit...
Source: Trials - February 14, 2021 Category: Research Source Type: clinical trials

The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme —for a randomised controlled trial protocol
Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myo... (Source: Trials)
Source: Trials - February 13, 2021 Category: General Medicine Authors: M. Elfghi, F. Jordan, D. Dunne, I. Gibson, J. Jones, G. Flaherty, S. Sultan and W. Tawfick Tags: Study protocol Source Type: research

The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme —for a randomised controlled trial protocol
This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high-quality, well-powered clinical trial.Trial registrationThis trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov (NCT03935776) which was registered on 02 May 2019. (Source: Trials)
Source: Trials - February 13, 2021 Category: Research Source Type: clinical trials

Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial
Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence ra... (Source: Trials)
Source: Trials - February 12, 2021 Category: General Medicine Authors: K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S. B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fr öhling, G. Egerer, J. Debus and M. Uhl Tags: Study protocol Source Type: research

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial
Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally ... (Source: Trials)
Source: Trials - February 12, 2021 Category: General Medicine Authors: Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng and Haiyong Chen Tags: Study protocol Source Type: research

Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of ca... (Source: Trials)
Source: Trials - February 12, 2021 Category: General Medicine Authors: Makito Miyake, Nobutaka Nishimura, Takashi Inoue, Shota Suzuki, Tomomi Fujii, Takuya Owari, Shunta Hori, Yasushi Nakai, Michihiro Toritsuka, Hitoshi Nakagawa, Shinji Tsukamoto, Satoshi Anai, Kazumasa Torimoto, Tatsuo Yoneda, Nobumichi Tanaka and Kiyohide Tags: Study protocol Source Type: research

Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial
Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effecti... (Source: Trials)
Source: Trials - February 12, 2021 Category: General Medicine Authors: Masafumi Haraguchi, Kunihiro Ichinose, Hisamitsu Miyaaki, Masatoshi Hanada, Masanori Fukushima, Ryu Sasaki, Satoshi Miuma, Takanobu Hara, Tota Kugiyama, Akihiko Soyama, Masaaki Hidaka, Ayumi Tsuji, Rintaro Yano, Motohiro Sekino, Hideaki Takahata, Susumu E Tags: Study protocol Source Type: research

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial
DiscussionThis trial will assess the efficacy of modified BXD in improving the clinical symptoms and quality of life of the patients suffering fromWei-Pi syndrome.Trial registrationClinicalTrials.govNCT04398888. Registered on May 21, 2020 (Source: Trials)
Source: Trials - February 12, 2021 Category: Research Source Type: clinical trials

Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
DiscussionThe goal of this trial is to determine the potential benefits of PDD-cTURBT and PDD-EBTUR followed by a single immediate postoperative intravesical chemotherapy in patients with low- or intermediate-risk NMIBC who undergo TURBT. Ultimately, our findings will lead to the development of better interventions and potentially change the standard of care.Trial registrationThis clinical trial was prospectively registered with the UMIN Clinical Trials Registry on 1 August 2020. The reference number isUMIN000041273, and the Ethics Committee of Nara Medical University Approval ID is 2702. (Source: Trials)
Source: Trials - February 12, 2021 Category: Research Source Type: clinical trials

Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial
DiscussionThe results of this study are expected to provide evidence regarding the effect of NMES combined with BCAA therapy on the skeletal muscle of post-LDLT patients.Trial registrationJapan Registry of Clinical ResearchjRCTs071190051. Registered on February 26, 2020. (Source: Trials)
Source: Trials - February 12, 2021 Category: Research Source Type: clinical trials