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

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial
Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. Ho... (Source: Trials)
Source: Trials - July 23, 2021 Category: General Medicine Authors: Na Nie, Le Chen, Tong Li, Chuanlong Zhou, Bangwei Li, Conghua Ji, Jie Zhou, Qin Chen, Qiushuang Li, Yi Liang and Jianqiao Fang Tags: Study protocol Source Type: research

Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence —a study protocol for a RCT
Stress urinary incontinence (SUI) is a subtype of urinary incontinence that occurs more commonly amongst women. The pelvic floor muscle training (PFMT) is considered the gold standard for treating SUI. Another... (Source: Trials)
Source: Trials - July 23, 2021 Category: General Medicine Authors: F átima Faní Fitz, Márcia Maria Gimenez, Letícia de Azevedo Ferreira, Mayanni Magda Perreira Matias, Maria Augusta Tezelli Bortolini and Rodrigo Aquino Castro Tags: Study protocol Source Type: research

Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence —a study protocol for a RCT
This study closes a gap, as voluntary PFM pre-contraction (the Knack) has not yet been included in the physiotherapeutic treatment of SUI, and if shown successful could be implemented in clinical practice.Trial registrationClinicalTrials.govNCT03722719. Registered on October  29, 2018. Study protocol version 1.Was this trial prospectively registered? YesFunded by: The present study did not receive funding.Anticipated completion date: The anticipated trial commencement and completion dates are October 2018 and October 2021, respectively.Provenance: Not invited. Peer reviewed.Human research ethics approval committee: Re...
Source: Trials - July 23, 2021 Category: Research Source Type: clinical trials

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial
This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2  Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks − 4–0), a 4-week-long treatment period (weeks 1–4) and a 12-week-long follow-up period (weeks 5–16). Twelve treatment sessions wil l be performed over a 4-week period (weeks 1–4). The primary outcome will be measured by the frequency of migraine attac...
Source: Trials - July 23, 2021 Category: Research Source Type: clinical trials

Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial
Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus fa... (Source: Trials)
Source: Trials - July 22, 2021 Category: General Medicine Authors: Wen Zhang, Qin Xie, Xiaoming Xu, Shuting Sun, Tian Fan, Xinxin Wu, Yao Qu, Jinhua Che, Tingrong Huang, Huacheng Li, You Zheng, Chao Jiang, Bangjiang Fang and Shuang Zhou Tags: Study protocol Source Type: research

Effects of real-time feedback during decline walking on kinematic and kinetic gait parameters in a healthy population: study protocol for a randomized trial — up and down
The control of the dynamic functional leg alignment (dFLA) and biomechanical load are important joint-related aspects regarding the development of osteoarthritis (OA). Research on level walking with feedback o... (Source: Trials)
Source: Trials - July 22, 2021 Category: General Medicine Authors: Klaus Widhalm, Sebastian Durstberger and Peter Putz Tags: Study protocol Source Type: research

Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University
Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in re... (Source: Trials)
Source: Trials - July 22, 2021 Category: General Medicine Authors: Tonya M. Esterhuizen, Guowei Li, Taryn Young, Jie Zeng, Rhoderick Machekano and Lehana Thabane Tags: Research Source Type: research

Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): study protocol for a randomized non-inferiority trial
Tonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. For decades, tonsillectomy was the surgical treatment of choice for recurrent acute tonsillitis. Tonsillo... (Source: Trials)
Source: Trials - July 22, 2021 Category: General Medicine Authors: Orlando Guntinas-Lichius, Katharina Gei ßler, Thomas Asendorf, Ralf Tostmann and Jan Löhler Tags: Study protocol Source Type: research

Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial
Opposing needling has an obvious curative effect in the treatment of post-stroke hemiplegia; however, the mechanism of the opposing needling in the treatment of post-stroke hemiplegia is still not clear. The p... (Source: Trials)
Source: Trials - July 22, 2021 Category: General Medicine Authors: Mindong Xu, Yinyu Zi, Jianlu Wu, Nenggui Xu, Liming Lu, Jiahui Liu, Yanling Yu, Haofeng Mo, Weifeng Wen, Xiaorong Tang, Wenjuan Fan, Yu Zhang, Churong Liu, Wei Yi and Lin Wang Tags: Study protocol Source Type: research

Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial —AkniPro 2
DiscussionProphylactic parenteral nimodipine treatment may have a positive effect on hearing preservation in VS surgery and would improve patient ’s quality of life. Further secondary analyses are planned. Except for dose-depending hypotension, nimodipine is known as a safe drug. In the future, prophylactic nimodipine treatment may be recommended as a routine medication in VS surgery. VS can be considered as an ideal model for clinical eval uation of neuroprotection, since hearing outcome can be classified by well-recognized criteria. The beneficial effect of nimodipine may be transferable to other surgical procedure...
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial
DiscussionThe study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19.Trial registrationChinese Clinical Trial RegistryChiCTR2000029869. Registered on 15 February 2020 (Source: Trials)
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

A cultural experience to support mental health in people aged 16 –24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial
DiscussionThe COVID-19 pandemic has provided a unique opportunity to design an innovative approach to supporting mental health in young adults. Findings derived from this study will allow us to evaluate the efficacy of this intervention and will inform the design of studies to further refine the resource and test it further.Trial registrationClinicalTrials.gov NCT04663594. Registered on 11 December 2020 (submitted in same form 27 November 2020). Protocol v1.0: 27 November 2020. Date recruitment began: 4 December 2020. Recruitment complete (estimate): February 2021 (Source: Trials)
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set
DiscussionThis protocol outlines the core outcome set development process and its novel application in the setting of genetic testing. This core outcome set will support the standardisation of outcome reporting in reproductive carrier screening research and contribute to an evolving literature on outcomes to evaluate genetic testing and genetic counselling as health interventions.COMET core outcome set registrationhttp://www.comet-initiative.org/Studies/Details/1381. (Source: Trials)
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): study protocol for a randomized non-inferiority trial
DiscussionTOTO is designed to evaluate the effectiveness and efficiency of tonsillectomy versus tonsillectomy for the management of patients with recurrent acute tonsillitis. Tonsil disease and surgery have a major impact on preschool and school children as well as on economically active young adults, with individual and societal costs through loss of school visits, earnings, and productivity. If tonsillotomy is at least as effective as tonsillectomy but with reduced morbidity, this would reduce costs to the healthcare system and society.Trial registrationGerman Clinical Trials RegisterDRKS00020823. Registered on 04 Septem...
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University
DiscussionGuided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January –November 2018 to 2021. We expect that this Mo...
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Effects of real-time feedback during decline walking on kinematic and kinetic gait parameters in a healthy population: study protocol for a randomized trial  — up and down
DiscussionThe findings aim at improving the understanding of the effects of real-time feedback on the control of the dFLA and lower limb loading. Following clinical practicable methods for effective feedback devices can be developed and evaluated. Additionally, the first dataset comparing kinematic and kinetic parameters for decline and incline ramp walking versus walking on an instrumented treadmill will be available for appropriate intervention planning.Trial registrationClinicalTrials.govNCT04763850. Prospectively registered on 21 February 2021. (Source: Trials)
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial
DiscussionThe aim of this trial is to explore the effect of opposing needling on the excitability of M1 of healthy participants and patients with post-stroke hemiplegia.Trial registrationChinese Clinical Trial RegistryChiCTR1900028138. Registered on 13 December 2019. (Source: Trials)
Source: Trials - July 22, 2021 Category: Research Source Type: clinical trials

Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial
Knee osteoarthritis (OA) is a common painful and disabling condition that affects older individuals. Proprioceptive training programs in the form of kinesthesia, balance and agility (KBA) exercises have been r... (Source: Trials)
Source: Trials - July 21, 2021 Category: General Medicine Authors: Aysha I. Adhama, Mukadas O. Akindele and Aminu A. Ibrahim Tags: Study protocol Source Type: research

Feasibility and diagnostic accuracy of Telephone Administration of an adapted wound heaLing QuestiONnaire for assessment for surgical site infection following abdominal surgery in low and middle-income countries (TALON): protocol for a study within a trial (SWAT)
Surgical site infection is the most common complication of abdominal surgery, with a global impact on patients and health systems. There are no tools to identify wound infection that are validated for use in t... (Source: Trials)
Source: Trials - July 21, 2021 Category: General Medicine Tags: Study protocol Source Type: research

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) ... (Source: Trials)
Source: Trials - July 21, 2021 Category: General Medicine Authors: Bassey Edem, Chukwuemeka Onwuchekwa, Oghenebrume Wariri, Esin Nkereuwem, Oluwatosin O. Nkereuwem and Victor Williams Tags: Research Source Type: research

Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial)
Endometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS can be asymptomatic, but it can result in pelvic pain and infertility by inducing local inflammation and pelvic adhesion. The p... (Source: Trials)
Source: Trials - July 21, 2021 Category: General Medicine Authors: Hyunji Lim, Soo Jin Park, Haerin Paik, Jaehee Mun, Eun Ji Lee, Seungmee Lee, Whasun Lim, Gwonhwa Song, Seung-Hyuk Shim, Chae Hyeong Lee, Ga Won Yim and Hee Seung Kim Tags: Study protocol Source Type: research

Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, ... (Source: Trials)
Source: Trials - July 21, 2021 Category: General Medicine Authors: Tara Ballav Adhikari, Dinesh Neupane, Arjun Karki, Arne Drews, Brendan Cooper, Marieann H ögman, Torben Sigsgaard and Per Kallestrup Tags: Study protocol Source Type: research

Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial)
This study is a randomized controlled, non-inferiority trial, where a total of 90 patients with ovarian EMS will be randomly assigned to the experimental (hemostatic agent) and control (suturing) groups. In the control group, a barbed suture will be applied for hemostasis, whereas a hemostatic agent will be applied in the experimental group. If two methods are insufficient, bipolar electrocoagulation will be applied for complete hemostasis. As the primary endpoint, the reduction rate of serum anti- M üllerian hormone (AMH) levels reflecting the ovarian reserve will be compared between the two groups 12 weeks af...
Source: Trials - July 21, 2021 Category: Research Source Type: clinical trials

Feasibility and diagnostic accuracy of Telephone Administration of an adapted wound heaLing QuestiONnaire for assessment for surgical site infection following abdominal surgery in low and middle-income countries (TALON): protocol for a study within a trial (SWAT)
DiscussionMethods to identify surgical site infection after surgery for patients after hospital discharge have the potential to improve patient safety, trial retention, and research efficiency. TALON represents a large, pragmatic, international study co-designed and delivered with LMIC researchers and patients to address an important research gap in global surgery trial methodology. (Source: Trials)
Source: Trials - July 21, 2021 Category: Research Source Type: clinical trials

Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial
DiscussionThe findings of this study may provide evidence on the effectiveness of KBA exercise training  and the ideal number of sessions needed to achieve the highest effectiveness in adults with knee OA.Trial registration Pan African Clinical Trials Registry (PACTR201810713260138). Registered on 28 November 2017. (Source: Trials)
Source: Trials - July 21, 2021 Category: Research Source Type: clinical trials

Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial
This study aims to evaluate the effect of a community-based health educational intervention administered by Female Community Health Volunteers (FCHVs) on the prevention and management of COPD. An open-label, two-group, community-based, cluster-randomized controlled trial will be implemented in the semi-urban area of Pokhara Metropolitan city (former Lekhnath Municipality) located in the Kaski district of Nepal. The estimated sample size of the intervention will be 1143. The unit of randomization is the ward (administrative unit) of the study area. The follow-up survey will be conducted immediately after 12  months o...
Source: Trials - July 21, 2021 Category: Research Source Type: clinical trials

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries
ConclusionDespite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials. (Source: Trials)
Source: Trials - July 21, 2021 Category: Research Source Type: clinical trials

Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial
Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, r... (Source: Trials)
Source: Trials - July 20, 2021 Category: General Medicine Authors: Alexander Ooms, Susan J. Dutton, Scott Parsons, Beth Fordham, Caroline Hing, Sarah Lamb and Toby Smith Tags: Update Source Type: research

Effectiveness of the Elos 2.0 prevention programme for the reduction of problem behaviours and promotion of social skills in schoolchildren: study protocol for a cluster-randomized controlled trial
Early interventions benefit the mental health, academic performance and productivity of children and adolescents throughout their life. The present study protocol will evaluate the effectiveness of the Elos 2.... (Source: Trials)
Source: Trials - July 20, 2021 Category: General Medicine Authors: Mar ília Mariano, Anderson Ribeiro da Silva, Jacqueline L. S. Lima, Nícolas Tenedine de Pinho, Hugo Cogo-Moreira, Márcia H. S. Melo, Jair J. Mari, Zila M. Sanchez and Sheila C. Caetano Tags: Study protocol Source Type: research

Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial
Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal eros... (Source: Trials)
Source: Trials - July 20, 2021 Category: General Medicine Authors: Kristin Helene Skullerud, Petter Gjersvik, Are Hugo Pripp, Erik Qvigstad and Anne Lise Ording Helgesen Tags: Study protocol Source Type: research

Effectiveness of the Elos 2.0 prevention programme for the reduction of problem behaviours and promotion of social skills in schoolchildren: study protocol for a cluster-randomized controlled trial
DiscussionThe current study will examine the effectiveness of the Elos 2.0 Programme in reducing problem behaviours (e.g., disruptiveness, aggressivity and shyness) and promoting social skills in the school context. The findings of this school-based prevention programme for children will influence the development and implementation of similar programmes for schools and educational policymakers by identifying mechanisms that are central to achieving positive outcomes for participants.Trial registrationRegistry of Clinical Trials of the Ministry of HealthRBR-86c6jp. Registered February 2, 2019 (Source: Trials)
Source: Trials - July 20, 2021 Category: Research Source Type: clinical trials

Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial
DiscussionThis paper provides details of the planned statistical analyses for the PEP-TALK trial. This is aimed to reduce the risk of outcome reporting bias and enhance transparency in reporting.Trial registrationInternational Standard Randomised Controlled Trials database, ISRCTN Number:29770908. Registered on October 2018. (Source: Trials)
Source: Trials - July 20, 2021 Category: Research Source Type: clinical trials

Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial
DiscussionThe study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis.Trial registrationClinicalTrials.govNCT0365666. Registered on 4 September 2018. (Source: Trials)
Source: Trials - July 20, 2021 Category: Research Source Type: clinical trials