Protocol For Randomised Trial Research Articles

Explanation for substandard of care comparators in rheumatology randomised trial protocols

Explanation for substandard of care comparators in rheumatology randomised trial protocols

Photobiomodulation therapy to prevent oral mucositis and functional impairment in adult patients with haematological cancer undergoing haematopoietic stem cell transplantation: randomised trial protocol

IntroductionOral mucositis is a highly prevalent condition in individuals treated for haematological neoplasms, primarily during haematopoietic stem cell transplantation (HSCT). The condition is known to delay recovery processes, increasing the...

“We are an active family”: a randomized trial protocol to evaluate a family-system social identity intervention to promote child physical activity

BackgroundRegular engagement in moderate-to-vigorous physical activity (MVPA) during childhood yields a myriad of health benefits, and contributes to sustained MVPA behaviors into adulthood. Given the influence of parents on shaping their child’s MVPA behaviour, the family system represents a viable target for intervention. The purpose of this study is to compare the effects of two intervention conditions designed to increase child MVPA: (1) A standard education + planning intervention providing information about benefits, action planning, and coping planning; and (2) An augmented physical activity education + planning intervention that includes the components of the standard intervention, as well as a focus on family identity promotion and developing as an active member of the family.MethodsA two-arm parallel single-blinded randomized trial will compare the two conditions over 6 months. Eligible families have at least one child aged 6–12 years who is not meeting the physical activity recommendations within the Canadian 24-Hour Movement Guidelines (i.e.,<60 min/day of MVPA). Intervention materials targeting family identity promotion will be delivered online via zoom following baseline assessment, with booster sessions at 6-weeks and 3-months. Child MVPA will be measured by wGT3X-BT Actigraph accelerometry at baseline, 6-weeks, 3-months, and 6-months as the primary outcome. At these same time points, parent cognition (e.g., attitudes, perceived control, behavioral regulation, habit, identity) and support behaviours, and parent-child co-activity will be assessed via questionnaire as secondary outcomes. Child-health fitness measures will be also administered through fitness testing at baseline and 6-months as secondary outcomes. Finally, upon completion of the trial’s 6-month measures, a follow-up end-of-trial interview will be conducted with parents to examine parents’ experiences with the intervention.ResultsSo far, 30 families have been enrolled from the Southern Vancouver Island and Vancouver Lower Mainland area. Recruitment will be continuing through 2026 with a target of 148 families.DiscussionThis study will contribute to the understanding of effective strategies to increase child physical activity by comparing two intervention approaches. Both provide parents with education on physical activity benefits, action planning, and coping planning supports. However, one intervention also incorporates components focused on promoting an active family identity and involving all family members in physical activity together. The findings from this study have the potential to inform the design and implementation of public health initiatives aimed at improving physical activity participation in children and guide the development of more effective interventions that leverage the crucial role of parents and the family system in shaping children’s physical activity behaviors.Trial RegistrationThe clinical trial registration ID is NCT05794789. This trial was registered with clinicaltrials.gov on March 2nd, 2023, with the last updated release on September 28th, 2023.

Newborn community health advancements among Ethiopian Orthodox Christian women in North Gondar, Ethiopia: community-based randomised trial protocol

IntroductionDespite significant progress over past decades, neonatal and infant morbidity and mortality remain unacceptably high in Ethiopia. Simple interventions have been shown to improve the health of children and reduce...

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial

BackgroundEndoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), plastic stents may resolve non-necrotic fluid collections effectively with lower costs and no LAMS-specific adverse events. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.MethodsThe WONDER-02 trial is a multicentre, open-label, non-inferiority, randomised controlled trial, which will enrol pancreatic pseudocyst patients requiring EUS-guided treatment in 26 centres in Japan. This trial plans to enrol 80 patients who will be randomised at a 1:1 ratio to receive either plastic stents or a LAMS (40 patients per arm). In the plastic stent group, EUS-guided drainage will be performed using two 7-Fr double pigtail stents. In the LAMS group, the treatment will be performed in the same way except for LAMS use. The step-up treatment will be performed via endoscopic and/or percutaneous procedures at the trial investigator’s discretion. The primary endpoint is clinical success, which is defined as a decrease in a pseudocyst size to ≤ 2 cm and an improvement in inflammatory indicators (i.e. body temperature, white blood cell count, and serum C-reactive protein). Secondary endpoints include technical success, adverse events including mortality, pseudocyst recurrence, and medical costs.DiscussionThe WONDER-02 trial will investigate the efficacy and safety of plastic stents compared to a LAMS in EUS-guided treatment of symptomatic pancreatic pseudocysts with a particular focus on the non-inferior efficacy of plastic stents. The findings will help establish a new treatment algorithm for this population.Trial registrationClinicalTrials.gov NCT06133023 registered on 9 November 2023. UMIN000052647 registered on 30 October 2023. jRCT1032230444 registered on 7 November 2023.

Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol

IntroductionRecurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue...

ENhancinG vAGinal dElivery in Greece through educational and behavioral interventions among maternity care providers regarding labor management: the ENGAGE stepped-wedge randomized prospective trial protocol

BackgroundThere is an emerging need to systematically investigate the causes for the increased cesarean section rates in Greece and undertake interventions so as to substantially reduce its rates. To this end, the ability of the participating Greek obstetricians to follow evidence-based guidelines and respond to other educational and behavioral interventions while managing labor will be explored, along with barriers and enablers. Herein discussed is the protocol of a stepped-wedge designed intervention trial in Greek maternity units with the aforementioned goals in mind, named ENGAGE (ENhancinG vAGinal dElivery in Greece).MethodsTwenty-two selected maternity units in Greece will participate in a multicenter stepped-wedge randomized prospective trial involving 20,000 to 25,000 births, with two of them entering the intervention period of the study each month (stepped randomization). The maternity care units entering the study will apply the suggested interventions for a period of 8–18 months depending on the time they enter the intervention stage of the study. There will also be an initial phase of the study lasting from 8 to 18 months including observation and recording of the routine practice (cesarean section, vaginal birth, and maternal and perinatal morbidity and mortality) in the participating units. The second phase, the intervention period, will include such interventions as the application of the HSOG (the Hellenic Society of Obstetrics and Gynecology) Guidelines on labor management, training on the correct interpretation of cardiotocography, and dealing with emergencies in vaginal deliveries, while the steering committee members will be available to discuss and implement organizational and behavioral changes, answer questions, clarify relevant issues, and provide practical instructions to the participating healthcare professionals during regular visits or video conferences. Furthermore, during the study, the results will be available for the participating units in order for them to monitor their own performance while also receiving feedback regarding their rates. Τhe final 2-month phase of the study will be devoted to completing follow-up questionnaires with data concerning maternal and neonatal morbidities that occurred after the completion of the intervention period. The total duration of the study is estimated at 28 months. The primary outcome assessed will be the cesarean section rate change and the secondary outcomes will be maternal and neonatal morbidity and mortality.DiscussionThe study is expected to yield new information on the effects, advantages, possibilities, and challenges of consistent clinical engagement and implementation of behavioral, educational, and organizational interventions described in detail in the protocol on cesarean section practice in Greece. The results may lead to new insights into means of improving the quality of maternal and neonatal care, particularly since this represents a shared effort to reduce the high cesarean section rates in Greece and, moreover, points the way to their reduction in other countries.Trial registrationNCT 04504500 (ClinicalTrials.gov). The trial was prospectively registered.Ethics Reference No: 320/23.6.2020, Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece

Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol

BackgroundSymptoms reported by patients who sustain a concussion are non-specific. As such, clinicians are better able to manage patients when a standardized clinical exam is performed to sub-type the driver(s) of symptoms. Aerobic exercise and multimodal rehabilitation have consistently shown to be a possibly effective means to manage this population; however, the optimal training prescription is unclear. Thus, there is a need to further examine the effectiveness of personalized rehabilitative treatments. Our primary aim is to evaluate the response to personalized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) when compared to an active control.MethodsWe will conduct a multi-center 12-week case-crossover randomized controlled trial. 50 participants will be recruited from out-patient University Health Network clinics and community-based clinical practices around the greater Toronto area. Participants will be randomized at baseline to Group A: a personalized care program followed by an active control or Group B: an active control followed by a personalized care program. Participants will be included should they be 21 years of age and older and have symptoms that have persisted beyond 4 weeks but less than 1 year. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6 weeks. At the end of 12 weeks, participants will undertake the endpoint examinations. The primary outcome will be the Rivermead Postconcussion Questionnaire (RPQ). The secondary outcomes will be changes in standardized clinical examination, Neck Disability Index (NDI), Patient Health Questionnaire (PHQ-9) and an electroencephalography (EEG) via NeuroCatch™. The statistical analysis to be performed is composed of an adjusted model using an analysis of variance, specifically using an unpaired t-test to test for associations between variables and outcomes.DiscussionGiven the recommendations from reviews on the topic of rehabilitation for adults with persistent concussion symptoms, we are undertaking a controlled trial. The documented high costs for patients seeking care for persistent symptoms necessitate the need to evaluate the effectiveness of a personalized rehabilitative program compared to the current standard of care.Trial registrationClinicalTrials.gov ID: NCT06069700.

Community health promotion and medical provision and impact on neonates (CHAMPION2) and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2): an update to the study protocol (v 11) for a cluster randomised trial in Madhya Pradesh, India

BackgroundThis update outlines amendments to the CHAMPION2/STRIPES2 cluster randomised trial protocol primarily made due to the COVID-19 pandemic and nationwide lockdown in India in 2020. These amendments were in line with national guidelines for health research during the COVID-19 pandemic.MethodsWe did not change the original trial design, eligibility, and outcomes. Amendments were introduced to minimise the risk of COVID-19 transmission and ensure safety and wellbeing of trial staff, participants, and other villagers. CHAMPION2 intervention: participatory learning and action (PLA) and fixed day service (FDS) meeting were revised to incorporate social distancing and hygiene precautions. During the COVID-19 pandemic, PLA participation was limited to pregnant women and birthing partners. STRIPES2 intervention: before/after-school classes were halted for a period and then modified temporarily (reducing class sizes, and/or changing meeting places) with hygiene and safe distancing practices introduced. Data collection: The research team gathered as much information as possible from participants by telephone. If the participant had no telephone or could not be contacted by telephone, data were collected in person. COVID-19 precautions: trial teams were trained on COVID-19 precautions and used personal protective equipment whilst in the villages for trial-related activities.After restarting the trial between June and September 2020 in a phased manner, some trial activities were suspended again in all the trial villages from April to June 2021 due to the second wave of COVID-19 cases and lockdown imposed in Satna, Madhya Pradesh. Trial timelines were also revised, with outcomes measured later than originally planned.Trial registrationClinical Trial Registry of India CTRI/2019/05/019296. Registered 23 May 2019.https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.

Adolescent idiopathic scoliosis: a prospective randomised trial protocol comparing clinical and radiological outcomes in minimally invasive surgery versus standard posterior spinal fusion in a single-centre, the Rizzoli Orthopaedic Institute, Bologna, Italy

IntroductionMinimally invasive spine surgery (MISS) has been shown to be safe and effective in adolescent idiopathic scoliosis (AIS) correction, even though there is no consensus on which treatment provides the...

Enhancing reporting through structure: a before and after study on the effectiveness of SPIRIT-based templates to improve the completeness of reporting of randomized controlled trial protocols

BackgroundDespite the improvements in the completeness of reporting of randomized trial protocols after the publication of the Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) guidelines, many items remain poorly reported. This study aimed to assess the effectiveness of using SPIRIT-tailored templates for trial protocols to improve the completeness of reporting of the protocols that master’s students write as part of their master’s theses.MethodsBefore and after experimental study performed at the University Master’s Degree in Orthopaedic Manual Physiotherapy of the Universitat Internacional de Catalunya (Barcelona, Spain). While students in the post-intervention period were instructed to use a trial protocol template that was tailored to SPIRIT, students in the pre-intervention period did not use the template. Primary outcome: Difference between the pre- and post-intervention periods in the mean number of adequately reported items (0–10 scale). The outcomes were evaluated independently and in duplicate by two blinded assessors. Students and their supervisors were not aware that they were part of a research project. For the statistical analysis, we used a generalized linear regression model (dependent variable: number of adequately reported items in the protocol; independent variables: intervention period, call, language).ResultsThirty-four trial protocols were included (17, pre-intervention; 17, post-intervention). Protocols produced during the post-intervention period (mean: 8.24; SD: 1.52) were more completely reported than those produced during the pre-intervention period (mean: 6.35; SD: 1.80); adjusted difference: 1.79 (95% CI: 0.58 to 3.00).ConclusionsSPIRIT-based templates could be used to improve the completeness of reporting of randomized trial protocols.

Status-neutral community-based multilevel intervention to address intersectional stigma and discrimination, and increase HIV testing, PrEP, and ART uptake among YGBMSM in Ghanaian Slums: A clustered randomized control trial protocol.

While GBMSM constitute less than 2% of Ghana's population, their HIV prevalence surpasses the national average by more than eightfold, emphasizing the critical need for targeted interventions to improve detection, care linkage, and reduce community transmission. This study seeks to increase HIV testing, Pre-Exposure Prophylaxis (PrEP), and Antiretroviral Therapy (ART) uptake (HPART) among YGBMSM through the adaptation of an evidence-based intervention (LAFIYA). We will employ the ADAPTT-IT framework to adapt LAFIYA and evaluate its feasibility and effectiveness in addressing intersectional stigma and increasing HPART uptake among YGBMSM residing in Ghanaian slums. In aim 1, we will hold focus groups (n=5) and interviews (n=20) among YGBMSM and two FGDs among GBMSM-led organizations. At the HCF level, we will hold 6 FGDs and interviews (n=20) among nurses. In AIM 2, we will randomly assign 6 healthcare facilities (HCFs) to receive the LAFIYA (n=3) or wait-list control (n=3). Friend groups (cluster) of YGBMSM (N=240) will be assigned to receive LAFIYA (n=120) or a wait-list control (n=120). We will collect 3-, 6-, and 9-months post-intervention data among YGBMSM(n=240) and HCWs(n=300) to measure HPART adherence (primary outcomes), ISD reduction, HIV and status-neutral knowledge (secondary outcomes), and intervention acceptability, appropriateness, and feasibility (implementation outcomes). The intervention group will observe increased HPART adherence, reduced ISD, and enhanced HPART knowledge and efficacy relative to the wait-list control group. The findings will inform ISD reduction and HIV status-neutral implementation strategies - and place-based interventions that address access to HIV prevention and care among YGBMSM, slum and in different settings. This study was registered on clinicalTrail.gov, with identifier number NCT06312514 on 03/14/2023. https://classic.clinicaltrials.gov/ct2/show/NCT06312514.

Cognitive training via mobile app for addressing eating disorders’ cognitions in adolescents: a randomized control trial protocol

During adolescence, individuals are particularly vulnerable to developing eating disorders (EDs). To address the dysfunctional beliefs linked to these disorders, a new mobile app has been developed. This app, called GG eating disorders-Adolescents (GGED-AD), was created based on CBT to help adolescents work on their self-dialogue related to the core beliefs of eating disorders. The objective is to present the protocol for a randomized controlled trial to explore the efficacy of GGED-AD.Methods The study will be carried out in adolescents aged 13 to 16 from an educational center in the Valencian Community. The participants will be randomized into two groups: the experimental group will use the GGED-AD app during 14 consecutive days for approximately 5 min each day; and the control group will use a neutral app (GGNEUTRAL) during the same time. Both groups will complete instruments that assess dysfunctional beliefs related to eating disorders, eating symptoms, symptoms of depression and anxiety, body satisfaction and self-esteem before and after the intervention. A follow-up will be conducted one month later.Results A decrease in the degree of ascription to dysfunctional beliefs associated with eating disorders and eating symptomatology is expected, as well as an increase in body satisfaction and the self-esteem of the participants of the experimental group.Discussion The app in this study could help tackle and prevent ED-related symptoms in adolescents.Trial registration NCT06039514.

Effectiveness of School-based Substance abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills among adolescents in selected public schools of Pokhara, Nepal–A cluster randomized trial protocol

ObjectiveEarly substance use has been linked to various adverse outcomes and escalates quickly during adolescence. Delaying the onset of substance use among adolescents is a primary public priority as it is associated with severe effects. The objective of the study is to develop and determine the effectiveness of a School-based Substance Abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards preventing substance abuse among adolescents. MethodPhase I of the study is a qualitative approach, where a focus group discussion (FGD) will be conducted among different stakeholders to explore their perceptions regarding the prevention of substance use among adolescents. The anticipated sample size is 38. Thematic analysis will be done by using ATLAS.ti software. The inputs given by the stakeholders will be incorporated in developing the intervention (SSPP). Phase II is a cluster randomized controlled trial. A minimum of 210 adolescents (105 each in the intervention and control groups) between the age group of 13 to 15 years from 8th and 9th grade will be recruited for the study. In this study, the school will be the cluster and will be randomly assigned either to an intervention or control arm. The data will be collected at pre, post, 3-month, and 6-month intervals. The ethical approval was obtained from the Nepal Health Research Council Committee, Nepal (NHRC 276/2023). The trial was also registered under the Clinical Trial Registry of USA-Clinical Trials.gov (CTRI 06004726/2023/08/22/). Descriptive and inferential statistics will be used to analyze the data. Expected resultsImplementation of the SSPP module will improve the awareness, attitude, peer pressure, and life skills of adolescents toward preventing substance use behavior. Overall, the study aims to achieve Sustainable Development Goal (SDG) 3.5- ‘Good Health and Well-being; strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol.’ ConclusionThe present study protocol will help to develop a unique training module (SSPP) focused on preventing substance use behaviour among adolescents in Nepal.

The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)

BackgroundAllergic rhinitis is a chronic respiratory disorder that significantly impacts patients’ quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient education and pharmaceutical care for managing allergic rhinitis patients. However, local clinical practice guidelines, particularly regarding pharmaceutical care in public healthcare institutions, are lacking. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm.MethodThis is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value < 0.05 is considered statistically significant.DiscussionThis study protocol will provide a framework for conducting a randomized controlled trial (RCT) to evaluate the effectiveness of pharmacist-led education intervention in managing allergic rhinitis within public healthcare settings. The parameters measured in this trial will quantify outcomes associated with improvements in symptoms and QoL. By systematically assessing these outcomes, we aim to contribute valuable insights into the role of pharmacist-led interventions in enhancing the management of allergic rhinitis in public healthcare settings.Trial registrationClinicalTrials.gov NCT06027736. Registered on 9 July 2023—retrospectively registered.

Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol.

Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group. The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets; completes consult, including priorities for improving prescribing negotiated with the patient; starts the care plan; ensures a detailed discharge medication reconciliation and circle-of-care communication; and sees the patient at least twice after hospital discharge via virtual visits to consolidate the care plan in the community. Control group receives usual care. Primary outcomes are feasibility - recruitment, retention, costs, and clinical - number of drug therapy problems improved, with secondary outcomes examining coordination of transitions in care, quality of life, and healthcare utilization and costs. Follow-up is to 3-month posthospital discharge. If results support feasibility of ramp-up and promising clinical outcomes, a follow-up definitive trial will be organized using a developing national platform and medication appropriateness network. Since the intervention allows a very scarce medical specialty expertise to be offered via virtual care, there is potential to improve the safety, outcomes, and cost of care widely. ClinicalTrials.gov identifier: NCT04077281.

Contralateral acupuncture for migraine without aura: a randomized trial protocol with multimodal MRI.

Migraine is a common clinical disorder, ranks as the second most disabling disease worldwide, and often manifests with unilateral onset. Contralateral acupuncture (CAT), as a classical acupuncture method, has been proven to be effective in the treatment of migraine without aura (MWoA). However, its neural mechanisms have not been investigated using multimodal magnetic resonance imaging (MRI). In this multimodal neuroimaging randomized trial, a total of 96 female MWoA participants and 30 female healthy controls (HCs) will be recruited. The 96 female MWoA participants will be randomized into three groups: Group A (CAT group), Group B [ipsilateral acupuncture (IAT) group], and Group C (sham CAT group) in a 1:1:1 allocation ratio. Each group will receive 30 min of treatment every other day, three times a week, for 8 weeks, followed by an 8-week follow-up period. The primary outcome is the intensity of the migraine attack. Data will be collected at baseline (week 0), at the end of the 8-week treatment period (weeks 1-8), and during the 8-week follow-up (weeks 9-16). Adverse events will be recorded. Multimodal MRI scans will be conducted at baseline and after 8-week treatment. This study hypothesized that CAT may treat MWoA by restoring pathological alterations in brain neural activity, particularly by restoring cross-integrated functional connectivity with periaqueductal gray (PAG) as the core pathological brain region. The findings will provide scientific evidence for CAT in the treatment of MWoA. The Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine has given study approval (approval no. 2022-006). This trial has been registered with the Chinese Clinical Trials Registry (registration no. ChiCTR2300069456). Peer-reviewed papers will be used to publicize the trial's findings. https://clinicaltrials.gov/, identifier ChiCTR2300069456.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

IntroductionSeasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission....

Comparing blastocyst euploid rates between the progestin-primed and gonadotrophin-releasing hormone antagonist protocols in aneuploidy genetic testing: a randomised trial protocol

IntroductionProgestin can inhibit the pituitary luteinising hormone (LH) surge during ovarian stimulation for in vitro fertilisation (IVF) and studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH...

Effects of cannabidiol on psychosocial stress, situational anxiety and nausea in a virtual reality environment: a protocol for a single-centre randomised clinical trial

IntroductionThe non-intoxicating plant-derived cannabinoid, cannabidiol (CBD), has demonstrated therapeutic potential in a number of clinical conditions. Most successful clinical trials have used relatively high (≥300 mg) oral doses of CBD....