The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)
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 r...
Source: Trials - April 25, 2024 Category: Research Source Type: clinical trials
Tracing Brain Tumors Through Deep Time
Conditions: Brain Tumor; Oncology Interventions: Diagnostic Test: Imaging with CT and MRI Sponsors: Tata Memorial Centre; Indian Statistical Institute, Kolkata Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 24, 2024 Category: Research Source Type: clinical trials
A methodological review of randomised n-of-1 trials
Conclusionsn-of-1 trials are still underused and the application of the n-of-1 design for the evaluation of health technologies for rare diseases has been particularly limited. We have summarised the characteristics of randomised n-of-1 trials in rare and non-rare conditions. We hope that it can inform researchers in the design of future n-of-1 studies. Further work is required to provide guidance on specific design considerations, implementation, and statistical analysis of these studies.Trial registrationNot applicable. (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)
DiscussionThis trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group.Trial registrationClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023). (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss
ConclusionsThis study will inform the development of best practice guidelines for remote hearing aid fittings. If no clinically significant differences are found between in-clinic and remote fit hearing aids, it has the potential to expand teleaudiology initiatives.Trial registrationAustralian New Zealand Clinical Trial Registry,ACTRN12623000028606p. Date of registration: 12 January 2023. (Source: Trials)
Source: Trials - April 12, 2024 Category: Research Source Type: clinical trials
Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data
Conditions: Total Elbow Replacement Interventions: Device: Total Elbow Replacement Sponsors: University of Manchester; The National Joint Registry; The Royal College of Surgeons of England; John Charnley Trust; University of Bristol Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 9, 2024 Category: Research Source Type: clinical trials
Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial
This study will be a randomized crossover trial. The participants for this study will be recruited from various places, including the University of Hartford, physical therapy clinics, and local businesses in the Hartford area, as well as online websites geared towards clinical trial recruitment. A total of 34 participants will receive all three treatments: active TENS, placebo TENS, and no treatment control. The treatment order will be randomized using a website-based randomization tool. For active TENS, a modulating frequency of 2 –125 Hz will be applied with a variable pulse duration and maximal tolerable intensity fo...
Source: Trials - April 6, 2024 Category: Research Source Type: clinical trials
Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review
ConclusionsThe results of this review indicate that in RCTs that use an ordinal outcome, there is variation in the target parameter and the analytical approaches used, with many dichotomising the ordinal outcome. Few studies provided assurance regarding the appropriateness of the assumptions and methods used to analyse the ordinal outcome. More guidance is needed to improve the transparent reporting of the analysis of ordinal outcomes in future trials. (Source: Trials)
Source: Trials - April 6, 2024 Category: Research Source Type: clinical trials
Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial
DiscussionThe trial will provide evidence from a direct comparison of colchicine and prednisolone regarding their efficacy of pain reduction in acute gout patients of primary care and to indicate possible safety signals.Trial registrationClinicalTrials.gov Identifier: NCT05698680 first posted on January 26, 2023 (retrospectively registered). (Source: Trials)
Source: Trials - April 3, 2024 Category: Research Source Type: clinical trials
Design and evaluation of mobile application for adolescents ’ self-care: protocol for a randomized controlled field trial
This study will be done in three stages: The first stage is the design and evaluation of a mobile application for adolescent self-care. The second stage is, designing and evaluating the psychometric properties of the “Questionnaire for Measuring Adolescent Self-Care Performance.” This questionnaire will be used before and after using the application in the third stage. The third stage is determining the effectiveness of self-care interventions based on mobile applications among adolescents. The target group will be adolescents aged 10–19 from the schools of Amol City. In the first stage, the opinions of 30 people ado...
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
Conditions: Autism Spectrum Disorder; Language Development; Literacy Interventions: Behavioral: Structural vs. Random sequences of stimuli; Behavioral: Intact vs. Degraded speech; Behavioral: Repeating 5-syllable nonwords or 2-syllable nonwords; Behavioral: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data. Sponsors: Northeastern University; University of Delaware; Boston University; Cornell University Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 27, 2024 Category: Research Source Type: clinical trials
Pneumococcal conjugate vaccination schedules in infants —acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study: statistical analysis plan
We describe the approach to analyses and how we will account for the effect of clustering. Defining the SAP prior to the conduct of analysis will avoid bias in analyses that may arise from prior knowledge of trial findings.Trial registrationISRCTN, ISRCTN7282161328. Registered on 28 November 2019.https://www.isrctn.com/ISRCTN72821613.Protocol: MRCG SCC number 1670, LSHTM Ref 17683.Current protocol version: 6.0, 24 May 2021.Version: 1.0 (5 April 2023); SAP revisions —none. (Source: Trials)
Source: Trials - March 26, 2024 Category: Research Source Type: clinical trials
Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
This article presents the statistical analysis plan to evaluate the outcomes of the ACCURE trial.Design and methodsThe ACCURE trial was designed as a multicentre, randomised controlled trial. UC patients with a new diagnosis or a disease relapse within the past 12 months, treated with 5-ASA, corticosteroids, or immunomodulators until complete clinical and endoscopic remission (defined as total Mayo score < 3 with endoscopic subscore of 0 or 1), were counselled for inclusion. Also, patients previously treated with biologicals who had a washout period of at least 3 months were considered for inclusion. Patients we...
Source: Trials - March 26, 2024 Category: Research Source Type: clinical trials
Sacral neuromodulation for constipation and fecal incontinence in children and adolescents – study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique
DiscussionThis is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM).Trial registrationThe study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021). (Source: Trials)
Source: Trials - March 22, 2024 Category: Research Source Type: clinical trials
Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial
This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population.Trial registrationClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
