Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
AbstractBackgroundTimely detection and management of gestational diabetes mellitus (GDM) have been identified as a high priority for policymakers in low- and middle-income countries (LMICs). The GUIDES trial will evaluate a package of three interconnected film-based interventions aimed at improving the timely detection and management of GDM. The protocol for this trial has previously been published; this publication outlines the statistical analysis plan for the trial.Methods and designThe GUIDES study is a multi-country cluster-randomised controlled trial consisting of one trial conducted in Uganda and one in India (30 cl...
Source: Trials - August 12, 2023 Category: Research Source Type: clinical trials
Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial
DiscussionThe MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period.Trial registrationClinicalTrial.govNCT05192629. Registered on 14 January 2022. Protocol version 2.1 (Source: Trials)
Source: Trials - August 11, 2023 Category: Research Source Type: clinical trials
A randomized controlled trial on using predictive algorithm to adapt level of psychological care for community college students: STAND triaging and adapting to level of care study protocol
DiscussionResults will provide a comparison on the traditional symptom severity decision-making and the novel multivariate decision-making with respect to treatment adherence, symptom improvement, and functional recovery. Moreover, the developed multivariate decision-making algorithms may be used as a template in other community college settings. Ultimately, findings will inform the practice of level of care triage and adaptation in psychological treatments, as well as the use of personalized mental health care broadly.Trial registrationClinicalTrials.gov NCT05591937, submitted August 2022, published October 2022. (Source: Trials)
Source: Trials - August 9, 2023 Category: Research Source Type: clinical trials
Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder
First positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years
Statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 7, 2023 Category: Pharmaceuticals Source Type: clinical trials
Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial
We present an RCT design comparing FCA vs PRC for SLAC/SNAC-induced OA. The results of this trial will assist in decision making when planning surgery for SLAC/SNAC.Trial registrationClinicalTrials.govNCT04260165. Registered February 7, 2020. (Source: Trials)
Source: Trials - August 7, 2023 Category: Research Source Type: clinical trials
Correction: OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain —a statistical analysis plan
(Source: Trials)
Source: Trials - July 27, 2023 Category: Research Source Type: clinical trials
The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)
DiscussionThe UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results.Trial registrationClinicalTrials.govNCT04663828. The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis. (Source: Trials)
Source: Trials - July 24, 2023 Category: Research Source Type: clinical trials
Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India ’s public education system and impact on numeracy and literacy scores (STRIPES2)
DiscussionThis update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial.Trial registrationRegistry of India: CTRI/2019/05/019296. Registered on 23 May 2019.http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27 (Source: Trials)
Source: Trials - July 22, 2023 Category: Research Source Type: clinical trials
Statistical Analysis Plan for the SANO-trial: Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Active Surveillance for Oesophageal Cancer
Conditions: Esophageal Cancer; Active Surveillance; Neoadjuvant Chemoradiotherapy; Surgical Oncology Intervention: Procedure: Active surveillance Sponsor: Erasmus Medical Center Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 20, 2023 Category: Research Source Type: clinical trials
