Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in patients with cystic fibrosis: the study protocol for a randomized controlled trial
DiscussionDue to persistent fat-soluble vitamin deficiency in CF disease, the nanomicelle formulation could be proposed as a new delivery method of fat-soluble vitamins in the treatment of cystic fibrosis.Trial registrationIranian Registry of Clinical Trials IRCT20220415054541N1. Registered on July 23, 2022. (Source: Trials)
Source: Trials - January 16, 2024 Category: Research Source Type: clinical trials
Efficacy of navigation system-assisted distraction osteogenesis for hemifacial microsomia based on artificial intelligence for 3 to 18 years old: study protocol for a randomized controlled single-blind trial
This study aims to clarify the effect of the EM navigation system in improving the MDO accuracy for hemifacial microsomia patients.MethodsThis study is designed as a single-centered and randomized controlled trial. Altogether, 22 hemifacial microsomia patients are randomly assigned to the experiment and control groups. All patients receive three-dimensional CT scans and preoperative surgical plans. The EM navigation system will be set up for those in the experiment group, and the control group will undergo traditional surgery. The primary outcome is the surgical precision by comparing the osteotomy position of pre- and pos...
Source: Trials - January 12, 2024 Category: Research Source Type: clinical trials
Ultrasound Guided Hematoma Block in Distal Radius Fractures
Conditions: Distal Radius Fractures; Fracture Dislocation; Dislocated Wrist; Dislocated Radius Interventions: Device: Ultrasound guided hematoma block.; Procedure: Blind hematoma block Sponsors: Medical Centre Leeuwarden Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 5, 2024 Category: Research Source Type: clinical trials
Comparison of the effects of esketamine, sufentanil, or lidocaine combined with propofol on tussis reflection during upper gastrointestinal endoscopy: study protocol for a randomised, two centre, three-blind, controlled trial
DiscussionEsketamine can reduce tussis occurrence with good tolerability and relax the bronchus and also provides high clearance rates and low possibility of adverse reactions. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to upper GI procedure is nevertheless superior to only administration of propofol or a combination of propofol with other anaesthetics, such as opioids or lidocaine.Trial registrationClinicalTrials.gov.NCT05497492, Registered 09 August 2022. (Source: Trials)
Source: Trials - January 4, 2024 Category: Research Source Type: clinical trials
Effects of individualized positive end-expiratory pressure on intraoperative oxygenation in thoracic surgical patients: study protocol for a prospective randomized controlled trial
This study is a prospective, randomized controlled, single-blind, single-center trial. A total of 112 patients undergoing thoracoscopic pneumonectomy surgery and OLV will be enrolled in the study. They will be randomized into two groups: the static lung compliance guided iPEEP titration group (Cst-iPEEP Group) and the constant 5 cmH2O PEEP group (PEEP 5 Group). The primary outcome will be the oxygenation index at 30 min after OLV and titration. Secondary outcomes are oxygenation index at other operative time points, PPCs, postoperative adverse events, ventilator parameters, vital signs, pH value, inflammatory factors, and ...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen ’s hernia: a study protocol for a multicenter randomized controlled trial
This study aims to compare the incidence of bowel obstruction above Clavien–Dindo classification grade III due to Petersen’s hernia between the mesenteric fixation method and the conventional methods after laparoscopic or robotic gastrectomy.MethodsThis study was designed as prospective, single-blind, non-inferiority randomized controlled multicenter trial in Korea. Patients with histologically diagnosed gastric cancer of clinical stages I, II, or III who underwent B-II or REY anastomosis after laparoscopic or robotic gastrectomy are enrolled in this study. Participants who meet the inclusion criteria are randomly assi...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Sight and Hearing Investigation Into Effects on Delirium
Conditions: Hearing Loss; Hearing Loss, Age-Related; Hearing Disability; Delirium; Delirium in Old Age; Delirium of Mixed Origin; Delirium With Dementia; Delirium on Emergence; Delirium, Cause Unknown; Delirium Superimposed on Dementia; Delirium Confusional State; Delirium;Non Alcoholic; Hearing Loss, Bilateral; Hearing Loss, Sensorineural; Hearing Loss, Functional; Hearing Loss, High-Frequency; Hearing Interventions: Behavioral: Communication Signage; Behavioral: Communication Signage& Amplifier Use Sponsors: Johns Hopkins University; National Institute on Aging (NIA) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 20, 2023 Category: Research Source Type: clinical trials
REtinal Detachment Outcomes Study (REDOS): study protocol for a factorial, randomized controlled trial
DiscussionThis will be the first 2 × 2 factorial RCT examining repair techniques in primary RRD. It will also be the first RCT to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel asp ect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina’s recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence g...
Source: Trials - December 20, 2023 Category: Research Source Type: clinical trials
Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial
DiscussionThe benefit-risk of OFA for patients after operation is contradictory in previous studies, so further study is required. This trial will focus on the effect of OFA on the incidence of PONV in patients undergoing thoracoscopic surgery. This trial adopts uniformed PONV and perioperative pain management, standardised randomised and blind, clear-cut inclusion and exclusion criteria, and standardised scales to assess the severity of PONV after surgery, the quality of postoperative recovery, and the health status at 6 months. The findings of this study will help to provide references to promote early recovery of pati...
Source: Trials - December 20, 2023 Category: Research Source Type: clinical trials
A protocol for a single center, randomized, controlled trial comparing the clinical efficacy of 3% diquafosol and 0.1% hyaluronic acid in diabetic patients with dry eye disease
This study will be a standardized, scientific, clinical trial designed to evaluate the therapeutic effects and safety of DQS and HA for diabetic dry eye treatment.Trial registrationClinicalTrials.govNCT05682547. Registered on December 05, 2022. (Source: Trials)
Source: Trials - December 12, 2023 Category: Research Source Type: clinical trials
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Conditions: Meningococcal Immunization Interventions: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).; Biological: Meningococcal Group C-CRM197 Conjugate Vaccine Sponsors: Sanofi Pasteur, a Sanofi Company Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials
Protecting the Eyes of Gamers With Lubricating Eyedrops
Conditions: Dry Eye Syndromes; Computer Vision Syndrome Interventions: Drug: TheaLoz Duo Eyedrop; Drug: Saline Eyedrop Sponsors: Aston University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials
Treating Amblyopia With SureSight
Conditions: Amblyopia Interventions: Device: CureSight Sponsors: Alaska Blind Child Discovery Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials
Single-blind RCT Comparing Smartphone vs. Paper-based HEP in Pelvic Floor PT
Conditions: Pelvic Floor Muscle Weakness Interventions: Behavioral: A smartphone based application free to download from the google play and iphone store to provide auditory and visual cues and counting for number of perscribed pelvic floor muscle contractions; Behavioral: Paper-based home exercise program for pelvic floor muscle exercise Sponsors: University of Central Arkansas Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 8, 2023 Category: Research Source Type: clinical trials
Clinical and cost-effectiveness of ‘Live Well with Parkinson’s’ self-management intervention versus treatment as usual for improving quality of life for people with Parkinson’s: study protocol for a randomised controlled trial
DiscussionIf successful, the Live Well with Parkinson ’s Toolkit could be used as a model for other complex long-term disorders, including dementia. This would bridge existing gaps in the NHS (as shown by the national Parkinson’s audit data), by enabling patients and carers to access personalised information, advice and support on symptom managemen t and ‘living well’ with Parkinson’s.Trial registrationISRCTN92831552. Registered on 26th Oct 2021. (Source: Trials)
Source: Trials - December 5, 2023 Category: Research Source Type: clinical trials
