Development of an international core outcome set for treatment trials in necrotizing enterocolitis —a study protocol
ConclusionsDevelopment of an international COS will help to improve homogeneity of outcome measure reporting in NEC, will enable adequate and efficient comparison of treatment strategies, and will help the interpretation and implementation of clinical trial results. This will contribute to high-quality evidence regarding the best treatment strategy for NEC in preterm infants. (Source: Trials)
Source: Trials - May 31, 2023 Category: Research Source Type: clinical trials
Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: study protocol for a randomized controlled trial
This study is a single-center, randomized, parallel-controlled, superiority trial with a 1:1 allocation ratio. Sixty patients whose age is between 18 and 65 years and scheduled for gynecological laparoscopic surgery will be randomized to the cuff pressure measurement and adjustment (CPMA) group and the only cuff pressure measurement without adjustment group (control group). The primary endpoint is the incidence of sore throat at rest within 24 h afte r extubation. The secondary endpoints include the incidence of cough, the incidence of hoarseness, the incidence of postoperative nausea and vomiting (PONV), POST, and pain...
Source: Trials - May 27, 2023 Category: Research Source Type: clinical trials
Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial
DiscussionThe FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery.Trial registrationClinicalTrials.gov NCT04223739. Registered on January 10, 2020. (Source: Trials)
Source: Trials - May 25, 2023 Category: Research Source Type: clinical trials
The effects of an e-health brisk walking intervention in increasing moderate-to-vigorous physical activity in physically inactive older people with cognitive frailty: study protocol for a randomized controlled trial
This study employs a single-blinded, two-parallel-group, non-inferiority, randomized controlled trial design with a 1:1 group allocation ratio. Eligible participants are aged 60 years or above, have cognitive frailty and physical inactivity, and possess a smartphone for more than six months. The study will be conducted in community settings. In the intervention group, participants will receive a 2-week brisk-walking training followed by a 12-week e-health intervention. In the control group, participants will receive a 2-week brisk-walking training followed by a 12-week conventional behavioural change intervention. The pr...
Source: Trials - May 17, 2023 Category: Research Source Type: clinical trials
Establishing the safety of selective digestive decontamination within the ICU population: a bridge too far?
ConclusionThe basis for the mortality difference between control and intervention groups of SDD studies remains unclear. Several paradoxical results are consistent with a spillover effect that would conflate the inference of benefit originating from RCCTs. Moreover, this spillover effect would constitute to herd peril. (Source: Trials)
Source: Trials - May 17, 2023 Category: Research Source Type: clinical trials
EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus ® versus Advagraf™ in liver transplant recipients
DiscussionC/D ratio is an estimate for tacrolimus bioavailability. Improving bioavailability and increasing C/D ratio using Envarsus could reduce renal dysfunction and other tacrolimus-related toxicities; previous trials have shown that a higher C/D ratio (i.e. slower tacrolimus metabolism) is not only associated with improved renal function but also linked to reduced neurotoxic side effects. A higher C/D ratio could improve clinical outcomes for LTx recipients; EnGraft has begun, with one third of patients recruited by January 2022.Trial registrationThis trial has been registered (4 May 2020) in the EU Clinical Trials Reg...
Source: Trials - May 11, 2023 Category: Research Source Type: clinical trials
Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial
This study protocol received ethical approval from the research ethics committee of Kashima Hospital, Fukushima, Japan (reference number: 2022002).DiscussionThis article describes the design of a cluster RCT that will evaluate the effects of FEEDBACK, a personalised, multicomponent intervention aimed at enhancing doctor-patient partnership to engage adults with T2DM more effectively in self-management behaviour.Trial registrationThe study protocol was prospectively registered in the UMIN Clinical Trials Registry (UMIN-CTR ID UMIN000049643 assigned on 29/11/2022). On submission of this manuscript, recruitment of participant...
Source: Trials - May 8, 2023 Category: Research Source Type: clinical trials
The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for multicenter randomized blinded controlled trial
This study is a multicenter randomized controlled trial comparing the influence of shunting left or right portal vein branch on post-TIPS hepatic encephalopathy for preventing rebleeding from GOV in patients with HBV-related cirrhosis. A total of 130 patients will be recruited over a period of 24 months across 5 centers in China. Eligible patients will be stratified 1:1 to constructing either a left or right portal vein shunt with an 8-mm Viatorr stent. The primary objective was to compare the incidence of post-TIPS hepatic encephalopathy between the two groups. The secondary objectives were to compare the grade and durati...
Source: Trials - May 6, 2023 Category: Research Source Type: clinical trials
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure
ConclusionThe PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials. (Source: Trials)
Source: Trials - May 2, 2023 Category: Research Source Type: clinical trials
Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol
The objective of this follow-up study is to assess 2-year neurodevelopmental and growth outcomes after exposure of preterm infants to the smell and taste of milk with tube feeding compared to routine care.MethodsThis is a neurodevelopmental follow-up study of a two-center, placebo-controlled randomized trial. Infants born before 29 weeks postmenstrual age and/or with a birth weight of less than 1250 g were randomized to smell and taste of milk with each tube feed or routine care. The current follow-up assessed the 2-year neurodevelopmental and growth outcomes of participants of the TASTE trial discharged from the hospit...
Source: Trials - April 22, 2023 Category: Research Source Type: clinical trials
Postoperative awake prone position in geriatric patients with hip fractures: a protocol for a randomized controlled trial on the efficacy of postoperative prone position in reducing pulmonary complications and improving oxygenation
We describe the protocol for a single-center RCT that will evaluate the efficacy of postoperative APP treatment in reducing pulmonary complications and improving oxygenation in geriatric patients with hip fractures.Ethics and disseminationThis protocol was approved by the independent ethics committee (IEC) for Clinical Research of Zhongda Hospital, Affiliated to Southeast University, and is registered on the Chinese Clinical Trial Registry. The findings of the trial will be disseminated through peer-reviewed journals.Ethics approval number2021ZDSYLL203-P01Trial registrationChiCTRChiCTR2100049311. Registered on 29 July 2021...
Source: Trials - April 18, 2023 Category: Research Source Type: clinical trials
EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life
DiscussionThe study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals Leuven (s65549). Recruitment started in January 2022. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.Trial registrationTrial Registration: ClinicalTrials.govIdentifier: NCT05256238Date of registration: February 25, 2022 (Source: Trials)
Source: Trials - April 15, 2023 Category: Research Source Type: clinical trials
Impact of the COVID-19 pandemic on a clinical trial of pneumococcal vaccine scheduling (PVS) in rural Gambia
AbstractThe COVID-19 pandemic represents an unprecedented challenge for clinical research. The Pneumococcal Vaccine Schedules (PVS) study is a non-inferiority, interventional trial in which infants resident in 68 geographic clusters are randomised to two different schedules for pneumococcal vaccination. From September 2019 onwards, all infants resident in the study area became eligible for trial enrolment at all Expanded Programme on Immunisation (EPI) clinics in the study area. Surveillance for clinical endpoints is conducted at all 11 health facilities in the study area. PVS is conducted as a collaboration between the Me...
Source: Trials - April 14, 2023 Category: Research Source Type: clinical trials
The Safety and Efficacy of AlphaWave ® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis
Condition: Stress Interventions: Dietary Supplement: AlphaWave® L-Theanine; Other: Placebo Sponsors: Ethical Naturals, Inc.; KGK Science Inc. Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 11, 2023 Category: Research Source Type: clinical trials