Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis
ConclusionsThis reanalysis of Study PRGF found no clinically or statistically significant benefit from PRGF compared to hyaluronic acid. The restoration of Study PRGF shows the urgency of important changes to trial reporting and oversight practices. In the future, timely access to all clinical trial documents is needed to minimize the risk of reporting bias. Similarly, ethics committees should be ready to intervene whenever a case of potential misconduct arises.Trial registrationThis is a RIAT project, whose original trial was approved and registered on 19 December 2007 by the Ethics Committee of the Basque Country, Spa...
Source: Trials - January 18, 2023 Category: Research Source Type: clinical trials
The effect of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in type 2 diabetes women: a blinded randomized controlled trial protocol
DiscussionThe present randomized controlled trial will aim to investigate any beneficial effects of bitter almond gum supplementation on the cardio-metabolic, immune-inflammatory, and oxidative stress biomarkers, as well as mental health in women with T2DM.Ethics and disseminationThe study protocol was approved by the Ethical Committee of the Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.726).Trial registrationIranian Registry of Clinical Trials (www.irct.ir/IRCT20150205020965N7) (Source: Trials)
Source: Trials - January 17, 2023 Category: Research Source Type: clinical trials
Rectal stimulation with prebiotics and probiotics before ileostomy reversal: a study protocol for a randomized controlled trial
This study is registered in the Brazilian Trial Registry (ReBEC) under RBR-366n64w. Registration date: 19/07/2022 (Source: Trials)
Source: Trials - January 17, 2023 Category: Research Source Type: clinical trials
Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies
The objective of this study is to evaluate, quantify, and compare the public ’s understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap).Methods and analysisThis is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and you...
Source: Trials - January 14, 2023 Category: Research Source Type: clinical trials
The effects of adjunctive treatment with l-carnitine on monitoring laboratory variables in ICU patients: a double-blinded randomized controlled clinical trial
Conclusionl-Carnitine supplementation in critically ill patients can improve several parameters including INR, Cr, ALT, lactate, Ca, Alb, and total protein.Trial registrationIranian Registry of Clinical Trials IRCT 20151108024938N2. This trial was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (registration code: IR.MUMS.fm.REC.1396.671) (available athttps://en.irct.ir/trial/30748, May 2018). (Source: Trials)
Source: Trials - January 3, 2023 Category: Research Source Type: clinical trials
Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth —a protocol for a randomized clinical trial
This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 50497321.4.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC) (number RBR-4j62jv6). This is the first version of the study protocol approved on 11/12/2021 prior to the start of participant recruitment. (Source: Trials)
Source: Trials - December 27, 2022 Category: Research Source Type: clinical trials
Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults —the TAKEOVER study
DiscussionEthical approval has been granted by the College of Medical Veterinary and Life Sciences Ethical Committee at the University of Glasgow (Project No 200190189) and recruitment is ongoing. Study findings will be disseminated through a presentation at scientific conferences and in scientific journals.Trial registrationClinicialTrials.gov NCT04676958. Prospectively registered on 21 December 2020. (Source: Trials)
Source: Trials - December 20, 2022 Category: Research Source Type: clinical trials
ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial
DiscussionThis paper presents the trial protocol and management structure, including international governance, remote site monitoring and biobanking activities and provides commentary on ethical and pragmatic considerations in establishing the ASCOT ADAPT trial under pandemic conditions.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12620000445976) and ClinicalTrials.gov (NCT04483960). (Source: Trials)
Source: Trials - December 14, 2022 Category: Research Source Type: clinical trials
Effect of positive event recording based on positive psychology on healthy behaviors and readmission rate of patients after PCI: a study protocol for a prospective, randomized controlled trial
This study will verify whether positive event recording based on positive psychology can make patients maintain healthy behaviors, reduce readmission rate, and improve anxiety after PCI. Then, this study will provide new ideas and references for the development of secondary prevention strategies for patients with CHD.Trial registrationChinese Clinical Trials Registry 2000034538. Registered on 10 July 2020. (Source: Trials)
Source: Trials - December 13, 2022 Category: Research Source Type: clinical trials
Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial
ConclusionThis detailed analysis plan will increase the validity of the NEO trial results by predefining the statistical analysis in detail.Trial registrationClinicalTrials.gov identifier:NCT01848886. Registered 25 February 2013. Danish Ethics committee number: H-3 –2012-116. Danish Data Protection Agency: 2007–58-0015/jr. n:30–0838. (Source: Trials)
Source: Trials - December 9, 2022 Category: Research Source Type: clinical trials
Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial
DiscussionThis SWAT will generate the first evidence for recruitment interventions for trials involving adults lacking capacity to consent and add to knowledge about the use of decision support interventions in trial participation decisions. The SWAT will be embedded in a range of trials, and the heterogenous nature of the host trials, settings and populations involved will enable the intervention to be evaluated in a wide range of contexts. However, a pragmatic and flexible approach to conducting the SWAT is needed.Trial registrationThe SWAT is registered asSWAT #159 with the Northern Ireland Hub for Trials Methodology Re...
Source: Trials - November 24, 2022 Category: Research Source Type: clinical trials
Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial
AbstractIntroductionBrain edema is the most frequent postoperative complication after brain tumor resection, especially in patients with high-grade glioma. However, the effect of SVV-based goal-directed fluid therapy (GDFT) on postoperative brain edema and the prognosis remain unclear.Methods and analysisThis is a prospective, randomized, double-blinded, parallel-controlled trial aiming to observe whether stroke volume variation (SVV)-based GDFT could improve the postoperative brain edema in patients undergoing supratentorial high-grade gliomas compared with traditional fluid therapy. The patient will be given 3 ml/kg hydr...
Source: Trials - November 19, 2022 Category: Research Source Type: clinical trials
The Effect of Dramatization Simulation on Nursing Students' Ethical Attitudes
Condition: ETIC Interventions: Behavioral: Dramatization simulation; Behavioral: In-class case studies Sponsor: Çankırı Karatekin University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 16, 2022 Category: Research Source Type: clinical trials
