non-inferiority trial
Small incision lenticule extraction (SMILE) versus laser in situ keratomileusis (LASIK): study protocol for a randomized, non inferiority trial
... this non-inferiority trial, we aim to demonstrate that SMILE is just as good as LASIK in terms of refractive outcome, as we do not expect to see a great improve- ment to the results from the already ...
5
A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol
... test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face ...controlled non- inferiority trial comparing both interventions will ...
5
The impact of maintaining serum potassium ≥3 6 mEq/L vs ≥4 5 mEq/L on the incidence of new onset atrial fibrillation in the first 120 hours after isolated elective coronary artery bypass grafting – study protocol for a randomised feasibility trial for the proposed Tight K randomized non inferiority trial
... pilot trial, at follow ...main trial outcomes will be by intention to treat (ITT) and given the non-inferiority trial design for the main trial, a per-protocol analysis will also ...
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Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial)
... multi-centre, non-inferiority trial we aim to test the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus ...
6
Blended CBT versus face to face CBT: a randomised non inferiority trial
... Methods/Design: The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six ...
8
Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol)
... Methods: The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with ...
7
Efficacy of cloxacillin versus cefazolin for methicillin-susceptible Staphylococcus aureus bacteraemia (CloCeBa): study protocol for a randomised, controlled, non-inferiority trial
... CloCeBa trial is an open-label, randomised, controlled, non-inferiority trial conducted in academic centres throughout ...the non-inferiority of cefazolin over cloxacillin, ...
8
A cluster randomized controlled non-inferiority trial of 5-day Dose Adjustment for Normal Eating ( DAFNE) training delivered over 1 week versus 5-day DAFNE training delivered over 5 weeks: the DAFNE 5 x 1-day trial
... DAFNE trial the mean HbA1c level for those who received the intervention was 79 mmol/mol ...original trial. However, HbA1c among the control group in the original trial went from 78 mmol/mol ...DAFNE ...
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Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non inferiority trial
... controlled trial in Denmark has concluded that a standardized physiotherapy exercise intervention resulted in statistically significant and clinic- ally relevant improvement in shoulder pain and function at 12 ...
11
Preimplantation genetic screening (PGS) still in search of a clinical application: a systematic review
... controlled trial of single blastocyst stage embryo transfer, and it really is ...a non-inferiority trial, demonstrating non-inferiority of transfer of a single embryo after PGS#2 ...
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Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial
... EFFECT trial is designed as a non-blinded, random- ized controlled non-inferiority trial comparing surgical treatment by TEP repair to watchful waiting in patients with a clinically ...
7
Methods for conducting a double blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol
... two-arm, non-inferiority trial is to determine whether or not treatment with 3 days of oral amoxicillin in HIV-uninfected children two to 59 months of age with chest indrawing pneumonia in a ...
10
Methods of defining the non inferiority margin in randomized, double blind controlled trials: a systematic review
... define non-inferiority margins, the impact of the FDA draft guidance on the use of the fixed-margin method, and the reporting of the rationale for the choice of the margin in CONSORT-endorsing and ...
9
Evidence-based sizing of non-inferiority trials using decision models
... this is particularly true of serious late treatment effects (e.g. cardiopulmonary toxicity and second malignancies) [36, 37]. Second, point estimates represent the average utility for a population [38, 39], yet equally ...
11
Randomized non inferiority and safety trial of dihydroartemisin piperaquine and artesunate amodiaquine versus artemether lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Cameroonian children
... controlled, non-inferiority trial was conducted among children of either gender aged six months (>5 kg) to ten years (n = 720) with acute uncomplicated Plasmodium falciparum ...The ...
10
Eliglustat tartrate for the treatment of adults with type 1 Gaucher disease
... III non-inferiority trial that examined the stability of patients who had been on the ERTs imiglucerase or velaglucerase for over 3 years when switched to oral ...
9
Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non inferiority, randomized controlled trial
... Methods/design: This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin TSB, defined as 3 mg/dl below[r] ...
10
Profile of once-daily zonisamide as monotherapy for treatment of partial seizures in adults
... Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Chad[r] ...
6
GRam stain guided Antibiotics ChoicE for Ventilator Associated Pneumonia (GRACE VAP) trial: rationale and study protocol for a randomised controlled trial
... a non-inferiority trial, we will compare the proportion of patients meeting the definition of clin- ical response using per-protocol analysis as a primary ...the non-inferiority of the ...
7
A double blind randomized active controlled clinical trial on the intra articular use of Md Knee versus sodium hyaluronate in patients with knee osteoarthritis (“Joint”)
... the non-inferiority limit by 24 % compared to the value measured in Group B, as established by the ...the non-inferiority limit calculated for the differences between averages was ...
8