Cross-sectional analysis characterizing the use of rank preserving structural failure time in oncology studies: changes to hazard ratio and frequency of inappropriate use
ConclusionsRPSFT is a common tactic used by the industry to reinterpret trial results. Nineteen percent of RPSFT use is appropriate. We recognize that while crossover can bias OS results, the allowance and handling of crossover in trials should be limited to appropriate circumstances. (Source: Trials)
Source: Trials - June 3, 2023 Category: Research Source Type: clinical trials
Treatment of haemorrhoids: rubber band ligation or sclerotherapy (THROS)? Study protocol for a multicentre, non-inferiority, randomised controlled trial
DiscussionThe THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1 –2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option.Ethics and disseminationThe study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproct...
Source: Trials - June 3, 2023 Category: Research Source Type: clinical trials
The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial
This study is supported by the Shanghai Shenkang Development Program (SHDC12019119), the Excellent Doctors-Excellent Clinical Researchers Program (SYB202008), the Shanghai Rising-Star Program (23QC1401200), the Shanghai Rising Stars of Medical Talent Youth Development Program (2021–99), the National Natural Science Foundation of China (81800912), and the National Natural Science Foundation of Shanghai (21ZR1411800).Trial registrationClinicalTrials.gov NCT04026932. Registered on 18 July 2019. (Source: Trials)
Source: Trials - June 2, 2023 Category: Research Source Type: clinical trials
The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial
Chronic subjective tinnitus has become an increasingly serious hazard that affects the health-related quality of life for millions of people. Due to the lack of curative treatment strategies, this study aims t... (Source: Trials)
Source: Trials - June 2, 2023 Category: General Medicine Authors: Dongmei Tang, Jinghan Wang, Xiaopei Yu and Huiqian Yu Tags: Study protocol Source Type: research
Publisher Correction: Effectiveness of motor control exercise, aerobic walking, and muscle strengthening programs in improving outcomes in a subgroup of population with chronic low back pain positive for central sensitization: a study protocol for a randomized controlled trial
(Source: Trials)
Source: Trials - June 1, 2023 Category: General Medicine Authors: G. Shankar Ganesh, Abdur Raheem Khan, Sakti Prasad Das, Ashfaque Khan, Raee S. Alqhtani, Adel Alshahrani, Mohammad Abdulrehman Mohammad Jarrar and Hashim Ahmed Tags: Publisher Correction Source Type: research
Development of an international core outcome set for treatment trials in necrotizing enterocolitis —a study protocol
Necrotizing enterocolitis (NEC) is the most lethal disease of the gastrointestinal tract of preterm infants. New and existing management strategies need clinical evaluation. Large heterogeneity exists in the s... (Source: Trials)
Source: Trials - May 31, 2023 Category: General Medicine Authors: Daphne H. Klerk, Otis C. van Varsseveld, Martin Offringa, Neena Modi, Martin Lacher, Augusto Zani, Mikko P. Pakarinen, Antti Koivusalo, Ingo Jester, Marie Spruce, Joep P. M. Derikx, Roel Bakx, Amine Ksia, Marijn J. Vermeulen, Elisabeth M. W. Kooi and Jan Tags: Study protocol Source Type: research
Euthyroidectomy under local versus general anesthesia in health camp settings in Uganda: a protocol for randomized prospective equivalence single-blind controlled trial
Endemic goiter is highly prevalent in Uganda at 60.2%, contributing to the high surgical burden. While compelling evidence suggest that in selected cases, thyroidectomy under local anesthesia (LA) is associate... (Source: Trials)
Source: Trials - May 31, 2023 Category: General Medicine Authors: Umaru Kabuye, Jane Odubu Fualal and Herman Lule Tags: Study protocol Source Type: research
Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a statistical analysis plan for a randomised controlled trial
The placement of an endotracheal tube for children with acute or critical illness is a low-frequency and high-risk procedure, associated with high rates of first-attempt failure and adverse events, including h... (Source: Trials)
Source: Trials - May 31, 2023 Category: General Medicine Authors: Shane George, Kristen Gibbons, Tara Williams, Susan Humphreys, Ben Gelbart, Renate Le Marsney, Simon Craig, David Tingay, Arjun Chavan and Andreas Schibler Tags: Update Source Type: research
Reporting of PPI and the MCID in phase III/IV randomised controlled trials —a systematic review
Patient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are relevant to patients. The minimal clinically important difference (MCID) i... (Source: Trials)
Source: Trials - May 31, 2023 Category: General Medicine Authors: Joseph Brennan, Michael T. C. Poon, Edward Christopher, Olivia Fulton, Carol Porteous and Paul M. Brennan Tags: Review Source Type: research
Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a statistical analysis plan for a randomised controlled trial
AbstractThe placement of an endotracheal tube for children with acute or critical illness is a low-frequency and high-risk procedure, associated with high rates of first-attempt failure and adverse events, including hypoxaemia. To reduce the frequency of these adverse events, the provision of oxygen to the patient during the apnoeic phase of intubation has been proposed as a method to prolong the time available for the operator to insert the endotracheal tube, prior to the onset of hypoxaemia. However, there are limited data from randomised controlled trials to validate the efficacy of this technique in children. The techn...
Source: Trials - May 31, 2023 Category: Research Source Type: clinical trials
Euthyroidectomy under local versus general anesthesia in health camp settings in Uganda: a protocol for randomized prospective equivalence single-blind controlled trial
The objective of this trial is to compare euthyroidectomy under local versus general anesthesia among patients with grade 1 –2 uncomplicated euthyroid goiter in Uganda.MethodsThis prospective equivalence randomized, single-blind controlled trial protocol will be conducted among eligible participants with grade 1 –2 uncomplicated euthyroid goiters. The recruitment processes will start in October 2022 and end in April 2023. Consenting participants with an indication for thyroidectomy will be randomized into two arms of 29 participants in each arm during the Bulamu Health Care Organization surgical camps in Uganda.Discuss...
Source: Trials - May 31, 2023 Category: Research Source Type: clinical trials
Reporting of PPI and the MCID in phase III/IV randomised controlled trials —a systematic review
ConclusionsPPI and the MCID are poorly reported, so it is uncertain how these contributed to trial design. Improvement in the reporting of these items would increase confidence that results are relevant and clinically significant to patients, contributing to improving the overall trial design.Trial registrationNot registered. (Source: Trials)
Source: Trials - May 31, 2023 Category: Research Source Type: clinical trials
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
Ultrasound-guided supraclavicular block versus Bier block for emergency reduction of upper limb injuries: a protocol for an open-label, non-inferiority, randomised controlled trial
DiscussionExisting evidence suggests UGSCB is effective when performed in the operating theatre by trained anaesthetists. SUPERB will be the first randomised controlled trial to elucidate the effectiveness and safety of UGSCB in the ED. The findings have the potential to provide an alternative safe and effective option for the management of upper extremity emergencies in the ED.Trial registrationThis trial has been registered on 21 October 2022 with Australia and New Zealand Clinical Trials Registry (ACTRN12622001356752). (Source: Trials)
Source: Trials - May 30, 2023 Category: Research Source Type: clinical trials
