Multisensory stimulation bundles on sleep and neurobehavioral development in the first year after birth in very preterm infants: a randomized crossover controlled study protocol
This study presents a protocol for an evaluator-blinded, randomized crossover trial. It aims to assess the sleep efficiency of hospitalized VPIs by providing multisensory stimulation bundles. Furthermore, it aims to observe the intervention impacts on sleep during hospitalization of the VPIs and their sleep and neurodevelopmental outcomes during the first year of post-discharge follow-up.MethodsThe study will be conducted in the neonatology department of a tertiary pediatric teaching hospital. All the eligible VPIs will undergo two types of care in random order: “standard care” (2 weeks) and “standard care plus multi...
Source: Trials - November 15, 2023 Category: Research Source Type: clinical trials
PROMISE: effect of protein supplementation on fat-free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial
AbstractIntroductionProtein malnutrition after bariatric surgery is a severe complication and leads to significant morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat-free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counseling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat-free mass. This double-blind randomized placebo-controlled intervention study a...
Source: Trials - November 9, 2023 Category: Research Source Type: clinical trials
Social Emotional and Ethical Development (SEED)
Conditions: Development, Child; Mindfulness; Mental Well-being Interventions: Behavioral: Social, Emotional, and Ethical Development (SEED) curriculum Sponsors: Chinese University of Hong Kong Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 8, 2023 Category: Research Source Type: clinical trials
Innovative and disruptive technologies to prescribe, encourage, and evaluate physical exercise in healthy adults: a protocol of exploratory study followed by a noninferiority, investigator-blinded randomized clinical trial
DiscussionAnticipated outcomes include improved exercise adherence through the gamified application, better maintenance of prescribed exercise intensity, and enhanced health biomarkers. The results of this study will inform health-related decision-making.Trial registrationThe study protocol received approval from the Ethics Committee of Universidade Federal de Ci ências da Saúde de Porto Alegre (54,492,221.80000.5345) and has been registered with the Brazilian Registry of Clinical Trials (ReBEC, RBR-359p69v). (Source: Trials)
Source: Trials - October 30, 2023 Category: Research Source Type: clinical trials
The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on metabolic and hormonal profile in patients with polycystic ovary syndrome: study protocol for a randomized clinical trial
DiscussionWe hypothesized that 10-h TRE administered alone or in combination with probiotic supplementation to overweight and obese PCOS subjects would lead to weight loss and improved metabolic, hormonal, inflammatory, and antioxidant markers compared to control subjects following a standard 3-meal-per-day CR diet.Ethical aspectsThe current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1401.425).Trial registrationIranian Registry of Clinical Trials IRCT20121110011421N5. Registered on 3 October 2022. (Source: Trials)
Source: Trials - October 25, 2023 Category: Research Source Type: clinical trials
Bad research is not all bad
AbstractIn this commentary, we discuss a recent article inTrials that raised concerns about the number of poorly performed randomised trials in the medical literature and discuss the trials literature more widely. Although we all aim for higher methodological standards in trials, we argue that (i) the idea that ‘most randomised trials are bad’, which the recent article concludes is an overly simplistic representation of the situation, and (ii) the suggestion that an increased focus on methodological review during trial development (e.g. ethical boards performing some assessment of the methodologists on a trial), while ...
Source: Trials - October 20, 2023 Category: Research Source Type: clinical trials
Response to Merz
AbstractJon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz ’s critique rests on a misunderstanding of our article, defend the daily life standard as a guardrail for leveraging cognitive biases, and argue that rejecting all behavioral influences is not a helpful nor a sustainable answer to their increasing use in trial recruitment. (Source: Trials)
Source: Trials - October 6, 2023 Category: Research Source Type: clinical trials
Use of Stratafix Symmetric ™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Conditions: C.Surgical Procedure; Disruption of Wound, Suture Interventions: Device: Stratafix suture; Device: Standard of care suture Sponsors: West Michigan Cancer Center; Ethicon, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 2, 2023 Category: Research Source Type: clinical trials
Dual tracer navigation for lymph node dissection in laparoscopic radical gastrectomy (DANCE trial): a protocol for a prospective, randomized clinical trial
This study will investigate the efficacy and safety of a novel strategy using dual tracers for laparoscopic gastrectomy. The protocol has been approved by the Ethics Committee of Nanjing Drum Tower Hospital (2021-361-02). The trial findings will be published in peer-reviewed journals.Trial registrationChinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021,https://www.chictr.org.cn/showproj.html?proj=133764. (Source: Trials)
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials
The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial
DiscussionThe aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS.Trial registrationClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022. (Source: Trials)
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials
Decreasing consumption of sugar-sweetened beverages and Raising tap water consumption through Interventions based on Nutrition and sustainability for Kids: study protocol of the “DRINK” cluster randomised controlled trial
The objective of this cluster randomised controlled trial is to evaluate the long-term effectiveness of nutrition- and environmental sustainability-based interventions on the reduction in SB intake and on the increase in tap water consumption in 3rd to 6th grade primary school children (8 to 11 years of age).MethodsForty-eight French-speaking Belgian primary schools (equivalent to around 3500 pupils involved in the evaluation) are randomised using a factorial plan: (i) control, (ii) nutrition-based intervention, (iii) sustainability-based intervention, and (iv) both. The interventions (encouragement of water breaks; prov...
Source: Trials - September 26, 2023 Category: Research Source Type: clinical trials
Protocol for a single-blind randomized clinical trial to test the efficacy of bilateral transcranial magnetic stimulation on upper extremity motor function in patients recovering from stroke
This study is currently in progress.Graphical Abstract (Source: Trials)
Source: Trials - September 22, 2023 Category: Research Source Type: clinical trials
The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial
AbstractIntroductionThe lumbar plexus originates from multiple segments of the spinal cord. Both single-level lumbar plexus block (LPB) and transmuscular quadratus lumborum block (TQLB) are commonly used to provide analgesia for the patients undergoing total hip arthroplasty (THA). However, neither of them can completely cover the lumbar plexus. Multiple-level LPB is also not recommended since this expert technique involves more potential risks. To achieve a better anesthetic effect and avoid risks, we propose to combine ultrasound-guided LPB with TQLB with Shamrock approach. We aim to assess the anesthetic efficacy of thi...
Source: Trials - September 18, 2023 Category: Research Source Type: clinical trials
Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol
AbstractIntroductionPulmonary segmentectomy, when combined with hilar and mediastinal lymphadenectomy, is currently considered the gold standard treatment for early-stage lung tumors (NSCLC) smaller than 2 cm in diameter. The preoperative planning for segmentectomies usually includes a contrast-enhanced CT with 2D reconstructions (axial, coronary, and sagittal). Recent technological advances allow 3D (volume rendering) reconstructions of preoperative CT scans, intended to improve the surgeon ’s understanding of the segmental anatomy.The study aims to investigate the added value of 3D reconstruction in enhancing the surge...
Source: Trials - September 16, 2023 Category: Research Source Type: clinical trials
A double-blind, randomised, placebo-controlled parallel study to investigate the effect of sex and dietary nitrate on COVID-19 vaccine-induced vascular dysfunction in healthy men and women: protocol of the DiNOVasc-COVID-19 study
This study aims to evaluate whether sex or dietary influences endothelial function and inflammatory responses in healthy volunteers after receiving the COVID-19 vaccine.Trial registrationClinicalTrials.gov NCT04889274. Registered on 5 May 2023. The study was approved by the South Central – Oxford C Research Ethics Committee (21/SC/0154). (Source: Trials)
Source: Trials - September 16, 2023 Category: Research Source Type: clinical trials
