Trials最新文献

Background: Urinary incontinence (UI) is a common and debilitating condition among people with multiple sclerosis (MS) and is more prevalent among women. Over the past decade, numerous studies have investigated the effects of pelvic floor muscle training (PFMT) as a treatment for UI in people with MS. MS negatively impacts pulmonary function even in the early stages of the disease and people with MS may experience respiratory muscle weakness. Considering the synergy between the pelvic floor muscle (PFM) and respiratory muscles, this trial will evaluate the effects of PFMT and breathing exercises on PFM activity and strength, diaphragm activity, and urinary symptoms in women with MS who experience UI.

Methods: Fifty women with MS and UI will participate in this parallel randomized controlled trial, comprising 32 treatment sessions. The intervention group consists of PFMT and breathing exercises, and the control group includes PFMT. The severity of UI symptoms, PFM activity, diaphragm activity, and PFM strength will be evaluated using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ultrasound imaging, and modified Oxford grading scale, respectively before and after the intervention.

Discussion: The current trial is designed to examine the effects of a combined exercise program for UI in women with MS. It is hypothesized that using breathing exercises in conjunction with PFM exercises will improve patient symptoms compared to PFMT alone.

Trial registration: The trial was registered in the Iranian Registry of Clinical Trials with code IRCT20180916041051N3 and was approved on 23 May 2024.

Background: With the population ageing, more victims of community crime are likely to be older adults. The psychological impact of crime on older victims is significant and sustained, but only feasibility trials have been published regarding potential interventions. The integration of public health and care services and cross-agency working is recommended, but there is little information on how this should be undertaken. Our recent Victim Improvement Package (VIP) randomised controlled trial (RCT) involved cross-agency collaboration between our university, a police service and a mental health charity. However, as the VIP trial only managed to recruit 131 out of 226 participants, we hope our reflections will help those wishing to conduct research in this population.

Methods: The trial management group (authors) and partners organisations identified the challenges and lessons learned from conducting the VIP trial in which the police identified and screened victims of reported community crime, aged 65 years or over, for distress. In the VIP trial, three screening methods were used: (1) visits by safer neighbourhood teams (SNTs), (2) police telephone screening and (3) employment of a university researcher embedded within the police service. Staff from the mental health charity were trained to deliver a manualised cognitive-behaviourally informed Victim Improvement Package (VIP) to be compared against treatment as usual (TAU).

Lessons learned: Factors promoting successful screening included simple IT systems, building rapport with the police and maintaining contact with participants. However, policy and staff changes within the police service and altered public confidence in the police compromised screening. The delivery of therapy was impaired by waiting times, therapist availability and the quality of therapy. Conducting research within an existing busy clinical service was challenging, but the COVID-19 pandemic demonstrated the acceptability and feasibility of offering online therapy to older victims.

Conclusion: SNT screening was an effective way to identify distressed victims, but service demands question whether it is viable for working police staff and the delivery of the therapy proved challenging in the context of a traditional RCT. Ways in which to strengthen research in this pioneering area of work are discussed.

Background: The aim of this study is to evaluate the efficacy and safety of diacylglycerol (DAG) edible oil intervention in patients with chronic metabolic syndrome complicated by asymptomatic hyperuricemia through a multicenter, prospective, double-blind, randomized controlled clinical trial.

Methods: A multicenter, double-blind, and randomized controlled trial involving 176 patients was designed. All patients with chronic metabolic syndrome complicated by asymptomatic hyperuricemia who meet inclusion and exclusion criteria will be included in the study and will be randomized to either group A or group B. Group A will receive DAG-rich oil (≥ 80%) and group B will receive conventional cooking oil (triacylglycerol (TAG)-rich oil) for 12 weeks. Serum uric acid level is the primary outcome. Fasting blood glucose, 2 h postprandial blood glucose, fasting insulin, glycated hemoglobin, lipid profile, and average carotid intima-media thickness will be evaluated as the secondary outcomes. Blood routine, urine routine, liver enzymes, and electrocardiogram will be tested to assess the safety. The sample size for each group was calculated to be 88 cases.

Discussion: We will evaluate the efficacy and safety of DAG oil compared with conventional TAG oil in patients with chronic metabolic syndrome with asymptomatic hyperuricemia. The dietary oil with superior efficacy and better safety will be recommended for reference use.

Trial registration: Chinese Clinical Trial Registry ChiCTR2400085336. Registered on June 5, 2024.

Background: A key challenge for many critical care clinical trials is that some patients will die before their outcome is fully measured. This is referred to as "truncation due to death" and must be accounted for in both the treatment effect definition (i.e. the estimand), as well as the statistical analysis approach. It is unknown which analytic approaches to this challenge are most relevant to stakeholders.

Methods: Using a modified Delphi process, we sought to identify critical attributes of analytic methods used to account for truncation due to death in critical care clinical trials. The Delphi panel included stakeholders with diverse professional or personal experience in critical care-focused clinical trials. The research team generated an initial list of attributes and associated definitions. The attribute list and definitions were refined through two Delphi rounds. Panelists ranked and scored attributes and provided open-ended rationales for responses. A consensus threshold was set as ≥ 70% of respondents rating an attribute as "Critical" (i.e., score ≥ 7 on a 9-point Likert scale) and ≤ 15% of respondents rating the measure as "Not Important" (i.e., a score of ≤ 3).

Results: Thirty-one (91%) of 34 invited individuals participated in one or both rounds. The response rate was 82% in Round 1 and 85% in Round 2. Participants included eight (26%) personal experience experts and 26 (84%) professional experience experts. After two Delphi rounds, four attributes met the criteria for consensus: accuracy (the approach will identify effects if they exist, but will not if they do not), interpretability (the approach enables a straightforward interpretation of the intervention's effect), clinical relevance (the approach can directly inform patient care), and patient-centeredness (the approach is relevant to patients and/or their families). Attributes that did not meet the consensus threshold included sensitivity, comparability, familiarity, mechanistic plausibility, and statistical simplicity.

Conclusions: We found that methods used to account for truncation due to death in the treatment effect definition and statistical approach in critical care trials should meet at least four defined criteria: accuracy, interpretability, clinical relevance, and patient-centeredness. Future work is needed to derive objective criteria to quantify how well existing estimands and analytic approaches encompass these attributes.

Background: Lung ultrasound-guided alveolar recruitment manoeuvres (RMs) may reduce the lung ultrasound score. However, whether the use of this strategy can reduce the incidence of postoperative pulmonary complications (PPCs) in the adult obese population has not yet been tested.

Methods/design: This is a single-centre, two-arm, prospective, randomised controlled trial. A total number of 476 obese patients scheduled for bariatric surgeries will be enrolled. They will be randomly assigned to receive either lung ultrasound-guided RMs (intervention group) or conventional RMs (control group) intraoperatively. The occurrence of PPCs will be recorded as the primary outcome.

Discussion: To the best of our knowledge, this is the first trial to test the effect of lung ultrasound-guided RMs on PPCs. The results of this trial will support the anaesthesiologists in choosing a potentially more efficient method to perform RMs for bariatric surgery patients.

Trial registration: www.chictr.org.cn ChiCTR2400080203. Registered on 23 January 2024.

Background: Cleft lip and/or palate is the most common congenital orofacial deformity, affecting 1/800 births. A thorough review of the literature has shown that children with cleft have poorer oral hygiene and dental health than other children, with higher levels of caries in both temporary and permanent teeth and poorer periodontal health. Cleft patients are treated by a multidisciplinary team that aims to provide comprehensive care from pre- or post-natal diagnosis to early adulthood and the end of growth. We aim to assess, through a single-center, prospective, randomized and controlled clinical trial conducted at the Nantes Cleft Centre, the impact of an enhanced dental program on oral hygiene and dental health in cleft patients.

Methods: Patients aged 3 to 15 years with unilateral or bilateral cleft lip and/or palate will be offered to participate in this study. After acceptance, patients will be randomly assigned to 2 groups: test group or control group. For the control group, there will be no change in the patient's care, and they will continue to see their surgeon on an annual basis. For the test group, a 30-45-min consultation will be added to the annual check-up. During this visit, patients and their parents will receive oral and written oral hygiene instructions to improve oral hygiene knowledge and brushing technique. If necessary, dental treatment will be provided at the same appointment or at a later date. In addition, patients will be contacted via telemedicine every 2 months to increase motivation, and an additional dental appointment will be scheduled at 6 months.

Discussion: This is a single-center study which, if conclusive, could lead to a paradigm shift in the dental care pathway for cleft patients.

Trial registration: NCT05867862 submitted 2023-07-05 https://clinicaltrials.gov/study/NCT05867862?locStr=Nantes,%20France&country=France&state=Pays%20de%20la%20Loire&city=Nantes&distance=50&cond=CLEFT%20LIP&rank=1- -Trial Sponsor Nantes University Hospital.

Trial status: 8th Version date 2023 May 05; recruitment began in June 2023 and will be completed in June 2024.

Background: Physical exercise is crucial in type 2 diabetes management (T2D), and training in the aquatic environment seems to be a promising alternative due to its physical properties and metabolic, functional, cardiovascular, and neuromuscular benefits. Research on combined training in aquatic and dry-land training environments is scarce, especially in long-term interventions. Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients.

Methods: This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. Participants with T2D, of both sexes, aged at 45 to 80 years old, will be randomized into two groups (aquatic combined training (AQUA) and dry-land combined training (LAND)), both performing combined aerobic and resistance training three times a week on alternate days for 24 weeks. Aerobic training will be performed using continuous and pyramidal methods, with linear exercise intensity and duration progression. Intensity will be prescribed by rated effort perception (Borg scale 6 to 20). Resistance training will be performed using exercise for the trunk, upper and lower limbs maximum speed, and target repetition zone in aquatic and dry-land environments, respectively, using multiple sets in a linear dosage progression. Before, at 12 weeks, and after the 24 weeks of training, biochemical analyses, functional capacity, maximum muscle strength, body composition assessments, cardiovascular measures, and the administration of questionnaires to assess mental, cognitive, sleep quality, and quality of life will be conducted. Throughout the 24 weeks, the training load date and acute capillary glucose and blood pressure measurements will also be conducted. The data will be analyzed using the SPSS (29.0) statistical package, using a significance level of 0.05. For intra- and inter-group comparisons, generalized estimating equations will be applied and analyzed by intention-to-treat and per-protocol adopting the Bonferroni post hoc test.

Discussion: The obtained results may provide insights to enhance understanding of the benefits of the aquatic and dry-land environment on various health outcomes, as well as acute aspects and safety considerations of the training. Moreover, this could support the development of intervention strategies to optimize the T2D management.

Trial registration: Brazilian Clinical Trial Registry (ReBEC) RBR-10fwqmfy. Registered on April 16, 2024.

Background: Prophylactic parenteral administration of antibiotics is strongly recommended to prevent surgical site infection (SSI). Cefoxitin is mainly administered intravenously in colorectal surgery. The current standard method for administering prophylactic antibiotics in adults is to administer a fixed dose quickly before skin incision. The percentage of time that the unbound concentration is maintained above the minimum inhibitory concentration (fT > MIC) during surgery is used as a surrogate measure for the effectiveness of prophylactic antibiotics. Target-controlled infusion (TCI) is a method of administration that changes the infusion rate to maintain a constant target concentration set by the user in consideration of the patient's physical characteristics. When cefoxitin is administered using the TCI method, it is possible that fT > MIC can be well maintained while reflecting the patient's physical characteristics compared to the standard method.

Methods: This prospective, single-centre, parallel-arm, single-blinded, randomised controlled trial with a 1:1 allocation was designed to compare the effectiveness of the TCI method with that of the standard cefoxitin administration method. We shall enrol 2494 patients scheduled to undergo colon or rectal surgery. Prior to the procedure, we shall randomise each patient to the control group (standard administration method) or study group (TCI method). In the control group, 2 g of cefoxitin was dissolved in 100 ml of normal saline and administered for approximately 10 min. Redosing was performed every 2 h from the start of the first dose of cefoxitin. In the study group, 2 g of cefoxitin was dissolved in 50 ml of normal saline and administered using a commercialised TCI syringe pump until the end of surgery. It was administered at a target concentration of 80 μg/ml using the total concentration pharmacokinetic model of cefoxitin. In all groups, 2 g of cefoxitin was administered using the standard administration method 12 h after the end of surgery. The primary outcome will be the incidence of SSI. The secondary outcome will be the administered dose of cefoxitin. Preoperative, intraoperative, and postoperative data were collected.

Discussion: This study will provide evidence for the effectiveness of administering cefoxitin using the TCI method compared to the standard method.

Trial registration: ClinicalTrials.gov, NCT05253339 , Registered on February 23, 2022 {2a, 2b}.

Background: Early neurological deterioration (END) is a critical determinant influencing the short-term prognosis of acute ischemic stroke (AIS) patients and is associated with increased mortality rates among hospitalized individuals. AIS frequently coexists with coronary heart disease (CHD), complicating treatment and leading to more severe symptoms and worse outcomes. Shared risk factors between CHD and AIS, especially elevated low-density lipoprotein cholesterol (LDL-C), contribute to atherosclerosis and inflammation, which worsen brain tissue damage. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer a promising treatment option. They effectively lower LDL-C levels and may help reduce END in AIS patients with CHD. This study aims to evaluate how effective PCSK9 inhibitors are in reducing END among this high-risk group and to provide new insights for treatment strategies.

Methods: This is a prospective, randomized, parallel-group, blinded-endpoint, single-center clinical study. A total of 156 AIS patients with a history of CHD and within 24 h from symptom onset will be recruited and randomized in a 1:1 allocation to either the PCSK9 inhibitor combined with statin treatment group (PI group) or the statin monotherapy group (AT group). The PI group will receive a combination therapy consisting of evolocumab and rosuvastatin calcium tablets, while the AT group will receive only oral rosuvastatin calcium tablets. The trial duration will last for 90 days and comprise three phases: screening, treatment intervention, and follow-up assessments. Participants will undergo comprehensive examinations and assessments on days 1, 7, 30, and 90 after enrollment.

Discussion: This study aims to investigate the potential preventive effects of PCSK9 inhibitors on END in AIS patients with a history of CHD. A positive outcome from this trial could provide novel clinical strategies for reducing the incidence of END and improving the short-term prognosis among these stroke patients.

Trial registration: China Clinical Trial Registry, ChiCTR2300078198. Registered on 30 November 2023.

Background: Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also on a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge, no randomised clinical trials (RCT) have compared RAKT to OKT. In this study, we will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation.

Methods: This is a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation recruited from Copenhagen University Hospital - Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for 2 years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses will follow intention-to-treat principles.

Discussion: Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify replacing an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival.

Trial registration: The trial was prospectively registered with ClinicalTrials.gov on February 15th, 2023, with the identifier NCT05730257.