Trials最新文献

Background: Research Ethics Committees (RECs) review the ethical, legal, and methodological standards of clinical research. Complying with all requirements and professional expectations while maintaining the necessary scientific and ethical standards can be challenging for applicants and members of the REC alike. There is a need for accessible guidelines and resources to help medical researchers and REC members navigate the legal and ethical requirements and the process of their review.

Methods: We employed an explorative search for resources on the websites of a purposively selected sample of relevant stakeholders, including 12 national umbrella organizations (six German-language and six English-language), three English-language international umbrella organizations, and 16 national RECs of major university hospitals (eight German- and eight English-language). We qualitatively mapped the identified resources onto the guiding principles of ethical clinical research and 35 related checkpoints. To describe the content of the resources, we conducted a thematic analysis.

Results: We extracted a total of 233 resources, including templates (n = 134, 58.5%), guidelines/recommendations (n = 62, 26.6%), checklists (n = 23, 9.9%), tools (n = 5, 2.2%), flowcharts (n = 5, 2.2%), glossaries (n = 3, 1.3%), and one (0.4%) software program. We extracted 101 German and 132 English resources created between 2004 and 2023. The majority (n = 204; 87.6%) could be assigned to one checkpoint. The remaining 29 (12.5%) resources were considered unspecific (e.g., a checklist which documents to be submitted for a German drug trial). The specific resources are discussed per checkpoint.

Conclusion: While much support is available for some aspects, such as participant information and informed consent forms, it is lacking in other areas, such as study design, analysis, and biometrics. More support should be provided in these areas to ensure that research projects are methodologically sound. A more detailed analysis of the quality of available resources could help identify other areas of need.

Background: Guidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients and not groups of patients. There are critical considerations for the analysis of cluster randomized trials, such as accounting for clustering, the risk of imbalances between the arms due to post-randomization recruitment, and the need to use small sample corrections when the number of clusters is small.

Methods: This paper outlines the protocol for the development of a set of reporting guidelines for the content of statistical analysis plans for cluster randomized trials (including variations such as the stepped wedge cluster randomized trial and other cluster cross-over designs) by extending the minimum reporting analysis requirements as previously defined for individually randomized trials to cluster randomized trials. The guideline will be developed using a consensus-based approach, modifying existing reporting items from the guideline for individually randomized trials and extending to include new items.

Discussion: The guideline will be developed so it can be used independently of the guideline for individually randomized designs. The consensus guidelines will be published in an open-access journal, including key guidance as well as exploration and elaboration.

Background: Tracheal intubation is a core skill in airway management for anesthesiologists as well as for other medical professionals involved in advanced airway procedures. Traditionally, tracheal intubation in hospitals has been performed using a Macintosh blade for direct laryngoscopy (DL). However, recent literature increasingly supports the potential benefits of routine video laryngoscopy (VL). The aim of this study was to assess whether primary training in hyperangulated VL improves the first-pass success rate of tracheal intubation among first-year anesthesiology residents, compared to conventional DL training, in the operating room.

Methods: The JuniorDoc-VL Trial is a randomized, controlled, patient-blinded clinical trial of novice anesthesiology residents trained in DL and VL. Thirty residents will be randomly assigned to either the intervention group (VL group) or the control group (DL group) with a 1:1 allocation. The first-pass-success (FPS) rates (primary endpoint) and complication rates (secondary endpoint) will be compared between groups.

Discussion: We hypothesize that the primary use of hyperangulated video laryngoscopy (VL) in the experimental group will increase first-pass-success rates among inexperienced residents and reduce complication rates associated with advanced airway management in a mixed patient population. This study may provide an opportunity to develop strategies that allow physicians not routinely involved in anesthesia to effectively learn and maintain their skills in tracheal intubation.

Trial registration: ClinicalTrials.gov Registry (NCT06360328). Registered on 09.04.2024.

Background: This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 6-week, novel, home-based stretching programme compared with usual care on the effect of symptoms experienced by patients with fibromyalgia. The hypothesis is that the total score of the Fibromyalgia Impact Questionnaire (FIQ-R) and other fibromyalgia symptoms will improve 6 weeks following the stretching intervention compared with usual care.

Methods: Fifty-eight adults under 65 years of age diagnosed with fibromyalgia will be recruited for this study. Participants will be randomised into an intervention group and a control group (waitlist). Randomisation will be stratified by sex. The intervention group will perform 6 weeks of daily stretching exercises for 6 min-a day. The control group will maintain usual care. A mHealth app will support stretching adherence. The primary outcome will be the total score of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The secondary outcomes include regional and widespread pain sensitivity, range of motion, quality of life (SF-36), mental and physical functioning and adherence. Evaluations will be performed at baseline, following 6 weeks of daily stretches (primary endpoint) and 6 months after the termination of the intervention period (secondary endpoint).

Discussion: By investigating the clinical efficacy of a 6-week, novel, home-based stretching programme, we hope to provide applicable and generalisable knowledge about the efficacy of stretching exercises that can potentially help ease the burden of symptoms experienced by patients with fibromyalgia.

Trial registration: NTC, NCT06487741. Registered on 24 June 2024.

Background: Breast cancer is the most common malignancy diagnosed in women worldwide. Triple-negative breast cancer (TNBC) is the most aggressive subtype, accounting for nearly one third of all breast cancers in India. The addition of pembrolizumab to neoadjuvant chemotherapy improved the pathological response and event free survival in patients with TNBC. However, for most patients in low- and middle-income countries, immunotherapy remains inaccessible due to its high cost. Pharmacological and early clinical data suggest that a lower dose of pembrolizumab may be effective. However, there are no prospective clinical trials in patients with TNBC.

Methods: This is a single-site phase II, randomized, open-labeled, parallel-group trial. Eligible patients will be randomized (1:1) to either of the two treatment groups. Patients in the control arm will be administered standard of care chemotherapy [4 cycles of dose-dense doxorubicin (60 mg/m²) and cyclophosphamide (600 mg/m²), followed by 4 cycles of dose-dense paclitaxel (175 mg/m²)]. Patients in the experimental arm will receive 3 doses of pembrolizumab 50 mg every 6 weeks along with neoadjuvant dose-dense chemotherapy. The primary objective of the study is to compare the pathological complete response with the addition of low-dose pembrolizumab to neoadjuvant chemotherapy in patients with TNBC. Secondary objectives include invasive disease-free survival and quality of life assessment.

Discussion: The PLANeT trial aims to establish the efficacy of low-dose pembrolizumab in addition to neoadjuvant chemotherapy in patients with triple-negative breast cancer patients. This strategy, if found effective, will help improve the outcomes of women with TNBC who currently have limited access to pembrolizumab.

Trial registration: Clinical Trials Registry of India-CTRI/2024/01/062088.

Introduction: This qualitative study explored patients' experiences and perceptions of the SCOPE2 trial. The trial studied radiotherapy dose escalation in patients with inoperable oesophageal cancer treated with definitive chemo-radiation. SCOPE2 embedded a phase II trial for patients with a poor early response using positron emission tomography (PET) scans.

Methods: This longitudinal interview study took place between 2017 and 2021. Patients eligible for chemoradiotherapy were recruited from five clinical sites in the UK. Participants were invited to participate in three semi-structured interviews across four different time points: baseline (before treatment) and at 2-3 months, 3-6 months or 6 months + after baseline. This paper focuses on recruitment to the trial, practical management, the impact of COVID-19 and reflections of being on the trial. Real-time reporting to the trial team was used to inform potential improvements to trial conduct and recruitment. The interviews were thematically analysed.

Results: Ten participants were interviewed in 16 longitudinal interviews. There were five female and five male interview participants; three participants were accompanied by companions during their interviews. Recruitment to the trial and qualitative study was challenging. Motivations for joining the trial included altruism, potentially receiving better care and monitoring and the opportunity to improve their quality of life. Participants required adequate time to consider information and regular updates regarding trial and treatment process. Participants felt that their trial experience was minimally impacted by COVID-19, although some delays to treatment were reported.

Conclusion: Increased opportunities for patients to discuss and receive appropriate and timely information from trial staff and third sector partners could enhance patients' understanding of future trials, treatments and procedures. Slow recruitment to the trial and qualitative study was further impeded by the COVID-19 pandemic and future trials would benefit from a more fully integrated approach to qualitative recruitment.

Clinical trial registration: ClinicalTrials.gov: NCT02741856 registered on 12 April 2016; ISRCTN: 9,712,546 registered on 26 October 2016.

Introduction: We assessed the effects of the Informed Health Choices (IHC) secondary school intervention on students' ability to think critically about choices 1 year after the intervention.

Methods: We randomized eighty secondary schools to the intervention or control (usual curriculum). The schools were randomly selected from the central region of Uganda and included rural and urban, government, and privately-owned schools. One randomly selected class of year-2 students (ages 14-17) from each school participated in the trial. The intervention included a 2-day teacher training workshop, 10 lessons accessed online by teachers and delivered in classrooms during one school term (May-August 2022). The lessons addressed nine prioritized IHC concepts. We used two multiple-choice questions for each concept to evaluate the students' ability to think critically about choices at both the end of the school term and again after 1 year. The primary outcome was the proportion of students with a passing score (≥ 9 of 18 questions answered correctly) on the "Critical Thinking about Health" (CTH) test.

Results: After 1-year, 71% (1749/2477) of the students in the intervention schools and 71% (1684/2376) of the students in the control schools completed the CTH test. In the intervention schools, 53% (934/1749) of students who completed the test had a passing score compared to 33% (557/1684) of students in the control schools (adjusted difference 22%, 95% CI 16-28).

Conclusions: The effect of the IHC secondary school intervention on students' ability to assess health-related claims was largely sustained for at least 1 year.

Trial registration: Pan African Clinical Trial Registry PACTR202204861458660. Registered on 4 April 2022.

Background: In the field of global health, meeting the energy requirements of athletes has surfaced as an essential concern. This study seeks to evaluate the effectiveness of royal jelly (RJ) in improving exercise performance in endurance-trained men.

Methods: In this randomized, crossover, double-blind, placebo-controlled study, we will enroll 18 male endurance athletes. Participants will be randomly assigned to one of two conditions: the intervention condition, which will receive royal jelly (RJ) in 500 mg capsules taken orally twice daily for 2 weeks, or the control condition, which will receive a placebo consisting of 500 mg starch capsules taken orally twice daily for the same duration. The study will utilize a 2 × 2 crossover design with a 2-week washout period between treatments. To evaluate aerobic performance, we will determine each participant's maximal aerobic speed (MAS), followed by a test conducted at 80% of the MAS to measure time to exhaustion. Blood samples (5 cc) will be collected from all participants before and after the treadmill tests to analyze mRNA expressions of Nrf2 and PGC-1α, as well as oxidative stress parameters. Additionally, participants' dietary intake will be assessed using 3-day food records, and their blood pressure will be monitored before exercise, immediately after, and half an hour post-exercise.

Discussion: This trial aims to evaluate the effectiveness of RJ as a nutraceutical agent for enhancing endurance athletic performance. We anticipate that the results will provide new insights into the clinical and molecular benefits of RJ. Additionally, these findings will offer valuable data to guide the design and execution of future clinical research involving RJ.

Trial registration: This study was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20231209060310N1, date: December 21, 2023).

Background: Postoperative pain is a common complication following endodontic treatment, often caused by acute inflammatory responses in the periapical tissues. Several factors contribute to this, including inadequate instrumentation, apical extrusion of debris during canal preparation, and other aspects of the procedure. Advances in technology have led to the development of nickel-titanium (NiTi) instruments that have shown potential to reduce postoperative discomfort. The purpose of this study was to evaluate postoperative pain in patients undergoing endodontic treatment with different NiTi systems.

Methods: This randomized clinical trial will include 128 patients between the ages of 18 and 50 years with a diagnosis of pulp changes in molars without pain or radiographic lesions requiring endodontic treatment. Patients will be randomized to receive root canal preparation with the rotary ProTaper Ultimate rotary system or the Reciproc Blue reciprocating single-file system. The primary outcome will be the intensity of postoperative pain measured by a numerical rating scale (NRS-10 cm) in 24 h postoperatively. Secondary outcomes will include the intensity of postoperative pain measured by a visual analog scale (VAS-0-10 cm) at 6 and 12 h and spontaneous pain, occlusion sensitivity, and quality of life, assessed by the OHIP-14 questionnaire.

Discussion: Our null hypothesis is that there will be no significant difference in postoperative pain between the two systems. The results of this study will provide information on the incidence and intensity of postoperative pain after instrumentation of root canal instrumentation with different NiTi systems and may help improve patient outcomes and quality of life.

Trial registration: Brazilian Clinical Trials Registry (REBEC): RBR-10kbw6nx. Registered on April 6, 2024.