Trials最新文献

Background: Various devices and techniques have been used for plaque modification in the treatment of severe coronary artery calcification. This prospective, multicenter, randomized, open-label study aims to evaluate the safety and efficacy of cutting balloon angioplasty using a novel bioabsorbable polymer-coated everolimus-eluting coronary stent for treating various degrees of calcified coronary lesions.

Methods: We outline the trial design aimed at assessing whether the cutting balloon (Wolverine™) is non-inferior to the non-compliant balloon in treating patients with calcified lesions, encompassing both de novo and in-stent restenosis (ISR) lesions. We aim to enroll 250 patients who have undergone bioabsorbable polymer-coated everolimus-eluting coronary stent (Synergy™) implantation. The primary endpoint is the minimal stent cross-sectional area at the calcium site as determined by intravascular ultrasonography. The secondary endpoints include major adverse cardiac events and target lesion revascularization at 12 months, alongside procedural convenience and operator-centric parameters, such as the number of balloons used, procedure time, and total contrast medium volume used.

Discussion: In this study, we will evaluate the efficacy and safety of Wolverine™ and non-compliant balloon in patients with calcified coronary lesions and provide a rationale for which type of balloons will optimally modify calcium lesions. In addition, we will attempt to expand the indications of the cutting balloon for treating mild-to-severe calcified coronary lesions. As the scope of insurance coverage for cutting balloons remains limited in some countries, this study may provide evidence for extending insurance coverage to the treatment of de novo calcified and ISR lesions.

Trial registration: ClinicalTrials.gov NCT06177808. Registered on January 1, 2024.

Background: Annually, about 4000 US children undergo a tracheostomy procedure to provide a functional, safe airway. In the hospital, qualified staff monitor and address problems, but post-discharge this responsibility shifts entirely to caregivers. The stress and constant demands of caregiving for a child with a tracheostomy with or without ventilator negatively affect caregivers. The aims of the study are to relieve the burden and stress experienced by caregivers at home, improve safety and outcomes for children post-discharge, and identify facilitators and barriers to implementation of comprehensive pediatric discharge programs.

Methods: The Boosting REsources and cAregiver empowerment for Tracheostomy care at HomE (BREATHE Study) is a pragmatic two-arm, randomized trial with six sites across the US. Caregivers of a child with a tracheostomy are randomized to comparator ("Trach Me Home") or intervention ("Trach Plus"). The Comparator arm is the current gold standard focusing on caregiver education, technical skill building, and case management. The Intervention arm contains all elements of the Comparator plus educational resources, social support and communication with the outpatient pediatrician. Caregivers will complete three surveys: baseline (pre-discharge), 4-week and 6-month post-discharge. Outpatient pediatricians will complete a survey to assess self-confidence in caring for a child with tracheostomy and satisfaction with discharge communication. Interviews with clinicians and staff will identify facilitators and barriers to implementation. The study will examine whether the Intervention arm leads to lower caregiver burden, lower readmission rates and higher pediatrician satisfaction than Comparator arm.

Discussion: The BREATHE Study will advance our understanding of how hospitals can support caregivers with a child with a tracheostomy as they resume life, work, and family activities after discharge.

Trial registration: Registered on clinicaltrials.gov (NCT06283953). February 28, 2024.

Background: In supporting primary healthcare in delivering high-quality care for individuals with type 2 diabetes mellitus (T2DM), previous research emphasized strategies to facilitate communication and collaboration between primary healthcare providers and hospitals. This study aims to evaluate the effectiveness of case discussion conferences between specialists from hospitals and primary healthcare providers in China on the optimization of diabetes management and the improvement of patient health outcomes.

Methods: This study will be a parallel cluster randomized controlled trial in which primary healthcare institutions in Shouguang city and Shangsi County will be randomly allocated to the intervention and control groups. The intervention will involve regular case discussion conferences where attendants will meet to discuss complex cases with patients diagnosed with type 2 diabetes mellitus, exchange experiences, and seek and provide expert advice. Family doctor teams from primary healthcare institutions and specialists from secondary or tertiary hospitals will engage in these conferences. Data will be collected at baseline and at the 6- and 12-month follow-ups. The primary clinical outcome measures will focus on the changes in the HbA1c and FBG levels of patients under management. The secondary outcomes will include other physiological indicators, such as blood pressure, BMI, and cholesterol. The evaluation will extend to changes in the capabilities and behaviors of primary healthcare providers. Furthermore, the feasibility and adherence of this intervention will be thoroughly assessed.

Discussion: This study is designed to generate robust evidence on the effectiveness of case discussion conferences, an interprofessional collaboration strategy, in enhancing diabetes care delivery in primary healthcare, with the ultimate goal of improving patient health outcomes.

Trial registration: Chinese Clinical Trial Registry ChiCTR2300078829. Registered on December 19, 2023. https://www.chictr.org.cn/showproj.html?proj=210293.

Background: Guidelines recommend operative treatment followed by cast immobilization for acute complete ulnar collateral ligament (UCL) ruptures, including Stener lesions. This recommendation is based on expert opinion, anatomic theories, and low-quality observational case series. High-quality studies comparing non-operative treatment to operative treatment are lacking. We hypothesize that primarily non-operative treatment with cast immobilization (cast immobilization) is non-inferior regarding functional outcome and carries concomitant lower costs compared with immediate operative treatment followed by cast immobilization (operative treatment) for complete UCL ruptures, including Stener lesions.

Methods: This is a multicenter randomized controlled non-inferiority trial (RCT) including patients of 18 years and above, requiring treatment for an acute complete UCL rupture, including Stener lesions. Patients are randomized to cast immobilization or operative treatment followed by cast immobilization. Immobilization consists of 4 weeks of a non-removable cast around the metacarpophalangeal (MCP) and carpometacarpal (CMC) joint of the thumb in a neutral position, followed by a removable cast for 4 weeks for both groups. Patients in the cast immobilization group are re-evaluated 2 to 3 weeks after the start of cast immobilization to examine thumb stability and determine if secondary surgery is required. In case of persistent laxity, secondary surgery is required. The primary outcome is hand function expressed as the Michigan Hand outcome Questionnaire (MHQ) at 6 months (from injury to 6 months after).

Discussion: If cast immobilization is non-inferior to operative treatment, the proposed treatment strategy will reduce patient burden by preventing surgery. It is expected that about one in ten patients who started with cast immobilization will need secondary surgery during re-evaluation. As a result, completion of the treatment will take longer for these patients compared to patients who received immediate operative treatment.

Trial registration: Central Committee on Research Involving Human Subjects (CCMO), NL78886.100.21; registered on 4 October 2021. Medical Research Ethics Committees United (MEC-U), R21.006; registered on 09 December 2021. Clinical Trial register, identifier: NCT05291260; retrospectively registered on 22 March 2022.

Background: Intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end-expiratory pressure (PEEP) with recruitment maneuvers (RMs) that result in a low ΔP has the potential to prevent PPCs. This trial tests the hypothesis that compared to standard low PEEP without RMs, an individualized high PEEP strategy, titrated to the lowest ΔP, with RMs prevents PPCs in patients receiving intraoperative protective ventilation during anesthesia for minimally invasive abdominal surgery.

Methods: "DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery (GENERATOR)" is an international, multicenter, two-group, patient and outcome-assessor blinded randomized clinical trial. In total, 1806 adult patients scheduled for minimally invasive abdominal surgery and with an increased risk of PPCs based on (i) the ARISCAT risk score for PPCs (≥ 26 points) and/or (ii) a combination of age > 40 years and scheduled surgery lasting > 2 h and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery will be included. Patients are assigned to either an intraoperative ventilation strategy with individualized high PEEP, titrated to the lowest ΔP, with RMs or one with a standard low PEEP of 5 cm H₂O without RMs. The primary outcome is a collapsed composite endpoint of PPCs until postoperative day 5.

Discussion: GENERATOR will be the first adequately powered randomized clinical trial to compare the effects of individualized high PEEP with RMs versus standard low PEEP without RMs on the occurrence of PPCs after minimally invasive abdominal surgery. The results of the GENERATOR trial will support anesthesiologists in their decisions regarding PEEP settings during minimally invasive abdominal surgery.

Trial registration: GENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023.

Background: Worldwide, mild traumatic brain injury, synonymous with concussion, affects more than 30-50 million each year. The incidence of concussion in Denmark is estimated to be about 20,000 yearly. Although complete resolution normally occurs within a few weeks, up to a third develop persistent post-concussion symptoms (PPCS) beyond 3 months. Evidence for effective treatment strategies is scarce. The objective of this study is to evaluate the efficacy of the novel intervention GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only.

Methods: An open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Potential participants will be identified through the hospital's Business Intelligence portal of the Central Denmark Region or referred by general practitioners within 2-4 months post-concussion. Participants with mild-to-moderate PPCS will be randomly assigned to either (1) EUC or (2) GAIN Lite added to EUC. GAIN Lite is characterised as a complex intervention and has been developed, feasibility-tested and process evaluated before effect evaluation in the RCT. GAIN Lite contains an initial remote interview, self-administrated e-learning videos and voluntary remote counselling with an allocated occupational- or physiotherapist. Sixty-six participants will be recruited to each group. Primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline.

Discussion: GAIN Lite is a low-intensity intervention for adults with mild-to-moderate PPCS. Offering a remote intervention may improve access to rehabilitation and prevent chronification for individuals with mild-to-moderate PPCS. Moreover, GAIN Lite will facilitate access to healthcare, especially for those with transportation barriers. Overall, GAIN Lite may provide an accessible, flexible and convenient way to receive treatment based on sound theories and previous evidence of effective interventions for adults with mild-to-moderate PPCS.

Trial registration: ClinicalTrials.gov NCT05233475. Registered on February 10, 2022.

Background: Retrospective and descriptive molecular epidemiology studies have shown that Mycobacterium tuberculosis whole genome sequencing can identify outbreaks and disease transmission events with higher resolution than conventional epidemiological investigations. Those studies have strengthened our understanding of genomic polymorphisms correlating with person-to-person transmission and helped resolve putative transmission clusters. To date, systematic genomic surveillance programs implemented for M. tuberculosis were only implemented in low-incidence settings. The purpose of this study is to determine whether there is an impact of routine M. tuberculosis whole genome sequencing on tuberculosis case detection in a high-incidence setting.

Methods: A cluster randomized controlled trial will be performed. Forty-eight rural village groups (or Fokontany) in the Vohibato district of Madagascar will be randomized to one of three interventions arms. Arm 1 (standard of care) involves healthcare facility-based passive case detection with smear microscopy testing. Arm 2 (best practice) consists of active case finding and Xpert MTB/RIF Ultra PCR testing followed by household contact investigations. Arm 3 (novel intervention) includes the same interventions as arm 2, with addition of sputum culture and M. tuberculosis whole genome sequencing for all newly diagnosed cases. In arm 3, molecular suggested putative outbreaks are investigated, and additional TB suspects are appropriately tested. The intervention observational period will be 2 years. The primary outcome will be the number of detected cases/100,000/year in each arm after 1 year of intervention.

Discussion: This study is designed to determine whether there is an impact of prospective whole genome sequencing-based molecular typing on tuberculosis case detection in high-incidence settings. Investigating potential outbreaks and focusing active case finding in spatiotemporal settings where disease transmission is suggested by genomic typing is hypothesized to improve case detection in rural communities.

Trial registration: ClinicalTrials.gov NCT05406453 . Retrospectively registered on June 6, 2022.

Background: Avoidant personality disorder (AvPD) and social phobia (SP) are associated with high personal and societal costs. While psychotherapy can be efficient, many patients drop out during treatment. Little is known about what can be done to increase a patient's readiness for psychotherapy. However, research highlights the fields of collaborative and therapeutic assessment as a possible means to enhance readiness for psychotherapy.

Methods: We conducted a randomized controlled feasibility and superiority trial on patients with SP or AvPD who were to initiate psychotherapeutic treatment in outpatient mental health services. Patients were randomized 1:1 to either assessment as usual or modified collaborative assessment (MCA), provided as a pre-treatment intervention before psychotherapy initiation. MCA included the collaborative administration of a battery of psychological tests designed to assess the patient's psychopathology more systematically. The tests were administered in collaboration with the patient, and detailed oral and written feedback was provided. We investigated the feasibility of the MCA intervention regarding acceptability, patient satisfaction, and adherence. We also investigated MCA's effect on readiness for psychotherapy, as assessed with the University of Rhode Island Change Assessment Scale (URICA), and outcomes relating to symptomatology and dropout rates.

Results: All three prespecified feasibility outcomes were met. At the end of treatment, no significant difference was observed in any other outcome, except client satisfaction, which favored MCA (- 7.42 (95% CI - 11.75; - 3.09; p = 0.002)).

Discussion: We found that MCA was feasible, and patients were highly satisfied with the intervention. It is relevant to investigate another implementation of MCA.

Trial registration: ClinicalTrials.gov NCT05018312. Registered on August 24, 2021.