Trials最新文献

{"title":"Publication bias and time to the publication of randomised trials conducted in sub-Saharan Africa: a cross-sectional study.","authors":"Ameer Hohlfeld, Lorenzo Douglas Maurice Bennie, Tamara Kredo, Michael Clarke","doi":"10.1186/s13063-026-09753-w","DOIUrl":"https://doi.org/10.1186/s13063-026-09753-w","url":null,"abstract":"<p><strong>Background: </strong>Ideally, evidence-based decisions about healthcare interventions should be informed by access to up-to-date information from all relevant RCTs, making it essential that the reports are published soon after study completion. However, studies have consistently shown that between 25 and 50% of clinical trials remain unpublished or are only published many years after completion. The WHO has noted a slow but steady increase in the number of RCTs since the mid-2000s, particularly in sub-Saharan Africa (SSA). However, the extent of publication bias of SSA RCTs remains unknown. Therefore, our study objectives were to assess (1) the proportion of completed RCTs from SSA that have been published and (2) the time from completion to publication.</p><p><strong>Methods: </strong>This cross-sectional study, consisting of a retrospective analysis of registered SSA RCTs, aims to report the proportion of completed and terminated SSA RCTs registered in ClinicalTrials.gov and the Pan African Clinical Trials Registry (PACTR) and their time to publication.</p><p><strong>Results: </strong>Our search yielded 7896 records, of which 3026 RCTs met our inclusion criteria for analysis. We identified journal publications for 1983 (65.5%) RCTs. The overall median time to publication from the primary completion date was 34.2 months (95% CI: 32.4 to 35.5).</p><p><strong>Conclusions: </strong>Overall, we found a substantial proportion (34.5%) of unpublished SSA RCTs. Moreover, the median time to publication from primary completion was 34.2 months. The persistence of publication bias threatens the integrity of evidence-based healthcare practice, particularly given that consumers depend on peer-reviewed journal publications as conventional and trusted sources to stay informed. Our findings underscore the importance of continued research to test and implement preventative strategies to mitigate publication bias.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Testing the biobehavioral regulation of negative emotion as a mechanism of change in transdiagnostic youth psychotherapy: study protocol for a randomized controlled trial.","authors":"Madison Aitken, Brendan F Andrade, Claire E Krasinkiewicz, Sabrina W S Chan, Sera P Gandhi, Jessica W Pun, Andrew Hamilton-Wright, Wei Wang, Leah Sack, John R Weisz, Robert Bancroft, Jo Henderson, Kristel Thomassin","doi":"10.1186/s13063-026-09739-8","DOIUrl":"https://doi.org/10.1186/s13063-026-09739-8","url":null,"abstract":"<p><strong>Background: </strong>Youth (i.e., child and adolescent) mental health difficulties are a prevalent concern, with anxiety, depression, and disruptive behavior disorders being the most common presentations. Even though psychotherapy is often recommended to help youth and families manage mental health difficulties, recent meta-analyses suggest that youth psychotherapy is only moderately effective, highlighting a need for further improvement and innovation. Emotion dysregulation is a transdiagnostic risk factor across childhood emotional and behavioral disorders, yet despite the important connection between emotion regulation and psychopathology, little research has been conducted on emotion regulation as a potential mechanism of change during psychotherapy. This study will test the biobehavioral regulation of negative emotion as a transdiagnostic mechanism of change in youth psychotherapy using the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH). MATCH is a well-researched therapy program for youth that is suitable for testing transdiagnostic mechanisms of treatment response.</p><p><strong>Methods: </strong>This protocol describes a two-site randomized controlled trial that aims to recruit 202 youth between the ages of 8 to 15 years with anxiety, depression, and/or disruptive behavior. Participants are randomized to the MATCH intervention condition or a waitlist control condition. Youth and their parent(s) in both conditions complete in-lab assessments and online questionnaires at the start of the study, every 3 months (i.e., quarterly), and at post-test (i.e., following the intervention/waitlist period). Physiological measures of emotion regulation such as heart rate variability and skin conductance are acquired during lab-based tasks. Youth symptoms and emotion regulation are monitored weekly for both conditions. The primary outcome is change in youth symptoms of psychopathology at post-treatment, and whether this change is mediated by change in behavioral and physiological emotion regulation. Secondary outcomes include parental functioning, parenting, family functioning, impairment, and additional measures of youth psychopathology.</p><p><strong>Discussion: </strong>Findings from the study are expected to enhance the understanding of processes that drive therapeutic change, ultimately leading to better therapy personalization and effectiveness.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05637320. Prospectively registered on November 15, 2022. https://clinicaltrials.gov/study/NCT05637320.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges of delivering a lifestyle intervention before surgery in multiple surgical specialties in the NHS: experience from the INSPIRE trial.","authors":"Emma Bridgeman, Chloe Beard, Katherine Joyce, Denny Levett, Dawn Phillips, Maria Pufulete, Lucy Culliford","doi":"10.1186/s13063-026-09757-6","DOIUrl":"https://doi.org/10.1186/s13063-026-09757-6","url":null,"abstract":"<p><p>This paper describes the challenges of undertaking a trial of a pre-operative lifestyle intervention in multiple surgical specialties, the INSPIRE trial, and additional challenges of doing so during the COVID-19 pandemic. The INSPIRE trial was a randomised controlled trial to test if inspiratory muscle training could reduce the incidence of postoperative pulmonary complications in patients undergoing cardiac, thoracic and abdominal elective surgery. We present the challenges of trial conduct alongside the adaptations introduced to mitigate the impact of those challenges. The INSPIRE trial was halted by the funder at the end of the internal pilot phase. We were therefore unable to assess the effect of some of the adaptations, and there were further adaptations we were unable to make. We are using our experience to make recommendations for future similar trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tools to help patients and other stakeholders' input into choice of intercurrent event strategy for estimands in randomised trials.","authors":"Joanna Hindley, Charlotte Hartley, Jennifer Hellier, Kate Sturgeon, Sophie Greenwood, Ian Newsome, Katherine Barrett, Debs Smith, Tra My Pham, Dongquan Bi, Beatriz Goulao, Suzie Cro, Brennan C Kahan","doi":"10.1186/s13063-026-09767-4","DOIUrl":"https://doi.org/10.1186/s13063-026-09767-4","url":null,"abstract":"<p><strong>Background: </strong>Estimands can help to clarify the research questions being addressed in randomised trials. Because the choice of estimand can affect how relevant trial results are to patients and other stakeholders, such as clinicians or policymakers, it is important for them to be involved in these decisions. However, there are barriers to having these conversations. For instance, discussions around how intercurrent events (post-randomisation events which affect the interpretation or existence of the outcome) should be addressed in the estimand definition typically involve complex concepts as well as technical language. We aimed to provide tools that could facilitate conversations between researchers and patients and other stakeholders about the choice of intercurrent event strategy for estimands.</p><p><strong>Methods: </strong>We developed three tools: (i) a video explaining the concept of an estimand and the five different ways that intercurrent events can be incorporated into the estimand definition; (ii) an infographic outlining these five strategies; and (iii) an editable PowerPoint slide which can be completed with trial-specific details to facilitate conversations around choice of estimand for a particular trial. Each tool was produced through collaboration between researchers and public partners. This involved (i) an initial meeting between researchers and public partners to discuss the aims of the tool; (ii) a draft of the tool being prepared by the research team; (iii) public partners providing feedback; and (iv) the research team updating and finalising the tool.</p><p><strong>Results: </strong>These resources can help to start conversations between the trial team and patients and other stakeholders about the best choice of estimand and intercurrent event strategies for a randomised trial. The video and infographic-which explain estimands and intercurrent events with reference to imagined examples-can be sent to stakeholders in advance of a consultation, or presented in the meeting itself. It is important that a member of the trial team is available to answer questions or clarify concepts following this. The editable slide can be completed by the trial team with the specific details of their trial, and then shown to patients or other stakeholders during the meeting to facilitate discussion around which intercurrent event strategy is most relevant for the trial. An example of a completed editable slide is also provided for an example weight loss trial.</p><p><strong>Conclusions: </strong>We developed three tools to help researchers to have conversations with patients and other stakeholders about estimands, and how intercurrent events should be incorporated into the target estimand for a randomised trial. Further work to evaluate the tools in real-world settings across different stakeholder groups could help to validate the tools and reveal any further refinements necessary to improve their utility.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomised controlled trial of physical activity and cognitive training in older adults: the PhABHeaD study.","authors":"Nicolas Cherbuin, Joseph M Northey, Erin I Walsh, Richard A Burns, Hollie Speer, Nicholas Lawlis, Tergel Namsrai, Amanda Scott, Vicki McCarthy, Jo Lane, Jeroen J A van Boxtel, Amit Lampit, Anne Brüstle, Ben Rattray","doi":"10.1186/s13063-026-09681-9","DOIUrl":"https://doi.org/10.1186/s13063-026-09681-9","url":null,"abstract":"<p><strong>Background: </strong>Robust empirical evidence supports the effectiveness of physical and cognitive training in preventing and delaying cognitive decline. Emerging research suggests distinct neurobiological mechanisms underpin the effects of these different training modalities. An unresolved question is whether the mechanisms through which these training modalities impart their effect interact synergistically to improve cognitive outcomes, rather than exerting additive effects, differ. In addition, past research has been inconsistent in adequately controlling for or documenting the dosage of physical and/or cognitive training. Consequently, the aim of this study is to assess the relative effectiveness of physical and cognitive training conducted in isolation or concurrently, whilst rigorously controlling and documenting the treatment parameters.</p><p><strong>Methods: </strong>This study is a three-arm randomised controlled trial conducted over a 3-month period, comparing cognitive training, physical activity, and a combination of both interventions. Older cognitively healthy participants (n = 126) aged 60-75 years will be recruited from the community. The physical only training will require participants to cycle on a cycle ergometer at above 60% of their age-predicted heart rate maximum for 50 min with a 3-min warm-up and cool-down period. The cognitive only training will require participants to complete up to five different cognitive tasks selected from a set of eight on the BrainHQ platform during each 50-min training session. The concurrent cognitive and physical training will require participants to undertake both treatments at the same time. Primary outcomes, assessed pre- and post- intervention, will include speed of processing and episodic memory assessed with the NIH Toolbox, as well as general driving skills assessed on a driving simulator.</p><p><strong>Discussion: </strong>Findings will inform the design of interventions and population health advice aimed at mitigating cognitive decline. If a substantial synergetic effect is detected, it may lead to the use of more widespread concurrent physical and cognitive training and the potential development of methods to make concurrent training practical. Findings will also provide important clarification as to the relative benefit of the two modes of training.</p><p><strong>Trial registration: </strong>Prospective registration with Australia and New Zealand Clinical Trial Registry (ACTRN12624001088538) on 10th September 2024 and World Health Organisation International Clinical Trials Registry (U1111-1280-3851).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Existential distress in advanced cancer: study protocol of a pragmatic randomized controlled trial of a short-term psychodynamic therapy (ORPHYS) compared to usual psycho-oncological treatment (TAU).","authors":"Rebecca Philipp, Charlotte Walbaum, Carsten Bokemeyer, Ulrike Dinger, Martin Härter, Barbara Hemsen, Steffen Holsteg, André Karger, Uwe Koch, Levente Kriston, Susanne Lezius, Reinhard Lindner, Imad Maatouk, Karin Oechsle, Isabelle Scholl, Anna Wagner, Sigrun Vehling","doi":"10.1186/s13063-026-09744-x","DOIUrl":"10.1186/s13063-026-09744-x","url":null,"abstract":"<p><strong>Background: </strong>As improvements in anti-cancer treatments have extended survival, patients with advanced cancer and their family caregivers face existential tension between engaging in life and coping with uncertainty about illness trajectory and the course of treatment. For a subgroup, this tension is associated with overwhelming fear and existential distress. Such adjustment difficulties may increase the risk of mental disorders, poor quality of life, and suicidality, and impair prognostic awareness and patient-clinician communication. Despite growing interest in open conversations about end-of-life issues, systematic evidence on effective psychotherapies to best support psychological adaptation in patients with high levels of existential distress is still scarce. We aim to evaluate the effectiveness of a short-term psychodynamic therapy (ORPHYS) to mitigate existential distress compared to usual psycho-oncological treatment (TAU).</p><p><strong>Methods: </strong>We conduct a two-arm parallel randomized controlled trial with an active control group. ORPHYS is a manualized individual face-to-face psychotherapy focusing on emotional and relational conflicts specific to cancer patients' illness situation. Treatment lasts between 5 and 11 months with 15 to 31 weekly sessions (50 min). TAU includes at least one individual session provided by physicians or psychologists with experience in psycho-oncological care. Patients will be assessed pre-intervention and 3, 6, 9, and 12 months after baseline. Target sample size is 160 randomized participants. We recruit patients with stage III/IV solid tumors or advanced hematological cancer and clinically significant existential distress from psycho-oncology clinics and referring oncologists at Hamburg, Düsseldorf, and Würzburg Comprehensive Cancer Centers, Germany. The primary outcome is demoralization (Demoralization Scale-II). Secondary outcomes include diagnoses of affective, anxiety and stress-related disorders, death anxiety, dignity-related distress, and quality of life. Outcome assessments are conducted via self-report questionnaires and diagnostic interviews. Linear mixed models examine outcome differences between trial arms. A confirmatory test of the group contrast at 6-month follow-up after baseline is conducted.</p><p><strong>Discussion: </strong>Due to an aging population and prolonged survival, there is a growing demand to help patients deal with existential challenges undergoing palliative cancer care. The study will contribute to knowledge about how clinicians can best help patients with advanced cancer who substantially struggle with uncertainty at the end of life.</p><p><strong>Trial registration: </strong>German Clinical Trials Registry, DRKS00038173. Registered October 20th, 2025, https://drks.de/search/en/trial/DRKS00038173 .</p><p><strong>Clinicaltrials: </strong>gov, NCT07312760. Registered December 30, 2025, https://clinicaltrials.gov/study/NCT07312760 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13151140/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reperfusion thrombolytic therapy for ischemic stroke in patients on non-vitamin K antagonist oral anticoagulants: study protocol of a phase II randomized clinical trial.","authors":"Bartosz Karaszewski, Bartosz Jabłoński, Dariusz Gąsecki, Sebastian Szczyrba, Adam Wyszomirski","doi":"10.1186/s13063-026-09699-z","DOIUrl":"https://doi.org/10.1186/s13063-026-09699-z","url":null,"abstract":"<p><strong>Background: </strong>Cardioembolic stroke accounts for more than 20% of all acute ischemic strokes (AIS) and is mainly caused by cardiac arrhythmias, particularly atrial fibrillation (AF). The presence of specific or multiple additional vascular risk factors indicates the need for oral anticoagulant (OAC) therapy in AF patients (according to the CHA2DS2-VASc classification). While OAC treatment significantly reduces the risk of AIS by over 80% in this population, the risk remains higher compared to the general population. Approximately half of AF patients on OAC therapy who experience AIS do not meet the criteria for thrombolytic (high blood activity of OAC) or mechanical thrombectomy (non-large vessel occlusion stroke) treatment.</p><p><strong>Aim: </strong>This study aims to assess the efficacy and safety of recombinant tissue plasminogen activator (rtPA) in AIS patients who have been on chronic non-vitamin K antagonist oral anticoagulant (DOAC) therapy after receiving a specific reversal agent.</p><p><strong>Methods and design: </strong>Patients with acute ischemic stroke (AIS) who are treated with specific oral anticoagulants (OACs) with anti-Xa activity have been on chronic non-vitamin K antagonist oral anticoagulant e included in the study. The protocol involves administering a fast-acting antidote (andexanet alfa for rivaroxaban or apixaban) or a placebo, followed by intravenous thrombolytic therapy with rtPA or a placebo. The study arms for rivaroxaban and apixaban are designed as prospective, randomized, placebo-controlled interventional trials that meet phase II trial criteria.</p><p><strong>Discussion: </strong>The STRoke on Oral AntiCoagulants for Thrombolysis (STROACT) trial is, to our knowledge, the first randomized phase II study designed to explore the feasibility, efficacy, and safety of reversal-enabled intravenous thrombolysis in a highly selected population of acute ischemic stroke patients on factor Xa inhibitors. The results are expected to be hypothesis-generating and may inform the design of future confirmatory trials.</p><p><strong>Trial registration: </strong>www.clinicaltrialsregister.eu; EudraCT Nr: 2020-004898-41; March 31, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The REACT MCI study: a randomized controlled clinical trial on the effect of repeated advanced cognitive training in mild cognitive impairment.","authors":"S S Hernes, P R Nordnes, H R Hol, G Ringstad, A B Knapskog, P Emhjellen, G Løhaugen, M Emini, T H Edwin","doi":"10.1186/s13063-026-09711-6","DOIUrl":"https://doi.org/10.1186/s13063-026-09711-6","url":null,"abstract":"<p><strong>Background: </strong>Mild cognitive impairment (MCI) and its course have multiple determining factors with both detrimental and compensatory processes in the brain. Computerized working memory training can improve cognitive function and individuals with MCI are potential targets. Since more than 1/3 of these individuals develop dementia within 5 years, any intervention postponing the progression will be immensely important. We aim to investigate the efficiency and cost-effectiveness of working memory training in MCI.</p><p><strong>Methods: </strong>In this blinded randomized controlled trial, 213 participants will be allocated to three groups: (1) one 5-week period of working memory training, (2) two 5-week periods of working memory training, or (3) the active control group. The participants are followed for a period of 48 months (3, 6, 12, 24, and 48 months). Furthermore, we investigate microstructural effects of working memory training on magnetic resonance imaging and seek to identify high responders to training by assessing the association with function in the glymphatic system and genetic variations. Finally, the impact of working memory training on quality of life and relatives' stress, and whether it is a cost-effective approach in MCI, will be assessed.</p><p><strong>Discussion: </strong>Effective therapy for MCI is lacking. Finding an intervention postponing the progression of MCI is of great importance for patients as well as for the global economy and health care.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04792528. Registered on 02.23.2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147842444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of the gut microbiome on health impacts of Haskap berries: study protocol for a randomized control trial.","authors":"Morgan L Chamberlin, Meghan L Spears, Gwendolyn Cooper, Zachariah J Miller, Brian Bothner, Seth T Walk, Carl J Yeoman, Mary P Miles","doi":"10.1186/s13063-026-09759-4","DOIUrl":"https://doi.org/10.1186/s13063-026-09759-4","url":null,"abstract":"<p><strong>Background: </strong>Haskap berries have great potential as a superfood due to high polyphenolic content which confers both anti-inflammatory and antioxidant activity. These health impacts are mitigated, at least in part, by the gut microbiome as most ingested polyphenols pass to the large intestine for microbial enzymatic action and conversion to secondary phenolic metabolites. These microbial actions mediate both the bioavailability and the bioefficacy of Haskap-derived phenolics. However, clinical intervention trials characterizing the impact of long-term Haskap consumption on human health and the interaction between Haskap-derived phenolics and the gut microbiome are limited. This study aims to determine the impact of Haskap consumption on gut microbiome composition, gut microbial and serum metabolites, and other health outcome metrics in a cohort of adults with both low and high risk of metabolic syndrome.</p><p><strong>Methods: </strong>This is a four-armed, randomized, triple-blind, placebo-controlled clinical trial conducted in a cohort of adults with both low and high risk of metabolic syndrome. A total of 120 participants (60 metabolically healthy, 60 metabolically unhealthy) will be randomized in a 1:1 ratio to consume a daily dose of either Haskap or placebo juice for 8 weeks. Outcome measures will be collected before and after the intervention period to determine the health impacts of Haskap in both groups. Primary outcome measures include fasting blood markers of glucose and lipid metabolism and inflammation, fat oxidation rates during submaximal exercise, 16S rRNA fecal microbial composition data, and mass spectrometry-acquired fecal and serum metabolomic data. Secondary outcome measures include anthropometric and sleep quality measures as well as acute and habitual dietary intake data.</p><p><strong>Discussion: </strong>Investigating how the gut microbiome influences the health benefits of consuming Haskap berries will help elucidate potential mechanisms of Haskap-induced metabolic health benefits and help inform the development of effective strategies to decrease metabolic disease risk through Haskap consumption.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06546020. Registered on 1 August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1.","authors":"Sebastian Wallon, Caroline Williamsson, Victor Karlsson, Johanna Wennerblom, Svein-Olav Bratlie, Per Sandström, Bobby Tingstedt, Bergthor Björnsson","doi":"10.1186/s13063-026-09762-9","DOIUrl":"https://doi.org/10.1186/s13063-026-09762-9","url":null,"abstract":"<p><strong>Background: </strong>Routine use of surgical drains after abdominal operations has largely been abandoned over the past decades. Studies have failed to demonstrate benefits of routine drainage following liver, gallbladder, gastric, and colorectal surgeries. Until recently, intraoperative placement of abdominal drains was the gold standard in pancreatoduodenectomies (PDs) due to concerns about uncontrolled postoperative pancreatic fistula (POPF). A large randomized trial in 2014 reported increased mortality in patients without postoperative drain placement. However, as the study did not stratify participants based on their preoperative risk of developing a POPF, further research is needed. Limited evidence from a non-randomized cohort suggests that omitting drains may be safe in very low-risk settings. However, a larger comparative study, including a broader range of PD cases, is necessary to confirm these findings.</p><p><strong>Methods: </strong>This is a two-arm, randomized, controlled, non-blinded, multicenter trial comparing intra-abdominal drain placement with no drain placement during planned pancreatoduodenectomies (PDs). Eligible patients who meet the inclusion criteria will be assessed for their individual risk of postoperative pancreatic fistula (POPF) using a risk scoring system. They will then be randomized into either the drain placement or no drain placement group. The groups will be compared using the chi-square test for categorical variables and Fisher's exact test. Logistic regression models will be used to calculate odds ratios for morbidity. Univariable and multivariable models will assess the impact of drain placement on clinical outcomes.</p><p><strong>Discussion: </strong>This trial aims to determine whether omitting routine intraoperative drain placement reduces the risk of complications in patients undergoing pancreatoduodenectomy (PD). It will provide level 1 evidence on the association between routine intra-abdominal drainage and postoperative complications in patients with a low to intermediate risk of developing a postoperative pancreatic fistula (POPF). The findings will contribute to future treatment guidelines by expanding the available knowledge on optimal drainage strategies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT05270564. Registered on February 16 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13147858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}