Negative / Null Result ReportOpen accessMedicine
Herbert S. B. Baraf, Puja Khanna, Alan Kivitz et al. · 2023 · Lara D. Veeken
OBJECTIVES: Serum urate (SU) lowering with PEGylated uricases in gout can reduce flares and tophi. However, treatment-emergent anti-drug antibodies adversely affect safety and efficacy and the currently approved PEGylated uricase…
View details →DOI: 10.1093/rheumatology/kead333Cited by 21 Negative / Null Result ReportOpen accessMedicine
Mohan Li, Yuelun Zhang, Lijian Pei et al. · 2022 · Frontiers in Oncology
Background Effects of anesthetic interventions on cancer prognosis remain controversial. There is evidence that estrogen receptor (ER)-negative breast cancer patients have an early recurrence peak. We aimed to assess the potential benefit of regional anesthesia-analgesia versus general anesthesia regarding early recurrence in breast cancer according to ER expression. Methods Based on a multicenter randomized controlled trial (clinicaltrials.gov, NCT00418457), we included all the patients from Peking Union Medical College Hospital research center in this study. The primary outcome was breast ca
View details →DOI: 10.3389/fonc.2022.837959Cited by 20 Negative / Null Result Report
Mohammed Al-Asadi, Michelle Sherren, Hassaan Abdel Khalik et al. · 2024 · The American Journal of Sports Medicine
Background: Evidence-based care relies on robust research. The fragility index (FI) is used to assess the robustness of statistically significant findings in randomized controlled trials (RCTs). While the traditional FI is limited to…
View details →DOI: 10.1177/03635465231202522Cited by 19 Negative / Null Result Report
Travis J. Matics, Nadia Khan, Priti Jani et al. · 2019 · Pediatric Critical Care Medicine
Objectives: The Fragility Index measures the number of events on which the statistical significance of a result depends and has been suggested as an adjunct statistical assessment for interpretation of trial results. This study aimed to…
View details →DOI: 10.1097/pcc.0000000000001922Cited by 19 Negative / Null Result ReportOpen accessMedicine
Sarah S. Mougalian, Ronda Copher, Jonathan Kish et al. · 2018 · Cancer Medicine
INTRODUCTION: Real-world data are critical to demonstrate the consistency of evidence and external generalizability of randomized controlled trials (RCTs). This study examined characteristics and outcomes of metastatic triple-negative breast cancer (mTNBC) patients treated with eribulin mesylate at community oncology practices in the United States. METHODS: Physicians identified mTNBC patients initiating eribulin between 1 January 2011 and 1 January 2014 and abstracted data into an electronic case report form (eCRF). Eribulin treatment in the metastatic setting was categorized as early use (EU
View details →DOI: 10.1002/cam4.1705Cited by 19 Negative / Null Result ReportOpen accessNursing
Paul Montgomery, Thees F. Spreckelsen, Alice Burton et al. · 2018 · PLoS ONE
BACKGROUND: Omega-3 fatty acids are central to brain-development of children. Evidence from clinical trials and systematic reviews demonstrates the potential of long-chain Omega-3 supplementation for learning and behavior. However, findings are inconclusive and in need of robust replication studies since such work is lacking. OBJECTIVES: Replication of the 2012 DOLAB 1 study findings that a dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) had beneficial effects on the reading, working memory, and behavior of healthy schoolchildren. DESIGN: Parallel group, fixed-do
View details →DOI: 10.1371/journal.pone.0192909Cited by 17 Negative / Null Result ReportOpen accessMedicine
Tarek Mohamed Ashoor, Ahmad Mahmoud Hasseb, Ibrahim M. Esmat · 2020 · Korean journal of anesthesiology
Background: Nebulized heparin has been effectively used in the management of many pulmonary diseases. However, its effect on mechanically ventilated patients with acute exacerbation chronic obstructive pulmonary disease (AECOPD) has never…
View details →DOI: 10.4097/kja.19418Cited by 17 Negative / Null Result ReportOpen accessMedicine
Junichi Kitagawa, Ryo Kobayashi, Yasuyuki Nagata et al. · 2020 · International Journal of Cancer
Oral mucositis is a common and distressing complication in patients receiving high-dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT). We reported previously in a single-center retrospective analysis that…
View details →DOI: 10.1002/ijc.33316Cited by 15 Negative / Null Result Report
Heather M. Wasser, Amanda L. Thompson, Chirayath M. Suchindran et al. · 2020 · BMC Pediatrics
Abstract Background Non-Hispanic black (NHB) infants are twice as likely as non-Hispanic white infants to experience rapid weight gain in the first 6 months, yet few trials have targeted this population. The current study tests the…
View details →DOI: 10.1186/s12887-020-02273-9Cited by 15 Negative / Null Result ReportMedicine
Geri R. Donenberg, Jessica Fitts, Charles Ingabire et al. · 2022 · JAIDS Journal of Acquired Immune Deficiency Syndromes
Background: Adolescents living with HIV have elevated mental distress and suboptimal antiretroviral therapy (ART) adherence. Setting: Two urban clinics in Kigali, Rwanda. Methods: A 2-arm individual randomized controlled trial compared…
View details →DOI: 10.1097/qai.0000000000002911Cited by 15 Negative / Null Result ReportOpen accessPsychology
Yvonne Stikkelbroek, Gerko Vink, Maaike H. Nauta et al. · 2020 · Scientific Reports
We examined if manualized cognitive behavioral therapy (CBT) was more effective than Treatment As Usual (TAU) for clinically depressed adolescents within routine care. This multisite Randomized controlled trail included 88 clinically depressed adolescents (aged 12-21 years) randomly assigned to CBT or TAU. Multiple assessments (pre-, post treatment and six-month follow-up) were done using semi-structured interviews, questionnaires and ratings and multiple informants. The primary outcome was depressive or dysthymic disorder based on the KSADS. Completers, CBT (n = 19) and TAU (n = 26), showed a
View details →DOI: 10.1038/s41598-020-71160-1Cited by 14 Negative / Null Result Report
Martin S. Davey, Eoghan T. Hurley, Tom R. Doyle et al. · 2022 · The American Journal of Sports Medicine
Background: Debate centering on the management of anterior shoulder instability (ASI) in recent years has led to many randomized controlled trials (RCTs) being published on the topic. The fragility index (FI) has subsequently emerged as a…
View details →DOI: 10.1177/03635465221077268Cited by 13 Negative / Null Result ReportOpen accessSocial Sciences
Kate Ambler, Kelly Jones, Michael O’Sullivan · 2025 · Journal of Development Economics
We conduct a randomized controlled trial to test a novel intervention for increasing women’s empowerment in Uganda. The intervention includes a within-household transfer of a productive asset, which has a lower cost than an external…
View details →DOI: 10.1016/j.jdeveco.2025.103575Cited by 13 Negative / Null Result ReportOpen accessMedicine
Ryota Nishio, Tomotaka Dohi, Miho Yokoyama et al. · 2025 · JMIR mhealth and uhealth
Background: Cardiac rehabilitation (CR) is effective in preventing cardiovascular diseases; however, participation in CR programs remains limited due to the associated challenges. The integration of wearable devices and real-time monitoring offers a potential solution to enhance adherence to remote CR programs and their outcomes. Objective: This study aimed to evaluate the efficacy of a remote CR program using wearable devices and real-time monitoring with or without online coaching (OLC) in improving exercise capacity in patients with coronary artery disease (CAD). Methods: We enrolled 50 pat
View details →DOI: 10.2196/63797Cited by 13 Negative / Null Result ReportOpen accessPsychology
Amy D. Herschell, David J. Kolko, Ashley T. Scudder et al. · 2021 · Journal of Clinical Child & Adolescent Psychology
OBJECTIVE: This study (NIMH RO1 MH095750; ClinicalTrials.gov Identifier: NCT02543359) evaluated the effectiveness of three training models to implement a well-established evidence-based treatment, Parent-Child Interaction Therapy (PCIT).…
View details →DOI: 10.1080/15374416.2021.2001745Cited by 13 Replication FailureOpen accessMedicine
Lisa H. Glynn, E Moloney, Stephen Lane et al. · 2025 · JMIR mhealth and uhealth
BACKGROUND: Chronic obstructive pulmonary disease (COPD) negatively impacts clinical health outcomes, resulting in frequent exacerbations, increased hospitalizations, reduced physical activity, deteriorated quality of life, and diminished self-efficacy. Previous studies demonstrated that a self-management program tailored for adults with COPD improves self-management decisions, resulting in a positive effect on clinical health outcomes. Limitations of these studies include issues regarding heterogeneity among interventions used, patient population characteristics, outcome measures, and longitu
View details →DOI: 10.2196/56318Cited by 11 Negative / Null Result ReportOpen accessImmunology and Microbiology
Shih-Hong Chen, Wing-Sum Chan, Chih‐Min Liu et al. · 2020 · Annals of Intensive Care
Abstract Background Endotoxins can induce an excessive inflammatory response and result in microcirculatory dysfunction. Polymyxin-B hemoperfusion (PMX-HP) has been recognized to effectively remove endotoxins in patients with sepsis and…
View details →DOI: 10.1186/s13613-020-00699-zCited by 10 Replication FailureOpen accessImmunology and Microbiology
Caroline Thng, Sharareh Eskandari, Fengyi Jin et al. · 2026 · npj Vaccines
Neisseria gonorrhoeae (NG) causes significant morbidity globally, and no licensed vaccine currently exists. Observational studies suggest the four-component meningococcal B (4CMenB) vaccine may provide cross-protection against NG. We conducted MenGO, an open-label, randomized controlled trial to evaluate the efficacy, safety, and immunogenicity of 4CMenB against NG in gay and bisexual men (GBM). Participants were randomized 1:1 to receive two doses of 4CMenB, or no vaccine, and were followed for 2 years with 3-monthly visits. 4CMenB vaccination did not significantly reduce gonorrhoea incidence
View details →DOI: 10.1038/s41541-026-01422-yCited by 10 Negative / Null Result ReportMedicine
Andrew Goudie, Douglas H.J. Elder, Harshal Deshmukh et al. · 2014 · European Journal of Heart Failure
BACKGROUND: The use of oral anticoagulation in patients with heart failure in sinus rhythm remains controversial as previous large randomized controlled trials (RCTs) have not shown a survival benefit. However, heterogeneity exists among…
View details →DOI: 10.1002/ejhf.199Cited by 10 Negative / Null Result ReportOpen accessMedicine
Jack W. O’Sullivan, Anil Palepu, Khaled Saab et al. · 2026 · Nature Medicine
The scarcity of subspecialist medical expertise poses a considerable challenge for healthcare delivery. This issue is particularly acute in cardiology, where timely, accurate management determines outcomes. We explored the potential of Articulate Medical Intelligence Explorer (AMIE), a large language model-based experimental medical artificial intelligence system, to augment clinical decision-making in this challenging context. We conducted a randomized controlled trial comparing large language model-assisted care with the usual care of complex patients suspected of having a genetic cardiomyop
View details →DOI: 10.1038/s41591-025-04190-9Cited by 10 Negative / Null Result ReportOpen accessMedicine
Mahima Chillakanti, Elaine Young, April Hopcroft et al. · 2024 · touchREVIEWS in Endocrinology
AID systems can achieve near-desired glycaemic targets with minimal hypoglycaemia in pregnant women with T1D. Randomized controlled trials are needed to confirm these findings and to win FDA indications in pregnancy.
View details →DOI: 10.17925/ee.2024.20.2.14Cited by 10 Negative / Null Result ReportOpen accessMedicine
Geri R. Donenberg, Jessica Fitts, Charles Ingabire et al. · 2022 · PubMed
BACKGROUND: Adolescents living with HIV have elevated mental distress and suboptimal antiretroviral therapy (ART) adherence. SETTING: Two urban clinics in Kigali, Rwanda. METHODS: A 2-arm individual randomized controlled trial compared…
View details →DOI: 10.1097/qai.0000000000002911Cited by 10 Negative / Null Result Report
Wei Tang, Yuwei Qiu, Huijie Lu et al. · 2021 · Frontiers in Surgery
Study Objective: This study aimed to investigate whether stroke volume variation (SVV)-guided goal-directed therapy (GDT) can improve postoperative outcomes in elderly patients undergoing minimally invasive esophagectomy (MIE) compared…
View details →DOI: 10.3389/fsurg.2021.794272Cited by 9 Replication FailureOpen accessMedicine
Lizl Veldsman, GA Richards, D. G. Nel et al. · 2025 · Journal of Parenteral and Enteral Nutrition
BACKGROUND: Muscle wasting is a hallmark of critical illness. We evaluated the effect of amino acid supplementation and mobilization on early muscle loss in critically ill patients. METHODS: We conducted a randomized parallel-group trial…
View details →DOI: 10.1002/jpen.70041Cited by 9 Replication FailureMedicine
Jason Smith, Rebecca Cardigan, Emily Sanderson et al. · 2026 · New England Journal of Medicine
BACKGROUND: Whole-blood transfusion has recently gained favor in the management of severe hemorrhage; however, data from large clinical trials evaluating its clinical effectiveness and safety are lacking. METHODS: We conducted a pragmatic,…
View details →DOI: 10.1056/nejmoa2516043Cited by 9 Negative / Null Result ReportOpen accessMathematics
Ezequiel Mauro, Tiago de Castro, Marcus Zeitlhoefler et al. · 2025 · Journal of Hepatology
BACKGROUND & AIMS: Non-proportional hazards (NPH) can lead to discrepancies between interim (IA) and final analyses (FA) in randomized controlled trials (RCTs) of hepatocellular carcinoma (HCC). We assessed the impact of NPH in pivotal HCC…
View details →DOI: 10.1016/j.jhep.2025.08.042Cited by 9 Replication FailureOpen accessSocial Sciences
Cristina Expósito-Álvarez, Manuel Roldán-Pardo, Gail Gilchrist et al. · 2024 · Psychosocial Intervention
Objective: Intimate partner violence (IPV) perpetrators with alcohol and/or other drug use problems (ADUPs) have been identified as one of the main high-risk and highly resistant groups of perpetrators requiring special attention in…
View details →DOI: 10.5093/pi2024a13Cited by 9 Negative / Null Result ReportOpen accessComputer Science
Michael Vaccaro, Mikayla Friday, Arash E. Zaghi · 2025 · Applied Sciences
Multi-agent large language models promise flexible, modular architectures for delivering personalized educational content. Drawing on a pilot randomized controlled trial with middle school students (n = 23), we introduce a two-agent GPT-4 framework in which a Profiler agent infers learner-specific preferences and a Rewrite agent dynamically adapts science passages via an explicit message-passing protocol. We implement structured system and user prompts as inter-agent communication schemas to enable real-time content adaptation. The results of an ordinal logistic regression analysis hinted that
View details →DOI: 10.3390/app15137579Cited by 9 Replication FailureOpen accessMedicine
Jennifer Duffecy, Arfa Rehman, Scott Gorman et al. · 2025 · JMIR mhealth and uhealth
Unlabelled: Background: Perimenopausal and menopausal symptoms affect many women's well-being and quality of life. Digital technologies, especially smartphones, allow self-management interventions for menopausal symptoms, but they are understudied., Objective: We evaluated whether a novel digital care app, Caria, effectively reduced vasomotor and behavioral health symptoms of menopause., Methods: We enrolled 149 women for a 6-week randomized controlled trial (app treatment: n=112; web-based educational control: n=37). Enrolled participants had problematic vasomotor symptoms and at least one el
View details →DOI: 10.2196/58204Cited by 9 Negative / Null Result ReportOpen accessPsychology
Pim Cuijpers, Mathias Harrer, Clara Miguel et al. · 2026 · Journal of Affective Disorders
It is not yet clear whether baseline severity is associated with the effects of psychotherapies. We examined baseline severity at the study level in a large sample of randomized controlled trials comparing psychotherapies against a control condition for the treatment of depression. We used an existing large database of randomized trials comparing psychotherapies for depression with control groups ( www.metapsy.org ). We converted baseline severity scores across different depression measures into a common metric. We ran bivariable and multivariable meta-regression analyses to examine the associ
View details →DOI: 10.1016/j.jad.2025.121106Cited by 9 