Clinical Trials
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Clinical efficacy evaluation and economic analysis of regulating-yinyang moxibustion therapy for primary dysmenorrhea of cold induced blood stasis: a randomized controlled trial
CONCLUSION: Regulating-yinyang moxibustion therapy effectively alleviates pain and TCM syndromes in patients with PD of cold induced blood stasis, which may be related to the decrease of the contents of NGF and PGF2α in serum. This therapy shows its advantages in terms of health economics compared with the conventional gentle moxibustion therapy.
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Effect of pasteurized Akkermansia muciniphila MucT on insulin sensitivity, body composition, and GLP-1 production in subjects with metabolic syndrome: impact of low baseline gut Akkermansia levels
Pasteurized Akkermansia muciniphila MucT was found to improve barrier function in preclinical models and a proof-of-concept study in obese and prediabetic adults. Here, we describe the results of a double-blind placebo-controlled multicenter (Ireland and Germany) trial in 142 adults with metabolic syndrome, with or without prediabetes. The primary endpoint of whole-body insulin sensitivity (Matsuda index)…
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Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study
CONCLUSION: The safety profile of upadacitinib remained consistent with previous analyses, with no new safety concerns through 7 years. Upadacitinib and adalimumab (continuous or rescue treatment) maintained disease activity targets throughout the 7-year treatment period. Upadacitinib exhibited an acceptable benefit-risk profile for long-term RA treatment.
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Effect of a patient-driven perioperative intervention on health literacy: A stepped-wedge cluster randomised sub-study
We hypothesised that a patient-driven safety checklist would enhance patients’ health literacy. This study was conducted as a sub-study of a multicentre cluster trial with a stepped wedge design. Data were collected between March 2022 and February 2024. Healthcare personnel were partially blinded to group allocation and fully blinded to the health literacy questionnaire outcome.…
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Exploratory Clinical Trial of Honghua Xiaoyao Pills for the Treatment of Liver Depression and Haemostasis-Type Hyperplasia of Mammary Glands: A Single-Centre, Single-Arm Study
CONCLUSION: Honghua Xiaoyao pills are effective in reducing breast pain, shrinking breast masses and improving lower abdominal distension, breast distension, menstrual blood clots, chest tightness/discomfort and emotional symptoms in patients with liver depression and haemostasis-type HMG.
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Asciminib Provides Better Efficacy and Favorable Safety and Tolerability Against Investigator-Selected Tyrosine Kinase Inhibitors in East Asian Patients With Newly Diagnosed Chronic Myeloid Leukemia: Results From a Subgroup Analysis of the Pivotal ASC4FIRST Study
ASC4FIRST (ClinicalTrials.gov NCT04971226) is a pivotal phase 3 clinical trial comparing the efficacy and safety of asciminib vs. standard of care (SoC) tyrosine kinase inhibitors (TKIs) in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP). The study demonstrated superior efficacy and a favorable safety profile for asciminib vs. all current SoC TKIs;…
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Postoperative anlotinib plus radiotherapy in patients with newly diagnosed, unmethylated O6-methylguanine-DNA methyltransferase glioblastoma: A single-arm, phase 2 study
CONCLUSIONS: Postoperative anlotinib plus radiotherapy demonstrated clinically meaningful activity with a manageable safety profile in patients with unmethylated MGMT glioblastoma (Chinese Clinical Trials Registry identifier: ChiCTR2000040116).
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Mitigation of COVID-19 through onsite testing and education among formerly incarcerated individuals (the MOSAIC study): an open-label, single-centre, randomised controlled trial
BACKGROUND: Criminal legal system-involved individuals face barriers to care after release from carceral settings. Elevated SARS-CoV-2 risk while incarcerated, together with living in congregate settings post-incarceration, increase the risk of respiratory viral infection transmission. This study evaluated a community health worker-led point-of-care SARS-CoV-2 testing and education intervention in a re-entry-focused community-based organisation compared with standard…
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Do probiotics modulate dietary intake? Pilot data from a randomized controlled sub-study of the ProBioHRV clinical trial in patients with depression and healthy controls
CONCLUSION: Probiotic supplementation did not produce consistent changes in nutrient intake but showed exploratory, time- and group-dependent patterns for selected measures, including vitamin D intake and dietary variety and diversity. Given the pilot nature of the study, these findings are descriptive and hypothesis- generating. Larger, well-powered studies with objective nutritional and microbiome measures are required.
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Improving the field accuracy of a malaria diagnostic algorithm combining sequential interpretation of rapid diagnostic test detecting PfHRP2 and pLDH in febrile children in a seasonal hyperendemic malaria transmission area in Burkina Faso
CONCLUSIONS: The sequential diagnostic approach improves the diagnosis of malaria in a real world setting, compared to the use of PfHRP2-(only) based RDT. However, relying only on history of antimalarial treatment in undetermined cases may decrease algorithm’s sensitivity, which could result in missing active or recurrent malaria infections.