Clinical Trials
Category Added in a WPeMatico Campaign
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Phase Ib, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered mosunetuzumab in participants with systemic lupus erythematosus
CONCLUSIONS: Mosunetuzumab demonstrated dose-dependent peripheral B-cell depletion and a safety profile consistent with prior studies in follicular lymphoma. Based on these data, mosunetuzumab is currently being evaluated in a phase II study in severe SLE (NCT07598396).
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Trauma-focused therapy integrated with cognitive behavioural therapy for psychosis for people with post-traumatic stress disorder and psychosis (the STAR trial): a multicentre, pragmatic, randomised trial in the UK
BACKGROUND: People with psychosis have high rates of post-traumatic stress disorder (PTSD), which is associated with a poor prognosis. We aimed to investigate the effectiveness of a trauma-focused therapy integrated with cognitive behavioural therapy for psychosis (CBTp) in people with psychosis.
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Safety and efficacy of levacetylleucine in ataxia-telangiectasia: a phase 3, randomised, double-blind, placebo-controlled crossover trial
BACKGROUND: Ataxia-telangiectasia is a rare, autosomal recessive neurodegenerative disorder. Levacetylleucine (N-acetyl-L-leucine) has been shown to be efficacious for the treatment of neurological manifestations and to have a disease-modifying effect in lysosomal storage disorders such as Niemann-Pick disease type C. We aimed to assess the safety and efficacy of levacetylleucine for paediatric and adult patients with…
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Phase II Study of Adavosertib in Patients With Tumors Containing BRCA1 and BRCA2 Mutations: Results From the NCI-MATCH ECOG-ACRIN Cancer Research Group (EAY131) Subprotocol Z1I
CONCLUSION: In heavily pretreated, advanced solid tumor patients with PV in BRCA1/2, adavosertib treatment resulted in low ORR, and this trial did not meet the primary end point.
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Early vs Late Initiation of Extracorporeal Membrane Oxygenation: Protocol for a Prospective, Randomized, Multicenter Study
CONCLUSIONS: The ELIEO trial will provide robust evidence regarding the optimal timing of vvECMO initiation in patients with severe ARDS. The findings may influence clinical decision-making, resource allocation, and organizational strategies for the management of ARDS in specialized intensive care settings.
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Identifying MicroRNA Biomarkers in Idiopathic Intracranial Hypertension: A Pilot Study
BACKGROUND AND OBJECTIVES: Idiopathic intracranial hypertension (IIH) is characterized by raised intracranial pressure (ICP). It predominantly affects women with obesity and can cause disabling headaches and permanent visual loss. IIH is misdiagnosed in up to 40% of cases. Diagnosis and monitoring often rely on frequent invasive lumbar puncture. This pilot study aimed to identify serum…
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Integrating Metronomic Therapy With Standard Chemotherapy in Advanced Unresectable Head and Neck Cancer: A Randomized Trial Addressing Global Cancer Care Equity (METRO PLUS)
CONCLUSION: In platinum-sensitive advanced HNSCC, the addition of triple OMCT to PC significantly improved OS and PFS with acceptable toxicity. PC + OMCT represents a feasible and cost-conscious first-line option in resource-constrained settings.
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CT Perfusion Blood Flow Provides an Early Response Marker for Progression-free Survival in a Prospective Randomized Clinical Trial of Metastatic Renal Cell Carcinoma
IntroductionThere is currently no biomarker for progression-free survival (PFS) for patients undergoing treatment for metastatic renal cell carcinoma (RCC). The aim of our study was to evaluate computed tomography perfusion (CTp) blood flow as an early marker of PFS in patients with mRCC treated with targeted agents.MethodsAssociations between CTp blood flow and PFS were evaluated…
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A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol
BACKGROUND: Despite significant advancements in obstetric care, the incidence of preeclampsia remains a substantial public health challenge, and effective strategies to prevent the disease progression remain limited, particularly in low-resource settings. N-acetylcysteine (NAC), an antioxidant and glutathione precursor, has demonstrated anti-inflammatory and vasodilatory effects, making it a promising candidate for repurposing. However, robust evidence from…
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A Single Session of Slackline Training Induces Rapid, Task-Specific Balance Improvements and Elevated Resting-State Beta Band Power
Balance training underpins both sports performance and rehabilitation, while its efficacy depends on the amount of training and task difficulty. Here, we characterized neurophysiological changes accompanying the earliest phase of slackline-specific balance acquisition within a closely matched active-control design. For this purpose, 35 healthy, slackline-naïve adults were randomized to a slackline intervention or a time-matched…